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.”