Monday report

CMS

Monday report

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

Simplicity is a virtue.

From Washington, DC

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

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

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

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

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

From the Medicare Advantage front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

From the Nobel Prize front,

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

Weekend update

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

Simplicity is a virtue.

From Washington, DC

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

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

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

No Surprises Act News,

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

From the public health and medical research front,

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

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

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

Friday report

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

Simplicity is a virtue.

From Washington, DC

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

From the Medicare Advantage front,

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

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

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

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

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

No Surprises Act news,

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

From the judicial front,

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

From the public health and medical /Rx research front,

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

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

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

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Medicare Advantage front,

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

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

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

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

No Surprises Act News,

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

From the public health and medical / Rx research front,

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

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

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

OPM Releases 2027 Premiums

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

Simplicity is a virtue.

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

More News from Washington, DC,

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

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

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

From the Medicare Advantage front,

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

From the public health and medical / Rx research front,

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

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

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

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Beckers Payer Issues reports,
    • “CMS released initial insights on the 2027 Medicare Advantage landscape Sept. 28, along with data breaking down plans.
    • “One wrinkle gaining attention: enrollment capacity limits. In April, CMS said insurers could include enrollment caps for specific plans in their 2027 MA bids, relying on existing regulatory authority. With these caps, plans cannot disenroll current members. Once a plan hits its cap, it must stay closed to new enrollees until space opens up through natural attrition, according to the April memo. The agency baked enrollment caps into its August guidance for MA payers. 
    • ‘Ceci Connolly, president and CEO of the Alliance of Community Health Plans, recently told Becker’sthat her organization made progress with CMS on “tweaks with respect to the regulatory perspective,” including enrollment caps.” * * *
    • Becker’s reviewed the 65 MA plans — including MA plans with prescription drug coverage and special needs plans — with enrollment caps. [As disclosed in the article, t]hese plans are available in 11 states and span 15 parent organizations. The caps range from 410 to 56,345 members.
  • The New York Times relates,
    • “The Department of Veterans Affairs announced new measures on Monday that will require written informed consent by patients before they are prescribed certain psychiatric drugs.
    • “The shift reflects a growing disenchantment with psychotropic medications that has animated the Make America Healthy Again movement and its chief standard-bearer, Health Secretary Robert F. Kennedy Jr.
    • “The new policy will require veterans under age 30 to sign consent forms before receiving antidepressants, and it mandates documented discussions about the risks and benefits of the treatments, including how to safely discontinue them.
    • “The guidance also requires a signed consent form when patients are concurrently prescribed opioids and benzodiazepines. The measure will go into effect in 2027.”
  • STAT News adds,
    • “A growing number of congressional lawmakers are urging the Trump administration to rethink a federal rule going into effect next month over concerns it will prevent Americans from obtaining prescription medicines from licensed international pharmacies.
    • “The pending rule requires medicines mailed from abroad to go through a customs process that mandates a licensed customs broker and a financial guarantee in the form of an entry bond. This is an added burden — and cost — for Americans who, for years, have been able to receive prescriptions from Canada and other countries with relatively little difficulty as they sought to save money on expensive drugs.”
  • and
    • “In the last month, manufacturers have announced “breakthrough” status from the Food and Drug Administration for a menagerie of devices: triage algorithms for abdominal CT scans, diagnostic panels for urinary tract infections, and thrombectomy robots, to name a few.
    • “They’re coming in just under the wire: As of October, new breakthrough-designated devices will no longer be eligible for special treatment when it comes to qualifying for extra Medicare payments. These devices, and more than a dozen others, are included in the latest update of STAT’s Breakthrough Device Tracker, which since 2022 has captured nearly 800 devices reported to have FDA breakthrough status.” 
  • Beckers Hospital Review notes,
    • “Section 232 tariffs on patented pharmaceutical products and associated pharmaceutical ingredients take effect today, Sept. 29, for companies not covered by the earlier July 31 implementation date. The tariffs follow a Commerce Department investigation that found U.S. dependence on imported pharmaceuticals and pharmaceutical ingredients threatened to impair national security.” * * *
    • “Companies with qualifying most-favored-nation pricing and onshoring agreements with the administration receive a zero tariff rate through Jan. 20, 2029. As of an Aug. 31 White House announcement, all 17 Annex III companies, including AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer and Sanofi, have signed MFN deals, meaning none currently pay the tariff.”

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

  • Per an OPM news release,
    • The White House Task Force to Eliminate Fraud and the US Office of Personnel Management (OPM) today announced more than $500 million in anti-fraud savings for calendar year 2025.
    • The results cover the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) Programs. $237.7 million was saved from claims stopped or reduced before payment, and an additional $271.9 million in losses were prevented due to changes in billing and policy.  An additional $21.9 million were recovered after payment. This work was done in coordination with the Special Investigation Units of the FEHB and PSHB Carrier organizations that administer the health plans.
    • “Fraud in federal health benefits programs drives up costs for employees, retirees, and taxpayers,” OPM Director Scott Kupor said. “These results demonstrate the importance of strong carrier oversight, better data sharing, and earlier detection. Working with Vice President Vance and the White House Task Force to Eliminate Fraud, OPM is strengthening accountability and protecting the premiums paid by enrollees and the federal government.”
  • Fox News adds,
    • “Kupor’s previous experience working with artificial intelligence has led to his name being floated to serve as the AI czar in the Trump administration – a role cast into the spotlight as data center development and artificial intelligence have become midterm election talking points.” * * *
    • “When asked about whether he has had any conversations with the White House about the role, Kupor said he had seen the reports he was being floated, and discussed President Donald Trump’s views on artificial intelligence broadly.
    • “I’ve read all the same reports you’ve read and don’t have anything to add there,” he said. “What the president has said is exactly 100% right, which is that AI is the most important piece of technology that will determine economic growth for us, national security, sovereignty for our country.
    • “One of the things that I know, again, having spent all my life in the venture world, is there is no limit to the intellect and inventiveness of entrepreneurs in this country. And we just need to make sure that the conditions around, you know, regulatory controls and others continue to allow the U.S. to flourish in the way that it’s always done.”
    • “Kupor did not rule out accepting the role if Trump should offer it to him, saying that while he is focused on his job as director of the agency, he serves “at the will of the president.”
    • “Reports had suggested that Treasury Secretary Scott Bessent was being considered for the AI czar position, but last week Trump said he would not be selecting him for the role.”

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

  • The Hill reports,
    • “If you are one of millions of Americans taking medication to lower blood pressure, you may want to check the label.
    • “Inventia Healthcare Limited, based in Mumbai, India, is voluntarily recalling 13,567 bottles of chlorthalidone tablets that may not dissolve properly, potentially lowering the dosage that gets absorbed by the body. The bottles of 25 mg tablets being recalled nationwide have the batch number RISA24002 and an expiration date of March 2027.”
  • Cardiovascular Business relates,
    • “Tempus AI has received U.S. Food and Drug Administration (FDA) clearance for a new artificial intelligence (AI) tool designed to evaluate standard 12-lead resting electrocardiograms (ECGs) for signs of undiagnosed mitral regurgitation (MR). 
    • “The newly cleared software, Tempus ECG-MR, identifies signs of moderate or severe MR and then flags clinicians to ensure the patient receives follow-up medical imaging as needed. It was built to assess diagnostic ECG recordings of any patients 65 years old or older who face a risk of developing cardiovascular disease.  
    • “A standard ECG contains far more information than we have traditionally been able to use,” Brandon Fornwalt, MD, PhD, senior vice president of cardiology at Tempus, said in a statement. “With the fourth FDA-cleared Tempus ECG-AI product, we’re building a growing portfolio that can identify signals across numerous types of heart and vascular disease from the same ECG, helping provide clinicians with more actionable information from a test already embedded in everyday care.”

From the public health and medical/Rx research front,

  • Beckers Clinical Leadership reports,
    • “The infant mortality gap between Black and white babies in the U.S. increased between 2020 and 2024, with sudden unexpected infant death identified as the largest single contributor to the disparity, according to a study published Sept. 22 in JAMA Network Open.
    • “Researchers analyzed federal birth and infant death records covering nearly 58 million live births and 366,384 infant deaths from 2003 to 2024 to determine the factors behind the Black-white infant mortality gap.” * * *
    • “This study provides evidence that there is an acute crisis right now in sudden unexplained infant death, a category of cause of death that we assumed we got under control a long time ago,” Leslie Root, PhD, study co-author and assistant research professor at the University of Colorado Boulder’s Institute of Behavioral Science, said in a Sept. 23 news release.” 
  • Health Day relates,
    • “A powerful new lab-made opioid is moving through the illegal U.S. drug supply, and federal officials warn it could keep spreading. 
    • “The drug, called cychlorphine, may be up to 10 times stronger than fentanyl, according to the White House Office of National Drug Control Policy (ONDCP).
    • “In an April 30 drug threat notice, the office said cychlorphine had turned up in every region of the country. It was most common in Ohio, Texas and Tennessee.
    • “As of that notice, at least 55 deaths nationwide had been linked to the drug in 2025 and 2026.”
  • and
    • “A diagnosis of type 2 diabetes at a young age is much more likely in people who have autism or attention deficit hyperactivity disorder (ADHD), new research says.
    • “More than 14% of people diagnosed with type 2 diabetes before the age of 20 had an ADHD diagnosis, compared to close to 7% of people of similar age without diabetes. That’s more than double the number, findings being presented at a conference in Italy this week show. 
    • “As for autism, 5.7% of people diagnosed with type 2 diabetes before the age of 20 also had the neurodivergent condition, the study found.”
  • MedPage Today tells us,
    • “Hearing loss is considered a key modifiable risk factor for dementia.
    • “Hearing aids did not reduce progression from mild cognitive impairment to dementia in the CHOICE trial, but cognitive improvement occurred more often with their use.
    • “Low dementia conversion rates in this study underpowered conclusions, making replication and confirmation essential.”
  • Cardiovascular Business adds,
    • “When adults with type 2 diabetes are already being treated 1-mg doses of semaglutide, moving to a 2-mg dose is associated with better cardiovascular outcomes than switching to tirzepatide. That was the primary takeaway from new data presented at the European Association for the Study of Diabetes Annual Meeting 2026 in Milan, Italy.
    • “Researchers explored real-world data from more than 600,000 adults with type 2 diabetes who were receiving once-weekly injections of semaglutide at 1 mg per dose. While 67.2% of patients stayed on that exact same dose, 29.2% made the move to a 2-mg dose of semaglutide. Another 3.6% of patients, meanwhile, switched to taking up to 15 mg of tirzepatide per dose. The number of patients moving to a stronger dose or switching to tirzepatide did increase over time. 
    • “Overall, the study’s authors found that the higher semaglutide dose was associated with a 6% lower risk of major adverse cardiovascular events—an outcome that includes heart attack, stroke and all-cause mortality—than tirzepatide.” 
  • Per Genetic Engineering and Biotechnology News,
    • “Researchers at Washington University School of Medicine in St. Louis have developed a potential antibody-based approach to reducing neurodegeneration in diseases known as tauopathies, including Alzheimer’s disease. Studying mice with Alzheimer’s-like tau protein accumulation in their brains, the team showed that injecting the animals with an antibody to a protein called CXCR3 over several months blocked the route used by T cells to get into the brain, reducing the number of those cells in the brain by about half.
    • “The treated mice kept roughly 40% more tissue in memory centers of the brain and did better on a memory test compared with untreated mice—even though the levels of tau in their brains didn’t change. “In tauopathies, including Alzheimer’s disease, there’s no treatment right now that actually decreases neurodegeneration,” said David M. Holtzman, MD, the Barbara Burton and Reuben M. Morriss III Distinguished Professor in WashU Medicine’s Department of Neurology. “If we can show that we’re really decreasing brain cell death, it’s certainly worth trying to pursue that pathway to prevent the most devastating consequences of these diseases.”
    • “Holtzman is senior author of the team’s published paper in Neuron, titled “Peripheral CXCR3 blockade mitigates T cell infiltration and neurodegeneration in a mouse model of tauopathy,” in which they concluded “Our study defines the CXCR3 axis as a critical target that, when blocked, mitigates CD4+ and CD8+ T cell infiltration and confers neuroprotection in a model of tau-mediated neurodegeneration in vivo without influencing levels of soluble or insoluble tau.”
  • Per STAT News,
    • “An experimental gene therapy for Huntington’s disease, developed by the biotech company UniQure, continued to slow the progression of the neurodegenerative disease four years after it was surgically implanted into the brains of patients, the company reported Tuesday. 
    • “However, the magnitude of the treatment’s benefit has waned compared to a similar analysis conducted one year ago, which may raise questions about its durability just as the Food and Drug Administration begins to review UniQure’s marketing application.” 
  • Per BioPharma Dive,
    • “A CAR-T treatment from Adicet Bio has shown in human testing the potential to drive lupus into remission, providing early but notable evidence that therapies like it could be useful in treating autoimmune conditions.
    • “After a year of follow-up in an early-stage trial, 50% of lupus nephritis patients treated with Adicet’s therapy and evaluable for efficacy had a “complete” kidney response to treatment and 54% met a widely used statistical criteria for remission. All of those patients, who had previously tried multiple other treatments, stopped using immunosuppressive drugs.
    • “Adicet also noted that there were no serious cases of cytokine release syndrome or instances of neurological side effects, both of which are concerns with cell therapy treatments. The company intends to start up a pivotal study in lupus in the fourth quarter.” 

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

  • Beckers Hospital Review reports,
    • “Bloomington, Minn.-based HealthPartners and Duluth, Minn.-based Essentia Health announced Sept. 29 that their boards approved an agreement to combine, forming a nonprofit system with 22 hospitals, more than 135 clinics, 6,000 clinicians and 45,000 colleagues.
    • “The combined organization will be called HealthPartners and led by HealthPartners President and CEO Andrea Walsh. David Herman, MD, CEO of Essentia since 2015, will serve as president of combined clinical care group operations, and Essentia facilities will keep the Essentia Health name while operations are integrated.
    • “No money is changing hands. The organizations will combine their assets under a single community-based board and expect the combination to be effective Jan. 1, pending a Minnesota public interest review and federal filings.” 
  • and
    • “Kansas City, Kan.-based The University of Kansas Health System has signed a definitive agreement to acquire full ownership of St. Francis Campus and its affiliated care sites in Topeka from Brentwood, Tenn.-based Ardent Health.”
  • and
    • Los Angeles-based Cedars-Sinai Health System recorded operating income of $261 million (2.8% margin) for fiscal year 2026, compared with operating income of $239 million (2.8% margin) in fiscal 2025, according to its Sept. 25 financial report. 
  • Per Healthcare Dive,
    • “Oura said Tuesday that it will delay its planned initial public offering due to market uncertainty.
    • “The smart ring maker said in May that it confidentially filed for an IPO, and recently revealed that it sought to raise up to $2.2 billion in the offering. The company has reached profitability, and its revenue has grown over the last three years, according to Oura’s prospectus. The company said it expects revenue to grow 90% year over year for its fiscal 2026; Oura reported $907.9 million in revenue in its 2025 fiscal year. The company has 5.7 million paid members.
    • “We aim to deliver an extraordinary IPO for our employees and investors and we have the luxury of choosing our moment,” CEO Tom Hale said in a statement. “In the meantime, we will execute against the opportunities ahead.”
  •   and
    • “Name: Robert Hunter
    • “Previous title: CEO of government programs, UnitedHealthcare
    • “New title: President, UnitedHealthcare
    • “Hunter, who has held a variety of roles at UnitedHealthcare over the past 15 years, will take on the role of president of Minnesota-based UnitedHealth’s payer arm, he announced in a LinkedIn post on Monday. 
    • “Hunter will focus on helping UnitedHealthcare, the largest insurer in the U.S., escalate its “modernization agenda,” toward “a future where healthcare is more connected, easier to navigate and simpler to understand,” he said in the LinkedIn post. The company is in the middle of an effort to streamline and modernize patients’ digital experience with the insurer.”
  • The Wall Street Journal relates,
    • “Novo Nordisk NOVO.B has signed a licensing deal for a weight-loss treatment being developed by Hengrui Pharma that could be worth up to $2.6 billion.
    • “The Danish drugmaker will pay China-based Hengrui $300 million upfront, with the rest of the potential deal value tied to milestones.
    • “Novo will obtain exclusive rights to develop, manufacture and commercialize HRS-1596 globally, excluding mainland China, Hong Kong, Macau and Taiwan. Hengrui is also eligible to receive royalties based on sales of the drug within the licensed territory.
    • “The move is in line with Novo’s efforts to continuously advance its pipeline across obesity, diabetes and other cardiometabolic diseases, said Martin Holst Lange, chief scientific officer at Novo.”
  • Fierce Healthcare tells us,
    • “Digital health company Waltz Health is teaming up with drugmaker Fresenius Kabi to support direct-to-employer efforts for key biosimilar medications.
    • “Through the partnership, commercial employers, health plans and pharmacy benefit managers can access transparent pricing information for three therapeutic categories: rheumatology, dermatology and gastroenterology. The agreement encompasses three FK biosimilars, which are interchangeable with popular branded drugs Humira, Stelara and Actemra.
    • “Teaming with Fresenius makes for Waltz’s first expansion to its direct-to-employer offering, which initially partnered with Novo Nordisk and Eli Lilly on GLP-1s and went live at the beginning of this year.
    • “Jeff Park, president of Waltz Health, told Fierce Healthcare that while direct-to-consumer platforms like the White House’s Trump Rx have grabbed the lion’s share of attention, there’s significant opportunity in the direct-to-employer space to address affordability and access.”
  • Beckers Hospital Review lets us know,
    • “Elevance Health plans to require hospitals to identify the physical location where care was provided on billing forms and adjust payments for off-campus services accordingly.
    • “The insurer said Sept. 29 the new policies will apply across its commercial, Medicare Advantage and Medicaid plans and are designed to address situations where care delivered at off-campus locations is billed at higher hospital outpatient rates. Elevance said it is the first commercial payer to go public with requiring physical location data on claims and tie reimbursement to that information. The company plans to roll the policies out through the end of 2027.
    • “Catherine Gaffigan, MD, president of health solutions at Elevance, announced the change during a Tuesday morning panel at the MAHA Summit in Washington, D.C., where she appeared alongside leadership from UnitedHealth, AHIP and CMS.
    • “Patients and employers should be able to trust that healthcare bills accurately reflect where care was provided,” Dr. Gaffigan said in a news release.”
  • and
    • “Hospital outpatient departments were paid an average of 102% more per unit than physician offices for the same physician-administered medications, a premium that adds up to about $12.7 billion a year in employer health spending, according to new research from the Washington, D.C.-based Employee Benefit Research Institute.
    • “If HOPDs were reimbursed at physician-office rates, employers and workers could save about $12.7 billion annually, or roughly $101 per covered member, according to a Sept. 28 news release. The analysis examined 2023-24 commercial claims for 106 of the highest-spending physician-administered outpatient drugs, which accounted for about 51% of claims and 77% of spending in the category, using the Merative MarketScan Commercial Database for adults ages 18 to 64 with employment-based coverage.
    • “HOPDs received higher reimbursement for 93 of the 106 medications, with a median per-unit difference of 64%. The median annual difference was $5,531 per patient, reaching $135,306 for one oncology drug. About 59% of administrations occurred in HOPDs, compared with 31% in physician offices. The median HOPD markup on drugs from EBRI’s earlier analysis fell from 98% in 2019 to 70% in 2024, largely because physician-office reimbursement rose rather than HOPD rates falling.”
       
  • Beckers Health IT points out,
    • “AI can perform care represented in 16% to 22% of U.S. outpatient claims, according to an analysis from McKinsey & Co. That work accounts for 13% to 19% of outpatient spending.
    • “The Sept. 28 analysis of 2024 commercial, Medicare and Medicaid claims found that roughly 2 billion to 3 billion outpatient claims involve services clinical AI could potentially perform. McKinsey calls this category “discursive care,” meaning reasoning- and dialogue-based work such as intake, triage, diagnosis, referrals and follow-up that doesn’t require a hands-on exam.
    • Evaluation and management visits involving no additional care, or only low-complexity care, made up 11% to 15% of outpatient claims and 8% to 12% of spending. Interpretation of diagnostic or imaging results accounted for 5% to 7% of both claims and spending.
    • “Physician offices, clinics, virtual settings and urgent care are likely to see the largest share of AI-driven change, the authors said.”

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) today announced significant premium savings for millions of Medicare beneficiaries in 2027, with weighted average MA premiums projected to fall more than 16% from 2026 to 2027, and average prescription drug premiums in Medicare Advantage projected to plummet 38%. 
    • “Additionally, average premium for stand-alone Part D prescription drug plans is projected to rise by less than $1 per month in 2027. Despite speculation and misleading reports related to the appropriate sunsetting of the Part D Stabilization Demonstration Project, there is broad pricing stability across the Part D market.
    • “The strong 2027 outlook means Medicare beneficiaries will continue to have access to affordable coverage and broad plan choice without relying on billions of dollars in temporary subsidies to insurance companies. More than 99% of Medicare beneficiaries will have access to at least one Medicare Advantage Plan, while 97% will have access to 10 or more options. 
    • “CMS is releasing this key information ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2026, through December 7, 2026.” * * *
    • “To view premiums and costs for 2027 MA and Part D plans, visit: www.cms.gov/medicare/coverage/prescription-drug-coverage, and select the 2027 landscape source file under “Downloads.”
    • “For state-by-state information, important dates, and enrollment resources for MA and Part D in 2027, visit: https://www.cms.gov/files/document/2027-medicare-advantage-part-d-landscape-state-state-fact-sheets.pdf.” 
  • Beckers Hospital Review reports,
    • “The Comprehensive Care for Joint Replacement (CJR) model saved Medicare $180 million in its final three performance years without changing care quality, according to the program’s final evaluationreleased Sept. 24.
    • “CMS launched CJR in 2016 as its first mandatory bundled payment program, requiring hospitals in randomly selected cities to take financial responsibility for hip and knee replacements and the 90 days after discharge. Hospitals could earn a payment from CMS or owe money back depending on whether episode spending came in under or over a target price. The model ended in December 2024. 
    • “The final report covered the three years after CMS extended and reworked the model (October 2021 through December 2024). During that stretch, 321 hospitals across 34 metro areas performed about 143,000 joint replacements that counted toward the model, which was about 9% of all hospital-based joint replacements in the U.S. CMS had narrowed the model to higher-spending markets, so CJR patients tended to be somewhat older and sicker than joint replacement patients nationwide.”
  • and
    • “The Trump administration is developing an initiative aimed at moving production of 86 essential medicines to the U.S. within 18 months, according to a Sept. 25 Bloomberg report.
    • “Under the initiative, the Office of Management and Budget would solicit proposals from the healthcare industry on opportunities to move production of drugs on the list to the U.S., according to the report. A committee would identify and act on industry proposals.
    • “The effort cites “national security” and aims to reduce or eliminate dependence on medicines produced by foreign entities of concern, including China, Russia, Iran and North Korea, according to an OMB document cited by Bloomberg.
    • “The initiative builds on broader federal efforts to strengthen domestic supplies of critical drugs. The Economic Development Administration put $15.97 million toward a Civica-led project to build a fully domestic supply chain for four sterile injectables. Nine drugmakers that signed most-favored-nation pricing agreements with the administration this month also committed to invest at least $19.6 billion collectively in U.S. manufacturing.”
  • Beckers Payer Issues relates,
    • “House Democrats have drafted an 84-page health policy agenda outlining what the party would pursue if it wins a House majority in November, according to a Sept. 25 report from Politico, which first obtained the document.
    • “The new agenda follows reports earlier this month that the caucus was privately discussing a broader expansion of the Medicare program, along with policies aimed at breaking up vertically integrated healthcare companies such as UnitedHealth Group and CVS Health.”
  • and
    • “Medicare Advantage plan choice will fall in more than half of states in 2027, even as CMS projects lower average premiums and a nearly unchanged number of available plans nationwide.
    • “The decline follows widespread disruption in 2026, when as many as 2.9 million MA enrollees had to find new coverage after their plans were discontinued or the insurer exited the market. Individual insurers have signaled a similar pullback for next year, with Humana saying in July that its 2027 plan exits are expected to affect about 600,000 members.”
  • Beckers Hospital Review adds,
    • “Researchers at Yale University have outlined 10 new policy proposals they say could save billions in healthcare spending, targeting Medicare Advantage payments, site-neutral payments, drug costs, nursing home care and other areas.
    • “Nine of the proposals carry annual savings estimates that together range from about $70 billion to $84 billion, while the remaining proposal is estimated to save households $44 to $58 a month. 
    • “The proposals are the latest additions to the Yale Health Care Affordability Lab’s 1% Steps project, which now includes 23 policies with estimated annual savings of about $450 billion, or roughly 8% of the $5.5 trillion the U.S. spends on healthcare annually, according to a Sept. 28 news release. The lab cautioned that the total is not a Congressional Budget Office-style estimate and does not account for potential interactions among the proposals.
    • “None of these ideas alone will fix the American health care system, but stacked together, these targeted reforms add up to substantial savings,” Zack Cooper, PhD, director of the lab, said in the release.”
  • HR Dive lets us know,
    • “The U.S. Department of Labor is trying to help workplaces prepare for opioid-related overdoses in the workplace, according to a news release issued Thursday. 
    • “DOL’s Occupational Safety and Health Administration released a fact sheet Thursday that “provides practical information that focuses on empowering workplaces to recognize the signs of an overdose and act immediately.” 
    • “The guidance comes as employers grapple with drug use among employees, with some reports showing nearly 20% of workers use some kind of substance.”

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

  • Federal News Network reports,
    • “As agencies walk back the Trump administration’s controversial essay question from federal job postings, the Office of Personnel Management is directing them to replace it with a new prompt.
    • ‘Agencies must now include a question stating, “In this role, you will be expected to professionally and efficiently implement executive direction. Provide an example where you implemented leadership direction on a strategy or policy decision that differed from your own recommendation.”
    • “A Sept. 18 memo from OPM told agencies to begin including the new question on all upcoming federal job announcements. It replaces a prompt from the Trump administration that previously asked applicants to name a few executive orders or policy initiatives “significant” to them and explain how they would help implement those orders if hired.
    • “Agencies are expected to include OPM’s replacement question on job announcements that close on or after Sept. 26. So far, about 2,400 job announcements contain the revised question, OPM said Friday in a court filing.”

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

  • STAT News reports,
    • “The FDA has approved AbbVie’s once-daily Parkinson’s pill, tavapadon, to be sold as Juvmo. The drug is part of its $8.7 billion acquisition of Cerevel Therapeutics. The dopamine receptor agonist was approved for adults with Parkinson’s based on a late-stage study that showed the drug helped improve symptoms, Reuters writes. 
    • “AbbVie has said it sees more than $5 billion in combined sales from its Parkinson’s portfolio, though Citi analysts have cautioned that Juvmo’s uptake could be gradual as Medicare coverage negotiations play out.”
  • Fierce Pharma relates,
    • “Roche’s Gazyva just increased its foothold in the autoimmune market with a fresh FDA approval, becoming the first new treatment option in 70 years for patients with idiopathic nephrotic syndrome (INS).
    • “The regulator cleared the anti-CD20 monoclonal antibody to reduce the risk of relapse in adults and children 2 and older with frequently relapsing or steroid-dependent, childhood-onset INS who are in complete remission.
    • “The FDA green light, Gazyva’s second autoimmune indication in less than 12 months, cementing the 2013 cancer drug’s second act in immune-mediated diseases.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure and adverse effects on metabolism) in patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome. Emcitate is the first therapy approved by the FDA to treat symptoms of this very rare, devastating genetic disease. This approval reflects the FDA’s dedication to patients with rare genetic diseases, many of whom have serious unmet medical needs.
    • “Until now, patients living with MCT8 deficiency and their families had no FDA-approved treatment option,” said Marina Zemskova, M.D., Deputy Director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research. “Emcitate’s approval reflects the FDA’s deep commitment to patients with rare conditions who are in need of meaningful treatment options.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration last week released a draft guidancedocument spelling out what the agency wants to see in premarket submissions for robotically assisted surgical devices.
    • “The 50-page document details criteria for system stability and latency, instrument motion and position control, visualization, software, wireless technology, cybersecurity, sterilization, clinical data, labeling, training and more.
    • “The agency also said it will hold a two-day public workshop on Dec. 2-3 focused on evaluating the benefits and risks of robotic medical devices with autonomous or remote teleoperation capabilities.”

From the judicial front,

  • Beckers Behavioral Health reports,
    • “A federal jury in Fort Worth, Texas, convicted Kevin Curry, 64, of nearby Frisco on Sept. 24 in a $26 million healthcare fraud, kickbacks and money laundering scheme.
    • “Mr. Curry billed TRICARE, the military’s health program, for transcranial magnetic stimulation therapy that was medically unnecessary or not provided, according to a Sept. 25 news release from the Department of Justice.”

From the public health and medical / Rx research front,

  • Beckers Behavioral Health reports,
    • “Breast and prostate cancer incidence is rising among people of every race and ethnicity in the U.S., while lung cancer incidence and death rates are dropping sharply, according to the CDC’s “Annual Report to the Nation on the Status of Cancer,” published Sept. 22 in Cancer.
    • “Researchers analyzed data from population-based cancer registries and the National Center for Health Statistics’ National Vital Statistics System to track cancer incidence through 2022 and death rates through 2023 by cancer type, sex, race and ethnicity and age.
    • “The CDC report follows the American Association for Cancer Research’s 16th annual “Cancer Progress Report,” which found the U.S. cancer death rate declined 35% between 2015 and 2024.
    • “The decline in cancer deaths was driven largely by “accelerated progress against lung cancer,” the CDC said in a Sept. 22 news release.”
  • The New York Times relates,
    • “More than 50 new cases of measles have been reported in Pennsylvania since Wednesday, state health officials said, as efforts continue to combat an outbreak that has spread across the state.
    • “The 55 new cases, reported by the Pennsylvania Department of Health in a statement on Friday, bring the total number of cases to 890 across 39 counties so far this year.
    • “The outbreak has led to 173 hospitalizations and four measles-associated deaths, according to the department.
    • “While daily numbers fluctuate,” the department said, “tracking these trends provides Pennsylvanians and health care providers with visibility into community transmission across the Commonwealth and helps inform the department’s ongoing response.”
  • STAT News tells us,
    • “Metal mixtures found in the leftover smoke, ash and debris from the deadly 2023 Maui wildfires were harmful to the lung health of people living nearby long after the burning ended, a new study says.
    • “The work shows that major wildfires, which are worsening with the planet’s warming, could have lasting effects beyond immediate exposure.
    • “New research published in the journal Proceedings of the National Academy of Sciences on Monday found higher metal levels, associated with respiratory harm, in nearby residents up to a year and a half after the fires.”
    • “As part of the Maui Wildfire Exposure Study, one of the largest postfire investigations in the country, University of Hawai‘i researchers studied the urine of 1,400 adults. They found substantially elevated concentrations of metals such as arsenic, cadmium, copper and antimony.”
  • MedPage Today asks “One Shot or Two? What to Know About HPV Vaccination Recommendations.”
    • — Guidance is evolving
  • Per Health Day,
    • “Cutting back on ultra-processed food could provide a boost to your mental health, a new pilot study says.
    • “People had less depression and anxiety after cutting their ultra-processed food intake by more than 85%, researchers reported Sept. 23 in JAMA Psychiatry.
    • “The results indicate that junk food “may harm your gut in ways that ripple up to your brain,” lead researcher Dr. Nyasha Chagwedera, an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, said in a news release.”
  • Per Healio,
    • “Approximately one in four adults with hepatitis C virus infection who initiated treatment with direct-acting antivirals did not undergo follow-up RNA testing, according to a research letter published in JAMA Network Open.
    • “However, 90% of that unmonitored population had been prescribed at least 56 days of DAA therapy, potentially leaving cured individuals unaccounted for and highlighting a notable gap in HCV surveillance efforts.
    • “Measuring care outcomes is essential to monitoring progress toward hepatitis C elimination,” Hasan Symum, PhD, of the CDC’s division of viral hepatitis, and colleagues wrote.”
  • BioPharma Dive informs us,
    • “Shares in eye-drug developer Kodiak Sciences more than doubled Monday after the company said its two drugs for macular degenerationsucceeded in a Phase 3 clinical trial that compared them with Regeneron Pharmaceuticals’ Eylea.
    • “Kodiak’s Zenkuda was able to match Eylea’s eyesight improvement using an individualized dosing strategy that allowed more than half of trial participants to receive injections only once every six months compared with once every eight weeks for Eylea, Kodiak said. The biotech’s second drug, called tabirafusp alfa tedromer, also matched Eylea using an individualized dosing strategy.
    • :The company expects to ask the Food and Drug Administration for approval of Zenkuda in wet age-related macular degeneration, the condition treated in the trial reported Monday, along with two other eye disorders in the fourth quarter of 2026. The news marks a turnaround for Kodiak and Zenkuda, which failed to match Eylea in a trial that read out more than four years ago. Kodiak’s market value climbed by more than $3 billion
  • The Wall Street Journal notes,
    • Roche Holding ROP  said it stopped work on one of its obesity-drug candidates, after clinical-trial data suggested the medicine wouldn’t hit internal targets.
    • The Swiss drugmaker said it returned rights to the medicine, emugrobart, to its majority-owned business Chugai Pharmaceutical, which originally discovered the drug and licensed it to Roche.
    • “We have made the decision to discontinue development,” Roche’s pharmaceuticals chief executive, Teresa Graham, said at an event with investors in London on Monday. “We are returning that molecule to Chugai, and Chugai is looking to further development in [spinal muscular atrophy] as well as considering potential outlicensing opportunities.
    • “Roche had previously estimated the drug had potential to reach annual peak sales of between 1 billion and 2 billion Swiss francs ($1.21 billion-$2.41 billion). The company is also developing two obesity injections and a pill, and sees potential for each of them to exceed 3 billion francs in peak sales.”

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

  • Modern Healthcare reports,
    • “UConn Health’s proposed acquisitions of Bristol and Day Kimball hospitals have been delayed. “Farmington, Connecticut-based UConn said Friday it is committed to the deal but needs more time for due diligence and planning to ensure the facilities’ long-term financial sustainability.
  • STAT News relates,
    • “Blockbuster GLP-1 drugs have transformed the lives of millions of people. Lately, they’re undergoing a makeover of their own.
    • “Once promoted as tools to address obesity as a medical issue, GLP-1 drugs are increasingly being seen — and marketed — as a way to look and feel better generally. And, as the pioneer in the field, Novo Nordisk, in particular, has leaned into the shift.
    • “In advertisements around the world, the company has trotted out slogans like “Live lighter” and “Summer Glow Up.” On its website, Novo no longer labels its treatment, Wegovy, as a “weight management” drug or “anti-obesity” medicine, but instead as a “weight loss” drug. And the company now often refers to the people who take its drugs less as “patients” and more as “customers.”
    • “It’s a long way from the pitch Novo and its rival GLP-1 maker, Eli Lilly, once made — that obesity is a chronic biological disease, just like diabetes and heart disease, and the drugs don’t merely help people lose weight, but also improve health outcomes.
    • “The shift, observers note, is no accident.” 
  • Physicians Practice tells us,
    • “About a third of medical groups have used AI to build their own software, and many of those homegrown tools sit in the parts of the practice that handle patient data: scheduling, prior authorization, denials and patient-facing workflows.
    • “A Sept. 22 MGMA Stat poll of 228 medical group leaders found 34 percent have built an app or workflow tool in-house using AI, according to MGMA’s write-up of the results. Another 8 percent tried but never launched a project, 54 percent haven’t tried and 10 percent weren’t sure.
    • “The approach, often called “vibe coding,” lets someone describe what they want in plain language and have a generative AI tool write the code. It puts working software within reach of physicians and administrators who have never written a line of it.
    • “Respondents described building tools for scheduling, prior authorization and denial work, internal dashboards, inventory management, call handling, recalls and staff tracking. Some projects moved closer to protected health information, including charting support, biologic-ordering workflows, coding and audit guidance, and patient-facing tools.”
  • Healthcare IT News adds,
    • “Artificial intelligence capabilities are creating a new operational reality in healthcare right now and are needed to alleviate immense systemic pressures, said Seema Verma, general manager of Oracle Health and Life Sciences, on Wednesday as she opened the 2026 Oracle Health and Life Sciences Summit in Orlando, Florida.
    • “Verma announced a series of specifically engineered AI agents for clinical workflows, revenue cycle management and life sciences in her opening keynote address.
    • “These are not isolated product announcements,” she explained. “They are pieces of a much larger transformation across payers, providers, pharma and for all patients.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Services news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), today announced that it has awarded $247.9 million in grants to expand access to addiction treatment, mental health services, and recovery support in communities across the country. The investments will strengthen mental health support in schools, expand trauma treatment for children and families, equip first responders and communities to reverse overdoses, and help people in recovery return to work and rebuild their lives.
    • “HHS is investing nearly $250 million to put lifesaving treatment and recovery services directly into communities across America,” said HHS Secretary Robert F. Kennedy, Jr. “Through President Trump’s Great American Recovery, we are expanding addiction treatment, preventing fatal overdoses, helping children and families heal from trauma, and giving Americans in recovery the support they need to rebuild their lives. We are equipping communities with proven tools that save lives and help people recover.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is launching an initiative with a founding group of 37 state partners to focus on how quality is measured in Medicaid and the Children’s Health Insurance Program (CHIP). The effort will put health outcomes — not processes and paperwork — at the center of how success is defined. CMS and its partners will prioritize measures that demonstrate meaningful improvements in prevention, chronic disease management, and behavioral health.
    • “For too long, Medicaid has measured whether boxes are checked instead of whether patients are getting healthier — that must change,” said CMS Administrator Dr. Mehmet Oz. “We should judge success by what matters — preventing disease, managing chronic conditions, and improving patients’ health.”
    • “We are shifting the focus from paperwork and process to real accountability for what matters: health outcomes. We are encouraged at this level of commitment from states, and we are ready to get to work with them to implement this vision,” said CMS Deputy Administrator Stephanie Carlton.”
  • Fierce Healthcare reports,
    • “A new coalition is bringing together employers, clinicians and other stakeholders to push for the expansion of direct contracting.
    • “The Association for Direct Care will advocate for policies that ease barriers to direct contracting arrangements between employers and providers, boost transparency and support new payment models. A key goal, according to the announcement, is to support lower costs and better quality as well as the relationship between providers and their patients.
    • “The organization will focus on the expansion of direct employer contracting in the commercial space as well as in federal health programs.”
  • Healthcare Dive relates,
    • “A new report from a conservative think tank is accusing 340B hospitals of providing less charity care than other nonprofit hospitals, despite receiving discounted drugs.
    • “Hospitals participating in the 340B drug discount program spent 2.16% of their operating expenses on free or discounted care for low-income patients, called charity care, compared with 2.82% at non-340B hospitals, according to a Thursday analysis from the Pioneer Institute and CancerCare.
    • “Hospitals pushed back on the report, with the American Hospital Association saying 340B hospitals provide support for patients in other ways. “This report is another in a long line of misleading studies that wrongly singles out charity care as the only way to measure how hospitals provide for their patients and communities,” Bharath Krishnamurthy, director of pharmaceutical policy at the AHA, said in an email.”
  • Per MedTech Dive,
    • “Diagnostics companies, under pressure from proposed Medicare reimbursement cuts, are renewing calls for Congress to pass legislation that could provide relief by changing how data for setting laboratory test payment rates is collected.
    • “A new clinical laboratory fee schedule proposed this week by the Centers for Medicare and Medicaid Services would usher in the cuts beginning next year. Lab service providers face payment reductions of 15% on 775 tests under the preliminary schedule for 2027, according to the American Clinical Laboratory Association. 
    • “Getting legislation through Congress that would avert the reductions will be a tough task, however. The House of Representatives is now in recess until after the November midterm elections.”

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

  • OPM Director Scott Kupor writes (Substack link) in his Secrets of OPM blog about his efforts to recruit young people into federal service.
    • “My message to students has been really simple – we don’t need you to make a 40-year decision to be a federal employee. Instead, give it a shot for 2-3 years and see if you like it. I hope some will and may re-up for another stint, but for sure many will decide to seek their calling elsewhere. That’s fine; we don’t need to fight that or denigrate that. Any public service is better than none and getting a firsthand understanding of how government works will engender a sense of patriotism that we can’t replicate in any better way.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Eli Lilly received FDA approval Sept. 24 for Onswik, a once-weekly basal insulin injection for adults with Type 2 diabetes.
    • “The FDA approved Onswik for use alongside diet and exercise to improve glycemic control. The drug delivers steady basal insulin levels over seven days. Lilly said the drug is designed to eliminate more than 300 injections per year compared with once-daily basal insulin.”
    • “Onswik is not indicated for Type 1 diabetes because it raises the risk of severe hypoglycemia in those patients.
    • “Lilly plans to launch the Onswik KwikPen in the U.S. in the coming months in two concentrations: 500 units/mL and 1,000 units/mL. The company did not disclose pricing.”
  • Fierce Pharma adds,
    • “In just over a month, the FDA has cleared not one, but two treatments for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic condition that causes soft tissues to turn to bone. 
    • “Regeneron’s Pasatru earned regulatory clearance in late August, and Friday, Mirum Pharmaceutical’s zilurgisertib, to be marketed as Atebrioz, joined the race. The FDA has grantedMirum’s once-daily oral medication a green light to treat FOP in patients ages 12 and up.  
    • “Atebrioz has fallen under Mirum’s purview thanks to a licensing deal between the rare disease pharma and Incyte in April. Under the deal, Mirum paid $16 million up front for global commercial rights to the drug, with additional regulatory and sales milestones potentially to follow.”

From the fraud, waste, and abuse front,

  • Govexec reports,
    • “The Trump administration claims it found more than $1.2 billion in suspected fraud and stopped $41 million more across five COVID-related contracts, according to a Wednesday press release from the General Services Administration.
    • “GSA said although the COVID-19 national emergency and related acquisition flexibilities were cancelled in 2023, unnamed federal contractors continued to receive funding. The alleged fraud was uncovered in collaboration with the Health and Human Services Department and under the direction of the White House Task Force to Eliminate Fraud.
    • “The COVID emergency ended over three years ago, yet fraudsters continue to weaponize outdated emergency contracts to abuse taxpayer dollars,” GSA Administrator Edward Forst said in the release. “GSA will continue to work with the Vice President’s task force to stop improper payments, refer suspected fraud to law enforcement, and fight to recover every dollar.”
    • “GSA estimates that about 93% of the contract funding — which would have been distributed for COVID vaccines and other pandemic-related services — has not yet been distributed to vendors, while roughly 6.78% has already been expended, according to a Fox News exclusive attached to the release. The agency has suspended payments to contractors, although the uncovered funding is not currently tied to criminal charges for contractors, the outlet reported.”

From the judicial front,

  • The Hill reports,
    • “The U.S. Court of Appeals for the D.C. Circuit sided with the Trump administration in its blacklisting of the artificial intelligence firm Anthropic, allowing the Pentagon to label the AI firm a supply chain risk. 
    • “The 2-1 ruling, issued Friday [DC Circuit link], rejected Anthropic’s challenge of the designation, finding the Department of Defense had “ample support” for its belief that the continued use of Anthropic’s Claude models by the agency or its contractors presented a national security risk.” * * *
    • “Friday’s ruling breaks with a California federal judge’s decision last month finding the government violated the First Amendment when it issued the supply chain risk.” * * *
    • “A spokesperson for Anthropic said the firm “respectfully disagrees” with the appeals court ruling.
    • “Another federal court has already held the government’s parallel designation unlawful,” they added. “We remain confident in our position and are considering all options, including further review.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 25, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
      • “COVID-19 activity remains elevated but is declining nationally. COVID-19 hospitalizations remain low.
      • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
      • “RSV activity is very low.
      • “Seasonal flu activity is low.”
  • The University of Minnesota CIDRAP reports,
    • “The US measles count has climbed to 3,659 confirmed cases, with 171 new cases added this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “Of the 3,659 confirmed cases, 18% are in children age 5 and under, 43% in children and teens aged 5 to 19, and 38% are in adults 20 and older. Nine percent of case-patients have been hospitalized. Ninety-five percent of case-patients are unvaccinated or have unknown vaccination status.” * * *
    • “Pennsylvania remains the nation’s hot spot, with 129 new cases in the past seven days and 890 for the year, according to an update today from the Pennsylvania Department of Health. Lancaster County, where two of the state’s measles deaths have been reported, has been the hardest hit, with 342 cases. 
    • “Other states with notable increases in measles cases include Ohio, which added nine new cases this week and now has 189 for the year; Kentucky, which added 10 new cases and has 67 for the year; and Wisconsin, which added four new cases and has 171.”
  • and
    • “The bivalent (two-strain) respiratory syncytial virus (RSV) vaccine made by Pfizer (RSVpreF, or Abrysvo) reduced the risk of hospitalization and emergency department (ED) visits for at least three seasons after vaccination in older adults with a high prevalence of comorbidities, according to a study published last week in Infectious Diseases and Therapy. 
    • “A separate study published the same day in JAMA Network Openfound that RSV vaccines provided substantial protection against RSV-related hospitalization and death among adults aged 65 and older and people with weakened immune systems during the 2023-24 respiratory virus season. 
    • “RSV is a leading cause of lower respiratory tract disease (LRTD) with severe outcomes, particularly among older adults and those with compromised immune systems. The Centers for Disease Control and Prevention estimates that RSV contributes to around 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths among older adults in the United States each year.” 
  • Beckers Clinical Leadership relates,
    • “The death rate tied to three common, treatable emergency surgical conditions increased about 50% between 1999 and 2020, according to an abstract being presented at the American College of Surgeons Clinical Congress 2026 in Washington, D.C., Sept. 26-29.
    • “Researchers at Peoria, Ill.-based OSF HealthCare analyzed nearly 20,000 deaths from the CDC WONDER Multiple Cause of Death database to assess mortality trends tied to emergency general surgery conditions.”
    • “The conditions included in the study were appendicitis, acute cholecystitis and abdominal wall hernia with obstruction or gangrene, recorded as a contributing factor to — not necessarily the main cause of — death.” * * *
    • “The study “raises important questions about whether patients are getting to surgical care in time, especially in rural communities, and whether workforce shortages or other pressures are contributing,” Vishnu Mani, MD, the study’s lead author and emergency general surgery medical director at OSF HealthCare, said in a Sept. 25 news release.”
  • Beckers ASC Review tells us,
    • “Patients who had an appendectomy for acute appendicitis had a 58% lower relative risk of a later colorectal cancer diagnosis than similar patients treated with antibiotics alone, according to new research set to be presented at the American College of Surgeons Clinical Congress 2026 in Washington, Sept. 26-29.” * * *
    • “The management of acute appendicitis has changed significantly over the last decade, and antibiotic therapy is now an accepted option,” Valentine Nfonsam, MD, the study’s senior author and professor and executive vice chair of the department of surgery at Morehouse School of Medicine, said in the release. “We wanted to ask a different question: Are there potential long-term oncologic implications of leaving the appendix in place after appendicitis?”
    • “The exact mechanism behind the association is unclear, but researchers said it could involve earlier detection of an underlying malignancy, removal of a source of inflammation, or the appendix’s role in the gut microbiome and immune system. Dr. Nfonsam cautioned that the findings shouldn’t be read as a reason for every appendicitis patient to undergo surgery, and said age, genetic predisposition, family history and other colorectal cancer risk factors should still guide patient selection and follow-up. The findings are being presented as a research abstract and have not yet been peer-reviewed.”
  • Cardiovascular Business informs us,
    • “For-profit hospitals in the United States may be starting to fall behind their nonprofit counterparts when it comes to heart attack outcomes, according to new data published in JACC: Advances.[1] Readmission rates—a recognized sign of care quality—seem to be falling at nonprofit hospitals while they remain mostly unchanged at for-profit facilities.
    • “The study’s authors reviewed data from more than 4.6 million acute myocardial infarction (AMI) hospital admissions from 2013 to 2022. All data came from the Agency for Healthcare Research and Quality’s Nationwide Readmissions Database. ST-segment elevation myocardial infarction (STEMI) and non-STEMI diagnosis codes were used to identify AMI hospitalizations. 
    • “Overall, the AMI readmission rate at for-profit hospitals remained relatively stable from 2013 (13%) to 2022 (12.7%). At nonprofit hospitals, on the other hand, the AMI readmission rate dropped from 11.5% in 2013 to 10.5% in 2022. This same pattern was true when only looking at patients undergoing percutaneous coronary intervention (PCI) procedures. For patients undergoing coronary artery bypass grafting (CABG), meanwhile, both for-profit and nonprofit hospitals saw readmission rates decline over the course of the study.
    • “The authors also found that for-profit and nonprofit hospitals were linked to comparable in-hospital mortality rates. One area where for-profit hospitals bested nonprofit hospitals was reducing cardiac complications. Respiratory and renal complications, on the other hand, were more common at for-profit hospitals than they were at nonprofit hospitals.”
  • Healio adds,
    • “The stroke incidence rate among young adults nearly doubled from 1993 to 2020 while decreasing among older adults, according to research published in Neurology.
    • “Over that same time, researchers saw an increase in the percentage of patients with stroke who had substance use as well as conditions associated with vascular risk, such as hypertension, diabetes and atrial fibrillation, said Emily R. Fisher, MD, a neurology resident and fellow at the University of Cincinnati.
    • “Our findings highlight the importance of regular primary care, even for younger adults without chronic medical conditions,” Fisher told Healio. “Routine medical care and recommended screenings are very important to detect stroke risk factors and to address them appropriately, as one may not have symptoms from these conditions.”
  • and
    • “The risk for egg or peanut allergy in 1-year-olds was not lower among women who ate high vs. standard amounts of eggs and peanuts during pregnancy and lactation, according to data published in The New England Journal of Medicine.
    • “Based on these new large-scale trial results, clinicians can reassure pregnant women that they do not need to eat high amounts of common food allergy causing foods (such as eggs and peanuts) to reduce the risk of their baby developing these food allergies,” Debra J. Palmer, PhD, associate professor and head of nutrition in early life at The Kids Research Institute Australia, told Healio.”
  • Nature notes,
    • “Most people taking the popular GLP-1 drugs shed substantial amounts of weight — an average of one-quarter of their body weight according to one study1. So why do 10–15% of people using the drugs lose minimal weight or none at all?
    • “There is tremendous heterogeneity” in the response to these medications, says Daniel Drucker, an endocrinologist at the University of Toronto in Canada, whose work aided in the development of GLP-1 drugs. “And we really don’t understand that.”
    • “Solving this mystery might lead to new medications for people who do not benefit from today’s versions of such drugs and could make it possible to match individuals to treatments that are most likely to work for them. Those tantalizing possibilities have made people’s individualized responses to GLP-1s a key line of enquiry for obesity scientists. The Endocrine Society, a leading medical and research organization in Washington DC, has already called for it to be a priority for the field, with scientists looking into various explanations, including biological sex, genetics and behavioural factors.
    • “For now, research to identify the differences between those who do or don’t respond to the drugs is in its early days, and precision medicine for obesity remains “largely aspirational”, according to a scientific statement published by the Endocrine Society earlier this month. But researchers are starting to dig into these questions with energy.”

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

  • Per Tech Target,
    • “Employers can expect to pay 9.5% more for employee health benefits in 2027, with new reporting from professional services firm Aon projecting average employee healthcare costs totaling more than $19,000 in the coming year.
    • “These numbers reflect the fourth consecutive year of healthcare cost growth approaching double digits, the firm said.
    • “At this level, rising health care costs become much more than a budgeting challenge and influence organizational decisions from benefits strategy and employee affordability to broader workforce and financial planning priorities,” Mike Pasterick, North America Health Solutions leader at Aon, said in a statement. “Leaders are undergoing pressure to maintain affordable benefits while continuing to invest in attracting, supporting and retaining talent.”
    • “The drivers behind these healthcare cost increases might not be surprising. According to Aon, trends like increased healthcare utilization, greater chronic disease prevalence and the volume of high-cost claims all contribute to rising health benefits costs.”
  • Modern Healthcare reports,
    • “Penn Medicine, Independence Blue Cross and Regent Surgical are forming a company and plan to build and operate at least 18 ambulatory surgery centers. 
    • “The facilities will be located in Penn Medicine’s service area of Pennsyvania, New Jersey and Delaware. The first one is expected to open next year, a spokesperson said Friday. A timeline for when all facilities will be complete has not been announced.
    • “The venture will be structured as a for-profit company. Additional details were still being finalized, a spokesperson said. Regulatory approvals, market conditions and community needs will factor into the decisions.”
  • and
    • “Rightway, an upstart pharmacy benefit manager covering about 3 million people, is considering an initial public offering in the years ahead as it tries to chip away at a market long dominated by some of the largest healthcare conglomerates in the U.S.
    • “The closely held company was valued at $1.75 billion after it closed a recent fundraising round, according to a person familiar with the matter who wasn’t authorized to speak publicly.
    • “The public markets are where some of the best companies in the world are built,” Chief Executive Officer Jordan Feldman said in an interview. Rightway, which is profitable, is weighing a public market debut in the next four years, he said. “That public currency and transparency are certainly something that we strive toward.” * * *
    • “Rightway’s only revenue stream is a per-enrollee fee that is not related to the price of the drug, Feldman said. That leads to savings for clients on their overall drug expenses and slower spending growth, he said.”
  • The Wall Street Journal relates,
    • “Novo Nordisk agreed to pay up to $1.3 billion to license and develop Swedish pharmaceutical company Nanexa’s drug delivery technology in a deal that could cut the frequency that patients need to inject its obesity and diabetes drugs.
    • “The deal covers Nanexa’s PharmaShell technology, which is designed to enable controlled and sustained release of active pharmaceutical ingredients through an ultra-thin coating applied to individual drug particles.
    • “Under the exclusive deal announced late Thursday, Novo has licensed Nanexa’s technology in up to five development programs covering different drug administration frequencies, with the companies targeting monthly and quarterly administration.
    • “Novo will lead global development and commercialization, with Nanexa eligible to receive upfront consideration and potential milestone payments totaling up to 1.17 billion euros ($1.33 billion).
    • “The Danish drugmaker will pay 615 million euros in upfront and development and regulatory milestone payments, in addition to royalties on future product sales.”
  • Per BioPharma Dive,
    • “RNA drugmaker ADARx Pharmaceuticals on Thursday priced its $446.3 million initial public offering and received an additional boost with a separate investment from development partner AbbVie. 
    • “The biotechnology firm sold more than 26 million shares at $17 apiece, at the top end of the $15-$17 price point it originally laid out in federal filings. It also secured about $89 million through a private stock sale to AbbVie. ADARx begins trading on Nasdaq on Friday under the ticker symbol “ADRX.” 
    • “ADARx is one of a handful of companies specializing in what’s called RNA interference, a form of drugmaking that involves stopping the body from producing problematic proteins. Biotechs like Alnylam Pharmaceuticals and Arrowhead Pharmaceuticals have successfully brought RNAi drugs to market.”
  • Beckers Behavioral Health lets us know,
    • “OpenAI released MentalHealthBench, an open benchmark that measures how AI systems respond in realistic mental health conversations, on Sept. 23.
    • “The company built the benchmark with more than 80 licensed psychologists and psychiatrists from 22 countries. The cohort speaks 19 languages and represents nearly 20 mental health subspecialties. The benchmark scores model behaviors including safety, context-seeking, preservation of user agency and actionable guidance.” * * *
    • “OpenAI, whose ChatGPT reaches more than 1 billion people each week, released the benchmark openly so outside researchers can examine its methods and run their own evaluations.”
  • Per Radiology Business,
    • “Despite the increasingly unpredictable landscape of the healthcare sector, radiologists’ total cash compensation has remained steady, with some of the specialists enjoying an 18% increase in pay since 2024. 
    • “That’s according to new data from SullivanCotter’s 2026 Physician Compensation and Productivity Survey. The consulting firm’s annual survey includes data from 575 healthcare organizations representing approximately 235,000 physicians across 240 specialties. It contains detailed information organizations can use to help them navigate rising physician pay expectations, recruitment pressures and the changing metrics that define productivity. 
    • “According to the data, median total cash compensation increased year over year in 2026 across all major physician specialty categories. Adult medical specialties posted the largest gain, rising 7.2% from 2025 and 25.2% over the past five years.”  
  • Beckers Physicians Leadership tells us,
    • “Sixty-three percent of OB-GYNs and 63% of general surgeons have been named in a malpractice lawsuit, according to a new report from Medscape.
    • “Across all specialties, 33% of physicians said they had been a sole defendant, a co-defendant or both in a malpractice suit. That included 34% of specialists and 31% of primary care physicians.
    • “Medscape’s “Physicians and Malpractice Report 2026,” published Sept. 22, collected data from more than 1,100 full- and part-time physicians across nearly 30 specialties.”
  • Beckers ASC News informs us,
    • “The U.S. is projected to face a shortage of 27,940 surgeons by 2038, and vascular surgery is expected to be hit hardest, according to a study from the American College of Surgeons.
    • “The researchers called it the first unified assessment of the country’s surgical workforce. They used the Health Workforce Simulation Model from HHS to project supply and demand across 10 surgical specialties from 2023 to 2038, according to a Sept. 25 news release from the ACS.
    • “Nationally, surgeon supply is projected to fall 4.2% over the period while demand grows 12.8%. That would leave the workforce meeting 84.3% of need, with larger gaps in rural areas.”
  • Fierce Pharma notes,
    • “Total prescriptions for both Eli Lilly’s Foundayo and Novo’s Wegovy pill have bounced back following a holiday dip and reached new records. Weekly scripts for the Wegov pill jumped 14% sequentially to about 184K, compared with its previous high of 183K, according to IQVIA data cited by Citi. Foundayo climbed 13% to cross 50K for the first time, reaching 53,321.
    • “Foundayo now captures about 1 out of 3 new starts for oral GLP-1 obesity drugs, and “that’s growing week over week,” Lilly CEO David Ricks told CNBC in an interview this week. 
    • “As Leerink Partners analysts noted in a Sept. 23 note, effective Sept. 1, Lilly cut the initial-dose pricing for Foundayo 0.8 mg, 2.5 mg and 5.5 mg to $149, $149 and $199 per month for self-pay patients, respectively. The company framed the promotion as an elasticity experiment and as a push to the first maintenance dose, according to the Leerink note.
    • “As Jefferies analysts pointed out in a Sept. 25 note, the majority of Foundayo scripts seem to be cash pay, with about 80% of patients still on starting doses.”

Thursday report

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

Simplicity is a virtue.

From Washington, D.C.

  • STAT News reports,
    • “Congress is considering the first major overhaul of how Medicare pays doctors in more than a decade, and both Democrats and Republicans appear to agree on the outlines of an approach.
    • “The main policy under consideration would link Medicare’s doctor pay rates to a medical inflation measure, giving doctors guaranteed pay boosts, as hospitals and other parts of the health care system have long received.  
    • “In doing so, Congress would be retreating from the notion that Medicare can control how many services physicians provide on a national basis, an idea that has undergirded Medicare’s doctor payments for decades. And it would reduce the government’s push to get clinicians to engage in value-based care, where they get paid more to keep patients healthy.” * * *
    • “The measure under consideration is called the Patients First Act, and would establish a permanent, annual payment hike linked to the Medicare Economic Index (MEI), minus 1%. 
    • “During a recent House committee hearing, Republicans and Democrats praised the Patients First Act. No one in either party spoke against it. Congressional Medicare advisers also recommended the MEI minus 1% formula.
    • “Following the hearing, Energy and Commerce health subcommittee Chair Morgan Griffith (R-Va.) predicted that Congress would pass some of the doctor pay measures, but he cautioned about the need for “tweaks” due to their cost.
    • “Some of them may need a few tweaks, but I don’t think we would’ve done this today if we weren’t at least going to try to get some of them across the finish line during lame duck,” Griffith said.”
  • Fierce Healthcare relates,
    • “The Senate Finance Committee has advanced the nominees for two key Department of Health and Human Services posts.
    • “The committee members voted 15 to 12 to advance the nomination of Chris Klomp to serve as Deputy HHS Secretary and 14 to 13 to advance the nomination of Ge Bai, Ph.D., as Assistant Secretary for Planning & Evaluation (ASPE) at the agency. The nominees had addressed the committee on Sept. 15 alongside nominees for positions at the Internal Revenue Service and U.S. Tax Court.
    • “Klomp is a rising star at HHS and currently leads the Department of Medicare at the agency. If his nomination is approved, he would become second-in-command at the department, a position that has been vacant since Jim O’Neill departed in February.”
  • and
    • “The Senate Committee on Health, Education, Labor and Pensions (HELP) today questioned Heidi Overton, M.D., Ph.D., the president’s pick for FDA commissioner, in a hearing marked by tightrope-walking on issues like vaccines, abortions, flavored vapes and whether or not Donald Trump is capable of being wrong. 
    • “Overton conceded multiple times during the hearing that vaccines approved by the FDA, as well as the so-called “abortion pill” mifepristone, are safe and effective. But she stopped short of admitting that Trump has been wrong when dispensing medical information out of line with what the scientific evidence shows. 
    • “The committee will next vote on whether to send Overton’s nomination to the full senate for approval.” 
  • Healthcare Dive tells us,
    • “CMS Administrator Dr. Mehmet Oz delivered a candid assessment of artificial intelligence’s impact on healthcare costs Wednesday: It’s going to get worse before it gets better.
    • “Short term, AI is going to be inflationary because it’s going to turbocharge the ability of the current billing systems to work more effectively,” Oz said at Oracle’s annual health and life sciences summit in Orlando. 
    • “It’s the latest signal from the industry that AI could be inflating healthcare costs — even as its proponents argue the technology will lower them over time.” * * *
    • “For providers, AI-powered coding is enabling them to bill insurers for more conditions when they treat patients. They say the technology helps them more accurately bill for care, while insurers say doctors are using AI to charge more money without any actual increase in medical care.
    • “A study released by the insurer group Blue Cross Blue Shield Association on Thursday found that the increase of billing has added nearly $1 billion in healthcare costs between 2023 and 2025. The group said the study “raises concerns” that AI tools are contributing to higher spending.” * * *
    • “Although Oz noted the increase in healthcare costs, he said AI was still essential in the industry.
    • “I guarantee you we will lose lives if we don’t use AI in the day-to-day trench warfare of fighting disease in America,” he said.
    • “Oz said he hoped AI would lower healthcare costs in the long run, and that the government was relying on one particular area to make that happen: accountable care organizations.”

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

  • Following up on yesterday’s post about FedSmith’s helpful breakdown of the FEHB / PSHB questions for which OPM has requested public comment, it turns out that the public already has submitted 113 comments to the agency. You can access those comments here. In contrast to OPM’s limited posting of comments on its modified system of records notice, OPM has posted all 113 comments received to data on this new topic.
  • Tammy Flanagan, writing in Govexec, tells us,
    • “What changed in your federal benefits in 2026 — and what could change next? Agencies updated federal retirement, insurance, Social Security and Thrift Savings Plan programs, while Congress considered proposals affecting future pay and benefits. This article summarizes the changes that took place in 2026 along with the links to official sources.
    • “Review the 2026 changes now and watch for 2027 updates this fall. During Federal Benefits Open Season, OPM will soon begin to publish 2027 plans, premiums and coverage information. The September CPI release on Oct. 14, 2026, will provide the final CPI-W data used to determine 2027 Social Security and federal retirement COLAs.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “With some trepidation, a majority of an FDA advisory committee Thursday endorsed the Galleri multicancer early detection blood test.
    • “By 6-4 and 7-2 (with one abstention) margins, the molecular and clinical genetics panel of the Medical Services Advisory Committee voted that the test was effective and that its benefits outweigh the risks. However, many panel members who voted yes had reservations about their votes.
    • “The panel was more decisive on the question of safety, voting unanimously (10-0) in favor of Galleri.
    • “While most panel members agreed that as a diagnostic test Galleri was safe, effective, and demonstrated a positive benefit/risk profile, particularly for cancers for which screening tests are unavailable, they were concerned about the lack of outcome data supporting the test’s premarket approval (PMA) application, as well as the use of the term “early” in describing the purpose of the test.
    • “I really struggled with this one … I did change my vote twice,” said Jason Dominitz, MD, MHS, of the VA Puget Sound Health Care System in Seattle, explaining his yes vote on Galleri’s effectiveness. “Clearly, there are clinically impactful results of the test. People get a diagnosis work-up, cancers are found, but does that lead to clinically clinical benefit? I don’t see that we have evidence of clinical benefit at this time.”
    • “The question comes down to what do you call clinical effectiveness,” said Stanley Lipkowitz, MD, PhD, of the National Cancer Institute, who voted no. “As an oncologist, I generally look at that as outcome, and we don’t have that data.” * * *
    • “While not bound by its advisors’ recommendations, the FDA usually follows their advice.”
  • USA Today relates,
    • “Officials have classified the risk level of a thyroid medicine recall initiated last month to its most serious category.
    • “On Sept. 22, the U.S. Food and Drug Administration categorized the recall – which applies to one lot of thyroid tablets sold by Vitruvias Therapeutics Inc. – as a Class I recall, its highest risk level.
    • “Last month, Vitruvias Therapeutics Inc. recalled one lot of its 30 mg thyroid tablets because they could be superpotent, or stronger than intended, according to a FDA recall notice published on Aug. 24.
    • “The affected products include thousands of units distributed nationwide from January to September 2025 with an expiration date in September 2026, according to the notice.
    • “A Class I recall – the most serious FDA category – indicates that using the product is likely to cause serious health effects or death, according to the agency.”
  • CBS News considers “whether an FDA crackdown [noted in yesterday’s FEHBlog will] curb access to cheaper GLP-1 weight-loss drugs?
    • Scott Brunner, CEO of Alliance for Pharmacy Compounding, said that the FDA’s warning wasn’t about the volume alone, but the lack of documentation to prove that Empower was appropriately making the drug for individual patient needs.
    • “The FDA is possibly marking a line in the sand,” said Darshan Kulkarni, founding partner of the Kulkarni Law Firm and an expert in healthcare and pharmacy law. For now, though, the FDA’s warning shot is more likely to prompt compounding pharmacies to reframe how they differentiate their weight-loss products than to immediately stop making them, he said.
    • “But with the FDA taking a stance on the limits of compounded weight-loss drugs, he said, “That avenue is definitely getting narrower.”

From the public health and medical / Rx research front

  • Beckers Hospital Review reports,
    • “A recent study found 11.3% of healthcare personnel surveyed reported persistent long COVID symptoms.
    • “The study, published in the American Journal of Industrial Medicine, used electronic surveys to collect symptom data at three and six months post-infection from 1,496 healthcare personnel. Long COVID was defined as the same moderate or severe symptom reported at both time points. 
    • “Here are the findings.
      • “1. Older age was associated with higher odds of persistent symptoms, and female healthcare personnel had greater odds of persistent symptoms than male personnel. 
      • “2. Prior COVID infection or more than two underlying health conditions were also associated with higher odds of long COVID.
      • “3. Physicians, licensed practical and registered nurses, and therapists or therapy assistants had lower odds of long COVID than nonclinical healthcare personnel.”
  • MedPage Today tells us,
    • Lyme disease is the nation’s most frequently reported vector-borne disease.
    • In a U.S. cohort study, 29.5% of people positive for the bacteria that causes Lyme disease also tested positive for at least one of three other tick-borne pathogens.
    • The study suggests that even with typical Lyme disease symptoms, clinicians should consider the presence of other tick-borne pathogens, which may have implications for treatment.
  • and
    • “Residual lifetime ovarian cancer risk warrants consideration of risk-reducing bilateral salpingo-oophorectomy for healthy older BRCA carriers.
    • “Individualized decision-making about surgery should weigh risk reduction against impact on fertility and quality of life.
    • “Substantial residual risk remains for women who delay surgery to age 50, particularly for BRCA1 carriers.”
  • Health Day adds,
    • “Glucose patterns captured by continuous glucose monitors (CGMs) are linked to cardiometabolic risk in adults without diabetes, according to a study published online Sept. 17 in Diabetes Care.”
  • The American Medical Association lets us know “what doctors want patients to know about high cholesterol.” 
    • “Sorting through the good, the bad and the ugly about high cholesterol can be confusing. Understanding your overall risk, and not just one number, can help.”
  • Cardiovascular Business considers “Semaglutide is improving the heart health of millions—but how? Experts are stumped.”
    • “Professor Helen Colhoun, MBBChBAO, MD, a healthcare researcher and diabetes specialist with the University of Edinburgh, et al. tracked differences related to body weight, waist circumference, lipids, blood pressure and more in patients given semaglutide and those given a placebo. The overall conclusion was improvements in weight loss and waist circumference only partially explain the cardiovascular benefits being seen among patients given semaglutide. There is something more going on there—but what that happens to be is not yet totally clear.
    • “Our analyses could not fully ascribe the effects of semaglutide on cardiovascular disease to known risk factors with any certainty,” Calhoun said. “Whether we combine all risk factors together or look at some subsets of the risk factors, no more than half of the reduction in heart disease could be explained by the changes in these risk factors. These results suggest that semaglutide should be considered as a cardiovascular disease reduction drug and not just as a weight loss drug.” 
    • “She added that more research is still needed to help clinicians learn more about this significant trend. 
    • “Click here to read the full analysis.”
  • Reuters points out,
    • “Scientists have created a detailed map of gene activity within a crucial part of the brain called the prefrontal cortex, gaining insight into normal development and major brain disorders such as Alzheimer’s disease, Parkinson’s disease and ​schizophrenia.
    • “In nine separate studies, the researchers examined changes in individual types of brain cells that occur over time and made progress toward deciphering molecular processes ‌that underlie some of the most devastating brain disorders, a step toward possible new treatments.
    • “The prefrontal cortex is the front part of the brain’s outer layer, located behind the forehead. It helps a person plan, make decisions, regulate emotions and adapt behavior. It also is sensitive to age-related decline, and its functions are affected in many psychiatric and neurodegenerative disorders.” * * *
    • “The research identified patterns shared across some of the diseases as well as some ​specific to individual disorders.
    • “Together, these studies help explain where disease-related changes occur and which biological processes deserve closer investigation,” said Dr. Panos Roussos, director of the Center for Disease Neurogenomics at ​the Icahn School of Medicine at Mount Sinai in New York City and a leader of the research published on Wednesday in Nature, opens new tab and other journals.
    • “A useful treatment needs to influence the right biological process in the right cells. This map helps narrow that search. It can identify vulnerable cell populations, reveal processes associated with preserved brain function and help researchers decide which potential treatment targets to test,” Roussos ​said.”

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

  • Beckers Payer Issues reports,
    • “The Cigna Group is partnering with OpenAI to integrate AI into clinical workflows, with a first focus on cancer care.
    • “Under the collaboration announced Sept. 23, OpenAI’s tools will be built into workflows across Accredo Specialty Pharmacy and the insurance business, Cigna Healthcare. The first new capability will give oncology nurses and case managers an AI-enabled view that pulls together clinical, pharmacy, behavioral and benefits information for each member.
    • ‘The companies said the goal is to identify member needs earlier and personalize support between physician visits, when patients are often dealing with side effects, new symptoms and unanswered questions. The system is designed to feed insights from member responses back into future guidance and workflows over time.”
  • Cotiviti adds,
    • “Cotiviti and MedCity News just published the 2026 Healthcare AI Readiness Index revealing fascinating insights, including a striking contradiction.
    • “AI adoption is essentially universal in healthcare. Investment in AI is accelerating, and executives clearly see operational value. Yet only a minority feel prepared for AI-enabled cyberthreats. Less than 40% have detailed governance policies, more than 60% of respondents report shadow AI usage, and most still require human oversight for the highest-consequence decisions.
    • “Healthcare doesn’t have an AI adoption challenge. It has an AI readiness challenge. Governance, cybersecurity, and human oversight are all evidence of the broader gap between AI adoption and readiness. This gap may be the most important risk that healthcare executives aren’t measuring.”
  • Healthcare Dive points out,
    • “Investment in health IT is a top priority for a majority of providers and payers, though executives are seeking solutions for specific use cases that provide measurable results, a new survey from Bain & Company and KLAS Research shows.
    • “Tools that target revenue cycle management, patient engagement and clinical workflows are attracting attention — and investment dollars — from providers. Payers are focused on utilization management, care navigation and claims processing.
    • ‘Executives are especially emphasizing measurable return on investment when it comes to AI, with some seeking returns of 3x to 3.9x their original investment, according to the survey.”
  • Fierce Healthcare relates,
    • “UnitedHealth Group has named Jodee Kozlak to the newly created role of chief administrative officer, the healthcare giant announced Thursday morning.
    • “Kozlak will take the position on Sept. 28, per the announcement. In this role, she will be tasked with leading the company’s enterprise modernization efforts, including a portfolio that will initially include people, real estate, procurement and corporate security.
    • “Kozlak is currently chair of the board at C.H. Robinson Worldwide, a transportation and third-party logistics company, and is lead independent director for KB Home, a homebuilding company. She served as the global senior vice president for the Alibaba Group from 2016 to 2017, supporting the company’s expansion outside of China.
    • “She also held multiple leadership roles at Target Corporation between 2004 and 2015, including in human resources and legal, UnitedHealth said in the announcement.”
  • Beckers ASC Review informs us,
    • “Private equity ownership has become increasingly common across physician practices over the last decade, with investors backing groups in specialties like anesthesiology, orthopedics, gastroenterology and pain management. 
    • “Now, a new federal bill aims to ban it outright.
    • “Democratic lawmakers introduced the Stop Corporate Takeovers of Physicians Act on Sept. 16. The federal bill would ban private equity firms, insurers and other for-profit corporations from owning or controlling physician practices.
    • “Becker’s connected with 14 physicians, healthcare executives and attorneys to get their take on the bill. Most agreed the legislation is unlikely to pass or to fully undo private equity’s footprint in healthcare, but several said it targets the right problem and could shape future deals. Many also warned that the bill’s exemptions for hospitals and nonprofits could speed up hospital consolidation, and that it does little to address the reimbursement pressures pushing independent practices toward outside investors in the first place.”
  • Cardiovascular Business notes,
    • “The Heart Failure Society of America (HFSA) has released a new comprehensive look at heart failure (HF) clinics in the United States. The report includes more than 300 HF programs located in 47 states that serve approximately 626,000 patients.
    • “HFSA wanted to shine a spotlight on the country’s specialty clinics, often found in academic medical centers, while highlighting care gaps where many patients remain underserved. For instance, many Southern and Appalachian states—areas known for especially high risks of HF and other cardiovascular conditions—still have fewer clinics than are needed to ensure patients can easily access high-quality care.
    • “This report shows where specialty heart failure care exists in the United States and, just as importantly, where it doesn’t,” HFSA President Kenneth B. Margulies, MD, said in a statement. “The clinics in this database represent professional, multidisciplinary care. But the mismatch between where that care is concentrated and where the disease burden is heaviest is the central challenge our country needs to address.” * * *
    • “Click here for the full report. Its release comes just days before ASM 2026, HFSA’s annual scientific meeting.” 

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.”