“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC

• Politico Pro reports,
  • “The top Republican and Democrat on the Energy and Commerce Committee are taking seriously the pleas of large employers and health insurers who say the No Surprises Act is driving up insurance premiums.
  • “The House panel’s chair, Brett Guthrie of Kentucky, and ranking Democrat, Frank Pallone of New Jersey, asked the Congressional Budget Office on Monday to determine if and how the law will raise premiums over the next decade.
  • “The lawmakers’ letter to CBO Director Phillip Swagel — his office is Congress’ nonpartisan arbiter of the cost of legislation.”

• Beckers Behavioral Health adds,
  • “Health plans want the next federal mental health parity rule to do something regulators haven’t yet: show them what compliance looks like. The 2021 law called for illustrative examples of good compliance, and plans are still waiting for them, according to Debbie Witchey, president and CEO of the Association for Behavioral Health and Wellness.
  • “ABHW represents the health plans that provide mental health and substance use benefits, including Optum and Aetna. Its members cover about 200 million lives.” * * *
  • “She called a recent field assistance bulletin from the Employee Benefits Security Administration helpful because it narrows where enforcement should focus while a new rule is pending: utilization management, treatment exclusions and network adequacy, the areas the bulletin identifies as having the greatest impact on patients.
  • “Still, Ms. Witchey said the bulletin is no substitute for the compliance examples ABHW wants to see when the new rule comes out.”

• Healthcare Dive relates,
  • “Millions of seniors in standalone Medicare prescription drug plans could see their premiums skyrocket next year if they don’t switch to a cheaper option.
  • “Average monthly premiums for Part D plans are set to jump 50%, from $34 to $51 in 2027 — assuming seniors stay on their current plans, according to a new analysis from the KFF.
  • “But premiums for plans on offer vary widely, ranging from $6 to $204 among national Part D carriers, the KFF found. Researchers with the health policy think tank stressed the importance of plan shopping during Medicare open enrollment, which runs until Dec. 7.”

• CMS has posted the slide deck from its September 30, 2026, webinar about the Group Health Plan (GHP) Recovery: Best Practices Webinar.

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

• Govexec reports,
  • “For the second straight month, most offerings in the federal government’s 401(k)-style retirement savings program lost value, reflecting continued volatility across the economy.
  • “Only the fixed income (F) fund, and the G Fund, which is made up of government securities, posted gains in October. The F Fund grew 2.47%, while the G Fund increased by its statutorily mandated rate of 0.46%.
  • “Since January, the F Fund has lost 0.35%; the G Fund has gained 3.89%.
  • “The common stocks of the C Fund finished October 0.87% in the red, bringing its 2026 performance down to 11.75%. And the small- and mid-size businesses of the S Fund fell 0.40% last month; since January, the S Fund has increased 11.17% in value.
  • “The international investments in the I Fund lost 2.89% last month. So far this year, the I Fund is 13.09% in the black.”

• Per OPM news releases,
  • “The US Office of Personnel Management (OPM) today announced that applications are now open for the 2027–2028 class of White House Fellows, offering exceptional Americans a unique opportunity to serve at the highest levels of the federal government and help shape the future of our nation.
  • “Established in 1964, the White House Fellows Program is one of the nation’s most prestigious leadership and public service programs. Each year, a select group of accomplished individuals from across the country is chosen to spend a year working alongside cabinet secretaries, senior White House staff, and other top government officials, gaining firsthand experience in federal leadership and policymaking.” * * *
  • “Applications for the 2027–2028 White House Fellows class are open now. Interested candidates can learn more about the program and application process here.”
• and
  • “The US Office of Personnel Management (OPM) has identified approximately 50,000 deceased individuals who remain listed in the Federal Employees Health Benefits Program (FEHBP) by matching Treasury’s August 2026 Death Record Confidence Scoring Tool (DRCST) against OPM’s FEHB enrollment records.
  • “The review identified $96.3 million in improper payments made after date of death, including $70.6 million in government FEHB premium contributions and $25.7 million in retirement payments.
  • “OPM also estimates $10.4 million in carrier costs tied to over 20,000 individuals who remain on carrier rolls even though no government premium is being paid for them. Carriers charge FEHB funds each month for administrative and per-member costs. OPM will examine claims that may have been paid after date of death in the coming weeks.”
• FEHBlog observation — FEHB and PSHB plans have no way to reconcile premiums with individual enrollments. Plans would gain that ability if OPM simply adopted the HIPAA 820 enrollment transaction which has been in service since 2012.

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

• The American Hospital Association News reports,
  • “The Food and Drug Administration has identified Class I recalls of two products: certain platelet factor 4 radioimmunoassay products by Instrumentation Laboratories due to customer reports of obtaining an invalid calibration curve; and certain StatStrip Glucose Hospital Meters by Nova Biomedical due to a scanning issue that could lead to a glucose result being assigned to the wrong patient’s medical record or quality control ID. Nova Biomedical reported one serious injury related to the issue as of Oct. 5. The FDA said no deaths have been associated with either issue.” 
    
• Reuters relates,
  • “Dr Reddy’s (REDY.NS) said on Monday that the US FDA has tentatively approved a generic version of a new and highly effective HIV prevention drug, paving the way for ​sales in many low- and middle-income countries, though not yet in the United ‌States.
  • “Some doctors and activists say the new treatment could help control the 44-year-long AIDS epidemic which still infects 1.3 million people a year, and which the World Health Organization estimates has killed 44 million since it first ​emerged.” * * *
  • “FDA tentative approval is given to drugs that ​meet all the agency’s safety, efficacy and quality standards but cannot yet be sold in the ​US due to patent or exclusivity issues.”

• Per a FDA news release,
  • “The U.S. Food and Drug Administration today issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards. The guidance provides FDA’s recommendations for a Potency Assurance Strategy, which guides manufacturers to test and verify — before a product reaches a patient — that every batch meets a defined standard of potency to do what the product is supposed to do therapeutically.
  • “The Potency Assurance for Cellular and Gene Therapy Products final guidance replaces FDA’s 2011 potency testing guidance for CGT products and applies to treatments for serious and often life-threatening conditions. By law, manufacturers are expected to verify that their products work as intended, from the time of approval through post-approval monitoring. This final guidance provides FDA’s current thinking and recommendations on how manufacturers can meet that requirement.”  

• Beckers Behavioral Health adds,
  • “The American Medical Association is calling on the FDA to require botanical drug products, including kratom and cannabis, to prove safety and efficacy in clinical trials before they are marketed or prescribed, warning that unproven products can pose serious risks to patients.
  • “The AMA made its case in an Oct. 28 letter to FDA Deputy Commissioner Grace Graham. The physician group argued that rising consumer demand, anecdotal claims and influencer marketing on social media should not replace high-quality clinical trials or postmarket safety monitoring.
  • “AMA President Willie Underwood III, MD, said manufacturers are producing increasingly potent botanical products in forms ranging from gummies and powders to oils and injections. He said consumers face harms that include dependence, substance use disorders, overdose and death.
  • “Calling something ‘natural’ doesn’t make it safe,” Dr. Underwood said.”

From the public health and medical / Rx research front,

• Cardiovascular Business reports,
  • “A deep dive into a recent Heart Failure Society of America (HFSA) report makes it clear that heart failure (HF) outcomes can still be significantly influenced by where a person lives or how much money they earn. That report, the HFSA Heart Failure Clinic Database Annual Report, includes data from more than 300 U.S. clinics. And it says a lot about the modern healthcare landscape in the United States.
  • “Cardiology health policy experts Nicholas Chiu, MD, MPH, and Rishi K. Wadhera, MD, believe the report should be a wake-up call for healthcare policy reform. They made their case in a new editorial published in the Journal of Cardiac Failure Intersections.[1]. 
  • Wadhera is the associate director of the Richard A. and Susan F. Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center in Boston. Chiu is a cardiology fellow with Harvard Medical School and Mass General Brigham/Brigham and Women’s Hospital.
  • “The two co-authors said these stats provide a map of the policy choices that resulted in poor outcomes. At the same time, the numbers show how much room there is for improvement. 
  • “For example, the U.S. is one of the wealthiest nations in the world, but it has greater income inequality than most other high-income countries. In addition, the gap in health outcomes between the richest and poorest Americans is widening over time.
  • “Poverty is one of the most powerful and persistent determinants of health in the United States,” the authors wrote. “Patients with heart failure are especially vulnerable to the downstream effects of poverty, because effective care requires costly medications, frequent monitoring, and reliable access to specialty care. Despite a decade of therapeutic advances, poverty continues to shape who develops HF, who can access high-quality care, and how patients live with the disease.”

• tctMD adds,
  • “Hospitalizations for heart failure (HF) seem to go up with colder ambient temperatures, but the same rise is not seen when temperatures run warmer, an analysis of Medicare data suggests.
  • “Several prior studies have illuminated the relationship between cardiovascular health and climate, with many showing increases in cardiovascular death with rising heat and others showing profound negative effects of cold weather as well.
  • “The new analysis, published online this week in JAMA Network Open with first author Nathaniel Kuhrt, MD (Thomas Jefferson University, Philadelphia, PA), looks specifically at HF hospitalizations documented in Medicare claims data between 2007 and 2022.” 

• The American Medical Association lets us know what doctors want patients to know about perimenopause.
  • “Perimenopause symptoms can be confusing. Learn what perimenopause is, when it starts and what to know about symptoms, treatment and changing periods.”

• tctMD relates,
  • “Cancer survivors who adhere to a healthy dietary pattern appear to fare better over the long term compared with those who eat less healthy diets, an analysis of the UK Biobank shows.
  • “Out of eight different dietary patterns, better adherence to all but one of them was associated with lower risks of CVD and all-cause death over about a dozen years, lead authors Qing-Yuan Gao, PhD, and Jing-Wei Gao, PhD (both from Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China), and colleagues report.
  • “An average 45-year-old gained an estimated 1.66 to 3.32 years in life expectancy by consuming healthy foods.
  • “The findings, published online this week in JACC: Advances, highlight “the potential for diet to support cardio-oncology care,” the authors write, noting that “dietary interventions may exert cardioprotective effects in cancer survivors through modulation of metabolic dysfunction and aging processes.”
  • “There remains a need for more definitive research, however.”

• Medscape tells us,
  • “Remibrutinib, an investigational Bruton tyrosine kinase (BTK) inhibitor developed by Novartis, significantly reduced relapse rates and inflammatory brain lesions compared with teriflunonmide, the current standard of care, in patients with relapsing multiple sclerosis (MS), new findings from two industry-sponsored phase 3 trials showed.
  • “The REMODEL-1 and REMODEL-2 trials showed relative reductions in annualized relapse rates (ARRs) of 35% and 31.2%, respectively, although the absolute differences were small. Remibrutinib was also associated with a reduction in new or enlarging brain lesions by approximately 65%-70% compared with teriflunomide.
  • “The studies also suggested a potential benefit in delayed disability progression with remibrutinib although the findings were not statistically conclusive. The results also showed fewer liver enzyme elevations with remibrutinib vs teriflunomide.
  • “These findings support remibrutinib as a new safe and highly efficacious oral therapy for relapsing MS,” lead author Heinz Wiendl, MD, professor and chair, Department of Neurology, University of Freiburg, Freiburg, Germany, told Medscape Medical News.”

• MedTech Dive informs us,
  • “Abbott has started a pivotal clinical trial of its investigational Cephea mitral valve system, the company said Thursday.
  • “The device, which Abbott acquired in its 2019 takeover of Cephea Valve Technologies, replaces the diseased mitral valve to restore normal blood flow through the heart. 
  • “Cephea performs the same function as Abbott’s Tendyne but is delivered through a vein in the leg, rather than via a small incision in the chest.”

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

• Beckers Hospital Review reports,
  • “Corvallis, Ore.-based Samaritan Health Services joined Tacoma, Wash.-based MultiCare Health System Nov. 1, completing an affiliation announced in 2025.
  • “As part of the agreement, MultiCare has committed to investing $700 million over 10 years to expand access to care, recruit and retain clinicians, support workforce development and improve facilities and technology across Samaritan’s region, according to a Nov. 2 news release. A regional strategic planning process led by local leaders and shaped by community input will set longer-term service priorities and investments. 
  • “Samaritan keeps its name, now paired with MultiCare’s, along with its local leadership and community-based governance. Samaritan operates five hospitals and serves more than 280,000 residents in Oregon’s mid-Willamette Valley and central coast.” 

• Modern Healthcare adds,
  • “Providence has completed the final phase of a joint venture with home care company Compassus to provide home health, hospice and palliative care services in Oregon.
  • “The joint venture will operate under the name Providence at Home with Compassus, the two organizations said Monday in a news release. Under terms of the deal, Brentwood, Tennessee-based Compassus will manage 17 home care programs Providence previously operated across Oregon.
  • “The Oregon Health Authority gave final approval for the arrangement last July following a 19-month review. The state sought public input of the deal over concern the joint venture could alter the way patients receive home health and hospice services.” * * *
  • “Providence is a nonprofit Catholic health system that operates across seven states. Compassus offers home care services across 34 states.”
    
• Beckers Hospital Review relates,
  • “UnitedHealthcare will stop requiring prior authorization for more than 2,000 pediatric care codes for members under 18 starting Dec. 1.
  • “The payer published the full list of CPT codes Nov. 2. The codes span common services, diagnostic imaging, sleep studies, cancer treatment and orthopedic care, according to a UnitedHealthcare news release. Examples are ear tube and tonsil procedures, MRI and CT scans, joint and cardiac procedures, and some oncology and chemotherapy services.
  • “UnitedHealthcare said it chose services widely considered safe and effective in the medical community. The selection cuts pediatric prior authorization volume by nearly two-thirds and fulfills a commitment the insurer made in May. 
  • “Some complex services will still require prior authorization. These include certain injectable medications, genetic tests, surgical procedures and services that must be managed under state regulations. Some pediatric services will also still require advance notification.
  • “The changes apply to UnitedHealthcare commercial plans, Individual Exchange plans and UnitedHealthcare Community Plans, where permissible by state law.”
• and
  • “Franklin, Tenn.-based Community Health Systems is still waiting longer for insurers to pay its claims, but the slowdown has not worsened, CFO Jason Johnson said on the system’s Oct. 29 third-quarter earnings call.
  • “In July, Mr. Johnson said insurers were auditing more claims before paying them and asking for more records. Payers used to run those audits after payment. He said CHS’s accounts receivable was growing as a result. He called it a timing issue rather than a collection problem and said the system would return to a normal run rate once it anniversaried the change. 
  • “It has not worsened. We continue to see a slowdown in the payment of claims,” Mr. Johnson said on the Oct. 29 call. “No worse than it was in the first quarter when we really first started seeing that shock. But it has not changed either. Our days in A/R are consistent from [June 30 to Sept. 30], so we have kind of maintained.”
  • “CHS’s cash flow improved in the third quarter despite the slowdown. Cash generated from operations was $168 million, excluding taxes on divestiture gains, up from $121 million a year earlier. On a reported basis, it rose to $155 million from $70 million. Mr. Johnson credited better management of accounts payable and continued collection of accounts receivable, including the timing of state-directed payments.”
• and
  • “Blockbuster medicines now account for nearly half of prescription medicine spending worldwide, according to an Oct. 22 report from the IQVIA Institute for Human Data Science that analyzes blockbuster drugs from 2000 to 2024.”

• Fierce Healthcare tells us,
  • “Teladoc Health raised its 2026 outlook after better-than-expected third-quarter results, as BetterHelp’s insurance pivot gained traction and Integrated Care profitability improved.
  • “The virtual care company posted declining revenue but still beat Wall Street on both revenue and profit. Teladoc Health’s Q3 beat drove shares up nearly 27% Thursday after the company reported Q3 earnings Wednesday after market close.
  • “Teladoc Health faces near-term pressure as it transitions its virtual mental health business, BetterHelp, from a cash pay model to an in-network, insurance-covered model.” 

• Healthcare IT News adds,
  • “Telemedicine is becoming an increasingly important part of cancer care, allowing patients to access specialized expertise without always traveling to a hospital. At The University of Texas MD Anderson Cancer Center, virtual visits now account for one-quarter of ambulatory encounters.
  • “The organization conducted more than 295,000 virtual visits in fiscal 2026, with 60% of patients having used telemedicine at some point. Those numbers are helping MD Anderson understand where virtual care works best, where it falls short and how it can reshape cancer treatment.”

• Beckers Health IT gives us a look at Amazon’s healthcare playbook.

• Fierce Health points out,
  • “Electronic health record company athenahealth is opening up patient health records to outside AI assistants, starting with Anthropic’s Claude, through a new connection designed to give patients personalized answers based on their clinical data.
  • “The new server solution, athenaPatient MCP, uses the Model Context Protocol to connect Claude directly with the athenaOne platform. Patients authenticate using their athenahealth patient portal credentials and decide what information Claude can access, according to the EHR company. Credentials are not shared with Claude.
  • “Paul Brient, athenahealth’s chief product and operations officer, said that information is encrypted in transit, patients control what information is shared, and they can revoke access at any time. “Once the connection is established and patients approve what types of data they would like to share, the rest is between Claude and the patient,” he told Fierce Healthcare in an interview.”

• BioPharma Dive notes,
  • “Karyopharm Therapeutics, a cash-strapped cancer drugmaker, has filed for bankruptcy in a bid to sell itself and reorganize.  
  • “Through the Chapter 11 filing announced Monday, Karyopharm intends to hold an auction in which Ayrmid, the parent of cell therapy maker Gamida Cell, will serve as the lead bidder. Karyopharm will continue to operate during the proceedings with the help of a $55 million bankruptcy loan from its current lenders. An acquisition should close in early 2027.  
  • “Karyopharm sells the blood cancer drug Xpovio, which was first approved for multiple myeloma in 2019 and has since been cleared for a common form of lymphoma. U.S. regulators could soon clear use in myelofibrosis, too. In a statement, Ayrmid CEO Joe Wiley said adding Xpovio to Gamida Cell’s line of blood cancer cell therapies could “build a broader, stronger commercial-stage hematology business with meaningful opportunities for future growth.”

Simplicity is a virtue.

From Washington, DC

• Beckers Payer Issues reports,
  • “Pharmacies have been seeing compelling interest in Medicare’s GLP-1 Bridge program since its July launch, NPR first reported.
  • “The demonstration, designed to give eligible Medicare Part D beneficiaries access to certain GLP-1s at a fixed monthly cost, will run through 2027. Manufacturers are supplying GLP-1s at a monthly net price of $245, and beneficiaries cover $50. Unlike the proposed voluntary “Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth” — or BALANCE — model pilot, Bridge bypasses Part D sponsors.” * * *
  • “Becker’s connected with Walgreens and CVS Health to unpack how Bridge has been progressing so far. To date, each company has filled more than 100,000 GLP-1 prescriptions through the program.
  • “We have seen actually uptake be pretty strong in the first part of the program,” Rick Gates, chief pharmacy officer for Walgreens, told Becker’s. “… I would say it is far exceeding from a volume perspective what we expected at this point.”
  • “Mr. Gates said Bridge is continuing to grow. When asked about expectations for 2027, he said the program could still hit a ceiling with participation, though.”

• Beckers Hospital Review relates
  • “Federal health officials are exploring how Medicare could pay for artificial intelligence tools that provide medical care or diagnoses as the Trump administration pushes to expand the technology’s role in patient care, The New York Times reported Sept. 14.
  • “Officials are working to develop a new Medicare payment category that could reimburse companies for AI software supporting medical care or diagnosis, according to the Times. Medicare officials have also encouraged private insurers to reimburse for certain forms of technology-supported care if they improve care and lower costs.
  • “The efforts come as federal officials move forward with several initiatives involving AI in patient care, including technologies capable of performing tasks traditionally handled by physicians.
  • “Within the administration, officials have discussed whether AI doctors operated by technology companies and startups should be paid as much as 60% to 80% of what human physicians earn for the same service, according to a person involved in the discussions cited by the Times.
  • “The payment discussions are unfolding as regulators determine how to oversee increasingly autonomous AI tools. The FDA has approved more than 1,500 medical devices that include AI and perform discrete tasks, such as identifying tumors or blood clots. But the agency does not have rules designed to address newer models, including chatbots and agentic AI systems capable of performing tasks such as prescribing medications.”

• Fierce Healthcare tells us,
  • “The country’s largest hospital lobby is urging antitrust regulators to look beyond commercial insurance prices and market-wide concentration when weighing the impact of a proposed hospital merger.
  • “The American Hospital Association (AHA), armed with a new analysis report commissioned from healthcare advisory firm Kaufman Hall, called on Monday for a “more comprehensive analysis” of deals under increasing scrutiny because research ties consolidation to higher healthcare prices. 
  • “Regulators, the association and the report said, should place more weight on the types of patients merging hospitals serve, what could happen to care delivery if a deal falls through, and how hospitals within a shared market compete at the service-line level.
  • “Hospital mergers receive careful antitrust review. But careful review is not the same thing as a narrow review,” AHA General Counsel and Secretary Chad Golder wrote in a blog post highlighting the new report. “The relevant question is not just whether a transaction might affect the prices commercial insurers negotiate. It is what the transaction—or its failure—is likely to mean for patients: whether healthcare services remain available, whether hospitals can invest in their workforce and facilities, and whether local communities retain access to care.”

• Healthsystem CIO informs us
  • “Almost 90 percent of the information blocking complaints filed with the federal government target healthcare providers, according to ASTP. The portal collecting them had logged 2,450 claims through July 31, up from roughly 1,600 in February. The conduct those claims describe is records release, patient registration and app access. That puts a health system’s exposure inside workflows the technology executive rarely supervises.”

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

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

From the Food and Drug Administration front,

• Reuters reports,
  • “Doctors, veterans, pharmacists and therapists on Monday urged the U.S. Food and Drug Administration to establish clear safety ‌and access standards for psychedelic therapies during a four-hour public meeting convened by the agency amid efforts to speed up their development.
  • “The hearing is the latest in a months-long push launched by U.S. President Donald Trump’s administration in April to bring qualified psychedelic drug programs to market.
  • “Discussions at the ​meeting focused on practical issues that could shape how psychedelic therapies are tested and delivered, including provider training ​and credentials, patient screening and monitoring, access and reimbursement, clinic capacity and the collection of long-term ⁠safety data.
  • “Experts said any approved psychedelic treatment must include trained staff in the room during sessions — which could last six ​to 12 hours — alongside proper screening, follow-up care and community support.”

• STAT News adds,
  • “Definium Therapeutics said Monday that its LSD therapy helped patients with anxiety in a second late-stage trial, setting up the company to seek the first approval of a psychedelic drug for anxiety.
  • “In the 12-week trial, patients taking a 100-microgram dose of the drug, called DT120, experienced a 9.8-point drop on a test called the Hamilton Anxiety Rating Scale, while those on placebo experienced a 4.7-point drop. The difference of 5.1 points is similar to what was seen in Definium’s first late-stage anxiety study and larger than what’s been observed with many other anxiety therapies, though it’s difficult to compare results across studies.
  • “Definium is among the first wave of biotechs nearing regulatory approval for psychedelic therapies, a class of treatments that may be especially attractive to patients since they appear to exert rapid benefits. (In the latest trial, Definium said patients experienced changes as early as the second day after dosing.) In contrast, the effects of traditional options like antidepressants take weeks to kick in.
  • “However, commercializing the drug could be challenging. Patients will have to commit a large amount of time traveling to a clinic and taking the treatment under monitoring by a clinician, potentially for up to eight hours. 
  • “Still, Definium’s development approach may give it an advantage. Many other biotechs are studying psychedelics specifically in depression, including Compass Pathways, which is furthest ahead with its psilocybin candidate. Definium is testing its therapy in both anxiety and depression, and because there are so many people with both conditions, doctors may be inclined to prescribe Definium’s product to such patients.”
    
• The Wall Street Journal notes
  • Regulators are trying to curb the supply of illicit, unapproved versions of Eli Lilly’s experimental weight-loss drug retatrutide.
  • The black-market compound enters the U.S. from overseas suppliers, often based in China or India, and is sold by clinics and online sellers.
  • The Ohio State Board of Pharmacy conducted 1,102 proactive inspections of wellness clinics and medical spas between March 2025 and August 2026.

• BioPharma Dive relates,
  • “The Food and Drug Administration has approved a new kind of medication for the rare genetic disease spinal muscular atrophy. 
  • “Called apitegromab and to be sold as Isembyld, the treatment on Friday was cleared for use alongside existing targeted therapies in adults with SMA as well as children at least 2 years of age. For a typical SMA patient, the drug will have an annual list price of about $310,000 per year, executives revealed on a Monday conference call. Costs will vary person-to-person based on a patient’s weight and insurance coverage.
  • “Isembyld’s clearance will once again change the treatment landscape for a potentially lethal disease that had no approved medicines as recently as a decade ago.” 

• MedTech Dive tells us,
  • “Beta Bionics received Food and Drug Administration clearance on Friday for the company’s first insulin patch pump.
  • “The device, called Mint, has a three day wear time and a 200-unit insulin reservoir. It is designed with a mixture of disposable and reusable components. 
  • “Leerink Partners analyst Mike Kratky wrote in a research note Monday that the FDA authorization should help level the playing field with competitor Insulet, which has dominated new device starts with its patch pump.”

• Radiology Business adds,
  • “The U.S. Food and Drug Administration has approved a new brain cancer imaging agent from Telix, the Australia-based pharma firm announced Monday. 
  • “Pixclara is a radioactive diagnostic drug paired with positron emission tomography imaging. It’s used to help doctors distinguish between returning brain cancer or harmless changes caused by previous treatments.
  • “The agency’s approval of Telix’s New Drug Application comes after the company previously received a rejection from the agency last year. 
  • “As the first FDA-approved PET imaging drug for glioma [a type of brain cancer], Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients,” Kevin Richardson, CEO of Telix Precision Medicine, said in a statement Sept. 14.” 

From the judicial front,

• Beckers Hospital Review reports,
  • “Brentwood, Tenn.-based optometric physician Helen Boerman has been sentenced to 42 months in federal prison for defrauding Medicare and other government health care programs out of nearly $7 million, according to a Sept. 14 news release from the U.S. Attorney’s Office for the Middle District of Tennessee.
  • “Ms. Boerman, 48, used her practice, Brentwood Eye Care, to submit false Medicare claims over about three and a half years, billing for services patients did not receive and for wound care products she split for single use rather than purchasing separately, according to court documents. She also submitted false claims to TennCare and the Federal Employees Health Benefits Program between March 2020 and October 2024. As part of her guilty plea, she admitted to submitting roughly $11 million in false claims and receiving about $6.9 million.
  • “Chief U.S. District Judge William Campbell Jr. imposed the sentence Sept. 10, along with one year of supervised release, $6.9 million in restitution and a $100 special assessment.”

• The Wall Street Journal reports,
  • “Abbott Laboratories has agreed to pay $385 million to settle allegations related to its management of a baby formula facility where deadly bacteria was suspected of causing infant deaths, the Justice Department said Monday.
  • “The settlement is a more lenient outcome than some prosecutors had advocated for, believing they had evidence to criminally charge Abbott under a law that has been used to pursue other businesses for selling contaminated foods, the Journal previously reported. But senior Justice Department officials believed criminal charges would have been heavy handed and closed the probe. 
  • “They opted instead for the civil settlement, which claws back money the company earned from selling formula through federally funded nutrition programs.”

From the public health and medical / Rx research front,

• Beckers Clinical Leadership reports,
  • “In 2024, 71.5% of adults reported experiencing fatigue at least some days in the past three months, a Sept. 3 CDC report found. 
  • “The CDC used 2024 National Health Interview Survey data to estimate fatigue symptoms among about 27,000 adults 18 and older. Fatigue statistics are based on the reported frequency of fatigue in the past three months. Fatigue is defined as physical or mental tiredness or exhaustion that does not improve with additional sleep or rest. 
  • “Fatigue is “one of the most frequently reported health concerns in primary care visits in the U.S.,” sociologist Natalie Young, PhD, lead author of the report, said.”  
  • “Among adults who reported fatigue in the past three months, 54.9% of adults reported it on some days, 10.7% most days, and 5.9% every day.
  • “Frequent fatigue was most common among women at 20% — compared to 13% of men — and younger adults.”

• Wallet Hub offers a chart showing the U.S. States that vaccinate the most.
  • “In order to see where people are most responsible about getting vaccines, WalletHub examined the 50 states and the District of Columbia across 16 key metrics. Our data set ranges from the rates of children, teens and adults vaccinated against various diseases to the share of people without health insurance.”

• Per National Institutes of Health news releases,
  • “The National Institutes of Health (NIH) is awarding $21 million to launch a research program aimed at spurring the development of computer-based methods that model and simulate the self-regulating processes of human hormones, known as hormone homeostasis. Hormone activity varies widely, resulting in differences in how men and women react to drug therapy, including varying outcomes to dosing, treatment response, and drug toxicity. The program, known as the Computational Modeling of Hormone Homeostasis Initiative, will advance novel human-based, data-driven models tailored to a man or a woman’s complex physiology through advanced computational techniques.
  • “Current mathematical and animal models do not sufficiently capture variations between men and women. Addressing this gap is critical to the understanding of sex-specific biology and the development of more individualized approaches to therapeutics,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives. “By leveraging advanced computer-based models that use human biological data to simulate hormone activity across the lifespan, we can help researchers improve the evaluation of new treatments and support more informed clinical decisions.”
• and
  • “A National Institutes of Health (NIH)-funded scientific team has shown that a new brain-computer interface (BCI) can allow people with vocal tract and bodily paralysis to convey both speech and upper-body gestures simultaneously. While BCIs have facilitated one or the other in the past, this new system is the first to enable both modes of communication at once, more closely replicating natural expression.
  • “Scientists at the University of California, San Francisco, used machine learning to decipher the unique brain activity that underpins concurrent speech and physical gesture in three patients. Their BCI successfully translated the thoughts of two participants into commands that dictated the expressions of a full-body virtual avatar.
  • “Conversation is about much more than the words being spoken. It’s a multilayered, dynamic process involving the whole motor cortex,” said corresponding author Edward Chang, M.D., a professor of neurological surgery at UCSF. “This proof-of-concept shows us it’s possible for a BCI to restore some of this freedom and flexibility.”
• and
  • “Advancing Childhood Cancer Research: A Conversation with Dr. Brigitte Widemann.”
    • “September is Childhood Cancer Awareness Month, a time to recognize children and adolescents with cancer, their families, and those working to improve their lives. Brigitte C. Widemann, M.D., is chief of the Pediatric Oncology Branch in NCI’s Center for Cancer Research and special advisor to the NCI director for childhood cancer. A pediatric oncologist and physician-scientist who cares for patients at the NIH Clinical Center, she has devoted her career to developing better treatments, particularly for young people with rare tumors and genetic cancer predisposition syndromes. In this Q&A, Dr. Widemann discusses recent advances, the importance of sustained federal investment, and the promise of shared data and artificial intelligence.”

• Health Day relates,
  • “Patients with a cancer diagnosis have an increased risk for ischemic stroke (IS), with risk peaking during the first three months, according to a study published online Sept. 8 in Cancer.
  • “Carmit Libruder, from the University of Haifa in Israel, and colleagues conducted a retrospective cohort study linking the Israel National Cancer and Stroke Registries to examine the risk for IS after cancer diagnosis. Residents aged 40 years and older diagnosed with a first invasive cancer during 2014 to 2021 were followed for first-ever IS within one year.”
• and
  • “A spinal implant can significantly reduce pain suffered by people with diabetes-related nerve damage, a new study says.
  • “Spinal cord stimulation blunted pain and improved sensation in patients suffering from diabetic neuropathy, researchers reported Sept. 9  in the journal Diabetes Care.” 

• Beckers Behavioral Health informs us,
  • “Frequent smartphone check-ins predicted 75% of suicide attempts and 87% of suicide-related events like hospitalization in the week before they occurred, according to a Sept. 11 Boston Globe report. 
  • “Researchers from Cambridge, Mass.-based Harvard followed 619 adults and adolescents who had sought care for suicidal thoughts or behavior at two Boston-area hospitals. On a sliding scale from 1 to 10, participants were asked how hopeless and agitated they felt, how strong their urge to kill themselves was and how capable they felt of resisting that urge. For three months, participants received 20-question surveys on their smartphones six times a day. Researchers used the responses and information about survey completion in machine-learning models to predict suicide attempts or other suicide-related crises in the following seven days. 

• MedPage Today points out,
  • “Menopause hormone therapy is FDA approved for other common menopause symptoms but not for mood disturbances.
  • “In an observational study, women using menopause hormone therapy had significantly improved scores for psychological symptoms, including depressive mood, irritability, anxiety, and mental exhaustion.
  • “The proportion of patients with severe mood symptoms decreased from 62.3% at baseline to 24.6% at follow-up.”
• and discusses
  • “Preserving Muscle During GLP-1 Weight Loss
    • — Experts advise tracking body composition, boosting protein, and resistance training.”

• Per Genetic Engineering and Biotechnology News,
  • “The results of a study by scientists at Wellcome Sanger Institute, University of Cambridge, University College London, and collaborators indicate that cancer treatments, including chemotherapy and radiotherapy, give a growth advantage to cells with particular genetic changes in healthy tissue. The team used DNA sequencing to map mutations in normal esophagus tissue from esophageal cancer patients who had received either chemotherapy, chemotherapy and radiotherapy, or no treatment before surgery.
  • “The results showed that different cancer treatments changed the landscape of mutations in normal tissue. In particular, combined treatment using chemotherapy and radiotherapy led to significantly more normal cells with cancer-related mutations in these patients. The team suggests that sequencing normal tissue from cancer patients receiving treatment could show how our genes regulate our tissue’s response to drugs, including side effects.”

• Per BioPharma Dive,
  • “Akeso and Summit Therapeutics’ experimental dual-acting cancer drug helped people with lung cancer live about eight months longer than those who got Merck & Co.’s Keytruda in a Phase 3 clinical trial and showed an even stronger benefit in people whose tumors express high levels of a protein that both medicines target.
  • “The findings could help Akeso and Summit shed doubts about the promise of their drug, called ivonescimab, as well as other experimental therapies that target the proteins “PD-1” and “VEGF” as potential heirs to Keytruda as a backbone of lung cancer care.”

• Per Fierce Pharma,
  • “An unfavorable overall survival trend in a phase 3 trial threatens to thwart AstraZeneca and Daiichi Sankyo’s bid to establish their star antibody-drug conjugate Enhertu as a first-line treatment for patients with HER2-mutant non-small cell lung cancer.
  • “Treatment with Enhertu showed a preliminary 15% increased risk of death compared with Keytruda plus chemotherapy in the phase 3 Destiny-Lung04 study, according to results shared at the 2026 World Conference on Lung Cancer.
  • “At an interim analysis of the study, patients in the Enhertu arm lived a median 29.3 months, versus 33.1 months in the Keytruda-chemo arm. At that point, 213 patients (46.9%) enrolled in the study had passed away, including 115 (50.7%) in the Enhertu group and 98 (43.2%) in the control arm.” 
• and
  • “GSK is advancing its inaugural lung cancer asset, Jideytro, toward a landmark first-line FDA approval, aided by an unprecedented complete response rate.
  • “In a quick return for GSK’s $10.6 billion acquisition of Nuvalent, an early FDA nod in July has made Jideytro GSK’s first commercial lung cancer drug, with a label covering advanced ROS1-positive non-small cell lung cancer following treatment with a prior ROS1 tyrosine kinase inhibitor (TKI). Now, the company is gunning for an expansion into the TKI-naïve population. 
  • “That plan is supported by new data from the single-arm Arros-1 trial. Among 94 efficacy-evaluable TKI-naïve patients, Jideytro triggered an objective response in 88 patients (94%), according to data presented at the 2026 World Conference on Lung Cancer in Seoul. These patients were allowed to have received up to one prior line of chemotherapy with or without immunotherapy before entering the study.”
• and
  • “Akeso and Summit Therapeutics’ ivonescimab reduced the risk of death by 27% compared with Keytruda in patients with treatment-naïve, PD-L1-positive advanced non-small cell lung cancer in the phase 3 Harmoni-2 trial conducted in China.
  • “The result, to be presented at the 2026 World Conference on Lung Cancer in Seoul, marks another positive readout from ivonescimab, whose Keytruda head-to-head win two years ago on the trial’s primary endpoint of progression-free survival sparked a gold rush for similar PD-(L)1xVEGF bispecific antibodies. 
  • “In Keytruda’s monotherapy setting, having such strong data help[s] physicians understand that this is an approach capable of beating current PD-1 standards of care in this indication,” Akeso CEO Michelle Xia, Ph.D., told Fierce.”

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

• Beckers Payer Issues reports,
  • “Nationally, the average annual deductible for single coverage under an employer-based health insurance plan is $2,169, according to an analysis from KFF.”
• and
  • “Nationally, the average annual deductible for family coverage under an employer-based health insurance plan is $3,997, according to an analysis from KFF.”
    
• Chief Health Executive explains how Baptist Health reduced emergency room boarding in its Arkansas facilities,
  • “Predictive discharge analytics shifted discharge ordering earlier, aligning bed availability with afternoon admission surges and improving system-wide throughput and transfer capacity. 
  • “Real-time identification of modifiable discharge barriers enabled safe, prompt disposition, recapturing capacity without new brick-and-mortar and reducing ED boarding by about 525 patients per month. 
  • “A phased, two-hospital start with iterative frontline feedback built provider trust in the data, reinforcing a “work smarter” culture rather than intensifying labor demands. 
  • “Robust governance integrating physicians, nursing, IT, laboratory, radiology, and environmental services supported transparency, accountability, and sustained process redesign to maintain flow improvements.”

• Healthcare Dive relates,
  • “Oracle Health’s clinical artificial intelligence agent is now available for nurses in the U.S., roughly two years after the tool launched first for physicians, the company announced Monday.
  • “For doctors, the AI agent works autonomously to draft clinical notes, propose follow-up lab tests and generate discharge summaries. Oracle tacked on new capabilities in August, adding chart review assistance, dictation and automated coding.
  • “The tool works similarly for nurses, but with role-specific considerations, Oracle says. Nurses can use voice commands to search for and navigate patient charts and generate nursing summaries to limit administrative work.”

• Fierce Healthcare adds,
  • “Abridge expanded its artificial intelligence capabilities into the mid-revenue cycle workflow. The company launched a pre-bill review capability designed specifically for clinical documentation integrity (CDI), coding and revenue cycle teams.
  • “The pre-bill reviews inpatient claims before submission, comparing coded diagnoses and diagnosis-related groups (DRGs) against what the clinical documentation supports to identify potential discrepancies and provide supporting evidence, the company announced on Monday.
  • “Abridge started with ambient listening and AI-powered clinical notes and has steadily expanded beyond clinical documentation to tackle other admin tasks, developing what it calls a “clinical intelligence” platform. The company has built its platform around the clinical conversation and is expanding both upstream to support visit preparation and downstream into administrative and revenue cycle workflows.
  • “Abridge says its clinical AI technology captures the record as the clinical interactions happen and the company can extend that into reimbursement workflows. Extending that same platform into pre-bill review allows Abridge to compare the clinical record with the diagnoses and DRG on the claim and show where they do not align. CDI and coding teams can then determine before submission whether the coded record accurately reflects the documented complexity of care.”

• The Wall Street Journal lets us know,
  • “Wegovy maker Novo Nordisk NOVO.B is rebranding as Novo, betting a shorter name will help it resonate more with consumers as it competes with rival Eli Lilly.
  • “The move by the Danish drugmaker comes as Chief Executive Mike Doustdarworks to revive the fortunes of a company that has ceded the crown in the weight-loss market it pioneered to Lilly.
  • “Since taking the reins in August last year, Doustdar has implemented a cost-savings plan that included 9,000 job cuts and the launch of a pill version of Wegovy, placing the company ahead of its U.S. rival in the market for oral weight-loss medications. Doustdar is expected to detail the next phase of his comeback plan in an investor update later this month.”

• Medtech Dive informs us,
  • “Medtronic said Monday that it has started an exchange offer to split off up to 80.1% of the shares of MiniMed.
  • “Formerly Medtronic’s diabetes technology business, MiniMed went public in March as part of a two-step separation process. Exchanging the remainder of Medtronic’s shares is the second part of the process. Medtronic currently owns 89.9% of the company.
  • “Medtronic CEO Geoff Martha said the offer “reflects our confidence in MiniMed as an independent company, giving the diabetes company more focus and flexibility, and allowing Medtronic to focus capital on its cardiovascular, neuroscience and surgical portfolios.”