Thursday report

Mental health care

Thursday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “A Democratic effort to extend expiring healthcare subsidies drew some Republican votes but failed to advance in the Senate on Thursday, leaving no clear path in Congress for aiding millions of Americans facing soaring costs for their Affordable Care Act coverage next year.
    • “The proposal would have extended the enhanced Covid-era ACA subsidies for three years. The bill was backed by 51 senators—including Republican Sens. Lisa Murkowski and Dan Sullivan of Alaska, Susan Collins of Maine and Josh Hawley of Missouri—with 48 opposed, short of the 60 votes needed to advance under the Senate’s filibuster rule.
    • “Republicans, who control the chamber 53-47, put forward an alternative healthcare bill that wouldn’t extend the subsidies but instead offers federal funds to some households to put toward out-of-pocket healthcare costs. That proposal failed with 51 in favor and 48 opposed. All Republicans except Sen. Rand Paul of Kentucky supported the measure, while no Democrat voted for it.
    • “The lack of progress in Congress has left many of the nation’s ACA enrollees in a precarious situation. With open enrollment closing on Dec. 15 for plans starting Jan. 1, households are signing up now for coverage with sharply higher costs, with no guarantee that Congress will act to restore subsidies and bring the price tag down. Others are expected to skip coverage altogether.
    • “With the failure of the two votes Thursday, hope is fading for any deal to extend the subsidies before the end of the year, if at all. The next major legislative deadline is Jan. 30, when lawmakers need to pass a new bill funding the government. Still, some lawmakers believed a deal could still be reached.
    • “I hope that there are enough people on both sides who want to come to the table and get a compromise,” said Sen. Jeanne Shaheen (D., N.H.).”
  • Tammy Flanagan, writing in Govexec, tells us,
    • “OPM’s retirement application pile remains large as the year draws to a close
    • “New retirees awaiting full benefits may face holiday heartache as the backlog swelled to nearly 50,000 by the end of November.”

From the Food and Drug Administration front.

  • The Washington Post reports,
    • “An in-home headset that allows people with depression to send mild electrical current to their brains has been cleared by the Food and Drug Administration, in what medical experts consider a milestone for expanding mental health treatment beyond drugs.
    • “The prescription device, made by Flow Neuroscience, is designed to counteract moderate to severe depression in adults by delivering electric stimulation to an area of the brain that controls mood and stress. While such stimulation is widely used to treat depression, Flow is aiming to fill a niche with a product that delivers a relatively low dose of current at home, instead of at specialized clinics. The FDA said testing showed “modest” results for patients.”
  • Per MedTech Dive,
    • “Intuitive Surgical said Wednesday its da Vinci SP surgical robot received Food and Drug Administration clearance for use in inguinal hernia repair, gallbladder removal and appendectomy procedures.
    • “The clearances add to the single port robot’s indications in urology, colorectal, thoracic and transoral procedures, as Intuitive works to expand adoption of the platform, launched in the U.S. in 2018.
    • “The SP system, for surgery through a single incision or natural orifice, is designed to help surgeons access narrow or deep spaces within the body to perform more complex procedures. The surgeon can control up to three multi-jointed instruments and a 3D-HD imaging endoscope through the entry point.”
  • Fierce Pharma relates,
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • “The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • “Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.
    • ‘At the core of the guidance is a call for all promotional materials to be “accurate, truthful, and non-misleading.”
  • STAT News tells us,
    • “Exactly a month after it announced the removal of black box warning labels on estrogen therapy products used in menopause, the Food and Drugs Administration hosted an expert panel to discuss the other sexual hormone with a potentially outdated black box: testosterone. 
    • “Nine experts, including academics, clinicians, and the CEO of a pharmaceutical startup focused on testosterone products, delivered lectures and answered questions highlighting the importance of testosterone as a marker of broader male health. They also promoted increased engagement with its therapeutic value and recommended changes in labeling and substance control.” 
  • Beckers Hospital Review shares background about and FDA review process.
    • “The FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency has not formally issued draft guidance, recent public comments, advisory committee discussions and internal policy memos outline a framework that is intended to streamline clinical trials, tighten manufacturing oversight and modernize postmarket safety monitoring.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “South Carolina’s measles outbreak is “accelerating” in the wake of Thanksgiving travel and a lack of vaccinations, an epidemiologist for the state’s Department of Public Health (DPH) warned Wednesday, after authorities traced a sizable outbreak to a church in the state’s northwest.
    • “Of the 111 measles cases recorded in that area, known as the Upstate region, 105 involved people who were unvaccinated while three involved those who were partially vaccinated, state epidemiologist Linda Bell said at a news briefing. One dose of the vaccine is 93 percent effective against measles, while the full two-dose regimen is 97 percent effective, according to the Centers for Disease Control and Prevention.
    • “At least 254 people had been placed in quarantine as of Tuesday, 16 of whom are in isolation, the DPH said in a news release.
    • “Bell said that 27 new cases had been reported since Friday, bringing the total reported to the DPH this year to 114. “Accelerating is an accurate term. That is a spike in cases we are concerned about,” she said in response to a question from a reporter, adding that South Carolina has “lower than hoped for” vaccination coverage.”
  • NBC News tells us,
    • “Heart disease has long been the top killer of women in the United States, but new research suggests uterine fibroids, which many may not even be aware they have, could be putting them at a significantly greater risk.
    • “A large, 10-year study found that women with leiomyomas had an 81% higher long-term risk of heart disease than those without the common condition. Women with fibroids — generally benign tumors that can form on or in the uterus — also had higher individual risks of cerebrovascular, coronary artery and peripheral artery diseases a decade after diagnosis.
    • “The study involved more than 2.7 million U.S. women and was led by scientists at the University of Pennsylvania Perelman School of Medicine. It was published Wednesday in the Journal of the American Heart Association.
    • “We do hope that our study adds to this growing evidence that reproductive health may provide important insights into cardiovascular health,” said lead author Julia DiTosto, a doctoral candidate in epidemiology at Penn. “There is a need for more information on how exactly, biologically, these conditions are related and also identifying potential strategies for cardiovascular prevention.”
  • Per Healio,
    • “Younger age at diagnosis did not appear to affect outcomes among women with breast cancer who harbor BRCA mutations, according to study results presented at San Antonio Breast Cancer Symposium.
    • “In addition, survival did not differ between very young women — defined as 30 years or younger — and those aged 31 to 40 years.
    • “Age per se should not be considered a negative prognostic factor in BRCA carriers when appropriate treatment is provided,” Matteo Lambertini, MD, PhD, associate professor of medical oncology and consultant in medical oncology at University of Genova-IRCCS Policlinico San Martino Hospital in Italy, said during a presentation.”
  • Per Radiology Business,
    • “Targeting women who are eligible for both lung and breast cancer screening pays off, according to new research.  
    • “Numerous studies have explored poor LCS adherence, a problem less pronounced in screening mammography. One previous study estimated about 58% of LCS-eligible women reported having a mammogram over the past two years versus just 8% who underwent low-dose CT for lung cancer. 
    • “This presents a potential opportunity, experts detailed Dec. 1 in the Journal of the American College of Radiology. Researchers at two academic medical centers recently aimed to leverage mammography adherence to bolster LCS uptake and are finding success, with a significant uptick in total LDCT examinations. 
    • “It has been more than 10 years since annual screening for lung cancer was recommended, and screening rates still are disappointingly low. There are many reasons for these low rates, but mostly identifying eligible individuals is challenging in the primary care setting, and there is evidence showing a surprising lack of awareness about lung cancer screening among eligible individuals,” study co-investigator Robert Smith, PhD, with the American Cancer Society, which funded the analysis, said in a statement. “There is enormous potential here, and the ACS is thrilled with the outcome of this study.” 
  • Medscape discusses the rising number of double diabetes cases and “What Doctors Should Know About Viral Sleep Trends.”
  • Per Health Day,
    • “Many young Americans are still smoking nicotine, tobacco or cannabis, even as edibles and vapes continue to grow in popularity.
    • “A University of Michigan study looked at how 12- to 34-year-olds are using these substances today. Researchers examined data from 8,722 individuals who had used at least one of these products within the last 30 days.
    • “On average, users tried about two products during that time, and researchers identified six main patterns of use:
      • “Combustible tobacco: 31%
      • “Multiple forms of cannabis: 27%
      • “Vaping nicotine: 18%
      • “Using multiple forms of nicotine, tobacco and cannabis: 14%
      • “Cannabis edibles only: 5%
      • “Multiple forms of nicotine and tobacco: 5%
    • “The largest group, and still the most concerning, were people who smoked tobacco, researchers said.”
  • BioPharma Dive relates,
    • “An experimental Eli Lilly obesity medicine helped patients lose more than a quarter of their body weight while offering relief from knee osteoarthritis in a Phase 3 study released Wednesday.
    • “Patients on the highest dose of retatrutide lost an average of 28.7% of their body weight after 68 weeks of treatment, compared with 26.4% on the lower dose and 2.1% on placebo, Lilly said. Additionally, 39% of patients on the highest dose achieved weight loss of 30% or more and 24% of those on that dose saw their weight drop by 35% or more, Lilly said.
    • “Lilly has now produced a drug with the best weight loss results of any medication to date, Leerink Partners analyst David Risinger wrote in a note to clients. Before the release, Risinger said he was looking for weight loss in the mid-high 20% range, which would surpass the effects seen with Lilly’s tirzepatide, the world’s best-selling drug, sold as Zepbound for obesity.”
  • Per Genetic Engineering and Biotechnology News,
    • “In 2022, monkeypox virus (mpox) caused more than 150,000 cases—causing flu-like symptoms and painful rashes and lesions. The outbreak resulted in almost 500 deaths. At the time, vaccines developed to fight smallpox were repurposed to help the most vulnerable patients. But that vaccine—manufactured from a whole, weakened virus—is complicated and costly to make.
    • “Now, a major inroad towards a new and more effective way to fight monkeypox virus has been published. A team used the AlphaFold 3 model to identify a viral surface protein—OPG153—as a good target for developing new antibody therapies to treat mpox or for use in a vaccine. When mice were injected with the viral surface protein, the animals produced antibodies that neutralized the monkeypox virus, suggesting the breakthrough could be used in a new mpox vaccine or antibody therapy.
    • “This work is published in Science Translational Medicine in the paper, “Antigen-agnostic identification of poxvirus broadly neutralizing antibodies targeting OPG153.”
    • “Unlike a whole-virus vaccine that’s big and complicated to produce, our innovation is just a single protein that’s easy to make,” said Jason McLellan, PhD, professor of molecular biosciences at The University of Texas at Austin.”
  • and
    • “Findings from a new study led by scientists at Stanford University School of Medicine and their colleagues elsewhere show that a single signaling pathway controls whether immune cells attack or befriend cells that they encounter in the body. By manipulating this pathway, scientists may be able to tweak the immune response to treat a range of diseases, including cancers, autoimmune disorders, and more. Full details are provided in a new Nature paper titled “Erythropoietin receptor on cDC1s dictates immune tolerance.”  
    • “The findings build on work published in an earlier study by the same research group that described a role for erythropoietin (EPO) in the immune system—specifically, controlling how dendritic cells respond to real or perceived threats. The current study, which was performed in mice, helps to illuminate an aspect of peripheral immune tolerance, which is responsible for preventing inappropriate attacks on healthy tissue. The scientists who discovered regulatory T cells (Tregs), which are the key cellular players in peripheral immune tolerance, were awarded the 2025 Nobel Prize in physiology or medicine.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark and Blue Cross and Blue Shield Kansas City have announced plans to affiliate.
    • “The insurers revealed on Thursday that they will enter into an affiliation where Blue Cross KC will maintain its local brand and operations, but will be able to tap into Highmark’s resources to accelerate innovation for its members. Highmark is the fifth-largest Blues plan in the U.S.
    • “Through the affiliation, Blue Cross KC’s financial reserves and earnings will remain within its organization, and Highmark will support its evolution through administrative capabilities, technology and new tools to enable the insurer to build new products and operational efficiencies.
    • “Erin Stucky, CEO of Blue Cross KC, said in the announcement that after a “comprehensive” process to find a partner, the team is “confident” that Highmark was the right choice to “help us deliver greater value for our community.”
  • and
    • “Connecticut’s Office of Health Strategy (OHS) approved on Wednesday Hartford HealthCare’s Emergency Certificate of Need application to acquire two hospitals and related assets from the bankrupt Prospect Medical Holdings. 
    • “The expedited decision ensures continuity of care for Eastern Connecticut residents, while imposing specific conditions designed to ensure preservation of healthcare access and quality and control cost growth,” Amy Porter, the state regulator’s acting commissioner, said in an announcement. “The OHS staff conducted a rigorous and highly efficient process made possible by the emergency [certificate of need] statute.”
    • “Hartford HealthCare’s $86.1 million bid was the only one received for Manchester Memorial and Rockville General, and had previously been accepted by Prospect and green lit by a bankruptcy judge. The facilities had been at the heart of a now-settled legal dispute between bankrupt Prospect Medical Holdings and Yale New Haven Health, which prior to the bankruptcy had offered hundreds of millions more for the locations.”
  • and
    • “Aradigm Health, a new benefits platform aimed at easing the financial sting of coverage for cell and gene therapies, has launched out of stealth.
    • “The company is making its debut backed by a $20 million series A funding round that it intends to use to further enhance platform development, building out its team and growing its partnerships with payers and providers. The round was led by Frist Cressey Ventures with backing from Andreessen Horowitz and Morgan Health.
    • “Andreessen Horowitz led the company’s $5 million seed round in 2024 as well, according to an announcement.”
  • Healthcare Dive tells us,
    • “Elevance has added a former Pfizer executive to its board, the latest addition of pharmaceutical industry veteran as the insurer focuses on building its pharmacy services.
    • “Amy Schulman will start as an independent director of Elevance effective Jan. 12, the insurer announced Wednesday. Schulman will serve on the board’s audit and finance committees.
    • “Schulman’s “insight into the intersection of science, technology, and patient care makes her an exceptional addition as we continue to advance and expand our services,” Ramey Peru, chair of Elevance’s board, said in a statement.”
  • Beckers Hospital Review reports,
    • “Austin, Texas-based UT Health Austin intends to go live with a new inpatient Epic EHR on the same day it opens its new multibillion-dollar academic medical center.
    • “With the net-new implementation, the health system will be able to easily adopt many of the vendor’s latest AI and automation features.
    • “It is a really unique opportunity to build this from scratch, from the ground up,” UT Health Austin CIO Michael Ryan told Becker’s. “We’re really taking a fresh-eyes look at it. … We don’t have many existing legacy processes or legacy ways of working.”
    • “The $2.5 billion University of Texas at Austin Medical Center, slated to break ground in 2026, will include a new UT hospital and MD Anderson Cancer Center. Austin is currently the largest American city without an academic medical center.”
  • and
    • “U.S. News & World Report released its 2026 Best Hospitals for Maternity Care ratings Dec. 9, which also recognize hospitals providing services to underserved communities.
    • “The media company used self-reported maternity care data to identify 147 hospitals as Maternity Care Access Hospitals for providing maternity services in areas that would otherwise lack adequate access to such care.:”
    • The article lists all 147 identified hospitals by State.
  • and
    • “Many health systems are expanding their participation in value-based care models over the next few years, though few have substantial revenue at risk in value-based contract arrangements, according to a new Sage Growth Partners report. 
    • “The report, published Dec. 11, is based on a survey of 101 hospital and health system C-suite leaders from academic medical centers, integrated delivery networks and independent hospitals.’
  • Per an Institute for Clinical and Economic Research news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation. Our primary comparison was with the smoking cessation drug varenicline.
    • “Smoking cigarettes is the number one cause of preventable deaths in the US, and so any new therapy to assist with smoking cessation is extremely important,” said ICER’s Chief Medical Officer, David Rind, MD. “The drug we reviewed for this assessment, cytisinicline, is the same molecule as cytisine, a drug long used for smoking cessation in Eastern Europe. Our analyses show that cytisine/cytisinicline has similar efficacy but significantly fewer gastrointestinal side effects than varenicline, a common prescription drug used for smoking cessation in the US. We heard from experts that they are hopeful cytisinicline will be priced so as to be widely available to those who need it.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), on January 15, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • Per MedTech Dive,
    • “Natera last week said it completed the acquisition of Foresight Diagnostics, expanding the company’s position in solid tumor molecular residual disease detection, particularly in lymphoma, a cancer of the lymphatic system.
    • “The all-stock transaction was valued at $275 million upfront, plus up to $175 million in revenue- and reimbursement-based milestone payments.
    • “Foresight’s PhasED-Seq technology will be integrated into Natera’s Signatera platform to further differentiate performance in solid tumors.”

Tuesday report

David Ermer–ACA, CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • MedPage Today reports,
    • “The number of Americans signing up for Affordable Care Act (ACA) health insurance for 2026 is moderately higher than it was at a similar time last year, initial new federal data show, even as subsidies set to expireopens in a new tab or window at the end of 2025 will make the coverage more expensiveopens in a new tab or window for many.
    • “Seen at face value, the data from the Centers for Medicare and Medicaid Services seem to defy predictions that many Americans facing pricier plans would drop out of marketplace coverage altogether next year. But experts caution that the numbers are an incomplete snapshot of total enrollment, which could still show a decline by the end of the open enrollment period.
    • “Overall, it’s just too early to know what any of this means,” said Jason Levitis, a senior fellow in the health policy division at the Urban Institute.
    • “The data released Friday show that by day 29 of the window for Americans to shop for ACA plans this year, nearly 5.8 million people had picked one. That’s nearly 400,000 more enrollments than by day 30 of the open enrollment period last year.
    • Meanwhile, this year’s enrollment numbers are about 1.5 million lower than the 7.3 million or so people who had signed up 32 days into the open enrollment period 2 years ago, showing there is some fluctuation year to year in when people sign up for coverage.
    • “In most states, for Americans who want coverage to start Jan. 1, the window to shop for ACA coverage began Nov. 1 and ends Dec. 15. People who want their coverage to start later can continue to select plans through Jan. 15.”
  • The Wall Street Journal adds,
    • “Senate Majority Leader John Thune (R., S.D.) said he would hold a vote later this week on a Republican measure aimed at controlling healthcare costs, amid party division over how best to head off big price increases next year for millions of households.
    • “Thune said Republicans have coalesced around legislation from Sens. Bill Cassidy (R., La.) and Mike Crapo (R., Idaho) [discussed in yesterday’s FEHBlog post] that would put as much as $1,500 a year into tax-advantaged health savings accounts when paired with lower-priced insurance plans in 2026 and 2027. The proposal doesn’t extend enhanced Affordable Care Act subsidies, which are due to expire after this year.
    • “The measure aims to provide an alternative to a Democratic proposal that extends the ACA subsidies for three more years. Votes on the two plans in the GOP-controlled Senate are set for Thursday, as Thune follows through on a promise made to Democrats as a condition for ending the government shutdown last month.
    • “So there will be something out there that Republicans will be able to talk about and support and vote for, and then we’ll see what happens Thursday,” Thune said. If neither proposal gets the 60 votes required to advance in the Senate, he said, “then we’ll see where it goes from there.”
  • Per a Senate news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is seeking information from stakeholders regarding the American Medical Association’s (AMA) monopoly of Current Procedural Terminology (CPT®) codes and its impact on patients, providers, and health care costs. Cassidy is asking stakeholders with relevant experience and knowledge of CPT ® coding contracts with the AMA to inform the Committee’s inquiry by responding to this questionnaire.
    • “As chair of the HELP Committee, Cassidy is using all tools at his disposal to lower costs for American patients. Thus far, the AMA evaded questions and failed to cooperate with Cassidy’s inquiry. If the AMA does not respond in a fulsome and transparent manner by December 15, 2025, the Chairman is committed to finding answers by other means.
    • “The federal government mandated the use of CPT codes. This creates the potential for abuse in that if someone has to buy your product, you can charge them what you want,” said Dr. Cassidy. “There may be nothing wrong here, but we should get answers to make sure the CPT system is working for the American patient and for the American health care system.”
  • Beckers Hospital Review tells us,
    • “Nearly 4 million Medicare-eligible Americans face heightened risk of disrupted medication access as restructuring efforts by the U.S. Postal Service slow mail delivery in rural and underserved communities reliant on mail-order prescriptions, according to a Dec. 4 analysis from The Brookings Institution
    • “In 2024, USPS launched its Regional Transportation Optimization initiative, which consolidates mail processing into regional hubs. While the initiative aims to improve efficiency, early analyses suggest it has exacerbated delivery slowdowns in rural areas, according to the report.”
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Dec. 9 issued a proposed rule that would make changes to the Increasing Organ Transplant Access Model beginning July 1, 2026. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1 of this year. To comply with statutory requirements, CMS proposes to modify the eligible kidney transplant hospital criteria to exclude Department of Veterans Affairs medical facilities and military medical treatment facilities. The agency also proposes to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. Regarding IOTA participant performance, CMS proposes updates to the composite graft survival rate metric, including adding a risk-adjustment methodology that includes several transplant recipient and donor characteristics. In addition, CMS proposes other policy changes related to repayments, the extreme and uncontrollable circumstances policy, transparency and public posting of information, voluntary health equity plans, beneficiary protections, monitoring activities, and remedial actions and termination.” 
  • Modern Healthcare relates,
    • “Health insurance companies spent two years getting ready for a new Medicare Advantage quality metric intended to tackle health disparities. Then the government pulled the plug.
    • “The Excellent Health Outcomes for All measure — also known as EHO4All and formerly known as the health equity index— likely won’t be part of the Medicare Advantage Star Ratings program in 2027 after all, the Centers for Medicare and Medicaid proposed in a draft regulation last month.
    • “It’s a mixed bag for the insurance sector. In conjunction with implementing EHO4All, CMS also planned to scrap the Star Ratings program’s so-called reward factor, which benefits companies that demonstrate high quality scores over multiple years. But other companies stood to gain from an emphasis on health equity. 
    • “Moreover, the industry at large carried out intensive preparations to boost their performance on EHO4All measures, which were intended to boost insurers that cover large numbers of beneficiaries who qualify for both Medicare and Medicaid, are eligible for low-income subsidies, or have disabilities.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA has launched a safety review of approved respiratory syncytial virus therapies for infants, including Beyfortus from Sanofi and AstraZeneca and Enflonsia from Merck, Reuters reported Dec. 9.
    • “Senior executives from the three companies were informed last week that the agency would seek further data on the therapies following internal concerns raised by FDA officials appointed under Health and Human Services Secretary Robert F. Kennedy Jr. Tracy Høeg, MD, PhD, recently namedacting director of the FDA’s Center for Drug Evaluation and Research, initiated the safety inquiry over the summer. As a noted vaccine skeptic, the appointment of Dr. Høeg has raised serious concerns among healthcare experts.”
  • Bloomberg Law lets us know,
    • “The FDA’s effort to curb high drug costs by accelerating approvals of cheaper medicines similar to expensive biologics will need other policy reforms to boost access to the biosimilars, drug pricing experts say. 
    • “The Food and Drug Administration is seeking to lower drug costs by simplifying the development of biosimilars, products that are highly similar to FDA-approved biologics, have no clinically meaningful differences, and can treat patients the same way. Biologics, such as AbbVie Inc.‘s blockbuster treatment Humira for rheumatoid arthritis and Merck & Co.‘s cancer medicine Keytruda, are complex drugs made from sources such as plant or animal cells. 
    • “Biosimilars are often available at a lower cost compared to biologics. While insurance varies for patients, the list price of Humira can run above $6,000 a dose. Amgen Inc.‘s Amjevita, a biosimilar to the inflammatory drug, can be purchased at either 55% or 5% below Humira’s list price.
    • “The FDA action, however, might not immediately yield patient access to the cheaper medicines without reforming other policies that seek to make biosimilars available upon approval, drug pricing experts say. Biosimilars often face hurdles before hitting the market, frequently due to patent litigation, agreements between drug companies to defer entry, and how they’re treated in health insurers’ prescription drug plans.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first approval achieved through this review pathway. The approval was completed in just two months, representing a major reduction of the review timeline for this type of application.
    • “Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over – we’re entering a new era of manufacturing here at home,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security.”
    • “The Augmentin XR application demonstrated clear alignment with the CNPV program’s national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility. This approval will also help address antibiotic shortages in the U.S. that have plagued the healthcare system over the past two decades.”
  • and
    • “The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “The FDA continues to exercise flexibility in the regulatory approach for rare diseases by considering all available data sources, including as appropriate data from expanded access programs, to facilitate the advancement of life-changing treatments while ensuring scientific requirements are satisfied.”
  • Per MedTech Dive,
    • “Sometimes, the line between medical and wellness products can blur. Regulators’ pushback on a blood pressure feature that Whoop incorporated into its wellness wristband illustrates the challenges wearables developers face as they add increasingly sophisticated features.
    • “Whoop received a warning letter from the Food and Drug Administration this summer after rolling out the blood pressure offering without regulatory authorization.
    • “The company has pushed back on the warning letter, however, arguing that blood pressure is a wellness feature. The FDA disagreed, saying blood pressure is inherently related to a medical diagnosis. 
    • “The FDA isn’t likely to concede on its challenge, experts said. Whoop’s skirmish with the FDA offers lessons on where to draw the line between wellness and medical features.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Justice Department is weighing a challenge to a deal between two of the largest companies offering software to small, independent pharmacies, as antitrust enforcers step up their focus on the health-care industry.
    • “The deal, which the companies didn’t publicly announce, involves the acquisition ofMicro Merchants Systems, the operator of pharmacy management software platform PrimeRx, by RedSail Technologies, said the people, who asked not to be named discussing a confidential matter. Micro Merchants is backed by TA Associates Management, while RedSail is the result of multiple acquisitions backed by investment firms including Francisco Partners. 
    • “Representatives of the companies met with DOJ antitrust chief Gail Slater in late November, said the people. Such meetings indicate significant government opposition to a deal, although they don’t always precede a federal lawsuit if the companies are able to make proposals that allay the agency’s concerns. Companies submit confidential filings to US authorities as part of a merger review process.”
  • STAT News relates,
    • “In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs.
    • “Skinny labeling refers to a process in which a generic drug company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.” * * *
    • “Doubts were raised about the maneuver, however, when the Supreme Court two years ago declined to hear an appeal of a lower court ruling, which questioned the practice. Now, this second case is being seen as a test for whether skinny labeling can survive as a way for generic companies to market medicines, according to legal experts following the issue.”
  • The Wall Street Journal brings us to date on Luigi Mangione’s evidence hearing in New York state court.

From the public health and medical / Rx research front,

  • ABC News reports,
    • “Concerns about the flu spreading in the U.S. are growing as the U.K. continues to see a spike in cases among children and young adults.
    • “The increased number of cases in the U.K., could be a predictor for the flu season in the U.S., according to ABC News chief medical correspondent Dr. Tara Narula.
    • “We know that England or other places can be a marker for what is going to happen here, because their flu season happens a few weeks earlier than ours,” Narula said on “Good Morning America” Monday, adding, “We have low numbers of cases so far but they are increasing.”
    • “Some hospitals are starting to implement flu season visitor restrictions, including the Detroit Medical Center and Children’s Hospital of Michigan, which are allowing, as of Monday, up to two visitors per patient and only those 13 years of age and older are permitted on inpatient hospital floors or in observation units.
    • “According to data from the Centers for Disease Control and Prevention, flu activity in the U.S. is up at least 7% in the last week, and so far, there have been nearly 2 million illnesses, 19,000 hospitalizations, and 730 deaths from the flu.”
  • The Green Science Policy Institute tells us,
    • “New research led by the California Department of Public Health and partners found that replacing foam-containing furniture made before 2014 would cut in half levels of certain harmful flame retardants in people’s bodies in just over a year. Published today in the peer-reviewed journal Environmental Pollution, the study is the first to show measurable health benefits from California’s 2014 furniture flammability standard update, which made it possible for manufacturers to comply without adding chemical flame retardants.
    • “Specifically, volunteers who swapped their old sofas and living room chairs for new, flame-retardant-free versions saw their blood concentrations of polybrominated diphenyl ethers (PBDEs) drop by half in just 1.4 years. Due to the overall declining use of these chemicals, levels in participants who did not replace furniture dropped as well, but two to four times more slowly. PBDEs are linked to cancer risk, hormone disruption, and neurodevelopmental effects. Epidemiological studies have shown that the average U.S. child has lost three to five IQ points from exposure to one PBDE. Further, a recent research paper estimated those with highest levels of this flame retardant in their blood had about four times the risk of dying from cancercompared with people with the lowest levels.
    • “This study shows that the update to California’s flammability standard not only changed what goes into furniture—it changed what goes into people’s bodies,” said co-lead author Kathleen Attfield, a Research Scientist Supervisor with the California Department of Public Health. “Through biomonitoring, we can assess how policy changes and consumer choices can work together to lower exposures to toxic chemicals.”
  • NBC News reports,
    • “Despite previous excitement around a potential link between GLP-1 drugs and a reduced risk of cancer, new research suggests the popular medications “probably have little or no effect” on a person’s risk of developing one of the 13 obesity-related cancers.
    • “The findings, published Monday in the Annals of Internal Medicine, may seem counterintuitive, said co-author Dr. Cho-Han Chiang, who conducted the study earlier this year as an internal medicine resident at Mount Auburn Hospital, a Harvard Medical School teaching hospital in Cambridge, Massachusetts.” * * *
    • “The new study has two major limitations, Chiang said. One is that none of the nearly 50 trials his team analyzed was designed to measure cancer outcomes.
    • “Dr. Kandace McGuire, chief of breast surgery at the Massey Comprehensive Cancer Center at Virginia Commonwealth University, said that might explain the counterintuitive nature of the findings.
    • “When you take a bunch of studies that weren’t looking at cancer risk and you throw them together, sometimes you find things that are contrary to what you would hypothesize,” said McGuire, who wasn’t involved in the research. “Some of that may be just the makeup of the studies, rather than the actual data itself.”
    • “From a cancer prevention perspective, I think more data is needed,” Chiang said, noting that there’s also a lack of data on GLP-1 usage among patients who already have cancer.”
  • Health Day points out,
    • “Laughing gas might live up to its name for people struggling with depression, a major new study says.
    • “Treatment with nitrous oxide can provide rapid relief for people with depression, especially those who aren’t helped by antidepressants, researchers reported recently in the journal eBioMedicine.
    • “This is a significant milestone in understanding the potential of nitrous oxide as an added treatment option for patients with depression who have been failed by current treatments,” senior researcher Dr. Steven Marwaha, an academic psychiatrist with the University of Birmingham in the U.K., said in a news release.
    • “This population has often lost hope of recovery, making the results of this study particularly exciting,” Marwaha added.”
  • Today was the last day of the 2025 American Society for Hematology conference.
    • Per BioPharma Dive,
      • “A regimen involving Johnson & Johnson’s dual-acting drug Tecvayli could be curative when used early in the disease course of people with multiple myeloma, according to data disclosed Tuesday.
      • “Released at the annual meeting of the American Society of Hematology in Orlando, the results come from a trial called MajesTEC-3. J&J in October claimed early success for the study, which evaluated Tecvayli alongside another J&J drug called Darzalex, against Darzalex and a standard combination in people whose disease had advanced after one to three treatment lines. But it didn’t provide specific details, saving them for a spotlighted presentation at ASH on Tuesday.
      • “According to those results, the Tecvayli-Darzalex combination cut the relative risk of disease progression or death by 83% when compared to Darzalex and other therapies. Progression was also uncommon for treatment recipients who went six months without relapsing. According to J&J, 90% of those enrollees were still progression-free three years after the study’s start, leading researchers to suggest the combination could have curative potential.
      • “The efficacy is truly remarkable with this combination,” said Surbhi Sidana, an associate medical professor at Stanford University and a trial investigator. “We can see a light at the end of our tunnel with all of these therapies for our patients, having maybe a functional cure in the future.”
  • BioPharma Dive adds,
    • “An experimental Novartis drug helped bring an autoimmune condition causing low platelet counts under control in a Phase 3 trial, further lifting the prospects of a therapy the company acquired in a multibillion-dollar deal last year.
    • “The drug, ianalumab, acts by destroying misfiring immune cells and blocking signaling that creates new ones. Novartis has been testing it in a disorder called immune thrombocytopenia, in which the body erroneously wipes out blood-clotting platelets. The company intends for the drug to work hand-in-hand with another therapy, Promacta, that it sells for the condition.”

From the U.S.healthcare business front,

  • Fierce Healthcare reports,
    • “Healthcare giant CVS Health boosted its outlook for the year as part of its investor day on Tuesday.
    • “The company said it now expects full-year revenues of at least $400 billion and earnings per share (EPS) between $6.60 and $6.70. Previous estimates projected at least $397.3 billion in revenue and EPS of $6.55 to $6.65.
    • “CVS also projects its compound annual growth rate to be in the mid-teens for the next three years, reflecting the efforts it’s made to improve performance at multiple units. For example, CVS said it’s on track to return to target margins at Aetna, and it’s driving sustained earnings at CVS Pharmacy.
    • “We are closing out 2025 with meaningful momentum across our businesses and we expect another year of strong earnings growth in 2026,” said Chief Financial Officer Brian Newman in a press release. “We are committed to doing what we say.”
  • Fierce Pharma tells us,
    • “Eli Lilly has unveiled the location of the third of its four large-scale manufacturing facilities that it plans to build in the U.S.
    • “The drugmaker has selected Huntsville, Alabama, as the site of a $6 billion plant that will produce active pharmaceutical ingredients (APIs) for peptide and small-molecule medicines, including the highly anticipated GLP-1 weight-loss pill, orforglipron.
    • “Lilly plans to employ 450 at the complex, including engineers, scientists, operations personnel and lab technicians. The Indianapolis-based company expects to begin construction in 2026 and complete the facility in 2032. Lilly estimated that the project will also generate 3,000 construction jobs.”
  • Beckers Hospital Review informs us,
    • “Pfizer has entered into a global collaboration and license agreement with YaoPharma for the development, manufacturing and commercialization of YP05002, a small-molecule GLP-1 receptor agonist currently in phase 1 development for chronic weight management.
    • “YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical Group, will complete the ongoing phase 1 clinical trial and grant Pfizer exclusive worldwide rights to further develop and commercialize the therapy, according to a Dec. 9 news release.
    • “Pfizer will pay $150 million upfront and may pay up to $1.935 billion in development, regulatory and commercial milestone payments, along with tiered royalties on sales if the therapy is approved.”
    • Fierce Health relates,
      • “Artificial intelligence was a key theme in a session on how digital tools are changing the payer industry at this year’s Fierce Health Payer Summit.
      • “The panel took place last Thursday at the annual event and was moderated by Staff Writer Emma Beavins. The panelists spoke about the importance of improving payer-provider relationships and the member experience through AI and data-sharing.
      • “Consumers are used to the convenience offered by platforms like Netflix and Amazon, yet healthcare is lagging. AI can help streamline the member experience, including by surfacing transparent pricing. Doing so carries a high return on investment, Brittany Poche, director of solutions at revenue cycle management company Norwood, said. “Having that whole transparency and that experience, that is going to really move us,” Poche said on the panel.”

    Tuesday Report

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

    From Washington, DC

    • The American Hospital Association News reports,
      • “President Trump Dec. 1 signed the AHA-supported SUPPORT Act (H.R. 2483) into law. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder. It also includes programs to support the behavioral health workforce.”
    • and
      • “The House Dec. 1 passed the Hospital Inpatient Services Modernization Act (H.R. 4313), legislation extending certain Medicare waivers authorizing the hospital-at-home care program for five years. The AHA expressed support for the bill in September.” 
    • The House Oversight and Government Reform Commitee posted a wrap-up concerning the mark-up session held today and mentioned in yesterday’s FEHBlog.
    • Fierce Healthcare tells us,
      • “Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., is doubling down on his scrutiny of the American Medical Association’s (AMA’s) handling of billing and claims processing codes, telling the professional organization this week that it dodged several of the questions he posed on pricing and other topics back in October.
      • “The senator, a Republican from Louisiana and Congress’ most prominent healthcare legislator, has been putting the screws on the professional association for, in his words, “abusing” its widely adopted Current Procedural Terminology (CPT) coding system with “exorbitant fees” that drive higher healthcare costs.” 
    • The American Hospital Association News informs us,
      • “The Centers for Medicare & Medicaid Services Dec. 2 repealed the minimum staffing requirements for nursing homes that participate in Medicare and Medicaid that the agency adopted in 2024. Specifically, CMS is removing the requirements for nursing homes to provide a minimum of 3.48 hours of nursing care per resident day, including 0.55 hours of care from a registered nurse per resident day and at least 2.45 hours of care from a nurse aide per resident day. The agency is also removing the requirement for nursing homes to have 24/7 onsite RN services and is reinstating its prior policy requiring facilities to use the services of an RN for at least eight consecutive hours a day, seven days a week and to designate an RN to serve as the director of nursing on a full-time basis except when waived. The facility assessment requirements adopted in the 2024 final rule will remain in place. CMS’ actions are consistent with the budget reconciliation bill enacted in July, which imposed a 10-year implementation and enforcement moratorium on the minimum staffing requirements for long-term care facilities.”
    • Fierce Healthcare points out,
      • “As vaccine policy uncertainty reaches a new level in the U.S., the Centers for Disease Control and Prevention’s (CDC’s) team of vaccine advisors is set to deliberate later this week on childhood immunizations under a new chairman. 
      • “The Advisory Committee on Immunization Practices (ACIP), which was overhauled and repopulated by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. over the summer, is set to meet Dec. 4 and Dec. 5. 
      • “On the agenda (PDF) is a vote on hepatitis B vaccines plus discussions on “vaccine safety” and “the childhood and adolescent immunization schedule,” according to a Federal Register notice.” * * *
      • “Stepping up the plate as chairman of the ACIP is Kirk Milhoan, M.D., Ph.D., a pediatric cardiologist and former U.S. Air Force flight surgeon. Milhoan, one of five new ACIP panelists added to the roster in September, is a senior fellow with the Independent Medical Alliance (IMA) who specializes in treating patients with long COVID and “vaccine-related cardiovascular toxicity,” according to his IMA bio.”

    From the Food and Drug Administration front,

    • Fierce BioTech reports,
      • “Mere weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., is taking steps to retire as head of the FDA’s Center for Drug Evaluation and Research, an FDA spokesperson confirmed to Fierce Biotech.
      • “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the spokesperson said. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.”
      • “Pazdur has filed papers to retire at the end of this month and informed FDA colleagues of his decision at a Tuesday meeting, according to a report from Stat News.”
    • Per an FDA news release,
      • “The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri.
      • “The seizure focused on foods and dietary supplement products—including liquid shots and tablets—containing concentrated 7-OH as an added ingredient. Concentrated 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. It cannot be lawfully added to dietary supplements or conventional foods. These products are considered adulterated because 7-OH does not meet applicable safety standards. Also, the FDA has not approved 7-OH for medical use.
      • “This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We must be proactive and vigilant to address emerging threats to our communities and our kids.”
    • Per MedTech Dive,
      • “BD has written to users of its Alaris pump modules about a risk associated with two complaints of serious injury.
      • “The Food and Drug Administration, which shared details of the letter Friday, has categorized the correction as a Class I recall because of the potential for serious injury or death.
      • “BD paid a $175 million civil penalty last year to settle charges that it misled investors about problems with its Alaris infusion devices and in September recalled pumps with variable performance.” 
    • and
      • “Cleveland Diagnostics said Monday it received Food and Drug Administration approval for a test that analyzes the structure of protein biomarkers in the blood for prostate cancer signals, to aid in determining whether a biopsy is needed.
      • “The IsoPSA technology is for men aged 50 and older whose results from a traditional prostate-specific antigen blood screening showed elevated PSA levels.
      • “Elevated PSA levels can be a sign of prostate cancer, but may be caused by other conditions. The IsoPSA test can help clarify whether a patient with an elevated PSA should have a biopsy procedure or can extend the interval between biopsies, Cleveland Diagnostics Chief Commercial Officer Bob Rochelle said in an interview.”

    From the judicial front,

    • Thompson Reuters notes,
      • “The Ninth Circuit has vacated a trial court’s ruling that an insurer acting as a third-party claims administrator (TPA) for self-insured health plans violated Affordable Care Act (ACA) Section 1557 when it administered discriminatory plan exclusions of coverage for gender-affirming care.” * * *
      • “On appeal, the Ninth Circuit ruled that the trial court correctly concluded that the TPA’s provision of health insurance is a health program or activity, part of which is receiving federal financial assistance, and that TPAs can be liable for violating Section 1557 even when implementing plan terms drafted by a plan sponsor. However, the Ninth Circuit ordered the trial court to reconsider its ruling that the gender-affirming care exclusions were discriminatory in light of the U.S. Supreme Court’s Skrmetti decision. (Skrmetti upheld a state’s ban on gender- affirming care for transgender teenagers, reasoning that the ban did not draw classifications based on sex— rather, it prohibited such treatments for certain medical uses with respect to all minors, regardless of sex or gender.) Although the trial court’s reasoning was undercut by Skrmetti, the Ninth Circuit noted that there may be factual distinctions in this case that distinguish it from Skrmetti, such as whether an individual was denied care for a diagnosis other than gender dysphoria or whether discrimination based on a gender dysphoria diagnosis is a pretext for “invidious discrimination” based on transgender status.”
    • The New York Times updates us about New York State’s prosecution of Luigi Mangione who is accused of murdering a United Healthcare executive last December.
      • “Prosecutors have said that Mr. Mangione had personal writings with him at the time in which he denounced America’s for-profit health care system and the “parasites” of the insurance industry. The police also found a journal by Mr. Mangione in his possession that described plans for an assassination, prosecutors said.
      • “Mr. Mangione’s lawyers have argued that the police violated his constitutional rights and so physical evidence taken from his backpack and statements he made at the time should be excluded.
      • “The hearings, which began Monday and are expected to last several days, are the first time Mr. Mangione has appeared in Manhattan state court since the judge overseeing the case, Gregory Carro, threw out terrorism charges against him in September. He still faces second-degree murder and other charges, and if convicted, he could receive a sentence of 25 years to life. Mr. Mangione also faces a federal prosecution.”

    From the public health and medical / Rx research front,

    • Cardiovascular Business reports,
      • “Abdominal obesity—the phenomenon commonly known as “beer belly”—is associated with significant cardiovascular risks, according to new data being presented at RSNA 2025 in Chicago.
      • “Abdominal obesity, a high waist-to-hip ratio (WHR), is associated with more concerning cardiac remodeling patterns than high body mass index (BMI) alone,” lead author Jennifer Erley, MD, a radiology resident at University Medical Center Hamburg-Eppendorf in Germany, said in an RSNA statement. “It appears to lead to a potentially pathological form of cardiac remodeling, concentric hypertrophy, where the heart muscle thickens but the overall size of the heart doesn’t increase, leading to smaller cardiac volumes. In fact, the inner chambers become smaller, so the heart holds and pumps less blood. This pattern impairs the heart’s ability to relax properly, which eventually can lead to heart failure.”
    • Health Day relates,
      • “People with severe asthma often take daily steroid medications to help prevent attacks, yet the drugs can bring about serious side effects. Is there another way?
      • “In a new trial, researchers examined how much an add-on treatment, already approved in the United States and United Kingdom, for severe asthma helped people with their symptoms and need for steroid pills.
      • “They found that an injected antibody called tezepelumab allowed 90% of people with severe asthma to reduce their use of daily steroids — and half of patients who received the injection were able to stop taking steroid pills altogether.
      • “Two-thirds of participants in the year-long trial also saw their asthma attacks disappear.
      • “This is an incredibly encouraging development for the future of asthma care that could transform the lives of people with severe asthma,” said Samantha Walker, who directs research at Asthma + Lung UK, a nonprofit advocacy group for people with asthma.”
    • and
      • “Tea, coffee, berries, cocoa, nuts, whole grains, olive oil: They’re all rich in antioxidant compounds called polyphenols, and they’re all good for your heart, a new British study shows.
      • “This research provides strong evidence that regularly including polyphenol-rich foods in your diet is a simple and effective way to support heart health,” said study lead author Yong Li, a PhD candidate in nutrition at Kings College London.
      • “As her team explained, polyphenols are natural compounds that have long been known to be beneficial for heart, brain and gut health.”
    • Per MedPage Today,
      • “A phase III trial of investigational valiltramiprosate (ALZ-801) did not meet its primary endpoint in people with early symptomatic Alzheimer’s disease, but the drug did show benefits in a prespecified population with mild cognitive impairment who carried two copies of APOE4.“
    • and
      • “An mRNA influenza vaccine was approximately 35% more effective than an inactivated quadrivalent flu vaccine against two different strains, based on new data from a phase 3 randomized trial.” * * *
      • “The new data provide compelling evidence that the mRNA platform may protect against influenza, which could be meaningful for future use for both seasonal and pandemic influenza, if warranted, [Kelly] Lindert [M.D., a Pfizer employee] said.
      • “The investigators have identified areas to refine the mRNA influenza vaccine, and they are working to evaluate these candidates in ongoing studies, Lindert told Medscape Medical News. “Our long-term goal is to develop an influenza vaccine that is broadly protective against influenza A and B strains, including protection against severe influenza in children through elderly adults,” she said.”

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

    • McKinsey and Co. explains why “US healthcare organizations should rethink care and business models in response to substantial economic pressures and evolving care demands.”
      • “To address these cost and acuity challenges, healthcare stakeholders should continue to pursue innovative, outcome-focused care models that balance cost and care quality. Four archetypes of outcome-focused care models are in practice today. While these models have demonstrated promise, none have fully realized their potential. In this article, we delve into the value-creating opportunities within the four models:
        • “episodic models focused on shifting sites of care
        • “payer-led models focused on utilization, benefit, and care management
        • “primary care provider (PCP)–led models focused on risk-bearing, value-based care (VBC)
        • “specialty-led models focused on complex disease conditions.”
    • Adam Fein, writing in his Drug Channels blog, opines,
      • “Contrary to popular belief, the Inflation Reduction Act’s (IRA) maximum fair prices (MFPs) could temporarily boost profits for retail pharmacies serving Medicare Part D patients. 
      • “The bad news? The IRA is also one of the five key forces deflating the gross-to-net bubble. 
      • “That’s why any IRA-related pharmacy profits will vanish if manufacturers lower list prices to be closer to net prices. At least 13 brand-name drugs—five of which have MFPs—reportedly plan to reduce list prices within the next two months.
      • “[R]etail pharmacies risk becoming collateral damage from significant deflation in the gross-to-net bubble for drugs subject to an MFP. Welcome to our bonkers healthcare system—where everyone wants lower prices, until they actually get them. 
      • “What’s more, list price cuts will reduce profits from 340B contract pharmacy operations, while weakening covered entities’ main objections to a 340B rebate model. Get ready for a 340B slowdown.”
    • MedCity News considers that “The healthcare industry is contending with a difficult question: how to properly wield AI without taking on too much risk? Inherent in this battle is the role of humans. Here’s how Merck’s chief data officer is viewing AI.” It’s an interesting interview.
    • Healthcare Dive reports,
      • “The share of family physicians working in rural areas decreased 11% from 2017 to 2023, according to a study published this month in the Annals of Family Medicine.
      • “The Northeast saw the greatest loss in rural family physicians over the study period at 15.3%, while the West lost just 3.2% of rural family doctors.
      • ‘The data adds to concerns about physician shortages nationwide. America is expected to need more doctors than ever by 2030 to care for aging Baby Boomers, yet physicians say they’re struggling to hire and retain qualified talent amid high levels of burnout.” 
    • Per Beckers Hospital Review,
      • “Franklin, Tenn.-based Community Health Systems has completed the sale of select ambulatory outreach laboratory assets to Labcorp for $194 million in cash.
      • “The deal includes certain assets of CHS-affiliated hospitals’ lab services in 13 states, such as patient service centers and in-office phlebotomy locations. CHS will retain and continue operating its inpatient and emergency department laboratories, including lab services for hospital-based care like imaging and pre-admission testing.
      • “Completing this transaction with Labcorp allows our health systems to focus on core services and improve the overall patient experience, aligning with our unwavering commitment to providing high-quality, accessible healthcare to our communities,” CHS President and Interim CEO Kevin Hammons said in a Dec. 2 news release. “Labcorp’s scale and investment in technology supports its ability to efficiently deliver outreach laboratory services to patients and healthcare consumers.”

    Monday report

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

    From Washington, DC

    • Per a November 28, 2025, Congressional news release,
      • “Today, House Committee on Oversight and Government Reform Chairman James Comer (R-Ky.) announced a markup will take place on Tuesday, December 2 at 10:00am ET to consider a series of legislation to reform procedures in the federal workforce, to promote greater transparency, and bring accountability to federal agencies and the District of Columbia.
      • “The American people deserve a productive federal government that provides transparency and accountability across all agencies, processes, and procedures. The House Oversight Committee is dedicated to ensuring that Americans’ voices are not diluted and that they can be employed in the federal workforce without undue burdens and other hinderances. Working in tandem with President Trump’s mission to reform the federal government, the Committee will do its part to examine the efficiency of agencies’ operations and remove any barriers that prevent Americans from fully participating in them,” said Chairman Comer.” * * *
      • “The markup will be open and available to the public and press and will be livestreamed online at https://oversight.house.gov/.”
    • Beckers Health IT tells us,
      • “A bipartisan group of federal lawmakers has introduced a bill they say would extend the availability of healthcare AI to rural Americans and seniors.
      • “The Health Tech Investment Act would assign all FDA-approved AI-enabled devices a temporary payment classification for a minimum of five years, pending the sufficient collection of cost data and the issuance of a permanent CMS payment code.”
    • Bloomberg News informs us,
      • “The US Office of Personnel Management is ending a program that gives federal workers discounted college tuition. 
      • “OPM Director Scott Kupor said in a memo Monday that the office would cancel the Federal Academic Alliance at the end of the current academic term. The voluntary partnership between universities and the federal government offered special rates for government employees and their families.
      • “Kupor wrote that the program is outdated and rarely used, with less than 0.2% of the federal workforce participating. More agencies are offering their own training programs, he said.”
    • Politico adds,
      • “The Trump administration wants federal agencies to shuffle top civil servants to more effectively implement the president’s agenda.
      • “The head of the Office of Personnel Management on Monday issued guidance encouraging agency leaders to review their rosters of top civil servants known as the Senior Executive Service and to consider reassigning them to new posts.
      • “The guidance marks the Trump administration’s latest move to overhaul the federal workforce and its senior management. The administration says the move will help dislodge “entrenched” civil servants, but critics accuse the administration of exerting undue political influence over federal workers.”
    • The Congressional Research Service released a report offering its analysis of No Surprises Act Independent Dispute Resolution data for 2024.
      • “The year 2024 marks the first year in which the IDR process was operational throughout the year without suspension, since it first began accepting dispute submissions in April 2022. This report, building on a prior CRS report analyzing 2023 data on IDR operations, reviews and analyzes data made publicly available by the Departments of Health and Human Services, Labor, and the Treasury—pursuant to NSA requirements—regarding IDR operations in calendar year 2024. In general, the data show an IDR process that was still maturing in 2024, as the year saw significant increases in the use of the IDR process (relative to 2022 and 2023) by providers; a large increase in the number of determinations made relative to 2023 and improvements in the amount of OON emergency/nonemergency service dispute determinations made within the generally required 33 business days (though a majority of determinations were still made outside of that window); and continued notable increases in payment determination amounts in certain medical specialties.”
    • Per the American Hospital Association News,
      • “The Centers for Medicare & Medicaid Services Innovation Center will launch a new, outcome-aligned payment model for providers offering technology-supported care to individuals with Original Medicare for managing common chronic conditions. The Advancing Chronic Care with Effective, Scalable Solutions Model will focus on conditions such as high blood pressure, diabetes, musculoskeletal pain and depression. CMS said it will pay participants in fixed installments for managing patients’ qualifying conditions, with full payment tied to achieving measurable health outcomes. CMS will begin accepting applications for the 10-year voluntary model Jan. 12, 2026, with an initial deadline of April 1, 2026. The model will begin July 1, 2026.”
    • and
      • “The Centers for Medicare & Medicaid Services announced Dec. 1 that it intends to expand the Inpatient Rehabilitation Facility Review Choice Demonstration to include IRFs in Texas and California. The demonstration, which is currently active for IRFs in Alabama and Pennsylvania, subjects all Original Medicare IRF claims to either pre-claim or post-payment review. IRFs in Texas will need to select either pre-claim or post-payment review by Feb. 13, 2026, and the demonstration will begin March 2, 2026. IRFs in California will need to select pre-claim or post-payment review by April 14, 2026, and the demonstration will begin on May 1, 2026. The AHA has opposed this demonstration, indicating its unnecessarily burdensome nature, and will continue to encourage the agency to pause its expansion.” 
    • Per an HHS news release,
      • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Martin Kulldorff, Ph.D., as chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE).  Kulldorff recently chaired the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) and previously taught at Harvard Medical School. He is a biostatistician and epidemiologist with more than 200 peer-reviewed publications.
      • “ASPE serves as HHS’ in-house think tank, providing policy advice to the Secretary. It also leads special initiatives, coordinates departmentwide research and evaluation activities, manages major planning processes, and produces analyses and cost estimates for policy options across public health, health care, and human services.”
    • The Wall Street Journal reports,
      • “The U.K. will increase the net price paid for new patented medicines by 25% to avoid U.S. tariffs on pharmaceutical exports.
      • “The U.K. government will reduce the clawback tax on high-value drugs to 15% next year, down from as much as a quarter or more.
      • “The U.S. guaranteed zero tariffs for U.K. pharmaceutical exports for at least three years as part of the agreement.”
    • Bloomberg Law adds,
      • “A deal between President Donald Trump and Novo Nordisk A/S to slash Ozempic and Wegovy prices under a most-favored-nation plan will override the costs for the blockbuster drugs negotiated separately by the Medicare agency.
      • “Due to the terms and timelines of the negotiated deals, the MFN prices for covered GLP-1 drugs are expected to supersede the IRA prices,” a spokesperson for the Centers for Medicare & Medicaid Services said in an email Friday.” * * *
      • “The prices under the most-favored-nation plan are scheduled to launch in 2026, while the negotiated drug prices for the second were slated to run in 2027.”
    • Fierce Pharma further adds,
      • “On the heels of striking a deal with the Trump administration to reduce the prices of several of its most popular drugs for U.S. patients, Eli Lilly has unveiled additional savings for cash-paying users of its obesity and sleep apnea med Zepbound.
      • “In the early November announcement of its agreement with the government, Lilly pledged to reduce the self-pay price of Zepbound in multidose pen form—which has yet to be approved by the FDA. Once the approval is secured, the multidose pens will be available via the LillyDirect online pharmacy platform for $299 to $449.
      • “Monday’s announcement adds discounts to single-dose vials of Zepbound, which are already approved and available in the U.S. Self-paying patients prescribed the GLP-1 will now be able to access the vials at $50 to $150 off their previous prices on LillyDirect.”
    • Per Politico,
      • “Three blockbuster drugs will exit Medicare’s price negotiation program in 2027 after regulators determined they now face generic or biosimilar competition, according to a Centers for Medicare and Medicaid Services memo obtained by POLITICO.
      • “The removal means that Novartis’ chronic heart failure treatment Entresto, Janssen’s anti-inflammatory medicine Stelara, and Bayer and Janssen’s blood clotting drug Xarelto will no longer be subject to the negotiated price reached during the first cycle of Medicare drug price talks.”

    From the Food and Drug Administration front,

    • Per an FDA news release,
      • “The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees. Agentic AI capabilities will enable the creation of more complex AI workflows — harnessing various AI models — to assist with multi-step tasks.
      • “Agentic AI refers to advanced artificial intelligence systems designed to achieve specific goals by planning, reasoning, and executing multi-step actions. These systems incorporate built-in guidelines — including human oversight —to ensure reliable outcomes. The tool is entirely optional for FDA staff and is used voluntarily.  
      • “We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” said FDA Commissioner Marty Makary, M.D., M.P.H. “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”
    • Beckers Hospital Review relates,
      • “Merck’s investigational antibody MK-2214 has received fast-track designation from the FDA for the treatment of Alzheimer’s disease.
      • “MK-2214 targets phosphorylated serine 413 tau (pS413), a marker of abnormal protein accumulation in the brain, according to a Dec. 1 news release from the company. The designation was announced alongside the first-in-human phase 1 trial data to be presented at the Dec. 1-4 Clinical Trials on Alzheimer’s Disease 2025 event in San Diego. The data supported dose selection for an ongoing phase 2 trial.”
    • The American Hospital Association News reports,
      • “The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through internal testing. The devices are being permanently recalled and the FDA advised customers to stop using the product. The FDA said unauthorized individuals could potentially change device therapy settings or access device data if it is left unattended, which could lead to the life-supporting air delivery function not working as intended.   
      • “In addition, the FDA identified Class I recalls of Becton Dickinson Alaris Pump Modules and Balt USA Mega Ballast Distal Access Platforms.”  

    From the judicial front,

    • The American Hospital Association New points out,
      • “The AHA, the Maine Hospital Association and four safety-net health systems from across the country Dec. 1 filed a lawsuit in the U.S. District Court for the District of Maine to challenge the 340B Rebate Model Pilot Program. The AHA and its co-plaintiffs are seeking a temporary restraining order to stop the rebate program from going into effect Jan. 1, 2026.
      • “If implemented, the program would impose overwhelming financial and administrative burdens on 340B hospitals, many of which already operate on razor thin margins while playing a vital role in their communities, often serving as the only source of care. The lawsuit alleges that the Department of Health and Human Services’ decision to move forward with the rebate program through a rushed, opaque process violates the most basic principles of administrative law, including by ignoring the concerns of over 1,000 340B hospitals and other stakeholders, many of which highlighted the significant costs and community impact of administering the rebate model.”

    From the public health and medical / Rx research front,

    • Genetic Engineering and Biotechnology News reminds us,
      • “World AIDS Day, first observed on December 1, 1988, is an international day to raise awareness of the global HIV/AIDS pandemic. Since its inception, the website notes, communities have stood together to show strength and solidarity against HIV stigma and to remember lives lost. 
      • “As of 2024, over 40 million people in the world are diagnosed with human immunodeficiency virus (HIV)—a chronic, life-threatening infection that remains one of the leading global causes of death. Today, we take a moment to reflect on the progress made in the global fight against HIV, while recognizing the challenges that remain.”
    • The Washington Post reports,
      • “A small, highly anticipated study shows a glimmer of hope in the long effort to control HIV without medication and search for a cure for a virus that attacks immune cells.
      • “Researchers gave 10 people with HIV a complex regimen of experimental immunotherapies, then discontinued the daily pills that kept the virus at bay. In six participants, the virus rebounded slowly and stayed at a low level for months, and one person’s immune system kept the virus in check for more than a year and a half — giving scientists hope that they could optimize the approach to create a cure.
      • “It’s provocative, but I’ve been doing treatment interruption studies for 30 years, and this is unexpected and unparalleled,” said Steven Deeks, a professor of medicine at the University of California at San Francisco and one of the leaders of the study. He and other scientists were quick to caution that this is a promising step forward, not a solution. The small study did not include a control group, so more studies will be needed to confirm and flesh out the exciting signal.”
    • Healio tells us,
      • “From 2008 to 2023, there has been a significant decrease in cystic fibrosis mortality rates and a significant rise in sickle cell disease mortality rates in the U.S., according to findings published in JAMA Pediatrics.
      • “For frontline clinicians, these results are a call to action,” Nansi S. Boghossian, PhD, associate professor in the Arnold School of Public Health at the University of South Carolina, told Healio. “They highlight the barriers many patients with sickle cell disease face including limited access to proven therapies, under-resourced systems and the high costs of newer treatments.”
    • NBC News explains why “Doctors seek to understand why quitting antidepressants causes withdrawal for some. A “deprescribing” movement is building up in the psychiatry field, aimed at helping patients reduce or stop their medications when no longer considered necessary.”
    • MedPage Today informs us,
      • “Changes in driving frequency, complexity, and spatial range were associated with mild cognitive impairment in older adults.
      • “Trip distances, speeding, and destination variability distinguished mild impairment from normal cognition with strong predictive accuracy.
      • “Continuous, real-world driving data may signal impairment before safety events occur, researchers suggested.”
    • The American Medical Association lets us know what doctors wish their patients knew about end of life care planning.
    • Per Health Day,
      • “About half of people who die by suicide show no prior warning signs.
      • “Many do not have mental health diagnoses or genetic psychiatric risks.
      • “Researchers hope to improve how doctors screen for suicide risk.”
    • Per BioPharma Dive,
      • “An experimental drug from Belite Bio succeeded in a Phase 3 trial in the most common form of Stargardt disease, positioning the company to seek regulatory approval next year of what could be the first marketed medicine for the condition.
      • “According to Belite, treatment with its drug, known as tinlarebant, was associated with a roughly 36% reduction in the growth rate of retinal lesions compared to a placebo over the course of two years, meeting the trial’s main goal. Both study groups had a minimal overall change in visual acuity, but Belite said that finding was “consistent” with historical data.
      • “Belite said tinlarebant was “well tolerated,” with only four patients stopping treatment due to adverse events. The most common eye side effects related to treatment were a type of color vision deficiency and issues seeing at night or adjusting to a dark environment. The majority of those cases were mild, and most resolved during the trial, the company said.”

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

    • Fierce Healthcare identifies its ten Women of Influence for 2025. Congrats to these ladies.
    • Fierce Healthcare adds,
      • “As healthcare providers increasingly adopt artificial intelligence tools, researchers, physicians and health tech companies are moving quickly to assess the verifiable impact of these technologies.
      • “Early studies looking at the use of AI tools, such as ambient scribes, among physicians are showing promising results. The use of AI scribes leads to lower burnout and lighter cognitive load for users, plus measurable cuts in documentation time, according to recent studies.
      • “Primary care doctors are also reporting that AI features embedded in the electronic health record (EHR) are helping them provide higher-quality care, according to a new survey from Elation Health.”
    • STAT News adds,
      • “The biggest radiology practice in the United States is leaning even further into artificial intelligence. The tech arm of Nashville-based Radiology Partners, which includes more than 4,000 radiologists reading more than 55 million images every year, last month acquired a new AI company for $80 million: Cognita Imaging, a Stanford researcher-founded startup that’s hoping to win the race to capitalize on foundation models in radiology.
      • “By training vision-language models on large numbers of radiological images and their written radiology reports, the hope is that AI will be able to read an X-ray or CT scan like a radiologist would: Not just by looking for a single, predetermined abnormality, but for any finding that looks important. Many existing and new radiology companies have launched themselves at that goal, despite concerns about whether such broadly-targeted technology can be validated and used safely.”
    • Beckers Health IT notes that
      • “Hospital-at-home treatment could be one way to “solve the rural healthcare crisis,” researchers from Somerville, Mass.-based Mass General Brigham say.”
    • and
      • “EHR vendors have expanded their patient-record sharing capabilities in recent years, but clinicians still report little improvement in how usable that data is, a Dec. 1 report from KLAS Research found.
      • “The report examines provider-to-provider record exchange, third-party application integration and payer-provider data sharing.”
    • Beckers Hospital Review tells us,
      • “Estes Park (Colo.) Health officially joined Aurora, Colo.-based UCHealth Dec. 1 as UCHealth Estes Valley Medical Center.
      • “This not only gives us financial stability and additional access to resources and subject matter experts, but also assistance in recruiting and retaining staff and providers, and importantly, continued access to healthcare for our patients,” Vern Carda, president of Estes Valley Medical Center, said in a news release.” 
    • BioPharma Dive informs us,
      • “Regeneron Pharmaceuticals is putting more money into gene editing, announcing Monday a partnership with Tessera Therapeutics to develop an experimental program for a rare liver and lung disease. 
      • “At the center of the deal is a treatment Tessera, a well-funded startup backed by Flagship Pioneering, is developing for alpha-1 antitrypsin deficiency. Regeneron is paying Tessera $150 million upfront, in the form of cash and an equity investment, to collaborate on the program and split future development costs and profits. Tessera could receive another $125 million in unspecified near and mid-term development milestone payments.   
      • “Tessera will lead the initial first-in-human trial, with Regeneron taking the reins for future development and eventually commercialization.” 

    Weekend update

    David Ermer–CMS, Congress, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

    From Washington, DC,

    • Roll Call offers a preview of these Capitol Hill activities.
    • The Centers for Medicare and Medicaid Services posted fact sheets on the following topics:

    From the public health and medical / Rx research front,

    • The New York Times reports,
      • “A recently recognized form of dementia is changing the understanding of cognitive decline, improving the ability to diagnose patients and underscoring the need for a wider array of treatments.
      • “Patients are increasingly being diagnosed with the condition, known as LATE, and guidelines advising doctors how to identify it were published this year. LATE is now estimated to affect about a third of people 85 and older and 10 percent of those 65 and older, according to those guidelines. Some patients who have been told they have Alzheimer’s may actually have LATE, dementia experts say.
      • “In about one out of every five people that come into our clinic, what previously was thought to maybe be Alzheimer’s disease actually appears to be LATE,” said Dr. Greg Jicha, a neurologist and an associate director of the University of Kentucky’s Sanders-Brown Center on Aging.
      • “It can look like Alzheimer’s clinically — they have a memory problem,” Dr. Jicha said. “It looks like a duck, walks like a duck, but then it doesn’t quack, it snorts instead.”
    • The Washington Post relates,
      • “Vaccines don’t just shield you from specific infectious diseases or help make symptoms less severe if you get sick but can also prevent common chronic illnesses, including some cancers, according to public health experts.
      • “We now have a more full understanding of how these vaccines go beyond just protecting us against the disease that they helped prevent,” said Richard Martinello, chief medical officer and infectious diseases physician at Yale School of Medicine.
      • “In addition to cancer, a growing body of research has shown that vaccines can reduce the risk of developing dementia and heart conditions. Vaccines can also help people with existing chronic conditions avoid getting sicker.”
      • The article identifies the common vaccines experts recommend
        • HPV
        • Shingles
        • Hepatitis B
        • Flu, coronavirus and RSV,
        • Bacterial vaccines
    • The Wall Street Journal reassures us,
      • “Why does a glass of wine make a holiday party feel more festive? It might be because our forebears used to party.
      • “Not the ancient Greeks, though they did name a god of wine. Go back even further than that—some 50 million years further, when our primate ancestors began seeking out fermented fruits that naturally contained ethanol, scientists say.
      • “Those that could sniff out ethanol (or alcohol)—which gives off an odor, as we all know from the smell of a beer hall—were rewarded with a tasty nutritional gold mine: plant carbs and calorie-rich ethanol.
      • “All primates can metabolize ethanol, mining it for energy. But research that examined enzymes from ancestral primates indicated that around 10 million years ago, a digestive enzyme mutation allowed African apes—including the common ancestor of humans, gorillas and chimpanzees—to metabolize that alcohol 40 times more efficiently than other primates.
      • “The change made it even more beneficial to be able to find and consume alcohol in the wild, according to Nathaniel Dominy, a professor of anthropology at Dartmouth College.
      • “Fast forward to the advent of agriculture roughly 10 millennia ago, and humans began making alcohol intentionally in large and potent quantities. Today, of course, we have wide access to it.
      • “It’s been argued that the whole reason we domesticated cereals in the first place was to make beer, not bread,” Dominy said. “Our brains are wired to like it.”
    • Medscape points out,
      • “Among patients with obesity and type 2 diabetes (T2D), those who underwent metabolic bariatric surgery experienced greater weight loss and reductions in A1c levels than patients who did not undergo surgery.” * * *
      • “These results support current clinical guidelines that recommend metabolic bariatric surgery for individuals with severe obesity or obesity-related complications who do not achieve adequate results through more conservative treatments,” the authors of the study wrote.”

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

    • Beckers Health IT reports,
      • “Amazon plans to invest up to $50 billion to ramp up AI and supercomputing capabilities for federal agencies, boosting healthcare research and pharmaceutical breakthroughs.
      • “The tech giant intends to break ground on the data centers in 2026, providing Amazon Web Services’ U.S. government customers with an additional 1.3 gigawatts of AI and supercomputing capacity.
      • “We’re giving agencies expanded access to advanced AI capabilities that will enable them to accelerate critical missions from cybersecurity to drug discovery,” Amazon Web Services CEO Matt Garman said in a Nov. 24 news release. “This investment removes the technology barriers that have held government back and further positions America to lead in the AI era.”
    • and
      • Best Buy took a $192 million accounting loss after ending its hospital-at-home partnerships with health systems.
      • The tech retailer recorded the pretax, noncash asset impairments related to Best Buy Health in the third quarter of fiscal 2026, according to a Nov. 25 earnings report.
      • “The impairments were prompted by a change in Best Buy Health’s customer base during the quarter and reflect downward revisions in our long-term projections, in part due to pressures in the Medicaid and Medicare Advantage markets,” Best Buy CEO Corie Barry said in a Nov. 25 earnings call.
    • Beckers Payer Issues identifies the “[t]en providers [which] recently posted job listings seeking leaders in payer contracting and relations.
    • HR Dive informs us,
      • “After a year of mass layoffs and uncertainty, 2026 could stabilize hiring trends and bring equilibrium to the U.S. labor market, according to a Nov. 18 report from HireQuest.
      • “In particular, the job market appears to be stabilizing around skills-based hiring, the report found. In addition, late 2025 layoffs could reset — but not reverse — the market, as well as spur employee reskilling and contract-based hiring.
      • “2026 won’t be defined by a hiring boom or a bust but by more balance,” Rick Hermanns, president and CEO of HireQuest, said in a statement. “We’re seeing a labor market that’s stabilizing around new priorities: flexibility, fit and the kind of skilled work that can’t be automated.”

    Monday report

    David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Mental health care, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

    From Washington, DC,

    • Beckers Hospital Review reports,
      • “President Donald Trump has postponed a planned announcement of a proposal to extend enhanced ACA subsidies, CNN reported Nov. 24.
      • “Trump was expected to unveil a proposal as early as Nov. 24 that would extend the subsidies for two years while introducing new eligibility restrictions, according to earlier reports from Politico and MS Now. 
      • “The proposal, dubbed the “Healthcare Price Cuts Act,” would also establish an income cap limiting subsidies to individuals earning up to 700% of the federal poverty line, three people familiar with the plan told Politico. All enrollees would be required to make minimum premium payments, two White House officials told MS Now. 
      • “The plan also includes a health savings account component. Enrollees who switch to lower-premium marketplace plans could direct the difference in premium costs into tax-advantaged savings accounts funded with their subsidy dollars, according to both reports.
      • “Additionally, the White House intends to ask Congress to appropriate funding for cost-sharing reductions, which lower out-of-pocket expenses for ACA enrollees, Politico reported.”
    • MedCity News considers whether President Trump can do for branded expensive drugs what he just did for GLP-1s?
      • “While many are applauding the Trump administration for taking this step to expand access to GLP-1s, some believe that specifically targeting weight loss drugs actually does very little to bring down overall prescription drug costs.
      • “I think that focusing on market solutions on GLP-1s alone misses the mark, because it’s a market problem,” said Chris Deacon, principal and founder of VerSan Consulting. “[Whether it’s] GLP-1s or other medications, we have a problem of a complete lack of transparency for the purchaser.”
      • “Another expert echoed these comments, stating that while this is a positive move, there needs to be a broader effort in order to effectively bring down drug costs entirely.
      • “This is a step in the right direction,” said Edgar Asebey, an FDA regulatory attorney at Frier Levitt. “A policy initiative that is more of a blanket policy with branded drugs would be much better for the American patients.”
    • Modern Healthcare tells us,
      • “Juan Carlos “JC” Scott, president and CEO of the Pharmaceutical Care Management Association since 2018, stepped down Friday. 
      • “PCMA Chief Government Affairs Officer Lucia Lebens is serving in the president and CEO roles on an interim basis, a spokesperson for the pharmacy benefit manager trade group said Monday. The spokesperson did not respond to questions about whether Lebens also still holds the chief government affairs officer position. 
      • “A search is underway for Scott’s permanent replacement. 
      • “Scott announced in October he would be leaving the organization by the end of the year.
      • “The trade group declined to respond to a request for comment on why Scott decided to depart from the organization. 
      • “An October news release, however, said 2025 was the last year of Scott’s contract.”
    • Per an HHS news release,
      • “The U.S. Department of Health and Human Services (HHS) today announced five new agency leaders who will serve our nation’s families and advance goals to Make America Healthy Again. Four of these five presidential appointees required and recently received Senate confirmation.”
        • Brian Christine, MD, Assistant Secretary for Health
        • Alex J. Adams, PharmD, MPH, Assistant Secretary for Family Support, Administration for Children and Families
        • Gustav Chiarello, Assistant Secretary Financial Resources
        • Michael Stuart, General Counsel
        • Alicia Jackson, Ph.D., Director, Advanced Research Projects Agency for Health (ARPA-H)
    • The American Hospital Association News adds,
      • “The Advanced Research Projects Agency for Health announced Nov. 21 that it will fund up to $100 million in projects for quantitative measures of mental and behavioral health through its new Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health initiative. The program will focus on data regarding individual clinical outcomes and patient response to novel treatments. ARPA-H said it is seeking multimodal, longitudinal data collected in clinical trials testing the effects of rapid behavioral health interventions. The agency said the awards will be actively managed contracts, where continuation would be contingent upon satisfactory performance reviews.”
    • The National Bureau of Economic Research points out,
      • “We use comprehensive tax data to study how saving behavior responds to the Health Savings Account (HSA) “catch-up” contribution provision, which raises HSA contribution limits for individuals aged 55 and older. Using a regression discontinuity design, we find a sharp increase in contributions among those previously near the limit and smaller increases among unconstrained savers. Induced contributions are not immediately withdrawn and do not appear to crowd out retirement savings. Responses are strongest among payroll contributors and long-term savers. However, married couples do not appear to coordinate their HSA behavior to take advantage of the complex spousal rules governing catch-up contributions. Our findings highlight how tax incentives shape HSA saving and suggest that tax-advantaged account design meaningfully affects household financial behavior.”
    • Bloomberg Law informs us,
      • “Employers hope a forthcoming [federal] rule to improve surprise medical bill arbitration will strengthen their hand against doctors and improve transparency into insurers’ processes.
      • “Doctors win a high percentage of disputes, and industry groups are lobbying lawmakers and regulators to make changes, with employers arguing that doctors are abusing the process by refusing to negotiate and submitting ineligible claims for arbitration.
      • “The forthcoming rule is expected to address many of employers’ complaints, but it could also face legal fights similar to those that overturned a series of previous rules and guidance.”
    • Federal News Network interviews OPM Director Scott Kupor about the next executive development programs that OPM announced last week.

    From the Food and Drug Administration front,

    • MedTech Dive reports,
      • “Abbott has issued a medical device correction for about 3 million Freestyle Libre 3 and 3 Plus sensors in the U.S. after determining that some sensors may provide incorrect low glucose readings, the company announced Monday.
      • “Abbott has received reports of 736 severe adverse events and seven deaths overall associated with the problem. In the U.S., 57 severe adverse events and no deaths were reported.
      • “The problem could lead to incorrect treatment decisions, such as people skipping or delaying insulin doses and excessive carbohydrate intake. Abbott said it has resolved the cause of the problem, which was related to one production line, and will replace any potentially affected sensors at no charge.”
    • Reuters notes,
      • “The U.S. Food and Drug Administration has approved Novartis’ (NOVN.S) new gene therapy for patients with a rare muscle disorder, the drugmaker said on Monday.
      • “The therapy, branded as Itvisma, was approved for the treatment of spinal muscular atrophy patients of age two years and older who have a confirmed mutation in the survival motor neuron 1 gene.
      • “Itvisma contains the same active ingredient as the Swiss drugmaker’s older therapy, Zolgensma, which is approved in the U.S. to treat SMA patients less than 2 years of age.”

    From the public health and medical / Rx research front,

    • The Washington Post reports,
      • “Unlike much of Europe and East Asia, America hasn’t reached the point at which we have more people dying than we do being born.
      • “At least not in the long run. We briefly blew past that point in a few winter months at the height of the covid-19 pandemic, according to our analysis of birth- and death-certificate data collected by the National Vital Statistics System.”
      • The article digs into the details.
    • The AP relates,
      • “The U.S. flu season is starting slowly, and it’s unclear if it will be as bad as last winter’s, but some health experts are worried as U.S. Centers for Disease Control and Prevention data posted Friday shows a new version of the virus has emerged.
      • “An early analysis suggests current vaccines may still be somewhat effective against the new version of the flu, which has been the main driver of recent infections, CDC data shows.
      • “Some scientists and medical professionals are more worried about disappointing vaccination rates, a main reason why flu hospitalizations and deaths were unusually bad during last year’s flu season — one of the deadliest this century.” * * *
      • “Some sources have suggested flu vaccinations are down. Over two million fewer flu shots were given at U.S. pharmacies through the end of October compared to last year, according to data from IQVIA, a health information and research company.
      • “But the latest CDC data indicates that for children, the vaccination rate this year is about the same as it was at this point last fall, at 34%. And the vaccination rate for adults is up a few percentage points to about 37%, according to the CDC data, which relies on survey information.
      • “It is early in the season and too early to know if the increase will be sustained or what is causing it, CDC officials said.”
    • Per Health Day,
      • “Many people don’t know they have a genetic risk factor for high cholesterol
      • “Nearly 90% of people carrying variants for familial hypercholesterolemia didn’t know it
      • “Researchers say 1 in 5 had already developed heart disease”
      • “Our findings expose a blind spot in current national guidelines, which rely on cholesterol levels and family history to determine who should receive genetic testing,” lead researcher Dr. Niloy Jewel Samadder, a cancer geneticist at the Mayo Clinic Comprehensive Cancer Center in Phoenix, said in a news release.”
    • Per MedPage Today,
      • “Girls ages 16 years or younger who received HPV vaccines were 80% less likely than their unvaccinated counterparts to develop cervical cancer.
      • “Evidence from 23 studies showed with moderate certainty that HPV vaccination lowered the incidence of high-grade cervical precancers.
      • “Vaccinated persons had 25 fewer cases of anogenital warts per 1,000 participants at 48 months, regardless of HPV type.”
    • Per the Washington Post,
      • “People who stopped taking weight-loss drugs before or during pregnancy were associated with greater gestational weight gain and had a higher risk of preterm delivery and gestational diabetes compared with those who had not been prescribed the drugs before, according to a study published Monday in JAMA.
      • “Researchers from Mass General Brigham in Boston reviewed medical records from nearly 150,000 pregnancies between June 2016 and March 2025. They found that people who had been prescribed GLP-1 drugs, a class of medications used to treat Type 2 diabetes and obesity, were more likely to gain more weight than recommended during pregnancy.
      • “Sixty-five percent of 448 pregnancies among people previously prescribed GLP-1 medications included excess gestational weight gain, compared with 49 percent of 1,344 pregnancies among those who did not receive the medication but had similar characteristics to those who received a GLP-1.
      • “If we can find those at risk of cardiovascular disease early, we can treat it early and change its course and likely save lives,” Samadder said.”
    • Per BioPharma Dive,
      • “The theory that GLP-1 medicines, which have profound benefits on metabolism and heart health, can also help combat Alzheimer’s disease suffered a major blow Monday with the failure of two large, closely watched clinical trials.
      • “The studies, titled Evoke and Evoke+, together enrolled more than 3,800 people with early-stage Alzheimer’s to evaluate whether Novo Nordisk’s semaglutide can help preserve brain function. According to Novo, its drug was not significantly better than a placebo on that measure after two years of follow-up. And though semaglutide treatment did improve some biological markers tied to Alzheimer’s, it didn’t delay the progression of the disease.”
    • STAT News adds,
      • “A promising Alzheimer’s disease treatment from Johnson & Johnson failed to slow the progress of the disease in a closely watched study, news that could dampen enthusiasm for a new class of potential medicines.
      • “J&J terminated its mid-stage study of the injectable medicine posdinemab, the company said Friday, after an early look at results determined the treatment would not prove more effective than placebo. J&J said it would present full data from the trial at a later date.
      • “Posdinemab’s failure could cast a shadow over a cadre of in-development Alzheimer’s treatments meant to improve on the standard of care. Biogen, UCB, and Voyager Therapeutics are developing similar treatments of their own.”
    • The New York Times discusses how certain hospitals lowered their C-section rates,
    • and tells us,
      • “Dialing down the use of social media for a week reduced symptoms of anxiety, depression and insomnia in young adults, according to a study published on Monday in the journal JAMA Network Open.
      • “Researchers followed 295 volunteers, ages 18 to 24, who opted to take a break from social media. Instructed to stay off social media as much as possible, the group on average reduced it to a half-hour per day from just under two hours. Before and after, the participants answered surveys measuring depression, anxiety, insomnia, loneliness and a number of problematic social media behaviors.
      • “Overall, they reported positive changes: On average, symptoms of anxiety dropped by 16.1 percent; symptoms of depression by 24.8 percent; and symptoms of insomnia by 14.5 percent. The improvement was most pronounced in subjects with more severe depression. At the same time, there was no change in reported loneliness — perhaps, the authors wrote, because the platforms play a constructive social role.”
    • The American Medical Association lets us know what doctors wish their patients knew about cutting down on screen time.
      • “Too much time with smartphones or TVs can do harm. Three physicians share tips on how to reduce screen time before it turns toxic.”
    • Per BioPharma Dive,
      • “Bayer’s experimental blood thinner asundexian met its main goal in a closely watched Phase 3 stroke prevention trial, reducing the recurrence of a stroke in people who took the therapy along with standard treatments. The trial compared treatment with a combination of asundexian and an antiplatelet therapy against a placebo and the same antiplatelet treatment. 
      • “The German-based company didn’t release detailed data, stating that researchers will disclose them at an upcoming medical meeting while company executives discuss them with regulators ahead of possible approval applications.
      • “Results of the trial lifted optimism for asundexian’s drug class, called Factor XIa inhibitors, following a series of clinical setbacks. Most recently, a rival drug missed its main goal in a trial of people who’d had a recent heart attack.”

    From the U.S. healthcare business front,

    • Fierce Healthcare reports,
      • “Optum Rx will reduce reauthorizations on 40 additional medications Jan. 1, surpassing initial goals set out earlier this year.
      • “The pharmacy benefit management arm of UnitedHealth Group first revealed earlier this year that it was aiming to reduce reauthorizations, a specific model for prior authorization, by up to 25%. The new additions bring the total number of drugs in the initiative up to 180, surpassing that 25% goal.
      • “The new group of 40 medications includes therapies for chronic conditions and two new classes of drugs: hormone therapy and injectables for knee osteoarthritis.
      • “In addition, Optum announced that it will expand the PreCheck Prior Authorization program, covering more than 45 medications beginning Jan. 1. The tool will reach 20 health systems, Optum said.”
    • and
      • “Three former Amazon employees launched a new online healthcare marketplace earlier this year aiming to make healthcare a better experience for patients. The vision, executives said, was to make healthcare as easy as shopping online.
      • “General Medicine, started by the founding team that built PillPack and Amazon Pharmacy, connects consumers to providers to either address specific medical needs or to chat about the symptoms they’re having. Consumers can use General Medicine for a wide variety of medical issues, and the platform provides both insurance and cash pricing. There’s no subscription or access fee. 
      • “General Medicine executives refer to it as a “one-stop-shop” for telemedicine, prescriptions, imaging, labs and specialists. PillPack co-founders TJ Parker and Elliot Cohen teamed up with Ashwin Muralidharan, who most recently served as technical advisor and chief of staff to Amazon’s top health executive Neil Lindsay, to launch General Medicine.”
    • Cardiovascular Business tells us,
      • “Medtronic had a strong second quarter, reporting a worldwide revenue of $8.96 billion, and earnings per share (EPS) of $1.36. Both figures exceeded the company’s expectations. 
      • “Medtronic’s cardiovascular portfolio helped lead the way with a worldwide revenue of $3.44 billion, an increase of 9.3%. 
      • “This was our strongest growth in over a decade, excluding the easy comparisons we had after the pandemic,” Thierry Piéton, Medtronic’s chief financial officer, explained during an earnings call.
      • “Ablation devices—particularly those built for pulsed field ablation (PFA)—played a critical role in Medtronic’s triumphant quarter. In fact, worldwide revenue was up 71% for cardiac ablation solutions, including a 128% increase in the United States.”  
    • MedTech Dive informs us,
      • “Insulet laid out plans for new diabetes devices at an investor event last week, including a fully automated insulin delivery system for people with Type 2 diabetes. 
      • “The company is working on updates to its current Omnipod 5 device, plans to debut its Omnipod 6 device in 2027 and expects to launch a separate, fully-closed loop system for people with Type 2 diabetes in 2028, CEO Ashley McEvoy said.  
      • “Insulet, which leads the market for insulin patch-pumps, is also working on bringing its devices to more people with Type 2 diabetes, after receiving an expanded label from the Food and Drug Administration last year.”

    Thursday report

    David Ermer–CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

    From Washington, DC,

    • Roll Call reports,
      • “The top four House and Senate appropriators met Thursday for the first time since the partial government shutdown but emerged with no breakthroughs that could pave the way for a new spending package.
      • “The meeting marked a small, positive step toward bipartisan negotiations that would be needed for an eventual deal. But so far, the two chambers and the two parties remain on different paths when it comes to fiscal 2026 spending bills.
      • “Senate Appropriations Chair Susan Collins, R-Maine, favors moving a massive package of up to five bills, featuring the two largest — Defense and Labor-HHS-Education. But there is no sign of any bipartisan agreement on overall spending limits, a major impediment to moving a package that would well exceed $1 trillion and make up the bulk of the year’s discretionary spending.
      • “By contrast, House Appropriations Chairman Tom Cole, R-Okla., wants to move a smaller batch of bills that could conceivably be enacted before Christmas.
      • “House Appropriations ranking member Rosa DeLauro, D-Conn., said no decisions about the contents of the next package were made during the meeting, though it was discussed. Senate Appropriations ranking member Patty Murray, D-Wash., also attended.”
    • Healthcare Dive tells us,
      • “Republicans and Democrats in Congress remain largely stuck in partisan gridlock over how to lower healthcare costs. But one area of potential compromise emerged during a contentious Senate Finance Committee hearing on Wednesday — resuscitating pharmacy benefit manager reform.
      • “Senate Finance Chair Mike Crapo, R-Idaho, and Ranking Member Ron Wyden, D-Ore., plan to reintroduce a bipartisan package cracking down on PBMs, middlemen in the drug supply chain, Crapo said during the hearing. 
      • “The legislation almost made it out of Congress late last year as part of a larger appropriations bill but eventually failed after public opposition from billionaire Elon Musk, a key ally of President Donald Trump at the time. Crapo said the PBM legislation would be reintroduced “shortly” and hopefully moved to the president’s desk soon after.”
    • The FEHBlog strongly doubts that “cracking down” on PBMs will lead to lower healthcare costs.
    • Genetic Engineering and Biotechnology News informs us,
      • “A bipartisan group of senators and representatives introduced legislation to establish a National Biopharmaceutical Manufacturing Center of Excellence (COE), inspired by recommendations from the National Security Commission on Emerging Biotechnology (NSCEB) April 2025 Action Plan for Congress.
      • “In the Senate, the legislation was introduced by Sen. Coons (D-DE) and Sen. Budd (R-NC), and in the House, the bill was introduced by Rep. Houlahan (D-PA, 06), Rep. Baird (R-IN, 04), Rep. Rouzer (R-NC, 07), and Rep. Ross (D-NC, 02).
      • “The bill would create a public-private partnership focused on advancing innovation in biopharmaceutical manufacturing methods, especially for products important to U.S. national security, health security, and economic security. It would also improve regulatory understanding of innovative manufacturing methods and provide workforce training opportunities in this fast-growing field.”
    • Bloomberg lets us know,
      • The Health and Human Services Department is proposing new initiatives for the Centers for Disease Control and Prevention, including a program to increase hepatitis B screening for pregnant women, as part of a broader push to restructure the agency, according to an internal document viewed by Bloomberg News.
      • Leading five of the 16 initiatives is Sam Beyda — a carryover from the Department of Government Efficiency — who was recently named deputy chief of staff at the CDC, according to people familiar with the matter who were not authorized to speak on the subject. 
      • The new programs are not yet formalized, with details to be settled before they are rolled out to the CDC in January, the document said. The list was developed over the last several months in collaboration with HHS senior advisers and CDC leadership. It includes strategic reviews on existing initiatives.
    • Per a CMS news release,
      • “On November 20, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after Jan. 1, 2026. This final rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2026 and updates requirements for the ESRD Quality Incentive Program (QIP).
      • “For CY 2026, CMS will increase the ESRD PPS base rate to $281.71, which CMS expects to increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%. The CY 2026 ESRD PPS final rule also includes a new payment adjustment for certain non-labor costs for ESRD facilities located in Alaska, Hawaii, and the United States (U.S.) Pacific Territories.
      • “CMS is shortening the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey to 39 questions, removing 23 questions. CMS is also eliminating three health equity reporting measures from the ESRD QIP. CMS also is finalizing the early termination of the ESRD Treatment Choices Model.”
    • The American Hospital News adds,
      • “The Centers for Medicare & Medicaid Services will retroactively pay claims for telehealth services provided during the government shutdown through Jan. 30, the agency said in an updated FAQ Nov. 20. Telehealth flexibilities will expire at the end of January if government funding is not extended. CMS added that some telehealth practitioners could list their physical practice location instead of their personal address on Medicare enrollment and billing forms when they provide telehealth services from their home. Virtual-only telehealth practitioners will need to enroll their home address as a practice location, but they will have the option to suppress their street address details.” 
    • The Government Accountability Office (GAO) released a report about “Health Savings Accounts: Information on Features and Use, and Characteristics of Account Holders” and a WatchBlog post about “Who Benefits from Health Savings Accounts?”

    From the Food and Drug Administration front,

    • The New York Time reports,
      • “ByHeart, the company linked to an outbreak of botulism from infant formula, said late Wednesday that a private lab had found the bacteria that causes the illness in samples of its product.
      • “So far, 31 babies in 15 states have been hospitalized, many in intensive care units, after becoming weak and unable to swallow. No deaths have been reported.
      • “ByHeart said in a statement that it sent its formula to an independent testing lab on Nov. 7, as soon that the Food and Drug Administration notified the company about the outbreak.”
    • STAT News points out,
      • “Paradromics announced Thursday that the Food and Drug Administration approved a clinical study to evaluate whether the company’s brain-computer interface for speech restoration is safe and capable of providing the ability to communicate via text or synthesized speech to someone with paralysis. 
      • “The Austin-based company is one of a handful of startups — including Elon Musk’s Neuralink, Synchron, and Precision Neuroscience, among others — that have transformed brain-computer interfaces from an obscure academic niche to a promising neurotechnology that Morgan Stanley recently valued at $400 billion.” 
    • Fierce Pharma notes,
      • “After months of back-and-and forth with the FDA and a third-party manufacturer, Regeneron has secured two long-awaited approvals for Eylea HD, gaining a new indication and a more flexible dosing option for the eye disease drug.
      • “The FDA has signed off on Eylea HD for patients with macular edema following retinal vein occlusion (RVO), making it the first treatment available in the indication with dosing up to every eight weeks. The agency also endorsed a monthly dosing option for Eylea HD across each of its approved indications, which include wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR) and now RVO.
      • “The nods allow Regeneron to better compete with Roche, which stormed the market in 2022 with Vabysmo. The Swiss drugmaker’s long-acting treatment can be administered up to every four months, as opposed to Regeneron’s original 2 mg version of Eylea, which has a maximum dosing interval of every two months.” 
    • Per Radiology Business,
      • “Siemens Healthineers has issued a correction for its 3T MRI systems that were recently the subject of a Class 1 recall. 
      • “Siemens first alerted customers about safety issues with nine different scanners from its Magnetom series of MRI offerings in August. Authorities said there have been problems with the systems’ ventilation, which could be subject to pressure buildup of helium in the event of a quench—rapid loss of superconductivity in the machine’s magnet. Such a buildup could cause the helium containment system to rupture and leak helium into the scanning room or potentially trigger an explosion. The issue was categorized as a Class 1 recall due to its potential to cause serious bodily harm or death. 
      • “The U.S. Food and Drug Administration announced the recall in early October. Now, Siemens is issuing an official device correction with more detailed information to assist operators in the event of a system error that could trigger the issue.” 

    From the judicial front,

    • Bloomberg Law reports,
      • “The 11th Circuit denied an air ambulance company’s attempt to overturn a surprise billing arbitration award, delivering another blow to medical providers trying to challenge the decisions in court.
      • “Wednesday’s ruling confirms the U.S. District Court for the Middle District of Florida’s decision that REACH Air Medical Services LLC lacked a right to sue Kaiser Health Plan Inc. after losing arbitration under the No Surprises Act, which REACH alleged was based on fraud. 
      • “Lower courts have split on whether doctors and insurers can sue to enforce or overturn the awards outside of a limited set of circumstances outlined in the law.”

    From the public health and medical / Rx research front,

    • The AHA News reports,
      • “Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19 infections are also growing or likely growing in 20 states. The agency said it would begin tracking respiratory syncytial virus trends soon.” 
    • The Wall Street Journal relates,
      • “Tens of thousands of kids who take prescription ADHD medication also wind up on other powerful psychotropic drugs—including antipsychotics and antidepressants, studies show. For some of them, the ADHD drugs themselves can be a trigger, according to doctors, patients and psychologists, who say additional medications are often prescribed to manage side effects such as insomnia, despite limited scientific evidence supporting these combinations in young, developing brains. 
      • About 7.1 million American children ages 3 to 17 have an ADHD diagnosis, according to an analysis of 2022 federal data. About half took ADHD medication for it that year, and prescriptions are growing. 
      • “The decision to treat ADHD with medication is often made by desperate parents trying to keep their kids from falling behind or being kicked out of school or daycare, parents and mental health clinicians say. For preschool-age kids, the drugs are often dispensed against pediatric guidelines, which call first for behavioral therapy, a treatment that can be hard to get. And mental health providers say the drugs are frequently prescribed to treat childhood trauma that has been misdiagnosed as ADHD.
      • “For one in five kids who take them, ADHD drugs are just the beginning. A Wall Street Journal analysis of Medicaid data from 2019 through 2023 shows that children who were prescribed a medication for ADHD were far more likely to take additional psychiatric drugs over the ensuing four years.”
    • Per Health Day,
      • “Long COVID can follow one of eight different symptom paths, as patients suffer for months past their initial infection, a new study reports.
      • “The eight identified “trajectories” show how long COVID can differ between patients based on its severity and duration, as well as whether their symptoms improve or worsen over time, researchers reported Nov. 17 in the journal Nature Communications.
      • “The variability we identified will enable future studies to evaluate risk factors and biomarkers that could explain why patients vary in time of recovery, and help identify potential therapeutic targets,” lead researcher Tanayott Thaweethai, an assistant professor at Harvard Medical School and associate director of Massachusetts General Hospital Biostatistics in Boston, said in a news release.”
    • Per MedPage Today,
      • “Higher physical activity in midlife was associated with a 40% lower dementia risk over 26 years.
      • “Late-life physical activity also was linked with less dementia risk.
      • “Exercise and activity can increase cerebral blood flow, reduce inflammation, and boost neuroplasticity.’
    • Per Genetic Engineering and Biotechnology News,
      • “A new paper from the laboratory of David Liu, PhD, at the Broad Institute describes a genome-editing strategy that could result in a one-time treatment for multiple unrelated genetic diseases. The new technique dubbed prime editing-mediated readthrough of premature termination codons or PERT is detailed in Nature in a new paper titled “Prime editing-installed suppressor tRNAs for disease-agnostic genome editing.” The work is spearheaded by co-first authors Sarah Pierce, PhD, and Steven Erwood, PhD, both of whom are postdoctoral associates in the Liu lab.  
      • “According to its developers, PERT is designed to maximize the potential of gene editing by using a single agent to target multiple disorders. Specifically, it uses prime editing, also developed by the Liu lab, to rescue nonsense mutations, which, when they appear, cause cells to stop protein synthesis early, resulting in malfunctional forms of proteins that are linked to various rare diseases.
      • “Importantly, PERT does not directly edit nonsense mutations, which account for 24 percent of pathogenic alleles in the ClinVar database. It works by “permanently converting a dispensable endogenous tRNA into an optimized [suppressor]-RNA.” This conversion equips edited cells to produce functional forms of the necessary protein, regardless of which gene has the mutation.” 

    From the U.S. public health business front,

    • Fierce Healthcare reports,
      • “The average amounts of a hospital’s denied inpatient and outpatient claims have increased by 12% and 14%, respectively, with greater denial volumes also accompanying an uptick in payer’s audits, according to a vendor report released this week. 
      • “The analysis, which looked at real-world data from the first three quarters of 2025 among MDaudit’s network of more than 1.2 million providers and 4,500 facilities, echoes reports from health system executives and management teams describing heightened payer denial activity as a drag on their revenues.
      • “Specifically, for external payer audits, the billing compliance and revenue integrity tech platform said it spotted a 30% year-over-year increase per customer in total at-risk amount.
      • “The average amount per claim also rose by 18%, according to the report. Among these, 45% of the at-risk amount came from commercial payers with Medicare and Medicaid accounting for 28%.”
    • Beckers Payer Issues informs us,
      • “More and more payers and employers have been getting on board with surgical alternatives to GLP-1s for weight loss.
      • “A 2024 survey found most employer-sponsored plans covered these procedures, and covering GLP-1s for diabetes and obesity was much less likely. KFF reported that the majority of organizations with at least 5,000 employees said covering GLP-1 agonists had a “significant” impact on prescription drug spending.
      • “One doctor told Becker’s that insurers see “more reliable outcomes and savings” when they pay for bariatric surgery. During a panel on GLP-1s at Becker’s Fall 2025 Payer Issues Roundtable this month, Select Health Senior Medical Director Kenny Bramwell, MD, echoed that sentiment.
      • “A handful of years ago, I never would have said this, but some people may need to consider — or we need to at least consider — the costs of surgical options,” Dr. Bramwell said. “Bariatric surgery suddenly seems inexpensive compared to $1,000 a month in perpetuity.”
      • The article considers whether recent GLP-1 drug price reductions may change perspectives.
    • Per MedTech Dive,
      • “Abbott has agreed to acquire cancer test-maker Exact Sciences for about $21 billion.
      • “Exact Sciences makes the Cologuard noninvasive screening test for colorectal cancer. The company also makes tests to detect multiple types of cancer early and identify molecular residual disease to assess the risk of recurrence. 
      • ‘The deal is expected to close in the second quarter of 2026, subject to shareholder and regulatory approvals. Abbott expects Exact Sciences to generate more than $3 billion in revenue this year and grow Abbott’s total diagnostics sales to more than $12 billion annually after the acquisition closes.”
    • Per Biopharma Dive,
      • “Biotechnology company Moderna said Thursday it has secured a loan of $1.5 billion as it reevaluates its pipeline in an effort to break even by 2028.
      • ‘The vaccine maker signed a five-year loan facility with Ares Management Credit Funds, a move Chief Financial Officer Jamey Mock said, in a statement, will enable “increased flexibility over the coming years.” The influx of capital provides an additional lifeline as the drugmaker navigates a post-pandemic market.
      • ‘Moderna also announced a three-year business strategy, targeting up to 10% revenue growth in 2026. Company shares subsequently rose over 2%.”
    • Chief Health Executive reports,
      • “Bob Farrell says health plans and providers have plenty of data on their patients, but they’re not always getting the most of it.
      • “Farrell is the CEO of mPulse, a company working with health systems and health plans to get more insights on their patients. The company has been growing significantly in recent years, completing the acquisition of Clarity Software Solutions over the summer. Clarity is the fifth company mPulse has acquired since December 2021.
      • “With the addition of Clarity, Farrell says the goal is to use AI technology to “provide a plan or a provider with a 360-degree view of their members or their patients.”
      • “With that information, he says, “They can do the things that allow that member or patient to really take charge of their health care, and ultimately to improve outcomes, while simultaneously driving efficiencies for the plan or the provider themselves.”
      • “The company works with 450 healthcare organizations and 50 of the nation’s 60 largest health plans.”

    Monday report

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

    From Washington, DC,

    • The Hill reports,
      • “President Trump said he is talking with Democrats about a direct health care payment plan Sunday amid negotiations to tackle rising health insurance premiums. 
      • “I’ve had personal talks with some Democrats,” Trump told reporters in West Palm Beach, Fla., on Sunday before returning to Washington. 
    • STAT News adds,
      • “Sen. Bill Cassidy (R-La.) is pitching Democrats on his compromise to make Affordable Care Act marketplace plans affordable without extending the extra tax credits that currently lower premium payments.
      • “Cassidy, the chair of the Senate health committee, is among the team of Republican senators picked to negotiate with Democrats on the credits in preparation for a mid-December vote. Republicans agreed to the vote in exchange for Democrats’ support to reopen the government. 
      • “Cassidy’s plan is not the official Republican plan, but he said his proposal is in line with the thinking of his GOP colleagues. Its structure jibes with President Trump’s demand to end the extra federal subsidies for ACA insurance and instead give an equal amount of cash directly to people to spend on health care. 
      • “The crux of Cassidy’s plan is to fund health savings accounts with money that currently goes toward the enhanced premium tax credits. His plan would not affect the original ACA premium tax credits. It would only apply to the extra, pandemic-era credits that expire at the end of the year. Cassidy described his plan to reporters during a briefing on Monday but has not yet released corresponding legislation.
      • “Cassidy’s proposal is for these HSAs to accompany ACA bronze plans. Trump’s tax bill changed the rules so that all bronze plans are eligible for HSAs, starting Jan. 1.
      • “Cassidy said he has not yet figured out how to allocate the HSA subsidies to enrollees, which could be complicated.
      • “Bronze plans have the lowest premiums among the three metal-tier plans and the highest cost sharing. Premiums vary significantly by state, but the average lowest monthly bronze plan premium is $456 and the average lowest silver premium is $611, before any subsidies, according to KFF.” 
    • Roll Call provides an overview of Congressional activities this week.
    • The American Hospital Association News tells us,
      • “The Centers for Medicare & Medicaid Services Nov. 14 released preliminary guidance to states on implementing provider tax provisions in the One Big Beautiful Bill Act. CMS clarified the meaning of “enacted” and “imposed” for purposes of section 71115, which establishes new indirect hold harmless thresholds effective Oct. 1, 2026. A tax is considered enacted when the legislative process authorizing the tax is fully completed and any required waiver is approved by CMS as of July 4, 2025. A tax is imposed when the state or locality was actively collecting revenue under that tax structure on the same date. These definitions establish that only taxes in effect as of July 4, 2025, are included in the new indirect hold harmless threshold, effectively prohibiting new or increased provider taxes beyond those limits. 
      • “CMS also addressed transition periods under section 71117, which specified circumstances in which a provider tax is not considered generally redistributive and therefore noncompliant. States with noncompliant managed care organization taxes approved before July 4, 2025, have until the end of their fiscal year ending in 2026 to comply, while other affected provider taxes have until the end of the fiscal year ending in 2028, but no later than Oct. 1, 2028. CMS emphasized that these transition periods are intended to allow states to prioritize compliance while maintaining Medicaid fiscal integrity and will be finalized through notice-and-comment rulemaking.” 
    • Federal News Network interviews an OPM official Holly Schumann and Consumer Checkbook’s director Kevin Moss about the ongoing Federal Benefits Open Season.
    • The Wall Street Journal informs us,
      • “The Federal Aviation Administration said it would lift its flight restrictions related to the government shutdown, clearing the way for normal operations to resume at U.S. airports after weeks of delays and cancellations. 
      • “Transportation Secretary Sean Duffy and FAA Administrator Bryan Bedford said Sunday that the 6% traffic cut implemented last week would be terminated at 6 a.m. ET Monday morning. They said the move came after the FAA reviewed safety trends and saw improving staffing levels.
      • “Now we can refocus our efforts on surging controller hiring and building the brand new, state of the art air-traffic control system the American people deserve,” Duffy said.”

    From the Food and Drug Administration front,

    • STAT News reports,
      • “The Food and Drug Administration has green-lit home use of a device that helps people with spinal cord injuries regain mobility and functioning. Onward Medical announced Monday that the company had received clearance to expand the use of its spinal cord stimulator outside of clinics.
      • “People living with [spinal cord injuries] will now be able to benefit from use of the ARC-EX System in the comfort and convenience of their own homes,” said CEO Dave Marver in a press release.”
    • Per Fierce Pharma,
      • “The clock is up on Biogen’s extra two years of a biosimilar-free U.S. market for its blockbuster multiple sclerosis (MS) med Tysabri. After waiting in the wings post-FDA approval in 2023, Sandoz’s biosimilar rival Tyruko has officially launched in the U.S.
      • “Tyruko is not only the first Tysabri biosimilar, but it’s also the first U.S. biosimilar that can treat multiple sclerosis. The launch marks an “important opportunity to help people with MS navigate this disease in a way that is more cost-effective,” Sandoz’s North America president Keren Haruvi explained in the company’s Nov. 17 press release. 
      • “Sandoz pinned its name on the drug through a global commercialization agreement with Polpharma Biologics in 2019, which developed Tyruko and handles manufacturing and supply. The biosimilar is also available in 14 European countries and is expected to be a “key contributor to the Sandoz growth strategy,” according to its release, fitting into the company’s ambitions to be “#1 in biosimilars in the US and a leader in the treatment of MS globally.”
    • Per MedTech Dive,
      • Zimmer Biomet said Friday [November 14] that it has received 510(k) clearance for an updated version of its Rosa knee surgery robot.
      • The Food and Drug Administration clearance covers Rosa Knee with Optimize. Compared to the older system, Zimmer has simplified the user interface and streamlined the surgical workflow.
      • Zimmer CEO Ivan Tornos predicted at investor events earlier this year that the new system would accelerate Rosa installs and be a “meaningful contributor” to sales in 2026.

    From the public health and medical / Rx research front,

    • Beckers Clinical Leadership reports,
      • “A Washington state resident has contracted a bird flu strain previously only found in animals, health officials confirmed Nov. 14. 
      • “The individual has been hospitalized since early November with influenza H5N5, an avian influenza strain never before reported in humans, according to the Washington State Department of Health. The patient is an older adult with underlying health conditions who has a “mixed backyard flock of domestic poultry at home that had exposure to wild birds,” officials said, adding the animals likely exposed the virus to the individual but an investigation is ongoing. 
      • “The CDC said the risk to the public remains low. 
      • “As of Nov. 14, the CDC has confirmed 71 cases of human bird flu and one death. The most common strain in animals and humans is H5N1. Richard Webby, PhD, a virologist and influenza expert at St. Jude’s Children Research Hospital in Memphis, Tenn., told The Washington Post the H5N5 strain behaves similarly to H5N1 in models.” 
    • The American Medical Association lets us know what doctors wish older adults knew about physical activity.
      • “From aerobics to balance workouts for seniors, it’s key to find a physical activity that works as you age. Two Northwell Health physicians share more.”
    • Parkinsons News Today points out,
      • “Frequently eating sweets, red meat, and processed meats appears to increase the risk of developing Parkinson’s disease, while consuming more fruits — especially citrus — may be protective against it, according to a large study from Italy.
      • “The researchers found, however, that certain nondietary influences were more strongly linked to the risk of Parkinson’s than eating habits. Key among these, the team noted, were family history, digestive problems, and exposure to pesticides, oils, metals, and general anesthesia.
      • “This study suggests that eating habits might have some impact on [Parkinson’s disease], but they are not the main cause,” the scientists wrote. “Future research should look at both diet and other lifestyle habits to better understand how to prevent [Parkinson’s].”
      • “The study, “The impact of diet on Parkinson’s disease risk: A data-driven analysis in a large Italian case-control population,” was published in the Journal of Parkinson’s Disease.”
    • Per Health Day,
      • “Want to avoid migraines? Stick to your boring routine, a new study suggests.
      • “Any major disruption to a person’s daily routine — called a “surprisal” event — is strongly linked to a higher risk of a migraine attack within the next 12 to 24 hours, researchers reported Nov. 11 in JAMA Network Open.
      • “Too much food or drink, staying up late, a stressful incident, unexpected good or bad news or a severe mood swing could pose a “surprise” to the body, setting it up for a next-day migraine, researchers said.
      • “Incorporating measurement of surprisal into migraine forecasting tools could provide individuals with a more effective, personalized strategy for managing headache risk,” concluded the research team led by Dana Turner, an assistant professor of anesthesia, critical care and pain medicine at Harvard Medical School.
      • “In fact, the findings support a person-centered approach to treating a migraine “that moves beyond static lists of potential causes to account for the unpredictable and context-sensitive nature of daily life.”
    • Per Medscape,
      • “More than half of the people who stop using GLP-1 drugs regain at least some of the weight within a year, new real-world data showed.
      • “The new findings, from a large national claims database, “corroborate the clinical trial data that treatment discontinuation leads to weight recurrence. Optimizing and personalizing the approach toward treating obesity and maximizing gastrointestinal tolerability will maximize long-term use and long-term benefits of weight reduction,” study author Michael A. Weintraub, MD, an endocrinologist at New York University Langone Health, New York City, told Medscape Medical News.
      • “Weintraub reported the data on November 5, 2025, at Obesity Week 2025. “Treatment discontinuation leads to weight recurrence in clinical trials, but few real-world studies have evaluated this issue,” Weintraub said in his introduction.”
    • Medscape also shares insights about “Breakthrough Therapies in Chronic Kidney Disease.”
    • Genetic Engineering and BioTechnology News relates,
      • “The human papillomavirus (HPV) vaccine is a triumph of modern medicine—but it cannot eliminate an existing infection. Once HPV takes hold, no approved vaccines can stop its progression to cervical cancer, leaving surgery and chemotherapy as the main options. Researchers at Chiba University are working to change that with a nanogel nasal vaccine that shows promise in preclinical models.
      • “The study, led by associate professor Rika Nakahashi-Ouchida, MD, and Hiromi Mori of Chiba University Hospital, was published in Science Translational Medicine. The paper, titled “Cationic nanogel–based nasal therapeutic HPV vaccine prevents the development of cervical cancer,” describes a vaccine that activates local immune responses and slows tumor growth in animal models.
    • STAT News reports,
      • “The biotechnology firm Nuvalent said Monday that its drug for a genetically defined type of lung cancer shrank tumors in more than a quarter of patients whose disease had returned after trying other targeted medicines, and that the response endured in most of those people for at least a year.
      • “According to the company and an analyst who follows it, the results could mean that the medicine might be approved quickly and adopted by patients and doctors who might prefer it based on its efficacy and side effect profile to existing treatments for this type of lung cancer, which is caused by alterations in a gene called ALK (anaplastic lymphoma kinase).”
    • Per Fierce Pharma,
      • “Nearly three years after striking up a Zymeworks licensing pact with an eye on challenging the status quo in HER2-positive cancers, Jazz Pharmaceuticals is seeing its vision with Ziihera come into clearer focus.
      • “In a press release Monday, Jazz described a positive phase 3 readout as boosting its confidence that it has a HER2-targeted “agent-of-choice” for first-line patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction and esophagus.
      • “For a combination of Ziihera plus chemotherapy and BeOne Medicines’ Tevimbra, Jazz sees a “new standard of care” coming into form.”

    From the U.S. healthcare business front,

    • Modern Healthcare reports,
      • “UnitedHealth Group’s Optum Health and CVS Health’s Oak Street Health are struggling to adapt to the modified Medicare Advantage risk-adjustment system. 
      • “These healthcare delivery subsidiaries are renegotiating insurance contracts to offset dwindling Medicare Advantage revenue.
      • “Optum Health and Oak Street Health are disproportionately reliant on reimbursements from their parent companies’ insurance arms, UnitedHealthcare and Aetna.”
    • and
      • “GoodRx is the latest telehealth company to launch a subscription weight loss program.
      • “GoodRx’s subscription program will initially start at $39 per month before going up to $119 per month in February, the company said in a release.”
    • The American Medical Association News tells us,
      • “The AHA Nov. 17 released Fast Facts: Is My Hospital Rural, featuring updated information on the important role rural hospitals play in their communities, the people they serve and the challenges they face. The infographic features updated information on the important role rural hospitals play, the people they serve and the challenges they face. The infographic is being released before National Rural Health Day on Thursday, Nov. 20.”
    • Per MedTech Dive,
      • “Boston Scientific and Siemens Healthineers have partnered to develop and commercialize Siemens Healthineers’ next-generation intracardiac echocardiography catheter, the companies said Thursday.
      • “The new cardiac imaging catheter is intended for use in structural heart procedures, including standalone Watchman left atrial appendage closure, Farapulse pulsed field ablation, and the Farawatch approach combining PFA with the Watchman implant. 
      • “Boston Scientific expects the agreement to encourage adoption of its Watchman device by more sites, furthering growth of an already successful business. Boston Scientific will become the exclusive distributor of the Acunav 4D ICE catheter in the U.S. and Japan, once the device is commercially available.”

    From the artificial intelligence front,

    • Fierce Healthcare reports,
      • “Health tech investor the SymphonyAI Group aims to leverage the best of both companies’ AI expertise to expand its reach among health systems.
      • “RhythmX AI and Get Well, two companies under the SAI Group’s banner, have merged to form GW RhythmX, the investor announced last week. The combined company already has broad reach in the healthcare market. It currently serves 150 health systems, SAI Group said in a press release.
      • “The companies’ combined capabilities will engage patients and help them navigate the healthcare system, while delivering personalized insights to physicians at the point of care, according to the investor in a press release.
      • “The former standalone company RhythmX AI is a personalized care platform that supports physician decision-making and boosts physician productivity by providing AI-powered care recommendations tailored to the patient. The platform also helps proactively manage patient care by identifying at-risk patients and projecting disease progression. It also routes patients to the right clinician at the right time.” 
    • Beckers Health IT informs us,
      • “Patients are increasingly turning to AI chatbots for health information, driven by long wait times, high healthcare costs and dissatisfaction with clinical interactions, The New York Times reported Nov. 16.
      • “About 17% of adults said they use AI chatbots at least once a month for health information and advice, according to a 2024 KFF poll. This figure increased to 25% among adults under age 30. 
      • “The Times interviewed dozens of patients about their chatbot use, many of whom reported the technology as a more responsive and accessible alternative to their physicians.” * * *
      • “While chatbots can help improve patients’ health literacy and access to timely information, researchers warn that the tools can generate incorrect, overly confident or clinically unsafe advice.
      • “A preprint study from Oxford University found that users rarely made a correct diagnosis or identified appropriate next steps when using ChatGPT to assess symptoms. The study has not yet been peer reviewed.” 

    Midweek update

    David Ermer–CDC, Congress, FDA, Federal employment benefits, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, OPM, U.S. Healthcare, Uncategorized–

    From Washington, DC,

    • The government shutdown is over. Per the Wall Street Journal,
      • “The GOP-led House passed a spending package reopening the government and President Trump signed it into law late Wednesday, drawing to a close a record-long 43-day shutdown driven by Democrats’ demands to extend expiring healthcare subsides.
      • “The House approved the measure 222 to 209, largely along party lines, two days after the bill cleared the Senate.”
    • The Washington Post reports,
      • “Federal paychecks will begin going out Saturday, a senior administration official said, speaking on the condition of anonymity to discuss personnel matters.
      • “The deal will fund the government through Jan. 30, pass three appropriations bills, reverse more than 4,000 federal layoffs the Trump administration attempted to implement earlier in the shutdown and prevent future layoffs through the end of January. It will appropriate funding for the Supplemental Nutrition Assistance Program, also known as SNAP or food stamps, through September 2026.”
    • The Wall Street Journal discusses the secret meeting that led to this outcome.
      • “A group of centrist Democrats and an independent senator initiated talks with Senate Republicans to end the government shutdown, negotiating without Senate Minority Leader Chuck Schumer.
      • “The negotiations led to an agreement to reopen the government, but it divided Democrats as it didn’t guarantee the extension of expiring Obamacare health-insurance subsidies.
      • “Eight Democrats ultimately supported the deal, providing the critical votes needed to advance the measure to reopen the government with a 60-40 vote.”
    • Beckers Health IT tells us,
      • “Sen. Bill Cassidy, R-La., is pushing to tighten protections for health information gathered by wearable devices and mobile health apps, citing growing privacy concerns as the technology becomes more common, Politico reported Nov. 11.”
    • Per a Senate news release,
      • “On Wednesday, November 19, [at 10 am ET] the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on the U.S. Organ Procurement and Transplantation Network (OPTN) and improving access to lifesaving organs.” * * *
      • “Click here to watch live.”
    • Per the Federal Register, the CDC’s Advisory Committee on Immunization Practices will meet on December 4 and 5, 2025.
      • “The agenda will include discussions on vaccine safety, the childhood and adolescent immunization schedule, and hepatitis B vaccines. The agenda will include updates on ACIP workgroups. Recommendation votes may be scheduled for hepatitis B vaccines. Vaccines for Children (VFC) votes may be scheduled for hepatitis B vaccines. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda, visit https://www.cdc.gov/acip/index.html.” * * *
      • “The docket will be opened to receive written comments November 13 – 24, 2025. Written comments must be received no later than November 24, 2025.”
    • Neil Cain, writing in Govexec, discusses the Medicare Part B late enrollment penalty for folks enrolled in the FEHB program.

    From the Food and Drug Administration front,

    • BioPharma Dive reports,
      • “The Food and Drug Administration is unveiling a new blueprint for the regulation of bespoke drug therapies, announcing on Wednesday a way for these treatments to quickly get to market if they meet certain standards.
      • “Called the “plausible mechanism” pathway, the new framework is designed to help accelerate treatments for serious conditions that are so rare they may only affect individuals or handfuls of people and can’t feasibly be tested in randomized clinical trials. It was announced through an article authored by FDA Commissioner Martin Makary and top deputy Vinay Prasad and published Wednesday in the New England Journal of Medicine.
      • “Critics may contend that there is no need for an alternative pathway and that existing FDA operations are able to address bespoke, transformative therapies,” they wrote. “Unfortunately, the FDA has heard from patients, parents, researchers, clinicians, and developers that current regulations are onerous and unnecessarily demanding, provide unclear patient protection, and stifle innovation. We share this view.”

    From the public health and medical / Rx research front,

    • The University of Minnesota’s CIDRAP relates,
      • “Arizona and Utah reported an increase in measles case counts today, as did South Carolina, according to state dashboards. 
      • “The outbreak that straddles the Utah-Arizona border has now grown to 182 cases, and is the second largest measles outbreak this year following the West Texas outbreak, which sickened at least 762 people, with three deaths.” * * *
      • “The Upstate outbreak in South Carolina also grew, with eight more cases reported by the South Carolina Department of Public Health today. The state total is now 46.
      • “Six of the eight new patients are household members of previously identified patients. All new patients are in quarantine. 
      • “Two cases, however, occurred within the same household, but the source of infection is unknown.”
    • and
      • “A test-negative, case-control study across 14 hospitals in England finds that the respiratory syncytial virus (RSV) pre-F (Abrysvo) vaccine helps protect against related hospital admissions in older adults. 
      • “For the study, published in The Lancet Infectious Diseases, UK researchers identified 1,006 adults aged 75 to 79 hospitalized with acute respiratory illness (ARI) from October 2024 to March 2025. The participants were predominantly White, with a mean age of 80 years and had a high rate of chronic conditions such as heart and respiratory disease and immunosuppression. 
      • “The researchers noted that while the RSV vaccine has been shown to protect against all-cause RSV-associated hospital admissions, there’s limited data on the vaccine’s effectiveness against different RSV-associated illnesses and complications such as exacerbation of chronic illness.”
    • Per a November 11, 2025, City of Philadelphia news release,
      • “The Philadelphia Department of Public Health is notifying travelers and others who were at the Philadelphia International Airport Terminals A and B on Sunday, November 9, 2025, between 8:50 am and 4:00 pm of a possible measles exposure. The individual with measles was traveling through the airport. The Health Department is encouraging people who were exposed to check their vaccination status and watch for symptoms.”
    • Biopharma Dive reports,
      • “An antimalarial drug developed by Novartis could become the first novel treatment for the parasitic infection in more than two decades, following study results that showed it helped cure most people treated with it in a Phase 3 trial.  
      • “According to Novartis, the therapy, known in short as GanLum, was “non-inferior” to standard treatment in a trial evaluating it in 1,688 adults and children. By one analysis, the drug helped clear symptoms and signs of initial infection in 97% of recipients after 28 days, versus 94% among those receiving standard drugs. By another, that cure rate was as high as 99%. Novartis added that treatment appeared effective against drug-resistant parasites and was able to block disease transmission.
      • “The results cleared the World Health Organization’s 95% target and positions Novartis to seek approvals of GanLum “as soon as possible,” the company said in a statement Wednesday. If so, it would help combat growing resistance to a class of medicines, called “artemisinins,” that have been the gold standard for treating malaria since 1999.” 
    • The New York Times informs us,
      • “In a modern glass complex in Geneva last month, hundreds of scientists from around the world gathered to share data, review cases — and revel in some astonishing progress.
      • “Their work was once considered the stuff of science fiction: so-called xenotransplantation, the use of animal organs to replace failing kidneys, hearts and livers in humans.
      • “But as the scientists traded notes, it became ever more clear that it wasn’t fiction anymore. They were nearing breakthroughs that might help alleviate the shortage of donor organs plaguing every nation.
      • “Transplants with organs from genetically modified pigs, designed not to trigger rejection by the human body, have begun to show great promise. “The future is here,” said Dr. Muhammad M. Mohiuddin, the outgoing president of the International Xenotransplantation Association, which hosted the conference.”
    • Per Beckers Oncology,
      • “GLP-1 medication use was associated with lower mortality among colon cancer patients, according to a study published Nov. 11 in Cancer Investigation. 
      • “Researchers from the University of California San Diego used real-world clinical data from the University of California Health Data Warehouse to assess any association between GLP-1s and five-year mortality in 6,871 colon cancer patients.”
    • Per a JAMA Cardiology report,
      • “In this cross-sectional study among a nationally representative sample, chronic kidney disease (CKD) affected 1 in 7 US adults, yet fewer than 15% of adults with CKD were aware of their diagnosis. Although overall awareness increased modestly from 2011 to 2020, younger adults, women, and Hispanic adults experienced lowest awareness rates without improvement. These findings highlight a significant gap in CKD recognition and underscore the need for targeted strategies to improve awareness in the population.”
    • The Los Angeles Times reports,
      • “Food always powered Anahi Araiza through study sessions and cultural gatherings. But after putting on some weight in her college years, she decided to get serious about weight loss, often restricting her food consumption overall — and that’s when everything shifted.
      • “One day, I overate whatever calories or macros I established for myself,” says Araiza in a phone call. “Then it turned into a spiral where every single day I was unable to do anything but think about food.”
      • “After a while, she developed binge eating disorder (BED), which is defined as repeated episodes of binge eating, or eating large amounts of food quickly.””
      • “BED is the most common eating disorder in the United States, yet it is chronically underdiagnosed among Latino communities.”
    • Neurology Advisor lets us know that “Early Administration of Remote Electrical Neuromodulation Enhances Migraine Relief.”
    • Per Radiology Business,
      • “New research is raising questions pertaining to the effectiveness of a newer Alzheimer’s treatment that has been proven to reduce cognitive symptoms related to the disease. 
      • “Lecanemab, sold under the brand name Leqembi, was approved by the U.S. Food and Drug Administration in January 2023. The monoclonal antibody treatment treats early Alzheimer’s disease (AD) by essentially scrubbing the brain of amyloid-β (Aβ) plaques.   
      • “The drug’s approval was roundly celebrated at the time, as clinical trials suggested it could reduce Alzheimer’s-related cognitive decline by up to 27%. Post-approval data has been positive as well, but new research out of Osaka Metropolitan University in Japan is prompting new questions on the mechanisms that underlie the drug’s therapeutic effects. 
      • “Published in the Journal of Magnetic Resonance Imaging, the findings suggest lecanemab does not change the waste clearance function in the brains of AD patients in the short term. This could indicate that the medication does little to treat the nerve damage AD has inflicted on the glymphatic system, which clears waste from the brain, prior to starting the treatment.” “
    • Per Medscape,
      • “Statin therapy remains a cornerstone for primary and secondary prevention of major adverse cardiac events (MACEs) but prescribing based on patient phenotype identified through imaging may boost its effectiveness, according to a new study.
      • “While population-level primary-prevention trials have established the efficacy of statins, it remains unclear whether their benefit depends on the extent of underlying atherosclerotic disease. Our work addresses this evidence gap by assessing whether the treatment effect varies with disease characteristics,” lead investigator Bálint Szilveszter, MD, PhD, a researcher at the Semmelweis University Heart and Vascular Centre in Budapest, Hungary, wrote in an email to Medscape Medical News.
      • “Clarifying this relationship could enable more personalized and also intensified therapy,” Szilveszter added.”

    From the U.S. healthcare business front,

    • Fierce Healthcare reports,
      • “Key provider performance metrics appear steady in aggregate but are showing stark differences between hospitals and practices at the top and bottom of their class, according to a pair of new reports from Kaufman Hall.
      • “For hospitals, the firm’s operating margin index was 2.9% across nine months of 2025 (including health system allocations for the cost of shared services), a slight uptick from the 2.5% reflected through eight months. Splitting the report’s 1,300 nationwide hospitals into quartiles, however, showed a 14.7% year-to-date operating margin index among the top 25% of hospitals and a -1.8% year-to-date operating margin for the bottom quartile of hospitals.
      • “The gap between strong performers versus struggling hospitals continues to widen,” said Erik Swanson, managing director and data and analytics group leader with Kaufman Hall, said of the trend in a release.
      • “Broadly speaking, the overall margin improvement from August to September stemmed from greater volumes and per-adjusted-admission revenue gains and was partially mitigated by higher supply and drug costs, according to the firm’s monthly report. On a month-over-month basis, daily net operating revenue rose 4%, daily total expense rose 3% and daily adjusted discharges increased 2%.”
      • “As for practices, Kaufman Hall’s quarterly check-in highlighted, for the first time since the COVID-19 pandemic, a sequential decline in the median investment/subsidy per provider in medical groups. That metric—net patient service revenue minus total expense, then divided by provider full-time equivalents—was $237,911 in Q3, a 1% year-over-year increase but a minor dip from Q2’s $239,338.
      • “Similar to hospitals, however, Kaufman Hall found a disparity within the report’s sample of 200,000 providers. The investment/subsidy per provider at the 25th percentile was $141,371, but $325,634 at the 75th percentile.”
    • and
      • “The country’s largest for-profit hospital chain isn’t sitting on its hands when it comes to artificial intelligence.
      • “Speaking Wednesday morning at the 2025 UBS Global Healthcare Conference, HCA Healthcare Executive Vice President and Chief Financial Officer Michael Marks offered an update on key clinical, operational and administrative deployments of AI tools across the 191-hospital system.
      • “Broadly, I’m pleased with where we are,” Marks said. “We’re in early innings with this effort. We’re trying to be judicious in our allocation of resources and making sure that we’re getting either a clinical or a financial return on these investments as we scale them.”
      • “Clinical use cases are the steepest hill for AI due to the “inherent risks” around patient safety, the executive said, and as such are taking longer to roll out. Still, HCA has multiple projects aimed at improving patient safety and quality outcomes, among which is a partnership with Google to tighten the roughly 400,000 weekly shift handoffs between the system’s nurses.”
    • MedCity News considers “What Are the Biggest Mistakes Employers Make When Introducing Digital Mental Health Solutions? At the Behavioral Health Tech conference, panelists said employers often rush to adopt digital mental health tools without tailoring them to employee needs or effectively promoting their use.”
    • HR Dive informs us,
      • “Employers significantly misjudge how well their benefit offerings are meeting employee demands: While 75% believe their workforce is satisfied with what they offer, only 65% of employees agree, according to Aflac’s 2025-2026 benefits trend report.
      • “One noticeable misunderstanding involves communication, spring surveys of 1,002 employers and 2,000 employees across the U.S. found. Nearly 2 in 5 (37%) of employees said they want to talk to a real person to help with benefits enrollment, but only 28% of employers offer this option. Similarly, 32% of employees said they want one-on-one access to a benefit consultant, but only 28% of employers provide it.
      • “Employers are also out-of-touch with employee concerns about medical bills: 78% believe employees can handle this financial burden, but 44% of workers say they couldn’t cover $1,000 in unexpected health expenses. Almost 1 in 5 (19%) said they wouldn’t be able to afford $500 in healthcare costs.”

    Midweek update

    David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, Telehealth, U.S. Healthcare–

    From Washington, DC,

    • Politico reports,
      • “Republicans say they are close to finalizing a package of full-year funding measures for select federal agencies — a critical piece of bipartisan negotiations over the terms for ending the prolonged government shutdown.
      • “The mini-package should be nearing completion, and that will be the vehicle” for the stopgap spending bill to reopen the government, Senate Majority Leader John Thune said Wednesday after a closed-door GOP lunch.
      • “Thune met Tuesday night with Democratic negotiators on the shutdown, including Sen. Jeanne Shaheen of New Hampshire and Sen. Angus King (I-Maine), who caucuses with Democrats. Bipartisan negotiators want the Senate to stay in session through the weekend to finish a deal, according to two people granted anonymity to disclose private dynamics. 
      • “While Thune didn’t rule out staying past the Senate’s normal Thursday afternoon exit time, he said he’d need to first see how much progress was being made.”
    • The Wall Street Journal reports,
      • “The Federal Aviation Administration said it was ordering airline traffic to be reduced by 10% at 40 airports while air-traffic controllers work without pay during the government shutdown.
      • “Transportation Secretary Sean Duffy said starting Friday, the reduction would help keep air travel safe as flight delays and cancellations pile up. The shutdown, which began Oct. 1, has exacerbated staffing issues in the ranks of federal transportation employees, leading to flight delays and long lines at security checkpoints. 
      • “This is about where’s the pressure and how do we alleviate the pressure,” Duffy said Wednesday at a news briefing.”
    • Per an OPM news release,
      • “The U.S. Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) today released new guidance to federal agencies on how to implement President Donald Trump’s Executive Order 14356, Ensuring Continued Accountability in Federal Hiring. In his first year in office, President Trump met and exceeded the ratio of four employee departures for each new hire, this guidance directs agencies on how to ensure federal hiring remains cost-effective, mission-focused, and aligned with administration priorities.
      • “This is about ensuring government works better for the American people,” OPM Director Scott Kupor said. “We’re bringing accountability and discipline to every hiring decision, making sure agencies are staffing for mission need, not bureaucratic habit.” * * *
      • “Read the memo here and Director Kupor’s blog on this here.”
    • Federal News Network points out,
      • “As Open Season approaches, one Republican is raising concerns about funding for the Federal Employees Health Benefits program. Sen. James Lankford (R-Okla.) is questioning the Office of Personnel Management on how it plans to avoid exhausting the FEHB’s trust fund. He said it’s a concern, since there aren’t any incoming contributions to the trust fund under the government shutdown. In response to Lankford’s questions, OPM said that if needed, it would be able to let health carriers request additional funding from contingency reserves. But for the time being, OPM said all FEHB plans have sufficient funds to pay claims.(Letter to OPM on FEHB program under shutdown – Sen. James Lankford (R-Okla.))”
    • and
      • “The Office of Personnel Management is hinting at some upcoming tech hiring initiatives. The specific timeline for launching the OPM initiatives is unclear, and many details of the tech hiring efforts are still in the works. But agencies should be focused on tech recruitment, particularly in artificial intelligence, according to OPM Director Scott Kupor. “I think the thing that government has to do is not be the last dinosaur. If we do that, there’s no amount of organizational structure or marketing or anything else that’s going to save us, we have to be willing to embrace these things,” Kupor said at a NAPA conference on Monday. (OPM’s Kupor wants more tech expertise in the federal workforce – Federal News Network)”

    From the judicial front,

    • Per Fierce Biotech,
      • “Amid the rapidly unfolding saga revolving around Metsera, a judge has denied Pfizer’s request to block Novo Nordisk’s buyout bid for the biotech, Bloomberg reports.
      • Delaware Chancery Judge Morgan Zurn has refused to deliver a Pfizer-requested temporary restraining order, saying the pharma’s objections to the proposed deal weren’t a legitimate reason for stopping Novo’s offer, according to the publication.” * * *
      • “Meanwhile, Pfizer has said it remains “confident” in the merits of its claims and its belief that Metsera is breaching its contractual obligations.
      • “Today’s decision does not address the merits of the underlying legal issues raised, and Pfizer intends to continue to pursue its claims vigorously through the ongoing litigation process as well as in its parallel antitrust litigation pending in Delaware federal court,” the pharma said in a Nov. 5 statement in response to the ruling.”
    • STAT News reports,
      • “The Federal Trade Commission has raised concerns about Novo Nordisk’s attempt to outbid Pfizer to acquire obesity startup Metsera, the latest complication in a dramatic bidding war between two pharma giants.
      • “Companies normally have to seek FTC review for acquisitions under a law called the Hart-Scott-Rodino Premerger (HSR) Notification Act. The companies must wait a prescribed amount of time after the filings are submitted before concluding their transaction.
      • “Novo’s deal is structured so that it would first pay a large amount to acquire half of Metsera’s stock. If Novo does that before seeking regulators’ review, then it may violate the act, Daniel Guarnera, director of the bureau of competition at the FTC, wrote in a letter sent Tuesday to lawyers of Novo and Metsera.”

    From the public health and medical / Rx research front,

    • The American Hospital Association News tells us,
      • “There have been 1,681 confirmed cases of measles in the U.S. so far this year, according to the latest Centers for Disease Control and Prevention data. Cases have been reported by 42 states and jurisdictions, and 12% of cases have been hospitalized. There have been 44 reported outbreaks, and 87% of all cases are outbreak-associated. The vaccination status of 92% of all confirmed cases is classified as “unvaccinated or unknown.” 
    • and
      • “An AHA blog examines how the Cleveland Clinic’s food-as-medicine strategy reaches far beyond clinical care by using a multi-angle approach to food access and nutrition. READ MORE” 
    • Health Day informs us,
      • “Tobacco remains the leading preventable cause of cancer death in the U.S., despite a dramatic decline in smoking, a new American Cancer Society report says.
      • “More than 80% of lung cancer deaths are linked to tobacco, according to data from the inaugural release of the American Heart Association’s U.S. Tobacco Atlas.
      • “That’s even though cigarette smoking among adults cratered from 42% in 1965 to just 11% in 2023, researchers said.
      • “Quit rates also have skyrocketed, with a record 62% of smokers trying to drop the habit in 2022, the reports say.
      • “However, smokers are shunning the low-dose CT chest scans that are recommended for lung cancer screening, results show.
      • “Only 18% of eligible current or former smokers were up to date with screening in 2022 — such screening can catch cancers early and improve survival odds.”
    • MedPage Today adds,
      • “Though the percentage of U.S. teenagers who vape nicotine has declined in recent years, daily vaping among those already doing so increased, as did unsuccessful quit attempts, a cross-sectional study suggested.
      • “In a pooled sample of more than 115,000 respondents from the Monitoring the Futureopens in a new tab or window survey, prevalence of past-30-day nicotine vaping declined from 17.8% in 2020 to 10.1% in 2024 (RR 0.88, 95% CI 0.86-0.89), reported Abbey Masonbrink, MD, MPH, of the Keck School of Medicine at the University of Southern California in Los Angeles, and colleagues.
      • “However, among more than 15,000 respondents who currently vape, prevalence of daily vaping increased from 15.4% in 2020 to 28.8% in 2024 (RR 1.14, 95%CI 1.11-1.18), they reported in JAMA Network Openopens in a new tab or window. And among more than 3,500 daily vapers, prevalence of unsuccessful quit attempts rose from 28.2% in 2020 to 53% in 2024 (RR 1.08, 95%CI 1.02-1.15).
      • “Despite recent trends in decreasing overall prevalence of nicotine vaping in youth, our research team was concerned about the potential for increasing hardening among current youth users,” Masonbrink told MedPage Today in an email. “As recently evolving nicotine vaping products allow for higher nicotine exposure and known treatment barriers for youth, we wanted to assess for increasing frequency of use and nicotine dependence in this population.”
      • “Ultimately, the study found a “concerning recent trend of increasing trends in daily use among youth who are current users by nearly double and increasing inability to successfully quit, a marker of nicotine dependence, in this population,” she said.”
    • The Wall Street Journal offers advice from Team USA’s doctor on how to avoid becoming ill during air travel.
    • The Washington Post discusses prospects for an experimental pancreatic cancer treatment pill.
      • “Based on early clinical trial results, the Food and Drug Administration in October awarded the drug’s sponsor, biotech company Revolution Medicines, a new and unconventional accelerated review designed to get promising drugs to patients faster than ever. The pancreatic cancer drug, and other medications selected under the “Commissioner’s National Priority Voucher” initiative, will test whether it can expedite novel treatments without compromising the rigor of agency reviews, experts say.” * * *
      • “The FDA’s selection of Revolution Medicines’ daraxonrasib appeared to cement its status as one of the most promising experimental cancer drugs. It also is being studied for treating lung and colorectal cancer.
      • One of the company’s first clinical trials gave daraxonrasib to 83 patients whose pancreatic cancer had spread after undergoing at least one earlier intervention, such as chemotherapy. Over more than 16 months, at least 29 percent of the participants saw their tumors shrink while more than 90 percent saw no tumor growth. The median overall survival was 15.6 months, according to the results, which by some measures is about twice as long as such patients typically fare with standard treatments. Results of its first major, randomized trial, with about 460 patients, are expected next year.”
    • Medscape adds,
      • “A blood-based biomarker test, PancreaSure, demonstrated high sensitivity and specificity in differentiating patients with early-stage pancreatic ductal adenocarcinoma (PDAC) from control individuals at high risk. The test outperformed CA19-9 alone, showing higher sensitivity across two independent clinical validation studies.”
    • Cancer Therapy Advisor notes,
      • “Beginning statin therapy within 36 months of breast cancer diagnosis is linked to improved survival for patients with early-stage disease, compared to patients who do not use statins, according to research published in JAMA Network Open.
      • “These findings highlight the potential of statins as an adjunctive therapy in [breast cancer] treatment, offering a promising avenue for enhancing clinical outcomes,” study researchers wrote.”
    • Per MedPage Today,
      • “Moderate to severe obstructive sleep apnea (OSA) independently correlated with development of cerebral microbleeds seen on brain MRI.
      • “Cerebral microbleeds are considered an early marker of cerebral vasculopathy and are associated with increased risk of developing symptomatic stroke and dementia.
      • “Moderate to severe OSA should be a potential target for early diagnosis and treatment to potentially prevent future strokes and dementia in aging populations, although the study did not assess those outcomes.”
    • and
      • “Survival rates of people with young-onset dementia — dementia diagnosed before age 65 — varied considerably by clinical type, a population-based cohort study in Finland showed.
      • “The median survival for young-onset dementia (also known as early-onset dementia) was 8.7 years, said Eino Solje, MD, PhD, of the University of Eastern Finland in Kuopio, and co-authors.
      • “The shortest survival was seen in people with young-onset frontotemporal dementia (6.9 years) or alpha-synucleinopathy (7.0 years). The longest survival was seen in people with young-onset Alzheimer’s disease (9.9 years) and those with mixed or other dementias (more than 10 years).”
    • Beckers Hospital Review identifies “14 recent drug shortages and discontinuations, according to FDA drug supply databases.”

    From the U.S. healthcare business front,

    • Healthcare Dive reports,
      • “Humana is convinced that it can grow both the size and profitability of its Medicare Advantage business in 2026, despite concerns that the insurer’s plans are too generous and could saddle the company with undesired costs.
      • ‘Executives said they’re confident in their plan pricing and design on a call to discuss Humana’s third quarter results Wednesday morning — though, they noted there are steps Humana can take to manage membership growth if it starts looking like it may get out of hand as open enrollment continues.
      • “Humana said it’s still on track to double pre-tax margins in the privatized Medicare plans next year compared to 2025. But that forecast excludes the impact of quality or “star” ratings. The number of Humana members in highly rated plans dropped for 2026, complicating its path to profit recovery during a difficult time for payers in government programs.”
    • and
      • “Amwell is considering divesting some non-core assets as the telehealth vendor looks to narrow its business focus and improve financial performance, executives said on a third quarter earnings call Tuesday. 
      • “The company is mulling selling legacy assets that could be more easily separated from the rest of the business without creating challenges for customers, executives said. “These are distinct assets that have a certain profile of clients that we could, in fact, cordon off,” said Amwell CFO and COO Mark Hirschhorn.
      • “Amwell already sold its virtual psychiatric care business to fellow telehealth provider Avel eCare for about $21 million early this year.” 
    • and
      • “The fate of bankrupt Prospect Medical Holdings’ two Rhode Island hospitals hangs in a precarious balance this week, as the health system and the state’s attorney general clash in court over Prospect’s desire to close the facilities by year end. 
      • “Prospect sought court approval to close the two safety-net hospitals on Thursday, saying in court documents that the facilities are losing millions each month and that sale conditions imposed by state regulators make a deal untenable.
      • “The Centurion Foundation, the hospitals’ proposed buyer, and attorney general Peter Neronha opposed the motion in their own filings on Monday. Neronha warned closures would be “catastrophic” for patients.”
    • Fierce Healthcare relates,
      • “Hinge Health wrapped up another strong quarter—its second as a public company—as its results beat Wall Street expectations and the company boosted its 2025 outlook.
      • “The virtual physical therapy company, which went public in late May, brought in third-quarter revenue of $154 million, up 53% from the same period a year ago. Wall Street analysts expected revenue of $142 million.
      • “Hinge’s third-quarter revenue performance exceeded the high end of its guidance range of $141 million to $143 million “due to strong billings performance stemming from the continued strength of the company’s underlying fundamentals,” the company’s chief financial officer James Budge told investors and analysts on the company’s third-quarter earnings call Tuesday.”
    • and
      • “Medicare Advantage (MA)-focused insurtech Clover Health saw its revenue climb by 50% year over year in the third quarter, per its earnings report released late Tuesday.
      • “Clover reported $496.6 million in total revenue for the quarter, up from $331 million in the third quarter of 2024. Through the first nine months of the year, revenues were $1.4 billion, compared to the company’s haul of $1 billion through the first three quarters of 2024.
      • “The company also posted a $24.4 million net loss in the quarter, with its losses increasing from $9.2 million in the prior-year quarter. Clover has reported $36.2 million in losses through the first three quarters of the year, up from $20.9 million in losses a year ago.
      • “The company reported $2 million in earnings before interest, taxes, depreciation and amortization.
      • “Our model of care continues to perform well as we bring our technology-powered care to more Medicare Advantage seniors,” said Clover Health CEO Andrew Toy in the earnings release.”
    • and
      • “Carrum Health launched a substance use disorder treatment program for employers a year ago and has now expanded it to include cannabis, cocaine and methamphetamine as employer demand surges.
      • “It’s estimated that 29 million U.S. employees—1 in 6 working adults—are struggling with substance use disorder. Approximately 6.5% of full-time U.S. employees met the criteria for a cannabis use disorder in a 2021-22 study. Another study found that workplace cannabis consumption was highest among workers in states with “recreational” cannabis laws.
      • “This poses a major health challenge for employers, and there’s a critical unmet need for cost-effective prevention and treatment strategies.”
    • The American Journal of Managed Care tells us,
      • “Adequate outpatient follow-up within 30 days significantly reduces 30-day all-cause hospital readmissions, impacting hospital finances and patient care quality.
      • “The study analyzed 83 studies, primarily US-based, showing reduced readmission risks for heart failure and acute myocardial infarction with timely follow-up.
      • “Heterogeneity in study designs and US-centric data limit the generalizability of findings to other health systems.
      • “Authors emphasize considering patient-specific risk factors in prioritizing post-discharge follow-up to optimize outcomes.”
    • Per BioPharma Dive,
      • Novo Nordisk reined in expectations for full-year sales and profit amid expected price cuts and a disappointing third quarter for its obesity drug Wegovy.
      • The Danish drugmaker now expects sales growth of 8% to 11% for the year after previously predicting revenue might expand by as much as 14%. Operating profit will likely grow between 4% and 7%, down from an estimate of as much as 10%, Novo said Wednesday, a shift executives attributed on a conference call to “intensifying competition and pricing pressure.”
      • Sales of semaglutide, sold as Wegovy for obesity and Ozempic for diabetes, continued to rise in the third quarter and together brought in more than 51 billion Danish kroner, or about $7.9 billion. But analysts had been looking for more from Wegovy, and the combined total fell short of Eli Lilly’s rival Zepbound/Mounjaro drug, which became the world’s best-selling medicine in the third quarter with more than $10 billion in revenue.
    • Per Fierce Pharma,
      • “Madrigal’s Rezdiffra generated sales of $287 million in the third quarter for a 35% sequential jump from Q2. In just its fifth full quarter on the market, the world’s first treatment for metabolic dysfunction-associated steatohepatitis (MASH) is now annualizing at more than $1 billion.
      • “While the numbers are heady and a second MASH treatment has recently entered the market, Madrigal says there is significant room for growth. Because the disorder is underdiagnosed, the company figures that competition from Novo Nordisk’s GLP-1 Wegovy—which gained an FDA label expansion to treat MASH three months ago—will help increase the patient pool.
      • “We welcome new entrants to this evolving market. Wegovy’s recent approval in MASH adds momentum to a market that’s just starting to take shape,” Madrigal CEO Bill Sibold said on a quarterly conference call. “Novo is targeting a much larger population, which will raise awareness and drive more screening, diagnosis and treatment.”