Midweek report

Uncategorized

Midweek report

David Ermer–CDC, CMS, Electronic health records, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Healthcare Dive reports,
    • “The leader of an influential congressional advisory group is defending its estimates of Medicare Advantage overpayments amid growing controversy over how to best analyze spending in the privatized Medicare program.
    • “Dr. Amol Navathe, the chair of the Medicare Payment Advisory Commission, or MedPAC, took the stage during an MA industry event in Washington, D.C. on Tuesday in support of the group’s research that the U.S. government is set to spend 14% more — an extra $76 billion — this year on seniors that opt into MA than it would if those same beneficiaries went into traditional Medicare.
    • MedPAC isn’t interested in making MA look bad, Navathe said at the event hosted by the Better Medicare Alliance, an influential MA lobby.
    • “The estimate that MA costs 14% more than traditional Medicare doesn’t mean MedPAC is advocating for a 14% cut to MA. Instead, the legislative agency’s goal is to support competition in the popular Medicare alternative and produce reliable research that spurs meaningful conversations about potential reform, according to Navathe, who was named MedPAC’s chair in May.” * * *
    • “Insurers argue that MedPAC’s estimate — which is broadly cited by members of Congress, health policy experts and other stakeholders in the healthcare industry — is flawed and makes MA seem costlier than it really is. MA plans instead prefer a CMS analysis from January that yields a dramatically lower estimate of overpayments, or industry-funded research that finds MA is actually cheaper for taxpayers.”
  • The Wall Street Journal relates,
    • “More than two million people in the U.S. who take prescription drugs bought them from outside the country to save money, according to a 2020 study published in JAMA Network Open, some of the most recent research available on the topic. 
    • “The practice has operated for decades in a legal gray area: technically barred under FDA rules, importers say it is rarely enforced. Customs agents have historically waved through low-value, personal-use packages rather than individually checking each one against the agency’s criteria.
    • “The U.S. government has already made these imports more difficult. Starting in August of last year, patients ordering medication by mail have had to start paying customs fees on shipments that previously arrived free of charge.
    • “The new rule fully closes the regulatory gap on Oct. 22.
    • “After that, prescription drugs will need to move through a formal entry process with an accountable company or person legally on the hook if a shipment doesn’t qualify.”
    • More than two million people in the U.S. who take prescription drugs bought them from outside the country to save money, according to a 2020 study published in JAMA Network Open, some of the most recent research available on the topic. 
    • The practice has operated for decades in a legal gray area: technically barred under FDA rules, importers say it is rarely enforced. Customs agents have historically waved through low-value, personal-use packages rather than individually checking each one against the agency’s criteria.
    • “The U.S. government has already made these imports more difficult. Starting in August of last year, patients ordering medication by mail have had to start paying customs fees on shipments that previously arrived free of charge.
    • “The new rule fully closes the regulatory gap on Oct. 22.
    • “After that, prescription drugs will need to move through a formal entry process with an accountable company or person legally on the hook if a shipment doesn’t qualify.” * * *
    • “The rule applies to any FDA-regulated mail shipment from any country, including smaller medication pipelines from India, the United Kingdom, Australia and Turkey. It doesn’t change regulations around Americans who buy medication in person while traveling.”
  • Beckers Health IT tells us,
    • “Health systems are not the only groups pushing back against a CMS proposal to restrict remote patient monitoring.
    • “In July, CMS pitched banning Medicare payments for remote patient monitoring services carried out by third-party companies. As proposed, starting Jan. 1, 2027, payments for remote physiologic and therapeutic monitoring would be permitted only when furnished by clinical staff directly employed by the billing practice. CMS accepted comments on the proposed rule until Sept. 14.
    • “On that date, UnitedHealth Group, CVS Health and Kaiser Permanente all voiced concerns in their respective letters to CMS.”
  • The American Hospital Association News informs us,
    • “The AHA Sept. 23 recommended the Department of Homeland Security make healthcare workers exempt from its proposed H-1B visa fee of $103,265 for petitions subject to statutory caps. In a letter to DHS on the proposal, the AHA said it is concerned that the fee would hinder hospitals and health systems’ ability to use the H-1B program to address healthcare worker shortages and would particularly have adverse impacts on hospitals in rural and underserved communities. The AHA also urged DHS to mitigate potential impacts on foreign-trained physicians with a waiver of the home-country physical presence obligation provided through the Conrad 30 Waiver Program. The proposed fee from DHS is separate from the $100,000 H-1B visa fee issued by the administration through a presidential proclamation Sept. 18.”
  • Per Department of Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced $51 million in awards to 28 HRSA-funded health centers to improve access to dental care for children with neurodevelopmental disorders, including autism spectrum disorder, Down syndrome, cerebral palsy, and intellectual disabilities.
    • “The new Quality Improvement Fund – Improving Access to Dental Services for Children with Neurodevelopmental Disorders (QIF-DNDD) investment will help health centers build on evidence-based models and test innovative approaches to improve dental care for children with neurodevelopmental disorders. The funding will support expanded and tailored preventive and other dental services, strengthen the health center workforce, and identify promising approaches that can be replicated in other communities.” * * *
    • “Visit the QIF-DNDD webpage for more information and the list of FY 2026 award recipients.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), today released a Request for Information (RFI), “Improving Patient Access to Deceased Donor Islet Cells and Cell Products,” seeking public input on how the federal government should regulate certain deceased donor islet cells and cell products used to treat type 1 diabetes. The RFI asks whether the current FDA-led biological product framework creates barriers to patient access and whether an alternative transplant-based framework could improve access while maintaining rigorous safety and quality protections.
    • “Under the current framework, therapies made from deceased donor pancreatic islet cells are regulated by the FDA as biological products. FDA’s approval process evaluates product safety, effectiveness, and manufacturing quality, and approved products remain subject to ongoing safety oversight.
    • “Deceased donor islet cells can give some people with type 1 diabetes the ability to produce insulin again,” said HHS Secretary Robert F. Kennedy, Jr. “HHS is taking a hard look at whether federal regulations unnecessarily stand between patients and these potentially life-changing treatments. We will protect rigorous standards for safety and quality while examining every responsible path to expand access and put patients first.” * * *
    • “HHS encourages all interested parties to submit comments by November 8, 2026. To review the RFI and submit a response, visit the federal register and reference Docket No. FDA-2026-N-10738.”
  • Beckers Hospital Review adds,
    • “Nashville, Tenn.-based Vanderbilt Health has been given an up to $11.2 million, five-year HHS contract to develop a platform to test and validate new technologies designed to improve ICU patient outcomes.
    • “The federal program is called CIRCLE — the Critical Illness Immunological Reprogramming and Control Point Learning Engine — and is part of HHS’ Advanced Research Projects Agency for Health, according to a Sept. 22 news release from Vanderbilt Health.
    • ‘Focused on ICU patient care, “CIRCLE will harness advances in diagnostics and AI to speed development of next-generation interventions that identify and respond to harmful immunoinflammatory states before life-threatening complications occur,” the release said.” 

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

  • FedSmith helpfully breaks down the FEHB / PSHB questions for which OPM has requested public comment.
    • “Comments can be submitted through November 16, 2026, on Regulations.gov under docket number OPM-2026-0661. Keep in mind that comments are posted publicly as submitted, including any names or contact details you include.
    • “Sharing specific experiences and suggested improvements is likely to carry more weight than general complaints, for example, how a premium increase affected your plan choice, whether you’ve tried an HDHP, or where the plan comparison tool fell short.”
  • FedWeek tells us,
    • “OPM has set a cap of 40 percent for the top two ratings levels combined in performance evaluations for the large majority of employees under the GS system effective with the rating cycle ending September 30.
    • “A memo assigns a number to the limit on Level 5 and Level 4 ratings under the recently finalized rules implementing a forced—what OPM calls “standardized”—ratings pattern in response to what the administration has criticized as too many employees being rated as “outstanding” and “exceeds fully successful.”
    • “Says the memo, “Distribution caps are intended to address these concerns by establishing a governmentwide ceiling on the share of employees who may receive the highest rating levels. This approach promotes more consistent and credible ratings across agencies, while requiring agencies to make more meaningful distinctions among the levels rather than defaulting to ratings that avoid difficult assessments.”

From the Food and Drug Administration front,

  • Beckers Hospital Review relates,
    • “The FDA has issued a warning letter to Houston-based Empower Pharmacy after an inspection found evidence that certain compounded drugs failed to meet conditions for exemptions under federal law.
    • “The agency said Empower compounded products that appeared to be essentially copies of FDA-approved semaglutide and tirzepatide products “regularly and in inordinate amounts,” according to the Sept. 18 warning letter. FDA investigators also cited insanitary conditions and current good manufacturing practice violations.
    • “Among the issues, investigators said Empower failed to perform adequate smoke studies under dynamic conditions and its media fills were not performed under the most challenging or stressful conditions. The FDA also cited deficiencies involving aseptic processing, environmental monitoring, quality control and production procedures.”
  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has shared an early alert about a new safety issue with certain Impella Automated Impella Controllers (AICs) from Johnson & Johnson MedTech. 
    • “Devices included in this alert should be removed from where they are used or sold so they can be serviced by Johnson & Johnson MedTech. While awaiting service, however, the AICs can still be used as necessary to ensure patients can still undergo treatment. 
    • “This new announcement covers three devices in total:
      • “Impella Controller, Packaged, US – 0042-0000-US
      • “Impella Optical Controller, Packaged, US – 0042-000010-US
      • “Optical, AIC, Impella Controller, Packaged, US – 0042-0040-US
    • “Customers can click here for a list of all serial numbers included in this alert as well as information on how to locate the serial number.” 
  • Radiology Business adds,
    • “The U.S. Food and Drug Administration has cleared a radiology artificial intelligence tool to check for 10 additional findings on abdomen-pelvis CT scans. 
    • “Imaging startup a2z Radiology AI Inc. on Monday touted the regulatory approval, which applies to its Abdo-Triage product. This expands the AI software’s range of suspected findings it can flag for clinical review up to 17, building on a previous clearance earned in late 2025. 
    • “Found in 2024, the Boston-based company says it’s building the “intelligence layer for medical imaging,” hoping to make radiologist interpretations “accessible on demand.” 
    • “Care teams need support that reflects the range of cases they see,” Samir Rajpurkar, co-founder and CEO of a2z Radiology AI, said in a statement Sept. 21. “We’re building a platform around that need. This clearance extends the range of clinically important findings we can flag on CT scans, bringing us closer to our goal of helping teams focus their attention where it is needed.”
  • Cure tells us,
    • “The Food and Drug Administration (FDA) approved Lyrfigtu (lirafugratinib) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 gene fusion or other rearrangement.
    • “Cholangiocarcinoma is a cancer that begins in the bile ducts. Unresectable means the cancer cannot be removed with surgery, while metastatic cancer has spread to other parts of the body.
    • “The approval was based on findings from the REFOCUS trial, which included 116 patients who had previously received chemotherapy or chemoimmunotherapy and had not previously received an FGFR inhibitor.”
  • Beckers Behavioral Health informs us,
    • “The FDA granted Breakthrough Device Designation to the NET Device, made by Costa Mesa, Calif.-based NET Recovery, as an aid in reducing psychostimulant use in adults 18 and older diagnosed with stimulant use disorder.
    • “The designation covers a proposed new indication for the device, including cocaine use disorder and amphetamine-type/methamphetamine use disorder, according to a Sept. 23 news release from the company. No drug is FDA-approved and no medical device is FDA-cleared to treat cocaine or methamphetamine use disorder.
    • “Approximately 4.5 million Americans struggle with both opioid and stimulant use. Stimulant-involved overdose deaths also accounted for 59% of U.S. overdose deaths from January 2021 through June 2024, according to the CDC.”

From the fraud, waste and abuse front,

  • Beckers Hospital Review points out,
    • “Off-label GLP-1 use increased 15-fold between 2021 and 2025, according to a study published Sept. 22 in Obesity.
    • “Researchers analyzed medical records from more than 92 million U.S. adults to examine GLP-1 use among patients without a documented condition that would make them eligible for the medications, such as obesity or diabetes.” * * *
    • “The findings may underestimate off-label use. Researchers said their analysis may not capture prescriptions obtained through telehealth companies or compounded GLP-1 medications.”
  • The New York Times adds,
    • “There is little data on how the [GLP-1] drugs might affect people without obesity or diabetes, because they were largely excluded from major clinical trials.
    • “These medications might pose unique risks to people who are not overweight, Dr. Krüger said. Those risks include malnutrition, as well as muscle mass loss, side effects of the drug that can affect anyone but that could be especially concerning in people with lower starting B.M.I.s.
    • “We don’t know how this will play out,” Dr. Krüger said. “It’s like this big Ozempic experiment.”
  • The Paragon Institute explains that the 760,000 “persons” disenrolled from Obamacare plans yesterday are phantom enrollees.
    • “First, CMS identified enrollees who were likely phantoms using four criteria:
      • “The application was submitted by an agent or broker without a Social Security number or immigration number for the applicant;
      • “The enrollee paid nothing toward the premium because the federal subsidy covered the entire amount;
      • “The enrollee had no medical claims; and
      • “The insurer had no record of actual contact with the enrollee.
    • “Second, for applicants meeting those four criteria, CMS required insurers to send notices through two different modes of communication, providing the enrollee with an opportunity to respond. Insurers had significant incentives to get in touch with these applicants because they were receiving subsidies to cover the full premium.
    • “Third, if there was no response, the enrollment was deemed unauthorized and canceled.
    • “Importantly, CMS has put in place a safeguard if any of the enrollees removed are legitimate: The enrollee can contact the federal exchange, provide verified identifying information, and have their coverage reinstated.
    • “To be clear, most of the fraud and improper enrollment is perpetrated by corrupt agents and brokers. But it is enabled by Obamacare subsidies so large that they produce “free” plans for applicants claiming low incomes, while the resulting improper enrollment financially benefits large health insurance companies.”
  • Federal News Network reports,
    • “The Treasury Department is on track to expand the full use of its Do Not Pay system to all federal agencies in the near term, as Treasury officials aim to fill payment verification gaps and help agencies prevent issues earlier in the payment lifecycle.
    • “Just over a year ago, only 4% of federal programs had done the compliance paperwork necessary to fully access Do Not Pay databases, according to Justin Marsico, executive director for financial integrity at the Treasury Department’s Bureau of Fiscal Service.
    • “But following an executive order and guidance issued by the Trump administration to streamline access to Do Not Pay, Marsico said many more agency programs now have full access to the data, with more progress expected in the coming months.
    • “We’ve gone now from 4% of government programs to 45% of government programs as of last week, and we’re on track for 70-80% by the end of the fiscal year,” Marsico said Tuesday during a fraud prevention conference hosted by AGA. “With another little push into the next fiscal year, we should be able to get to 100[%].”

From the judicial front,

  • Beckers Hospital Review reports.
    • “The Department of Justice revised its manual Sept. 18 to support its fight against fraud under the False Claims Act through more clearly outlined standards to promote fairness and effective enforcement.
    • “The first change in the manual reinstates and expands on the department’s 2017 policy that subregulatory guidance can’t impose legal obligations beyond those established by regulation or statute, according to a Justice Department news release.” * * *
    • “The second manual revision flags that the Justice Department should consider exercising its dismissal authority when declining to intervene in a qui tam case. Where it does not look for dismissal, the department should revisit the assessment as needed during litigation.” * * *
    • “The full Justice Manual revisions can be found here and here.” 
  • Per a FDA news release,
    • “A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.
    • “The U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction against Gold Star Distribution, Inc., a Minnesota-based multi-commodity warehouse operator, and its owner, Bassam Abu Samrah, after the FDA observed persistent insanitary conditions, including severe rodent and pest infestations, that put food, drugs, medical devices, and cosmetics at risk of potential contamination with filth.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Americans are drinking less for the first time since the coronavirus pandemic began, but drinking levels are still higher than before the pandemic, according to a new study published this week.
    • “Researchers analyzed data from more than 114,000 U.S. adults from the National Health Interview Survey and found that any alcohol use declined by almost 2 percent, and heavy drinking fell by more than 8 percent from 2022 to 2024.
    • “In the same period, Gen Z adults saw the largest decline in any alcohol consumption of around 5 percent, according to the study published in the Annals of Internal Medicine. Millennials saw a 17 percent drop in heavy drinking.”
    • “Not all Americans are following the trend. Drinking among those ages 50-64 is still higher than before the pandemic; the group’s overall alcohol consumption is up by almost 4 percent and heavy drinking increased by 36 percent between 2018 and 2024.
    • ‘Brian Lee, a hepatologist and liver transplant specialist with Keck Medicine of the University of Southern California, said that was especially concerning because that age group faces a higher risk of many alcohol-associated diseases like cirrhosis and alcohol-related cancers.
    • “We’re seeing the increases in exactly the age group that we’re most worried about in terms of health and organ damage,” said Lee, the study’s principal investigator.”
  • Beckers Behavioral Health lists rates of 2025 deaths by opioid overdoses and suicides by State.
    • “New Mexico had the highest opioid overdose death rate in the U.S. in 2025, while Nebraska had the lowest, according to a KFF analysis of provisional CDC data.
    • “The national opioid overdose death rate was 13.1 per 100,000 individuals in 2025. New Mexico’s rate of 33.9 per 100,000 was more than 2.5 times the national figure.”
    • “Alaska had the highest suicide rate in the U.S. in 2025, while New Jersey had the lowest among states, according to a KFF analysis of provisional CDC data.
    • “The national suicide rate was 13.7 per 100,000 individuals in 2025. Alaska’s rate of 31 per 100,000 was more than double the national figure.”
  • Beckers Hospital Review lets us know,
    • “Only 13% of hospital-onset sepsis cases met current U.S. criteria for reportable healthcare-associated infections, but an expanded surveillance system could catch many of these potentially preventable events, a recent study found.
    • “The study, published Sept. 17 in JAMA Network Open, analyzed 558,037 admissions of adults 18 and older at nine Mass General Brigham acute care hospitals between January 2021 and December 2023. Patients with hospital-onset sepsis were identified using the CDC’s Adult Sepsis Event criteria. In total, 5,212 patients, or 0.9%, had hospital-onset sepsis. Researchers randomly selected 250 cases for detailed record reviews by two physicians to determine the likelihood and source of infection. Then 100 infection-related cases were selected for preventability assessments considering patients’ intrinsic risks and extrinsic healthcare-related factors. 
    • “Hospital-onset sepsis events identify serious complications of hospitalization that are largely missed by current HAI surveillance programs yet are highly morbid and often preventable,” the study’s authors wrote. “Hospital-onset sepsis surveillance could provide a more comprehensive framework for identifying preventable harms and expanding opportunities for quality improvement.”
  • MedPage Today informs us,
    • “Hospitalizations complicated by acute kidney injury (AKI) surged among patients in pediatric units or children’s hospitals over the past 25 years, a large retrospective study indicated.
    • “Among more than 24.3 million discharges, hospitalizations involving AKI increased tenfold, rising from 15.7 per 10,000 discharges in 1997 to 168.7 in 2022. Rates of AKI requiring dialysis (AKI-D) more than doubled over the same period, growing from 2.4 to 5.5 per 10,000 discharges.
    • “National weighted annual incidence of AKI cases jumped from 6,318 to 63,923, while AKI-D cases increased from 981 to 2,075, reported Alexander Kula, MD, MHS, of Ann and Robert H. Lurie Children’s Hospital of Chicago, and colleagues in JAMA Network Open.
    • “However, in-hospital mortality among pediatric patients with AKI improved significantly, dropping from 1,814.0 to 643.4 per 10,000 hospitalizations between 2003 and 2022. Mortality for patients requiring dialysis remained stable at approximately 25%.
    • “Rising AKI rates should not be viewed “solely as worsening care,” cautioned Laura Rangel Rodriguez, MD, of Cincinnati Children’s Hospital Medical Center, and David Selewski, MD, of Arkansas Children’s Hospital in Little Rock, in an accompanying commentary.
    • “Children with complex congenital heart disease, malignant neoplasms, transplants, and critical illness are surviving longer and being exposed to therapies and physiologic stressors that increase the risk of kidney injury,” they wrote. “Increasing AKI rates may therefore reflect both improved case identification and the growing medical complexity of contemporary pediatric hospital care.”
  • Healio tells us,
    • “Only about one in six U.S. adults eligible for lung cancer screening discussed the procedure with a health care professional in the past year, according to study results.
    • “Current smokers and those with comorbidities more often reported having those discussions, a finding researchers say suggests clinicians prioritize individuals most at risk.
    • “However, an analysis of Health Information National Trends Survey (HINTS) data revealed what investigators called “persistent gaps” in communication that appeared more pronounced based on individuals’ race, insurance status and social context.
    • “We know lung cancer screening is not well utilized compared with screening for other cancer types, so we expected conversations about this topic would be infrequent. However, it was surprising to see such a low rate,” lead author Sofia W. Viana, MD, research fellow in the department of thoracic surgery at University of Cincinnati, told Healio.”
  • Health Day points out,
    • “There is no evidence that chiropractic neck manipulation increases the risk of a rare artery tear.
    • “Researchers studied over 862,000 adults with new neck pain or headaches and compared chiropractic neck adjustments with ibuprofen
    • “People should still watch for sudden or unusual headaches, different neck pain or neurological symptoms.” * * *
    • “An author of the study said people often ask her whether chiropractic care for neck pain is safe.
    • “This study is some of the best evidence yet that the answer to that question is yes,” said co-author Christine Goertz, a professor in orthopaedic surgery at the Duke Clinical Research Institute.”
  • Genetic Engineering and Biotechnology New notes,
    • “As we age, some of the cells in our body enter a state of senescence, in which they stop dividing but do not die. Those senescent cells can contribute to age-related disorders such as cancer, tissue degeneration, and inflammatory diseases.
    • “In an advance that could lead to better ways to diagnose and treat those diseases, MIT researchers have developed a noninvasive way to detect biomarkers of senescence. Their method is based on Raman microscopy, which can reveal the biochemical composition of cells without harming them.
    • “Using the new technique, “RamanOmics,” which combines Raman microscopy with gene expression data at single-cell resolution from the same cells, the researchers were able to identify unique “barcodes” that can be used to quickly identify senescent cells. And while their reported study was carried out in mouse cells, the scientists are now working on adapting it for use with human tissue.
    • “You can imagine that one day we may develop an endoscope that can look inside your body and identify cellular senescence,” says Jeon Woong Kang, PhD, an MIT research scientist and co-senior author of the team’s published study in Nature Aging, titled “RamanOmics decodes the spatial vibrational–molecular architecture of senescence in aging and repair,” in which they concluded, “Together, RamanOmics provides a tissue-agnostic framework for scalable, multimodal profiling of cellular states.”
  • The Wall Street Journal relates,
    • “Roche Holding RO said a drug candidate for an autoimmune disease known as IgA nephropathy met the primary goal of a late-stage clinical study, paving the way for the company to seek regulatory approval.
    • “The Swiss drugmaker said Wednesday that interim results from a continuing study of its investigational medicine sefaxersen showed it significantly reduced proteinuria—a key indicator of kidney damage—in people with IgA nephropathy, which is also known as Berger’s disease.
    • “The company said it would share the study’s interim data with health authorities with the aim of bringing the treatment to the market as soon as possible.
    • “The data pointed to the drug’s potential to reduce the so-called urine protein-to-creatinine ratio, which is associated with the preservation of long-term kidney function, Roche said. The safety and tolerability results of the medicine—a once-monthly subcutaneous injection—were consistent with known data, it added.”

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

  • Beckers Payer Issues reports,
    • “UnitedHealthcare, Cigna and Centene are among the initial participants in a national shared provider credentialing program, launching in the fall.
    • “CertifyOS, a provider data intelligence company, announced the program Sept. 23. The initiative aims to standardize credentialing and verification, speed up the time to join an insurance network and serve as a reliable source of truth on provider data.
    • “Healthcare providers often face duplicative credentialing requirements that create unnecessary complexities,” Mike Kane, UnitedHealthcare’s senior vice president of provider data operations, said in a CertifyOS news release. “This model will help streamline that process and allow providers to spend more time focused on patient care.”
  • Fierce Pharma relates,
    • “Sign-ups for Medicare’s GLP-1 coverage plan keep expanding, and Eli Lilly is dominating the market with a 70% share, the company’s CEO David Ricks said.
    • “Since its rollout on July 1, the Medicare GLP-1 Bridge has attracted about 700,000 seniors who’ve started treatment, Ricks said in an interview with CNBC.”
  • MedTech Dive adds,
    • “Wearables firm Oura is seeking up to $2.2 billion in an initial public offering, the company disclosed in a Monday securities filing. 
    • “While the IPO has not been priced yet, Oura estimates its shares will be valued at $40 to $44 each. Oura plans to offer 13.5 million shares of common stock, and selling stockholders plan to offer 36.5 million shares, for a total of 50 million shares.
    • “Oura is going public as wearables firms grapple with the line between wellness features and medical devices. Oura currently faces a proposed class action lawsuit over the accuracy of its sleep tracking features.”
  • Beckers Hospital Review points out,
    • “Public threats by hospitals or insurers to end network contracts are concentrated in markets where neither side dominates, according to a study published Sept. 23 in Health Affairs.
    • “The study, by researchers at Brown University in Providence, R.I., examined 14,918 relationships between 3,772 hospitals and 92 in-market commercial insurers for contracts ending between August 2021 and July 2025. Researchers cataloged public threats using a news database and manual review.
    • “Researchers documented 1,249 episodes in which a hospital or insurer publicly announced or threatened network withdrawal, about 8% of relationships. Of those, 348, or 28%, ended with the hospital actually leaving the network, corresponding to about 2% of all relationships studied. Most episodes occurred after August 2023.
    • “The rate climbed to about 16% where the hospital system controlled roughly 23% to 45% of local beds and the insurer held 30% to 44% of commercial lives. “There is a ‘Goldilocks zone’ where hospitals and insurers assess that the anticipated advantages of brinkmanship trump anticipated disadvantages,” the authors wrote, noting a party may be less able to credibly threaten withdrawal when its counterpart controls a very high share of beds or lives.”
  • and
    • “The state of Hawaii and Kaiser Permanente will fund the restoration and reopening of Kula Hospital on Maui, which closed after storm damage in March.
    • “The project is preliminarily estimated at about $65 million, with the state providing $42 million and Oakland, Calif.-based Kaiser Permanente investing $23 million, according to a Sept. 22 news release. The state and Kaiser noted costs may change as planning and construction details are finalized.”
  • and
    • “A growing number of health systems are continuing to push across state lines through acquisitions, affiliations and new facilities, as they seek greater scale, broader population bases and stronger regional footprints.
    • “Cross-market transactions have become an increasingly prominent growth strategy, offering systems opportunities to diversify risk and strengthen negotiating leverage while financially challenged hospitals and portfolio exits create openings in new markets.
    • “[The article identifies] nine health systems that have announced, advanced or completed significant cross-state expansions this year.”
  • Per Modern Healthcare,
    • “Oracle Health announced new artificial intelligence revenue cycle management capabilities and an oncology electronic health record Wednesday at the Oracle Health and Life Sciences Summit. 
    • “The revenue cycle management tools help with the prior authorization process by checking coverage, pulling documentation requirements and automatically adding the information and evidence. The goal is to help reduce delays and denials, the company said in a Wednesday news release.
    • “The new capabilities also include AI agents that evaluate reimbursement documentation and make recommendations to improve coding. Oracle Health also released agents focused on limiting denials and automating appeal packets.”
  • Beckers Health IT lets us know about “10 AI takeaways from Mass General Brigham’s World Medical Innovation Forum.”
  • Per BioPharma Dive,
    • “Colorado-based AI drug discovery specialist Enveda Biosciences has raised $311 million in a Series E financing, a sum rivaling totals secured in some of the biotechnology sector’s larger initial public offerings this year.
    • “In a Wednesday announcement, the startup said it would use the cash to continue advancing its pipeline of drugs through the clinic. Three are in human testing. 
    • “Enveda uses artificial intelligence to identify molecules in living organisms like plants and microbes and predict their structure and function. Its system then ranks these molecules by their drug potential, after which Enveda’s chemists turn the most promising ones into drug prospects. In June, Enveda CEO and founder Viswa Colluru told BioPharma Dive that the company is already evaluating 17 programs to emerge from that research.
    • “As much as the industry has gotten comfortable with the more iterative approaches, the thing that moves the needle for patients and seeds power law returns for companies is first-in-class mechanisms that shift the paradigm,” Colluru said at the time.”
  • Per Cardiovascular Business,
    • “Heart researchers have developed a new way to determine a person’s cardiovascular age, sharing their findings in the European Heart Journal.[1] Their secret? A combination of artificial intelligence (AI) and routine CT exams.
    • “The group, a research team at Emory University’s Empathetic AI for Heart Institute in Atlanta, focused their work on the fat that surrounds a person’s aorta. By evaluating that fat, they believed they may be able to detect whether someone’s cardiovascular health is older or younger than their real age. 
    • “The aorta is the body’s largest blood vessel and carries blood from the heart to the rest of the body,” first author Mendel Lebowtiz, a graduate student with Emory University, explained in a statement. “We wanted to see whether the fat surrounding it could tell us something about how a person’s heart and blood vessels are aging.”
    • “Lebowitz et al. used advanced AI to evaluate more than 48,000 chest CT examinations. More than 4,000 exams were used to train their AI model and then more than 44,000 exams were used to validate that model. By the end, they found that this method was able to estimate an individual’s “true cardiovascular age” and gain a better understanding of the health risks they may face over time.”
  • Per MedCity News,
    • “Pelago, a virtual substance use care provider, launched the Pelago Behavioral Health Platform on Tuesday at the Behavioral Health Tech conference in Nashville, Tennessee. The platform unifies substance use, mental health and behavioral addiction care in one place.
    • “New York City-based Pelago offers treatment for substance use like drinking or prescription pain medication, as well as mental health conditions like stress and anxiety. It also treats patients battling habits like gambling or gaming. The company serves both employers and payers.
    • “Now, the Pelago Behavioral Health Platform allows Pelago’s customers to manage substance use, mental health and behavioral addiction care under one contract and one member record. This allows the company to better treat co-occurring conditions. About half of Pelago’s patients battle co-occurring depression and anxiety, according to Dr. Yusuf Sherwani, CEO and co-founder of Pelago.”

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, HSA, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

  • Govexec reports,
    • “More than 100 members of Congress urged House and Senate leaders last week to advance legislation rejecting President Trump’s planned pay freeze for most civilian federal workers next year.
    • “Last month, Trump issued his alternative pay plan, which formally confirmed the White House’s proposal to freeze most civilian workers’ pay at 2026 levels. Trump separately instructed the Office of Personnel Management to prepare to issue a 3.8% raise to federal law enforcement officers, and he has proposed pay increases between 5% and 7% for military service members, depending on their rank.
    • “In a letter to House Speaker Mike Johnson, Minority Leader Hakeem Jeffries, Senate Majority Leader John Thune and Minority Leader Chuck Schumer, sent last week but published Monday, a bipartisan group of 110 lawmakers led by Rep. James Walkishaw, D-Va., and Sen. Chris Van Hollen, D-Md., warned that with inflation hovering over 3%, forcing federal workers to forgo a pay raise is “an effective pay cut.”
    • “The administration’s own proposal on federal pay increases demonstrates why such an increase is necessary,” they wrote. “President Trump has proposed that federal law enforcement personnel receive a 3.8% pay increase to improve recruitment and retention, and has proposed a 5-7% pay increase for service members given the critical support they provide our nation. The same rationale applies to all federal workers.”
  • MedPage Today informs us,
    • “A proposal from CMS to cut in half the payment for secondary services performed during outpatient visits is drawing fire from a variety of healthcare groups.
    • “The damage would be extensive to practices who offer procedures and E/M [evaluation and management] visits on the same day as it impacts many clinical scenarios (dermatology, otolaryngology, ophthalmology, and many more),” Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association (MGMA), said in an email to MedPage Today. “MGMA members have relayed to us significant projected financial losses if this cut would go into effect.”
    • “Under the proposed rule, known as the “modifier 25 rule,” if two or more services are performed on the same day, “the most expensive service (either surgical or E/M visit) would be paid at 100%, and all other surgical procedure(s) or E/M visit(s) would be paid at 50%,” CMS explained in a July 16 Federal Register noticeopens in a new tab or window.
    • “For example, suppose a patient goes to the doctor for an outpatient E/M visit, which is billed using CPT code 99212, and then has two skin lesions removed, one billed under CPT code 11300, and the other — a slightly bigger lesion — billed under CPT code 11301. Because the second skin lesion removal code is the highest-paid service of the three, that code will get paid at 100%, while payments for the office visit and removal of the smaller skin lesion will be reduced by 50%.
    • “We continue to believe that there are efficiencies when the same physician (or a physician in the same group practice) provides an E/M service for the same patient in conjunction with a procedure with a global period, and that we are likely duplicating payment under the current payment methodology,” the authors wrote in explaining the proposal, which was originally proffered in 2019 but later withdrawn.” * * *
    • “The comment period on the proposal, which is part of a larger rule on physician payment and other issues, ended Monday. The agency has until Nov. 1 to issue a final rule; it could include the modifier 25 proposal as-is, make changes to it, or leave it out entirely.”
  • Fierce Healthcare points out,
    • “The American Medical Association (AMA) is urging the U.S. Centers for Medicaid and Medicaid Services (CMS) to uphold its Jan. 1, 2027 deadline for electronic prior authorizations under its Interoperability and Prior Authorization final rule.
    • “In a Sept. 18 letter (PDF) to CMS Administrator Mehmet Oz, M.D., AMA President John Whyte, M.D., wrote the agency should maintain its deadline and “reject broad enforcement discretion during 2027.”
    • “CMS should stay the course and remain steadfast in its commitment to ‘axe the fax’ and make [electronic prior authorization (ePA)] a reality for physicians and patients,” Whyte wrote.”
  • The American Hospital Association News relates,
    • “The White House issued a presidential proclamation Sept. 18 renewing the $100,000 fee for new H-1B visa petitions for individuals entering the U.S., initially levied in September 2025. The fee, currently blocked by a court order, was vacated by a district court in June and is pending appeal. The AHA had asked the administration last year to make healthcare personnel exempt from the fee. The Sept. 18 proclamation to renew the fee extends it for an additional year. The administration also issued an executive order that would further scrutinize companies seeking to hire H-1B workers, particularly organizations that directly or indirectly had layoffs within the previous year or plans future layoffs impacting U.S. workers. The renewal of the $100,000 H-1B fee is separate from the Department of Homeland Security’s proposed $103,265 filing fee for H-1B visa petitions that are subject to statutory numerical caps.”
  • Per a Health Resources and Services Administration news release,
    • “The Health Resources and Services Administration (HRSA) today announced nearly $19 million in new awards to expand access to high-quality healthcare through telehealth and technology-enabled learning. Announced during Telehealth Awareness Week, the awards will increase access to nutrition services, expand the use of emerging technologies to improve healthcare delivery, and strengthen the healthcare workforce in rural communities and other areas with limited access to care.
    • “Telehealth and innovative technologies are changing what access to healthcare looks like for Americans,” said HRSA Administrator Tom Engels. “No longer is telehealth the exception to the rule — it is an essential part of the healthcare system, and the Trump Administration is helping providers put these tools to work to expand access and improve health outcomes. For a patient in a rural community, that can mean getting specialized care without traveling hours from home. For a clinician, it can mean having expertise and new tools at their fingertips to better serve their patients. Through these investments, HRSA will help test what works and identify successful approaches that can be replicated in communities across the country.”
    • “The awards announced today include:
      • “Telehealth Centers of Excellence ($8.5 million) will pilot and test innovative telehealth solutions to expand access and improve health outcomes.
      • “Telehealth Nutrition Services Network Grant Program ($5.4 million) will increase access to nutrition services that help prevent and manage chronic diseases through telehealth networks.
      • “Technology-enabled Collaborative Learning Program ($4.75 million) will improve provider retention and expand access to care in rural communities using technology-enabled learning models.
    • “These awards build on HRSA’s leadership in telehealth by advancing innovative, high-value programs that expand access to high-quality care. HRSA’s broader telehealth portfolio includes more than 3,600 awards associated with telehealth.”

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

  • Federal News Network reports,
    • “After finding little change in the number of adverse actions taken against federal employees, the Office of Personnel Management is now looking for more feedback on how to “appropriately incentivize” federal managers to take action.
    • “The push comes after OPM released new data showing that for fiscal 2026, adverse actions involving poor performance and misconduct have been on par with last year.
    • “As of June 2026, OPM reported that there have been 3,105 federal employee terminations and separations based on poor performance or misconduct governmentwide. That’s compared with 3,492 in all of fiscal 2025 — excluding only the Postal Service, intelligence agencies and some other smaller government entities.
    • “Despite President Trump’s significant changes to how federal agencies address poor performance and misconduct, the federal government has not seen significant increases in performance-based and adverse actions,” OPM said in a Sept. 15 Federal Register notice.
    • “As a result of its findings, OPM reopened a public comment period and is soliciting feedback for an additional two weeks on a recent proposal to overhaul agencies’ processes for taking performance-based and adverse actions against federal employees.”
  • and
    • “Agencies will now be able to more easily offer bonuses of up to $25,000 to federal employees for exceptional work. The Office of Personnel Management is delegating authority to agency leaders to approve larger bonuses for feds. Previously, bonuses of that size required OPM approval. OPM says it’s removing the hurdle as a way to help agencies distinguish high levels of performance.” 
  • Serving Those Who Serve discusses funding an health savings account in retirement and optimizing a conversion to a Roth IRA.

From the Food and Drug Administration front

  • Per an FDA news release,
    • “The Food and Drug Administration’s Innovative Science and Technology Approaches for New Drugs (ISTAND) program has accepted a letter of intent (LOI) for a wearable sensor-derived digital outcome measure intended to quantify foot drop severity and its impact on gait in adult patients with Charcot-Marie-Tooth disease type 1A (CMT1A), a progressive, degenerative disease. This LOI represents the first submission to be accepted into the ISTAND program for a digital health technology (DHT) for a rare neurological condition.”
  • OncLine reports,
    • “The FDA has granted final approval to lutetium Lu 177 dotatate (Bravnetsa; PNT2003), a lutetium Lu 177 dotatate (Lutahera) biosimilar for the treatment of adult patients with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.1
    • “The agent was approved through the FDA’s abbreviated new drug application pathway, and the agency determined it to be bioequivalent and therapeutically equivalent to the reference product.
    • “As the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to lutetium Lu 177 dotatate approved in the United States, [the biosimilar’s] approval marks an important milestone, bringing additional treatment options to people living with GEP-NETs,” said Mary Anne Heino, executive chairperson and CEO of Lantheus in a news release. “We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access.”
  • Fierce Pharma relates,
    • “Merck’s Winrevair continues to steadily expand its reach. A new FDA sign-off updated the pulmonary arterial hypertension (PAH) blockbuster’s label to include new data on patients who are newly diagnosed with PAH and receiving treatment for other conditions. * * *  Winrevair came out of Merck’s $11.5 billion buyout of Acceleron in 2021. The drug is a key part of the drugmaker’s plans to offset looming off-patent Keytruda competition.   
    • “Nuvation Bio also has a label addition to boast about. The FDA update allows the oncology drugmaker to add 14 months of additional data to the label of its CNS-active oral tyrosine kinase inhibitor, Ibtrozi. Ibtrozi is cleared by the FDA to treat locally or advanced metastatic ROS1-positive non-small cell lung cancer. Now, the added data from Nuvation’s Trust-I study showed a median duration of response of nearly 50 months in patients who had not received a tyrosine kinase inhibitor. That’s more than four years of “sustained clinical benefit,” the company said in a statement.  The updates came with no changes to the drug’s safety profile.”
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has cleared the X°Port Heart Preservation System from Ontario-based Traferox Technologies. The new device offers static 50 degrees F (10 degrees C) heart preservation during transport prior to transplantation, which has been shown in studies to improve outcomes.
    • “Peer-reviewed evidence has linked 10 degrees C heart preservation to reductions in severe primary graft dysfunction and improved post-transplant survival compared to conventional ice storage and exposure to hypothermic temperatures. Improved outcomes were also seen involving transplants of higher-risk donor hearts.[1,2]
    • “The strong clinical evidence supporting 10 degrees C heart preservation, together with the successful adoption of 10 degrees C preservation across leading lung transplant programs, has demonstrated the potential of this approach to improve donor organ preservation and transport,” Rick Mangat, PhD, chief executive officer of Traferox, said in a statement. “We look forward to working with transplant centers across the US to support the continued adoption of 10 degrees C preservation in routine clinical practice.”

No Surprises Act news,

  • Bloomberg Law reports,
    • “The Trump administration is launching a program to audit arbitrators of disputes between doctors and insurers under the No Surprises Act, stepping up oversight of a process plagued by litigation since it took effect in 2022.
    • “The law bars doctors from balance-billing patients for unexpected out-of-network care in emergencies and when procedures are performed by out-of-network providers at in-network facilities. While it’s largely shielding patients from surprise bills, implementation has increased medical spending, triggered a wave of lawsuits and raised allegations of bad actors on both sides.
    • “The new audits by the Centers for Medicare & Medicaid Services will “allow the Departments to more closely review the work done” by arbitrators, also known as “independent dispute resolution entities,” or IDREs, a spokesperson said.
    • “These audits will assess certified IDR entities’ full compliance with the NSA and its associated regulations and are anticipated to be a much more in-depth review of the process, programs and operational policies utilized by certified IDR entities,” the spokesperson said.”

From the fraud, waste, and abuse front,

  • Beckers Hospital Review reports,
    • “CMS said Sept. 22 that it canceled plan year 2026 ACA policies covering 760,000 people.
    • “CMS canceled 315,000 policies covering these individuals Aug. 31. According to federal rulemaking records — set to publish in the Federal Register on Sept. 23 — these people enrolled with agent or broker help but lacked verified citizenship or immigration documentation. Policy issuers could not identify claims or contact these consumers, either. During a Sept. 22 press conference, Vice President JD Vance said the government will do “additional verification” concerning legal status and income for 419,000 people.
    • In a Sept. 22 news release, CMS said it is anticipating a return of about $2.2 billion in advance payments of the premium tax credit. The removals were spearheaded by the White House Task Force to Eliminate Fraud. 
    • “CMS is also temporarily freezing new agent and broker registrations with federally facilitated exchanges for plan year 2027. This pause will be in effect until Feb. 1. The rulemaking documents said that based on two methodologies, agent and broker noncompliance leading to unauthorized enrollment could amount to roughly $1.5 billion or $6.6 billion in annual improper federal spending.
    • “Temporarily pausing the registration of new agents and brokers narrowly targets the category of agents and brokers that CMS has determined warrant additional scrutiny, while allowing CMS time to implement additional safeguards designed to prevent unauthorized enrollments and other noncompliant practices before new agents and brokers begin assisting consumers on the federally-facilitated exchanges,” the rulemaking document said.
    • “In the release, CMS said it will take on further work with insurance companies to address what may be unauthorized enrollments, focus on terminating noncompliant brokers and agents, and carry out other integrity efforts.”
  • Fierce Healthcare relates,
    • “Health tech company Cotiviti is building out its payment accuracy platform for payers with two new additions that will allow plans to see all inpatient claims in one place.
    • “The company said in an announcement that the enhanced platform reduces administrative complexity and unites elements that insurers typically managed through separate programs or vendors. Reducing those silos can support more accurate claims management, Cotiviti said.
    • “The first add-on is called Itemized Bill Review, which digs into high-cost facility claims to identify potential billing errors including miscoding, upcoding or duplicative charges. The Inpatient Coding Validation tool, meanwhile, supports a stronger diagnosis-related group review process that offers a fuller coding and clinical analysis before payments are made.
    • “Cotiviti said that the tools taken together can identify between 9% and 12% in additional errors for submitted inpatient claims, alongside simplifying the process on the payer’s end.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Suicide moved into the 10 leading causes of death in the U.S. in 2024, even as the number of suicide deaths declined from the year before.
    • “The finding comes from the CDC’s National Center for Health Statistics’ Sept. 22 report, “Deaths: Leading Causes for 2024.” The report is based on final mortality data from all death certificates filed in the 50 states and the District of Columbia in 2024.
    • “According to Paul Nestadt, MD, medical director at the Johns Hopkins Center for Suicide Prevention, limiting access to firearms could have the greatest effect on preventing suicide deaths and “will save the most lives.”  
    • “More than 28,000 people died by gun suicide last year — more than half of all suicide deaths nationwide, based on preliminary federal figures. The overall suicide rate has recently trended down, yet gun suicides have climbed to record levels for a fifth straight year. ” * * *
    • “The other leading causes, in order, were diseases of heart; malignant neoplasms; accidents (unintentional injuries); cerebrovascular diseases; chronic lower respiratory diseases; Alzheimer’s disease; diabetes mellitus; nephritis, nephrotic syndrome and nephrosis; and chronic liver disease and cirrhosis. The 10 causes accounted for 70.9% of all U.S. deaths.” 
  • Beckers Behavioral Health adds,
    • “The CDC released new data Sept. 21 showing improvements in several mental health, suicide risk, and dietary indicators among U.S. high school students from 2023 to 2025. 
    • “The findings are included in the CDC’s Youth Health in Focus report, which examines mental health and suicide risk alongside dietary behaviors, physical activity, sleep and digital behaviors. The report presents national Youth Risk Behavior Survey data from 2023 to 2025 and 10-year trends from 2015 to 2025.”
  • Beckers Hospital Review offers six things to know about the relationship betweek GLP-1 drugs and blindness due to nonarteritic anterior ischemic optic neuropathy (NAION)
    • “NAION is a rare condition that causes sudden, often permanent vision loss in one or both eyes. Sometimes called an “eye stroke,” the condition is caused by disrupted blood flow to the optic nerve. It typically affects people 50 and older, with an incidence of two to 10 cases per 100,000 people annually in that age group, according to the American Academy of Ophthalmology.” * * *
    • “Research remains mixed. A 2024 Mass General Brigham and Harvard Medical School study and a 2025 study in Diabetes, Obesity and Metabolism found an association between semaglutide and NAION but did not establish causation. Other studies, including a Novo Nordisk-funded study from earlier this year, found no association.” * * *
    • “NAION is not the only eye condition studied in connection with GLP-1s. A 2025 study found semaglutide users had a higher risk of neovascular age-related macular degeneration, and the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society have said semaglutide may also worsen diabetic retinopathy, causing macular complications and blurry vision. A 2024 study first drew wide attention to a possible NAION association, and a follow-up study later that year also found an association.”
  • Health Day relates,
    • “Wildfire smoke might pose a greater health risk to humans than other sources of air pollution, two new Mount Sinai studies say.
    • “Particle pollution from wildfires appears to diminish the survival odds of lung cancer patients, a study published Sept. 15 in The Lancet Oncology found.
    • “Wildfire smoke is also linked to an increased risk of hospitalization for heart or lung disease, researchers reported Sept. 17 in the journal Nature Communications.
    • “Wildfire smoke is no longer a regional environmental issue. It is becoming a nationwide public health challenge,” said Yaguang Wei, senior author of both studies. He is an assistant professor of environmental medicine at Icahn School of Medicine at Mount Sinai in New York City.
    • “Our research shows that wildfire-related (particle pollution) appears to be more harmful than equivalent levels of pollution from other sources,” Wei said in a news release. “As wildfire activity increases, public health and environmental policies must account for both the quantity and the source of air pollution.”
  • and
    • “Vitamin D may play a bigger role in pregnancy than simply supporting bone health.
    • “A new study suggests that optimizing vitamin D levels before and during pregnancy may improve outcomes for both mother and baby, including the risk of preterm birth.
    • “We learn about vitamin D’s role in bone health, but no one teaches us about the various roles in pregnancy, especially this relationship with preterm birth we are uncovering,” said study author Anjali Borsum, a student at the Medical University of South Carolina College of Medicine in Charleston.”
  • Cardiovascular Business tells us,
    • “When heart patients are diagnosed with severe aortic stenosis (AS), waiting any longer than six months to perform transcatheter aortic valve replacement (TAVR) is associated with worse long-term outcomes. That was the key takeaway from a new analysis published in Open Heart.
    • “The study’s authors highlighted the fact that asymptomatic severe AS is increasingly being treated. At the same time, however, it is still common for patients to wait and then undergo a follow-up clinical and imaging exam six to 12 months later. The group hoped to learn more about the potential impact TAVR timing may have on patient outcomes, performing a retrospective study on data from 149 patients treated at a single facility from 2021 to 2023. The mean age was 85.8 years old, and 36% of patients were men.” * * *
    • “Click here for the full analysis.”
  • The Wall Street Journal informs us,
    • “Roche ROP Holding said an obesity drug candidate met the main objectives of a midstage clinical trial by helping patients reduce their blood glucose and body weight.
    • “The Swiss pharmaceutical company is seeking to enter the weight-loss drug market that Eli Lilly LLY and Novo Nordisk NOVO currently dominate, and sees the latest trial results reinforcing its ambitions to rapidly develop a portfolio of medicines for people with obesity, diabetes and cardiovascular disease.
    • “Roche said its drug, enicepatide, achieved a mean reduction in blood-sugar levels of 2.65 percentage points, as well as a mean weight loss of 15.5%, after 48 weeks for patients who received the highest dose.
    • “The trial enrolled adults with Type 2 diabetes who also had obesity or were overweight, and follows an earlier study that showed the drug helped patients without diabetes shed weight.
    • “Among patients who were on the highest dose, 62% restored blood glucose to levels considered normal, having started the trial as diabetic, Roche said.
    • “The safety and tolerability profile of enicepatide was consistent with that of similar therapies, and treatment discontinuation rates in the trial due to adverse events were low at 2%, it said.”
  • BioPharma Dive points out,
    • “An experimental Amgen drug has succeeded in the first of two Phase 3 trials in Sjögren’s syndrome, driving the California biotechnology giant’s stock price up as much as 5% on Tuesday. 
    • “Amgen didn’t provide specific details about the performance of its drug dazodalibep. But it said in a Tuesday statement that treatment led to a “statistically significant and clinically meaningful improvement” on a widely used measure of disease activity after 48 weeks, meeting the trial’s primary objective. Positive effects were observed as early as four weeks after treatment and persisted through the evaluation period, Amgen said. 
    • “Investigators didn’t spot an “imbalance” in the rate of blood clots or opportunistic infections in the Phase 3 study, a potential concern of drugs with dazodalibep’s mechanism. Side effects were generally mild to moderate, and study discontinuations were infrequent and balanced across study arms, the company said.”
  • and
    • “Trial enrollees taking Viking Therapeutics’ dual-acting obesity drug maintained nearly all of their weight loss after switching from a weekly shot to less frequent dosing, the company said Tuesday.
    • “Viking enrolled 180 people with obesity and no related health conditions in the Phase 2 trial. They were randomized to receive one of four dosing regimens of VK2735 or a placebo over 21 weeks, and then switched to a biweekly or once-monthly maintenance shot for another 12 weeks. According to Viking, enrollees taking VK2735 ended up retaining as much as 90% of their weight loss.
    • “The “stellar” data “build on [VK2735’s] potentially differentiated profile,” Leerink Research analyst Thomas Smith wrote in a note to clients, potentially allowing the drug to overcome some of the adherence issues associated with GLP-1 medications for obesity.”

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

  • The Wall Street Journal reports,
    • “Western pharmaceutical companies are urging the administration to allow them to keep doing deals with Chinese companies for promising drug candidates, despite a 2025 law restricting U.S. investment in Chinese technology.
    • “The group that represents pharmaceutical companies such as Pfizer, Merck and Eli Lilly has been lobbying to make sure that the new rules the Treasury Department is writing, as part of that 2025 law, maintain the drugmakers’ ability to do deals in China.
    • “At stake are billions of dollars in deals and an increasingly important source of experimental drugs for Western companies, which they need to restock their pipelines as they face big upcoming revenue holes with key drugs losing exclusivity in coming years.
    • “The 2025 law, called the Comprehensive Outbound Investment National Security Act or COINS, requires the federal government to screen deals with certain countries involving sensitive technology. So far, the Treasury Department has been reluctant to fully incorporate pharmaceuticals, according to two people familiar with the matter, as it finalizes regulation for other technology under the law, like AI systems and semiconductors.
    • President Trump is meeting Chinese President Xi Jinping this week, a summit that pharmaceutical leaders believe will be instrumental in determining how far the administration goes with putting curbs on Chinese biotech investment. The rules need to be finalized by March.”
  • Beckers Hospital Review identifies 32 “contract breaks between major health systems and certain Medicare Advantage insurers [that have occurred in] 2026. Providers dropping plans often cite prior authorization denials and slow reimbursement; in other cases, insurers are terminating the contracts themselves.”
  • Kaufmann Hall tells us.
    • “For decades, rural healthcare has been organized primarily around hospitals and clinics connected through traditional referral relationships. But the pressures facing rural providers challenge that structure. Rural communities today are asking what a more sustainable approach should look like.
    • “The hub-and-spoke model is familiar to rural healthcare, concentrating complex services centrally while extending others into local communities. But today’s pressures demand an evolution of that approach. The network of tomorrow must combine physical care sites, digital capabilities, and trusted community connections to deliver the right care in the right place.
    • “That requires adding a new element: the node. The result is a hub-spoke-node network built around the patient.”
  • Beckers Clinical Leadership lets us know,
    • “Adult medical specialties posted the largest increase in median work relative value unit productivity from 2025 to 2026, the second consecutive year the category has led on productivity growth, according to a survey from SullivanCotter.
    • “The Chicago-based consulting firm released findings from its 2026 Physician Compensation and Productivity Survey Sept. 17. The report includes data from 575 healthcare organizations representing about 235,000 physicians across 240 specialties.
    • “Productivity gains were modest across the board, with year-over-year changes ranging from 0.8% to 2.8%. Median total cash compensation rose across all major specialty categories over the same period, led by adult medical specialties at 7.2%.”
  • and
    • “Is pneumonia contagious?” is the most-Googled respiratory health question in the U.S., drawing an estimated 137,000 searches per month, according to a Sept. 22 analysis from healthcare staffing firm Soliant Health.
    • “The data offer a glimpse at patients’ health concerns heading into the 2026-27 virus season. 
    • “To compile the ranking, Soliant Health analyzed 30,000 question-based search queries in September using data from the search engine optimization platform Ahrefs. Soliant identified the medical questions tied to respiratory illness season and ranked them by estimated monthly U.S. search volume. The firm excluded branded queries, entertainment searches and near-duplicate questions. 
    • “Together, the 15 questions draw more than 731,000 estimated searches a month, according to a Sept. 22 news release shared with Becker’s.
    • “Alongside traditional internet search engines, AI platforms are emerging as another key tool patients use to find health answers. Thirty-four percent of Americans use AI chatbots for health information, and symptom diagnosis is one of the top reasons, according to a Pew Research Center survey released in August.”
    • [The article lists the top 15 Googled questions.]
  • Drug Channels notes,
    • “For more than a decade, the answer to “Where do drug wholesalers make their money?” has been generic drugs.
    • “Although wholesaler revenues are linked most closely to sales of brand-name drugs, the majority of wholesalers’ gross profits comes from generic drugs. We estimate that in calendar year 2026, generic drugs will contribute 52% of total drug distribution gross profits of the Big Three wholesalers, but only 9% of drug distribution revenues.
    • “Generic drugs are the long-running hit show that has carried wholesalers’ profits for 15+ seasons. The show is still on the air, but a supporting character is starting a spinoff.
    • “Generic drugs’ share of distribution gross profits has declined, from 68% in 2022 to 52% in 2026. This partially reflects the growth in profits from provider-administered biosimilars. Biosimilars now account for 6% of wholesalers’ drug distribution revenues, but 23% of total gross profits.”

Weekend update

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

Simplicity is a virtue.

From Washington, DC,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Congress, Cybersecurity, Uncategorized–

From the frontier AI front,

  • The Wall Street Journal reports,
    • “Google’s Gemini model accessed the internet and hacked other companies during a test of its cybersecurity capabilities, the first known example of the company’s artificial-intelligence systems autonomously committing such an act. 
    • “The hacks, which the company confirmed on Friday [September 18], occurred in May as part of a test run by the company Irregular, which was also involved in similar incidents disclosed by OpenAI, Anthropic and Meta. 
    • “In one of the cases, the model guessed passwords until it gained access to a protected system. In the other two cases, the model found credentials in a public repository that allowed it to then access protected systems. In each case, the model ended the intrusion after determining it had accessed a real company’s systems, Google said.
    • “Irregular notified Google about the hacks at the end of July, Google and Irregular said, in the wake of the discovery that OpenAI’s agents had hacked the AI software company Hugging Face. Google didn’t disclose the hacks until The Wall Street Journal reached out with inquiries this week.” * * *
    • “Worries about the cybersecurity capabilities of new models have increased since the July discovery of the Hugging Face hack. In that case, up to 1,200 agents coordinated on a secret message board inside OpenAI to try to cheat on an evaluation, a report by the third-party testing company METR revealed in August. 
    • “Last week, those concerns spilled into the mainstream after the dramatic quitting of Jacob Coxon, a former OpenAI researcher who had gone to Anthropic earlier this year. Over the weekend, leaders from Anthropic, OpenAI, Google and SpaceX all agreed on the need to slow down the rate of AI progress, although none of the companies have outlined exactly how that would happen.”
  • and
    • “The WSJ Technology Council Summit kicked off Monday afternoon [September 14] in New York City with an informal poll of the audience during a town hall conversation. In a show of hands, only a few people said they feared that AI could kill us all in the next decade, while about half of attendees indicated that they were in support of slowing down AI development at the frontier and prioritizing safety guardrails.
    • “But that slowdown didn’t apply to the deployment of AI within their organizations, where not all models are at the cutting edge and even the most advanced of them tend to be relatively well understood and tested by experience.
      “It’s in our hands and it’s up to us to apply [AI] for good, and I think it can do a lot of good for society,” said Vishal Talwar, president, FedEx Dataworks, and chief digital and information officer, FedEx.
      “Much of ensuing town hall discussion focused on the myriad ways in which companies were operationalizing AI.”
  • Cyberscoop adds,
    • “The AI hacking apocalypse is not inevitable.
      • “While large language models present real risks to society, experts say they can be tested and largely controlled using well-worn cybersecurity and policy choices.”
      • “Juan Andres Guerrero-Saade, a fellow for AI and security research at SentinelOne and an adjunct professor at Johns Hopkins University, said the hacks are worth taking seriously, but at a time when businesses and open-source maintainers should be focused on further hardening their systems and policymakers should be discussing new solutions, “what we see is cybersecurity being used essentially as an excuse for these AI doomer arguments.” * * *
      • “Guerrero-Saade is among a growing chorus of cybersecurity professionals who say that while AI systems pose real, unique threats to our systems, the apocalypse is far from inevitable. Most of the public concerns around the incidents, let alone worries about killer AIs attacking critical infrastructure, assuming control of the internet and wiping out humanity, are either technically impossible or can largely be controlled through established cybersecurity principles.
      • “There is this “narrative or magical thinking of ‘Well, AI is going to be able to hack everything, and therefore it can control everything, and therefore it’s going to kill us all,’” he told CyberScoop. “And you [think] these just don’t add up. They’re not very well-reasoned arguments.”
      • “This fatalistic narrative tied to AI’s eventual dominance doesn’t hold up under scrutiny, according to experts CyberScoop spoke with. In recent conversations, cybersecurity and national security professionals raised questions about both the technical solutions OpenAI and Anthropic use to contain their models, as well as the glaring absence of federal oversight from federal regulators or truly independent third-party review.”

From the cybersecurity policy and law enforcement front.

  • Per a Senate Finance Committee news release,
    • “U.S. Sens. Mark R. Warner (D-VA) and Ron Wyden (D-OR) today reintroduced the Health Infrastructure Security and Accountability Act, legislation to improve cybersecurity in our health care system amid a growing wave of cyberattacks that are compromising Americans’ sensitive information and disrupting access to critical care across the country.” * * *
    • “Specifically, the Health Infrastructure Security and Accountability Act would require the Department of Health and Human Services (HHS) to establish, enforce, and regularly update strong minimum cybersecurity standards for health care providers, health plans, clearinghouses, and business associates, with heightened standards for systemically important entities and entities critical to national security.
    • “The legislation would also require covered entities to develop continuity plans describing how it would resolve a tech failure or intrusion, conduct annual cybersecurity tests, and undergo independent security audits, while increasing fines for failure to meet security requirements and strengthening HHS oversight through annual cybersecurity audits. Additionally, this legislation would provide $1.3 billion to help hospitals strengthen their cybersecurity, including $800 million for hospitals in rural and underserved urban communities.
    • “Full text of the bill can be found here. A summary of the bill can be found here.”
  • Cybersecurity Dive reports,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) will stop publishing weekly roundups of newly disclosed software vulnerabilities at the end of September, the agency announced on Thursday.
    • “CISA is ending its Vulnerability Bulletin “as part of its shift from severity‑based vulnerability management to a modern, risk‑based approach,” the agency said in a statement.
    • “The weekly bulletins, published since early 2004, listed vulnerabilities published during the reporting period along with their CVEs, severity scores and brief descriptions.” * * *
    • “CISA said in its Thursday statement that sunsetting the bulletin aligns with the prioritization directive it issued in July, “which directs federal agencies to prioritize vulnerabilities based on real‑world risk factors, including evidence of exploitation and exposure, rather than severity scores alone.”
    • “As it discourages organizations from relying solely on Common Vulnerability Scoring System (CVSS) scores to decide which vulnerabilities to fix, CISA has also been highlighting the Stakeholder-Specific Vulnerability Categorization (SSVC) system as a more nuanced approach to vulnerability analysis.
    • “Chris Butera, CISA’s acting executive assistant director for cybersecurity, said on Wednesday at Google’s Cyber Defense Summit that the agency has been discussing SSVC with companies that sell vulnerability management software. “They’re building some of this prioritization into their vulnerability tooling,” Butera said.”
  • and
    • “The Cybersecurity and Infrastructure Security Agency (CISA) wants to hire critical infrastructure experts with broad, rather than specialized, knowledge as it tries to help defend the infrastructure community with limited resources.
    • “I need to be able to hire people that are highly adaptive, because I think the threat is continuing to evolve so much, and the exposure that we have within these critical infrastructure sectors is evolving so much,” acting CISA Director Nick Andersen told reporters after speaking at Google’s Cyber Defense Summit here on Wednesday [September 16]. “I need people that can pivot from day to day to be able to help meet all of these stakeholders where they are.”
    • “Andersen’s comments come as CISA prepares to onboard roughly 250 new employees as part of a hiring sprint meant to fill critical vacanciescreated by the Trump administration’s sweeping downsizing of the agency over the past two years. As ransomware gangs and nation-state hacker groups increasingly menace infrastructure operators, in some cases aided by destabilizing advances in AI, CISA’s supporters say its mission — and its partnerships — have become more important than ever.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) today [September announced a settlement with Ambry Genetics Corporation (Ambry) concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. Ambry, headquartered in Aliso Viejo, California, is a covered entity that provides genetic testing and clinical genomics services.
    • “In January of 2020, Ambry discovered that an employee’s email account was compromised by a phishing attack. The protected health information (PHI) of 225,370 individuals was potentially exfiltrated by the threat actor. Affected PHI included names, addresses, dates of birth, some Social Security numbers or driver’s license numbers, financial information, diagnoses and conditions, lab results, medications, and treatment information.” * * *
    • “The settlement resolves an investigation that OCR initiated after Ambry filed a breach report in March 2020 about the phishing incident that occurred in January 2020.  OCR found that Ambry had potentially violated provisions of the Security Rule, including:
      • “Failing to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the electronic protected health information (ePHI) held by Ambry;
      • “Failing to implement procedures for terminating access to ePHI when the employment of or other arrangement with a workforce member ends or access is no longer appropriate; and
      • “Failing to assign a unique name and/or number for identifying and tracking user identity in electronic systems containing ePHI.” * * *
  • “The resolution agreement and corrective action plan may be found at https://www.hhs.gov/sites/default/files/ocr-ra-cap-ambry-genetics-corporation.pdf [PDF, 51.88 MB].”
  • Cyberscoop adds,
    • “Another core member of the hacker subset of The Com involved in a spree of extortion attacks from at least 2021 to 2023 pleaded guilty to federal charges, according to court records released Tuesday.
    • “Ahmed Hossam Eldin Elbadawy, a 24-year-old from Texas, pleaded guilty exactly one year ago to wire fraud conspiracy and aggravated identity theft. His guilty plea wasn’t shared publicly until prosecutors filed an order of forfeiture this week seeking proceeds from Elbadawy’s criminal activities. 
    • “Elbadawy and his co-conspirators — Noah Michael Urban, a Florida man sentenced to 10 years in prison last year, and Tyler Robert Buchanan, a Scottish man who pleaded guilty to multiple cybercrimes in April and awaits sentencing — were part of an aggressive subset of The Com coined Scattered Spider.”
  • and
    • “Authorities seized the primary domain and other websites linked to NightmareStresser, one of the longest-running and most popular distributed denial-of-service operations used by cybercriminals globally, the Justice Department said Tuesday. 
    • “Cybercriminals of various motivations used the DDoS-for-hire service to launch hundreds of thousands of DDoS attacks or attempted attacks since at least 2022, officials said. 
    • “The takedown, part of an ongoing globally coordinated effort dubbed “Operation PowerOFF,” marks law enforcement’s continued targeting of IP stressers or DDoS booters that inundate websites, servers and networks with junk traffic, rendering legitimate sites inaccessible. The seizures were executed by the FBI Anchorage field office and the Royal Canadian Mounted Police.”

From the cybersecurity vulnerabilities and breaches front

  • HIPAA Journal notes,
    • “A hacking group has claimed responsibility for an August 2026 cyberattack on Cedar County Memorial Hospital in Missouri. Hacking-related data breaches have been reported by Next Level Medical in Texas and Grafton City Hospital in West Virginia.”
  • MSSP Alert adds,
    • “Artificial intelligence is fundamentally altering the economics of cybercrime, making attacks faster and less expensive to execute, as first reported by Channel Insider. Ransomware victims saw a 45% increase in the first half of 2026, while the average underground price for initial access dropped by 69%, from $1,427 to $439. This shift indicates that AI is enabling threat actors to target more organizations with greater speed and scale, even if individual attacks are not necessarily more successful.”
  • Cyberscoop reports,
    • “Researchers said they used Anthropic’s Claude and OpenAI’s Codex to identify a damaging flaw embedded in a popular software decoding tool that could leave major internet platforms, enterprise services, and web frameworks vulnerable to data theft and remote access.
    • “The vulnerability, nicknamed HEIF Heist, refers to the malware’s ability to trigger memory corruption errors in affected software, allowing the attacker to pilfer sensitive data from its victims. In a report published Thursday, the researchers laid out the potential damage an attacker could cause, including gaining access to internal OpenAI repositories, leaking user files, access tokens, and other sensitive data for online services like Amazon Web Services, and gaining remote code execution privileges across a range of online services, including Meta’s core product suite, GitHub Enterprise servers and open-source internet forum Discourse.”
  • and
    • “North Korean hackers are infiltrating tens of thousands of job seekers’ computer networks by posing as prospective employers, such as artificial intelligence firms, to steal sensitive information and millions of dollars worth of cryptocurrency, U.S. and allied governments warned Friday.
    • The security agencies behind the alert, attributed the group, known as WaterPlum or Contagious Interview, as operating under the 313 General Bureau of the Munitions Industry Department subordinate to the Central Committee of the Workers Party of Korea. The efforts dovetail with those of North Korean IT workers.
    • “WaterPlum actors pose as prospective employers to target software developers and IT professionals worldwide under the pretext of attractive job opportunities,” the agencies wrote. “They often impersonate legitimate Artificial Intelligence (AI), cryptocurrency, or Non-Fungible Token (NFT) companies and have also used recruiting services.”
    • Additionally, “Some WaterPlum actors also operate as North Korean IT workers performing web system design and development tasks on corporate web systems for clients,” read the alert from agencies in Japan, Australia and Germany, alongside the FBI and the Department of Defense’s Cyber Crime Center.”
  • Help Net Security tells us,
    • “A fake ChatGPT billing email is steering users to a copy of the OpenAI login page that keeps whatever username and password they type. Josh Varden of Cofense’s Phishing Defense Center traced the email’s payment button through a Google redirect to the attacker’s page.
    • “The lure targets ChatGPT users on work and personal accounts alike, and it copies the kind of bill a subscriber already expects. Credentials entered on the fake page go to the attacker, and the victim is sent on to an error page.” * * *
    • “Cofense listed three indicators: the Google redirect link and two paths on the same nxcli[.]io host, login.php and key.php. Mail teams can search their logs for all three. If you use ChatGPT, the check that matters takes two seconds: read the address bar and confirm it says auth.openai.com before you type a password.”

From the ransomware front,

  • Industrial Cyber informs us,
    • “New data from Comparitech disclosed a record 997 ransomware attacks worldwide in August 2026, averaging 32 attacks per day and representing a 23% increase from 809 attacks in July. The total surpassed the previous monthly record of 988 attacks recorded in February 2025. Businesses accounted for 861 attacks, up 24% from July, while ransomware incidents targeting healthcare providers rose 30% to 69. Utility companies recorded the sharpest sector increase, with attacks doubling from five in July to 10 in August. 
    • “Ransomware surge was led by Qilin and The Gentlemen, which together accounted for more than 26% of August’s attacks, with Qilin claiming 157 incidents and The Gentlemen 107. Qilin’s attack claims increased 22% during the month, while The Gentlemen’s declined 21%; Qilin also had 12 confirmed attacks, compared with eight for The Gentlemen.” * * *
    • “Attacks on healthcare providers increased by 30% from July 2026 to August 2026, rising from 53 to 69. Eight attacks were confirmed in August. Three of the confirmed attacks took place in the U.S. Nutex Health Inc. noted unauthorized activity on its systems in a SEC filing on Aug. 24, 2026, and The Gentlemen claimed the attack. Cedar County Memorial Hospital experienced disruption to its IT networks on the afternoon of Aug. 14, 2026, with operations returning to normal on the morning of Aug. 28. Wallstreet claimed the attack. At Windrose Health Network, hackers exploited a vulnerability in the network’s remote-management tool in early August, resulting in a data breach. Storm claimed the attack.” 
  • Beckers Health IT reports,
    • “Jackson-based University of Mississippi Medical Center did not pay a ransom in connection with the cyberattack that disrupted its systems in February, according to officials.
    • “UMMC Vice Chancellor of Health Affairs LouAnn Woodward, MD, told SuperTalk Mississippi the state did not compensate hackers following the Feb. 19 attack. State Sen. Nicole Akins Boyd, who chairs the Universities and Colleges Committee, corroborated Dr. Woodward’s account.
    • “The statements come after State Auditor Shad White said his office would investigate the incident and notify the public if the government had paid a ransom.
    • “The cyberattack knocked out UMMC’s phones, website, records database and IT systems, forcing partner clinics to close for nine days and staff to record patient information by hand. The medical center returned to full operations Feb. 27.”
  • Cybersecurity Dive relates,
    • “Security researchers warn that a newly discovered ransomware variant called Settra has targeted virtual private network environments or compromised credentials for initial access before deploying remote monitoring and management tools to gain persistent access in targeted environments. 
    • “Researchers from Huntress observed two specific attacks in recent months, including a July incident at a consumer services and retail organization and a September incident at a manufacturing firm, according to a blog post published Thursday [September 17].
    • “The attackers could be described as capable rather than sophisticated,” said Lindsey O’Donnell-Welch, principal technical community engagement writer at Huntress. “They used effective, established ransomware tradecraft: MeshAgent for persistence, a vulnerable driver to potentially impair defenses, log clearing and recovery tampering.”
    • “Researchers from MoxFive said Settra used compromised VPN credentials to gain initial access and posted numerous victim organizations on its shaming site. The group claims to target organizations with exploitable weaknesses, such as unpatched systems or weak access management, according to a blog post from MoxFive.”
  • Bleeping Computer lets us know,
    • “The ShinyHunters extortion gang breached the Clop (aka Cl0p) ransomware operation’s data leak site, defacing the Tor site and allegedly stealing server data and the private keys for its onion service.
    • “The attack began Friday night [September 18] when ShinyHunters exploited what they claim is an unauthenticated file upload vulnerability in Grav CMS, which they used to upload a small text file to Clop’s site.
    • “The small text file contained a message from the threat actors to the Clop ransomware gang, warning not to threaten them and including a link to ShinyHunter’s own data leak site.”
  • InfoSecurity Mag tells us,
    • “It is a scenario that every CISO hopes they never face: the network encrypted by ransomware attack and cybercriminals who claim to have stolen sensitive data which they will leak if they don’t receive a ransom payment.
    • “Unfortunately for Zach Lewis, CISO at the University of Health Science and Pharmacy (UHSP) in St. Louis, this was the reality he faced when the organization was hit by a LockBit ransomware attack in summer 2023. The University recovered without paying the ransom, but it was a challenging time for all involved.
    • “In a conversation with Infosecurity, Lewis opened up about how it felt to be the victim of a ransomware attack and the toll it took on his team, as well as how the organization recovered from the incident and the lessons other cybersecurity leaders can learn from this experience.”

From the cybersecurity business and defenses front

  • The Wall Street Journal reports,
    • “Companies are facing a new era in cyberattacks driven by AI. But according to one cybersecurity CEO, having the right technology for defense isn’t necessarily the problem. It’s the humans who need to step up—particularly CEOs.
    • “What we’ve seen practically from working with some of the largest organizations in the world is that the technology is already there,” Galina Antova, CEO of the AI-driven security platform Kai, said at the Leadership Institute’s WSJ Technology Council Summit this week. “We could implement so many improvements,” using autonomous AI, she added.
    • “But what it really comes down to is having “the right incentive for the leaders to pursue that,” and “are they enabling their security organization to really move at machine speed?” 
    • “Companies need courage and leadership, she told enterprise tech bureau chief Steve Rosenbush, in a discussion that included Oege de Moor, founder and CEO of cybersecurity firm XBOW. 
    • Some additional insights from their conversation:
      • “Companies may need to redesign their security workflows. Attackers are “already moving at machine speed,” and they’re encountering a patchwork of protections, Antova reported. She has found that many Fortune 500 companies use some 80 to 120 security tools “that are organized in a very fragmented way,” she said. That means that when a company has an exposure, it can take time—days, weeks, or months—to find and close it. By contrast, she said, an end-to-end autonomous defense system that’s supervised by humans can reduce that time to minutes.” * * *
      • “[B]oth CEOs noted that the gap between frontier and open models was shrinking—and Antova added that with the right cybersecurity expertise and a surgical approach to deployment, the cost of AI-enabled security no longer needs to be prohibitive.”
  • Cybersecurity Dive adds,
    • “Artificial intelligence is now the leading driver behind new investment into cybersecurity budgets, according to a report released Tuesday from IANS and Artico Search.  
    • “About seven of every 10 chief information security officers surveyed said AI was their top priority for new cybersecurity spending. Two specific areas for AI-related spending shown in the report include automating security operations and enhancing identity and access management. 
    • “Overall security spending rose 5% in the current survey, which is barely ahead of the 4% spending increase in the year-ago report. AI spending priorities come at a time of relatively modest growth in overall security spending.”
  • Per CISA news releases,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) hosted Cyber Storm X this week, a four-day national cybersecurity exercise designed to test and ultimately strengthen the nation’s resilience. This year’s exercise included 2,000 participants from across the public and private sectors and marks the tenth exercise in the 20-year history of Cyber Storm. The biennial exercise brings together the people who manage the services our nation relies on, including water, energy, and other vital sectors. During the exercise, participants practice how they would respond to a major cyber incident affecting critical infrastructure.
    • “Cyber Storm helps critical infrastructure owners and operators understand how we would manage a large-scale cyber incident,” said Acting CISA Director Nick Andersen.  “Exercises strengthen our national resilience by making sure our plans, policies, and partnerships are ready when we need them.  As a nation, we need the ability to respond swiftly and effectively to critical threats. That’s exactly what Cyber Storm does and why it’s a vital exercise for our nation’s security.”
    • “This year’s exercise focused on a scenario involving a nation-state adversary targeting the transportation systems sector, including rail and ports, along with the water and wastewater systems sector. The exercise allowed participants to test response plans, practice coordination, and strengthen information sharing in a safe environment. Cyber Storm X included over two hundred organizations across all levels of government and the private sector.
    • “CISA will now collaborate with participating organizations to identify lessons learned from the exercise. We will use these findings in a public after-action report that captures observations, analyses, and recommendations. CISA is committed to providing access to a wide range of cybersecurity tools and training opportunities, with exercises being a critical part of that toolkit to enhance our nation’s cyber preparedness.
    • “For more information, please visit Cyber Storm X: National Cyber Exercise.”
  • and
    • “Today [September 16], the Cybersecurity and Infrastructure Security Agency (CISA) released guidance that helps critical infrastructure owners and operators implement realistic decoy systems and information assets to quickly detect and disrupt malicious activity occurring in their networks, which will ultimately improve their cyber defenses. Using Cyber Decoys to Strengthen Detection and Response is the first guide from CISA that offers a detailed explanation of the defensive cyber decoy process.
    • “Many organizations struggle to detect adversaries who use legitimate credentials, native tools, and living off the land techniques to conduct discovery, move laterally, and access data. In this guide, CISA encourages critical infrastructure organizations to incorporate cyber decoy capabilities alongside existing Zero Trust models. Cyber decoy strategies operate on the expectation that malicious actors may eventually gain some level of access. By placing decoys within internal networks and systems, especially in high-value areas, organizations can enable defenders to:
      • “Detect adversaries operating within the environment early in the intrusion lifecycle;
      • “Gather and analyze information taken from intrusions and attempted intrusions;
      • “Allocate defensive resources more effectively based on observed adversary behaviors;
      • “Reduce mean time to detection (MTTD) by generating high-fidelity alerts.” * * *
    • “To effectively use this guide, cyber defenders should have a basic understanding of the MITRE ATT&CK ® Matrix and common enterprise security controls and tools. The guide provides a practical approach to designing and implementing decoy strategies by leveraging the MITRE ATT&CK® knowledge base and the MITRE Engage™ framework.
    • “For more information, please visit Cybersecurity Best Practices.”
  • and
    • “The Cybersecurity and Infrastructure Security Agency (CISA) and the National Institute of Standards and Technology (NIST) today [September 15] released Interagency Report (IR) 8587, Protecting Tokens and Assertions from Forgery, Theft, and Misuse: Implementation Recommendations for Agencies and Cloud Service Providers (CSPs). The report guides federal agencies and CSPs in defending the identity tokens and assertions that underpin modern single sign-on (SSO), federation, and application programming interface (API)-based access, systems adversaries increasingly target to move laterally through enterprise networks and reach sensitive data.
    • “The final report incorporates key feedback from nearly 250 public comments on token validation, secrets management, and detection at scale. The report also reflects input from CISA’s long-term, strategic collaboration with industry CSPs and interagency partners through the Joint Cyber Defense Collaborative. CISA and NIST engagements with this group included a technical exchange in June 2025 with over 50 industry experts to identify approaches to harden identity infrastructure and a webinar in January 2026 to review the draft report. Dozens of individual meetings with CSPs were also held to discuss feedback that included Google, HashiCorp, an IBM Company, IBM, Microsoft Corporation, Okta Inc., the OpenID Foundation, Oracle America, Inc., Amazon Web Services, and Wiz.” * * *
    • “The recommendations in the final report apply across commercial and government-operated cloud services and support implementation of Executive Order 14306 on secure software development practices.
    • “CISA urges federal agencies, CSPs and cloud consumers to review and implement IR 8587 to improve the security of their cloud systems. 
    • “For more information on this effort, read NIST’s News Release.“
  • Tech Target offers a tip about “how to verify the value of AI-powered business analytics.”
    • Executives can separate AI analytics capabilities from marketing hype by taking steps to confirm the platform improves decision-making and gives results that hold up.
  • Here is a link to Dark Reading’s CISO Corner.

Monday report

David Ermer–Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Beckers Payer Issues reports,
    • “Pharmacies have been seeing compelling interest in Medicare’s GLP-1 Bridge program since its July launch, NPR first reported.
    • “The demonstration, designed to give eligible Medicare Part D beneficiaries access to certain GLP-1s at a fixed monthly cost, will run through 2027. Manufacturers are supplying GLP-1s at a monthly net price of $245, and beneficiaries cover $50. Unlike the proposed voluntary “Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth” — or BALANCE — model pilot, Bridge bypasses Part D sponsors.” * * *
    • “Becker’s connected with Walgreens and CVS Health to unpack how Bridge has been progressing so far. To date, each company has filled more than 100,000 GLP-1 prescriptions through the program.
    • “We have seen actually uptake be pretty strong in the first part of the program,” Rick Gates, chief pharmacy officer for Walgreens, told Becker’s. “… I would say it is far exceeding from a volume perspective what we expected at this point.”
    • “Mr. Gates said Bridge is continuing to grow. When asked about expectations for 2027, he said the program could still hit a ceiling with participation, though.”
  • Beckers Hospital Review relates
    • “Federal health officials are exploring how Medicare could pay for artificial intelligence tools that provide medical care or diagnoses as the Trump administration pushes to expand the technology’s role in patient care, The New York Times reported Sept. 14.
    • “Officials are working to develop a new Medicare payment category that could reimburse companies for AI software supporting medical care or diagnosis, according to the Times. Medicare officials have also encouraged private insurers to reimburse for certain forms of technology-supported care if they improve care and lower costs.
    • “The efforts come as federal officials move forward with several initiatives involving AI in patient care, including technologies capable of performing tasks traditionally handled by physicians.
    • “Within the administration, officials have discussed whether AI doctors operated by technology companies and startups should be paid as much as 60% to 80% of what human physicians earn for the same service, according to a person involved in the discussions cited by the Times.
    • “The payment discussions are unfolding as regulators determine how to oversee increasingly autonomous AI tools. The FDA has approved more than 1,500 medical devices that include AI and perform discrete tasks, such as identifying tumors or blood clots. But the agency does not have rules designed to address newer models, including chatbots and agentic AI systems capable of performing tasks such as prescribing medications.”
  • Fierce Healthcare tells us,
    • “The country’s largest hospital lobby is urging antitrust regulators to look beyond commercial insurance prices and market-wide concentration when weighing the impact of a proposed hospital merger.
    • “The American Hospital Association (AHA), armed with a new analysis report commissioned from healthcare advisory firm Kaufman Hall, called on Monday for a “more comprehensive analysis” of deals under increasing scrutiny because research ties consolidation to higher healthcare prices. 
    • “Regulators, the association and the report said, should place more weight on the types of patients merging hospitals serve, what could happen to care delivery if a deal falls through, and how hospitals within a shared market compete at the service-line level.
    • “Hospital mergers receive careful antitrust review. But careful review is not the same thing as a narrow review,” AHA General Counsel and Secretary Chad Golder wrote in a blog post highlighting the new report. “The relevant question is not just whether a transaction might affect the prices commercial insurers negotiate. It is what the transaction—or its failure—is likely to mean for patients: whether healthcare services remain available, whether hospitals can invest in their workforce and facilities, and whether local communities retain access to care.”
  • Healthsystem CIO informs us
    • “Almost 90 percent of the information blocking complaints filed with the federal government target healthcare providers, according to ASTP. The portal collecting them had logged 2,450 claims through July 31, up from roughly 1,600 in February. The conduct those claims describe is records release, patient registration and app access. That puts a health system’s exposure inside workflows the technology executive rarely supervises.”

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

  • OPM released the following request for public input today in the Federal Register,
    • This request for information (RFI) seeks public input on how to optimize health benefits plan options offered in the Federal Employees Health Benefits (FEHB) Program, which includes the Postal Service Health Benefits (PSHB) Program, to give enrollees high value choices at competitive costs while ensuring the appropriate number and distribution of options are available to enrollees. Currently, health benefits plans in the FEHB Program are limited to offering three options or two options and a high-deductible health plan (HDHP) pursuant to 5 CFR 890.201(b)(3)(i). The information gathered through this RFI will inform the Office ofPersonnel Management (OPM) as to whether modifications to the current FEHB regulations are needed through future notice and comment rulemaking as OPM explores ways to optimize the FEHB and PSHB portfolio and provide enrollees with high value choices at competitive costs.
    • The public comment deadline is November 16, 2026.
  • FEHBlog observation — In order for such a proposal to be successful, OPM should allow plans to combine plan reserves and use a combined medical loss ratio so that the new options can grow.

From the Food and Drug Administration front,

  • Reuters reports,
    • “Doctors, veterans, pharmacists and therapists on Monday urged the U.S. Food and Drug Administration to establish clear safety ‌and access standards for psychedelic therapies during a four-hour public meeting convened by the agency amid efforts to speed up their development.
    • “The hearing is the latest in a months-long push launched by U.S. President Donald Trump’s administration in April to bring qualified psychedelic drug programs to market.
    • “Discussions at the ​meeting focused on practical issues that could shape how psychedelic therapies are tested and delivered, including provider training ​and credentials, patient screening and monitoring, access and reimbursement, clinic capacity and the collection of long-term ⁠safety data.
    • “Experts said any approved psychedelic treatment must include trained staff in the room during sessions — which could last six ​to 12 hours — alongside proper screening, follow-up care and community support.”
  • STAT News adds,
    • “Definium Therapeutics said Monday that its LSD therapy helped patients with anxiety in a second late-stage trial, setting up the company to seek the first approval of a psychedelic drug for anxiety.
    • “In the 12-week trial, patients taking a 100-microgram dose of the drug, called DT120, experienced a 9.8-point drop on a test called the Hamilton Anxiety Rating Scale, while those on placebo experienced a 4.7-point drop. The difference of 5.1 points is similar to what was seen in Definium’s first late-stage anxiety study and larger than what’s been observed with many other anxiety therapies, though it’s difficult to compare results across studies.
    • “Definium is among the first wave of biotechs nearing regulatory approval for psychedelic therapies, a class of treatments that may be especially attractive to patients since they appear to exert rapid benefits. (In the latest trial, Definium said patients experienced changes as early as the second day after dosing.) In contrast, the effects of traditional options like antidepressants take weeks to kick in.
    • “However, commercializing the drug could be challenging. Patients will have to commit a large amount of time traveling to a clinic and taking the treatment under monitoring by a clinician, potentially for up to eight hours. 
    • “Still, Definium’s development approach may give it an advantage. Many other biotechs are studying psychedelics specifically in depression, including Compass Pathways, which is furthest ahead with its psilocybin candidate. Definium is testing its therapy in both anxiety and depression, and because there are so many people with both conditions, doctors may be inclined to prescribe Definium’s product to such patients.”
  • The Wall Street Journal notes
    • Regulators are trying to curb the supply of illicit, unapproved versions of Eli Lilly’s experimental weight-loss drug retatrutide.
    • The black-market compound enters the U.S. from overseas suppliers, often based in China or India, and is sold by clinics and online sellers.
    • The Ohio State Board of Pharmacy conducted 1,102 proactive inspections of wellness clinics and medical spas between March 2025 and August 2026.
  • BioPharma Dive relates,
    • “The Food and Drug Administration has approved a new kind of medication for the rare genetic disease spinal muscular atrophy. 
    • “Called apitegromab and to be sold as Isembyld, the treatment on Friday was cleared for use alongside existing targeted therapies in adults with SMA as well as children at least 2 years of age. For a typical SMA patient, the drug will have an annual list price of about $310,000 per year, executives revealed on a Monday conference call. Costs will vary person-to-person based on a patient’s weight and insurance coverage.
    • “Isembyld’s clearance will once again change the treatment landscape for a potentially lethal disease that had no approved medicines as recently as a decade ago.” 
  • MedTech Dive tells us,
    • “Beta Bionics received Food and Drug Administration clearance on Friday for the company’s first insulin patch pump.
    • “The device, called Mint, has a three day wear time and a 200-unit insulin reservoir. It is designed with a mixture of disposable and reusable components. 
    • “Leerink Partners analyst Mike Kratky wrote in a research note Monday that the FDA authorization should help level the playing field with competitor Insulet, which has dominated new device starts with its patch pump.”
  • Radiology Business adds,
    • “The U.S. Food and Drug Administration has approved a new brain cancer imaging agent from Telix, the Australia-based pharma firm announced Monday. 
    • “Pixclara is a radioactive diagnostic drug paired with positron emission tomography imaging. It’s used to help doctors distinguish between returning brain cancer or harmless changes caused by previous treatments.
    • “The agency’s approval of Telix’s New Drug Application comes after the company previously received a rejection from the agency last year. 
    • “As the first FDA-approved PET imaging drug for glioma [a type of brain cancer], Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients,” Kevin Richardson, CEO of Telix Precision Medicine, said in a statement Sept. 14.” 

From the judicial front,

  • Beckers Hospital Review reports,
    • “Brentwood, Tenn.-based optometric physician Helen Boerman has been sentenced to 42 months in federal prison for defrauding Medicare and other government health care programs out of nearly $7 million, according to a Sept. 14 news release from the U.S. Attorney’s Office for the Middle District of Tennessee.
    • “Ms. Boerman, 48, used her practice, Brentwood Eye Care, to submit false Medicare claims over about three and a half years, billing for services patients did not receive and for wound care products she split for single use rather than purchasing separately, according to court documents. She also submitted false claims to TennCare and the Federal Employees Health Benefits Program between March 2020 and October 2024. As part of her guilty plea, she admitted to submitting roughly $11 million in false claims and receiving about $6.9 million.
    • “Chief U.S. District Judge William Campbell Jr. imposed the sentence Sept. 10, along with one year of supervised release, $6.9 million in restitution and a $100 special assessment.”
  • The Wall Street Journal reports,
    • “Abbott Laboratories has agreed to pay $385 million to settle allegations related to its management of a baby formula facility where deadly bacteria was suspected of causing infant deaths, the Justice Department said Monday.
    • “The settlement is a more lenient outcome than some prosecutors had advocated for, believing they had evidence to criminally charge Abbott under a law that has been used to pursue other businesses for selling contaminated foods, the Journal previously reported. But senior Justice Department officials believed criminal charges would have been heavy handed and closed the probe. 
    • “They opted instead for the civil settlement, which claws back money the company earned from selling formula through federally funded nutrition programs.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “In 2024, 71.5% of adults reported experiencing fatigue at least some days in the past three months, a Sept. 3 CDC report found. 
    • “The CDC used 2024 National Health Interview Survey data to estimate fatigue symptoms among about 27,000 adults 18 and older. Fatigue statistics are based on the reported frequency of fatigue in the past three months. Fatigue is defined as physical or mental tiredness or exhaustion that does not improve with additional sleep or rest. 
    • “Fatigue is “one of the most frequently reported health concerns in primary care visits in the U.S.,” sociologist Natalie Young, PhD, lead author of the report, said.”  
    • “Among adults who reported fatigue in the past three months, 54.9% of adults reported it on some days, 10.7% most days, and 5.9% every day.
    • “Frequent fatigue was most common among women at 20% — compared to 13% of men — and younger adults.”
  • Wallet Hub offers a chart showing the U.S. States that vaccinate the most.
    • “In order to see where people are most responsible about getting vaccines, WalletHub examined the 50 states and the District of Columbia across 16 key metrics. Our data set ranges from the rates of children, teens and adults vaccinated against various diseases to the share of people without health insurance.”
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) is awarding $21 million to launch a research program aimed at spurring the development of computer-based methods that model and simulate the self-regulating processes of human hormones, known as hormone homeostasis. Hormone activity varies widely, resulting in differences in how men and women react to drug therapy, including varying outcomes to dosing, treatment response, and drug toxicity. The program, known as the Computational Modeling of Hormone Homeostasis Initiative, will advance novel human-based, data-driven models tailored to a man or a woman’s complex physiology through advanced computational techniques.
    • “Current mathematical and animal models do not sufficiently capture variations between men and women. Addressing this gap is critical to the understanding of sex-specific biology and the development of more individualized approaches to therapeutics,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives. “By leveraging advanced computer-based models that use human biological data to simulate hormone activity across the lifespan, we can help researchers improve the evaluation of new treatments and support more informed clinical decisions.”
  • and
    • “A National Institutes of Health (NIH)-funded scientific team has shown that a new brain-computer interface (BCI) can allow people with vocal tract and bodily paralysis to convey both speech and upper-body gestures simultaneously. While BCIs have facilitated one or the other in the past, this new system is the first to enable both modes of communication at once, more closely replicating natural expression.
    • “Scientists at the University of California, San Francisco, used machine learning to decipher the unique brain activity that underpins concurrent speech and physical gesture in three patients. Their BCI successfully translated the thoughts of two participants into commands that dictated the expressions of a full-body virtual avatar.
    • “Conversation is about much more than the words being spoken. It’s a multilayered, dynamic process involving the whole motor cortex,” said corresponding author Edward Chang, M.D., a professor of neurological surgery at UCSF. “This proof-of-concept shows us it’s possible for a BCI to restore some of this freedom and flexibility.”
  • and
    • “Advancing Childhood Cancer Research: A Conversation with Dr. Brigitte Widemann.”
      • “September is Childhood Cancer Awareness Month, a time to recognize children and adolescents with cancer, their families, and those working to improve their lives. Brigitte C. Widemann, M.D., is chief of the Pediatric Oncology Branch in NCI’s Center for Cancer Research and special advisor to the NCI director for childhood cancer. A pediatric oncologist and physician-scientist who cares for patients at the NIH Clinical Center, she has devoted her career to developing better treatments, particularly for young people with rare tumors and genetic cancer predisposition syndromes. In this Q&A, Dr. Widemann discusses recent advances, the importance of sustained federal investment, and the promise of shared data and artificial intelligence.”
  • Health Day relates,
    • “Patients with a cancer diagnosis have an increased risk for ischemic stroke (IS), with risk peaking during the first three months, according to a study published online Sept. 8 in Cancer.
    • “Carmit Libruder, from the University of Haifa in Israel, and colleagues conducted a retrospective cohort study linking the Israel National Cancer and Stroke Registries to examine the risk for IS after cancer diagnosis. Residents aged 40 years and older diagnosed with a first invasive cancer during 2014 to 2021 were followed for first-ever IS within one year.”
  • and
    • “A spinal implant can significantly reduce pain suffered by people with diabetes-related nerve damage, a new study says.
    • “Spinal cord stimulation blunted pain and improved sensation in patients suffering from diabetic neuropathy, researchers reported Sept. 9  in the journal Diabetes Care.” 
  • Beckers Behavioral Health informs us,
    • “Frequent smartphone check-ins predicted 75% of suicide attempts and 87% of suicide-related events like hospitalization in the week before they occurred, according to a Sept. 11 Boston Globe report. 
    • “Researchers from Cambridge, Mass.-based Harvard followed 619 adults and adolescents who had sought care for suicidal thoughts or behavior at two Boston-area hospitals. On a sliding scale from 1 to 10, participants were asked how hopeless and agitated they felt, how strong their urge to kill themselves was and how capable they felt of resisting that urge. For three months, participants received 20-question surveys on their smartphones six times a day. Researchers used the responses and information about survey completion in machine-learning models to predict suicide attempts or other suicide-related crises in the following seven days. 
  • MedPage Today points out,
    • “Menopause hormone therapy is FDA approved for other common menopause symptoms but not for mood disturbances.
    • “In an observational study, women using menopause hormone therapy had significantly improved scores for psychological symptoms, including depressive mood, irritability, anxiety, and mental exhaustion.
    • “The proportion of patients with severe mood symptoms decreased from 62.3% at baseline to 24.6% at follow-up.”
  • and discusses
    • “Preserving Muscle During GLP-1 Weight Loss
      • — Experts advise tracking body composition, boosting protein, and resistance training.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of a study by scientists at Wellcome Sanger Institute, University of Cambridge, University College London, and collaborators indicate that cancer treatments, including chemotherapy and radiotherapy, give a growth advantage to cells with particular genetic changes in healthy tissue. The team used DNA sequencing to map mutations in normal esophagus tissue from esophageal cancer patients who had received either chemotherapy, chemotherapy and radiotherapy, or no treatment before surgery.
    • “The results showed that different cancer treatments changed the landscape of mutations in normal tissue. In particular, combined treatment using chemotherapy and radiotherapy led to significantly more normal cells with cancer-related mutations in these patients. The team suggests that sequencing normal tissue from cancer patients receiving treatment could show how our genes regulate our tissue’s response to drugs, including side effects.”
  • Per BioPharma Dive,
    • “Akeso and Summit Therapeutics’ experimental dual-acting cancer drug helped people with lung cancer live about eight months longer than those who got Merck & Co.’s Keytruda in a Phase 3 clinical trial and showed an even stronger benefit in people whose tumors express high levels of a protein that both medicines target.
    • “The findings could help Akeso and Summit shed doubts about the promise of their drug, called ivonescimab, as well as other experimental therapies that target the proteins “PD-1” and “VEGF” as potential heirs to Keytruda as a backbone of lung cancer care.”
  • Per Fierce Pharma,
    • “An unfavorable overall survival trend in a phase 3 trial threatens to thwart AstraZeneca and Daiichi Sankyo’s bid to establish their star antibody-drug conjugate Enhertu as a first-line treatment for patients with HER2-mutant non-small cell lung cancer.
    • “Treatment with Enhertu showed a preliminary 15% increased risk of death compared with Keytruda plus chemotherapy in the phase 3 Destiny-Lung04 study, according to results shared at the 2026 World Conference on Lung Cancer.
    • “At an interim analysis of the study, patients in the Enhertu arm lived a median 29.3 months, versus 33.1 months in the Keytruda-chemo arm. At that point, 213 patients (46.9%) enrolled in the study had passed away, including 115 (50.7%) in the Enhertu group and 98 (43.2%) in the control arm.” 
  • and
    • “GSK is advancing its inaugural lung cancer asset, Jideytro, toward a landmark first-line FDA approval, aided by an unprecedented complete response rate.
    • “In a quick return for GSK’s $10.6 billion acquisition of Nuvalent, an early FDA nod in July has made Jideytro GSK’s first commercial lung cancer drug, with a label covering advanced ROS1-positive non-small cell lung cancer following treatment with a prior ROS1 tyrosine kinase inhibitor (TKI). Now, the company is gunning for an expansion into the TKI-naïve population. 
    • “That plan is supported by new data from the single-arm Arros-1 trial. Among 94 efficacy-evaluable TKI-naïve patients, Jideytro triggered an objective response in 88 patients (94%), according to data presented at the 2026 World Conference on Lung Cancer in Seoul. These patients were allowed to have received up to one prior line of chemotherapy with or without immunotherapy before entering the study.”
  • and
    • “Akeso and Summit Therapeutics’ ivonescimab reduced the risk of death by 27% compared with Keytruda in patients with treatment-naïve, PD-L1-positive advanced non-small cell lung cancer in the phase 3 Harmoni-2 trial conducted in China.
    • “The result, to be presented at the 2026 World Conference on Lung Cancer in Seoul, marks another positive readout from ivonescimab, whose Keytruda head-to-head win two years ago on the trial’s primary endpoint of progression-free survival sparked a gold rush for similar PD-(L)1xVEGF bispecific antibodies. 
    • “In Keytruda’s monotherapy setting, having such strong data help[s] physicians understand that this is an approach capable of beating current PD-1 standards of care in this indication,” Akeso CEO Michelle Xia, Ph.D., told Fierce.”

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

  • Beckers Payer Issues reports,
    • “Nationally, the average annual deductible for single coverage under an employer-based health insurance plan is $2,169, according to an analysis from KFF.”
  • and
    • “Nationally, the average annual deductible for family coverage under an employer-based health insurance plan is $3,997, according to an analysis from KFF.”
  • Chief Health Executive explains how Baptist Health reduced emergency room boarding in its Arkansas facilities,
    • “Predictive discharge analytics shifted discharge ordering earlier, aligning bed availability with afternoon admission surges and improving system-wide throughput and transfer capacity. 
    • “Real-time identification of modifiable discharge barriers enabled safe, prompt disposition, recapturing capacity without new brick-and-mortar and reducing ED boarding by about 525 patients per month. 
    • “A phased, two-hospital start with iterative frontline feedback built provider trust in the data, reinforcing a “work smarter” culture rather than intensifying labor demands. 
    • “Robust governance integrating physicians, nursing, IT, laboratory, radiology, and environmental services supported transparency, accountability, and sustained process redesign to maintain flow improvements.”
  • Healthcare Dive relates,
    • “Oracle Health’s clinical artificial intelligence agent is now available for nurses in the U.S., roughly two years after the tool launched first for physicians, the company announced Monday.
    • “For doctors, the AI agent works autonomously to draft clinical notes, propose follow-up lab tests and generate discharge summaries. Oracle tacked on new capabilities in August, adding chart review assistance, dictation and automated coding.
    • “The tool works similarly for nurses, but with role-specific considerations, Oracle says. Nurses can use voice commands to search for and navigate patient charts and generate nursing summaries to limit administrative work.”
  • Fierce Healthcare adds,
    • “Abridge expanded its artificial intelligence capabilities into the mid-revenue cycle workflow. The company launched a pre-bill review capability designed specifically for clinical documentation integrity (CDI), coding and revenue cycle teams.
    • “The pre-bill reviews inpatient claims before submission, comparing coded diagnoses and diagnosis-related groups (DRGs) against what the clinical documentation supports to identify potential discrepancies and provide supporting evidence, the company announced on Monday.
    • “Abridge started with ambient listening and AI-powered clinical notes and has steadily expanded beyond clinical documentation to tackle other admin tasks, developing what it calls a “clinical intelligence” platform. The company has built its platform around the clinical conversation and is expanding both upstream to support visit preparation and downstream into administrative and revenue cycle workflows.
    • “Abridge says its clinical AI technology captures the record as the clinical interactions happen and the company can extend that into reimbursement workflows. Extending that same platform into pre-bill review allows Abridge to compare the clinical record with the diagnoses and DRG on the claim and show where they do not align. CDI and coding teams can then determine before submission whether the coded record accurately reflects the documented complexity of care.”
  • The Wall Street Journal lets us know,
    • “Wegovy maker Novo Nordisk NOVO.B is rebranding as Novo, betting a shorter name will help it resonate more with consumers as it competes with rival Eli Lilly.
    • “The move by the Danish drugmaker comes as Chief Executive Mike Doustdarworks to revive the fortunes of a company that has ceded the crown in the weight-loss market it pioneered to Lilly.
    • “Since taking the reins in August last year, Doustdar has implemented a cost-savings plan that included 9,000 job cuts and the launch of a pill version of Wegovy, placing the company ahead of its U.S. rival in the market for oral weight-loss medications. Doustdar is expected to detail the next phase of his comeback plan in an investor update later this month.”
  • Medtech Dive informs us,
    • “Medtronic said Monday that it has started an exchange offer to split off up to 80.1% of the shares of MiniMed.
    • “Formerly Medtronic’s diabetes technology business, MiniMed went public in March as part of a two-step separation process. Exchanging the remainder of Medtronic’s shares is the second part of the process. Medtronic currently owns 89.9% of the company.
    • “Medtronic CEO Geoff Martha said the offer “reflects our confidence in MiniMed as an independent company, giving the diabetes company more focus and flexibility, and allowing Medtronic to focus capital on its cardiovascular, neuroscience and surgical portfolios.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Never forget.

The New York Times reports

  • “Mourners and dignitaries gathered this morning in Lower Manhattan to honor the thousands of people who were killed on this day 25 years ago, when terrorists crashed two airplanes into the World Trade Center, shaking America and the world. It took four hours for family members of the victims to read aloud the names of all of the nearly 3,000 people who lost their lives: Gordon M. Aamoth Jr.; Edelmiro Abad; Marie Rose Abad …
  • “Solemn ceremonies were also held at the Pentagon and in Shanksville, Pa., where the other hijacked planes crashed. At the Pentagon, President Trump spoke of American resilience: “Sept. 11 reminded us of the terrible power of hate,” he said. “The 25 years since have shown us the even greater power of the American spirit to endure and prevail and to win.”
  • “All four other living presidents attended the memorial in New York. Zohran Mamdani, the city’s first Muslim mayor, was also in attendance, despite a petition signed by thousands of people, including the family members of some victims, urging him to stay away.
  • “That ceremony began, as always, at 8:46 a.m., with a beat of silence honoring the moment when the first plane, American Airlines Flight 11, struck the North Tower. Five more silences marked the times when other flights crashed and buildings fell. But this year, a new, seventh moment of silence was observed, to mourn those who have died from cancer and other illnesses inflicted by the toxic dust they inhaled after the attacks.”

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, tells us,
    • Every year, the anniversary of Sept. 11, 2001, brings back the same difficult truth: federal service is not always performed behind a desk, and risk does not always announce itself in advance. Sixty-nine federal employees were among those who died that day — including 62 at the Pentagon, three at the World Trade Center, three aboard Flight 93, one aboard Flight 77 at the Pentagon and one aboard Flight 175 at the World Trade Center. Many more reported for duty afterward to secure facilities, investigate the attacks, transport people, provide emergency assistance and help the country recover.
    • For their families, the lesson is not only one of remembrance. It is also a benefits lesson. If a civilian federal employee is injured, develops an occupational illness or dies because of federal employment, the Federal Employees’ Compensation Act may provide important protection.
    • FECA is the federal government’s workers’ compensation program for civilian employees, administered by the Labor Department’s Office of Workers’ Compensation Programs. It can pay for medical treatment, replace part of lost wages, provide compensation for permanent impairment and, in fatal cases, provide benefits to eligible survivors.
    • This is where many employees and families get into trouble: They know there are “benefits,” but they do not know which benefit applies, who administers it or what evidence is needed. A traumatic injury is generally tied to a specific incident during one workday or shift and is reported on Form CA-1. An occupational disease or illness develops over more than one workday or shift and is reported on Form CA-2. Wage-loss compensation is generally claimed separately, often with Form CA-7.
    • These distinctions are more than paperwork. They affect deadlines, agency responsibilities, medical documentation and how the claim is developed.
  • FEHBlog observation: While OWCP pays benefits before FEHB /PSHB plans for OWCP compensable illnesses and injuries, OWCP does not give the beneficiary an OWCP benefits ID card which would put the provider on notice to bill OWCP, not the FEHB/PSHB plan.
  • Healthcare Dive reports,
    • “The number of hospitals complying with price transparency rules is increasing. But more than half of facilities still aren’t posting full information about the cost of their services, according to the latest analysis from PatientRightsAdvocate.org.
    • “About 51% of U.S. hospitals aren’t fully complying with the rules, despite them taking effect more than half a decade ago, according to the patient advocacy group’s latest scorecard of 2,000 hospitals.
    • “Still, the roughly 49% of hospitals in compliance is up significantly from the last time PRA analyzed the industry in 2024, and is the highest rate since the group began tracking the issue in 2021. PRA chalked the improvement up to regulators stepping up enforcement.”
  • AHIP adds,
    • “Hospital spending makes up the largest share (40%) of health insurance premiums and continues to grow, now exceeding $1.6 trillion annually. One major driver of high hospital costs is that routine services are often reimbursed at substantially higher prices — sometimes up to 13 times more — in hospital outpatient departments (HOPDs) than in physician offices and other non-facility settings, even though the care is the same.” 
  • Beckers ASC Review tells us,
    • “Physician assistants and advanced practice registered nurses can now order every noninvasive colorectal cancer screening test Medicare covers, ending a long-standing physician-only requirement under a CMS coverage change.
    • “CMS authorized the expanded coverage in June when it finalized a decision memo revising the “Screening for Colorectal Cancer — Non-Invasive Biomarker Tests” national coverage determination, the American Academy of Physician Associates said in a Sept. 10 news release.
    • “The determination previously covered the tests only when a physician ordered them. CMS reopened it after new evidence emerged on stool-based RNA tests.
    • “PAs and APRNs may now order RNA-based stool tests, DNA-based stool tests, DNA-based blood tests and fecal occult blood tests.”
  • Beckers Hospital Review informs us,
    • “Johnson & Johnson will require 340B covered entities to submit claims-level data for its covered outpatient drugs starting Sept. 15, according to a notice the drugmaker sent to providers Sept. 4.
    • “Covered entities that don’t submit will receive at least two noncompliance notices and a notice of pricing suspension, with suspension beginning at least five business days after the final notice. J&J said 340B pricing will be restored within 10 business days once a covered entity submits compliant data.
    • “The policy applies to all covered entity types regardless of dispensing or administration location, inventory management system or payer coverage. J&J said it will continue to offer 340B pricing upfront at the time of purchase rather than moving to a rebate model, and that the policy supersedes claims-data provisions in a prior notice from February 2023.
    • “Covered entities must submit data within 45 days of a drug’s dispensation; a list of oncology, autoimmune and other specialty drugs, including Stelara, Darzalex and Tremfya, carries a 60-day window.” 

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

  • Federal New Network offers an interview with OPM Director Scott Kupor, and further reports
    • “Federal employees’ performance ratings will now be the top consideration during future reductions in force, as a final rule from the Office of Personnel Management takes full force this month.
    • “OPM’s final regulations, which became effective Sept. 2, mark a significant turning point in the way agencies develop RIF retention registers, which determine whether employees are retained, reassigned, demoted or separated during RIFs.
    • “Following the publication of the final rule in August, OPM detailed further expectations about the new system in guidance to agencies. During any future RIFs, agencies will have to rank employees using a point system directly tied to their performance ratings. An employee with a level 5 performance rating will receive seven points on the RIF register, while level 4 receives five points; level 3 receives three points; and levels 1 and 2 each receive zero points.
    • “Agencies will also place competitive service and excepted service employees on separate retention registers in any future RIFs. Within each list, employees will then be numerically ranked based on their performance levels, with points added for veterans’ preference. Tenure and seniority will be used only as tiebreakers between employees.”

From the Food and Drug Administration front,

  • The Pharmacy Times reports,
    • “The FDA approved leniolisib (Joenja; Pharming Healthcare) tablets for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 to 11 years who weigh at least 27 kg. The decision makes leniolisib the first FDA-approved treatment for children in this age and weight group with the rare genetic immune disorder.”
  • Cardiovascular Business relates,
    • “Emboline, a California-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for its Emboliner Embolic Protection System. The device was built to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) procedures. This is seen as a way to reduce the risk of stroke, which clinicians have been battling since TAVR was first introduced, as well as other potential complications.
    • “We developed the Emboliner to address important unmet needs with existing embolic protection approaches for TAVR,” Scott Russell, president and CEO of Emboline, said in a statement. “We are excited to now be able to put the Emboliner in the hands of physicians so that they can offer a more comprehensive embolic protection solution for their patients. We are grateful to the clinical investigators whose partnership and feedback helped us reach this point.”
    • “The Emboliner device includes a self-expanding filter that covers all three cerebral vessels. The filter’s double-layer mesh captures debris without restricting blood flow in any way.
    • “Emboline plans on beginning its commercial launch of the newly approved device by the end of 2026.”
  • Fierce Pharma tells us,
    • “The FDA has delayed its approval decision for Exelixis’ oral kinase inhibitor zanzalintinib in combination with Roche’s Tecentriq for the treatment of patients with metastatic colorectal cancer (mCRC). 
    • “Exelixis explained in a Securities and Exchange Commission filing that the agency has asked for the extension while it awaits updated safety and efficacy data from the company. It means the biopharma should now expect a decision in March 2027 as opposed to the previous deadline of Dec. 3, 2026.”

No Surprises Act News

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury have added Physio Solutions, LLC as a new independent dispute resolution entity increasing the total to 17. IDR arbitrators help make payment determinations in disputes between providers, group health plans and health insurance issuers under the No Surprises Act.”
  • Beckers Payer Issues summarizes five other recent NSA updates for us.

From the judicial front,

  • Bloomberg Law reports,
    • “A federal judge blocked the Trump administration’s use of a question for federal job applicants that critics said amounted to a test of their political beliefs. 
    • “The Trump administration can no longer require thousands of government job seekers to say why the president’s policies are personally significant to them, and how they would further them if hired, according to a Friday ruling in the US District Court for the District of Massachusetts.” * * *
    • “While the ruling prevents the administration from using the question on job applications, O’Toole denied the unions’ request for a broader preliminary injunction barring the government from incorporating applicants’ answers or non-answers into hiring decisions. 
    • The case is AFGE v. Kupor, Office of Personnel Management, D. Mass., 25-13305-GAO, 9/11/26

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 11, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP adds,
    • “The number of confirmed US cases of measles has reached 3,294, fully 1,000 more than all of last year, the Centers for Disease Control and Prevention (CDC) noted in its weekly update today. 
    • “The total includes 160 new cases, most of them in Pennsylvania, the nation’s measles hot spot. The country has now seen five straight weeks of triple-digit increases.”* * *
    • “As noted in the data from the CDC map, cases in Wisconsin are also ramping up. In an update today, the Wisconsin Department of Health Services (DHS) confirmed 163 cases across the state so far this year. Four cases are new since September 8.” * * *
    • “Ohio this week confirmed 11 new cases, 133 total. In good news, Utah, which was a measles hot spot earlier this year, has gone more than three weeks without a confirmed case. Its case count stands at 518.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 10 released an advisory on a nationwide increase of reported human exposures to rabid or possibly rabid animals and rabies post-exposure prophylaxis administration errors. The CDC said it received 17% more rabies-related inquiries from July through August this year — including reports of mass exposure events — compared to the same period in 2025. The agency said that weekly pharmacy data as of Sept. 2 showed that utilization for the two rabies vaccines and two rabies immunoglobulins licensed in the U.S. increased by an estimated 33% and 76%, respectively, compared with the same period last year. The advisory includes recommendations for clinicians and healthcare facilities on rabies treatment and appropriate rabies PEP assessment and administration.”
  • The Wall Street Journal informs us,
    • “Public-health officials declared an end to a cyclosporiasis outbreak linked to iceberg lettuce that spread across the U.S. this summer.
    • “The outbreak has resulted in a total of 12,883 reported cases of the gastrointestinal food-borne illness across 21 states, the Centers for Disease Control and Prevention said Friday.
    • “Federal health officials have linked the outbreak to shredded iceberg lettuce from Taylor Farms, a major supplier of fresh produce to retailers such as Walmart, Costco Wholesale and Amazon.com’s Whole Foods Market, as well as restaurant chains including McDonald’s and Yum Brands’ Taco Bell.
    • “The CDC said the contaminated lettuce linked to the outbreak is no longer available in stores or restaurants, and the products’ best-by dates have passed. Recent infections linked to the outbreak have declined, with fewer than two infections per day on average in August compared to a peak of more than 1,000 daily infections, the CDC said.”
  • Health Day points out,
    • “Talking to a counselor before major surgery might boost seniors’ recovery following a procedure, a new study says.
    • “Mental health coaching before surgery can help reduce seniors’ risk of post-surgery anxiety and depression, researchers reported Sept. 9 in JAMA Network Open.
    • “The time around surgery is a window of both risk and opportunity,” lead researcher Joanna Abraham said in a news release.
    • “The stress of surgery can worsen anxiety and depression symptoms and affect patients’ recovery and overall health, but it also offers a critical opportunity to identify these concerns proactively and connect patients with the support they need,” said Abraham, a professor of anesthesiology at Washington University School of Medicine in St. Louis.”
  • Nature notes,
    • “Injected vaccines can raise an army of antibodies in the blood to stave off major illness, but don’t prevent infection at the points where respiratory viruses enter the body. Researchers hope that nasal vaccines could bolster protection at the moist mucosal barriers that line the respiratory tract, which could enable a person to rapidly ward off pathogens and prevent them from spreading a virus to others. A long line of failures demonstrates that developing a mucosal vaccine is a challenging task, but their promise is still enough to maintain commercial interest.”
  • Per Beckers Clinical Leadership,
    • “The rise of GLP-1 medications is one of the most consequential changes in obesity care in decades. Not surprisingly, bariatric surgery is feeling the impact. As patients gain access to powerful medications such as semaglutide and tirzepatide, fewer are immediately choosing an operation. The trend is real, but [as explained in the article,] the conclusion that GLP-1s will simply replace bariatric surgery misses the larger story.”

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

  • Beckers Hospital Review reports,
    • “Septicemia is the most expensive condition treated in hospitals, amounting to $60 billion in annual costs, a Healthcare Cost and Utilization Project report found. 
    • “The report, published February 2026, used 2022 data from the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project on hospital costs of inpatient stays in nonfederal acute care hospitals. Using the 2022 HCUP National Inpatient Sample, the report found the distribution of costs by primary expected payer and the conditions that accounted for the largest percentage of payer’s hospital costs. Hospital charges were converted to costs using HCUP cost-to-charge ratios. Payers included Medicare, Medicaid, private insurance and self-pay/no charge. 
    • “The report found: 
      • “The aggregate hospital costs for 32.9 million hospital stays totaled $548.5 billion.
      • “The 20 most expensive conditions account for 46.8% of aggregate hospital costs in 2022, and amounted to 43.1% of all hospital stays.
      • “Septicemia accounted for 10.9% of aggregate costs for all hospital stays in 2022 across all payer groups — more than three times higher than the next most expensive condition: liveborn infants which accounted for 3.6% of aggregate costs.
      • “Among the most expensive conditions, liveborn infants were the most common reason for hospitalization at 10.6% of all hospital stays, followed by septicemia at 7.4%, heart failure at 3.3% and COVID-19 at 2.5%.
      • “Circulatory system conditions were the most frequent of the top 20 diagnoses for Medicare, private insurance or self-pay/no charge.
      • “Pregnancy and childbirth conditions were the most frequent among the top 20 conditions for Medicaid.”
  • and
    • “More than 150 independent rural hospitals across eight states have banded together into clinically integrated networks over the past three years, betting that shared scale, data and negotiating leverage can keep them out of the arms of consolidating systems and payers.
    • “The newest addition is the Show-Me High Value Network, a Missouri coalition of 23 independent hospitals that collectively serve more than 1.8 million residents across urban, rural and underserved communities. It joins a fast-growing map of rural high-value networks that includes: 
    • “Cibolo Health, a Texas-based consultancy that specializes in building rural hospital collaboratives, manages seven of the networks, including those in North Dakota, Minnesota, Ohio, Montana, Nebraska, Wisconsin and Kansas.”
  • and
    • “St. Louis-based Mercy recorded an operating income of $500.8 million (4.5% margin) for fiscal year 2026, up from $21.4 million (0.2% margin) in fiscal 2025, according to its Sept. 11 financial report.”
  • and
    • “Hershey, Pa.-based Penn State Health reported a $131.2 million operating gain on $5 billion in revenue for the fiscal year ended June 30, a significant improvement from the prior year, according to its audited financial statements.”
  • Beckers Payer Issues relates,
    • “Ujjwal Ratan has joined UnitedHealth Group’s consulting and analytics division, Optum Insight, as chief AI officer.
    • “In a Sept. 10 LinkedIn post, Mr. Ratan said his role is to enable Optum Insight to operate as a connected agentic network in healthcare.”
  • and
    • “Taft Parsons III, MD, is leaving his role as CVS Health’s chief psychiatric officer.
    • “Executives decide to try something different, and organizational structures and jobs change,” he said Sept. 11 on LinkedIn. “I’ve benefited from those changes more often than not, and I understand this is simply my turn to find another path toward improving healthcare.”
  • Beckers ASC Review tells us,
    • “National Healthcare Properties completed the sale of 30 primarily multi-tenant outpatient medical facilities for $198 million.
    • “The transaction represents the first tranche of its previously announced sale of 86 outpatient medical facilities for approximately $528 million, according to a Sept. 10 news release from the company. The remaining 56 facilities are expected to close in the fourth quarter of 2026.”
  • The Wall Street Journal points out,
    • “France’s Ipsen IPN is considering building a production site in the U.S., joining other European drugmakers looking across the pond when planning new investments.
    • “Discussions are ongoing,” Ipsen Chief Executive David Loew said in an interview. “No decision has been reached yet on exactly when, but this is certainly something that we are taking into consideration.”
    • “Loew said the next big plant the company builds will manufacture either its Dysport drug—a rival to AbbVie’s ABBV Botox—or a next-generation medicine called corabotase that is still under development.
    • “Many of the world’s top pharmaceutical companies pledged to make multibillion-dollar investments to bring manufacturing and other operations to the U.S. over the coming years, in a bid to mitigate tariff threats by the Trump administration. In addition to big companies like AstraZeneca and Roche, smaller drugmakers like Belgium’s UCB and Australia’s CSL also plan to invest in new U.S. facilities.”
  • Fierce Pharma lets us know,
    • “Both Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo saw their highest total prescriptions so far over the past week as the companies’ oral obesity battle continues to play out.  
    • “According to IQVIA data cited by Citi, the Wegovy pill reached an approximate 183K total scripts for the most recent reporting period, versus 181K the week prior. Foundayo, for its part, climbed nearly 8% to reach 47.5K scripts. Citi analysts emphasized that IQVIA may still be missing some Foundayo prescriptions made through telehealth channels. 
    • “Meanwhile, using the last four weeks as a guide, total GLP-1 prescriptions have increased by 5.4%, compared to a 6.8% decline the prior year, the Citi team said. Citi analysts attributed the 12-percentage-point swing to the expansion of oral GLP-1 therapies, which is likely broadening access to the class and drawing in new patients.  
    • “Across the broader landscape, Lilly’s tirzepatide currently holds a nearly 57% share of the total GLP-1 market, compared to around 49.5% last year, while Novo’s semaglutide has stayed relatively flat at a 37% share, the analysts added.”  

Monday report

David Ermer–Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Federal News Network reports,
    • “House lawmakers return to Washington on Monday with a short to-do list after five weeks back in their home districts. The first order of business is likely a vote on a stopgap spending bill designed to keep the federal government fully funded through early December, removing the possibility of a shutdown before the midterm elections.” * * *
    • “House Speaker Mike Johnson is expected to tee up the funding bill early in the week. The bill underwent some significant changes in the Senate, which made it more palatable for Democrats. It delays a proposed rule from the Office of Management and Budget that would give political appointees more power over the distribution of federal grants. It also includes language to ensure the administration can’t transfer funds to the Border Patrol.
    • “But a provision that delays for one month a federal ban on intoxicating hemp THC products has prompted criticism from many GOP lawmakers. As a result, GOP leaders will likely place the bill on a fast-track process that avoids a separate procedural vote. Suspension bills require a two-thirds vote to pass, meaning a significant number from both parties need to support the measure for it to pass and advance to Trump’s desk.
    • “Lawmakers are anxious to avoid the possibility of a shutdown as voters weigh their options going into November. The funding bill passed by a 90-6 vote in the Senate, showing that lawmakers from both political parties want to avoid a repeat of the two historic shutdowns that occurred this past year.”
  • The Wall Street Journal relates,
    • The Trump administration reached agreements for most-favored-nation drug pricing with nine pharmaceutical companies, including Teva Pharmaceuticals, Astellas Pharma, and BridgeBio.
    • The agreements provide for all state Medicaid programs to pay prices for prescription drugs that match the lowest prices paid by other developed nations, the White House said Monday, adding that the agreements also guarantee MFN pricing for all new medicines the companies bring to market.
    • The U.S. has now reached 26 such deals covering 89% of the branded drug market, the White House said.
    • The nine companies—which include Alcon, BeOne Medicines, CSL, Kyowa Kirin, Sun Pharma, and UCB—also agreed to collectively commit $19.6 billion to manufacturing in the U.S. in the near term, the White House said. Some of the companies also agreed to donate active pharmaceutical ingredients to a federal stockpile.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced on Overdose Awareness Day that it has awarded $77 million in new grant funding to strengthen substance use prevention, treatment and recovery, community mental health, suicide prevention, and crisis services. The announcement comes as National Substance Use Primary Prevention Month draws to a close, with more than $22 million of the funding supporting critical substance use prevention efforts in communities.
    • “Every American deserves the chance to live free from addiction and the devastation of untreated mental illness,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump’s Great American Recovery is taking on these crises at their roots. We are investing in prevention, expanding access to effective treatment, strengthening crisis response, and helping communities intervene before tragedy strikes. Our goal is clear: save lives, restore families, and help more Americans achieve lasting recovery and better health.”
  • The Census Bureau tells us,
    • “The share of the world population age 65 and older is projected to nearly double from 10.5% to 19.6% between 2025 and 2060, according to a new report released today by the U.S. Census Bureau.
    • “An Aging World: 2025 finds that the global population is aging faster than ever before. Between 2020 and 2025, the proportion of the population age 65 and older exceeded the population age 5 and younger for the first time in recorded history.
    • “In 2025, the United States ranked the 48th oldest country out of 227, with 18.9% of its population age 65 or older. By 2060, older adults are projected to make up 23.4% of the U.S. population. Yet the United States will fall to 110th place globally because other countries are aging much more rapidly.”

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “Boston Scientific plans to stop selling certain angiographic catheters after a manufacturing problem led the company to pull the devices from the market. 
    • “The medical device manufacturer sent a letter to customers last week instructing them to immediately stop using or distributing all Imager II Angiographic Catheters due to an issue that can increase the risk of the tip detaching. The Food and Drug Administration posted an early alert on Friday.
    • “Boston Scientific had reported two serious injuries associated with the problem as of July 16.”
  • Fierce Pharma informs us
    • “These are heady days for PharmaEssentia, a biotech that got its start 23 years ago in Taiwan, went public 10 years later and is now deepening the foothold of its first commercial product, Besremi.
    • “There’s a lot of electricity in the air in the organization right now,” Samuel Lin, PharmaEssentia’s Head of U.S. Global Operations, said in an interview with Fierce. “Sometimes you have to stop and pinch yourself a little bit.”
    • “The excitement ramped up on Monday as the FDA signed off on a key label expansion for Besremi, endorsing it as a treatment for the rare bone marrow disorder essential thrombocythemia (ET). 
    • “The label specifically covers adults with ET regardless of their genotype or disease status, including newly diagnosed patients who haven’t received cytoreductive therapy, according to an Aug. 31 release.”

From the public health and medical / Rx research front,

  • Healio reports,
    • “The United States’ death rate likely dropped to a record low last year, according to provisional CDC data.
    • “The National Center for Health Statistics (NCHS) released the report, which offers an early estimation of the deaths that occurred in 2025, in late July.” * * *
    • “The new data show that, in 2025, there were 3,094,593 deaths, and the overall mortality rate was 689.2 per 100,000 people — 4.6% lower than the 2024 rate of 722.1 per 100,000 people. The leading causes of death remained the same, though, with heart disease, cancer and unintentional injuries in the top three spots.
    • “In the 2025 provisional data, the age-adjusted mortality rate was 582.9 for women and 811.1 for men. It dropped for every age group. Additionally, the age-adjusted mortality rates were the highest in the Black non-Hispanic population at 869 per 100,000 and lowest for “the multiracial non-Hispanic population” at 187.3 per 100,000.” * * *
    • “Although nothing is confirmed, some experts have pointed to the decline in overdose deaths as a reason for the lowered mortality rate.”
  • The New York Times points out,
    • “It’s been two months since Ericka Ratliff, 55, fell ill with cyclospora, yet she is still dealing with sharp abdominal pains and sudden urges to go to the bathroom. “It’s very unpredictable,” she said, as if “my stomach is just extremely angry.”
    • “Ms. Ratliff, who lives in Adrian, Mich., has tried following a bland diet and eating small, frequent meals to quell her symptoms, but she said she worried that her gut would “never be the same again.”
    • “Research suggests that roughly 10 to 20 percent of people who get intestinal illnesses from bacteria, viruses or parasites will end up having symptoms, like diarrhea and abdominal pain, that can last for months or even years. This condition is called post-infection irritable bowel syndrome.
    • “It’s too soon to know whether Ms. Ratliff is dealing with post-infection I.B.S. But after the recent surge in cyclospora infectionsin the United States, along with other foodborne illness outbreaks linked to jalapeños, sprouts, frozen blueberries and more, some gastroenterologists worry that they may soon be seeing more patients with the condition.
    • “I’m expecting our clinics to be getting inundated,” said Dr. Baha Moshiree, a gastroenterologist and professor of medicine at Wake Forest University School of Medicine in North Carolina.”
  • and
    • “After the unpredictability of last year’s flu season, when a new variant of the virus spread widely and rapidly, infectious disease experts are hoping for a tamer fall and winter this year.
    • “Scientists look to countries like Australia, in the Southern Hemisphere, for clues about how the flu will play out. This year, the flu seems to be circulating in those regions at relatively moderate levels, and this year’s flu shots appear well matched to combat the virus. But it’s uncertain whether that will change as flu season unfolds in the Northern Hemisphere.
    • “I’m cautiously optimistic,” said Dr. Scott Roberts, an assistant professor of infectious diseases at the Yale School of Medicine, emphasizing “cautiously.”
    • “Doctors are also reassured that there are new options for vaccination against the flu, and that at-home tests have entered the market in recent years.”
  • Health Day relates,
    • “For people with asthma or COPD, reaching for a rescue inhaler too often may be a warning sign — not just for their lungs, but for their heart.
    • “It’s estimated nearly 1 in 5 asthma patients and 1 in 3 COPD patients overuse these products.
    • “Researchers analyzed real-world health data from more than 280,000 asthma and COPD patients in Belgium.
    • “They found frequent use of short-acting reliever inhalers, also called bronchodilators, was associated with a higher risk of cardiovascular disease and death, including heart failure, heart attack and ischemic stroke.”
  • and
    • “Integrated cognitive behavioral therapy (CBT) is effective for primary care patients with depression, according to a study published in the June issue of The Lancet Primary Care.
    • “Debbie Tallon, from University of Bristol in the United Kingdom, and colleagues evaluated the clinical effectiveness of integrated therapist-delivered CBT (consisting of combined one-to-one CBT delivered by instant messaging with an accredited CBT therapist and online resources) in reducing depressive symptoms for primary care patients. The analysis included 334 adults meeting depression criteria, randomly assigned to nine integrated CBT sessions through the INTERACT therapy platform or usual care.
    • “The researchers found that at six months, the mean Beck Depression Inventory score was significantly lower in the intervention group versus control (22.5 versus 27.4; adjusted difference in means, –4.4; effect size, 0.43). There were more adverse events in the intervention group (33 versus 21 in the control group), including serious adverse events (12 versus two in the control group). Self-harm (six patients) and referrals to a mental health team (six patients) were the most common. Of the serious adverse events, none were definitely or probably related to the intervention.”
  • The American Medical Association lets us know “what doctors want patients to know about sodium consumption.” 
    • Sodium isn’t just lurking in heavily salted snacks. Two physicians discuss where sodium resides and which choices to make to avoid it in excess.
  • tctMD tells us,
    • “People over age 70 with no history of cardiovascular disease see dramatic reductions in major adverse cardiovascular events when newly prescribed statin therapy for primary prevention, according to results of the STAREE trial.
    • “Compared with those given placebo, patients taking 40 mg of atorvastatin once daily had a 30% lower incidence of CV death, nonfatal MI, stroke, or coronary revascularization (6.0% vs 8.3%; P < 0.001) over the 6-year study period. There was, however, no difference between groups in the incidence of disability-free survival, defined as a composite of death from any cause, dementia, or persistent physical disability.
    • “In a media briefing here prior to the presentation at the European Society of Cardiology Congress 2026, lead author Sophia Zoungas, MBBS, PhD (The George Institute for Global Health, Sydney, Australia),  said the data answer important questions about the safety and efficacy of statins in older people.”
  • MedPage Today informs us,
    • “Nearly half of adults who started semaglutide (Wegovy) for obesity management stopped treatment within a year, a Danish cohort study showed.
    • “Among 157,822 first-time semaglutide initiators without diabetes, 49% discontinued treatment by 12 months, defined as a prescription gap of 60 or more days. Discontinuation steadily increased from 13% by 3 months, to 27% by 6 months, and 39% by 9 months.
    • “However, one in four discontinuers restarted therapy within 3 months, Aurélie Mailhac, MSc, of Aarhus University Hospital in Denmark, and co-authors reported in JAMA Network Open.
    • “These findings may reflect frequent temporary treatment interruptions or self-adjusted dosing below guideline-recommended levels,” they wrote.”
  • Per BioPharma Dive,
    • “Novartis and Bristol Myers Squibb have paused multiple trials evaluating their respective cell therapy programs against autoimmune conditions after observing inflammatory side effects in testing, the companies confirmed Monday afternoon.
    • “Novartis, which is testing a personalized cell therapy called rap-cel in a handful of autoimmune studies, found three cases of immune effector cell-associated hemophagocytic syndrome, a rare and possibly life-threatening reaction. The company said it initiated holds on those trials — which are evaluating rap-cel in lupus, myasthenia gravis, multiple sclerosis and more — on Aug. 24. Novartis is “engaged” with regulators and is reviewing the findings, according to a company spokesperson. 
    • “The temporary halt will allow for a more comprehensive review of the evolving clinical and safety data across the program,” the spokesperson wrote in an email to BioPharma Dive.”

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

  • Beckers Payer Issues reports,
    • “High deductible health plans may reduce how much people spend on healthcare in the short term, but they don’t appear to slow the rate at which that spending grows over time, according to a study of more than 324,000 commercially insured members published in the International Journal of Health Economics and Management.
    • “The study, published in May, was led by researchers at the University of Pennsylvania’s Wharton School and included co-authors from Analysis Group, the Elevance Health Public Policy Institute and Georgia State University.”
  • Beckers ASC Review adds,
    • “From a jointly built AI documentation tool with Abridge to three distinct growth partnership models, Oakland, Calif.-based Kaiser Permanente has spent the past few months navigating expansion, labor tension and legal exposure.”
  • Fierce Healthcare relates,
    • “It’s been nine months since the opening of the country’s largest all-electric acute care hospital in Irvine, California.
    • “UCI Health was already in the planning stages of its new Irvine campus when the University of California (UC) established a policy that no new or renovated buildings could burn fossil fuels for space and water heating. 
    • “The health system may have gotten an exemption as a healthcare facility. But leadership decided to push the boundaries of hospital design by going all-electric. The ambitious plan was not purely a cost-saving strategy. According to Tony Dover, UCI Health’s energy management & sustainability officer, it was a moral imperative.
    • “We were doing it because it was the right thing to do,” Dover told Fierce Healthcare. “It was for decarbonization, resilience, and we’re mitigating our pollution for the community that we serve.”
  • Healthcare Dive notes,
    • Name: Michael Grasher
    • Previous title: Chief financial officer, IFG Companies
    • New title: Chief financial officer, Teladoc Health
    • Teladoc has appointed Grasher as its CFO effective immediately, the telehealth firm announced Monday. He’s succeeding Mala Murthy, who departed in November after six years for another opportunity.
    • Grasher has more than three decades of experience across insurance and financial services, including more than 12 years as a chief financial officer.
  • Beckers Hospital Review tells us,
    • “Contract breaks between major health systems and certain Medicare Advantage insurers are continuing in 2026. Providers [listed in the article] dropping plans often cite prior authorization denials and slow reimbursement; in other cases, insurers are terminating the contracts themselves.
  • and
    • “Charlotte, N.C.-based Advocate Health recorded an operating income of $775.3 million (3.8% operating margin) during the first six months of 2026, down from $824.4 million (4.4% margin) during the same period last year, according to its Aug. 27 financial report.”
  • and
    • “Burlington, Mass.-based Tufts Medicine’s operating margin fell to -3.4% through the first nine months of fiscal 2026, compared with -2.3% during the same period a year earlier, as the health system’s CEO and CFO prepare to step down.
    • “Tufts reported an operating loss of $79.5 million on $2.4 billion in revenue for the nine months ended June 30, according to financial documents filed Aug. 28. That compares with an operating loss of $50 million on $2.2 billion in revenue during the same period in fiscal 2025.”
  • Beckers Clinical Leadership informs us,
    • “Internal medicine is the most in-demand physician specialty and locum tenens specialty, Doximity found.
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of more than 23,000 responses collected in 2025, according to a company news release. To find the most in-demand jobs, the company analyzed tens of thousands of job postings across its network in 2025.
    • “Doximity also found the specialties with the highest demand for locum tenens. This is an increasingly popular way for physicians to supplement their income and practice with more flexibility, according to the report. 
    • “Three of the four most in-demand specialties and locum tenens were primary care specialties. Eight specialties appeared on both lists [found in the article]. 
  • and
    • “Three out of four physicians say they would accept lower pay in exchange for greater autonomy or work-life balance, a preference that has remained remarkably consistent over the past four years, according to a Doximity poll of nearly 1,000 physicians conducted in July 2026.
    • “The share of physicians willing to trade compensation for autonomy or work-life balance has held steady at 71% in 2023, 75% in 2024, 77% in 2025 and 76% in 2026. The preference is significantly stronger among women physicians at 86% compared with 71% of men, which has slightly widened compared to the prior year.”
  • The Wall Street Journal lets us know,
    • “Eli Lilly remains on a shopping spree, agreeing to pay up to $2.875 billion in cash for biotechnology company Merida Biosciences in a deal that bolsters the drugmaker’s immunology portfolio.
    • “Eli Lilly on Monday said privately held Merida is advancing a new class of precision therapeutics for serious autoimmune and allergic diseases, with its lead program in Phase 1 development for Graves’ disease and thyroid eye disease.
    • “The Merida deal continues a spate of acquisitions by the Indianapolis company, which is flush with cash from its market-leading weight-loss-drug franchise.”
  • The New York Times adds,
    • “Revolution Medicines set a sticker price of about $480,000 a year, or $663 a tablet, for its new pancreatic cancer drug — a cost that would have once been unthinkably high.
    • “Today, such prices are routine for cancer drugs.
    • “One cutting-edge CAR-T therapy now goes for $600,000 for a one-time infusion. A competitor, given the same way, is listed at $550,000. A daily pill for gastrointestinal cancer has a sticker price of $520,000 a year. A twice-daily pill for leukemia? It’s $430,000 a year.
    • “In 2024 alone, nine cancer drugs were approved and then introduced with sticker prices above $400,000 annually, according to a tally by the Institute for Clinical and Economic Review, which evaluates the value of medicines.
    • “That these prices have become commonplace would have been hard to imagine two decades ago, when even the prospect of a $100,000-a-year cancer drug evoked fierce criticism.
    • “But since then, cancer drug prices have steadily increased, with few constraints beyond what a company thinks the market will bear. The expense is borne by government programs like Medicare, employers, patients and Americans who pay taxes and health insurance premiums.”

Wednesday report

David Ermer–FDA, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

Quick Hits

  • Reuters adds,
    • “About 14% of employers in the United States have already or plan to drop GLP-1 drugs in 2027, as companies see ​rising healthcare costs, according to a survey released on Tuesday by the Business Group ‌on Health.
    • “Healthcare costs are set to increase 9.2% if employers do not make changes to manage costs in 2027, up from 8.5% in 2026, the group said. Two-thirds of employers surveyed said they saw rising utilization of ​the drugs.”
  • Healthcare Dive reports,
    • “The federal process for insurers and providers to settle disputes over out-of-network bills appears to be dramatically adding to U.S. healthcare spending, fueling calls for reform.
    • “That mechanism, set up by the No Surprises Act, has generated more than $22.4 billion in extra costs over just four years, according to new estimates from Georgetown University. That’s a significant acceleration from researcher’s past estimates of $5 billion in extra costs over the dispute resolution process’ first two years.
    • “But dispute volumes and total awards have continued to increase since — a worrying finding, given costs could push premiums up. The researchers urged policymakers to revisit the NSA.
  • The Wall Street Journal reports,
    • “For four decades, cancer researchers fought to disable a stubborn mutation that made pancreatic cancer a death sentence—to little avail. 
    • “Now, doctors have a medicine that targets the mutation. The Food and Drug Administration’s approval of the drug from Revolution Medicines on Wednesday marks a milestone in treatment of one of the most intractable kinds of tumors. 
    • “This is life-altering,” said Carla Kurkjian, an oncologist at Mercy Hospital in Oklahoma City, who wasn’t involved in the studies. “Not just for patients, as far as helping them extend their lives beyond anything we’d ever seen, but for us as physicians, to be able to have a different conversation than we’ve had for so long.”
    • “The drug, called Rasonque, helped subjects in a late-stage study live more than 13 months, nearly twice as long as those on chemotherapy alone. When presented at the world’s largest gathering of cancer researchers last spring, the results drew a nearly minute-long standing ovation.” 
    • “Yet the drug does have side effects, including a harsh rash across the body and gastrointestinal issues. Former Nebraska Sen. Ben Sasse, who went public in the spring with what he described as a significant reduction in his tumors while in a clinical trial of the drug, appeared on television with his face covered in red blotches.
    • “RevMed said the drug will cost $39,800 a month, or more than $477,000 a year.
    • “Wall Street expects Rasonque, which was approved for use in patients for whom other treatments failed, to be a big seller. The drug could generate more than $20 billion in annual sales, according to pharmaceutical commercial intelligence firm Evaluate, if the drug proves to work safely in earlier stages of the disease and with different types of cancers.”
  • The New York Times adds,
    • “The Food and Drug Administration’s approval on Wednesday of a new drug for pancreatic cancer marked the end of a long quest to develop a medicine that can hit one of cancer’s most elusive targets.
    • “Researchers hope the new drug is just the beginning, opening a new chapter in treatment for a range of cancer types.
    • “At least 79 drugs that take a similar approach are being tested in 238 clinical trials worldwide, according to one tally by academic researchers.
    • “Large drugmakers like Eli Lilly, Pfizer, Amgen and AstraZenecaare among the companies racing to develop their own medicines that work like the new drug, daraxonrasib, which is made by Revolution Medicines and will be sold as Rasonque.”
  • STAT News notes,
    • “The newer shingles vaccine has been turning heads since its link to lower dementia rates was reported two years ago. Now the same research team behind that observation has found an association between receiving the Shingrix shot and a reduced risk of heart disease.
    • “There have been signals before of cardiovascular benefits in people who got the newer, recombinant vaccine to prevent shingles, a painful, often serious flare-up in older people of the chickenpox virus from childhood. Those who got Shingrix were less likely than unvaccinated people to have heart attacks, strokes, or heart failure.” * * *
    • “Although the benefits are relatively small on an individual basis, millions of people receive shingles vaccination, meaning that even a small cardiovascular benefit could translate into a substantial number of cardiovascular events prevented at a population level,” Mark Russell, clinical senior lecturer and consultant rheumatologist of King’s College London, said in a statement shared by the Science Media Centre.” 

Weekend Report

David Ermer–Agentic & Generative AI, CDC, Congress, COVID-19, Medical / Rx research, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • The House of Representatives is on a District work break until August 31, 2026, and the Senate is on State work break until September 14, 2026.
  • The Western Journal discusses the federal government’s efforts to stop paying benefits to beneficiaries who have passed away. FEHB and PSHB plans, as private entities, cannot use the federal government’s Do Not Pay system. It obviously would be helpful if OPM used the HIPAA 820 enrollment roster transaction which would allow FEHB and PSHB plans to reconcile premiums payments with individual enrollees. The HIPAA 820 tranaction has been in use since 2012, and FEHB and PSHB plans are reportedly the only plans serving large employers that do not benefit from the HIPAA 820.

From the public health and medical / Rx research front

  • IFL Science reports,
    • “Currently, there are more COVID cases in [California] than there were during the winter season. It is thought that this is being driven by the mutated “cicada” variant.
    • “Known more formally as BA.3.2, the variant was first identified in southern Africa in 2024. Since then, it has spread around the world, having now been detected in least 32 countries, including Australia, Germany, and the US.
    • “The variant has caught the attention of virologists and researchers because it has more than 70 spike mutations compared to the original wild-type virus.” * * *
    •  “Our summer peak was much higher in 2025 than it was in the winter,” Dr. Erica Pan, director of the California Department of Public Health and the state public health officer, said in a briefing.
    • “Summer is really the bigger peak. So if you do have patients or loved ones who have not gotten the ’25-’26 vaccines, it is still effective and highly recommended, given this surge we’re starting to see.”
    • “It seems that the shift from bigger winter to summer peaks started to occur around 2024. While so far this has been more noticeable in California, there is also evidence for this trend emerging right across the country.
    • “Why it is happening, and if the trend will continue, is still unknown.
    • “What is known, however, is that the COVID vaccines are safe and effective. A newly formulated shot is expected in the coming fall, but those at an increased risk of the disease can get a booster shot earlier if needed.”
  • The American Medical Association lets us know,
    • “One case of measles is concerning. Thousands are a warning.
    • “Our nation is experiencing the largest measles resurgence in decades—even though we have had a vaccine for more than 60 years. This year’s case count has already surpassed the total reported in all of 2025, making 2026 the worst year for measles our country has experienced in decades.
    • “For many physicians, measles is something they have read about rather than seen firsthand. That is a testament to the success of vaccination. It is also a reminder that vaccine-preventable diseases return when vaccination rates decline.
    • “For all clinicians, this resurgence is more than a public health statistic. It is a reminder that conversations about vaccination remain among the most important forms of preventive care we provide”
  • PBS News adds,
    • “The nationwide cyclospora outbreak is very likely a result of sewage contaminationin the food supply, according to scientific researchers and public health officials.” * * *
    • “As floods and droughts occur routinely across the U.S. and around the world, sewage may overflow into bodies of water or be used directly on crops. That increases the risk that diseases, including protozoa such as cyclospora, which are transmitted through ingestion of fecal matter, may spread through food and water supplies.
    • “And because cyclospora oocysts mature in outdoor heat, it is possible that increasing temperatures, such as heat domes, could speed up their maturation, exposing more people to the infectious form of the parasite.
    • “Modern technology and techniques are capable of monitoring water quality, detecting harmful pathogens and eliminating them. Expanding monitoring of wastewater for protozoan diseases and other dangers can help prevent outbreaks and slow the spread of disease from sewage-contaminated water in the future.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Memories can survive even after the brain temporarily loses more than half of its synaptic connections, according to the results of a study in mice that challenge the long-held view that long-term memories depend on stable individual synapses. The researchers, headed by a team at Okinawa Institute of Science and Technology (OIST), and including teams at the University of Tsukuba, Exploratory Research Center on Life and Living Systems (ExCELLS), and National Institutes of Physiological Sciences, used a mouse model of artificial hibernation to examine structural mechanisms underlying memory retention.
    • Their findings indicate that memory may be preserved not through individual synapses, but through resilient patterns of neural architecture, including specific clusters of connected synapses that remain protected during widespread hibernation-associated brain remodeling. These preserved structural motifs could act as a “core memory trace,” allowing the brain to rebuild functional networks after major disruptions.
    • “Research lead Kazumasa Tanaka, PhD, head of OIST’s Memory Research Unit, said, “Previously, synaptic strengthening was thought to be key to memory recall, and that stronger synapses with larger dendritic spines were fundamental to long-term memory retention. Here, we show that not every synapse matters, and demonstrate instead the vital importance of engram architecture. The study indicates that small clusters of engram-engram synapses are preserved to enable accurate recall even after hibernation.”
    • “Tanaka is senior and corresponding author of the team’s published paper in Science, titled “Artificial hibernation reveals synaptic engram architecture associated with memory retention.”
  • Health Exec points out,
    • “Higher doses of semaglutide were associated with significantly lower cardiovascular risk in patients with pre-existing cardiovascular disease, while the amount of weight loss achieved did not appear to predict subsequent cardiovascular protection, according to a large real-world analysis. This was according to a new article in the journal Nature.[1]
    • “The findings raise the possibility that semaglutide’s cardiovascular effects extend beyond weight reduction. This adds to growing clinical data showing how GLP-1 drugs are having a positive impact on patient health separate from weight loss outcomes.
    • “The degree of weight loss surprisingly did not correlate with cardiovascular protection as measured by all-cause mortality or multiple individual incident disease diagnoses,” explained lead author Karthik Murugadoss, a data scientist with nference and its Metabolism Agentic Intelligence Atlas (MAIA) initiative. “In a direct comparison of semaglutide to other anti-diabetic medications, semaglutide was associated with reduced rates of multiple cardiovascular endpoints after treatment initiation.”
    • “He said the findings suggest a cardioprotective role of semaglutide which may be related to attained dose, but is not explained simply by the amount of weight loss achieved while on therapy.”

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

  • The Wall Street Journal reports,
    • “Patients, families and healthcare professionals are turning to AI tools to help identify rare and hard-to-diagnose diseases.
    • “A study published in a JAMA journal found that two AI chatbots suggested the correct rare-disease diagnoses more often than doctors did.
    • “Doctors and researchers caution that AI tools still make mistakes and are limited by a lack of digitized data for rare conditions.”
  • Beckers Payer Issues relates,
    • “Point32Health, the parent organization of Harvard Pilgrim Health Care and Tufts Health Plan, logged an adjusted net income of $68 million for the second quarter of 2026. 
    • “According to an Aug. 14 update shared with Becker’s, this profit was up from an adjusted net loss of $25 million during the same period in 2025.
    • “For the second quarter of 2026, operating income was $38 million. The operating loss in the second quarter of 2025 was $57 million.
    • “Point32Health had 1.9 million members during the second quarter of 2026, slightly down from 2 million members during the same time in 2025. Revenue was $2.3 billion for the second quarter of 2026, down about 4% year over year.”
  • and
    • “Health insurers denied between 12% and 18% of standard prior authorization requests across Medicare Advantage, Medicaid managed care and ACA marketplace plans in 2025, with wide variation among the largest payers, according to a KFF analysis published Aug. 13.
    • “CMS previously finalized a rule requiring certain insurers to publicly report prior auth metrics, including denial rates, processing times and appeal overturn rates. The first reports, covering 2025, were due March 31. The data is aggregated across all items and services, with no breakdown by service type, so there’s limited insight into what services are being approved or denied. Payers are also not required to report reasons for denials.
    • “The rankings below only cover standard prior auth requests and they don’t include data for prescription drugs (though CMS has proposed a rule to require that information to be public as well). Denial rates for urgent requests, which are included in KFF’s analysis, were slightly lower across all markets.
    • “Prior auth denials are rarely appealed, but when they are, a considerable share are overturned, including 67% for Medicare Advantage plans, 47% in Medicaid managed care and 43% in the ACA marketplace.”

Thursday report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Service news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced $102 million in New Access Points awards to significantly expand the reach of the Health Center Program. The awards represent the first major expansion of the Health Center Program since the first Trump Administration in 2019, supporting 158 new and existing health centers to establish 415 new sites and expand access to comprehensive primary care for nearly 1 million people nationwide.
    • “Strong primary care prevents disease and gives Americans greater control over their health,” said HHS Secretary Robert F. Kennedy, Jr. “This $102 million investment will bring high-quality care to nearly one million more Americans, expand prevention and nutrition services, and help communities tackle chronic disease at its roots. We are giving more Americans the tools to live healthier lives and Make America Healthy Again.”
    • “Learn more about the Health Center Program and find a health center near you.
    • “Visit the New Access Points webpage for more details on the program and a list of 2026 award recipients.”
  • Per a Government Accountability Office news release about a new report,
    • “National Crisis and Support Hotlines: Contact Volume Increased and Operations Remained Relatively Consistent in 2025
    • “GAO-26-109046. Published: Aug 13, 2026
    • “The federal government operates the following hotlines:
      • “Health and Human Services’ 988 Suicide & Crisis Lifeline provides 24/7 support to people in distress
      • “HHS’s National Maternal Mental Health Hotline provides emotional support to pregnant and postpartum women
      • “Veterans Affairs’ Veterans Crisis Line provides support to veterans, service members, and their families
    • In February 2025, the President issued an executive order aimed at reducing the size of the federal workforce. While HHS and VA reduced their staff, the hotlines’ operations and services remained mostly consistent, with an increase in chats, texts, and calls.
  • FEHBlog observation: While aware of the 988 line, he wants to call attention to the other two lines.

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

  • Federal News Network reports about, “FEHB and Medicare: Understanding how they work together in retirement.”
  • Fedweek explains “How FEDVIP Differs from FEHB in Retirement.”
  • Tammy Flanagan, writing in Govexec, advises “Before you take money out of your TSP, weigh these trade-offs.”
    • “A withdrawal can affect everything from your tax bill and Medicare premiums to how long your savings last and what your heirs receive.”
  • Federal News Network tells us,
    • “Following a year of sweeping staffing reductions, the Trump administration is laying the groundwork for agencies to ramp up recruitment efforts. The Office of Personnel Management has directed agencies to begin assembling “annual staffing plans” for fiscal 2027.”
  • Chief Data Officer Magazine informs us,
    • “The U.S. Office of Personnel Management (OPM) has directed federal agencies to make technology recruitment a key component of their fiscal year 2027 workforce plans. Guidance issued by OPM directs agencies to include dedicated hiring strategies for roles in artificial intelligence (AI), cybersecurity, software engineering, data science, digital services, and other technology fields in staffing plans due by Sept. 30.
    • “Agencies are also expected to assess how the adoption of modern technologies will affect workforce needs and align hiring accordingly.”
  • Federal News Network adds,
    • “The Merit Systems Protection Board is officially transitioning away some of its authority over adverse action appeal decisions. A new final rule from MSPB removes all references to the board’s prior jurisdiction over appeals due to firings or demotions during a reduction in force, probationary period or for a suitability-related reason. The adjustments at MSPB come after the Office of Personnel Management finalized rules to take over decisions in those three categories of workplace disputes. The change takes full effect in early September.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports.
    • “Novartis is recalling a single lot of valsartan, a blood pressure drug the company sells under the brand name Diovan, due to failed dissolution specifications. This means it is not dissolving correctly, which can impact the drug’s effectiveness. 
    • “The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, meaning exposure to the drug may lead to “temporary or medically reversible adverse health consequences.” 
    • “Diovan is an angiotensin II receptor blocker used to treat hypertension and heart failure. It may also be prescribed to patients after a heart attack. This specific lot, AV5913C, includes packages of 90 160-mg tablets that expire in June 2027. The drugs were manufactured by Pantheon Manufacturing Services in Greenville, North Carolina, and distributed by Novartis Pharmaceutical Corp. in Hanover, New Jersey.”
  • Yahoo News relates,
    • “There’s an ongoing recall on a specific type of bladder medication distributed and prescribed nationwide, according to the U.S. Food and Drug Administration (FDA). This is due to an impurity issue.
    • “The medication being recalled is 25-milligram, 30-count bottles of mirabegron extended-release tablets manufactured by Zydus Lifesciences. The recalled bottles contain a lot code of “E408618,” an NDC of “70710-1159-3” and the expiration date “11/30/2026.” * * *
    • “Check your medication, and if you have the recalled product on hand, contact your pharmacy for a refund or replacement. Seek medical attention if you are experiencing any health concerns after consuming the affected pills.”
  • Reuters tells us,
    • “The U.S. FDA on Thursday approved Bristol Myers Squibb’s (BMY.N) oral combination treatment for patients ​with a rare form of blood cancer whose illness had relapsed or ‌not responded to other treatments, the health regulator said.
    • “The drug, iberdomide, with brand name Zenbexus, is given in combination with J&J’s (JNJ.N), opens new tab Darzalex and dexamethasone, a prescription medication used to reduce inflammation.” * * *
    • “The list price of Zenbexus is $29,500 ‌for ⁠a 28-day cycle, Bristol said. The company expects product availability within the coming weeks.”
  • The American Hospital Association News adds,
    • “The AHA Aug. 13 responded to a Food and Drug Administration request for input on the risks and benefits to health and safety associated with non-device software. Among its recommendations, the AHA supported the benefits of clinical decision support software and requested the FDA to permanently adopt flexibilities for CDS that generate only one clinical recommendation. The AHA also requested that the FDA clarify its general wellness guidance by providing additional resources on labeling and clarifying or removing references to allow non-device general wellness applications to make recommendations on escalation to a healthcare provider. Finally, the AHA encouraged the FDA to continue to update guidance, education and other materials to account for novel artificial intelligence applications, including generative AI. Input will support an agency report, as required under Section 3060 of the 21st Century Cures Act.”

No Surprises Act News

  • Following up on yesterday’s discussion of the U.S. Court of Appeals for the Fifth Circuit’s opinion about the calculation of qualifying payment amounts (“QPA”), the American Hospital Association tells us,
    • “A statement posted Aug. 13 on the Centers for Medicare & Medicaid Services website said that the agencies are reviewing the court’s opinion and judgement and anticipates issuing guidance shortly.” 
  • FEHBlog Observation: The Fifth Circuit is a victory for the majority of health care providers who accept the QPAs. No one can object to that outcome.
  • Beckers Hospital Review recounts “the never-ending No Surprises saga.”
    • “When President Trump signed the No Surprises Act into law in 2020, the straightforward premise was that patients should not be blindsided by massive emergency care bills from out-of-network physicians they never chose. On that front, the law has largely worked. 
    • “But the system Congress built to resolve payment disputes between insurers and providers has led to an increasingly expensive and bitter standoff that insurers say is driving up premiums, while physicians report waiting months to get paid. And employers, particularly the self-funded plans that cover the majority of commercially insured workers, say they’re the ones now stuck with a big chunk of the bill. In recent months, the courts, Congress and federal regulators have all been moving in different directions on exactly what to do about it.”

From the judicial front,

  • Beckers Hospital Review reports,
    • “The federal government has referred dozens of hospitals, pharmacy benefit managers and pharmacies to investigators over potentially fraudulent billing related to pediatric gender-affirming care.
    • “Vice President JD Vance referred hospitals and clinics identified in a new HHS report to the Justice Department, while HHS Secretary Robert F. Kennedy Jr. referred flagged organizations to HHS’ Office of Inspector General over “potentially anomalous billing patterns” identified through an analysis of insurance claims, according to an Aug. 13 news release.” * * *
    • “In the report, HHS shared its analysis of claims data spanning 2015 to 2025, identifying $47.6 million in claims for puberty-blocking drugs prescribed to patients 9 to 17 years old with endocrine disorder diagnoses, excluding precocious puberty. The patients also did not have a gender-related diagnosis documented. Of those claims, $42.6 million stemmed from an unspecified endocrine disorder diagnosis, the report said.” * * *
    • “The referrals mark the latest escalation in a federal crackdown on pediatric gender-affirming care that began shortly after President Donald Trump returned to office in January 2025. Some pediatric hospitals, most recently Hartford-based Connecticut Children’s Medical Center, have struck deals with the Justice Department and stopped providing gender-affirming care services.”
       
  • The Wall Street Journal relates,
    • “Luigi Mangione is expected to plead guilty Friday in a Manhattan federal court, where he is facing stalking charges in connection with the killing of UnitedHealthcare CEO Brian Thompson outside a Midtown hotel in 2024, people familiar with the matter said.
    • “The expected plea potentially resolves the federal case just a month before Mangione is scheduled to go to trial in New York state court on murder and other charges. But the people familiar with the matter cautioned that Mangione still could change his mind. And his defense team has abruptly shifted strategies previously.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Arthritis in its many manifestations is among the most common chronic conditions, affecting some 53 million adult Americans, and its associated pain often impairs the ability to perform daily activities including work.
    • “The Healthy People 2030 initiative set a goal of reducing the prevalence of joint pain in the U.S. to about 52%.
    • “In this analysis of National Health Interview Survey data from 2023, moderate to severe joint pain was reported by 58% of those with arthritis, with no change from 2019 (57%) after adjusting for age distribution.”
  • and
    • “Estrogen-only menopausal hormone therapy was linked with reduced Alzheimer’s pathology in an autopsy study.
    • “Estrogen treatment was also tied to lower odds of dementia diagnosis.
    • “More than 20 years after the landmark Women’s Health Initiative trial, hormone replacement therapy remains controversial.”
  • Beckers Behavioral Health relates,
    • “A nationwide, evidence-based tobacco treatment program for cancer patients and survivors in the U.S. would save $12.32 billion in healthcare costs over 10 years, according to a study published July 14 in JCO Oncology Practice.
    • “Led by researchers from Houston-based University of Texas MD Anderson Cancer Center, the study projected 10-year survival trends and healthcare cost savings associated with a nationwide smoking cessation program targeted to 18 million U.S. cancer survivors.” * * *
    • “Read the full study here.” 
  • Healio adds,
    • “Exercise capacity, oxygen uptake and ventilation at peak exercise were significantly reduced in e-cigarette and conventional cigarette users vs. never smokers.
    • “Vascular function also followed this pattern.”
  • BioPharma Dive lets us know,
    • “Taiho Oncology and partner Cullinan Therapeutics said a targeted medicine they’re developing has succeeded in a Phase 3 trial in frontline lung cancer, with investigators halting the study at an early data check because of clearly positive results.
    • “Taiho and Cullinan have been testing that therapy, zipalertinib, alongside chemotherapy in the first-line setting in people whose lung tumors have a so-called exon 20 insertion in a gene called EGFR. They didn’t release detailed data, but on Wednesday said that the combination “demonstrated a statistically significant and clinically meaningful improvement” in progression-free survival, meeting a pre-planned threshold for unblinding the trial.
    • “The Food and Drug Administration is already reviewing zipalertinib as a second-line treatment and is expected to make a decision by Feb. 27. If approved, the drug will add to an already competitive market battle. Johnson & Johnson’s Rybrevant and AstraZeneca and Dizal’s Zegfrovy are both available, and another biotechnology company, ArriVent BioPharma, is expecting Phase 3 data later this year.”
  • and
    • “Boulevard Bio, a new startup co-founded by pioneering autoimmune disease researcher Georg Schett, officially launched Wednesday with $65 million in its coffers and three experimental drugs.
    • “One of those medicines is already in early testing. Called BLVD-101, that drug is a so-called bispecific antibody aimed at a pair of targets known to drive the progressive kidney condition IgA nephropathy.
    • “IgAN has become a popular target for drugmakers of late. In the last year, U.S. regulators have approved two drugs, Vera Therapeutics’ Trutakna and Otsuka Pharmaceutical’s Voyxact. A third from Vertex Pharmaceuticals could follow.”
  • Fierce Pharma notes,
    • “Roughly a year and a half after the approval of Vykat XR, a group of clinicians with deep ties to the Prader-Willi syndrome (PWS) community is flagging potential safety concerns about the rare disease med, acquired in Neurocrine’s $2.9 billion buyout of Soleno Therapeutics last spring.
    • “The package insert for Vykat XR (diazoxide choline)—a potassium channel activator that became the first drug approved to treat the sensation of insatiable hunger, or hyperphagia, in PWS in March 2025—already cites the risk of fluid overload, based on an increased incidence of edema seen during clinical trials. 
    • “Since becoming more widely available, additional reports of edema and related complications in patients taking Vykat XR have been posted to the FDA’s Adverse Event Monitoring System (AEMS), including seven reports of death and more than 100 other reports of serious adverse events, mostly tied to edema, respiratory and cardiac complications.
    • “The adverse event trend, which doesn’t establish that Vykat XR caused the events, was flagged in a statement (PDF) from PWS patient organizations the Foundation for Prader-Willi Research, the International Prader-Willi Syndrome Organization and Prader-Willi Syndrome USA. The issue was first reported by Stat News earlier on Wednesday.” 

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

  • The American Hospital Association News reports,
    • “A blog by Robyn Tessin, AHA director of policy, discusses the ways value-based care can meet patients’ needs, resulting in improved affordability and access to timely, coordinated care. “The promise of value-based care is a healthcare system that feels less like a collection of separate transactions and more like a connected journey centered on each patient,” Tessin writes. “No single payment model can solve every affordability challenge. But providers, policymakers, payers and patients can build on what is working — strengthening existing models such as [accountable care organizations], scaling innovations in care coordination and ensuring that the models’ financial incentives are meaningful for patients.” READ MORE 
  • Beckers Payer Issues adds,
    • “Mishawaka, Ind.-based Franciscan Alliance has partnered with Millennium Physician Group to expand value-based care and primary care access across Indiana.
    • “Fort Myers, Fla.-based Millennium is part of a national value-based care platform partially owned by Elevance Health.
    • “The partnership will combine Franciscan’s physician network with Millennium’s practice management, analytics and value-based care capabilities. Franciscan physicians will remain part of the health system’s physician network while gaining access to additional operational support, technology, care coordination resources and analytics.
    • “As Franciscan Alliance celebrates 150 years of serving Indiana, this partnership represents the next chapter in that mission,” Franciscan Alliance President and CEO Kevin Leahy said in an Aug. 12 news release. “By combining our trusted community presence with Millennium’s proven expertise in value-based care, we are strengthening our ability to expand access, enhance quality and deliver more affordable healthcare for generations to come.
    • “The organizations said the partnership is designed to reduce administrative burdens for physicians, improve clinical performance and strengthen chronic disease management and care coordination.”
  • Reuters relates,
    • “Novo Nordisk (NOVOb.CO) CEO Mike Doustdar said investors are underestimating the demand for differentiation among obesity drugs, ‌and that new treatment options like pills will keep it from becoming a winner-take-all battle with rival Eli Lilly.
    • “Novo was first to bring a highly effective GLP-1 weight-loss injection, Wegovy, to the U.S. market, but is under pressure to regain ground lost to Lilly’s (LLY.N) Zepbound in a business that ​analysts expect will be worth more than $100 billion a year by 2030.
    • “Doustdar, who took the helm at the Danish ​drugmaker a year ago, said that patients are just beginning to understand which GLP-1 drug is ⁠best suited to them, and he expects more segmentation as new medicines are approved. More than 100 million U.S. adults ​are classified as obese.
    • “Right now the investor community has thought this is supposed to be a zero-sum game between two players – ​there’s a loser and a winner,” Doustdar said in an interview with Reuters on Wednesday.
    • “As you foresee the future of GLP-1s and obesity and weight-loss drugs, it will not be Coke versus Pepsi. It will be Coke and Pepsi and Fanta and Dr Pepper and Red Bull. People are ​thirsty, and they can make their choices,” he said.”
  • Beckers ASC Review tells us,
    • “For much of the past decade, the story of physicians’ practice has moved decidedly away from independence. 
    • “Hospital and corporate employment of physicians climbed from 62% to 78% between 2019 and 2023, and private practice fell from 60% of physicians in 2012 to just 42% in 2024, according to data from the Government Accountability Office.
    • “But 2026 is producing early signs that the pendulum may be swinging back, not toward the traditional solo practitioner model, but toward a new one built around management services organizations, physician practice networks and other arrangements designed to help physicians reclaim ownership and autonomy without giving up the scale and capital that made employment attractive in the first place.”
  • Healthcare Dive informs us,
    • “Nonprofit hospitals and health systems rated by credit ratings agency Fitch raised their operating margins and extended their financial recovery last year, according to a Fitch Ratings report based on audited fiscal 2025 data.
    • “The median operating margin among 222 nonprofit providers rose to 1.5%, compared to 1.1% in 2024, according to the report, and gains were increasingly concentrated among more financially stable providers. 
    • “Still, Fitch warned that 2025 could prove to be an “operational peak” before Medicaid funding reductions and other policy changes begin to pressure hospital revenue more significantly in 2027. Financially unstable and Medicaid-dependent providers have less financial cushion to absorb the coming strain, according to the credit ratings agency.”
  • Fierce Healthcare points out,
    • “Aetna is seeing its value-based care efforts pay off in both preventive care metrics and cost savings, according to a new analysis from the company.
    • “The insurer compared (PDF) outcomes across 20 different measures for individuals in its Medicare Advantage plans between value-based models and fee-for-service, and found that the value-based arrangements supported better results across 17 of the included measures.
    • “For example, value-based care models far outpaced fee-for-service in managing blood sugar and high blood pressure. Under value-based care, 43% more members controlled their HbA1C and 34% had controlled blood pressure, according to the analysis.
    • “In addition, 20% more patients were screened for colorectal cancer under value-based care and there were 7% fewer hospitalizations. These providers also generated $315 million in savings during plan year 2023, 2.6% higher than fee-for-service providers.”
  • and
    • “Cedar, a patient financial platform for healthcare providers, launched an agentic artificial intelligence platform Thursday aimed at patient medical billing.
    • “Kora Platform is a suite of purpose-built AI agents that integrates with healthcare organizations’ existing electronic health records (EHRs), telephony and call center systems. Some of the capabilities included within the suite include autonomous inbound voice, autonomous outbound voice, two-way text and advanced reporting.
    • “We really want Kora Platform to be this agentic advocate that’s sitting in the pocket of every patient,” Cedar Chief Strategy Officer Dugan Winkie told Fierce Healthcare.”
  • The American Medical Association lets us know about “four AI prompts to help prepare for your doctor’s appointment.”
    • “Here are some top expert tips on how to use AI chatbots in a way that makes the most of your time in the exam room with your physician.”