Tuesday report

Federal employment benefits

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a DataSpring news release,
    • “The Provider Data Collective, convened by DataSpring, powered by CAQH, today announced a new standard to improve the measurement of provider directory data quality for individual clinicians. It is the first solution from the industry-led coalition bringing together health plans, a health professional organization and an accreditation body to tackle challenges no organization can solve alone. The Collective’s mission is to improve the accuracy and reliability of provider information — clinician data that underpins directories, network operations and other essential health care workflows — so patients, clinicians and health plans can rely on information they trust.
    • Founding organizations of the Collective include Aetna, the American Medical Association, Centene, The Cigna Group, DataSpring, Elevance Health, Horizon Healthcare Services, Inc., Humana, the National Committee for Quality Assurance (NCQA) and UnitedHealthcare. * * *
    • “Inaccurate provider data can create real barriers across healthcare. Patients struggle to confirm whether a clinician is in-network, providers face delays joining networks and seeing patients, and care teams often lack the reliable information needed to coordinate care,” said Tim Kaja, executive vice president of UnitedHealth Group Enterprise Services and board chair of DataSpring. “While CMS established a method to measure provider data accuracy, inconsistent application made it difficult to establish a common baseline for improvement of provider data quality across the industry. The Collective aligned the industry around a shared framework — a more consistent way to measure data quality, identify gaps and track progress.”
    • “The data quality measurement standard creates a foundation for tracking and improving provider data quality across the ecosystem. It also allows this industry-led work to inform regulatory activity as policymakers seek to modernize provider data infrastructures. With that foundation in place, the Collective will next focus on other industry challenges, including how accepting-new-patients status is determined, updated and reflected in directories to improve accuracy and patient access.”
  • Modern Healthcare reports,
    • “The Centers for Medicare and Medicaid Services has gained unprecedented authority to remove providers, insurers and suppliers from federal health programs over fraud concerns.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. published a notice Tuesday announcing he is officially delegating those powers, which had been solely held by the HHS Office of Inspector General, to CMS.”
    • “The two-page document formalizes remarks Kennedy made at a news conference in July. “Both CMS and the Office of Inspector General will be able to use that authority to remove bad actors from federal healthcare programs and, in many cases, permanently ban them from returning,” Kennedy said at the time.
    • “The policy shift gives CMS a significant enforcement tool as the agency toughens up its oversight and fraud detection strategy.”
  • Bloomberg Law adds,
    • “US Health Secretary Robert F. Kennedy Jr.’s proposal to pay doctors to collect information about vaccine injuries drew criticism from medical groups over concerns it would create perverse incentives and a perception of causality not based on evidence.
    • “The idea is one pillar of the Department of Health and Human Services’ new vaccine injury research project formally announced on Thursday, three days after agency leaders secretly met at the National Institutes of Health to pitch it. 
    • “The proposal to compensate Medicare providers was tucked into a wide-ranging physician payment rule expected to be finalized next month as part of an annual rulemaking process.”
  • Beckers Hospital Review relates,
    • “Four House lawmakers, Reps. Rob Bresnahan, R-Pa., Debbie Dingell, D-Mich., Tracey Mann, R-Kan., and Lois Frankel, D-Fla., have introduced bipartisan legislation that would pause HRSA’s 340B rebate model pilot.” * * *
    • “The bill, the 340B Rebate Model Delay Act, would require drugmakers to provide 340B discounts upfront at the time of purchase from Jan. 1, 2027, through Dec. 31, 2028. It would also bar the use of federal funds to implement the rebate pilot or a substantially similar program during that period.
    • “The pause would give Congress time to consider broader 340B reform, including the SECURE 340B Act in the House and the SUSTAIN 340B Act in the Senate, according to an Oct. 9 statementfrom Advocates for Community Health. The group said health centers could be forced to cut services if they have to absorb full drug costs while awaiting rebates.”
  • Per a HRSA news release,
    • “The Health Resources and Services Administration (HRSA) today announced $12.7 million in Fiscal Year 2026 awards through the Maternal Produce Prescription Program (MP3) to help pregnant and postpartum women and their families in low-income and medically underserved communities access healthy foods.
    • “MP3 provides produce prescriptions or vouchers and nutrition education to help pregnant and postpartum women and their families access fruits and vegetables. The program strengthens partnerships among healthcare providers, community-based organizations, and local food systems and aims to increase fruit and vegetable consumption, improve household food security, and improve maternal and birth outcomes.”

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

  • Federal News Network discusses “FEHB and Medicare: Understanding how they work together in retirement.”
  • FedScoop adds, “OPM updates terms of service for USAJobs data following user confusion.
    • “The human capital agency again updated terms for its USAJobs application programming interface to reflect that the data is public and expressly allow analysis.” * * *
    • “In new updated terms released Friday, the agency enshrined its clarifications into its policy.
    • “The terms now state that information from the API is public data and as such, can be “copied, stored, reformatted, adapted, analyzed, published, redistributed, and used for lawful commercial or noncommercial purposes” without prior approval from OPM. 
    • “They also include language protecting analysis, while making it clearer that fraudsters are the target. Under the terms, API users can “modify, summarize, analyze, or combine” the public data, but may not falsely represent the information. ” * * *
    • “In response, the user community cheered the update.”

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

  • CBS News reports,
    • “The Food and Drug Administration received reports in recent months that two people died after taking bootleg versions of an experimental weight-loss drug, according to documents reviewed by CBS News.
    • “The reports link the deaths to products claiming to be retatrutide, a drug being developed by Eli Lilly that hasn’t been approved by the FDA. Federal law prohibits the commercial sale of unapproved drugs, but that hasn’t stopped vendors from selling imitation versions of the experimental drug online at a scale with no modern precedent. 
    • “The cases appear to be the first public accounts in the U.S. alleging that unauthorized use of retatrutide — or products claiming to contain it — played a role in a patient’s death, though the details aren’t verified and it is unclear whether the drug was to blame.” * * *
    • “CBS News was not able to independently verify the information included in the reports, which were obtained under the U.S. Freedom of Information Act and redacted by the agency to remove details that could identify the people mentioned in them. They are part of an emerging picture of potential side effects from a drug that many people are obtaining from unregulated sellers and with minimal to no medical supervision.
    • “America’s Poison Centers, a nonprofit, has tallied a steady increase in reported exposures to retatrutide since it began tracking them late last year, which is common for a newly monitored drug. The centers logged 862 exposures to retatrutide in the three months ending in September, up from 460 in the three months prior and 249 in the first three months of 2026.” * * *
    • “In a statement, Eli Lilly said that the reported deaths “make clear the two individuals were taking black-market retatrutide.” The company said it has found suspect products “with too much, too little, or the wrong active ingredient,” along with contaminants that “can put patients at serious risk.”
    • “Eli Lilly is taking legal action against companies selling bootleg versions of retatrutide, claiming that people will associate bad reactions to them with its product, “poisoning the well for the future of retatrutide medicines.” 
  • DI Cardiology tells us,
    •  “Endovascular Engineering (E2) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for both the Hēlo Thrombectomy System and Hēlo Return (Blood Return System).
    • “Hēlo, which is a physician-inspired, purpose-built thrombectomy platform for treating pulmonary embolism, leverages a unique design that consistently led to efficient single-pass procedures in the Engulf IDE study. The platform showcased the highest reported clot reduction and the lowest estimated blood loss across all PE Thrombectomy IDE studies.1 
    • “While Engulf provided important clinical validation of the platform’s capabilities, the FDA clearances represent a significant step forward as E2 brings its innovative platform to a broad range of physicians and patients. PE remains a leading cause of cardiovascular death and disability, and there is growing demand for mechanical solutions that support clot removal while reducing procedural complexity and right heart strain.”
  • MassDevice adds,
    • “BridgeSource Medical obtained de novo clearance from the FDA for its handheld cardiac implant identifier, designed to help emergency department clinicians quickly identify a patient’s hardware brand.
    • “According to the Austin, Texas–based company, about half the time a patient enters the ER they don’t know, can’t communicate or aren’t carrying the wallet card listing the specific brand of their pacemaker or implanted defibrillator. This causes delays in triage and treatment — with different approaches being needed for each manufacturer — and clinicians often have to resort to an X-ray to determine the type of device.
    • “BridgeSource’s SmartRead system can be used by frontline healthcare workers to identify an implant within 20 seconds. It works by mimicking the initial communication pings sent by the programming wands from each major implant manufacturer and waiting for a response, including devices from Abbott, Biotronik, Boston Scientific, Medtronic and MicroPort.”

From the public health and medical / Rx research front,

  • JACC offers information about “Cardiovascular Disease Mortality [CVD] by County, Race and/or Ethnic Population, United States, 2000-2019.”
    • “While declining CVD mortality reflects meaningful clinical and public health progress, persistent and pervasive disparities demand solutions-oriented, place-informed research to drive further progress. Critically, these pre-Covid data establish a baseline essential for isolating Covid-era–attributable shifts from preexisting trends. These granular county-level data stratified by CVD cause, race, and/or ethnicity offer a scalable, repeatable framework for agencies to tailor health interventions and rigorously track disparities over time.”
  • Health Day adds,
    • “Monitoring blood pressure at home could help prevent a life-altering injury for some seniors, a new study warns.
    • “Seniors older than 78 with “masked” high blood pressure have a 70% higher risk of falls than those who’ve been properly diagnosed, according to results presented at the American Heart Association’s annual meeting on hypertension.
    • “Researchers said masked high blood pressure involves seniors’ readings appearing normal at a doctor’s office but consistently high at home.
    • “These findings highlight that, in addition to office blood pressure measurement, home blood pressure readings can be an important way to identify hidden home high blood pressure and risk of falls in older adults,” lead investigator Frances Wang said in a news release. She is a researcher at Beth Israel Deaconess Medical Center in Boston.
    • “Changes in blood pressure can increase fall risk by causing dizziness or fainting, according to the American Heart Association (AHA).”
  • Per a National Institutes of Health news release,
    • “A scientific team funded by the National Institutes of Health (NIH) has built a super intelligence (SI)-based interface that enables real-time communication between patients and epilepsy monitoring devices. As part of a small clinical study at the University of Pennsylvania, Philadelphia, patients used a smart-phone application to inquire about their own physiological data and received accurate information in response. Conversely, the system learned from patient feedback to improve seizure detection, ultimately reducing its false alarms by about 80%. 
    • “This proof-of-concept showcases a technology with the exciting potential to shift management of epilepsy and possibly other diseases in a more adaptive direction that puts patients in the driver’s seat,” said Amy Bany Adams, Ph.D., acting director of the NIH’s National Institute of Neurological Disorders and Stroke (NINDS).” 
  • Radiology Business reports,
    • “Alterations in brain connectivity may be associated with anxiety in adolescents, according to new research. 
    • “Published in Imaging Neuroscience, the findings implicate brain circuits connecting the cerebellum, amygdala and thalamus in adolescent anxiety. Experts involved in the study are hopeful that their research could help guide personalized approaches to youth mental health care in the future. 
    • “Precision psychiatry is likely to play an important role in future mental health care,” noted study leader Caterina Stamoulis, PhD, principal investigator in Boston Children’s Computational Neuroscience Laboratory. “In this study, we have identified specific circuits that are implicated in anxiety, which could become the targets of precision interventions to improve short- and longer-term mental health outcomes in youth.” * * *
    • “While the findings are promising and offer scientists a deeper level of understanding of the underlying mechanisms of anxiety disorders in adolescents, additional research will be needed to determine whether the imaging markers can predict individual outcomes or help clinicians select and evaluate targeted interventions. 
    • “Read more here.” 
  • BioPharma Dive relates,
    • “An experimental mRNA cancer immunotherapy from BioNTech failed to delay tumor progression in a late-stage study in a form of head and neck cancer, the company said Tuesday.
    • “According to BioNTech, a combination of its treatment BNT 113 and the widely used drug Keytruda didn’t extend progression-free survival at an interim data check. The trial is testing the dual regimen against Keytruda alone as a first-line treatment in head and neck squamous cell carcinoma that’s driven by a high-risk strain of human papillomavirus. 
    • “A data monitoring committee encouraged BioNTech to continue the trial to determine whether the BNT 113-Keytruda regimen can meet the study’s other main objective by extending survival. Should it do so, BioNTech could still claim success. The early results “support continued evaluation” and show the drug combination is “engaging its intended therapeutic mechanism,” said co-founder and Chief Medical Officer Özlem Türeci.”
  • and
    • “Bristol Myers Squibb said Monday that its experimental lung disease drug admilparant succeeded in a Phase 3 trial in idiopathic pulmonary fibrosis, significantly slowing the decline of study participants’ breathing capacity when compared to a placebo over the course of a year.
    • “However, trial investigators only found a clear benefit among those who received a 60 milligram dose of admilparant. A 120 milligram dose was associated with an impact on disease progression, but the difference didn’t meet the threshold for statistical significance, the company said.
    • “The failure of the high-dose arm is “confounding and requires further explanation,” RBC Capital Markets analyst Trung Huynh wrote in a client note. Bristol Myers previously made certain trial revisions that sparked liver-related safety concerns about admilparant, too, although the company said Monday that the drug “demonstrated a well-tolerated safety profile” and treatment-related study discontinuations were similar between study groups.”

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

  • The Wall Street Journal reports,
    • “UnitedHealth UNH Group reported earnings that came in above analysts’ expectations and again raised its projection for the year, as the healthcare company continued charting a financial turnaround.
    • “The announcement comes more than a year after Chief Executive Stephen Hemsley returned to the top job, promising major changes after a meltdown that cut the company’s valuation by hundreds of billions of dollars.
    • “For the third quarter of 2026, UnitedHealth reported net income of $4.11 billion, or $4.56 a share. That compared with net income of $2.35 billion, or $2.59 a share, a year earlier.” * * *
    • “UnitedHealthcare, the insurance arm, reported a medical-loss ratio of 88.4%, a closely watched number that represents the share of premiums spent on medical costs. The FactSet consensus projection was 89.7%.”
  • and
    • “Johnson & Johnson JNJ is “leaning” toward spinning out the hips-and-knees business that the company has been looking to hive off, Chief Financial Officer Joseph Wolk said.
    • “We think the best value creation at this moment in time for J&J shareholders is to spin it straight out,” Wolk said in an interview. The company talked with private-equity firm Apollo Global Management about a roughly $20 billion sale, The Wall Street Journal has reported.
    • “Wolk made the remarks as J&J said its sales grew a healthy 5.9% in the recent quarter to $25.4 billion, and the company raised its forecast for full-year performance.
    • “Sales of prescription drugs powered J&J’s quarterly results. The company’s medical-device business didn’t grow as much. While acknowledging the medical-device unit needed work, the company said it was on track to surpass $100 billion in yearly sales.
    • “J&J is considered a bellwether for the healthcare industry because its portfolio spans so many different products. Its results show the enduring demand for medical treatment, as other industries grapple with consumers tightening spending because of higher fuel and other costs.”
  • and
    • “Roche ROP Holding struck a deal with China’s Rona Therapeutics to license worldwide rights to an experimental therapy for obesity and metabolic diseases for up to $1.16 billion, moving to bolster its portfolio with a new weight-loss approach.
    • “Under the agreement, Shanghai-based Rona will get upfront and near-term payments of up to $100 million and be eligible to receive an extra $1.06 billion subject to reaching development, regulatory and commercial goals, as well as royalties on potential sales, Rona said Tuesday.
    • “Roche has sought to build and expand a portfolio of weight-loss drugs in recent years, joining a growing group of drugmakers vying to challenge Eli Lilly and Novo Nordisk. It completed in 2024 its $2.7 billion purchase of U.S. obesity drug developer Carmot Therapeutics and entered into an up to $5.3 billion licensing deal with Denmark’s Zealand Pharma to jointly develop a different kind of weight-loss medicine last year.”
  • Beckers Payer Issues relates,
    • “Humana has agreed to form a new joint venture with investment management firm BlackRock to own and operate nearly 150 CenterWell Senior Primary Care clinics, replacing CenterWell’s existing joint ventures with private equity firm Welsh, Carson, Anderson & Stowe. 
    • “Funds and accounts managed by HPS Investment Partners, part of BlackRock, will acquire Welsh Carson’s equity stake, valued at about $2.8 billion, according to an Oct. 13 Humana news release. BlackRock will hold majority ownership, while CenterWell will retain a minority stake and continue managing the clinics.
    • “Unlike the previous agreements, the new deal does not give BlackRock the right to force Humana to buy out its stake. Humana said removing that obligation will significantly reduce liabilities on its balance sheet and lower its cost of capital.
    • “Beginning in 2028, CenterWell can buy clinics from the joint venture, according to the release. If CenterWell has not acquired all of them by the end of 2033, BlackRock can exit through a sale of the remaining clinics, with CenterWell holding the right to make the first offer.”
  • and
    • “Centene will launch its National Performance-Based Gold Card Program in November.
    • “Gold carding aims to streamline prior authorization, reducing requirements for trusted providers. The program will first be available to more than 160,000 qualifying providers across the country for some outpatient services. Eligibility is determined by approval history, documentation quality, medical policy compliance and adherence to regulatory requirements. The insurer anticipates expanding the program to other service types and providers in the future.
    • “Centene COO Susan Smith said the program “was shaped through deep collaboration with providers, ensuring its review process is grounded in the real-world needs of those delivering care every day.” Providers spanning 24 states anonymously contributed feedback to inform the program, according to an Oct. 13 news release.” * * *
    • “In recent years, UnitedHealthcare and Humana have also announced gold card programs. Centene’s update comes as prior authorization reforms pick up steam.”
  • Per a Healthcare Cost Institute news release,
    • “Health care spending for people with employer-sponsored insurance reached $6,743 per person in 2023, according to the nonprofit Health Care Cost Institute’s latest Health
    • “Care Cost and Utilization Report. Per-person spending rose 18.8% from 2019 to 2023, with higher prices, not greater use of care, driving most of the increase.
    • “From 2022 to 2023, spending per person grew 6.5% while utilization was essentially flat. Average prices rose 6.7% that year, continuing a five-year pattern of annual price growth.
    • “Prices are the primary force behind high health care costs,” said Katie Martin, HCCI president and CEO. “Employers, policymakers and other decisionmakers need to focus on price growth to make care more affordable for people and families with job-based coverage.”
  • Beckers Hospital Review tells us,
    • “Hospital margins fell in August as financial pressures mounted and the share of hospitals operating at a loss is growing, according to Kaufman Hall’s [Augut 2026] “National Hospital Flash Report,” released Oct. 13.
    • “The report is based on August 2026 financial performance data from 1,300 hospitals, provided by Strata Decision Technology. The hospitals represent all regions of the country and range from small to large institutions.
    • “The average hospital margin has declined steadily since hitting 5.6% in June. The average fell to 1.8% in August, down from 3.8% in July. The year-to-date average operating margin dropped from 3.8% in July to 2.5% in August.
    • “Mounting financial challenges from increasing bad debt and charity care, payer mix erosion and rising expenses may prompt hospitals to strengthen enterprise margin preservation efforts,” the report said.
    • “About 43% of hospitals are operating in the red, up from 33% before the COVID-19 pandemic. Hospitals have experienced many challenges in the last six years, including staffing shortages, supply cost increases, tech and AI spend and more.”
  • Per a Vizient news release,
    • “The sustained momentum in hospital and health system M&A activity has shown that health systems continue to advance active positioning and portfolio management, with 16 hospital and health system transactions announced in Q3 2026. The 16 announced transactions in Q3 2026 (Figure 1) are on par with what we saw in Q3 2025. As deal volume continued, mega mergers also continued to make waves across the industry. For the third consecutive quarter, multiple mega mergers—transactions in which the smaller party had annual revenue exceeding $1 billion—were announced, along with several transactions that fell just shy of the $1 billion threshold.
    • “The size of these transactions kept the average seller size elevated relative to recent year-end figures, continuing to suggest that M&A activity is increasingly involving larger organizations opting to partner with even larger ones.
    • “Divestitures of specific health system assets represented five of the 16 announced transactions in Q3 2026.”
  • Beckers Payer Issues notes,
    • “CMS’ 2.5% efficiency adjustment cut work relative value units on about 7,700 non-time-based codes starting Jan. 1. It was a percentage cut that came with a conversion factor increase, so the dollar effect is easy to miss. For physicians paid per wRVU, it runs from nothing to more than $13,000 a year, depending on specialty.” * * *
    • “The Medical Group Management Association and consulting firm PYA have flagged procedural and imaging-heavy groups on formula-based wRVU incentives as the most exposed. MGMA also noted exposure for groups whose commercial contracts or benchmarks are tied to wRVU counts.”
  • MedCity News informs us,
    • “Outro, a neuroscience-based platform, announced last week that it raised $7 million in pre-seed and seed funding.
    • “The New York-based company helps patients discontinue psychiatric medications. Patients visit with clinicians trained in safe deprescribing and receive access to personalized tapering plans. They also gain access to compounded medication doses.
    • “Roughly 1 in 6 Americans take antidepressants. There are tens of millions of people on these drugs, yet no science-based way to get off safely. … Outro is the off-ramp that should have been built from the beginning. We want getting off a medication to be as supported as getting on it – arguably even more,” said Brandon Goode, co-founder and CEO of Outro.”
  • Beckers Health IT points out,
    • “The American Medical Association released a governance framework Oct. 13 for agentic AI that takes on clinical functions. The framework says an AI system’s clinical authority must be earned through evidence and maintained through ongoing performance.
    • “The AMA said an AI system’s authority and oversight can change as its evidence, performance, risk or underlying technology changes.”

Holiday Weekend update

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

Happy Columbus Day!

From Washington, DC

  • Congress remains on the campaign trail this week.
  • The Social Security Cost of Living Adjustment will be announced on Wednesday, October 14,
  • Beckers Hospital Review reports,
    • “Health systems told CMS in public comment letters how much its proposed cut to 340B drug payments would cost them, with estimates ranging from about $7 million to $109 million a year [as detailed on the article].
    • “The 2027 outpatient payment rule, proposed July 2, would pay hospitals for drugs bought through the 340B program at average sales price minus 33.4%, down from average sales price plus 6%. CMS estimates the change would cut Original Medicare drug payments by $4.55 billion in the first year. Because the rule must be budget neutral, CMS would raise payments for nondrug outpatient services by 8.44% for all hospitals, including those that do not participate in 340B.

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

  • David Setia, writing in Federal News Network, breaks down why federal employees “should consider retiring after 62, why it just got even more compelling, and how you can make this decision slightly less painful.”
  • FedSmith explains ‘how federal employees can build a financial cushion before the next shutdown.
    • “Federal shutdowns are unpredictable, but financial preparedness isn’t. Here’s how to build a savings cushion before the next funding lapse.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Alignment Healthcare sued federal regulators, alleging that its 2027 Medicare Advantage star ratings were determined “in flagrant violation” of statute.
    • “In the lawsuit filed Friday in District of Columbia federal court, the insurer says that the Centers for Medicare & Medicaid Services “has completely departed from Congress’s vision of leveraging predictable, valid measures developed with input from providers, plans, and the public” in establishing the methodology for the star ratings.
    • “The company argues that rather than establish “consistent, stable specifications” for metrics through the traditional rulemaking process, the agency instead detailed key measures through a series of “technical notes.” This violates the Administrative Procedure Act, per the lawsuit.”
  • Modern Healthcare adds,
    • “The Centers for Medicare and Medicaid Services excluded 20 measures from its 2027 Medicare Advantage star ratings methodology for Clover Health PPOs.
    • “Clover Health successfully sued CMS to get those metrics excluded from its 2026 scores.
    • “Other Medicare Advantage insurers were evaluated on different metrics than Clover Health.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “A 39-year-old unvaccinated woman from Franklin County, Pennsylvania, who had been diagnosed with measles has died, according to the local coroner’s office, marking the sixth such death reported since the state’s outbreak began this year.
    • “The woman’s primary cause of death was a “probable acute cardiac event due to possible complications of the measles,” the coroner’s office said in an emailed statement.
    • “The patient had “a recent history” of having contracted the highly contagious disease, the coroner’s office wrote in a Facebook post, adding that it meets the state health department’s definition of a measles-associated death. The woman had several underlying health conditions and had a “past diagnosis of measles with treatment.”
  • Beckers Clinical Leadership relates,
    • Flu season is off to an early start, with weekly lab-confirmed flu hospitalizations nearly tripling between early September and early October, according to CDC data. 
    • Hospitals reported 3,334 flu admissions in the week ending Oct. 3. That’s up from 2,572 the week before and 1,133 in the week ending Sept. 5. The national admission rate rose to 1.0 per 100,000 people, up from 0.3 in early September.
    • The West is furthest ahead. “California has a full-on flu epidemic right now,” Scott Gottlieb, MD, a former FDA commissioner, said in an interview with CNBC.
  • and
    • “Hospital and health system leaders are grappling with the balance between keeping patients safe and what to do when aging physicians continue to practice amid declining abilities, The Washington Post reported Oct. 12. 
    • “Nearly 47% of the active physician workforce is 55 or older, up from 38% in 2007, and in 2025, 22.4% of physicians are over 65. At older ages, reaction times slow, knowledge can become outdated and some can experience cognitive decline. Mild cognitive impairment increases with age, going from 8.4% in adults 65 to 69, up to 25.3% in adults 80 to 84, according to the American Academy of Neurology.
    • “Studies from Yale New Haven Hospital and Hartford (Conn.) Healthcare found 12.7% to 14.4% of physicians over 70 who were screened showed some degree of cognitive impairment.  
    • “It’s becoming a bigger issue with each passing year,” clinical neuropsychologist Victor Del Bene,PhD, of the University of Alabama at Birmingham, told the Post.”
  • The American Medical Association lets us know “what doctors want patients to know about the common cold.”
    • “Nearly everyone will experience a cold, most often caused by rhinovirus. While there is no cure, there are several ways to manage your symptoms.”
  • Health Day tells us,
    • “Late-night snack may be doing more than affecting your waistline — it could be hurting your liver health.
    • “A few studies have hinted at this idea but this is among the first long-term analyses to explicitly draw the connection to fatty liver disease,” lead author Dr. Robert Wilechansky said in a news release. He’s a hepatologist at Oregon Health & Science University in Portland who specializes in liver transplantation.
    • “Researchers analyzed diet and lifestyle data from nearly 200,000 healthy people who were monitored for about 16 years.
    • “Those who reported eating after dinner or after bedtime had a 36% higher risk of developing non-alcoholic fatty liver disease and a 28% higher risk of cirrhosis.
    • “The results were consistent even after adjusting for factors like age, diabetes status, physical activity and body mass index (BMI), an estimate of body fat based on height and weight.”
  • The Washington Post offers an interview with an oncologist who tells us what to know about DCIS or Stage 0 breast cancer.
    • Experts are starting to question whether identifying ductal carcinoma in situ as cancer leads to unnecessary interventions such as radiation and surgery.
  • The New York Times explains “why ketamine immobilizes some users.”
    • “Potent powders can produce a nearly catatonic state, particularly in those who have not tried the drug before.”
  • and
    • considers whether we ever will understand dementia.
      • “Today dementia is estimated to affect more than 55 million people worldwide, and nearly 10 million cases are added every year. By 2050 — as populations age and the power of diagnosis improves — that number is projected to rise as high as 139 million. We’re already on our way to becoming a society of caregivers, looking after an aging population unable to support itself.
      • “And yet, in a sense, we understand little more about the plaques and tangles of Alzheimer’s disease than we did 120 years ago, when Alois Alzheimer first noticed them. In recent years, we may have even lost ground. A decades-long consensus about the meaning of those plaques and tangles has collapsed as treatments built on those theories have failed, reopening what now must be understood as one of the most urgent unsolved problems in medical science: What is dementia, and how can we possibly slow its advance and reduce its terrible toll?” * * *
      • “A recent overview of the Alzheimer’s literature in the journal Cell offers “hope for a future where AD is not only treatable but also preventable,” while still acknowledging the condition’s “complex pathologic underpinnings.”
      • “This, after all, was Arnold Pick’s insight: that dementia is many things. What if we could nip these complex problems in the bud genetically, before the crippling health care costs and heartbreaking losses — before the ones we love lose much of what makes them who they are?
      • “With the gene carriers, you can get in very early, maybe even before any age-related change is happening, any pathology is present at all,” Dr. Miller said. “I think it’s going to be a really huge decade. We’re just beginning.”
  • Per Genetic Engineering and Biotechnology News,
    • “Domestic dogs offer a useful model for understanding the biology of aging because their lifespans vary dramatically with body size. Large dogs tend to be shorter lived than their smaller counterparts, but why? Headed by a team at Arizona State University, a study of nearly 900 dogs now suggests that the answer may be written into the animals’ epigenomes.
    • “Research professor Noah Snyder-Mackler, PhD, at Arizona State University School of Life Sciences, and colleagues developed an epigenetic clock that predicted mortality in dogs and showed that epigenetic aging is fastest early in life. The study results indicated that male dogs and larger dogs undergo accelerated molecular aging, with male dogs exhibiting pronounced DNA methylation (DNAm) changes on the X chromosome, and larger animals exhibiting methylation changes at transposable elements (TEs), stretches of DNA that can influence genome stability and gene regulation.”
    • “Snyder-Mackler is senior and corresponding author of the researchers’ published paper in Science (“Epigenetic aging and transposon dysregulation reflect size-related lifespan compression in dogs,”) in which they concluded, “Our findings broadly establish companion dogs as a translational model for uncovering molecular mechanisms of lifespan variation, epigenomic instability, and age-related disease.”
  • Per Fierce Pharma,
    • “Mirum pharmaceutical is on a hot streak. On the heels of an FDA approval and a phase 3 win in hepatitis delta, the rare disease company just announced another phase 3 victory for Livmarli, its ileal bile acid transporter (IBAT) inhibitor.
    • “Mirum’s Expand trial tested Livmarli in patients aged 6 months or older with cholestatic pruritus, an intense itch caused by an ultra-rare cholestatic liver disease. The topline readout showed the trial met its primary endpoint achieved significance across all five secondary endpoints.

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “More GLP-1 prescriptions are being filled without ever touching a patient’s insurance, and pharmacists say the shift is accelerating.
    • “Nearly seven in 10 pharmacists (68%) have seen cash-pay GLP-1 transactions increase over the past year, according to a Buzz Health survey of 256 U.S. pharmacists conducted in July 2026. The trend shows up weekly at the pharmacy counter, where patients often pay cash for a GLP-1 while still running their other prescriptions through insurance.
    • “Price isn’t the only factor. More than half of pharmacists say patients have paid cash even when a cheaper or equivalent option was covered by their plan, which suggests convenience and product preference play a role. Pharmacists credit manufacturer direct-to-consumer programs, telehealth pricing and new oral GLP-1s with pulling patients away from their benefits. That is the same growing mix of channels physicians already navigate when patients can’t access the GLP-1 they prescribe.
    • “The shift also creates a data problem. Cash purchases don’t always appear in the claims records that health plans and PBMs use to track utilization and adherence, and most patients don’t realize their insurer can’t see those fills. As online GLP-1 options continue to multiply, that blind spot could make it harder to know what patients are actually taking.”
  • Beckers Hospital Review relates,
    • “Durham, N.C.-based Duke University Health System recorded operating income of $453.1 million (5.4% margin) for fiscal year 2026, compared with operating income of $179 million (2.5% margin) in fiscal 2025, according to its Oct. 5 financial report.”
  • and 
    • “Many large health system layoffs in 2026 feature a common theme: Leadership is cutting corporate and administrative support roles while protecting positions that focus on patient care. It’s a pattern that shows how organizations are deciding what to cut as costs rise and federal policy changes reshape the industry.” * * *
    • “Even while administrative ranks thin, systems are still spending to retain workers. Becker’s has reported that 49 hospitals and health systems have announced plans to raise workers’ pay since December 2025. For example, Hartford (Conn.) HealthCare shared in late September that it will raise its minimum wage to $20 an hour Dec. 27, affecting about 4,000 employees. An additional 4,000 employees will receive pay adjustments to address wage compression resulting from the increase.”
  • Radiology Business tells us,
    • “Siemens Healthineers has officially ceased all sales of its general imaging ultrasound systems. The healthcare giant announced the shift in strategy on Monday, Oct. 12, saying it will now increase its focus on procedural imaging and image-guided therapies. The goal is to build on its strength in cardiovascular imaging, specifically in the areas of intracardiac echocardiography (ICE) and AI, and help care teams perform more complex procedures than ever as technologies continue to evolve. 
    • “Going forward, Siemens Healthineers remains focused on technologies used by electrophysiologists and interventional cardiologists for the detection and management of cardiovascular disease. The company’s Acuson Origin, for example, is a cardiovascular ultrasound system with advanced artificial intelligence (AI) capabilities that first gained U.S. Food and Drug Administration clearance in 2024. The Acuson P500 and Acuson Freestyle systems are also still part of the Siemens Healthineers portfolio.
    • “On the other hand, the company will no longer be selling its Acuson Sequoia, Acuson Redwood, Acuson Juniper or Acuson Maple systems.”
  • Beckers Payer Issues explains why payers have invested in ambulatory surgical centers and lets us know that
    • “Former UnitedHealth Group CEO Sir Andrew Witty has been named chairman of Hatteras Venture Partners, a venture capital firm focused on healthcare innovation, investing across biopharmaceuticals, medical devices and health technology.
    • “Mr. Witty is returning to Hatteras, where he served as a venture partner from 2017 to 2019, according to a Sept. 30 news release from the company.” 
  • Beckers Physician Leadership considers whether any physician can be truly independent.
    • “Independent” has become one of the most loaded words in physician practice. As hospitals, health systems and private equity firms have absorbed practices over the past two decades, the label has come to signal a practice that has stayed outside all three.
    • “Siddharth Tambar, MD, a rheumatologist and physician owner of Chicago Arthritis and Regenerative Medicine, questions how much that label actually describes.
    • “I understand what people mean when they say independent practice, right? That you’re not part of a large either group system, hospital system, PE-owned system,” Dr. Tambar told Becker’s. “So I get that, but realistically, if you are part of the American healthcare system, if you accept insurance, you’re part of these large networks. You’re part of these flows of how patients get to you, and so I don’t think any of us are truly independent in that regard.”
    • “Physicians have little leverage inside those networks. Only 5% of physicians report significant negotiating leverage in private-payer contract talks, and more than 40% report none, according to a Medscape‘s report, “Private-Payer and Government Insurance Report 2026: Medicare, Medicaid, and More,” published Oct. 2.” * * *
    • “Despite continuous shifts in the structures and regulations shaping the physician practice space, Dr. Tambar maintains that strong patient relationships and a desire to stay connected to them is what will keep practices growing in the future — regardless of their independence. 
    • “Long term, obviously, if you’re offering good care to patients, ethical care, that’s how you maintain, right?” he said. “As a physician or as an owner, you have to keep on finding ways to offer value to patients, and whatever treatments are new that can be helpful for the patients, you have to find a way to somehow introduce them and stay relevant and stay present in their minds.”

Thursday report

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

Simplicity is a virtue

From Washington, DC

  • The Wall Street Journal reports,
    • “Newly installed Centers for Disease Control and Prevention Director Dr. Erica Schwartz said she wants to change a culture of “paternalism” at her agency.
    • “Americans need to be better informed about how and why the CDC makes its recommendations, and the agency needs to be willing to listen to people’s concerns, she said. 
    • “There is a sense of paternalism that we have had at the CDC,” Schwartz said. “It shouldn’t be this black box that we say, ‘Verily thou shalt, and then that’s the answer.’”
    • Schwartz made the comments Wednesday at a Wall Street Journal Future of Health event in Washington, D.C.
    • “Schwartz said Wednesday that parents should prioritize receiving measles vaccines for their children amid current U.S. outbreaks, saying the shot is “absolutely safe, absolutely effective.” She defended the secretary, a skeptic of vaccines who has said they are a “personal decision,” saying he channels concerns from parents who are wary of the full slate of childhood immunizations.
    • “The secretary does represent the voices of a number of Americans who are asking questions about certain vaccines,” she said, adding that doctors shouldn’t approach vaccine-skeptical parents with “a paternalistic way of thinking.”
  • Casey B. Mulligan, HHS chief economist and chief regulatory officer, writes in STAT News,
    • “Some Medicare patients owe more in coinsurance than the hospital paid for their drug. That arithmetic sounds impossible. It is a consequence of the 340B drug discount program and Medicare’s payment formula. Now the Department of Health and Human Services, where I work, is proposing to narrow that gap.
    • “Congress created the 340B drug discount program in 1992 to financially support safety net hospitals that serve low-income patients. Drug manufacturers must give them steep discounts. But Medicare, Medicaid, and commercial insurers generally reimburse them at the full amount, allowing these hospitals to keep the spread above the discounted purchasing costs.
    • “A new report from the Department of Health and Human Services shows other unintended consequences of this well-intended program. The spread grows with the price of the drug. It therefore rewards hospitals for using more and costlier drugs and makes physician practices and infusion clinics more valuable after a 340B hospital acquires them. The patient’s treatment needn’t change. The owner and billing site do.” * * *
    • “On April 18, 2025, President Trump directed HHS to obtain the cost information the statute requires. CMS surveyed hospitals from January through April 2026 and has proposed paying for affected 340B drugs at ASP minus 33.4% in 2027. CMS estimates that Medicare drug payments would fall by $4.55 billion in the first year and beneficiary drug copayments by $1.15 billion.
    • “For a drug with an ASP of $1,000, a beneficiary’s standard 20% coinsurance would fall from $212 to $133.20. The prescription hasn’t changed. The patient’s share of the hospital’s bill has. Narrowing the spread also weakens the incentive to steer patients toward costlier drugs and to acquire physician practices and infusion clinics — the very behaviors that have made care more expensive.” * * *
    • “Medicare patients should not pay coinsurance as though the discount did not exist.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) this week launched a series of actions to strengthen how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination, with a focus on improving patient care and generating better evidence about potential vaccine-related injuries.
    • “To address health problems Americans report after vaccinations, HHS:
      • Opened a new National Institutes of Health (NIH) clinic dedicated to studying and caring for patients experiencing health problems following vaccination;
      • Proposed reimbursing physicians for reporting suspected vaccine-related injuries to the Vaccine Adverse Event Reporting System (VAERS) through a new Centers for Medicare & Medicaid Services (CMS) policy, bringing vaccine reporting in Medicare in line with typical Medicare reimbursement policies;
      • Will require electronic health records to capture vaccine-related adverse events so that information can follow patients across the health care system; and
      • Is modernizing the Centers for Disease Control and Prevention’s (CDC) VAERS to make reporting simpler and improve the tools available to researchers and medical professionals investigating potential safety signals.
    • “We must listen to patients and families who report vaccine injuries—not dismiss or gaslight them,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump and I are building a health system that takes them seriously, follows the evidence, and uses what we learn to make vaccines safer. This is how we earn back trust in our public health institutions.”
  • Beckers Hospital Review informs us,
    • “The Trump administration is preparing a stopgap that would allow certain previously restricted peptides to be sold temporarily while federal health officials write new regulations, according to an Oct. 7 Washington Post report citing two people familiar with the matter.
    • “The move would let some compounding pharmacies dispense peptides marketed as medical treatments and wellness products, even though the claims for what they treat have not been fully safety tested. The plan has not been announced, and the Post reported that its timing is unclear, it could still change and it is not known which peptides would be included. The sources said federal officials are seeking guardrails around the policy, and HHS did not comment.
    • “The FDA has been weighing whether to let compounding pharmacies produce seven peptides for conditions such as insomnia, obesity and wound healing. FDA scientists said there is not enough evidence on their safety and effectiveness, but the agency’s Pharmacy Compounding Advisory Committee, which was reshaped with wellness clinic physicians before the meeting, voted in July to recommend six of the seven. It voted against emideltide, a proposed treatment for opioid withdrawal and insomnia.
    • “The FDA is not required to follow the panel’s advice, and the Post said it is not clear when formal rulemaking will be released. Safety groups ECRI and ISMP warned after the vote that gaps in safety and efficacy data remain unresolved.”
  • The American Hospital Association News points out,
    • “The Department of Homeland Security Oct. 8 issued a proposed rule that would establish new fees for foreign students seeking Optional Practical Training, a program that allows F-1 students to work in the U.S. in positions related to their field of study after graduation. Specifically, DHS proposes a fee of $70,000 for an initial OPT authorization and $30,000 for any subsequent OPT authorization, citing concerns about fraud, program integrity and protection of U.S. workers. The agency is accepting comments through Nov. 9.
    • “The proposal could have significant implications for hospitals and health systems that rely on international graduates, including nurses, physicians, pharmacists and other healthcare professionals, as OPT often serves as a pathway into the healthcare workforce. The AHA will review the proposed rule and evaluate its potential impact on workforce recruitment and retention.”
  • and
    • “The Agency for Healthcare Research and Quality Oct. 7 announced the launch of the Super Intelligence for Healthcare Improvement Initiative, a two-part artificial intelligence competition focusing on medical evidence reviews and data. The first competition, called the Clinical Evidence Synthesis Transformation Challenge, aims to reduce analysis times from a year or longer to hours. This competition consists of two phases, where up to five finalists will receive $100,000 each after the first, and one winner will receive $5.35 million following the second. The challenge submission period will run from Jan. 11 to March 12, 2027.
    • “The next part of the initiative, called the SI Tech Sprint for Healthcare Research and Implementation Quality and Safety, aims to use AI to leverage AHRQ’s cost, utilization and quality databases to establish an AI-enabled ecosystem of applications for research, quality improvement and public access. The total prize pool is $2.1 million for selected winners. Submissions will be accepted from March 1 to Sept. 9, 2027. AHRQ’s webpage for the competition provides additional details, including information on registration, resources and an FAQ.”

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

  • FedWeek reports,
    • “Federal employees who have been watching the government’s renewed focus on reductions in force (RIFs) should pay close attention to one development in particular: newly finalized changes that make performance ratings far more important in determining who stays and who goes.
    • “These regulations are now final law and apply to any agency issuing a specific RIF notice on or after September 2, 2026. As a result, many employees will find that their last several performance appraisals carry greater weight in whether they keep their jobs. That means the time to review your record is now, not after an RIF notice arrives.
    • “This article is not legal advice for any individual employee. But it outlines practical steps federal employees can take now to protect their retention standing, preserve appeal rights, and avoid being caught flat-footed under OPM’s finalized RIF framework.”
  • Federal News Network relates,
    • “There’s a new way to look at data about the federal workforce. The Office of Personnel Management has launched an AI chatbot to answer the public’s questions about workforce trends. The new feature has been added to OPM’s “federal workforce data” website, which details employment numbers and other information about the civil service. Users can enter questions and get AI-generated answers about government hires and separations, as well as workforce demographics like age, veteran status and education level. — Drew Friedman(FWD Chat – Office of Personnel Management)”
  • Edward Zurndorfer, writing in My Federal Retirement, discusses “The Biggest Medicare Mistakes That Can Cost Federal Retirees.”
  • Tammy Flanagan, writing in Govexec, advises “Don’t let 5% become your TSP retirement strategy.”
    • “Getting the full agency match is a good baseline, but if retirement is around the corner there’s more to consider before deciding what to do with the rest of your paycheck.”

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

  • NBC News reports,
    • “The Food and Drug Administration expects to complete its safety review of the abortion pill mifepristone in March, according to a court document the Justice Department filed Wednesday.
    • “In the filing, the FDA said it plans to compare mifepristone’s safety to that of surgical abortions through 10 weeks’ gestation. Its review will measure the frequency of side effects among roughly 100,000 women who took mifepristone, it said. 
    • “Results of the FDA’s review are expected in mid-December. From there, the agency will analyze the data and draft a final report — a process it expects to wrap up in March.” * * *
    • “The update Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.
    • “The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022. Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.
    • “In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person. But the Supreme Court quickly blocked the decision while the case plays out.”
  • Food Safety relates,
    • “The U.S. Food and Drug Administration (FDA) has issued a draft guidance that, if finalized, will provide enforcement discretion from the requirements of the Food Traceability Rule, also known as Section 204(d) of the Food Safety Modernization Act (FSMA 204),  for certain smaller retail food establishments (RFEs) and restaurants that were not previously captured as part of the full exemption for small RFEs and restaurants offered as part of the rule. 
    • “FDA said it believes “this additional flexibility will maintain the intended public health benefits of the rule, as it would only impact a small percentage of total food sales, while also providing relief to numerous smaller RFEs and restaurants.”
  • MedPage Today tells us,
    • “The FDA flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, Newron Pharmaceuticals said Thursday.
    • “The notice follows an announcement in April that the agency halted patient enrollment in the phase III ENIGMA-TRS 2 trial after the sudden death of a participant in an evenamide clinical trial. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added.
  • Cardiovascular Business informs us,
    • “Houston-based Leader Formulas is recalling one lot of its Rapture Preworkout dietary supplement due to the presence of 1,3-dimethylamylamine (DMMA), an ingredient not listed on the product label. 
    • “DMMA, often referred to as “geranium extract,” has been linked to a heightened risk of high blood pressure. It is also known to lead to certain cardiovascular problems, including heart attack, shortness of breath and chest pain. Its presence was first identified by the U.S. Food and Drug Administration (FDA) during a routine test. 
    • ‘This voluntary recall includes three different products—Rainbow Twist, Electric Lemonade and Berry Mojito—that were all part of lot 260327-4.
    • “Consumers who have purchased the Rapture Preworkout products which are being recalled should stop using the products and return to the place of purchase for a full refund,” according to Leader Formulas statement.”
  • Beckers Hospital Review adds,
    • “The FDA has flagged patient safety risks tied to nine products sold through Amazon that the agency said are unapproved new drugs marketed to treat sexually transmitted infections or their symptoms.
    • ‘The agency identified the violations after reviewing labeling for products it purchased from Amazon in July 2026, according to an Oct. 1 warning letter. The FDA said the products were introduced or delivered for introduction into interstate commerce by Amazon through its Fulfillment by Amazon service.
    • “The FDA said no OTC drug product has been approved for the treatment, cure, mitigation or prevention of any STI. The agency said effective treatment requires diagnosis and supervision by a licensed healthcare professional.” * * *
    • “Amazon was directed to respond within 15 business days of receiving the letter with steps taken to correct the violations and prevent their recurrence.”

From the Medicare Advantage front,

  • In a CMS fact sheet, CMS published 2027 Medicare Advantage and Part D Star Ratings.
    • “The information included in this Fact Sheet is based on the 2027 Medicare Advantage (MA) and Part D Star Ratings published on the Medicare Plan Finder on Oct. 8, 2026. For details on the methodology of the MA and Part D Star Ratings, please refer to the 2027 Part C & D Star Ratings Technical Notes available at http://go.cms.gov/partcanddstarratings.”

No Surprises Act News,

  • Bloomberg Law reports,
    • “Insurers and providers share common concerns about ineligible claims under a federal surprise billing law, bolstering Senate HELP Committee Chair Bill Cassidy’s push for a legislative fix before he leaves Congress, Erin Durkin and Victoria Knight report.
    • “The No Surprises Act, a 2020 statute designed to protect patients from unexpectedly large bills from emergency rooms and other out-of-network providers, established an arbitration process for payment disputes between providers and insurers. A flood of ineligible claims is clogging that process — and closed-door meetings convened by Cassidy have put the issue on the table as a shared concern
    • “Cassidy says he’d like to put out legislation before he departs the Senate at the end of the year. While time is running short, the veteran legislator signaled the issue is gaining traction.
    • “Believe it or not, there’s common ground there,” Cassidy said.”
  • STAT News adds,
    • “A new proposal in Congress to scrap a surprise billing ban’s controversial arbitration system will need to to survive an onslaught of attacks from provider groups, for whom arbitration has been a gold mine.
    • “After Rep. Frank Pallone (D-.N.J.) unveiled his Lower Premiums, Faster Payments Act on Thursday, it quickly garnered praise from academics and consumer advocates, as well as condemnation from provider groups. It would dismantle the problem-plagued process that’s currently used to resolve disputes between health insurers and out-of-network providers and replace it with a payment system based on median in-network rates.”
  •  FEHBlog observation — Good luck, Rep. Pallone.

From the fraud, waste and abuse front,

  • NextGov reports,
    • “The Centers for Medicare and Medicaid Services is exploring a new contract operating model and technologies so that the agency can more effectively prevent fraud, instead of chasing after money already in the hands of bad actors, according to documents posted on SAM.gov Monday.
    • “CMS has traditionally contracted with private companies to boost its investigative capabilities and support administrative actions, such as imposing payment suspensions, according to the listing. But under a draft operating model, CMS wants to take a greater role in leading the development, prioritization and direction of those investigations, the website adds.
    • “The old model “worked in the past but new technology and new techniques mean it is time to see if it still works as well,” Kimberly Brandt, a CMS Deputy Administrator, posted on LinkedIn.
    • “Under the draft model, CMS would assign fraud investigations to contractors whose primary role is to develop the investigation and administrative actions under the agency’s oversight, according to a draft Statement of Objectives posted on SAM.gov.”
  • Per a Justice Department news release,
    • “Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division (the Fraud Division) today released Directive 26-13, outlining the Division’s comprehensive approach in the fight against fraud.
    • “Expanding on earlier guidance regarding the Division’s priorities (available here) and corporate enforcement policy (available here), Directive 26-13 sets out the Division’s prosecutorial methodology for investigating, disrupting, and prosecuting fraud. This directive marks a significant operational shift, requiring the Division’s prosecutors to attack fraud from all angles using the Division’s tax, securities fraud, consumer fraud, and cybercrime authorities.
    • ‘This directive also requires Division prosecutors to deploy early, pre‑indictment asset seizures and digital‑infrastructure takedowns to halt fraud schemes and freeze assets in real time. Finally, this directive urges Division prosecutors to develop practice cooperators, zealously prosecute corporate bad actors, seek arrest and detention in appropriate cases, and deliver fulsome advocacy at sentencing. This new, comprehensive approach will drive the Division forward in its mission to preempt, disrupt, and dismantle fraudulent networks before they can inflict widespread harm.
    • “Read the full memo here.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Taylor Farms, the produce giant linked to last summer’s deadly cyclospora outbreak, is suspending sales of iceberg lettuce from central Mexico during the parasite’s peak season. 
    • “Chief Executive Bruce Taylor said the company won’t sell iceberg lettuce in the U.S. or Canada that was harvested or processed in the region between May 1 and Aug. 31, starting next year. The period covers central Mexico’s rainy season, Taylor said, and it matches the time when the Centers for Disease Control and Prevention sees an increase in illnesses caused by the cyclospora parasite. 
    • “The company hasn’t determined when the suspension will be lifted.”
  • Reuters relates,
    • “Centers for Disease Control and Prevention Director ​Erica Schwartz said on Wednesday the risk to the US ‌from an unconfirmed pneumonic plague case in Siberia was extremely low, but the agency was prepared to monitor and screen travelers.
    • “We are working with Department of Homeland Security, ​working (with) Department of State, Department of War, and other agencies within ​the government to make sure that we know exactly if ⁠anyone from that area comes into the United States,” Schwartz said at ​the Wall Street Journal’s The Future of Health event in Washington.”
  • and
    • “Using artificial intelligence, researchers may have found a way to make vaccines based ‌on mRNA technology, such as Moderna’s (MRNA.O) and Pfizer’s (PFE.N) COVID shots, storable at room temperature, which would lower costs and make them available in regions where ultra-cold storage is not possible.”
  • and
    • “AI may improve doctors’ ability to detect heart transplant rejection without surgery and appeared to be more accurate than standard blood tests, according to a report in Journal of Heart and Lung Transplantation.”
  • Fierce Healthcare adds,
    • “Utah is expanding the state’s AI regulatory sandbox program with new pilots to test AI-supported prescription renewals, dermatology and physical therapy, while stepping up physician oversight and adding independent third-party evaluators.
    • “Utah is bringing the Utah Department of Health and Human Services, Intermountain Health, University of Utah Health, medical licensing officials and outside experts into the state’s AI policy process. State officials and health systems leaders say the initiative is designed to test AI in real-world clinical settings, generate evidence on its benefits and risks and address key questions around liability, privacy and regulation.”
  • The Washington Post tells us,
    • “Brandon Luu began thinking about the body’s circadian machinery as a teenager, when he was routinely unable to fall asleep until late, sometimes well past 2 a.m. The schedule made mornings miserable and school harder.
    • “But it also left him with a question: What happens when the body’s sense of time falls out of sync with the world around it?
    • “Fifteen years later, Luu is exploring that question through one of psychiatry’s most common disorders: attention-deficit/hyperactivity disorder (ADHD). Sleep problems have long been seen as a consequence of the condition. But now researchers are looking at the possibility that the relationship might run in reverse: that disruptions to circadian rhythms — the biological machinery governing when we sleep and wake — might be a cause.”
  • MedPage Today notes,
    • “Adults with ADHD had substantially higher risks of mild cognitive impairment or dementia.
    • “Genetic ADHD risk predicted cognitive impairment, supporting an association beyond clinical diagnoses.
    • “Findings do not prove a causal link; treatment effects and other variables require further study.”
  • Beckers Clinical Leadership informs us,
    • “Suicide became the 10th-leading cause of death in the U.S. in 2024, up from No. 11 in 2023, according to final mortality data from the CDC’s National Center for Health Statistics. Suicide deaths fell 1% over the same period, from 49,316 in 2023 to 48,824 in 2024, and accounted for 1.6% of all deaths in both years. Suicide’s move into the top 10 happened as COVID-19 deaths declined 37%, dropping COVID-19 from 10th to 15th.
    • “Recent data show patterns that differ by method, age and geography. Gun suicides reached record levels for a fifth straight year even as the overall suicide rate trended down. Emergency department visits for suspected suicide attempts declined among adolescents but rose among adults 26 and older. In 2025, rates ranged from 5.3 per 100,000 in the District of Columbia to 31 in Alaska. At the same time, researchers, children’s hospitals and states are pursuing a range of prevention approaches, from smartphone-based risk forecasting and universal ED screening to firearm access laws.
    • [The article notes] seven things to know about the state of suicide in the U.S.
  • The National Cancer Institute points out,
    • “Mutations in a family of genes called RAS, and the rogue proteins they produce, help drive roughly a third of all cancers, including more than 90% of pancreatic cancers. Yet RAS has long been one of the most elusive drug targets in cancer research. Unlike other proteins targeted by cancer drugs, RAS proteins have relatively smooth surfaces, with no obvious place for a drug molecule to bind. That made RAS notoriously “undruggable.” 
    • “Despite the long odds, federally funded research continued to push the field forward. Researchers eventually revealed the structure of RAS proteins and how they function, and those insights led to new approaches for blocking mutant RAS, particularly KRAS, which is involved in the vast majority of RAS-driven cancers.
    • “Today, three RAS inhibitors—sotorasib (Lumakras), adagrasib (Krazati), and, most recently, daraxonrasib (Rasonque)—are helping patients live longer, and many additional molecules that block mutant RAS are moving through the research pipeline.”
    • “These life-changing drugs would not have been possible without the sustained public investments that laid the groundwork for the field, said Harold E. Varmus, M.D., former Director of the National Cancer Institute (NCI) and the National Institutes of Health, who launched NCI’s RAS Initiative.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Hospitals continue to shift care to outpatient settings, according to a new analysis of data from the first half of the year by Strata Decision Technology.
    • “As a result, hospitals are seeing sicker patients in their inpatient wards as they send lower-acuity patients to outpatient departments. 
    • “Patients in some service lines, like gynecology, had procedures done less in hospitals as minimally invasive surgery options in outpatient settings grew. However, other service lines like breast health saw more, sicker patients in the hospital, likely due to an increase in breast cancer testing and diagnoses, according to the data.”
  • Beckers Hospital Review relates
    • “In early January, Tamar Goldblatt was named vice president of payer revenue strategy and contracting at St. Louis-based Ascension. 
    • “Since then, Ms. Goldblatt has worked closely with system and ministry leaders to understand the distinct needs of each market and align them with Ascension’s broader payer strategy. Her work comes at a time where Medicare Advantage instability, rising denial rates and growing administrative burden have turned once-routine payer discussions into high-stakes negotiations. 
    • “Becker’s connected with Ms. Goldblatt to discuss her top priorities nearly one year into the role, the trends that are reshaping payer partnerships and how she approaches payer collaboration.”
  • and
    • “CVS Health unveiled its first pharmacy-focused CVS Pharmacy in the Boston area Oct. 7. The site is meant to expand access to medications, immunizations and other pharmacist-provided services in the community.
    • “Nearly 20 pharmacy-focused locations will open in select communities across the country in 2026. The sites average about 3,000 square feet and include a full-service pharmacy with a limited selection of over-the-counter products.
    • “CVS has already opened pharmacy-focused locations in Birmingham, Ala., Chicago, Detroit, Houston and Washington, D.C. The company also plans to open more than 40 new CVS Pharmacy locations this year, including traditional stores and pharmacies inside Target stores. CVS cited its 2025 Rx Report, which found 80% of patients prefer face-to-face pharmacy care and 48% would switch pharmacies if limited to digital-only options.”
  • The Wall Street Journal tells us,
    • “Viatris VTRS has agreed to buy pain-drug maker Pacira BioSciences PCRX for $1.65 billion in a deal that expands the healthcare company’s medicines portfolio.
    • “Viatris on Thursday said it would pay $36.50 a share in cash for Pacira, a roughly 45% premium to Wednesday’s closing price of $25.20 for the Brisbane, Calif., company.
    • “The deal is slated to close by the end of the year.
    • “Shares of Pacira were recently up 44% at $36.33 in premarket trading, while shares of Viatris edged down 0.1% to $17.47.
    • “Viatris said the addition of Pacira’s Exparel and Zilretta products to its proposed meloxicam treatment for moderate-to-severe acute pain, positions the Canonsburg, Pa., company as a leader in non-opioid pain-management therapies.”
  • and
    • Argenx ARGX shares fell sharply after the biotech company stopped a late-stage clinical trial of its Vyvgart drug due to lack of efficacy for the treatment of autoimmune condition Sjogren’s disease.
    • “Shares in Argenx were down 18% in European morning trading Thursday, wiping out the stock’s gains in the year to date. If sustained until close, this would be the stock’s biggest one-day percentage drop since December 2023.
    • “The Amsterdam-based company said it would discontinue the study following the recommendation from an independent data-monitoring committee, which concluded that the trial would fall short of its primary goal.
    • “The study evaluated the effects of Vyvgart in subcutaneous formulation in adults with moderate-to-severe Sjogren’s disease, a chronic autoimmune disorder that can cause symptoms including dry eyes and mouth, fatigue and joint pain. No new safety signals were identified in the trial, and safety data were consistent with the drug’s known profile, Argenx said.”
  • BioPharma Dive adds,
    • “On Wall Street, a major search is underway to find struggling public companies that can serve as the raw materials for a niche but booming business. A promising candidate may have just emerged.
    • “This business revolves around “reverse mergers,” a type of deal where a private company combines with a public counterpart, often as a quick way to access the broad and deep-pocketed array of investors found on marketplaces like the Nasdaq. While previously disparaged, reverse mergers have recently become so popular that some deal experts question whether there are enough quality “shell” companies to meet the demand.
    • “Shell hunters could have another option following a Tuesday announcement from Caribou Biosciences, the once high-flying biotechnology startup co-founded by CRISPR gene editing pioneer Jennifer Doudna. In a statement, Caribou CEO Rachel Haurwitz said the current financing environment has made it “increasingly challenging” to secure the money needed to advance the company’s two main research programs, which focus on a hard-to-make form of medicine known as “off-the-shelf” cell therapy.” * * *
    • “To Daina Graybosch, an analyst at Leerink Partners who covers Caribou, the natural end for the company now is either a reverse merger or an acquisition by Tang Capital, a San Diego-based investment firm that made a name for itself by buying up cash-rich biotechs and returning much of their value to shareholders. Caribou ended the second quarter with $114 million worth of cash, cash equivalents and marketable securities.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services has published its list of participants for its mandatory Comprehensive Care for Joint Replacement Expanded Model, or CJR-X. The payment model focuses on lower extremity joint replacement procedures. CMS is requesting participating hospitals to complete the online primary point of contact form and identify two individuals to serve as their primary points of contact for CJR-X-related communications from the agency. The model, which initially ran in specific geographic areas from 2016-2024, was expanded this year to all acute care hospitals nationwide, except those participating in the Transforming Episode Accountability Model and hospitals located in Maryland. Participation in CJR-X begins Jan. 1, 2028.”
  • Beckers Payer Issues points out “6 payers entering ACA markets in 2027” and “12 insurers exiting ACA market” at the end of this year.
  • Kiplinger projects IRMAA brackets for 2027.
    • “If you have Medicare Part B or Medicare Part D prescription drug coverage, your monthly costs could look drastically different than the standard rates. High-income retirees are subject to the Income-Related Monthly Adjustment Amount (IRMAA) — a progressive surcharge added directly to your Medicare premiums if your income crosses specific thresholds.
    • “Understanding how the projected 2027 IRMAA brackets are calculated and how the two-year tax lag impacts you is essential to preserving your retirement savings. Failing to plan for these thresholds can trigger an unexpected financial “cliff,” at which a single dollar of excess income can cost you thousands in annual surcharges.
    • “This year, forecasting the 2027 numbers has been difficult because the Bureau of Labor Statistics (BLS) did not publish official CPI-W data for October 2025, due to last year’s federal government shutdown. The Centers for Medicare & Medicaid Services (CMS) should release the numbers by early November.”

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

  • FedSmith points out 12 pieces of information to gather and consider before you start comparing FEHB or PSHB plans this coming Open Season.
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Varney & Co. on Fox Business for his first television appearance since President Trump announced his appointment as Vice Chair of the White House Super Intelligence Task Force. Kupor discussed the President’s vision for maintaining American leadership in superintelligence, protecting national security, and holding industry accountable while advancing innovation.”
  • OPM Director Kupor writes about technology development in his Secrets of OPM blog.
    • “In 1980, AT&T hired McKinsey to forecast the size of the future U.S. cell phone market (for the year 2000). McKinsey forecast the market at about 900,000 subscribers, based in large part on the fact that cell phones in 1980 were bulky, had poor battery life, patchy coverage, and high costs. McKinsey was only slightly off; by the year 2000, the actual figure was 109 million, and worldwide, roughly 900,000 new mobile subscribers were being added every three days.
    • “What do these markets and nearly every other technology market have in common?
    • “An over-abundance of focus on the current limitations often blinds people to how quickly the technology is in fact improving. History has taught us repeatedly that one person’s toy is another person’s opportunity.”

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

  • Per a BridgeBio news release,
    • “BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.
    • “Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia,” said Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias. “We also understand that for many families, it’s about more than just height or having an oral option. To that end, we are excited by the data we have generated on arm span, sleep apnea, ear infections, and proportionality, and we remain committed to further evaluate and share the impact of oral infigratinib on measures beyond growth. We are grateful to the families and investigators who have partnered with us, and we are moving with urgency alongside the FDA.”
  • Cardiovascular Businss reports,
    • “Abbott has secured a new approval from the U.S. Food and Drug Administration (FDA) that allows users of its popular CardioMEMS platform to view their own pulmonary artery pressure (PAP) readings and receive personalized updates through a smartphone app. 
    • “Heart failure patients with an implanted CardioMEMS sensor use the CardioMEMS Hero device, which just gained FDA approval in February, to monitor their PAP over time. This approval helps those patients track any PAP changes through the CardioGuide HF App. According to Abbott, this helps patients take a more active role in managing their own health.
    • “Abbott is reshaping heart failure care by bringing meaningful, actionable information directly to patients,” Katie Spayde, vice president of Abbott’s heart failure division, said in a statement. “For many people living with heart failure, managing their condition is part of everyday life. By giving patients greater visibility into their condition, these new capabilities help them stay informed, engaged and connected to their care between doctor visits.”
  • and
    • “Riverain Technologies, an Ohio-based cardiothoracic imaging company, has announced that its U.S. Food and Drug Administration-cleared suite of artificial intelligence (AI) tools is being added to RapidAI’s Rapid Enterprise Platform.
    • “The Rapid Enterprise Platform, a collection of dozens of advanced algorithms, is already helping radiologists evaluate imaging results in more than 2,500 hospitals all over the world. This partnership gives those users access to Riverain’s ClearRead Chest suite, which scans chest CTs and chest X-rays for signs of pulmonary nodules, pneumothoraces and coronary artery calcification. 
    • “ClearRead was developed to help radiologists see subtle chest findings more clearly and confidently within the workflows they already rely on every day,” Steve Worrell, CEO of Riverain Technologies, said in a statement. “By integrating ClearRead Chest into the Rapid Enterprise Platform, we’re expanding access to our advanced chest imaging technology to support earlier detection of leading global killers like lung cancer, and cardiovascular disease and reduce the burden on radiologists facing increasingly complex imaging workloads.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Heart failure contributed to 452,573 U.S. deaths in 2023, a new peak, and the disease is increasingly affecting younger adults, a new Heart Failure Society of America report found. 
    • “The “HF Stats 2026: An Updated Report on Heart Failure Epidemiology and Outcomes Statistics from the Heart Failure Society of America” report compiles principal findings for a comprehensive picture of the changing state of heart failure in the U.S., according to an Oct. 5 association news release. 
    • “Nearly 1 in 4 Americans will develop heart failure in their lifetime, the report found. Heart failure contributed to 452,573 deaths in 2023, representing 14.6% of all-cause deaths. Age-adjusted heart failure mortality rose approximately 37% from 2010 to 2023 — reversing more than a decade of progress. Early 2024 data suggest the increase is continuing. 
    • “Between 2010 and 2022, heart failure hospitalization rates rose in adults younger than 65 but declined in adults over 65.
    • “Between 2001 and 2020, crude heart failure mortality rates jumped 121% for adults 25 to 44 and 96% for those 45 to 64. By comparison, older adults saw an increase of 21% to 23%, “signaling a fundamental shift in the epidemiological landscape of heart failure,” the report said.”
  • and
    • “The CDC is calling for greater surveillance of Cladophialophora bantiana after a clinical reference laboratory recorded a sharp increase in detections of the rare fungus, which is associated with a 60% to 70% case-fatality rate.
    • “The findings were published Oct. 2 in the CDC’s Morbidity and Mortality Weekly Report.”
  • Chief Healthcare Executive adds,
    • “A substantial cohort with early cardivascular disease, occult cancers, metabolic and autoimmune disease produces actionable pre-symptomatic signals, but remains unengaged due to care models optimized for reactive, symptom-driven encounters. 
    • “Existing clinical data are often sufficient for earlier identification; the limiting factor is delivery infrastructure that operationalizes insights into consistent follow-up, diagnostics, referral, and treatment at scale. 
    • “AI and analytics can reduce mortality in acute settings, but predictive models create value only when embedded in workflows that reliably trigger intervention rather than generating unactioned risk flags. 
    • “Precision medicine illustrates the same implementation bottlenecks, with barriers including reimbursement, workflow integration, clinician adoption, data management, and engagement; only ~35% of eligible lung cancer patients receive biomarker-driven therapy. 
    • “Competitive advantage in precision health will hinge less on maximal data acquisition than on building an “operating system” that converts what is already known into earlier, lower-cost, outcome-improving care pathways.”
  • The American Medical Association lets us know what doctors want patients to know about headaches.
    • “Headaches affect nearly everyone, though some can be especially debilitating like migraine attacks. Each type requires specific treatment and approaches.”
  • Health Day relates,
    • “If you’ve developed type 2 diabetes before age 45, it’s possible to push the disease into remission with weight-loss dieting and a fitness program that includes aerobic and muscle-building resistance exercise, a new study confirms.
    • “In early-onset type 2 diabetes, combining structured aerobic and resistance exercise with a low-calorie diet produces high remission rates, induces fat loss while preserving muscle mass, improves muscle quality and function, enhances cardiovascular health, and leads to meaningful improvements in patient-reported outcomes,” concluded a team co-led by Dr. Kaberi Dasgupta. She directs general internal medicine at McGill University in Montreal.
    • “Her team presented its findings Wednesday in Milan at a meeting of the European Association for the Study of Diabetes. The findings were simultaneously published in The Lancet Regional Health Americas.”
  • and
    • “A teenager’s daily step count may improve more than their physical health — it may also help protect their mental health.
    • “Researchers tracked more than 5,500 adolescents (average age: 12), using Fitbits, brain scans and mental health assessments.
    • “After one year, teens who took 12,000 or more steps a day had fewer mental health symptoms than those who took fewer than 5,000.
    • “More steps were also associated with greater thickness in two specific regions of the brain involved in motor and cognitive functions.
    • “Dr. Claudine Higdon, a child and adolescent psychiatrist at Northwell Health in Glen Oaks, New York, called the findings exciting.
    • “The good thing about it is this particular brain region is really linked with decision-making; the attention part of the brain,” said Higdon, who reviewed the study results. “And so that can thereby improve choices and improve impulse control. And that might also lead to improved mental health.”
  • MedScape tells us,
    • “The list of possible side effects attributed to statins is long: muscle pain, memory problems, depression, sleep disturbances, diabetes, and liver damage. However, a meta-analysis by the Cholesterol Treatment Trialists’ (CTT)Collaboration in The Lancet calls many of these associations into question. At the same time, the study confirmed that certain effects on muscles, the liver, and glucose metabolism can indeed occur. What matters, however, is their magnitude — and that is usually significantly lower than what the public criticism of these drugs would suggest.”
  • BioPharma Dive informs us,
    • “A combination of Genmab and AbbVie’s bispecific antibody Epkinly and standard chemotherapy cut the risk of disease progression or death by nearly half when compared to chemo alone in a Phase 3 trial in newly diagnosed lymphoma patients, the companies said Monday.
    • “The data in diffuse large B-cell lymphoma surpassed investor expectations, bested a rival Roche treatment and could significantly propel sales of Epkinly, one Wall Street analyst said. Epkinly is now on track to become the first drug of its kind to gain approval in first-line DLBCL, the most common form of lymphoma. 
    • “Genmab splits ownership rights to Epkinly with AbbVie and reported $312 million in global net sales on the therapy in the first half of the year.”
  • Per an Arrivent news release,
    • “ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the FURVENT (NCT05607550) Phase 3 trial evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review (BICR). Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed objective response rate by BICR. Although not yet mature, a trend toward an improvement in overall survival was also observed.  The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.
    • “These disappointing results are not what we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options,” said Bing Yao, Ph.D., Chairman, Chief Executive Officer of ArriVent. “While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study. We are deeply grateful to the patients, investigators and clinical teams who made this program possible and are evaluating the full FURVENT dataset as we determine the most appropriate development path for firmonertinib.”

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

  • Fierce Healthcare reports,
    • “Highmark is making a change at the top, with Karen Hanlon stepping to the role of CEO on Jan. 1.
    • “The Pittsburgh-based insurer announced Tuesday that current CEO David Holmberg, who has held the title since 2014, will transition to executive chairperson at Highmark. Hanlon, who is currently Highmark’s president, will become the company’s first female CEO.
    • “At the helm of Highmark, Hanlon will spearhead strategy, operations and performance across Highmark’s health plans, diversified businesses and Allegheny Health Network. She’s spent nearly three decades at Highmark, during which the organization grew from a $17 billion revenue business in 2014 to a projected $35 billion at the end of this year.”
  • and
    • “Option Care Health, a provider of infusion therapy services, is being acquired by private equity firm CD&R and healthcare conglomerate McKesson in a deal valued at $5.8 billion, the companies announced Tuesday morning. 
    • “The purchase will take Option private at a per-share offer price of $32.05, a 37% premium over the company’s closing price. Its stock had begun trending higher after close when early reports of the definitive agreement began to swirl, and as of Tuesday morning, it is trading at about $31 per share.
    • “The deal is expected to close in the first half of 2027, subject to customary closing conditions like regulatory approvals and shareholder go-ahead. It would leave CD&R with a 51% stake in the company and McKesson a roughly 49% interest, for which it plans to invest about $1.4 billion. The agreement also outlines a framework for McKesson to acquire CD&R’s interest in the future, according to the announcement.”
  • Beckers Hospital Review relates,
    • “HCA Healthcare owned more general hospitals than any other U.S. health system at the end of 2025, according to an analysis from the Lown Institute, published Oct. 6.
    • “The analysis draws on Lown’s hospital ownership dataset, which tracks the ownership of U.S. acute care and critical access hospitals from 2020 through 2025. Counts may differ from systems’ own figures, since Lown includes only those hospital types.
    • “Together, the 10 largest systems own 695 hospitals, or about 16% of general hospitals, and nearly 20% of beds in the dataset. Their hospitals accounted for about 25% of hospital profits in 2024, based on Medicare cost reports.
    • “Seven of the 10 systems owned fewer hospitals in 2025 than in 2020, according to Lown. Advocate Health added the most, 21 hospitals, following the 2022 merger of Advocate Aurora Health and Atrium Health.”
  • and
    • “Hospitals are the leading source of medical debt in the U.S., with more than half of adults with medical debt owing money for hospital services, according to an Oct. 6 Urban Institute report funded by the Robert Wood Johnson Foundation.
    • “The report draws on December 2025 data from the institute’s Well-Being and Basic Needs Survey. The nationally representative survey covers more than 10,000 adults ages 18 and older, who reported debt owed by themselves or family members.
    • “Overall, 26.6% of U.S. adults said they or a family member owed medical debt.”
  • Fierce Healthcare adds,
    • “Datavant is partnering with identity verification company ID.me to help patients request their medical records faster and more easily via simple digital credentials.
    • “By integrating ID.me’s digital identity verification into Datavant’s Patient Request Tool, the companies aim to reduce friction, speed up access to records and strengthen safeguards against unauthorized access.
    • “ID.me is a secure, private digital identity platform that acts as an independent “identity wallet.” Twenty-three federal agencies, 50 state government agencies and more than 100 healthcare organizations use ID.me for secure identity verification and the company boasts more than 175 million users.
    • “Datavant offers a data exchange network that connects more than 80,000 hospitals and clinics, 75% of the 100 largest health systems and an ecosystem of 350-plus real-world data partners. Its platform connects datasets across electronic health records, claims, specialty pharmacy, registries, imaging, labs and social determinants of health. Datavant’s data collaboration platform enables more than 60 million healthcare records to move between thousands of organizations.”
  • and
    • “Gilead Sciences is taking a step into the wellness space to support patients with chronic diseases by offering resources that go beyond physical health. The company is partnering with mindfulness app Calm to provide curated content for those impacted by cancer, HIV and liver conditions. 
    • “More than one-third of people living with HIV in the U.S. experience depression, while 28% have an anxiety disorder, according to Gilead and Calm. Additionally, those with HIV often struggle with stigma that can stir up feelings of shame and anxiety. 
    • “Meanwhile, about 50% of people with cancer experience distress, with some two in ten people with cancer reporting symptoms of depression. For those with liver conditions such as primary biliary cholangitis (PBC), symptoms such as fatigue, chronic itch and brain fog can take a toll on daily life, Gilead points out.”  

Nobel Prize

  • The Wall Street Journal reports,
    • “Belgian particle physicist Francis Halzen was awarded the 2026 Nobel Prize in Physics for his contributions to astronomy and his work on the IceCube Neutrino Observatory at the South Pole.
    • “Francis Halzen has led an international team of researchers and engineers who have provided us with a fantastic instrument,” said Mark Pearce, chair of the Nobel Committee for Physics, on Tuesday.
    • “His tenacity and scientific vision has paved the way for a new kind of astronomy.”
    • “As the spearhead behind the IceCube Neutrino project, Halzen wanted a way to capture and study astrophysical neutrinos—tiny, electrically neutral subatomic particles from deep space.
    • Neutrinos with extremely high energies are created in the same environments as other types of particles, but unlike other particles, neutrinos reach Earth without changing direction or losing energy. This means they can provide information about distant galaxies that isn’t available in any other way.
    • “Halzen, who is 82-years-old and based at the University of Wisconsin-Madison, first presented his vision for capturing high-energy neutrinos at the South Pole—a giant particle detector buried deep in the Antarctic ice—in 1988.”

Monday report

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

Simplicity is a virtue.

From Washington, DC

  • Beckers Payer Issues reports,
    • “The Trump administration is overhauling federal price transparency rules for payers and self-insured employers, including cutting so-called “ghost rates,” expanding out-of-network price disclosures and requiring executives to vouch for the accuracy of the data.
    • “The final rule, released Oct. 5 by CMS and the Labor and Treasury departments, revises the price transparency regulations first finalized in 2020 during President Trump’s first term, which have required payers to post their negotiated rates since 2022. Hospitals have been required to post their prices under separate federal rules since 2021. The new rule takes effect Dec. 5, though most of the data requirements will be phased in across 2027. 
    • The change follows a CMS proposal and an executive order from the president last year that directed federal agencies to step up price transparency enforcement.”
  • The rule is applicable to the FEHB and PSHBP programs pursuant to the Public Health Act, which CMS regulates.
  • Here is a CMS link to the agency’s fact sheet on the new TiC rule.
  • Also today, CMS released an update to its Group Health Plan user guide for Section 111 reporting.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Michael R. Caputo to the President’s Cancer Panel. The panel is an independent federal advisory body charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the President on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.
    • “Caputo brings 35 years of global public affairs experience spanning government, public policy, political campaigns, and the private sector. He previously served as Assistant Secretary for Public Affairs at HHS in 2020, where he led the Department’s communications during the COVID-19 response and helped establish and guide Operation Warp Speed.”
  • Beckers Hospital Review lets us know,
    • “Healthcare accounted for about 3 of every 4 U.S. jobs added from September 2025 to September 2026, according to an Oct. 5 analysis from the Peterson-KFF Health System Tracker.
    • “The sector added 372,000 jobs during that period, a 2% increase, while the rest of the economy added 124,000, a 0.1% increase. Healthcare job growth outpaced every other sector, and the industry now makes up a record 11.7% of all U.S. jobs.
    • “In September, healthcare added 17,000 jobs, below its average monthly gain of 33,000 over the prior 12 months, according to Bureau of Labor Statistics data.”
  • and
    • “The Federal Trade Commission has warned 24 of the nation’s largest health systems that incomplete, inaccurate or untimely price disclosures could violate federal consumer protection law, even if the organizations comply with CMS’ hospital price transparency requirements.
    • “FTC Chair Andrew Ferguson on Oct. 5 sent letters to the organizations urging them to review their pricing practices and take corrective action where needed, particularly for routine, nonemergency services scheduled in advance.
    • “The letters mark another layer of federal scrutiny for hospitals’ pricing practices. The FTC said CMS’ price transparency rules establish a baseline for disclosures but do not provide hospitals with a “safe harbor” from liability under Section 5 of the FTC Act, which prohibits unfair or deceptive business practices.”
  • MedTech Dive adds,
    • “The Advanced Research Projects Agency for Health has awarded more than $100 million to four organizations working on biosensors.
    • “The Massachusetts Institute of Technology received the largest award, securing up to $37.9 million to develop a wearable patch for continuous sensing of heart failure biomarkers.
    • “The other recipients include Novelna, New York University and University of Washington, which are working on devices focused on heart attacks, inflammation and perimenopause. ARPA-H said it plans to commit a total of $117.4 million to the program over 4.5 years.”

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

  • Kevin Moss, writing in Federal News Network, explains “how the 2027 FEHB premium increase will impact federal employees and annuitants.”
  • FedSmith offers a potpourri of Open Season news.
    • “2027 FEHB Changes: Weight Loss Drug Rules, a New FSA Card, and Plans Leaving
    • “From weight loss drug rules to a new FSA card and plans leaving the program, here are the biggest 2027 FEHB changes to know before Open Season.” * * *
    • “Full FEHB, PSHB, and FEDVIP plan brochures and OPM’s Plan Comparison Tool will be available on OPM.gov in early November.
    • “Open Season changes for non-postal employees take effect January 10, 2027. Changes for PSHB enrollees and annuitants take effect January 1, 2027.”

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

  • ABC News reports,
    • “More than 122,000 cases of Gatorade are being voluntarily recalled due to undeclared food dyes, according to the U.S. Food and Drug Administration.
    • “The recalled cases of Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange and Gatorade Orange Zero were distributed in more than two dozen states, the FDA said.
    • “The recall impacts 28-ounce bottles of Gatorade Lemon Lime, Lemon Lime Zero, Orange, and Orange Zero that did not declare the presence of Yellow No. 6 and/or Yellow No. 5 colors and bear lot dates between April 2027, May 2027 and June 2027. A full list of lot dates and states where the recalled drinks were distributed can be viewed on the FDA website.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches. The RFI seeks comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight.
    • “This RFI marks the latest FDA action to advance President Trump’s April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness, which directed agencies to accelerate research into psychedelic medicine.” * * *
    • “The public will have 45 days following publication in the Federal Register to submit comments, data or information to the docket. Stakeholders are encouraged to submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429. Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • “The comment period closes Friday, November 20, 2026. Late comments will not be considered.”
  • Becker’s Hospital Review relates,
    • “The FDA has approved pirtobrutinib (Jaypirca, Eli Lilly) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion.
    • T”he Oct. 2 approval was based on BRUIN CLL-313, a trial involving 282 patients randomized 1:1 to receive pirtobrutinib or bendamustine plus a rituximab product for six cycles.
    • With an estimated median follow-up of 28 months, median progression-free survival was not estimable in the pirtobrutinib arm and was 33.5 months in the bendamustine and rituximab arm.
    • Serious adverse reactions occurred in 28% of patients taking pirtobrutinib. The most common nonlaboratory adverse reactions were upper respiratory tract infections (27%), rash (22%) and COVID-19 (21%). The recommended pirtobrutinib dose is 200 milligrams orally once daily until disease progression or unacceptable toxicity. The drug received orphan drug designation.
  • Radiology Business tells us,
    • “The U.S. Food and Drug Administration has cleared AI software designed to improve pediatric bone age assessments. 
    • “The 510(k) clearance covers Visiana’s BoneXpert, a machine learning software that determines bone age in patients ages 2 to 21 using the Greulich-Pyle method. The software is intended to support pediatric radiologists in evaluating children with growth and pubertal disorders. 
    • “Bone age assessments are commonly used to evaluate whether a child’s skeletal development is consistent with their chronological age. Manual assessment is a known challenge and can vary between readers, potentially making longitudinal evaluation more difficult.  
    • “BoneXpert addresses this by analyzing radiographs of either hand and providing an annotated image showing the contours of the bones it evaluated and the individual bone ages assigned to them. The software also checks each radiograph and withholds a result when an image falls outside its validated scope, while the radiologist remains responsible for the final assessment and diagnostic decision.” 
  • Benzinga adds,
    • “The U.S. Food and Drug Administration has extended its review of Novo Nordisk A/S’ (NYSE:NVO) Biologics License Application for denecimig, an investigational hemophilia A treatment, following a manufacturing plant inspection.
    • “Mike Doustdar, president and CEO of Novo Nordisk, said the company is addressing agency requests as efficiently as possible while working closely with regulators to make better care something patients can count on.”

From the Medicare Advantage front,

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. has cut its Medicare Advantage footprint in half less than two years after buying Cigna’s Medicare business for $3.3 billion, but the Chicago-based insurer says the narrowed focus will allow it to achieve sustainable growth over time.
    • “The company is coming off a costly year, posting a net loss of more than $1.9 billion in 2025, after net income of $659 million the year prior. HCSC attributed the loss to elevated utilization and higher acuity across all of its lines of business.
    • “We’re actually at or ahead of most of the targets we set before the deal closed, from an integration and financial performance perspective,” Stephen Harris, president of government markets at HCSC, told Becker’s. “We feel really good about where we are and the momentum we have going into 2027.”

From the judicial front,

  • Fierce Healthcare offers a overview of “healthcare’s high-stakes courtroom battles.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Pennsylvania’s measles outbreak has hit a sobering milestone, surpassing 1,000 cases — the first U.S. outbreak to do so in 35 years.
    • “In Pennsylvania, the virus has moved through communities where many children and adults have gone years without the two doses of measles vaccine needed for reliable protection. The widening outbreak has infected 1,004 people spread across 39 counties and hospitalized nearly 200 people, authorities reported Monday.”
  • The New York Times adds,
    • “Gov. Kathy Hochul declared a statewide health emergency in New York State on Monday as measles cases increased dangerously across rural counties where vaccination rates have lagged.
    • “As of Saturday, 108 measles cases had been reported across the state this year, the most since 2019, when New York was the epicenter of a national outbreak. Most of the cases are in rural areas, concentrated in the Finger Lakes region.
    • “Ms. Hochul’s declaration will relax rules about who can administer vaccines to make it easier for midwives, pharmacists and other health care workers to give shots to prevent measles.”
  • NBC News relates,
    • “The chickenpox vaccine appears to protect against shingles, according to a large new analysis. 
    • “Anyone who got infected with chickenpox as a child is at risk of later developing shingles, a painful, blistering rash that usually appears on one side of the body. For unknown reasons, cases of shingles have been gradually rising, even among younger adults, research has shown.
    • “However, new data suggests that a steep decline in chickenpox cases over the last three decades, thanks to the chickenpox vaccine, may contribute to a decline in shingles in the coming years.
    • “New data suggests that people ages 34 and younger may be less likely to develop shingles than previous generations. That’s because they are more likely to have been vaccinated against the varicella zoster virus, or chickenpox, which can reactivate years later as shingles.
    • “Our data suggest that trend is now reversing in the very youngest adults, the first generation eligible to be vaccinated against chickenpox as children,” said registered nurse Kersten Bartelt, lead author of the report from Epic Research, which conducts research on health trends.”
  • MedPage Today tells us,
    • “Hormone therapy should be the first-line treatment for women with menopausal vasomotor symptoms, according to new guidance from the American College of Physicians (ACP).
    • “Women with a uterus should receive estrogen in combination with progestogen, while those without a uterus can receive estrogen monotherapy as first-line therapy, according to ACP’s new clinical guidelineopens in a new tab or windowon pharmacologic treatments for vasomotor symptoms.
    • “Both are listed as strong recommendations based on high-certainty evidence, Amir Qaseem, MD, PhD, MHA, and guideline authors wrote in the Annals of Internal Medicine.”
  • Beckers Behavioral Health calls attention to “the drug trends mot worrying to behavioral health leaders.”
    • “Fentanyl is no longer the only substance keeping addiction clinicians up at night. Some of the newest threats are being sold not by dealers, but at gas stations, smoke shops and online.
    • “From potent animal sedatives contaminating the opioid supply in the Northeast and Midwest to concentrated kratom derivatives marketed as botanical supplements, the substances patients are using are changing faster than the systems built to respond to them. At the same time, technology is making behavioral addictions such as online sports betting more accessible than ever. 
    • “Becker’s asked three psychiatry and addiction medicine leaders what trends they are seeing among their patients, which drugs they expect to take off and what worries them most.”
  • Cardiovascular Business informs us,
    • “Orforglipron, a GLP-1 pill being sold by Eli Lilly and Company under the brand name Foundayo, is both safe and effective in obese or overweight patients with type 2 diabetes. That was the primary takeaway from new data presented at the European Association for the Study of Diabetes annual meeting in Milan, Italy, and simultaneously published in The Lancet.[1]
    • “In April, the U.S. Food and Drug Administration (FDA) approved orforglipron as a once-daily treatment for weight-related medical problems in obese and overweight adults. When the FDA requested additional data on the drug’s effect on cardiovascular outcomes, Lilly shared early positive results from ACHIEVE-4, a randomized trial of more than 2,700 patients who received either orforglipron or insulin glargine. Now, the full results of that analysis have been shared with the public for the first time.
    • “Overall, the researchers behind ACHIEVE-4 found that orforglipron was associated was a 16% lower risk of major adverse cardiovascular events (MACEs) than insulin glargine. A MACE was defined as either cardiovascular death, a heart attack, a stroke or a hospitalization for unstable chest pain. This finding met the prespecified criteria to be seen as noninferior to insulin glargine.”
  • BioPharma Dive points out,
    • “An experimental pneumococcal vaccine from Vaxcyte succeeded in the first of three late-stage studies, sending the biotechnology company’s shares soaring and inching it closer to a potential regulatory submission.
    • “Called VAX-31, the shot met all of its main efficacy objectives in the study. Among adults 50 years or older, VAX-31 matched the effectiveness of Pfizer’s Prevnar 20 and Merck & Co.’s Capvaxive in protecting against 28 strains of the bacteria that causes pneumococcal disease and proved superior against three “unique” strains. VAX-31 was inferior compared to Capvaxive on two strains when using a more rigorous statistical threshold. But that finding surpassed analyst and investor expectations heading into the readout.
    • “Vaxcyte said its vaccine was “well tolerated” and demonstrated a safety profile similar to Prevnar 20 and Capvaxive across all ages studied. The most common adverse events were “generally mild-to-moderate,” and the majority resolved within two days of vaccination. Vaxcyte will report results from two additional late-stage trials next year and seek approval if the data are positive.”

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

  • STAT News reports,
    • “Workers and employers are drowning in their health insurance premiums. The reason for that deluge: the health care industry’s high and inscrutable prices.
    • “Health insurers don’t set their premiums in a vacuum. The biggest factor is the care people receive. And the biggest factor driving the cost of that care, STAT has found, is not how often people are going to the hospital or doctor’s office, but the out-of-control prices charged by every part of the health care industry, which workers and businesses are often powerless to stop.
    • “For Gerard Anderson, America’s high prices are as obvious, yet unnoticeable, as the oxygen we breathe. He has studied health care spending and policy for the past four decades, even helping design Medicare’s hospital payment system in the 1980s. He co-wrote a seminal paper in 2003, and again in 2019, that blared the culprit of America’s outlier health spending figures: “It’s the prices, stupid.” 
    • “Some things don’t change,” Anderson, a professor at Johns Hopkins, told STAT. 
    • “One thing is changing, however, Anderson said. He and others are working with state policymakers and employers, who are signaling an openness to government intervention to curb health care costs — an idea normally anathema in the private sector.”
  • BioPharma Dive relates,
    • “Shionogi is expanding in rare diseases, announcing Monday a deal to acquire Texas-based IntraBio for a drug called Aqneursa that has gained approvals in two inherited disorders.
    • “Per deal terms, Shionogi will pay IntraBio’s shareholders $2 billion in cash and turn the company into a wholly owned subsidiary of its New Jersey-headquartered U.S. division. Shionogi said it will review the transaction’s effects on its financial outlook for the current fiscal year, which ends next March.
    • “The transaction will help expand a rare disease business Shionogi launched with the acquisition last year of the ALS drug Radicava from Tanabe Pharma. Aside from Radicava, Shionogi’s U.S. portfolio includes the COVID-19 medicine Xocova and a treatment for complicated urinary tract and hospital acquired respiratory infections.”
  • The Wall Street Journal adds,
    • “GE HealthCare Technologies GEHC said Monday it planned to purchase a manufacturer of radioactive substances used in medical imaging procedures for $945 million in cash.
    • “The deal marks a continued push by medical-equipment maker GE HealthCare into the growing market for radiopharmaceuticals, which have uses for both diagnosing and treating diseases including cancer, heart disease and Alzheimer’s. 
    • “Drugmakers such as Novartis and other devicemakers have been investing in the segment. In August, Curium struck a deal to acquire Lantheus Holdings for an initial $6.7 billion in a consolidation of two radiopharma companies.”
  • Beckers Hospital Review tells us,
    • “Chicago-based CommonSpirit Health will consolidate its five regions into three service areas, West, Central and East, effective in January, CFO Michael Browning said during the system’s fiscal 2026 earnings call Oct. 2.
    • “The change replaces the California, Central, South, Mountain and Northwest regions established after a 2024 portfolio review that consolidated eight operating divisions into five. Each service area president will sit on the system’s enterprise leadership cabinet.
    • “CommonSpirit confirmed in a September statement to Becker’s that it was evolving its operating model “to better leverage our system scale and more effectively support our markets.”
  • and
    • “Salt Lake City-based Intermountain Health is exiting Trinsic, a Colorado clinically integrated network it operates as a joint venture with Aurora, Colo.-based UCHealth, with UCHealth taking over the network after Dec. 7, according to a WARN notice Intermountain filed Oct. 2 with the Colorado Department of Labor and Employment.
    • “The notice says Trinsic’s Broomfield, Colo., operating unit will close Dec. 4 and 117 employees will be affected, with first separations expected Dec. 9. Affected roles include 29 nurse care managers, 24 clinical care coordinators and 14 nonclinical care coordinators.
    • “Intermountain said in the notice that it expects most, if not all, Trinsic employees who live and work in Colorado will have the opportunity to keep working for Trinsic, subject to UCHealth’s hiring decisions. Employees who live and work outside Colorado may not have the same opportunity.”
  • Fierce Healthcare informs us,
    • ‘Trinity Health grew its operating income from a narrow loss to a $281.1 million gain (1.1% operating margin) in the fiscal year ended June 30, 2026, a performance improvement the large nonprofit attributed to stronger volumes, expense management and payment rates. 
    • “Operating revenue across the organization rose 5.2% year over year to $26.8 billion, outpacing a 4.4% rise in operating expenses, according to recently shared financial documents. 
    • “When disregarding “other items” including asset impairment charges ($42.7 million in FY2026) and restructuring costs ($103.9 million in FY2026), the 91-hospital system more than doubled its operating income to $427.8 million (1.6% operating margin) in the fiscal year ended June 30, 2026, its management touted in a financial summary.”
  • and
    • “iRhythm completed on Monday its acquisition of cardiac remote patient monitoring company VitalConnect for $237.5 million.
    • “iRhythm provides end-to-end cardiac monitoring services, while VitalConnect’s monitoring platform supports multiple modalities—and has the capability to monitor up to 11 physiological parameters, according to an Oct. 5 press release.
    • “In addition to the $237.5 million deal, iRhythm provided VitalConnect with $10 million in working capital between signing and closing, executives say. The acquisition is expected to increase iRhythm’s revenue growth rate and maintain its 15% adjusted EBITDA margin target for 2027.”
  • and
    • “Grindr is ramping up its focus on healthcare with plans to acquire PurposeMed Inc., the parent company of telehealth provider Freddie.
    • “Freddie provides access to HIV prevention and PrEP care through telehealth visits. Grindr plans to pick up PurposeMed for $250 million in cash and stock, consisting of $190 million in cash and $60 million in Grindr common stock. 
    • “The agreement also includes the potential for up to $70 million in additional cash consideration tied to 2027 performance targets, payable in 2028. The companies expect the deal to close in the fourth quarter, subject to applicable closing conditions.”
  • Beckers Clinical Leadership points out the ten most in-demand physician specialties.
    • “Hematology/oncology
    • “Gastroenterology
    • “Cardiology (interventional)
    • “Endocrinology
    • “Cardiology (noninvasive)
    • “Radiology
    • “Urology
    • “Anesthesiology
    • “Neurology
    • “Obstetrics/gynecology
      • View the full report here.

From the Nobel Prize front,

  • The Wall Street Journal reports,
    • “A trio of neuroscientists were awarded the 2026 Nobel Prize in Physiology or Medicine for their pioneering work on optogenetics, a method of controlling nerve cells with light, which makes it possible to study how the brain shapes memories, feelings and behaviors.
    • “Announcing the prize recipients Monday at the Karolinska Institute in Stockholm, the Nobel committee said the work of Drs. Karl Deisseroth, Peter Hegemann and Georg Nagel had laid the foundation of a new era in neuroscience.
    • “The work “unlocked new understanding of how the brain works, new possibilities for treating neurological and psychiatric disorders,” said Jonathan Levin, president of Stanford University, where Deisseroth is a neuroscientist and psychiatrist. 
    • “Hegemann is based at Humboldt University in Berlin and Nagel at the University of Würzburg in Germany.”

Weekend update

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

Simplicity is a virtue.

From Washington, DC

  • Both Houses of Congress have left Capitol Hill for the campaign trail.
  • SCOTUSblog reports,
    • The Supreme Court’s 2026-27 term will officially kick off on Monday [October 5]. The justices will hear argument that morning in two cases: Suncor Energy Inc. v. County Commissioners of Boulder County, on whether a lawsuit filed in Colorado state court seeking to hold energy companies responsible for their alleged role in climate change can go forward, or whether federal law instead bars such claims; and Johnson v. United States Congress, on whether a federal district court may hear a constitutional challenge to a law limiting disability benefits for certain incarcerated veterans.”
  • The Centers for Medicare and Medicaid Services announced last Thursday,
    • Medicare Improvement Fund Premium Rebate Frequently Asked Questions
    • Q: What will the Medicare Improvement Fund do for Medicare beneficiaries? 
    • A: The Administration is making a $90 Premium Rebate available for Part B premiums to certain Medicare beneficiaries because the best way to improve Medicare is to put healthcare dollars back where they belong – in the hands of our Medicare beneficiaries – and make coverage more affordable. 
    • Q: How much is the Medicare Improvement Fund Premium Rebate and when will beneficiaries receive it?
    • A: Eligible beneficiaries will receive one $90 rebate in October 2026. Most beneficiaries will receive a direct deposit for $90 on or around October 8th followed by an email or a letter from the President in mid-October. Some beneficiaries will receive a paper check for $90 from the U.S. Department of the Treasury later in October with the following accompanying message “Medicare Improvement Fund Payment; $90 Payment to Offset October Premium.” 
    • Q: Who will receive the Medicare Improvement Fund Premium Rebate?
    • A: The 20.8 million Americans in Original Medicare Part B who are: (1) Living in the United States, are (2) not receiving premium assistance from Medicaid; or, (3) not paying an Income-Related Monthly Adjustment Amount. Beneficiaries enrolled in Medicare Advantage are not eligible.
  • FEHBlog observation — While the FEHBlog is on Original Medicare Part B and lives in the U.S. he is ineligible for the rebate because he pays an IRMAA fee on top of his Part B premiums. It’s still a good deal.
  • The Wall Street Journal reports
    • “A new White House task force will have 120 days to report on the risks and opportunities of artificial intelligence—and determine the federal government’s responsibility—according to Jay Clayton, the director of national intelligence who effectively becomes the administration’s AI czar.
    • “The president asked that a group be put together that was going to ensure exactly what he said,” Clayton said, that “we stay the leaders in superintelligence, and that the interests of the American people are put first.” 
    • “Clayton will chair the “Super Intelligence Force” which takes President Trump’s preferred name for AI: super intelligence or SI.” * * *
    • “The task force will have three vice chairs: Emil Michael, undersecretary of war for Research and Engineering, who will be responsible for coordination with AI companies; Scott Kupor, director of the Office of Personnel Management, who will be responsible for coordination with critical infrastructure providers and other industry stakeholders; and Andrew Ferguson, chairman of the Federal Trade Commission, who will oversee consumer interests and groups advocating for people of faith, children, privacy, freedom of speech, freedom of expression, and freedom of association.
    • “Members of the task force will include Vice President JD Vance, Defense Secretary Pete Hegseth, Richard Walters, White House deputy chief of staff, Bessent, Wiles and others. External participants will include venture capitalists David Sacks, co-chair of the president’s Council of Advisors on Science and Technology and Condoleezza Rice, former Secretary of State in the George W. Bush administration, who will provide advice on national security.”

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

  • My Federal Retirement considers whether “Fraud is driving your FEHB premium increase based on what OPM’s numbers reveal.
    • OPM’s numbers fail to consider that the proper payment rate for the carriers that cover the vast majority of FEHB and PSHB members is 99.9% according to paymentaccuracy.gov and what’s more OPM, not withstanding carrier requests, has not implemented the HIPAA 820 electronic roster transaction which would allow carriers to reconcile premiums with individual enrollee coverage. The HIPAA 820 has been around since 2012.
  • FedSmith reports,
    • “Seven months ago, the OPM retirement backlog stood at a record 65,237 claims. At the end of September 2026, it stood at just 8,814, the lowest total in data going back to January 2012.
    • “September also closed out fiscal year 2026 (FY 2026), which ran from October 2025 through September 2026. It was by far the busiest year in the data for both incoming and completed retirement claims.
    • “New claims received: 179,958, up 59% from FY 2025 (112,857) and well above the previous high of 116,463 in FY 2013
    • “Claims processed: 178,551, up 70% from FY 2025 (104,800)
    • “Backlog: began the year at 23,552, peaked at 65,237 in February, and ended at 8,814
    • “The wave of claims that defined the first half of the year followed the end of the deferred resignation period in September 2025 and broader reductions to the federal workforce. Monthly intake has since settled back toward more typical levels, with fewer than 9,000 new claims in three of the last four months.”
  • FEHBlog observation: The favorable change is attributable to the OPM Director’s implementation of a digital retirement claim system. The HIPAA 820 would similarly reduce the time needed to process premiums and for the first time allow carriers to reconcile premiums with individual enrollments.

No Surprises Act News,

  • The Centers for Medicare and Medicaid Services announced last Friday
    • “On November 1, 2026, the Notice of IDR Initiation web form will include new functionality to enforce certain batching provisions under the Federal IDR Operations Final Rule (final rule).
    • “The new functionality to be added to the Notice of IDR Initiation web form includes:
    • Any batched dispute submitted with an open negotiation period start date on or after November 1, 2026, will be limited to 50 dispute line items.
    • “System validations will enforce the timely initiation of a dispute after a 30-business-day cooling off period by preventing any dispute initiated after the cooling off period from being initiated before the end of the cooling off period or more than 4 business days after the end of the cooling off period.
    • “In addition to the Notice of Initiation web form changes, the payment determination letters will reflect the correct cooling off period based on the dispute type and open negotiation period start date.”
  • CMS Notes:
    • “Batched disputes with an open negotiation period start date before November 1, 2026, will continue to be subject to the 90-calendar-day cooling off period.
    • “Single and bundled disputes will also continue to be subject to the 90-calendar-day cooling off period regardless of the open negotiation period start date.
    • “For disputes subject to a 90-calendar-day cooling off period, disputing parties will continue to have 30 business days after the end of the cooling off period to submit a dispute to the Federal IDR process for any items or services whose open negotiation period expired during the cooling off period.
    • “System validations will continue to prevent any dispute from being initiated before the end of the 90-calendar-day cooling off period.
    • “Furthermore, system validations were added on September 24, 2026, to enforce timely initiation of disputes following a 90-calendar-day cooling off period, preventing any dispute initiated after the cooling off period from being initiated more than 30 business days after the end of the cooling off period.”‘

From the public health and medical research front,

  • The New York Times reports.
    • “The Food and Drug Administration said on Friday that it had found two samples of the cyclospora parasite during its investigation of Taylor Farms facilities in Mexico, strong new evidence that an outbreak that sickened thousands in the United States this summer came from lettuce produced by the company.” * * *
    • “Also on Friday, the F.D.A. announced a series of actions intended to prevent future cyclospora outbreaks. Those included greater surveillance of foods that have caused past outbreaks, which can include cilantro and raspberries, and outreach to growers about how to reduce the risk of produce contamination with the parasite.
    • “It is difficult to know whether those steps will be effective at preventing future outbreaks, since the F.D.A. has not yet determined how the lettuce at Taylor Farms was contaminated, said Jim Gorny, a produce safety expert who retired from the agency in 2024.
    • “Aside from that,” he said, “it’s just a recommitment to employ the same strategies and tactics over and over again hoping for a different outcome.”
    • “Bill Marler, a lawyer based in Washington State whose office represents about 500 people sickened in the outbreak, said there is still more to learn from additional analysis of the samples from the inspection and stool samples of those who fell ill.
    • “But before next growing season, he said, it would be ideal if federal officials could invest in the development of a water test to routinely surveil water for cyclospora, which does not currently exist. He would also like to see officials enforce a federal rule requiring food companies to hand over supply chain records in 24 hours after a product is implicated in an outbreak.
    • “The F.D.A. finalized such a rule but delayed its implementation last year, potentially slowing down the response to this outbreak, The New York Times found.”
  • The Independent relates,
    • “Florida is experiencing its largest dengue outbreak in decades, with 252 locally acquired cases reported as of late September, among the highest totals seen in the continental U.S. in several decades.
    • “The vast majority of cases have been reported in Hillsborough County, home toTampa, where officials are ramping up mosquito-control efforts, according to the latest numbers released by state health officials. Florida has also recorded 245 travel-associated cases this year, while at least 13 Hillsborough County cases involved people who had recently traveled.
    • “The surge has prompted Hillsborough, Pasco and Pinellas counties to declare local states of emergency and step up efforts to kill mosquitoes and eliminate standing water where they breed.” * * *
    • “Dengue is a viral infection spread primarily through bites from infected Aedes aegypti and Aedes albopictus mosquitoes, both of which are found in Florida. Some people have no symptoms, while others can develop a sudden fever, severe headache, pain behind the eyes, muscle and joint pain, nausea or vomiting.
    • “Most people recover, but dengue can sometimes become severe, causing bleeding, shock and death. Florida has reported one dengue-related death this year, involving an elderly Tampa woman who died on September 4.”
  • MedPage Today reminds us,
    • “It’s October and time for flu shots.
    • “Medical experts urge getting a flu vaccination soon, before influenza starts spreading widely — and to get up to date on protection against other fall respiratory viruses, too. Updated COVID-19 shots are available now, plus shots for people especially vulnerable to another winter risk, respiratory syncytial virus (RSV).
    • “While these infections make many people feel miserable for a few days before they recover, every year flu alone causes hundreds of thousands of hospitalizations in the U.S. and kills tens of thousands.”
  • Surprisingly, Health Day informs us,
    • “Colon cancer in U.S. adolescents is on the rise, experts say, and a new report finds it’s typically caught in its more deadly later stages.
    • “Colorectal cancer is, unfortunately, becoming more common in adolescents and young adults and represents a different disease than colorectal cancer diagnosed in older adults,” said study author Dr. Erica Arnold, a pediatric surgery research fellow at Nationwide Children’s Hospital in Columbus, Ohio.
    • “She said colon cancer diagnosed in adolescents “is often aggressive, presenting with late-stage disease and associated with high rates of disease relapse and mortality.” She spoke in a news release from the American Academy of Pediatrics (AAP).” * * *\
    • “The study said symptoms that could indicate colon cancer in young people include unexplained weight loss, rectal bleeding, back/abdominal pain and changes in bowel habits. 
    • “Because colon cancer is so unexpected in this age group, diagnosis is often delayed, the study group warned. 
    • “Children and adolescents without known colorectal cancer predisposition syndromes experience delays in diagnosis and the majority do not have a known family history,” the researchers noted in their study. 
    • “Routine colon cancer screening for people at average risk usually begins at age 45.
    • “The study authors urged physicians to consider this cancer in any young person presenting with symptoms such as abdominal pain or rectal bleeding. 
    • “Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal.”

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

  • The New York Times reports,
    • Starting Thursday [October 1], women across the United States will be able to find out their risk of developing breast cancer in the near future with the help of an A.I. tool that examines a single recent mammogram.
    • “Everlywell, a digital health company, announced it would now offer patients nationwide access to Clairity Breast, an A.I. tool approved by the Food and Drug Administration last year to predict a woman’s five-year risk of breast cancer based on imaging. The test, which was previously available only at select locations in Massachusetts and Colorado, will cost $249. It is not covered by insurance.
    • “Doctors use mammograms to detect the presence of cancer, sometimes with the help of A.I. models that can read the images. But Clairity’s software uses the scans for a different purpose: predicting the risk of developing cancer and providing a probability score that reports the patient’s future risk in the form of a percentage, from zero to 100.
    • “That score, which doctors should consider along with other clinical information like family and patient medical history and other risk factors, could aid in efforts to detect cancers earlier, when they are more treatable and more likely to have better outcomes, said Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at Valley Health System in Paramus, N.J.”
  • BioEngineer relates,
    • “Sleep problems in children are far more than a nightly nuisance for exhausted families. According to a recent nationally representative study by Carney and colleagues published in the Journal of Clinical Sleep Medicine, sleep disorders among children and adolescents in the United States add an estimated 2.88 billion dollars in health care expenditures every year, a burden significantly higher than that carried by children without sleep disorders.
    • “The finding, highlighted in an open access commentary by pediatric sleep specialist Sally L. Davidson Ward of Children’s Hospital Los Angeles and the Keck School of Medicine of USC, reframes pediatric sleep health as a major economic and public health issue rather than a niche clinical concern. The commentary argues that recognizing, treating, and where possible curing sleep disorders in individual children could simultaneously reduce spending, improve quality of life, boost school attendance, and free parents to work and care for their families.
    • “The underlying evidence comes from the Medical Expenditure Panel Survey, administered by the US Agency for Healthcare Research and Quality, covering the years 2017 through 2022. This survey is unusual in that it captures data from households themselves as well as from their medical providers, including clinics, hospitals, home health agencies, and pharmacies, along with a sample of insurance plans offered by employers. Crucially, the analysis adjusted for covariates and comorbidities that either facilitate or impede access to health care, or that influence the perceived need for care. That methodological rigor matters, because the question of whether sleep disorders drive excess spending, or whether sicker children simply use more services of every kind, is exactly the kind of confounding that national datasets can help untangle when handled carefully.”
  • The Washington Post discusses how to use patient advocates at the time of a family health crisis.
  • Last but certainly not least, AHIP created an illuminating infographic breaking up a dollar bill based on prescription drug spending.
    • “Health plans and PBMs [combined] retain just over one cent of every dollar spent on prescription drugs as profits — compared to 6.5 cents brand manufactures take in profits.”

Friday report

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

Simplicity is a virtue.

From Washington, DC

  • AHIP reports,
    • “The House Ways and Means Committee’s recent advancement of the Apples to Apples Comparison Act (H.R. 4093) signals policymakers recognize the growing need for more accurate data and assessments comparing Medicare Advantage (MA) and fee-for-service (FFS) Medicare. If enacted, this legislation would require Medicare to report more complete expenditure data and direct the Medicare Payment Advisory Commission (MedPAC) to compare MA and FFS using a more transparent and reliable methodology. 
    • “Key Context: Accurate and reliable analyses are essential to understanding how MA compares to FFS. It requires accounting for key differences between the programs – including the benefits provided within MA, different enrollment requirements, and demographics and health characteristics among MA enrollees. 
    • “A growing body of research points to significant questions and concerns with MedPAC’s current approach to comparing spending in MA and FFS, including its estimates of alleged favorable selection into MA and failure to account for the key programmatic, enrollment, and other differences.
    • “The Apples to Apples Comparison Act would address these concerns and ensure that policymakers have the information needed to accurately assess both programs.
    • “Why It Matters: Accurate comparisons between MA and FFS show that MA provides better care at lower costs than FFS. With 36 million American seniors and people living with disabilities choosing MA, policymakers should ensure they protect and strengthen MA for the seniors who count on it.”
  • Beckers Behavioral Health relates,
    • “HHS will provide $96 million over four years to eight communities through its new Safety Through Recovery, Engagement, and Evidence-based Treatment and Support program.
    • “The funding will help communities build coordinated systems of care for people who are homeless and have serious mental illness, substance use disorders or co-occurring disorders.
    • “The program combines street-based engagement and treatment with recovery supports, housing and other community services.
    • “The Substance Abuse and Mental Health Services Administration will administer the STREETS program, according to an Oct. 2 news release from HHS. Each selected community will receive $3 million a year for four years.”
  • and
    • “The 988 Suicide & Crisis Lifeline has brought back specialized crisis support for LGBTQ+ youth through its “Press 3” option, with the service available again starting Sept. 30, the Los Angeles Times reported Oct. 1.
    • “Launched in 2022 in partnership with the Trevor Project, the option connects callers and texters directly with counselors trained to support young LGBTQ+ people. The service was suspended in July 2025 after the Substance Abuse and Mental Health Services Administration said it would “no longer silo LGB+ youth services” from the general hotline.”
  • STAT News tells us,
    • “Finding information from the National Institutes of Health about human health, disease, and biomedical research is about to look a lot different. On Monday, the NIH will unveil a new version of its website that shifts attention away from individual institutes and centers and towards eight thematic hubs focused on health, research, data, clinical studies, rare diseases, technology, cancer, and grants.
    • “Agency officials say the redesign — which is part of an ambitious project to consolidate the NIH’s digital footprint — is intended to streamline what was a sprawling and fractured information ecosystem, requiring users to understand NIH’s organizational structure, into an intuitive experience that more closely reflects what type of information people seek out most often.
    • “The goal, said NIH deputy director for public affairs, Amanda Fine, is “to make trusted NIH information across the agency easier and faster to find.”
    • “The beta version, which was soft-launched this week, is still under development and will continue to evolve in the coming months, NIH officials told STAT. Some functions, including search, do not yet appear to be operational. During this transition period, NIH’s existing websites will continue to remain available, and they will sunset on a rolling basis “as critical and mandated content is verified and redirects are put in place,” Fine told STAT.” 

From the Medicare Advantage front,

  • Beckers Hospital Review reports,
    • “SCAN Health Plan and Costco shared Oct. 1 that their co-branded Medicare Advantage plans will go live in California and Nevada in 2027.
    • “The HMO will be available in 17 California counties and two Nevada counties on Jan. 1, a SCAN news release said. This is Costco’s first time offering MA.
    • “Entering Medicare Advantage is a natural extension of our commitment to delivering quality and value for our members,” Richard Stephens, Costco’s senior vice president of pharmacy, said.
    • “The plans do not include Costco memberships, but non-Costco plan members can use over-the-counter benefits and get hearing aids and eyewear elsewhere.”
  • “KFF Examines the 2027 Marketplace for Medicare Advantage and Part D Stand-Alone Drug Plans.”
    • “A companion analysis of the stand-alone Part D prescription drug plan (PDP) marketplace finds that the number of stand-alone plans available to the average beneficiary will fall for the fourth year in a row, from 11 in 2026 to 9 in 2027. It also finds that many PDP enrollees will see premium reductions or only modestly higher premiums in 2027 if they keep their current plan, while others will face substantially higher premiums unless they switch.
    • “Notably, there will be no zero premium PDPs available for Part D enrollees in 2027 (except low-income beneficiaries who receive extra financial help from the government.) That means that 4 million PDP enrollees who paid no monthly premium in 2026 will face higher premiums in 2027 if they keep PDP coverage.” 

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

  • Govexec reports today,
    • “Federal employees and retirees will pay an additional 10.9% on average toward their health insurance premiums in 2026, the third straight year of double-digit increases, according to the Office of Personnel Management.
    • “The government’s share of Federal Employee Health Benefits Program premiums will increase by an average of 8.6% in 2026, making the overall cost increase 9.3%. This year, the increase in employees’ share of insurance premiums was 12.3%, and in 2025 that increase apexed at 13.5%.”
    • “Unlike past years, OPM did not provide reporters with the average premium increases for the three plan types—self, self plus one and family—on a per paycheck basis. When asked for the information, the agency sent a copy of its “Open Season Highlights” document, and then a collection of spreadsheets listing every FEHB plan’s premium increase.” * * *
    • As in past years, OPM encouraged federal workers to shop around from among the more than 100 insurance plan offerings and to take advantage of using pre-tax money to pay for out-of-pocket costs via a flexible spending account. New for next year is the availability of a debit card via FSAFEDS, reducing some of the administrative burden of needing to submit paperwork and receipts for reimbursement.
    • Kevin Moss, a senior editor with Consumers’ Checkbook’s Guide to Health Plans for Federal Employees, said it is more important than ever to actually follow that advice. That’s because hidden behind the average premium increase figures are a number of wide swings on the individual plan level.

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

  • Fierce Pharma reports,
    • “The FDA has approved Bristol Myers Squibb’s application to expand the label of its cardiac myosin inhibitor, Camzyos, to include pediatric patients.  
    • “Camzyos is used to treat symptoms and improve functionality in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), a genetic condition that causes the heart muscle to thicken. Camzyos was first approved to treat adults in 2022, and the new approval makes it the first oHCM treatment available to pediatric patients.” 
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has accepted CeleCor Therapeutics‘ new drug application (NDA) for zalunfiban (Disaggpro). The investigational drug was developed to treat ST-elevation myocardial infarction (STEMI) heart attacks to dissolve clots and reopen the coronary artery as soon as possible to prevent death or irreversible heart damage.
    • “Zalunfiban is a new type of small-molecule inhibitor of the platelet GPIIb/IIIa receptor that is designed to quickly prevent clotting during a heart attack.
    • “The company presented positive Phase 3 clinical trials results from its CeleBrate study at the 2025 American Heart Association (AHA) Scientific Sessions, and those findings were later published in The New England Journal of Medicine Evidence.[1] The multinational CeleBrate study found that rapid zalunfiban treatment for STEMI at the first point of medical contact reduced the risk of cardiovascular events over 30 days following treatment.”

No Surprises Act news,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “On Thursday, October 1, 2026, the Centers for Medicare & Medicaid Services (CMS) convened leaders from across the federal government and from certified independent dispute resolution (IDR) entities to discuss issues impacting the federal IDR process. CMS Administrator Dr. Mehmet Oz, Department of Labor Assistant Secretary Daniel Aronowitz, and officials from the Departments of Health and Human Services, Labor, and the Treasury (the Departments) met with representatives from all certified IDR entities to address the increasingly high IDR-associated costs affecting the United States healthcare system. The ideas discussed in the meeting build on the system reforms that were a part of the Federal IDR Operations final rule as well as the fundamental technological evolution of the Federal IDR Portal into the IDR Gateway, which will launch in late 2026.” * * *
    • “The No Surprises Act has succeeded in its primary objective: protecting American consumers from surprise medical bills. The Departments and certified IDR entities expressed their shared responsibility to improve the federal IDR process. The participants, representing all active certified IDR entities, are committed to enhancing their processes in collaboration with the Departments. 
    • “The Departments will consider the insights offered by the certified IDR entities as they continue to explore all available regulatory and operational solutions.”

From the judicial front,

  • The SCOTUSblog reports today,
    • “On Thursday, the Supreme Court added three new cases to its oral argument docket for the 2026-27 term, including a case on the Trump administration’s policy of detaining noncitizens apprehended within the United States (as opposed to at the border) without the opportunity for a bond hearing and a dispute over the enforcement of zoning ordinances against religious institutions.” * * *
    • “Unlike past years, OPM did not provide reporters with the average premium increases for the three plan types—self, self plus one and family—on a per paycheck basis. When asked for the information, the agency sent a copy of its “Open Season Highlights” document, and then a collection of spreadsheets listing every FEHB plan’s premium increase.” * * *

From the public health and medical /Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country.
    • “COVID-19 activity remains elevated in some regions but is declining nationally.
    • “Seasonal flu activity is low but is increasing.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.”
  • The University of Minnesota’s CIDRAP calls to our attention
    • “With three months left of 2026, the United States is closing in on a number of measles cases that would have been unheard of just a couple years ago. With 228 new cases logged this week, the country reached 3,886 infections, just 114 shy of 4,000, according to the Centers for Disease Control and Prevention’s (CDC’s) weekly update today.
    • “It could top that milestone next week. And US cases could be more than double the 2025 total this month.
    • “The national wave comes as Pennsylvania, the nation’s hot spot, adds more than 100 new cases in the past week to its total for the year. More than two-thirds of the cases in the state involve adults. * * *
    • “Cases in other states are also climbing. The Wisconsin Department of Health Services today added 72 infections to its total, which has now grown to 243. Kentucky added 27 new cases and has 94 for the year. And Ohio’s health department lists 206 measles cases, which is 17 more than last week. Utah lists 527 cases, nine of which are new.”
  • and
    • “Measles infections make people miserable for up to two long weeks, commonly causing dangerously high fevers, a painful sensitivity to light and, of course, a tell-tale red rash.
    • “Sufferers who escape without developing pneumonia, brain swelling, or other serious complications may believe the worst is over. 
    • “Yet the measles virus has only gotten started.
    • “The virus also damages the immune system, leaving people vulnerable to other infections for up to five years.
    • “The rash and the fever, that’s the tip of the iceberg,” Michael J. Mina, MD, PhD, coauthor of two seminal studies in Science on the effect of measles on the immune system, told CIDRAP News. “The majority of the damage being done is under the surface.”
  • The Wall Street Journal reports,
    • “Grip strength is increasingly being viewed as an important biomarker of our overall strength and fitness.
    • “While not used as widely as body-mass index, or BMI, as a screening tool for health, doctors and researchers say awareness of its value is growing. That’s happening as research shows that grip strength is associated with future health risks and even longevity. 
    • “At the University of Michigan Medical School, many clinics test patients’ grip strength, says Mark Peterson, a professor of physical medicine and rehabilitation. 
    • “We do it with our older populations but I have also gotten it pulled into clinics in our neurological population,” he says.
    • “Some doctors think grip strength should be used more routinely in wellness appointments. “I have really tried to encourage geriatricians to think about incorporating grip strength, it seems to trump almost every single measure including cardiovascular fitness training,” Peterson says.
    • “Even in children, studies have found grip strength to be associated with cardiometabolic health.” 
  • Nature relates,
    • “Armed with new tools and fresh optimism, researchers seeking to subdue pancreatic cancer — one of the world’s deadliest — are chasing a radical strategy: cancer interception.
    • “In this approach, tissues that are growing abnormally are treated to keep them from turning cancerous and spreading. Interception is already being trialled for breast and skin cancers, among others. But now the success of a new drug that quashes pancreatic tumours is raising scientists’ hopes that interception could succeed even for this recalcitrant cancer.
    • “Cancer interception was one of the main themes at September’s American Association for Cancer Research Conference (AACR) on Pancreatic Cancer in San Diego, California — the first such meeting since the US Food and Drug Administration approved the landmark pancreatic-cancer drug daraxonrasib (Rasonque) in August. Its success has renewed optimism that researchers can combine it or other emerging therapies with early-detection methods to revolutionize how pancreatic tumours are treated.
    • “A combination of early-detection techniques and interception is “going to be the breakthrough strategy that really changes survival”, says Diane Simeone, director of the Moores Cancer Center at University of California San Diego Health. At the AACR meeting, Simeone argued that such an approach could more than triple the proportion of people who survive for five years after being diagnosed with pancreatic cancer, from 13.7% to 50%.
    • “It’s a lofty aspiration, but other researchers are also eyeing interception. “We’re so excited that we are at this juncture now to even be considering this,” says Anirban Maitra, director of the Perlmutter Cancer Center at New York University Langone Health in New York City. “This wasn’t possible even a few years ago.”
  • CNN adds,
    • “Sugary foods combined with antibiotic treatment can damage the gut microbiome in ways that could leave people vulnerable to dangerous infections, a new study shows.
    • “The new research, published Wednesday in the journal Nature, took advantage of a natural experiment: It looked at what happened to gut bacteria in cancer patients who were hospitalized and treated with sustained antibiotics before receiving stem cell transplants. Because the patients only ate food prepared by the hospital, researchers knew exactly what and how much food they ate – a rarity in nutrition studies, which typically rely on participants to recall what they ate hours or days earlier, something people are notoriously bad at.
  • Health Day tells us,
    • “Functional decline begins many years before clinically apparent cardiovascular disease (CVD) events, according to a study published online Sept. 23 in JAMA Cardiology.
    • “Aung Zaw Zaw Phyo, Ph.D., from Monash University in Melbourne, Australia, and colleagues examined how functional performance trajectories change in the years preceding a CVD event. The analysis included data from 12,015 participants (2,403 cases and 9,612 matched controls) in the Aspirin in Reducing Events in the Elderly cohort.”
    • “Results of this nested case-control study show that declines in functional aging markers were prominent before clinically apparent CVD, suggesting that they may represent the culmination of progressive multisystem aging and indicating a prolonged window of opportunity for closer clinical evaluation and early intervention,” the authors write.”
  • and
    • “Isometric exercises like wall sits may help lower your blood pressure.
    • “And just one session a week could help you maintain those healthier numbers.
    • “A team led by Harry Swift of King’s College London studied 100 adults with an average age of 37 who had normal to high-normal blood pressure. Eighty were assigned to do wall sits three times a week.
    • “After four weeks, their systolic blood pressure — the top number in a blood pressure reading — had dropped by an average of about 9.5 points compared with the control group.
    • “For the next month, participants either kept the same schedule, cut back or stopped.
    • “Cutting back to once a week still left systolic pressure about 6.6 points lower than at the start.
    • “But three sessions a week delivered a much bigger benefit — down nearly 14 points.
    • “When participants stopped exercising, the improvements reversed.”
  • The American Medical Association lets us know how to do a wall sit.
  • Per BioPharma Dive,
    • “An experimental eczema drug from Pfizer met its primary goal in a mid-stage clinical trial, achieving stronger skin clearance in significantly more people at multiple doses compared to a placebo after 16 weeks.
    • “According to detailed data from an ongoing Phase 2 trial shared at a European medical meeting Thursday, a substantially higher percentage of patients given Pfizer’s three-pronged antibody drug, tilrekimig, as opposed to a placebo experienced a 75% reduction in the scope and severity of their disease. The trial enrolled participants with moderate to severe atopic dermatitis, and the latest results build on data previously announced in March.
    • “Analysts described the findings as “very strong” and indicative that Pfizer’s drug could compete with already approved therapies like Eli Lilly’s Ebglyss and Sanofi and Regeneron Pharmaceuticals’ market-leading Dupixent. In a statement Thursday, Pfizer said it has pushed tilrekimig into advanced testing for asthma, chronic obstructive pulmonary disease and atopic dermatitis — including a head-to-head trial against Dupixent.”

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

  • The Wall Street Journal reports,
    • “Bayer BAYN  said it plans to spend $2.2 billion to build a new manufacturing site in Ohio for its pharmaceutical business, becoming the latest European drugmaker to invest in the U.S.
    • “The German agricultural and pharmaceutical group said Friday that its new site in New Albany will create around 600 jobs, with plans to open a first module dedicated to drug substance manufacturing in 2031, followed by a second module for finished products in 2034.
    • “Bayer’s pharma business has been looking to expand in the U.S., betting that an enlarged presence in the world’s largest drug market can help it revive sales growth after two key products went off patent.
    • “With the move, the company joins a growing list of European pharma companies committing to invest in the U.S. Under pressure from the Trump administration’s tariff threats, big drugmakers like AstraZeneca, Novartisand Roche, as well as smaller rivals, pledged to make multibillion-dollar investments in the country and have started to execute their plans.
    • “The U.S. is our largest and fastest-growing market,” Bayer’s U.S. president, Sebastian Guth, said in an interview.”
  • and
    • “Novartis NOVN struck a deal valued at up to $7.8 billion to license a messenger RNA drug candidate from Abogen Biosciences and gain options over future therapies, turning to China to fill its pipeline.
    • “Many of the world’s biggest drugmakers have set their sights on China to look for new drug ideas, seeking to bolster their portfolios in preparation for older medicines going off patent. Novartis has sealed several tie-ups with emerging Chinese biotech players in recent years.
    • “Novartis is paying $575 million upfront and could make additional payments of up to $7.2 billion if options on all programs are exercised and targets are met, Abogen said Friday.
    • “Under the deal, Novartis will acquire worldwide rights over Abogen’s lead drug candidate, called ABO2203, which uses mRNA to boost the production of so-called T-cell engagers within the body to fight malignant cells. Abogen said its lead drug has potential to transform the treatment landscape for patients with autoimmune diseases—those in which the body’s immune system attacks healthy cells instead of protecting them.”
  • Modern Healthcare relates,
    • “HCA Healthcare has completed a deal to sell 31 home health and hospice locations in eight states to Deaconess Associations.
    • “The former HCA sites and their employees are now part of Deaconess subsidiary Central Pyramid, the Cincinnati-based provider announced in a news release Thursday. Neither Deaconess nor Nashville, Tennessee-based HCA disclosed the financial terms of the transaction.
    • “The home health and hospice locations are spread across Colorado, Florida, Kansas, Kentucky, Missouri, Tennessee, Texas and Virginia. The companies agreed to the transaction in June.”
  • Beckers Payer Issues tells us,
    • “San Francisco-based Dignity Health, part of Chicago-based CommonSpirit, reached an agreement to transfer its share of co-owned Arizona managed care health plan, Mercy Care, to CVS Health subsidiary Aetna.
    • “CommonSpirit had a 49.75% ownership interest in Mercy Care as of June 30, 2026, and June 30, 2025, according to CommonSpirit’s fiscal year 2026 report. 
    • “Dignity Health co-owns the plan with Ascension, which said it had also reached an agreement with Aetna to transfer its portion of Mercy Care to the company. 
    • “The transaction is expected to close in fiscal year 2027, subject to required regulatory reviews and approvals, a spokesperson for Aetna said in an Oct. 2 statement shared with Becker’s.” 
  • and
    • “New Jersey Democratic Gov. Mikie Sherrill launched the State Health Benefits Program Reform Working Group on Oct. 1 to review and advise on health coverage for public employees.
    • “Ms. Sherrill announced the working group following a Sept. 2 agreement with 17 state employee unions. Along with unions, participants include public employer organizations, legislative offices and healthcare groups, such as the New Jersey Association of Health Plans and New Jersey Hospital Association. Aetna, Horizon Blue Cross Blue Shield of New Jersey, and UnitedHealth Group’s pharmacy benefit manager, Optum Rx, are all vendors serving the benefits program. All three are also members of the working group.
    • “The working group will form advisory recommendations for the governor, focusing on benefits administration, provider network structures and payment, plan pricing and premium contributions, plan design, employer and member participation, and whether the program has resources to manage costs. The working group will have subcommittees targeting these areas.”
  • Fierce Healthcare adds,
    • “Tacoma, Wash.-based MultiCare Health System is set to launch its own health plan next year, the organization announced Thursday.
    • “The creation of the plan—dubbed the MultiCare Health Plan—is part of the organization’s continuing advancement from a traditional provider to an integrated organization, executives say. It will be a wholly owned subsidiary of the health system, with support from MultiCare’s population health partner, PSW.”
  • Beckers Hospital Review informs us,
    • “Chicago-based CommonSpirit Health has launched CommonSpirit Ambulatory Ventures, a new division aimed at organizing and expanding the health system’s ambulatory surgery center portfolio.
    • “The move is part of CommonSpirit’s broader effort to diversify beyond acute care and “accelerate growth” in ambulatory services, according to financial documents published Oct. 1. The system said the new division will establish an ASC vertical “from which to organize and enhance our current and future capability in the ASC space.” 
    • “CommonSpirit currently has 239 ambulatory joint ventures spanning dialysis, imaging, oncology and other services. That portfolio includes 80 ASCs, either wholly owned or operated through partnerships, along with six specialty surgical hospital partnerships.” 
  • Beckers Physician Leadership points out,
    • “After years of steady gains, compensation for registered nurses and licensed practical nurses (LPNs) showed no measurable growth in 2026 for the first time in the past 5 years, according to a report from Medscape. 
    • “The “Medscape RN/LPN Compensation Report 2026: Where Did the Growth Go?,” published Oct. 2, surveyed 3,253 registered nurses and 1,337 licensed practical nurses on compensation and pay trends.” 
  • Per Radiology Business,
    • “Patients grappling with medical debt appear more likely to face later-stage cancer diagnoses, according to new research published Thursday. 
    • “Such financial obligations are a pervasive challenge among U.S. households and a key social determinant of health, experts write in JAMA Network Open. About 1 in 6 individuals here report having at least some medical debt, with millions facing collections—a situation disproportionately impacting low-income households, minorities and the uninsured. 
    • “Researchers aimed to better understand how these IOUs impact patient outcomes, analyzing data spanning nearly 3,000 U.S. counties. They found that higher burden of medical debt was associated with significantly increased incidence of late-stage lung, colorectal, cervical, skin, kidney, bladder, and head/neck cancer. 
    • “These findings suggest that medical debt may be an area-level marker of structural and financial barriers associated with cancer detection and cancer outcomes at the population level,” study co-author Xin Hu, PhD, with the Department of Radiation Oncology at Emory University, Atlanta, and colleagues wrote Oct. 1.” 
  • Per Fierce Pharma,
    • “Eli Lilly’s Foundayo is showing clearer signs of acceleration. Total prescriptions for the oral GLP-1 receptor agonist surged about 21% to 64,268 during last week, according to IQVIA data cited by Citi. That haul came off a 13% sequential increase the week before that.
    • “We’re seeing early signs of growth in Q3 for Foundayo,” Jefferies analysts wrote in an Oct. 2 note.
    • “Recent expansion of Foundayo could be attributed to a direct-to-consumer ad first aired in late August featuring Martha Stewart, as well as the Medicare GLP-1 Bridge program which, as of July, offers eligible seniors GLP-1 obesity drugs at a $50 monthly copay.”
  • Cardiovascular Business adds,
    • “More and more young children are starting to be prescribed GLP-1 drugs to manage their weight, according to new research published in Pediatrics.
    • “The study’s authors focused exclusively on obese children without diabetes between the ages of 8 and 11. In 2019, just 0.03% of those children were on GLP-1 medications. However, that number skyrocketed to 9.3% in 2026. The group estimated that approximately 20,000 children between the ages of 8 and 11 have been prescribed GLP-1 drugs during that time. 
    • “Our study offers the first national overview in young children of the use of GLP-1 drugs to fight the obesity epidemic in the United States and shows that while the absolute numbers of children under the age of 12 receiving GLP-1 treatment is still low, GLP-1 use is accelerating rapidly,” first author Babak J. Orandi, MD, PhD, MSc, a transplant surgeon and obesity specialist with NYU Langone Health’s NYU Grossman School of Medicine, said in a statement. “The careful use of GLP-1s remains a valuable tool in confronting the obesity epidemic among young Americans.”
  • Beckers Payer Issues lets us know,
    • “Booking an appointment with a provider often means confirming they’re in network, working through an automated phone menu and trading available times with a receptionist. But for some UnitedHealthcare and Aetna members, an AI agent is now handling that work.
    • “Senior executives at both insurers have described their scheduling tools publicly in recent months as part of broader AI investments aimed at cutting administrative costs and simplifying how members get care.
    • “If I would usually schedule an appointment, I’d make a phone call, sit on hold, figure out my calendar, juggle my children. All that is gone, because Avery will do it for me,” Prianka Advani, senior vice president of AI delivery and telephony at UnitedHealth Group, said during a media event in June.”  

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • CBS News reports,
    • “The Senate confirmed Keith Sonderling to lead the Department of Labor on Wednesday, officially installing the nominee who has been leading in an acting capacity since Lori Chavez-DeRemer’s exit in April.
    • “In a party-line 47 to 41 vote, the Senate confirmed Sonderling.
    • “Sonderling served in several roles at the Department of Labor and the Equal Employment Opportunity Commission during President Trump’s first administration. He previously practiced employment and labor law at a Florida law firm.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services’ 340B Part D claims data repository became available Oct. 1 for voluntary data submissions. While data submissions will remain voluntary for now, the agency has proposed making data submissions mandatory starting Jan. 1, 2027. CMS has multiple resources available to support 340B entities and their third-party administrators with data submissions, including a user guide, companion guide, fact sheet and an FAQ.” 
  • and
    • “The Department of Health and Human Services’ Health Resources and Services Administration Oct. 1 announced approval of 10 drug companies to participate in the 340B Rebate Model Pilot Program. The approved companies are AbbVie, Amgen, Astellas Pharma US, AstraZeneca, Bristol Meyers Squibb, Boehringer Ingelheim Pharmaceuticals, GlaxoSmithKline, Merck Sharp & Dohme, Pfizer and Teva Pharmaceuticals. See the HRSA webpage for more details about the drug companies approved to participate in the Rebate Model Pilot Program, as well as FAQs.
    • “The AHA Aug. 7 issued a Regulatory Advisory that includes a detailed summary of the HRSA announcement on the rebate model pilot program. The program would begin Jan. 1, 2027.
    • “The AHA remains deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Pilot Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients,” an AHA spokesperson said. “We are reviewing today’s materials and are considering all available options to prevent this flawed program from going into effect.”
  • Beckers Hospital Review adds,
    • “An October report from Berkeley Research Group estimates how much patients and payers spend on 340B drugs, beyond what covered entities pay to acquire them.” * * *
      • “BRG calculates the gap between acquisition cost and reimbursement, which it calls “340B drug margin,” at $142.2 billion in 2025, more than double the $63.6 billion margin in 2021.
      • “Private and commercial insurers covered the largest share of that margin (63%), followed by Medicare (25%) and Medicaid managed care plans (7%). Medicaid fee-for-service generates no margin because it reimburses covered entities at acquisition cost.
      • “As a share of the overall U.S. pharmaceutical market, 340B prescriptions now account for 27% of net spending, up from about 18% in 2021. BRG attributed the program’s growth mainly to hospitals acquiring off-site clinics, expanded hospital participation following the Affordable Care Act and growing use of contract pharmacies, which now number roughly 35,000 nationally, up from about 1,300 in 2010.”
  • CMS has posted a table showing the “Top 10 Section 111 Group Health Plan (GHP) Reporting Error Codes from January 1- June 30, 2026”

From the Medicare Advantage front,

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

  • Govexec reports
    • “Nearly all of the portfolios in the federal government’s 401(k)-style retirement savings program lost value last month, as the broader investment market encountered broad volatility.
    • “The small- and mid-size businesses in the Thrift Savings Plan’s S Fund saw the worst decline, falling 3.86% in September. Since January, the S Fund is up 11.62%. The C Fund’s common stocks nearly broke even, finishing the month just 0.35% in the red. So far this year, the C Fund has grown 12.73%.” * * *
    • “The only TSP fund to post gains was the government securities of the G Fund, which grew at a statutorily mandated rate of 0.40%. So far this year, the G Fund has grown 3.41%.”
  • Tammy Flanagan, writing in Govexec, considers “Retiring in 2027? Picking the right date could pay off.”
    • “The date you leave federal service can affect when your annuity begins and how much you receive for unused annual leave.”

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

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved the Edwards Lifesciences Autus surgical pulmonary valvethat is the first size-adjustable valve designed for pediatric patients with congenital heart disease. The valve previously received FDA Breakthrough Device designation for its potential to address an important unmet need.
    • “Typically, children with congenital heart disease outgrow their valves and require repeat open-heart surgeries to explant the old valves and implant larger valves. Instead of repeat surgeries, the Autus is designed to be expanded as a child grows through a minimally invasive transcatheter procedure, offering a new, less invasive way to care for these children over the long term.
    • “This valve is a game changer,” explained Jennifer Romano, MD, MS, a heart surgeon at C.S. Mott Children’s Hospital, and past-president of the Society of Thoracic Surgeons (STS), in a statement from September when her team performed the first Autus procedure in the U.S. “Typically, we give these children a temporary fix, knowing they will need more surgeries down the road. “Now, we may be giving a child a valve that could potentially last them a lifetime. This could be transformative.”
  • MedTech Dive relates,
    • “The Food and Drug Administration has selected the first participants for an innovation challenge for home devices that could be used to reduce hospital readmissions.
    • “The first five participants include large medtech firm BD, wearable EEG startup Epitel, infant care company Prapela, Current Health, a company making software for cancer care, and Skribe Medical, which makes a device to assess cardiac function.
    • “The FDA’s device center plans to choose a total of nine participants by Dec. 4 for the challenge, called Reducing Readmissions through Device Innovation for the Home, or READI-Home. The selected manufacturers will have opportunities for early engagement with the FDA, including feedback on device design and testing, and demonstrations at the agency’s research facilities.”
  • and
    • “Medtronic said Wednesday it received a breakthrough device designation from the Food and Drug Administration for a drug-coated balloon catheter to treat peripheral artery disease below the knee.
    • “While drug-coated balloons are commonly used to treat PAD above the knee, none are indicated in the U.S. for use below the knee, where improved treatment options are needed, Medtronic said. PAD causes reduced blood flow to the limbs due to plaque buildup in the arteries. Patients with advanced PAD can be at risk for amputation.
    • “Medtronic said it is planning a randomized pivotal trial to study the paclitaxel-coated device, called IN.PACT BTK, in about 400 patients with below-the-knee lesions.”
  • BioPharma Dive identifies “5 FDA decisions to watch in the fourth quarter of 2026.”
    • “The next three months will feature anticipated decisions on a new kind of cancer immunotherapy, as well as medicines important to the futures of Roche, GSK and Gilead.”

No Surprises Act News,

  • Federal Hearings and Appeals Services, a certified independent dispute resolution entity, informs us,
    • “Our Account Services team members spend their days immersed in the Independent Dispute Resolution (IDR) process and fielding questions from parties. FHAS recently launched a new “Common Questions” series on our blog to share the questions we receive most often, and the answers we’re providing.
    • “Lately, we’ve seen some confusion around the new IDR Registry and the new IDR Gateway, so we’ll address those common questions, here. As a starting place, let’s clarify some basics.
    • “The Gateway is the platform. The Registry is a database inside it.
    • “The IDR Gateway is CMS’s new secure, account-based platform for managing Federal IDR disputes. It replaces the single-use web forms that parties have used since 2022.
    • “Both providers and payers need to register or sign up for a Gateway account. See our earlier post, The IDR Gateway Is Here, for more details on the Gateway roll-out.
    • “The IDR Registry is different. It is a searchable database of payer information that will live inside the Gateway.
    • “Only payers register in the IDR Registry – health insurance issuers, self-insured group health plans and their sponsors, and FEHB carriers. Each payer will carry an IDR registration number, and initiating parties will be able to access this number by referring to a given health plan’s notice of payment or denial.” * * *
    • “When might the Registry be available?
    • “Not right away, and the timeline has several steps. The Final Rule does not set a calendar date for the Registry. Instead, the Registry provisions become applicable 90 business days after the Departments issue guidance announcing that the Gateway functionality supporting the Registry is available, and payers have until the later of that date, or the date they begin offering coverage, to register. The Departments extended that window from the 30 business days originally proposed and noted that the extra time is meant to let payers set up lines of communication across their TPAs and service providers. CMS’s published implementation timeline lists the Registry first among the Gateway-dependent provisions it plans to roll out beginning in spring 2027, ahead of the new open negotiation, initiation, and IDRE selection workflows. Counting forward from a spring 2027 announcement, 90 business days runs roughly four to four and a half months. A reasonable expectation is that payers will be fully registered, and registration numbers will begin appearing on remittances, in the second half of 2027. The Departments have said they will publish updates as each provision is operationalized, and we will share those as they arrive.
    • “In the meantime, one related change lands sooner. Beginning with items and services furnished on or after Jan. 1, 2027, payers must use specified claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs) to indicate whether a claim is subject to the No Surprises Act and the Federal IDR process. That is a separate requirement from the Registry, but it addresses a neighboring question and arrives first.”
  • FEHBlog observation: I created a Gateway account for my client and upon doing so, all of the IDR cases showed up in a list. I compared the Gateway list against my list and I found two cases on my list that weren’t on the Government’s list. I am assuming that those cases were dropped without letting me know which is OK with me.

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Over 2 million new cancer cases were attributable to infections globally in 2024, according to an analysis of worldwide cancer incidence, highlighting the importance of effective prevention measures.
    • “Infections led to an estimated 2.3 million new cancer cases in 2024, including gastric cancer, cervical cancer, hepatocellular carcinoma, leukemias and lymphomas, and nasopharyngeal cancer, which accounted for 12% of all cancer cases worldwide.
    • “Among 12 carcinogenic infectious agents, the largest numbers of cancer cases were attributable to:
      • “Helicobacter pylori: 760,000 cases, population-attributable fraction (PAF) 4%
      • “Human papillomavirus (HPV): 750,000 cases, PAF 4%
      • “Hepatitis B virus (HBV): 360,000 cases, PAF 2%
      • “Epstein-Barr virus (EBV): 260,000 cases, PAF 1%
      • “Hepatitis C virus (HCV): 160,000 cases, PAF <1%
      • “Kaposi’s sarcoma-associated herpesvirus (KSHV): 35,000 cases, PAF <1%
    • Most cancers attributable to H. pylori were non-cardia gastric cancers (700,000 cases), while cervical cancer accounted for most HPV-attributable cases (600,000). HBV and HCV were responsible for 330,000 and 130,000 cases of hepatocellular carcinoma, respectively, while EBV led to 110,000 nasopharyngeal cancers, reported Harriet Rumgay, PhD, of the International Agency for Research on Cancer in Lyon, France, and colleagues in Lancet Oncology.”
  • and
    • “Maternal infection or sepsis is the third-leading cause of pregnancy-related death in the U.S., and Mississippi is the state with the third highest maternal mortality rate.
    • “In this study of Mississippi births, maternal sepsis disproportionately affected mothers with preterm births or c-sections, those with chronic comorbidities, Black women, and Medicaid enrollees.
    • “Overall, sepsis was recorded in 0.06% of the births from 2016 to 2025, but was involved in 32.4% of the delivery-associated hospital deaths.”
  • The American Medical Association lets us know “5 things patients should know about GLP-1 medications.”
    • “Sean Hashmi, MD, talks about the benefits of GLP-1 medications—as well as some misunderstandings—on the latest “Health vs. Hype” podcast episode.”
  • The latest issue of the National Institutes of Health’s Research Matters covers the following topics:
    • “Antiviral drug did not improve Long COVID symptoms” 
      • “A clinical trial for Long COVID found that treating patients with a common antiviral drug for up to 25 days did not improve symptoms.
      • “The findings suggest that other approaches to manage symptoms and treat Long COVID are needed.”
    • “tRNA treatment may help restore cystic fibrosis proteins” 
      • “Lipid nanoparticles that deliver engineered transfer RNA restored functional proteins in cell and animal models of cystic fibrosis.
      • “This strategy may represent a potential therapeutic approach for cystic fibrosis and other genetic diseases caused by nonsense mutations.”
    • “Bacterial infection may alter developing gut” 
      • “C. difficile bacteria caused lasting changes to cells in the intestines of newborn mice.
      • “The findings suggest that early-life C. difficile infections may alter gut stem cells and immunity into adulthood.”
  • Health Day relates,
    • “Stable employment in midlife is associated with better cognitive health in later life, according to a study published online Sept. 23 in Alzheimer’s & Dementia.
    • “Erika T. Beidelman, from the Columbia University Mailman School of Public Health in New York City, and colleagues used data from 2,418 participants in the Health and Retirement Study (1998 to 2014) to examine associations of workforce participation and job insecurity with later cognition.
    • “The researchers found that among women, compared with secure employment, self-employment, early retirement, not being in the labor force, and secure-to-retirement trajectories were significantly associated with lower memory and executive function scores (β range = −0.13 to −0.32 standard deviation units). For men, inconsistent employment was associated with poorer performance across most cognitive domains versus secure employment. In women, employment instability and early retirement were associated with higher odds of cognitive impairment.”
  • The New York Times offers “Clues to Why a Breakthrough Pancreatic Cancer Drug Eventually Stops Working”
    • “Researchers are asking why patients, like former Senator Ben Sasse, inevitably develop resistance to the drug daraxonrasib.”
  • Genetic Engineering and Biotechnology News tells us,
    • Methicillin-­resistant Staphylococcus aureus (MRSA) has rapidly risen to become one of the gravest threats to global health, with deaths from Staphylococcus aureus (S. aureus) having doubled worldwide since 1990. In severe cases, the bacteria invade the bloodstream in life-threatening systemic infections, which have a high risk of kidney injury and failure.
    • S. aureus is one of the most concerning bacterial pathogens, given that MRSA accounts for the largest increase in the global antimicrobial resistance burden. In addition, deaths attributable to S. aureus infections have doubled since 1990, making it a leading cause of bacterial mortality worldwide. Despite the continued focus on research, tissue reservoirs that permit bacterial persistence remain poorly defined.
    • “Now, a new study reveals how MRSA exploits the osmotic environment of the inner kidneys to establish a bacterial reservoir and hide from the immune system. This work suggests that MRSA can establish niches in the kidneys and the findings provide a mechanistic explanation for a longstanding question in the field of MRSA biology, and could inform future strategies aimed at limiting kidney damage from infections.
    • “This work is published in Science Translational Medicine in the paper, “Hyperosmotic niche adaptation and tissue polyamines underlie MRSA persistence in the kidney.”
  • STAT News informs us,
    • “Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await
      • “The small biotech company is developing an injectable, low-dose monoclonal antibody.”
  • Per Fierce Healthcare,
    • “Taiho Pharmaceutical, together with U.S.-based subsidiary Taiho Oncology, has inched closer to approval of another oral combination treatment for patients with blood cancers.  
    • “In new phase 3 topline results, Taiho reported that its investigational, all-oral drug combination of azacitidine and cedazuridine successfully treated patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML), two blood disorders that can lead to acute myeloid leukemia (AML).
    • “Azacitidine is an established chemotherapy already used to treat MDS and AML. But Taiho’s formulation uniquely pairs the chemo with the cytidine deaminase inhibitor cedazuridine, which blocks the chemo-disintegrating enzyme cytidine deaminase in the digestive tract, allowing the cancer treatment to survive oral delivery.”
  • and
    • “While Foundayo’s insulin-matching potential in type 2 diabetes had been established in a topline readout earlier this year, Eli Lilly on Wednesday unveiled the fullest picture yet of its oral GLP-1’s ability to keep blood sugar in check, cut weight and, crucially, demonstrate cardiovascular safety in patients with compounding metabolic conditions.
    • “In a deep dive into the Indianapolis drugmaker’s late-stage Achieve-4 trial, which compared Foundayo (orforglipron) with titrated insulin glargine in adults with type 2 diabetes and obesity or overweight who were at increased cardiovascular risk, Lilly’s drug proved noninferior to insulin on the risk of major adverse cardiovascular events (MACE) while delivering greater reductions in A1C and weight.
    • “The comprehensive results were presented as part of Lilly’s showing at the European Association for the Study of Diabetes (EASD) annual meeting in Milan this week and simultaneously published in The Lancet.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
    • “Downloads: Evidence Report | Voting Questions | Public Comments | Response to Public Comments
    • “High blood pressure is common, leads to serious complications like heart disease, strokes, and kidney failure, and is frequently undertreated,” said ICER’s Chief Medical Officer David Rind, MD, MSc. “Baxdrostat and lorundrostat are from a new class of medications intended for patients that may need more than standard first-line therapies. The hope is that they may have fewer side effects and reduce clinical events, but evidence for such benefits is currently limited.”
    • “Register here to watch the live webcast of the October 29th ICER public meeting.”

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

  • Beckers ASC Review reports,
    • “Philadelphia-based Penn Medicine, Independence Blue Cross and Franklin, Tenn.-based Regent Surgical are building an ASC company with a structure Regent CEO Travis Messina said the industry has not seen before: a health system, a health plan and a management company, all as owners.
    • “All the research that I’ve done suggests that there has never been a partnership in the ASC space that included a health system, a health plan and a management company,” Mr. Messina told Becker’s. “We believe it’s the first of its kind in that regard.”
    • “The three organizations announced Sept. 24 they will develop at least 18 ASCs across Pennsylvania, New Jersey and Delaware.” 
  • Beckers Hospital Review relates,
    • “Vizient named its 2026 top performers for quality, recognizing hospitals across seven cohorts and five medical groups for ambulatory care.
    • “The Bernard A. Birnbaum, MD, Quality Leadership Award is based on the Vizient Quality and Accountability Study. The study scores hospitals in six domains: safety, mortality, effectiveness, efficiency, patient centeredness and variation in care, according to a Sept. 24 news release from the company.
    • “The data comes from the Vizient Clinical Data Base, the Hospital Consumer Assessment of Healthcare Providers and Systems survey and the CDC’s National Healthcare Safety Network. The clinical database covers more than 1,600 hospitals across more than 250 health systems in 49 states.”
  • and
    • “Chicago-based CommonSpirit recorded an operating loss of $430 million (-1.0% operating margin) in fiscal 2026 — excluding special charges — compared to an operating loss of $687 million (-1.8% margin) the year prior, according to its Sept. 30 financial report.”
  • and
    • “Nashville, Tenn.-based Vanderbilt Health recorded operating income of $452 million (4.7% operating margin) in fiscal 2026, compared to operating income of $255 million (3.0% margin) the year prior, according to its Sept. 30 financial report.” 
  • and
    • “Morgantown, W.Va.-based WVU Health System has acquired Greensburg, Pa.-based Independence Health System’s five hospitals and their affiliated physician practices and outpatient facilities. 
    • “The hospitals are Butler (Pa.) Memorial Hospital, Clarion (Pa.) Hospital, Frick Hospital in Mount Pleasant, Latrobe (Pa.) Hospital and Westmoreland Hospital in Greensburg. They will begin operating under WVU Medicine’s brand immediately, according to an Oct. 1 news release.
    • “WVU Health System signed a definitive agreement June 2 to acquire the hospitals. The parties shared plans for the acquisition in mid-November 2025.”
  • and
    • “Tallahassee-based Florida State University and Tallahassee Memorial HealthCare have finalized core agreements that set the long-term framework for FSU Health, the university’s integrated academic health system for North Florida.
    • “The agreements include lease and operating agreements and other definitive legal documents, including an academic and clinical framework covering Tallahassee Memorial Hospital and a planned FSU Health hospital in Panama City Beach, Fla., according to a Sept. 30 news release.
    • “TMH will keep running day-to-day operations under the FSU Health brand. That includes Tallahassee Memorial Hospital, the future Panama City Beach hospital, TMH’s other clinical sites and its employed physician network, TMH Physician Partners. The deal keeps TMH’s existing charity care policy at both hospitals. It also creates a new governance structure that lets FSU nominate board candidates in Tallahassee and Panama City Beach.”
  • The Wall Street Journal lets us know,
    • “Walgreens’ private-equity owner is nearing a deal to sell U.K. pharmacy chain Boots for close to $9 billion including debt, according to people familiar with the matter.
    • “It has been discussing a deal to sell Boots to the Canadian arm of the Weston family, which owns a food-business empire, the people said. A deal could be completed in the coming weeks, assuming talks don’t fall apart.
    • “Sycamore Partners took Walgreens private in 2025 in a deal valued at $24 billion including debt (and roughly $10 billion without). It separated the company into five units to facilitate potential sales of noncore units, including Boots.
    • “Boots houses the former international businesses of Walgreens, which includes Boots operations in the U.K. and businesses in Thailand, Mexico, Germany and China.”
  • and
    • “France’s Sanofi SAN and Regeneron REGN Pharmaceuticals said they would expand their longstanding alliance to jointly develop and market new immunology medicines, in a deal that could net the U.S. drugmaker up to $8 billion.
    • “The two companies have collaborated for more than two decades in a partnership that spawned one of the top-selling medicines worldwide, Dupixent, approved for a range of conditions that include asthma and eczema.
    • “With Dupixent due to begin losing patent protection in the early 2030s, both sides had signaled they were discussing an updated framework for their relationship.” 
  • Fierce Healthcare tells us,
    • “Specialty pharmacy is a key cost driver for employers and insurers, with developments in this space showing no signs of slowing down.
    • “For example, a recent study from the Pharmaceutical Strategies Group found that 43% of employers and benefit leaders view managing specialty pharmacy spend as a top goal. And, per that report, while specialty drugs generally make up about half of the development pipeline, 76% of novel new drugs approved by the Food and Drug Administration in 2025 were specialty products.
    • “It’s with that backdrop that Blues-backed pharmacy benefit manager Prime Therapeutics convened stakeholders from across the pharmaceutical supply chain for its annual Specialty Summit last month. One of the prevailing themes of the conference—a need to break down silos between the pharmacy benefit and medical benefit to more effectively manage the full patient care journey.”
  • and
    • “Since 2022, federal price transparency rules have required health insurers to publish their negotiated hospital rates, aiming to give providers, employers and patients greater visibility into healthcare costs. However, the resulting machine-readable files are often so large and inconsistent that most organizations struggle to use them effectively.
    • A single payer’s pricing file can contain billions of rows, often published in varying formats and riddled with errors. According to a recent provider survey, nearly 40% of organizations report limited or no meaningful use of Transparency in Coverage data when preparing for payer negotiations. 
    • Startup Payerset launched four years ago to tackle this challenge, building the infrastructure required to normalize the data and render it usable across the formats healthcare organizations rely on. 
    • The company launched an artificial intelligence-powered, self-service research assistant that unifies negotiated rate data, claims, policy and market benchmarking into one platform. Payerset’s platform draws on 20 trillion rate records retained since 2024, with more than 10 trillion more processed every quarter, according to the company.
    • Using the research assistant tool, health systems can ask plain-English questions about their market position and get instant, data-backed answers, executives say.
    • “It’s like having extra researchers on your team,” Jerry DiMaso, Payerset co-founder and CEO, told Fierce Healthcare.
  • Healthcare Dive adds,
    • “Patients are less willing to use artificial intelligence for healthcare if it requires access to personal data or protected health information, according to a new survey.
    • “Healthcare consumers are primarily concerned about data privacy and the accuracy of AI-generated information, with around 89% saying AI responses in healthcare need human oversight, the survey by Wolters Kluwer shows.
    • “This trust gap means that less than a third of U.S. adults are using AI to find a healthcare provider, navigate their health insurance or create a diet plan, even though these applications are frequently marketed as key uses for AI in healthcare.”

OPM Releases 2027 Premiums

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

Simplicity is a virtue.

  • Per an OPM news release,
    • “Today, the U.S. Office of Personnel Management (OPM) announced that the 2026 Federal Benefits Open Season will run from November 9 through December 14, 2026. The rates and benefits for the 2027 Federal Employees Health Benefits (FEHB) Program, Postal Service Health Benefits (PSHB) Program, and Federal Employees Dental and Vision Insurance Program (FEDVIP) are now available for review on OPM.gov.
    • “During Open Season, eligible federal employees and annuitants can enroll in, change, or cancel FEHB, PSHB, and FEDVIP coverage. Eligible employees can also make elections for the Federal Flexible Spending Account Program (FSAFEDS).
    • “OPM encourages employees and annuitants to review their coverage and choose the options that best meet their needs and those of their families. FEHB, PSHB, and FEDVIP coverage will continue into 2027 if enrollees make no changes. FSAFEDS participants, however, must make a new election each year to continue that benefit. OPM also encourages eligible employees who do not currently participate in FSAFEDS to consider its pretax benefits and enroll.
    • “Open Season is the time to look beyond your current plan and make sure your coverage still works for you and your family,” OPM’s Associate Director for Healthcare and Insurance Matthew Kiley said. “We encourage employees and annuitants to compare their options, review their costs, and make any changes before the December 14 deadline.”
  • FedWeek adds
    • “Federal employees and retirees enrolled in FEHB will pay an average annual increase of 10.9 percent more for their share of premiums in 2027 (down from 12.3 percent for the current year), according to an OPM announcement. PSHB enrollees will see an average increase in their share by 8.2% (11.3 percent in 2026).
    • “Dental and vision premiums are rising just 1 percent and 1.6 percent on average.
    • “According to the announcement, increases are due largely to “rising prices and utilization across inpatient, physician, outpatient, and surgical services; Continued growth in behavioral and mental health care; and; Higher prescription drug spending—particularly on GLP-1s, specialty drugs, and other high-cost therapies.”
  • Federal News Network also has an article on the OPM announcement.

More News from Washington, DC,

  • The Hill reports,
    • “A group of lawmakers spanning both parties and chambers is introducing legislation that would require insurance plans to cover genetic testing for patients with hereditary risk factors and expand education and outreach about gynecologic cancer risk. 
    • “Sens. Elissa Slotkin (D-Mich.) and Katie Britt (R-Ala.) are leading the bill, the Ovarian Cancer IMPACT Act, which was shared exclusively with The Hill. Their House counterparts on the legislation are Reps. Rosa DeLauro (D-Conn.) and Don Bacon (R-Neb.).” * * *
    • “In addition to some provisions about insurance coverage of genetic screenings, the new bill includes reauthorization of a 20-year-old Centers for Disease Control and Prevention program, Johanna’s Law, that provides funding for a federal education campaign about gynecological cancers.” 
  • The Washington Post adds,
    • “President Donald Trump’s pick for surgeon general cleared a major hurdle Wednesday as the Senate health committee voted to advance her nomination to the floor.
    • “In a 12-11 party line vote, Nicole Saphier — a former Fox News contributor and radiologist at Memorial Sloan Kettering Cancer Center in New York — took a step closer to becoming the nation’s top doctor.” * * *
    • The [12-11] vote included advancing the nomination of Timothy Westlake, Trump’s pick to head the Substance Abuse and Mental Health Services Administration, which leads policy efforts on mental health and addiction. He is a board-certified emergency physician. It also included one more health nominee, Mary Lazare, to be assistant secretary for aging.
  • Bloomberg Law relates,
    • “The Trump administration finalized on Wednesday a new drug payment modeldesigned to help carry out its most-favored-nation policy, cementing a plan that pharmaceutical companies have signaled are ripe for legal challenges.
    • “The pricing demo, known as GLOBE, would test whether alternative methods for calculating rebates for Medicare Part B medicines administered in doctors’ offices, based on international pricing metrics, will reduce drug costs.
    • “Still, over two dozen drugmakers — including Eli Lilly & Co., Novo Nordisk A/S, and Pfizer Inc.— have indicated they’ve gotten exemptions after entering separate agreements with the administration to voluntarily offer discounts on certain medicines to state Medicaid programs known as GENEROUS. The rule text appears to confirm that carve-out.” * * *
    • “The model is set to start Jan. 1, 2027 with the collection of voluntary manufacturer-submitted international drug net pricing data. It will be tested over five performance years, running through March 31, 2032. 
    • “A separate model targeting Medicare Part D drugs, which are prescription medications dispensed at pharmacies, is still under review at the White House.” 
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), today launched a major effort to transform how clinical trials are designed and conducted — using advanced computational models, real-time analysis, shared infrastructure, and automation to evaluate drugs and biologics faster, at lower cost, and with fewer participants. The new Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, together with three complementary projects announced today, aims to remove barriers that slow clinical development and help promising treatments reach patients sooner.
    • “America should lead the world in turning medical breakthroughs into treatments for patients,” said HHS Secretary Robert F. Kennedy, Jr. “HHS is taking on the delays, duplication, and unnecessary costs that slow clinical trials down. Through ARPA-H, we are building a modern clinical trial system that can generate rigorous evidence faster, reduce the burden on patients, and move effective treatments from discovery to the people who need them sooner.”
    • “Together, these efforts advance the Trump administration’s work to modernize clinical development, reduce unnecessary delays and costs, and strengthen U.S. competitiveness in biotechnology and drug development. By making clinical trials faster, more efficient, and less burdensome for patients, ARPA-H aims to help promising treatments reach patients sooner while reinforcing the United States as a global leader in medical innovation.”
  • The American Hospital Association News tells us,
    • “Two executive orders on artificial intelligence were released Sept. 29 by the White House. One announced a new website that will use AI to deliver federal government information and services. The website, America.gov, is intended to eliminate the need for navigating multiple agency websites, according to a fact sheet. The order directs the Administrator of General Services in coordination with the Director of the Office of Management and Budget to establish and operate America.gov as the lone entry point for accessing covered services online, such as public-facing federal services that serve more than 100,000 users in a 12-month period and can be accessed or applied for online.
    • “The second executive order announced a rebrand of AI as “super intelligence.” The order and correspondingfact sheet said that the administration will use “super intelligence” and “SI” in place of “artificial intelligence” and “AI” in official correspondence, public communications, websites, reports, policy documents and other non-statutory documents.” 
  • Beckers Hospital Review informs us,
    • “The Pharmaceutical Research and Manufacturers of America has named Eric Cantor its next president and CEO, effective Nov. 9.
    • “Mr. Cantor will succeed Stephen Ubl, who has led PhRMA since 2015, according to a Sept. 29 news release. Mr. Ubl will continue to serve as a strategic adviser.
    • “Mr. Cantor represented Virginia in the U.S. House of Representatives from 2001 to 2014 and served as House majority leader from 2011 to 2014. Since leaving Congress, Mr. Cantor has served as vice chairman and managing director at Moelis & Company and as a member of its board of directors. He will continue serving on the board while leading PhRMA.”

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

  • BioPharma Dive reports,
    • “The Food and Drug Administration has accepted an approval application for Roche’s experimental multiple sclerosis pill fenebrutinib, kickstarting a review of the treatment in two forms of the disease.
    • “The agency will begin evaluating fenebrutinib in both the “relapsed” and “primary progressive” types of MS, positioning the treatment to possibly become the first of its kind approved in both settings. Roche didn’t say when a decision might come, though the agency has initiated a “priority review” that has a six-month timeline.
    • “Roche’s application is based on a trio of late-stage studies that met their main objectives. However, an imbalance in the number of deaths observed among treatment recipients and regulators’ pre-existing concerns about the liver safety of drugs like fenebrutinib could complicate the company’s approval chances.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health. As part of an effort to broaden and strengthen participation on its advisory committees, the FDA is publishing two Federal Register notices: one seeking qualified scientific, technical, and professional voting members across all committees with current or anticipated vacancies, and a companion notice seeking consumer representatives to ensure the public’s voice is at the table.  
    • “FDA advisory committees bring together leading scientific minds to engage with the most difficult questions in public health. We are actively inviting people from across the country who are on the forefront of their fields — clinicians, researchers, and community voices who can bring the latest science, real-world experience, and fresh perspectives to the FDA’s deliberations,” said Acting FDA Commissioner of Food and Drugs, Kyle Diamantas, J.D. “These panels provide independent expertise and rigorous scrutiny as the FDA navigates complex and rapidly evolving areas of science. The Trump Administration is deeply committed to strengthening the partnership between the FDA and the nation’s brightest minds.”  

From the Medicare Advantage front,

  • Beckers Payer Issues reports,
    • “There will be four new entrants to the Medicare Advantage market in 2027, according to CMS data.” * * *
      • The Muscogee (Creek) Nation will offer one HMO, called Native Advantage, in 11 Oklahoma counties.
      • Boise, Idaho-based St. Luke’s Health System will offer three HMOs with drug coverage through its health plan in seven counties across Idaho. St. Luke’s launched its health plan with individual and employer coverage in 2023.
      • Tacoma, Wash.-based MultiCare Health System will offer two HMOs with drug coverage in three Washington counties through its newly launched health plan. 
      • MedCare Partners Health Plan of Texas will offer three plans in Harris County, including one HMO and two C-SNPs.
  • Beckers Hospital Review adds,
    • Seven health system-affiliated insurers are among the 11 total health plans exiting the individual Medicare Advantage market for 2027, according to CMS data.
      • Irving, Texas-based Christus Health Plan offered plans in 36 Texas counties and eight New Mexico counties.
      • Wausau, Wis.-based Aspirus Health Plan offered plans in 21 Wisconsin counties.  In February, CMS suspended new MA enrollment into the health plan after its claims processor, UCare, was taken over by Minnesota regulators.
      • Renton, Wash.-based Providence Health Plan offered plans across six Oregon counties, six Washington counties and Orange County, Calif. The MA exit is part of the wider shutdown of the health plan.
      • WellSense Health Plan, part of Boston Medical Center, offered plans in all 10 New Hampshire counties.
      • Houston-based Memorial Hermann Health Plan offered plans in six Texas counties. In July, the plan confirmed it would also shut down its commercial business.
      • Mass Advantage, part of Worcester-based UMass Memorial Health, offered plans in Worcester County.
      • San Diego-based Sharp Health Plan offered plans in San Diego County.

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Pennsylvania reported Wednesday that a fifth person who had measles has died as rising infections in the state continue to push up the country’s record-breaking count of cases.
    • “The Pennsylvania Department of Health said an unvaccinated Lancaster County resident who tested positive for measles had died. No additional information about the person was immediately released.”
  • Health Day relates,
    • “Type 2 diabetes dramatically increases a person’s short-term risk of death or life-threatening illness, a new study says.
    • Within five years of their diagnosis, patients with type 2 diabetes have a 33% increased risk of dying or developing kidney disease or heart failure, researchers are slated to report this week at a meeting of the European Association for the Study of Diabetes.
    • “That risk increases to 55% over 10 years, researchers added.
    • “Our findings clearly show how the serious complications associated with type 2 diabetes rise sharply over time as the often-common combination in patients of obesity, abnormal blood fats, high blood pressure and higher blood sugar damages blood vessels and vital organs,” lead researcher Naveed Sattar said in a news release. He is a professor of cardiometabolic medicine at the University of Glasgow in Scotland.”
  • Cardiovascular Business tells us,
    • “The American College of Cardiology (ACC) has published a new scientific statement focused on how eating well can help with the prevention and management of cardiovascular disease (CVD). The document, published in full in JACC, is the work of a committee of experts from the fields of cardiology and nutrition that first met in April.[1]
    • “Suboptimal diet is a key risk factor for CVD, and diet and lifestyle modification is widely considered essential for both primary and secondary prevention,” Frank B. Hu, MD, PhD, chair of the department of nutrition at Harvard T.H. Chan School of Public Health and chair of this document, said in a statement. “However, the concept of a ‘heart-healthy’ diet has evolved over time from nutrient-centric approaches to more holistic, food- and pattern-based strategies that better reflect advances in the understanding of the complex relationship between diet and cardiometabolic health.”
    • “The ACC scientific statement highlights the importance of following a heart-healthy diet, pointing to the Mediterranean diet and dietary approaches to stop hypertension (DASH) diet as two specific examples. Plant-based foods and healthy fats and proteins are recommended over foods high in refined starches, added sugars and unhealthy fats. The document also gets more specifics, emphasizing the benefits of vegetables, fruits, whole grains, nuts and legumes, while warning against the risks associated with eating too many ultra-processed foods.”
  • Health Day informs us,
    • “Insomnia is associated with an increased risk for stroke and with higher odds of hospital admission, according to an umbrella review funded by the European Academy of Neurology and published online Sept. 7 in Sleep Medicine Review.
    • “Luca Vignatelli, M.D., from the IRCCS Istituto delle Scienze Neurologiche di Bologna in Italy, and colleagues identified systematic reviews with meta-analyses (SRMAs) that examined insomnia as a predictive factor for dementia, stroke, depression, suicide, death, occupational injuries, and hospitalization. Sixteen SRMAs were included, and three additional original reviews were conducted for stroke, occupational injuries, and hospitalization.
    • “The researchers found that insomnia was consistently identified as a predictor of dementia, depression, and suicide, but not death, in SRMAs. Insomnia was a predictor of stroke (hazard ratio, 1.26) and of hospitalization for any reason (odds ratio, 1.28) based on two original SRMAs. A meta-analysis could not be performed on the two studies relating to occupational injuries. There was an association with unintentional fatal injuries and commuting injuries, but data were insufficient to draw a conclusion.”
  • and
    • “Chronic stress may hit women’s brain power harder than men’s as they age.
    • “A new study of nearly 3,900 healthy adults age 50 and older without dementia found women with higher levels of ongoing stress had steeper declines in attention and language than men.
    • “Researchers said it’s not yet clear why — or whether the difference is tied to biology, such as hormones, or social factors like gender roles.
    • “Hispanic participants with higher stress also had greater memory decline than non-Hispanic white participants.
    • “But there was an encouraging finding across all groups: Greater social support was linked to less decline in attention.”
  • Beckers Behavioral Health points out,
    • “The prevalence of benzodiazepine dispensing in the U.S. fell 26.7% from 2013 to 2024, with the largest relative decline among adults ages 18-29, according to a study published Sept. 30 in the American Journal of Psychiatry.
    • “Researchers from Rutgers University in New Brunswick, N.J., and Columbia University in New York City analyzed 1.1 billion benzodiazepine prescription fills among 252 million patients age 2 and older using the IQVIA Longitudinal Prescription dataset. The study examined changes in prescription prevalence, prescription counts and mean total dose dispensed by patient age and prescriber type.
    • “The declines may reflect greater caution in benzodiazepine prescribing, potentially tied to growing awareness of the drugs’ role in opioid-related overdoses and to FDA boxed warnings issued in 2016 and 2020, according to the researchers. The 2016 warning cautioned against prescribing benzodiazepines alongside opioids, and the 2020 warning addressed risks of misuse and addiction.” 
  • Health Day adds,
    • “A quick spritz to the nose could bring rapid pain relief to injured kids cared for in emergency rooms, new research shows.
    • “According to experts, too many pediatric ER patients are waiting too long for pain relief.
    • “Nearly a third of children with moderate to severe pain do not receive adequate pain relief within the 15 to 20 minutes recommended in international guidance,” noted study lead author Dr. Shammi Ramlakhan of Sheffield Children’s Hospital in England. 
    • “The new nasal spray combines two medications, sufentanil and ketamine. This combo eased pain within a half-hour for most injured kids in the study, Ramlakhan’s team said. 
    • “The results suggest it helps to reduce pain quickly and effectively, without the need for an injection,” said Dr. Maša Sorić, head of the emergency department at University Hospital Merkur, Zagreb, Croatia.
    • “Sorić, who wasn’t involved in the study, noted that “the treatment did not cause too much drowsiness, and the side effects were mild.”
  • BioPharma Dive notes,
    • “Bristol Myers Squibb has changed a late-stage study of its experimental pulmonary fibrosis drug admilparant to more closely monitor for liver-related side effects, following a “limited number” of instances of liver damage as well as the death of a participant from liver injury, a spokesperson said Wednesday.
    • “The change to the long-term safety extension to its Phase 3 “Aloft” trial raised investor worries about admilparant’s drug class, called LPA1R inhibitors, which are viewed as a new way to slow progression of the lung disease idiopathic pulmonary fibrosis. Shares in Bristol Myers as well as Contineum Therapeutics, the developer of a similar drug, fell sharply in late-day trading Tuesday before rebounding early Wednesday. 
    • ‘A spokesperson confirmed that it’s unclear whether the patient who died received admilparant. Wall Street analysts also called the brief share pullback “overdone,” pointing to multiple factors that could’ve contributed to the death and the relatively mild nature of the other side effects observed. Bristol Myers expects to report study results by the end of the year, an announcement that could shed more light on the safety of admilparant and other drugs in its class.”
  • STAT News lets us know,
    • “An investigational combination therapy from Eli Lilly led to significant weight loss in a mid-stage study, but high rates of people stopping the treatment may raise questions about its tolerability. 
    • “Lilly, which is racing to bring next-generation obesity drugs to the market, tested different combinations of its blockbuster GLP-1 drug Zepbound with eloralintide, a candidate that targets the amylin hormone, in people with obesity and type 2 diabetes.
    • “After 48 weeks, participants who stayed on the treatment at the highest dose of the combination therapy lost 23.3% of their weight, according to results presented Wednesday at the annual meeting of the European Association for the Study of Diabetes. That’s more than the weight loss seen with those taking only Zepbound and those taking only the highest dose of eloralintide — 14.8% and 11.1%, respectively.
    • “The results were also notable because patients with diabetes don’t tend to lose as much weight on medications as those who don’t have diabetes.
    • “However, there were high rates of participants stopping the combination therapy due to adverse events — ranging from 10.8% to 27.0% among the different dose groups. Those taking only eloralintide had discontinuation rates ranging up to 10.8% across dose groups, and those taking only Zepbound had a rate of 2.9%.
    • “The new combination therapy, called EloraTZP, is a potential competitor to Novo Nordisk’s CagriSema, an investigational combination of an amylin drug called cagrilintide and its own Wegovy that’s further along in development. Given the high discontinuation rates in the new trial, it’s difficult so far to compare EloraTZP with CagriSema.”

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

  • Modern Healthcare reports,
    • “Cigna Group is forecasting future growth and billions in cost savings, the company disclosed Wednesday.
    • “The healthcare behemoth reaffirmed its guidance for this year and projected at least $45 in adjusted earnings per shareby 2030 during the company’s investor day.
    • “Cigna Group will also save $3 billion over multiple years, partly from automating workflows and implementing artificial intelligence, said Ann Dennison, executive vice president and chief financial officer. Some of those savings will be invested back into the company, she said.”
    • “Cigna Healthcare is launching Health Sense early next year as part of its new partnership with OpenAI. Health Sense is a personalized clinical support model, which the company claims will reduce inefficient care by 10% by 2030.
    • “The company is also building a fifth “clean room,” a sterile facility where complex drugs are compounded and mixed. It will take up to three years to fully build and license, according to executives.
    • “This will create capacity for millions of new prescriptions to keep up with rising demand,” said Matt Perlberg, president of pharmacy and care delivery at Evernorth Health Services and executive vice president of customer innovation at Cigna Group. 
    • “Evernorth is also launching a wholesale distribution channel alongside its specialty distributor division CuraScript, which serves more than 12,000 healthcare providers, to gain access to new medications.”
  • Beckers Payer Issues relates,
    • “Tom Curtin was named executive vice president of Kaiser Permanente’s National Health Plan after serving as its interim leader since May.
    • “In the role, effective immediately, Mr. Curtin will lead health plan strategy and operations with a focus on growth, affordability and expanding access to the Oakland, Calif.-based system’s value-based care model, according to a Sept. 29 news release. He reports to Chair and CEO Greg Adams.
    • “During his time as interim leader, Kaiser Permanente added more than 223,000 members in 2026, positioning the organization for its strongest membership growth since 2018, the release said.”
  • Fierce Healthcare tells us,
    • “Performance-based contracting is becoming the norm for digital health solutions, with the majority of employers and health plans tying vendor payments to clinical and financial outcomes, according to a new survey from Peterson Health Technology Institute (PHTI).
    • “Specifically, 68% of employers and 55% of health plans are using such contracts. Eighty-five percent of contracts tie at least a quarter of fees to performance while 31% tie more than half, PHTI analysts wrote in the report (PDF).
    • “The report drew insights from 321 digital health professionals responsible for purchasing across health plans, employers and health systems. Four main areas were covered: purchasing approach, artificial intelligence adoption, contracting process and future plans.”
  • and
    • “Satisfaction with pharmacy benefit managers has stabilized in 2026, though the likelihood of contract renewal without a competitive request for proposal declined, a new report from Pharmaceutical Strategies Group (PSG) found. 
    • “The report drew insights from 250 benefits leaders representing employers, health plans, healthcare organizations and union plans. Respondents were asked to rate satisfaction with PBMs on a 10-point scale, with overall satisfaction receiving a 7.2 score, up from 7.1 in 2025. 
    • “On a similar scale, the likelihood to renew contracts without issuing competitive RFP fell to 6.4—which analysts note is the “lowest point in recent history.”
  • MedTech Dive informs us,
    • “Abbott said Wednesday it is launching Freenome’s SimpleScreen CRCblood-based test for colorectal cancer in the U.S. as an option for people who decline to complete medical guideline-recommended screening.
    • “SimpleScreen CRC is an addition to the Cologuard Plus stool-based test in Abbott’s colorectal cancer screening portfolio. Abbott acquired Cologuard in March in the $21 billion buyout of Exact Sciences.
    • “Freenome developed the SimpleScreen test and manufactures it. Abbott will distribute SimpleScreen in the U.S. under a commercial agreement with Freenome. The test, which won Food and Drug Administration approval this summer, will compete in the market with Guardant Health’s Shield blood test for colorectal cancer screening.”
  • Fierce Healthcare points out,
    • “Trinity Health System, a four-hospital system in eastern Ohio, will officially be handed over from CommonSpirit Health to University of Pittsburgh Medical Center (UPMC) on Oct. 1, the large nonprofit organizations shared Wednesday. 
    • “The deal is a geographic expansion for UPMC, which to date has limited its acute footprint to Pennsylvania. Financial terms of the deal still have not been disclosed. 
    • “By integrating Trinity Health System into UPMC, we are building upon a foundation of trusted collaboration to ensure that high-quality, patient-centered care remains accessible and sustainable for years to come,” Dwayne Richardson, interim market president, of Trinity Health System, said in the announcement. “We know that UPMC shares our dedication to clinical excellence.”
    • “Alongside the hospitals—Trinity West and Trinity East in Steubenville, Trinity Twin City Medical Center in Dennison and Trinity St. Clairsville Neighborhood Hospital in St. Clairsville—UPMC is acquiring associated clinics and sites delivering urgent care and behavioral health care.” 
  • Per Beckers Hospital Review,
    • “Dallas-based Baylor Scott & White Health reported operating income of $1.5 billion (8.3% margin) during the fiscal year ending June 30, 2026, down from a $1.7 billion operating gain (10% margin) in the previous fiscal year, according to financial statements published Sept. 30.”
  •  and
    • The number of first-year students at U.S. medical schools that grant MD degrees rose 36.8% from the 2005-06 academic year to 2025-26, but fewer are staying in their home state. 
    • Over the same period, the share of those students who come from the school’s home state declined, according to a study published Sept. 29 in JAMA.
    • The study’s authors, Barbara Barzansky, PhD, and Felicia Walker, work for the American Medical Association, which funded the research. They used data from the Liaison Committee on Medical Education’s 2025-26 Annual Medical School Questionnaire. Of the 160 medical schools the committee accredits, 158 responded.
  • Per MedCity News,
    • “AstraZeneca is making a $2 billion equity investment in Summit Therapeutics, a business deal that also kicks off a research collaboration that could pursue multiple drug combinations with an initial focus on gastrointestinal cancers.
    • “The deal announced after Monday’s market close is a vote of confidence in the Summit cancer drug ivonescimab, a bispecific antibody designed to bind to two targets, PD-1 on T cells and VEGF on cancer cells. Several oncology-focused pharmaceutical companies have already struck deals to add such drugs to their pipelines. Summit’s late-clinical drug gives AstraZeneca access to a contender in the class.
    • “Ivonescimab was developed by China-based Akeso Therapeutics. Phase 3 trial results in lung cancer raised hopes for the molecule as data showed it beat Merck’s blockbuster PD-1 inhibitor Keytruda in a head-to-head study. But those results were from a trial in China, where the drug has approvals in lung cancers and is marketed by Akeso. For Summit, ivonescimab’s prospects ride on the results of clinical trials the company is conducting in outside of China. Summit holds rights to the drug in North and South America, Europe, the Middle East, Africa, and Japan.”
  • Per Radiology Business,
    • “Solis Mammography has inked a new imaging joint venture with HCA Healthcare, the two announced on Monday. 
    • “The Addison, Texas-headquartered breast imaging provider is teaming with America’s largest health system to expand services in South Carolina. It will work with HCA Healthcare’s Trident Hospital, with its breast imaging services now branded under the Solis Mammography name. 
    • “This marks the private equity-backed imaging group’s first foray into South Carolina. Solis said the two have plans to further expand into additional HCA facilities across the greater Charleston area, boosting local access to breast imaging services. 
    • “Partnering with Solis Mammography reflects our deep commitment to the women and families who call the Lowcountry home,” Hugh Tappan, MBA, president of HCA Healthcare’s South Atlantic Division, said in a statement Sept. 28. “We want every woman to feel supported and confident in her breast health journey, with access to exceptional care close to home.”
  • Per Cardiology Business,
    • “Artificial intelligence (AI) is increasingly being incorporated into cardiovascular imaging, but at Mass General Brigham, some of the most practical applications are focused on streamlining the imaging workflow rather than replacing or double-checking what radiologists and cardiac imagers already do.
    • “Brian Ghoshhajra, MD, MBA, medical director of radiology and clinical operations for integrated imaging services at Mass General Brigham and an associate professor of radiology at Harvard Medical School, discussed the health system’s approach to AI and automation with Cardiovascular Business.
    • “Ghoshhajra said imaging can be viewed as a chain that begins with ordering and scheduling, moves through protocoling and quality assurance and ends with interpretation and reporting. While much of the attention surrounding AI has focused on interpretation, he said there may be significant opportunities to improve the earlier steps of the process.
    • “At Mass General Brigham, for example, automation has been used to reduce the amount of manual work required for protocoling cardiovascular CT examinations. Ghoshhajra said the system has grown from performing about five cardiac CT examinations per day when he was a fellow 18 years ago to approximately 85 to 100 studies per day across multiple hospitals using a hub-and-spoke model.”

Weekend update

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

Simplicity is a virtue.

From Washington, DC

  • The Senate will be in session this week on Capitol Hill for Committee business and floor voting. The Senate will join the House of Representatives on the election campaign trail at the end of the week.
  • Roll Call discusses anticipated Senate activities this week.
  • The U.S. Supreme Court will gear up for its October 2026 term this week. On Friday, the Court will release its long list of orders on cert petititions and more that have piled up since June.

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

  • The FEHBlog expects that OPM will publicize 2027 FEHB and PSHB premiums sometime over the next two weeks. Last year, OPM publicized 2026 premiums on October 9, 2025.

From the public health and medical / Rx research front,

  • Healio reports,
    • “Autism prevalence has not significantly changed since 2005, according to a large population-based study of schoolchildren in South Korea.
    • “HHS Secretary Robert F. Kennedy Jr. and other U.S. health officials have claimed there is an autism “epidemic,” blaming vaccines, acetaminophen and environmental toxins as potential causes for the rise in diagnoses.” * * *
    • “Research has shown that there has been an increase in autism diagnoses, but experts say that is due to earlier detection and expanded diagnostic criteria. Young Shin Kim, MD, MS, MPH, PhD, a developmental psychopathologist at University of Texas Dell Medical School, told Healio that it is difficult to interpret data about autism prevalence because of the large variation in how those data are collected and reported in different states, countries and health systems. * * *
    • “Kim and colleagues investigated autism prevalence in South Korea. Elementary education is mandatory in South Korea, and Kim said homeschooling is rare, which allowed the researchers to screen nearly every child in the country when they started school.” * * *
    • “Our findings do not support interpreting increases in reported autism prevalence as evidence of an ‘autism epidemic,’” Kim said. “Much of the increase may reflect improved awareness, broader identification and the recognition of children who were previously missed.”
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) today [September 24] launched Linked Discoveries, an experimental tool designed to help scientists more easily see how an individual research finding relates to the larger body of biomedical evidence. From a citation in PubMed, users can use the Linked Discoveries tool to explore a “neighborhood” of publications closely related to that article, including replication studies. More than 29 million PubMed publications are represented in Linked Discoveries at launch. 
    • “Developed by NIH’s National Library of Medicine (NLM), which oversees PubMed, Linked Discoveries is an early product of NIH’s agency-wide initiative to strengthen replication and reproducibility in NIH-funded research. In particular, this tool seeks to address the difficulty of determining how a finding fits within the existing evidence. Relevant studies and other research information may be dispersed across different resources, and traditional approaches to finding scientific literature can favor already prominent or frequently cited work. Linked Discoveries begins to address that challenge by giving researchers a more connected view of publications related to a particular study.” * * *
  • Health Day relates,
    • “A well-known brain-healthy diet appears to ward off decline and dementia by protecting a person’s arteries, a new study says.
    • “People who followed the MIND diet had healthier blood vessels in their brains, contributing to larger brain sizes and better cognitive function, researchers report in the journal Alzheimer’s & Dementia.
    • “One of the most striking findings was that the relationship remained significant even after accounting for factors such as physical activity, body mass index, race and vascular disease,” said lead researcher Puja Agarwal, an assistant professor of internal medicine at Rush University in Chicago.
    • “This suggests that diet may have an independent role in supporting brain health,” she added in a news release.”
  • and
    • “Loneliness and social isolation can cost a person up to six years of healthy life, a new study says.
    • “Physical and mental health suffer when people feel lonely and become isolated, even if they largely stick to healthy habits, researchers reported recently in the journal Nature Communications.
    • “The two conditions are different. Social isolation refers to having few relationships or limited contact with others, while loneliness is a distressing feeling caused by a lack of meaningful connection, according to the National Council on Aging.
    • “In other words, people can be socially isolated but still not feel lonely if they are getting what they need from whatever connections they do have.” * * *
    • “Notably, a healthier lifestyle — diet, exercise, sleep and not smoking — narrowed the loss of disease-free years linked to social isolation, but did not significantly reduce the health risks of loneliness.
    • “The findings weren’t surprising to me,” Qi concluded. “Previous studies found that social isolation and loneliness are related to mortality, especially premature mortality, and this study provides additional evidence.”

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

  • The Business Group on Health considers “Why are Healthcare Costs So Difficult to Forecast?” 
    • “Explore why healthcare costs are increasingly difficult to forecast and how employers are responding to volatility with greater urgency and accountability.”
    • “Healthcare cost volatility is no longer a temporary disruption. It is becoming a defining feature of the healthcare landscape. After consecutive years of missing cost projections and facing record-high increases, employers are confronting a fundamental question: Which new strategies and approaches do we need to deploy to address this persistent and volatile landscape? 
    • “The employers that thrive in this environment will be the ones willing to rethink how care is purchased, act with a sense of urgency, demand greater accountability from partners, and embrace disruption when it creates better outcomes. In a market defined by uncertainty, standing still may be the riskiest strategy of all.” 
  • The Hill reports,
    • “After analyzing claims data from 2021 to 2023, the personal finance site [MoneyGeek] found the average out-of-pocket cost of a vaginal delivery was $2,563 and a C-section was $3,071.
    • “These estimated totals include the cost of staying at the hospital, the line item charges for medication, and seeing different types of physicians (obstetricians, anesthesiologists, etc.).
    • “The states with the highest bills, surprisingly, are places often thought of having a low cost of living, like Nebraska, Oklahoma and South Dakota. Average deliveries in all three states can cost patients upwards of $2,500 out-of-pocket.” * * *
    • “Meanwhile, in Michigan, the average delivery costs $974 out-of-pocket. What accounts for such a big difference? In most cases, it comes down to what hospitals have negotiated with insurers, according to MoneyGeek.”
    • “As the California Health Care Foundation explains, differences in price between different hospitals has little to do with the quality of care received. It has more to do with how much competition there is in a market. 
    • “Decades of research shows that prices for inpatient and outpatient services — from C-sections to CT head scans — are higher when there is less competition,” write Kristof Stremikis and Catherine Teare. “This happens when hospitals, medical groups, or health plans merge or buy their competitors. With fewer choices, a big system in one area can set higher prices and anti-competitive contract terms.”
  • The Wall Street Journal lets us know “People Are Lining Up for Full-Body Scans. But Are They Necessary?”
    • “Neko Health, a Spotify founder’s preventative-health startup, opened its first U.S. clinic.”
    • [Neko Health] had amassed a wait list of around 25,000 New Yorkers before the location was announced, a company spokesperson said. It opened its doors on Thursday [September 24]. The Swedish brand is the brainchild of Spotify founder Daniel Ek and Hjalmar Nilsonne, Neko Health’s CEO.
    • “It is the latest in a wave of preventative-health companies hitting the U.S. market, pitching patients on the notion that more information can give them more control over their health. For $499, which people can use HSA or FSA funds to help cover, the “radiation-free” visit includes a skin examination with visual and thermal cameras, a cardiovascular assessment, a body-composition analysis and on-site blood-testing. That takes about 30 minutes, then a clinician will meet with patients for another 30 minutes to discuss the results. It aims to help people assess risk of skin cancer, cardiovascular disease and metabolic conditions.” * * *
    • Some medical professionals have criticized preventive MRIs as unnecessary. But their potential for early detection, even before symptoms arise, shouldn’t be dismissed, said Dr. Zahi Fayad, director of the Biomedical Engineering and Imaging Institute at the Icahn School of Medicine at Mount Sinai.
    • “We still need to learn which people benefit most, how often to scan them and whether earlier detection changes their long-term outcomes,” he said.” * * *
    • “He shared advice for patients interested in getting a scan: “First, tell me what you are hoping to learn. If there is a symptom or a strong family history, we should choose the test that addresses that concern.”
    • “He added, “Neither service should replace recommended cancer screening or attention to blood pressure, cholesterol, diabetes risk, exercise and smoking.”