Midweek report

No Surprises Act

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.”

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “To stop payments above market rates for laboratory services in Medicare and save taxpayer dollars, the Centers for Medicare & Medicaid Services (CMS) plans to better align the 2027 clinical laboratory fee schedule rates with private sector payment rates, saving an estimated $1 billion annually. While final rates won’t be released until later this year, CMS is releasing the data and information used to determine the preliminary 2027 Medicare payment rates for laboratory services showing that Medicare has been paying about 16% more for laboratory services than private payors. Basing Medicare’s rates on those paid by the private sector helps ensure that Medicare is paying appropriate amounts for laboratory tests and protecting taxpayer dollars.” * * *
    • By law, Medicare payment for a clinical diagnostic laboratory test cannot be reduced by more than 15% per year through 2029. CMS will gradually phase in the reductions through 2029. 
    • The public has 30 days from today to review and submit comments on the preliminary Calendar Year (CY) 2027 Clinical Laboratory Fee Schedule rates and supporting data. For laboratory tests that didn’t get any private-payor data reported to CMS, CMS held a public meeting September 15 and 16 to decide how to price them. These determinations will be published in early October along with a 30-day comment period.
    • CMS anticipates finalizing the CY 2027 payment rates for clinical diagnostic laboratory tests under the Clinical Laboratory Fee Schedule in November 2026. The final payment rates will go into effect beginning January 1, 2027. 
    • View a fact sheet on the Preliminary CY 2027 Medicare Clinical Laboratory Fee Schedule Payment Rates. 
    • To view the preliminary CY 2027 Clinical Laboratory Fee Schedule rates and data, visit https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs.
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services announced Sept. 18 that all 50 states, Washington, D.C., and Puerto Rico have applied to participate in its initiative to make certain prescription drugs available to people with Medicaid at prices aligned with those paid in other countries, known as most-favored-nation pricing. The initiative, called the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model, is being implemented by the CMS Innovation Center. CMS said that 40 states and Puerto Rico have already signed agreements to participate in the model, and that the remaining applicants have until Sept. 30 to sign agreements. The GENEROUS Model launched in January and will run for five years.”
  • Beckers Hospital Review reports,
    • Pfizer agreed to give HHS a portion of its increased revenue if it is able to charge higher drug prices abroad, according to a “most favored nation” contract released Sept. 19, Bloomberg reported. 
    • The contract, released by consumer watchdog Public Citizen and obtained from a Freedom of Information Act lawsuit, showed documents related to Pfizer and Eli Lilly contracts, though some information is redacted. More than two dozen other deals remain confidential. * * *
    • “Pfizer agreed to share a portion of its net increased revenue from charging higher prices abroad, effective Jan. 1, 2026, through Jan. 20, 2029. The rate and medicines included were redacted. 
    • “The company said it stands “by our belief that the agreement Pfizer voluntarily reached with the administration last September is a win for American patients” and achieves priorities to lower prices for patients, redistribute global research and development costs, and create a predictable investment environment, Pfizer spokesperson Amy Rose told Bloomberg.”  
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) is making its biggest push yet to move biomedical research beyond animal model use, unveiling five major initiatives that could reshape how new drugs and treatments are developed and evaluated. Together, the efforts signal a significant investment into human-based technologies as the future of preclinical science, aiming to make research faster, more predictive, and more directly relevant to human health.
    • “Efforts include more than $88 million in funding for biomedical infrastructure projects nationwide; a new challenge offering over $7 million in awards to demonstrate how quantum-enabled approaches can improve detection and measurement in lab-based New Approach Methodologies (NAMs); a state-of-the-art laboratory at the NIH Clinical Center that will integrate standardized human organoid models, robotics, AI, and advanced data capabilities to enable experiments on reproducible human biological systems; an initiative to recruit grant reviewers who are experts in human-based science; and a new request for information from the scientific community to assess the feasibility of an annual public report tracking the number of vertebrate animals used in NIH-funded research.
    • “NIH is building the scientific infrastructure needed to develop, validate, and scale technologies that better reflect human biology,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “Our goal is to give researchers better tools to understand human disease and translate discoveries into treatments that improve patients’ lives.”

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

  • FedWeek reports,
    • “OPM has proposed to revise regulations governing hiring into the excepted service to align them with several Trump administration policies.
    • “Rules proposed in the September 18 Federal Register would “conform OPM regulations to current excepted-service schedules, including Schedules E, Policy/Career, and G; modernize part 302 procedures while preserving veterans’ preference, compensable-injury restoration rights, and other priority placement rights; authorize and clarify Pathways conversions to Schedule Policy/Career.”
    • “Schedule E was created in the first Trump term relating to hiring of administrative law judges, which Schedule Policy/Career and Schedule G were created during the current term; both apply to certain policy-related positions, with the former applying to career employees and the latter to political appointees.
    • “The Pathways Program is a longstanding program of internships for students and appointments of recent graduates, with the potential for non-competitive conversion to the competitive service; Trump last year abolished one element, the Presidential Management Fellows for those with advanced degrees, typically in public service administration.”
  • and
    • “I’ve promised this article twice now — in Part 3 on SSDI and again in Part 6 on the benefits of disability retirement — because it answers the question every client eventually asks: “If I get both, what do I actually take home?” The word “offset” scares people. Some employees hear it and conclude that SSDI isn’t worth the fight after their initial application is denied (which is very common).
    • “Let me show you why that’s the wrong conclusion, with real numbers. Remember, of course, that SSDI is only available to those who generally cannot work at all — or can earn only very little.”
  • FedSmith adds,
    • “For many federal employees, reaching Minimum Retirement Age (MRA) with 30 years of service feels like the finish line.
    • “The pension becomes available. The FERS Retirement Supplement may begin. FEHB can continue into retirement. The Thrift Savings Plan becomes accessible without early withdrawal penalties.
    • “After decades of federal service, retiring at MRA + 30 often feels emotionally justified and financially achievable. But there is an important distinction many employees overlook: retirement eligibility is not the same thing as retirement readiness.
    • The federal retirement system gives employees the ability to retire relatively early compared to many private-sector workers. That flexibility is valuable.
    • “But it also means employees must evaluate whether they are truly prepared for what may become a 30-year retirement. The question should not simply be: “Can I retire?” It should also be: “Can my retirement survive stress?”

From the Food and Drug Administration front,

  • Per a Department of Health and Human Services news release,
    • “The U.S. Food and Drug Administration (FDA) today issued a direct final rule updating its regulations to remove references to animal testing and implement the FDA Modernization Act.” * * *
    • “HHS also launched a new webpage providing a comprehensive accounting of actions of more than 20 actions the Department has taken to reduce animal testing and advance NAMs.”
  • Reuters reports,
    • “The US FDA’s staff reviewers did not raise major concerns about the accuracy and safety of Grail’s (GRAL.O), blood test designed ​to detect more than 50 cancers, sending the company’s shares soaring 35% on Monday.
    • “The ‌findings on the screening test, called Galleri, will be discussed at the FDA’s external advisers’ meeting on Wednesday [September 23] to review Grail’s request for premarket approval.
    • “The FDA ​has no outstanding questions for the external panel on ​analytical performance, study design and the primary safety analyses of ⁠Galleri, according to the briefing documents.”
  • Fierce Pharma relates,
    • “IntraBio is on a roll with its expansion plans for chemically altered amino acids, Aqneursa.
    • “The Texas-based pharma just secured FDA approval to expand the label of Aqneursa, which is now the first treatment indicated for a rare and prematurely fatal neurodegenerative disease called ataxia-telangiectasia (A-T).
    • “The positive ruling was based on data from IntraBio’s phase 3 IB1001-303 phase 3 data announced earlier this year. In the crossover study, which included 73 A-T patients ages 4 to 50, Aqneursa significantly improved ataxia symptoms and provided functional benefits for everyday life compared with placebo within 12 weeks of starting treatment.” * * *
    • “The FDA cleared Aqneursa, given as an oral suspension, for both children and adults with A-T, as long as they are over 15 kilograms (33 pounds).”
       
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has approved the Cordis Selution SLR (Sustained Limus Release) drug-eluting balloon (DEB) for the treatment of coronary in-stent restenosis (ISR). This is the first sirolimus DEB cleared in the U.S.
    • “The FDA previously designated this device as a breeakthrough device because of its sustained limus release, allowing the anti-proliferative drug to continue to prevent the growth of scar tissue inside a stent over a longer period of time to prevent further ISR. 
    • “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary ISR,” Matt Muscari, president of the Americas at Cordis, said in a statement. “This innovative device will enable physicians to address one of the most complex coronary clinical challenges.”

No Surprises Act News,

  • Fierce Healthcare reports,
    • “Self-funded employers are facing the brunt of costs associated with the No Surprises Act (NSA) arbitration process, a new report from the ERISA Industry Committee (ERIC) found.
    • “The report (PDF)—entitled Employer Exposure Under the No Surprises Act—was in part informed by confidential interviews with larger self-funded employer plan sponsors. 
    • “Employer-sponsored insurance covers approximately 154 million non-elderly Americans, with 67% of covered workers enrolled in self-funded plans, according to the report. With firms of 200 or more employees, the share is 80%.
    • “In Independent Dispute Resolution (IDR) cases, employers fund outcomes, the report notes.
    • “This is no trivial matter,” analysts wrote. “As IDR payouts reach upwards of $15 billion dollars throughout the life of the program, the direct cost to employers is quickly becoming untenable.” * * *
      • “Analysts put forth several policy recommendations, including:
      • “Restoring the “intended role” of qualifying payment amounts (QPAs)
      • “Establishing a limited appeals mechanism
      • “Addressing volume abuse
      • “Enacting transparency reform”
  • FEHBlog Observation – The necessary tranparency report — good faith estimates by providers and advance explanations of benefits by providers — is already law; we just need the No Surprises Act regulators to implement the law for insured people.

From the judicial front,

  • The U.S. Court of Appeals for the Sixth Circuit issued its opinion in the Commonwealth of Kentucky v. Express Scripts case last Friday.
    • The Commonwealth of Kentucky filed this lawsuit in state court, alleging that a group of healthcare firms contributed to Kentucky’s opioid crisis by conspiring with drug manufacturers to increase the supply of prescription opioids. The defendant firms include two Pharmacy Benefit Managers that negotiate with drug manufacturers to provide prescription drug coverage for federal employees. The Pharmacy Benefit Managers removed the case to federal court under the federal officer removal statute. Kentucky moved to remand, arguing that its complaint effectively disclaimed liability for any conduct the firms undertook at the behest of a federal officer. The district court agreed and granted Kentucky’s motion. In view of our decision in Ohio ex rel. Yost v. Ascent Health Services, LLC, 165 F.4th 999 (6th Cir. 2026), we reverse.
  • FEHBlog observation — This opinion is quite favorable to FEHB and PSHB carriers, large providers, underwriters and administrators.
  • Beckers Payer Issues reports,
    • “A New York state court has dismissed a lawsuit brought by two medical practices seeking more than $1.7 million from Elevance Health subsidiaries over unpaid No Surprises Act arbitration awards, ruling that the providers failed to make a viable claim under state law.
    • “Suffolk County Supreme Court Justice Paul Hennings granted the insurer’s motion to dismiss Sept. 17, throwing out all seven claims brought by True North Medical of Manhasset and True North Medical of Suffolk against four Anthem companies.
    • “The two Long Island practices provided out-of-network care to members of Anthem-administered health plans. After disputing certain payment amounts, the providers took their claims through the independent dispute resolution process and won 13 determinations totaling more than $1.7 million, which they alleged Anthem did not pay.
    • “Rather than filing under the No Surprises Act itself, the practices brought claims under New York state law, including unjust enrichment, violation of New York’s Prompt Pay statute, implied contract, insurance bad faith and declaratory judgment. They argued the IDR awards established what they were owed and that state law independently allowed them to collect.
    • “The court found that every claim depended on the IDR determinations for both the obligation to pay and the dollar amount owed. The No Surprises Act does not create a private right of action to enforce those awards, and state-law claims cannot fill the gap when the underlying payment obligation comes entirely from the federal process.”
  • Healthcare Dive relates,
    • “A judge in Texas last week approved a bankruptcy plan for CVS’ Omnicare, winding down the pharmacy services division after it sold its business operations for $250 million and settled an almost $1 billion judgment for improperly billing government healthcare programs.
    • “Judge Stacey G. C. Jernigan of the U.S. Bankruptcy Court for the Northern District of Texas greenlit the plan on Thursday, almost a year after Omnicare filed for Chapter 11 bankruptcy.
    • “The plan, which reorganizes some Omnicare assets and liquidates others, will pay all creditors in full, and go into effect in October, a lawyer for Omnicare told Bloomberg Law.“

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Chronic kidney disease (CKD) is known to significantly increase a person’s risk of heart disease or stroke. However, women with CKD often receive a delayed diagnosis and are less likely to receive a kidney transplant. It is with these trends in mind that multiple researchers collaborated for a new American Heart Association (AHA) scientific statement. The document, published in Circulation, highlights the importance of diagnosing CKD early in women and includes new recommendations designed to improve care for them going forward.”
    • “Many cases go undiagnosed in women because common tests and research do not always reflect women’s biology and life stages,” Eman Y. Gohar, PhD, MS, volunteer chair of the scientific statement’s writing group and an assistant professor of medicine with Vanderbilt University Medical Center, said in a statement. “Biological differences include genetics, sex chromosomes, hormones, immune-system responses and differences in how the body processes and responds to medication. We also need to acknowledge female-specific factors that do not apply in the same way to male patients. These include menstrual health, pregnancy, postpartum changes and menopause, as well as socioeconomic factors like financial barriers or cultural expectations. Each of these creates considerations that are unique to women and may require tailored care.”
    • “The statement emphasizes that women face many challenges when it comes to receiving kidney care. If clinicians fail to keep these challenges in mind, they risk letting patients with CKD go untreated until symptoms get much worse.
    • “Women are not simply smaller versions of men,” Gohar added. “Their biology, reproductive life stages and responses to medication may differ, and those differences need to be reflected in clinical care and research.” 
  • Health Day relates,
    • “Strength training is not linked to ventricular arrhythmia for people living with arrhythmogenic cardiomyopathy (ACM), according to a study published online Sept. 10 in JACC: Clinical Electrophysiology.
    • “Katia Chiampas, from Johns Hopkins University in Baltimore, and colleagues evaluated the risk for ventricular arrhythmia (VA) in individuals with ACM and/or pathogenic/likely pathogenic ACM gene variants exposed to strength-based exercise. The analysis included 355 individuals (median age, 34 years) identified from the Johns Hopkins Arrhythmogenic Right Ventricular Cardiomyopathy Registry, with follow-up from age 10 years.
    • “The researchers found that overall lifetime risk for VA was higher with increased aerobic exercise (dual + endurance) than without (strength + sedentary). However, there were no differences identified between dual versus endurance athletes or strength athletes versus sedentary. There was also no association between VA and strength training, but there was a significant association with endurance exercise.”
  • MedPage Today tells us,
    • “Patients with frailty are often undertreated with effective medications due to concerns around potentially attenuated benefits and safety risks.
    • “Baseline frailty did not limit the clinical benefits of semaglutide in a post-hoc trial analysis of patients with cardiovascular disease and overweight/obesity.
    • “The most frail participants experienced greater quality-of-life gains and lower treatment discontinuation rates due to adverse events.”
  • Healio discusses us,
    • “When should older adults get a flu vaccine? Experts offer advice.
    • “One expert simplified it for older adults, saying: “Don’t try to fake out flu. Just get your vaccine.”
    • “Another expert who is aged over 65 years said he may get the mRNA flu shot that just hit the market.”
  • Beckers Clinical Leadership informs us,
    • “A blood test correctly identified 87% of stage 1 and 2 pancreatic cancers, according to a study published Sept. 16 in Nature Medicine.
    • ‘For the study, researchers from Duarte, Calif.-based City of Hope tested the PANXEON liquid biopsy in nearly 1,800 patients across the U.S., Europe and Asia.
    • “The test identifies three biomarkers — circulating microRNAs, exosomal microRNAs and the protein CA19-9 — and assigns a single AI-generated pancreatic cancer risk score.
    • ‘The test’s false-positive rate was 3% among low-risk patients and 16% among high-risk patients. It also detected precancerous high-grade dysplasia in more than 64% of cases.
    • “The test is designed to complement, rather than replace, existing diagnostic strategies by flagging high-risk patients for further evaluation, researchers said in the release. 
    • “Read the full study here.”
  • Fierce Pharma notes,
    • “As Johnson & Johnson’s $14.6 billion bet on Intra-Cellular Therapies continues to pay off with blockbuster sales of Caplyta, the atypical antipsychotic has passed a phase 3 test that puts it one step closer to a wider psychiatric label.
    • “Caplyta (lumateperone), first approved back in 2019 under Intra-Cellular’s stewardship for schizophrenia, helped deliver rapid improvement in manic symptoms and improved overall illness severity, among other benefits versus placebo, over three weeks in a late-stage trial in adults with manic episodes associated with bipolar I disorder, J&J said in a release Monday.
    • “The results, which pointed to improvements in bipolar mania on Caplyta starting as early as day 3 of treatment, were presented with a clutch of other J&J readouts at the recent 2026 Psych Congress annual meeting in New Orleans. The study, coded 451, is part of a pair looking at Caplyta in adults with bipolar I-associated manic episodes.”
  • BioPharma Dive lets us know,
    • “A gene therapy from Beacon Therapeutics succeeded in a late-stage study involving people with a rare, often blinding eye condition, setting the company up to seek regulatory approval. 
    • “Called laruparetigene zovaparvovec, or laru-zova, the treatment helped a higher proportion of trial enrollees with X-linked retinitis pigmentosa read at least 15 more letters on a visual acuity test in low-light conditions than untreated participants after a year of follow-up. Beacon said the adverse events associated with treatment were “predominantly mild to moderate.”
    • “Further details from the study will be revealed at a medical meeting in October. The biotechnology firm plans to begin submitting a “rolling” approval application, which can be submitted in piecemeal fashion, by the end of the year.”
  • STAT News points out,
    • “Drugs called orexin agonists have been hailed for their ability to treat rare sleep disorders, but with new data, Alkermes is showing for the first time that the new class of therapies may benefit people with ADHD.
    • “In a randomized Phase 1 study, the company’s new drug, called ALKS 7290, was well tolerated and showed a signal of efficacy, Alkermes said Monday.
    • “Participants in the study started with a median score of 39 on a diagnostic known as the Adult ADHD Investigator Symptom Rating Scale, indicating that they had moderate to severe symptoms. After two weeks, those taking a high dose of 50 milligrams of ALKS 7290 experienced a 19-point reduction on the scale, indicating that their symptoms had become mild.
    • “Common ADHD treatments like stimulants have shown a similar magnitude of effect in trials over a longer period of time, four weeks, said Greg Mattingly, founding partner of St. Charles Psychiatric Associates, who consults for Alkermes.”
  • Per Genetic Engineering and Biotechnology News,
    • “Scientists have traditionally thought of the brain as a single, unified organ. But new research by Stanford Medicine scientists, working with collaborators from the California Institute of Technology and the University of California, San Francisco, indicates that what we call the brain is two distinct organs that evolved independently over hundreds of millions of years.
    • “The discovery overturns a prevailing model of brain development, based on the theory that there is a single progenitor cell early in development that gives rise to the entire brain. This model suggested that all parts of the brain shared a common developmental origin. The newly reported findings show that the human brain consists of two ancient nervous systems cleverly packaged together—a more primitive part that regulates the heart beating, our breathing and other functions, and another part that makes us distinctly human, capable of poetry, mathematics and wondering about our own origins.
    • “The results could help explain why scientists have struggled for decades to grow certain types of brain cells in the laboratory—and it opens new avenues for studying devastating diseases that affect the brain stem, such as spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS).”
    • “We’ve shown for the first time that the front of the brain arises from a totally different progenitor cell than the back of the brain,” said Kyle Loh, PhD, associate professor of developmental biology. “Our discovery means that we can now grow neurons from the back of the brain, the hindbrain, in a petri dish and study their functions.” Loh is senior author, and Carolyn Dundes, PhD, and Rayyan Jokhai are co-first authors of the scientists’ published paper in Nature Neuroscience, titled “Two parallel neural ectoderm progenitors contribute to the developing brain,” in which they concluded that “… the emerging notion of two parallel brain progenitors has a number of ramifications for development, differentiation and evolution.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare is pushing toward an average of 20 outpatient facilities for every hospital by the end of the decade as the company continues to make ambulatory expansion a centerpiece of its long-term growth strategy.
    • “CFO Mike Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference that HCA has already increased its outpatient footprint from about 12 facilities per hospital in 2023 to more than 14 today.
    • “Our goal, based on what we’re seeing in our markets, is that that would likely be 20 outpatient facilities per hospital by the end of the decade,” Mr. Marks said. “That reflects what we’re seeing for demand in our markets and just the value of having a comprehensive network of ambulatory sites to support your hospitals.”
    • “The target builds on several years of accelerated outpatient investment. HCA added about 100 outpatient facilities in 2025 and entered 2026 with roughly 2,700 outpatient sites. CEO Sam Hazen said in January the system had “significant capital in the pipeline” for additional outpatient development in 2026 and 2027, with growth expected through both new construction and acquisitions.”
  • and
    • Financial pressure is accelerating consolidation at a pace not seen in years. Staffing shortages, aging infrastructure, heavy Medicaid and Medicare dependence, and mounting payer denials have left hundreds of community hospitals with a stark choice: find a partner or close. 
    • Academic health systems, large nonprofits and regional powerhouses are all moving aggressively to absorb distressed and independent facilities, expanding geographic footprints, offloading debt and locking in patient pipelines in the process. 
    • [The article identifies] 34 academic health systems that have announced or plan to close strategic mergers, acquisitions or partnerships this year.
  • and
    • “Novo Nordisk unveiled its 2030 strategic targets at a Capital Markets Day in London Sept. 21, aiming to reassure investors it can navigate looming patent expirations for semaglutide, the active ingredient in Ozempic and Wegovy, according to a Sept. 21 report from the Financial Times.”
  • The Wall Street Journal adds,
    • “Ipsen IPN shares fell sharply after the U.S. Food and Drug Administration approved a generic competitor to its flagship hormone drug earlier than expected.
    • “Shares fell 6.6% to a seven-month low of 145.60 euros in morning European trade, making Ipsen the worst performer in the Europe-wide Stoxx 600 index.
    • ‘The FDA approved Amneal Pharmaceuticals’ AMRX 9.25%increase; up pointing triangle lanreotide injection—a generic of Ipsen’s Somatuline drug—at a dose of 120 milligrams, the New Jersey-based drugmaker said in a release after market close Friday.
    • “The drug will launch immediately and be produced in-house, Amneal said.
    • “The launch comes sooner than Ipsen had expected. Following the company’s second-quarter results in July, Chief Financial Officer Aymeric Le Chateliersaid he expected “some delay on the entry of [the] generic,” with Somatuline’s competitor expected to arrive in the fourth quarter.”
  • Beckers Payer Issues relates,
    • “Nationally, employees contribute an average of $7,314 per year toward the cost of employer-sponsored family health insurance, according to an analysis from KFF.
    • “The 2025 data comes from the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey Insurance Component, an annual survey of employers.”
  • Fierce Healthcare tells us,
    • “Zocdoc, the marketplace for booking provider visits, is making its infrastructure available to enterprise partners to support bookings anywhere patients look for care. 
    • “The new enterprise offering, Care Access Network, enables payers and tech or consumer platforms to embed Zocdoc’s appointment-booking capabilities directly into their own websites and apps. The infrastructure is built on two decades of connecting provider orgs, payers, electronic health records (EHRs) and practice management systems with scheduling workflows. Zocdoc’s marketplace today connects to over 200,000 providers across over 200 specialties and 10,000 plans. 
    • “I’m incredibly proud of the door we built with Zocdoc.com, but I’ve come to the conclusion that the front door to healthcare can’t be owned,” Oliver Kharraz, M.D., founder and CEO of Zocdoc, told Fierce Healthcare in an advanced interview. Wherever a consumer is searching, “you should be able to book right there and then.”
  • and
    • “Biological threat intelligence is increasingly becoming a workforce and business issue, not just a public health concern. Emerging threats—infectious disease outbreaks, pandemics and potential bioterrorism events—can cause significant workforce and operational disruptions.
    • “The Business Group on Health is partnering with biological intelligence service BioRadar to help employers better prepare for emerging biological threats. The collaboration will give employers access to BioRadar’s AI-powered biological intelligence platform, designed to identify and assess threats in real time before they escalate into widespread health concerns and business disruptions. 
    • “The collaboration reflects lessons learned during the COVID-19 pandemic, the organizations said, exposing the need for more proactive monitoring and planning rather than relying solely on public health alerts after threats have already spread. The COVID-19 pandemic forced sudden operational shutdowns, severe revenue contractions and historic labor shifts across nearly every sector.”
    • “Through the partnership, employers will also help to shape the next generation of biological intelligence tools so that workforce needs, business continuity considerations and public health priorities are considered from the outset, the organizations said.
    • “The health, well-being, safety and productivity of the workforce increasingly depends on timely insight into emerging biological threats,” Ellen Kelsay, president and CEO of Business Group on Health, said in a statement.”
  • Fierce Pharma points out,
    • “Bayer has decided to offload its aging cancer drug Stivarga to German compatriot Grünenthal as competition mounts.
    • “Grünenthal announced Monday that it will pay up to 375 million euros ($431 million) to acquire Stivarga, an oral multikinase inhibitor. 
    • “According to Grünenthal, patent protection for Stivarga is expected to last until 2029 in the European Union and by 2030 in the U.S. But loss of exclusivity in China has already taken a toll on sales.”

Thursday report

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

Happy Constitution Day!

From Washington, D.C.,

  • The American Hospital Association News reports,
    • “A Capitol Hill briefing Sept. 17 in Washington, D.C., hosted by 11 national healthcare organizations, including the AHA, highlighted the growing epidemic of workplace violence and its effects on staff well-being and patient safety. At the briefing, titled Protecting Those Who Care: Addressing Violence Against Healthcare Workers, Hill staff heard panelists’ personal experiences with physical and verbal attacks on the job and how hospitals are working to reduce the incidence of violence. The panelists were: Elizabeth Wells, M.D., executive vice president, chief clinical officer, and physician-in-chief, Children’s National Hospital; Jonathan Ripp, M.D., chief wellness officer and dean for well-being, Icahn School of Medicine at Mount Sinai; Tiffany Covarrubias-Lyttle, RN, associate professor of nursing, University of Lynchburg; and, Sheila Roth, Ph.D., professor emeritus, Carlow University. Reps. John Joyce, R-Pa., and Joe Courtney, D-Conn., also made brief remarks during the event.
    • “In a joint statement, the AHA and other participating organizations said, “Workplace violence, including physical assaults, threats, intimidation, and harassment, erodes the safety and dignity of healthcare workers, directly contributes to staff burnout and turnover, and staffing shortages, and compromises the quality of care and patient safety. This violence undermines providers’ ability to ensure safe, healing environments for all.”
    • “The AHA’s Hospitals Against Violence initiative includes resources and best practices for hospitals to use and share to address workplace and community violence.” 
  • Beckers Clinical Leadership relates,
    • “HHS Secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, bringing the influential preventive care panel to 16 members.
    • “Mr. Kennedy made the appointments Sept. 17 through the Agency for Healthcare Research and Quality. The eight join eight members currently serving on the volunteer panel of prevention and evidence-based medicine experts.
    • “The task force carries outsized weight for health system and payer leaders: preventive services that the panel grades “A” or “B” must be covered by most private insurers without cost-sharing under the ACA. Its composition effectively shapes which screenings and preventive services patients can get at no cost.” * * *
    • “Seth Corey, MD, a pediatric hematologist-oncologist at Cleveland Clinic, will chair the task force. The other seven appointees are:
      • “Patrick Hunter, MD, a pediatrician at Pensacola (Fla.) Pediatrics and member of the Florida State Board of Medicine
      • “Ronald Karlsberg, MD, a clinical professor of medicine at Los Angeles-based Cedars-Sinai Medical Center’s Smidt Heart Institute
      • “Venkatesh Murthy, MD, PhD, professor of preventive cardiology at the University of Michigan in Ann Arbor
      • “Stephen Parente, PhD, a health finance professor at the University of Minnesota’s Carlson School of Management in Minneapolis
      • “Goldie Stands-Over-Bull, MD, lead family medicine physician at Texas Native Health in Dallas
      • “Louis Wilson, MD, a gastroenterologist and managing partner at Wichita Falls (Texas) Gastroenterology Associates
      • “Dennis Wulfeck, MD, a diagnostic radiologist and president of the practice board at Radiology Partners’ MBB Radiology in Jacksonville, Fla.” 
  • U.S. News and World Report tells us,
    • “The U.S. Senate ⁠health ⁠committee will hold a confirmation ⁠hearing next week for Dr. Heidi Overton, President Donald Trump’s pick to ​lead the embattled Food and Drug Administration, the panel said on Thursday.
    • “The hearing will take place ‌on September 24, the Senate Health, ‌Education, Labor, and Pensions Committee said in a statement. Trump nominated Overton, a White ⁠House policy aide, ⁠in August, turning to an “America First” ally to steady an agency ​shaken by staff losses, low morale and fights over vaccines, the abortion pill and drug approvals.
  • Per Department of Health and Human Services news releases,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today launched the new Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a major research effort to transform how autism is understood, diagnosed, and supported across the lifespan. SPECTRA will bring together biological, clinical, behavioral, and real-world data with advanced computational tools to enable earlier and more accurate diagnosis, identify factors that shape individual health and developmental trajectories, and develop more precise approaches to care tailored to each person’s needs.
    • “Autism is not one-size-fits-all, and our science and care cannot be either,” said HHS Secretary Robert F. Kennedy, Jr. “Millions of American families are impacted by autism, and they need better answers about why it presents so differently from one person to another and which approaches can best meet each person’s needs. SPECTRA will harness the best of American science and innovation to deliver those answers — and turn them into better outcomes for people with autism and their families.” * * *
    • “Learn more about SPECTRA on its program page, including information about the solicitation.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today issued a Request for Information (RFI) calling on Americans, scientists, physicians, industry, and public health experts to submit evidence and information on the potential health effects of electromagnetic fields (EMFs), radiofrequency (RF) radiation, and wireless radiation exposure.
    • “The RFI will help HHS evaluate the state of the science, compare U.S. and international safety standards and regulatory approaches, identify critical research gaps, and develop practical, evidence-based recommendations for policymakers, families, schools, communities, and public health professionals.
    • “Wireless technologies are part of daily life, and our science must keep pace,” said HHS Secretary Robert F. Kennedy, Jr. “The MAHA Strategy directed HHS to examine electromagnetic radiation and health research, and we are acting on that directive. I encourage scientists, physicians, industry, public health experts, workers, parents, and citizens to bring us the best available evidence so we can identify the gaps and focus federal research where it is needed most.” * * *
    • “More information about the RFI can be found at the Federal Register [PDF].”
  • The International Foundation of Employee Benefit Plans helpfully shares information about “Red Flags for Mental Health Parity Compliance Problems.”

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

  • FedSmith reports,
    • “Federal retirees and Social Security recipients are only one inflation report away from knowing their 2027 cost-of-living adjustment (COLA). The Bureau of Labor Statistics (BLS) will release the September inflation report on October 14. That report will provide all three CPI-W figures needed to calculate the 2027 COLA.”
    • “The latest estimate from The Senior Citizens League (TSCL) puts the 2027 Social Security COLA at 3.5%. The organization lowered its estimate from 3.6% after the latest inflation report.
    • “Because Social Security and Civil Service Retirement System (CSRS) benefits use the same underlying inflation measure, that estimate also indicates the COLA CSRS retirees may receive. For most Federal Employees Retirement System (FERS) retirees eligible for a COLA, however, a 3.5% increase in the CPI-W would result in a 2.5% FERS COLA because FERS uses a different formula.”
  • Serving those We Serve tells us what federal and Postal employees should know about the redesigned Social Security Statement.
  • Tammy Flanagan, writing in Govexec, lets us know how to navigate the Pay.gov maxe for federal retirement deposits.
    • “Don’t let missing service credits or opaque OPM billing notices shrink your monthly annuity. Here is what you need to know before clicking submit.”
  • MeritTalk informs us,
    • “The Office of Personnel Management (OPM) used governmentwide OneGov deals to give every employee access to six artificial intelligence (AI) platforms, and more than 70% of its workforce actively uses at least one, according to OPM CIO Adam Starr.
    • “Speaking Tuesday at the GovExec Government & AI Summit in Washington, D.C., Starr said OPM has leaned heavily on the General Services Administration’s (GSA) OneGov agreements to rapidly expand employee access to AI.
    • “The OneGov deals were key to our ability to innovate at OPM with AI,” Starr said. “We basically bought all of the AI offerings at $1, and so we gave every employee six AI tools, and we encourage them to use it.”
    • “Those tools include Google’s Gemini, Microsoft Copilot, xAI’s Grok, OpenAI’s ChatGPT, Anthropic’s Claude, and Perplexity AI, Starr said.
    • “The strategy is intentionally multi-model. Starr said he wants employees to have access to several platforms because AI models are evolving quickly and vendors are regularly “leapfrogging each other.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A., MPS IIIA is a rare inherited disease that progressively damages the brain and nervous system, causing children to lose cognitive, language and other developmental abilities over time. Until today, treatment was limited to managing symptoms; there was no FDA-approved therapy designed to change the underlying course of the disease.
    • “The Trump Administration is committed to bringing safe and effective treatments to patients with the most urgent and unmet needs. The approval of Fayuvi marks a historic moment for children and families living with MPS IIIA, which is a disease that has, until now, offered no approved treatment to alter its devastating course,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Gene therapy holds tremendous promise for rare diseases like Sanfilippo syndrome type A, and this milestone reflects the FDA’s commitment to action.”  
    • “Fayuvi is a one-time, intravenous (given directly into a vein) gene therapy that uses a modified, non-infectious virus called an adeno-associated virus serotype 9 (AAV9) to deliver a working copy of the SGSH gene into the patient’s cells. This enables the body’s cells to produce sulfamidase — the enzyme that is missing or deficient in MPS IIIA — allowing heparan sulfate to be properly broken down in lysosomes and reducing its harmful buildup throughout the body and brain.”
  • Targeted Oncology reports,
    • “FDA 510(k) clearance covers robotic colonoscopy for screening, surveillance, diagnostic evaluation, and advanced therapy including EMR and ESD across the full colon. 
    • “Triton 1 targets limitations of manual scope manipulation by adding robotic control intended to enhance stability, maneuverability, and procedural efficiency during flexible endoscopy. 
    • “CARE I (NCT06935734) reported 100% cecal intubation and no adverse events, meeting primary safety/efficacy end points in a first-in-human cohort. 
    • “Detection performance in CARE I included ADR 54.2% and polyp detection rate 67.5%, exceeding a cited 35% ADR industry threshold. 
    • “Endoscopist ergonomics improved, with a 67% lower perceived procedural workload versus manual colonoscopy on NASA-TLX, suggesting reduced physical and cognitive operator burden.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for a vessel-sealing technology used with its Hugo soft tissue robotic surgery system.
    • “The clearance, which Medtronic disclosed Wednesday, brings LigaSure technology, used in more than 45 million procedures worldwide, to the company’s robotic-assisted surgery platform.
    • “Targeting markets dominated by Intuitive, Medtronic has identified an opportunity to win share by pairing its platform with energy instruments that physicians use in non-robotic surgeries.”
  • MedPage Today informs us,
    • “Unapproved use of deoxycholic acid injection (Kybella) outside of the submental fat region may carry a risk of neuromuscular and other potentially serious adverse events, according to an FDA labeling update.
    • “A review of the FDA Adverse Event Reporting System (FAERS) revealed 129 cases of adverse events associated with use of deoxycholic acid in unapproved areas since the product was approved in 2015, the agency stated in a safety communication. The reports included some serious adverse events, such as blurred or reduced vision with periorbital use of deoxycholic acid injection and muscle or nerve injury, including facial paresis and paresthesia.
    • In announcing deoxycholic acid injection’s approval, the FDA emphasized, “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”

From the judicial front,

  • Bloomberg Law reports,
    • “An out-of-network healthcare provider can’t sue Cigna Health and Life Insurance Co. to recover more than $3 million it won against the plan through the No Surprises Act’s independent dispute resolution process, a federal appeals court said Thursday.
    • “The text and structure of the federal law, which created a process for resolving disputes between health plans and out-of-network providers, make clear that it doesn’t provide a private right of action to enforce arbitration awards obtained through that process, Judge Michael H. Park said. The US Court of Appeals for the Second Circuit thus affirmed the dismissal of East Coast Advanced Plastic Surgery LLC’s suit against Cigna.
    • “Although the NSA gives providers a right to payment from health plans for certain services, it delegates enforcement authority to multiple federal agencies and to states,” Park said for the unanimous panel. “This statutory scheme reflects Congress’s intent that the NSA, including payment of IDR awards, be enforced through administrative action rather than private litigation.”
  • Beckers ASC Review relates,
    • “San Tan Valley, Ariz.-based Rita Ntusa Anagho has been sentenced to 14 years in federal prison for orchestrating a $69 million Medicaid fraud scheme through her addiction treatment clinic, according to a Sept. 17 news release from the Department of Justice.
    • “Ms. Anagho, 54, a licensed nurse practitioner, owned and operated Tusa Integrated Clinic, which fraudulently billed Arizona’s Medicaid agency more than $69 million between about May 2022 and March 2023; the agency paid roughly $54.9 million on the false claims, according to court documents. 
    • “Ms. Anagho and her co-conspirators allegedly targeted patients covered under Arizona Medicaid’s American Indian Health Care Program, which reimburses at higher rates than other Medicaid plans, paid illegal kickbacks to sober home owners for patient referrals, and falsified treatment records to conceal the scheme.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “The U.S. cancer death rate declined 35% between 2015 and 2024, averting more than 4.8 million deaths, according to the American Association for Cancer Research’s 16th annual Cancer Progress Report, published Sept. 16.
    • Here are [three] things [the article has eight] healthcare leaders need to know from the report:
    • Death rates fell an average of 4.2% per year for lung cancer, 1.3% for colorectal cancer and 1.2% for female breast cancer between 2015 and 2024.
    • An estimated 2.1 million new cancer cases will be diagnosed in 2026.
    • By 2050, the number of annual cancer diagnoses is projected to rise to 2.5 million.
    • More than 18.6 million people with a history of cancer were living in the U.S. as of Jan. 1, 2025.
    • AACR researchers expect 22 million people to be living with cancer or a history of cancer by 2035.
    • “Read the full report here.”
  • Healio points out,
    • “Around 2.71 billion people worldwide were exposed to secondhand smoke in 2023.
    • “An expert encouraged clinicians to screen women, children and patients with cardiac issues for exposure.” * * *
    • “Despite the findings, Flor and colleagues highlighted progress from tobacco-reducing policies in the Americas, as “of the 79 countries attaining the highest level of achievement in smoke-free protections globally, 24 are in the Americas, approximately 70% of the countries in that region.”
  • STAT News adds,
    • “For years, researchers have known that, among people diagnosed with lung cancer, the prevalence of nonsmokers has been increasing. But they have been trying to determine what factors — whether genetic, environmental, or something else — might put these “never-smokers” at heightened risk. 
    • “Now, researchers have identified a very rare genetic variant that is associated with 25-fold higher odds of lung cancer, they reported in the journal Science on Thursday. In the U.S., the variant is far more common among people in Southern Appalachia than in other regions. 
    • Experts said that the variant likely only plays a role in a small portion of never-smoker lung cancer cases. But the research provides further evidence that these types of tumors can be tied to distinct risk factors, which may in turn require thinking differently about screening programs and treatment strategies. More broadly, the new study highlights the types of narrow but crucial discoveries that can be made by turning to large datasets replete with health information from millions of people. In this case, the investigators relied on genetic data from 23andMe.” * * *
    • “The variant in question — known as T790M — is a version of a gene called EGFR, which typically helps regulate how cells grow and divide. Select EGFR mutations can crop up over a person’s life and are among the most important drivers of lung cancer, and in turn are targeted by some cancer drugs.”
  • The Washington Post calls attention to “5 movements physical therapists say every adult over 50 should do daily.”
    • These simple moves can help you maintain mobility and independence as you age.”
  • Beckers Behavioral Health informs us,
    • “A 13-item Mental Wellness Tool detected common or severe mental disorders, substance use disorders and suicide risk among patients receiving psychiatric emergency department care at a New York City hospital, according to a Sept. 17 Medscape report.
    • “Existing mental health screening tools typically assess for one disorder, and screening for a range of psychiatric conditions can take well over 45 minutes and require several assessment tools. The mwTool-13 is designed to screen for multiple conditions in a single assessment.
    • “The mwTool-13 can be administered in 2 to 10 minutes, according to a Sept. 3 study published in Psychiatric Services.”
  • The Wall Street Journal shares readers views on patient portals.
  • Health Day tells us,
    • “Nearly two-thirds of suspected poisonings in young children probably do not need the emergency department and can be handled by a call to the local poison control center, according to a study published in the August issue of Clinical Toxicology.
    • “Liam P. McLoughlin, M.D., from Rutgers New Jersey Medical School in Newark, and colleagues investigated the medical necessity of pediatric emergency department presentations for poison cases where a poison control center was not contacted prior to presenting at the emergency department. The analysis included toxicologist reviews of summaries from 348 poison control center cases, originating from a health care facility, involving patients aged younger than 6 years.” * * *
    • “A big takeaway from the paper is that more needs to be done to make sure parents, schools, and communities know the poison center is a resource they can turn to when a poisoning is suspected,” McLoughlin said in a statement. “The poison center is available 24/7, 365, and is staffed by amazing people who can provide life-saving information by phone at no cost.”
  • and
    • “Exercise is already recommended to help people with cancer manage fatigue and improve quality of life. Now, there is evidence the benefits may go further.
    • “A new study finds structured exercise may help people with cancer live longer and have more time free of disease.
    • “Chih-Chen Tzang of the National Taiwan University and colleagues analyzed 21 clinical trials involving more than 8,400 cancer patients.
    • “Some followed supervised exercise programs that included aerobic exercise, strength training or both. Others did not.
    • “Over an average follow-up of about five years, those who exercised were 23% less likely to die and 17% less likely to have their cancer return before death.
    • “The benefits were strongest among people with early-stage cancer, those who did aerobic exercise — alone or with strength training — and those who completed at least 70% of their exercise program.”
  • Per Genetic Engineering and Biotechnology News,
    • “The genome editing toolbox provides unprecedented opportunities to engineer the human genome. However, genome editing for therapeutic benefit continues to have its limitations. Most current methods rely on untargeted gene delivery or short DNA edits that need to be individualized to each patient.
    • “Now, a new paper describes a novel genome engineering method, prime assembly, that allows long DNA fragments to be integrated into precise and programmable target positions within living cells. This approach, which leverages CRISPR-targeted dual flap synthesis, may allow for the development of universal gene therapies.
    • “This work is published in Nature in the paper, “Targeted genomic integration and rearrangement using prime assembly.”
  • Per Fierce Pharma,
    • “Roche’s T-cell engager portfolio has notched another milestone, as a phase 3 trial of the company’s Lunsumio met its primary endpoint in earlier-line follicular lymphoma.
    • “Without sharing any specific data, Roche and its subsidiary Genentech said Lunsumio’s combination with lenalidomide (Revlimid) demonstrated a statistically and clinically meaningful improvement in progression-free survival against rituximab (Rituxan) plus lenalidomide, known as R2, in the phase 3 Celestimo study. 
    • “The trial enrolled follicular lymphoma (FL) patients who have received at least one prior line of treatment, and it serves as the confirmatory study required to convert Lunsumio’s existing accelerated approval as a monotherapy in third-line FL into a full approval, while also potentially moving the drug earlier into the second-line setting.”

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

  • Beckers Payer Issues reports,
    • “The National Committee for Quality Assurance has named the highest quality and most effective health plans of 2026 based on clinical quality, patient experience and health plan accreditation status.
    • “The ratings were released Sept. 16 and are based on 2025 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover approximately 236 million people. Some MA plan data is from 2024 because of reporting schedules, and NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 956 plans received a rating.
    • “Commercial plans that received a five-star rating:
      • BCBS Massachusetts
      • Capital District Physicians’ Health Plan (New York)
      • Capital District Physicians’ Healthcare Network (New York)
      • Harvard Pilgrim Health Care (Massachusetts, Maine)
      • Independent Health (New York)
      • Kaiser Mid-Atlantic (Washington, D.C.; Maryland; Virginia)
      • Kaiser Northern California
      • UPMC Benefit Management Services
      • UPMC Health Plan
  • and
    • “When Providence announced it was shutting down its health plan earlier this year after a $102 million loss in 2025, it joined a growing list of health systems stepping back from the insurance business. Carle Health’s Health Alliance, Michigan Medicine’s U-M Health Plan and others have wound down or are exiting, citing volatility in Medicare Advantage and government payer markets that have made provider-sponsored plans increasingly difficult to sustain.
    • “Terry Gilliland, MD, president and CEO of Danville, Pa.-based Geisinger, is watching the same environment unfold and coming to the opposite conclusion.
    • “Rather than say, this is hard and dump the plan, we’ve made the necessary changes including leadership top to bottom to grow profitably,” Dr. Gilliland said.”
  • and
    • “CVS Health’s Aetna is expanding prior authorization bundles for cancer, available to some Medicaid members as of Sept. 1.
    • “The update impacts Medicaid members with providers in Oklahoma, Illinois, Maryland, New Jersey, Virginia, Florida, Kentucky and West Virginia who use the Eviti portal for prior authorizations. Aetna anticipates broadening eligibility to Medicare and commercial members in the first half of 2027.
    • “According to a Sept. 17 news release, Aetna observed providers submitting four different prior authorizations, on average, for its members needing cancer treatments. These bundles allow a single prior authorization request that could encapsulate medical oncology and radiation oncology services with high-tech imaging needs. The expansion builds upon an early rollout of the bundles. 
    • “By approving a broader set of treatments and related services upfront, we’re removing barriers that can delay care,” Aetna COO and Medicaid President Katerina Guerraz said.”
  • Beckers Hospital Review relates,
    • “St. Louis-based Ascension has reached an agreement to transfer full ownership of its co-owned Arizona managed care health plan, Mercy Care, to CVS Health subsidiary Aetna, a spokesperson for Ascension confirmed with Becker’s. 
    • “Ascension co-owns the plan with San Francisco-based CommonSpirit’s Dignity Health, the spokesperson confirmed. The agreement is subject to regulatory reviews and approvals.
    • “Mercy Care has long served vulnerable populations, families and individuals across Arizona through Arizona Health Care Cost Containment System Medicaid programs and Medicare Duals Special Needs Plans,” the spokesperson said. “Aetna has successfully managed Mercy Care’s day-to-day operations and administrative services for over 20 years.”
  • and
    • “HCA Healthcare CFO Mike Marks said payers have outpaced hospitals on AI-driven claims processing, adding another layer to the friction hospitals face on denials, underpayments and prior authorization.
    • “I know there’s a lot of talk about AI in the hospital revenue cycle, we’re behind the payers, in my view,” Mr. Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference in Nashville, Tenn., where the 190-hospital system is also headquartered.
    • “Payers, he said, have real incentives driving their AI investments, including medical loss ratios and patient populations to manage.
    • “They’ve been working really hard on their version of AI in their claims shop,” he said.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare is seeing softer elective surgery volumes as patients lose coverage through the health insurance exchanges, with broader affordability pressures potentially contributing to the slowdown, CFO Mike Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference.
    • “The 189-hospital, for-profit system continues to see strong overall demand for healthcare services, but the movement of patients from exchange coverage to uninsured status is weighing on elective procedures.
    • “On the inpatient side of elective, and frankly, on the outpatient surgery side as well, the biggest issue is HICS,” Mr. Marks said, referring to health insurance exchange coverage. “This movement out of HICS to uninsured — as people in our communities have lost coverage on the exchange [and] become uninsured — they generally lose access to elective care. That is the primary driver of the slowdown in our elective surgery volumes is exchanges.”
  • Beckers ASC Review tells us,
    • “Brentwood, Tenn.-based Surgery Partners has completed the sale of its ownership interests in its Idaho Falls, Idaho, facilities to Intermountain Health for $797 million in gross proceeds, according to a Sept. 17 news release.
    • “The deal includes Mountain View Hospital and Idaho Falls Community Hospital, values the combined facilities at about $1.15 billion, and delivered Surgery Partners $587 million in net cash proceeds at closing, subject to customary post-closing adjustments. Physician ownership of Mountain View Hospital will remain unchanged under Intermountain’s leadership, and the proceeds will primarily go toward paying down debt, which is expected to improve the company’s balance sheet leverage by about 30 basis points from 4.4x at the end of the second quarter.
    • “Excluding the Idaho Falls facilities, Surgery Partners expects a 50% reduction in its Medicaid payor mix, to under 2% of revenue, along with the elimination of its neonatology, obstetrics, inpatient pediatrics and retail and compounding pharmacy service lines.”
  • Fierce Healthcare informs us,
    • “Big box retailer Walmart is launching a six-month pilot program that places pharmacists in a new “Health Ambassador” role at five rural stores to help customers navigate health and wellness resources.
    • “Walmart’s Health Ambassador Associate will be able to aid patients in understanding their health goals and help connect them to relevant services and resources.
    • “The Health Ambassador role will be piloted at locations serving rural and underserved communities across the U.S., including in Lexington, Tenn.; Caro, Mich.; Franklin, Va.; Fort Scott, Kan.; and Searcy, Ark.
    • “The pilot will initially focus on three healthcare areas: diabetes, weight management and maternal health. Health Ambassadors can also aid customers in nutrition, movement, sleep and stress management through the program’s in-person conversations and tailored coaching.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.”
  • and
    • “Blue Shield of California announced Thursday that it plans to expand its Virtual Blue program, doubling program enrollment for members.
    • “Beginning in January 2027, the benefit will be included in fully insured preferred provider organization (PPO) plans for employers with 101 to 3,000 employees, as well as for certain individual and family plans, the insurer said.
    • “The expansion will allow an additional 200,000 mid-size employer PPO members and 60,000 individual and family plan members to utilize the program, increasing its total enrollment to more than 410,000 participants, executives say.
    • The virtual-first program, first launched in 2023 in collaboration with Accolade and TeleMed2U, has more than 150,000 members as of April. The program gives members access to a range of virtual health services at no additional cost, along with care from providers in Blue Shield’s PPO network.
  • Per BioPharma Dive,
    • “Novo is investing in oral biologics, signing a deal with fellow Danish company Orbis Medicines to discover multiple “macrocycles” that have the “potential to replace injectable medicines,” Orbis said Thursday.
    • “Orbis could receive as much as $1.4 billion in up front and downstream payouts, as well as sales royalties, in the deal. The companies didn’t specify the number of drugs on which they would collaborate, nor specific diseases, only mentioning that they’ll pursue unnamed cardiometabolic targets.
    • “The use of macrocycles is one way Novo could overcome some of the limitations of standard oral peptide medicines, such as poor digestive absorption. The highest dose of Novo’s Wegovy pill contains 20 times the highest injectable dose because most of the drug’s active ingredient is chewed up before reaching the bloodstream.”
  • and
    • “North Immunology, in the early stages of developing a potential competitor for the widely popular inflammatory disease drug Dupixent, plans to go public next year via a reverse merger with Aethlon Medical.
    • “After the merger, the companies expect North Immunology investors to own 95.25% of the new entity, with the rest going to Aethlon shareholders. Those who own Aethlon stock immediately prior to the merger will also get a contingent value right entitling them to potential proceeds from Aethlon’s legacy Hemopurifier business. 
    • “The new company will operate as North Immunology and trade on the Nasdaq under the ticker symbol “NRTX,” Aethlon said Thursday. North Immunology’s executives will lead the combined entity, and its directors will populate the board, along with some new independent directors. The companies expect the transaction to close in the first quarter of 2027.”
  • Healthcare Dive points out,
    • “Healthcare organizations are rapidly adopting agentic artificial intelligence, but governance frameworks for managing the technology are not evolving at the same pace, according to a new survey from digital identity security firm Imprivata.
    • “More than 85% of leaders responsible for AI strategy at healthcare organizations say they’re confident they have visibility into AI agent activity and are able to fully control and govern an autonomous agent’s actions.
    • “However, 72% of respondents admit AI tools are deployed without IT approval at least occasionally within their organizations, highlighting a disconnect between confidence and reality.”

Midweek report

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

Simplicity is a virtue.

From Washington, D.C.,

  • STAT News reports,
    • “Normally, discussions about how congressional advisers study Medicare spending are quite dry. Not so at the House Ways and Means Committee on Wednesday.
    • “In a party line vote, committee Republicans pushed forward a bill that seeks to change how the Medicare Payment Advisory Commission studies Medicare Advantage spending. In particular, this bill would direct the nonpartisan agency to study the topic of overpayments to Medicare Advantage plans in a manner that’s more favorable to insurers.” * * *
    • “It’s a bit of a change in tune for some Republicans, especially those who are doctors, who had become frustrated with Medicare Advantage insurers that deny care to patients. 
    • “However, Rep. Greg Murphy (R-N.C.), who is among those doctors who have criticized certain industry practices, said he had no problem supporting the bill. 
    • “Asking for more information so that we can make real choices and reform the Medicare Advantage system, I am absolutely for,” he said.”
  • and
    • “Democrats are vowing to aggressively pursue oversight if they win control of either the House or Senate in November’s midterm elections. Health care issues, including President Trump’s drug pricing deals, are potential targets. 
    • “It’s common for parties to turn to oversight when they take control of a congressional chamber. Lawmakers can use oversight to tell a story about the other side. It also avoids intraparty divisions by focusing attention on what the other party has done. And if Democrats want to keep the focus on Trump, even though he can’t run again, oversight is a good way to do that.”
  • MedPage Today adds,
    • “Nicole Saphier, MD, President Donald Trump’s third surgeon general nominee, was grilled at her confirmation hearing Wednesday about her stance on childhood vaccines, voicing support for immunization as she seeks to serve in an administration that has moved to make sweeping changes to vaccine guidance.
    • Saphier, a radiologist and former Fox News Channel contributor, faced tough questioning about her views on the safety of childhood vaccines by Sen. Bill Cassidy, MD (R-La.), who pressed her to declare whether she believed there was a link between vaccines and autism — which widespread scientific consensus has concluded doesn’t exist, yet which the Trump administration has repeatedly pushed to revisit.
    • “I do not believe childhood vaccines cause autism,” Saphier said. She also said “the MMR [measles, mumps, and rubella] vaccine is our greatest tool for combating measles,” in response to a question by Cassidy over whether parents should give children that shot, and which the president recently ordered be spaced out.
  • Healthcare Dive relates,
    • “Health plans are generally performing better on quality and performance ratings, though nonprofit insurers continue to surge past their for-profit peers.
    • “The National Committee for Quality Assurance released its 2026 ratings on Tuesday, which score commercial, Medicare and Medicaid plans across a range of measures of clinical quality, patient experience and health outcomes. Eighteen plans nabbed the standards organization’s highest 5-star rating, up from 11 last year. All of them are nonprofits.
    • “Of the major publicly traded carriers, CVS had the highest scores, averaging at about 4 stars, according to a Healthcare Dive analysis of the data. Meanwhile, plans’ average rating ticked up slightly, from 3.483 last year to 3.493 in 2026 thanks to improvements in commercial and Medicaid plans, though Medicare insurers’ average rating slipped.”
  • Healthcare Finance News tells us
    • “The American Hospital Association and American Medical Association are urging the Centers for Medicare & Medicaid Services to reconsider proposed reductions to Medicare physician payments for 2027, warning that the cuts could threaten patient access and the financial stability of physician practices.
    • “Comments on the proposed rule, which was released in July, were due Monday.
    • “The AMA voiced its concerns earlier this month about a CMS plan to cut physician pay when doctors provide a separately identifiable office or outpatient evaluation and management (E/M) visit on the same day as most procedures are performed. 
    • “The agency scrapped this same plan eight years ago, the AMA said, after physicians and other stakeholders raised serious concerns. 
    • “But CMS is pitching a similar idea in its 2027 Medicare physician payment schedule proposed rule,” the AMA said. “If finalized, most changes, including this one, would be scheduled to take effect Jan. 1.”
    • “The AMA called for annual physician payment updates tied to medical inflation, arguing that the lack of consistent inflationary adjustments has contributed to the erosion of physician practice sustainability.”
  • The American Hospital Association News tells us,
    • “The Workgroup for Electronic Data Interchange has launched its fall 2026 survey to assess industry readiness for the Centers for Medicare & Medicaid Services’ interoperability and prior authorization final rule. Survey responses are anonymous, and all results are aggregated. The survey will close on Oct. 9. WEDI plans to use the results to make recommendations to CMS, inform stakeholders and assist WEDI in its development of industry guidance and education.” 

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

  • Govexec reports,
    • “Senate Democrats again urged the Trump administration Wednesday to abandon its plans to collect detailed health information from federal workers, retirees and their families, saying recent tweaks to “de-identify” records are insufficient to protect employees’ privacy.
    • “Last December, the Office of Personnel Management published an information collection request in the Federal Register that would require insurers who participate in the Federal Employees Health Benefits and Postal Service Health Benefits programs to provide monthly reports with identifiable health data on their enrollees.
    • “Following pushback from federal employee groups and medical ethicists, OPM in June revised its proposal, purporting to take steps to mask employees and retirees’ identities in the data collection. But organizations that represent federal workers and retirees warned that the agency still hadn’t done enough to protect patients’ privacy.
    • “In a letter to OPM Director Scott Kupor, a group of six Senate Democrats, led by Sens. Adam Schiff, D-Calif., and Mark Warner, D-Va., who previously requested the proposal’s withdrawal, wrote that the proposed pseudonymization of records does not their “fundamental” concerns with the plan, particularly the agency’s insistence that it may re-identify insurance claimants in the future.”
  • FedWeek relates,
    • “OPM has provided some additional information on agency responsibilities to conduct the annual survey of federal employees—which it plans to shift to them from itself under a pending rules proposal—although still not setting a schedule for conducting this year’s version.
    • “A September 17 Federal Register notice states that the survey traditionally called the Federal Employee Viewpoint Survey will be renamed as the Annual Employee Survey, and reaffirms the intention in the earlier rules proposal to reduce the number of core questions from 16 to 10.
    • “That is to include dropping longstanding questions asking employees about their overall level of satisfaction with their job; with the recognition they receive for doing good work; with their organization overall; with the information they receive about what is going on in it; with their level of involvement with decisions that affect their work; and whether they would recommend their organization as a good place to work.
    • “OPM traditionally used those satisfaction-related questions in creating an index that was widely—although not officially—seen as a proxy for morale.”

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

  • Good Housekeeping reports,
    • “FDA issued a Class II recall on September 11 for six hand soap products from Intercon Chemical Co. distributed across 15 states. The original recall happened on June 29 due to potential bacterial contamination.
    • “Two soap variants contained harmful bacteria including Pseudomonas aeruginosa and Serratia marcescens, which can cause serious infections like pneumonia, UTIs, and blood infections, especially in immunocompromised individuals.
    • “Consumers should identify recalled products by UPC codes and lot numbers listed for Intercon, Clearly Better, Summit, Vestis, and Laura Lynn brands, then stop use immediately and seek medical attention if symptoms develop.”
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new generic radiopharmaceutical alternative from drugmaker Curium, aimed at competing with another treatment on the market. 
    • “Bexlutry (lutetium Lu 177 dotatate) is a radioligand therapy designed to deliver targeted radiation for treating a group of rare cancers originating in the digestive track and pancreas. Boston-based Curium scored the approval through the FDA’s 505(b)(2) pathway, supported by published evidence and targeted bridging data. 
    • “This demonstrated that Bexlutry achieved a similar biological and chemical profile to the previously approved Lutathera, manufactured by rival firm Novartis. 
    • “Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer,” Mike Patterson, Curium’s CEO of North America, said in a statement Sept. 14. “Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy.”

No Surprises Act News

  • Politico reports,
    • “A Senate committee held stakeholder roundtables on Tuesday to discuss reforms to the 2020 No Surprises Act, which set up how doctors and insurers are paid for unexpected medical bills, Simon reports.
    • “The act, originally co-sponsored by Health, Education, Labor and Pensions Chair Bill Cassidy, shielded patients from unexpected out-of-network emergency care bills. But it has come under fire for creating a case backlog in a system that critics argue can pay disproportionately in favor of doctors.
    • “Employers, physicians, insurers and unions — groups typically at odds — held a cordial, constructive talk about possible solutions, according to four people familiar with the meetings who were granted anonymity to speak candidly. Committee staff also met separately with the arbitrators responsible for overseeing and resolving payment disputes.
    • “Over three hours, the stakeholder group didn’t settle on any policy changes, but they agreed on the need to eliminate the dispute backlog by filtering out ineligible claims and encouraging faster payouts. The group emphasized the importance of benchmark rates for medical services, known as qualified payment amounts, when determining payouts and that only emergency care bills should be eligible for arbitration.
    • “It is early, and the devil will be in the details, so to speak, as conversations continue, but overall a positive vibe,” said one of the four people familiar with the discussion. Another of the four, who was a provider attendee, said, “It was pointed but respectful.” * * *
    • “What’s next: The Senate HELP Committee will hold a roundtable with members next week to talk through legislative solutions.”

From the judicial front,

  • Healthcare Dive reports,
    • “A group of independent pharmacies in Arkansas are suing Express Scripts, one of the largest pharmaceutical middlemen in the U.S., for allegedly underpaying for tens of thousands of prescriptions.
    • “The lawsuit filed Tuesday, which seeks hundreds of millions of dollars in damages, is the first filed under a state law passed last year giving Arkansas pharmacies the ability to go after PBMs for reimbursing them below the acquisition cost of drugs, according to lawyers for the plaintiffs.
    • “We’re committed to reimbursing pharmacies at competitive rates and will defend ourselves against these allegations,” an Express Scripts spokesperson said.

From the public health and medical / Rx research front,

  • The New York Times offers advice on whether you are eating enough fiber in your diet.
    • “With so much attention on protein lately, you’d be forgiven for forgetting about fiber.
    • “But if you’re like most adults in the United States, you’re probably falling short of the recommended minimum of 21 to 38 grams per day, depending on your age and sex. The average U.S. woman consumes about 15 grams of fiber daily, and men consume about 18 grams per day.
    • “Closing that gap may be one of the best strategies for improving your health. Fiber nourishes gut microbes, lowers blood pressure and cholesterol, improves digestion and reduces the risks of heart disease, Type 2 diabetes and certain cancers.
    • “It can seem like a big challenge to eat enough fiber, but nutrition experts say it doesn’t have to be. You just have to know where to look.”
  • Cardiovascular Business adds,
    • “Eating four to six servings of whole-grain foods per day is associated with multiple cardiovascular benefits, according to a new meta-analysis published in European Heart Journal. 
    • “The authors focused on data from more than 6,500 adults from the United States, Europe, Asia, Canada, Australia or Brazil who participated in one of 87 different clinical trials. Overall, eating 48 grams of whole-grain food—oats, brown rice or quinoa, for example—each day was associated with improvements in body weight, waist circumference, total cholesterol, blood pressure, LDL cholesterol, glucose and interleukin-6 levels. These are all known risk factors of cardiovascular disease.
    • “This is the largest and most comprehensive meta-analysis of randomized controlled trials on whole grain intake and cardiovascular risk factors,” senior author Helda Tutunchi, PhD, a nutrition specialist with Tabriz University of Medical Sciences in Iran, explained in a statement. “Unlike previous reviews, we looked specifically at how much whole grain people need to eat to get the greatest benefits. We also evaluated the certainty of the evidence and found high-certainty evidence for improvements in several outcomes, including body weight, waist circumference and total cholesterol.”
    • “Tutunchi added the impact of eating more whole-grain foods appears to be through “several modest improvements acting together” as opposed to “one large effect on a single risk factor.”
  • Health Day relates,
    • “Women’s risk of having a harmless tumor caught and treated as a result of breast cancer screening is much lower than once thought, a new evidence review has concluded.
    • “Overdiagnosis — the detection of breast cancers that never would have harmed a woman’s health during her life — occurs in fewer than 5% of cancer screenings, researchers reported Sept. 14 in the Journal of the National Cancer Institute.
    • “That’s far lower than previous estimates, which held that as many as 30% to 50% of breast cancer detected through screening might represent overdiagnosis, researchers said.
    • “These earlier studies were inaccurate because they tracked breast cancer screenings for a limited period of time, the research team argued.”
  • and
    • “ADHD is linked to a nearly 50% increase in GI problems, a new evidence review says.
    • The association was even stronger for specific GI problems, including an almost doubled risk of constipation, a 58% increase in irritable bowel syndrome and more than four times higher odds of losing bowel control, researchers reported Sept. 10 in the Journal of Attention Disorders.
    • “Almost every gut symptom we looked at: constipation, IBS, even indigestion, appeared to be associated with ADHD,” said lead researcher Sarah Blake, a medical student at the University of Warwick Medical School in the U.K.
    • “These symptoms can have a real impact on daily life, but they could easily be overlooked if the focus is on ADHD itself,” she added in a news release.
    • “There are several potential explanations for these links, including ADHD-related eating patterns, side effects from medication and even ties between ADHD and gut bacteria, researchers said.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Scientists studying Alzheimer’s disease have long focused on genes, proteins, and cells, but one class of molecules has remained largely outside the playbook: microproteins. These small proteins, produced from small open reading frames (ORFs) and typically measuring 150 amino acids or fewer, have been difficult to detect and study. Yet growing evidence suggests they may have important roles in health and disease.
    • “Now, researchers at the Salk Institute have created what they describe as the first microprotein atlas of the human frontal cortex with and without Alzheimer’s disease. The study, “A microprotein atlas of the human frontal cortex in Alzheimer’s disease,” was published in Nature Aging. The resource integrates transcriptomics, mass spectrometry, and deep-learning-predicted spectra across postmortem brain samples to identify microproteins that have been overlooked in standard protein catalogs.
    • “We still do not fully understand the molecular mechanisms of healthy aging, and that is especially true for microproteins, which have been inadvertently overlooked for decades,” said senior and co-corresponding author Alan Saghatelian, PhD, professor and the Dr. Frederik Paulsen Chair at Salk, in a press release. “Our atlas allows scientists to systemically investigate microproteins in aging and neurodegeneration, which should bring us closer to understanding and tackling diseases like Alzheimer’s or Parkinson’s.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “Downloads: Evidence Report | Voting Questions | Public Comments | Response to Public Comments
    • “Parkinson’s disease is a chronic and progressive neurological condition largely characterized by the loss of motor skills and physical function,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “There are currently no disease-modifying treatments, so symptom management is paramount. While tavapadon provides some relief from key symptoms, benefits were similar to those of older, generic drugs, and discontinuation from tavapadon due to adverse events was relatively high. The combination of modest benefit and uncertainties around discontinuation raise important questions about tavapadon’s long-term value.”
    • Register here to watch the live webcast of the October 1st ICER public meeting.

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

  • Beckers Hospital Review reports,
    • St. Louis-based Ascension narrowed its operating loss by $371 million in fiscal 2026, as stronger revenue, higher patient volumes and operational improvements moved the health system closer to breakeven, according to financial documents published Sept. 16.
  • and
    • “Fitch revised Chicago-based CommonSpirit Health’s rating outlook to negative from stable on Sept. 16, while affirming the health system’s “A-” rating. 
    • “The revision follows CommonSpirit’s financial results through the quarter ended March 31, which fell short of management’s internal margin targets, Fitch said in a Sept. 16 report. Fitch pointed to an uneven path to sustained profitability as the system executes several overlapping initiatives at once, including an Epic EHR rollout, insourcing revenue cycle operations and its multiphase Project Impact plan, which targets an 8% EBITDA margin by fiscal 2029.” 
  • Beckers Behavioral Health relates,
    • “U.S. News & World Report named 50 hospitals to its 2026-2027 Best Children’s Hospitals Pediatric & Adolescent Behavioral Health list.
    • “U.S. News evaluated 91 hospitals for their care of children and teens with mental and behavioral health conditions, including autism, anxiety, depression, eating disorders, ADHD, bipolar disorder, schizophrenia, language and learning disorders, and substance abuse and addiction.
    • “Programs and care in areas such as medication screening and safety, speed and efficiency of the emergency department, and management of side effects were among the factors used to rank hospitals.”
  • Beckers Payer Issues tells us,
    • “SCAN Health Plan has emerged as a major Medicare Advantage partner for retailers, with Walmart now partaking in a co-branded plan.
    • “The health insurer and retailer are launching the plan in two states, according to a Sept. 16 SCAN news release. More than 2 million enrollees are expected to have access.
    • “The MA offering could tie in pharmacy and vision services, food, and over-the-counter benefits, pending regulatory approval. The news release also said Walmart will leverage Everyday Health Signals, its AI-driven platform for tailored nutrition and wellness, in the collaboration.
    • “What makes this collaboration unique is Walmart’s role in customers’ everyday lives. Because customers regularly turn to Walmart for groceries and other everyday essentials, we have an opportunity for those who choose to participate, to use insights from their shopping experiences to make nutrition guidance more relevant and actionable,” said Pravene Nath, MD, group director for consumer health and data solutions at Walmart U.S.” * * *
    • “In August, SCAN announced plans to roll out insurance products with Costco, as well.” 
  • Beckers Physician Leadership shares the new math of physician independence.
    • “Independent physicians have spent more than a decade watching the share of their peers who own their own practices shrink. 
    • “New data exists that tells the story of what it now costs to stay independent, how much deal-making and closure activity is still working against that choice, and where regulators and a new wave of physician-owned infrastructure are starting to push back.
    • “Taken together, the figures describe less a single trend than a recalculated equation — one where the cost of going it alone, the cost of selling and a growing set of options in between are all moving at once.”
  • MedCity News informs us,
    • “Thatch, a health benefits platform, announced on Tuesday that it raised $108 million in funding, reaching a $1 billion valuation.
    • “Thatch helps employers offer Individual Coverage Health Reimbursement Arrangements (ICHRAs) — which recently rebranded as CHOICE Arrangements — in which employers can provide their employees tax-free money so they can purchase their own individual health insurance plans. Employees can also use the funds for certain healthcare expenses, including GLP-1s and therapy. More than 5,000 employers use the company, including Jersey Mike’s and Smoothie King. 
    • “The Series C funding round was from The General Partnership, Index Ventures, General Catalyst and Andreessen Horowitz. ADP Ventures, Paychex, Eli Lilly and Company, Scale Venture Partners, QuantumLight, SemperVirens, Quiet Capital and Avid Ventures also participated. In total, Thatch has raised $192.5 million in equity funding.”
  • Fierce Healthcare adds,
    • “Ayble Health secured a $16 million oversubscribed series A funding round to accelerate its expansion into artificial intelligence-driven precision digestive and autoimmune healthcare.
    • “Neon led the funding round, with participation from Unum Ventures, Upfront Ventures, M13, Cleveland Clinic Ventures, DigiTx, Accomplice and several individual investors. 
    • “I’ve been tracking the GI space closely for years, and what Ayble has built is different,” said Kimmy Scotti, Neon founding and managing partner, in a statement. “Having invested early in top digital health companies, I’ve seen what it takes to build a category-defining company in healthcare. Ayble has spent years building the clinical evidence before they scaled the business. That earns trust from the full ecosystem: health systems, payers, and most importantly, patients, and it’s what makes a durable market leader.”
  • BioPharma Dive points out,
    • “Novartis will pay $125 million up front for rights to a delivery platform designed to get drugs into the brain.
    • “Sironax, a Boston-area biotechnology company, said Tuesday that Novartis has exercised an option to acquire full ownership of that startup’s brain delivery platform. Sironax’s technology is meant to overcome a major challenge in neurological drug development: delivering therapeutics across the “blood-brain barrier.”
    • “Sironax will receive the nine-figure payout following the close of the transaction and will continue to retain rights to develop, manufacture, and commercialize certain assets with the platform. The company currently has three programs in early-stage trials that it plans to move forward using the purchase proceeds.”
  • Cardiovascular Business notes,
    • “Jaguar LAA, a new California-based medtech startup, has purchased key assets related to performing left atrial appendage (LAA) closure procedures from Johnson & Johnson. 
    • “Johnson & Johnson has owned these assets since it acquired the medtech company Laminar for $400 million back in 2023. Now, some original Laminar employees have partnered with investment firm Santé Ventures to buy back the assets and push forward as Jaguar LAA, a brand new company.
    • “The financial terms of this acquisition have not yet been made public.” 
  • The Wall Street Journal lets us know,
    • “Novo Nordisk NOVO.B, the Danish drugmaker behind blockbuster diabetes and weight-loss drugs Ozempic and Wegovy, is partnering with Anthropic to use artificial intelligence for drug research.
    • “Novo said Wednesday it would use Anthropic’s science-specific platform, known as Claude Science, to help speed up the discovery and development of new medicines and strengthen the pharmaceutical company’s software development.
    • “The partnership is the latest by a slate of major drugmakers, including Eli Lilly, Merck and Roche, that are placing big bets that AI can help them discover and produce medicines more quickly. 
    • “AI can help us increase productivity in R&D and compress the path from research to marketed product. But beyond this, AI tools can also offer completely new scientific opportunities and aid reasoning and understanding of human biology and drug mechanics,” Novo Chief Executive Mike Doustdar said.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Energy and Commerce Subcommittee on Health held a hearing Sept. 15 to discuss more than a dozen legislative proposals regarding Medicare provider payment and healthcare cybersecurity. The AHA provided comments to the subcommittee on bills designed to improve long-term physician payments, including proposals to increase the budget neutrality threshold in the Medicare physician fee schedule and a bill to replace the Merit-based Incentive Payment System with the Data-driven Performance Payment System. The AHA also commented on bills to provide grants for the adoption of cybersecurity best practices, direct the Department of Health and Human Services to create a strategy for rural hospital cybersecurity staff training, and improve obstetric emergency preparedness in rural healthcare settings.” 
       
  • MedPage Today relates,
    • “Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearing Tuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • “Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearingopens in a new tab or windowTuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • “Committee chairman Sen. Mike Crapo (R-Idaho) took the opposite view. “You have met all of the requirements and standards of this committee in vetting a nominee, and you are completely and well qualified to be deputy secretary at the Department of Health and Human Services,” he told Klomp.” 
  • The Wall Street Journal adds,
    • “Pennsylvania health officials announced Tuesday a fourth measles-associated death, the latest fatality in the commonwealth where recently reported deaths from the vaccine-preventable disease have inflamed politics at the local and national level.
    • “The death follows those of two infants in the state’s Lancaster County in mid-August amid a growing measles outbreak. The state health department’s classification of those deaths spurred a highly politicized debate over vaccinations and sparring between the state’s Democratic governor and the nation’s health secretary.
    • “Over the weekend, a coroner in Pennsylvania’s Jefferson County said a 40-year-old woman there died from complications from measles. The Mifflin County Coroner’s Office on Tuesday said an 18-year-old resident died due to a rare neurological complication from measles. The state health department said it worked with local coroners’ offices to determine both individuals tested positive for measles and the deaths didn’t result from an unrelated cause.
    • “That’s four total measles-associated deaths in our Commonwealth and the first Pennsylvania has seen in 35 years,” Pennsylvania Gov. Josh Shapirosaid in a post on social media Tuesday. “These are tragedies, and four families are grieving.”
  • Per a U.S. Census Bureau news release,
    • “The U.S. Census Bureau today announced that real median household income was $87,460 in 2025, the highest on record dating back to 1967.
    • “The official poverty rate fell 0.5 percentage points to 10.2% in 2025. The following 2025 findings were not statistically different from 2024: the Supplemental Poverty Measure (SPM) rate in 2025 was 13.1% and in 2025, 26.7 million people (7.9%) were uninsured for the entire year, according to the 2026 Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • ‘These findings come from three Census Bureau reports, “Income in the United States: 2025,” “Poverty in the United States: 2025” and “Health Insurance Coverage in the United States: 2025.”
  • Beckers Hospital Review tells us,
    • CMS will add four condition tracks to its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model starting in spring 2027, the agency said in a Sept. 15 news release.  
    • Four things to know: 
      • “The expansion adds heart failure, chronic obstructive pulmonary disease, substance use disorders and tobacco cessation to the model. CMS will also expand support for chronic musculoskeletal pain, extending coverage for certain conditions beyond the model’s initial 12-month care period.
      • “The model already covers hypertension, diabetes, chronic musculoskeletal pain and depression. CMS says 3 out of 4 Medicare beneficiaries qualify for at least one track.
      • “The ACCESS model ties Medicare payments to measurable improvements in patient health rather than paying solely for individual services. Participating organizations can offer virtual care, health coaching, remote monitoring, and connected devices and wearables between regular doctor visits.
      • “There are currently 160 organizations participating in the ACCESS model, and CMS said Medicare will continue to add to the list throughout the model’s 10-year run. The model supports those with traditional Medicare. Medicare Advantage enrollees are not eligible, but CMS said MA plans may offer similar programs.”

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

  • OPM included the following additions in today’s Federal Register.
    • Rules
      • Reduction in Force; Correction
      • Shared Certificates and Pooled Hiring Actions
    • Proposed Rules
      • Promoting Employee Accountability
  • Federal News Network reports,
    • “The fewest number of federal employees submitted their retirement papers in August as compared to the rest of 2026. The Office of Personnel Managements says it received only 7,618 retirement claims last month. This is down from more than 10,000 claims OPM received in July. Additionally, OPM’s backlog of retirement claims is at the lowest of the year at just over 15,400. The average number of days to process a claim for August also dropped considerably: to 70 days for a digital claim, down from 98 days the month before, and to 79 days for all claims, down from 109 days in July. (Federal retirement claims down, as the backlog hit lows for 2026 – OPM)”
  • Kevin Moss, writing in Federal News Network, discusses
    • “Healthcare affordability series part 8: Enrollment flexibility for two-person families can lead to premium savings.”
      • “Most of the time, self-plus-one is cheaper, but there are plans where you’ll save more enrolling as self & family.”
  • Govexec relates,
    • “More ‘Big Balls’-type young feds are what the OPM chief wants 
      • “In an interview on Monday, Scott Kupor also discussed implementing skills-based hiring, which had been a priority of the Biden administration as well.”

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

  • STAT News relates,
    • “The Food and Drug Administration is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday. 
    • “The pilot was first announced in June as part of Operation TrialBlazer, the Department of Health and Human Services initiative that pledged to shorten the FDA’s drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia.
    • “Too often, the U.S. pathway can be measured in years, while other countries’ pathways are measured in months,” the department wrote in the TrialBlazer roadmap.”
  • and
    • “Vera Therapeutics said Tuesday that its recently approved drug Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease, according to final, two-year results from a Phase 3 clinical trial. 
    • “In July, the Food and Drug Administration granted accelerated approval to Trutakna for the treatment of IgA nephropathy, or IgAN, a disease caused by the buildup of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.
    • “With the final data from the study in hand, Vera said it will seek full approval of the drug from the FDA during the fourth quarter.”
  • Cardiovascular Business tells us,
    • “XCath Robotics has received the FDA’s breakthrough device designation for its Iris surgical robotic system that performs remote robotic-assisted mechanical thrombectomy in acute ischemic stroke patients.
    • “This represents a significant step forward for the Houston-based medtech company. The FDA’s breakthrough devices drogram helps support the development of medical devices that have the potential to provide more effective treatment for patients with life-threatening or irreversibly debilitating conditions. This provides XCath Robotics with more opportunities to interact with FDA experts and receive support as the company works toward U.S. regulatory approval for the Iris system.
    • “Back in March, the Iris system was used to complete the world’s first telerobotic stroke thrombectomy. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the system to perform the historic procedure in Santiago, Panama, while the patient was 120 miles away in Panama City.”

No Surprises Act News

  • The FEHBlog did receive his CMS invitation to join its Independent Dispute Resolution Gateway this morning, and the FEHBlog promptly took CMS up on its offer. The process went smoothly.
  • The Paragon Institute September 15, 2026, Newletter’s kicks off with an article about “Fixing the No Surprises Act’s Broken Arbitration System.”
    • “Congress already required much of this transparency through the NSA’s Advanced Explanation of Benefits provisions, but those requirements have yet to be fully implemented. The administration should finish that work. Once patients have meaningful advance information about networks and prices, there is no justification for a federal arbitration system setting payments for elective care.
    • “For emergency services, a different approach is needed, and Congress has two reasonable options. It could eliminate federal IDR entirely while maintaining the prohibition on balance billing, leaving insurers and providers to settle payment disputes through private arbitration, litigation, or state law.
    • “Alternatively, Congress could retain IDR solely for emergency services but impose meaningful guardrails. Awards should have a reasonable upper limit so arbitration does not continue producing payments wildly disconnected from market prices. Congress should also reform how arbitrators are paid, and if an upper limit is implemented, insurers should face penalties when they fail to pay awards on time.
    • “The administration can make additional improvements now: require arbitrators to explain their decisions, audit firms with unusually high provider win rates or awards, strengthen eligibility reviews, improve arbitrator training, prohibit conflicts of interest and forum shopping, and restore a meaningful filing fee.
    • “The No Surprises Act solved a real problem by protecting patients from bills they could neither anticipate nor avoid. Those protections should remain. But protecting patients from surprise bills does not require a federal arbitration system that rewards providers for staying out of network and raises health care costs for everyone.”

From the fraud, waste, and abuse front,

  • Healthcare Dive reports,
    • “The federal government is once again targeting fraud in durable medical equipment suppliers, publishing a report Monday through the HHS’ Office of the Inspector General that urges regulators to crack down on suspect billing in Medicare Advantage.
    • “The OIG found that, in addition to other issues, MA organizations don’t screen for fraudulent medical equipment suppliers as often when they’re out of network, compared to in-network suppliers.
    • “MA organizations should tighten the screening process for suppliers and the CMS should use its fraud prevention tool more regularly, the OIG said.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “In recognition of Suicide Prevention Month, Susan Szulewski, M.D., president and chief operating officer, McLean Hospital and vice president, Mass General Brigham Behavioral and Mental Health, wrote on the importance of healthcare organizations working to reduce the stigma surrounding suicide and create a supportive environment with timely access to care and a clear path forward. READ MORE“
  • Per a CDC news release,
    • “Today, the Centers for Disease Control and Prevention and the Ad Council are launching a new round of public service announcements (PSAs) encouraging people to understand their risk of prediabetes and take action to prevent or delay type 2 diabetes.
    • “Now in its 10th year, the national “Do I Have Prediabetes?” campaign encourages viewers to take a 1-minute prediabetes risk test on DoIHavePrediabetes.org. This year’s “Undo It” PSAs spotlight that while there are many scenarios in life we can’t undo, prediabetes is something that can be reversed. 
    • “Prediabetes is a serious health condition that increases the risk of type 2 diabetes, heart attack and stroke. Because prediabetes often has no symptoms, many people do not know they have it. Research shows that early diagnosis can inspire individuals to adopt healthier habits, including eating better, being active and managing weight, that can reverse prediabetes and delay or prevent type 2 diabetes.
    • ‘If someone receives a high score on the risk test, that person is encouraged to speak to a doctor to confirm a diagnosis of prediabetes with a blood test, then enroll in the National Diabetes Prevention Program.” 
  • Healio tells us,
    • “Development of alcohol use disorder, depression or stress after a traumatic event was a strong predictor of major adverse cardiac and cerebrovascular events for both men and women, researchers reported.
    • “Evaluation of psychiatric predictors of major adverse events may be an important step in the prediction of CV risk after a traumatic event, according to data published in the Journal of the American Heart Association.
    • “Experiencing traumatic events can have long-lasting consequences for mental health that can take many forms, but research to date had yet to comprehensively consider these. Indeed, nearly all work on trauma and CVD had focused on PTSD and other stress-related disorders — the quintessential trauma-related mental health disorders — but depression, anxiety and substance use disorders are also common following trauma and are relevant to cardiovascular disease risk,” Jennifer A. Sumner, PhD, associate professor of psychology at the University of California, Los Angeles, told Healio. “We wanted to comprehensively investigate different posttraumatic mental health conditions as possible predictors of CVD onset. Also, given sex differences in both posttraumatic psychopathology and CVD, we examined whether links between various psychiatric disorders following trauma and CVD might differ for men vs. women.”
  • Health Day informs us
    • “New research suggests that the blood pressure and heart rate guidelines doctors use to guide emergency treatment in children are misleading in cases of traumatic injury. 
    • “These thresholds for “hemodynamic instability” — the inability of the circulatory system to get blood to organs — may be different for children with traumatic injuries versus healthy children, researchers wrote Sept. 9 in the Journal of the American College of Surgeons.
    • “Recognizing hemodynamic instability is fundamental in trauma care because these vital signs tell us when a child may be at increased risk of death or complications and when we may need to intervene,” explained study senior author Dr. Zain Hashmi. He’s an assistant professor of trauma and acute care surgery at the University of Alabama at Birmingham.
    • “Blood pressure and heart rate guidelines are often used by doctors to decide when to start resuscitation treatments, including blood transfusions, Hashmi said in a news release. However, the values used in children were not developed specifically for trauma patients and may not accurately reflect when the risk of death begins to rise in injured children, he added.” 
  • Medscape points out,
    • “A new international consensus statement providing evidence-based guidance on smoking cessation for people with type 2 diabetes (T2D) has been issued by a multidisciplinary international panel called the DiaSmokeFree Working Group. 
    • “The central message “is that smoking cessation needs to be treated as an integral part of diabetes management rather than as generic lifestyle advice,” statement co-author Riccardo Polosa, MD, PhD, professor of internal medicine at the University of Catania in Catania, Italy, told Medscape Medical News.
    • “There is evidence that this is under-prioritized in diabetes care,” he added. “Clinicians understandably focus on glucose, blood pressure, lipids, and medications, while smoking may receive only brief and mostly ineffective advice.”
  • Today’s issue of NIH’s Research Matters covers the following topics:
    • “Depression may stall development of new neurons 
      • “Researchers found that a part of the brain important for memory struggles to make new neurons in people with depression.
      • “The study sheds light on how the brain is altered in depression and suggests new treatment targets.”
    • GLP-1 drug slows aging in mice 
      • A GLP-1 drug extended lifespan and prevented age-related decline in older female mice.
      • Understanding how calorie restriction and GLP-1 drugs slow aging could lead to new ways to treat age-related diseases.
    • Antibodies may prevent tick-related syndrome 
      • “Researchers identified rare antibodies that may help combat alpha-gal syndrome, a condition that causes allergic reactions to red meat and dairy products.
      • “With further development, the finding could lead to treatments for this tick-related allergic condition.”

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

  • Beckers Payer Issues reports,
    • “Aetna’s two-year financial turnaround has taken hold following a leadership overhaul, thousands of ongoing cost management initiatives and a margin recovery plan expected to complete by 2027.
    • “Once you get the fundamentals in place, you start getting credibility, not only with investors, but internally with our employees, and then, in particular, with our members,” Aetna President Steve Nelson said Sept. 9 at the Wells Fargo Healthcare Conference. “We can be a little more disruptive and innovative. Aetna has a legacy of being innovative in terms of product and clinical programs, and we are getting back to that.”
    • “The insurer has spent the past two years in recovery mode after a period of financial turmoil driven by Medicare Advantage cost pressures, previously unfavorable star ratings and major losses in the ACA business, which it exited for 2026. Mr. Nelson, who also serves as executive vice president at CVS Health, was tapped to lead the insurer in late 2024.”
  • and 
    • “Health Care Service Corp. has completed the rebranding of its Medicare supplement and supplemental health and life products under the HealthSpring name.
    • “The move finishes a transition that began last year, when HCSC shifted the Medicare Advantage and Part D business it acquired from Cigna for $3.3 billion to the HealthSpring brand. 
    • “HealthSpring has more than 3 million members. HCSC said it is the second-largest Medicare supplement carrier by policyholders, with plans available in 48 states and Washington, D.C. Its supplemental health and life products, which include hospital indemnity and dental, vision and hearing benefits, are offered in 49 markets and D.C.”
  • and
    • “The Blue Cross Blue Shield Association has tapped Daniel Serrano to serve as CFO.
    • “The president and CEO of the BCBS Association, Kim Keck, announced the update Sept. 14 on LinkedIn. 
    • “With critical capabilities for this moment, including a practitioner’s orientation to data-driven financial management and a strong track record of aligning financial performance with operational outcomes, Dan is a great fit for our organization,” she said.”
  • Fierce Healthcare adds,
    • “Member trust in insurers is on the decline among Gen Z and Millennials, down 10.5% between 2023 and 2026, new research from Accenture found.
    • “This trust gap, according to analysts, could cost $3 billion in future member lifetime value for the largest commercial payers over the next decade. 
    • “When members don’t trust their health plan, they don’t just disengage; they route around it,” said Bracken Flynn, Accenture’s Health industry principal director, in a statement. “Our data shows that younger consumers aren’t asking for less from their insurer. They want more. They’re looking for a partner that helps them navigate care, understand costs, and make confident decisions. The insurers that earn that trust now will define what health coverage means for the next generation.”
    • “During a Sept. 14 AHIP webinar, Flynn said the report—which polled 1,200 consumers—found members trust insurers when they believe the health plan will help them make good healthcare decisions and navigate them to the best care.
    • “That’s across clinical and administrative touchpoints,” Flynn said. “And so it’s a partnership. In practice, it’s a partnership.”
    • “The lack of trust in insurers is causing younger members to turn to artificial intelligence tools, with 62% of respondents saying they have used AI to help choose a health plan.”
  • The American Hospital Association News relates,
    • “A new report from Kaufman Hall prepared for the AHA highlights new insights and data on hospital mergers and acquisitions. An AHA blog accompanying the report is also available.
    • “The report discusses how hospital merger reviews should look beyond the potential impact on commercial insurance prices and consider what proposed transactions mean for all patients, particularly the nearly 60% of hospital patient days attributable to Medicare, Medicaid and Medicare Advantage beneficiaries whose payment rates are largely set by government programs. Drawing on analyses of challenged and canceled transactions, the report also finds that hospitals seeking partners often serve more vulnerable communities and face greater financial pressures, and that when proposed deals do not move forward, struggling hospitals can experience significant financial deterioration that threatens services, workforce stability and access to care.
    • “These findings suggest that a more comprehensive analysis of hospital M&A transactions, one that considers impacts on all patients served, broadens the focus to impacts beyond pricing, and considers the consequences if an M&A transaction is not permitted to proceed, would ensure not only competitive but also healthy hospital markets that can continue to provide the fullest possible range of services,” the report says.”
  • AHIP relates,
    • “New data highlighted by Washington Post Intelligence show hospital system consolidation continues to accelerate, with 40 new mergers and acquisitions announced already in the first half of 2026 — nearly as many as throughout all of 2025. 
    • “Clear evidence demonstrates that anticompetitive hospital consolidation leads to higher healthcare costs for patients, families and employers. Hospital spending already makes up the largest share (40%) of insurance premiums, accounting for over $1.6 trillion in spending nationwide.”
  • Beckers Hospital Review adds,
    • “Salt Lake City-based Intermountain Health has acquired the nine-story, 235,000 square-foot Fairbourne Building in West Valley City, Utah, and plans to convert it into a medical campus.”
  • and
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said.”
  • Cardiovascular Business points out,
    • “U.S. News & Report has published its annual ranking of the top children’s hospitals in the United States, once again producing a separate list for the best hospitals for cardiology and heart surgery. This represents the 20th year that U.S. News.& World Report has compiled these rankings.
    • “For two decades, U.S. News has helped guide families to top-tier pediatric care,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement. “Finding the right medical team for a rare diagnosis or complex surgery can be overwhelming, and U.S. News’ annual evaluation of the Best Children’s Hospitals provides a clear starting point for parents and referring pediatricians alike.”
    • “Nearly 200 U.S. facilities were eligible for these rankings. Each one is either a freestanding children’s hospital or a large multidisciplinary pediatric department working within a major medical center.
    • “This latest ranking of the Best Children’s Hospitals for Cardiology and Heart Surgery includes some familiar names at the top. For instance, Texas Children’s Hospital in Houston is No. 1, just like it was in 2019, 2020, 2021, 2022, 2023, 2024 and 2025. 
    • “Meanwhile, Children’s Hospital Colorado and Duke Children’s Hospital and Health Center are No. 2 and No. 3, respectively. That is where each one landed in the previous year’s ranking as well. 
    • “Going a bit deeper, Children’s Hospital of Philadelphia came in at No. 4, and Children’s Health Dallas came in at No. 5.” 
  • MedCity News lets us know,
    • “Virtual solutions for chronic kidney disease (CKD) management don’t slow disease progression, nor do they reduce total healthcare spending, according to a new analysis by the Peterson Health Technology Institute (PHTI).
    • “PHTI is an independent evaluator of digital health solutions. For the analysis, PHTI reviewed more than 5,400 articles and other evidence. The solutions evaluated in the report include DaVita IKC, Evergreen Nephrology, Healthmap Solutions, Interwell Health, Kidneylink, Monogram Health, Somatus and Strive Health. These companies take on financial responsibility for the total cost of care for patients with stage 3–5 CKD, and typically work with Medicare Advantage plans and Medicare’s Kidney Care Choices model.
    • “The assessment focuses on managing chronic kidney disease before patients progress to end-stage kidney disease, including the need for dialysis or a kidney transplant.”
  • Managed Healthcare Executive tells us,
    • “GLP-1s now dominate market momentum, with obesity products surging from near-zero in 2022 to $55B annually and diabetes GLP-1s sustaining double-digit year-over-year growth. 
    • “Independent pharmacies are reassessing dispensing economics, with refusal rates declining to 35% for weight-loss GLP-1s and 8% for diabetes GLP-1s. 
    • “Distribution remains retail-heavy (~80%), but mail fulfillment is increasing, reaching 12.9% of GLP-1 prescriptions as direct-to-consumer channels expand. 
    • “Diabetes category mix is shifting away from insulin, whose sales share has dropped to 9.8% and prescription share to 16%, reflecting GLP-1 substitution dynamics. 
    • “Medicare Part D Bridge uptake appears immediate, with 9,000 paid claims in three days, alongside a large pipeline exploring neuropsychiatric, SUD, cancer-risk, women’s health, and systemic inflammation indications.”
  • The Wall Street Journal informs us,
    • “Legend Names Novartis Executive as CEO
      • “Ingrid Zhang takes the helm of the cancer therapy company, filling a post vacant since its previous CEO abruptly resigned in July.”
  • Per Beckers Health IT,
    • “Oracle has expanded its fiscal 2026 restructuring plan by approximately $700 million, bringing expected costs to roughly $2.8 billion as the company pursues strategic initiatives and operational efficiencies that include adopting and integrating AI across certain functions.
    • “The Sept. 11 Securities and Exchange Commission filing does not specify what actions the additional $700 million will cover or how many employees could be affected. Oracle said restructuring expenses under the broader plan include employee severance, contract termination and other exit costs.
    • “As of Aug. 31, prior to the additional $700 million, Oracle estimated total restructuring costs of up to $2.1 billion.
    • ‘The disclosure comes as Oracle employees across social media reported a recent round of layoffs, including at Oracle Health. Business Insider first reported the layoffs Sept. 14, citing three people affected and an email notification.”
  • and
    • “Mayo Clinic and Thermo Fisher Scientific have launched Precure, a joint venture designed to detect biological signs of disease before patients develop symptoms, according to a news release shared with Becker’s.
    • “Rochester, Minn.-based Mayo Clinic, will serve as majority owner of the entity and Thermo Fisher joins as a minority partner. Precure will build one of the world’s largest human multi-omics datasets — integrating proteomic and genomic data with longitudinal clinical information drawn from 1 million biospecimens collected over several years, according to the release.
    • “At Mayo Clinic, we are committed to transforming patient care through innovation,” said Gianrico Farrugia, MD, president and CEO of Mayo Clinic. “By harnessing the full potential of multi-omics data, Precure, LLC aims to help us better understand disease before symptoms appear.”
    • “Thermo Fisher will contribute its Olink Explore HT proteomics platform and Orbitrap mass spectrometry technology to the effort. Marc Casper, Thermo Fisher Scientific’s chairman and CEO, said the venture has “the potential to create a step change in how we generate and apply multi-omics data to improve human health.”
    • “Target disease areas include cancer, cardiometabolic conditions, neurological disorders and immune-mediated disease — conditions where biological changes often precede clinical diagnosis by years. Advanced AI and large-scale data analytics will be used to identify patterns across the datasets and translate them into actionable insights.”
  • Per Beckers Clinical Leadership,
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said. 
    • “These efforts aim to create a public, multimodal dataset to “help reach a future where cancer patients can get rapid personalized cancer vaccines when they are diagnosed,” the OpenAI Foundation said in a Sept. 15 news release. 
    • “UNC Lineberger’s $40 million grant is part of a $125 million funding program, called Public Data for Health, established by the foundation.”
  • and
    • “Ambient artificial intelligence handed many physicians their evenings back. For nurses, the same promise is proving harder to keep, and the reason is buried in the flow sheet.
    • “Physician ambient scribes listen to a visit and draft a narrative note when it ends. Nursing documentation does not work like that. It lives in structured flow sheets, entered field by field across a shift, every time a nurse assesses, medicates or turns a patient.
    • “Nursing documentation occurs throughout the entire shift. It’s every time we interact with a patient,” said Stephanie Clements, BSN, RN, senior vice president and chief nurse executive at Chesterfield, Mo.-based Mercy. “It’s very different than summarizing care at the end of a period.” 
    • “That difference is why early attempts to copy the physician model — record the encounter, generate the note — have not mapped cleanly onto the bedside, and why some nurses have found the tools slower, not faster, at first.
    • “Yet the systems furthest along say the payoff is real when the technology is built for nurses from the get-go.” 

Notable Deaths

  • The New York Times reports
    • “Harold P. Freeman, an influential oncology surgeon whose knowledge of the devastating effects of breast cancer on poor Black women inspired him to create a landmark program at Harlem Hospital Center, helping patients navigate the health care bureaucracy, died on Aug. 11 in Atlanta. He was 93.
    • “His death, at a hospital, was confirmed by his son Neale.
    • “Dr. Freeman’s patient navigation program became a model for hospitals around the world, helping to eliminate barriers to early cancer detection. The program’s success influenced the passage of the federal Patient Navigator Outreach and Chronic Disease Prevention Act of 2005, which provided $25 million for similar programs across the United States. In 2024, Medicare began providing providers with reimbursement for some navigation services for cancer, heart failure, H.I.V./AIDS and other high-risk conditions.
    • “There are no navigation events or meetings that don’t acknowledge Dr. Freeman’s role in patient navigation,” Dr. Shanthi Sivendran, the interim chief patient officer of the American Cancer Society, said in an interview. “There wasn’t a patient navigation concept before him.”
  • and
    • “The milk truck would pull up to the house, and out would come the groceries — not just milk, but also eggs, cheese, juice, cereal and baby formula. It might have stopped at a rich family’s house, or a poor one. No one could tell the difference, which was precisely the point.
    • “Vermont’s supplemental food program for low-income women, infants and children, the first in the nation to be implemented statewide, began in 1974. It was the brainchild in part of Dr. Anthony Robbins, then one of the country’s youngest state health commissioners, at 33; he had secured a federal grant to made the program possible.
    • “Not only did the program provide much-needed supplies, but it also shielded families from the stigma of receiving public assistance.
    • “The milk truck was stopping at practically every house — high income, low income, whatever,” Donna Bister, a former director of the program, known widely as WIC, said in an interview. The program is now available in all 50 states.” * * *
    • “Dr. Robbins died on July 5 at his home in Rockport, Mass. He was 85. His death, which was not widely reported at the time, was caused by complications of long Covid, heart disease and Parkinson’s disease, his wife, Phyllis Freeman, said.
    • “He was considered to be on the cutting edge of health care,” Madeleine Kunin, a former governor of Vermont, said in an interview. “He was a bright light.”
  • RIP Doctors.

Weekend update

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Hill explains,
    • “House and Senate lawmakers will return to Washington this week with a packed agenda before much of their focus shifts to the fast-approachingmidterm elections.
    • “The Senate is expected to continue talks over the budget resolution and hold a procedural vote on the cryptocurrency regulation bill, among other priorities. The House, meanwhile, will reportedly consider a Senate-passed Russia sanctions bill prior to departing again until mid-November, after House Republican leaders recently cut two weeks from the chamber’s September schedule ahead of the midterms.”
  • MedPage Today reports,
    • “Healthy Moms, Healthy Babies America, a bipartisan campaign founded by philanthropists Olivia and Tom Walton, announced a $100 million pledge to make giving birth in the U.S. safer.
    • “The 5-year commitment aims to cut the maternal mortality rate in the U.S. in half by 2031.
    • “For millions of moms in America, maternal health is bad and getting worse,” Olivia Walton told the Associated Press in an interview. “There’s just so much bipartisan consensus around wanting to fix this. I really think the political will is there and part of our job is to help surface that with an information campaign.” * * *
    • “According to the most recent data available, the U.S. has one of the highest maternal mortality rates among wealthy nations. The CDC said 688 people died in 2024 during pregnancy or shortly after giving birth. The maternal mortality rate rose to 19 deaths per 100,000 live births in 2024, up from 18.6 the year before.
    • “Improving data collection and accelerating hospitals’ reporting of deaths is an important pillar of the new Healthy Moms, Healthy Babies America initiative, Walton said. The most recent state-level data on maternal mortality is still from 2022, with annual totals based on provisional data available through 2024.”

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

  • Per Department of War news release,
    • “The Department of War has extended and expanded the Pilot Health Insurance Enhancement for DOW Civilian Employees in Japan, reaffirming its commitment to securing high-quality healthcare navigation and mitigating upfront medical costs for its overseas civilian workforce and their families.
    • “The contract extension, awarded to International SOS Government Services, Inc., begins Sept. 30, 2026, and runs through Sept. 29, 2027. In direct response to feedback from the DOW civilians, eligibility is now expanded to include authorized dependents of DOW civilian employees, provided they are enrolled in a participating Federal Employee Health Benefit plan.” * * *
    • “The pilot program, which originally launched on Jan. 1, 2025, was designed to provide no-cost supplemental health support services to DOW civilian employees. The program addresses longstanding challenges in navigating Japan’s healthcare system and managing upfront medical costs. In response to DOW civilian employee feedback, the program previously added interpreter services to address language barriers and improve access to care.
    • “Alongside the expansion of eligibility to dependents and as part of the contract extension, the program is updating call center hours. Beginning Sept. 30, 2026, the bilingual call center will operate Monday through Friday, from 7 a.m. to 7 p.m. Japan Standard Time.
    • “To participate in the pilot, DOW civilian employees and their dependents must be enrolled in one of the following participating FEHB plans:
      • “Federal Blue Cross Blue Shield
      • “Foreign Service Benefit Plan
      • “Hawaii Medical Service Association
      • “Government Employees Health Association
      • “Mail Handlers Benefit Plan
    • “Nonappropriated Fund employees and their dependents in Japan are also eligible if enrolled in Aetna International and should coordinate support through their insurance carrier first.”

From the Food and Drug Administration front,

  • MedCity News reports,
    • “Nutromics landed FDA breakthrough device designation this week for its wearable patch that monitors vancomycin levels in real time. 
    • “Vancomycin is a widely used antibiotic for treating life-threatening infections like sepsis, but it’s notoriously difficult to dose correctly, with doctors typically relying on periodic blood draws to track it.
    • “Nutromics was founded in 2017 with the goal of replacing these blood draws with continuous data for the roughly 2.9 million patients in the U.S. who receive vancomycin each year. The new designation gives the company faster, closer engagement with the FDA as it works toward an eventual commercial launch.”

No Surprises Act News

  • On September 15, 2026, the Centers for Medicare and Medicaid Services will open its Independent Dispute Resolution Gateway to registration by non-initiating parties, typically health insurers and plans.
    • “All potential users of the IDR Gateway can begin creating accounts on September 15, 2026.
    • “Your organization should select at least one IDR Gateway administrator (CMS recommends two, and no more than 10) to set up your organization in the IDR Gateway.
    • “The Federal IDR Team will email selected administrators instructions to create their accounts and set up their organizations.
    • “If your organization selects you as an administrator and the Federal IDR Team did not email you instructions, email IDRGatewayHelp@cms.hhs.gov.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A 40-year-old Pennsylvania woman died Saturday from complications associated with measles, the local coroner said.
    • “It was the first measles-related death in Jefferson County, according to county coroner Greg Furlong. The woman was unvaccinated, Furlong said.” * * *
    • “Measles cases in the U.S. are at their highest level in three decades, with 3,924 confirmed cases so far this year, according to the Centers for Disease Control and Prevention. There were 2,289 confirmed measles cases in the U.S. last year, including the first measles-related death in a decade.
    • “The rapid spread illustrates a new normal in the U.S., where falling vaccination rates have made more communities vulnerable to the highly infectious disease that the country declared eliminated more than 25 years ago.”
  • The Washington Post relates,
    • “The number of cancer deaths estimated to be attributable to alcohol in the United States doubled from 1990 to 2023, particularly among men and people aged 55 years and older, according to a University of Miami study published this month, adding to the body of recent research underscoring the health risks of alcohol consumption.
    • “Around 23,126 people died of alcohol-attributable cancer in 2023, up from 11,361 in 1990, according to the study, which estimated the deaths using a global database of disease mortality and population-level estimates of alcohol exposure.
    • “The impact of alcohol, a known carcinogen, increased over the past decades as cancer mortality decreased overall, according to the study. 
    • “Even though overall the cancer mortality was going down for some of these cancers … alcohol-associated mortality was going up,” said Chinmay Jani, a hematology-oncology fellow at the University of Miami’s Sylvester Comprehensive Cancer Center and one of the authors of the study. “Which means that alcohol as a risk factor was impacting more cancer deaths in 2023 than it was in 1990.” * * *
    • “Gilberto Lopes, chief of the division of medical oncology at Sylvester and another author of the study, added that the data did not establish a safe threshold for alcohol consumption. 
    • “It is difficult to ascertain exactly what the safe level of alcohol is,” Lopes said. But “it is quite clear that we do know the mechanisms through which alcohol causes cancer. So that there’s no dispute about.”
  • The New York Times considers whether “Motion Sickness is Preventable?”
    • “Experts say there are ways to stave off that dreaded queasy feeling.”
  • Health Day tells us,
    • “A widely used weight-loss and diabetes drug may offer a surprising bonus: healthier lungs.
    • “Researchers compared tens of thousands of patients prescribed either a GLP-1 medication or another type of diabetes treatment to see if they helped with asthma or COPD.
    • “The results: Only one — semaglutide, the active ingredient in drugs like Ozempic and Wegovy — made a difference.
    • “It was associated with nearly 40 percent fewer asthma attacks and 20 percent fewer COPD flare-ups.
    • “No significant association was found with the other GLP-1 meds, regardless of dose or underlying lung disease.
    • “The lead researcher calls the findings encouraging but says, for now: “People with asthma or COPD should not start GLP-1 receptor agonists specifically for their lung condition outside current prescribing guidance.”
  • STAT News informs us,
    • “AstraZeneca said Friday that a breast cancer pill failed in a pivotal trial testing it as a first-line therapy in advanced tumors, a result that could limit the use of the medicine.
    • “The drug, camizestrant, in combination with another medicine did not outperform standard treatment on a measure of how long patients went before their cancer progressed. The SERENA-4 trial enrolled patients with ER-positive, HER2-negative advanced cancer who hadn’t had another systemic therapy for advanced disease.”
    • “Camizestrant earlier this month won accelerated approval in the U.S. as Etcamah as a treatment for patients who develop a mutation in their tumors that’s a sign of emerging drug resistance. The SERENA-4 trial, had it been successful, could have opened up a much larger market for the drug. 
    • “AstraZeneca is also testing camizestrant in early breast cancer.
    • “Early breast cancer represents an important opportunity, and we remain confident in the long-term potential of Etcamah in the early setting as we advance our broader program,” Susan Galbraith, AstraZeneca’s head of oncology R&D, said in a statement, adding that the company was “disappointed by the SERENA-4 outcome.”
  • The New York Times points out,
    • “Until last Friday, cardiologists thought they were on the verge of a new frontier in treating heart disease.
    • “Three companies were conducting large clinical trials on experimental drugs that slash levels of a blood protein, Lp(a), thought to cause heart attacks and stroke. Doctors were eagerly awaiting the results, hoping the drug could be as important as a statin.
    • “When Novartis, the first company to complete its trial, announced its results, late Friday afternoon, after the markets closed, cardiologists were shocked. The drug could lower Lp(a) levels by 80 percent, but it did not prevent heart attacks and strokes. It had failed.
    • “There’s something we don’t understand here,” said Dr. John Alexander, a cardiologist at Duke.
    • “Cardiologists regularly see patients who have had heart attacks even though their cholesterol and blood pressure levels are low. They do not have diabetes or obesity, and they do not smoke, either. All too often, though, they have high levels of Lp(a).”
    • “About 20 percent of Americans have elevated levels; people with the highest levels of the protein can have double or triple the risk of a heart attack.
    • “So there was no question that Lp(a) was important. A drug to lower the level of the protein, cardiologists hoped, could provide a way for these patients to protect themselves.
    • “But the failure of the Novartis study raised an uncomfortable possibility: Maybe Lp(a) is not a cause of heart disease, but instead is a marker of heart disease risk, like white hair is a mark of aging.
    • “If Lp(a) is a marker, though, what is it marking? Is there another cause of heart disease that no one has thought of?
    • “That is “the nagging question we are all pondering,” said Dr. David Maron, president of the American Society for Preventive Cardiology.”

From the U.S. healthcare business front,

  • Benefits Pro reports,
    • Executives from Aetna and its parent, CVS Health, are hoping that focusing on Aetna’s relationships with doctors will be good medicine for soaring health coverage costs.
    • Steve Nelson — an executive vice president at CVS and president of Aetna — talked about Aetna’s efforts to hold down health coverage cost increases today [September 9, 2026], in Boston, during a session at a health care conference for investors organized by Wells Fargo.
    • “Absolute health care costs are still much higher than any of us would like to see them,” Nelson said.
    • “Aetna is organizing about 2,000 different initiatives to get cost trends under control, he said.
    • “If initiatives to support relationships with the providers succeed, that should make many of the initiatives work more smoothly, Nelson said.
    • “CVS streamed audio of the call live on the web and posted a recording online.”
  • Reuters relates,
    • “GE HealthCare Technologies (GEHC.O) is ​in talks over a possible $1 ‌billion deal to buy radiopharmaceutical developer Sofie Biosciences, the Financial Times reported on ​Sunday [September 13, 2206], citing people familiar with ​the matter.
    • “A deal ⁠for Sofie, which specializes in ​radioactive chemicals used in cancer scans, ​could be announced as soon as next week, the report said.
    • “Reuters could not immediately ​verify the report. GE HealthCare ​declined to comment while Sofie Biosciences could ‌not ⁠be immediately reached for comment outside regular business hours.”

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.”  

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

No Surprises Act News

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

From the fraud, waste, and abuse front,

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

From the public health and medical / Rx research front

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

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

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

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “House Republicans are scrapping the last two weeks the chamber was scheduled to be in session before the midterm elections.
    • “Under the revised schedule announced Thursday, the House will return for votes the evening of Monday, Sept. 14, a week after Labor Day, for what is now expected to be only a one-week session before members return to their home districts.
    • “President Donald Trump signed a stopgap spending bill on Wednesday that will keep the government open through Dec. 11, which some argue has essentially negated the need for an extended September session. 
    • “I don’t think there’s any probably compelling reason that we need to be here” late in the month, said Rep. Robert B. Aderholt, R-Ala., a House appropriator.
    • “I think everybody’s so focused on the election at this point that we’ll just have to wait till the election’s over,” he added, when asked about passing more of the House’s fiscal 2027 spending bills.”
  • FEHBlog observation — September 14 also is the first day that the Senate returns from its State work break.
  • Fierce Healthcare relates,
    • “A leading Democrat in the House is probing the behavior of No Surprises Act arbiters.
    • Energy and Commerce Committee Ranking Member Frank Pallone, D-New York, sent letters to six certified independent dispute resolution (IDR) entities, seeking details on how each of them is conducting arbitration and staying in compliance with the law as IDR payouts rise.
    • “Pallone’s office sent letters to C2C Innovative Solutions, Inc.; Commence; Dane Street, LLC; EdiPhy Advisors, LLC; National Medical Reviews, Inc.; and ProPeer Resources, LLC on Thursday, per an announcement.
    • “In the letters, he notes the rising number of surprise medical bills that are reaching IDR, rather than being resolved in negotiations, and escalating payments for services resolved through arbitration. A study released in August by researchers at the Georgetown University Center on Health Insurance Reforms estimated that costs related to IDR reached $22.4 billion at the end of 2025.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $120 million investment is being delivered to strengthen rural health and expand access to high-quality care for Hoosiers through the federal Rural Health Transformation Program (RHTP). These investments will support locally driven solutions across eight regions of the state including removing barriers to technology, transportation, and health education. They will provide nutritional support and counseling with community-specific pilot programs that will address the impact food and nutrition have on health and healthcare. This funding will also help address prevention and management of chronic conditions such as diabetes and obesity.
    • “This investment will strengthen maternal and infant health services, expand access to primary and behavioral health care, and provide critical mental health and crisis response resources. It will also help build the next generation of the rural health workforce through expanded recruitment, training and retention efforts, while creating a coordinated transportation network to help patients get to the care they need.” 
  • Beckers ASC Review lets us know,
    • The Federal Trade Commission has widened its scrutiny of healthcare deal-making and dominant vendors over the past month, touching hospital M&A, ASC consolidation and the EHR  market in quick succession. 
    • [The article points out] three recent FTC moves to know.

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

  • Tammy Flanagan, writing in Govexec, discusses reliable rules for your retirement recordkeeping.
  • Ronald Sanders, a NAPA fellow, former OPM associate director and former agency CHCO, writing in Federal News Network, “explains why federal HR leaders should be treated like adults and held accountable.”

From the Food and Drug Administration front,

  • Eating Well reports,
    • “The FDA recalled 75,250 packages of Hodo’s Chili Crisp Lightly Fried Tofu due to potential contamination.
    • “The 8-ounce packages contain UPC 850565007842 and contain use-by dates from May 15 through November 7, 2026.
    • “The recall affects 29 states; check your fridge and return or dispose of affected tofu for a refund.
    • “The tofu may contain ink; seek medical care if you are experiencing any health concerns.”
  • Per FDA news releases,
    • “As part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation, the U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
    • “Botanical drug products are products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials and are intended to diagnose, cure, mitigate, treat or prevent disease. While there is broad interest in botanical products, their inherent complexity and variability can present unique challenges for research, product development and regulatory review.” * * *
    • “The public will have 60 days following publication in the Federal Register to submit comments to the docket. Stakeholders are encouraged to submit comments electronically at https://www.regulations.gov by searching for Docket No. FDA-2026-N-9550, entitled “Advancing Development of Botanical Drug Products; Request for Information.”  Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
    • “The comment period closes November 3, 2026.”
  • and
    • “The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro is the first FDA-approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease.
    • “For patients with Alexander disease and their families, there have been no approved treatment options — only supportive care while the disease progresses,” said Emily Freilich, M.D., Director of the Division of Neurology I in the FDA’s Center for Drug Evaluation and Research. “Today’s approval is a landmark moment for this community, offering the first therapy that addresses the underlying cause of this rare and serious disease.”
    • “Alexander disease is a rare, progressive neurological disorder caused by mutations in the gene that produces glial fibrillary acidic protein (GFAP). When this protein is abnormal, it accumulates in the brain’s supportive cells, causing damage to the nervous system over time. The disease affects less than 1 in a million people and can cause a wide range of serious and potentially life-threatening problems, including seizures, loss of developmental milestones, difficulty walking, muscle weakness, and increased pressure in the brain.
    • “Zanvastro is an antisense oligonucleotide — a type of medicine that works by reducing the production of the abnormal GFAP protein before it can accumulate and cause further damage. It is administered as an injection into the spinal canal every three months by a trained healthcare professional.”
  • Cardiovascular Business adds,
    • “Boston Scientific is warning clinicians about an ongoing safety concern with its LUX-Dx family of insertable cardiac monitors (ICMs). 
    • “The U.S. Food and Drug Administration (FDA) has classified the issue as a Class II recall. No patient injuries have been reported at this time. 
    • “According to Boston Scientific, no devices need to be returned or replaced. However, there are steps users can take to address the issue until it can be properly fixed.”
  • and
    • “Heartvue.ai, a medtech company based in Tennessee, has secured U.S. Food and Drug Administration (FDA) clearance for its new artificial intelligence (AI)-enabled imaging software that views, processes and evaluates cardiac MRI scans. Innolitics, an Austin-based consulting firm, helped guide Heartvue.ai through the regulatory process.
    • “The newly cleared software, Heartvue.Proton, uses advanced AI algorithms to automate measurements of 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification. Automating these measurements saves time, though each result is still reviewed and confirmed by a trained clinician. The software was designed to integrate with a hospital’s PACS or EHR system and slide right into any existing cardiology or radiology workflow.
    • “This clearance also includes a Predetermined Change Control Plan (PCCP), which helps Heartvue.ai make specific updates to this software without submitting additional requests to the FDA.”

From the public health and medical / Rx research front,

  • Per a CVS Health news release,
    • “CVS Health® (NYSE: CVS) today announced that updated 2026-2027 COVID-19 vaccines are now available at CVS Pharmacy® and MinuteClinic® locations for patients at no-cost with most insurance plans. Appointments are available at CVS.com, MinuteClinic.com and through the CVS Health® app, and walk-ins are accepted at CVS Pharmacy and MinuteClinic.
    • “We know patients value having convenient access to the vaccines and preventive care services they need,” said Amy Compton-Phillips, MD, Executive Vice President and Chief Medical Officer, CVS Health. “With updated COVID-19 vaccines available at CVS Pharmacy and MinuteClinic, we’re making it easier for people to get vaccinated close to home and on a schedule that works for them.”
    • “CVS Pharmacy offers COVID-19 vaccinations for eligible patients based on state regulations*, while MinuteClinic provides vaccinations for patients beginning at 18 months of age. Pharmacists and MinuteClinic providers are available to answer questions and help patients make informed decisions about vaccination based on their individual health needs.”
  • Nature reports,
    • “Just one week after the landmark US approval of a game-changing drug for advanced pancreatic cancer, the same therapy is showing promise against the world’s biggest cancer killer: lung cancer.
    • “In a small clinical trial of the drug daraxonrasib (Rasonque), tumours shrank in more than 30% of participants with the most common form of lung cancer, non-small-cell lung cancer. Each participant had a tumour-promoting mutation in a member of the RAS family of proteins, and had previously tried other therapies.
    • “We consider the results incredibly promising,” says Kathryn Arbour, a thoracic oncologist at the Memorial Sloan Kettering Cancer Center in New York City, and an author of the study, which was published on 2 September in the New England Journal of Medicine1. “These are exciting times.”
    • “A larger study in which participants with non-small-cell lung cancer are randomly assigned to receive either daraxonrasib or standard chemotherapy is under way. Regulators such as the US Food and Drug Administration (FDA) are likely to require results from that trial before approving the drug as a lung cancer treatment.”
  • Beckers Hospital Review interviews five health system leaders about their “plans to fast-track breakthrough pancreatic cancer drug.”
  • The New York Times relates,
    • “Can psilocybin, the hallucinogenic compound also known as magic mushrooms, inoculate cancer patients against the debilitating nerve damage caused by chemotherapy? At first blush, such an outcome might seem like wishful thinking.
    • “But a study published on Thursday in the journal Science makes a compelling case that administering psilocybin shortly before cancer treatments might prevent chemotherapy-induced peripheral neuropathy, a condition that affects about two-thirds of patients who receive chemo.
    • “The scientists studied mice, but the results are so promising that human trials are beginning this month. If successful, the treatment could revolutionize cancer therapy and improve the quality of life for millions.
    • “There are no effective treatments for neuropathy, which causes pain, tingling and numbness in the hands and feet, and can force patients to scale back or halt chemotherapy when the discomfort becomes too much to bear.” * * *
    • “Researchers said they did not yet know whether psilocybin could treat or reverse the symptoms of neuropathy in patients who already have it.
    • “If the results hold up in humans, the treatment could open a new chapter in the emerging field of psychedelic medicine, which until now has largely been focused on psychiatric conditions.”
  • Beckers Hospital Review considers whether medication safety is improving.
  • BioPharma Dive adds,
    • “A dual-acting cancer drug developed by China-based Akeso helped people with lung cancer live longer after treatment than did Merck & Co.’s blockbuster immunotherapy Keytruda, the company said Thursday, results that support an emerging body of evidence suggesting the medicine may become a future backbone of non-small cell lung cancer care.
    • “Akeso and its U.S.-based licensee Summit Therapeutics didn’t disclose full results, which came from a new data cut of the trial in Chinese enrollees with non-small cell lung cancer that first brought wide attention to “ivonescimab.” Full data is expected at a lung cancer conference later this month.
    • “The trial won’t be used as the main evidence to support U.S. approval, as the Food and Drug Administration will want to see outcomes from a global trial in this setting. Those are expected to come in 2028. It does, however, build confidence that a separate, all-important trial could show ivonescimab in combination with chemotherapy outperforms Keytruda and chemo.”
  • MedTech Dive notes,
    • “Ablation with Abbott’s dual-energy catheter, the TactiFlex Duo, was safe and effective in treating atrial fibrillation patients after one year, study results showed.
    • “The device combines pulsed field ablation, or PFA, and radiofrequency energy in one catheter to give physicians more flexibility in complex cases of AFib, an irregular heart rhythm that can lead to stroke or heart failure.
    • “Data from the FlexPulse IDE study, presented at the European Society of Cardiology Congress last week and published in the journal EP Europace, is the basis for Abbott’s Food and Drug Administration submission to market TactiFlex Duo in the U.S. The catheter received Europe’s CE mark earlier this year.” 
  • Cardivascular Business tells us,
    • “Xylitol, a sugar substitute often found in gum, baked goods and toothpaste, may significantly increase a person’s risk of dying or experiencing a heart attack or stroke, according to new data presented at the European Society of Cardiology (ESC) Congress 2026.
    • “The study’s authors noted that xylitol is a sugar alcohol that does occur naturally in the body in very low amounts. However, high levels of xylitol are also added to many sugar-free foods to help them taste sweeter, and the long-term cardiovascular implications of this trend have not been sufficiently explored. 
    • “The group reviewed data more than 17,000 participants in one of two datasets: the Canadian Longitudinal Study on Aging (CLSA) and the European Prospective Investigation into Cancer (EPIC)-Norfolk. According to CLSA data, the six-year risk of a major adverse cardiovascular event (MACE) was 57% higher among individuals who consumed the most xylitol than it was among those who consumed the least xylitol. According to EPIC-Norfolk data, the 30-year risk of a MACE was 18% higher among individuals who consumed the most xylitol than it was among those who consumed the least xylitol.” 
  • and
    • “Stroke patients should begin their road to recovery as soon as they are medically stable, according to a new guideline from the American Stroke Association (ASA) and American Heart Association (AHA). In fact, starting within the first 48 hours is recommended to maximize the patient’s chance of a full recovery.
    • “The new document, published in full in Stroke, highlights the importance of giving each patient a rehabilitation plan personalized to meet their own needs.[1] It is also critical that delays are kept to a minimum, and that specialists should start addressing physical, cognitive, communication and emotional concerns as quickly as possible.
    • “Each person faces a different set of challenges,” Lorie Gage Richards, PhD, an associate professor at the University of Utah and chair of the volunteer writing group behind this new guideline, said in a statement. “Recovery doesn’t look the same for everyone, and care should be personalized to fit each person’s needs. The goal is to help individuals gain as much independence as possible to perform everyday activities while improving their overall quality of life.”
    • “Sara Kutzle, who survived a stroke in 2021 at the age of 39 years old, helped craft the new guideline. She shared her perspective with the writing group, noting that it took a lot of hard work to feel like herself again.”
  • Health Day informs us,
    • “For community-dwelling older adults without clinical cardiovascular disease, atorvastatin is associated with a lower risk for major cardiovascular events, but does not improve disability-free survival, according to a study published online Aug. 28 in the New England Journal of Medicine to coincide with the annual meeting of the European Society of Cardiology, held from Aug. 28 to 31 in Munich.”
  • and
    • “Heart disease often starts decades before symptoms appear, and a major new study shows just how early.
    • “Currently, a person’s risk of developing atherosclerotic cardiovascular disease is estimated according to their risk factors, such as age, sex, smoking status, blood pressure and cholesterol levels, and this determines whether primary prevention strategies are prescribed,” said co-lead author Dr. Henning Bundgaard of Rigshospitalet-Copenhagen University Hospital in Denmark. 
    • “This approach relies on an estimation — not on knowledge of the presence of the actual disease (i.e., atherosclerotic plaques),” he said. “And we may be missing important opportunities to prevent cardiovascular events in individuals in whom atherosclerosis has built up many years previously.”
  • MedPage Today adds,
    • “Unruptured brain aneurysms were identified more frequently in recent years, a systematic review and meta-analysis showed.
    • “In studies of healthy people who had MR or CT angiography, the prevalence of an unruptured intracranial aneurysm rose from 2.9% to 6.6% over two decades, reported Nima Etminan, MD, of the University of Heidelberg in Mannheim, Germany, and co-authors.
    • “After adjusting for age and sex, the prevalence ratio was 1.8 (95% CI 1.1-2.8) for 2016-2022 compared with 2002-2015.
    • “The increase in unruptured aneurysms “is only in part explained by aging of the population and improvements in vascular imaging, which suggests that other, as yet unknown (e.g., environmental), risk factors play a role as well,” Etminan and colleagues wrote in Lancet Neurology.”
  • Genetic Engineering and Biotechnology News points out,
    • “A study by researchers at Harvard Medical School has shown that loss of function in the aldehyde dehydrogenase family 3 member B2 (ALDH3B2) gene can convert human pancreatic duct cells into functional β-like cells that can secrete insulin in response to glucose, and which lowered blood glucose levels when transplanted into diabetic mice. The team, headed by Peng Yi, PhD, an investigator at Joslin Diabetes Center, and assistant professor of medicine at Harvard Medical School, suggests that their results point to ALDH3B2 as a gene that could potentially be targeted in human pancreatic duct cells to replenish β cell mass for diabetes therapy.
    • “Senior and co-corresponding author Yi, together with first and co-corresponding author, Jian Li, a postdoctoral research fellow in the Yi lab at Joslin Diabetes Center and Harvard Medical School, reported on their findings in Science Translational Medicine, in a paper titled “Loss of function of ALDH3B2 transdifferentiates human pancreatic duct cells into β-like cells.”

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

  • Beckers Hospital Review reports,
    • “After a brief post-pandemic lull, hospital consolidation is accelerating again, with large health systems expanding across state lines, absorbing independent hospitals and reshaping regional care markets. 
    • “From portfolio resets and strategic exits to cross-market mergers and billion-dollar investments, these moves reflect how scale, capital access and geographic reach are becoming critical advantages in today’s healthcare landscape.
    • “[The article includes a non-exhaustive list of] 31 large health systems that have announced or plan to close strategic mergers, acquisitions or partnerships this year.”
  • Beckers ASC Review relates,
    • “A Brookings Institution analysis published Sept. 3 maps how deeply the five largest U.S. health insurers — covering 126 million Americans — have expanded into owning the physician practices, ASCs, pharmacies and PBMs they also pay for care through. Researchers used 2025 SEC filings, IRS Form 990s and state insurance-subsidiary schedules to trace the money.”
  • Fierce Healthcare tells us,
    • “West Virginia University Health System and Independence Health System’s have come to terms with Pennsylvania’s Attorney’s General Office on a planned acquisition that would bring the former organization to 30 hospitals.
    • “The settlement deal (PDF), filed in state court on Aug. 31 and shared Wednesday by the attorney general, includes terms requiring WVU Health System to keep the Independence hospitals and facilities open for at least five years, and to notify the office of any significant service changes. 
    • “WVU Health System also must install policies to block competitively sensitive information from flowing between its insurance and provider subsidiaries, maintain charity care and financial assistance policies and negotiate in good faith with payers, among other terms outlined in the agreement.”
  • Per Beckers Hospital Review,
    • “Salem (Ore.) Health Hospitals & Clinics completed its affiliation Sept. 1 with Stayton, Ore.-based Santiam Hospital and Clinics.
    • “The affiliation received approval in August from the Oregon Health Authority and Oregon Department of Justice. Both parties initially submitted the transaction for review in April through Oregon’s Health Care Market Oversight program, but withdrew the filing July 3, which ended the agency’s comprehensive review, and submitted a request for an emergency exemption that same day. 
    • “Under the affiliation, Santiam employees will become Salem Health staff, with Salem Health investing millions into improvements on healthcare infrastructure at Santiam Health, according to a news release.”
  • Modern Healthcare adds,
    • “Centene will exit California and Oregon commercial group markets next year.
    • “Nationwide, Centene serves nearly 500,000 enrollees through its commercial plans, representing less than 2% of its 25.9 million members.
    • “Centene has announced leadership changes, market exits in multiple states and voluntary employees buyouts as it navigates declining enrollment and federal funding cuts.”
  • Beckers Payer Issues informs us,
    • “Pharmacy benefit managers LucyRx and Abarca Health completed their strategic combination, according to an Aug. 20 news release.
    • “Across commercial and government markets, the PBMs serve more than 9 million members total. The companies now operate as wholly owned subsidiaries of Healthcare Revolution Partners. They still maintain their independent brands, leadership and client relationships.
    • “The combination unifies LucyRx’s employer focus and clinical capabilities with Abarca’s integrated claims and benefits platform, Darwin, and its knowledge of the government, regulatory, compliance and health plan landscape.”
  • Per Fierce Healthcare,
    • “Judi Health is expanding its list of clinical partners with the addition of Color Health, WellTheory and Cylinder.
    • “Each of these organizations targets a key area of focus for employers and plan sponsors and will be immediately available to Judi Health’s clients. Initially launching as pharmacy benefit manager Capital Rx about a decade ago, the company has invested in becoming an enterprise health solution that brings medical and pharmacy together.
    • “Other partners already in the Judi fold include Sword Health and Progyny, the company said in an announcement.
    • “Color Health operates the country’s first virtual cancer clinic with certification from the American Society of Clinical Oncology, and cancer care is the top condition driving healthcare costs for many employers. WellTheory, meanwhile, offers a solution for managing autoimmune and inflammatory conditions.”
  • and
    • “Telehealth platform GoodRx announced Thursday the launch of a companion family plan as part of its subscription service that offers free and low-cost prescriptions and savings on common healthcare services.
    • “GoodRx Companion Family Plan covers a primary member and up to four members, with no age restrictions and the inclusion of pets. The plan costs $24.99 per month or $16.99 for members paying annually. 
    • “Families don’t experience healthcare costs one person at a time,” said Wendy Barnes, president and CEO of GoodRx. “They’re simultaneously managing prescriptions and care for kids, parents, partners, and even pets. Expanding Companion across the entire household allows us to support consumers in a way that reflects this reality.”
    • “Barnes added that the new plan also advances the platform’s strategy to be a “more central part of how consumers navigate and pay for healthcare.”

Thursday report

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

Simplicity is a virtue.

  • Fierce Pharma points out,
    • “The Trump administration looks set to unveil a new slate of most-favored-nation (MFN) drug pricing deals with several mid-sized biopharma companies, according to Bloomberg.
    • “The announcement is expected on Monday [August 31, 2026], the news service reported this week, citing sources familiar with the plan. Drugmakers that have agreed to the voluntary deals are expected to provide their products to state Medicaid programs at prices aligned with those they charge in foreign countries.  
    • “In exchange, the companies could secure tariff relief and may win exemption from Medicare pilot discount programs that are in the works, Bloomberg wrote.” 
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $93.3 million investment is being delivered to help rural hospitals advance new state-of-the-art models of care and improve health outcomes for Georgians through the federal Rural Health Transformation Program (RHTP). 
    • “This investment will help 87 rural hospitals prepare for value-based care, expand training and recruitment for nurses, EMTs and paramedics, and improve access to maternal and behavioral health services, newborn screening, and other critical health services through telehealth, transportation and expanded care networks. It will also bring next-generation technology to rural communities—including surgical robotics, dementia care capacity, and telehealth infrastructure—to modernize care. By strengthening and expanding rural care, this funding will also help retain health care professionals in rural Georgia. This investment will strengthen rural hospitals, expand telehealth and healthcare access, build dementia care capacity, and grow the rural healthcare workforce through technology-enabled care initiatives across the state. With these investments, Georgia has now committed the full $218 million awarded to the state for its first year of funding through the RHTP.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services has released a fact sheet and FAQs on the 340B Part D claims data repository that will go live Oct. 1. Data submissions would currently be voluntary for 340B hospitals. However, the agency recently proposed to make data submissions mandatory starting in 2027. The fact sheet and FAQ provide an overview of the repository along with other key details.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced [in the news release] the nine winners of the 2026 KidneyX EMPOWER: Living Link Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them. The challenge was run through the Kidney Innovation Accelerator (KidneyX), a public-private partnership between HHS and the American Society of Nephrology (ASN).
    • “Every American waiting for a kidney deserves the best chance at a longer, healthier life,” said HHS Secretary Robert F. Kennedy, Jr. “Living kidney donation saves lives, yet too many willing donors face barriers that should not exist. We are removing those barriers and backing innovators with practical solutions that support donors, strengthen transplant care, and give more Americans a chance to live.”
  • The International Foundation of Employee Benefit Plans reports,
    • “The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments) released Affordable Care Act (ACA) and Health Insurance Portability and Accountability Act (HIPAA) Implementation Frequently Asked Questions (FAQs) Part 74 addressing health-contingent wellness programs, including tobacco-related wellness programs. The FAQs cover completion of reasonable alternative standard and disclosure requirements. 
    • “The new guidance comes after tobacco-related wellness programs have been the subject of recent class-action lawsuits challenging the tobacco surcharges some employers add to premiums for their group health plans through workplace wellness programs. The FAQs released today announce the Departments’ approach to enforcement for health-contingent wellness programs that reward an employee if they satisfy a standard related to a health factor.
    • “Until further guidance or regulations are issued, the departments will not take enforcement action against plans or issuers that do not give employees the wellness program reward retroactively to the beginning of the plan year after the employee completes a reasonable alternative standard. Under the terms of the enforcement relief in these FAQs, plans and issuers only need to provide the reward prospectively, from the point where the employee completes the alternative standard, if retroactive rewards are not otherwise provided.”
  • Beckers Hospital Review tells us,
    • “Medicare’s GLP-1 Bridge program is seeing early uptake at major retail pharmacies, with CVS and Walgreens each filling about 100,000 prescriptions less than two months after the program launched in July, according to an Aug. 26 NPR report.
    • “We expected there would be uptake,” Walgreens’ chief pharmacy officer Rick Gates told NPR. “I think there’s been a little bit more uptake than we even expected.”
    • “Walgreens stocked additional Wegovy, Zepbound and Foundayo ahead of the launch but has not experienced supply issues. Walmart said Bridge prescriptions have also increased week over week and have been filled at more than 5,000 Walmart and Sam’s Club pharmacies nationwide.
  • The No Suprises Act’s (“NSA”) regulating agencies, which includes OPM, corrected errors found in the final Independent Dispute Resolution rule published in the Federal Register on June 5, 2026.

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

  • Federal News Network reports,
    • “Artificial intelligence may become a more prominent part of the federal hiring process, following new guidance from the Office of Personnel Management.
    • “In a memo Thursday, OPM encouraged agencies to more widely adopt AI tools in their recruitment efforts. Without increasing AI use, agencies may be compromising the effectiveness and efficiency of the federal hiring process, OPM said.
    • “Despite 2025 guidance from the Office of Management and Budget defining “high-impact” standards for AI usage, agencies have been “overly cautious” about using the technology in hiring, said Adam Starr, OPM’s CIO and a senior advisor.
    • “Too often, agencies were defaulting to the view that any use of AI in hiring was subject to the high-impact standard. In reality, that is not the case,” Starr said Thursday in a blog post. “Instead, the inclusion of AI as a complement to human judgment is not only acceptable but leads to better outcomes.”
  • Tammy Flanagan, writing in Govexec, advises “Want to retire at the end of 2026? Start planning now.”
    • OPM is still working through a sizable retirement backlog, and year-end retirees have plenty to sort out before they leave federal service.

From the Food and Drug Administration front,

  • The American Hospital Association reports,
    • “The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and 37 serious injuries as of Aug. 17. The alert was issued due to the products experiencing purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly. Abiomed sent a letter to all affected customers recommending the devices be removed from where they are used or sold.” 
  • The Washington Post relates,
    • “The Food and Drug Administration on Thursday green-lit updated coronavirus vaccines for higher-risk Americans, such as older adults and people with at least one underlying health condition, vaccine manufacturers announced.
    • “The approved shots from vaccine manufacturers Pfizer-BioNTech and Moderna, which make mRNA-based vaccines, have an updated formulation aimed at better targeting the coronavirus variants circulating around the country. The FDA also cleared an updated vaccine from Sanofi, which doesn’t use mRNA-based technology and was originally licensed by Novavax, a Sanofi spokesperson confirmed. The companies said the vaccines are expected to be available in the coming days.”
    • “Most Americans typically get vaccinated against the coronavirus at retail pharmacies.
    • “Pharmacies are actively preparing to receive the updated shots, so they can begin vaccinations as soon as they receive shipments and all state requirements are met, according to Brigid Groves, a vice president at the American Pharmacists Association.”
  • Reuters tells us,
    • “The U.S. Food and Drug Administration said on Thursday it approved a ​treatment from Roivant (ROIV.O) and partner Priovant Therapeutics for a rare disease, ‌making it the first oral drug for the condition affecting skin and muscles.” * * *
    • “Branded as Lisraya, the drug was approved for ​dermatomyositis, a condition that causes painful skin rashes and progressive muscle weakness ​and, if untreated, can severely reduce quality of life.”
  • CNBC informs us,
    • “The Food and Drug Administration approved a once-daily HIV pill from Gilead that could help simplify care for some patients whose virus is already under control but who remain on complicated treatment regimens. 
    • “The tablet combines bictegravir, the backbone of Gilead’s blockbuster HIV pill Biktarvy, with lenacapavir, a centerpiece of the company’s long-term strategy for HIV treatment and prevention. 
    • “The new pill is also aimed at people who are doing well on a single-tablet regimen, including Biktarvy, and want to switch to a new treatment.”

From the judicial front,

  • Michelle Roberts, an attorney, lets us know,
    • In Central States v. McClain [decided August 26, 2026, a panel of the U.S. Court of Appeals for the] Seventh Circuit held that ERISA does not preempt Arkansas Insurance Department Rule 128. Applying Rutledge, the court treated the Rule’s dispensing fee requirement as a permissible cost regulation rather than a mandate dictating plan choices, and under Gobeille, it held that the Rule’s reporting requirement fell within the exception for reporting incidental to an unpreempted state law. The panel affirmed dismissal at the pleading stage while expressly reserving whether Congress’s new pharmacy-compensation reporting provision under 29 U.S.C. § 1185o will change the analysis once it takes effect.
  • In National Infusion Centers v. Kennedy, also decided August 26, 2026, held
    • “The Plaintiffs challenge the constitutionality of the Drug Pricing Program created by the Inflation Reduction Act of 2022. They claim violations of the nondelegation doctrine, the Eighth Amendment’s Excessive Fines Clause, and the Fifth Amendment’s Due Process Clause. The district court granted the Government’s motion for summary judgment. We AFFIRM.”
  • Govexec reports,
    • “The Equal Employment Opportunity Commission voted 2-1 Wednesday to propose new regulations that would overhaul how federal workers may pursue workplace discrimination claims, removing employees’ right to request a hearing before an administrative judge and outright banning class action cases outside of federal court.
    • “Currently, federal workers alleging discrimination at their employing agency must undergo up to 90 days of pre-complaint counseling, which includes informing employees about the EEO process and sometimes mediation, after which their agency will conduct an internal investigation. Once that is complete—or after 180 days—the employee may request a hearing before an EEOC administrative judge.
    • “But under a new proposed rule, set for publication Friday in the Federal Register, complainants would no longer go through pre-complaint counseling, instead directly filing their complaints to EEOC within 60 days of the alleged discriminatory incident. And they would no longer be guaranteed a hearing; that decision would instead be made by officials within the EEOC’s Office of the Federal Sector.
    • “Under the plan, complainants would have to affirmatively request a hearing when they appeal a final agency decision, and in some cases submit an explanation justifying its need. Those who do receive a hearing under the new process would no longer have the benefit of discovery, a practice by which parties can request and receive documentation related to the case.
    • “Additionally, while employees with similar allegations of discrimination may elect to have their individual complaints processed “jointly,” EEOC would cease consideration of class action cases. If employees wish to proceed as a class, they would each have to exhaust their individual cases before the agency and then file a class action lawsuit in federal court.”

From the public health and medical / Rx research front

  • The Wall Street Journal reports.
    • “[H]ow much water do we really need to drink a day? The question feels more pressing than ever given rising temperatures, heat waves and the fact that chugging water is almost a competitive sport these days. The answer may be less than you think and varies based on your size, health, activity level and where you live.” * * *
    • “The most cited recommendations for water come from the National Academy of Medicine, which calls for a total daily fluid intake of 3.7 liters for men and 2.7 liters for women. 
    • “But here’s the thing: That is total fluid intake, not water specifically. And here’s the other thing: Roughly 20% of our fluids come directly from food, studies have found.
    • “That leaves roughly two liters of fluids daily for women and three for men, says Kavouras. That translates to about 68 ounces and 101 ounces from beverages. 
    • “Stavros Kavouras, founding director of Arizona State University’s Hydration Science Lab in Phoenix and DrHydration on social media. estimates the average pour of water in the U.S. is 12 to 16 ounces. So that works out to about four to six glasses of fluids daily for women and six to eight for men.”
  • The New York Times relates,
    • “Scientists have uncovered a wealth of clues about how genetic mutations lead to severe forms of autism, offering opportunities for testing drugs that could treat the condition, according to a study published Thursday.
    • “The researchers charted how mutations change the way proteins work together in cells, altering the development of the brain.
    • “This is making maps of unknown territories that’s really necessary to move the biology forward,” said Dan Geschwind, a neurogeneticist at the University of California, Los Angeles, who was not involved in the study.
    • “Researchers have been studying autism for over 80 years, but it has only been in recent years that they have been able to explore its molecular biology. One reason that progress has been so slow is that autism is not just one condition, but a broad constellation of them.”
  • Radiology Business adds,
    • “A new analysis details the prevalence of amyloid-related imaging abnormalities (ARIA) on MRI in individuals who are being treated with new Alzheimer’s disease therapies. 
    • “Kisunla (donanemab) is an FDA-approved intravenous monoclonal antibody infusion for early symptomatic Alzheimer’s disease; it works by essentially scrubbing amyloid deposits from the brain, which in turn helps reduce cognitive symptoms associated with the neurodegenerative disease. While effective, a known side effect of the treatment is that is causes ARIA. 
    • “Symptoms of ARIA include headache, confusion, dizziness, vision changes and nausea, but if left unchecked, the symptoms can become severe. This is why experts (and the FDA) recommend scheduled MRI brain scans on individuals being treated with modern monoclonal antibody infusion treatments. 
    • “Now, a new study is offering detailed insight into how common ARIA is in individuals being treated with donanemab. Published in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitorin, the analysis suggests that up to 20% of patients may exhibit signs of ARIA on imaging.” 
  • MedPage Today tells us,
    • “Despite recommendations by the U.S. Preventive Services Task Force and the American Cancer Society, cervical cancer screening rates are declining.
    • “From 2005 to 2023, the proportion of women ages 21 to 29 never screened for cervical cancer increased from 12.5% to 31.9% (average annual percentage change [AAPC] 5.2%), with a notable increase from 2010 to 2023 (AAPC 7.9%).
    • “Regional-stage and distant-stage cervical cancer incidence has increased by 2.3% and 2.6%, respectively, per year among women ages 30 to 64 since 2017.”
  • and
    • “Almost 80% of patients with early-stage rectal cancer avoided surgery for a year or longer when treated with chemoradiation in a randomized trial.
    • “The organ-preservation strategies of chemoradiation and radiotherapy were both associated with few adverse events without sacrificing oncologic control.
    • “Longer follow-up is needed to determine long-term disease control and safety.”
  • and
    • “People who experience an opioid overdose are at greater risk of death, but data on which opioid agonist treatments are most effective in supporting this high-risk population are limited.
    • “In a retrospective cohort study of opioid overdose survivors, starting methadone was associated with a reduced risk of death during the subsequent year compared with starting buprenorphine-naloxone.
    • “In an accompanying commentary, experts questioned whether methadone is truly “intrinsically superior” to buprenorphine-naloxone.”

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

  • Beckers Payer Issues reports,
    • “Mona Chitre, PharmD, will serve as the market president for the newly created employer and government markets segment under Optum Rx, UnitedHealth Group’s pharmacy benefit manager.
    • “Dr. Chitre will begin her role Aug. 31, according to an Aug. 26 LinkedIn post. She said the role unifies the commercial, health system, coalition, labor and trust, and public sector businesses.
    • “Dr. Chitre most recently founded and was the president of Candesa Pharmacy Solutions, under The Lifetime Healthcare Companies. Under the same parent, she previously was Excellus BlueCross BlueShield’s chief pharmacy officer, according to her LinkedIn profile. She brings 26 years of experience across healthcare and pharmacy, she said.”
  • Fierce Healthcare relates,
    • “Cigna is looking to better link medical and supplemental benefits for its members, and has unveiled a new employer benefit that aims to further that goal.
    • “The insurer’s new Medical with Smart Coverage plans will be available as an option for employers with 500 to 2,999 employees that currently offer a high-deductible health plan. Cigna intends to expand access further in 2028, according to an announcement.
    • “The plan is designed to offer members support in managing unexpectedly high costs should they occur. Enrollees can access up to $7,000 in supplemental cash benefits that they can use during these health events to cover key needs such as transportation, child care or hotel stays.”
  • Beckers Hospital Review non-exhaustively lists “68 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • and tells us
    • New Haven, Conn.-based Yale New Haven Health System reported operating income of $33 million (0.5% operating margin) through the third quarter of 2026, up from an operating loss of $40.2 million (-0.7% margin) during the same period last year, according to its Aug. 25 financial report. 
  • and
    • “Pittsburgh-based UPMC recorded an operating loss of $18.3 million (-0.2% operating margin) for the second quarter of 2026, down from operating income of $111.2 million (1.3% margin) during the same period last year, according to its Aug. 27 financial report.”
  • Fierce Healthcare adds,
    • “Corewell Health showed its plans for two major hospital campus expansions that will run the Michigan nonprofit system $1.7 billion.
    •  “As our communities grow and patient needs become more complex, we are building the capacity, technology and care environments needed today for our patients and team members for many years to come,” President and CEO Tina Freese Decker said in the organization’s Thursday announcement. 
    • “The larger of the two projects is coming to Corewell Health Butterworth Hospital in Grand Rapids. The 780,000-square-foot, 11-story tower will include a new ED, 180 private patient rooms, 17 operating rooms and a hyperbaric chamber, Corewell said.” * * *
    • “The other new tower comes with a $440 price tag for the organization and will be built at Corewell Health Beaumont Troy Hospital, which serves a “rapidly growing” community and is also “consistently” above 90% capacity.”
  • and 
    • “Healthcare navigation platform Transcarent launched on Tuesday a bundled payment model for cancer therapies.
    • “The payment model, which the company touts as a first-of-its-kind, supports bispecific T-cell engager (BiTE) and CAR T therapies. Transcarent connects its members to leading oncology providers across various settings, including academic medical centers and high-quality community-based cancer care sites.
    • “Advanced cancer therapies are changing what’s possible for patients, but they’re also creating new challenges for employers trying to manage costs and access,” said Snezana Mahon, Transcarent’s president, in a statement. “This model gives employers more predictable costs while helping Members receive expert care closer to home without sacrificing quality.”
    • “The model enhances Transcarent’s Centers of Excellence (COE) program through easier access and navigation of more affordable care—offering potential savings of up to $150,000, executives say.
    • “Moreover, members undergoing treatment through the COE network are supported throughout their journey by certified oncology nurse navigators (ONNs).” 
  • Beckers Physician Leadership informs us,
    • “More than half of U.S. physicians, 59.4%, are now employed by a hospital or health system, according to a new analysis from Trilliant Health that assessed 700,000 physicians across the country.
    • “Here are four more things to know
      • “1. The hospital-employment rate is highest in the Midwest at 67.2% and lowest in the South at 52.4%, with the Northeast at 62.9% and the West at 60%. Multiple factors are driving the trend, with declining Medicare reimbursement chief among them. 
      • “2. The AMA estimates Medicare physician pay has declined 33% in real terms between 2001 and 2025 while practice costs rose 59% over the same period. 
      • “3. Among physicians who sold their practices to a hospital or health system, 79.5% cited the ability to negotiate higher payment rates as an important or very important reason for doing so. 
      • “4. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, with an additional 4,200 absorbed by insurers, private equity firms and pharmacy chains between 2024 and 2025.”