Monday report

FDA

Monday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, 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 U.S. Census Bureau informs us,
    • “Veterans Day originated as “Armistice Day” on Nov. 11, 1919, the first anniversary of the end of World War I. Congress passed a resolution in 1926 making it an annual observance, and it became a national holiday in 1938. Sixteen years later, then-President Dwight D. Eisenhower signed legislation changing the name to Veterans Day to honor all those who served their country during war or peacetime. On this day, the nation honors military veterans — living and dead — with parades and other observances across the country and a ceremony at the Tomb of the Unknown Soldier at Arlington National Cemetery in Virginia.
    • “The following facts are made possible by the invaluable responses to U.S. Census Bureau surveys. We appreciate the public’s cooperation as we continuously measure America’s people, places and economy. 
    • “Veteran Population
      • “15.7 million
        • “The number of military veterans in the United States in 2025, representing 5.9% of the total civilian population age 18 and over.
      • “0.3%
        • “The share of veterans in 2025 who served during World War II. Additionally, 2.3% of veterans served during the Korean War, 30.9% during the Vietnam War, 25.6% during the Persian Gulf War, and 31.4% during the Post-9/11 period (September 2001 to present).
      • “30.5%
        • “The share of veterans age 75 and older in 2025. At the other end of the spectrum, 8.4% of veterans were under age 35.”
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Nov. 9 announced allocations for the second year of the Rural Health Transformation Program, which will award $10 billion annually to all states from fiscal year 2026 through FY 2030. The program helps rural hospitals fund projects to expand access to care, bolster the rural workforce, modernize facilities and technology, and support innovative payment and care delivery models. Fifty percent of the funding is distributed equally among all states, while the additional 50% is allocated based on rural health needs and proposed impact.” 
  • Here is a CMS link to its fact sheet on this announcement.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced an expansion of the TOPx HHS Tech Sprint for AI and Invisible Illness prize pool from $2 million to $3.8 million, responding to strong public interest and the quality of submissions. Today’s announcement recognizes 40 Phase 2 winners receiving $3.7 Million from the expanded prize pool for working prototypes that use AI and federal open data to address complex chronic conditions.” * * *
    • Explore TOPx submissions and participate in People’s Choice voting at InvisibleIllness.Crowdicity.com. Learn more about HHS Lyme disease initiatives at HHS.gov/Lyme.
  • Beckers Hospital Review relates,
    • “CMS is seeking public comment on what should count as “reasonable and relevant” terms in contracts between Medicare Part D plan sponsors and network pharmacies, with comments due Nov. 23, according to a Sept. 24 request for information in the Federal Register. The SBA’s Office of Advocacy flagged the deadline to small businesses Nov. 9.
    • “Part D plans must already contract with any pharmacy that accepts their standard terms and conditions, and those terms must be “reasonable and relevant,” but CMS has never defined the phrase. The request is a first step toward implementing a provision of the Consolidated Appropriations Act of 2026 that makes the standards apply to plan years starting on or after Jan. 1, 2029.”

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

  • Fedweek reports,
    • “OPM has issued a memo seeking comment on how it plans to implement raises for federal law enforcement personnel in 2027 – while pay for most civilian personnel remains frozen.
    • “Covered law enforcement personnel will get a 3.8 percent raise, but newly covered groups could see a 2.77 percent catch up for last year on top of that, totaling around 6.7 percent. Those proposed groups include:
      • “GS employees in approved law enforcement officer (LEO) positions under 5 U.S.C. 5541(3), except those who qualify based on frequent direct contact with detained suspects or convicts
      • “GS-0083 Police, except VA police on title 38 special rates, whose adjustment will be handled separately
      • “GS-0080 Security Administration employees who regularly perform both physical security and law enforcement duties and have arrest authority
      • “GS-1811 Criminal Investigators
      • “Certain OIG positions. * * *
    • “OPM may separately set 3.8 percent special rates for CBP agricultural inspectors and certain firefighters, and it will contact agencies for staffing data, according to the memo. Coverage applies automatically unless agencies opt out by Nov 25. Special rates remain capped at $197,200, and the new special rates are expected by the end of the year.”
  • FedSmith discusses,
    • “The $7,500 Dependent Care FSA in 2027: Who Saves, and Who Should Take the Tax Credit Instead
      • “The Dependent Care FSA limit is now $7,500, but a rewritten tax credit means some federal families may come out ahead by skipping it this Open Season.”

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

  • Beckers Hospital Review reports,
    • “The FDA is requiring safety labeling changes for GLP-1 receptor agonists over a potential increased risk of a rare eye condition that can cause vision loss.
    • “The agency is requiring drugs including Eli Lilly’s Mounjaro and Zepbound and Novo Nordisk’s Ozempic and Wegovy to add information about non-arteritic anterior ischemic optic neuropathy, or NAION, to the warnings and precautions section of their labeling, according to a Nov. 9 drug safety communication. NAION can cause sudden, painless vision loss in one eye, which can be permanent. The FDA said it evaluated clinical trial, animal and postmarket data, including observational studies and case reports, in reaching its decision.”
  • The Wall Street Journal adds,
    • “Dozens of patients have sued Novo Nordisk and Eli Lilly, the biggest makers of these drugs, arguing the medications caused them to lose vision. The companies are fighting the lawsuits and have said previously that studies don’t prove any GLP-1s cause NAION. 
    • “A spokeswoman for Eli Lilly said the company is evaluating the FDA update and will respond to the agency soon. A Novo spokeswoman said the company continues to monitor the safety of its medicines and work with regulators, and that it remains confident the benefits outweigh the risks of its GLP-1s.” 
  • Fierce Healthcare relates,
    • “The FDA has launched a safety investigation into Novartis’ gene therapy Zolgensma following reports of tumors in patients, as concerns flare up over genomic insertion risks.
    • “Friday, the FDA confirmed it is evaluating cases of tumor formation in children previously treated with Zolgensma for spinal muscular atrophy (SMA). The agency’s diligence extends to Itvisma, a sister intrathecal formulation of the intravenously infused Zolgensma, as the two products contain the same vector and construct, even though Itvisma itself has no reported cases of tumor to date, the FDA said.
    • “At the center of the investigation is a biological process known as insertional oncogenesis, where the viral vector used to deliver functional copies of the therapeutic material inserts itself into human genes.” 
  • BioPharma Dive lets us know,
    • “The Food and Drug Administration on Monday approved a new kind of blood thinner meant to lower the risk of stroke in certain adults, marking a major milestone for cardiovascular research as well as the medicine’s developer, Bayer.
    • “The pill, which will be sold under the brand name Sunharbo, doesn’t work like established stroke prevention drugs. It inhibits a blood-clotting protein called Factor XIa. While this protein plays a minor role in sealing up blood vessels after an injury, it also amplifies a coagulation “cascade” that helps clots grow and makes them harder to break down, increasing the risk of strokes or heart attacks.”
  • MedTech Dive tells us,
    • “Novocure has been denied Food and Drug Administration approval for its device intended to treat non-small cell lung cancer that has spread to the brain.
    • “The FDA’s not approvable letter cited uncertainty around the degree of clinical benefit provided by Novocure’s device, Optune Mya, the company said Monday. The system uses low-energy electrical fields to disrupt cancer cells’ ability to grow and divide.
    • “The regulator did not raise concerns about the device’s safety profile, Novocure said. The company intends to meet with the FDA to determine if there are other options that would support approval without additional clinical studies.”
  • Fierce Pharma notes,
    • “Eli Lilly could soon see two label expansions for Foundayo, its oral GLP-1, in swift succession: In September, the drugmaker filed for U.S. review in Type 2 diabetes. And now, with new phase 3 data in hand, Lilly plans to approach the FDA about an application for obstructive sleep apnea (OSA).
    • “Backing the potential OSA label expansion is Lilly’s two-study, phase 3 Attain-OSA trial, presented Monday at the American Heart Association (AHA) Scientific Sessions 2026 and published in JAMA. At 52 weeks, the collective 712-patient program met its primary endpoint, with Foundayo (orforglipron) significantly reducing sleep apnea severity as measured using the standard apnea-hypopnea index (AHI) disease rating scale.” 
  • and
    • “Veradermics’ hair loss data package looks to be FDA-ready.
    • “Topline results are in for part B of the New Haven biotech’s phase 2/3 clinical trial in men with mild-to-moderate pattern hair loss, and the drug candidate, VDPHL01, did not disappoint. VDPHL01 achieved continued hair growth through one year and reported its highest hair count in the phase 3 program so far.
    • “VDPHL01 is an oral extended-release formulation of minoxidil—best known for being the active ingredient in Rogaine. Minoxidil was originally approved in the 1970s as a treatment for high blood pressure. Today, the generic is commonly prescribed off label as a hair-loss treatment, but the instant-release formulation can come with unwanted cardiac side effects and less-than-optimum impacts on hair growth. Veradermics attests that its extended-release design provides a steady absorption for better hair growth while avoiding the high concentrations that impact blood pressure.” 
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration is seeking feedback on a discussion paper released Nov. 6 on the benefits and risks of robotic medical devices with autonomous or remote teleoperation capabilities. The paper discusses devices intended for surgical procedures and those with nonsurgical applications such as positioning or controlling instruments or imaging tools to perform specific tasks. Comments on the paper are due by Jan. 5, 2027. The discussion paper follows guidance the agency released in September that includes recommendations on nonclinical testing, clinical data and labeling for premarket submissions of certain robotically-assisted surgical devices. The FDA seeks comments on the draft guidance by Nov. 24.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Elevance Health is the latest insurer to sue the feds over its performance in the latest round of star ratings for the Medicare Advantage program.
    • “The company sued the Centers for Medicare & Medicaid Services in District of Columbia federal court on Friday, arguing that the 2027 star ratings calculations violated the Administrative Procedure Act in using 11 measures that it says were adopted unlawfully.
    • “In the lawsuit, the company said that the harm from including these measures is “concrete and substantial.” If they were excluded, it would increase the scores for 12 of its Medicare Advantage contracts and generate $516 million in additional quality bonus payments.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership points out “seven infection threats hospitals are tracking this winter.”
  • The New York Times adds,
    • “On the last Friday in August, Gay Rabb Small went for her daily walk along the Tampa shore. Nearing 80, she was determined to stay healthy and walked at least five miles a day.
    • “That night at dinner, her daughter, Anna Small, noticed that her mother seemed a little off. “I thought she had overdone it,” Ms. Small said.
    • “By Saturday, Gay Small had developed a tremor, and her daughter took her to the emergency room, where she was diagnosed with dengue, a viral illness transmitted by mosquitoes. She died the following Friday, Sept. 4, her 80th birthday.
    • “Gay Small got dengue from a mosquito bite, probably from one of her daily walks. She is so far the only fatality among hundreds of people in Florida who have been sickened in a dengue outbreak that scientists and public health officials are struggling to understand. The size of the outbreak, they say, indicates that dengue may be making a comeback in the continental United States at a level not seen for many decades.” * * *
    • Dr. Gabriela Paz-Bailey [from the CDC] said she did not expect to see “explosive” outbreaks like in Puerto Rico because of the higher standard of living in the continental United States. “But I do think that we will continue to see locally acquired dengue — that this will become the norm,” she said.
  • STAT News relates,
    • “High blood pressure has earned its reputation as the silent killer. If someone has diabetes or has had a stroke, the risk of serious cardiovascular events posed by hypertension climbs even higher.  
    • “Three studies presented Saturday at the American Heart Association’s scientific sessions reported on recent attempts to lower blood pressure in people with these challenging medical histories, and how medical care should reach across specialties to treat them. One small but diverse trial tested a common diuretic after a stroke, another looked at intensifying treatment to reach lower-than-standard post-stroke blood pressure goals, and the third looked at going lower in people living with type 2 diabetes. 
    • “Each of the scientists leading the studies and the experts commenting on them at a media briefing emphasized the role of blood pressure. Adding a widely available drug earlier held promise for controlling blood pressure, but it was a split decision between the effects of lower numbers post-stroke and with diabetes.”
  • Health Day adds,
    •  Valvular heart disease (VHD) death rates increased from 2018 to 2023 and are predicted to remain higher than prepandemic levels through 2040, according to a study presented at the American Heart Association Scientific Sessions 2026, held from Nov. 6 to 9 in Chicago.
    • Hritvik Jain, M.D., from Allegheny General Hospital in Pittsburgh, and colleagues examined trends in VHD among older adults. The analysis included age-adjusted mortality rates (AAMR) using data from the U.S. Centers for Disease Control and Prevention WONDER database (1999 to 2023) for adults aged 65 years and older.
  • and
    •  Patients with early-onset Alzheimer disease (EOAD) have more extensive deposits of tau compared with those with late-onset Alzheimer disease (LOAD), according to a study published online Nov. 4 in Science Translational Medicine.
    • Konstantinos Chiotis, M.D., Ph.D., from the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues compared baseline and longitudinal tau positron emission tomography (PET) burden measured with 18F-flortaucipir and its relationship with clinical variables in amyloid PET-positive, cognitively impaired participants from the Longitudinal Early-Onset Alzheimer’s Disease Study (390 participants with EOAD) and Alzheimer’s Disease Neuroimaging Initiative (211 participants with LOAD).
  • Cardiovascular Business offers more insights from the American Health Association’s recent scientific sessions.
  • The American Medical Association lets us know what doctors want patients to know about urinary incontinence
    • “Urinary incontinence becomes more common with age, but patients do not have to live with it. Kegel exercises are one option that may help.”
  • BioPharm Dive informs us,
    • “An experimental two-drug combination from Vir Biotechnology has succeeded in the first of three Phase 3 trials against chronic hepatitis D, the company said Sunday. 
    • “Vir’s drugs, “elebsiran” and “tobevibart,” met their main objective in the study by largely eliminating detectable signs of the virus and normalizing levels of an important liver enzyme in 44% of treatment participants after 48 weeks. By comparison, none in a “delayed treatment” cohort achieved those results, according to Vir. 
    • “The regimen also met a key secondary endpoint focused solely on dropping viral levels, with 79% of treated patients achieving a treatment response. 
    • “Two additional Phase 3 trials are ongoing and should produce data early next year. Results from all three studies, if positive, would support a regulatory submission in 2027.” 

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

  • Healthcare Dive reports,
    • “More than 500 U.S. hospitals are owned by private equity firms, representing 11.9% of all private hospitals, according to new data from the watchdog group Private Equity Stakeholder Project.
    • “PE firms also own around a third of all for-profit hospitals in the U.S., according to the data.
    • “A small group of investors own the bulk of PE-owned facilities, the PESP data added. Apollo Global Management, which owns Lifepoint Health and ScionHealth, owns 200 facilities in the U.S. Meanwhile, the firm Welsh, Carson, Anderson & Stowe owns 124 facilities.”
  • Beckers Clinical Leadership points out,
    • “Hospitals with better nurse staffing levels had lower average emergency department boarding times than hospitals with high patient-to-nurse ratios, a recent study found.
    • “The study, published in the November issue of the Journal of Emergency Nursing, analyzed nurse staffing data and ED boarding times from 335 hospitals in Florida, New Jersey and Pennsylvania. 
    • “In hospitals with patient-to-nurse ratios of four or fewer, the average ED boarding time was about 20 minutes shorter than in hospitals where nurses cared for five or more patients. The study authors said improving nurse staffing levels is “often overlooked as a strategy” to cut boarding times and improve patient throughput.” 
  • Beckers Hospital Review relates,
    • “Palo Alto, Calif.-based Stanford Medicine and Sacramento, Calif.-based Sutter Health held a ribbon-cutting ceremony ahead of the planned Dec. 1 opening of the Stanford Medicine Sutter Health Cancer Center in Oakland, Calif.
    • “The outpatient cancer center is located on Sutter Health’s Alta Bates Summit Medical Center campus, according to a Nov. 9 news release from Stanford Medicine.
    • “The center will offer outpatient clinics, infusion, imaging, radiation oncology, ambulatory surgery, breast health and pharmacy services, along with clinical research, genetic counseling, nurse navigation and survivorship programs.”
  •  and
    • “Morgantown, W.Va.-based WVU Health acquired Wheeling, W.Va.-based Orchard Park Hospital Nov. 1, according to a news release.
    • “The hospital now operates as a remote campus of WVU Medicine Wheeling Hospital and has been renamed WVU Medicine Healthy Minds – Kids. The facility held a ribbon-cutting Nov. 9 and will continue Orchard Park’s specialized behavioral and mental health care for children.
    • “The acquisition continues WVU Health’s system expansion. In October, the system acquired Greensburg, Pa.-based Independence Health System’s five hospitals and their affiliated physician practices and outpatient facilities.”
  • BioPharma Dive tells us,
    • “Argenx, a Netherlands-based biotechnology company focused on antibody drugs, on Monday said it has agreed to acquire a protein specialist in a potentially billion-dollar-plus deal.
    • “Unnatural Products has a platform that pairs machine learning, screening and other techniques to engineer “macrocyclic peptides.” These peptides are larger and more complex than typical small molecules, which allows them to more effectively bind to tricky proteins and address some challenging diseases. Yet, they’re still tiny enough that they can be swallowed. Argenx plans to use the platform to develop oral, durable medicines for serious immune-mediated diseases.
    • “The acquisition carries a $550 million upfront cash payment. Unnatural Products could receive up to $595 million more if specific milestones are hit. The companies expect their deal to close before the end of the year.”
  • Fierce Healthcare informs us,
    • “HealthTap is rolling out a new program for Medicare Advantage plans that seeks to help members form a connection with a primary care doctor that carries forward.
    • “The program leans on a combination of proactive outreach and access to a patient’s historical medical records to support plans in identifying needs or risks, filling care gaps and coordinating follow-up or other necessary care. It’s built to directly support individuals who may not have a PCP on file.
    • “HealthTap reaches out to those members proactively, the company said, and helps them schedule an initial virtual visit with a provider who stays connected for preventive services, chronic condition management and medication concerns.”
  • Per Healthcare Dive,
    • “Hospitals collectively lost an estimated $132 billion last year due to write-offs for bad debt and final claim denials, according to a new report from revenue cycle analytics company Kodiak Solutions.
    • “Revenue leakage was up by nearly 18% compared to 2024, as hospitals continued to see write-offs take up about 10 percent of net revenue last year, the analysis of Kodiak’s proprietary data showed.
    • “This increase comes in the face of rising revenue cycle technology budgets, with more AI tools coming to market promising to improve hospitals’ financial performance, Kodiak executives said.”

Friday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, 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 Washington, DC,

  • Govexec reports,
    • “Rep. James Walkinshaw, D-Va., fresh off his reelection this week, said Thursday that he will press for a 2027 pay raise for federal workers to be part of any deal to keep the government open past December 11.
    • “The congressman, whose district is home to roughly 50,000 federal employees, told Editor-in-Chief Frank Konkel at GovExec’s After the Midterms event that the government must increase compensation in order to compete for talent, particularly after the last two years of buyouts, layoffs and mass firings. In August, President Trump formally proposed freezing most civilian federal workers’ pay next year.” * * *
    • “Walkinshaw told reporters his starting point in spending negotiations will be the 4.1% average pay increase as proposed earlier this year in his Federal Adjustment of Income Rates Act.
    • “Walkinshaw said he was also optimistic that lawmakers would pass legislation restoring the collective bargaining rights of more than 1 million federal employees, though likely not in full until after the new Congress is seated in January. The House this year has passed standalone legislation that would unwind President Trump’s executive orders, which banned unions at most federal agencies on national security grounds, and it has included language in its draft of the annual National Defense Authorization Act that would roll the edicts back for Defense Department workers.”
  • Healthcare Finance News adds,
    • “Base physician pay will decrease in 2027 under the Centers for Medicare & Medicaid Services Physician Fee Schedule Final Rule released on Wednesday.
    • “For 2026, the Working Families Tax Cut legislation provided a one-year PFS conversion factor increase of 2.5% that will no longer be in effect for 2027, CMS said. 
    • “This means that current law requires a 2.5% reduction in Medicare payment.
    • “The American Medical Association on Thursday said the lame duck session, along with the continuing-resolution bill that has funded the federal government and is set to expire on Dec. 11, creates an opportunity. 
    • “This creates an opportunity for Republicans and Democrats to unite on an end-of-year legislative package that makes real progress toward fixing the unsustainable Medicare physician payment system,” the AMA said. 
    • “Among other priorities, the AMA wants Congress to extend the 2.5% physician payment update through 2027.”
  • The Wall Street Journal relates.
    • “President Trump said on Friday that longtime adviser Stephen Miller would become his chief of staff, replacing Susie Wiles after Republicans suffered far-reaching losses in this week’s midterm election. 
    • “In a Truth Social post, Trump called Miller one of his most trusted advisers and said he would be starting in the new role on Monday. Wiles, who has served as chief of staff since the beginning of his second term, will move to the president’s political operation, Trump said.
    • “I want to thank her for her service as Chief of Staff—She has done a great job!” Trump wrote of Wiles. Wiles was the first female White House chief of staff.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced a Notice of Funding Opportunity (NOFO) for the Women’s Initiative for Screening and Health (WISH) program. The program will award up to $1 million in fiscal year 2027 to establish a multidisciplinary coalition to update the HRSA-supported Women’s Preventive Services Guidelines (Guidelines) to reflect gold-standard evidence and support their use in clinical practice.
    • “The funding opportunity advances priorities outlined in President Trump and First Lady Melania Trump’s Executive Order 14437, Advancing Women’s Health to Improve Outcomes in All Phases of Life, including translating scientific research into improved clinical care and strengthening prevention for women and girls throughout every stage of life.” * * *
    • “Applications are due January 8, 2027, at 11:59 p.m. ET through Grants.gov under opportunity number HRSA-27-072. Applicants must have active SAM.gov and Grants.gov registrations.
    • “For details and application instructions, visit the WISH funding opportunity page.”
  • Today “the Internal Revenue Service announced the tax year 2027 annual inflation adjustments for almost 70 tax provisions, including the tax rate schedules, standard deduction amounts and other tax changes. Revenue Procedure 2026-35 PDF provides details about these annual adjustments.”

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

  • Radiology Business reports,
    • “The U.S. Food and Drug Administration has cleared a new artificial intelligence-powered intravascular ultrasound imaging system, the product’s developer announced on Wednesday.
    • “San Jose, California-based Evident Vascular says the regulatory win applies to its Guidance System and Evident peripheral imaging catheters. They’re intended for examination of pathology during certain peripheral vascular procedures handled by radiologists and other docs. 
    • “Evident says the system is designed to improve the clinician experience by combining high-fidelity imaging, “purpose-built AI,” and simple workflows without disruptions. Features include flush-less plug-and-play catheters, an “intuitive” user interface, and hands-free voice controls.
    • “FDA clearance marks an important milestone for Evident and the physicians who believed in this platform from our company’s inception,” Howard Rosen, CEO and co-founder of Evident Vascular, said in a statement Nov. 4. “We engineered the entire imaging architecture to deliver the image fidelity physicians need in a system that is both intuitive and easy to use.”
  • STAT News relates,
    • “The U.S. Food and Drug Administration conducted more unannounced drug inspections in India and China in Fiscal Year 2026 compared to the previous year, Regulatory Focus tells us. The increase is attributed to an effort by the agency to increase unannounced foreign inspections to achieve inspection parity between domestic and international facilities. The proportion of unannounced inspections in India increased from 47% in FY 2025 to 87% in FY 2026. In China, the percentage of unannounced inspections rose from 19% in FY 2025 to 61% in FY 2026.”
  • BioPharma Dive tells us,
    • “Eli Lilly will offer its obesity drugs Zepbound and Foundayo on Hims & Hers’ telehealth platform, the companies announced Friday. Under the deal, eligible patients with a prescription can use Hims to gain access to Lilly’s drugs at the same “self-pay” prices available elsewhere. Foundayo carries an initial $149 monthly price tag, while Zepbound starts at $299 per month.
    • “Hims had previously used legal loopholes to make lower-cost, compounded versions of GLP-1 weight loss drugs. But it changed course in March after a legal challenge from Novo, adopting a new strategy based on providing U.S. consumers access to an array of FDA-approved weight loss medicines. Hims struck a similar deal with Novo in March.”
  • Fierce Pharma adds,
    • “Eli Lilly has successfully challenged Good Life Meds’ claims about the health benefits and personalization of a compounded tirzepatide product.  
    • “Lilly, which sells the GLP-1/GIP drug tirzepatide as Mounjaro and Zepbound, challenged the telehealth provider’s claims through BBB National Programs’ National Advertising Division (NAD). The drugmaker, the only provider of FDA-approved tirzepatide products, disputed Good Life’s claims about the effect of the compounded drug on body weight, blood sugar, energy and lean muscle. 
    • “After assessing Good Life’s response to the challenge, the NAD recommended that the company stop making the express health benefit and personalization claims challenged by Lilly and modify its ads to remove unsupported implied claims about safety, efficacy and personalization.”

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 low.
    • “RSV activity is low in most areas of the country.
    • “COVID-19 activity is declining nationally.
    • “Seasonal flu activity continues to increase in many parts of the country.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated nationally, and respiratory adenovirus (HAdV) is elevated in some regions of the country.”
  • The American Hospital Association News lets us know
    • “Nationally, there are now 5,182 confirmed measles cases this year, according to a Nov. 6 update from the Centers for Disease Control and Prevention. The vaccination status of 96% cases is unvaccinated or unknown.”  
  • The New York Times tells us,
    • “A resident of Washington State died this week after a severe case of bird flu, a new and worrying sign that the virus continues to be a threat in the United States.
    • “The news followed reports that the bird flu virus had been detected in dairy cattle on dozens of farms across the country over the past month. It has also been spreading unchecked for months at a mink farm in Utah.
    • “The death, in Yakima County, Wash., is the first related to bird flu in the country this year, and the third since 2024. But it was only on Thursday, one day after an inquiry from The New York Times, that the Centers for Disease Control and Prevention updated its website. It still has not made any statements to the public about the death.” * * *
    • “Bird flu is not yet a threat to most humans, but it does pose a significant risk to the millions of agricultural workers and veterinarians in the country, said Kristen Coleman, an expert an airborne infections at the University of Maryland.”
  • Genetic Engineering and Biotechnology News adds,
    • “Researchers at the University of Cambridge and Cambridge’s spin-out DIOSynVax, along with collaborators, reported on the development of a broad-spectrum bird flu vaccine that in animal trials provided complete protection against globally circulating, diverse H5Nx variants of the disease. Current pandemic preparedness relies on stockpiling vaccines against individual virus variants that have already emerged. The Cambridge team’s approach uses AI-guided engineering to create broadly protective vaccines intended to remain effective across a wide range of existing and future variants.
    • “The team’s study, described in Cell Reports Medicine, found the new digitally engineered multi-antigen mRNA vaccine to be superior to bird flu vaccines currently stockpiled by many governments for use in the event of a human outbreak. Their preclinical trial results showed that the existing vaccines tested protected only around 50% of animals exposed to multiple H5N1 bird flu variants, compared with complete protection achieved by the team’s new vaccine, DVX-panH5Nx.
    • “The results demonstrate the potential of AI-guided vaccine design in developing broad protective population immunity ahead of evolving biological threats. The researchers say the vaccine represents the third success with their AI-guided technique for designing vaccines against highly infectious viruses that threaten animal and human health. The new study in addition demonstrates that the team’s ‘plug and play’ approach can be used to create safe, highly effective vaccines for a plethora of infectious diseases threatening animal and human health globally.”
  • Health Day informs us,
    • “A common test used to diagnose obstructive sleep apnea may miss the condition in Black patients, potentially impacting important treatment decisions.
    • “Sleep studies often use pulse oximeters — small devices that measure blood oxygen levels — to help determine the severity of sleep apnea.
    • “In the new study, oxygen-based scoring counted roughly 20 percent fewer breathing events in Black participants than in white participants.
    • “But heart-rate-based scoring showed no comparable racial difference.
    • “The first author says the findings have “potential implications for diagnosis and severity classification.”
  • and
    • “A new study suggests a woman’s reproductive history may play an important role in her brain health later in life.
    • “Women are affected by Alzheimer’s disease more often than men. This may be related, in part, to fluctuations in estrogen levels throughout life,” said study author Anna Marseglia, an assistant professor at the Karolinska Institutet in Stockholm.
    • “Estrogen is known to have protective effects on both neuronal cells and blood vessels in the brain,” she added in a news release. “However, its potential role in women’s cerebrovascular health in later life has been largely understudied.”
  • MedPage Today points out,
    • “A retrospective-cohort analysis showed that GLP-1 receptor agonists were associated with a lower risk of obesity-related cancers as compared with insulin or sulfonylurea.
    • “Cancer risk with GLP-1 agonists did not differ significantly from metformin, DPP4 inhibitors, or SGLT2 inhibitors.
    • “The effect of GLP-1 agonists on cancer risk versus other diabetes medications was most noticeable in patients with low-severity diabetes.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Humana raised its full-year earnings outlook as consolidated income and revenue rose in the third quarter.
    • “The health insurer now expects 2026 adjusted earnings of at least $9.50 a share, up from its previous forecast of at least $9 a share.
    • “Humana’s third-quarter revenue jumped 26% to $41.16 billion, beating Wall Street estimates of $40.87 billion.”
  • and
    • “Moderna raised its full-year revenue growth outlook to 15% to 25% after swinging to a profit and logging higher revenue in the recent quarter.
    • “The higher outlook follows the U.S. approval of mFLUSIVA, Moderna’s mRNA-based influenza vaccine.
    • “Moderna swung to a third-quarter profit of $162 million, beating analyst expectations for a loss.”
  • Beckers Hospital Review relates,
    • “Atlanta-based Piedmont Healthcare reported a 10.7% operating margin for fiscal year 2026, generating more than $1 billion in operating income for the second consecutive year as revenue climbed to nearly $9.5 billion.
    • “The health system recorded $1.02 billion in operating income for the fiscal year ended June 30, up slightly from $1 billion in fiscal 2025, according to its financial documents published Nov. 6. However, its operating margin narrowed from 11.4% to 10.7% as expenses increased faster than revenue.
    • “Piedmont also strengthened its liquidity position, ending the fiscal year with $3.8 billion in cash and cash equivalents, while continuing to invest in hospital expansion projects across Georgia.
  • and
    • “Grand Forks, N.D.-based Altru Health System’s operating margin fell to -3% through the first nine months of 2026, as expenses outpaced revenue growth and the system moved closer to acquiring three more North Dakota hospitals from Chicago-based CommonSpirit Health.
    • “Altru Health reported an $18.2 million operating loss for the nine months ended Sept. 30, compared with a $1.7 million operating loss and -0.3% margin during the same period in 2025, according to its financial statements published Nov. 2.
    • “Revenue increased 8.3% year over year to $610.4 million, up from $563.6 million, while operating expenses climbed 11.2% to $628.6 million, compared with $565.3 million in the prior-year period.”
  • The Wall Street Journal tells us,
    • “The practice of keeping admitted patients in the emergency room while they wait for a bed, known as boarding, is increasing in American hospitals.
    • “One in four admitted patients spent at least four hours waiting in the E.R. for a bed in September 2024, up from one in eight in September 2017.
    • “Studies show that patients stuck boarding in the E.R. face a higher risk of worse care and early clinical deterioration.”
  • Fierce Pharma informs us,
    • “Heading into Halloween weekend, both Novo and Lilly saw scripts for their oral obesity medicines tick up. 
    • “In its 30th launch week, Lilly’s Foundayo racked up roughly 65K prescriptions, seemingly topping a record of more than 64K scripts set in week 25 of the rollout, according to IQVIA data cited by Jefferies. Still, the medicine’s performance pales in comparison to Novo’s Wegovy pill at week 30 of its own launch, when the semaglutide tablet reeled in roughly 173K scripts. 
    • “For the last weekly period, the Wegovy pill charted a 0.5% script increase—or around 8K new prescriptions—to land at around 184K total. That’s roughly on par with the height of the pill’s script performance in 2026 so far and marked a rebound from roughly 183K the prior week. 
    • “Novo reported earlier this week that the Wegovy pill generated 5.39 billion Danish kroner (nearly $811 million) in third-quarter sales. Over the same period, Lilly reported $184 million in sales of Foundayo. 
    • “On an analyst call, Novo’s EVP of U.S. operations, Jamey Millar, resurfaced caveats with the data IQVIA is using to track the oral GLP-1 launches, arguing that Novo boasts “a much more extensive ecosystem of partners for Wegovy” than Lilly, and that those partners “don’t report to IQVIA in absolute terms.” 
    • “So we’ve consistently seen a lower capture rate for Wegovy pill than the competitive oral product,” he suggested. 
    • “Based on the latest weekly metrics, Lilly holds a little more than a 26% share of the overall oral obesity market compared to Novo’s nearly 74%, the Jefferies team said in its note.” 

Thursday report

David Ermer–CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, 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,

  • Beckers Hospital Review reports,
    • “CMS proposed a sweeping deregulation rule Nov. 5 that would remove hospital staff training requirements tied to Biden-era obstetric standards. It would also roll back several nursing home requirements, rescind a Medicaid payment transparency rule and exempt certain critical access hospitals from distance requirements.
    • “The proposed rule follows a CMS review of the conditions of participation for all 21 provider and supplier types. Providers must meet these baseline standards to bill Medicare and Medicaid.
    • “CMS said the rule is meant to eliminate obsolete or excessively burdensome requirements so healthcare organizations can devote more time and resources to improving patient care.
    • “The agency estimates the proposals would save $320 million a year and return more than 3.26 million hours of staff time to providers. Nursing homes would see the largest share at $142.6 million a year. Hospitals would save $123.2 million, CAHs $16.6 million and intermediate care facilities for individuals with intellectual disabilities $6.6 million. Rescinding a Medicaid payment reporting requirement accounts for another $30.4 million.”
  • and
    • “CMS has finalized a rule that sets ongoing policies for the Medicare Drug Price Negotiation Program, starting with negotiated prices that take effect in 2029.
    • “The agency said the rule is designed to give drugmakers in the program a clearer, more predictable process going forward, according to a Nov. 5 news release.
    • “CMS plans to pick up to 20 additional Part D or Part B drugs for the program’s fourth negotiation cycle by Feb. 1, 2027. It may also select previously negotiated drugs for renegotiation.
    • “This rule provides additional tools to help CMS negotiate better deals, achieve greater savings for taxpayers and beneficiaries, and improve health outcomes for seniors who rely on the Medicare Prescription Drug Program,” CMS Administrator Mehmet Oz, MD, said in the release.”
  • and
    • “HHS’ Administration for Strategic Preparedness and Response, the Commerce Department’s Bureau of Industry and Security and the Department of War’s health affairs office are assessing the U.S. industrial base for pharmaceutical key starting materials. The materials are the chemical precursors and intermediates used to make active pharmaceutical ingredients.
    • “The assessment will examine the upstream supply chain behind U.S. drug manufacturing, including limited domestic production capacity and reliance on foreign or single sources of critical materials, according to a Nov. 3 news release. BIS is surveying U.S. manufacturers, chemical suppliers, distributors, procurers and customers under Section 705 of the Defense Production Act. The one-time survey collects information on production capabilities, sourcing practices, customers, supply chain disruptions, workforce and research and development.
    • “The findings will be compiled into a report on U.S. production capacity, supply chain vulnerabilities and emergency response capabilities, with recommendations to improve resilience and public health emergency preparedness. The government plans to use the findings to develop funding strategies for the availability, quality and security of the materials.”
  • STAT News adds,
    • “Medicare will finalize a controversial proposal that will prevent providers, such as hospitals, from using third parties to deliver remote patient monitoring services, brushing away widespread opposition to the idea. However, Medicare will delay implementing the rule for two years to give providers enough time to hire and train staff to deliver the services. (I pulled the RPM section of the fee schedule here.)
    • “A common use case for RPM is using a connected blood pressure cuff to monitor a patient’s response to hypertension drugs and helping them manage the condition. Despite evidence RPM can be helpful for patients, use of the services has soared, and Medicare is worried about fraud in RPM billing.” 
  • Per a Health and Human Services Department news release,
    • “Women with higher blood levels of two common per- and polyfluoroalkyl substances, also familiarly known as PFAS, were more likely to develop estrogen receptor-negative, or ER-negative, breast cancer, according to a new study by the National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services (HHS). PFAS are a large group of chemicals used in common consumer products. Often referred to as “forever chemicals,” PFAS do not break down easily in the environment and can remain in the body for years.
    • “The study found that women with higher blood plasma levels of two of these substances, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), were associated with a higher incidence of ER-negative breast cancer. No clear association was observed between the two chemicals and breast cancer risk overall.
    • “Women deserve clear answers about how chemicals in their environment may affect their health,” said HHS Secretary Robert F. Kennedy, Jr. “This NIH study links two forever chemicals to a higher risk of ER-negative breast cancer and demands further investigation. Under President Trump’s leadership, we will pursue the evidence, confront environmental health risks, and give women the information they need to protect their health.”

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

  • FedSmith advises,
    • “Protect Your FEHB Benefits: Who Qualifies, What to Verify and How to Keep Coverage.”
      • “Review your family’s FEHB eligibility before Open Season. Learn who qualifies, what documents may be required and how to avoid losing coverage for eligible family members.”
  • Tammy Flanagan, writing in Govexec, suggests,
    • “Make these health coverage decisions before you retire
      • “From FEHB eligibility rules to Medicare enrollment deadlines, the right steps before your last day can protect coverage for you and your spouse.”

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

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has confirmed that a safety issue with certain accessories used to implant the Sapien M3 transcatheter mitral valve replacement (TMVR) system has been ruled a Class I recall. 
    • “This is the agency’s most severe recall classification. It means using the devices in question could cause “serious adverse health consequences or death.”
    • “This Class I recall only covers four specific lots of these devices: 67718561, 67804014, 67887043 and 67887044. Delivery systems distributed as part of those four lots should not be used to treat any patients going forward. However, all other delivery systems sold with the Sapien M3 TMVR system can be used as normal. 
    • “The FDA first released information about this recall in October while the issue was still under investigation. As the agency explained at the time, four lots of the Commander M delivery systems sold with the Sapien M3 TMVR systems were being recalled due to an increased risk of the balloons bursting during inflation. Four serious injuries and one death were linked to the issue.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. HNSCC is an aggressive, life-threatening disease for which there is a high unmet need for effective therapies.
    • “Rybrevant Faspro is not indicated as a treatment for patients with oropharyngeal squamous cell carcinoma that is associated with human papillomavirus (HPV). 
    • “Approval was based on trial results showing that more than double the percentage of patients responded to the drug compared to currently approved therapies. This is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy.” 
  • The Acting FDA Director writes about “Delivering Answers and Hope for Rare Disease Families.”

From the judicial front,

  • Per a Human Rights Campaign news release,
    • [On November 4,] the Human Rights Campaign Foundation and the law firm Correia & Puth filed an application for a preliminary injunction in their federal lawsuit to block the Office of Personnel Management’s (OPM) prohibition on health insurance coverage for transgender medical care under the Federal Employee Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) plans. Implemented this year, OPM’s mandate has subjected federal employees and their families to even higher barriers to access potentially life-saving medical care, forcing many to leave their jobs, take on heavier financial burdens or go without care altogether. As Open Season for enrollment in these healthcare plans ends on December 14, a preliminary injunction is crucial to prevent imminent harm to federal employees who need continuing gender-affirming care.”
  • The Wall Street Journal reports,
    • “Elevance Health sued autism-therapy provider the Perfect Child, alleging that it paid the company $160 million due to misleading claims over the last five years.
    • “The lawsuit, filed in New York state court on Wednesday, cites a Wall Street Journal article that detailed the Perfect Child’s practices of charging insurers rates that could exceed $30,000 a day and attempting to collect directly from families when they balked at the bills, despite promises they would face little or no out-of-pocket costs.”
  • Beckers Hospital Review relates,
    • “A federal judge has lifted CMS’ freeze on new ACA marketplace broker registrations, clearing the way for approximately 19,000 licensed agents and brokers to assist consumers with 2027 coverage.
    • “The U.S. District Court for the District of Maryland ruled Nov. 5 in favor of the National Association of Benefits and Insurance Professionals, which challenged the moratorium in an Oct. 15 lawsuit. The ruling immediately lifts the registration restrictions, with training for newly eligible agents and brokers set to begin Nov. 6, according to the association.
    • “CMS implemented the moratorium Sept. 22, blocking agents and brokers who had not registered with the federally facilitated Marketplace for the 2026 plan year from completing registration for 2027. The freeze was originally set to remain in effect through Feb. 1, 2027.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “An infant in Wisconsin has died of measles, the state’s first measles death since 1990, the Wisconsin Department of Health Services said Nov. 5.
    • “The coroner listed measles as the immediate cause of death. The department is withholding further details to protect the family’s privacy.
    • “Any death of a child is a tragedy and even more so when it is related to a vaccine-preventable disease,” DHS Secretary Kirsten Johnson said in the news release.
    • “As of Nov. 3, Wisconsin had reported 431 measles cases in 2026, the state’s highest count in more than 35 years. Nine patients have been hospitalized with severe symptoms. The department said official counts likely understate the outbreak’s reach because not every sick person seeks care or gets tested.”
  • Health Day relates,
    • “More than 6 in 10 American drivers admit they’ve driven while dangerously sleepy.
    • “A new National Sleep Foundation report estimates 145 million adults have driven drowsy, including nearly 35 million who do so at least monthly.
    • “And about 40% don’t recognize warning signs like frequent blinking, head-nodding or drifting out of their lane.
    • “Drowsy driving is responsible for 1 in 5 deadly crashes, according to data cited in the report.
    • “Every signal in this year’s report points the same way: Drowsy driving is common, it’s under-recognized and the public is ready for solutions,” said Joseph Dzierzewski, senior vice president of research and scientific affairs at the foundation. “When 4 in 10 drivers can’t identify even the most basic of warning signs, too many people don’t realize they’re impaired and shouldn’t be behind the wheel.”
    • “The researchers say drowsy driving deserves the same serious attention as drunken driving.”
  • and
    • “Cutting-edge weight-loss drugs like Ozempic and Zepbound are helping people reverse prediabetes and avoid heart attack and stroke more effectively than standard diabetes medications, a new study says.
    • “People with prediabetes had 53% better odds of getting their blood sugar levels back to normal if they were taking a GLP-1 drug rather than the diabetes drug metformin, researchers are slated to report Monday at the annual meeting of the American Heart Association (AHA) in Chicago.
    • “They also were less likely to develop type 2 diabetes or suffer life-threatening heart problems on a GLP-1, researchers said.
    • “The great news with prediabetes is that it’s still possible to reverse the progression of the disease,” investigator Dr. Vinicius de Sousa Barzon Serra said in a news release. He is a research fellow in the department of cardiovascular medicine at the Mayo Clinic in Scottsdale, Arizona. 
    • “This research may add to the case for considering GLP-1 medications earlier for certain patients, rather than waiting until they develop Type 2 diabetes,” he said.”
  • Healio adds,
    • “Bariatric surgery can offer long-term cancer-protective effects for people with obesity regardless of their sex or age, findings of a population-based cohort study suggest.
    • “An analysis of registry data from nearly 800,000 people showed those who underwent the procedure exhibited an overall significantly lower risk for 10 obesity-related malignancies.
    • “The magnitude of risk reduction remained consistent between younger and older adults, and analyses that focused on cancer types that affect both sexes showed comparable benefits for men and women.”
  • MedPage Today tells us,
    • “The share of newborns who missed routine vitamin K shots rose to 6.8% in 2025.
    • “Infants who didn’t receive vitamin K shots faced a 47% higher bleeding risk in their first 6 months of life.
    • “Newborns without vitamin K shots also had doubled intracranial hemorrhage and bleeding-related death risks.”
  • STAT News informs us,
    • “When statins aren’t enough, other cholesterol-lowering drugs come into play. But which one is most effective?
    • “Cardiologists looking to help their patients reduce the amount of LDL, or “bad,” cholesterol threatening to clog their coronary arteries often consider two long-approved drugs, each acting through a different mechanism delivered by a different route. A new trial based on real-world evidence pitted the injectable PCSK9 inhibitor evolocumab, sold by Amgen as Repatha, against the oral cholesterol absorption inhibitor ezetimibe, now generic but previously sold by Merck as Zetia.
    • “Repatha was the winner.” 
  • and
    • “Novartis has acknowledged seven previously unknown instances in which tumors were found in children who were treated with its spinal muscular atrophy therapy, a surprising development that has raised concerns among families, physicians, and patient advocacy groups.
    • “The cases, which for the moment are being seen as only a potential safety signal, were publicized on Thursday by an advocacy group and on a Facebook page after Novartis earlier this week disclosed the information to neurologists. One advocacy group, SMA Europe, issued a statement saying that regulatory authorities are now examining the cases.
    • “The drugmaker issued its own statement saying that since its treatment — called Zolgensma — was approved in 2019, it has received nine reports of tumors in previously treated patients. Of those, two cases to date showed evidence that the tumors may be linked to the treatment itself.” 
  • Beckers Hospital Review points out,
    • “Active U.S. drug shortages stood at 225 at the end of the third quarter, similar to the past three quarters, according to the American Society of Health-System Pharmacists. The 87 new shortages reported through September nearly equal the 89 reported for all of 2025, and chemotherapy shortages in particular have outlasted drugmakers’ resupply estimates. The FDA’s databasecontinues to reflect new discontinuations weekly.
    • [The article identifies] 11 recent shortage and discontinuation listings, according to the FDA database.”

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

  • The Wall Street Journal reports,
    • “Cigna Group CI lifted its outlook and reported higher sales in the recent quarter, driven by growth in both its healthcare and pharmacy-benefit businesses.
    • “The healthcare company on Thursday reported a third-quarter profit of $1.44 billion, or $5.47 a share, compared with $1.87 billion, or $6.98 a share, a year earlier.
    • “Stripping out certain one-time items, earnings were $7.98 a share. Analysts polled by FactSet expected adjusted earnings of $7.52 a share.
    • “Total revenues climbed 5.6% to $73.68 billion, ahead of Wall Street models for $72.64 billion. The company attributed the growth to gains across both its namesake healthcare business and Evernorth Health Services.”
  • and
    • “Inside CVS Health, a small group of top executives spent months engaged in a strategic review that developed into a secret plan: a decision to split up the $400 billion healthcare giant, hiving off its ubiquitous pharmacies. 
    • “It was an unlikely and radical step. The stores, with CVS’s signature red-letter logo, weren’t only how Americans thought of CVS but also the heart of its identity as a healthcare giant. Chief Executive David Joyner, a longtime veteran at the company, publicly rejected a split when he landed the top job in 2024. 
    • “This year, the C-suite’s annual planning exercise delivered a different verdict. The company should break off its drugstores from the Aetna health-insurance unit and Caremark pharmacy-benefit manager. The breakup, revealed Tuesday, will put Aetna and Caremark into one company, and the approximately 9,000 retail pharmacies into another.
    • “The logic: Its balance sheet was strong enough to support the two resulting companies, and the breakup would create more agile, focused firms. “It basically gives you confidence and strength about how each of the businesses are going to perform,” Joyner said in an interview. 
    • “The board supported the move. CVS wanted to get ahead of dynamics reshaping the healthcare market. Regulators appeared increasingly hostile to healthcare conglomerates.”
  • Beckers Payer Issues adds,
    • “Oscar Health reported $167.3 million in profit for third-quarter 2026, compared to a net loss of $137.5 million in the same period last year.
    • “The company reported its third-quarter earnings Nov. 5. Oscar brought in $5.1 billion in revenue, a 72% year-over-year increase. That includes a $250 million benefit from updated risk adjustment estimates.
    • “Earnings from operations reached $178 million, up from a $129.3 million loss in the third quarter of 2025.
    • ‘The company’s medical loss ratio fell from 88.5% in third-quarter 2025 to 84%.
    • “Oscar’s membership grew about 27% year over year, nearing 2.7 million effectuated members as of Sept. 30.”
  • Fierce Healthcare relates,
    • “Clover Health is continuing to see strong traction in its Medicare Advantage plan, with membership growing 49% year-over-year in the third quarter to approximately 157,000 members.
    • “Alongside continued membership growth, executives touted the company’s star ratings from the Centers for Medicare & Medicaid Services for payment year 2028.
    • “We are incredibly proud that our flagship PPO plan achieved five stars for payment year 2028, making it the largest five-star PPO contract in the country,” Andrew Toy, Clover Health CEO, said during Wednesday’s earnings call. “Additionally, our HMO plan achieved four and a half stars, meaning 100% of Clover members are enrolled in plans rated at least four and a half stars for payment year 2028.” 
    • “Toy said the ratings give Clover “continued flexibility to invest” in benefits and affordable care access for members, adding that the company’s HEDIS quality performance remains “industry leading.”
  • Beckers Hospital Review tells us,
    • “Indianapolis-based Indiana University Health reported an operating income of $110 million (4% margin) in the third quarter, up from $6.4 million (0.3% margin) in the third quarter of 2025, according to its most recent financial report. 
    • “IU Health’s operating expenses were $2.6 billion for the three months ended Sept. 30, 2026, up from $2.4 billion the previous year. Total revenue was $2.7 billion in the third quarter of 2026, up from $2.4 billion in the third quarter of 2025.
    • “The system’s long-term debt was $3.3 billion as of Sept. 30, 2026.”
  • Beckers ASC Review informs us,
    • “McAllen, Texas-based UT Health RGV Surgery Center has joined the ASC network of Phoenix-based Atlas Healthcare Partners, marking Atlas’ expansion into Texas, according to a Nov. 5 news release shared with Becker’s.
    • “The center is part of a new collaboration between Atlas and the University of Texas Rio Grande Valley. It has four ORs and one procedure room and offers orthopedics, gastroenterology, surgical oncology, general surgery, podiatry, gynecology and ENT.
    • “Atlas partners with nonprofit health systems, including Banner Health, Corewell Health, ChristianaCare and Prisma Health, to operate 47 ASCs across eight states. The company performs more than 110,000 procedures a year and generates about $400 million in annual revenue.”
  • and
    • “Palm Harbor, Fla.-based American Vascular Associates has formed a strategic partnership with New England Endovascular Center, a West Springfield, Mass.-based provider of minimally invasive vascular and endovascular care, the organizations announced Nov. 4 in a news release shared with Becker’s.
    • “AVA is a vascular management and growth organization. It supports office-based labs and ASCs with operations, revenue cycle management, finance, IT, compliance, marketing, physician recruitment and growth strategy.
    • “NEEC was the first interventional and endovascular medical center in Western New England. It serves patients across the Pioneer Valley, the Greater Springfield region, the Berkshires and Northern Connecticut.”
  • STAT News points out,
    • “The commercial debut of Revolution Medicines’ pancreatic cancer drug Rasonquewas eye-popping and jaw-dropping: $198 million in sales in just five weeks following the U.S. approval of the groundbreaking pan-RAS inhibitor. More than 5,000 patients have already been treated with the drug, the company said Wednesday evening. 
    • “The U.S. launch of Rasonque is off to a strong start,” said Revolution Chief Commercial Officer Anthony Mancini, on the company’s earnings call — perhaps the understatement of the year in commercial biotech.”
  • Per Healthcare Dive,
    • “Mayo Clinic’s health tech innovation arm, Mayo Clinic Platform, has launched an artificial intelligence tool to bring patients’ medical information and relevant clinical evidence together during patient interactions, the health system said Tuesday.
    • “The solution offers clinicians specific guidance for more than 35 specialties, helping answer clinical questions, explore diagnoses and assess care options. The tool aims to reduce the time clinicians spend finding the information they need across different resources and to focus more on patient care. 
    • “The tool is available to clinicians at the Mayo Clinic and others who work for organizations that participate in Mayo Clinic Platform’s provider programs.”
  • Per MedTech Dive,
    • “Study results supporting Edwards Lifesciences’ transcatheter aortic valve replacement in patients with less severe disease were a highlight of the Transcatheter Cardiovascular Therapeutics conference.
    • “Also notable were findings on Medtronic’s renal denervation system in a broader patient population and the performance of Abbott’s Amulet 360 left atrial appendage closure device one year after implant.
    • “The TCT conference, which wrapped up in San Diego this week, is the Cardiovascular Research Foundation’s annual scientific symposium.”
  • and
    • “Edwards Lifesciences’ third-quarter sales exceeded its expectations, prompting the heart valve maker to raise its full-year forecast for the third time this year.
    • “Executives on Wednesday’s earnings call pointed to several catalysts for the business going forward, including data supporting expanded use of transcatheter aortic valve replacement to treat aortic stenosis.
    • “In the PROGRESS trial, presented this week at the Transcatheter Cardiovascular Therapeutics conference, Edwards’ Sapien 3 TAVR device demonstrated superiority to standard-of-care clinical surveillance in people with moderate aortic stenosis and at-risk features.”

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.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, 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

  • It’s a national election day. More tomorrow.
  • Beckers Payer Issues reports,
    • “Medicare beneficiaries in 193 counties across 16 states will have no Medicare Advantage prescription drug plans available for general enrollment in 2027, up from 123 counties in 2026, according to an Oct. 9 KFF analysis of CMS plan landscape data.” 
  • The American Hospital Association News relates,
    • “The Administration for Strategic Preparedness and Response announced Nov. 3 that it will partner with the Bureau of Industry and Security and the Assistant Secretary of Defense for Health Affairs on an assessment of U.S. pharmaceutical key starting materials in an effort to identify supply chain vulnerabilities and strategies to improve domestic manufacturing capabilities. The assessment would examine supply chain elements of U.S. pharmaceutical manufacturing efforts, including domestic production capacity and the country’s reliance on foreign or single sources of critical materials.”
  • Bloomberg Law tells us,
    • “A forthcoming proposed rule will expand employers’ ability to help workers pay for health insurance in the individual market, boosting the one major surviving insurance policy from President Donald Trump’s first term.
    • “Trump first created independent coverage health reimbursement arrangements in 2019, and they’ve now been rebranded as custom health option and individual care expense, or CHOICE arrangements. The policy allows employers to contribute money tax-free to pay for health expenses, including insurance premiums in the individual market.
    • “CHOICE is Trump’s least controversial insurance plan with Democrats, in part because it helps strengthen the Affordable Care Act exchanges by increasing enrollment in the individual market — even though most CHOICE plans are purchased off-exchange. Backers say small employers can offer benefits they couldn’t otherwise afford, while critics question whether employees are better off under individual market plans than traditional employer-sponsored plans.”

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

  • Beckers Hospital Review reports,
    • “Macleods Pharma USA has recalled 3,744 bottles of a combination blood pressure medication nationwide after the product failed dissolution specifications, according to an FDA enforcement report.
    • “The voluntary recall covers olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 milligrams/10 milligrams/12.5 milligrams, in two lots: 3,528 30-count bottles (NDC 33342-246-07, lot 12251163A) and 216 90-count bottles (NDC 33342-246-10, lot 12251163B), both expiring May 31, 2027. The company, which notified consignees by letter, initiated the recall Oct. 7. The FDA classified it as Class II on Oct. 26, and the recall is ongoing.”
  • and
    • “The FDA has approved Novo Nordisk’s Awiqli as the first once-weekly, long-acting basal insulin for children 10 years and older with Type 2 diabetes.
    • “Awiqli (insulin icodec-abae) injection, 700 units/milliliter, was approved as an adjunct to diet and exercise to improve glycemic control, according to an Oct. 23 news release from Novo Nordisk. The treatment reduces basal insulin injection frequency from seven times per week to one.
    • “The approval was supported by evidence from studies in adults with Type 2 diabetes and a single-dose pharmacokinetic study in pediatric patients ages 10 to 17. Efficacy and safety were also demonstrated in the ONWARDS clinical trial program.
    • “Awiqli is available at more than 70,000 pharmacies nationwide.”
  • BioPharma Dive adds,
    • “Vertex, ahead of FDA decision, calms fears surrounding kidney drug
      • “On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to its future.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A 7-month-old, unvaccinated child in New York’s North Country died after contracting measles, the first death in the state from the viral disease in 30 years, officials announced.
    • “Gov. Kathy Hochul said on Monday that the death was a signal that public health protections were eroding as a growing number of families forgo vaccinations.
    • “The child died in Lewis County, which is northeast of Syracuse and has recorded 15 measles cases this year, according to the health authorities, who shared few details about the case. New York is in the midst of a significant measles outbreak. Amish communities, where vaccination rates tend to be lower, have been particularly hard hit.”
  • Per Beckers Hospital Review,
    • “States with heavier chronic disease burdens tend to report somewhat lower rates of skipped checkups, according to a Becker’s analysis of three new KFF datasets. Chronic conditions typically require regular physician visits, which likely keeps patients connected to routine care. 
    • “However, 14 jurisdictions break that pattern: seven with high rates on both measures and seven with low rates on both.
    • “Arkansas, Ohio, Wyoming, Oregon, Wisconsin, Montana and Oklahoma reported above-median rates of chronic disease among working-age adults in 2025 and above-median rates of adults skipping a routine checkup — a sign that preventive care may not be reaching people in states where need is high.”
  • and
    • “Patients who could not tolerate semaglutide or tirzepatide, or who lost little weight on them, lost substantial weight after bariatric surgery, according to a Cleveland Clinic study published Nov. 3 in Annals of Surgery.”
  • Cardiovascular Business relates,
    • “GLP-1 medications such as semaglutide and tirzepatide may outperform metformin in patients with prediabetes, according to new data being presented at the American Heart Association’s Scientific Sessions 2026 in Chicago. 
    • “Metformin is typically the therapy of choice for patients with prediabetes, but GLP-1 drugs appear to be better at preventing type 2 diabetes while also reducing the risk of heart attack and stroke.
    • “The great news with prediabetes is that it’s still possible to reverse the progression of the disease,” co-author Vinicius de Sousa Barzon Serra, MD, a research fellow in the department of cardiovascular medicine at the Mayo Clinic in Scottsdale, Arizona, said in a statement ahead of the conference. “This research may add to the case for considering GLP-1 medications earlier for certain patients, rather than waiting until they develop type 2 diabetes.”
    • “This study included data from more than 250,000 adult patients with prediabetes and obesity. The mean age was 52 years old, and 72% were women. Participants were followed for approximately three years. Overall, approximately half of these patients were on GLP-1 drugs such as semaglutide, tirzepatide, liraglutide or dulaglutide. The remaining patients were taking metformin.”
  • and
    • “Cannabis use is associated with a heightened risk of cardiovascular disease (CVD), according to new data being presented at the American Heart Association’s Scientific Sessions 2026 in Chicago.
    • “Researchers tracked data from more than 440,000 American adults who responded to telephone interview questions about cannabis use. These interviews were conducted as part of the Behavioral Risk Factor Surveillance System. 
    • “Overall, the group found that using cannabis one to five days per month was linked to a 23% higher odds of reporting a history of CVD. These low-frequency users also had a 40% higher odds of experiencing a stroke. Heavy cannabis users, meanwhile, were associated with a 23% higher odds of reporting a history of CVD and a 25% higher odds of experiencing a stroke.
    • “When it came to heart attack risk, on the other hand, the study’s authors did not identify any comparable trends.
    • “We were surprised to find that the link between cannabis use and cardiovascular disease was not straightforward,” study co-author Aabha Divya, MBBS, MCh, an assistant professor of cardiothoracic surgery at the Tulane University School of Medicine, said in a statement ahead of the conference. “We expected that the chances of heart disease would gradually rise as people used cannabis more often, but that wasn’t the case. Both low-use and heavy-use groups had higher odds of developing heart disease.”
  • Per a Census Bureau news release,
    • “As the U.S. population age 65 and older grew from 2008 to 2025, so did the number of older adults with a disability.
    • “But while the number of older Americans with a disability climbed 38.0% to 21.7 million, the overall share actually dipped 7.0 percentage points, from 40.5% to 33.5% during the same period, according to newly released 2025 American Community Survey (ACS) 1-year estimates.
    • “The decline was particularly pronounced among women and adults with less than a high school education.
    • “The drop in the percentage of older adults with a disability is a promising public health trend. But the increase (66.9%) in the share of the total population 65 and over presents care challenges for families, hospitals and public support programs, particularly for those with chronic health issues and disabilities.”
  • Bloomberg Law tells us,
    • “People whose long Covid affects multiple body systems are far less likely to improve than overall recovery estimates suggest, with fewer than one in five experiencing sustained improvement within three years of infection, according to a US study.
    • “Researchers followed 1,019 adults who still had probable long Covid a year after their initial infection. About half experienced sustained symptom improvement over the following three years, while roughly a quarter had complete symptom remission, the study, published Monday in Annals of Internal Medicine , found.
    • “But outcomes differed dramatically depending on the pattern of illness. About 60% of people whose long Covid was dominated by changes in smell or taste had improved by three years, compared with less than 19% of those with symptoms affecting multiple body systems.”
  • Health Day informs us,
    • “E-bike crashes involving kids are soaring — and the injuries are getting more serious, according to a new study.
    • “We’ve been seeing more and more kids on e-bikes, both on the street and in the hospital,” said co-author Dr. Stephanie Chao of the Stanford University School of Medicine.
    • “Researchers examined more than 13,000 injury cases at six children’s hospitals across the country.
    • “They found e-bike injuries jumped 33% per quarter from early 2023 through March 2026.
    • “E-scooter injuries rose 15% per quarter. In all, 8% of e-bike injuries were classified as severe — double the rate for traditional bikes.
  • and
    • “Parental autoimmune diseases were associated with a higher risk of type 1 diabetes in offspring.
    • “Risk grew substantially when either mothers or fathers had type 1 diabetes.
    • “The study did not account for disease severity, autoantibody levels, disease activity during pregnancy, or medication use.”
  • Medscape points out,
    • “A year after completing treatment for obesity, adolescents trained in regulating their emotions were significantly more likely to sustain their weight loss than peers who received standard behavioral therapy alone, according to a randomized clinical trial published in JAMA Network Open.
    • “Those who learned the add-on skills also reported significantly less emotional eating at follow-up compared with those who went through just the diet and exercise program.
    • “Emotional eating is one of the triggers for overeating and binge eating for many — over time, the goal is for teens to see food as one of many ways to feel better, but not the only one,” said Kerri Boutelle, PhD, professor of pediatrics and psychiatry at the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego, who led the study.”
  • Healio adds,
    • “A low-carbohydrate, ketogenic diet was found to have the most benefits for liver health vs. other diets.
    • “The keto diet also appeared to be most effective at improving blood sugar control.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of tavapadon (JuvmoTM, AbbVie Inc.) for Parkinson’s disease.
    • “ICER’s report on this therapy was the subject of the October 2026 public meeting of the CTAF, one of ICER’s three independent evidence appraisal committees that discusses and votes on ICER’s report findings. Currently available evidence indicates that tavapadon provides some relief from key symptoms. Benefits from tavapadon appear to be similar to those of older, generic drugs, however, and discontinuation from tavapadon due to adverse events was relatively high.
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
    • “Tavapadon provides a net health benefit over no additional pharmacological treatment, but there are open questions about its benefits compare to other available symptomatic treatments,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “Unfortunately, the manufacturer chose a price for tavapadon far above any reasonable estimate of a value-based price. This may lead payers to implement formulary restrictions to limit provider and patient access to this new treatment.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health will split into two companies, dividing its retail pharmacies from its insurance and pharmacy-benefit operations in a move that will reverse one of the signature deals defining an era of health-industry gigantism, the company said.
    • “The breakup is set to occur in the first half of 2028, a decade after the transformative nearly-$70 billion acquisition that knit together insurance giant Aetna with CVS’s namesake drugstores, its pharmacy-benefit manager Caremark and other assets. 
    • “The two resulting companies will both be publicly traded, and current CVS shareholders will own shares in both. The Financial Times earlier on Tuesday reported the breakup.
    • “One of the two new firms will keep the CVS Health name, and will be run by David Joyner, who is chief executive of today’s CVS, the company said. 
    • “In addition to the insurance and PBM assets, that company will include senior-focused clinics business Oak Street Health, the home-visit provider Signify Health, and CVS’s specialty-drug business, a key growth lever.”
  • and
    • “Pfizer boosted its guidance for the year, as momentum in new products helped it offset declining sales for its Covid-19 vaccine and treatments.
    • “The New York company said Tuesday that sales for its recently launched and acquired products—which include cancer treatments Padcev and Lorbrena—gained 32% in the latest quarter. Higher sales for other products, like blood thinner Eliquis and heart-disease treatment Vyndaqel, also boosted the company’s top line.
    • “Sales of Covid products like Paxlovid and Comirnaty, meanwhile, continued to slide.”
  • Fierce Healthcare relates,
    • “Hinge Health is seeing early traction with its migraine and gastrointestinal care programs as it pushes beyond musculoskeletal care and builds a broader, multi-condition platform.
    • “But the company’s core MSK business remains the engine fueling its robust growth. 
    • “Our vision has always been to automate the delivery of care using technology to close the gap between the care people need and the care they actually receive. We’re now applying that same approach and the same trusted relationships with employers and partners in neurology and gastrointestinal care,” Daniel Perez, Hinge Health co-founder and CEO, told analysts and investors on the third-quarter earnings call Monday. “We’re not starting from scratch in each new category. We’re extending a platform that’s already proven into conditions that are often connected to the ones we already treat. We believe that’s a fundamentally different and more powerful way to expand than what other companies in our space are attempting.”
  • and
    • “Humana and athenahealth are expanding electronic prior authorizations nationwide in a newly announced collaboration. 
    • “Through athenaPayer, Humana is able to connect with over 180,000 providers across the athenaOne network, which the partners said will create a more connected experience between the health plan and clinicians.” 
  • Beckers Clinical Leadership tells us,
    • “As AI races into exam rooms and onto patients’ phones, the physician’s role is more important than ever — not because doctors must police the technology, but because chatbots cannot replace trust, judgment and the patient-physician relationship, according to Jan Carney, MD.
    • “Dr. Carney, 2026-2027 president of the American College of Physicians, published a statement Nov. 3 about AI hype. Dr. Carney is associate dean for public health and health policy and chief of the division of public health at the University of Vermont’s medical college in Burlington, Vt.
    • “Her message follows a September MAHA summit wherein HHS Secretary Robert F. Kennedy Jr. said AI can offer “a second opinion that is much better informed than any doctor in the country” — a claim six physician organizations, including ACP, publicly refuted. Those groups said physicians must “help lead the responsible development and use of AI in medicine.”
  • Beckers Health IT adds,
    • “Health systems have spent the past few years building the case for AI one use case at a time. Less clear is what AI will do to the nation’s healthcare bill.
    • “It came up during the opening keynote at Becker’s 11th Annual IT + Revenue Cycle Conference in Chicago, where Bobbie Byrne, MD, executive vice president and CIO of Charlotte, N.C.-based Advocate Health, gave an answer that rarely shows up in an AI vendor’s pitch deck.
    • “I do think … AI in general is going to raise the cost of healthcare, not for our organization, but in total,” Dr. Byrne said at the September event. “We’ve talked about how we’re using AI to improve care. Well, care is what? Cost.”
    • “The research cuts both ways. A 2023 National Bureau of Economic Research working paper estimated that wider AI adoption could save 5% to 10% of U.S. healthcare spending. A September Blue Cross Blue Shield Association white paper pegged the cost of rising hospital coding intensity at about $942 million over two years and linked it to the spread of AI-assisted billing tools, findings the American Hospital Association challenged in October. Health system CIOs are also working to rein in usage-based AI token costs that grow as adoption does.”
  • MedTech Dive informs us,
    • “Bracco is investing $230 million to construct its first U.S. manufacturing facility for injectable contrast media, the company said last week. 
    • “Bracco will build the facility in Sanford, North Carolina. The company expects to create 200 jobs and could receive a $2.9 million grant over 12 years. 
    • “Adding U.S. production capacity could enhance the resilience of the supply chain, which failed to meet demand for iodinated contrast media during a pandemic-related lockdown in 2022.” 

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.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Per a Department of Labor news release,
    • “The U.S. Department of Labor’s Employee Benefits Security Administration today finalized a landmark rule that will require pharmacy benefit managers and their affiliated brokers and consultants to disclose their fees and compensation to large employers’ self-insured group health plans. 
    • “In finalizing this rule, the Department has ensured that employers can see how much drug manufacturers, pharmacies, and others pay pharmacy benefit managers for the first time. Employers can use that information to negotiate contracts and seek lower prescription drug costs for workers and their families.” * * *
    • Issued under ERISA’s statutory service provider prohibited transaction exemption, the final rule requires PBMs to disclose the following information for the first time:
      • Rebates and other payments from drug manufacturers.
      • Compensation received when the price paid by the plan for a prescription drug exceeds the amount reimbursed to the pharmacy. 
      • Payments recouped from pharmacies in connection with prescription drugs dispensed to plan participants.   
    • “The final rule also allows plan fiduciaries to audit the accuracy of PBM disclosures and provides additional relief for plan fiduciaries if a PBM fails to meet its obligations.
    • This final rule is applicable to plan years beginning on or after July 1, 2027.
    • “Read the notice of the final rule on pharmacy benefit manager disclosures.”
  • The American Hospital Association News relates,
    • “A coalition of healthcare organizations, including the AHA, sent a letter Oct. 27 to the Center for Medicare and Medicaid Innovation recommending changes to its Ambulatory Specialty Model. The mandatory payment model, set to begin Jan. 1, 2027, focuses on specialty care for beneficiaries with heart failure or low back pain. The organizations recommended delaying the launch of the model and holding participants harmless from downside risk in the first year if the launch is not delayed. They also requested CMMI to maintain ongoing communications and support, including timely data, operational guidance, technical support and a single, consolidated help desk. Additionally, the organizations urged CMMI to share prospective performance thresholds for cost and quality performance categories prior to the model’s start date. CMMI was also asked to allow practice-level reporting of quality measures to align with other Centers for Medicare & Medicaid Services models and programs and minimize participant burden.”
  •  and
    • “Extending Medicaid coverage by 12 months following childbirth increased use of postpartum care among mothers with pregnancy complications such as diabetes and hypertension, according to a study published Oct. 14 by the Columbia University Mailman School of Public Health. The study analyzed Medicaid claims data on births from 2019-2023 in New York and Texas. Researchers found postpartum outpatient visits rose 28% for those with diabetes and 19% for those with hypertension in New York, and 58% and 51% in Texas, where baseline postpartum care rates were lower. Diabetes screening increased 5 percentage points in New York and 12 in Texas. Diabetes screening then declined in Texas after coverage ended during the unwinding of the continuous enrollment provision of the COVID-19 public health emergency.”
  • Modern Healthcare tells us,
    • “The Centers for Medicare and Medicaid Services is offering states mitigation strategies as they hustle to implement Medicaid work requirements by the Jan. 1 deadline. 
    • “CMS has created checklists of mitigation strategies states can choose to implement as they race to complete their work requirement verification systems. Starting next year, most working-age adults without disabilities must prove they work, volunteer or go to school for at least 80 hours a month to qualify for Medicaid.
    • “States seeking flexibility from CMS will need to identify actions that may not be complete before the deadline, explain how they intend to resolve those problems and offer alternative implementation timeframes, according to the memo CMS sent to states. CMS will conduct its own analyses and approve flexibilities or offer enforcement discretion.” 
  • Healthcare Dive discusses “Prior authorization in the real world: Takeaways from Epic ahead of looming API deadline.”
    • “As a Jan. 1 deadline looms for payers to adopt new prior authorization tech, Epic’s Vice President of Value-Based Care Ryan Bohochik breaks down the industry’s progress so far.”
    • “CMS-regulated payers, such as Medicare Advantage, Medicaid and marketplace insurers, are now confronting a Jan. 1 deadline to implement the three prior authorization application programming interfaces — sets of rules that enable computer programs to communicate directly with one another —  under a federal interoperability rule that was finalized in 2024.”

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

  • Fedweek reports,
    • “OPM has stressed to agencies the legal protections for federal supervisors and managers who take disciplinary actions against their subordinates and for federal employees who report issues with performance or conduct that can lead to such actions.
    • “OPM has received reports from some agencies that employees are reluctant to report a colleague’s misconduct or to serve as a witness — and supervisors and managers are reluctant to recommend or propose discipline — because they fear the subject of the report will respond with an equal employment opportunity (EEO) complaint, a grievance, an Inspector General (IG) complaint, or some other proceeding naming them personally,” says a memo.
    • “Some of the reluctance reported to OPM rests on an understandable but mistaken premise: that an EEO complaint, grievance, or appeal filed by the subject of a report is a proceeding against the official who made it. It is not,” it adds.”
  • FedSmith discusses “When an HDHP and HSA Make Sense—and When They Don’t.”
    • “Learn how FEHB High-Deductible Health Plans with HSAs can lower premiums, offer tax advantages, and build long-term healthcare savings.”
  • and points out
    • “Before federal managers call employees resistant to AI, they should find out what employees are resisting. The same hesitation may reflect fear of job loss, uncertainty about approved tools or a legitimate concern that AI-generated information could be wrong. The overhaul of federal employee surveys gives agencies an opportunity to ask.”
  • Tammy Flanagan, writing in Govexec, answers “more Medicare questions? Here’s what federal retirees need to know.”
    • “Got questions about HSA contributions, TRICARE For Life or keeping FEHB or PSHB when you enroll in Medicare? Here are answers to help you navigate the details of your federal health benefits.”

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

  • Bloomberg Law reports,
    • “Infant formula manufacturers face new requirements to change the amount of four nutrients they must include in products designed to replace or supplement breast milk under a proposed rule the FDA released Thursday. 
    • “A baby formula product’s level of iodine, Vitamin A, Vitamin D, and manganese would have to change under the Food and Drug Administration’s proposal, which estimates implementing the changes by reformulating and relabeling products will cost manufacturers between $8.4 million to $31.7 million annually. 
    • “The agency’s proposal comes after the Trump administration in 2025 launched the first comprehensive review in decades of nutrients FDA regulations require in baby formula products.” 
  • A Department of Health and Human Services news release adds, “While that process moves forward, the FDA is taking action now — releasing new chemical contaminant testing data showing that most infant formula samples had low or non-detectable levels of contaminants.”
  • The Pharmaletter relates,
    • “German drugmaker Stada said Thursday that the US regulator has approved Lucamzi (ranibizumab-blrz), a biosimilar to Lucentis (ranibizumab), providing another treatment option for wet age-related macular degeneration (wAMD) and other serious eye conditions.
    • “The company and its partners are finalizing preparations for a US commercial launch. Stada did not disclose a launch date or price in its announcement, although it said the product would offer a lower-cost option and help improve patient access.”
  • Reuters tells us,
    • “The US Food and Drug Administration on Thursday warned of safety ​risks associated with Medline (MDLN.O), opens new tab beds and accessories after ‌the company reported two deaths and 16 serious injuries linked to fire, entrapment and asphyxiation hazards.
    • “According to the regulator, Medline has ​told customers it is discontinuing and exiting the ​market for all Medline-branded beds and associated products, ⁠including homecare, bariatric and long-term care beds, as ​well as pendants, accessories and replacement parts.”
  • Cardiovascular Business tells us,
    • The U.S. Food and Drug Administration (FDA) has shared an update about an alert the agency first published in September about certain Automated Impella Controllers (AICs) from Johnson & Johnson MedTech. 
    • At the time, the FDA said these devices should be removed from where they are used or sold, but it was still investigating the issue to learn more. Now, with its investigation complete, the agency has officially ruled that this is a Class I recall, which means using the devices could cause “serious adverse health consequences or death.”
  • and
    • “Medtronic is recalling its CareLink SmartSync device manager due to a risk of inaccurate longevity estimates being displayed for the Micra AV2 leadless pacemaker or Micra VR2 leadless pacemaker. Unlike many recalls, no devices need to be returned to the manufacturer. Instead, customers can download a software update to resolve the issue going forward.
    • “The U.S. Food and Drug Administration (FDA) has ruled this a Class II recall, which means using the technology without a software update could cause “temporary or medically reversible adverse health consequences.” No adverse events have been reported at this time.
    • “Click here for additional details from the FDA.”

From the public health and medical / Rx research front,

  • Reuters reports,
    • “With wildfires becoming larger and more prevalent, ​today we report on a study that suggests a link between exposure during pregnancy to harmful particles in smoke from the ‌infernos and autism in the women’s children. Speaking of harmful particles, we also feature a study that may have discovered one way in which microplastics in our systems are causing health problems.”
  • Beckers Clinical Leadership adds,
    • “A PNAS analysis led by Stanford researchers suggests earlier estimates of long COVID’s effects may have been inflated by how studies selected their comparison groups, though the authors said the findings do not mean long-term symptoms are not real.”
  • Health Day relates,
    • “More people in the United States are vaping and at a higher frequency since 2013, according to a study published online Oct. 20 in Tobacco Control.
    • “Makenna N. Gomes, from the University of Waterloo in Ontario, Canada, and colleagues examined population-level patterns of e-cigarette use between 2013-2014 and 2022-2023 in both youth (aged 12 to 17 years) and adults. The total number of vaping days was determined using data from the Population Assessment of Tobacco and Health study.
    • “The researchers observed increases in total vaping days (+183 percent), past 30-day vaping (+45 percent), and daily vaping (+230 percent) over time. Among those under the minimum legal age of 21 years and those who vaped in the past 30 days, vaping days more than quadrupled (+337 percent) and accounted for 16 percent of all vaping days in the 2022-2023 wave. Since the pandemic, adult vaping days continued to increase due to increases in vaping frequency and population growth.”
  • and
    • “Suicidal thoughts and actions spiked among middle-aged and senior Americans in the years following the COVID-19 pandemic, a new study says.
    • “Suicidal thoughts increased by nearly 43% among Americans 50 and older, according to findings recently published in the Journal of Affective Disorders.
    • “Meanwhile, suicide planning and suicide attempts more than tripled, researchers found.
    • “These increases were concentrated among people without traditional risk factors for suicide, such as major depression or alcohol use disorder, researchers said.
    • “These findings suggest that many older adults who are struggling are not the ones our current screening approaches are designed to catch,” noted lead researcher Dr. Kevin Yang, a research fellow in psychiatry at the UCLA National Clinician Scholars Program.
    • “If a growing share of suicidal thoughts and plans is showing up in people without a depression diagnosis or recent substance use, we need to rethink how we identify risk and reach older adults before a crisis occurs,” Yang said in a university news release.”
  • STAT News tells us,
    • “For years, scientists have struggled to elucidate key biological differences between early onset colorectal cancer, typically in patients under the age of 50, and older patients. They’ve long believed that these cancers must be biologically distinct, since younger patients tend to be far more difficult to treat. They’re often diagnosed at later stages with tumors with more aggressive features.” * * *
    • On Thursday, Kimmie Ng, a colorectal cancer researcher and director of the Dana-Farber Cancer Institute Young-Onset Colorectal Cancer Center published a new study in Nature Medicine that may help illuminate critical differences between older and younger colorectal cancer patients. With 189 tumors, it’s the largest biological database — what researchers call a single cell atlas — of colorectal cancer tumors in patients ranging from their 20s to their 90s. The atlas, along with the technology Ng and her colleagues used, should help researchers control for variables that confounded studies in the past.
    • “It has the largest number of young onset tumors, 54 of them,” Ng said. “We intentionally designed our study to try to overcome these prior limitations in the published literature.”
    • “The atlas has enabled Ng and her team to see some characteristics  that may set early onset colorectal cancers apart. In particular, their analysis suggested that tumors in younger patients seem to be surrounded by a different cell environment that may make it more difficult for chemotherapies and immunotherapies to attack them. They also seem to have genetic differences that are associated with more aggressive and metastatic behavior.”
    • The article includes an interview with Dr. Ng.
  • Beckers Hospital Review informs us,
    • “A case report from researchers at the University of Colorado Anschutz Medical Campus in Aurora links tirzepatide, sold as Zepbound, to lithium toxicity in a 50-year-old woman with bipolar disorder. It is the fourth reported case of tirzepatide-associated lithium toxicity, MedPage Todayreported Oct. 26.
    • “Jay Davis, MD, and colleagues published the case in the Journal of Clinical Psychopharmacology. The patient’s serum lithium level was 0.7 mmol/L before she started weekly 2.5-milligram tirzepatide injections for weight management.
    • “Three weeks later, she arrived at a psychiatry appointment with a tremor in both hands, slurred speech and blurred vision. Her lithium level had climbed to 1.2 mmol/L. She had not changed her lithium dose or started other drugs, but said she was eating smaller meals and feeling full sooner.
    • “Her physicians cut her nightly lithium dose from 900 milligrams to 450 milligrams, and her symptoms resolved. Her lithium level measured 0.4 mmol/L 17 days later. She and her physician decided not to restart tirzepatide.
    • ‘Dr. Davis told MedPage that the leading explanation is that eating and drinking less causes the kidneys to reabsorb more lithium. He said incretin drugs will likely be prescribed more often to patients on lithium, and awareness of the interaction still needs to grow.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports on several quarterly financial reports from pharmaceutical manufacturers.
    • “Gilead Sciences raised its full-year product sales guidance to between $31 billion and $31.3 billion.
    • “The company’s third-quarter revenue grew to $8.3 billion, driven by strong sales in its HIV portfolio.
    • “The company’s third-quarter profit came in at $2.43 billion, down from $3.05 billion a year earlier.”
  • and
    • Merck’s third-quarter sales rose 5% to $18.09 billion, beating Wall Street expectations.
    • The cancer drug Keytruda generated $8.6 billion in sales, representing nearly half of Merck’s total worldwide sales in the quarter.
    • Merck raised its full-year adjusted earnings forecast to a range of $2.77 to $2.82 per share.
  • and
    • “Eli Lilly’s third-quarter revenue rose 39% to $24.4 billion, driven by high demand for its diabetes and obesity drugs Mounjaro and Zepbound.
    • “The pharmaceutical company raised its full-year revenue guidance to a range of $91 billion to $92 billion.
    • “Eli Lilly executives said a majority of new patients in Medicare’s Bridge coverage expansion program started on one of the company’s medicines.”
  • and
    • “Bristol Myers Squibb raised its full-year revenue outlook after third-quarter revenue increased 7% to $13.1 billion.
    • “The company’s third-quarter net income was $2.2 billion, or $1.05 a share, compared with $2.2 billion, or $1.08 a share, a year earlier.
    • “Bristol Myers Squibb cut its full-year adjusted earnings view to $6.35 to $6.55 a share due to charges and licensing impacts.”
  • Fierce Healthcare relates,
    • “Strong performance across its hospital and ambulatory businesses during the third quarter led Tenet Healthcare to raise its 2026 earnings guidance by 4%, with executives asserting that the core strength of operations will yield continued earnings growth in 2027 despite policy headwinds. 
    • “The for-profit this week reported $5.63 billion in net operating revenues for the quarter, not counting $646 million in contract termination revenue tied to its divorce with CommonSpirit Health that was recognized during the quarter. The tally was 6.5% above the same period last year and above the $5.47 billion consensus estimate, per Zacks Investment Research. 
    • The bigger standouts were its $6.64 adjusted earnings per share, well above the prior year’s $3.70 earnings per share and more than 40% above the consensus estimate of $4.60 per share. “Further, executives highlighted third-quarter adjusted EBITDA of $1.36 billion (about 16% above the street, per Stephens), about 10% year-over-year growth when excluding $147 million in one-time items stemming from the shifting timing of its CommonSpirit contract winddown.”
  • Beckers Hospital Review tells us,
    • “Seattle-based Fred Hutchinson Cancer Center recorded operating income of $25.7 million (1% margin) for fiscal year 2026, down from operating income of $82.8 million (3.3% margin) in fiscal 2025, according to its audited financial statements for the 12 months ended June 30. 
    • “Fred Hutch reported total revenue of $2.7 billion in fiscal 2026, a 6.4% increase year over year. Patient service revenue rose 17% to $1.9 billion, while research grants and contracts revenue decreased 1.4% to $493 million. Contributions decreased 27.1% to $141.8 million, and investment income and realized gains fell 44.3% to $76.9 million.
    • “Total expenses were $2.6 billion for fiscal 2026, a 9% increase year over year. Supplies and pharmaceuticals rose 21.7% to $891.1 million. Salaries, wages and benefits increased 5.4% to $902.7 million, and purchased services were flat at $349.2 million.”
  • and
    • “Salisbury, Md.-based TidalHealth reported a $49.1 million operating loss (-3.8% margin) in the fiscal year ending June 30, 2026, compared to a $33.9 million operating loss (-3.4% margin) in 2025, according to financial documents posted Oct. 28.”
  • Beckers Behavioral Health informs us
    • “Houston-based PsychPlus has acquired Precision Psychiatric Services, a California psychiatric group, adding more than 100 psychiatrists to its clinical network. PsychPlus announced the deal Oct. 23. Financial terms were not disclosed.
    • Precision, founded in 2018, is a physician-led organization with hospital partnerships across California. It provides psychiatric care in emergency departments, inpatient behavioral health facilities, medical-surgical units, outpatient clinics and addiction treatment settings. Its hybrid model pairs in-person psychiatry with telepsychiatry.
    • “PsychPlus plans to use the combined network to help hospitals and health systems manage psychiatric workforce shortages, expand clinical coverage and improve patient throughput.
    • “Precision has built an exceptional psychiatric organization with deep clinical expertise and strong hospital relationships throughout California,” said Faisal Tai, MD, founder and CEO of PsychPlus.”
  • Fierce Healthcare points out.
    • “Optum Rx is launching a new program that aims to integrate specialized care for women navigating menopause into the pharmacy benefit.
    • “The program is a virtual-first offering that connects eligible women with clinicians that have been certified with the Menopause Society. Through the program, they can access both hormonal and nonhormonal therapies, symptom tracking, education and one-on-one patient coaching.
    • “Tracy Spencer, senior vice president for product and strategy at Optum Rx, told Fierce Healthcare that 50 million women are currently experiencing symptoms related to either perimenopause, menopause and post-menopause. And 40% of those women say those symptoms impact their work performance.
    • “This is an area that remains one of the most underserved in healthcare, which is why we’re here today, because closing that gap for women’s health is really important,” Spencer said.”
  • and
    • “Blue Cross Blue Shield of Massachusetts is teaming up with precision medicine company Medzown to make it easier for members with complex conditions to participate in clinical trials.
    • “In the partnership, Medzown’s tech stack will identify the members that are most likely to benefit from a novel therapy for their condition and then match them with potential clinical trials. The company will then deploy a team of scientists, clinical trial experts and care navigators to work alongside the patient and their care team through the process.
    • “Jennifer Levin Carter, M.D., the CEO of Medzown, told Fierce Healthcare that there’s no shortage of new drugs and therapies coming through the pipeline for complex diseases like cancer, but access is a significant challenge.
    • “The next frontier for precision medicine is making sure that the right patient can actually get access,” Carter said.”
  • Healthcare Dive notes,
    • “When nine widely used AI models were prompted with questions about medication dosing, about 19.5 per 1,000 answers contained an error that was serious or potentially lethal, according to new research from health tech company Doximity.
    • “Doximity’s research, which was launched in tandem with the company’s new dose verification tool, claims other popular AI models got doses wrong in at least 2.3% of answers.
    • “It’s the company’s latest attempt to differentiate itself from major AI companies like OpenAI and Anthropic that are expanding their presence in healthcare.”

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.”

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • Beckers Health IT reports,
    • “The Department of Health and Human Services finalized a rule Oct. 26 eliminating 14 federal health IT certification criteria and scaling back AI transparency requirements, with the agency projecting more than $1.5 billion in regulatory cost savings.
    • “The final rule, known as Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity, or HTI-5, reduces compliance requirements for developers participating in the Office of the National Coordinator for Health Information Technology’s certification program.
    • “HHS initially proposed eliminating 34 of the program’s 60 certification criteria in December 2025. The final rule takes a narrower approach, removing 14 criteria and revising seven while leaving 39 unchanged.
    • “Among the changes is the elimination of AI model-card requirements within the decision support interventions certification criterion. Those requirements, established under the HTI-1 rule, were intended to give healthcare organizations information about predictive algorithms and other decision-support tools incorporated into certified health IT.
    • “The rule also removes or revises requirements involving care coordination, patient engagement and certain health data exchange capabilities, and formally removes a clinical decision support criterion that expired Jan. 1, 2025.”
  • More is information about the final rule can be found at healthit.gov/hti5, on LinkedIn, or by following @ONC_HealthIT on X.
  • Healthcare Dive adds,
    • “The healthcare industry is slowly but surely moving away from the old, fragmented and manual way of handling prior authorization toward a modernized electronic system.
    • “CMS-regulated payers, such as Medicare Advantage, Medicaid and marketplace insurers, are now confronting a Jan. 1 deadline to implement the three prior authorization application programming interfaces — sets of rules that enable computer programs to communicate directly with one another —  under a federal interoperability rule that was finalized in 2024.
  • Beckers Hospital Review considers five big questions as the 340B drug rebate pilot nears launch on January 1, 2027.
  • Beckers Payer Issues relates,
    • “Ghost networks have long been a point of frustration, with health plan members sometimes left scrambling to check if a provider is in network — or available at all.
    • “Several health insurers — including Elevance Health and Blue Shield of California, in recent months — have faced lawsuits concerning the accuracy of their provider directories. Some of these complaints said that seemingly bigger networks draw more customers, even if that appearance is ultimately misleading.
    • “But more recent developments have pointed to ongoing issues. One study published in October found more than half of secret-shopper calls made to psychiatrists and psychologists across six Blue Cross Blue Shield plans’ directories indicated errors. Separately, this fall, UnitedHealthcare mistakenly told members that eight clinicians had died before correcting the issue. 
    • “While the No Surprises Act, state laws and CMS rules have targeted ghost networks and network adequacy before, there has been a renewed focus on getting directories right.
    • “On Oct. 13, DataSpring, powered by CAQH, rolled out a new standard to measure provider directory data quality for individual clinicians. DataSpring convened major insurers, the American Medical Association and the National Committee for Quality Assurance to develop a framework rooted in the CMS quality foundation for provider directories.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. brought his “Take Back Your Health Tour” to Texas and Florida last week to advance President Trump’s Make America Healthy Again agenda. Across four days, Secretary Kennedy announced new actions on kidney disease and dementia, promoted stronger nutrition education for future doctors, and worked to expand access to women’s healthcare.
    • “From Tuesday through Friday, Secretary Kennedy met with healthcare providers, patient advocates, medical educators, and pharmaceutical manufacturers in Fort Worth, Texas, and Orange Park, Fort Lauderdale, and Miami, Florida.  At each stop, he advanced concrete actions to prevent chronic disease, improve patient care, and give Americans more information and choices to protect their health.
    • “President Trump has directed us to confront chronic disease and put patients first,” said HHS Secretary Robert F. Kennedy, Jr. “Across Texas and Florida, we put that mission into action — detecting kidney disease earlier, strengthening nutrition education for future doctors, advancing prevention and care for families facing dementia, and expanding access to women’s health treatments. HHS is moving prevention to the center of American health care and giving patients more control over their health.”
  • Bloomberg Law notes,
    • “One of the Department of Labor’s key policy advisers is departing the Employee Benefits Security Administration, following completion of the agency’s recent rulemaking on pharmacy benefit managers and healthcare price transparency.
    • “EBSA Senior Policy Advisor Caitlin Soto announced on LinkedIn that Friday would be her last day, calling her time at the DOL “the honor of my career.”
    • “Leading the Department’s PBM Fee Disclosure rulemaking, after nearly a decade of PBM transparency work, was the highlight,” she wrote in her post. “I’m also proud of our work on behalf of this administration to advance fertility benefits, transparency in coverage, and mental health parity. The list goes on.”
    • “The department is expected to release a rule in the coming days requiring PBMs — which negotiate drug prices for health plans — to disclose detailed compensation information to employers and other health plan sponsors. DOL also recently finalized a rule aimed at strengthening price transparency for medical services.”

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

  • Federal News Network reports,
    • “More details are emerging on the Trump administration’s revisions to paid administrative leave. Agencies’ ability to pay employees not to work during workforce reduction efforts has been formalized. Paid leave will also be allowed during reduction-in-force notice periods, the Office of Personnel Management said. OPM’s latest guidance comes after it finalized regulations to conform with the rules for the deferred resignation program. OPM is expected to soon update other online resources to reflect the new regulations. — Drew Friedman (Revised administrative leave regulations – Office of Personnel Management)”
  • and
    • “The White House is following a court’s order when it comes to reduction-in-force policies. The Office of Management and Budget and the Office of Personnel Management have formally rescinded two memos calling for reductions in force during shutdowns. The Trump administration agreed to terminate the two memos as part of its settlement in September to end a lawsuit by a coalition of federal employee unions including the American Federation of Government Employees, National Federation of Federal Employees and National Treasury Employees Union. Along with the removing the two memos, the Trump administration agreed to rescind every RIF notice issued during the 2026 shutdown and reinstate employees with back pay from the State Department, General Services Administration and Small Business Administration. Additionally, agencies must remove from their shutdown contingency plans any language authorizing RIFs, or RIF work, during a lapse in appropriations, unless a statute expressly permits it. — Jason Miller (OMB rescinds memo allowing RIFs during shutdowns – Office of Management and Budget)

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

  • Bloomberg Law reports,
    • “A recently launched FDA initiative targeting rare diseases is a top focus to carry out, the agency’s acting chief said ahead of a public meeting Wednesday to solicit feedback on the framework. 
    • “We’ve got to make sure that that process is in place. We’re working really hard to do it,” Kyle Diamantas, acting commissioner for the Food and Drug Administration, said Monday at the National Organization for Rare Disorders’ breakthrough summit. “It’s a top priority of mine.”
    • “Earlier this month, the agency introduced the Rare Disease Framework Initiative, which seeks to give patients more input and drug companies more transparency in the regulatory process for rare treatments. The initiative aims to develop a fit-for-purpose plan that considers the nuances of each disease and patient needs.”
  • Michigan Engineer relates,
    • “Conventional methods of pulling clots out through the blood vessels can damage fragile vessel walls.
    • “The newly FDA-cleared technology gently pulls on the clot with suction, stretches and thins it with an agitator, and vacuums it out of the body. 
    • “The device was designed by a team of neurosurgeons and engineers at the University of Michigan and is being commercialized by U-M startup Endovascular Engineering.”
  • Per a Pfizer news release,
    • “Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has expanded approval of TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) to the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (PC) with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations. mAPMN/S is also known as metastatic hormone-sensitive prostate cancer (mHSPC).
    • “This approval makes TALZENNA, an oral poly ADP-ribose polymerase (PARP inhibitor), plus XTANDI, an androgen receptor pathway inhibitor (ARPI), available in an earlier line, providing an opportunity to delay disease progression at a critical stage when more patients may experience greater benefit.”

From the judicial front,

  • Bloomberg Law reports,
    • “Eli Lilly & Co. is forming a new battlefront over a weight loss treatment that has yet to secure FDA approval, intensifying a legal drive to protect its blockbuster obesity franchise.
    • “The pharmaceutical giant has filed at least 11 federal lawsuits against a range of online vendors and wellness clinics making copycat versions of its experimental drug retatrutide, accusing them of illegally selling or facilitating access to a product not approved by any regulator in the world.
    • “The crackdown escalates the company’s broader legal campaign against businesses making copies of its powerful therapies, establishing a new wave of aggressive challenges over a drug predicted to outperform currently marketed weight loss treatments. Retatrutide is still in clinical trials for obesity, type 2 diabetes, and other related conditions.” * * *
    • “Lilly’s endeavor to protect retatrutide is also focusing on the FDA, as it plans to submit an application to the regulator in the first quarter of next year. 
    • “The drugmaker is simultaneously in a legal battle with the regulator after the agency determined a few years ago that retatrutide is a drug and not a biologic — a crucial designation that shapes its market exclusivity and when Medicare can negotiate its price.
    • “A biologic designation would grant retatrutide 12 years of protection from competitors, while small molecule drugs get five. Significant for Lilly, a biologic classification would prohibit compounded versions. 
    • “The FDA earlier this month doubled down on retatrutide’s drug label after a federal court sent the determination back to the agency for review, concluding the product doesn’t meet an amino acid length threshold that would count it as a biologic.
    • “An appeals court is now weighing whether it has jurisdiction to review the battle.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Nearly 1 in 10 adults hospitalized with respiratory syncytial virus infection died in the hospital or within 30 days of discharge, according to preliminary CDC data.
    • “Researchers analyzed RSV hospitalization data from the CDC’s Respiratory Virus Hospitalization Surveillance Network, which tracks hospitalizations with lab-confirmed influenza, COVID-19 or RSV in 14 states and more than 300 hospitals. The analysis included 18,301 RSV hospitalizations among adults across eight seasons from 2014 to 2024.” 
  • MedPage Today lets us know,
    • “Obesity in young adulthood was associated with significantly increased likelihood of early-onset cancers in an observational study, a risk that persisted into middle age.
    • “Men had a higher cancer risk than women, and abdominal fat further increased cancer risk beyond BMI alone.
    • “Cancer rates were highest for thyroid, endometrial, and ovarian cancers.”
  • STAT News relates,
    • “Women’s hearts are different from men’s. Research from clinical trials that have required female participants only since 1993 have repeatedly drummed home that message, from varying chromosomes in heart muscle cells to different heart attack symptoms and causes. Yet wide gaps remain in heart health care for girls and women across specialties. 
    • “Recognizing that clinical fragmentation and the resulting harm to women’s health, four medical societies — the American Heart Association, American Academy of Pediatrics, Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists — have issued a framework intended to unite clinicians and patients over a lifetime of care, all aimed at dethroning cardiovascular disease as the leading cause of death in women. In that spirit, three articles offering guidance across the course of a woman’s life were published Monday in Circulation.
    • “Their message: Because female-specific biology affects girls’ and women’s hearts throughout their lives, it requires connected, holistic care starting in adolescence to reflect transitions not found in the male models that have dominated health care: periods, pregnancy, perimenopause, and menopause.” 
  • Radiology Business points out,
    • “The performance of digital breast tomosynthesis—commonly referred to as 3D mammography—improves steadily with patient age, underlying the effectiveness of screening in an elderly population. 
    • “That’s according to new large-scale research from Massachusetts General Hospital, published Friday in RSNA’s Radiology Imaging Cancer. 
    • Current mammography guidelines remain largely age-based, with the influential U.S. Preventive Services Task Force’s last update in 2024 advocating for screening starting at 40. However, USPSTF claimed current evidence was insufficient to weigh the benefit of screening for women 75 and older. 
    • “Researchers with the Harvard University-affiliated institution recently sought to address this knowledge gap, analyzing data from over 300,000 mammograms. They found screening to be increasingly effective, particularly among the elderly, based on common quality benchmarks. 
    • “Cancer detection and sensitivity increased, false-positive rates declined, and specificity improved, resulting in particularly strong performance among female individuals aged 70 years and older,” lead author Leslie R. Lamb, MD, MSc, with Boston-based Mass General’s Department of Radiology, and colleagues wrote Oct. 23. “These findings provide a contemporary benchmark for screening DBT performance across age groups and contribute to the ongoing reassessment of age-based screening guidelines,” they added later. 
  • Healio notes,
    • “Most U.S. women know physical activity reduces breast cancer risk, but only one-quarter meet recommended levels.
    • “A majority know alcohol raises cancer risk, but two-thirds consume alcohol to some extent.”
  • Health Day adds,
    • Marijuana legalization may be landing more people in the hospital with heart problems, a new study suggests.
    • For the study, researchers analyzed more than 50 million hospital discharge records spanning 2012 to 2018. They compared Western states, where recreational marijuana sales began in 2014, with other U.S. regions.
    • The study — led by Dr. Samuel Slavin, of the Boston University Chobanian & Avedisian School of Medicine — found that hospital admissions for several serious heart conditions rose faster after legalization.
    • For each year of sales, admission rates were nearly 4% higher for heart failure, 3% higher for heart attacks and just over 2% higher for atrial fibrillation — an abnormal heart rhythm.
    • Rates for stroke, deep vein blood clots and tachycardia — a fast heartbeat — were also higher, but not statistically significant.
    • While the study cannot prove cause and effect, researchers said their findings “point to potential adverse effects of recreation legalization on population health.”
  • The Washington Post tells us about “the most important things to do to stay healthy while traveling.
    • “An infectious-diseases doctor shares essential tips to prepare for any health issues while traveling in another country.”
  • Beckers Behavioral Health informs us,
    • “Nearly 1 in 3 young adults in the U.S. reported using generative AI to seek substance-related information, with higher rates of use among Black and male respondents, according to a study published Oct. 19 in JMIR Formative Research.
    • “Researchers at Rutgers, the State University of New Jersey in New Brunswick, surveyed 995 U.S. adults ages 18-29 in April 2026 through the online research platform Prolific. The cross-sectional study examined the prevalence and frequency of, and reasons for, substance-related AI use, along with demographic differences and perceptions of the technology.”
  • and
    • “Researchers have identified evidence supporting a potential subtype of clinical depression, known as “circadian depression,” defined by disrupted sleep-wake patterns and associated with more severe symptoms and poorer responses to commonly prescribed antidepressants, according to a study published Oct. 20 in The British Journal of Psychiatry.
    • “The study, led by researchers from the University of Sydney’s Brain and Mind Centre, analyzed data from 11,380 adults with depression in the Australian Genetics of Depression Study. Researchers classified participants as having a circadian subtype if they met at least three of six criteria related to sleep and circadian disruption: social jetlag, seasonality, delayed sleep midpoint, evening chronotype, morning tiredness and hypersomnia. They compared clinical characteristics, self-reported antidepressant responses and genetic risk profiles between groups.”
  • Physicians’ Weekly informs us,
    • “Compared with patients with normal weight or overweight, the odds of death after emergency general surgery increase 92% for patients with underweight and 59% for patients with frailty, according to findings presented at the American College of Surgeons (ACS) Clinical Congress 2026 in Washington, DC.
    • “Our study shows that patients who are both underweight and frail have the worst outcomes,” said lead study author Ellen Cohn, MD, MPH, of the University of Chicago, in a news release. “We also saw that frailty reduces the positive impact of the obesity paradox — the finding that patients who are overweight, but not at the extremes of obesity, tend to have better outcomes. That protective effect is lost if a patient is frail.”   
  • Per Fierce Pharma,
    • “Fresh off the excitement of Rasonque’s big splash in pancreatic cancer, the oncology community has another impressive clinical win to celebrate. Amgen’s T-cell engager Imdelltra has posted a massive survival benefit in small cell lung cancer, delivering what Chief Medical Officer Paul Burton, M.D., Ph.D., called a “watershed moment” for the field.
    • “When added on top of AstraZeneca’s Imfinzi, Imdelltra reduced the risk of death by 58% as a first-line maintenance therapy for patients with extensive-stage SCLC who had not progressed following initial treatment with Imfinzi and chemotherapy.
    • “The result came from the phase 3 DeLLphi-305 study, which showed that, compared with Imfinzi alone, Imdelltra plus Imfinzi improved median overall survival by 8.4 months to 21.1 months. These data are being presented during a presidential symposium at the European Society for Medical Oncology Congress 2026 and simultaneously published in The New England Journal of Medicine.”
  • and
    • “As a cornerstone of Merck & Co.’s post-Keytruda oncology strategy, sac-TMT has cleared a clinical milestone. In its first global phase 3 win, the TROP2 antibody-drug conjugate delivered results that are “pretty consistent” with earlier China data, according to Marjorie Green, M.D., Merck’s head of oncology clinical development.
    • “Sac-TMT, partnered with China’s Kelun-Biotech, reduced the risk of death by 32%—and the risk of disease progression or death by 41%—compared with chemotherapy in patients with previously treated endometrial cancer. The patients had received prior treatment with platinum-base chemo and PD-(L)1 inhibitor therapy.
    • “Derived from the TroFuse-005 trial and presented at the European Society for Medical Oncology 2026 Congress, the data gave sac-TMT its first positive global phase 3 report out of 18 trials that Merck has launched in one of the industry’s broadest clinical development programs for a single drug.” 
  • and
    • “Novartis lifted the veil on its phase 3 wins in relapsing multiple sclerosis (RMS), announced in early September. 
    • “Not only did the company’s BTK inhibitor Rhapsido reduce relapses and disease progression compared to Aubagio, an older RMS treatment from Sanofi, but it did so without inciting any liver issues, a side effect that has proven to be an ongoing barrier to success of the drug class in this indication. 
    • “Novartis said it plans to seek regulatory approval globally in RMS. Its applications will be backed by data from the Remodel-1 and Remodel-2 trials presented at MSToronto last week and simultaneously published in The Lancet.”
  • BioPharma Dive adds,
    • “An antibody-drug conjugate from BioNTech and DualityBio met its main goal in a Phase 3 study in breast cancer, but may only have a “limited” impact in people with the condition, the companies said Monday.
    • “The treatment, known as trastuzumab pamirtecan, successfully delayed tumor progression in a trial of people whose breast tumors express low, but still detectable levels of the HER2 protein. The improvement on that measure was “modest,” though, and treatment was also associated with higher rates of interstitial lung disease — a potentially deadly kind of lung inflammation — than the companies had seen in earlier testing.” 
  • The Wall Street Journal reports,
    • “Roche Holding ROP said it expects a pill it is developing to become the new standard treatment for an advanced form of lung cancer, and the company’s first shot at an emerging field within the oncology market.
    • “The Swiss drugmaker is working on several drugs that target a driver of cancers that long eluded the industry. A breakthrough in pancreatic cancer from U.S. biotech Revolution Medicines put the field on investors’ radar, and Roche aims to venture into it with lung-cancer medicine divarasib.
    • “In study results presented Sunday at the annual congress of the European Society for Medical Oncology in Madrid, Roche said its drug lowered the risk of death by 44% compared with available treatments from Amgen and Bristol-Myers Squibb. The late-stage clinical trial compared the effects of the drugs on patients with a specific type of lung cancer who had been previously treated.
    • “Fewer participants who took divarasib dropped out of the trial due to side effects than those who received the existing drugs, Roche said.
    • “The data are practice-changing,” Roche’s Deputy Chief Medical Officer, Stefan Frings, said in an interview.”

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

  • Fierce Healthcare reports,
    • “Earlier this year, UnitedHealthcare unveiled Avery, a generative AI companion aimed at supporting care coordination for its members.
    • “At the time, the tool was available to about 6.5 million of its members in employer plans and 160,000 people enrolled in Medicare Advantage. Now, the insurer is expanding access to 21 million of its members, growing the tool’s reach at a faster clip than was initially expected.
    • “To date, the company has found that Avery has resolved 90% of its member interactions, and in the remaining 10% of cases, can complete a handoff to a human advocate to offer member support. 
    • “As we’re seeing some of the statistics and some of the feedback that we’re getting from users around the success we’ve had within the early phases of Avery, it’s just making sense to open up that application into more and more of the population,” Craig Kurtzweil, chief data and analytics officer at UnitedHealthcare, told Fierce Healthcare.”
  • and
    • “Building stronger bridges between payers and providers will prove critical in addressing the biggest challenges facing healthcare: affordability and access.
    • “It’s with that backdrop that Aetna is releasing its latest provider survey, a quarterly poll that seeks to better understand providers’ perspective on their insurer counterparts and where there’s room to continue developing trust between the two. In the third quarter survey, provided first to Fierce Healthcare, Aetna found a trust score of 6 out of 10, on par with the 6.1 score seen in Q2.
    • “The tally makes for a significant increase from the first quarter, where the trust score was 5.4.
    • Steve Nelson, president of Aetna, told Fierce that “trust is at an all-time low,” so the insurer has been putting an emphasis on addressing some of the biggest pain points that erode that trust, including administrative burdens like prior authorization and increasing transparency.
    • “It’s not just a hope and a prayer here,” he said. “We’re actually making progress.” 
  • and
    • “Doximity inked a partnership with Wolters Kluwer Health to embed UpToDate’s evidence-based clinical content directly within Doximity Ask, the company’s AI clinical decision support tool.
    • “In the coming weeks, at health systems that use both products, clinicians will see an answer based on UpToDate’s 13,000 clinical topics and best practice guides alongside Doximity Ask’s response, without leaving the Ask workflow.
    • “Doximity is a digital platform for U.S. medical professionals that offers workflow tools such as a telehealth solution, a clinician-to-patient dialer tool and digital faxing capabilities.
    • “The company aims to become a leading AI platform for doctors with plans to scale its clinical AI suite, including its ambient note-taking tool Scribe and clinical AI assistant and medical search engine Ask. A year ago, Doximity acquired clinical AI company Pathway and then integrated Pathway’s datasets and its AI into its free Doximity GPT product to offer DoxGPT (now Ask).”
  • Beckers ASC Review relates,
    • “On Oct. 26, Cincinnati-based Bon Secours Mercy Health agreed to acquire Brentwood, Tenn.-based Surgery Partners through its affiliate HealthSpan Partners in a take-private deal valued at about $5.7 billion including debt. 
    • “The transaction would add more than 200 ASCs, surgical hospitals and physician practices across 30 states, along with about 5,000 affiliated physicians, to a 47-hospital system — making the latest in a growing group of health systems that have shifted ambulatory care from a nice-to-have to a strategic imperative.
    • “It most recently follows St. Louis-based Ascension’s $3.9 billion acquisition of Nashville, Tenn.-based Amsurg, which closed earlier this year, and comes as Dallas-based Tenet Healthcare keeps adding to United Surgical Partners International, its surgical arm and the nation’s largest ASC portfolio.”