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.”