Midweek report

Mental health care

Midweek report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare–

“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.”

Weekend update

David Ermer–Congress, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, Obesity, U.S. Healthcare–

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

From Washington, DC

  • The mid-term elections campaign trail ends on Tuesday, which is Election Day. Both the House and the Senate return to Capitol Hill next for a lame duck session.
  • Roll Call reports,
    • “Republicans in both the Senate and House will hold their leadership contests on Nov. 10, just a week after a high-stakes Election Day that will determine whether they keep their majorities.” 
  • Beckers Health IT relates,
    • “U.S. Sen. Bill Cassidy, MD, R-La., has released a discussion draft of the PATIENT AI Act, proposing to clarify whether the FDA or ONC oversees healthcare AI tools and to create a federal payment pathway for AI-based services.
    • “The Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act comes from Dr. Cassidy, who chairs the Senate Health, Education, Labor and Pensions Committee. AI applications that don’t qualify as FDA-regulated devices would be added to the definition of ONC’s certified health IT.
    • “The FDA would get a risk-based review process for software-based devices, including authority to accept premarket software changes and review updates on a rolling basis. HHS would certify third-party bodies to review low- to moderate-risk software. The Oct. 29 draft also applies existing federal preemption of state product liability laws to integrated and software-based devices.
    • “On reimbursement, HHS would build a coverage evaluation framework for AI-based services, propose payment methodologies and establish a process to use Healthcare Common Procedure Coding System Level II codes for them. The Center for Medicare and Medicaid Innovation would test a payment model for AI applications that deliver care autonomously.”
  • The Street tells us,
    • “A rare pricing shift is coming for Medicare beneficiaries in 2027, but taking advantage of potential savings will depend on the coverage decisions they make before the December 7, 2026, enrollment deadline.
    • “Medicare Advantage premiums are expected to fall next year, while Medicare Part B premiums are projected to rise more modestly than some retirees may have feared, according to the Centers for Medicare and Medicaid Services (CMS). 
    • “Prescription drug coverage, however, comes with a higher annual out-of-pocket limit and deductible in 2027.”
    • “Meanwhile, major insurers are reducing their coverage in some areas, leaving certain counties and limiting provider choices while cutting extra benefits like dental care in some regions.”‘
  • FEHBlog Observation — The FEHBlog’s guess is that CMS will announce 2027 Part B and D premiums shortly after Election Day.
  • The New York Times lets us know “What to Know About the 6 Experimental Peptides Kennedy Has Cleared for Use.
    • “Patients will now have widespread access to the peptides, despite experts’ safety concerns.”

From the public health and medical / Rx research front.

  • MedPage Today reports,
    • “As Measles Outbreak Hits Pennsylvania Amish Country, More Show Openness to Vaccines.
      • “— After a decline in trust, some minds are changing.
  • Health Day relates,
    • “No single exercise is best for weight loss, and varying workouts helps prevent progress from stalling
    • “Cutting calories drives most weight loss, but regular activity is key to keeping the weight off
    • “A sports doctor recommends pairing 30-minute cardio sessions with strength training that targets the legs and large muscles.”
  • and
    • “Low-risk prostate cancer (PC) has become less common at diagnosis since 2010, and low-risk patients are increasingly avoiding treatment, according to a study published online Oct. 26 in Cancer.”
  • and
    • “A vaginal swab test in development could help some women with abnormal bleeding avoid a painful uterine biopsy
    • “Early company-reported results suggest the swab catches at least 90% of endometrial cancers
    • “Developer PinkDx hopes to offer the test by mid-2027, pending results from a larger 3,000-woman study.”
  • The New York Times tells us,
    • “Knee Surgery Isn’t Always the Answer. Here’s How to Avoid It.
      • “If you want to avoid the knife, you have to be patient.”
  • and
    • “Why Your Mental Health Needs an Annual Checkup, Too
      • “Here are a few questions to ask yourself — and your primary care doctor — to keep your psychological well-being on track.”
  • Medscape informs us,
    • “For many problem drinkers, the after-work drink is automatic. Now, some patients of Sylvie Stacy, MD, tell her they pour a glass, take a sip or two, and walk away.
      “That sense of anticipation isn’t there anymore, and the situations that used to trigger an immediate craving for alcohol suddenly feel very neutralized to them,” said Stacy, an addiction medicine specialist and chief medical officer for Rehab.com.
    • “Why? These patients are using GLP-1 medications.”
  • and`
    • “In a small pilot trial, adults who had lost weight while they were on a GLP-1 receptor agonist (GLP-1 RA) and then stopped it regained less weight over 4 months with either a digital wellness app or dietitian-developed meal deliveries compared with usual care.

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

  • Modern Healthcare reports,
    • “Hospital units dedicated to treating the nation’s sickest kids are disappearing nationwide. In the past year alone, hospitals have closed pediatric intensive care units for critically ill kids in Montana, Oregon, and Missouri. Overnight hospital wings for kids have also shuttered in Illinois and California.
    • “Depending on the hospital, pediatric units — which are separate from neonatal intensive care units — can serve patients ranging from a few weeks old to well into their teens or early adulthood. As hospitals look to cut costs, many are converting those beds into more services for newborns or adults. As a result, pediatric intensive care has become centralized in medical hubs, requiring critically ill children to travel farther for lifesaving care.
    • “You can’t expect that people will be fine if the next-closest children’s hospital is a flight away or an eight-hour drive,” said Elizabeth Mack, a pediatric critical care doctor and spokesperson for the American Academy of Pediatrics.
    • “Hospitals cutting pediatric care tend to cite low patient volumes; it’s relatively rare for a child to need intensive care. It’s also hard to find doctors to treat those rare cases because the nation is short on pediatric subspecialists, who earn less than those focused on adults. Meanwhile, hospitals are often paid less to treat children than adults, and buying gear tailored to kids adds extra costs.
    • “The gap in care is acute in rural places. Cutbacks are happening across community hospitals, whether owned by small nonprofits or massive private equity companies.
  • Beckers Physicians Leadership relates,
    • “San Ramon, Calif.-based Hill Physicians Medical Group has agreed to have the Santa Clara County Independent Practice Association join its enterprise, according to an Oct. 29 news release.
    • “As part of the deal, Hill Physicians would also acquire the IPA’s management services organization, Pacific Partners Management Services, from an affiliate of HCA Healthcare. The addition would bring about 1,000 physicians and other providers into Hill Physicians’ network and give it a presence in all nine Bay Area counties.
    • “Hill Physicians is Northern California’s largest independent physician association, with more than 6,000 physicians serving more than 400,000 patients across 14 counties. The deal is subject to regulatory approvals, and financial terms weren’t disclosed.”
  • Beckers Health IT informs us,
    • “When Dallas-based Baylor Scott & White Health and Thrive Global, the behavior change technology company founded and led by Arianna Huffington, announced their collaboration in October, they set out to help people make healthier decisions about sleep, food, movement, stress and connection through what Ms. Huffington called “microsteps.”.
    • “For Ms. Huffington, supporting people through microsteps between doctor visits is an important part of moving healthcare beyond treating illness.
    • “One of our mottos is that health is also what happens between doctor visits. If we don’t nail how we can help people sleep better, eat better, move more, stress less and connect more, it’s going to be very hard to transform what is really a sick care system into a healthcare system,” she told Becker’s in an interview alongside Pete McCanna, CEO of Baylor Scott & White.
    • “Mr. McCanna said the idea resonated with him when he heard Ms. Huffington describe Thrive Global’s approach at a dinner, because it fit with the system’s effort to redefine what a modern health system should be, one he described as customer-centric and demand-driven.”
  • Fierce Healthcare informs us,
    • “Building on its recent guidance for organizations’ use and governance of clinical AI, the American Medical Association on Thursday gave a deeper breakdown of how it believes different parties should be responsible for decisions, actions and failures involving the technology. 
    • “The latest framework from AMA’s Center for Digital Health and AI addresses liability issues the group said are currently unanswered by existing liability frameworks. Those structures, it said, could leave physicians facing “liability for risks they cannot reasonably prevent, while patients may struggle to seek remedies when AI causes harm.”
    • “Other key issues with the status quo liability frameworks, AMA said, are ambiguity around when product liability applies to AI; how contract terms and disclaimers from developers can distance responsibility from risk control; and whether deploying healthcare organizations hold various responsibilities specific to AI, such as local testing or outcomes monitoring. 
    • “AMA said the clinical AI liability framework it’s advancing “recognizes that multiple parties may bear liability for the use of AI when something goes wrong,” and then aligns that accountability based on a party’s ability to prevent harm. Responsibility is spread out in areas where control is shared, but it does not become interchangeable, and no party’s obligations disappear because another party also bears some,” AMA wrote in a brief outlining its thinking.” 

Friday report

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

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

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Obesity, OPM, Rx coverage, U.S. Healthcare–

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.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • Beckers Hospital Review reports,
    • “Thirteen Senate Democrats are demanding answers from the largest ACA marketplace insurers about their involvement in recent [ACA federal marketplace] coverage terminations that cut more than 760,000 people from their health plans.
    • “The Oct. 26 letters, led by Sen. Ron Wyden, D-Ore., and Sen. Bernie Sanders, I-Vt., accuse the insurers of “quietly colluding” with the Trump administration on what the lawmakers said was an improper process to terminate qualified enrollees without sufficient notice or compliance with consumer protections.”
    • It’s worth adding the Administration claims the 760,000 people were unauthorized enrollments.
  • and
    • “House Democrats introduced a bill Oct. 22 that would lower Medicare’s eligibility age to 50 from 65.
    • “The bill comes from Reps. Pramila Jayapal of Washington, Chris Deluzio of Pennsylvania, Debbie Dingell of Michigan and Pat Ryan of New York. Provisions would generally go into effect six months after enactment.
    • “Millions leave the workforce before 65, and with Trump’s cuts to healthcare, many are now left without any options as they wait, sometimes years, for Medicare enrollment,” Ms. Jayapal said in an Oct. 23 news release. “Expanding this program is a commonsense step towards ensuring that all Americans have the care they deserve.”
    • “If passed, the bill would sunset five years after most of its provisions go into effect.” 
  • The American Hospital Association News relates,
    • “The Department of Health and Human Services Oct. 27 announced a new initiative to improve breast cancer screening and detection efforts. The initiative, led by the Office on Women’s Health, the Agency for Healthcare Research and Quality, and DenseBreast-info.org, will coordinate actions that include expanding breast density education and improving diagnostic follow-up. HHS said more than 40 health systems will expand evidence-based practices and address delays in care under the program, called the OWH-AHRQ Breast Cancer Screening and Diagnostic Follow-up Initiative. The department said OWH and DenseBreast-info.org will also expand access to educational resources to improve breast density awareness, support informed discussions between women and healthcare providers, and promote understanding of breast cancer screening and diagnostic follow-up options.”
  • and
    • “The Department of Health and Human Services Oct. 26 announced that more than 250 hospitals have signed its voluntary pledge related to hospital efforts on healthy food. The pledge asks hospitals to align patient food services with the 2025-2030 Dietary Guidelines for Americans. It also asks hospitals to ensure inpatient meals meet individual nutritional needs and support healing, recovery and long-term health; and to provide accessible nutrition resources and education as part of discharge planning to help patients sustain healthy habits. The pledge was announced during the AHA Annual Membership meeting in April.”
  • Per an Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today released new analysis from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) examining America’s record-low overall age-adjusted death rate in 2025 and substantial progress in reducing prescription opioid exposure and expanding treatment. An article in Health Affairs Forefront and a new ASPE report highlight how actions across President Trump’s two terms to reduce unnecessary opioid prescribing, combat illicit fentanyl, and strengthen treatment and recovery have led opioid-related deaths in the United States to plummet to the lowest since President Trump declared a public health emergency in 2017. HHS Secretary Robert F. Kennedy, Jr. announced the findings at an event at Detroit Wayne Integrated Health Network in Detroit, Michigan.” * * *
    • “The ASPE report The U.S. Age-Adjusted Death Rate Reached a Record Low in 2025: What Drove the Decline? can be found here.
    • “The Health Affairs Forefront article can be found here.”
  • Beckers Clinical Leadership tells us,
    • “CDC deputy director and chief medical officer Jennifer Shuford, MD, is leaving the agency after six months, The Washington Post reported Oct. 26.
    • “Dr. Shuford, an infectious disease physician, previously served as Texas’ health commissioner and was hired in April as part of a new leadership team meant to increase trust in the agency. CDC scientists were optimistic about her hiring due to her public health background and willingness to speak out during Texas’ measles outbreak last year, the Post reported.
    • “She is expected to leave after the midterm elections Nov. 3.”

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

  • Federal News Network reports,
    • “Agencies now have explicit authority to put federal employees on paid administrative leave for “workforce realignment” reasons, according to final regulations the Office of Personnel Management published earlier this month.
    • “Paying federal employees not to work, after they agree to leave their jobs during workforce reduction efforts, is now an officially acceptable use of paid administrative leave under OPM’s final rule. The leave category is also permissible during reduction-in-force (RIF) notice periods, as well as physical fitness activities in limited cases. And agencies can now deny employees’ requests to withdraw their resignations while under a deferred resignation program (DRP).
    • “The regulations provide more transparency and accountability, provide a firmer legal foundation for allowing or prohibiting certain uses of administrative leave, promote consistency across agencies, clarify the authority of agencies and reduce potential disputes,” OPM wrote in its Oct. 19 final rule.”
  • Govexec relates,
    • “Americans’ satisfaction with public-facing services provided by the federal government has fallen for the first time in five years, according to new findings released by the American Customer Satisfaction Index.  
    • “ACSI reports that citizen satisfaction has fallen to a score of 68.6 out of 100 – a 2.6% decrease. 
    • “This marks the first decline tracked by the index since 2021, when many federal employees were put on mandatory work-from-home schedules at the height of the COVID-19 pandemic and agencies struggled to bring more of their public-facing services online.” 
  • FedSmith advises “Check your FEHB plan’s provider network before Open Season to ensure your trusted doctors, hospitals, and pharmacies are still covered.
  • OPM’s Inspector General has posted its Fiscal Year 2027 Oversight Plan, which is worth a gander.

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

  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Food and Drug Administration, today issued a draft guidance for industry to help sponsors develop and seek approval for personalized gene therapies designed to treat patients with rare genetic diseases.
    • “The guidance, Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management, provides a clear regulatory framework for submitting and managing Biologics License Applications (BLAs) for individualized genome editing (GE) products. The Trump Administration is committed to modernizing approaches to safely get more cures and meaningful treatments to all Americans, regardless of the size of the patient population.” * * *
    • “A recorded webinar, Individualized Human Genome Editing Products: Considerations for BLA and Postapproval Management, summarizing the key elements of the guidance is available on the FDA’s YouTube channel.
    • “The FDA is inviting public comment on the draft guidance. Comments may be submitted to the docket FDA-2026-D-11783 at regulations.gov within 30 days of publication in the Federal Register.”
  • Health tells us,
    • “A popular plant-based butter has been recalled in 10 states due to yeast, mold, and E. coli, the Food and Drug Administration (FDA) announced. The Miyoko’s butter was initially recalled on Sept. 11, and on Oct. 23, the FDA gave the recall the second-highest risk level, Class II. This means the butter is unlikely to cause permanent health issues, but may cause temporary or reversible effects.”
  • Cardiovascular Business adds,
    • “Medtronic is recalling certain OmniaSecure defibrillation leads due to an increased risk of implant issues. No adverse events have been reported, but clinicians did report experiencing difficulties that could potentially lead to “tissue trauma.” 
    • “The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall, which means using the devices “may cause temporary or medically reversible adverse health consequences.”
    • “Medtronic initiated the recall in September, notifying customers that they should “quarantine and return” any affected OmniaSecure defibrillation leads.
    • “Medtronic recently requested the retrieval of a subset of nonimplanted OmniaSecure defibrillation leads for an engineering evaluation,” a company spokesperson told Cardiovascular Business. “The notification request for retrieval was limited to a subset of leads that may have undergone a specific manufacturing sequence as identified by an internal quality process. There have been no reports of patient harm.”
    • “This recall covers more than 700 OmniaSecure defibrillation leads distributed throughout the United States. The two item numbers are 3930M74 or 3930M79. Only the leads specifically included in this recall are being recalled. Click here for a list serial numbers.”

From the judicial front,

  • Bloomberg Law reports,
    • “Novo Nordisk A/S lost a bid in a US court to temporarily block Eli Lilly & Co. from using advertisements that claim its drugs are more powerful, a setback to Novo as it battles to regain a larger share of the obesity and diabetes drug markets.
    • “US District Judge Zahid Quraishi ruled Monday that Lilly can continue to make the disputed claims in its ads while Novo proceeds with a lawsuit filed in July in federal court in Trenton, New Jersey. The judge said Novo’s case for a preliminary injunction was “less than persuasive” because it failed to show irreparable harm.”
  • Fierce Healthcare relates,
    • “CVS Heath’s Aetna is joining the ranks of insurers suing over its results in the 2027 Medicare Advantage star ratings.
    • “The insured filed suit Monday in Georgia’s Southern District Court, and argues that 28 measures used by the Centers for Medicare & Medicaid Services to calculate its scores were “unlawfully adopted” and should have been excluded.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “A single mutation in the H1N1 influenza virus — G155E — is emerging as the defining feature of a flu season that has arrived months ahead of schedule and may slip past some people’s immunity, researchers told Nature, CNN and Today. 
    • “Becker’s reported Oct. 5 that H1N1 had overtaken H3N2 in early West Coast surveillance. The mutation now drawing scrutiny helps explain why.” * * *
    • “Because this year’s shots were formulated in the spring, before G155E spread, the H1N1 component may not be well-matched if the mutation dominates, Dr. Bloom told Nature, though he cautioned it is too early to know. 
    • “Scott Hensley, PhD, a virologist at the University of Pennsylvania in Philadelphia told Nature the H3N2 and influenza B components appear well-matched. Experts stressed that a mismatch means reduced protection, not none. 
    • “This is one of those seasons where the key message is to go get vaccinated now,” Dr. Greninger told CNN. He added that a second, more conventional wave could follow once H1N1 peaks.”
  • and
    • “The CDC found four drug-resistant pathogens require urgent and aggressive action, according to its 2026 Antimicrobial Resistance Threats Report.
    • “The 2026 report, published Oct. 27, estimates the impact of 19 drug-resistant bacterial and fungal pathogens on human health in the U.S. They are categorized into three threat levels. Urgent threats require urgent and aggressive action. Serious threats require prompt and sustained action, and concerning threats require careful monitoring and prevention action, the report said. The CDC also included a watch list of pathogens being monitored because their full burden is not yet understood. 
    • “The CDC updated its methodologies and data sources to make the 2026 report the most comprehensive to date. As a result, direct comparisons to previous reports should not be made, the CDC said.”
  • and
    • “Older adults who received two weeks of home-delivered meals post-discharge were 69% less likely to be readmitted within 14 days, a Durham, N.C.-based Duke University study found.
    • “The study, published on Sept. 19 in Journal of Hospital Medicine, analyzed data from 368 adults 60 and older who were discharged from Duke hospitals between September 2022 and April 2024. All the adults were at risk of food insecurity or malnutrition and were referred to a state-funded Meals on Wheels hospital discharge pilot program that provided two weeks of home-delivered meals. 
    • “Meal recipients also had 54% lower odds of readmission at 21 days. Two weeks post-discharge, nearly 5% of patients who received meals were readmitted, compared with roughly 13% of those who did not.” 
  • Health Day relates,
    • “Ultra-processed foods appear to rewire kids’ brains so they crave more junk food, a new study says.
    • “Pictures of cookies or fries trigger a powerful reaction in the brain reward systems of children who eat more ultra-processed food, researchers reported Oct. 23 in JAMA Network Open.
    • Those children subsequently have higher odds of weight gain and more body fat, researchers found.
    • “Children’s brains are still developing, habits are still forming and food preferences are still being made,” senior researcher Dr. Kathleen Page, a professor of medicine and pediatrics at the Keck School of Medicine of USC, said in a news release. “It’s an important period where the brain is very sensitive to food and the food environment.”
  • and
    • “Nearly 1 in 5 young adults in the U.S. feel anxious every single day, a new study says.
    • “Just under 20% of Americans between 18 and 25 said they suffered from daily anxiety in 2024, up from 15% in 2020, researchers report in the American Journal of Public Health.
    • “The odds of receiving an anxiety diagnosis or a prescription for anxiety meds also rose by roughly a third during the same period, researchers found.
    • “This anxiety might stem from the COVID-19 pandemic and its lasting impact on the psyche of Americans, researchers said.”
  • Genetic Engineering and Biotechnology News tells us.
    • “A study by researchers at the Centre for Genomic Regulation (CRG) has identified six different genes that can help forecast survival of patients with acute myeloid leukemia (AML), a type of cancer that has very variable outcomes between patients.
    • “Headed by ICREA Research Professor Luciano Di Croce, PhD, a researcher at the CRG, the team created a scoring system by moving repeatedly between laboratory experiments with mice and patient records, crossing the two to look for genes that behaved consistently in both. * * *
    • “Findings from the study could point to new ways of helping to predict outcomes in patients with this type of blood cancer, contributing to the development of future prognostic tests, and may suggest new therapeutic targets. Patients suspected of having AML already give a bone marrow sample for laboratory analysis, and measuring six genes is simpler and cheaper than reading a broader genetic profile.”
  • The New York Times informs us,
    • “Millions Use Antidepressants. We Still Don’t Understand How They Work.
      • “Here’s how psychiatrists like me think about the most promising hypotheses.”
  • Fierce Pharma points out,
    • “Vanda Pharmaceutical’s Nereus may soon break out of its motion sickness niche to become a treatment option for the burgeoning GLP-1 market. 
    • “Topline results from the D.C.-based pharma’s phase 3 called “Study 3601” are in, and Nereus demonstrated a 27% reduction in vomiting among patients on GLP-1 receptor agonist therapy and a 35% reduction in severe nausea and vomiting.
    • “Nausea and vomiting are among the biggest obstacles to GLP-1 adherence. Roughly half of patients quit the treatments within their first year, and gastrointestinal challenges are among their cited reasons. Vanda believes Nereus has the potential to help more patients stay on their therapy. Data in hand, the drugmaker is now heading for the FDA in hopes of a label expansion.”
  • and
    • “Pfizer’s Elrexfio has taken another step on its path to potential commercial momentum: The drugmaker just announced another phase 3 win for the bispecific antibody, this time as a treatment for patients with relapsed or refractory multiple myeloma (RRMM) whose disease has progressed after first-line treatment.
    • “The topline readout, announced Tuesday, came by way of Pfizer’s MagnetisMM-32 trial, one of multiple ongoing phase 3 trials evaluating Elrexfio as an earlier-line option for RRMM. 
    • “According to Pfizer, patients who took Elrexfio after at least one prior line of treatment had a significantly lower risk of disease progression or death compared to an investigator’s choice regimen of BMS and AbbVie’s Empliciti (elotuzumab) with Bristol’s Pomalyst (pomalidomide), Pomalyst with Takeda’s Velcade (bortezomib), or Amgen’s Kyprolis (carfilzomib), all paired with the steroid dexamethasone.” 
  • MedTech Dive adds,
    • “Abbott on Monday launched a new version of its Oncodetect molecular residual disease test designed to better monitor for traces of cancer in the body after treatment.
    • “MRD tests look for tiny amounts of circulating tumor DNA, or ctDNA, in the blood to act as an early warning signal for cancer recurrence. The goal is to detect recurring disease earlier than traditional methods like imaging scans.
    • “Abbott’s new test, based on technology developed at the Broad Instituteof MIT and Harvard, uses whole-genome sequencing to track as many as 5,000 patient-specific cancer mutations, compared with up to 200 variants in the earlier Oncodetect test.”

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

  • The Wall Street Journal reports,
    • “Centene CNC raised its full-year outlook for the third time as the health insurer continued to control medical costs.
    • “However, its total at-risk membership fell to 25.7 million as of Sept. 30, down from 28 million a year earlier, primarily reflecting a contraction in its Health Insurance Marketplace enrollment.
    • “The company’s health-benefits ratio, a measure of how much was paid out to cover enrollees’ medical expenses, held steady at 92.7%, below the mean analyst estimate of 92.9%, based on FactSet. The company said the underlying performance in its Medicare Advantage and Prescription Drug Plans drove the stability, alongside improved pricing and risk transfer in Marketplace reflecting member acuity.”
  • and
    • “GSK expects to nearly double the number of cancer medicines it is testing in clinical trials next year, according to one of its top scientists, highlighting how the company’s dealmaking spree is filling its drug pipeline.
    • “Hesham Abdullah, head of oncology research and development at the U.K. drugmaker, said in an interview that the company is firing on all cylinders to speed up its return to the field of cancer medicine.
    • “Right now we have five approved [cancer] medicines, I think probably in a few weeks’ time there’ll be six,” Abdullah said. “We have a clinical-stage portfolio of about 15 assets that’s probably going to, I would say, close to double in 2027.”
  • Fierce Healthcare relates,
    • “HCA Healthcare’s earnings landed above internal and analyst expectations for the third quarter as accelerated volume growth and cost reductions blunted a weakening payer mix.
    • “On Tuesday morning, executives at the country’s largest for-profit health system said it’s now on track to land in the upper half of its 2026 estimated guidance ranges, and in an earnings call gave an early prediction that earnings performance next year “will be generally consistent with 2026” despite expected policy and macroeconomic headwinds. 
    • “I’ve often mentioned that HCA has strong staying power because of our scale, the important role we play in providing critical services to communities and our disciplined culture,” CEO Sam Hazen said during the call. “Despite the challenges this year brought about by federal policy changes, we have continued to move the company forward and believe we are positioned to end the year positively as we look ahead to 2027.”
  • Beckers Hospital Review tells us,
    • “King of Prussia, Pa.-based Universal Health Services reported an operating income of $454 million (9.6% margin) in the third quarter of 2026, down from a $522 million operating income (11.6% margin) during the same period last year, according to financial results published Oct. 27. 
    • “The news release comes after UHS completed its acquisition of Talkspace, a virtual behavioral health company, in mid-August for $835 million.” * * *
    • “UHS comprises 30 inpatient acute care facilities, 388 inpatient behavioral health facilities, 169 outpatient and other facilities, nationwide virtual behavioral health services, an insurance offering, a physician network and various related services with locations in 40 states, Washington, D.C., Puerto Rico, Ireland and the United Kingdom. It has more than 102,000 employees.”
  • and
    • “Healthgrades released its 2027 Specialty State Rankings Oct. 27, naming the top three or five hospitals in each of 19 specialties across 30 states.
    • “The rankings use Medicare inpatient data from 2023 to 2025 on 31 conditions and procedures. To be ranked, a hospital must have no one-star ratings and at least one five-star rating in the cohort being measured. States with six or fewer eligible hospitals in a specialty are not ranked in that specialty, states with seven to 10 eligible hospitals receive a top three and states with 11 or more receive a top five. This year’s ranked specialties include emergency hospitalization, which was not ranked last year and covers 12 common emergency conditions.
    • “The 30 states with rankings are Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.”
    • The article lists those hospitals by State.
  • and
    • “Pharmacist pay swings by tens of thousands of dollars depending on the state. Technician pay is lower and depends heavily on local cost of living. Meanwhile, the jobs themselves are shifting out of retail and into hospitals, where pay tends to be higher.
    • “[The article shows] what pharmacy pay looks like in 2026, based on the latest federal wage data.”
  • BioPharma Dive informs us,
    • “Ferring Pharmaceuticals has agreed to buy fertility treatment startup Gameto in a potentially $1.4 billion deal that boosts the Swiss drugmaker’s portfolio of reproductive medicines. 
    • “Ferring didn’t disclose exactly how much it’s paying up front for Gameto in its announcement Tuesday, only noting that the transaction involves payments tied to unspecified development, regulatory and sales milestones. The two entities will also continue to operate independently until the buyout closes. 
    • “Once completed, the acquisition will hand Ferring “Fertilo,” a novel technology the biotech developed to help simplify and shorten in vitro fertilization cycles.” 
  • and
    • “Artiva Biotherapeutics will lay off most of its staff and stop developing an experimental “natural killer” cell therapy for autoimmune conditions after reporting the deaths of two participants in a clinical trial. 
    • “Artiva made clear in a Tuesday statement that both of the deaths appear unrelated to its therapy, which is known as AlloNK and was being tested in inflammatory diseases like rheumatoid arthritis.” 
  • Beckers Health IT points out,
    • “Anthropic has acquired Mithril Medicine, a one-person startup developing treatments for two rare forms of muscular dystrophy. The AI company also released early results from Claude-assisted drug development work with six outside organizations, it said Oct. 27.
    • “The partners are BigHat Biosciences, Bristol Myers Squibb, Divergence Labs, Enveda, Generate Biomedicines and the Column Group. Most of the work is still preclinical, meaning most of the drug candidates have not yet been tested in humans.”

Midweek update

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

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

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

From the judicial front,

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

From the fraud, waste, and abuse front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Friday report

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

Simplicity is a virtue

From Washington, DC,

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

From the U.S. Office of Personnel Management front

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

From the U.S. Food and Drug Administration front

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

From the Medicare Advantage front,

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

From the fraud, waste and abuse front

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

From the public health and medical / Rx research front,

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

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

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

Midweek update

David Ermer–Agentic & Generative AI, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Fierce Healthcare reports,
    • “A group of 17 senators penned a letter to U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. seeking more information on recent appointments to a key health panel—echoing concerns of key medical groups.
    • “In the letter (PDF), the legislators called the appointments a “major break from the historic makeup of [the] U.S. Preventive Services Task Force (USPSTF) membership,” as it is typically comprised of primary care practitioners and preventionists.
    • “Kennedy named eight new members to the USPSTF in mid-September—five of whom were specialists and one healthcare finance expert. The new appointments came months after Kennedy dismissed the panel’s vice chairs and did not replace five other members after their terms expired at the start of 2026.
    • “Legislators expressed concerns over an April 23 Federal Register notice seeking nominations for the panel, given the change in nominee parameters—outside of primary care and preventive medicine—and timeline. The letter notes members in specialty areas have “always played a role” in the panel’s operations, though primarily in consultant roles in part to avoid conflicts of interest.”
  • The American Hospital Association News relates,
    • “The Health Resources and Services Administration Maternal and Child Health Bureau has released the latest data from the National Survey of Children’s Health. The survey provides national and state-level data on children’s physical and mental health, healthcare access and quality, special healthcare needs, adverse childhood experiences and family and community well-being. HRSA also plans to release a data brief featuring survey findings on the health and well-being of children living in rural communities.”
  • Beckers Hospital Review tells us,
    • “CMS is penalizing 2,334 hospitals, about 80% of those evaluated, under the Hospital Readmissions Reduction Program in fiscal 2027, according to new CMS data. The penalties took effect on Oct. 1.” * * *
    • “The share of hospitals receiving no penalty will drop to 19.8% (578 hospitals) from 21.8% (641) in 2026. The bulk of hospitals, 71.8% in fiscal 2027 compared with 70.1% in 2026, will see penalties below 1%.”

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

  • Reuters reports,
    • “The US Food and Drug Administration has expanded the use of Novartis’ (NOVN.S), drug to treat adults with ​a chronic skin condition that causes recurring itchy welts [Rhapsido], ‌the Swiss drugmaker said on Wednesday.
    • “The condition, called symptomatic dermographism, is a form of chronic hives in which scratching, rubbing or ​friction on the skin can trigger itchy welts.
    • “The ​approval adds to momentum for the drug, remibrutinib, which investors ⁠have increasingly focused on after recent late-stage failures of the ​company’s cholesterol drug pelacarsen and muscle-wasting disease therapy del-desiran ​increased scrutiny of its pipeline.”
  • PharmExec relates,
    • “The FDA has approved Pfizer’s Tukysa (tucatinib) in combination with trastuzumab and pertuzumab as maintenance treatment for adults with unresectable locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have completed induction therapy, the company announced Oct. 7.1
    • “The decision moves the oral therapy from later-line use into the first-line setting, where it is added to an established antibody pair.”
  • Stock Titan adds,
    • “vTv Therapeutics (Nasdaq: VTVT) received FDA Orphan Drug Designation for HPPD, its investigational oral treatment for sickle cell disease.
    • “Preclinical studies at Augusta University used the Townes sickle cell disease mouse model. HPPD was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling. Fetal hemoglobin increases were time- and dose-dependent, with effects comparable to or exceeding hydroxyurea, the current standard fetal hemoglobin-inducing therapy.
    • “vTv said the designation supports partnering discussions for HPPD while it continues to prioritize cadisegliatin, its lead late-stage type 1 diabetes program. HPPD remains investigational; its safety and efficacy have not been established, and approval or commercial availability is not guaranteed.”

No Surprises Act News

  • The Coalition against Surprise Medical Billing reports,
    • “After a new federal rule slashed the administrative fee for initiating IDR disputes by 87% — from $115 to just $15, nearly 400,000 disputes were initiated in July 2026 alone. This 24% jump in just one month is one of the latest signals that the IDR process has veered even further off course and needs an overhaul.
    • “IDR was supposed to be a last resort for resolving legitimate payment disputes between providers and health plans. Instead, organizations built to file disputes at scale have turned it into a profit center — initiating over 7 million disputes between April 2022 and the end of July 2026. The result is more administrative burden, more unnecessary costs, and more pressure on the employers, workers, and families who ultimately pay the bill. IDR costs have increased to $22.4 billion, according to recent data published in Health Affairs.” * * *
    • “An overused IDR system drives up costs across the entire healthcare system. Every dispute requires employers and health plans to spend resources processing and defending claims, while arbitration outcomes drive higher payments that ultimately put pressure on premiums and healthcare costs.”

From the fraud, waste, and abuse front,

  • Beckers Hospital Review reports,
    • “Federal prosecutors have secured guilty pleas or prison sentences in at least six durable medical equipment fraud cases tied to more than $1.5 billion in claims since late May, and CMS has barred 11 DME suppliers from Medicare Advantage payments.
    • “The cases follow a familiar pattern: telemarketers target Medicare beneficiaries, practitioners sign orders for orthotic braces without examining patients and DME companies bill Medicare for equipment no one needed. Becker’s tracked DME fraud actions against 10 people between March 24 and May 26.
    • “CMS imposed a six-month moratorium on new Medicare enrollment for certain DME, prosthetics, orthotics and supplies providers in February, citing more than $1.5 billion in suspected fraudulent billing stopped in 2025.  The moratorium expired Aug. 27, according to the American Orthotic & Prosthetic Association. On Sept. 8, CMS barred 11 DMEPOS suppliers from future Medicare Advantage and Part D payments, citing more than $3.4 billion in suspected fraudulent billing in 2025 and 2026.”
  • STAT News adds,
    • “In a warning to life sciences companies, the Department of Justice last week issued a new directive for combating fraud that made a point of noting the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry.
    • “Typically, the agency has pursued health fraud cases centered on providers, clinics, home health agencies, and hospices. By expressly including the Federal Food, Drug, and Cosmetic Act in the directive, the National Fraud Enforcement Division appears to be placing drug and device makers, among others, more clearly in its crosshairs.
    • “This is a subtle but significant expansion of their jurisdiction,” said Kevin Lowell, a member of the Miller & Chevalier law firm, who spent a decade at the DOJ, where he most recently had been a deputy chief in the National Fraud Enforcement Division’s health care fraud section.
    • “The directive brings into focus all of the FDA-regulated companies and the division is pointing to a specific statute that refers to a part of the health care industry that has not previously been a focus. … And it’s one of first items on the list of priorities” for investigating potential fraud.”

From the judicial front,

  • STAT News reports,
    • “The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.
    • “The Pharmaceutical Research and Manufacturers of America said Wednesday that it had filed a complaint in the U.S. District Court for the District of Columbia asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority.
    • “The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices. 
    • “But it would set a precedent that the industry wants to nip in the bud. PhRMA says the voluntary agreements are acceptable, but the mandatory GLOBE program is not.
    • “The administration is still considering a separate pilot, called GUARD, that would require MFN prices in Medicare Part D. The status of that proposal is not clear.”
  • Beckers Hospital Review adds,
    • “Hospitals affiliated with Nashville, Tenn.-based HCA Healthcare have sued multiple insurers over alleged claim denials and reimbursement issues in 2025 and 2026. These cases contribute to a broader landscape of legal battles between providers and insurers.
    • “Most recently, seven hospitals filed a lawsuit Oct. 5 against Anthem Blue Cross and Blue Shield Georgia, part of Elevance Health. The complaint argued the insurer is on the hook for more than $501,213 in reimbursement, alleging underpaid or denied claims.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “The overall mortality rate for U.S. patients with cardiovascular disease (CVD) has improved significantly in the last two decades, according to new findings published in JACC.[1] However, despite the continued efforts of cardiologists and other cardiovascular care professionals, disparities remain for certain racial and/or ethnic groups. 
    • “This new analysis represents a county-by-county dive into the heart health of Americans from 2000 to 2019. Data came from both the U.S. National Vital Statistics System and the National Center for Health Statistics.
    • “In total, the study’s authors found that CVD mortality rates “varied substantially” from one county to the next. There were often considerable differences in the same state. This highlights the importance of ensuring all patients, no matter where they live, receive high-quality care. 
    • In 2019, the overall age-standardized mortality rate (ASMR) for CVD in the United States was 237.8 deaths per 100,000 adults. The ASMR was the highest for Black patients and the lowest for Asian patients.” 
  • Beckers Clinical Leadership relates,
    • “A coalition of Texas health systems, professional organizations and community groups has launched a five-year plan to eliminate cervical cancer in the state.
    • “The Texas Lone Star Cervical Cancer Elimination Plan 2027-2032 was developed by the Cancer Alliance of Texas Cervical Cancer Elimination Priority Area Workgroup, according to an Oct. 7 news release from Houston-based University of Texas MD Anderson Cancer Center.
    • “Cervical cancer elimination is defined as fewer than four new cases per 100,000 women a year. Texas’ current cervical cancer rate is 9.5 cases per 100,000, with rates in some counties reaching 15 to 21 per 100,000. Uninsured, rural, border and minority communities carry the heaviest share of cases, the release said.
    • “The plan is built on three pillars: vaccination, screening, and timely follow-up, diagnosis and treatment. Read the full plan here.” 
  • The American Hospital Association News tells us,
    • “As part of the AHA’s Opportunities for Innovations in Rural Maternal Care initiative, a recent Commonwealth Fund blog discusses strategies hospitals can use to sustain maternal care within the communities they serve. Hear from Julia Resnick, AHA senior director of health outcomes and care transformation, and Aisha Syeda, AHA senior program manager of health outcomes and care transformation, on ways to solidify leadership commitment, build a skilled workforce, strengthen partnerships and address community needs. LEARN MORE“
  • The latest post of NIH Research Matters covers the following topics:
    • Device helps people with paralysis communicate
      • “A brain-computer interface linked to a virtual avatar helped people with paralysis express speech and body language at the same time.
      • “Translating neural signals for both types of communication could enable people with paralysis to express themselves more fully.”
    • Improving lung cancer detection
      • “Researchers developed a protein-based MRI contrast agent that could detect a common lung cancer in mouse models and determine if it spread to other organs.
      • “With further development, the approach could help doctors detect lung cancer earlier and tailor treatment to the needs of each patient.”
    • Estimating cognitive impairment risk, timing
      • “Combining blood p-tau217 levels together with APOE4 gene status improved predictions of dementia risk.
      • “The findings may help doctors better assess patients’ risk for cognitive impairment and estimate when symptoms may develop.”
  • Radiology Business points out,
    • “A minimally invasive, image-guided procedure can provide lasting relief for carpal tunnel syndrome, according to new research published in RSNA’s Radiology. 
    • “This common occupational ailment is frequently encountered among the middle-aged, leading to morbidity and loss of work hours. Common carpal tunnel syndrome management strategies may include conservative therapy or surgical decompression, experts note. 
    • “However, image-guided interventions such as steroid shots or nerve hydrodissection—which involves carefully injecting fluid around the impacted area—have emerged as alternatives for mild to moderate cases. Researchers in India recently aimed to investigate the efficacy of these options, sharing their findings Tuesday. 
    • “Most of our patients had been suffering from carpal tunnel syndrome for months to years and did not get much relief despite trying various treatments like pain medications, splints, lifestyle modification and corticosteroids,” study co-author Anupama Tandon, MD, a professor with the University College of Medical Sciences and Guru Teg Bahadur Hospital in Delhi, India, said in a statement Oct. 6. “It came as a pleasant surprise to find that a simple procedure of dissecting the median nerve under ultrasound guidance with normal saline provided them long-term relief.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of research headed by a team at the University of Birmingham suggest that inflammatory conditions in the brain, including traumatic brain injury (TBI) and degenerative diseases such as Alzheimer’s disease and Parkinson’s disease, could be targeted with an existing developmental drug.
    • “Using live cultures of human brain cells and slices of brain tissue obtained during neurosurgery, the researchers, headed by Nicholas Barnes, PhD, professor at the University of Birmingham College of Medicine and Health, investigated the role of the P2X7 receptor, which is responsible for triggering inflammatory signaling. Their findings revealed that these P2X7 receptors drive the release of cytokines involved in controlling inflammation. By blocking this receptor with a specific antagonist, the team was able to significantly reduce the inflammatory response in human brain tissue.
    • “The team suggests that their results could open the door to treating a wide spectrum of chronic neurological conditions, including TBI, neurodegenerative diseases, and even psychiatric disorders such as depression and psychosis, which are increasingly understood to have a neuroinflammatory component.”

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

  • Beckers Payer Issues reports,
    • “Harbor Health, an Austin, Texas-based insurer that also runs its own medical clinics, plans to acquire 27 Village Medical primary care clinics in the Houston area.
    • “The deal is expected to close at the end of the year, according to an Oct. 6 news release, and financial terms were not disclosed. Once the deal closes, Harbor will operate nearly 70 clinics and more than double its count of physicians and advanced practice providers.
    • “The company offers large employer plans in 29 Texas counties, including the four Houston-area counties. It will also offer individual and family plans on the Texas exchange in 13 of those counties for 2027.
    • “Village Medical is the clinic brand of VillageMD, which Walgreens previously owned a majority stake in. VillageMD has operated as a standalone company since private equity firm Sycamore Partners took Walgreens private in August 2025, while Cigna continues to hold a minority stake. Harbor also bought 32 VillageMD clinics in Austin, Dallas, El Paso and San Antonio in September 2025.” 
  • Fierce Healthcare relates,
    • “Cigna is rolling out a new patient experience platform that aims to harness the power of data to drive greater personalization.
    • “Called Health Sense, the tool brings together information on an individual’s health needs, medical coverage, pharmacy benefits, cost exposure and other previous interactions with the health plan. This allows for more complete context, as the insurer’s clinical teams offer tailored experiences to members.
    • “Having a more complete picture of the patient also allows Cigna’s clinicians and care managers to collaborate more effectively with a member’s treating providers, the company said. It surfaces insights for the member about next steps, potential costs for care, any supports available in-network and potential preparation for an upcoming appointment.
    • “Cigna plans to roll out Health Sense in early 2027, with an initial focus on members with cancer or cardiometabolic conditions.”
  • Beckers Behavioral Health tells us,
    • “Mental healthcare, including care for substance use disorders, accounted for 7% of total U.S. healthcare expenditures from 2021 to 2023, Medscape reported Oct. 7. Annualized mental health spending totaled $174 billion, compared with $2.5 trillion in overall healthcare expenditures captured by the survey.
    • “Researchers analyzed data from the 2021 to 2023 Medical Expenditure Panel Survey, which represents the civilian noninstitutionalized U.S. population. The analysis included 67,532 person-year observations, including 15,407 involving outpatient mental healthcare. The study, led by Carlos Blanco, MD, PhD, of the National Institute on Drug Abuse in Bethesda, Md., was published online Sept. 30 in JAMA Psychiatry.”
  • Modern Healthcare informs us,
    • “Prime Therapeutics, one of the largest U.S. pharmacy benefit managers, aims to shift to upfront drug pricing and away from a complicated rebates-based system that critics say increases patient costs. 
    • “The company intends to offer its clients — health insurers and employers — what it calls a net cost model for 2028, Chief Executive Officer Mostafa Kamal said in an interview Wednesday. He said patients should get the discounts that drug companies pay when they fill their prescriptions at the pharmacy. Prime seeks to keep its clients’ overall costs the same or lower than the current setup.” 
  • BioPharma Dive adds,
    • “Caribou Biosciences, one of the first companies founded to advance CRISPR gene-editing technology in medicine, is discontinuing research, laying off staff and looking for “strategic alternatives” because it can’t raise the money to continue.
    • “The decision means the end of Caribou’s work on two “off-the-shelf” CAR-T cancer therapies, one of which was ready for Phase 3 testing. “Despite the progress we’ve made, the current financing environment for allogeneic CAR-T cell therapies has made it increasingly challenging to secure the capital necessary to responsibly advance these programs,” Caribou CEO Rachel Haurwitz said in a statement Tuesday.
    • “The company’s board will consider mergers, acquisitions or other transactions related to the company as a whole or for its assets, Caribou said. In the meantime, a “substantial reduction in workforce” will be mostly completed by the end of the year, the company added.”
  • Healthcare Dive points out,
    • “Telehealth company Teladoc Health is adding new artificial intelligence capabilities to its virtual care platform for hospitals and health systems, it announced Wednesday.
    • “The new capabilities include a “contactless” approach to remotely monitoring patients’ vital signs and an AI scribe that will record and transcribe clinical encounters to create notes, according to the announcement.
    • “The scribing tool is now available but only select customers can currently use the vitals monitoring feature in private preview. The latter is expected to be released broadly in December.”
  • Becker’s Hospital Review notes,
    • “The American Medical Association has honored 92 hospitals, health systems and medical groups through its 2026 Joy in Medicine program.
    • “The Joy in Medicine program recognizes healthcare organizations for their commitment to “reduce burnout and improve the professional fulfillment physicians find in caring for patients,” according to an Oct. 7 news release from the AMA.
    • “There are three levels of recognition in the program, gold, silver and bronze, which are valid for two years. Find the hospitals and health systems honored in the AMA’s 2025-26 Joy in Medicine program here.” 
  • McKinsey & Co. discusses the AI powered future of healthcare.
    • “AI won’t replace clinicians, but it can improve quality, increase access, and reshape the workforce, payments, and patient volumes. Today, AI can perform some 16 to 22 percent of US outpatient care.”

Nobel Prize

  • The Wall Street Journal reports,
    • “Henri Kagan and Kenso Soai were awarded the 2026 Nobel Prize in Chemistry for breakthroughs that have helped advance the development of modern pharmaceuticals.
    • “Kagan, of France’s Université Paris-Sud, and Soai, who is based at Tokyo University of Science, will share the 12 million Swedish kronor, or roughly $1.2 million, prize.
    • “The pair’s research relates to a concept called homochirality, which is the tendency of living systems to use just one of two possible mirror-image forms of a molecule. It’s important for the synthesis of small molecules in drugs that can interact with amino acids and sugars in the body in powerful ways.
    • “Thanks to Henri Kagan and Kenso Soai, we now know how homochirality can emerge,” the Royal Swedish Academy of Sciences said Wednesday. “Their discoveries have been decisive for chemists who design reactions for the manufacture of pharmaceuticals.”

Monday report

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

Simplicity is a virtue.

From Washington, DC

  • Beckers Payer Issues reports,
    • “The Trump administration is overhauling federal price transparency rules for payers and self-insured employers, including cutting so-called “ghost rates,” expanding out-of-network price disclosures and requiring executives to vouch for the accuracy of the data.
    • “The final rule, released Oct. 5 by CMS and the Labor and Treasury departments, revises the price transparency regulations first finalized in 2020 during President Trump’s first term, which have required payers to post their negotiated rates since 2022. Hospitals have been required to post their prices under separate federal rules since 2021. The new rule takes effect Dec. 5, though most of the data requirements will be phased in across 2027. 
    • The change follows a CMS proposal and an executive order from the president last year that directed federal agencies to step up price transparency enforcement.”
  • The rule is applicable to the FEHB and PSHBP programs pursuant to the Public Health Act, which CMS regulates.
  • Here is a CMS link to the agency’s fact sheet on the new TiC rule.
  • Also today, CMS released an update to its Group Health Plan user guide for Section 111 reporting.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Michael R. Caputo to the President’s Cancer Panel. The panel is an independent federal advisory body charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the President on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.
    • “Caputo brings 35 years of global public affairs experience spanning government, public policy, political campaigns, and the private sector. He previously served as Assistant Secretary for Public Affairs at HHS in 2020, where he led the Department’s communications during the COVID-19 response and helped establish and guide Operation Warp Speed.”
  • Beckers Hospital Review lets us know,
    • “Healthcare accounted for about 3 of every 4 U.S. jobs added from September 2025 to September 2026, according to an Oct. 5 analysis from the Peterson-KFF Health System Tracker.
    • “The sector added 372,000 jobs during that period, a 2% increase, while the rest of the economy added 124,000, a 0.1% increase. Healthcare job growth outpaced every other sector, and the industry now makes up a record 11.7% of all U.S. jobs.
    • “In September, healthcare added 17,000 jobs, below its average monthly gain of 33,000 over the prior 12 months, according to Bureau of Labor Statistics data.”
  • and
    • “The Federal Trade Commission has warned 24 of the nation’s largest health systems that incomplete, inaccurate or untimely price disclosures could violate federal consumer protection law, even if the organizations comply with CMS’ hospital price transparency requirements.
    • “FTC Chair Andrew Ferguson on Oct. 5 sent letters to the organizations urging them to review their pricing practices and take corrective action where needed, particularly for routine, nonemergency services scheduled in advance.
    • “The letters mark another layer of federal scrutiny for hospitals’ pricing practices. The FTC said CMS’ price transparency rules establish a baseline for disclosures but do not provide hospitals with a “safe harbor” from liability under Section 5 of the FTC Act, which prohibits unfair or deceptive business practices.”
  • MedTech Dive adds,
    • “The Advanced Research Projects Agency for Health has awarded more than $100 million to four organizations working on biosensors.
    • “The Massachusetts Institute of Technology received the largest award, securing up to $37.9 million to develop a wearable patch for continuous sensing of heart failure biomarkers.
    • “The other recipients include Novelna, New York University and University of Washington, which are working on devices focused on heart attacks, inflammation and perimenopause. ARPA-H said it plans to commit a total of $117.4 million to the program over 4.5 years.”

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

  • Kevin Moss, writing in Federal News Network, explains “how the 2027 FEHB premium increase will impact federal employees and annuitants.”
  • FedSmith offers a potpourri of Open Season news.
    • “2027 FEHB Changes: Weight Loss Drug Rules, a New FSA Card, and Plans Leaving
    • “From weight loss drug rules to a new FSA card and plans leaving the program, here are the biggest 2027 FEHB changes to know before Open Season.” * * *
    • “Full FEHB, PSHB, and FEDVIP plan brochures and OPM’s Plan Comparison Tool will be available on OPM.gov in early November.
    • “Open Season changes for non-postal employees take effect January 10, 2027. Changes for PSHB enrollees and annuitants take effect January 1, 2027.”

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

  • ABC News reports,
    • “More than 122,000 cases of Gatorade are being voluntarily recalled due to undeclared food dyes, according to the U.S. Food and Drug Administration.
    • “The recalled cases of Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange and Gatorade Orange Zero were distributed in more than two dozen states, the FDA said.
    • “The recall impacts 28-ounce bottles of Gatorade Lemon Lime, Lemon Lime Zero, Orange, and Orange Zero that did not declare the presence of Yellow No. 6 and/or Yellow No. 5 colors and bear lot dates between April 2027, May 2027 and June 2027. A full list of lot dates and states where the recalled drinks were distributed can be viewed on the FDA website.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches. The RFI seeks comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight.
    • “This RFI marks the latest FDA action to advance President Trump’s April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness, which directed agencies to accelerate research into psychedelic medicine.” * * *
    • “The public will have 45 days following publication in the Federal Register to submit comments, data or information to the docket. Stakeholders are encouraged to submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429. Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • “The comment period closes Friday, November 20, 2026. Late comments will not be considered.”
  • Becker’s Hospital Review relates,
    • “The FDA has approved pirtobrutinib (Jaypirca, Eli Lilly) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion.
    • T”he Oct. 2 approval was based on BRUIN CLL-313, a trial involving 282 patients randomized 1:1 to receive pirtobrutinib or bendamustine plus a rituximab product for six cycles.
    • With an estimated median follow-up of 28 months, median progression-free survival was not estimable in the pirtobrutinib arm and was 33.5 months in the bendamustine and rituximab arm.
    • Serious adverse reactions occurred in 28% of patients taking pirtobrutinib. The most common nonlaboratory adverse reactions were upper respiratory tract infections (27%), rash (22%) and COVID-19 (21%). The recommended pirtobrutinib dose is 200 milligrams orally once daily until disease progression or unacceptable toxicity. The drug received orphan drug designation.
  • Radiology Business tells us,
    • “The U.S. Food and Drug Administration has cleared AI software designed to improve pediatric bone age assessments. 
    • “The 510(k) clearance covers Visiana’s BoneXpert, a machine learning software that determines bone age in patients ages 2 to 21 using the Greulich-Pyle method. The software is intended to support pediatric radiologists in evaluating children with growth and pubertal disorders. 
    • “Bone age assessments are commonly used to evaluate whether a child’s skeletal development is consistent with their chronological age. Manual assessment is a known challenge and can vary between readers, potentially making longitudinal evaluation more difficult.  
    • “BoneXpert addresses this by analyzing radiographs of either hand and providing an annotated image showing the contours of the bones it evaluated and the individual bone ages assigned to them. The software also checks each radiograph and withholds a result when an image falls outside its validated scope, while the radiologist remains responsible for the final assessment and diagnostic decision.” 
  • Benzinga adds,
    • “The U.S. Food and Drug Administration has extended its review of Novo Nordisk A/S’ (NYSE:NVO) Biologics License Application for denecimig, an investigational hemophilia A treatment, following a manufacturing plant inspection.
    • “Mike Doustdar, president and CEO of Novo Nordisk, said the company is addressing agency requests as efficiently as possible while working closely with regulators to make better care something patients can count on.”

From the Medicare Advantage front,

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. has cut its Medicare Advantage footprint in half less than two years after buying Cigna’s Medicare business for $3.3 billion, but the Chicago-based insurer says the narrowed focus will allow it to achieve sustainable growth over time.
    • “The company is coming off a costly year, posting a net loss of more than $1.9 billion in 2025, after net income of $659 million the year prior. HCSC attributed the loss to elevated utilization and higher acuity across all of its lines of business.
    • “We’re actually at or ahead of most of the targets we set before the deal closed, from an integration and financial performance perspective,” Stephen Harris, president of government markets at HCSC, told Becker’s. “We feel really good about where we are and the momentum we have going into 2027.”

From the judicial front,

  • Fierce Healthcare offers a overview of “healthcare’s high-stakes courtroom battles.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Pennsylvania’s measles outbreak has hit a sobering milestone, surpassing 1,000 cases — the first U.S. outbreak to do so in 35 years.
    • “In Pennsylvania, the virus has moved through communities where many children and adults have gone years without the two doses of measles vaccine needed for reliable protection. The widening outbreak has infected 1,004 people spread across 39 counties and hospitalized nearly 200 people, authorities reported Monday.”
  • The New York Times adds,
    • “Gov. Kathy Hochul declared a statewide health emergency in New York State on Monday as measles cases increased dangerously across rural counties where vaccination rates have lagged.
    • “As of Saturday, 108 measles cases had been reported across the state this year, the most since 2019, when New York was the epicenter of a national outbreak. Most of the cases are in rural areas, concentrated in the Finger Lakes region.
    • “Ms. Hochul’s declaration will relax rules about who can administer vaccines to make it easier for midwives, pharmacists and other health care workers to give shots to prevent measles.”
  • NBC News relates,
    • “The chickenpox vaccine appears to protect against shingles, according to a large new analysis. 
    • “Anyone who got infected with chickenpox as a child is at risk of later developing shingles, a painful, blistering rash that usually appears on one side of the body. For unknown reasons, cases of shingles have been gradually rising, even among younger adults, research has shown.
    • “However, new data suggests that a steep decline in chickenpox cases over the last three decades, thanks to the chickenpox vaccine, may contribute to a decline in shingles in the coming years.
    • “New data suggests that people ages 34 and younger may be less likely to develop shingles than previous generations. That’s because they are more likely to have been vaccinated against the varicella zoster virus, or chickenpox, which can reactivate years later as shingles.
    • “Our data suggest that trend is now reversing in the very youngest adults, the first generation eligible to be vaccinated against chickenpox as children,” said registered nurse Kersten Bartelt, lead author of the report from Epic Research, which conducts research on health trends.”
  • MedPage Today tells us,
    • “Hormone therapy should be the first-line treatment for women with menopausal vasomotor symptoms, according to new guidance from the American College of Physicians (ACP).
    • “Women with a uterus should receive estrogen in combination with progestogen, while those without a uterus can receive estrogen monotherapy as first-line therapy, according to ACP’s new clinical guidelineopens in a new tab or windowon pharmacologic treatments for vasomotor symptoms.
    • “Both are listed as strong recommendations based on high-certainty evidence, Amir Qaseem, MD, PhD, MHA, and guideline authors wrote in the Annals of Internal Medicine.”
  • Beckers Behavioral Health calls attention to “the drug trends mot worrying to behavioral health leaders.”
    • “Fentanyl is no longer the only substance keeping addiction clinicians up at night. Some of the newest threats are being sold not by dealers, but at gas stations, smoke shops and online.
    • “From potent animal sedatives contaminating the opioid supply in the Northeast and Midwest to concentrated kratom derivatives marketed as botanical supplements, the substances patients are using are changing faster than the systems built to respond to them. At the same time, technology is making behavioral addictions such as online sports betting more accessible than ever. 
    • “Becker’s asked three psychiatry and addiction medicine leaders what trends they are seeing among their patients, which drugs they expect to take off and what worries them most.”
  • Cardiovascular Business informs us,
    • “Orforglipron, a GLP-1 pill being sold by Eli Lilly and Company under the brand name Foundayo, is both safe and effective in obese or overweight patients with type 2 diabetes. That was the primary takeaway from new data presented at the European Association for the Study of Diabetes annual meeting in Milan, Italy, and simultaneously published in The Lancet.[1]
    • “In April, the U.S. Food and Drug Administration (FDA) approved orforglipron as a once-daily treatment for weight-related medical problems in obese and overweight adults. When the FDA requested additional data on the drug’s effect on cardiovascular outcomes, Lilly shared early positive results from ACHIEVE-4, a randomized trial of more than 2,700 patients who received either orforglipron or insulin glargine. Now, the full results of that analysis have been shared with the public for the first time.
    • “Overall, the researchers behind ACHIEVE-4 found that orforglipron was associated was a 16% lower risk of major adverse cardiovascular events (MACEs) than insulin glargine. A MACE was defined as either cardiovascular death, a heart attack, a stroke or a hospitalization for unstable chest pain. This finding met the prespecified criteria to be seen as noninferior to insulin glargine.”
  • BioPharma Dive points out,
    • “An experimental pneumococcal vaccine from Vaxcyte succeeded in the first of three late-stage studies, sending the biotechnology company’s shares soaring and inching it closer to a potential regulatory submission.
    • “Called VAX-31, the shot met all of its main efficacy objectives in the study. Among adults 50 years or older, VAX-31 matched the effectiveness of Pfizer’s Prevnar 20 and Merck & Co.’s Capvaxive in protecting against 28 strains of the bacteria that causes pneumococcal disease and proved superior against three “unique” strains. VAX-31 was inferior compared to Capvaxive on two strains when using a more rigorous statistical threshold. But that finding surpassed analyst and investor expectations heading into the readout.
    • “Vaxcyte said its vaccine was “well tolerated” and demonstrated a safety profile similar to Prevnar 20 and Capvaxive across all ages studied. The most common adverse events were “generally mild-to-moderate,” and the majority resolved within two days of vaccination. Vaxcyte will report results from two additional late-stage trials next year and seek approval if the data are positive.”

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

  • STAT News reports,
    • “Workers and employers are drowning in their health insurance premiums. The reason for that deluge: the health care industry’s high and inscrutable prices.
    • “Health insurers don’t set their premiums in a vacuum. The biggest factor is the care people receive. And the biggest factor driving the cost of that care, STAT has found, is not how often people are going to the hospital or doctor’s office, but the out-of-control prices charged by every part of the health care industry, which workers and businesses are often powerless to stop.
    • “For Gerard Anderson, America’s high prices are as obvious, yet unnoticeable, as the oxygen we breathe. He has studied health care spending and policy for the past four decades, even helping design Medicare’s hospital payment system in the 1980s. He co-wrote a seminal paper in 2003, and again in 2019, that blared the culprit of America’s outlier health spending figures: “It’s the prices, stupid.” 
    • “Some things don’t change,” Anderson, a professor at Johns Hopkins, told STAT. 
    • “One thing is changing, however, Anderson said. He and others are working with state policymakers and employers, who are signaling an openness to government intervention to curb health care costs — an idea normally anathema in the private sector.”
  • BioPharma Dive relates,
    • “Shionogi is expanding in rare diseases, announcing Monday a deal to acquire Texas-based IntraBio for a drug called Aqneursa that has gained approvals in two inherited disorders.
    • “Per deal terms, Shionogi will pay IntraBio’s shareholders $2 billion in cash and turn the company into a wholly owned subsidiary of its New Jersey-headquartered U.S. division. Shionogi said it will review the transaction’s effects on its financial outlook for the current fiscal year, which ends next March.
    • “The transaction will help expand a rare disease business Shionogi launched with the acquisition last year of the ALS drug Radicava from Tanabe Pharma. Aside from Radicava, Shionogi’s U.S. portfolio includes the COVID-19 medicine Xocova and a treatment for complicated urinary tract and hospital acquired respiratory infections.”
  • The Wall Street Journal adds,
    • “GE HealthCare Technologies GEHC said Monday it planned to purchase a manufacturer of radioactive substances used in medical imaging procedures for $945 million in cash.
    • “The deal marks a continued push by medical-equipment maker GE HealthCare into the growing market for radiopharmaceuticals, which have uses for both diagnosing and treating diseases including cancer, heart disease and Alzheimer’s. 
    • “Drugmakers such as Novartis and other devicemakers have been investing in the segment. In August, Curium struck a deal to acquire Lantheus Holdings for an initial $6.7 billion in a consolidation of two radiopharma companies.”
  • Beckers Hospital Review tells us,
    • “Chicago-based CommonSpirit Health will consolidate its five regions into three service areas, West, Central and East, effective in January, CFO Michael Browning said during the system’s fiscal 2026 earnings call Oct. 2.
    • “The change replaces the California, Central, South, Mountain and Northwest regions established after a 2024 portfolio review that consolidated eight operating divisions into five. Each service area president will sit on the system’s enterprise leadership cabinet.
    • “CommonSpirit confirmed in a September statement to Becker’s that it was evolving its operating model “to better leverage our system scale and more effectively support our markets.”
  • and
    • “Salt Lake City-based Intermountain Health is exiting Trinsic, a Colorado clinically integrated network it operates as a joint venture with Aurora, Colo.-based UCHealth, with UCHealth taking over the network after Dec. 7, according to a WARN notice Intermountain filed Oct. 2 with the Colorado Department of Labor and Employment.
    • “The notice says Trinsic’s Broomfield, Colo., operating unit will close Dec. 4 and 117 employees will be affected, with first separations expected Dec. 9. Affected roles include 29 nurse care managers, 24 clinical care coordinators and 14 nonclinical care coordinators.
    • “Intermountain said in the notice that it expects most, if not all, Trinsic employees who live and work in Colorado will have the opportunity to keep working for Trinsic, subject to UCHealth’s hiring decisions. Employees who live and work outside Colorado may not have the same opportunity.”
  • Fierce Healthcare informs us,
    • ‘Trinity Health grew its operating income from a narrow loss to a $281.1 million gain (1.1% operating margin) in the fiscal year ended June 30, 2026, a performance improvement the large nonprofit attributed to stronger volumes, expense management and payment rates. 
    • “Operating revenue across the organization rose 5.2% year over year to $26.8 billion, outpacing a 4.4% rise in operating expenses, according to recently shared financial documents. 
    • “When disregarding “other items” including asset impairment charges ($42.7 million in FY2026) and restructuring costs ($103.9 million in FY2026), the 91-hospital system more than doubled its operating income to $427.8 million (1.6% operating margin) in the fiscal year ended June 30, 2026, its management touted in a financial summary.”
  • and
    • “iRhythm completed on Monday its acquisition of cardiac remote patient monitoring company VitalConnect for $237.5 million.
    • “iRhythm provides end-to-end cardiac monitoring services, while VitalConnect’s monitoring platform supports multiple modalities—and has the capability to monitor up to 11 physiological parameters, according to an Oct. 5 press release.
    • “In addition to the $237.5 million deal, iRhythm provided VitalConnect with $10 million in working capital between signing and closing, executives say. The acquisition is expected to increase iRhythm’s revenue growth rate and maintain its 15% adjusted EBITDA margin target for 2027.”
  • and
    • “Grindr is ramping up its focus on healthcare with plans to acquire PurposeMed Inc., the parent company of telehealth provider Freddie.
    • “Freddie provides access to HIV prevention and PrEP care through telehealth visits. Grindr plans to pick up PurposeMed for $250 million in cash and stock, consisting of $190 million in cash and $60 million in Grindr common stock. 
    • “The agreement also includes the potential for up to $70 million in additional cash consideration tied to 2027 performance targets, payable in 2028. The companies expect the deal to close in the fourth quarter, subject to applicable closing conditions.”
  • Beckers Clinical Leadership points out the ten most in-demand physician specialties.
    • “Hematology/oncology
    • “Gastroenterology
    • “Cardiology (interventional)
    • “Endocrinology
    • “Cardiology (noninvasive)
    • “Radiology
    • “Urology
    • “Anesthesiology
    • “Neurology
    • “Obstetrics/gynecology
      • View the full report here.

From the Nobel Prize front,

  • The Wall Street Journal reports,
    • “A trio of neuroscientists were awarded the 2026 Nobel Prize in Physiology or Medicine for their pioneering work on optogenetics, a method of controlling nerve cells with light, which makes it possible to study how the brain shapes memories, feelings and behaviors.
    • “Announcing the prize recipients Monday at the Karolinska Institute in Stockholm, the Nobel committee said the work of Drs. Karl Deisseroth, Peter Hegemann and Georg Nagel had laid the foundation of a new era in neuroscience.
    • “The work “unlocked new understanding of how the brain works, new possibilities for treating neurological and psychiatric disorders,” said Jonathan Levin, president of Stanford University, where Deisseroth is a neuroscientist and psychiatrist. 
    • “Hegemann is based at Humboldt University in Berlin and Nagel at the University of Würzburg in Germany.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • CBS News reports,
    • “The Senate confirmed Keith Sonderling to lead the Department of Labor on Wednesday, officially installing the nominee who has been leading in an acting capacity since Lori Chavez-DeRemer’s exit in April.
    • “In a party-line 47 to 41 vote, the Senate confirmed Sonderling.
    • “Sonderling served in several roles at the Department of Labor and the Equal Employment Opportunity Commission during President Trump’s first administration. He previously practiced employment and labor law at a Florida law firm.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services’ 340B Part D claims data repository became available Oct. 1 for voluntary data submissions. While data submissions will remain voluntary for now, the agency has proposed making data submissions mandatory starting Jan. 1, 2027. CMS has multiple resources available to support 340B entities and their third-party administrators with data submissions, including a user guide, companion guide, fact sheet and an FAQ.” 
  • and
    • “The Department of Health and Human Services’ Health Resources and Services Administration Oct. 1 announced approval of 10 drug companies to participate in the 340B Rebate Model Pilot Program. The approved companies are AbbVie, Amgen, Astellas Pharma US, AstraZeneca, Bristol Meyers Squibb, Boehringer Ingelheim Pharmaceuticals, GlaxoSmithKline, Merck Sharp & Dohme, Pfizer and Teva Pharmaceuticals. See the HRSA webpage for more details about the drug companies approved to participate in the Rebate Model Pilot Program, as well as FAQs.
    • “The AHA Aug. 7 issued a Regulatory Advisory that includes a detailed summary of the HRSA announcement on the rebate model pilot program. The program would begin Jan. 1, 2027.
    • “The AHA remains deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Pilot Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients,” an AHA spokesperson said. “We are reviewing today’s materials and are considering all available options to prevent this flawed program from going into effect.”
  • Beckers Hospital Review adds,
    • “An October report from Berkeley Research Group estimates how much patients and payers spend on 340B drugs, beyond what covered entities pay to acquire them.” * * *
      • “BRG calculates the gap between acquisition cost and reimbursement, which it calls “340B drug margin,” at $142.2 billion in 2025, more than double the $63.6 billion margin in 2021.
      • “Private and commercial insurers covered the largest share of that margin (63%), followed by Medicare (25%) and Medicaid managed care plans (7%). Medicaid fee-for-service generates no margin because it reimburses covered entities at acquisition cost.
      • “As a share of the overall U.S. pharmaceutical market, 340B prescriptions now account for 27% of net spending, up from about 18% in 2021. BRG attributed the program’s growth mainly to hospitals acquiring off-site clinics, expanded hospital participation following the Affordable Care Act and growing use of contract pharmacies, which now number roughly 35,000 nationally, up from about 1,300 in 2010.”
  • CMS has posted a table showing the “Top 10 Section 111 Group Health Plan (GHP) Reporting Error Codes from January 1- June 30, 2026”

From the Medicare Advantage front,

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

  • Govexec reports
    • “Nearly all of the portfolios in the federal government’s 401(k)-style retirement savings program lost value last month, as the broader investment market encountered broad volatility.
    • “The small- and mid-size businesses in the Thrift Savings Plan’s S Fund saw the worst decline, falling 3.86% in September. Since January, the S Fund is up 11.62%. The C Fund’s common stocks nearly broke even, finishing the month just 0.35% in the red. So far this year, the C Fund has grown 12.73%.” * * *
    • “The only TSP fund to post gains was the government securities of the G Fund, which grew at a statutorily mandated rate of 0.40%. So far this year, the G Fund has grown 3.41%.”
  • Tammy Flanagan, writing in Govexec, considers “Retiring in 2027? Picking the right date could pay off.”
    • “The date you leave federal service can affect when your annuity begins and how much you receive for unused annual leave.”

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

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved the Edwards Lifesciences Autus surgical pulmonary valvethat is the first size-adjustable valve designed for pediatric patients with congenital heart disease. The valve previously received FDA Breakthrough Device designation for its potential to address an important unmet need.
    • “Typically, children with congenital heart disease outgrow their valves and require repeat open-heart surgeries to explant the old valves and implant larger valves. Instead of repeat surgeries, the Autus is designed to be expanded as a child grows through a minimally invasive transcatheter procedure, offering a new, less invasive way to care for these children over the long term.
    • “This valve is a game changer,” explained Jennifer Romano, MD, MS, a heart surgeon at C.S. Mott Children’s Hospital, and past-president of the Society of Thoracic Surgeons (STS), in a statement from September when her team performed the first Autus procedure in the U.S. “Typically, we give these children a temporary fix, knowing they will need more surgeries down the road. “Now, we may be giving a child a valve that could potentially last them a lifetime. This could be transformative.”
  • MedTech Dive relates,
    • “The Food and Drug Administration has selected the first participants for an innovation challenge for home devices that could be used to reduce hospital readmissions.
    • “The first five participants include large medtech firm BD, wearable EEG startup Epitel, infant care company Prapela, Current Health, a company making software for cancer care, and Skribe Medical, which makes a device to assess cardiac function.
    • “The FDA’s device center plans to choose a total of nine participants by Dec. 4 for the challenge, called Reducing Readmissions through Device Innovation for the Home, or READI-Home. The selected manufacturers will have opportunities for early engagement with the FDA, including feedback on device design and testing, and demonstrations at the agency’s research facilities.”
  • and
    • “Medtronic said Wednesday it received a breakthrough device designation from the Food and Drug Administration for a drug-coated balloon catheter to treat peripheral artery disease below the knee.
    • “While drug-coated balloons are commonly used to treat PAD above the knee, none are indicated in the U.S. for use below the knee, where improved treatment options are needed, Medtronic said. PAD causes reduced blood flow to the limbs due to plaque buildup in the arteries. Patients with advanced PAD can be at risk for amputation.
    • “Medtronic said it is planning a randomized pivotal trial to study the paclitaxel-coated device, called IN.PACT BTK, in about 400 patients with below-the-knee lesions.”
  • BioPharma Dive identifies “5 FDA decisions to watch in the fourth quarter of 2026.”
    • “The next three months will feature anticipated decisions on a new kind of cancer immunotherapy, as well as medicines important to the futures of Roche, GSK and Gilead.”

No Surprises Act News,

  • Federal Hearings and Appeals Services, a certified independent dispute resolution entity, informs us,
    • “Our Account Services team members spend their days immersed in the Independent Dispute Resolution (IDR) process and fielding questions from parties. FHAS recently launched a new “Common Questions” series on our blog to share the questions we receive most often, and the answers we’re providing.
    • “Lately, we’ve seen some confusion around the new IDR Registry and the new IDR Gateway, so we’ll address those common questions, here. As a starting place, let’s clarify some basics.
    • “The Gateway is the platform. The Registry is a database inside it.
    • “The IDR Gateway is CMS’s new secure, account-based platform for managing Federal IDR disputes. It replaces the single-use web forms that parties have used since 2022.
    • “Both providers and payers need to register or sign up for a Gateway account. See our earlier post, The IDR Gateway Is Here, for more details on the Gateway roll-out.
    • “The IDR Registry is different. It is a searchable database of payer information that will live inside the Gateway.
    • “Only payers register in the IDR Registry – health insurance issuers, self-insured group health plans and their sponsors, and FEHB carriers. Each payer will carry an IDR registration number, and initiating parties will be able to access this number by referring to a given health plan’s notice of payment or denial.” * * *
    • “When might the Registry be available?
    • “Not right away, and the timeline has several steps. The Final Rule does not set a calendar date for the Registry. Instead, the Registry provisions become applicable 90 business days after the Departments issue guidance announcing that the Gateway functionality supporting the Registry is available, and payers have until the later of that date, or the date they begin offering coverage, to register. The Departments extended that window from the 30 business days originally proposed and noted that the extra time is meant to let payers set up lines of communication across their TPAs and service providers. CMS’s published implementation timeline lists the Registry first among the Gateway-dependent provisions it plans to roll out beginning in spring 2027, ahead of the new open negotiation, initiation, and IDRE selection workflows. Counting forward from a spring 2027 announcement, 90 business days runs roughly four to four and a half months. A reasonable expectation is that payers will be fully registered, and registration numbers will begin appearing on remittances, in the second half of 2027. The Departments have said they will publish updates as each provision is operationalized, and we will share those as they arrive.
    • “In the meantime, one related change lands sooner. Beginning with items and services furnished on or after Jan. 1, 2027, payers must use specified claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs) to indicate whether a claim is subject to the No Surprises Act and the Federal IDR process. That is a separate requirement from the Registry, but it addresses a neighboring question and arrives first.”
  • FEHBlog observation: I created a Gateway account for my client and upon doing so, all of the IDR cases showed up in a list. I compared the Gateway list against my list and I found two cases on my list that weren’t on the Government’s list. I am assuming that those cases were dropped without letting me know which is OK with me.

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Over 2 million new cancer cases were attributable to infections globally in 2024, according to an analysis of worldwide cancer incidence, highlighting the importance of effective prevention measures.
    • “Infections led to an estimated 2.3 million new cancer cases in 2024, including gastric cancer, cervical cancer, hepatocellular carcinoma, leukemias and lymphomas, and nasopharyngeal cancer, which accounted for 12% of all cancer cases worldwide.
    • “Among 12 carcinogenic infectious agents, the largest numbers of cancer cases were attributable to:
      • “Helicobacter pylori: 760,000 cases, population-attributable fraction (PAF) 4%
      • “Human papillomavirus (HPV): 750,000 cases, PAF 4%
      • “Hepatitis B virus (HBV): 360,000 cases, PAF 2%
      • “Epstein-Barr virus (EBV): 260,000 cases, PAF 1%
      • “Hepatitis C virus (HCV): 160,000 cases, PAF <1%
      • “Kaposi’s sarcoma-associated herpesvirus (KSHV): 35,000 cases, PAF <1%
    • Most cancers attributable to H. pylori were non-cardia gastric cancers (700,000 cases), while cervical cancer accounted for most HPV-attributable cases (600,000). HBV and HCV were responsible for 330,000 and 130,000 cases of hepatocellular carcinoma, respectively, while EBV led to 110,000 nasopharyngeal cancers, reported Harriet Rumgay, PhD, of the International Agency for Research on Cancer in Lyon, France, and colleagues in Lancet Oncology.”
  • and
    • “Maternal infection or sepsis is the third-leading cause of pregnancy-related death in the U.S., and Mississippi is the state with the third highest maternal mortality rate.
    • “In this study of Mississippi births, maternal sepsis disproportionately affected mothers with preterm births or c-sections, those with chronic comorbidities, Black women, and Medicaid enrollees.
    • “Overall, sepsis was recorded in 0.06% of the births from 2016 to 2025, but was involved in 32.4% of the delivery-associated hospital deaths.”
  • The American Medical Association lets us know “5 things patients should know about GLP-1 medications.”
    • “Sean Hashmi, MD, talks about the benefits of GLP-1 medications—as well as some misunderstandings—on the latest “Health vs. Hype” podcast episode.”
  • The latest issue of the National Institutes of Health’s Research Matters covers the following topics:
    • “Antiviral drug did not improve Long COVID symptoms” 
      • “A clinical trial for Long COVID found that treating patients with a common antiviral drug for up to 25 days did not improve symptoms.
      • “The findings suggest that other approaches to manage symptoms and treat Long COVID are needed.”
    • “tRNA treatment may help restore cystic fibrosis proteins” 
      • “Lipid nanoparticles that deliver engineered transfer RNA restored functional proteins in cell and animal models of cystic fibrosis.
      • “This strategy may represent a potential therapeutic approach for cystic fibrosis and other genetic diseases caused by nonsense mutations.”
    • “Bacterial infection may alter developing gut” 
      • “C. difficile bacteria caused lasting changes to cells in the intestines of newborn mice.
      • “The findings suggest that early-life C. difficile infections may alter gut stem cells and immunity into adulthood.”
  • Health Day relates,
    • “Stable employment in midlife is associated with better cognitive health in later life, according to a study published online Sept. 23 in Alzheimer’s & Dementia.
    • “Erika T. Beidelman, from the Columbia University Mailman School of Public Health in New York City, and colleagues used data from 2,418 participants in the Health and Retirement Study (1998 to 2014) to examine associations of workforce participation and job insecurity with later cognition.
    • “The researchers found that among women, compared with secure employment, self-employment, early retirement, not being in the labor force, and secure-to-retirement trajectories were significantly associated with lower memory and executive function scores (β range = −0.13 to −0.32 standard deviation units). For men, inconsistent employment was associated with poorer performance across most cognitive domains versus secure employment. In women, employment instability and early retirement were associated with higher odds of cognitive impairment.”
  • The New York Times offers “Clues to Why a Breakthrough Pancreatic Cancer Drug Eventually Stops Working”
    • “Researchers are asking why patients, like former Senator Ben Sasse, inevitably develop resistance to the drug daraxonrasib.”
  • Genetic Engineering and Biotechnology News tells us,
    • Methicillin-­resistant Staphylococcus aureus (MRSA) has rapidly risen to become one of the gravest threats to global health, with deaths from Staphylococcus aureus (S. aureus) having doubled worldwide since 1990. In severe cases, the bacteria invade the bloodstream in life-threatening systemic infections, which have a high risk of kidney injury and failure.
    • S. aureus is one of the most concerning bacterial pathogens, given that MRSA accounts for the largest increase in the global antimicrobial resistance burden. In addition, deaths attributable to S. aureus infections have doubled since 1990, making it a leading cause of bacterial mortality worldwide. Despite the continued focus on research, tissue reservoirs that permit bacterial persistence remain poorly defined.
    • “Now, a new study reveals how MRSA exploits the osmotic environment of the inner kidneys to establish a bacterial reservoir and hide from the immune system. This work suggests that MRSA can establish niches in the kidneys and the findings provide a mechanistic explanation for a longstanding question in the field of MRSA biology, and could inform future strategies aimed at limiting kidney damage from infections.
    • “This work is published in Science Translational Medicine in the paper, “Hyperosmotic niche adaptation and tissue polyamines underlie MRSA persistence in the kidney.”
  • STAT News informs us,
    • “Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await
      • “The small biotech company is developing an injectable, low-dose monoclonal antibody.”
  • Per Fierce Healthcare,
    • “Taiho Pharmaceutical, together with U.S.-based subsidiary Taiho Oncology, has inched closer to approval of another oral combination treatment for patients with blood cancers.  
    • “In new phase 3 topline results, Taiho reported that its investigational, all-oral drug combination of azacitidine and cedazuridine successfully treated patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML), two blood disorders that can lead to acute myeloid leukemia (AML).
    • “Azacitidine is an established chemotherapy already used to treat MDS and AML. But Taiho’s formulation uniquely pairs the chemo with the cytidine deaminase inhibitor cedazuridine, which blocks the chemo-disintegrating enzyme cytidine deaminase in the digestive tract, allowing the cancer treatment to survive oral delivery.”
  • and
    • “While Foundayo’s insulin-matching potential in type 2 diabetes had been established in a topline readout earlier this year, Eli Lilly on Wednesday unveiled the fullest picture yet of its oral GLP-1’s ability to keep blood sugar in check, cut weight and, crucially, demonstrate cardiovascular safety in patients with compounding metabolic conditions.
    • “In a deep dive into the Indianapolis drugmaker’s late-stage Achieve-4 trial, which compared Foundayo (orforglipron) with titrated insulin glargine in adults with type 2 diabetes and obesity or overweight who were at increased cardiovascular risk, Lilly’s drug proved noninferior to insulin on the risk of major adverse cardiovascular events (MACE) while delivering greater reductions in A1C and weight.
    • “The comprehensive results were presented as part of Lilly’s showing at the European Association for the Study of Diabetes (EASD) annual meeting in Milan this week and simultaneously published in The Lancet.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
    • “Downloads: Evidence Report | Voting Questions | Public Comments | Response to Public Comments
    • “High blood pressure is common, leads to serious complications like heart disease, strokes, and kidney failure, and is frequently undertreated,” said ICER’s Chief Medical Officer David Rind, MD, MSc. “Baxdrostat and lorundrostat are from a new class of medications intended for patients that may need more than standard first-line therapies. The hope is that they may have fewer side effects and reduce clinical events, but evidence for such benefits is currently limited.”
    • “Register here to watch the live webcast of the October 29th ICER public meeting.”

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

  • Beckers ASC Review reports,
    • “Philadelphia-based Penn Medicine, Independence Blue Cross and Franklin, Tenn.-based Regent Surgical are building an ASC company with a structure Regent CEO Travis Messina said the industry has not seen before: a health system, a health plan and a management company, all as owners.
    • “All the research that I’ve done suggests that there has never been a partnership in the ASC space that included a health system, a health plan and a management company,” Mr. Messina told Becker’s. “We believe it’s the first of its kind in that regard.”
    • “The three organizations announced Sept. 24 they will develop at least 18 ASCs across Pennsylvania, New Jersey and Delaware.” 
  • Beckers Hospital Review relates,
    • “Vizient named its 2026 top performers for quality, recognizing hospitals across seven cohorts and five medical groups for ambulatory care.
    • “The Bernard A. Birnbaum, MD, Quality Leadership Award is based on the Vizient Quality and Accountability Study. The study scores hospitals in six domains: safety, mortality, effectiveness, efficiency, patient centeredness and variation in care, according to a Sept. 24 news release from the company.
    • “The data comes from the Vizient Clinical Data Base, the Hospital Consumer Assessment of Healthcare Providers and Systems survey and the CDC’s National Healthcare Safety Network. The clinical database covers more than 1,600 hospitals across more than 250 health systems in 49 states.”
  • and
    • “Chicago-based CommonSpirit recorded an operating loss of $430 million (-1.0% operating margin) in fiscal 2026 — excluding special charges — compared to an operating loss of $687 million (-1.8% margin) the year prior, according to its Sept. 30 financial report.”
  • and
    • “Nashville, Tenn.-based Vanderbilt Health recorded operating income of $452 million (4.7% operating margin) in fiscal 2026, compared to operating income of $255 million (3.0% margin) the year prior, according to its Sept. 30 financial report.” 
  • and
    • “Morgantown, W.Va.-based WVU Health System has acquired Greensburg, Pa.-based Independence Health System’s five hospitals and their affiliated physician practices and outpatient facilities. 
    • “The hospitals are Butler (Pa.) Memorial Hospital, Clarion (Pa.) Hospital, Frick Hospital in Mount Pleasant, Latrobe (Pa.) Hospital and Westmoreland Hospital in Greensburg. They will begin operating under WVU Medicine’s brand immediately, according to an Oct. 1 news release.
    • “WVU Health System signed a definitive agreement June 2 to acquire the hospitals. The parties shared plans for the acquisition in mid-November 2025.”
  • and
    • “Tallahassee-based Florida State University and Tallahassee Memorial HealthCare have finalized core agreements that set the long-term framework for FSU Health, the university’s integrated academic health system for North Florida.
    • “The agreements include lease and operating agreements and other definitive legal documents, including an academic and clinical framework covering Tallahassee Memorial Hospital and a planned FSU Health hospital in Panama City Beach, Fla., according to a Sept. 30 news release.
    • “TMH will keep running day-to-day operations under the FSU Health brand. That includes Tallahassee Memorial Hospital, the future Panama City Beach hospital, TMH’s other clinical sites and its employed physician network, TMH Physician Partners. The deal keeps TMH’s existing charity care policy at both hospitals. It also creates a new governance structure that lets FSU nominate board candidates in Tallahassee and Panama City Beach.”
  • The Wall Street Journal lets us know,
    • “Walgreens’ private-equity owner is nearing a deal to sell U.K. pharmacy chain Boots for close to $9 billion including debt, according to people familiar with the matter.
    • “It has been discussing a deal to sell Boots to the Canadian arm of the Weston family, which owns a food-business empire, the people said. A deal could be completed in the coming weeks, assuming talks don’t fall apart.
    • “Sycamore Partners took Walgreens private in 2025 in a deal valued at $24 billion including debt (and roughly $10 billion without). It separated the company into five units to facilitate potential sales of noncore units, including Boots.
    • “Boots houses the former international businesses of Walgreens, which includes Boots operations in the U.K. and businesses in Thailand, Mexico, Germany and China.”
  • and
    • “France’s Sanofi SAN and Regeneron REGN Pharmaceuticals said they would expand their longstanding alliance to jointly develop and market new immunology medicines, in a deal that could net the U.S. drugmaker up to $8 billion.
    • “The two companies have collaborated for more than two decades in a partnership that spawned one of the top-selling medicines worldwide, Dupixent, approved for a range of conditions that include asthma and eczema.
    • “With Dupixent due to begin losing patent protection in the early 2030s, both sides had signaled they were discussing an updated framework for their relationship.” 
  • Fierce Healthcare tells us,
    • “Specialty pharmacy is a key cost driver for employers and insurers, with developments in this space showing no signs of slowing down.
    • “For example, a recent study from the Pharmaceutical Strategies Group found that 43% of employers and benefit leaders view managing specialty pharmacy spend as a top goal. And, per that report, while specialty drugs generally make up about half of the development pipeline, 76% of novel new drugs approved by the Food and Drug Administration in 2025 were specialty products.
    • “It’s with that backdrop that Blues-backed pharmacy benefit manager Prime Therapeutics convened stakeholders from across the pharmaceutical supply chain for its annual Specialty Summit last month. One of the prevailing themes of the conference—a need to break down silos between the pharmacy benefit and medical benefit to more effectively manage the full patient care journey.”
  • and
    • “Since 2022, federal price transparency rules have required health insurers to publish their negotiated hospital rates, aiming to give providers, employers and patients greater visibility into healthcare costs. However, the resulting machine-readable files are often so large and inconsistent that most organizations struggle to use them effectively.
    • A single payer’s pricing file can contain billions of rows, often published in varying formats and riddled with errors. According to a recent provider survey, nearly 40% of organizations report limited or no meaningful use of Transparency in Coverage data when preparing for payer negotiations. 
    • Startup Payerset launched four years ago to tackle this challenge, building the infrastructure required to normalize the data and render it usable across the formats healthcare organizations rely on. 
    • The company launched an artificial intelligence-powered, self-service research assistant that unifies negotiated rate data, claims, policy and market benchmarking into one platform. Payerset’s platform draws on 20 trillion rate records retained since 2024, with more than 10 trillion more processed every quarter, according to the company.
    • Using the research assistant tool, health systems can ask plain-English questions about their market position and get instant, data-backed answers, executives say.
    • “It’s like having extra researchers on your team,” Jerry DiMaso, Payerset co-founder and CEO, told Fierce Healthcare.
  • Healthcare Dive adds,
    • “Patients are less willing to use artificial intelligence for healthcare if it requires access to personal data or protected health information, according to a new survey.
    • “Healthcare consumers are primarily concerned about data privacy and the accuracy of AI-generated information, with around 89% saying AI responses in healthcare need human oversight, the survey by Wolters Kluwer shows.
    • “This trust gap means that less than a third of U.S. adults are using AI to find a healthcare provider, navigate their health insurance or create a diet plan, even though these applications are frequently marketed as key uses for AI in healthcare.”