Midweek report

Midweek report

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

From the national election front,

  • The Wall Street Journal reports.
    • “Vice President JD Vance blamed the Iran war for Republicans’ heavy midterm losses, saying “everyone knows why we lost.” The comments came a day after Democrats took control of the Senate and House in a blue wave that surged across the country, extending into traditionally red states in a repudiation of President Trump.
      • House: As more races are called, Democrats are expanding the majority they clinched in the chamber last night. [As of this writing, the Democrats have 237 seats and the Republicans 147.] Meanwhile, with House Speaker Mike Johnson saying he wouldn’t run for minority leader, House Republicans are already jockeying for the job.
      • Senate: Democrats have flipped seven seats so far in the Senate. [As of this writing the Democrats have 54 seats and the Republicans 44.] Two races have yet to be called in which the Democratic candidate currently has a slight edge over the Republican incumbent: Alaska and Mississippi. It’s unclear when those results will be announced.
      • Trump: The president appeared at the site where his ballroom is being constructed and took a few questions from reporters. Among other things he said Vance’s assessment of the impact that the war with Iran had on the midterms was “largely true” and that he wasn’t considering replacingDefense Secretary Pete Hegseth.
  • Beckers Hospital Review tells us,
    • “Health insurer and hospital stocks climbed Nov. 4 after Democrats won majorities in both chambers of Congress in the Nov. 3 midterm elections, as analysts said the new Congress could delay Medicaid cuts and restore enhanced ACA subsidies.”
  • Fierce Healthcare lets us know in more depth “what Democratic control of Congress means for healthcare in 2027.”
  • Beckers ASC Review points out “Physicians who won in the 2026 midterms.”

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

  • Govexec reports,
    • “Following the drubbing of congressional Republicans in Tuesday’s midterm election, federal employee unions are hopeful that the change in control on Capitol Hill will precipitate action to roll back some of the Trump administration’s efforts to reshape the federal workforce.”
  • Fedweek tells us,
    • “The annual federal benefits open season starting next Monday (November 9) and running through December 14 provides an opportunity for current enrollees change FEHB/PSHB health insurance plans’ change levels of coverage, for plans that have more than one; and change among self-only, family and self plus one options.” * * *
    • “Even enrollees happy with their same coverage should look at the offerings, experts advise, since benefits do change somewhat year to year. And within the average premium increase there is variation, with some plan premiums increasing by well more than the average.
    • “A summary of general changes to coverage terms in both programs is here; check a plan’s brochure for its specifics. OPM’s main open season resources page is here.
    • “Tables of plans leaving the programs or reducing service areas are here for FEHB and here for PSHB. Affected enrollees in these plans who don’t choose a new one will be moved to Compass Rose Standard if in FEHB and in FEP Blue Focus if in PSHB.”
  • and
    • “While most of the attention focuses on the FEHB health insurance program during the annual benefits open season—this year November 9-December 14—the open season also provides federal employees and retirees the opportunity to elect or change vision and/or dental coverage in the FEDVIP program, and for employees to begin or renew flexible spending accounts for the new year.” * * *
    • “Those who wish to have a dependent care and/or health care flexible spending account must make a new election during the open season. The IRS has not yet announced the maximums in those programs for 2027; for 2026, they were $7,500 individually or for a couple filing federal income taxes jointly ($3,750 for married individuals filing separately) for dependent care accounts and $3,400 (individually) for health care accounts.” * * *
    • “The open season does not apply to the other two federal insurance programs, the FEGLI life insurance program and the FLTCIP long-term care insurance program. FEGLI conducts open seasons only rarely, although new enrollments or coverage changes are allowed in certain circumstances at other times. The FLTCIP has not accepted new applications for enrollment or changes in existing enrollment since 2022; there has been no indication of that suspension being lifted.”
  • FedSmith discusses “Preparing for Medicare: FEHB Decisions at Age 65
    • “Learn how Medicare and FEHB work together at 65. Understand Medicare Part A, Part B, and make smart retirement healthcare decisions early.”

From the Medicare front,

  • Beckers Hospital Review notes,
    • “On Jan. 1, 2027, Medicare’s negotiated prices for 15 more drugs take effect, including the semaglutide products Ozempic, Wegovy and Rybelsus. They join the 10 drugs whose first-round negotiated pricestook effect this year. For hospital pharmacies, the date matters twice: several of the same drugs also move to rebate-only 340B pricing that day if the program takes effect as scheduled.”

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

  • STAT News reports,
    • “Democrats’ landslide victory in the midterm elections may have significant implications for the upcoming negotiations over a key funding source for the Food and Drug Administration, in part by empowering a major critic of the program.
    • “The FDA collects user fees from pharmaceutical companies to fund the agency’s reviews of their medicines. The Prescription User Fee Drug Act must be renewed before the current law expires on Sept. 30. Otherwise, it could disrupt the FDA’s ability to approve medicines.
    • “The power to shape that legislation will fall to senior Democrats, including Sen. Bernie Sanders (I-Vt.), who will likely lead the Senate’s health committee. Sanders is one of the few lawmakers who have opposed the core premise of the user fee structure.
    • “Now, he will have a chance to fundamentally alter how the FDA interacts with the companies it regulates.” 
  • Cardiovascular Business relates,
  • Contemporary OB/GYN shares professional “reactions to FDA’s boxed warning removals for menopausal hormone therapy.”

No Surprises Act News

  • The New York Times reports,
    • “The federal government plans to end contracts with two arbitration firms that settle medical billing disputes under the No Surprises Act, a consumer protection law that has come under scrutiny for high payouts for doctors.” * * *
    • “The arbitrators’ contracts last five years, and the government is now reviewing those awarded in 2022.
    • “Two firms, Island Peer Review Organization and Network Medical Review Company, were notified on Wednesday that the government does not plan to renew their contracts, according to a notice published that day.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Lung cancer remains the leading cause of cancer death in the U.S. and sits at the intersection of several pressures health systems are already managing: an aging patient population, uneven access to screening and a disease that is still most often caught too late. 
    • “How lung cancer affects a health system depends heavily on where it operates. Incidence, mortality, screening and smoking rates, along with Medicare spending, vary widely from state to state.
    • “For healthcare leaders, those state-level differences can inform decisions about screening programs, patient volume and investment in early detection.
    • “Becker’s compiled a list of the facts and figures healthcare leaders need to know about lung cancer using data from the American Cancer Society, the CDC, CMS and a lung cancer screening study published Dec. 9, 2025, in CHEST.”
  • and
    • “Hawaii and Louisiana continue to report the highest percent of influenza-like illnesses as the U.S. experiences an earlier-than-usual flu season.
    • “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 6,100 new flu admissions in the week ending Oct. 24, up from 4,811 the week prior, according to the CDC’s latest FluView report. This accounts for a 27% week-over-week increasein flu admissions. 
    • “About 2.4% of outpatient visits involved patients with respiratory illness. This metric sits below the national baseline of 2.9% and is up from 2.2% the week prior.”
  • The Washington Post relates,
    • “Peanuts, and peanut butter in particular, are some of the most ubiquitous elements of a child’s diet, and so when a kid is allergic to them, it can be a unique vexation for parents. It means no PB&Js for lunch — but also an endless list of logistics, from having to check in with the parents any time their kid goes over to a friend’s house to communicating with school officials.
    • “It turns out that for many kids thought to have peanut allergies, much of that vigilance may not be necessary. 
    • “A new peer-reviewed study, published Nov. 4 in the Journal of Allergy and Clinical Immunology: In Practice, suggests that fewer young children than previously thought have long-lasting peanut allergies. The findings could change how we make early-childhood allergy diagnoses and how to think about treating allergies moving forward.”
    • “Tim Brettig, a pediatric allergist and immunologist, and a senior research clinician at the Murdoch Children’s Research Institute in Melbourne, Australia. said that means many parents who think their children have lifelong allergies to peanut butter might want to reexamine the matter carefully. “If you’ve had a clear reaction, I would be less inclined to accept a peanut allergy diagnosis,” said Brettig, one of the lead researchers on the new study. “I’d want to continue that work-up. I think food challenges should play a greater role in the allergy assessment of children. Give them a chance to prove that they’re not allergic.” 
    • “The key is a controlled environment, such as a doctor’s office, for checking again, Brettig said. About 12 percent of the babies given the oral food challenge did experience anaphylaxis, the whole-body and sometimes life-threatening reaction that is the most severe response to an allergen. But because they were in an environment with medical professionals to administer care, no long-term harm came to any of the children. “It’s not necessarily something that I’d be doing in a community setting,” said Brettig. “You’d want it to be done with specialists that are skilled in performing these food challenges.”
  • The New York Times adds,
    • “Kratom, long used by people seeking relief from addiction to prescription opioids and alcohol, is increasingly being pitched as a wellness product that purports to raise energy, sharpen focus and enhance athletic performance.
    • “Some makers of kratom, a substance that is derived from the leaves of a tropical tree and often sold in the form of drinks, powder or capsules, have distributed free samples at gyms. Others have sponsored sporting events or trumpeted the product’s benefits with the help of social media influencers and wellness podcasts.
    • “What this marketing often fails to acknowledge is the potential for kratom to lead to addiction, liver injury, seizures and in some cases, fatal overdoses.”
  • Healio tells us,
    • “Individuals with inflammatory bowel disease who have at least two first-degree relatives with colorectal cancer appear to have the greatest increase in risk for CRC, according to results of a Swedish cohort study.
    • “Analysis also showed that having a relative with early-onset CRC was associated with a more modest risk, a finding that diverges from prior research.”
  • Health Day informs us,
    • “Gestational weight gain (GWG) outside of recommended ranges is associated with increased severe maternal morbidity (SMM) risk, according to a study published online Oct. 22 in JAMA Network Open.
    • “Sahar Khademioore, from McMaster University Medical Center in Hamilton, Ontario, Canada, and colleagues examined the association between GWG and SMM across prepregnancy body mass index (BMI) categories.”
  • Per an NIH news release,
    • “Results from a clinical trial funded by the National Institutes of Health (NIH) in five major United States cities show that delivering integrated HIV and substance use disorder (SUD) services using peer navigation in mobile medical units reduced all-cause deaths by 71% compared to participants who received peer navigation to community-based services alone. While scientists found no difference in the use of daily, oral preexposure prophylaxis (PrEP) and medication for opioid use disorder (MOUD) between the groups, the secondary outcome of reduced mortality was significant. 
    • “Injection drug use is an important contributor to HIV in the U. S. that also increases risk for other serious infectious diseases,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA), which funded the study. “Although we have effective interventions for this population, there are significant barriers to their accessibility and use. Nonetheless, these findings suggest that delivering low threshold services through mobile units could save lives.” 
  • Beckers Behavioral Health adds,
    • “Researchers at St. Louis-based Washington University School of Medicine found that among patients presenting to the emergency department with a substance-related problem, cannabis was most common among adolescents while alcohol was most common among older adults. 
    • “The study, published Nov. 4 in The American Journal of Psychiatry, analyzed data from large health insurance databases for more than 1.3 million patients ages 16 to 64 who had at least one substance-related emergency care visit between January 2016 and December 2023. Researchers analyzed the data by age group and substance used.” 
  • BioPharma Dive points out,
    • “Sanofi has stopped development of an experimental protein-degrading immune disease drug licensed from biotechnology company Nurix.
    • “Nurix on Tuesday revealed Sanofi’s decision to scrap “SAR448272,” an oral medicine designed to eliminate STAT6, a protein involved in many inflammatory conditions. Nurix didn’t specify the reason for the decision, but Sanofi separately told analyst firm Leerink Partners “emerging nonclinical findings … didn’t warrant further development” in eczema, according to a note to investors. 
    • “Nurix received a $10 million payment from Sanofi in August when a Phase 1 study began and would’ve been eligible for additional payouts if the treatment moved forward in testing.”
  • and

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

  • The Wall Street Journal reports,
    • “CVS Health raised its full-year guidance on gains in its health-care benefits and pharmacy segments, but said it remains cautious amid high costs and potential macroeconomic headwinds.
    • “The outlook comes after the company said Tuesday that it plans to split in two, with one company housing its insurance giant Aetna and pharmacy-benefit manager Caremark, and the other its 9,000 retail pharmacies.
    • “CVS said the breakup, slated for early 2028, will enable the two separate management teams to focus more on their respective businesses and be more agile, The Wall Street Journal reported.
    • “For the current fiscal year, the company on Wednesday said it now expects adjusted earnings of at least $8.20 a share, up from its previous forecast of between $7.90 and $8.10 a share. Analysts polled by FactSet anticipate adjusted earnings of $8.05 a share.
    • “CVS also said it now projects revenue of at least $420 billion for the year, compared with its previous forecast of at least $414 billion. Wall Street is modeling for revenue of $417.7 billion.
    • “Each of our businesses delivered another quarter of strong results,” Chief Executive David Joyner said. “We continue to advance our strategy by improving the consumer experience, lowering health care costs, and connecting care for the people we serve.”
  • and
    • “Novo Nordisk raised its annual guidance due to an improved outlook for its key obesity and diabetes drugs.
    • “The Danish drugmaker now expects adjusted sales and operating profit to range from a 2% decline to 2% growth at constant exchange rates.
    • “Third-quarter sales of the Wegovy pill reached the equivalent of $807.2 million, beating analyst expectations of 4.5 billion kroner.”
  • and
    • “AstraZeneca recently made a roughly $10 billion offer to buy Rhythm Pharmaceuticals RYTM 28.04%increase; up pointing triangle, according to people familiar with the matter, a deal that would expand its portfolio of rare disease treatments. 
    • “The U.K. pharmaceutical giant offered to pay $124 a share for the biotech last month, the people said. 
    • “Rhythm specializes in treatments for metabolic conditions and severe obesity. Its shares were trading Wednesday afternoon at around $95 apiece before The Wall Street Journal reported on the offer. They closed up 28% at over $110 a share following the report, giving the company a market value of roughly $7.6 billion. AstraZeneca had a market value of close to $300 billion.”
  • Beckers Hospital Review lets us know how “Health system CEOs close margin gaps with operational redesign.”
  • Fierce Healthcare informs us,
    • “As health plans and employers contend with a growing array of virtual care and AI-enabled tools, Amwell is positioning its digital health platform as the infrastructure layer for AI-enabled care.
    • “Executives at Amwell, formerly known as American Well, touted the company’s platform strategy, government contracts and higher-value clinical services as the main drivers of future growth during the company’s third-quarter earnings call Tuesday.
    • “Rising healthcare costs are pushing health plans and employers to adopt tech-enabled care solutions, but they are looking for measurable engagement and outcomes from digital health vendors, not just access, according to Ido Schoenberg, M.D., Amwell chairman and CEO.
    • “The proliferation of point solutions, accelerated by AI, is creating more vendor sprawl and member confusion, Schoenberg told investors and analysts during the call.” * * *
    • “This is the problem Amwell is determined to solve for our customers. We help them improve clinical and financial outcomes. We do it through activation, getting more of their members into technology-enabled care in place of conventional care that often costs more. We give our customers one platform under their brand with one integration. It provides reliable, scalable rails to bring in a program, exchange data with it, and tests whether it works. The member’s experience stays consistent, simple, and engaging. A common data structure proves the outcomes and improves performance over time,” he said.
    • “As AI adoption grows, a unified care platform becomes more valuable, Schoenberg asserted.”

Friday report

Simplicity is a virtue.

From Washington, DC

  • The Wall Street Journal reports,
    • “Affordable Care Act plan premiums will rise by 13% in 2027, the second straight year of double-digit increases in a strained market that is already facing shrinking enrollment.
    • “Next year’s boost follows a 26% surge this year and is the second biggest rise since 2018, according to KFF, the health-research nonprofit that calculated the increase based on federal data released Friday.
    • “The hike means an average monthly premium of about $704 for a 40-year-old buying an ACA “benchmark” plan for 2027, compared with $624 this year and around $497 in 2025. Benchmark plans are midtier products in each region that are used to set federal subsidy amounts.
    • “People can start shopping for next year’s ACA plans on Nov. 1. The latest increase will add to the strain for the slice of ACA consumers who pay the full price for their plans. Most people with ACA coverage get the government subsidies, but federal support was reduced sharply at the start of this year, leading millions of people to drop out of the market.” * * *
    • “For the ACA plans, as with other types of insurance, a main driver of higher premiums for next year is the growth in spending in areas like hospital care and drugs, said Cynthia Cox, a senior vice president at KFF.”
  • Here’s a link to the CMS Fact Sheet on this news.
  • Per a CMS news release,
    • ‘The U.S. Department of Health & Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has finalized a rule to help more donated organs reach patients by strengthening oversight of Organ Procurement Organizations (OPOs). OPOs connect donor hospitals and transplant programs by securing authorization for donations, recovering organs, and coordinating safe, timely delivery for transplantation. This rule builds upon President Trump’s 2019 Executive Order, Advancing American Kidney Health, and helps advance a key goal of the Department’s Kidney Care National Plan to reform organ transplantation
    • “While more than 49,000 transplants were performed in the United States in 2025, over 100,000 Americans are waiting for lifesaving transplants. To improve access to transplants, the final rule allows high-performing OPOs to compete for multiple donation service areas, clarifies OPO recertification procedures, and reinforces longstanding process performance standards.” * * *
    • “The final rule is available in the Federal Register at: https://public-inspection.federalregister.gov/2026-22381.pdf. 
    • “View the final rule fact sheet at: https://www.cms.gov/newsroom/fact-sheets/medicare-medicaid-programs-organ-procurement-organizations-conditions-coverage-revisions-conditions.”
  • Beckers Hospital Review reports,
    • “In the first six months of Medicare’s Wasteful and Inappropriate Service Reduction pilot, the use of targeted services fell in participating states relative to the rest of the country, according to a research letter published Oct. 26 in JAMA.
    • “The study, from researchers at the University of Minnesota School of Public Health and Brown University School of Public Health, gives early insights into WISeR. The pilot, which brings AI-enabled prior authorization to traditional Medicare, is taking place for six years across six states, according to CMS.
    • “Compared with trends in other states, monthly epidural steroid injections declined 15%, while other targeted services declined nearly 20%. Services with delayed WISeR implementation served as a negative control, showing no significant change.” * * *
    • “The key question we can’t yet answer is whether the care not received was wasteful or necessary,” Hannah Neprash, PhD, lead author and University of Minnesota School of Public Health associate professor, said in an Oct. 26 news release.” 
  • GSA announced today,
    • “The Federal Acquisition Regulatory Council has released an update to the FAR Companion as part of the ongoing Revolutionary FAR Overhaul (RFO) Initiative, in accordance with Executive Order 14275 and OMB Memorandum M-25-26.
    • “FAR Companion, Version 3.0 was posted on October 30, 2026. FAR Companion, Version 3.0, includes:
      • “Embeds a feedback form directly in the FAR Companion;
      • “Captures best practices for industry engagement across the acquisition lifecycle;
      • “Adds guidance on non-federal past performance, contractor self-assessments, performance monitoring, and reprocurement to the next highest-rated offeror;
      • “Includes annotations that cover all RFO smart accelerators and Periodic Table of Acquisition Innovations techniques;
      • “Moves common acquisition practices into FC 7.102(a) for consistency across buying pathways;
      • “Clarifies outcome-based contracting as a subset of performance-based acquisition;
      • “Clarifies use of modular contracting; updates definitions, procedures, and guidance on commercial contracting, including commercial construction contracting;
      • “Expands guidance on construction and architect-engineer contracting; adds guidance on contract closeout and termination settlements;
      • “Provides context on non-FAR based authorities such as OT, SCO, and the SBIR/STTR program; and
      • “Adds relevant program management concepts for improved cross-functional usability; and includes updates to FC parts 5, 6, 7, 11, 15, 24, 32, and 36 based on practitioner and interagency feedback.
    • “To view the FAR Companion, Version 3.0, visit: https://www.acquisition.gov/sites/default/files/page_file_uploads/far-companion.pdf.
    • “To view all available rewritten FAR Parts and agency deviations, visit: https://www.acquisition.gov/far-overhaul/far-part-deviation-guide.”

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

  • Federal News Network reports.
    • “With two months left for agencies to conduct a required annual assessment of federal employee satisfaction and engagement, the Office of Personnel Management is finalizing major changes to the structure and distribution of the now-defunct Federal Employee Viewpoint Survey.
    • “Following final regulations published Thursday, OPM has formally moved forward with ending the distribution of FEVS, which it has overseen for more than 20 years. Instead, it’s telling agencies to issue their own versions of the workforce survey by the end of the calendar year.
    • “OPM said the changes are meant to make the engagement survey more useful and actionable. But critics of OPM’s changes contend that removing the governmentwide survey will undermine years of comparable workforce data and reduce transparency into the results.
    • “In its final rule, OPM pointed to three large agencies that have already discontinued using FEVS — NASA, the Department of Veterans Affairs and the Securities and Exchange Commission — as evidence that the engagement survey needed to be individualized.

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

  • Contemporary OB/GYN reports,
    • “The FDA has approved updated labeling for 3 additional menopausal hormone therapy (MHT) products, removing statements on cardiovascular disease, breast cancer, and probable dementia from their boxed warnings, according to an October 30, 2026, release from the US Department of Health and Human Services (HHS). All 3 products are estradiol transdermal patches from 2 applicants, though the FDA did not provide details on brand or manufacturer names.1
    • “The approvals follow the agency’s February 2026 action on labels for 6 MHT products. The FDA began engaging companies on the changes in November 2025, and 29 drug companies have submitted proposed labeling changes to date, the agency stated. HHS added that the latest actions support the executive order “Advancing Women’s Health to Improve Outcomes in All Phases of Life,” signed October 19, 2026.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP), a rare disease caused by human papillomavirus (HPV) that leads to the formation of small, wart-like growths in the patient’s airways. This approval, the first for a plasmid DNA-based immunotherapy in the U.S., offers patients a new therapeutic option that targets the root cause of RRP and has been shown to reduce the burden of surgical intervention, representing an important step forward for a patient population with limited treatment options.” * * *
    • “The FDA granted Voceryq Breakthrough and Orphan Drug designations. The FDA granted accelerated approval of Voceryq to Inovio Pharmaceuticals, Inc.”
  • Cardiovascular Business relates,
    • “Sotagliflozin has been linked to key cardiovascular benefits for a wide range of patients. In fact, the team behind new research published in The Journal of Clinical Investigation believe it may be a “wonder drug” of sorts with untapped potential.[1]
    • “Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor sold by Lexicon Pharmaceuticals under the brand name Inpefa. It first secured U.S. Food and Drug Administration (FDA) approval in 2023 to reduce the risk of heart failure among high-risk patients, including those with type 2 diabetes.
    • “Multiple studies have linked this drug to a reduced risk of adverse cardiovascular events, including one from 2025 that found it may protect patients from heart attack and stroke. To learn more, a group of researchers with the University of Michigan performed a series of experiments focused on learning how, exactly, sotagliflozin achieves these results.
    • “A drug that can both decrease the risk for diabetes along with the risk for having a heart attack or stroke could be a turning point in our ability to safely treat this growing population in the US and abroad,” co-senior author Michael A. Holinstat, PhD, MS, a professor of pharmacology, internal medicine and surgery at University of Michigan Medical School, said in a statement.
    • “Sotagliflozin appears to be in the sweet spot because compounds that have higher levels of SGLT1-selective inhibitors can cause gastrointestinal issues,” added co-author Bertram Pitt, MD, professor emeritus of internal medicine at University of Michigan Medical School. “We think this could be a wonder drug with potential to offer benefit for many conditions.”

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Departments of Labor, Health and Human Services, the Treasury, and the Office of Personnel Management released guidance Oct. 29 for independent dispute resolution entities on batched and bundled items or services, reflecting changes finalized in the No Surprises Act IDR operations rule in May on how qualified IDR items and services can be batched. The guidance explains how the finalized batching requirements will be used and specifies the permissible current procedural terminology code ranges for anesthesiology, radiology, pathology and laboratory items and services considered to relate to the treatment of a similar condition. It also explains the definition of a bundled payment arrangement and provides examples to guide how disputing parties and certified IDR entities should apply the finalized batching and bundled payment provisions.” =
  • STAT News adds,
    • “It was a simple urinary tract infection. A textbook urgent care visit. 
    • “Kristin Gills knew the drill. She peed in the cup, and the doctor confirmed her suspicion. He prescribed antibiotics. Before she left Methodist Legacy ER & Urgent Care in Allen, Texas, Gills paid her $211 bill and figured that was the end of it.
    • “Then the real bill came, for another $1,756.
    • “I was like, ‘What in the world?’ I immediately tried calling them,” she said. When she couldn’t reach anyone, she sent three MyChart messages. Nothing.” * * *
    • “The facility Gills visited doubles as both an emergency room and an urgent care clinic. Intuitive Health, the private equity-backed company that runs the hybrid facility and nearly 50 others like it, says they’re great for patients because they prevent them from having to guess whether their conditions are emergencies. But patients told STAT they visited for what they thought were obvious urgent care issues — coughs, congestion, flu symptoms — and were shocked when they got bills for ER care instead, often totaling thousands of dollars. 
  • FEHBlog observation — This patient must have been cash only because if she had used health insurance the provider would have collected the cost sharing and then proceeded to the No Surprises Act dispute resolution process. It is ironic

From the judicial front,

  • The American Hospital Association News reports,
    • The U.S. District Court for the District of Massachusetts yesterday ruled in favor of 25 states and the District of Columbia to vacate the Centers for Medicare & Medicaid Services’ definition of “medically frail” from its Medicaid community engagement requirements.
    • “The definition would have required medically frail individuals to demonstrate they had a qualifying condition that significantly impairs their ability to comply with the community engagement requirements. The requirements call for certain adults to complete 80 hours per month of “qualifying activities,” such as employment, education, community service or participation in a work program, or meet equivalent income thresholds. In the decision, District Judge Richard Stearns said CMS went beyond its scope in authorizing the provision and narrowing the definition of “medically frail.”  
    • “Because enforcement of an unlawful definition of ‘medically frail’ may lead to the disenrollment of otherwise eligible vulnerable individuals relying on Medicaid coverage for continuity of care, the States (and public) face potential for great hardship in the absence of an injunction,” Stearns wrote. The remaining provisions under the community engagement requirements will be enforced beginning Jan. 1, 2027.” 

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 low in most areas of the country.
    • “COVID-19 activity is declining nationally.
    • “Seasonal flu activity remains low nationally but is increasing in many parts of the country.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated but decreasing nationally, and human parainfluenza viruses (PIV) are increasing.”
  • The University of Minnesota’s CIDAR adds,
    • It used to be that 200-plus US measles cases would reflect the total for the year or even for two years, but the Centers for Disease Control and Prevention (CDC) today confirmed 264 new cases in just the past seven days, raising the country’s total to 4,852 cases, by far the highest yearly total in 35 years.
    • “The new data mark the 12th straight week of triple-digit increases nationwide. Rising cases in multiple states have contributed to the escalation, but Pennsylvania continues to be the nation’s hot spot, logging 88 new cases this week, followed closely by Wisconsin.
    • “The United States will very likely lose its measles elimination status—which it gained in 2000—in the coming month. Even an analysis published in May, when the country had only around 1,800 cases, said as much.
    • “The CDC has logged 43 measles outbreaks across the country so far this year, compared with 48 for all of last year, which saw 2,289 cases by year’s end. An outbreak involves three or more people. All but 18 infections this year have been locally acquired, with the rest involving international travelers.
    • “Of the confirmed cases, 17% have been in children under the age of 5 years, and 41% have been in kids and teens ages 5 to 19. Eleven percent of cases overall have required hospitalization, a number that has been slowly climbing and now matches the 2025 rate. Hospitalization rates are highest in preschoolers (16%), with a 14% rate in adults 20 and older.”
  • and
    • “Measles is highly contagious, and quickly identifying who is infected is critical from a public health perspective: Delays lead to additional cases since patients, caregivers, and clinicians won’t know to take precautions to prevent viral spread. 
    • “Yet an estimated 6.9% of patients with measles who sought medical care were misdiagnosed at least once in the two weeks before an accurate diagnosis, according to a study published this week in Infection Control and Hospital Epidemiology. 
    • “While the findings suggest these errors are not common, the University of Iowa authors argue the study shows the need to consider early measles testing among patients with respiratory symptoms.
    • “The risk of transmission is increased when patients spend time in busy waiting rooms or clinics, because virus aerosols remain airborne for hours,” said the authors, led by biostatistician Alan T. Arakkal, PhD.” 
  • The American Medical Association lets us know what doctors want patients to know about sciatica.
    • “A sharp, shooting pain that starts in your lower back can be a sign of sciatica. Learn what causes sciatica, how long it lasts and when to see a doctor.”
  • Contemporary OB/GYN relates,
    • “The American College of Obstetricians and Gynecologists (ACOG) has issued a practice advisory recommending that ob-gyns counsel patients on the lack of sufficient safety data for glucagon-like peptide-1 receptor agonists (GLP-1RAs) in pregnancy, advise considering discontinuation 1 to 2 months before conception, and advise against use during pregnancy. For lactation, the guidance supports shared decision-making on a postpartum care plan that may include GLP-1RAs, with close surveillance of neonatal weight gain, and recommends against use in individuals breastfeeding or chestfeeding preterm infants and neonates.
    • “Prescribing of GLP-1RAs in the perinatal period increased more than 30- between 2019 and 2024, according to a large retrospective cohort study cited in the advisory. The long half-lives of semaglutide, tirzepatide, and dulaglutide make avoiding the medication during pregnancy more challenging, and because GLP-1RA-associated weight loss may improve fertility, patients who can become pregnant should be counseled on effective contraception.
    • “Currently, as many as 1 in 300 women are exposed to GLP-1s prior to pregnancy,” said D. Yvette LaCoursiere, MD, FACOG, lead author of the guidance, in an ACOG news release. “This is a fast-moving area of research, so for now we need to proceed with caution and reassess as more data becomes available.”
  • Beckers Behavioral Health tells us,
    • “The share of U.S. children and adolescents ages 5-17 who have ever received an attention-deficit/hyperactivity disorder diagnosis rose from 9.9% in 2019 to 13.8% in 2025, according to CDC data published Oct. 29.
    • “The CDC’s National Center for Health Statistics released the findings as a QuickStats feature in the Morbidity and Mortality Weekly Report.
    • “Nazik Elgaddal of the National Center for Health Statistics wrote the analysis, which draws on National Health Interview Survey data from 2019 through 2025. The estimates measure whether a child had ever received an ADHD diagnosis, not whether the condition is currently active or under treatment. The CDC also published a supplementary table with year-by-year figures by sex.”
  • and 
    • “Calls to the Washington Poison Center involving kratom and one of its active compounds, 7-hydroxymitragynine, or 7-OH, rose 433% over the past three years, with the sharpest increase in 2026, CBS affiliate KIRO 7 News reported Oct. 29.
    • “The center logged 176 kratom- and 7-OH-related calls through the end of September, ranging from overdoses to withdrawal cases. In September, the center received calls nearly every day.
    • Jimmy Leonard, PharmD, chief clinical officer at the Washington Poison Center, “told KIRO that 7-OH is “essentially an unregulated opioid” that can slow or stop breathing and may cause death. Dr. Leonard said he is particularly concerned about accidental exposures in children because some 7-OH products come as small, candy-like tablets in flavors such as Sour Strawberry and Blue Razz. A few children have required naloxone, he said.
    • “Washington has no statewide kratom regulations and no statewide minimum purchase age. Cities including Bellingham, Mount Vernon and Spokane have enacted local bans. Nationally, 33 states have adopted some form of kratom regulation and nine have banned it, according to the American Kratom Association.
  • Health Day informs us,
    • “Nicotine pouches are catching on in the U.S., as increasing numbers of Americans try and become regular users of the non-tobacco products, a new study says.
    • “More than 1 in 10 Americans (10.2%) have tried a nicotine pouch, researchers reported Oct. 28 in the journal Addiction.
    • “Further, among tobacco users — people who already smoke, vape or use chewing tobacco, for example — about 1 in every 10 were using nicotine pouches in 2024. That’s more than triple the 3% of tobacco users who were using them in 2021, the study says.
    • “That’s a swift increase, given that the pouches only hit U.S. markets a decade ago, in 2016, researchers said.
    • “Our data show that what was once considered a niche nicotine product is becoming a mainstream product among U.S. adult tobacco users,” said lead researcher Ashley Merianos, a professor of human promotion and education at the University of Cincinnati.”
  • Medscape points out,
    • “Waiting times for an initial neurology appointment for memory concerns average more than 4 months, potentially delaying diagnosis and treatment.
    • “In a nationwide telephone survey of 150 neurology clinics nationwide, researchers found that wait times averaged 21.1 weeks at specialized centers and 15.6 weeks at community neurology clinics. Forty-one clinics reported wait times of at least 6 months, and five were not accepting new patients.
    • “A wait of more than 4 months for a first visit is one step in an already long path to diagnosis, and it pushes back the testing, diagnosis, and treatment planning that start at that visit,” study investigators Jennifer C. Knox, MS, and Jeremy J. Pruzin, MD, of the Banner Alzheimer’s Institute in Phoenix, told Medscape Medical News in an email.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Insurers are rolling out commercial offerings for 2027, and many are navigating a landscape of greater affordability pressures on employers and, ultimately, their employees. 
    • “Professional services firm Aon projected that average employer healthcare costs could surpass $19,000 per employee in 2027, a 9.5% increase. Between 2025 and 2026, employee premiums increased by 6.4%.
    • “Some commercial payers are introducing products designed to give employers another option beyond HMOs and PPOs: exclusive provider organizations, or EPOs.
    • “An EPO offers a strong middle ground between a PPO and an HMO,” Chris Fanning, executive vice president and chief commercial officer at Independence Blue Cross, told Becker’s in a statement. “Members have access to a broad network of providers and can see specialists without referrals, while employers can often realize cost savings because coverage is generally limited to in-network care. We already offer a range of PPO and HMO options, and EPOs give employers another choice to meet the needs of their workforce.”
  • Beckers Hospital Review relates,
    • “Sacramento, Calif.-based Sutter Health has scrapped plans to build a hospital on its Emeryville, Calif., property. The system cited regulatory uncertainty and the risk of litigation as the main reasons.
    • “The most significant barrier was the lack of a clear and predictable regulatory path,” Sutter said in an Oct. 30 statement. “Over two years, we pursued relief under the California Environmental Quality Act, or CEQA. Those efforts did not secure the certainty needed to advance the hospital project, leaving it vulnerable to litigation that could delay construction and new hospital services for years.”
  • and
    • “Livonia, Mich.-based Trinity Health is working to make primary care, rather than the emergency department, the main way patients enter its system, executives said during the system’s fiscal 2026 investor call Oct. 26. 
    • “Health systems have historically treated the emergency department as the primary entry point to care, said Ray Anderson, PhD, executive vice president and chief strategy officer. 
    • “We’re looking to flip that pyramid upside down and really have primary care be the most important entry point,” he said.
    • “Dr. Anderson said routing patients from primary care to specialists and then to community-based services brings in more elective patients who are “choosing us,” creates a more balanced payer mix and makes the system less dependent on seasonal swings in emergency volumes.”
  • Fierce Pharma tells us,
    • “Facing looming patent cliffs, AstraZeneca has launched a restructuring initiative aimed at generating $1.5 billion in annual savings by 2029.
    • “Savings from the “Reshaping for Sustainable Growth” program will be reinvested “principally in the pipeline,” AZ said Friday in its third-quarter earnings announcement.
    • “The company expects the three-year initiative to incur up to $2 billion in one-time restructuring costs.”
  • and
    • “Prescriptions for Eli Lilly’s Foundayo and Novo’s Wegovy pill ticked back up last week, although neither matched previous records.
    • “Foundayo enjoyed 63,110 total scripts in its 29th week of launch, still shy of its 64,268-script record set in week 25, according to IQVIA data cited by Citi. 
    • “The Wegovy pill’s roughly 183K scripts also came slightly below the 184K height it had briefly reached five weeks ago. During the week, the oral version of Novo’s obesity med constituted 36% of all Wegovy scripts.
    • “Approximately 4 in 10 patients starting an oral obesity medicine choose Foundayo, and the number of new Foundayo patients in the third quarter doubled from the previous quarter, Lilly’s CFO said on the company’s Q3 earnings call Thursday.
    • “In Q3, Foundayo sales reached $184 million, including $124 million from the U.S., missing consensus estimates by $50 million, according to a Jefferies note. Still, Lilly’s stock price jumped during Thursday’s earnings report, “which to us suggests investors are increasingly focusing on the breadth and depth of [Lilly]’s obesity franchise rather than near-term Foundayo [numbers],” Jefferies’ analysts said. Sales from both of Lilly’s tirzepatide products, Mounjaro and Zepbound, came in above Wall Street’s projections during Q3.”
  • MedTech Dive shares “three highlights from EY’s report on 2026 medtech trends.”
    • “M&A rose, but company valuations declined in the first half of 2026 compared with the year-ago period, according to EY’s Pulse of the Industry report.”
  • MedCity News informs us,
    • “Direct-to-consumer diagnostics are becoming increasingly popular. But what’s driving the rise of consumer diagnostics? This was the topic of conversation during a Thursday panel at the MedCity INVEST Digital Health conference in Dallas.
    • “One panelist — Leo Grady, CEO of gut microbiome testing company Jona — noted that people have been interested in analyzing themselves for a long time. Genetic testing company 23andMe started about 20 years ago, and Everlywell made home testing mainstream, he said. But Covid-19 really drove the rise in at-home diagnostics.
    • “I think it was partly driven by the fact that everybody was home, partly because health became more on your mind, and also partly because of some of the regulatory relaxations that happened that made it more possible to ship tests across state borders, to have more clinical-grade tests prescribed without having them to come from your doctor,” he said. “That really standardized and made more mainstream the ability for people to access tests and to then be able to get those results and even talk to medical professionals online.” * * *
    • “Pita Navarro, chief scientific officer of Evvy, noted that the women’s health space has seen slower growth than other areas. Evvy is a vaginal microbiome testing company.
    • “I think for me as a scientist and going through Covid specifically, I was watching the vaccine develop within months, the causing agent identified within months as well. And yet, I was going to the OB/GYN, and they were counting shapes under a microscope. And so we thought, ‘We have this new technology; why isn’t it being applied in women’s health as it’s being applied across the healthcare system?’”
    • “She added that this was a major driver for the creation of Evvy. Vaginal health is a leading reason that women seek healthcare advice, and if a female goes to an OB/GYN, they’re more likely to get misdiagnosed than correctly diagnosed, Navarro said. The vaginal microbiome is also predictive of numerous outcomes across the lifespan, including cervical cancer, sexually transmitted infection and infertility.”

Midweek update

Simplicity is a virtue.

From Washington, DC,

  • The Wall Street Journal reports
    • “The Trump administration will require the companies that manage hundreds of billions of dollars of drug spending to disclose details on how they get paid.
    • “Under a new regulation from the Labor Department expected to be released Thursday, pharmacy-benefit managers will have to provide their employer clients with granular information about the prices they pay for pharmaceuticals, as well as payments they receive from drugmakers, according to people with knowledge of the matter.
    • “The new rule is an effort to lower healthcare costs, said a Labor Department official, in line with an executive order from April 2025 and the Trump administration’s promise to significantly reform PBMs.” * * *
    • “Under the new rule, PBMs will have to tell employers upfront about compensation they expect to receive from drug manufacturers and pharmacies and then provide updates every six months on their actual earnings, according to people familiar with the matter. Employers would also get the right to audit their PBMs.
    • “PBMs will have to disclose rebates and other types of payment from drugmakers, the people said, including any that might lead patients to be steered to certain drugs over others. The disclosure requirements also include group purchasing organizations tied to PBMs, which can collect rebate payments on their behalf.
    • “The PBMs also need to tell employers about “spread pricing” arrangements, under which an employer may pay more for a drug than a pharmacy is reimbursed for the same medication, leaving a margin that the PBM can keep.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “Combating kidney disease starts with prevention, early detection, and timely treatment to help protect kidney health and slow disease progression. For Americans who depend on dialysis, high-quality care is vital to their health and daily lives. The Centers for Medicare & Medicaid Services (CMS) is committed to improving how our kidney care system serves patients by supporting access to lifesaving treatment so more Americans can live longer, healthier lives.
    • “CMS is advancing its goals for dialysis access and quality through the calendar year (CY) 2027 Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) final rule. On Oct. 28, 2026, CMS issued a final rule to update payment rates and policies under the ESRD PPS for renal dialysis services furnished to Medicare beneficiaries on or after Jan. 1, 2027. This rule also finalizes updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2027 and updates requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2027, CMS will increase the ESRD PPS base rate to $297.52, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7%. This amount includes a $12.85 increase to account for the incorporation of phosphate binders into the ESRD PPS base rate. The CY 2027 ESRD PPS final rule also finalizes changes to the low-volume payment adjustment, changes to the payment adjustments for pediatric patients, an increase to the home and self-dialysis training add-on payment adjustment amount, and modifications to the transitional drug add-on payment adjustment (TDAPA), and modifications to the post-TDAPA add-on payment adjustment policies.” * * *
    • “The final rule can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection/current.”

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

  • Govexec reports,
    • “The Office of Personnel Management is hosting a virtual hiring fair on Thursday as part of Director Scott Kupor’s push to bring more early-career workers into the civil service. 
    • “I’ll call it a hire-palooza for lack of a better word,” Kupor said on The Charlie Kirk Show, a podcast that was previously hosted by the slain conservative activist. “We’re going to have 16 agencies who are literally going to use an online campaign and do online interviews with folks, and we’re going to make job offers on the spot on Oct. 29.” 
    • “In response to questions from Government Executive, an OPM spokesperson clarified that the event is only for applicants who are already going through the hiring process. 
    • “The purpose of the hiring fair is to coordinate across agencies to complete virtual interviews and initiate job offers for early career positions across the country,” they said in a statement.” 
  • FedSmith explains why “Your FEHB Premium Can Rise Faster Than Your Plan’s Price.”
    • The government pays exactly 75% of FEHB premiums in some plans and a fixed amount in others. Here is how the [statutory] formula works and why it matters for 2027.

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

  • The Wall Street Journal reports,
    • “Health Secretary Robert F. Kennedy Jr. is temporarily allowing six unapproved peptides on the market, despite warnings from government scientists that there is not enough evidence to prove they are safe or effective.
    • “In a policy released Wednesday, Kennedy said his department would no longer stop compounding pharmacies from distributing a handful of widely used peptides. The Food and Drug Administration is deciding whether to officially allow them to be compounded—a decision that could take months or even longer. The new policy could make it more difficult for the FDA to restrict peptides in the future.” * * *
    • “The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500, which are marketed for antiaging, boosting metabolism and improving memory, among other things. Earlier this year, the FDA’s Pharmacy Compounding Advisory Committee voted in favor of easing restrictions on the peptides, despite warnings from career scientists. Many of the committee members were selected on Kennedy’s watch, and some had ties to peptide businesses.
    • “The interim policy is expected to lead to a boom in peptide sales, with major telehealth companies including Hims & Hers and Noom considering or planning to expand the list of peptides they offer. Leerink analysts have estimated that with legalization, the peptide business for telehealth companies could reach $2 billion a year.”
    • Note — The FEHBlog learned earlier this month that a peptide is a chain of amino acids.
  • Cardiovascular Business relates,
    • “Abbott has secured U.S. Food and Drug Administration (FDA) approval for its Amplatzer Paraclose PVL Occluder, a new transcatheter device specifically designed to treat paravalvular leak (PVL) following heart valve surgery.
    • “PVL is a known complication after valve replacement surgeries as well as transcatheter valve replacement procedures. It occurs when the new valve is implanted in a way that leaves a small gap that blood can then pass through.  
    • “The Amplatzer Paraclose PVL Occluder is the first device of its kind to ever receive FDA approval. It is delivered through an artery or vein in the leg, no additional open-heart surgery required, and it is positioned within the PVL to close the leak. 
    • “The FDA’s decision to approve the device was based on data from PARADIGM, a multicenter study of 200 patients who underwent an aortic or mitral valve replacement surgery.”

No Surprises Act News,

  • Healthcare Dive reports,
    • “Insurers and employers are asking the Trump administration to stop recertifying No Surprises Act arbiters until the law’s controversial dispute resolution process is reformed.
    • “The Coalition Against Surprise Medical Billing, a payer advocacy group, and the ERISA Industry Committee, which represents large employers, sent letters to top administration officials last week asking them to pause recertifications until they implement more rigorous standards for independent dispute resolution entities — third-party organizations responsible for mediating billing disagreements under the NSA.
    • “IDREs have contributed to “structural failures” in the arbitration process, which has generated billions of dollars in wasteful costs, the CASMB argued in its letter sent Oct. 22. The groups also want the CMS to allow more time for the public to comment on IDRE applicants.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “The cumulative flu hospitalization rate has climbed to the highest level for this point in the season in more than 15 years, according to CDC data.
    • “For the week ending Oct. 17, the cumulative flu hospitalization rate was 2.1 per 100,000 population — more than 10 times the rate seen during the same period last season. This marks the highest rate for this point in the season since at least the 2010-11 season, followed by the 2022-23 and 2023-24 seasons, historical CDC data shows. 
    • “The hospitalization rate comes as the U.S. sees an unusually early start to flu season, which researchers have linked to a single mutation in the circulating H1N1 influenza virus that may help it evade some pre-existing immunity.”
  • and
    • “States with lower breast cancer screening rates often report higher shares of breast cancers diagnosed at a regional or distant stage, according to U.S. Cancer Statistics data released in June by the CDC.
    • “The CDC classifies breast cancer stage at diagnosis based on how far the disease has spread: Localized cancers remain in the breast, regional cancers have spread to nearby tissue or lymph nodes and distant cancers have spread to other organs or distant lymph nodes. Regular breast cancer screening helps detect the disease before it spreads, when it is easier and less costly to treat, and reduces breast cancer deaths, according to the CDC.
    • “According to the National Cancer Institute, the five-year relative survival rate for breast cancer from 2016 to 2022 was 100% when the disease was localized, 87.5% when it was regional and 33.8% when it was distant.”
  • The American Hospital Association News adds,
    • “A study conducted by the University of Utah examined variations in risk behaviors for colorectal, cervical and breast cancer and trends in screening across rural and urban areas. The study, which used data from the Census Bureau and the Centers for Disease Control and Prevention, found that rural areas had greater socioeconomic disadvantages and more limited healthcare access, as well as higher smoking, physical inactivity and obesity prevalences than urban areas. The study found more variation in colorectal cancer screening rates (64.5% for urban vs. 61.2% for rural areas) than cervical and breast cancer screening rates (84.5% vs. 82.6% and 75.5% vs. 74.6%, respectively).”
  • Cardiovascular Business relates
    • “The Heart Failure Society of America (HFSA) has released a new scientific statement calling for right heart failure (RHF) to be recognized as its own distinct clinical syndrome instead of a secondary complication of left-sided heart disease.[1] The statement was published in full in the Journal of Cardiac Failure (JCF).[1]
    • By consolidating evidence and outlining clear knowledge gaps, the HFSA scientific statement aims to help clinicians apply a more consistent, pathophysiology-driven approach to RHF. Another goal is to lay the groundwork important research the writing group says is still needed to advance the field of heart failure care.
    • “The authors of the statement provided a structured framework to guide the earlier recognition of RHF and more consistent management in clinical practice. The group noted that RHF is growing more common as pulmonary vascular disease advances, which results in longer hospitalizations, heavier ICU use and frequent hospital readmissions that place substantial strain on the healthcare system.
    • “RHF has too often been treated as an afterthought of left heart disease,” Manreet K. Kanwar, MD, corresponding author of the statement and director of the heart failure and pulmonary hypertension program at the University of Chicago, said in a statement. “This statement makes the case that RHF should be recognized and managed as its own syndrome, with a diagnostic approach and treatment strategy tailored to right ventricular physiology.”
    • “Our hope is that this framework gives clinicians a structured way to recognize and manage right heart failure earlier, and gives the research community a foundation to close the gaps that have limited progress in this field,” added Ryan J. Tedford, MD, senior author of the statement and medical director of cardiac transplantation at the Medical University of South Carolina.
  • Health Day tells us,
    • “The pace of your daily stroll could show how close the Grim Reaper is behind you.
    • “In a new study, folks who walked at a brisker pace had a lower risk of an early death.
    • “Faster walking speed and more steps-per-minute are both associated with a lower risk of dying from any cause, researchers reported Oct. 23 in JAMA Network Open.
    • “Walking speed and step rate were “consistently associated with all-cause mortality, even after adjustment for daily step count,” the researchers wrote. The study was led by Rayane Haddadj, a fellow in public health and nursing at the Norwegian University of Science and Technology in Trondheim.”
  • and
    • “Showing teens how to better manage their emotions may help them maintain a healthier weight, a new study says.
    • “Teens engaged in a weight-loss program were less likely to regain weight if the program included training on how to understand and manage their moods, researchers reported Oct. 22 in JAMA Network Open.
    • “Doing so left teens less inclined to use snacking as a way to ease stress or boost mood, the research showed.
    • “Weight loss is only part of the story,” explained lead researcher Kerri Boutelle, a professor of pediatrics and psychiatry at the University of California-San Diego.”
  • BioPharma Dive informs us,
    • “Eli Lilly’s triple-acting metabolic drug retatrutide bested Novo’s Ozempic in a head-to-head Phase 3 trial, with the highest dose tested beating Novo’s drug on measures of blood sugar and weight loss, the company said Wednesday.
    • “After 80 weeks of treatment, a 12 milligram weekly dose of retatrutide lowered blood sugar by an average of 2.2 percentage points, significantly more than Ozempic’s 1.8 percentage points, Lilly said. A 9 mg dose of retatrutide also lowered blood sugar by 2.2 percentage points, but the difference when compared to Ozempic was statistically “nominal,” the company said.
    • “The results confirm earlier findings suggesting retatrutide — which acts on three metabolic pathways versus one for Ozempic — could be a differentiated diabetes and weight loss medicine. In an obesity trial, this “triple-G” drug stimulated weight loss that rivaled results seen in bariatric surgery.”
  • Medscape adds,
    • “The investigational weight-loss drug retatrutide (Eli Lilly) significantly reduced obstructive sleep apnea (OSA) severity in adults with overweight or obesity, with or without type 2 diabetes, in two phase 3 randomized trials.
    • “At 80 weeks, patients receiving once-weekly subcutaneous retatrutide had substantially greater reductions in breathing interruptions during sleep than those receiving placebo, along with marked weight loss.
    • “Retatrutide treatment enabled more participants to have remission of OSA or mild OSA without excessive daytime sleepiness,” reported the investigators, led by Ronald R. Grunstein, MD, PhD, of the Woolcock Institute of Medical Research and Macquarie University in Sydney, Australia.”
  • The Washington Post points out,
    • “At 80, he’s a top dementia expert. Here’s how he keeps his brain healthy.
      • “Researcher Ron Petersen says there are simple things we can all do for healthier cognitive aging.”

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

  • Beckers Hospital Review reports,
    • “Franklin, Tenn.-based Community Health Systems reported an operating income of $146 million (5.3% margin) in the third quarter, down from a $243 million operating gain (7.9% margin) in the same quarter last year, according to financial results published Oct. 29. 
    • “After accounting for interest and income tax expenses, the 59-hospital, for-profit system posted a net loss of $86 million (-3.1% margin) in the third quarter, down from a $130 million net gain (4.2% margin) in the same period in 2025.  
    • “Hospital divestitures, an unfavorable payer mix and higher medical specialist costs weighed on the health system’ financial results.”
  • and
    • “For several large health systems, the selling phase is ending. In May, Becker’s reported that Dallas-based Tenet Healthcare, St. Louis-based Ascension and Franklin, Tenn.-based Community Health Systems were shedding hospitals and putting the proceeds into surgery centers.
    • “Five months later, the next phase is clearer. These systems are reporting improved margins and are treating that recovery as permission to grow again, carefully and close to home.
    • “[The article describes] four patterns emerging as systems move from defense to offense.”
  • and
    • “As many hospitals and health systems face margin pressure from rising expenses, growing bad debt and shifting payer mix, some have made operational decisions that keep them on solid financial footing, from squeezing more capacity out of operating rooms and imaging to holding department leaders accountable for monthly budget variances.
    • “For University Health, staying in the black has really come down to growing business without the associated expenses growing more,” said Ed Banos, president and CEO of the San Antonio-based system.
    • “About 43% of U.S. hospitals are operating at a loss, up from about 33% before the COVID-19 pandemic, according to Kaufman Hall’s August 2026 “National Hospital Flash Report.” Kaufman Hall pointed to three converging forces: rising expenses, growing bad debt and charity care, and payer mix erosion.
    • “University Health, Lincoln, Neb.-based Bryan Health and Rapid City, S.D.-based Monument Health have credit ratings of AA+, AA- and AA-, respectively, according to Fitch. Their CEOs shared the operational decisions and financial strategies they credit with helping maintain that stability.”
  • The American Hospital Association News relates,
    • “The AHA has released its latest downloadable Fast Facts infographic providing statistics on the number of behavioral health hospitals and hospital services in the U.S. It also includes trend data on hospitals providing psychiatric screenings and on hospitals that are consulting/liaising behavioral healthcare with acute inpatient care, emergency services, extended care or primary care services.”
  • Insurance Business tells us,
    • “Fewer providers name prior authorization as their biggest administrative headache than did a quarter ago, and the shift points to something benefits advisors evaluating health plan and third-party administrator relationships should track closely.
    • “The finding comes from Aetna’s Q3 2026 Provider Survey, which polled 727 US healthcare providers, including hospital system executives, physicians, nurses, pharmacists, and health IT leaders, via Morning Consult. The survey is self-commissioned by Aetna, a CVS Health company. The underlying data, however, reflects actual movement in the administrative burden conversation.” * * *
    • “Among providers who cited administrative burden as their top challenge, 27% pointed to prior authorization as the leading contributor, down from 31% in Q2 and representing a meaningful shift from the previous quarter. That movement coincides with active regulatory pressure on prior authorization processes.” * * *
    • “The decline in prior authorization complaints has not reduced the overall weight of administrative burden. It has changed its shape. Among providers who cited administrative burden as a top challenge, 58% now identify updating patient medical records as the biggest contributor, up five percentage points from Q2. Nearly one in three providers said providing real-time patient information is the single most important action payers could take, the top answer when providers were asked to prioritize.”
  • Healthcare Dive informs us,
    • “Online scheduling company Zocdoc is now letting AI agents search for providers and book appointments on behalf of patients. 
    • “Agents must register with Zocdoc to gain access and obtain patient consent before booking or canceling an appointment on its online platform, the company said Wednesday. Google Gemini, Amazon Health AI, and text- and call-based AI agent Instinct are already connected, and other agents can apply for access with or without a human’s help.
    • “Zocdoc is taking a bet on agentic AI at a time when the industry is split on how to move forward with the technology. “I would say that welcoming agents the way we are is a bit of a contrarian move,” said Dr. Oliver Kharraz, founder and CEO of Zocdoc.”
  • Modern Healthcare adds,
    • “Health insurance companies are wagering that sleek artificial intelligence tools and directed care will lower costs for members.
    • “UnitedHealthcare parent company UnitedHealth Group, Aetna parent company CVS Health and Cigna Healthcare parent company Cigna Group are among the companies that have touted AI’s potential to simplify care navigation and upgradethe customer experience, as Wall Street looks for assurances the investments will pay off.
    • “Already investing heavily in AI to process claims, identify fraud and connect with members, insurers are further developing customer-facing tools.
    • “The last year has really seen an explosion,” said Nate Holobinko, managing director, senior partner and North America sector leader for healthcare services at Boston Consulting Group. 
    • “Aetna and UnitedHealthcare lead rivals in overall website and mobile app experience, according to a report that Corporate Insight, a research firm that analyzes digital platforms, published in August. 
    • “This new generation of AI tools that we’re seeing is really a big leap forward,” said Stephanie Chan, healthcare research manager at Corporate Insight.”
  • Beckers Clinical Leadership notes,
    • “Internal medicine represents the largest primary care specialty, with 48% of all primary care physicians practicing in this field, according to new data from KFF.
    • “In contrast, obstetrics and gynecology represents 10.1% of the primary care workforce, underscoring a significant disparity in physician distribution as the U.S. population continues to age, driving demand for specialized care.
    • “For its analysis, KFF obtained information on the number of active, licensed primary care physicians in the U.S., as of this September from Redi-Data. Figures include both allopathic and osteopathic physicians.
    • “Nationwide, 576,793 professionally active primary care physicians were practicing in the U.S., as of September.”
  • Per the Wall Street Journal,
    • “Here’s Why Moderna’s CEO Isn’t Fazed by Its Cancer-Vaccine Selloff
      • “Stéphane Bancel defends his melanoma data and argues that rivals can’t easily copy the technology.”

Friday report

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.”

Tuesday report

  • 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

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.”

Weekend update

Simplicity is a virtue.

From Washington, DC,

  • Congress remains on the campaign trail this week.
  • Beckers Hospital Review reports,
    • :CMS is pitching new guardrails for pharmacy benefit managers and Medicare Advantage plans under a proposed rule released Oct. 16.
    • “The proposed rule would implement sections of the Consolidated Appropriations Act of 2026. Comments are due Dec. 15.
    • “Starting Jan. 1, 2028, PBMs and their affiliates would only be able to accept flat-dollar, itemized service fees for Part D drugs. The fees could not depend on drug prices or rebates. Manufacturer rebates and discounts would remain allowed if they are fully passed through to the plan sponsor.” * * *
    • “Beginning in contract year 2028, MA organizations would need to estimate “a letter grade” for their provider directory accuracy based on a provider sample. In 2029, CMS would publicly post these scores, and plans would need to show them in their directories.
    • “If an MA enrollee books a provider listed as in network, that enrollee would pay no more than the lesser of the in-network or other cost-sharing. This would still apply if the provider ends up being out of network. That protection would begin in contract year 2028.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services announced that it will exercise enforcement discretion for inpatient rehabilitation facility admissions from Oct. 1, 2026 through March 31, 2027, with respect to the timing of the initial interdisciplinary team meeting requirement. As of Oct. 1, the initial IDT meeting must occur on or before four days from the date a patient is admitted to an IRF in order to implement appropriate treatment services; establish or review the patient’s stated rehabilitation goals; and identify problems that could impede those goals. This requirement was finalized in the fiscal year 2027 IRF prospective payment system final rule. The AHA had urged CMS not to finalize this requirement, in part due to its inconsistent descriptions of when the four-day threshold would be met relative to admission. 
    • “During this six-month moratorium, Medicare Administrative Contractors will enforce the initial IDT meeting timing requirement that had been in effect during FY 2026. This means they will not deny or non-affirm a claim based solely on the timing of the initial IDT meeting if an IDT meeting occurs at least once per week throughout the duration of a patient’s stay. CMS said that all other applicable IRF coverage and documentation requirements remain in effect.” 

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

  • The FEHBlog has noticed that 2027 FEHB and PSHB brochures are beginning to shown up in downloadable form on plan open season websites.
  • OPM posted in the Federal Register a Paperwork Reduction Act notice about its efforts to extend its Postal Service Health Benefits Program portal for collecting family member documentation to the FEHB Program. The public comment deadline is December 18. 2026.
  • OPM’s Office of Inspector General posted its Top OPM Management challenges for the current 2027 federal fiscal year.

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services announced that the submission period opened Oct. 16 for petitions to deny the recertification of five 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 five organizations seeking recertification are Maximus Federal Services, Inc.; ProPeer Resources LLC; C2C Innovative Solutions, Inc.; Medical Evaluators of Texas ASO, LLC; and Federal Hearings and Appeals Services, LLC. The petition period is open through Oct. 23. 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,

  • Beckers Hospital Review reports,
    • “AbbVie, Bristol Myers Squibb, Boehringer Ingelheim and PhRMA are asking to intervene in the hospital industry’s lawsuit seeking to block HRSA’s revised 340B Rebate Model Pilot Program, according to court filings in the U.S. District Court for the District of Maine.
    • “AbbVie and its Pharmacyclics unit, Bristol Myers Squibb and Boehringer Ingelheim filed a motion to intervene Oct. 14, and PhRMA filed its own motion Oct. 15 in American Hospital Association v. Kennedy. The drugmakers said they want to defend the rebate plans HRSA approved for their drugs, including AbbVie’s Imbruvica, Linzess and Vraylar, Bristol Myers Squibb’s Eliquis and Pomalyst and Boehringer’s Jardiance, Ofev and Tradjenta. They argued that the government’s representation of their interests “may be inadequate,” the standard for intervening, because, unlike HRSA, they face duplicate discount losses and civil penalties.”

From the public health and medical/Rx research front,

  • Beckers Clinical Leadership reports,
    • “The share of flu tests coming back positive rose from 3.9% to 5% in the week ending Oct. 10, the CDC’s first FluView report of the 2026-27 season shows. ED visits and outpatient visits for flu also climbed.
    • “Seasonal flu activity remains low, but test positivity, outpatient visits for flu-like illness, ED visits with a flu diagnosis and lab-confirmed hospitalizations have all been rising since late August or early September. Activity is highest on the West Coast, and the CDC said early-season levels are higher than typical for this time of year but within expected seasonal variation. Influenza A(H1N1) accounted for 96.4% of the influenza A viruses that public health labs subtyped during the week.”
  • Health Day relates,
    • “Poorer maternal dietary quality is associated with infantile colic and eczema, according to a study published online Oct. 12 in JAMA Network Open.
    • “Emily Oken, M.D., M.P.H., from Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston, and colleagues estimated associations of maternal diet quality and intakes of specific allergenic foods with infant eczema and colic in a prospective cohort of 2,128 mother-child pairs unselected for atopic risk. Food frequency questionnaires were administered in early and mid-pregnancy, and the Mediterranean Diet Score (MDS) and Dietary Inflammatory Index (DII) were calculated.”
  • and
    • “If you’re in your 60s, 70s or even older, you might think your days of productively pumping iron are behind you.
    • “That’s just not true, said Dr. Adil Ahmed, an assistant professor in the Joseph Barnhart Department of Orthopedic Surgery at Baylor College of Medicine in Houston.
    • Building and maintaining muscle is a great way to stay all-round healthy, he said.
    • “The protective effect of muscle and muscle mass has been well studied — everything from the musculoskeletal system to orthopedics and even brain health,” Ahmed said in a Baylor news release. “Building muscle in your body has been well shown to delay dementia and the effects of dementia and preserve cognitive function.”
    • “Strength training also helps your bones. It’s one of the best ways to help aging bones stay dense and strong, Ahmed said.
    • “It’s a very good protective long-term process,” he said.” 

From the U.S. healthcare business front,

  • Modern Healthcare tells us,
    • “Health systems are increasingly selling their real estate to ease financial pressure and fuel expansion, and regulators are pushing back.
    • “Health systems are seeking relief from higher costs and lower reimbursement by selling the buildings and land that house their hospital and outpatient facilities. Those deals provide an immediate capital infusion to shore up finances and fund growth, but can expose providers to higher long-term costs as buyers become more selective and state and federal policymakers increase oversight. 
    • “This is trading a short-term fix for a long-term cost,” said Jim Baker, founder and executive director of the Private Equity Stakeholder Project, a nonprofit watchdog group that opposes private equity investment in healthcare.” 
  • BioPharma Dive reports,
    • “Estuary Biotherapeutics, a California-based genetic medicines developer, officially launched on Friday, backed by nine figures worth of funding and a management team stocked with former Biogen leaders.
    • “Forged in 2022, Estuary is built around research conducted by its scientific co-founders Stefan Somlo and Michael Caplan, both professors at the Yale School of Medicine. Somlo’s lab has made major discoveries about an inherited disorder where certain genetic mutations cause cysts that progressively damage the kidneys and often lead to renal failure. Through a landmark study published in the journal Nature Genetics, Somlo’s team found that, in mice, reactivating proteins called polycystins could shrink the cysts and reverse kidney inflammation and scarring.
    • “And in Caplan’s lab, scientists determined that only a small piece of the full polycystin protein is needed to suppress this “autosomal dominant polycystic kidney disease.” Those findings suggest that helpful genetic material can be successfully packaged up and delivered to the kidneys with the standard “viral vectors” used for gene therapy.
    • “Taken together, Estuary believes its technology and expertise will bring about the first-ever treatment that can halt or reverse, rather than just slow, the most common inherited kidney disorder. Estimates hold that ADPKD affects about 1 in every 400 to 1,000 people. Just one drug, tolvaptan, is specifically approved to treat it.”
  • Fierce Pharma offers us a look inside “Teva’s Weltruza launch and Novo’s GLP-1 strategy.”

Friday report

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

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

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.”