Friday report

Medical / Rx research

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Beckers Payer Issues reports,
    • “The House Committee on Oversight and Government Reform announced an investigation into pharmacy benefit managers Optum Rx, CVS Caremark and Express Scripts Oct. 23, reviewing their auditing practices of independent pharmacies. 
    • “The investigation stems from concerns “that independent pharmacies have potentially been targeted for punitive audits in retaliation for their public support of legislation recently passed by the committee,” the committee’s chairman, James Comer, R-Ky., said.
    • “Under HR 6610, PBMs for Federal Employees Health Benefits Program plans would pay in-network pharmacies a benchmark price with a capped margin. The PBMs would also pay a dispensing fee that aligns with what the state Medicaid program pays. The Pharmaceutical Care Management Association, which represents PBMs, pushed back against the bill amid the committee’s July markup.
    • “Let’s understand this bill for what it is: a huge cash transfer from taxpayers to pharmacists and nothing more,” PCMA President and CEO David Marin said in a July 22 statement. “It makes providing health benefits to federal workers far more expensive, simply as a gift to one industry.”
    • “Mr. Comer said that since the July markup, several independent pharmacies that backed the bill received more audit notices than usual.”
  • The FEHBlog heartily agrees with PCMA. The FEHB and PSHB programs should not be treated like test subjects.
  • Beckers Hospital Review explains the “6 ways the federal government is going after drug prices.”and lists “Medicare’s proposed 2027 pay cuts, by specialty.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services has launched a new initiative to help recruit and retain nurses in nursing homes, the agency announced Oct. 23. Under the Nurses for Nursing Homes initiative, nursing students and licensed nurses interested in working in a nursing home could be eligible to qualify for up to $40,000 in student loan repayment and/or a $10,000 stipend in exchange for a three-year commitment to work in a qualifying nursing home in a rural or higher labor-shortage area. CMS said the $275 million program is expected to support more than 4,000 nurses nationwide and will be funded through civil monetary penalties collected by CMS and states from nursing homes. CMS has committed $100 million, while states are committing to at least $175 million. A website for the program includes details on eligibility requirements, open positions, details on how to apply and other information.”
  • and
    • “The Centers for Medicare & Medicaid Services Oct. 23 released a proposed rule implementing new Health Insurance Marketplace eligibility verification requirements enacted under public law 1, which was signed into law in July 2025. Beginning in plan year 2028, this proposal would require the Marketplaces to verify certain eligibility information before providing advance premium tax credits and cost-sharing reductions, particularly related to citizenship and lawful presence status; residency; non-employer-sponsored minimum essential coverage; and annual household income, family size and eligible noncitizen status. The rule also would require enrollees to provide or confirm key eligibility information annually to continue receiving financial assistance, essentially ending automatic reenrollment for enrollees receiving premium tax credits.  Comments are due 30 days after publication in the Federal Register.”
  • STAT News tells us,
    • “The Trump administration late on Thursday proposed a rule that would severely restrict future U.S. investment in the Chinese biotech sector but still allow American drugmakers to buy the rights to medicines invented in the country.
    • “The Treasury Department proposed the rule to implement a law, called the Comprehensive Outbound Investment National Security Act, that restricts U.S. investment in industries of concern to national security. The department added biotechnology to the list of industries subject to COINS restrictions, joining the likes of semiconductors, artificial intelligence, and quantum technology.
    • “The proposal would prohibit U.S. companies from entering financial transactions with Chinese biotech companies or Chinese manufacturers of biotechnology-related equipment and tools, according to the research firm Veda.
    • “We are surprised by the aggressiveness of the proposed rule,” Veda stated in a research note to clients. “Both in terms of its prohibition of all biotechnology-related transactions and the broadness of the definition of biotechnology.”

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

  • Kevin Moss, writing in Federal News Network, points out “What’s changing in FEHB for 2027 (and ways to save)” during the Federal Benefits Open Season which begins on November 9, 2026.
  • Fedsmith calls attention to benefit matters that federal and postal employees and annuitants may need to address before yearend.

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

  • Beckers Health IT reports,
    • “The FDA has issued its most serious recall classification for certain hospital glucose meters after a software issue that could cause test results to be assigned to the wrong patient was linked to one serious injury.
    • “The recall affects Nova Biomedical’s StatStrip Glucose Hospital Meter System Gen 2.0, a handheld device used by hospitals to measure patients’ blood glucose levels.”
  • Beckers Hospital Review adds,
    • “The FDA has warned Baxter International over significant manufacturing violations at its Baxter Healthcare drug manufacturing facility in Round Lake, Ill., including deficiencies involving contamination controls and sterile injectable production.
    • “The agency identified the violations during a March 23-April 2 inspection, according to a Sept. 29 warning letter. The FDA said environmental monitoring had detected cephalosporin in multiple areas outside the intended production area since January 2025 and cited deficiencies in Baxter’s monitoring program.
    • “The FDA also identified deficiencies involving aseptic processing, visual inspection of sterile injectable drugs and investigations into leaking products and sterility failures. The agency said Baxter’s current equipment, process and airflow design posed “excessive contamination risk.”
  • MedTech Dive relates,
    • “Edwards Lifesciences has won Food and Drug Administration approval for its Pascal Precision system for tricuspid valve repair, the company said Wednesday.
    • “Pascal’s expanded label covers use in patients with symptomatic severe tricuspid regurgitation. Edwards previously received FDA approval for the device in degenerative mitral regurgitation.
    • “The approval should expand the group of tricuspid repair patients that Edwards can treat, Leerink Partners said in a note to investors.”
  • PharmExec informs us,
    • “The FDA today approved a subcutaneous induction regimen for AbbVie’s Skyrizi (risankizumab-rzaa) in adults with moderately to severely active Crohn’s disease. The decision lets patients start treatment at home with an on-body injector (OBI) induction pack instead of an intravenous infusion and continue with the same device during maintenance.1
    • “AbbVie filed for the new regimen April 27 and had said it anticipated approval later in 2026. The decision changes how therapy begins, not who is eligible, because intravenous induction remains an option.1
    • “People living with Crohn’s disease need treatments that can deliver meaningful disease control from the start,” said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. “With the approval of subcutaneous induction, we are building on the strong efficacy of Skyrizi while giving patients and physicians greater flexibility in how treatment is initiated. This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn’s disease.”
  • Cardiovascular Business lets us know,
    • “Eko Health has received U.S. Food and Drug Administration (FDA) clearance for Core 300, a new artificial intelligence (AI)-enabled stethoscope that offers both traditional analog and advanced digital listening capabilities. 
    • “The Core 300 stethoscopes give clinicians the ability to instantly switch from traditional listening to digital listening when evaluating both pediatric and adult patients. The technology behind Eko Health’s digital listening capabilities includes up to 35x amplification, noise cancellation and real-time heart data that is then displayed on the device. 
    • “These stethoscopes can also be connected to the Eko App or Eko’s FDA-cleared AI models for additional benefits. In addition, the battery life was designed to last for weeks at a time.” 

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Oct. 23 announced that the submission period opened for petitions to deny the recertification of three independent dispute resolution entities. Members of the public, providers, facilities and others can submit a petition, which must identify the IDR entity seeking recertification and detail the reasons for the petition. The three organizations seeking recertification are National Medical Reviews Inc.; Keystone Peer Review Organization, Inc., which also does business as Acentra; and MCMC Services LLC. The petition period is open through Oct. 29. The departments of Health and Human Services, Labor, and the Treasury will make a final decision on recertification after reviewing any petitions submitted.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “Centene has become the latest insurer to sue the federal government over its 2027 Medicare Advantage star ratings.
    • “In a lawsuit filed Thursday in Georgia’s Southern District Court, the company argues that the Centers for Medicare & Medicaid Services violated the Administrative Procedure Act in determining its latest scores. Centene says that CMS ran afoul of “core statutory safeguards” in deploying 17 measures.
    • “The use of those measures ultimately caused “significant injury” to the company, according to the complaint. For 2027, 9% of Centene’s members are enrolled in plans with at least four stars, which declined from 18% in the prior year.
    • “In implementing each of the individual Star measures that Centene challenges, CMS violated applicable law and thereby caused Centene to lose out on hundreds of millions of dollars in revenue that Centene could use to strengthen benefits, reduce premiums, and improve health outcomes,” the company said in the lawsuit.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • RSV activity is very low in most areas of the country.
    • “COVID-19 activity remains elevated in some regions but is declining nationally.
    • “Seasonal flu activity is increasing in many parts of the country but remains low nationally.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated nationally, and parainfluenza viruses (PIV) are increasing.”
  • Beckers Clinical Leadership adds,
    • “Hawaii, Florida and Louisiana are reporting the highest percent of influenza-like illnesses.
    • “The CDC defines influenza-like illness, or ILI, as a fever of 100 degrees or greater, along with a cough and/or sore throat. The agency collects data on outpatient visits to healthcare providers for respiratory illness through ILINet. ILI percentages are weighted for state population and compared to baseline levels to assess flu activity. For more information on how the metric is calculated, click here.
    • “Hospitals reported 4,811 new flu admissions in the week ending Oct. 17, up from 4,024 the week prior, according to the CDC’s latest FluView report. About 2.2% of outpatient visits involved patients with respiratory illness. This metric sits below the national baseline of 2.9% and is up from 2.1% the week prior.”
    • The article ranks the State by their ILI percentages.
  • and
    • “The CDC has now activated six emergency responses for pathogens in 2026 — the latest a level 3 response to a record dengue outbreak in Florida — a pace that underscores how many infectious disease threats are landing on hospitals and public health agencies at once. 
    • “From a fatal new spillover in France to a bird flu outbreak left uncontained on a U.S. mink farm, the past several weeks have handed infection prevention and clinical leaders a dense cluster of public health concerns.”
  • The American Hospital Association News tells us,
    • “There are now 1,338 confirmed measles cases in Pennsylvania this year as the state’s ongoing outbreak continues, according to the latest data from the Pennsylvania Department of Health. Of those, 255 individuals have been hospitalized. The agency said that more than 56,000 doses of the measles, mumps and rubella vaccine were administered by healthcare providers across the state in September, and more than 39,000 have been administered so far this month. Providers typically administer 25,000 doses per month, the department said. Nationally, there have been 4,588 confirmed measles cases this year, according to the latest update from the Centers from Disease Control and Prevention. The vaccination status of 96% of cases is unvaccinated or unknown.” 
  • The University of Minnesota’s CIDRAP reports,
    • “Two new studies underscore the importance of the hepatitis B virus (HBV) vaccine birth dose, with a US study predicting that dropping or delaying initial vaccination would drive up chronic infections and an Ethiopian study finding lower mother-to-child transmission (MTCT) with birth-dose receipt.
    • ‘After US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. panned the first study, as well as the New York Times’coverage of it, on X, experts quickly pointed out deficiencies in his objections.”
  • The Washington Post relates,
    • “While cigarette smoking is still the primary risk factor for lung cancer, a growing proportion of patients with the disease are nonsmokers like [Bryant] Lin [M.D.]. Last week, Pope Leo had part of his right lung removed because of adenocarcinoma, the most common type of lung cancer. He is not known to have ever lit up.
    • “The drop in smoking rates in the United States and other countries has unexpectedly shed light on this as an emerging health issue. Never-smoker lung cancer is now the eighth leading cause of cancer-related death in the U.S. and the fifth most common cause of cancer-related deaths worldwide.
    • “Because I’m a physician, most people make the assumption I’ve never smoked, and they ask, ‘Why did you get lung cancer?’” Lin said. “Then I explain to them that roughly one out of five people with lung cancer in the United States have never smoked.”
    • “A growing body of research is identifying the disease’s unique clinical characteristics. In September, a study described a rare mutation concentrated in the southeastern U.S. that puts never-smokers at 60 times higher risk of developing lung cancer. The demographics of patients are also distinct — for instance, women who have never smoked are more than twice as likely to get lung cancer as men who have never smoked.”
    • “Two-thirds of nonsmoking-related lung cancer happens in women, so there’s certainly an association with female sex,” said Jaclyn LoPiccolo, a medical oncologist at the Dana-Farber Cancer Institute and author of the mutation study. “Nonsmoking-related lung cancer is also more common in people of East Asian descent, but whether that’s a genetic or environmental association, we don’t yet know.” 
    • “Regardless of gender or ethnicity, risk factors include exposure to secondhand smoke, radon, air pollution and asbestos. A family historyof any cancer diagnosed before age 50 in a first-degree relative is associated with increased lung cancer risk in nonsmokers.”
  • Health Day points out,
    • “For patients with atrial fibrillation (AF) and acute ischemic stroke, early initiation of rhythm control is associated with a lower risk for recurrent stroke or systemic embolism (SE), according to a study published online Oct. 21 in Neurology.”
  • and
    • “Women who enter menopause prematurely may have a higher risk of heart problems, due in part to higher blood sugar levels, a new study says.
    • “Women with menopause that occurred before age 40 had higher rates of heart disease and insulin resistance, researchers reported Tuesday at the annual meeting of The Menopause Society.
    • “Our findings suggest that insulin resistance may be one important pathway linking premature menopause with increased cardiovascular disease risk, highlighting the importance of cardiometabolic health in women who experience menopause before age 40,” lead researcher Zailing Xing said in a news release. She is assistant professor of epidemiology at Florida A&M University.”
  • MedPage Today adds,
    • “Neurokinin (NK)-receptor antagonists improved sleep disturbances in menopausal women, a meta-analysis of randomized controlled trials showed.
    • “Among women with moderate-to-severe vasomotor symptoms, the agents were associated with improvements in sleep disturbance as early as 4 weeks (standardized mean difference [SMD] -3.94, 95% CI -5.71 to -2.16) compared with placebo, reported Maria Julia Lemos, MD, of Kurah Women’s Health Institute in Macaé, Brazil, and colleagues.
    • “This trend continued at 12 weeks (SMD -3.11, 95% CI -4.60 to -1.61) and 24 weeks (SMD -2.04, 95% CI -3.93 to -0.15), Lemos reported during a presentation at the Menopause Society annual meeting that was co-published in Menopause.
    • “For women with hot flashes who can’t or don’t want to use hormone therapy, especially when poor sleep is one of their main complaints, these drugs are a good option to consider,” Lemos told MedPage Today. “They may help women sleep better, not just have fewer hot flashes.”
  • Harvard Health notes,
    • “A new pill that dramatically lowers harmful LDL cholesterol may be a good option for people who can’t tolerate statins or who haven’t lowered their LDL enough despite their current treatment with cholesterol-lowering drugs.
    • “Approved by the FDA in July 2026, enlicitide (Lipfendra) is the first oral version of a class of drugs known as PCSK9 inhibitors. These drugs work by mimicking the effect of a naturally occurring variant in the PCSK9 gene that leads to very low LDL levels. But the original drugs — which are given by injection once or twice a month — aren’t widely used. Some people aren’t comfortable giving themselves an injection. Also, most insurance companies won’t cover the cost (which range from $200 to $500 or more per month) until a person has tried other therapies without success.
    • “Enlicitide is a daily pill that must be taken on an empty stomach with a sip of water, black coffee, or plain tea. It lowers LDL by nearly 60%, which is similar to the injectable PCSK9 drugs. Less than 10% of users experienced either dizziness or diarrhea, the two most common side effects. A month’s supply will cost about $300; for now, insurance coverage remains unclear.”
  • Per STAT News,
    • “A multiple sclerosis treatment from Novartis cut by a third the rates of relapses that people with the condition have compared to a standard treatment, data presented Friday show. While that efficacy doesn’t match the performance of a rival drug from Roche, Novartis’ treatment has a cleaner safety profile that could give it a shot at being competitive in the market.”
  • and
    • “A chemotherapy-free combination of Tango Therapeutics’ experimental drug vopimetostat and Revolution Medicines’ recently approved Rasonque shrank tumors in 82% of patients with advanced pancreatic cancer, early-stage data presented at ESMO show. The Phase 1/2 trial enrolled 22 heavily pretreated patients whose tumors harbor MTAP deletions, a genetic alteration found in roughly 40% of pancreatic cancers.”
  • Beckers Hospital Review adds,
    • “Bristol Myers Squibb said Oct. 23 a study participant died from septic pneumonia about six weeks after receiving a dose of a CAR-T cell therapy being tested for multiple sclerosis. 
    • “The phase 1 trial included 66 patients with highly active relapsing multiple sclerosis or progressive forms of multiple sclerosis. In the study, most adverse events were “brief and reversible,” according to BMS. 
    • “After receiving the CAR-T therapy, zolacabtagene autoleucel, 28 of the 66 participants experienced cytokine release syndrome events, or hyperinflammation. Six patients had immune effector cell-associated neurotoxicity syndrome, including one life-threatening case, which resolved within two to four days.”

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

  • Beckers Payer Issues reports,
    • “Blue Cross Blue Shield of Massachusetts and Burlington, Mass.-based Tufts Medicine are partneringon a new health plan for BCBS employees, as well as AI implementation to streamline prior authorization.
    • “The HMO, Tufts Medicine Alliance Network, includes access to Tufts Medicine, Boston Children’s Hospital and Dana-Farber Cancer Institute. The HMO also provides next-day primary care access and specialist access within 21 days, according to an Oct. 22 news release.
    • “BCBS told Becker’s that about 35% of its workforce lives within the plan’s region, and that the plan will be available during their open enrollment. BCBS and Tufts Medicine said they are considering expanding the HMO’s availability to other employers in the future and are collaborating on similar offerings.”
  • Fierce Pharma relates,
    • “Last week’s federal holiday, Columbus Day, led to an unsurprising dip for prescriptions of both Novo Nordisk’s Wegovy pill and Eli Lilly’s oral GLP-1 rival Foundayo in the U.S. 
    • “In the prior-week reporting period, Novo’s Wegovy pill saw prescriptions fall slightly to around 173K versus the 173.5K tallied the week ending Oct. 9, according to Citi and Jefferies analysts, both of whom leverage prescribing data from IQVIA.”
    • “For that same period, prescriptions of Eli Lilly’s GLP-1 pill Foundayo slipped around 4% week over week to 58K. 
    • “The minor reversal for both drugs shouldn’t come as a surprise, given that national holidays are liable to impact weekly prescribing trends. 
    • “Looking at the broader oral GLP-1 market, Lilly’s share presently sits a little higher than 25%, according to the Jefferies team, while Novo holds a nearly 75% piece of the pie. 
    • “Meanwhile, as Novo and Lilly vie over the ever-important U.S. obesity market, the GLP-1 opportunity taking shape across other massive countries like China, India and Brazil could grow from $6.6 billion now to a whopping $22 billion by the middle of the next decade, according to a new J.P. Morgan estimate reported by Reuters Friday.” 
  • MedTech Dive tells us,
    • “Qiagen said Wednesday it has agreed to a takeover offer from EQT Private Equity valued at 10.8 billion euros (about $12.1 billion), including approximately $1.1 billion of debt.
    • “The agreement comes less than two months after the testing company, long a rumored takeover target, installed Jonathan Pratt as its new CEO. Six years ago, Thermo Fisher Scientific was set to buy Qiagen, but the deal fell apart after shareholders objected to the price.
    • “William Blair analysts, in a Thursday note, said EQT’s all-cash offer of 46.50 euros per share (about $52.20) was reasonable, given Qiagen’s relatively lower growth profile.”
  • Beckers Health IT informs us,
    • “Philadelphia-based Jefferson Health’s ambient AI rollout was associated with up to 16.6% less after-hours documentation and up to 39.3% faster chart closure among its most active users, according to a study published Oct. 23 in NEJM Catalyst Innovations in Care Delivery.
    • “The analysis covered 5,234 clinicians with access to Abridge’s ambient documentation tool, which runs inside Jefferson’s Epic EHR. It also covered 283,028 ambulatory encounters with matched patient experience surveys from July 1 to Dec. 31, 2025. Use was voluntary, and about 34% of clinicians with access actively recorded visits.
    • “Results were reported in two cohorts that reflect the separate EHR instances of Jefferson and Allentown, Pa.-based Lehigh Valley Health Network, which merged in August 2024. Among 637 clinicians who met the usage thresholds, Epic Signal data comparing 12 weeks before and after adoption showed several declines. Time in notes per appointment fell 10.5% and 17.3%. “Pajama time” fell 8.9% and 16.6%. Time to chart closure fell 25.3% and 39.3%. Weekly progress note volume held steady or rose.”

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • The Wall Street Journal reports,
    • “A top ally of Health Secretary Robert F. Kennedy Jr. is departing the Trump administration after frustrations with White House delays on Kennedy’s food agenda. 
    • “Calley Means, a senior adviser to Kennedy who also worked in the White House to further “Make America Healthy Again” policies, quit his role on Thursday, he told The Wall Street Journal.
    • “I leave with tremendous respect for President Trump and Robert F. Kennedy Jr.,” he said. “This movement is in the first inning and just getting started.” Means said he would continue working to further Kennedy’s MAHA agenda.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the 2026 Update to the National Plan to Address Alzheimer’s Disease and Related Dementias, taking Department-wide actions to guide coordinated federal action on dementia risk reduction, research and innovation, care, and support for people living with dementia and their families. Secretary Kennedy made the announcement at the Broward Health Medical Center in Fort Lauderdale, Florida.
    • “Millions of American families have seen the devastating toll of Alzheimer’s disease and related dementias,” said HHS Secretary Robert F. Kennedy, Jr. “Under President Trump, HHS is shifting the national strategy toward prevention, earlier detection, and faster development of better diagnostics and treatments. We are advancing gold-standard science, reducing risk where we can, improving care, and giving patients and families stronger support at every stage of the disease.”
    • “The updated plan puts greater emphasis on reducing dementia risk across the lifespan and translating scientific discoveries into better prevention, diagnosis, treatment, and care. It also formally recognizes related dementias in the plan’s title, reflecting public input and the shared challenges that patients and families face across different forms of dementia.” * * *
    • “Details on the National Plan and participating agencies’ initiatives are available at hhs.gov/aging/adrd.”
  • The New York Times adds,
    • “Alzheimer’s Researchers Look at an Unusual Data Point: Head Shape.
      • “Could the geometry of our brains increase the risk of Alzheimer’s disease? It’s a provocative question, but one that some scientists are beginning to explore.”
  • Beckers Health IT relates,
    • “HHS plans to award Anthropic a sole-source contract to keep its workforce on the company’s Claude AI tools without an open competition.
    • “The agency posted a notice of intent Oct. 19 on SAM.gov for a “limited continuity of services award.” The award would run until the department completes a competitive multiple-award blanket purchase agreement for enterprise frontier AI models. The notice did not list a contract value or projected award date.
    • “HHS argued that only Anthropic can meet the requirement because Claude is the company’s proprietary model family and is already integrated into department infrastructure. Covered capabilities include chat, drafting and summarization, coding assistance, agentic features, connectors, and administrative controls such as single sign-on and audit export.” * * *
    • “The notice comes as Anthropic’s discounted General Services Administration OneGov deal is set to expire Oct. 31, FedScoop reported. HHS rolled out Claude across the department in December 2025 after Anthropic offered its services to agencies for $1 a year.”
  • Beckers Hospital Review tells us,
    • “Under the Healthcare False Claims Act Self-Disclosure Pilot Program, companies that meet the requirements can settle disclosed conduct through a coordinated civil release that covers the False Claims Act and certain HHS administrative authorities, according to an Oct. 22 news release shared with Becker’s. 
    • “To qualify, healthcare companies must:
      • “Reveal all relevant details of the potential violations;
      • “Provide documents that show the full nature and scope of the conduct;
      • “Detail remedial steps taken;
      • “Repay the government under the protocol, which applies a multiplier of 1.25 to 1.6
    • “The multiplier depends on various factors, including how quickly the company provided disclosure, and the scope and duration of the misconduct, whether senior leadership was involved, the company’s financial benefit, and whether the company inherited the liability via a transaction but fixed the issue promptly.
    • “In return, companies will get a Justice Department release for disclosing the conduct. As part of the resolution, the HHS Office of Inspector General will not impose exclusion or require a corporate integrity agreement. CMS will also not revoke billing or enrollment privileges, and neither CMS nor OIG will impose civil monetary penalties.”

From the U.S. Office of Personnel Management front

  • Tammy Flanagan, writing in Govexec, considers
    • “If you already have FEHB, should you sign up for Medicare B?
      • “Pairing your federal health plan with Medicare can lower out-of-pocket costs, but monthly premiums and income-based surcharges add up. Here’s what to consider before deciding whether the extra coverage is worth the price.”
  • FedWeek tells us,
    • “Several key figures are increasing for 2027 in the Social Security program affecting both current employees and retirees.
    • “For the former group, the 6.2 percent Social Security payroll tax will apply on up to $192,300 of earnings, up from $184,500. For FERS employees, that tax cuts off at that threshold and from there on they pay only the civil service retirement contribution (which is 0.8, 3.1 or 4.4 percent, depending on when they were hired).
    • “Above the cutoff CSRS Offset employees continue to pay 6.2 percent into Social Security and their pertinent percentage into the federal retirement fund, but all the money after that point goes into the federal retirement fund instead. Employees under “pure” CSRS don’t pay the Social Security payroll tax.
    • “For those drawing Social Security benefits, the earnings test applying to beneficiaries aged 62 through their “full” retirement age (65-67, depending on year of birth; 67 for those born in 1960 and after), will rise from $24,480 to $25,56v0. Those beneficiaries lose $1 in Social Security benefits for every $2 in earnings through employment or self-employment earnings above the limit.
    • “A separate earnings test applies only to earnings for months in the year an individual reaches full retirement age but prior to the individual attaining that age. One dollar in benefits will be withheld for every $3 in earnings above $67,920, up from $65,160. There is no limit on earnings beginning the month an individual attains full retirement age.”

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

  • The Washington Post reports,
    • “Federal health officials are investigating a multistate salmonella outbreak that has been linked to raw oysters and sickened 27 people across a dozen states. 
    • “Five of the cases have involved hospitalizations, health officials said. 
    • “The Centers for Disease Control and Prevention said an investigation is underway of infections linked to raw oysters harvested by the Little Wicomico Oyster Co. from the Little Wicomico River’s harvest area in Virginia. 
    • “The company recalled oysters harvested from that area from Sept. 18 through Oct. 8. People are advised not to eat, sell or serve them, officials said.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program aligned with the Trump Administration’s efforts to accelerate medical innovation and deliver breakthrough treatments. NAIN is designed to advance the science, tools, and regulatory approaches needed to support the development of medical products for conditions affecting the brain and nervous system. NAIN’s inaugural initiative, the Alzheimer’s Prevention Accelerator, will focus on advancing medical products that help delay or prevent Alzheimer’s disease. Both efforts support the National Alzheimer’s Project Act (NAPA), the federal government’s comprehensive roadmap for coordinated action on Alzheimer’s and related dementias.”
  • Beckers Hospital Review tells us,
    • “The FDA has granted accelerated approval to Ultomiris (ravulizumab) to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression, making it the first and only C5 complement inhibitor approved for this use.
    • “The approval followed Priority Review and was based on a prespecified interim analysis of the I CAN phase 3 trial, according to an Oct. 21 news release. Ultomiris demonstrated a 43.4% reduction in proteinuria compared with placebo at 34 weeks.
    • “Ultomiris is administered intravenously every eight weeks in adults, based on body weight, following a loading dose. The trial’s safety profile was consistent with the known profile of Ultomiris, with no new safety concerns identified.”
  • BioPharma Dive informs us,
    • “Compounding pharmacy Apothecary Pharma has issued a voluntary recall of its copycat version of Eli Lilly’s obesity drug Zepbound, stating in a notice that it couldn’t definitively guarantee the medication’s safety.
    • “The recall, of which Apothecary notified the Food and Drug Administration in September, covers 22 lots of compounded tirzepatide, the active ingredient in Lilly’s medicine. Those lots have beyond-use dates ranging from Oct. 8 to Nov. 26.
    • “Apothecary’s recall comes as Lilly and Novo, the only makers of FDA-licensed GLP-1 obesity medications, have sought to stop companies from selling compounded counterparts. The recall could help bolster Lilly and Novo’s claims that the knockoff versions don’t have the same quality, safety or efficacy as the FDA-approved ones.”
  • STAT News adds,
    • “For the popular diabetes and obesity medications known as GLP-1s, addiction medicine is one of many possible promising next acts.
    • “Eli Lilly is investigating a new drug, brenipatide, and testing it in alcohol use disorder. A new company called Baseline Therapeutics is studying a GLP-1 receptor agonist in alcohol, cocaine, and methamphetamine use disorders; Altimmune is testing one called pemvidutide for alcohol. Addiction medicine specialists are hopeful that the Food and Drug Administration may soon approve a new medication for alcohol use disorder — the first in two decades. 
    • “But some telehealth platforms that specialize in treating addiction aren’t waiting. In the last year, a few companies have begun to market off-label prescriptions of GLP-1s, both branded and compounded, to treat alcohol use disorder and other addictions. 
    • “Trying to drink less but your doctor won’t prescribe a GLP-1?” reads a Facebook ad from a telehealth brand called Livelyhood, which started offering the drugs in April. “Livelyhood can.” 
    • “Another, called Quel, launched in September as an online extension of the off-label prescribing at a Pennsylvania-based addiction treatment center.” * * *
    • “Telehealth companies recognized the potential for opportunism in prescribing GLP-1s for addiction ahead of FDA approval, while maintaining that their platforms are the exception. And it’s not necessarily lucrative: “Economically, GLP-1 for alcohol use disorder is much tougher than pretty much any other GLP-1 indication,” said Lively. 
    • “If that’s the case, Witkiewitz wonders: Why not wait for an FDA approval? Klein and Lira said they look forward to prescribing new drugs if they are approved. But Witkiewitz worries that if early adopters see bad outcomes, patients could be deterred from seeking approved treatments in the future. “We’re so close to having this done right and well, or having it done in a way that protects patients to the best of our abilities,” she said. “Caution is warranted, and some patience is warranted.”

From the fraud, waste and abuse front,

  • Beckers ASC Review reports,
    • “Five physicians are among 15 defendants charged in a Los Angeles healthcare fraud takedown involving $2 billion in alleged fraudulent claims, according to an Oct. 22 news release from the U.S. Attorney’s Office for the Central District of California. 
    • “Most of that total comes from a $1.6 billion substance abuse treatment scheme that DOJ calls the largest of its kind it has ever prosecuted. The physicians’ cases make up a smaller share.”
  • The Wall Street Journal adds,
    • “A Southern California drug-rehab operator allegedly engaged in an elaborate scheme that involved providing recovering addicts with illegal drugs in order to keep billing their insurers for treatment, according to federal prosecutors. 
    • “Facilities associated with Nathan Young submitted more than $1.6 billion in claims to major health insurers and were paid over $210 million between 2020 and 2026, including billings for “non-existent and woefully inadequate ‘therapy’ sessions,” prosecutors said in a recently filed criminal complaint.
    • “Young and his father, David Young, were arrested last week. Lawyers representing the Youngs didn’t respond to requests for comment. The Youngs were charged with healthcare fraud and violating an anti-kickback statute, according to federal prosecutors.” 

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Forty-three percent of on-duty firefighter fatalities over the last 35 years were attributed to cardiac causes, according to a new study published in JACC: Advances.[1] These findings call into question the types of screenings firefighters should undergo to detect potential heart problems.
    • “Researchers at Cedars-Sinai Health Sciences University explored autopsy findings from more than 3,000 on-duty firefighter deaths. The group said the proportion of cardiac-related fatalities has steadily increased over the years However, cardiac related deaths have been on the decline for the general U.S. population over the same time period.  
    • “These findings might indicate the need to change annual health screenings for firefighters. Current national screening recommendations rely on exercise stress testing, which can identify ischemic issues with blood flow, but may miss hidden structural remodeling of the heart that could lead to sudden cardiac arrest.
    • “Our research shows there may be a blind spot when it comes to routine heart screenings for firefighters in the U.S.,” senior author Alan Kwan, MD, assistant professor of cardiology in the Smidt Heart Institute at Cedars-Sinai, said in a statement. “Identifying heart conditions when they can be treated is key to addressing these new findings.”
  • Health Day relates,
    • “Newly eligible younger adults are less likely to have discussed colorectal cancer (CRC) screening with their clinician compared with their older counterparts, according to a study published online Oct. 18 in the Journal of General Internal Medicine to coincide with the American Association for Cancer Research Conference on The Science of Cancer Health Disparities, held from Oct. 18 to 21 in Atlanta.” * * *
    • “This finding strongly suggests that patients who are newly age-eligible for screening are not receiving adequate information about their screening options from a health professional, and that could be contributing to low screening rates in this age group,” [lead researcher] Jordan Baeker Bispo, Ph.D., M.P.H. said in a statement.
  • and
    • “Smartphones are costing teenagers a good night’s sleep, a new study says.
    • “Teens who use their phones late into the evening suffer from delays in falling asleep, shorter total sleep time, and sleep that’s more restless and broken, researchers reported Oct. 19 in JAMA Pediatrics.
    • “These findings suggest that reducing evening smartphone use, particularly after 10 p.m. and immediately before bedtime, may help improve sleep health in adolescents,” concluded a team led by Dr. Dimitri Christakis, a professor of general pediatrics at Seattle Children’s Research Institute.”
  • Nature adds,
    • “The speed at which regions of the brain mature during early adolescence can forecast the emergence of mental-health conditions up to four years before symptoms develop, according to a study of nearly 12,000 young people in the United States.
    • “By tracking the brains of adolescents over six years in nearly 30,000 scans, researchers mapped how the brain’s outer layer, the cerebral cortex, thins as children grow into teenagers. The team observed that sensory areas of the cortex thinned, or matured, first, followed by the regions responsible for complex thought.
    • “The findings, posted on 11 October on the preprint server bioRxiv1 ahead of peer review, challenge the theory that psychiatric disorders are caused by defects in specific brain circuits. Instead, they indicate that vulnerability to mental-health symptoms could involve disruption of the brain’s developmental timeline and could be set in motion by genes that are active before birth.
    • “The work “provides one of the clearest pictures yet of how the cortex develops from childhood into adolescence”, says Avram Holmes, a systems neuroscientist at Rutgers University in New Brunswick, New Jersey, who was not involved in the study. “It makes you think about the timing of brain development, not just the location [in the brain], when we look at psychiatric symptoms,” he says.
  • Beckers Clinical Leadership informs us,
    • “Receiving a personalized mRNA-based cancer vaccine alongside immunotherapy lowered the risk of recurrence or death by 42% versus immunotherapy alone in a phase 3 clinical trial of patients with surgically resected stage 2B to 4 melanoma.
    • “The vaccine, called intismeran autogene and jointly developed by Merck and Moderna, was tested in combination with Merck’s immunotherapy Keytruda after surgery as part of the phase 3 INTerpath-001 trial, according to an Oct. 22 news release from the companies. 
    • “The trial results were leaked online Oct. 22, The Wall Street Journal reported, two days before Merck and Moderna were expected to present the data at the European Society for Medical Oncology conference in Madrid.” * * *
    • “Read the latest trial results from Merck and Moderna here.”  
  • Fierce Pharma points out,
    • “Delaying the use of subcutaneous Parkinson’s disease treatments by one year increases annual medical costs by 59.1%, AbbVie-sponsored research found.
    • “The study, which researchers will present (PDF) at the AMCP Nexus Conference this month, modeled the impact of delaying the initiation of two subcutaneous therapies by one year. One therapy comprised foslevodopa and foscarbidopa, the combination that AbbVie sells as Vyalev. The other therapy featured apomorphine, the active ingredient in Supernus Pharmaceuticals’ Onapgo.” 

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

  • The Wall Street Journal reports,
    • “A KFF survey shows the average cost of a family health plan rose 5% this year, while workers’ contributions increased 9% to $7,471.
    • “Employers are facing healthcare cost increases driven by high-cost drugs and hospitals raising prices and using AI tools to boost billing.
    • “To manage rising costs, some employers are increasing workers’ premium contributions, raising deductibles and dropping coverage for GLP-1 drugs.”
  • Beckers Payer Issues relates,
    • “Molina Healthcare reported $38 million in net income for the third quarter of 2026, a 52% year-over-year drop from $79 million.
    • “The insurer attributed the decline mainly to a higher consolidated medical loss ratio, which was  92.9% in Q3, up from 92.6% a year earlier. Total revenue for the quarter was $11.1 billion, down 3.4% year over year. Premium revenue fell approximately 4% to $10.5 billion, reflecting lower membership in Medicaid and the ACA marketplace, partially offset by rate updates.
    • “With the apparent plateauing of medical cost trend, which remains at elevated levels, and the strength of recent rate updates for 2027, we believe we are likely observing the beginning of the turn in Medicaid margins,” President and CEO Joseph Zubretsky said in an Oct. 21 news release.”
  • and
    • “Medicare Advantage annual enrollment kicked off Oct. 15, and the ACA open enrollment period is around the corner. Employers are also navigating cost pressures, opening the door to innovative plans.
    • “Insurers have been primed to consider new health plans across commercial and government programs, and many are biting.
    • “Not every organization rolling out health plans in the coming years is a traditional insurer, however. For example, Tacoma, Wash.-based MultiCare Health System and the Muscogee (Creek) Nation are entering the MA market.
    • “The trend has extended to the employer space. Tech-enabled healthcare company Included Health said it will introduce health plans for self-insured employers Jan. 1, 2028, following its acquisition of Firefly Health, a clinically integrated health plan and advanced primary care company. Health technology and benefits administration platform Judi Health is launching a Medicare Part D Employer Group Waiver Plan, as well.”
  • Fierce Healthcare tells us,
    • “Redesign Health is making a major push deeper into health system-led innovation, merging with Sheba Medical Center’s innovation arm ARC Global.
    • “Together, the organizations want to create an end-to-end platform that helps health systems turn ideas originating with their own clinicians and operators into technology products and standalone companies that can then be scaled across a global network, company executives said. The deal was announced Thursday.
    • “The combined company is valued at approximately $2 billion, according to a source with knowledge of the deal.”
  •  and
    • “Talkiatry is expanding virtual therapy services nationwide as part of a broader push to provide comprehensive behavioral health services across the acuity spectrum, from low to high.
    • “As a national mental health practice that provides in-network psychiatry and therapy, the expansion also positions the company to offer broader behavioral health services to health systems, payers and employers.
    • “The company initially built its scale around telepsychiatry, with more than 800 employed psychiatrists and a large national insurance footprint. Talkiatry claims to be the nation’s largest private employer of psychiatrists as well as the preferred in-network psychiatry partner for more than 70 U.S. health systems.”
  • Per MedTech Dive,
    • “Labcorp said Tuesday that it has agreed to acquire Myriad Genetics’ prenatal health testing business for $210 million.
    • “The deal covers tests for assessing fetal risk of certain conditions and other aspects of prenatal care. Labcorp expects the tests to add about $160 million in revenue in year one. 
    • “Evercore ISI analysts see room for Labcorp to improve the economics of the acquired business using its infrastructure and to broaden access to the tests through its provider relationships.”
  • SmartBrief informs us,
    • “AI is making medical information easier to access.  According to a recent KFF poll, nearly a third of US adults have used AI for health information or advice in the past year, and nearly 1 in 5 have used it to compare treatment options.
    • “The appeal is clear. People can ask health questions in their own words and get answers almost immediately. But receiving an answer and knowing how and when to use it—and whether they can rely on it—are different things.
    • “Health plans will see an increasing number of members using AI to evaluate their care options. That reality creates a need for plans to fill in the gaps of today’s AI capabilities.”
    • The article identifies pathways.
  • Beckers Health IT adds,
    • “Microsoft’s AI diagnostic system correctly diagnosed 83.2% of complex New England Journal of Medicine cases, compared with 36.1% for generalist physicians, according to a study published Oct. 22 in Science.
    • “The system, called Diagnostic Orchestrator, or DxO, simulates a panel of physicians. It starts from a brief clinical presentation, then asks questions, orders tests and revises the differential diagnosis step by step. Microsoft researchers tested it on 304 NEJM clinicopathological conference cases and 325 emergency department admissions from the MIMIC-IV-ED dataset.
    • “On the emergency cases, DxO running OpenAI’s GPT-5 reached 80.3% accuracy, compared with 46.8% for physicians.
    • “The researchers also tracked estimated testing costs, using the chargemaster of Kaiser Permanente Washington’s Central Hospital in Seattle. With no budget limits, DxO averaged $5,431 per complex case. With budget constraints, it hit 80.9% accuracy at $2,241. Physicians using search and reference tools averaged $4,725.” * * *
    • “Microsoft plans to evaluate DxO in real-world settings through a partnership with Beth Israel Deaconess Medical Center in Boston, TechCrunch reported Oct. 22.”

Midweek update

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Oct. 21 announced that Amazon, Axon Enterprise, Inc., Google, Meta and Oracle Corp. are in support of its prior authorization pledge announced last year. The pledge involves streamlining prior authorization processes and increasing transparency for patients and providers by 2027. The AHA recently launched a new website on prior authorization, containing prior authorization news and resources. The website will be updated with additional resources and guidance as they become available.”
  • and 
    • “The AHA submitted comments to the Centers for Medicare & Medicaid Services Oct. 21 on its preliminary calendar year 2027 Medicare clinical laboratory fee schedule rates. The AHA said the preliminary rates highlight the need for substantial reforms to CMS’ methodology, saying they are based on incomplete data. The AHA discussed the requirement under the Protecting Access to Medicare Act that called for hospital outreach laboratories and other clinical laboratories to report their private payer data to CMS between May 1 and July 31, 2026. Only 2% of laboratories paid under Medicare Part B reported any information at all to CMS. The AHA noted there was widespread confusion among laboratories that did report their data regarding whether they were suitably qualified as “applicable laboratories” and what data they needed to report. The AHA expressed concerns that the underreporting means CMS’ preliminary 2027 rates do not reflect the “market-based payments” that Congress mandated under PAMA, resulting in substantial proposed cuts to Medicare CLFS reimbursement for hundreds of codes. The AHA said these cuts threaten seniors’ access to essential clinical laboratory testing and continued investment in diagnostic innovation.
    • “The AHA also said it was concerned that CMS’ approach to collecting applicable private payer information directly from clinical laboratories is inadequate for setting fully “market-based” rates. To help address these concerns, the AHA urged CMS to provide support and technical assistance to Congress as it considers the Reforming and Enhancing Sustainable Updates for Laboratory Testing Services (RESULTS) Act of 2025, which consists of efforts designed to improve private payer data collection by CMS to set Medicare Part B CLFS rates.” 
  • Healthcare Dive relates
    • “Some major insurers in the Affordable Care Act exchanges are expanding into new counties for 2027, even as many of their peers run for the exit amid ongoing cost and policy turbulence.
    • Centene, the largest ACA insurer in the U.S., is expanding into 55 additional counties in Alabama, Iowa, Illinois, Louisiana, Michigan, New Jersey and Texas next year; while Oscar Health, one of the fastest-growing carriers in the exchanges, is adding 140 new counties, including by entering South Carolina for the first time.
    • “The changes, announced in press releases Tuesday, show a continued bet on the ACA among some major participants in the exchanges, which may see a growth opportunity as their competitors downsize and leave their members looking for new carriers.”

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

  • FedSmith explains “Prescription Drug Coverage: What Every Federal Employee Should Check.”
    • Learn how to save on FEHB prescription costs by reviewing your medications, checking formularies, and comparing mail-order and retail pharmacy options.
  • FedWeek reports,
    • “More than a year after creating the deferred resignation program—and enticing some 140,000 persons to leave federal employment under those offers last year—the Trump administration has formally put it into regulation.
    • “A notice in the October 19 Federal Register finalizes rules proposed in June giving agencies broad authority to use extended periods of administrative leave, formerly typically limited to only a few days or even hours, for that purpose. The rules also authorize putting employees on that form of paid leave—also called excused absence—between receiving a RIF notice and the RIF separation date, and “to facilitate the voluntary resignation of employees with documented poor performance or misconduct” under a settlement agreement.
    • “They also clarify certain technical aspects of deferred resignation offers, including specifying that agencies have sole authority over whether to grant an employee’s request to withdraw acceptance of such an offer.”

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

  • Fox 10 News in Mobile, Alabama, reports,
    • “The FDA issued its highest-risk warning for a California-based company amid concerns over a multistate cheese E. coli outbreak.
    • “The Class I classification applied to all affected Graziers raw milk cheese products manufactured by California-based Sierra Nevada Cheese Company, including Monterey Jack, jalapeño jack, medium cheddar and sharp cheddar varieties, according to a press release. 
    • “The affected products were distributed in Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, New Jersey, Oregon, Texas, Washington and Wisconsin.
    • “Investigators said 13 people in nine states became sick. More than half of those infected were children age 5 and younger.”
  • Health lets us know,
    • “Check your medicine cabinet: More than 4 million tubes of toothpaste have been recalled nationwide. According to the Food and Drug Administration (FDA), the toothpaste was initially recalled on Sept. 10 over deviations from Current Good Manufacturing Practice (CGMP), which ensures the identity, strength, quality, and purity of drugs. On Monday, the FDA gave the recall the second-highest risk level, Class II, for the possibility of temporary or reversible health effects.”
  • Per a company news release,
    •  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for use of the oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in adults and adolescents aged 12 years and older. The new 150 mg ORLADEYO pellet formulation provides an alternative administration option for adults and adolescents who may have difficulty swallowing, prefer not to take a capsule or choose to remain on a pellet formulation beyond age 12. 
    • With this approval, prescribers can now provide their adult and adolescent patients with the option to take once-daily, orally administered ORLADEYO for prophylaxis to prevent attacks of HAE [hereditary angioedema] in either capsule or pellet formulation. The ORLADEYO pellet formulation is sprinkle-like in appearance and size and can be poured directly into the mouth and swallowed immediately with water or milk, or sprinkled over a spoonful of soft, non-acidic food.
  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has cleared Elucid’s FFR-IQ software for the noninvasive estimation of fractional flow reserve from coronary CT angiography (FFR-CT). The artificial intelligence (AI)-based technology incorporates coronary anatomy and plaque composition into its estimation of coronary physiology to provide more accuracy.
    • “Plaque composition, coronary anatomy and physiology are closely connected,” Amir Ahmadi, MD, clinical associate professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai and Elucid’s lead scientific advisor, said in a statement. “BioIntegrated FFR-CT incorporates anatomy and plaque characteristics into the physiological estimate itself. Together with plaque assessment, this approach can help physicians evaluate the significance of an individual lesion while also addressing the patient’s broader atherosclerotic disease and need for preventive treatment.”
    • “Elucid said physicians told the company they want a more accurate FFR-CT algorithm that considered other factors that could impact hemodynamics; this newly approved algorithm does just that.
    • “Elucid is now the third vendor to offer FFR-CT commercially in the U.S., following prior approvals by Heartflow in 2016 and KeyaMed in 2022. Other vendors are also developing their own versions of FFR-CT. Interest in the technology has also increased rapidly recently as coronary CT angiography (CCTA) continues to rapidly gain momentum among care teams.”

From the judicial front,

  • The American Hospital News reports,
    • “The U.S. District Court for the District of Maine should deny motions by several drug companies and Pharmaceutical Research and Manufacturers of America to intervene in the lawsuit challenging the administration’s revised 340B rebate model, the AHA and its co-plaintiffs argued in a filing submitted Oct. 21.
    • “The AHA and plaintiffs noted that the court previously rejected similar intervention requests in litigation over an earlier version of the 340B rebate model, finding that the federal government could adequately defend its own policy.
    • “The AHA, Maine Hospital Association and four safety-net hospitals filed suit Oct. 9 to stop the revised rebate program, arguing that it would impose more than $1 billion in annual administrative costs on hospitals and divert resources away from patient care. The lawsuit seeks to prevent implementation of the program, which is scheduled to take effect Jan. 1, 2027.” 

From the fraud, waste, and abuse front,

  • The AP reports,
    • “President Donald Trump and Vice President JD Vance on Tuesday announced a $25 million program to encourage the public to blow the whistle on suspected fraud in the U.S. government as they ramp up efforts to end the abuse of federal programs and dollars.
    • “The White House said that under the Fraud Whistleblower Incentive Program, anyone who submits a tip that leads to a fraud conviction or a significant federal enforcement action is eligible to receive up to $30,000, and that the Justice Department will administer the program.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “[S]ome experts in health communication believe the time has come to reconsider the way government agencies communicate to the public about the [measles] virus. Yes, measles can be deadly, they say, but counterintuitively, health officials would have more success if their messaging clearly confirmed what many parents already know: Most children will survive.
    • “Public health agencies and experts should say forthrightly that for most healthy children measles is an unpleasant, self-limited illness from which they recover completely,” Peter Sandman, a retired risk communication expert formerly at Rutgers University, said in an email. “It has to be said repeatedly and emphatically.” 
    • “Public health experts STAT spoke to emphasized that there are many downstream health issues that could befall children who are infected with measles, and that vaccines are crucial and safer than trying to build immunity through exposure to the disease. But saying most children recover could ultimately build trust.”
  • NBC News adds,
    • “The Pennsylvania Department of Health issued an alert Monday to doctors about an increase in measles infections in pregnant women, as well as a concerning rise in congenital measles — a disease that’s rarely, if ever, seen in the U.S. 
    • “The department said that 66 pregnant women in Pennsylvania had been diagnosed with measles since the state’s outbreak began in April. “Getting measles while pregnant increases the risk of miscarriage, early labor, and low birth weight,” a department spokesperson said in an email.” 
  • Per MedPage Today,
    • “Children who started the two-dose human papillomavirus (HPV) vaccine series at age 9 or 10 years were more than twice as likely to get both shots versus those who began later, a cluster randomized trial showed.
    • “Across 31 U.S. pediatric practices, kids who were recommended to receive HPV vaccination starting at age 9 or 10 had better initiation and completion rates by age 13 versus those who received vaccination starting at age 11 or 12:
      • Initiation rates: 77.1% vs 67% (adjusted HR 2.52, 95% CI 1.93-3.27)
      • Completion rates: 61.6% vs 45.1% (aHR 2.85, 95% CI 2.12-3.83)
    • “What our data show is that the age at which families first hear about the HPV vaccine recommendation changes how many children are protected, and how soon,” said Sean O’Leary, MD, MPH, of the Children’s Hospital Colorado Anschutz Medical Campus in Aurora, during a press briefing ahead of the IDWeek annual meeting. “For clinicians who now start at 11 or older, we would suggest at least considering earlier introduction in their offices.”
  • The New York Times relates,
    • “In the United States, rabies can seem like a disease of the past, a remote risk caused by a mostly vanquished virus. But in recent months, this ancient foe has returned to the spotlight.
    • “A handful of unusual outbreaks have made headlines: rabid beavers at a Maryland state park, a cluster of goat cases at a North Carolina petting zoo. Officials in several states, including Idaho and Alabama, flagged surges in animal cases; California set an annual record for rabid bats.
    • “And last month, the Centers for Disease Control and Prevention issued a national health advisory, citing reports of “local increases in human rabies exposures.” The agency reported an uptick in the use of medical interventions — antibody treatments and vaccines — designed to protect people exposed to potentially rabid animals.
    • “So far, no human rabies cases have been reported in 2026. And it’s unclear whether the reported surges reflect a real increase in rabies risk. But they are worth keeping a close eye on, experts said, and highlight the persistence of rabies as a complex, ever-evolving threat.”
  • Beckers Clinical Leadership points out how this season’s flu cases compare to past seasons.
    • “As of early October, the rate of outpatient visits for flu-like illness was tracking as the third-highest since 2010. In the week ending Oct. 10, about 2.1% of outpatient visits were for respiratory illness — up from 1.6% during the same week last season, CDC data shows. This marks the third highest weekly rate behind the 2022-23 season (2.5%) and the 2023-24 season (2.4%). The CDC classified both of these seasons as moderately severe.”
  • Beckers Behavioral Health notes,
    • “States that legalized online sports betting saw increases in antidepressant and anti-anxiety medication use, along with outpatient diagnoses of depression and anxiety, a study published Oct. 14 in JAMA Psychiatry found.
    • “Researchers at the Baltimore-based Johns Hopkins Bloomberg School of Public Health analyzed employer-sponsored health insurance claims from January 2016 to December 2023. The study compared 22 states that legalized online sports betting between 2018 and 2022 with 13 states that had not legalized it by the end of 2023.
  • Health Day tells us,
    • “More teen girls are vaping than boys.
    • “About 7.8% of teen girls vape compared to 4.6% of boys.
    • “Less than half of 1% of all teens smoke cigarettes.”
  • and
    • “Black children’s race may put them at greater risk for a more severe form of asthma.
    • “Black kids are nearly three times as likely to suffer from T2-high asthma as white kids.
    • “This increased risk comes regardless of environmental or social factors like neighborhood air quality or family income, researchers say.”
  • Per BioPharma Dive,
    • “A Roivant subsidiary will ask regulators to approve a new indication for its anti-inflammatory medicine brepocitinib after posting successful results in two Phase 3 studies in an eye condition called non-infectious uveitis that can lead to blindness.
    • “In the trials, known as Clarity-1 and Clarity-2, patients were able to last for a median of more than 48 weeks before “treatment failure,” a measure of eye inflammation and other markers, compared with 12 weeks for those on a placebo. The brepocitinib patients also went 40 weeks without needing immunosuppressive steroids, setting a new bar in treating the disease. And the drug succeeded on every secondary endpoint, including resolving macular edema, the company said Wednesday.
    • “The Roivant unit, Priovant Therapeutics, already has Food and Drug Administration approval to sell brepocitinib under the brand name Lisraya to treat adults with the skin disease dermatomyositis. Priovant now plans to submit a supplemental application to expand the medicine’s use in the first half of next year.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Elevance Health ELV lifted its guidance for the year again after higher premium yields and pharmacy growth drove profit and revenue higher, offsetting a drop in membership.
    • “The health-insurance company on Wednesday said it now expects earnings per share of at least $22 for 2026, up from the prior $20.10. Adjusted earnings per share is now seen at $29 or higher, up from previous guidance of at least $27 a share.
    • “Analysts expect adjusted earnings of $27.26 a share for the year, according to FactSet.” * * *
    • “The company said it benefited from higher premium yields, increased product revenue from its pharmacy benefit manager CarelonRx, and growth in service fees.
    • “The benefit-expense ratio, a closely watched metric that compares health costs with premium revenue, improved by 70 basis points to 90.6%, driven by better performance in Medicare Advantage and individual Affordable Care Act plans.”
  • Beckers Payer Issues adds,
    • “Newly enabled competition between Blue Cross Blue Shield plans is continuing to contribute to Elevance Health’s commercial insurance business, leadership said on the company’s quarterly earnings call Oct. 21.
    • “Dubbed the “second blue bid,” the provision stems from a $2.67 billion settlement that resolved class action allegations dating back to 2012 that BCBS plans conspired to divide up markets to avoid competing with one another. The settlement eliminated a rule that required large employers to work with the BCBS plan covering their headquarters’ geography, thereby allowing certain national accounts to solicit bids from a competing Blues plan.
    • “Elevance, which owns 14 BCBS companies, said in January that it won nine of 11 second blue bid accounts in its first year competing under the provision. Morgan Kendrick, the company’s president of commercial and specialty health benefits, said on the third quarter earnings call that second blue bid opportunities have also been a component of its 1.7 million-member national accounts pipeline for 2027. 
  • and
    • “Elevance named Jeff Park as president of healthcare services subsidiary Carelon, effective Dec. 1. Mr. Park was most recently president of health technology company Waltz Health. Along with other healthcare leadership roles, he previously served as COO of pharmacy benefit manager Optum Rx, according to his LinkedIn profile.” * * *
    • “Carelon revenue grew 5.4% year over year, reaching $19.3 billion for the third quarter. This was spurred by CarelonRx product revenue and further expansion of Carelon Services risk-based solutions. Carelon’s operating margin was 4.7%, up from 4.2% in third-quarter 2025.
    • “CarelonRx’s operating gain was $616 million for the quarter, up 10.8% year over year. Its operating margin grew to 5.3%, up 20 basis points from the same period last year.”
  • and
    • “Horizon Blue Cross Blue Shield of New Jersey has agreed to acquire multispecialty physician group Summit Health’s New Jersey operations, including CityMD urgent care sites in the state, the insurer confirmed to Becker’s.
    • “We are excited by the opportunity to preserve access to high quality care for all of Summit Health’s patients, improve healthcare quality and affordability for our members, and to support the continued independence of Summit Health’s physicians and clinicians for the benefit of New Jerseyans,” a Horizon spokesperson said Oct. 21.
    • “The deal is subject to regulatory review and financial terms were not disclosed. Summit operates more than 120 locations across New Jersey, New York and Connecticut, while CityMD operates more than 180 urgent care centers across the three states.” 
  • Fierce Healthcare relates,
    • “Kaiser Permanente’s Risant Health has tapped Oklahoma’s largest nonprofit provider as the next to join its growing cadre of regional health systems.
    • “Integris Health and the nonprofit value-based care platform announced Wednesday their signed definitive agreement, which is subject to regulatory review but could close in early 2027. Financial terms were not disclosed. 
    • “The deal would make Integris the third regional health system to join Risant, following Pennsylvania’s Geisinger Health and North Carolina’s Cone Health, both deals that closed in 2024.”
  • and
    • “Alcon—the eye-focused pharma spun out of Novartis—is handing over $550 million to buy outNeurotech Pharmaceuticals, its encapsulated cell therapy platform and commercial medicine Encelto.
    • “Encelto, greenlit in March of 2025, is the first and only FDA approved therapy for macular telangiectasia type 2, a rare and progressive type of central vision loss. So far, the drug is only available in the U.S., where Neurotech estimates there are 25,000 MacTel patients and 2,000 to 3,000 new diagnoses each year. Through the merger, Alcon will now endeavor give the drug-device combo a more global reach, the pharma said in a statement. 
    • “Neurotech will also bring the tech behind Encelto to Alcon. The biotech’s encapsulated cell therapy approach pairs a surgically placed implant with cells that have been genetically engineered to produce therapeutic proteins. In the case of Encelto, the implant continuously releases recombinant human ciliary neurotrophic factor (rhCNTF), a protein that can travel to the retina and protect the photoreceptors—cells that are implicated in MacTel vision loss.” 
  • The Wall Street Journal informs us,
    • “Abbott ABT Laboratories plans to separate its nutrition business into an independent company by the end of next year, distancing itself from an embattled unit that has dragged down earnings and been the subject of years of litigation.
    • “The newly created company, set to house brands including Pedialyte electrolyte beverages and Similac infant formula, is expected to generate about $8.5 billion in annual sales.
    • “Chief Executive Robert Ford said the separation will allow both companies to sharpen focus and direct resources more effectively. Abbott will dial in on its core portfolio, which includes higher-growth categories such as medical devices and diagnostics, while the nutrition company will aim to capitalize on growing demand in the global nutrition market.
    • “We believe both businesses will be better positioned for the future as independent organizations,” Ford said on a call with analysts.”
  • Beckers Hospital Review lets us know,
    • “There are more than 400 birth centers in the U.S., and the number varies widely by state, from 92 in Texas to none in 10 states, according to Oct. 15 data the American Association of Birth Centers shared with Becker’s. Six states and the District of Columbia have one birth center.
    • “The count includes all birth centers known to the association, said Kate Bauer, executive director of AABC. She said state differences stem from factors such as state regulations, the midwifery workforce, insurance reimbursement and other elements that affect sustainability.
    • “An Oct. 20 Commonwealth Fund report on freestanding birth centers found that birth center births accounted for 0.62% of U.S. births in 2024, up from 0.23% in 2004, though access varies widely by state.”
  • Per Radiology Business,
    • “Capitol Imaging Services is expanding in South Florida with the acquisition of four outpatient centers. 
    • “The private equity-backed, Houston-based radiology group is buying Impression Imaging for an undisclosed sum, the two announced Tuesday. Capitol said the move establishes a strong presence in the Sunshine State and “marks an important step” as the group expands into molecular imaging and theranostics. 
    • “Founded in 2012 by physicians, Impression Imaging operates Florida locations in the communities of Tamarac, Pembroke Pines, Boca Raton and Coral Springs. 
    • “The addition of Impression Imaging to the Capitol Imaging Services network aligns perfectly with our mission to provide patients and physicians with the highest quality screening and advanced diagnostic imaging services,” John Stagg, CEO of Capitol Imaging, said in an announcement Oct. 20. “This acquisition expands our presence in Florida while strengthening our commitment to bringing cutting-edge imaging technology, precision diagnostics and greater patient access to every medical community we serve.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
  • Simplicity is a virtue.

From Washington, DC

  • The American Hospital Association News reports,
    • “The AHA Oct. 20 expressed support for the Addressing Boarding and Crowding in the Emergency Department (ABC-ED) Act (S. 1974), bipartisan legislation designed to improve data collection on hospital capacity and ED boarding. The bill is sponsored by Sens. Chris Coons, D-Del., and David McCormick, R-Pa. In its letter to the bill’s sponsors, the AHA emphasized that the causes of ED boarding and crowding are complex and have become persistent and growing challenges for hospitals and health systems nationwide.”
  • Beckers Payer Issues relates,
    • “A newly introduced House bill is targeting the methodology behind Medicare Advantage star ratings, adding more pressure to a program that has seen years of litigation from insurers.
    • “The Medicare Advantage Strengthening Transparency and Accountability in Rating Systems Act, or MA STARS Act, was introduced Sept. 21 by Rep. Mike Kelly, R-Pa., and would direct the federal government to rewrite star ratings policy beginning with the 2031 contract year.
    • ‘Under the bill, CMS would have to exclude any measure that is unrelated to clinical quality, outcomes or experience, or is not reasonably attributable to the actions of the plan and its delegated entities, such as contracted providers and subcontractors. Measures built on enrollee surveys would also be excluded if the survey has more than 10 questions, fails to draw responses from a diverse group, or misses minimum response and sampling standards set by HHS.
    • “Measures that no longer distinguish performance among most contracts would also come out of the calculations, while new measures could be added only if they relate to clinical quality, outcomes or experience.”
  • and
    • “As Medicare Advantage faces concerns regarding plan oversight, possible overpayments and care access, RAND researchers assembled experts to unpack potential reforms.
    • “Published in Health Affairs Oct. 5, the study consisted of two rounds with nearly 40 panelists. They rated 15 policy reform ideas on a nine-point scale. These ideas had high-level framing and were drawn from panelist suggestions and published research. The policy list was updated between the two rounds.
    • “While none of the proposed policies were found to simultaneously benefit all stakeholders — beneficiaries, plans and the government — the researchers identified the three “most feasible near-term reforms” that would benefit beneficiaries while not harming health plans and the government. These are standardizing supplemental benefits, limiting the number of plans an insurer can offer and reforming agent commissions.”
  • Medical Daily tells us,
    • “A senior federal health official has acknowledged that Medicare’s experiment with AI-assisted prior authorization is falling short. “There are a lot of things about WISeR that are not working,” Centers for Medicare & Medicaid Services (CMS) Deputy Administrator Kimberly Brandt said Oct. 15 at a conference in Santa Fe, New Mexico, Nextgov/FCW reported.
    • “The admission matters most for people with Original Medicare in the six states where the test runs: Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington.
    • “For older adults and their caregivers, the main issue is time. When a needed procedure waits on approval, pain, wound healing, and mobility can all suffer. Knowing how the system works can help families push for faster answers.”
  • Per Health and Human Services Department news releases,
    • “The U.S. Department of Health and Human Services (HHS) today launched the Kidney Care National Plan, a coordinated department-wide strategy focused on revitalizing American kidney care.
    • “As part of the Make America Healthy Again initiative, the new Kidney Care National Plan will address the root cause of disease and implement better treatments for Americans at every stage of kidney disease. The Plan identifies where federal action can improve kidney care across the entire spectrum of kidney disease, eliminate regulatory barriers to support innovation and a well-functioning kidney market, and deliver greater choice and superior outcomes to Americans.
    • “President Trump changed the course of kidney care in 2019 by challenging a system that waited for patients to reach kidney failure,” said HHS Secretary Robert F. Kennedy, Jr. “Now HHS is building on that work by detecting kidney disease earlier, expanding treatment and home-care options, removing barriers to innovation and transplantation, and strengthening safety across the transplant system. Our goal is simple: preserve kidney health, give patients more choices, and help more Americans avoid kidney failure and live longer, healthier lives.”
    • Link to the Kidney Care National Plan Fact Sheet
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced seven awards through its new Sickle Cell Disease Regional Care Excellence (SoRCE) Program. The awards establish Regional Coordinating Hubs to help people with sickle cell disease access high-quality care and community services closer to home.
    • “Americans living with sickle cell disease should not have to travel long distances or overcome unnecessary barriers to receive effective care,” said HHS Secretary Robert F. Kennedy, Jr. “Early treatment can prevent serious complications and help patients live healthier lives. The Trump Administration is expanding access to proven treatments and specialized care so more patients can get the support they need in the communities they call home.”
    • “Approximately 100,000 people in the United States live with sickle cell disease. Early and ongoing treatment can prevent or reduce serious complications, yet many people face barriers to preventive care, specialty services, and disease-modifying therapies. The SoRCE Program aims to improve access and quality of care while tracking indicators of quality of life.” * * *
    • “See the FY 2026 SoRCE Program award recipients.”

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

  • FedScoop has named OPM Director Scott Kupor one on its 11 FedScoop 50 2026 Golden Gov: Federal Executives of the Year. Congratulations Director Kupor.
  • Director Kupor added to his Secrets of OPM blog a post titled Free is Good which concerns open source software and super intelligence efforts.
  • The ABA Banking Journal reports,
    • “As the Office of Personnel Management considers possible changes to federal employee health benefits, it should create more opportunities for employees to select health savings account-qualified, high-deductible health plans, the American Bankers Association HSA Council said in a letter to the agency.”

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

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines. The guidance ends longstanding uncertainty by providing recommendations about when app content is subject to FDA submission requirements, when an app should be mentioned on a drug’s official label, and what companies should submit to the agency.
    • “Mobile apps are playing a growing role in how patients manage their medications and health conditions,” said Captain Chris Wheeler, Pharm.D., Director of the Division of Medical Policy Programs within FDA’s Center for Drug Evaluation and Research. “This guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated to both patients and their providers.”
    • “The guidance addresses three key questions for industry: when app content is treated as FDA-required labeling versus promotional labeling, when an app should be referenced in a drug’s official prescribing information, and what companies should submit to FDA when they distribute app content to users.”
  • and
    • “The U.S. Food and Drug Administration yesterday approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week. The approval aligns with FDA’s Public Health Pillar: Increasing Access to Affordable Medicines & Medical Products.
    • “Menopause is a universal experience for women, and it can greatly affect a person’s quality of life. This approval makes effective treatment more accessible,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Approvals like this reflect FDA’s ongoing commitment to expanding American patient access to safe, affordable, high-quality medications.”
    • “The generic estradiol and levonorgestrel transdermal system is therapeutically equivalent to Climara Pro, which is indicated for use in women with an intact uterus for:
      • “Treatment of moderate to severe vasomotor symptoms due to menopause
      • “Prevention of postmenopausal osteoporosis.”
  • and
    • “The U.S. Food and Drug Administration today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis. Hibsago is the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B. Hibsago is approved for certain adults without cirrhosis who have been taking HBV antiviral therapy for at least six months, have suppressed levels of HBV in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test. 
    • “For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, DO, Acting Director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research. “Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.”

No Surprises Act News

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 20 published two qualifying payment amount audits under the No Surprises Act. The audits were of CareSource in Indiana and the School Employees Retirement Systemin Ohio, with both required to complete corrective actions following the audits. The CareSource audit focused on almost 25,000 claims, primarily concerning emergency and non-emergency services, while the School Employees Retirement System audit focused on six air ambulance claims. Both audits were conducted between Jan. 1, 2022, and May 31, 2023.”

From the fraud, waste and abuse front,

  • The Oklahoma Voice reports.
    • “Oklahoma’s Medicaid payment error rate is well below the national average, according to the agency that administers the program. 
    • “Oklahoma’s “improper payment rate” for Medicaid, also known as SoonerCare, was 0.15% in 2025 compared to the national average of 6.12%, according to the Oklahoma Health Care Authority.” * * *
    • “Oklahomans expect every taxpayer dollar to be spent the right way, and we hold ourselves to that standard,” said Aaron Morris, interim CEO of the Health Care Authority, in a statement. “We are continuously enhancing our tools to ensure Medicaid dollars are preserved and available to fund services for Oklahomans in need.”
    • “In 2022 Oklahoma’s Medicaid program had not yet made the switch to managed care, but overall, the state’s Medicaid error rate was 1.95%, the second lowest rate in the nation. * * *
    • “In the three years since the last review, the agency worked on “rigorous staff quality control and enhanced data integrity,” said Rebecca Sheppard, a spokesperson for the Health Care Authority. 
    • “The Health Care Authority is “continually adapting its strategy” to combat fraud through firewalls, automated application screenings and data validation exchanges with partners like Equifax, according to a news release. 
    • “OHCA’s broader plan to protect program integrity combines strict provider credentialing and revalidations of high-risk providers with targeted post-payment audits that verify medical necessity and proper documentation,” according to a news release.” 

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Flu season is off to an unusually early start, with wastewater surveillance, emergency department data and local health departments from Virginia to California all indicating increased virus activity. 
    • “An earlier-than-usual rise does not guarantee a worse season, but on nearly every surveillance measure — and in a growing list of states — the virus is proliferating.
    • “Thirty-eight states are seeing a “high” level of influenza A in wastewater, according to Wastewater SCAN, a dashboard developed by Stanford (Calif.) University. The 12 states still at a “low” level are clustered in the Midwest: Kansas, Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, Nebraska, North Dakota, South Dakota and Wisconsin.” * * *
    • “Officials across states are urging residents to get vaccinated by the end of October, noting the shot takes about two weeks to take full effect. El Paso County, Colo., is “seeing an earlier rise in higher numbers of flu,” public health official Haley Zachary told CBS affiliate KKTV, after the state reported its first pediatric flu death of the season. In Kentucky, where cases are running above last year’s level, EDs are already treating flu-like illness earlier than usual, CBS and The CW affiliate WKYT reported.”
  • Health Day relates,
    • “Food sensitivity appears to change as a child ages
    • “More kids become sensitive to food allergens as they grow older
    • “Peanut is an early and persistent allergen, but others become prominent by age five.”
  • and
    • “Epilepsy is strongly associated with young-onset dementia (YOD; age younger than 65 years), according to a study published online Oct. 14 in Neurology.”
  • Radiology Business tells us,
    • “Despite anxiety pertaining to the exam, many breast cancer survivors report high confidence in contrast-enhanced mammography (CEM) and would recommend it to other survivors as part of their post-treatment surveillance plan. 
    • “Survey findings published in Insights Into Imaging are offering new insight into how patients feel about having to complete CEM exams for monitoring purposes after cancer treatment. In recent years, the exam has emerged as a promising alternative to digital mammography, which has limited sensitivity in post-op patients.” 
  • Cardiovascular Business informs us,
    • “Researchers with NYU Langone Health may have identified a new way to predict heart transplant rejection without the need for an invasive biopsy. Their findings were recently published in the Journal of Heart and Lung Transplantation.[1]
    • “The study combined blood biomarkers with electrocardiogram (ECG) heart rhythm recordings into an artificial intelligence (AI) model and then compared the results directly against the gold-standard myocardial biopsy results. The team found the AI accurately identified when a transplant patient’s body starts attacking a donated heart.”
  • and
    • “Advanced artificial intelligence (AI) models can anticipate when older heart failure patients may start to experience functional decline, according to new findings published in the Journal of Cardiac Failure.[1]
    • “Researchers explored data from more than 6,000 patients 65 years old or older who were hospitalized for heart failure and prescribed rehabilitation. The median age of the cohort was 82 years old. An advanced machine learning model was then developed capable of evaluating a patient’s one-year risk of experiencing functional maintenance, functional decline or death. Functional decline was specifically defined as anyone who transitions to a housebound/ bedridden lifestyle due to their health.” 
  • Healthcare IT News adds,
    • “The relationship between clinicians and clinical knowledge is changing, according to a new JAMA study that suggests a “growing share of knowledge access is shifting from recall to retrieval.” 
    • “Researchers also say by characterizing the scale, distribution and clinical content of clinician-AI interactions, their findings fill an evidence gap needed to further frameworks that properly evaluate and guide AI use in clinical practice.” * * *
    • A significant number of medical practitioners are using AI in the clinic to explore treatment options for their patients in areas outside their clinical specialty, said Harvard in announcing the findings of what it’s calling the “first large-scale study of how often clinicians use artificial intelligence tools in patient care.”
    • “Harvard Medical School and Brigham and Women’s Hospital – along with researchers from Seattle Children’s Hospital, New York University’s Grossman School of Medicine, Massachusetts General Hospital and the National Bureau of Economic Research in Cambridge, Massachusetts – analyzed two-and-a-half years of OpenEvidence usage data. 
    • “The goal was to understand what types of clinicians are making queries, and how they are using the AI-driven findings. 
    • “Among 950,000 clinicians who submitted more than 270 million queries of artificial intelligence over a two-and-a-half-year period, queries were highest for nurse practitioners, followed by physician assistants and physician residents and fellows, according to the report, published Oct. 15.
    • “Use of clinical AI was also higher among physicians in oncology/hematology, internal medicine and family medicine and lower among those in ophthalmology, radiology, orthopedics and anesthesiology, said researchers from Boston-based Mass General Brigham in an email to Healthcare IT News.” 
  • BioPharma Dive points out,
    • “An experimental pill from Boston-based Rapport Therapeutics narrowly succeeded in a mid-stage study focused on bipolar mania, an outcome that analysts described as unexpected and a potential stepping stone to a billion-dollar-plus market.
    • “Rapport’s study enrolled around 250 adults with bipolar mania, who, once a day for three weeks, were given either a placebo or the company’s drug, “RAP-219.” Researchers then evaluated participants on several health measures, with the most important being how they fared on a 0 to 60-point clinical scale where higher scores reflect more severe bipolar symptoms. According to Rapport, those on its drug improved an average of 15.4 points by the third week, versus 12.3 points among the placebo group.
    • “That 3.1-point difference was just enough for the results to be statistically significant. Rapport said that, compared to the control arm, drug-treated patients showed improvements across all 11 components of the scale, which evaluates things like mood, speech, irritability and aggression. RAP-219 also beat the placebo on a “secondary” measure that used a different mania severity scale.
    • “The drug was well-tolerated, according to Rapport, with all so-called treatment-emergent adverse events being mild to moderate.” 
  • The New York Times calls attention to “5 Common Medications That Can Mess With Your Sleep.”
    • “Certain prescription and over-the-counter drugs are known to keep people awake. We asked experts for some of the biggest offenders.” * * *
    • “Any sleep disruptions that result from taking a medication should be discussed with a doctor, Dr. Neubauer said.
    • “Adopting healthy sleep habits could also help counter the medication’s side effects, Dr. White added. Try to avoid consuming caffeine after around 2 p.m., don’t drink alcohol just before bed, keep your bedroom dark and cool and maintain a consistent sleep schedule.”

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

  • STAT News reports,
    • “Officials at Dana-Farber Cancer Institute and Beth Israel Lahey Health celebrated on Monday the start of work on their new $1.68 billion Boston hospital to treat cancer patients, the only medical center of its kind in New England.
    • “The clanking of cranes slated to descend over the Longwood site also brings the impending divorce of Dana-Farber and its longtime partner, Brigham and Women’s Hospital, one step closer. Meanwhile, Brigham’s parent, Mass General Brigham, has launched its own rival cancer institute and is constructing new buildings and renovating other spaces to compete.”
  • Fierce Healthcare relates,
    • “Hackensack Meridian Health has signed a definitive agreement to pick up Central New Jersey’s Hunterdon Health, a $230 million deal that would grow the state’s largest health system to 19 total hospitals. 
    • “The pair had signed a letter of intent to merge in June and are now pursuing state and federal regulatory reviews. The announcement did not outline a potential timeline for the merger’s close.
    • “The agreement does outline a $200 million capital investment on behalf of Hackensack Meridian, which the nonprofits said would go toward facilities, programs and Central New Jersey communities Hunterdon serves.” 
  • Beckers Hospital Review tells us,
    • “Tampa, Fla.-based Moffitt Cancer Center recorded operating income of $238.4 million (6.9% operating margin) for fiscal year 2026, up from operating income of $127.5 million (4.2% margin) in fiscal 2025, according to its financial report for the 12 months ended June 30.  
    • “Moffitt reported total revenue of $3.4 billion in fiscal 2026, a 14.3% increase year over year. Patient service revenue rose 14% to $3 billion. Other revenue, which includes state appropriations and grants, increased 14% to $345 million.
    • “Total expenses were $3.2 billion for fiscal 2026, an 11.1% increase year over year. Salaries, wages, benefits and faculty fees totaled $1.5 billion, a 12.7% increase. Supplies rose 8.1% to $1.2 billion. Purchased services increased 21% to $276 million.”
  • and
    • offers a “nonexhaustive” list of “87 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • The Wall Street Journal informs us,
    • “Front-line nurses are leaving bedside roles in droves due to burnout, understaffing, verbal abuse and workplace violence.
    • “The annual turnover rate for bedside registered nurses hit 18% last year, according to NSI Nursing Solutions.
    • “Losing a nurse is expensive for hospitals, with research at Emory Healthcare showing it costs the system around $78,000 anytime a nurse leaves.”
  • and
    • “AstraZeneca is partnering with Oracle to use artificial intelligence, cloud and data capabilities to refine clinical research.
    • “The collaboration will initially explore clinical-trial recruitment, earlier diagnosis and drug-safety monitoring.
    • “The first program under the partnership will focus on hypertension care and clinical research in Abu Dhabi.”
  • Beckers Health IT adds,
    • “OpenAI has acquired Orchestra Bio, an AI-powered platform that helps biopharma teams coordinate the drug development process.
    • “OpenAI announced the deal Oct. 20 and did not disclose financial terms. The company plans to combine Orchestra’s team and technology with Rosalind, its suite of AI models and tools for life sciences research, which includes the GPT-Rosalind reasoning model and Rosalind Workbench.
    • “Orchestra Bio’s platform lets scientists and program leaders hand off the monitoring and tracking of studies to AI agents. When a problem hits one part of a drug program, such as a failed manufacturing batch that could delay the start of a clinical trial, the agents identify which activities and timelines are affected, gather relevant information and compare response options. Scientists and program leaders then decide how to proceed.
    • “OpenAI said the combined effort aims to build agents that connect scientific findings to the studies, decisions and next steps needed to advance a potential medicine.”
  • Medical Economics discusses “how unbundled maternity care codes could change OB/GYN pay in 2027.”
  • Per the American Hospital Association News,
    • “The median annual net launch price for new prescription drugs increased 35% from 2022 to 2025, to $257,000, according to a report released by the Institute for Clinical and Economic Review and West Health. Nearly 25% of drugs in 2025 launched above $500,000 and 34% launched between $200,000 and $500,000. The groups found that even if drug characteristics impacting launch prices remain constant, such as product type, therapeutic class, and orphan or ultra-rare status, launch prices may continue to increase.”

Monday report

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

Simplicity is a virtue.

From Washington, D.C.

  • Per a White House news release,
    • “First Lady Melania Trump advanced a landmark program to improve women’s health through a new executive order that strengthens research, prevention, diagnosis, treatment, and care for girls and women throughout every stage of life.
    • “Previous generations fought for women’s rights. Our generation will fight to discover the cures that will ensure a woman can live her life in health and to the fullest,” The First Lady said from the White House.
    • “The Executive Order establishes a White House Women’s Health Task Force and establishes a new Women’s Health Division within the National Institutes of Health to accelerate scientific discoveries to improve women’s health outcomes.” * * *
    • “To learn more about the Executive Order, read the fact sheet released by the White House.”
  • Bloomberg Law reports,
    • “The Trump administration’s move to integrate artificial intelligence agents with Medicare patient data is facing concerns the tech push could put sensitive health information at risk.
    • ‘Since 2025, the Centers for Medicare & Medicaid Services has partnered with more than 700 companies, including Google, Microsoft, and OpenAI, to build its Health Technology Ecosystem, an agency revamp seeking to modernize how Medicare patients use their health data.
    • “Patient and privacy groups, though, warn that without safeguards, the rapid expansion into AI could leave Medicare patients vulnerable to the same pitfalls plaguing the broader health industry.
    • “We are at this incredible inflection point right now, but we really need strong consumer protections to keep pace with all of that innovation,” said Lisa Bercu, senior director of health policy at the National Consumers League.”
  • The American Hospital Association News adds,
    • T”he AHA provided recommendations to the Food and Drug Administration Oct. 19 on potential regulatory frameworks for generative artificial intelligence-enabled medical devices. The AHA expressed support for a flexible, risk-based regulatory framework that protects patients without impeding responsible innovation. Among its suggestions, the AHA recommended the FDA refine the proposed risk heuristic for evaluating the risk of GenAI applications and provide labelling guidance on “informational action directing” devices versus “action taking” devices. The AHA also requested the agency to align premarket clearance and post-deployment evaluation and monitoring activities under a total product lifecycle and clarify that GenAI-enabled clinical decision support and administrative tools are not subject to FDA oversight.” 
  • Beckers Health IT notes,
    • “Somerville, Mass.-based Mass General Brigham researchers built an AI foundation model, trained on more than 40 million face images, that estimates biological age and predicts cancer survival from a single photograph.
    • “The model, called FAHR-Face, powers two tools detailed in a study published Oct. 19 in The Lancet Digital Health. FAHR-FaceAge estimates a patient’s biological age more accurately than prior algorithms. FAHR-FaceSurvival predicts survival outcomes directly from a face photo of a patient with cancer.
    • “The gap between a patient’s FAHR-FaceAge and chronological age was independently linked to survival. The two tools’ predictions were only weakly correlated, and combining them improved survival-model fit in an external validation cohort of cancer patients.
    • “Hugo Aerts, PhD, director of the Artificial Intelligence in Medicine program at Mass General Brigham, said the work is, to the team’s knowledge, “the first demonstration” that an AI model can directly predict cancer survival from a photograph, per an Oct. 19 news release.”

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

  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) has finalized a rule removing the governmentwide time-in-grade restriction for advancement to covered competitive-service General Schedule positions at GS-6 and above. The restriction generally required employees to spend 52 weeks at a lower grade before they could be considered for promotion, even if they met the qualifications for higher-level work.
    • “The old rule made the calendar a gatekeeper. If someone is qualified and ready to take on more responsibility, the government shouldn’t make them wait another year just because the clock says so,” said OPM Director Scott Kupor. “This rule allows agencies to reward demonstrated merit over tenure. Employees still have to meet the standards for the job, and promotions still have to follow merit procedures.”
  • Director Kupor further discusses the significance of this rule change in his Secrets of OPM blog here.
  • FedWeek reports,
    • “OPM has issued a “Government-Wide Recruitment Strategic Plan” for senior agency leaders, HR officials and hiring managers that incorporates many of the administration’s previously announced hiring initiatives while setting a goal that one-third of hires should be “early career.”
    • “Aligned to the Trump administration’s workforce management agenda, Federal agencies should hire patriotic Americans and make hiring decisions based on merit, not proxies. A college degree, or years of tenure, may or may not tell us whether someone is the best fit for a job. Demonstrated skills do,” says the document, attached to a memo to agencies.
    • “Agencies will emphasize lawful, fair, and open competition, grounded in job-related competencies and merit-based skills assessments. Nowhere is this more urgent than in early career recruitment. The federal government is exponentially under-indexed on early career talent,” it says.”
  • and
    • “In its newly released “Governmentwide Recruitment Strategic Plan” (see related story), OPM said it is looking for “disciplined execution by all agencies, not just OPM” which will be looking for “indicators of success” by agencies in carrying it out.
    • “Says a cover memo from OPM director Scott Kupor, “Successful implementation requires unwavering commitment and disciplined execution by every agency, not just OPM. Agency leaders and Chief Human Capital Officers must align recruitment with workforce needs, strengthen early-career talent pipelines in pursuit of the Plan’s hiring goals, measure outcomes, and hold their organizations accountable for results.”
  • FedSmith encourages readers to “Look Beyond Premiums: Understanding the Real Cost of Your [FEHB or PSHB] Health Plan.
    • Learn to choose the best FEHB health plan by weighing premiums, deductibles, copays, and out-of-pocket costs for total yearly expenses.

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

  • Beckers Hospital Review reports,
    • “The FDA has granted accelerated approval to an immunotherapy that may spare some patients with locally advanced rectal cancer from undergoing chemotherapy, radiation and surgery.
    • “The approval covers London-based GSK’s dostarlimab-gxly — sold under the brand name Jemperli — as a standalone treatment for adults with previously untreated stage 2 or 3 locally advanced rectal cancer, according to an Oct. 19 news release from the agency.
    • “Eligible patients’ tumors must be identified by an FDA-authorized test as mismatch repair-deficient or microsatellite instability-high, the release said.” 
  • Reuters relates,
    • “Haemonetics (HAE.N) said on Monday the US Food and Drug Administration ​approved its device designed to seal ‌arterial openings created during minimally invasive heart and vascular procedures.
    • “The device, PerQseal ⁠Elite, uses a fully absorbable ​patch that dissolves over time ​and does not leave a permanent implant in the body.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration has cleared the Twiist automated insulin delivery, or AID, system for use in adults with insulin-treated Type 2 diabetes. 
    • “Sequel Med Tech, which sells the device, disclosed the 510(k) clearance on Friday. The FDA granted the clearance to Deka Research and Development, Sequel’s partner on Twiist.
    • “The FDA cleared Twiist after researchers linked the AID system to reduced blood sugar and increased time in the target glycemic range in a clinical trial.”
  • Cardiovascular Business adds,
    • “Masimo, a California-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its smartSET pulse oximetry platform to identify signs of atrial fibrillation (AFib) and deliver alerts to its Radius Vital Signs Monitor. The newly cleared feature continuously evaluates a patient’s pulse waveform data, flagging clinicians when additional follow-up care may be necessary.
    • “When a patient deteriorates on a general care floor, respiratory compromise and cardiac arrhythmias often develop silently between routine rounds,” Basil Matta, BA, MB, BCh, BAO, Masimo chief medical officer, said in a statement. “By bringing AI-driven pattern recognition directly into the pulse oximetry workflow, smartSET helps clinicians see subtle physiological shifts earlier. It bridges the gap between spot checks, giving care teams actionable insight when minutes count.”
    • “For more than three decades, Masimo has expanded what clinicians can expect from pulse oximetry,” added Tim Benner,Masimo president. “With smartSET, we are bringing intelligent sensing and AI-enabled detection to the bedside—building on our signal-processing expertise to turn continuous monitoring data into meaningful clinical insight.”
  • and
    • “A new size-adjustable pulmonary valve approved by the U.S. Food and Drug Administration (FDA) could reduce the number of open-heart surgeries children with congenital heart disease need as they grow.
    • “Cardiovascular Business spoke to Emile Bacha, MD, chair of the department of surgery and surgeon-in-chief at NewYork-Presbyterian Hospital/Columbia University Medical Center, to learn more. Bacha, a lead investigator in the clinical trial that supported FDA clearance of the Edwards Lifesciences Autus size-adjustable pulmonary valve, said this device addresses the longstanding challenge of valves not being able to grow with pediatric patients into adulthood.
    • “This is indeed an important new advance in the field of treatment of pediatric heart disease,” Bacha, a past president of the American Association for Thoracic Surgery (AATS), explained. “When we replace a valve in a one-year-old they will grow, but the valve is not going to grow. As a consequence, we have to constantly reoperate on this child to upsize the valve. It’s very traumatic for the kids. And those are very big surgeries that involve sternotomy. So it’s not insignificant at all. Instead of having two, three, four or more surgeries, that child will have two, three or four catheterization procedures, which are much, much less invasive.”

From the Medicare Advantage front

  • KFF offers
    • [an explainer that] tackles such subjects as what changes Medicare beneficiaries can make during open enrollment; how Medigap and other forms of supplemental coverage factor into coverage decisions; how Medicare Advantage plans and Part D stand-alone prescription drug plans vary; and the tradeoffs involved when deciding whether to enroll in traditional Medicare versus Medicare Advantage. Get the details.
    • Additional analyses explore how the average Medicare beneficiary will have 28 Medicare Advantage prescription drug (MA_PD) plans available for general enrollment in 2027 (the number of plans varies widely across states), and how Medicare Advantage plan availability varies widely by county in 2027.
    • An analysis of the Part D stand-alone prescription drug plan (PDP) marketshows that there will be a modest reduction in the number of PDPs for 2027, along with modest premium increases less than $10 per month for many enrollees — but much larger monthly premium increases of $50 or more for others if they don’t switch plans.

No Surprises Act News

  • STAT News reports,
    • “Before it won a lucrative government contract, iMPROve Health’s very future was in question.   
    • “The Michigan-based nonprofit lost over $2 million in 2022 alone — over a third of its revenue — on top of losses in previous years. There were budget cuts; it ditched the office, went remote, and even discussed selling the company. 
    • “We had conversations about, ‘Should we merge and be an organization that someone acquires?’ We had those conversations,” said Richard Murdock, a former iMPROve board member.
    • “Three years later, iMPROve boasts a 70% profit margin, almost as high as that of tech giant Nvidia. Its revenue has grown 13-fold. The turnaround is thanks to the company’s new government-backed role: picking winners in high-stakes payment disputes between health care providers and health insurers.
    • “It’s not the only nonprofit making massive sums by acting as an arbitrator in the program, created under a 2020 law to protect patients from unexpected out-of-network bills. Two others, C2C Innovative Solutions and IPRO, are raking in cash as well. For every dollar the three nonprofits made last year, about half was pure profit.” 

From the judicial front,

  • Bloomberg Law reports,
    • “The Trump administration requested the US Supreme Court weigh in on its latest loss over regulation of surprise medical bills, asking whether courts can use the Administrative Procedure Act to universally vacate federal rules.
    • “A ruling in favor of the administration could potentially upend a sprawling web of litigation over federal regulation, including ramifications for lawsuits over rules governing the Affordable Care Act, Medicare, and Medicaid.
    • “The US Court of Appeals for the Fifth Circuit improperly used universal vacatur as a default remedy to overturn provisions of a rule calculating payment benchmarks in arbitration disputes for unexpected out-of-network bills, the administration argued in its petition for certiorari filed Wednesday.”
  • Fierce Healthcare relates,
    • “Healthcare AI startups OpenEvidence and Doximity settled a contentious legal fight over allegations of corporate espionage and cyberattacks, alongside counterclaims of defamation and misinformation.
    • “The two companies reached a settlement in principle on Thursday, leading to a dismissal of all claims and counterclaims with prejudice on Friday, according to court filings in the U.S. District Court in the District of Massachusetts. As part of the dismissal, the judge also ruled that each party would bear its own costs and attorneys’ fees.
    • “Legal representatives for both companies did not respond to requests for comment. The joint notice of settlement did not provide details on the agreement.”
  • Per a Justice Department news release,
    • “Somerset Lifesciences Inc. (Somerset) has agreed to pay $4 million to resolve common law claims for causing Medicare Part D (Medicare) to pay for its prescription-only (Rx-only) generic drug Olopatadine when it was no longer eligible for Medicare coverage. Medicare does not cover drugs that can be purchased by retail customers over-the-counter (OTC) without a prescription. In 2020, the brand name version of Olopatadine switched from Rx-only to OTC, and Somerset was required to change Olopatadine’s label from Rx-only to OTC as well. Instead, Somerset continued to label and sell Olopatadine as Rx-only and caused Medicare to wrongfully pay claims for an OTC drug.” * * *
    • “Except for the admissions contained in the settlement agreement, the claims resolved by the settlement are allegations only and there has been no determination of liability.“

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Regular exercise is an essential piece of the puzzle when trying to prevent or manage cardiovascular disease (CVD), according to a new scientific statement from the American College of Cardiology. The team behind the document recommends prescribing exercise to patients whenever appropriate, explaining even a little bit of movement can make a major impact.
    • “The most important message is that some activity is better than none,” Jonathan N. Myers, PhD, chair of the statement’s writing committee and a health research scientist with the Palo Alto VA Healthcare System, said in a statement. “Patients do not need to become athletes to improve their cardiovascular health. Small increases in physical activity can produce meaningful benefits, particularly for those who are currently inactive.”
    • “Myers et al. emphasized that poor cardiorespiratory fitness is a “powerful and independent predictor” of adverse health outcomes. In fact, the risks of poor cardiorespiratory fitness are comparable to what clinicians see with smoking, hypertension, diabetes and other well-known risk factors. 
    • “To this day, however, cardiologists and other cardiovascular care professionals often meet with patients without prescribing any kind of regular exercise routine.” 
  • The American Medical Association lets us know “what doctors want patients to know about food poisoning.”
    • “Food poisoning can cause vomiting, diarrhea and dehydration. Learn how to spot warning signs, recover safely, prevent illness and when to call your doctor.”
  • MedTech Dive shares the opinions of “5 doctors [who] weigh in on the promise, limitations of Grail’s multicancer test.”
    • “As the closely watched screening test moves closer to Food and Drug Administration approval, MedTech Dive asked cancer experts what encourages and concerns them most about Galleri.”
  • Beckers Hospital Review tells us,
    • “Patients taking GLP-1 medications had lower rates of major cardiovascular complications and infections after surgery than those not taking the drugs, according to a study of more than 2 million adults presented Oct. 18 at the American Society of Anesthesiologists’ Anesthesiology 2026 annual meeting in San Diego.”
  • and
    • “As healthcare leaders celebrate the FDA’s approval of daraxonrasib — a pancreatic cancer drug that nearly doubled survival in clinical trials — two harsh realities remain: most pancreatic cancer patients are still diagnosed at a late stage, and those treated with daraxonrasib will eventually develop resistance to it.
    • “Pancreatic cancer is the third-leading cause of cancer death in the U.S., representing 3.2% of new cancer cases but 8.4% of cancer deaths. Only 14.6% of pancreatic cancers are diagnosed before they spread to other parts of the body, according to SEER data. 
    • “To catch pancreatic cancer before it spreads, researchers are turning to AI.”
  • Healio informs us,
    • “In the years after becoming eligible for biologic therapy, 70% of adults with severe asthma achieved a lower yearly rate of exacerbations with just standard care, according to data published in CHEST.
    • ““In patients with severe asthma and frequent exacerbations, review their blood eosinophil counts from previous years,” Freda Yang, MBChB, MD, honorary clinical senior lecturer at the National Heart and Lung Institute, Imperial College London, and consultant respiratory physician at Royal Brompton Hospital, told Healio.
    • “Persistent eosinophilia suggests continued frequent exacerbations and a likely need for long-term biologics,” Yang said. “Patients without it may improve with standard care or need biologics for a shorter period. As an observational study, these findings need confirming in prospective trials.”
  • STAT News points out,
    • “An oral treatment from Gilead Sciences eliminated the symptoms experienced by patients with a type of inflammatory bowel disease, mid-stage study results reported Monday that could boost the biotech’s push to develop new drugs for inflammatory and autoimmune conditions. 
    • “A 200-milligram daily dose of the Gilead pill, called emvistegrast, taken for 12 weeks resulted in a 23% placebo-adjusted clinical remission rate for patients with moderate to severe ulcerative colitis, the Phase 2 study showed. The statistically significant improvement exceeded Wall Street analyst expectations.
    • “Emvistegrast has the potential to be a best-in-class oral for patients with ulcerative colitis,” Swati Tole, Gilead’s senior vice president overseeing clinical development of its inflammatory disease medicines, told STAT on Friday. “Patients with inflammatory bowel disease, while they have other therapies available, still have persistent symptoms. A majority do not achieve remission, so seeing these data was encouraging for us.” 
  • BioPharma Dive adds,
    • “A rare disease drug previously spurned by the Food and Drug Administration will get another shot at approval after positive Phase 3 results that sent shares of its developer, Disc Medicine, soaring by more than 35%. 
    • “Disc said Monday that the treatment, bitopertin, met all of its main and secondary objectives in a Phase 3 trial in erythropoietic porphyria, an uncommon disease causing hypersensitivity to light. The findings position Disc to resubmit an approval application to the Food and Drug Administration by the end of the year and possibly launch the therapy in 2027.” 

From the healthcare business front,

  • Beckers Hospital Review reports,
    • “Austin, Texas-based Ascension Seton has signed a definitive agreement to acquire a hospital and two urgent care centers in the north Austin area from Cedar Park, Texas-based Family Hospital Systems.  
    • “The deal includes Austin-based Family Hospital at Lake Travis, according to an Oct. 1 news release from Ascension Seton shared with Becker’s. The hospital provides 24/7 emergency care and inpatient care, according to Family Hospital Systems’ website. 
    • “The deal also includes Cedar Park-based Family Medical Center at Lakeline and Family Medical Center at Round Rock (Texas), which offer urgent care, primary care and on-site imaging, according to Family Hospital Systems’ website. 
    • “Ascension Seton, which is part of St. Louis-based Ascension, said the acquisition will give families in Austin’s outer metro area more access to emergency services. The health system said the move supports the market’s growth, patient care and long-term sustainability.”
  • and
    • “UnitedHealth Group’s count of subsidiaries and related entities has reached 2,807, according to the latest “Sunlight Report,” updated in October.
    • “The report comes from the Center for Health & Democracy and is funded by Arnold Ventures. The updated report identified more entities since the findings published in July 2025, factoring in 2024 year-end and 2025 Schedule Y state insurance filings, publicly confirmed 2026 transactions and U.S. Securities and Exchange Commission filings through the second quarter of 2026.” * * *
    • “UnitedHealth’s acquisitions have slowed since the original report’s data window. From early 2024 to the end of 2025, 368 entities joined and 268 left. The report documented two acquisitions in 2026: benefits administration platform Alegeus Technologies and six surgery centers through a Federal Trade Commission order.” 
  • Beckers Clinical Leadership relates,
    • “Nurse scientists are calling on hospitals, payers and credentialing bodies to overhaul how they measure nursing care, arguing that today’s metrics capture only a sliver of what nurses actually do.
    • “In a viewpoint published Oct. 19 in JAMA Internal Medicine, three nurse researchers — led by Lori Kennedy, PhD, RN, director of the Center for Nursing Science at Sacramento, Calif.-based UC Davis Health — proposed a set of nurse-sensitive outcome measures spanning nine domains of acute and critical care nursing practice, along with a framework to develop them.
    • “Their central critique: the nurse-sensitive metrics CMS relies on focus almost entirely on patient harm, including hospital-acquired infections, falls, pressure injuries and restraint use. Those measures matter, the authors wrote, but they “measure nursing by its absence.”
    • “When nursing value is expressed only as harm incurred, the economic case for nursing investment becomes purely defensive,” they wrote. Institutions tally the cost of each central line-associated bloodstream infection, they noted, but not the value of a nurse catching signs of sepsis before a patient becomes hypotensive and requires an ICU transfer.” * * *
    • “The proposed framework builds on the 2024 “Blueprint for Change in Acute and Critical Care Nursing,” a call to action from a national panel of nursing science leaders that included Dr. Kennedy.”
  • Beckers ASC Review tells us,
    • “Chicago-based Northwestern Medicine has opened a new outpatient center on the Northwestern Medicine Huntley (Ill.) Hospital campus. 
    • “The 80,000-square-foot facility will provide services including general surgery, cardiovascular, gastroenterology and pulmonary medicine, according to an Oct. 19 news release from Northwestern Medicine. 
    • “The expansion will add about 300 new jobs over the next three years.” 
  • Beckers Payer Issues informs us,
    • “Cigna Healthcare in the first quarter of 2027 will roll out Health Sense, a tailored customer and clinical support model that brings together health, benefits and cost information. 
    • “While the model will initially roll out for customers with oncology and cardiometabolic needs, Stanley Crittenden, MD, chief medical officer at Cigna Healthcare, told Becker’s that the team is just getting started.
    • “Don’t look at this as just a one-time product launch, but think about this as a more iterative process where we’re going to be adding more conditions,” he said.
    • “Cigna chose to roll out Health Sense to those with oncology and cardiometabolic conditions first because they often have complex and costly care journeys, Dr. Crittenden said. He did not share which conditions could be on the horizon next, but he said the team is considering other areas where patients have “the greatest needs and the highest complexity that would benefit from earlier intervention.” Dr. Crittenden said Cigna is currently focused on learning from the initial rollout and validating outcomes.”
  • and
    • “CVS Health named Maria Wilson, MD, as chief medical officer of Oak Street Health, the company’s value-based primary care centers for older adults. 
    • “Dr. Wilson has been with Oak Street Health since 2017, most recently serving as an executive medical director, according to her LinkedIn profile. 
    • “It’s a privilege to take on this role in a place where I’ve seen firsthand what our providers and care teams can do,” Dr. Wilson said in an Oct. 16 LinkedIn post. “Value-based care is about getting the right care to patients at the right time while supporting the provider care teams who deliver it, and I’m excited to help lead that work.”
  • The New York Time points out “professionals [who] may be the best kept secret in elder care.
    • “They can arrange a move to a senior living facility, deal with Medicare and Medicaid, recommend doctors, drive a client to the dentist, and much more.”
  • NBC News notes, “Many Women Are Still Struggling to Fill Estrogen Patch Prescriptions. What to Do If You Can’t Get Yours
    • “As demand for menopause treatment increases, estrogen patches are hard to find at pharmacies. Here’s what to do if you can’t refill your prescription.”
  • Per the Wall Street Journal,
    • “Roche Holding entered a licensing agreement with Hansoh Pharmaceutical Group that could net the Chinese drugmaker more than $15 billion.
    • “Hansoh will receive $400 million upfront and $110 million after a year, plus potential payments subject to targets and royalties on sales.
    • “The collaboration aims to advance a portfolio of antibody-drug conjugates, which are targeted cancer therapies, across multiple cancer types.”
  • and
    • “Germany’s Merck KGaA agreed to buy U.K. biotech company Silence Therapeutics for $1.3 billion.
    • “Merck is offering $20 in cash for each American depositary share of Silence Therapeutics, more than double its Friday closing price.
    • “The deal aims to strengthen Merck’s rare-disease pipeline by adding divesiran, an experimental drug ready for late-stage clinical trials.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • Radiology Business reports,
    • “A U.S. senator has introduced legislation that would slash $2 billion in imaging spending while also bolstering radiologist pay. 
    • “Sen. Roger Marshall, MD, R-Kan., recently proposed the Patients First Act of 2026 [(S. 5672)] in the upper chamber. A companion bill to a version introduced in the U.S. House in July, the legislation would tie physician reimbursement in the Medicare program to a measure of inflation. 
    • “The proposal also incorporates language from the Radiology Outpatient Ordering Transmission (ROOT) Act—which would revive the stalled imaging appropriate-use criteria program. If approved, it would require referring physicians to consult clinical decision support before ordering scans, hoping to root out unnecessary and wasteful imaging. 
    • The American College of Radiology—which supports the bill—estimates that the ROOT Act would reduce federal spending on medical imaging by about $2 billion over the next decade. In addition, it would save Medicare beneficiaries another $1.5 billion during the same timeframe. 
    • “The ROOT Act provisions would modernize implementation of Medicare’s Appropriate Use Criteria program for advanced diagnostic imaging,” ACR said in a news update touting its support for the bill on Oct. 15. “The Patients First Act also includes broader Medicare physician payment reforms, including annual payment updates tied to the Medicare Economic Index, changes to Medicare budget-neutrality policies and reforms to quality reporting requirements.”
  • The Government Accountability Office posted a report about private health insurance.
    • “Multiple companies may sell health insurance in a given market, but only a small number of these insurers will have the most enrollees, as we previously reported. Known as market concentration, this can leave enrollees with fewer choices of insurers and higher premiums because of less competition in the market.
    • “Market concentration generally increased from 2011 through 2024, with three or fewer insurers holding at least 80% market share for the individual and employer group markets in at least 36 states. However, concentration in the markets for individuals peaked in 2019 and has become slightly less concentrated since.”
  • The Wall Street Journal explains “How to Get All the Tax Benefits From Your Health-Savings Account.”
    • “An HSA can cushion the blow of medical expenses, but it’s also a tax-favored investment vehicle.” * * *
    • “In 2026, new provisions took effect that benefit individuals with ACA coverage. They enable HSAs to be paired with Bronze and Catastrophic plans, which have the highest deductibles.
    • “This change is good news for several groups. One is self-employed workers. Another is early retirees who use ACA coverage and aren’t yet eligible for Medicare. Still another is the fairly small group who opt only for the ACA’s catastrophic coverage.”

From the U.S. Office of Personnel Management front

  • Bloomberg Law reports,
    • “The Trump administration has removed a mandatory waiting period for internal federal promotions, allowing employees to rise faster through the ranks.
    • “A final rule published Friday by the Office of Personnel Management removes a requirement that new hires remain in their current jobs for a set period before becoming eligible for a promotion. Many were required to stay at a given grade for a year before moving up the pay scale, which Trump administration officials said reinforced backward priorities.
    • “To me, it’s an anti-merit principle,” OPM Director Scott Kupor said in an interview last week. “If you’re doing awesome and we hired you three months ago, and it turns out you’re performing at a level that’s the next grade level relative to where we hired you, we should not have an arbitrary thing that slows us down from promoting you.”

From the U.S. Food and Drug Administration front

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about safety concerns associated with certain delivery systems sold with the Sapien M3 transcatheter mitral valve replacement (TMVR) system from Edwards Lifesciences. The affected devices should not be used for patient care. Any delivery systems that are not part of this recall can still be used like normal.
    • “The FDA announced this early alert due to issues with the Commander M delivery system that clinicians use to implant the Sapien M3 TMVR system during a minimally invasive procedure. Edwards Lifesciences has received multiple reports of balloons bursting during inflation.
    • “Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath, which may require additional intervention, including surgery,” according to the FDA’s advisory. “Because this patient population is deemed unsuitable for surgery, these interventions carry a high risk of serious adverse health consequences including death.”
    • “One death and one serious injury have been linked to this issue so far.”
  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration approved a new nonprescription eye drop treatment, Brytly, apraclonidine ophthalmic solution, 0.125%, for relief of eye redness due to minor irritations. This is the first nonprescription eye drop with apraclonidine.
    • “Expanding access to safe and effective nonprescription treatments is a priority for FDA,” said Mike Davis, M.D., Ph.D., Director of the FDA Center for Drug Evaluation and Research (CDER). “Today’s approval of Brytly gives consumers a new nonprescription option to manage eye redness conveniently and without needing to see a healthcare provider.”
  • The AP relates,
    • “U.S. health officials are moving ahead with a plan to allow specialty pharmacies to produce certain peptides, a class of largely unregulated injections that have become popular among followers of Health Secretary Robert F. Kennedy Jr. and other wellness influencers.
    • “Kennedy’s Department of Health and Human Services submitted a peptides “interim access policy” to the White House for review, according to a posting Thursday on a government website. The plan was sent to the Office of Management and Budget, which reviews federal rules and regulations with the potential for significant economic impact.
    • “HHS officials did not immediately respond to requests for comment Thursday afternoon.
    • “Peptides are the building blocks of more complex proteins, triggering hormones inside the body needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss.”

From the Medicare Advantage front,

  • Fierce Healthcare reports,
    • “CareCycle, a voice AI company serving Medicare agencies, has launched a free tool that helps Medicare beneficiaries compare plans.
    • “The tool, Match Your Medicare, coincides with Medicare’s Open Enrollment period and is set to be available indefinitely. It is free to use, takes no payments from payers or commissions and does not sell or share personal information. 
    • Based on information provided by users, the tool surfaces yearly cost estimates, including premiums, copays and drugs. It also shows what plans in a user’s area keep their docs in-network. Users can compare up to three plans side by side.
    • “MatchYourMedicare.com requires no account and makes no sales calls. Users only need to enter a ZIP code, date of birth and gender. They can also optionally submit their doctors’ prescriptions and health conditions. Additionally, the tool features a video guide that walks users through each step and can help them fill in forms by voice as users speak.”

From the fraud, waste and abuse front

  • Beckers Hospital Review reports,
    • “A top CMS official wants provider suspensions to quadruple in the next six months as part of a broader anti-fraud push that includes new exclusion authority and AI tools, Nextgov/FCW reported Oct. 15.
    • “CMS Deputy Administrator Kimberly Brandt discussed the agency’s enforcement efforts Oct. 15 at the ADAPT conference in Santa Fe, N.M. Ms. Brandt’s slideshow credited the anti-fraud effort with $41.9 billion in fiscal year 2025 savings, up 59% from the year before.
    • “My hope is that suspension number will quadruple over the course of the next six months,” Ms. Brandt said, according to Nextgov/FCW.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country.
    • “COVID-19 activity remains elevated in some regions but is declining nationally.
    • “Seasonal flu activity is increasing in many parts of the country but remains low.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated nationally.”
  • ABC News reports,
    • “More than 4,400 measles cases have been reported in the U.S., according to an update on Friday from the Centers for Disease Control and Prevention (CDC).
    • “A total of 4,410 cases have been confirmed, with most reported by 45 states and Washington, D.C. Eighteen of this year’s total have been among international visitors to the U.S., according to the CDC.
    • “At least 1,200 of those cases have been reported in Pennsylvania alone by local health officials, as have six measles-related deaths.
    • “It comes as the CDC is planning to send a “disease detective” to Pennsylvania in response to the outbreak.” 
  • STAT News adds,
    • “About 40% of high school students reported binge eating in the past month in a large new government survey, putting a spotlight on how widespread this common form of disordered eating is among young people in the U.S. 
    • “This is the first time the biennial survey, conducted by the Centers for Disease Control and Prevention, has asked about binge eating, and the first data on disordered eating collected by the Youth Risk Behavior Survey in a decade. Among its other striking findings: 17% of nearly 7,000 students said they had engaged in binge eating within the last three days.  “It was extremely alarming seeing how high those numbers were,” said Ariel Beccia, a researcher in the adolescent and children’s medicine division of Boston Children’s Hospital.
    • “Binge eating was more prevalent among female than male students (19% versus 16%). It was also more common among Black (19%), Hispanic (20%), and multiracial (20%) students compared to white (15%) and Middle Eastern or North African students (10%).
    • “The finding that young people of color are largely more likely to report binge eating is important because it counters longstanding stereotypes that eating disorders and disordered eating primarily affect white girls and young women, said Beccia.”  
  • USA Today relates,
    • “Research has shown ultra-processed foods may be the culprit behind rising colon cancer rates − but a new study suggests the type makes a difference.
    • “In the study, published in the journal PLOS Medicine on Oct. 15, researchers found no association between overall ultra-processed food intake and colorectal cancer incidence. Findings differed, however, by type of food.
    • “Higher intake of whole grain and dairy products from ultra-processed food sources was associated with lower colorectal cancer incidence, whereas processed meat from ultra-processed food sources was associated with higher risk, according to the study.
    • “Our findings support current dietary guidance to consume whole grains, fiber, dairy and calcium and avoid processed meat for (colorectal cancer) prevention,” the authors wrote.”
  • Healio adds,
    • “Lower ultra-processed food consumption was associated with reductions in anxiety and depression. 
    • “The crossover pilot trial showed the intervention was feasible and can be expanded in future clinical trials.” 
  • The New York Times tells us,
    • “Doctors are growing increasingly concerned that weight-loss drugs are driving new cases of anorexia, and that few safeguards are in place to protect patients with eating disorders.
    • “Tens of millions of patients now take these medications, which can sometimes cause symptoms that mirror the effects of anorexia: hair loss, dizziness, gastrointestinal issues, extreme calorie deficits.
    • “At that point, it’s like, is that anorexia? Is that disordered eating? Or is that just a side effect of the medication?” said Dr. Katherine Kiley, a family and sports medicine physician in Long Beach, Calif.
    • “Citing an “urgent need” for guidance, an international coalition of obesity medicine specialists, eating disorder clinicians and other experts released new recommendations last month on GLP-1 prescribing and eating disorders. Among their ideas for physicians: Screen all patients for signs of eating disorders before starting a GLP-1, and routinely monitor anyone on the drugs for them.” * * *
    • “Further complicating matters is that many people get the drugs through telehealth services, with little to no oversight from a physician. In a recent study, researchers who tried purchasing weight-loss drugs from 49 websites found that only about one-third required direct interaction with a clinician before prescribing the medications, and only around half asked about eating disorders.”
  • MedScape informs us,
    • “Patients with non-erosive reflux disease (NERD) who took once-daily tegoprazan — a novel, fast-acting, oral potassium-competitive acid blocker (P-CAB) — had a significant reduction in heartburn frequency, a phase III trial showed.
    • “Among patients randomized to placebo or tegoprazan 50 mg or 100 mg, mean percentages of 24‑hour heartburn‑free days through week 4 were 17.3%, 26.2%, and 30.1%, respectively, translating into relative improvements of 51% (P=0.0006) and 74% (P<0.0001) with tegoprazan over placebo, reported Ronnie Fass, MD, of Case Western Reserve University School of Medicine in Cleveland.
    • “Key secondary endpoints of percentages of days without daytime and nighttime heartburn were also significantly improved with tegoprazan, he said at the American College of Gastroenterologyopens in a new tab or window annual meeting in Nashville, Tennessee.”

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

  • Healthcare Dive reports,
    • “The time to start planning for your company’s 2028 health benefits? January of 2027.
    • “That’s according to Marybeth Gray, senior VP of health and welfare benefits consulting with Marsh McLennan Agency. Speaking to a crowd of finance leaders at the CFO Leadership Council’s fall conference in Colorado this week, Gray urged attendees to start thinking about health benefits as soon as feasibly possible.
    • “What might have long been considered strictly an HR issue, Gray said, has firmly become a finance issue.
    • “We need to get on solid footing,” she said, citing data from the Business Group on Health showing that healthcare costs have ticked up as much as 76% over the last decade.”
  • Fierce Pharma relates,
    • “The previous week was rather uneventful for the two oral GLP-1 drugs as Americans geared up for another national holiday, Columbus Day.
    • “Total prescriptions for Novo’s Wegovy pill dipped about 3% sequentially to approximately 173.5K last week. Again, the script number was the result of a compromise between Citi’s reported 173K and Jefferies’ 174K, both referencing IQVIA.
    • “Meanwhile, Lilly’s Foundayo scripts ticked up about 4% to 60,151, still shy of the small molecule’s previous record of 64,268.
    • “In the broader obesity market, Lilly’s Zepbound remained the leader with about 801.8K total scripts, relatively flat week over week. All Wegovy scripts across its injectable and oral forms trended 2.5% downward and landed at about 492.6K, according to Citi.”
  • Beckers Clinical Leadership tells us,
    • “Academic health systems are opening their own longevity medicine programs amid growing demand for preventive care, The New York Times reported Oct. 16.
    • “Since last fall, Los Angeles-based Cedars-Sinai, Chicago-based Northwestern Medicine and New York City-based Weill Cornell Medicine have launched programs aimed at extending health span, or the years a person lives without chronic disease or disability. New York City-based Mount Sinai Health System also expects to open its program this month.
    • “The academic systems’ research entities are playing important roles in shaping these programs. For example, Northwestern’s clinic draws partly on the university’s Potocsnak Longevity Institute, which is studying biomarkers of aging. 
    • “The systems are betting that their research ties will set them apart from the hundreds of private U.S. longevity clinics. Some of those clinics charge thousands to tens of thousands of dollars a year, and many offer screenings and therapies that are not yet proven effective.
    • “The field is still developing, and health systems are drawing different lines on clinical evidence. Northwestern does not offer whole-body MRI, citing a lack of evidence that it lengthens life span, nor does it offer genome sequencing. Meanwhile, Mount Sinai will offer both after patients review the risks and benefits with their physician.”
  • Radiology Business informs us,
    • “Breast imaging startup BeSound is launching its flagship clinic location with plans to eventually scale nationally. 
    • “The company officially opened its newest imaging center in Manhattan on Thursday. Founded in 2023, BeSound offers scanner technology that combines ultrasound with FDA-approved, near-infrared photo-acoustic imaging. It’s focused on targeting the more than 40% of women with dense breasts, whose cancer cases may be missed by traditional mammography.
    • “BeSound is now accepting appointments at its Flatiron District location, with no referral required. The company charges $349 per exam and promises screening results in 48 hours, with pain-free imaging that avoid compression, radiation and contrast dye. 
    • “BeSound said its scans also use proprietary artificial intelligence “designed to help physicians read scans faster, surface findings earlier, and track how a woman’s breast tissue changes over time.”
  • MedTech Dive points out,
    • “MiniMed completed its separation from Medtronic, the companies said Thursday.
    • “The diabetes technology firm, which went public in March, is now independent from its former parent. 
    • “Medtronic began an exchange offer last month to split off a portion of its MiniMed shares. The agreement included a provision where Medtronic could choose to sell all of its remaining shares in MiniMed if the offer is oversubscribed.
    • “Because the offer was 5.4x subscribed, Medtronic chose to exchange all of its remaining interest in MiniMed for shares of Medtronic, the company said Thursday. It no longer holds a stake in MiniMed.”
    • “As an independent company, we have the freedom to make the decisions we believe are right for our business and the people we serve, and the responsibility to see those decisions through,” MiniMed CEO Que Dallara said in a statement. “Our focus now is to put that independence to work and continue advancing what is possible in diabetes care.” 
       
  • Beckers Health IT lets us know about Anthropic’s eight big healthcare moves.

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • “The Department of Justice has a warning for health care executives: Don’t be another Theranos. 
    • “As the Trump administration continues its fight against Medicare and Medicaid fraud, it is also expanding its investigations into corporate wrongdoing, DOJ officials announced this month.”
    • “A key part of that plan is making it easier for companies themselves to report potential criminal activity, and encouraging whistleblowing, Jacob Foster, deputy assistant attorney general in the National Fraud Enforcement division, said Thursday at the STAT Summit in Boston. Foster oversees the unit that investigates health care fraud.” * * *
    • “Going forward, companies in the health care sector looking to file voluntary self-disclosures will find a one-stop shop at the DOJ, Foster said. They previously would’ve had to navigate a separate process at the Department of Health and Human Services, but that is now being consolidated under the health care fraud section at the DOJ. 
    • “Under the new policy, companies that report potential criminal misconduct can reap the benefits — such as a limited cap on financial damages — from both agencies at once. 
    • :The health care fraud section at the DOJ brings a range of expertise under one roof to handle issues like the emerging field of digital health technology, Foster said. DOJ will make use of data analytics and artificial intelligence algorithms to try and suss out instances of corporate wrongdoing, like providers billing for unneeded services, companies fabricating patient records, or health tech companies adding redundant diagnoses. 
    • “The department will also design new programs that “appropriately incentivize” whistleblowers to report fraud, according to an Oct. 1 memo from Assistant Attorney General Colin M. McDonald. Health care investigators also look at social media, news reports, and other sources of information to learn about companies possibly breaking the law, Foster said.” 
       
  • This new Justice Department policy “making it easier for companies themselves to report potential criminal activity, and encouraging whistleblowing” is available here.
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention issued a reminder Oct. 14 that the declaration supporting the emergency use of COVID-19 in vitro diagnostics tests will end Dec. 26. The December end date marks the end of a 180-day transition period from the end of the COVID-19 emergency use authorization declarations announced June 30. The EUA declarations were issued in 2020 to accelerate access to medical products during the COVID-19 pandemic.”

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

  • Federal News Network reports,
    • “The Office of Personnel Management and the White House Task Force to Eliminate Fraud are partnering to hire the next cohort of the US Tech Force. The two-year program will place applicants across agencies, including the General Services Administration, the Social Security Administration, the Office of Personnel Management, the Department of Health and Human Services, the State and Treasury departments. Vice President JD Vance says the partnership will help the government identify fraud, waste and abuse and reduce reliance on foreign technological advancements. Tech Force positions are open to the public and federal employees through career transition and reinstatement programs. The job announcement closes October 23.”
  • FedSmith offers an approach that allows federal and postal employees and annuitants to compare health coverage without getting overwhelmed.
  • Tammy Flanagan, writing in Govexec, explains that “Federal retirees face more than a COLA change in 2027.”
    • “From Medicare premiums and Social Security earnings limits to a federal pay freeze, several changes could affect retirees’ finances and the benefits available to them next year.”

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

  • The AP reports,
    • “For the first time in more than a quarter-century, Americans have a new option when shopping for sunscreen: a skin-protecting chemical that’s long been a go-to option in Europe and other parts of the world.
    • “The U.S. Food and Drug Administration approved bemotrizinol — sometimes called BEMT — in June. The first sunscreens containing it are now hitting U.S. store shelves, including formulas from Neutrogena and other manufacturers.
    • “Dermatologists say the chemical fills an important market gap by offering broad protection, like the most well-established sunscreen ingredients, but without their cosmetic downsides, including white streaking.”
  • Fierce Pharma tells us,
    • “U.S.-based generic drugmaker Par Health has issued a voluntary recall of 22 lots of the direct thrombin inhibitor argatroban for IV injection that could be contaminated with cellulose, polystyrene, polyethylene terephthalate, stopper material, and potentially even stainless steel.
    • “The recall, which was published to the FDA’s website on Oct. 14th, is Par’s third in a matter of weeks.”
  • Targeted Oncology relates,
    • “The FDA will review FYB206, an investigational biosimilar candidate referencing pembrolizumab (Keytruda), after accepting its biologics license application (BLA), marking the first publicly announced acceptance of a filing for a pembrolizumab biosimilar, according to a news release from Zydus Lifesciences and Formycon.1
    • “The application was sent to the FDA in the third quarter of 2026. The Biosimilar User Fee Amendments (BsUFA) set a 12-month goal from submission to completed review, made up of a filing review lasting as long as 60 days followed by a 10-month substantive review. On that schedule, a regulatory decision could come in the third quarter of 2027, and a regulatory dossier has also been filed with Health Canada, according to the companies.”

From the Medicare Advantage front,

  • Beckers Hospital Review reports,
    • “Kaiser Permanente led the 2027 U.S. News & World Report ratings for the “best overall” Medicare Advantage companies.
    • “The ratings, published Oct. 14, are based on a five-point scale, assigning weights to more than 30 CMS quality measures. After calculating contract ratings, U.S. News determined enrollment-adjusted average ratings for carriers. U.S. News considered MA companies among the “best” if they had an overall rating of at least 3.8 once rounded and served at least 1,000 beneficiaries in December 2025 in each of 10 or more states or territories where they still offer 2027 coverage.
    • “These ratings looked at standalone MA contracts, as well as ones that also cover Part D. For the publication’s Medicare Part D ratings, the same two companies secured the “best overall” recognition in 2026 and 2027. In 2027, Humana scored 3.8, and Centene scored 3.5. To qualify as a top Part D company, insurers needed to have served at least 1,000 Part D beneficiaries in each of at least 10 jurisdictions where they still offer coverage for 2027. The threshold was an enrollment-weighted average rating of at least 3.5 after rounding.”

From the Affordable Care Act marketplace front,

  • Beckers Payer Issues relates,
    • “CMS has reinstated a small number of enrollees who lost coverage after the agency canceled ACA policies for more than 760,000 people, according to a KFF Health News report published Oct. 15 in NPR.
    • “KFF Health News learned of the reinstatements through insurance industry sources, finding that not all of those who lost coverage were fraudulently enrolled. 
    • “On Aug. 31, CMS canceled 315,000 policies for 2026 that covered more than 760,000 individuals. These enrollees signed up with agent or broker assistance but lacked citizenship or immigration documentation, and issuers were unable to find claims or did not have records of contact, according to a September rulemaking document. CMS told Becker’s on Oct. 15 that another criterion was whether premiums were fully covered by advance payments of the premium tax credit. CMS expected that these cuts would lead to a return of roughly $2.2 billion in subsidies.”

No Surprises Act News

  • Beckers Payer Issues relates,
    • “Arbitration awards under the No Surprises Act can reach nearly 6% of total commercial medical spend in some regions, UnitedHealthcare CEO Tim Noel said during an Oct. 13 earnings call. 
    • “The medical cost trend for UnitedHealthcare’s commercial business is “exceeding” an initial expectation of 11%, Mr. Noel said. While Mr. Noel pointed to clinician cost intensity and expensive specialty drugs as part of that, he also said there has been “an acceleration of costs related to the No Surprises Act.” He cited “ongoing abuse” driven by “a relatively small number of clinician groups and third-party organizations.”
    • “Mr. Noel said this translates to billions of dollars in additional costs that hit consumers and employers.” 

From the judicial front,

  • Per a Justice Department news release,
    • “A Kansas CEO and owner of an internet platform was sentenced yesterday to 19 years in prison for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.
    • “The Department of Justice and our agency partners dismantled one of the largest telemedicine fraud schemes ever, and yesterday’s lengthy prison sentence holds the orchestrator of that scheme accountable,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “The defendant’s fraud scheme lured hundreds of thousands of elderly and disabled Americans into a sophisticated international telemarketing system with one goal: stealing as much as possible from the Medicare trust fund. The Fraud Division will continue to leverage its resources to take down complex fraud operations like Blackman’s DMERx.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Pediatric infectious disease specialists in Pennsylvania, home to the nation’s largest measles outbreak in more than three decades, are treating an influx of children with severe complications from a virus many physicians have little experience with, NBC News reported Oct. 14.
    • “Patrick Gavigan, MD, a pediatric infectious disease physician at Penn State Health Golisano Children’s Hospital in Hershey, said he expected measles to behave like COVID-19 in children, mainly manifesting as respiratory illness and hitting those with underlying conditions hardest. Instead, the virus is causing serious complications beyond the lungs in many previously healthy children, including in the gut, liver and brain, according to the report.
    • For example, some children are developing encephalitis, or brain inflammation, in response to the virus, according to Dr. Gavigan.
    • “They go from walking and talking one day to the next having significant neurologic dysfunction,” he told NBC News. Dr. Gavigan added that these patients recover slowly and often aren’t back to normal by the time they leave the hospital.”
  • and
    • “New dementia cases worldwide are projected to more than double by 2050, from an estimated 11.4 million in 2023 to 24.7 million, according to a meta-analysis published Oct. 12 in JAMA Neurology.
    • “Researchers led by the University of New South Wales in Sydney analyzed participant-level data from 22 population-based cohorts. The cohorts included 38,418 adults aged 60 and older without dementia at baseline, across 18 countries and territories on six continents. Approximately 3,001 participants developed dementia as of 2021. 
    • “The projection assumes age- and sex-specific dementia rates stay constant. That means the growth reflects an aging global population, not an increase in individual risk.”
  • MedScape relates,
    • “The combination of a low-calorie diet with a supervised exercise regimen induced nonpharmacologic remission of early-onset type 2 diabetes (T2D) in more than half of participants in a new study, with low drop-out rates and preservation of lean mass.
    • “The take-home message is that in early-onset type 2 diabetes, people should ideally have a potent nondrug option to tackle [the disease],” first author Kaberi Dasgupta, MD, a professor of medicine and director of the Division of General Internal Medicine at McGill University in Montréal, Quebec, Canada, told Medscape Medical News.
    • “In addition to inducing diabetes remission, the diet/supervised exercise intervention “shifts weight loss where we want it to be — from the fat compartment — and also increased muscle health, strength, and fitness, improving mood, lowering distress related to diabetes, and enhancing quality of life,” she said.”
  • MedPage Today tells us,
    • “Continuous glucose monitors (CGMs) are recommended for patients with type 1 diabetes and insulin-treated type 2 diabetes, but evidence has been limited in those with non-insulin-treated type 2 diabetes.
    • “Compared with routine care, adults with non-insulin-treated type 2 diabetes using CGMs had a significantly lower HbA1c level and more time spent in the target glucose range in a 26-week trial.
    • “Adherence to the device was high, and no cases of severe hypoglycemia or hyperglycemia-related serious adverse events were observed.”
  • The Washington Post informs us,
    • “About 12 percent of new cancer cases worldwide in 2024 were caused by infectious agents such as viruses and bacteria, according to a recent study by the International Agency for Research on Cancer.
    • “That means a sizable share of the cancer burden around the world is preventable with tools we already have, including vaccines and other preventative measures, researchers said.
    • “We have very actionable targets,” said Gary Clifford, a cancer epidemiologist and one of the authors of the study that published in the Lancet Oncology. “We have very many tools against these viruses already.” * * *
    • “Existing measures like condoms, vaccines for HPV and cervical cancer screening can prevent infection and cancers associated with infectious diseases, experts said.”
  • and
    • “A woman’s ovaries bring center-stage energy for decades of her life: governing fertility and interacting with organs from the brain to the heart, from the skeleton to the immune system. Because of that, they have attracted scads of scientific research.
    • “But after menopause, around age 50, the spotlight on the ovary has historically gone dark. A study published Wednesday in the journal Aging Cell shows that an ovary continues to play an important role even in its retirement years, with functions that do not diminish and may still affect the rest of the body.
    • “Above all, the study underscores why the postmenopausal ovary is worthy of attention.
    • “Women are living three [more] decades with this organ in their body, and we have no idea what it’s doing,” Francesca Duncan, an associate professor of obstetrics and gynecology at Northwestern University said. “We really owe it to half our population to understand what’s happening.”
  • Contemporary OB/GYN adds,
    • “The American College of Obstetricians and Gynecologists (ACOG) has issued its most comprehensive guidance to date on managing menopause, with a new clinical practice guideline covering menopausal hormone therapy (MHT), nonhormonal medications, and nonpharmacologic treatment of vasomotor symptoms (VMS), sleep disturbance, and mood symptoms. Clinical Practice Guideline No. 13, published online October 15, 2026, in Obstetrics & Gynecology, replaces Practice Bulletin No. 141 from January 2014.
    • “According to the guidance, 50% to 92% of women in menopause report VMS, 16% to 66% of women in the United States report menopause-related sleep disruption, and more than one-third of perimenopausal and postmenopausal women worldwide report depressive symptoms. ACOG is also developing companion guidance on genitourinary syndrome of menopause, expected in 2027.” * * *
    • “View the complete and full guidance via Obstetrics & Gynecology, here.”
      .
  • Beckers Hospital Review notes,
    • “An Oct. 13 analysis from the Health Transformation Alliance examined linked claims and EHR data for 12.7 million patients from 2018 through 2025 to identify who is most and least likely to respond to GLP-1 therapy.”
  • Beckers Behavioral Health points out,
    • “Adults with schizophrenia and Type 2 diabetes who started a glucagon-like peptide-1 receptor agonist were less likely to be hospitalized or seen in the emergency department for psychiatric reasons than peers who started a dipeptidyl peptidase-4 inhibitor, a sodium-glucose cotransporter-2 inhibitor or none of the three drug classes, according to a study published in The Lancet Psychiatry.
    • “The results point to a possible psychiatric upside to GLP-1 therapy beyond blood sugar and weight control, though the study’s observational design means it cannot show the drugs caused the lower risk.”
  • and
    • “The rate of opioid use disorder diagnoses among commercially insured patients rose 32.7% nationwide between 2022 and 2025, FAIR Health found in its latest analysis of commercial health claims.
    • “The national rate reached 596 patients with an opioid use disorder diagnosis per 100,000 commercially insured patients receiving medical services in 2025, up from 449 in 2022. The findings were published as part of FAIR Health’s annual Opioid Tracker update, according to an Oct. 14 news release from the organization.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of two new treatments: nomlabofusp (Larimar Therapeutics, Inc.) and omaveloxolone (Skyclarys®, Biogen Inc.) for Friedreich’s Ataxia, a rare, genetic disorder. 
    • “Downloads: Draft Evidence Report | Draft Voting Questions
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

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

  • The Wall Street Journal reports,
    • “Pharmaceutical companies are investing billions of dollars into protein degraders, a new class of drugs designed to target disease-driving proteins.
    • “These drugs work by using a cell’s recycling system to destroy smooth proteins that traditional medicines can’t easily latch on to.
    • “While the FDA has approved a handful of these drugs, scientists are still working to ensure they don’t accidentally destroy healthy proteins.”
  • and
    • “AstraZeneca is partnering with Insitro to use artificial intelligence to find new treatments for cardiometabolic diseases.
    • “AstraZeneca will pay Insitro $40 million upfront and up to $1.46 billion if development and commercial targets are met.
    • “Insitro will use its AI platform to identify disease causes, while AstraZeneca will lead clinical development and commercialization.”
  • Beckers Health IT relates,
    • “Epic is working with Amazon Pharmacy, Mark Cuban Cost Plus Drugs and other pharmacy companies to develop a tool that will allow clinicians and patients to compare prescription drug prices directly within its EHR system.
    • “The new feature, called Prescription Marketplace, will allow clinicians and patients at health systems using Epic to compare medication prices across pharmacies before a prescription is sent, according to an Oct. 15 news release from the EHR vendor.
    • “The tool will display pharmacies’ cash prices alongside what patients would pay through their insurance plans, allowing them to determine whether paying cash could be less expensive.
    • “Amazon Pharmacy has worked with Epic since early 2025 to help develop the feature. Mark Cuban Cost Plus Drugs is also working with the company on its development, and executives from Costco and Eli Lilly’s LillyDirect voiced support for the tool in the release.”
  • Cardiovascular Business informs us,
    • “U.S. healthcare payment policies are accelerating physician consolidation and driving up the cost of care, according to Rick Snyder, MD, president of HeartPlace and chief physician executive at U.S. Heart and Vascular. He is also the vice president of the American Independent Medical Practice Association (AIMPA) and a former president of the Texas Medical Association. In addition, Snyder has held policy-focused positions with the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.
    • “In his role with AIMPA, he testified before Congress during this year’s House Energy and Commerce Committee hearings focused on healthcare affordability. He argued that the nation’s healthcare system spends more than any other country of healthcare, but has lower life expectance and poorer outcomes than other Western nations. According to Snyder, this is not due to a lack of spending, but a lack of cost efficiency.” 
  • MedTech Dive points out,
    • “Labcorp has agreed to buy certain laboratory testing businesses from Opko Health subsidiary BioReference Health for $722 million, plus an additional sum of up to $150 million tied to revenue from a prostate cancer blood test. The final purchase price could be adjusted based on closing revenues, the companies said Thursday.
    • “Labcorp is acquiring businesses focused on clinical and women’s health testing services, urology and diagnostic services provided to correctional institutions. The deal also adds more than 80 patient service centers to Labcorp’s network.
    • “In addition, the lab services provider is gaining BioReference Health’s 4Kscore test, which has Food and Drug Administration approval to help predict the likelihood of finding aggressive prostate cancer before a biopsy decision.”
  • and
    • “Zimmer Biomet said Tuesday it has inked a multi-year extension to its exclusive distribution agreement with Think Surgical.
    • “The deal, which extends an agreement signed in 2024, positions Zimmer to continue distributing an exclusive version of Think’s TMINI wireless handheld miniature robotic system. 
    • “Zimmer’s exclusive version of TMINI is compatible with its Persona knee system, a personalized product used in total knee replacements.”
  • Per Fierce Healthcare,
    • “The Elevance Health Foundation has launched a new prize program aimed at supporting solutions aimed at improving patient safety, with the first crop of winners targeting challenges like health literacy, fall prevention and medication errors.
    • “Elevance will dispense $4 million in prizes to four organizations through the first round of the program. The goal is to identify scalable, community-based solutions to tackle critical patient safety risks. The Patient Safety Prize falls under the foundation’s Community Action Leadership umbrella, and the team saw an opportunity to move beyond its core focus areas with these programs.
    • “The winners include: Care Synergy’s CAPABLE, or Community Aging in Place—Advancing Better Living for Elders, program; NYU Grossman School of Medicine; the Public Health Institute’s Population Health Innovation Lab; and the Parkland Center for Clinical Evaluation.”
  • Per Beckers Health IT,
    • “OpenEvidence drew 271 million queries from 952,008 U.S. clinicians between January 2024 and June 2026, according to a study published Oct. 15 in JAMA.
    • “Researchers from Somerville, Mass.-based Mass General Brigham and Boston-based Harvard Medical School analyzed query logs from OpenEvidence users with verified National Provider Identifiers. Vishal Patel, MD, and Samuel Finlayson, MD, PhD, contributed equally as lead authors, and Anupam Jena, MD, PhD, oversaw the study.
    • “Dr. Finlayson and two other co-authors, including OpenEvidence’s chief medical officer, were OpenEvidence employees during the study. The company provided the data and contributed to the analysis.
    • “Monthly active users grew from 355 in January 2024 to 703,265 in June 2026. Average monthly queries per active user rose from 18 to 39.5, and month-over-month retention climbed from about 70% to 90%.
    • “Physicians accounted for 556,200 users. Nurse practitioners and physician assistants used the platform most intensively, at 44.5 queries per active user-month, compared with 37.1 for physicians. Physicians within a decade of medical school graduation made up 24.3% of the physician workforce but submitted 61.8% of physician queries.”

Midweek report

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

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • “The Trump administration is delaying by 90 days a federal rule that could prevent Americans from obtaining prescription drugs from licensed international pharmacies.
    • “The move follows growing criticism that the rule, which was initially slated to go into effect on Oct. 22, could drastically reduce the flow of medicines from Canada and other countries. In recent weeks, patient advocacy groups and dozens of congressional lawmakers urged the administration to rethink its approach.” * * *
    • “This gives the FDA time to work with CBP to ensure a pathway for patients to continue importing more affordable prescription drugs for personal use when the rule is implement, based on identifiable safety criteria,” said Gabriel Levitt, who heads Prescription Justice, an advocacy group. “That’s what members of Congress have called for and that’s what the law says FDA should do.”
  • Per Department of Health and Human Services news releases,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. yesterday determined that public health emergencies exist in Florida and Alabama as a result of Hurricane Isaias. The determinations follow President Trump’s October 9 emergency declarations for both states (Florida, Alabama).
    • “The President’s declarations and the Secretary’s determination allow HHS to authorize temporary waivers and modifications of certain requirements. These flexibilities help the Centers for Medicare & Medicaid Services (CMS) support healthcare providers and suppliers serving people enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) in the covered emergency areas.” * * *
    • “Prior to landfall, ASPR pre-positioned regional staff in areas at risk from the storm to monitor the impacts on public health and healthcare systems and provide technical assistance in anticipation of state requests. Healthcare System Assessment Teams also deployed to evaluate the storm’s impact on healthcare facilities.
    • “In addition, ASPR shared HHS emPOWER datasets with states in the storm’s path. These data can help responders identify, by geographic area, the number of Medicare beneficiaries relying on electricity-dependent medical equipment or certain essential healthcare services, including facility-based dialysis and home healthcare.”
    • In declaring the public health emergency and authorizing flexibilities for CMS providers, suppliers, and beneficiaries, Secretary Kennedy acted within his authority under the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to October 6, 2026, in the state of Florida and October 7, 2026, in the state of Alabama.
  • and
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., joined by Health Resources and Services Administration (HRSA) Administrator Tom Engels, today launched the HHS Health Center Healthy Lifestyle Commitment, a voluntary initiative that encourages health centers nationwide to put nutrition, prevention, and healthy living at the center of patient care.
    • “Secretary Kennedy announced the initiative during a visit to Piedmont Access to Health Services (PATHS) health center in Chatham, Virginia, where he highlighted the role health centers play in preventing chronic disease and helping patients build healthier lives.”
  • PBS News tells us,
    • “Social Security checks will increase by roughly $76 per month for the average retired worker in 2027, the federal government announced Wednesday.
    • “The payment jump is due to the Social Security Administration’s annual COLA, or cost-of-living adjustment, which has been determined each fall for decades. Next year’s increase is 3.6%, based on inflation data, amounting to a little more than $900 next year.”
  • Govexec adds,
    • Because “[t]he Social Security Administration announced Wednesday that Social Security beneficiaries will receive a 3.6% cost-of-living adjustment next year, Federal retirees in the Civil Service Retirement System will therefore receive a 3.6% increase to their annuities next year, but former feds who are part of the Federal Employees Retirement System, launched in the 1980s alongside 401(k)-style Thrift Savings Plan, will see only a 2.6% adjustment.
    • “That’s because FERS’ annual cost-of-living adjustment is based on an extrapolation of the CSRS and Social Security increase. Each year, if CSRS sees an increase of less than 2%, FERS retirees receives the full COLA. But if the figure falls between 2% and 3%, FERS participants receive only a 2% increase, while if the COLA is 3% or more, like this year, FERS enrollees receive that adjustment, minus 1 percentage point.”

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

  • OPM posted in the Federal Register a direct final rule amending OPM’s Family and Medical Leave Act (FMLA) regulations in subpart L of part 630 of title 5, Code of Federal Regulations (CFR) to reflect statutory changes enacted in January 2021 and December 2023.
  • Per a U.S. Office of Personnel Management news release.
    • “U.S. Office of Personnel Management (OPM) Director Scott Kupor, Vice Chair of the Super Intelligence Task Force, joined Kayleigh McEnany on Fox News’ Saturday in America to discuss the task force’s work, the importance of U.S. leadership in SI, and the responsibility of technology companies to develop and release safe products.”
  • Govexec reports,
    • “The federal government’s human resources agency is revamping one of the most heavily trafficked tools on its website: annual pay tables for federal employees. 
    • “The Office of Personnel Management is planning to launch a new version of the online tables that agencies and employees use to look up federal pay rates each year.
    • “Adam Starr, the agency’s chief information officer, said on Wednesday that the agency’s pay rates website gets about 14 million visits each year, but hasn’t changed much since 2011. 
    • “I always like to remember that ‘OPM’ really stands for ‘other peoples’ money.’ And in this case, it is your money. People come to OPM pay tables, asking us to show them the money, and for years these have been legacy, clunky sites,” Starr said Wednesday at the SAP Public Sector Summit sponsored by GovExec. “It’s not the experience that a federal employee deserves.” 
    • “Starr said the revamped OPM pay tables will launch “later this calendar year,” in the first quarter of fiscal 2027.” 
  • A FedWeek article provides “a detailed explanation by OPM of changes in coverage terms for the 2027 plan year in the FEHB and PSHB programs, ahead of the open season that will run November 9 – December 14 (brochures with specifics by plan are to be released in early November).
    • FEHBlog observation: Historically the FEHB and PSHB plan carriers have posted their brochure on their websites before OPM does in early November.

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

  • Fox Business reports,
    • “More than 112,000 bottles of Amazon-branded extra-strength acetaminophen are being recalled after consumers reported discolored pills, according to the Food and Drug Administration (FDA).
    • “Aurobindo Pharma USA, a New Jersey-based pharmaceutical company, initiated the voluntary recall on Sept. 18, affecting three bottle sizes of Amazon Extra Strength Acetaminophen 500 mg caplets.
    • “The recall remains ongoing, according to the FDA.”
  • Cardiovascular Business adds,
    • “This voluntary recall includes 22 different lots of Argatroban Injection, a direct thrombin inhibitor used for prophylaxis or to treat blood clots in adult patients with heparin-induced thrombocytopenia (HIT). It can also work as an anticoagulant in adult patients with or at risk of HIT who are undergoing percutaneous coronary intervention (PCI) procedures. 
    • “According to new details shared by the U.S. Food and Drug Administration (FDA), the particulate matter in question has been identified as cellulose, polystyrene, polyethylene, terephthalate and stopper material. Some of it may also be stainless steel. The Argatroban Injection being recalled is delivered to a patient intravenously. If patients were treated with the contaminated drug, they would face a risk “life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels and/or inflammation of the wall of veins, which may lead to clotting.
    • “Par Health did emphasize that there have been no reports of adverse events related to this issue. 
    • “The drugs included in this recall were distributed by Par Pharmaceutical or Endo USA from December to May 2026. The lots are all set to expire as early as October 2026 and as late as September 2027.” 
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guérin (BCG), to include adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG treatment. Anktiva is the first FDA-approved treatment specifically for patients with BCG-unresponsive, high-grade papillary-only disease. 
    • “The approval marks a new FDA approach to evaluating treatments for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The agency based its decision on evidence supporting an earlier approval of Anktiva for adults with another form of NMIBC, carcinoma in situ (CIS), with or without papillary tumors, and scientific similarities between CIS and high-grade papillary-only disease.
    • “We listen to patients, clinicians, and researchers, and we act when the science supports a new approach,” said R. Angelo de Claro, M.D., Director of the FDA’s Oncology Center of Excellence. “For Anktiva, our review of the similarities between these cancers allowed us to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumors alone. This approach may also help guide the development of future treatments.”
  • Beckers Behavioral Health points out,
    • “The FDA has taken a string of actions in recent months that could reshape how substance use disorders, ADHD and other behavioral health conditions are treated in the years ahead. 
    • “From clearing a novel alcohol use disorder drug for trials to approaching the first new ADHD medication class in decades and backing psychedelic research under a White House directive, the agency’s recent moves point to accelerating momentum in behavioral health drug development.” 
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases. As outlined in a new white paper, the Initiative will develop an optimized, fit-for-purpose framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type and the evidence that can be realistically generated in small patient populations.
    • “To solicit feedback on the Rare Disease Framework Initiative from patients and disease advocates, industry, and others, the FDA will host an October 28 meeting at the FDA’s White Oak campus. The meeting will be facilitated by the Reagan-Udall Foundation for the FDA.”

No Surprises Act News

  • CMS announced
    • “Beginning November 13, 2026, organizations with IDR Gateway accounts can submit “Notice of IDR Initiation,” “Notice of IDR Initiation Response,” “Notice of Certified IDR Entity Selection,” and “Notice of Offer” web forms in the Independent Dispute Resolution (IDR) Gateway.
    • “IDR Gateway users can also view reports and access dispute records for disputes started within the IDR Gateway, as well as disputes started outside the IDR Gateway that were successfully mapped to an organization using the dispute mapping process.”

From the Medicare Advantage front,

  • The New York Times discusses CMS’s upgraded Medicare Plan Finder website.
    • “For the first time, beneficiaries and those who help them can type in the name of any licensed health care provider — not just doctors, which was the case last year — and find which Advantage plans they accept.”

From the Affordable Care Act marketplace front,

  • Modern Healthcare reports,
    • “A new draft regulation would tighten access to health insurance exchange subsidies as federal agencies continue implementing President Donald Trump’s tax law.
    • “The IRS issued a proposed rule Wednesday that would set stricter definitions of who qualifies for tax credit subsidies, toughen eligibility verification requirements and narrow access to financial assistance for noncitizens.
    • “This regulation would complement pending rules from the Health and Human Services Department and the Centers for Medicare and Medicaid Services.
    • “The IRS and the Treasury Department characterized the policies as part of broader Trump administration efforts to reduce fraudulent activity on the exchanges, such as removing enrollees from the rolls and freezing broker enrollment.
    • “The proposed rules protect eligible taxpayers while strengthening the integrity of the premium tax credit,” IRS CEO Frank Bisignano said in a news release. “The enhanced verification measures are designed to curb improper claims, ensuring these vital tax benefits go strictly to the hardworking Americans who qualify for them.”
  • Per an HHS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) continue to crush fraud, waste, and abuse in America’s healthcare programs by stopping duplicative enrollment in government health programs, with the potential to save taxpayers approximately $1.5 billion over the next year.
    • “In 2026, CMS identified 189,000 people who had subsidized Obamacare coverage through the Federal Marketplace and either had duplicate Medicare, Medicaid or Children’s Health Insurance Program (CHIP) coverage or were deceased. CMS took swift action to remove Obamacare subsidies for these people to save taxpayer dollars.”

From the public health and medical / Rx research front,

  • Reuters reports,
    • “The US CDC said on Tuesday it would deploy additional support to Pennsylvania to help investigate the ongoing measles ​outbreak, as the state formally requested federal assistance through the ‌agency’s Epi-Aid emergency response program.” * * *
    • “The agency said it would work with local health officials to investigate the outbreak, strengthen response efforts and prevent spread.
    • “Texas, South Carolina, Virginia, Kansas, New ​Mexico, and Wisconsin requested CDC Epi-Aids and worked alongside federal teams to ​help bring their outbreaks rapidly and successfully under control,” the agency said in a ‌statement.”
  • The New York Times relates,
    • “Pope Leo XIV had a “good” second night in the hospital after surgery to remove a cancerous nodule on his lung, the Vatican said on Thursday.
    • “The pope had a good night in the hospital. He got up and had breakfast,” the Vatican said on Thursday morning.
    • “Leo’s lung cancer diagnosis has cast uncertainty over his agenda and raises questions about succession about a year and a half into his papacy.
    • “The Vatican said that doctors operating on the pope in Rome on Tuesday confirmed he has ​lung adenocarcinoma, a common form of lung cancer that can be highly treatable when caught early. Surgeons removed the lower lobe of his right lung.”
  • Healio tells us,
    • “In 2023, the age-standardized mortality rate for asthma was lower than that of 1990 by 50.94%, whereas the 2023 rate for COPD was higher than the 1990 rate by 8.9%, according to data published in The Lancet Respiratory Medicine.” * * *
    • Between 1990 and 2023, the estimated number of people living with chronic respiratory disease in the U.S. rose from 33.28 million to 54.5 million.
    • “Increases between these years were also observed in the age-standardized prevalence rate (+10.24%) and the age-standardized mortality rate (31.19 per 100,000 population to 34.56 per 100,000 population). According to researchers, the modest increase in the mortality rate signals “persistent gaps in disease control.”
    • “When broken down by disease type, the study found that the age-standardized mortality rate in 2023 was higher than that of 1990 for COPD (+8.9%) and ILD and pulmonary sarcoidosis (+87.47%), whereas the 2023 rate was lower than the 1990 rate for asthma (–50.94%) and pneumoconiosis (–75.19%).” * * *
    • “Integrating tobacco control measures, equitable vaccination programs and targeted health-system investments could help to address the uneven burden of chronic respiratory diseases across U.S. states and the growing mortality gap despite stable prevalence, although further research is needed to clarify which specific policy determinants underlie these associations,” Yon and colleagues wrote.”
  • and
    • “Women with polycystic ovary syndrome, now known as polyendocrine metabolic ovarian syndrome, may have elevated risk for Alzheimer’s disease and related dementias, a review article stated.
    • “However, the higher risk may be mediated by metabolic disorders, the researchers wrote. 
    • “In findings published in the Journal of the Endocrine Society, researchers identified multiple studies that reported people with PCOS/PMOS have increased risk for Alzheimer’s disease and dementia. However, there remain several unanswered questions, including whether PCOS/PMOS independently raises Alzheimer’s disease risk and if any interventions may reduce the elevated risk in the PCOS/PMOS population. 
    • “The data indicate that it is critical to further assess the possible link between PMOS, metabolic dysfunction and Alzheimer’s disease, but we should recognize that according to the information we reviewed, this link is still hypothetical and much more research is needed,” Ricardo Azziz, MD, MPH, MBA, executive director at the Foundation for Research & Education Excellence and professor in the School of Medicine and School of Public Health at University of Alabama at Birmingham, told Healio.”
  • Radiology Business tells us,
    • “Researchers have developed a way of adapting adult radiology artificial intelligence models for the pediatric population. 
    • “Currently, only about 17% of U.S. Food and Drug Administration-authorized AI medical devices are labeled for use with children. That’s because most models are trained on adult data and do not translate well for infants and kids, experts write Tuesday in Nature Biomedical Engineering. 
    • “One key impediment is that medical records in pediatrics are subject to strict privacy regulations, with data tending to remain at the institution where treatment occurred. Currently, kids represent less than 1% of public medical imaging datasets. 
    • “Because it’s so much harder to get data for children, this transformative technology is disproportionately being developed to help adults,” lead author Vishwanatha Rao, a MD-PhD student with the University of Pennsylvania and research fellow at Harvard, said in a statement Oct. 13. “Children are being left behind.”
    • “To address this, Rao and colleagues championed a way of adapting one model, trained on adult X-rays, for the pediatric population. Their approach used data from multiple hospitals without sensitive information ever leaving each institution. “The model travels, but the data stays in-house,” experts noted.” 
  • Genetic Engineering and Biotechnology News notes,
    • “Researchers at Baylor College of Medicine, the Duncan Neurological Research Institute (Duncan NRI) at Texas Children’s Hospital, and collaborating institutions have identified new genetic candidates that help explain why autism is diagnosed about four times more often in boys than it is in girls. The study, involving tests in induced pluripotent stem cell (iPSC)-derived neurons (iNeurons), revealed that small changes in the gene MECP2 on the X chromosome might help explain part of this difference.
    • “Huda Zoghbi, MD, Distinguished Service Professor at Baylor, director of Duncan NRI, and a Howard Hughes Medical Institute investigator, is senior and corresponding author of the team’s published paper in The American Journal of Human Genetics, titled “A massively parallel reporter assay of MECP2 cis-regulatory elements reveals genetic candidates for male-biased autism.” In their paper, the team concluded, “These findings suggest noncoding MECP2variants can cause idiopathic, male-biased autism and provide a framework for uncovering regulatory variants in other X chromosome neurodevelopmental genes that may contribute to autism’s missing heritability.”
  • MedPage Today informs us,
    • “There are no licensed vaccines targeting invasive E. coli disease, an acute illness that can lead to sepsis and death.
    • “In a phase III trial of older adults, the nine-valent ExPEC9V vaccine’s efficacy rate of 14.6% indicated no protective effect against invasive E. coli disease.
    • “The results led to an early termination of the trial, and development of the vaccine has been discontinued.”
  • Per Bio-Pharma Dive,
    • “An experimental RNA interference drug developed by Arrowhead Pharmaceuticals lowered levels of an Alzheimer’s-linked protein in an early trial in healthy volunteers, signaling the medicine might be helpful in treating the memory-robbing condition.
    • “Arrowhead said the highest dose of its drug, administered in two injections spaced two weeks apart, dropped levels of that protein, “tau,” by an average of 73% after 105 days. The findings suggest the medicine, called ARO-MAPT, could be injected once every three months.
    • “The news comes as developers of RNA-modulating medicines have been increasingly exploring ways to overcome a longstanding research limitation by aiming their treatments at targets outside the liver. Arrowhead said the results from this early-stage trial “provide clinical validation” of a development platform that enables its drugs to reach cells elsewhere, including those in the central nervous system protected by the “blood-brain barrier.”
  • and
    • “Verastem Oncology shares rose 18% Wednesday after the company released highly anticipated early data suggesting its experimental cancer drug could help certain patients with three different types of tumors.
    • “The drug, VS-7375, targets the most prevalent of the “KRAS” mutations that drive cancer, one known as G12D. The medicine is designed to bind to both the “on” and “off” states of the mutation, which may allow it to hold back tumor growth more completely than rival treatments that only target one or the other, Verastem said.
    • “The small study included patients with metastatic pancreatic ductal adenocarcinoma, metastatic colorectal cancer and advanced non-small cell lung cancer. Based on the results, the company plans to kick off a trio of late-stage trials before the end of June.”

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

  • Human Resource Director reports,
    • “Employer health costs are on track to rise 8.2 percent per employee in 2027, the steepest increase since 2003, and many employers say they cannot get the claims data needed to explain why.
    • “Marsh, the benefits consultancy formerly known as Mercer, reached that figure in its 2026 National Survey of Employer-Sponsored Health Plans, which collected responses from more than 1,800 US employers between June 10 and August 10, 2026. Employers said costs would climb 11 percent if they took no action, and 59 percent plan cost-cutting changes such as higher deductibles. A separate Marsh survey found that about two-thirds of employers with 500 or more workers expect to raise employees’ share of premiums, so many workers will see paycheck deductions rise by more than the average. Aon and Business Group on Health have published similar pre-mitigation forecasts of 9.5 percent and 9.2 percent for 2027.
    • “Our report on Marsh’s 2027 health benefit cost projections covers the three newer drivers. Marsh’s actuaries attribute roughly one percentage point each to glucagon-like peptide-1 (GLP-1) weight loss drugs, artificial intelligence (AI)-enabled claims submission software and disputes under the No Surprises Act’s Independent Dispute Resolution (IDR) process.”
  • Beckers Hospital Review relates,
    • “Chicago-based Rush University System for Health and Evanston, Ill.-based Endeavor Health announced plans to merge Oct. 14. The transaction is expected to close in early 2027.
    • “Endeavor plans to fund a $1 billion investment as part of the deal, including $300 million to broaden community impact, $500 million for academics and research, and $200 million for quality care and innovation, according to a joint press release. The investment will also fund community partnerships focused supporting social determinants of health and underserved members of the community.
    • “Together, Rush and Endeavor Health have an opportunity to create a stronger, more connected health system that sets a new standard for how care is delivered and experienced across our communities,” said Gerald “J.P.” Gallagher, president and CEO of Endeavor. “Patients and communities will benefit from improved access, advanced research and nationally recognized, high-quality care close to home.”
    • “When the deal is finalized, the system will operate under the Rush brand based on the brand’s “strong national reputation and position as a leading academic institution,” according to the press release, with a commitment to academics, care quality and innovation.”
  • and
    • “Greensboro, N.C.-based Cone Health is sunsetting its Hospital at Home program, according to an Oct. 14 statement from the health system shared with Becker’s. 
    • “Cone Health made the decision following a comprehensive review of its priorities and the model’s sustainability. 
    • “The statement noted that health systems across the U.S. continue to evaluate hospital-at-home programs as they navigate evolving reimbursement models, operational complexity and long-term sustainability. 
    • “The program, which launched in April 2025, reported strong first-year results on June 1, including no patient deaths or healthcare-acquired infections. Cone Health had limited the program to six patients at a time and had planned to expand it once more payers covered the model.” 
  • Healthcare Dive adds,
    • “Nonprofit health systems MultiCare and Samaritan Health Services will merge on Nov. 1 after gaining approval from state regulators, the companies announced Monday.
    • “As part of the deal, MultiCare – which operates 13 hospitals –  will begin an affiliation with Samaritan and its network of five hospitals. MultiCare, which is based in Tacoma, Washington, will also invest $700 million over 10 years into Oregon-based Samaritan. Samaritan will continue to use its name, alongside MultiCare’s branding, the health system said.
    • “This milestone brings us closer to putting the investment and resources of our partnership to work for the people we serve.” said Marty Cahill, Samaritan president and CEO, in a statement.”
  • Modern Healthcare tells us,
    • “Elevance Health is distinguishing itself from other insurers by proactively, and publicly, railing against high costs it says are driven by providers. 
    • “The insurer announced last year that its Anthem Blue Cross Blue Shield commercial plans would penalize healthcare facilities with a fee up to 10% if out-of-network clinicians are deployed for elective surgeries. That policy was soon expanded to additional states.
    • Last month, Elevance Health tightened the screws again by becoming the first insurer to require that hospitals identify and charge correct rates for off-campus care.
    • “Elevance Health’s site-of-care policy represents a “relatively consumer-protective attempt at reducing spending,” said Christine Monahan, an associate research professor at the Georgetown University Center on Health Insurance Reforms.
    • “Hospitals, however, have already begun to challenge the restrictions, which they deem as unilaterally imposed on them in spite of their contracts with the insurer. It’s possible more health systems will sue, said John Barnes, a partner at law firm Davis Wright Tremaine who represents providers on issues concerning insurance contracts.”
  • and
    • “Zocdoc, a virtual marketplace for booking providers, has acquired insurance technology company Sohar Health.
    • “The deal marks Zocdoc’s first acquisition since launching in 2007, according to a Wednesday press release. Zocdoc declined to disclose the financial terms of the acquisition, which closed on Oct. 2.
    • “Sohar’s platform automates insurance benefits eligibility checks.”
  • MedTech Dive informs us,
    • “Steris said Monday it struck a $2.1 billion deal to acquire Xodus Medical for its portfolio of consumable healthcare products. 
    • “Xodus’ portfolio includes Pink Pad patient-positioning products and the See Sharp laparoscopic cleaning and defogging device. The company expects annual sales to hit $245 million this year.
    • “Buying Xodus “makes sense” for Steris because it expands the company’s healthcare consumables offering with high-growth, high-margin products, Needham analysts said in a note to investors.”
  •  and
    • “Agilent said Tuesday that it has agreed to buy digital pathology software provider Proscia for $240 million upfront.
    • “The deal, which includes up to $30 million in milestones, will give Agilent control of technology that connects slide scanners, laboratory information systems and other parts of the pathology workflow.
    • “Agilent’s deal comes months after Roche agreed to buy PathAI for up to $1.05 billion. Evercore ISI analysts noted that Agilent “got the rights to play in this market at a lower price point.”
  • Beckers Health IT points out,
    • “The American Hospital Association, American Medical Association, Anthropic and Elevance Health are participating in a national workgroup developing recommendations for how state medical boards should oversee AI in medical practice, a spokesperson for the Federation of State Medical Boards confirmed to Becker’s.
    • “FSMB announced the workgroup in May to develop recommendations and/or model guidelines for state medical boards, particularly regarding AI systems that perform clinical functions with limited or no direct physician supervision. The effort comes as companies test how AI can be used in diagnosis, prescribing and other clinical functions, and as states propose and implement regulatory sandbox frameworks, according to FSMB’s news release.
    • “The group met in Washington in early October, the FSMB spokesperson confirmed to Becker’s.”
  • Fierce Healthcare adds,
    • “Johns Hopkins Medicine is teaming up with OpenEvidence to advance the use of artificial intelligence in medical education and clinical care.
    • “OpenEvidence and Johns Hopkins executives provided Fierce Healthcare with a first look at the partnership news.
    • “The health system and academic institution will partner with OpenEvidence to develop what they describe as “human-first AI systems” that combine the best available evidence with a patient’s medical history and Johns Hopkins’ clinical best practices to support care delivery. Sophisticated AI will help clinicians reason through that information more quickly, contextualize it, and make the best decisions for their patients, executives said.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a DataSpring news release,
    • “The Provider Data Collective, convened by DataSpring, powered by CAQH, today announced a new standard to improve the measurement of provider directory data quality for individual clinicians. It is the first solution from the industry-led coalition bringing together health plans, a health professional organization and an accreditation body to tackle challenges no organization can solve alone. The Collective’s mission is to improve the accuracy and reliability of provider information — clinician data that underpins directories, network operations and other essential health care workflows — so patients, clinicians and health plans can rely on information they trust.
    • Founding organizations of the Collective include Aetna, the American Medical Association, Centene, The Cigna Group, DataSpring, Elevance Health, Horizon Healthcare Services, Inc., Humana, the National Committee for Quality Assurance (NCQA) and UnitedHealthcare. * * *
    • “Inaccurate provider data can create real barriers across healthcare. Patients struggle to confirm whether a clinician is in-network, providers face delays joining networks and seeing patients, and care teams often lack the reliable information needed to coordinate care,” said Tim Kaja, executive vice president of UnitedHealth Group Enterprise Services and board chair of DataSpring. “While CMS established a method to measure provider data accuracy, inconsistent application made it difficult to establish a common baseline for improvement of provider data quality across the industry. The Collective aligned the industry around a shared framework — a more consistent way to measure data quality, identify gaps and track progress.”
    • “The data quality measurement standard creates a foundation for tracking and improving provider data quality across the ecosystem. It also allows this industry-led work to inform regulatory activity as policymakers seek to modernize provider data infrastructures. With that foundation in place, the Collective will next focus on other industry challenges, including how accepting-new-patients status is determined, updated and reflected in directories to improve accuracy and patient access.”
  • Modern Healthcare reports,
    • “The Centers for Medicare and Medicaid Services has gained unprecedented authority to remove providers, insurers and suppliers from federal health programs over fraud concerns.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. published a notice Tuesday announcing he is officially delegating those powers, which had been solely held by the HHS Office of Inspector General, to CMS.”
    • “The two-page document formalizes remarks Kennedy made at a news conference in July. “Both CMS and the Office of Inspector General will be able to use that authority to remove bad actors from federal healthcare programs and, in many cases, permanently ban them from returning,” Kennedy said at the time.
    • “The policy shift gives CMS a significant enforcement tool as the agency toughens up its oversight and fraud detection strategy.”
  • Bloomberg Law adds,
    • “US Health Secretary Robert F. Kennedy Jr.’s proposal to pay doctors to collect information about vaccine injuries drew criticism from medical groups over concerns it would create perverse incentives and a perception of causality not based on evidence.
    • “The idea is one pillar of the Department of Health and Human Services’ new vaccine injury research project formally announced on Thursday, three days after agency leaders secretly met at the National Institutes of Health to pitch it. 
    • “The proposal to compensate Medicare providers was tucked into a wide-ranging physician payment rule expected to be finalized next month as part of an annual rulemaking process.”
  • Beckers Hospital Review relates,
    • “Four House lawmakers, Reps. Rob Bresnahan, R-Pa., Debbie Dingell, D-Mich., Tracey Mann, R-Kan., and Lois Frankel, D-Fla., have introduced bipartisan legislation that would pause HRSA’s 340B rebate model pilot.” * * *
    • “The bill, the 340B Rebate Model Delay Act, would require drugmakers to provide 340B discounts upfront at the time of purchase from Jan. 1, 2027, through Dec. 31, 2028. It would also bar the use of federal funds to implement the rebate pilot or a substantially similar program during that period.
    • “The pause would give Congress time to consider broader 340B reform, including the SECURE 340B Act in the House and the SUSTAIN 340B Act in the Senate, according to an Oct. 9 statementfrom Advocates for Community Health. The group said health centers could be forced to cut services if they have to absorb full drug costs while awaiting rebates.”
  • Per a HRSA news release,
    • “The Health Resources and Services Administration (HRSA) today announced $12.7 million in Fiscal Year 2026 awards through the Maternal Produce Prescription Program (MP3) to help pregnant and postpartum women and their families in low-income and medically underserved communities access healthy foods.
    • “MP3 provides produce prescriptions or vouchers and nutrition education to help pregnant and postpartum women and their families access fruits and vegetables. The program strengthens partnerships among healthcare providers, community-based organizations, and local food systems and aims to increase fruit and vegetable consumption, improve household food security, and improve maternal and birth outcomes.”

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

  • Federal News Network discusses “FEHB and Medicare: Understanding how they work together in retirement.”
  • FedScoop adds, “OPM updates terms of service for USAJobs data following user confusion.
    • “The human capital agency again updated terms for its USAJobs application programming interface to reflect that the data is public and expressly allow analysis.” * * *
    • “In new updated terms released Friday, the agency enshrined its clarifications into its policy.
    • “The terms now state that information from the API is public data and as such, can be “copied, stored, reformatted, adapted, analyzed, published, redistributed, and used for lawful commercial or noncommercial purposes” without prior approval from OPM. 
    • “They also include language protecting analysis, while making it clearer that fraudsters are the target. Under the terms, API users can “modify, summarize, analyze, or combine” the public data, but may not falsely represent the information. ” * * *
    • “In response, the user community cheered the update.”

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

  • CBS News reports,
    • “The Food and Drug Administration received reports in recent months that two people died after taking bootleg versions of an experimental weight-loss drug, according to documents reviewed by CBS News.
    • “The reports link the deaths to products claiming to be retatrutide, a drug being developed by Eli Lilly that hasn’t been approved by the FDA. Federal law prohibits the commercial sale of unapproved drugs, but that hasn’t stopped vendors from selling imitation versions of the experimental drug online at a scale with no modern precedent. 
    • “The cases appear to be the first public accounts in the U.S. alleging that unauthorized use of retatrutide — or products claiming to contain it — played a role in a patient’s death, though the details aren’t verified and it is unclear whether the drug was to blame.” * * *
    • “CBS News was not able to independently verify the information included in the reports, which were obtained under the U.S. Freedom of Information Act and redacted by the agency to remove details that could identify the people mentioned in them. They are part of an emerging picture of potential side effects from a drug that many people are obtaining from unregulated sellers and with minimal to no medical supervision.
    • “America’s Poison Centers, a nonprofit, has tallied a steady increase in reported exposures to retatrutide since it began tracking them late last year, which is common for a newly monitored drug. The centers logged 862 exposures to retatrutide in the three months ending in September, up from 460 in the three months prior and 249 in the first three months of 2026.” * * *
    • “In a statement, Eli Lilly said that the reported deaths “make clear the two individuals were taking black-market retatrutide.” The company said it has found suspect products “with too much, too little, or the wrong active ingredient,” along with contaminants that “can put patients at serious risk.”
    • “Eli Lilly is taking legal action against companies selling bootleg versions of retatrutide, claiming that people will associate bad reactions to them with its product, “poisoning the well for the future of retatrutide medicines.” 
  • DI Cardiology tells us,
    •  “Endovascular Engineering (E2) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for both the Hēlo Thrombectomy System and Hēlo Return (Blood Return System).
    • “Hēlo, which is a physician-inspired, purpose-built thrombectomy platform for treating pulmonary embolism, leverages a unique design that consistently led to efficient single-pass procedures in the Engulf IDE study. The platform showcased the highest reported clot reduction and the lowest estimated blood loss across all PE Thrombectomy IDE studies.1 
    • “While Engulf provided important clinical validation of the platform’s capabilities, the FDA clearances represent a significant step forward as E2 brings its innovative platform to a broad range of physicians and patients. PE remains a leading cause of cardiovascular death and disability, and there is growing demand for mechanical solutions that support clot removal while reducing procedural complexity and right heart strain.”
  • MassDevice adds,
    • “BridgeSource Medical obtained de novo clearance from the FDA for its handheld cardiac implant identifier, designed to help emergency department clinicians quickly identify a patient’s hardware brand.
    • “According to the Austin, Texas–based company, about half the time a patient enters the ER they don’t know, can’t communicate or aren’t carrying the wallet card listing the specific brand of their pacemaker or implanted defibrillator. This causes delays in triage and treatment — with different approaches being needed for each manufacturer — and clinicians often have to resort to an X-ray to determine the type of device.
    • “BridgeSource’s SmartRead system can be used by frontline healthcare workers to identify an implant within 20 seconds. It works by mimicking the initial communication pings sent by the programming wands from each major implant manufacturer and waiting for a response, including devices from Abbott, Biotronik, Boston Scientific, Medtronic and MicroPort.”

From the public health and medical / Rx research front,

  • JACC offers information about “Cardiovascular Disease Mortality [CVD] by County, Race and/or Ethnic Population, United States, 2000-2019.”
    • “While declining CVD mortality reflects meaningful clinical and public health progress, persistent and pervasive disparities demand solutions-oriented, place-informed research to drive further progress. Critically, these pre-Covid data establish a baseline essential for isolating Covid-era–attributable shifts from preexisting trends. These granular county-level data stratified by CVD cause, race, and/or ethnicity offer a scalable, repeatable framework for agencies to tailor health interventions and rigorously track disparities over time.”
  • Health Day adds,
    • “Monitoring blood pressure at home could help prevent a life-altering injury for some seniors, a new study warns.
    • “Seniors older than 78 with “masked” high blood pressure have a 70% higher risk of falls than those who’ve been properly diagnosed, according to results presented at the American Heart Association’s annual meeting on hypertension.
    • “Researchers said masked high blood pressure involves seniors’ readings appearing normal at a doctor’s office but consistently high at home.
    • “These findings highlight that, in addition to office blood pressure measurement, home blood pressure readings can be an important way to identify hidden home high blood pressure and risk of falls in older adults,” lead investigator Frances Wang said in a news release. She is a researcher at Beth Israel Deaconess Medical Center in Boston.
    • “Changes in blood pressure can increase fall risk by causing dizziness or fainting, according to the American Heart Association (AHA).”
  • Per a National Institutes of Health news release,
    • “A scientific team funded by the National Institutes of Health (NIH) has built a super intelligence (SI)-based interface that enables real-time communication between patients and epilepsy monitoring devices. As part of a small clinical study at the University of Pennsylvania, Philadelphia, patients used a smart-phone application to inquire about their own physiological data and received accurate information in response. Conversely, the system learned from patient feedback to improve seizure detection, ultimately reducing its false alarms by about 80%. 
    • “This proof-of-concept showcases a technology with the exciting potential to shift management of epilepsy and possibly other diseases in a more adaptive direction that puts patients in the driver’s seat,” said Amy Bany Adams, Ph.D., acting director of the NIH’s National Institute of Neurological Disorders and Stroke (NINDS).” 
  • Radiology Business reports,
    • “Alterations in brain connectivity may be associated with anxiety in adolescents, according to new research. 
    • “Published in Imaging Neuroscience, the findings implicate brain circuits connecting the cerebellum, amygdala and thalamus in adolescent anxiety. Experts involved in the study are hopeful that their research could help guide personalized approaches to youth mental health care in the future. 
    • “Precision psychiatry is likely to play an important role in future mental health care,” noted study leader Caterina Stamoulis, PhD, principal investigator in Boston Children’s Computational Neuroscience Laboratory. “In this study, we have identified specific circuits that are implicated in anxiety, which could become the targets of precision interventions to improve short- and longer-term mental health outcomes in youth.” * * *
    • “While the findings are promising and offer scientists a deeper level of understanding of the underlying mechanisms of anxiety disorders in adolescents, additional research will be needed to determine whether the imaging markers can predict individual outcomes or help clinicians select and evaluate targeted interventions. 
    • “Read more here.” 
  • BioPharma Dive relates,
    • “An experimental mRNA cancer immunotherapy from BioNTech failed to delay tumor progression in a late-stage study in a form of head and neck cancer, the company said Tuesday.
    • “According to BioNTech, a combination of its treatment BNT 113 and the widely used drug Keytruda didn’t extend progression-free survival at an interim data check. The trial is testing the dual regimen against Keytruda alone as a first-line treatment in head and neck squamous cell carcinoma that’s driven by a high-risk strain of human papillomavirus. 
    • “A data monitoring committee encouraged BioNTech to continue the trial to determine whether the BNT 113-Keytruda regimen can meet the study’s other main objective by extending survival. Should it do so, BioNTech could still claim success. The early results “support continued evaluation” and show the drug combination is “engaging its intended therapeutic mechanism,” said co-founder and Chief Medical Officer Özlem Türeci.”
  • and
    • “Bristol Myers Squibb said Monday that its experimental lung disease drug admilparant succeeded in a Phase 3 trial in idiopathic pulmonary fibrosis, significantly slowing the decline of study participants’ breathing capacity when compared to a placebo over the course of a year.
    • “However, trial investigators only found a clear benefit among those who received a 60 milligram dose of admilparant. A 120 milligram dose was associated with an impact on disease progression, but the difference didn’t meet the threshold for statistical significance, the company said.
    • “The failure of the high-dose arm is “confounding and requires further explanation,” RBC Capital Markets analyst Trung Huynh wrote in a client note. Bristol Myers previously made certain trial revisions that sparked liver-related safety concerns about admilparant, too, although the company said Monday that the drug “demonstrated a well-tolerated safety profile” and treatment-related study discontinuations were similar between study groups.”

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

  • The Wall Street Journal reports,
    • “UnitedHealth UNH Group reported earnings that came in above analysts’ expectations and again raised its projection for the year, as the healthcare company continued charting a financial turnaround.
    • “The announcement comes more than a year after Chief Executive Stephen Hemsley returned to the top job, promising major changes after a meltdown that cut the company’s valuation by hundreds of billions of dollars.
    • “For the third quarter of 2026, UnitedHealth reported net income of $4.11 billion, or $4.56 a share. That compared with net income of $2.35 billion, or $2.59 a share, a year earlier.” * * *
    • “UnitedHealthcare, the insurance arm, reported a medical-loss ratio of 88.4%, a closely watched number that represents the share of premiums spent on medical costs. The FactSet consensus projection was 89.7%.”
  • and
    • “Johnson & Johnson JNJ is “leaning” toward spinning out the hips-and-knees business that the company has been looking to hive off, Chief Financial Officer Joseph Wolk said.
    • “We think the best value creation at this moment in time for J&J shareholders is to spin it straight out,” Wolk said in an interview. The company talked with private-equity firm Apollo Global Management about a roughly $20 billion sale, The Wall Street Journal has reported.
    • “Wolk made the remarks as J&J said its sales grew a healthy 5.9% in the recent quarter to $25.4 billion, and the company raised its forecast for full-year performance.
    • “Sales of prescription drugs powered J&J’s quarterly results. The company’s medical-device business didn’t grow as much. While acknowledging the medical-device unit needed work, the company said it was on track to surpass $100 billion in yearly sales.
    • “J&J is considered a bellwether for the healthcare industry because its portfolio spans so many different products. Its results show the enduring demand for medical treatment, as other industries grapple with consumers tightening spending because of higher fuel and other costs.”
  • and
    • “Roche ROP Holding struck a deal with China’s Rona Therapeutics to license worldwide rights to an experimental therapy for obesity and metabolic diseases for up to $1.16 billion, moving to bolster its portfolio with a new weight-loss approach.
    • “Under the agreement, Shanghai-based Rona will get upfront and near-term payments of up to $100 million and be eligible to receive an extra $1.06 billion subject to reaching development, regulatory and commercial goals, as well as royalties on potential sales, Rona said Tuesday.
    • “Roche has sought to build and expand a portfolio of weight-loss drugs in recent years, joining a growing group of drugmakers vying to challenge Eli Lilly and Novo Nordisk. It completed in 2024 its $2.7 billion purchase of U.S. obesity drug developer Carmot Therapeutics and entered into an up to $5.3 billion licensing deal with Denmark’s Zealand Pharma to jointly develop a different kind of weight-loss medicine last year.”
  • Beckers Payer Issues relates,
    • “Humana has agreed to form a new joint venture with investment management firm BlackRock to own and operate nearly 150 CenterWell Senior Primary Care clinics, replacing CenterWell’s existing joint ventures with private equity firm Welsh, Carson, Anderson & Stowe. 
    • “Funds and accounts managed by HPS Investment Partners, part of BlackRock, will acquire Welsh Carson’s equity stake, valued at about $2.8 billion, according to an Oct. 13 Humana news release. BlackRock will hold majority ownership, while CenterWell will retain a minority stake and continue managing the clinics.
    • “Unlike the previous agreements, the new deal does not give BlackRock the right to force Humana to buy out its stake. Humana said removing that obligation will significantly reduce liabilities on its balance sheet and lower its cost of capital.
    • “Beginning in 2028, CenterWell can buy clinics from the joint venture, according to the release. If CenterWell has not acquired all of them by the end of 2033, BlackRock can exit through a sale of the remaining clinics, with CenterWell holding the right to make the first offer.”
  • and
    • “Centene will launch its National Performance-Based Gold Card Program in November.
    • “Gold carding aims to streamline prior authorization, reducing requirements for trusted providers. The program will first be available to more than 160,000 qualifying providers across the country for some outpatient services. Eligibility is determined by approval history, documentation quality, medical policy compliance and adherence to regulatory requirements. The insurer anticipates expanding the program to other service types and providers in the future.
    • “Centene COO Susan Smith said the program “was shaped through deep collaboration with providers, ensuring its review process is grounded in the real-world needs of those delivering care every day.” Providers spanning 24 states anonymously contributed feedback to inform the program, according to an Oct. 13 news release.” * * *
    • “In recent years, UnitedHealthcare and Humana have also announced gold card programs. Centene’s update comes as prior authorization reforms pick up steam.”
  • Per a Healthcare Cost Institute news release,
    • “Health care spending for people with employer-sponsored insurance reached $6,743 per person in 2023, according to the nonprofit Health Care Cost Institute’s latest Health
    • “Care Cost and Utilization Report. Per-person spending rose 18.8% from 2019 to 2023, with higher prices, not greater use of care, driving most of the increase.
    • “From 2022 to 2023, spending per person grew 6.5% while utilization was essentially flat. Average prices rose 6.7% that year, continuing a five-year pattern of annual price growth.
    • “Prices are the primary force behind high health care costs,” said Katie Martin, HCCI president and CEO. “Employers, policymakers and other decisionmakers need to focus on price growth to make care more affordable for people and families with job-based coverage.”
  • Beckers Hospital Review tells us,
    • “Hospital margins fell in August as financial pressures mounted and the share of hospitals operating at a loss is growing, according to Kaufman Hall’s [Augut 2026] “National Hospital Flash Report,” released Oct. 13.
    • “The report is based on August 2026 financial performance data from 1,300 hospitals, provided by Strata Decision Technology. The hospitals represent all regions of the country and range from small to large institutions.
    • “The average hospital margin has declined steadily since hitting 5.6% in June. The average fell to 1.8% in August, down from 3.8% in July. The year-to-date average operating margin dropped from 3.8% in July to 2.5% in August.
    • “Mounting financial challenges from increasing bad debt and charity care, payer mix erosion and rising expenses may prompt hospitals to strengthen enterprise margin preservation efforts,” the report said.
    • “About 43% of hospitals are operating in the red, up from 33% before the COVID-19 pandemic. Hospitals have experienced many challenges in the last six years, including staffing shortages, supply cost increases, tech and AI spend and more.”
  • Per a Vizient news release,
    • “The sustained momentum in hospital and health system M&A activity has shown that health systems continue to advance active positioning and portfolio management, with 16 hospital and health system transactions announced in Q3 2026. The 16 announced transactions in Q3 2026 (Figure 1) are on par with what we saw in Q3 2025. As deal volume continued, mega mergers also continued to make waves across the industry. For the third consecutive quarter, multiple mega mergers—transactions in which the smaller party had annual revenue exceeding $1 billion—were announced, along with several transactions that fell just shy of the $1 billion threshold.
    • “The size of these transactions kept the average seller size elevated relative to recent year-end figures, continuing to suggest that M&A activity is increasingly involving larger organizations opting to partner with even larger ones.
    • “Divestitures of specific health system assets represented five of the 16 announced transactions in Q3 2026.”
  • Beckers Payer Issues notes,
    • “CMS’ 2.5% efficiency adjustment cut work relative value units on about 7,700 non-time-based codes starting Jan. 1. It was a percentage cut that came with a conversion factor increase, so the dollar effect is easy to miss. For physicians paid per wRVU, it runs from nothing to more than $13,000 a year, depending on specialty.” * * *
    • “The Medical Group Management Association and consulting firm PYA have flagged procedural and imaging-heavy groups on formula-based wRVU incentives as the most exposed. MGMA also noted exposure for groups whose commercial contracts or benchmarks are tied to wRVU counts.”
  • MedCity News informs us,
    • “Outro, a neuroscience-based platform, announced last week that it raised $7 million in pre-seed and seed funding.
    • “The New York-based company helps patients discontinue psychiatric medications. Patients visit with clinicians trained in safe deprescribing and receive access to personalized tapering plans. They also gain access to compounded medication doses.
    • “Roughly 1 in 6 Americans take antidepressants. There are tens of millions of people on these drugs, yet no science-based way to get off safely. … Outro is the off-ramp that should have been built from the beginning. We want getting off a medication to be as supported as getting on it – arguably even more,” said Brandon Goode, co-founder and CEO of Outro.”
  • Beckers Health IT points out,
    • “The American Medical Association released a governance framework Oct. 13 for agentic AI that takes on clinical functions. The framework says an AI system’s clinical authority must be earned through evidence and maintained through ongoing performance.
    • “The AMA said an AI system’s authority and oversight can change as its evidence, performance, risk or underlying technology changes.”

Holiday Weekend update

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

Happy Columbus Day!

From Washington, DC

  • Congress remains on the campaign trail this week.
  • The Social Security Cost of Living Adjustment will be announced on Wednesday, October 14,
  • Beckers Hospital Review reports,
    • “Health systems told CMS in public comment letters how much its proposed cut to 340B drug payments would cost them, with estimates ranging from about $7 million to $109 million a year [as detailed on the article].
    • “The 2027 outpatient payment rule, proposed July 2, would pay hospitals for drugs bought through the 340B program at average sales price minus 33.4%, down from average sales price plus 6%. CMS estimates the change would cut Original Medicare drug payments by $4.55 billion in the first year. Because the rule must be budget neutral, CMS would raise payments for nondrug outpatient services by 8.44% for all hospitals, including those that do not participate in 340B.

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

  • David Setia, writing in Federal News Network, breaks down why federal employees “should consider retiring after 62, why it just got even more compelling, and how you can make this decision slightly less painful.”
  • FedSmith explains ‘how federal employees can build a financial cushion before the next shutdown.
    • “Federal shutdowns are unpredictable, but financial preparedness isn’t. Here’s how to build a savings cushion before the next funding lapse.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Alignment Healthcare sued federal regulators, alleging that its 2027 Medicare Advantage star ratings were determined “in flagrant violation” of statute.
    • “In the lawsuit filed Friday in District of Columbia federal court, the insurer says that the Centers for Medicare & Medicaid Services “has completely departed from Congress’s vision of leveraging predictable, valid measures developed with input from providers, plans, and the public” in establishing the methodology for the star ratings.
    • “The company argues that rather than establish “consistent, stable specifications” for metrics through the traditional rulemaking process, the agency instead detailed key measures through a series of “technical notes.” This violates the Administrative Procedure Act, per the lawsuit.”
  • Modern Healthcare adds,
    • “The Centers for Medicare and Medicaid Services excluded 20 measures from its 2027 Medicare Advantage star ratings methodology for Clover Health PPOs.
    • “Clover Health successfully sued CMS to get those metrics excluded from its 2026 scores.
    • “Other Medicare Advantage insurers were evaluated on different metrics than Clover Health.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “A 39-year-old unvaccinated woman from Franklin County, Pennsylvania, who had been diagnosed with measles has died, according to the local coroner’s office, marking the sixth such death reported since the state’s outbreak began this year.
    • “The woman’s primary cause of death was a “probable acute cardiac event due to possible complications of the measles,” the coroner’s office said in an emailed statement.
    • “The patient had “a recent history” of having contracted the highly contagious disease, the coroner’s office wrote in a Facebook post, adding that it meets the state health department’s definition of a measles-associated death. The woman had several underlying health conditions and had a “past diagnosis of measles with treatment.”
  • Beckers Clinical Leadership relates,
    • Flu season is off to an early start, with weekly lab-confirmed flu hospitalizations nearly tripling between early September and early October, according to CDC data. 
    • Hospitals reported 3,334 flu admissions in the week ending Oct. 3. That’s up from 2,572 the week before and 1,133 in the week ending Sept. 5. The national admission rate rose to 1.0 per 100,000 people, up from 0.3 in early September.
    • The West is furthest ahead. “California has a full-on flu epidemic right now,” Scott Gottlieb, MD, a former FDA commissioner, said in an interview with CNBC.
  • and
    • “Hospital and health system leaders are grappling with the balance between keeping patients safe and what to do when aging physicians continue to practice amid declining abilities, The Washington Post reported Oct. 12. 
    • “Nearly 47% of the active physician workforce is 55 or older, up from 38% in 2007, and in 2025, 22.4% of physicians are over 65. At older ages, reaction times slow, knowledge can become outdated and some can experience cognitive decline. Mild cognitive impairment increases with age, going from 8.4% in adults 65 to 69, up to 25.3% in adults 80 to 84, according to the American Academy of Neurology.
    • “Studies from Yale New Haven Hospital and Hartford (Conn.) Healthcare found 12.7% to 14.4% of physicians over 70 who were screened showed some degree of cognitive impairment.  
    • “It’s becoming a bigger issue with each passing year,” clinical neuropsychologist Victor Del Bene,PhD, of the University of Alabama at Birmingham, told the Post.”
  • The American Medical Association lets us know “what doctors want patients to know about the common cold.”
    • “Nearly everyone will experience a cold, most often caused by rhinovirus. While there is no cure, there are several ways to manage your symptoms.”
  • Health Day tells us,
    • “Late-night snack may be doing more than affecting your waistline — it could be hurting your liver health.
    • “A few studies have hinted at this idea but this is among the first long-term analyses to explicitly draw the connection to fatty liver disease,” lead author Dr. Robert Wilechansky said in a news release. He’s a hepatologist at Oregon Health & Science University in Portland who specializes in liver transplantation.
    • “Researchers analyzed diet and lifestyle data from nearly 200,000 healthy people who were monitored for about 16 years.
    • “Those who reported eating after dinner or after bedtime had a 36% higher risk of developing non-alcoholic fatty liver disease and a 28% higher risk of cirrhosis.
    • “The results were consistent even after adjusting for factors like age, diabetes status, physical activity and body mass index (BMI), an estimate of body fat based on height and weight.”
  • The Washington Post offers an interview with an oncologist who tells us what to know about DCIS or Stage 0 breast cancer.
    • Experts are starting to question whether identifying ductal carcinoma in situ as cancer leads to unnecessary interventions such as radiation and surgery.
  • The New York Times explains “why ketamine immobilizes some users.”
    • “Potent powders can produce a nearly catatonic state, particularly in those who have not tried the drug before.”
  • and
    • considers whether we ever will understand dementia.
      • “Today dementia is estimated to affect more than 55 million people worldwide, and nearly 10 million cases are added every year. By 2050 — as populations age and the power of diagnosis improves — that number is projected to rise as high as 139 million. We’re already on our way to becoming a society of caregivers, looking after an aging population unable to support itself.
      • “And yet, in a sense, we understand little more about the plaques and tangles of Alzheimer’s disease than we did 120 years ago, when Alois Alzheimer first noticed them. In recent years, we may have even lost ground. A decades-long consensus about the meaning of those plaques and tangles has collapsed as treatments built on those theories have failed, reopening what now must be understood as one of the most urgent unsolved problems in medical science: What is dementia, and how can we possibly slow its advance and reduce its terrible toll?” * * *
      • “A recent overview of the Alzheimer’s literature in the journal Cell offers “hope for a future where AD is not only treatable but also preventable,” while still acknowledging the condition’s “complex pathologic underpinnings.”
      • “This, after all, was Arnold Pick’s insight: that dementia is many things. What if we could nip these complex problems in the bud genetically, before the crippling health care costs and heartbreaking losses — before the ones we love lose much of what makes them who they are?
      • “With the gene carriers, you can get in very early, maybe even before any age-related change is happening, any pathology is present at all,” Dr. Miller said. “I think it’s going to be a really huge decade. We’re just beginning.”
  • Per Genetic Engineering and Biotechnology News,
    • “Domestic dogs offer a useful model for understanding the biology of aging because their lifespans vary dramatically with body size. Large dogs tend to be shorter lived than their smaller counterparts, but why? Headed by a team at Arizona State University, a study of nearly 900 dogs now suggests that the answer may be written into the animals’ epigenomes.
    • “Research professor Noah Snyder-Mackler, PhD, at Arizona State University School of Life Sciences, and colleagues developed an epigenetic clock that predicted mortality in dogs and showed that epigenetic aging is fastest early in life. The study results indicated that male dogs and larger dogs undergo accelerated molecular aging, with male dogs exhibiting pronounced DNA methylation (DNAm) changes on the X chromosome, and larger animals exhibiting methylation changes at transposable elements (TEs), stretches of DNA that can influence genome stability and gene regulation.”
    • “Snyder-Mackler is senior and corresponding author of the researchers’ published paper in Science (“Epigenetic aging and transposon dysregulation reflect size-related lifespan compression in dogs,”) in which they concluded, “Our findings broadly establish companion dogs as a translational model for uncovering molecular mechanisms of lifespan variation, epigenomic instability, and age-related disease.”
  • Per Fierce Pharma,
    • “Mirum pharmaceutical is on a hot streak. On the heels of an FDA approval and a phase 3 win in hepatitis delta, the rare disease company just announced another phase 3 victory for Livmarli, its ileal bile acid transporter (IBAT) inhibitor.
    • “Mirum’s Expand trial tested Livmarli in patients aged 6 months or older with cholestatic pruritus, an intense itch caused by an ultra-rare cholestatic liver disease. The topline readout showed the trial met its primary endpoint achieved significance across all five secondary endpoints.

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “More GLP-1 prescriptions are being filled without ever touching a patient’s insurance, and pharmacists say the shift is accelerating.
    • “Nearly seven in 10 pharmacists (68%) have seen cash-pay GLP-1 transactions increase over the past year, according to a Buzz Health survey of 256 U.S. pharmacists conducted in July 2026. The trend shows up weekly at the pharmacy counter, where patients often pay cash for a GLP-1 while still running their other prescriptions through insurance.
    • “Price isn’t the only factor. More than half of pharmacists say patients have paid cash even when a cheaper or equivalent option was covered by their plan, which suggests convenience and product preference play a role. Pharmacists credit manufacturer direct-to-consumer programs, telehealth pricing and new oral GLP-1s with pulling patients away from their benefits. That is the same growing mix of channels physicians already navigate when patients can’t access the GLP-1 they prescribe.
    • “The shift also creates a data problem. Cash purchases don’t always appear in the claims records that health plans and PBMs use to track utilization and adherence, and most patients don’t realize their insurer can’t see those fills. As online GLP-1 options continue to multiply, that blind spot could make it harder to know what patients are actually taking.”
  • Beckers Hospital Review relates,
    • “Durham, N.C.-based Duke University Health System recorded operating income of $453.1 million (5.4% margin) for fiscal year 2026, compared with operating income of $179 million (2.5% margin) in fiscal 2025, according to its Oct. 5 financial report.”
  • and 
    • “Many large health system layoffs in 2026 feature a common theme: Leadership is cutting corporate and administrative support roles while protecting positions that focus on patient care. It’s a pattern that shows how organizations are deciding what to cut as costs rise and federal policy changes reshape the industry.” * * *
    • “Even while administrative ranks thin, systems are still spending to retain workers. Becker’s has reported that 49 hospitals and health systems have announced plans to raise workers’ pay since December 2025. For example, Hartford (Conn.) HealthCare shared in late September that it will raise its minimum wage to $20 an hour Dec. 27, affecting about 4,000 employees. An additional 4,000 employees will receive pay adjustments to address wage compression resulting from the increase.”
  • Radiology Business tells us,
    • “Siemens Healthineers has officially ceased all sales of its general imaging ultrasound systems. The healthcare giant announced the shift in strategy on Monday, Oct. 12, saying it will now increase its focus on procedural imaging and image-guided therapies. The goal is to build on its strength in cardiovascular imaging, specifically in the areas of intracardiac echocardiography (ICE) and AI, and help care teams perform more complex procedures than ever as technologies continue to evolve. 
    • “Going forward, Siemens Healthineers remains focused on technologies used by electrophysiologists and interventional cardiologists for the detection and management of cardiovascular disease. The company’s Acuson Origin, for example, is a cardiovascular ultrasound system with advanced artificial intelligence (AI) capabilities that first gained U.S. Food and Drug Administration clearance in 2024. The Acuson P500 and Acuson Freestyle systems are also still part of the Siemens Healthineers portfolio.
    • “On the other hand, the company will no longer be selling its Acuson Sequoia, Acuson Redwood, Acuson Juniper or Acuson Maple systems.”
  • Beckers Payer Issues explains why payers have invested in ambulatory surgical centers and lets us know that
    • “Former UnitedHealth Group CEO Sir Andrew Witty has been named chairman of Hatteras Venture Partners, a venture capital firm focused on healthcare innovation, investing across biopharmaceuticals, medical devices and health technology.
    • “Mr. Witty is returning to Hatteras, where he served as a venture partner from 2017 to 2019, according to a Sept. 30 news release from the company.” 
  • Beckers Physician Leadership considers whether any physician can be truly independent.
    • “Independent” has become one of the most loaded words in physician practice. As hospitals, health systems and private equity firms have absorbed practices over the past two decades, the label has come to signal a practice that has stayed outside all three.
    • “Siddharth Tambar, MD, a rheumatologist and physician owner of Chicago Arthritis and Regenerative Medicine, questions how much that label actually describes.
    • “I understand what people mean when they say independent practice, right? That you’re not part of a large either group system, hospital system, PE-owned system,” Dr. Tambar told Becker’s. “So I get that, but realistically, if you are part of the American healthcare system, if you accept insurance, you’re part of these large networks. You’re part of these flows of how patients get to you, and so I don’t think any of us are truly independent in that regard.”
    • “Physicians have little leverage inside those networks. Only 5% of physicians report significant negotiating leverage in private-payer contract talks, and more than 40% report none, according to a Medscape‘s report, “Private-Payer and Government Insurance Report 2026: Medicare, Medicaid, and More,” published Oct. 2.” * * *
    • “Despite continuous shifts in the structures and regulations shaping the physician practice space, Dr. Tambar maintains that strong patient relationships and a desire to stay connected to them is what will keep practices growing in the future — regardless of their independence. 
    • “Long term, obviously, if you’re offering good care to patients, ethical care, that’s how you maintain, right?” he said. “As a physician or as an owner, you have to keep on finding ways to offer value to patients, and whatever treatments are new that can be helpful for the patients, you have to find a way to somehow introduce them and stay relevant and stay present in their minds.”