Thursday report

CDC

Thursday report

David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Modern Healthcare reports,
    • “Enhanced subsidies for health insurance exchange plans would be extended for three years under a plan Senate Minority Leader Chuck Schumer (D-N.Y.) announced Thursday.
    • “The enhanced premium tax credits for marketplace policies expire at the end of the year, leading to significant cost increases for exchange enrollees in 2026. The Senate Democrats who sided with the Republican majority to end the government shutdown last month secured a promise from Majority Leader John Thune (R-S.D.) to hold a vote on the issue, which is slated for next week.
    • “Schumer described the Senate measure, which mirrors a House Democratic plan, as a “clean” extension that wouldn’t make other changes to Affordable Care Act of 2010 programs.
  • Fierce Healthcare adds,
    • “Congress is running out of time to address the expiring Affordable Care Act subsidies before many individuals are exposed to massive cost increases Jan. 1, and new plans are emerging on the Hill to tackle the challenge.
    • “A bipartisan group of 35 legislators—including 15 Republicans—in the House has introduced a plan that would extend the tax credits for one year with some modifications, such as a new income limit, according to a report in The New York Times. 
    • “The proposal also includes a second shift in year two, implementing more substantial reforms such as eliminating $0 premium plans except in cases where there is a need. Each piece of the plan would require a separate congressional vote, the NYT reported.
    • “Rep. Josh Gottheimer, D-N.J., said the lawmakers are urging for a vote on the package by Dec. 18 to “get something done before premiums rise in January,” per the NYT. Most of the Republicans who have signed on to the package represent districts where the race is expected to be competitive in the midterms next year, according to the article.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, is cosponsoring legislation alongside Finance Chairman Mike Crapo (R-Idaho), Ranking Member Ron Wyden (D-Ore.) and 18 senators to improve accountability and oversight of pharmacy benefit managers (PBMs) and bring down the price of prescription drugs for Americans. Grassley is an original cosponsor of the legislation, called the PBM Price Transparency and Accountability Act.
    • “Iowans at my 99 county meetings are fed up with the high cost of prescription drugs, and for good reason. PBMs are driving local pharmacies in Iowa out of business and making it harder for Iowans to access the medications they need. That’s why I’m introducing legislation with my colleagues to put patients over pharmacy benefit managers by shining a light on the complex and opaque tactics these middlemen use. This landmark bill builds on the bipartisan legislation I spearheaded during my time as Finance Chairman, and includes several proposals I helped craft,” Grassley said.
    • “The Grassley–led provisions included in the bill would:
      • “Increase PBM reporting requirements to Medicare Part D plan sponsors and the Department of Health and Human Services;
      • “Require retail community pharmacies and certain other pharmacies to participate in the National Average Drug Acquisition Cost (NADAC) survey; and
      • “Ban PBM spread pricing in the Medicaid program.”
  • Fierce Pharma tells us,
    • “The Centers for Disease Control and Prevention’s (CDC’s) newly reworked Advisory Committee on Immunization Practices (ACIP) met Thursday to finally offer its recommendations for a universal hepatitis B virus (HBV) vaccine for newborns, only to fall to the same pattern of debate and uncertainty that derailed its last attempt to vote on the matter.
    • ‘Day one of the ACIP’s meeting this week was meant to pick up where the committee left off on the HBV topic during its September meeting, when it scrapped its planned vote amid confusion on specific voting language. The committee was scheduled to officially clear the air with a vote Thursday afternoon, following a morning of discussion and commentary from stakeholders, according to the final agenda.
    • “Things didn’t quite go to plan, however. After a few hours of debate on the voting language at hand, the only vote that occurred Thursday was a 6-3 agreement on a motion to push back the HBV vote until Friday morning.” * * *
    • “A planned HBV vote Friday will further crowd the schedule for the day, which is set to include additional discussion on the childhood immunization schedule, comparisons to the Danish vaccine schedule and a presentation on “aluminum exposure” from childhood vaccines and potential implications for asthma later in life, the agenda reads.” 
  • The American Hospital Association News notes,
    • “The AHA released a report Dec. 4 that found patient safety in hospitals and health systems across the nation continues to improve. The report, which uses data analyzed by Vizient, examined key safety and quality metrics from the fourth quarter of 2019 to the second quarter of 2025. It found that despite caring for a sicker patient population, hospitals’ focus on safety led to improved patient outcomes and reduced infections.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday. 
    • “While historically the FDA has required two trials for added assurance of a drug’s safety and efficacy, it has become increasingly flexible and many drugmakers already submit just one pivotal clinical trial for approval. Makary said that while the agency will still require two in some cases, the default will be one trial.
    • “You can achieve the same statistical power with one trial as you would with two trials when it’s designed and controlled appropriately,” Makary told STAT by phone.” * * *  
    • “The agency will publish a press release soon, a spokesperson told STAT. Makary said the agency will also start updating policies to reflect the change, which could take three to six months. The change will take effect once the guidance is updated.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy. Breyanzi is a chimeric antigen receptor CAR T-cell therapy that genetically engineers a patient’s own T-cells to target and kill cancer cells.”
  • Per MedTech Dive,
    • “Medtronic said Wednesday it obtained U.S. clearance for its Hugo system in urologic procedures, positioning the medtech giant to challenge Intuitive Surgical in the world’s largest robotic surgery market.
    • “In addition to the initial urology indication, which includes common procedures such as prostate removal, the company plans to extend use of the robot to more surgical specialties in the U.S. over time, with general surgery and gynecology expected to follow next.
    • “The Food and Drug Administration clearance “means there is now choice” for hospitals looking to expand their robotic programs, Rajit Kamal, Medtronic’s vice president and general manager of robotic surgical technologies, said in a statement.”
  • and
    • “Olympus has updated the instructions for a device used with endoscopes to prevent or control bleeding, the Food and Drug Administration said Wednesday.
    • “As of Oct. 1, Olympus had reported 113 serious injuries and no deaths associated with problems releasing or detaching its PolyLoop ligation loop device, according to the FDA and its Australian counterpart.
    • “The FDA categorized the correction as a Class I recall because of the potential for the problems to result in severe tissue injury, bleeding, perforation, additional surgical intervention, extensive procedural delays and hospitalization.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has announced that Glycar SA, a South African medical device company, is recalling certain SJM Pericardial Patches with EnCap Technology due to potential issues with their strength and durability.
    • “The recall only covers one specific lot of these patches: lot T2502257. That lot included some devices that are 5 cm x 10 cm and others that are 9 cm x 14 cm. 
    • “The impacted lot may not meet the required tensile strength specification,” according to the FDA’s advisory. “Possible change in tensile strength is not detectable to the user intraoperatively. Postoperative loss of the patch’s mechanical properties causing dehiscence or rupture may require reintervention or reoperation, depending on the clinical indication that the patch was used for.”
    • “This is a Class I recall, which means the FDA believes using these devices could cause “serious adverse health consequences or death.” At this time, however, no serious injuries or deaths have been linked to the issue.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court cleared Texas to use a new Republican-drawn congressional map for next year’s election, bolstering GOP hopes of picking up as many as five new House seats in the state.
    • “Over three dissents, the justices lifted a lower court ruling that had blocked the map, which was drawn at President Donald Trump’s behest to help Republicans try to keep their House majority in the midterm election.
    • “The Supreme Court order applies only until the justices resolve the state’s appeal, and the decision doesn’t dictate whether the map can be used beyond 2026. 
    • “The unusual Texas mid-decade redistricting set off a partisan fight across the nation, prompting about a dozen states to either redraw their maps or consider doing so.
    • ‘It’s not clear whether Republicans will ultimately benefit from the frenzy. Californians voted in November to redraw that state’s districts, potentially flipping five House seats to the Democratic side. The new California map is being challenged in another case likely to reach the Supreme Court.”
  • Federal News Network relates,
    • “Federal employee unions are asking a court to block the State Department’s imminent plans to finalize layoffs for hundreds of employees, as well as reverse more layoffs than agencies have allowed under a spending deal that ended the recent government shutdown.
    • “The American Federation of Government Employees and the American Foreign Service Association are leading an emergency request for a temporary restraining order that would prevent the State Department from officially separating hundreds of employees from the agency.
    • “The emergency request, filed with the U.S. District Court for the Northern District of California, asks the court to bar the “imminent and unlawful execution” of hundreds of reduction in force notices the State Department sent this summer.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “A single HPV vaccination appears just as effective as two doses at preventing the viral infection that causes cervical cancer, researchers reported Wednesday.
    • “HPV, or human papillomavirus, is very common and spread through sex. Most HPV infections clear up on their own but some linger, causing cancers that appear years later, including cervical cancer in women and rarer cancers in both women and men.” * * *
    • “The U.S. recommends two HPV shots starting at age 11 or 12 for most girls and boys — as the virus also can cause head-and-neck and other cancers. Catch-up shots are recommended for anyone through age 26 who hasn’t been vaccinated. The Centers for Disease Control and Prevention has reported about 78% of 13- to 17-year-olds have gotten at least one dose.”
  • The Washington Post adds,
    • “The American Cancer Society has endorsed self-collected vaginal samples for cervical cancer screening — a change medical experts say will help expand access and improve detection.
    • “The updated ACS recommendations, released Thursday, reflect advancements in disease detection and access to screening options in the United States. The guidelines say self-collection to test for human papillomavirus, or HPV, a sexually transmitted infection that causes nearly all cervical cancer cases, is an acceptable option. But clinician-collected cervical samples are still preferred. The recommendations also offer new guidance on when people can stop being screened for cervical cancer.
    • “Self-collection could be “a game changer” for increasing screening, said Jane Montealegre, an associate professor in the department of behavioral sciences at the University of Texas MD Anderson Cancer Center.”
  • Beckers Hospital Review informs us,
    • “The Anesthesia Patient Safety Foundation and the Institute for Safe Medication Practices issued a joint warning urging hospitals to eliminate vials and ampules of tranexamic acid from perioperative settings due to the risk of fatal wrong-drug, wrong-route errors, according to a news release shared with Becker’s.
    • “The warning follows multiple reports of mix-ups in high-risk areas such as the operating room, labor and delivery, and emergency departments, where intravenous tranexamic acid has been mistakenly administered intrathecally instead of local anesthetics such as bupivacaine or ropivacaine, a “never event” with a mortality rate of up to 50%, according to a Dec. 3 news release. Survivors may experience permanent neurological harm.
    • “In response, the FDA added a boxed warning to the drug’s label, clarified that tranexamic acid is contraindicated for neuraxial injection and updated administration instructions to emphasize intravenous use only.”
  • Per Healio,
    • “Approximately 54% of individuals in the U.S. are affected by a neurological disorder, with headache the most prevalent.
    • “Stroke, Alzheimer’s disease and related dementias were the leading causes of health loss.”
  • and
    • “Most common pediatric infections only need 5- to 7-day antibiotic courses, but many providers still provide 10-day courses.
    • “Matthew Kronman, MD, MSCE, offers tips for discussing treatment plans with parents.”
       
  • Per Health Day,
    • “A painkiller could be tricking doctors into misdiagnosing heart failure.
    • “Gabapentinioids cause fluid retention, leading to swelling in the legs and feet.
    • “Many doctors chalked this side effect up to more dire conditions like heart failure.”
  • Medscape considers the pregnancy puzzle facing women stopping GLP-1s.
  • Genetic Engineering and Biotechnology News reports,
    • “A new paper published in Science Translational Medicine describes an experimental drug capable of repairing DNA damage caused by disease. Developed by scientists at Cedars-Sinai, the potential treatment is a prototype for a new class of medications that fix tissue damage caused by heart attacks, inflammatory disease, and other conditions. Details of the drug, dubbed TY1, can be found in the paper titled “Augmentation of DNA exonuclease TREX1 in macrophages as a therapy for cardiac ischemic injury.”  
  • and
    • “The microbes inside our bodies not only help break down food but also impact our health. Yet their precise influence is not always understood, especially in the presence of prescription drugs. Researchers at Princeton University Department of Chemistry have now reported how one of the most abundant gut bacteria, Bacteroides dorei, responds to tetracyclines, a class of commonly prescribed antibiotics.
    • “Using a technology known as UPLC-MS-guided high-throughput elicitor screening (HiTES), Mohammad R. Seyedsayamdost, PhD, and colleagues, examined how the metabolome of this commensal bacterium responds to hundreds of FDA-approved drug molecules. The team’s findings indicate how newly characterized signals released by the bacterium in response to tetracycline antibiotics could aid the host’s immune response, inhibit pathogens, and restructure the gut microbiome.”

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

  • Beckers Payer Issues relates,
    • “The 12 months since UnitedHealthcare CEO Brian Thompson was fatally shot have been among the most turbulent in UnitedHealth Group’s history. The company has cycled through senior executives, disclosed billions in unexpected medical costs, confirmed it is under criminal investigation by the Justice Department, and watched its stock plunge by around 50%. Here’s where things stand as the year comes to a close.”
  • Modern Healthcare lets us know,
    • “Humana Inc. is working with billionaire Mark Cuban on a potential pharmacy partnership, Cuban and Humana’s chief executive officer said at a conference Thursday, a move that could step up pressure on larger pharmacy middlemen.
    • “The remarks at the Forbes health care conference were light on details of the collaboration. Cuban, through his Cost Plus Drugs company, sells mail-order medications directly to consumers for transparent prices. Humana, which primarily sells Medicare health plans, is also expanding its pharmacy business through its CenterWell division.
    • “Cuban said he was talking to Humana about “putting together direct-to-employer programs” that would bypass traditional layers in the drug supply chain.
    • “Humana CEO Jim Rechtin said he aimed to “simplify” the process of getting drugs from manufacturers to patients. “How do you get rid of all that complexity?” he said.”
  • Fierce Healthcare informs us,
    • “Over the summer, Aetna made a commitment to ease friction for both patients and providers.
    • “Now, the company is offering a look at the progress it’s made toward that goal. The insurer, a subsidiary of healthcare giant CVS Health, said in an announcement that it is leaning on technology to make bundled prior authorization determinations. 
    • “Previously, authorization requests for medical claims and pharmacy claims needed to be submitted separately. For instance, a patient seeking in vitro fertilization treatment would need to have a request sent for the procedure itself, followed by a second request for the necessary medications, Aetna said.
    • “Beginning in November, however, providers could submit medical prior authorization requests to Aetna, and if approved, the associated medications under the pharmacy benefit are also approved automatically.
    • “In addition, in the same month, Aetna rolled out a bundled prior authorization offering in the musculoskeletal space, according to the announcement. That offering includes key x-rays, knee arthroplasty procedures, non-opioid pain medications, durable medical equipment and inpatient admissions if needed.
    • “The insurer launched similar prior auth bundles for lung, breast and prostate cancer earlier this year, Aetna said.”
  • and
    • “Angle Health, a payer working with employers, has raised $134 million in an oversubscribed series B round.
    • “The round was led by Portage alongside existing investors Blumberg Capital, SixThirty Ventures, Y Combinator and others. The raise included a combination of debt and equity, bringing total funding to nearly $200 million. The company plans to continue scaling operations to meet surging demand for alternative payer products. 
    • “Powered by an integrated, artificial-intelligence-enabled platform, Angle Health offers a digital-first care navigation experience with customizable plans for employers. It integrates medical and pharmacy data, demographic information, real-time claims patterns and population health data to help employers spot risk and design interventions accordingly. 
    • “The healthcare benefits ecosystem wasn’t designed for the small-to-medium-sized businesses that employ nearly half of America’s workforce, and legacy technology can’t deliver on the efficiencies and savings unlocked by AI,” Ty Wang, co-founder and CEO of Angle Health, said in a press release. “We’re rebuilding healthcare infrastructure and care pathways to give all employers access to the comprehensive benefits historically reserved for large enterprises.”
  • Per MedTech Dive,
    • “Medtronic began the U.S. rollout on Tuesday of its latest insulin pump system paired with a glucose sensor made by Abbott. The partnership marks a new foray for Medtronic, which has typically paired its insulin pumps and pens with its own continuous glucose monitors in the past.
    • “Abbott and Medtronic announced the partnership last year, with Abbott developing a new glucose sensor exclusively for Medtronic. The sensor, called Instinct, has a 15-day wear time, longer than any of Medtronic’s current CGMs.” 
  • The New York Times reports,
    • “People are Uploading their medical records to A.I. chatbots
    • “Despite privacy risks and inaccuracy concerns, people are feeding blood test results, doctor’s notes and surgical reports into ChatGPT and the like.”
  • McKinsey & Co. explains how to “unlock value with process intelligence in healthcare and beyond.”
    • “Process intelligence gives organizations a clear view of how work really happens, helping them uncover inefficiencies, streamline operations, and lay the foundation for success in an AI-powered future.”

Midweek Update

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

From Washington, DC

  • Fierce Pharma reports,
    • “The U.S. House of Representatives has given a unanimous thumbs-up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December of last year.
    • “Rep. Michael McCaul, R-Texas, introduced the legislation in February alongside support from five other Republican Congressmen and five Democrats. The bill now advances to a Senate vote.
    • “By strengthening incentives for pediatric drug development, restoring essential programs such as the FDA Rare Pediatric Disease Priority Review Voucher, and ensuring that life-saving therapies reach the children who need them most, we are making meaningful progress,” Rep. Gus Bilirakis, R-Fla., said in a release.”
  • The Government Accountability Office today published a report titled “Patient Protection and Affordable Care Act:Preliminary Results from Ongoing Review Suggest Fraud Risks in the Advance Premium Tax Credit Persist.”
    • “This report discusses the preliminary results of our work on fraud risk management in the advance premium tax credit—a subsidy that the government pays to insurance companies to make premiums more affordable for eligible Americans under the Affordable Care Act.
    • “So far, we’ve found that fraud risks have persisted since we first reported on this (2014-2016). For example, we were able to get subsidized insurance for fake enrollees. We also found some issues with enrollees’ Social Security numbers that could indicate identity fraud.
    • “The program’s fraud risks were last assessed in 2018, even though the program and its risks have since evolved.”
  • Similarly, on November 24, the U.S. Office of Personnel Management’s Office of Inspector General published a capstone report on the agency’s implementation of the Postal Service Health Benefits Program. One key issue regarding confirmation of dependent eligiblity remains open.
    • The FEHBlog’s internal control concern is that OPM fails to use the HIPAA 820 electronic enrollment roster transaction with FEHB and PSHB carriers. The HIPAA 820 transaction, whihc has been around since 2008, allows carriers to tell whether a particular enrollee is paying a premium and if so is paying the correct premium. Bear in mind that half of the FEHB enrollment is self only. The HIPAA 820 transaction will produces savings that would cover the cost of implementation.
  • FedWeed reminds us,
    • Flexible spending account “participants may carry over part of the account for use in the next year, so long as they have accounts for that following year. For unspent 2025 money carried into 2026, that limit is $660 (for unspent 2026 health care account money eligible to be carried into 2027, the limit will be $680).”
  • and
    • “Next Monday (December 8) is the last day of the current open season to enroll or change coverage for 2026 under the FEHB and PSHB health insurance programs and the FEDVIP vision-dental insurance program, or to newly enroll or re-enroll in the FSAFEDS flexible spending account program.”
  • Per an OPM news release,
    • “The U.S. Office of Personnel Management (OPM) today announced the release of a new mandatory training program, “Performance Management for Supervisors,” designed to equip federal supervisors with the essential skills needed to lead high-performing, engaged teams.
    • “The training, now available through the Federal Performance Management Toolkit focuses on an array of topics including employee recognition and awards, hiring and discipline, drafting effective performance goals, delivering meaningful feedback, and taking timely corrective action.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced strong actions to protect the rights of parents within the practice of pediatric medicine. HHS opened an investigation into a complaint that a Midwestern school illegally vaccinated a child with a federally provided vaccine without the parents’ consent by ignoring a religious exemption submitted under a state law. HHS also issued a Dear Colleague letter [PDF, 265 KB] reminding health care providers about federal law requiring them to provide parents access to their children’s health information. In addition, the Department directed the Health Resources and Services Administration (HRSA) to add a grant requirement stating that all funding recipients must comply with all applicable federal and state parental-consent laws for any services or care provided to minors at HRSA-supported health centers as a condition of receiving Health Center Program funds.”
  • The American Hospital Association News notes,
    • “The Centers for Medicare & Medicaid Services has updated its GitHub repository with new resources to help hospitals comply with changes to hospital price transparency requirements finalized in the Medicare hospital outpatient prospective payment system final rule for calendar year 2026.”
  • STAT News points out,
    • “A new health care advocacy group, which will represent the shrinking number of independent doctors in America, is launching Wednesday with an ambitious policy agenda.
    • “IndeMed, which expects to represent nearly 70,000 members at its launch, will take on a host of issues important to doctors wanting to resist the wave of consolidation in recent years, its leaders told STAT. The group’s agenda includes reducing the burden of prior authorization, promoting transparent and fair reimbursement from payers, encouraging new practice models, fighting consolidation, and reforming the No Surprises Act.
    • “The group, through its nonprofit and associated political action committee, will push for changes in Washington as well as in states, and plans to offer members a state-by-state advocacy playbook.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Former Food and Drug Administration commissioners said new vaccine standardsthreaten to put Americans’ health at risk and upend the agency’s scientific integrity.
    • “The 12 former FDA leaders criticized the agency’s actions under vaccine skeptic Health Secretary Robert F. Kennedy Jr., in a joint piece published by the New England Journal of Medicine Wednesday.
    • “The authors make up nearly all of the living former FDA commissioners and acting commissioners, including Dr. Scott Gottlieb, who served during President Trump’s first term, and Dr. Robert Califf, who helmed the agency during the Obama and Biden administrations. 
    • “The article takes aim at the FDA’s plans for new vaccine standards detailed by vaccine division director Dr. Vinay Prasad that the former leaders said would drastically change vaccine regulation and “undermine public interest.” 
    • “In an email to staff last week, Prasad said the FDA will change its annual flu vaccine framework and require companies to submit larger studies about the effects of administering several vaccines at once.” 
  • STAT News tells us,
    • “Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be the next leader of the Center for Drug Evaluation and Research, according to an announcement from the FDA.
    • “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” Høeg said in a statement. “This is an incredible opportunity to serve my fellow Americans.”
    • “Høeg’s appointment as the agency’s top drug regulator comes after director Richard Pazdur filed paperwork to retire at the end of the month.”
  • Healio points out,
    • “The FDA has approved an adeno-associated virus 9 gene replacement therapy to treat individuals aged 2 years and older with spinal muscular atrophy and a confirmed mutation of the survival motor neuron 1 gene, according to the manufacturer.
    • “In a press release, Novartis said the FDA’s approval positions Itvisma (onasemnogene abeparvovec-brve) as the first and only gene replacement therapy available to treat individuals with spinal muscular atrophy (SMA), a rare neuromuscular condition, virtually across the entire lifespan.”
    • “Itvisma is administered with a one-time fixed intrathecal dose that does not require adjustment based on a patient’s age or body weight, per the release. The drug is expected to be available within the U.S. in December.”

From the public health and medical / Rx research front

  • The University of Minnesota’s CIDRAP relates,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 30 more measles cases reported in the United States this past week, raising the national total to 1,828 confirmed cases so far in 2025. 
    • “Current US hot spots are Utah, Arizona, and South Carolina, where outbreaks among predominately unvaccinated or under-vaccinated people have led to community spread and widespread quarantines at schools. 
    • “In total, the country has had 46 outbreaks this year of three or more cases; for comparison, 16 outbreaks were reported during all of 2024.” 
  • Health Day tells us,
    • “As many as 1 in 4 breast cancers occur in women younger than 50, a new study has found.
    • “Among seven outpatient clinics in the New York region, 20% to 24% of breast cancers were found in women 18 to 49, according to results presented Monday at the Radiological Society of North America’s annual meeting in Chicago.
    • “This research shows that a significant proportion of cancers are diagnosed in women under 40, a group for whom there are no screening guidelines at this time,” researcher Dr. Stamatia Destounis, a radiologist with Elizabeth Wende Breast Care (EWBC)  in Rochester, New York, said in a news release.
    • “The U.S. Preventive Services Task Force recommends mammography every other year starting at 40 and continuing through age 74, researchers noted. 
    • “The American Cancer Society recommends annual mammograms starting at age 45, but added that women can choose to begin breast cancer screening as young as 40.”
  • MedPage Today reports,
    • “Vaccination against herpes zoster, or shingles, was tied to fewer deaths among people with dementia, an analysis of data in Wales showed.
    • “Dementia patients who received the live-attenuated zoster vaccine (Zostavax) had a 29.5 percentage point decrease (95% CI 0.6-62.9, P=0.046) in dementia-related deaths over 9 years, reported Pascal Geldsetzer, MD, PhD, of Stanford University in California, at the annual Clinical Trials on Alzheimer’s Diseaseopens in a new tab or window (CTAD) annual meeting. The findings were published simultaneously in Cellopens in a new tab or window.
    • “Zoster vaccination also was tied to a drop of 3.1 percentage points (95% CI 1.0-6.2, P=0.007) in mild cognitive impairment cases during that period, Geldsetzer added.
    • “Our findings suggest that the live-attenuated herpes zoster vaccine has a beneficial effect at both ends of the disease course of dementia,” he said.
    • “They also hint that the shingles vaccine might slow dementia progression, he noted.”
  • BioPharma Dive reports,
    • “Data from a closely watched study evaluating Bristol Myers Squibb’s mind-stabilizing medicine Cobenfy in patients with Alzheimer’s disease could now come a year later than expected.
    • “In late July, Bristol Myers executives said they were reviewing the company’s near-term clinical trials to ensure the “timely delivery” of results with the “highest probability of success.” The review included “ADEPT-2,” a late-stage experiment exploring whether Cobenfy, which is already used to treat schizophrenia, may also have positive effects on the moderate to severe psychosis that often accompanies Alzheimer’s.
    • “On Wednesday, Bristol Myers disclosed that it had identified “irregularities” in the way the study was conducted at a “small number” of sites. This discovery prompted the company to not only exclude patient data from those sites for the study’s primary analysis, but, after consulting with the Food and Drug Administration, also bring in an “independent party” to assess the data that had been collected.
    • “Based on that party’s findings, a data monitoring committee recommended the trial keep going and enroll more participants so as to hit its original target. Bristol Myers is following this advice. ADEPT-2 had recruited around 400 patients across 119 locations, according to its listing on a federal database of clinical trials.
    • “The company now expects results to come by the end of 2026.”
  • and
    • “Pharvaris said Wednesday its pill for the rare swelling disorder hereditary angioedema succeeded in a Phase 3 trial, helping to begin relieving symptoms of an attack within 1.28 hours, significantly faster than a placebo.
    • “The Netherlands-based biotechnology company said it plans on asking the Food and Drug Administration in the first half of 2026 to approve deucrictibant. An extended release formulation of the medication is also in a Phase 3 trial to test whether it can prevent HAE attacks, with data expected next year.
    • “If approved, deucrictibant would be entering an increasingly competitive market. The first oral HAE drug to relieve attacks, Kalvista’s Ekterly, got an FDA nod this year, while two injectable drugs, including one to relieve attacks, also recently launched.”

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

  • Modern Healthcare lets us know,
    • ‘Startup health insurance company Curative has raised more than $150 million in a funding round that pushes the company’s value at about $1.28 billion.
    • “Curative works to address skyrocketing employer health insurance expenses as inflation, pricey drugs and chronic diseases drive up costs.
    • “The company expects 2026 to be its first profitable year since the pandemic, and projects $570 million in revenue for this year.” * * *
    • “Curative’s approach differs from typical insurers. It eliminates cost-sharing like copays and deductibles for care in its network, as long as members complete an annual visit with a primary care provider and a “navigator” who guides their care, said Fred Turner, the company’s co-founder and chief executive.”
  • and
    • “Direct-to-consumer telehealth company Hims & Hers Health said Wednesday it has agreed to acquire YourBio Health, a medical device company that develops blood sampling technology.
    • “Financial terms of the transaction were not disclosed. 
    • “The deal is slated to close early next year pending customary closing conditions, according to a release.” * * *
    • “The acquisition will allow Hims & Hers to add YourBio Health’s TAP device, which uses smaller, thin needles to collect capillary blood samples in a way that differs from traditional methods, into its offerings. 
    • “YourBIO CEO Paul Owen and Chief Scientific Officer Dr. Michael Mina will join Hims upon completion of the deal, the company announced.”
       
  • The American Hospital News tells us,
    • “The AHA Dec. 3 released its 2026 Health Care Workforce Scan — an annual snapshot of America’s hospital and health system employment based on reports, studies and other data sources from leading organizations and researchers. It also offers insights and strategies from peers and experts on navigating the future of the health care workforce.”
  • Beckers Hospital Review identifies five health systems launched this year.
  • Per MedCity News,
    • “Samsung Healthcare unveiled a new ultrasound system this week designed to boost diagnostic accuracy and efficiency. 
    • “The system, named the R20, finally brings the full weight of Samsung Electronics’ AI and semiconductor capacity into an ultrasound platform, said Tracy Bury, chief commercial officer and vice president of global growth initiatives at Samsung Healthcare during an interview Tuesday at the Radiological Society of North America’s annual conference in Chicago.
    • “The R20 system pairs Samsung’s imaging hardware with improved beamforming software, which helps produce sharper, more consistent images, she stated. It supports a wide spectrum of imaging use cases, such as abdomen, thyroid, musculoskeletal, vascular, breast, gynecology and urology.” 
  • “MedTech Dive discusses “PitchBook: AI tuck-in deals to drive M&A acceleration in 2026. Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.”
    • “The medtech industry is approaching 2026 in an improving position, with investors increasingly optimistic and funding rebounding, PitchBook said in its outlook for next year.
    • “PitchBook analysts said strategic investors are targeting companies that are approaching clinical milestones in cardiology, orthopedics and diagnostics. The analysts named neurostimulation, artificial intelligence-powered surgical navigation and precision medicine as other top areas to watch.
    • “Tariffs on China-sourced components are a manageable, persistent headwind, the analysts said, but the potential for more levies is a risk. PitchBook sees Medline’s planned initial public offering as a strong indication that tariff uncertainties are now less top of mind.”

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.”

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Hill reports,
    • “President Trump on Tuesday said he would prefer not to extend Affordable Care Act subsidies that are set to expire at the end of the year, but he acknowledged it may be necessary to reach an agreement on health care legislation.
    • “Trump, in response to a question from The Hill, told reporters his preference was to pass legislation that gave money directly to Americans to allow them to purchase their own health care plan.
    • “I like my plan the best. Don’t give any money to the insurance companies, give it to the people directly. Let them buy their own health care plan. And we’re looking at that. If that can work. We’re looking at that,” Trump said.
    • “Asked if he is planning to extend the Affordable Care Act subsidies that were at the heart of the government shutdown debate, Trump said he’d “rather not.”
    • “Somebody said I want to extend them for two years. I don’t want to extend them for two years. I’d rather not extend them at all,” Trump said. “Some kind of extension may be necessary to get something else done, because the un-Affordable Care Act has been a disaster.”
    • “Trump told reporters he was talking with Democrats about health care, but when asked who specifically, he would not say.”
  • Roll Call adds,
    • “The front-runner to be the next top Republican on the House Budget Committee is eyeing a potential second reconciliation bill that could include tax and health care provisions that were dropped from the GOP’s “big, beautiful” package last summer.
    • “Rep. Lloyd K. Smucker, R-Pa., the first entrant and heavy favorite in the race to succeed retiring Budget Chairman Jodey C. Arrington, R-Texas, said he would like to see an extension of the Work Opportunity Tax Credit as part of a future reconciliation bill.
    • “That credit goes to employers who hire individuals from groups that face barriers to employment, such as veterans, ex-felons and recipients of Supplemental Nutrition Assistance Program benefits, among others. The credit is set to expire at the end of this year.
    • “I think there were a number of pieces of tax policy that were not included in the bill that we did, and I’d love to see some of those provisions passed,” he said.
    • “Speaker Mike Johnson, R-La., has pushed to do a second — and even a third — reconciliation package before the midterm elections, although the contours of a follow-up bill are still far from clear. But President Donald Trump has said he believes the reconciliation law that he signed in July is sufficient and that additional legislation is not necessary.”
  • The Wall Street Journal relates,
    • “The U.S. government negotiated lower prices in the federal Medicare program for 15 high-selling medicines including Ozempic, widening an effort to rein in drug costs.
    • “The new prices, which will take effect in 2027, shave 38% to 85% off the list prices for drugs for diseases including asthma, cancer and diabetes. The reductions are estimated to save Medicare, the health-insurance program for the elderly, $12 billion.
    • “For some patients, the lower prices could reduce spending on copays or other out-of-pocket charges imposed by their particular plan. Other patients taking the drugs might not see a direct savings, however, because they have fixed monthly copays. 
    • “Also, Medicare members now have a $2,000 annual cap on out-of-pocket drug costs. Yet the savings could help curb growth in plan premiums.
    • “In addition to Ozempic, other drugs that will cost Medicare less thanks to the negotiations include GSK’s Trelegy asthma treatment, Pfizer’s breast-cancer therapy Ibrance and Merck diabetes pill Janumet—all of them huge sellers.
    • “The price cuts apply to Medicare, not to private health-insurance plans. Medicare spends more than $150 billion a year on prescription drugs, and the cuts will mean reduced revenue for drugmakers. Yet some companies say the impact will be modest. 
    • “Some of the muted effect is because drugmakers already provide rebates and discounts to Medicare drug-benefit plans on many drugs. So, the negotiated prices aren’t as much of a discount off net prices as they are from list prices.”
  • Here’s a link to the CMS news release about the 2027 Medicare drug price negotiations.
  • Bloomberg adds,
    • “The Trump administration on Tuesday proposed a rule cementing changes to patient cost-sharing in Medicare’s Part D prescription drug benefit and updating the methodology used to rate private Medicare Advantage plans.
    • “If finalized, the rule, RIN 0938-AV63, would implement changes to Part D that Congress enacted as part of the Inflation Reduction Act under President Joe Biden, and update the methodology used to award insurers quality “star ratings” that determine bonuses and marketing privileges. The changes would take effect in 2027.” * * *
    • “The CMS also proposed eliminating star ratings measures that it said were based on “administrative processes” and not indicative of a plan’s quality. The agency is also proposing to forgo a change related to enrollees with social risk factors, and to add new measures focused on treating depression.
    • “The proposal would also allow Medicare Advantage members a special enrollment period when their doctor leaves their network.”
  • Here’s a link to the CMS fact sheet on this proposed rule.
  • Healthcare Dive offers a good summary of the Medicare changes found in the outpatient facility pricing final rule released last Friday. For example,
    • “Hospital outpatient departments currently receive higher reimbursement for providing the same services compared with freestanding physician offices and ambulatory surgery centers — a policy critics say drives up costs for patients and Medicare. 
    • “In the latest payment rule, the CMS finalized a regulation that would reimburse off-campus outpatient departments owned by hospitals at the same rates as physician offices for drug administration services. 
    • “That change should cut outpatient spending by $290 million in 2026, with $220 million of the savings going to Medicare and $70 accruing to beneficiaries, according to the CMS. 
    • “Additionally, the agency is moving to phase out the inpatient only list, a list of which surgical procedures have to be furnished in hospitals, over three years. The CMS will start with removing 285 mostly musculoskeletal procedures next year.
    • “The American Hospital Association lambasted the site-neutral policy changes, arguing they ignore the differences between care delivery at hospital outpatient departments and other care sites.” 
  • The Wall Street Journal reports,
    • “The Centers for Disease Control and Prevention appointed Louisiana surgeon general Dr. Ralph Abraham as the second in command, the latest move in a year of upheaval for the agency.
    • “Abraham, a vaccine skeptic, has been named the deputy principal director of the CDC. The agency has shuffled through multiple leaders since Health Secretary Robert F. Kennedy Jr., also a vaccine skeptic, began overseeing the CDC earlier this year.
    • “Kennedy’s views on vaccines have caused turmoil at the agency. Susan Monarez, the former CDC director, said she was ousted after refusing to approve all future recommendations from a vaccine advisory panel filled with Kennedy’s appointees and refusing to fire CDC vaccine-policy officials. Jim O’Neill, Kennedy’s deputy, is currently serving as the CDC’s acting director.
    • ‘Most recently, a CDC webpage that previously said vaccines don’t cause autism now says they might—an assertion former CDC employees and doctors outside the agency have fervently disagreed with.
    • “Abraham was appointed the Louisiana surgeon general last year and later criticized government vaccine mandates. He condemned Covid-19 vaccine mandates earlier this year as “an offense against personal autonomy that will take years to overcome.” * * *
    • “The family-medicine doctor and veterinarian also represented Louisiana in Congress from 2015 to 2021.”
  • Tammy Flanagan, writing in Govexec, opens her Mailbag: Retirement applications and processing/ A look at common retirement-processing snags, what causes delays and where OPM’s newer systems fit into the picture.”

From the Food and Drug Administration front,

  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil Speed Control Dials used with the SmartDrive MX2+ Power Assist Device for wheelchairs after identifying a design issue that can lead to unexpected behavior of the SmartDrive motor. The FDA said Max Mobility/Permobil reported two serious injuries associated with the issue.
    • “In addition, the FDA issued an early alert for certain Fresenius Kabi Ivenix LVP Primary Administration Sets due to an assembly defect.”
  • Per Fierce Pharma,
    • “AstraZeneca’s Imfinzi is adding yet another landmark perioperative label to its belt with a new FDA approval that gives the drug the title of the first and only immunotherapy marketed to treat early-stage stomach cancer patients both before and after surgery.
    • “With the nod, Imfinzi can be added to standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) to treat adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. The approval specifically allows Imfinzi to be used with chemotherapy before surgery, then after surgery with chemotherapy and eventually on its own as a monotherapy.”
  • and
    • “When the FDA reworked the prescribing information for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys earlier this month, the company touted a plan to study a regimen designed to reduce liver-associated risks and potentially reach patients left off of the drug’s new label. Now, with the FDA’s go-ahead, the company is commencing with that effort.
    • “The FDA gave Sarepta the green light to use an “enhanced immunosuppressive regimen” in the planned Cohort 8 of its Endeavor study, the company announced in a Tuesday press release. The regimen, which features the administration of sirolimus prior to and after the Elevidys infusion, will be studied in non-ambulatory individuals with DMD or those who can no longer walk independently.”
  • MedTech Dive relates,
    • “Ceribell has received 510(k) clearance to use its Clarity seizure-detection algorithm in neonates, the company said Monday.
    • “The algorithm processes data captured by a headcap with electroencephalography sensors to detect electrographic seizures. Subclinical seizures can go undetected without EEG monitoring.
    • “Ceribell executives have estimated that the neonatal and pediatric markets will add $400 million to its current $2 billion addressable market opportunity.” 
  • STAT News points out,
    • “The Food and Drug Administration on Tuesday approved the first drug from an emerging class of medicines for patients with chronic, autoimmune kidney disease, according to a notice on the agency’s website.
    • “The new drug, called Voyxact, is made by Otsuka, the Japanese pharmaceutical company. U.S. regulators cleared it to treat IgA nephropathy, or IgAN, a disease caused by the build-up of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.”

From the judicial front,

  • Healthcare Dive reports,
    • “The Trump administration will continue to fight in court over a Biden-era regulation that would audit Medicare Advantage plans and claw back billions of dollars in overpayments.
    • “In a Friday filing, the federal government said it would appeal a judge’s decision from September that vacated the Medicare Risk Adjustment Data Validation, or RADV, rule for violating the Administrative Procedures Act.
    • “The move to take the case to the Fifth Circuit Court of Appeals comes as regulators have said they’ll crack down on MA overpayments, including through a plan this spring to increase audits.”
  • Per Fierce Healthcare,
    • “Humana will appeal a court loss over the Medicare Advantage star ratings, according to a filing issued Tuesday.
    • “The insurer filed a notice that it will appeal the District Court ruling to the Fifth Circuit Court of Appeals. The filing doesn’t offer further details on the grounds to appeal.
    • “Humana first filed suit to challenge the star ratings methodology in October 2024 after the number of people enrolled in plans with four or more stars dropped from 94% in 2024 to 25% in 2025. In the most recent round of scores, the number of enrollees in plans with at least four stars decreased further to 20% for 2026.
    • “In the lawsuit, Humana argues that the Centers for Medicare & Medicaid Services determined that three test phone calls were poor, which drove the score drop.
    • “Texas Judge Reed O’Connor tossed the case in mid-October, saying that these determinations were not “arbitrary and capricious” and instead complied with federal law.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A new study found people with untreated obstructive sleep apnea could have an increased risk of developing Parkinson’s disease.
    • “Researchers studied medical records for more than 11 million military veterans between 1999 and 2022 and found those with obstructive sleep apnea had a higher chance of developing Parkinson’s disease compared with those without the disorder, according to the study published in JAMA Neurology on Monday. 
    • “It’s not at all a guarantee that you’re going to get Parkinson’s, but it significantly increases the chances,” said Dr. Gregory Scott, a co-author of the study and assistant professor at the Oregon Health & Science University School of Medicine, or OHSU.”
  • A commentator in STAT News tells us,
    • “For years, federal policymakers have tweaked lung cancer screening guidelines as if the barrier to saving lives is a math problem. Add a few years to the eligibility age. Drop a few pack-years — a measure combining how much and how long someone has smoked. Remove a quit-time rule. Repeat.
    • “But it was never really a math problem. A new study in JAMA Network Open makes clear what many of us in cancer prevention and control have been warning for over a decade: No amount of technical adjusting will fix a system built on stigma.
    • “I see the effects of this every day. As a behavioral scientist and nurse practitioner, I’ve sat with hundreds of patients confronting the potential of a lung cancer diagnosis. I’ve watched people brace themselves before they say the words “I used to smoke,” even when they quit decades ago. I have watched people who have never smoked rush to explain why they got lung cancer at all.
    • “These reactions aren’t personal quirks. They are predictable responses to a system that has taught people to expect judgment.”
    • “That system is failing on its own terms. The new study examined nearly 1,000 people diagnosed with lung cancer at a major academic medical center and found that 65% would not have qualified for screening under today’s U.S. Preventive Services Task Force (USPSTF) criteria.” * * *
    • “The population ineligible for screening is not random. It is disproportionately women, Asian Americans, and people who have never smoked. These are groups the current framework structurally misclassifies as “lower risk,” despite real-world evidence to the contrary.
    • “Only one approach captures nearly all of them: age-based screening. The test itself is straightforward: a low-dose CT scan that takes about 10 minutes and exposes patients to minimal radiation. Screen everyone ages 40 to 85, regardless of smoking history, and you detect 94% of cancers and prevent more than 26,000 deaths every year.  The cost is lower than what we routinely pay for breast or colorectal cancer screening. The number needed to screen to prevent one lung cancer death is 320. For comparison, mammography requires screening about 1,339 women to prevent one breast cancer death, and colonoscopy requires screening about 455 people to prevent one colorectal cancer death. Yes, broader screening means more false positives and follow-up imaging, but these trade-offs are manageable — and far less burdensome than the status quo, which misses two-thirds of cases entirely.”MedP
  • MedPage Today lets us know,
    • “Guidelines recommend a single dose of RSV vaccine for older adults, but long-term data on the duration of protection is limited.
    • “In this study of U.S. veterans, effectiveness slid from over 80% in the month following vaccination to about 60% through 18 months. Among the immunocompromised individuals, vaccine effectiveness fell from 75% to 40%.
    • “The potential benefits and risks of a second vaccine dose in certain groups should be examined,” according to the authors.”
  • The New York Times reports,
    • “Danish researchers were examining the use of medications during and after pregnancy when they noticed a clear trend: The number of women using weight-loss drugs like Ozempic and Wegovy soon after childbirth had risen sharply.
    • ‘In 2018, few women were using the drugs during the first six months after having a baby, with fewer than five prescriptions for every 10,000 new mothers. By mid-2022, that figure had increased to 34 prescriptions for every 10,000 new mothers, and by mid-2024, it had jumped to 173 prescriptions for every 10,000, or almost 2 percent of postpartum mothers. Most of the women were over 30, and two-thirds had more than one child. A majority were overweight, but they did not have diabetes, and they had no history of using the drugs, known as GLP-1s, the researchers wrote.
    • “In a period characterized by natural weight loss and marked hormonal change, this was unexpected,” said Mette Bliddal, a pharmacologist and researcher at University of Southern Denmark in Odense, Denmark, and the paper’s first author.
    • “The new study was published online on Monday in JAMA Network Open.” * * *
    • “Although semaglutide, the active ingredient in Wegovy and Ozempic, aids in weight loss, little is known about the drug’s effects after childbirth, when new mothers are experiencing hormonal changes.
    • “The American College of Obstetricians and Gynecologists has not issued a guidance about the use of weight-loss drugs postpartum because the drugs are so new and the data is insufficient. But First Exposure, a digital information hub and research network at the University of Toronto that provides evidence-based information about drug safety during pregnancy, recommends that patients avoid taking the drugs while breastfeeding. (First Exposure also recommends not taking the medications during pregnancy and stopping them a month or two before a planned pregnancy).”

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

  • The American Hospital Association News notes,
    • “The Trump administration issued an executive order Nov. 24 launching the Genesis Mission, an artificial intelligence initiative focusing on scientific research. The program will focus on efforts related to national, economic and health security, among other areas. The order adds to other White House actions in recent months regarding AI innovation and infrastructure to support health care and other sectors.”
  • Bloomberg points out,
    • “Thousands of health providers that treat lower-income and uninsured patients are scrambling to adjust to a new program to access steeply discounted medicines from drugmakers that stands to overhaul their operations and finances.
    • “The 340B Rebate Model Pilot Program, administered by the US Health Resources & Services Administration, is set to significantly change how the 340B Drug Pricing Program operates after the Trump administration approved rebate models from pharmaceutical companies such as Bristol Myers Squibb Co., Johnson & Johnson, and Novo Nordisk A/S.
    • “Drugmakers under the federal program currently provide up-front drug discounts to covered safety-net hospitals, clinics, and health centers that treat a disproportionate number of low-income and uninsured patients. But under the pilot, covered providers, starting on Jan. 1, 2026, will buy certain medicines at full price and then submit data to drugmakers to receive a rebate.
    • “Health providers are now preparing for the pilot—grappling with nine unique drugmaker models, weighing operational changes, and analyzing the financial risks with purchasing drugs at commercial prices.”
  • Per Beckers Payer Issues,
    • “UnitedHealth Group has purchased a four-story, 79,000 square foot medical office building in Henderson, Nevada.
    • “The $46.1 million building houses Optum Nevada’s new Cactus Healthcare Center and marks the largest medical office transaction in the Las Vegas market this year, according to real estate firm Colliers.
    • “UnitedHealth purchased the building through its Sierra Health and Life Insurance subsidiary in October, the Las Vegas Review-Journal reported.”
  • Fierce Healthcare informs us,
    • “Capital Rx has unveiled Capital Equilibrium, a new level-funding pharmacy benefit management offering.
    • “The program leans on an A-rated stop-loss carrier for reinsurance as well as Capital Rx’s PBM services to provide a fixed monthly payment plan that covers anticipated claims, administrative costs and stop-loss. The pricing is often below market rates, according to the announcement.
    • “The stop-loss insurance manages claims that exceed monthly limits, while the PBM piece is built on a “fair” pricing structure that eschews traditional discounts and rebates, Capital Rx said.
    • ‘Plan sponsors in all 50 states can sign on with Capital Equilibrium, according to the announcement.”
  • Genetic Engineering and Biotechnology News identifies the “Top 20 Drugs Heading for the Patent Cliff, 2026-2029. Last year, these treatments accounted for 75% of the $236B in annual sales set to vanish with the loss of exclusivity.”
  • McKinsey & Co. delves into the five dimensions of the wellness economy.
  • Per BioPharma Dive,
    • “Gilead Sciences is looking at a new way to attack cancer, buying into a preclinical program from the Swedish biotech Sprint Bioscience.
    • “The deal announced Monday centers on a target known as TREX1. Research suggests a healthy TREX1 gene can help prevent overactivation of the immune system that leads to conditions such as lupus, but it may also help cancer cells hide from the body’s natural attackers. In oncology, researchers are trying to inhibit TREX1 to unleash anti-tumor immune activity.
    • “TREX1 has demonstrated significant potential in the preclinical phase,” Sprint Bioscience CEO Johan Emilsson said in a statement. The new agreement calls for Gilead to pay Sprint $14 million up front and as much as $400 million more if the program meets certain clinical, regulatory and commercial milestones.”

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.”

Weekend update

David Ermer–CDC, Congress, Federal employment benefits, Generative AI, Obesity, U.S. Healthcare–

From Washington, DC,

  • Congress is out of session this week for the Thanksgiving holiday.
  • Modern Healthcare reports,
    • “President Donald Trump said he hopes to secure a solution by Jan. 30 for an impending surge in health insurance premiums for millions of Americans, the first timeline he has publicly offered for what he has pitched as an alternative to the Affordable Care Act.
    • “Trump said in an interview with Fox News Radio Friday that Republican senators Rick Scott of Florida and Katie Britt of Alabama are working on the proposal.
    • “We have a Jan. 30 day coming up, I’d like to see if we could do it by then,” Trump said. “They say, ‘well, let’s go another year.’ And I said, ‘let’s see if we can get it done by Jan. 30.’”
  • Federal News Network tells us,
    • “Last week’s conclusion of the record-breaking government shutdown was great news for federal employees in general. But for a few thousand specific feds, it was even better news. They’d been told they were about to lose their jobs completely, and as of Friday, [November 21, 2025] almost all of them have now had those notices formally rescinded.
    • “Filings the Justice Department submitted to a federal court in San Francisco on Friday indicate that each of the more than 3,000 federal workers who had received reduction in force (RIF) notices after the shutdown began have now been formally notified that those RIFs have been cancelled.
    • “That action came as a result of several provisions in the continuing resolution Congress passed last week to reopen the government. The legislation provided that not only any RIF notice an agency issued on Oct. 1 or later “shall have no force or effect,” but it also barred federal agencies from using any funding to conduct any further RIFs for as long as the current CR is in effect.”
  • Healthcare Dive informs us,
    • “Oracle Health has received Qualified Health Information Network status under the federal government’s health data sharing framework, the technology giant said Thursday. 
    • “The designation allows the Oracle Health Information Network to transfer health information between providers, payers and government agencies through the Trusted Exchange Framework and Common Agreement, or TEFCA. The HHS created the framework to facilitate the exchange of health records.
    • “Eleven data exchanges have now received QHIN status, more than double the number that were recognized when TEFCA went live at the end of 2023.” 
  • There are sixteen days left in the Federal Benefits Open Season.

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “A Washington [State] resident who was the first human case of bird flu in the U.S. since February died on Friday, state health officials said. The person was an older adult with underlying conditions and had been hospitalized since early November with a strain that was previously reported in animals but never before in humans.
    • “The person had been undergoing treatment for infection with H5N5 avian influenza, the health department said in a news release. State epidemiologist Scott Lindquist said last week that the person, who was hospitalized after developing high fever, confusion and respiratory distress, was “a severely ill patient.”
    • “State officials said the risk to the public remains low. No other people involved have tested positive for influenza, and public health officials are continuing to monitor anyone who was in contact with the patient — including more than 100 health care workers — for symptoms to ensure that human-to-human spread has not occurred, the health department said.
    • “That strain of the avian influenza virus, H5N5, had previously been reported in animals but not in humans. It is part of the family of avian influenza viruses and has been seen in wild birds in other U.S. states and Canada, state officials and experts have said.”
  • The Wall Street Journal examines “why autoimmune diseases rise sharply after 50. Scientists are making progress in understanding and treating these disorders, which can go unrecognized for years.”
    • “While there is no sure way to prevent autoimmune disease, research suggests that keeping chronic inflammation in check—through a healthy diet, regular exercise, good sleep, stress control, and maintaining a healthy weight—can help support a calmer, more balanced immune system. By contrast, unproven supplements or treatments that claim to boost the immune system could do more harm than good.”
  • Per MedPage Today,
    • “Rates of pertussis, also known as whooping cough, are surging in Texas, Florida, California, Oregon, and other states and localities across the country.
    • “The outbreaks are fueled by falling vaccination rates, fading immunity, and delays in public health tracking systems, according to interviews with state and federal health officials. Babies too young to be fully vaccinated are most at risk.
    • “Pertussis cases increase in a cyclical fashion driven by waning immunity, but the size of the outbreak and the potential for severe outcomes in children who cannot be vaccinated can be mitigated by high coverage and good communication to folks at risk,” said Demetre Daskalakis, MD, MPH, a former head of the CDC’s immunization program, who resigned in August.”
  • NPR Shots lets us know,
    • Millions of Americans have shed pounds with help from drugs like Wegovy and Zepbound.
    • But people who take these drugs often experience unpleasant side effects.
    • “They lose weight, which is a positive thing,” says Warren Yacawych of the University of Michigan, “but they experience such severe nausea and vomiting that patients stop treatment.”
    • “So, at this year’s Society for Neuroscience meeting in San Diego, Yacawych and other researchers held a session to describe their efforts to understand and solve the side-effect problem.”
    • The article discusses the expert presentation.
  • Medscape adds,
    • “The surge of demand for GLP-1s is likely very common in your practice, and during your follow-up discussions with patients, they may often share their progress on the medication. But some patients may share that they are not hitting weight-loss markers they thought they would. Some may even compare the rate of their weight loss to that of others they know.
    • As a primary care doctor, responding to this rhetoric is part of your role. [The article offers] some thoughts about messaging and directives to offer patients to get these conversations started and how to respond to feedback.
  • and
    • A first-in-human study suggested that tirzepatide — a dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist — modulated abnormal activity in the brain’s nucleus accumbens, thereby reducing food cravings and inducing weight loss in a patient with severe obesity.

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

  • Fierce Pharma reports,
    • “Maryland is becoming the home away from home for British drugmaker AstraZeneca. On Friday, the biopharma powerhouse upped its ante in the Old Line State, saying it will invest $2 billion to increase its manufacturing presence there.
    • “The funding will allow AZ to nearly double the production capacity at its flagship biologics plant in Frederick, Maryland, and also provide for the manufacture of the company’s rare disease products there for the first time, AZ said.
    • “The company will also establish a clinical manufacturing site in Gaithersburg, Maryland. The facility, which was acquired last month in a $60 million lease transfer, is the former headquarters of vaccine specialist Novavax and will host the production of molecules for medical trials, AZ added.
    • “The outlay will create 200 additional jobs at the Frederick site and 100 more at the new Gaithersburg facility, which is 25 miles to the southeast.”
  • and
    • “A Novo Nordisk challenge has driven a Pennsylvania-based telehealth company to voluntarily discontinue compounded semaglutide product claims, adding to the Danish drugmaker’s string of wins against companies selling copycat versions of its GLP-1 blockbuster.
    • “Novo challenged claims made by Regen Doctors via BBB National Programs’ National Advertising Division (NAD). The challenge centered on express and implied claims about the superiority, safety, efficacy and health benefits of Regen’s compounded semaglutide product. Novo sells the GLP-1 receptor agonist semaglutide under the brand names Ozempic and Wegovy.
    • “After the NAD began looking into the challenge, Regen told the self-regulatory body that it had permanently discontinued the claims, according to an NAD report Thursday. Regen’s actions prompted the NAD to stop reviewing the claims, and the watchdog said it will treat the discontinued claims as if it recommended that Regen stopped making the statements.
    • “The case is part of a series of challenges Novo has recently brought against semaglutide compounders via the NAD. Since June, Bayview Pharmacy, Medicine Center Pharmacyand Fletcher Family Medical Center have all voluntarily discontinued claims about compounded semaglutide. The NAD reported the conclusion of the Fletcher case one week before sharing details of Regen’s decision to discontinue its claims.”
  • Fierce Healthcare provides a look at how UnitedHealthcare is developing, deploying AI solutions.
  • HR Dive informs us,
    • “Despite increasing adoption of artificial intelligence tools at work, many U.S. employees remain uneasy about how AI may shape the future of work — and the companies that use it, according to a Monday report from SHL, a talent insight firm.
    • “Notably, 74% of workers said being interviewed by an AI agent would change their perception of the company, with 37% saying it’s “impersonal” and 23% saying it’s “innovative.” Although most workers said they’re open to interacting with an AI interviewer, they still want human involvement and accountability in the process, the report found.” * * *
    • “By 2026, 1 in 3 companies say AI will run their hiring process, according to a report from Resume.org. More than half already use AI in hiring, yet a similar amount also expressed concerns about AI screening out qualified candidates, introducing bias or lacking human oversight.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “A bipartisan group of House lawmakers released text of legislation Friday aimed at avoiding the health care subsidy cliff by extending Affordable Care Act tax credits for two years while installing income caps and anti-fraud measures.
    • “Reps. Tom Suozzi, D-N.Y., Don Bacon, R-Neb., Josh Gottheimer, D-N.J., and Jeff Hurd, R-Colo., see the measure as a viable compromise that includes Democrats’ demand for a subsidy extension alongside protections sought by many Republicans. It would also significantly lengthen the open enrollment window, which would allow more people into plans, thus strengthening risk pools and lowering premiums.
    • “The text arrives as much of Congress is divided on how to approach the possible end to enhanced premium tax credits under the 2010 health care law, which expire Dec. 31. Many Republicans see any extension as propping up the ACA and won’t support such a move. Without a solution, prices for insurance through state exchanges or healthcare.gov could force people to quit the coverage.” * * *
    • “A bill from Reps. Sam Liccardo, D-Calif., and Kevin Kiley, R-Calif., that also features a two-year extension largely follows a similar framework.
    • “Unlike the Liccardo-Kiley bill, however, this legislation does not include language that would limit excessive payments to Medicare Advantage, a practice known as upcoding. The Liccardo-Kiley bill incorporated the Medicare Advantage language as an offset to pay for the tax credit extension.”
  • and
    • “At least one of the Senate’s yet-to-be-unveiled fiscal 2026 appropriations bills could be released next week, even though lawmakers will be in their districts for the Thanksgiving recess.
    • “There is a good chance the Senate will post its version of the Energy-Water bill, one of the four the Senate has not yet released, House Appropriations Chair Tom Cole, R-Okla., said Friday.
    • “The issue was discussed when the top four House and Senate appropriators met Thursday, Cole said. “I don’t know about the other three, but we raised a lot of questions about Energy and Water, since we’ve actually passed that one across the [House] floor,” he said.
    • “Senate appropriators are aiming to release that bill and potentially more of the outstanding bills — Financial Services, Homeland Security and State-Foreign Operations — next week, a source familiar with the plan said. But that plan is not final, the source said.
    • “House Appropriations ranking member Rosa DeLauro, D-Conn., said Friday that the lawmakers discussed the outstanding Senate bills and that Senate Appropriations Chair Susan Collins, R-Maine, said the text could be posted early next week.”
  • Mercer consulting offers an overview of the current healthcare care policy debate in Congress.
  • OPM Director Scott Kupor posted a new Secrets of OPM blog entry, this time about ongoing Administration efforts to right size the federal workforce.
  • Per an HHS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is improving the quality of care for Medicare beneficiaries while significantly reducing unnecessary spending and improving choices and hospital price transparency for Medicare beneficiaries. The calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule (CMS-1834-FC) advances a series of patient-focused reforms that will modernize payments, expand access to care, enhance hospital accountability, and safeguard the Medicare Trust Funds from fraud, waste, and abuse.
    • “This final rule from CMS closes the loopholes hospitals exploit to hide real prices and advances President Trump’s demand for radical hospital price transparency,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are also confronting addiction head-on by expanding access to non-opioid treatments and implementing common-sense payment policies that make care more affordable and accessible for seniors.”
    • “We are strengthening Medicare’s foundation by protecting beneficiaries, eliminating fraud, and advancing medical innovation —all while maintaining strict provider accountability and responsible use of taxpayer funds,” said CMS Administrator Dr. Mehmet Oz. “These comprehensive reforms expand patient choice and establish the price transparency Americans need for confident healthcare decisions.” * * *
    • “The final rule can be viewed at the Federal Register at: www.federalregister.gov/public-inspection/.
    • “View the fact sheet on the final rule at: www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-ambulatory-surgical-center.
    • “For a fact sheet on the hospital price transparency policy changes in the final rule, visit: www.cms.gov/newsroom/fact-sheets/cy-2026-opps-ambulatory-surgical-center-final-rule-hospital-price-transparency-policy-changes.”
  • The American Hospital Association adds,
    • “The Centers for Medicare & Medicaid Services released an updated notice Nov. 20 on the processing of Medicare provider claims impacted by the government shutdown. The agency said it instructed Medicare Administrative Contractors to conduct mass adjustments to any paid claims that are inconsistent with the government funding legislation, which retroactively restored many payment provisions through Jan. 30. This includes a payment adjustment for low-volume inpatient hospitals and one for the Medicare-dependent Hospital program. In addition, CMS said that hospitals can resubmit returned claims for telehealth services and the Acute Hospital Care at Home program dated Oct. 1 or later.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “Hexoskin, a Canadian medtech company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new “smart shirt” capable of long-term heart and respiratory monitoring. 
    • “The Hexoskin Medical System was designed to deliver continuous evaluations of a person’s real-time electrocardiogram (ECG) and respiratory health. Signals are then evaluated through the company’s data management platform.
    • “According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as medical researchers. The device is now approved for use during clinical trials performed in the United States, for example, delivering ECG, heart rate, respiratory rate and other activity data that can research teams can track for extended periods of time.
    • “Hexoskin has also made it a priority to use advanced artificial intelligence algorithms to seek out new digital biomarkers that work “beyond traditional cardiopulmonary monitoring.” 
  • Fierce Pharma adds,
    • “As the researchers behind Pfizer and Astellas’ Padcev and Merck’s Keytruda have taken victory laps on the heels of the positive readout of Keynote-905 study—also known as EV-303—terms like “transformational,” “practice-changing” and “new standard of care” have been put to use.
    • “With an FDA approval on Friday, the combination now has its official go-ahead as a perioperative treatment regimen for people with muscle-invasive bladder cancer (MIBC) who can’t receive chemotherapy.
    • ‘Padcev and Keytruda is the first and only approved perioperative treatment regimen for cisplatin-ineligible patients with MIBC, Pfizer said in a media statement Friday, meaning the pairing can be used before and after surgery.
  • and
    • “The FDA has opened an investigation into Takeda’s recombinant protein med Adzynma following the reported death of a pediatric patient who received the drug.
    • “The probe comes as the regulator says it has received multiple postmarketing reports of patients developing neutralizing antibodies to ADAMTS13, the enzyme-creating gene that underpins Takeda’s drug. The single reported patient death “appears to be related to Adzynma,” the FDA said in a Nov. 21 safety communication.
    • “Takeda’s medicine was approved in November of 2023 as the first recombinant protein product for use as a preventive or on-demand enzyme replacement therapy in adults and children with the rare genetic blood-clotting disorder, congenital thrombotic thrombocytopenic purpura (cTTP). The condition is believed to be caused by a disease-triggering mutation in the ADAMTS13 gene, which produces an enzyme responsible for regulating clotting.
    • “The Tokyo-based pharma did not respond to Fierce Pharma’s request for comment on the situation by publishing time.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced Friday,
    • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old. Seasonal influenza activity remains low nationally but is increasing. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.’ * * *
    • “Season Outlook
      • “CDC expects the upcoming fall and winter respiratory disease season in the United States will likely have a similar number of combined peak hospitalizations due to COVID-19, influenza, and RSV compared to last season. CDC will update this outlook every two months throughout the season and as warranted by changes in the trajectories of any of the three diseases. Read more: 2025-2026 Respiratory Disease Season Outlook“
  • Beckers Clinical Leadership adds,
    • “Some hospitals are reporting an uptick in respiratory syncytial virus hospitalizations in recent days, though national data — delayed by the federal shutdown — has yet to offer a clear picture.
    • “Cincinnati Children’s Hospital reported an early uptick in admissions this fall, according to Hamilton County Public Health Medical Director Steve Feagins, MD.
    • “Last year, we saw it early. This year, we saw it even earlier, resulting in, like, September beginning to get some admissions and hospitalizations at Cincinnati Children’s,” he told CBS affiliate WKRC.
    • “The county reported 32 admissions in the week ending Nov. 15, up from 28 a week prior, state data shows.” 
  • The University of Minnesota CIDRAP relates,
    • “Over 40% of nearly 8,600 US adults who had advanced hepatitis B–related liver disease appear to have received no treatment for their infection, a gap especially apparent in women and Black or White patients, according to findings published yesterday in JAMA Network Open.
    • “A team led by a Stanford University researcher and including scientists from hepatitis B virus (HBV) drug maker and study funder Gilead Sciences evaluated the HBV treatment status of 8,594 infected patients included in an electronic health record data network from April 2016 to December 2022. The study focused on patients who met American Association for the Study of Liver Diseases 2016 and 2018 qualification criteria for HBV treatment.
    • “Treatment of hepatitis B virus (HBV) infection reduces the risk of disease progression and negative outcomes such as hepatic decompensation and hepatocellular carcinoma (HCC),” the researchers wrote. “Studies from select populations in the US suggest that treatment levels are low; whether this pattern occurs nationally remains unclear.” * * *
    • In a commentary in the same journal, Amir Mohareb, MD, of Massachusetts General Hospital, and Arthur Kim, MD, of Harvard Medical School, noted that the risk of perinatal HBV transmission from mother to child is very low in the United States due to the availability of HBV immunoglobulin and the HBV vaccine birth dose. 
    • “But “there is cause for concern that this policy may change, as newly appointed members of the Advisory Committee on Immunization Practices in 2025 debate removing the recommendation for birth-dose HBV vaccination in the US,” they wrote.
    • “Removing the recommendation for universal birth-dose vaccination would be a major step backward for elimination of HBV and would be potentially in direct contradiction to the Department of Health and Human Services Viral Hepatitis National Strategic Plan for the US,” they added”
  • Beckers Hospital Review tells us,
    • “The overall U.S. healthcare system received a “C” grade from a broad survey of U.S. adults, according to the West Health-Gallup Center for Healthcare in America, which released its inaugural report, “State of the States 2025: Insights on Healthcare in America.”
    • “Nationwide, the healthcare system received a “D+” for cost, a “C+” for quality and a “C+” for access. 
    • “The rankings are based on an online survey of 19,535 U.S. adults conducted June 9 to Aug. 25 across all 50 states and the District of Columbia. Respondents graded the healthcare system in their state, with letter grades converted to a 4.0 GPA scale for analysis.”
  • A medical specialist interviewed in MedPage Today identifies “13 Visible Signs of Heart Disease. What skin, nails, eyes, and more can reveal about cardiovascular disease.”
  • Health Day informs us,
    • “Even occasional or low-intensity smoking significantly increases cardiovascular and mortality risks, according to a study published online Nov. 18 in PLOS Medicine.
    • “Erfan Tasdighi, M.D., from the Johns Hopkins Ciccarone Center for Prevention of Cardiovascular Disease in Baltimore, and colleagues examined the relationships among smoking burden, intensity, and cessation duration across multiple cardiovascular outcomes. The analysis included data from 323,826 adult participants in 22 prospective cohort studies with median follow-up varying from 14.4 to 19.9 years.” * * *
    • “It is remarkable how harmful smoking is — even low doses of smoking confer large cardiovascular risks,” the authors said in a statement. “As far as behavior change, it is imperative to quit smoking as early in life as possible, as the [amount] of time passed since complete cessation from cigarettes is more important [than] prolonged exposure to a lower quantity of cigarettes each day.”
    • “Abstract/Full Text“
  • and
    • “The risk for motor vehicle crashes is increased after a concussion, according to a study published online Nov. 5 in BMJ Open.” * * *
    • “The risk of a motor vehicle crash after a concussion suggests current mitigating efforts are insufficient; however, driving cessation may be unreasonable since the risk also extends to patients as pedestrians,” the authors write. “Instead, clinicians might warn concussion patients to be cautious about prevailing motor vehicle crash risks along with standard anticoncussion campaigns.”
    • “Abstract/Full Text“
  • Healio points out,
    • “Child abuse is linked to long-term risk for negative health outcomes. 
    • “Boys and girls experienced decreases in confirmed maltreatment cases, but girls were subject to greater maltreatment.” * * *
    • “As a preventive measure, we need to address the drivers of maltreatment,” Richard T. Liu, PhD, director of suicide research in the division of child and adolescent psychiatry in the Depression Clinical and Research Program at Massachusetts General Hospital, told Healio. “One prominent driver of maltreatment risk is poverty. Reducing poverty would therefore be important for reducing risk for child maltreatment.”

From the U.S. healthcare business front,

  • This factoid along with more importantly this Brookings Institute report on PBM profitability support the FEHBlog’s view that cracking down on PBMs will not lower healthcare costs. The President’s efforts to lower drug costs could pay dividends.
  • Modern Healthcare adds,
    • “Eli Lilly & Co. and Novo Nordisk A/S plan to start selling their popular obesity shots to employers through a new approach that would bypass traditional drug sales channels in an effort to expand access to the costly weight-loss medicines.
    • “The drugmakers will offer Zepbound and Wegovy to companies starting Jan. 1 through Waltz Health, a firm that helps employers purchase cheaper medications. The shots will be available to employers at upfront, fixed prices, avoiding the rebates and fees that accompany traditional sales through middlemen who manage pharmacy benefits for many companies.” * * *
    • “The offering is aimed at employers that don’t cover obesity drugs right now. About 43% of companies with more than 5,000 workers cover weight-loss drugs, according to a recent survey from KFF. Thierer said four employer clients are signed up to launch the offering in January. Waltz is targeting a goal of making it available to 100,000 people by the end of the first quarter.
    • “The arrangements will only apply to the companies’ weight-loss drugs, not to similar medications intended for diabetes. Waltz will handle screening patients to see if they’re eligible for the drugs, sending prescriptions to pharmacies and supporting patients taking the drugs.
    • “Waltz was recently purchased by a larger firm, Eversana, that works with drug companies to commercialize and distribute their medications. Thierer, a former PBM executive, has said he aims to build an alternative to the “oligopoly” of PBMs and force the industry to change.”
  • Per Yahoo Finance,
    • “CVS Health® (NYSE: CVS) today announced that its Board of Directors has elected President and Chief Executive Officer David Joyner as Chair of the Board, effective January 1, 2026. Following the effective date of this appointment, Michael Mahoney will continue to serve as the Board’s Lead Independent Director, and Roger Farah, who is currently serving as Executive Chair of the Board, will continue to serve on the Board.
    • “Joyner was named President and CEO of CVS Health in October 2024, and has led significant operational, financial and cultural improvements in the Company’s performance over the past year. In recognition of his leadership, nearly 40 years of experience in the health care industry, and the Company’s future growth opportunities, the Board determined Joyner should also serve as Chair of the Board.”
  • Healthcare Dive lets us know,
    • “Western Pennsylvania-based Independence Health System plans to join West Virginia University Health System in the fall of next year, the systems announced Wednesday.
    • ‘Under the proposed merger, which is subject to regulatory reviews and approvals, Independence Health’s five hospitals as well as its affiliated physician groups will operate under WVU Medicine’s brand. 
    • “The systems say the deal will offer operational and financial efficiencies through resource sharing and allow the providers to expand clinical services and access to specialty care.”
  • Per MedTech Dive
    • “Solventum said Thursday it has struck a deal to buy wound care company Acera Surgical for $725 million in cash.
    • “The deal, which features up to $125 million in milestones, will give Solventum control of a portfolio of synthetic soft tissue repair products. Stifel analysts said in a note to investors that they believe the synthetic market “is growing at a double-digit pace.”
    • “Acera is Solventum’s first acquisition since it spun out of 3M. Solventum executives made M&A part of their focus after selling the company’s purification and filtration business to Thermo Fisher Scientific for $4.1 billion.”

From the artificial intelligence front,

  • Cardiovascular Business reports,
    • “Heartflow’s Plaque Analysis software is an effective tool for the diagnosis and management of coronary artery disease (CAD), according to a new retrospective analysis of more than three years of data. The findings were presented at the American Heart Association’s Scientific Sessions 2025 conference.
    • “The FDA-cleared Plaque Analysis software was designed to evaluate coronary CT angiography (CCTA) results and provide cardiologists with an artificial intelligence (AI)-powered assessment of the patient’s coronary plaques. It delivers an interactive 3D model of the coronaries and identifies high-risk CAD patients who may benefit from immediate care. 
    • “This latest analysis included nearly 8,000 symptomatic CAD patients who participated in the FISH&CHIP study. All patients were treated with Plaque Analysis as well as Heartflow’s new Plaque Staging framework. Plaque Staging separates patients into one of four categories—mild, moderate, severe or extensive—based on AI-powered total plaque volume (TPV) measurements. According to Heartflow, this study represents the largest validation to date of the Plaque Staging framework.”
  • McKinsey & Co. explores “the coming evolution of healthcare AI toward a modular architecture.”
  • The Advanced Research Projects Agency for Health (ARPA-H) announced
    • “The AIR program [which’ aims to solve these problems by developing robots that can do parts of or entire surgical interventions on their own. The program’s focus is twofold: first, to develop autonomous robotic systems that can perform thrombectomies, making curative stroke care available to all Americans. Second, to create very small, mechanical, electronic, or hybrid devices (microbots) that can perform medical procedures independently, revolutionizing healthcare delivery.
    • “Notice ID: ARPA-H-SOL-26-146
      • ARPA-H invites interested parties to review the solicitation, which is posted and maintained on SAM.gov. The solicitation outlines the opportunity and its requirements, key dates and deadlines, submission documents and templates, evaluation criteria for submissions, and information on how to apply.
    • “Key Dates:
      • Proposers’ Day: December 16, 2025, Bethesda, MD (Hybrid)
      • Solution Summaries due: January 26, 2026
      • Proposals due: March 30, 2026
    • “Reminder: Dates are estimates and are subject to change. Please reference the solicitation for the most up-to-date information.”

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.”

Tuesday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “Federal employees will be able to contribute more to their Thrift Savings Plan accounts next year. The IRS increased the maximum annual contribution limit to $24,500, which is a $1,000 increase over 2025. Additionally, employees aged 50 or older can save more money through their catch-up contributions. And if employees are aged 60 to 63, they can save even more with a higher catch-up contribution of $11,250. (IRS increases annual TSP savings limit for 2026 – IRS)”
  • The Wall Street Journal tells us,
    • “Calley Means, a confidant to health secretary Robert F. Kennedy Jr., is taking a permanent post in the Trump administration, where he is expected to serve as a bridge between the Make America Healthy Again movement and President Trump’s broader MAGA coalition.
    • “Means, who earlier this year served in a temporary role at the White House, has been tapped to be a senior adviser in Kennedy’s Department of Health and Human Services, charged with helping to ensure the success of the MAHA movement’s policy goals, according to people familiar with the matter.
    • “As of Tuesday, Means was listed in the department’s personnel directory—which is public—as a senior adviser in the office of Assistant Secretary for Health Brian Christine.”
  • Per an AHIP news release,
    • “Health plans contribute to the health and economic stability of communities throughout America. A new comprehensive report from AHIP offers a detailed state-by-state view of health coverage and underscores the indispensable role of health plans in communities nationwide. 
    • “Health plans support the health and well-being of Americans in all 50 states by delivering high-quality coverage and doing everything they can to shield consumers from the rising cost of care,” said Mike Tuffin, AHIP’s President and CEO.
  • The American Hospital Association News notes,
    • “The AHA and the Federation of American Hospitals Nov. 18 released a study conducted by Dobson | DaVanzo, underscoring the threat to patient care by expanding physician-owned hospitals in rural communities. The study found that if a new POH opens in the same market as a full-service rural hospital, the full-service hospital’s financial stability would be negatively affected as the POH would siphon off healthier and commercially insured patients, risking access to care and community jobs. 
    • “Full-service hospitals across the country are struggling, and rural hospitals are particularly vulnerable to headwinds. … Removing restrictions on POHs, which are notorious for selectively picking the healthiest and wealthiest patients and allowing them to open near full-service rural hospitals will jeopardize access to 24/7 care in rural America,” write Don May, FAH executive vice president of policy, and Ashley Thompson, AHA senior vice president of public policy analysis and development, in an accompanying blog.” 
  • The Centers for Medicare and Medicaid Services released today a new edition of the Section 111 user guide for group health plans, which term includes FEHB and PSHB plans.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved a new medication for a rare genetic condition in a decision that represents a long-awaited milestone for the drug’s developer, biotechnology company Arrowhead Pharmaceuticals. 
    • “The agency on Tuesday cleared the therapy, Redemplo, for familial chylomicronemia syndrome, or FCS, a rare condition that disrupts the body’s ability to break down fats in the bloodstream. It’s been specifically approved for use alongside a diet to help reduce levels of those fats, or triglycerides, in adults with FCS. The drug is self-administered via a subcutaneous injection once every three months.” 

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Health officials on Monday linked for the first time the measles outbreak that began in Texas with another in Utah and Arizona, a finding that could end America’s status as a nation that has eliminated measles.
    • “The news came in a phone call, a recording of which was obtained by The New York Times, among officials from the Centers for Disease Control and Prevention and state health departments.
    • “The chain of transmission began in January, in a conservative Mennonite group on the western edge of Texas and spread to Oklahoma and New Mexico.
    • “Countries lose their elimination status after 12 months of sustained transmission. If the outbreak cannot be extinguished by January, the anniversary of the first cases in Texas, the United States will lose what is known as “elimination status” as determined by the World Health Organization, which it has had for 25 years.”
  • Beckers Hospital Review informs us,
    • “Influenza activity remains low but is increasing across the U.S., according to the CDC’s latest FluView report. 
    • “The agency updated data on flu trends Nov. 14, offering the first national snapshot of respiratory virus activity since September. The update follows a nearly two-month blackout in national reporting, during which states had to pause dashboard updates or rely on internal data amid the federal government shutdown.
    • “Less than 1% of ED visits were flu-related, a figure that remained relatively stable compared to the previous week. However, flu-related ED visits are rising among children. The virus accounted for about 1% of visits among children 4 and younger, and 1.3% among those ages 5-17. 
    • “Nationally, 1,665 patients with laboratory-confirmed influenza were admitted to the hospital, up slightly from the previous week. Overall, flu activity remains low, with all states reporting “minimal” or “low” activity. 
  • NBC relates,
    • “While the average age for being diagnosed with heart disease in the United States is typically in the mid-60s for men and early 70s for women, the factors, such as high blood pressure, diabetes and bad cholesterol levels, can start years, sometimes decades, earlier. 
    • “A new online heart risk calculator could help younger adults learn whether they’re likely to develop heart disease, as much as 30 years in the future, according to a study published in the Journal of the American College of Cardiology on Monday. That’s a significantly longer time period compared with traditional screenings, including the Framingham risk calculator or the ASCVD Risk Estimator Plus, which measure a 10-year risk for people ages 40 and older. 
    • “This tool was motivated by helping younger adults understand their long-term risk for heart disease,” said senior study author Sadiya Khan, the Magerstadt professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine. “We all procrastinate, but prioritizing health has to start today — and can with this tool.”
  • Per CNN Health,
    • “Starting prenatal care after the first trimester of pregnancy appears to be a growing yet dangerous trend in the United States, according to a new report.
    • “The report, released Monday by the infant and maternal health nonprofit March of Dimes, says that only about 75% of babies last year were born to mothers who started prenatal care in the first trimester of pregnancy.
    • “We’ve always known that getting that prenatal care started early is important,” said Dr. Michael Warren, March of Dimes’ chief medical and health officer. He added that now, in the United States, it’s moving in the “wrong direction.” * * *
    • “The new March of Dimes report gives the United States a D+ grade for having a preterm birth rate of 10.4% for the third year in a row.
    • “Sadly, I actually have to say that there was nothing that surprised us” in the new report, said Divya Sooryakumar, the vice president of programs and impact of the maternal health nonprofit Every Mother Counts, who was not involved in the report.”
  • BioPharma Dive points out,
    • “With new, positive data in hand, Merck & Co. plans to move its cardiovascular drug Winrevair into late-stage testing as a treatment for a condition often caused, at least in part, by high blood pressure.
    • “This condition — known as heart failure with preserved ejection fraction, or “HFpEF” — is common, affecting more than half of the roughly 6.7 million people in the U.S. believed to be living with heart failure. In these people, the heart’s main pumping chamber stiffens over time due to a variety of possible factors, including age, obesity and hypertension. While the chamber still pumps a “normal” amount of blood, patients with HFpEF can experience fatigue, shortness of breath, as well as life-threatening health complications.”
    • “The Food and Drug Administration has already approved several medicines for HFpEF, among them AstraZeneca’s Farxiga, Novartis’ Entresto, and Eli Lilly and Boehringer Ingelheim’s Jardiance. Merck has been trying to expand that list with Winrevair, a first-of-its-kind therapy that works by regulating signals from “activin” proteins that spur cell growth and division. In heart failure, the over-production of certain cells, molecules and proteins can harden the organ and impair its function.
    • “On Tuesday, Merck announced Winrevair had hit the main goal of a mid-stage clinical trial that enrolled 164 adults with high blood pressure in their pulmonary arteries caused by HFpEF.” 
  • and
    • “An experimental pill from Roche succeeded in a Phase 3 trial in early-stage breast cancer, helping prevent recurrence for longer than standard hormone therapies when administered after surgery in people with a common form of the disease.
    • “Roche didn’t provide specifics, but said that its drug, known as giredestrant, successfully extended disease-free survival compared to hormone therapy in people with ER-positive, HER2-negative breast cancer following surgical removal of a tumor. A “clear positive trend” was also observed on survival, though Roche said it’s too early to tell whether treatment clearly extended lives. 
    • “Giredestrant is part of a new class of oral “selective estrogen receptor degraders,” or SERDs, that aim to supplant a decades-old injectable therapy. So far, these drugs have largely only proven helpful for a particular subset of patients with advanced disease. Roche’s medicine is the first so far to show a benefit in the “adjuvant” setting, though others are also in late-stage testing.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Former Food and Drug Administration Commissioner Scott Gottlieb, M.D., is joining the board at industry giant UnitedHealth Group.
    • “The company announced the move Tuesday, with CEO and Board Chair Stephen Hemsley saying Gottlieb’s “exceptional healthcare career in both the public and private sectors” will bring valuable insight to the company.
    • “He is an innovator who constantly advocates for a more integrated healthcare approach supported by the latest technology,” Hemsley said. “We welcome his deep expertise and thought leadership as we strive to help people live healthier lives and make the health system work better for everyone.”
    • “Gottlieb served as the FDA Commissioner from 2017 to 2019, and during his tenure, he focused on transparency, patient safety and promoting competition. He took on the opioid epidemic and youth tobacco use during his time at the agency.”
  • Healthcare Dive adds,
    • “Optum Health, the care delivery arm of UnitedHealth, has tapped Krista Nelson as its new CEO effective immediately. Nelson announced the C-suite reshuffling via LinkedIn last week. 
    • “The executive has worked for UnitedHealthcare, UnitedHealth’s payer arm, off and on since 2009, according to her LinkedIn. Nelson was last responsible for overseeing the growth of government programs before switching over to UnitedHealth’s health services division Optum
      in May, when she was tapped as COO of Optum Health.
    • “Now, Nelson replaces Dr. Patrick Conway as the chief executive of Optum Health. Conway has been CEO of Optum since May and CEO of Optum Health since June.
    • “Conway will remain in his post as CEO of Optum following the reshuffling, according to his LinkedIn.”
  • Per Fierce Healthcare,
    • “Cigna Healthcare has unveiled Clearity, a new, copayment-only health plan designed to promote transparency and predictability.
    • “The new plan leans on Cigna’s in-house suite of artificial intelligence tools to make it easier for enrollees to make decisions for their care by arming them with critical information such as upfront pricing and verified patient reviews within a simple digital experience.
    • “The plan features a tiered copay model that does away with deductibles and coinsurance, Cigna said. Employers that select Clearity as an option can choose from five different packages with different cost-sharing options that don’t require narrowing networks or restricting access.
    • “Each package includes four in-network tiers and one out-of-network tier, according to the announcement.”
  • and
    • “Employers expect to see health benefits rise by 6.7% in 2026, reaching more than $18,500 per employee on average, according to a new report.
    • “Analysts at Mercer estimate that health costs in 2025 reached an average of $17,496 for each employee, growth of 6%. That’s a rate that outpaced inflation and wage growth, according to the report.
    • “The increase was driven by a sharp spike in prescription drug spending, which increased by 9.4% on average for large employers, or firms with at least 500 employees. Within that, large employers were more likely to cover GLP-1 drugs for weight loss this year, with 49% offering coverage compared to 44% in 2024.”
  • Per Fierce Pharma,
    • “Only days after revealing an unsolicited buyout bid from Lundbeck, Avadel—which has already signed an agreement to sell itself to Alkermes—has officially determined that the Lundbeck offer is sweeter.
    • “After “discussions and negotiations” with Lundbeck and separate consultations with its advisors, Avadel on Monday confirmed that it views the Lundbeck deal as a “superior company proposal.”
    • “The distinction is important because under Avadel’s existing transaction agreement with Alkermes, the latter company now has five business days to “discuss or negotiate in good faith” any potential amendments to its prior offer. Back in October, the companies got together on a $2.1 billion buyout agreement.
    • “Avadel says Lundbeck’s offer is worth up to $2.4 billion. The proposal features a $21-per-share upfront payment plus a contingent value right worth up to $2 per share based on future sales performance of Avadel’s narcolepsy drug Lumryz and pipeline candidate valiloxybate.”
  • Beckers Hospital Review lets us know,
    • “Novo Nordisk is temporarily offering doses of Type 2 diabetes drug Ozempic and weight loss medication Wegovy for $199, the drugmaker said Nov. 17. 
    • “Between Nov. 17 and March 31, self-paying patients of Wegovy or Ozempic can order their first two months’ worth of the medications for $199 per month, Novo Nordisk said. The discount applies to the two lowest doses, 0.25 and 0.5 milligrams, which are the recommended dosages for the first two months. 
    • “Following the first two months of treatment, self-paying patients will be eligible to order Wegovy or Ozempic for $349 per month. On Nov. 6, Novo Nordisk and the U.S. government reached a pricing agreement to sell Ozempic and Wegovy for $245 through Medicare and Medicaid, with a $50 copay for patients. The monthly prices will be $350 through TrumpRx, a direct-to-consumer website set to launch in early 2026. 
    • “GoodRx, Costco, WeightWatchers, CVS and other pharmaceutical retailers will participate in the offering.” 
  • The Wall Street Journal adds,
    • “The trillion-dollar club has become crowded with mostly tech names riding the AI boom. Eli Lilly LLY might soon join them for a far different reason: the weight-loss bonanza.
    • “Crucially, Lilly’s trajectory doesn’t hinge on artificial-intelligence sentiment or cloud-spending cycles that investors are suddenly questioning. In fact, it could even benefit from an investor rotation away from technology into other sectors. Its staying power above a $1 trillion market value will come down to two questions: how quickly it can expand the obesity-drug market and how completely it can dominate it. 
    • “On both fronts, its future looks promising. This year, Lilly has moved sharply ahead, securing Medicare access while widening its lead over Wegovy maker Novo Nordisk NOVO.B. That is why investors shouldn’t assume the rally stops at a trillion. 
    • “The key thing to remember is that—much like the AI boom—the GLP-1 surge is still in its infancy. Lilly only began selling its weight-loss drug Zepbound in late 2023, and the Food and Drug Administration only declared an end to a supply shortage of obesity drugs last year. As production has scaled up and new clinical data has emerged, Zepbound has pulled ahead of Wegovy. Despite Zepbound’s later launch, Lilly now captures a clear majority of new obesity-drug prescriptions, a sharp shift in market dynamics.”
  • Per Beckers Payer Issues,
    • “Medica plans to purchase certain contracts and assets from UCare as the latter’s legacy business winds down operations next year, the two companies said Nov. 17.
    • “We have the opportunity to build upon both Medica’s strengths and UCare’s legacy, allowing Minnesotans to continue to have a health care experience that ensures they feel cared for,” Medica CEO Lisa Erickson said.
    • “The agreement encompasses UCare’s Medicaid and ACA businesses that cover more than 300,000 Minnesotans. The transaction is expected to wrap during the first quarter of 2026. Individuals in UCare’s 2026 Medicaid and individual and family plans will still receive services without interruption.”
  • Per MedTech Dive,
    • “Medtronic’s pulsed field ablation business took off last quarter as competition in the space continues to heat up nearly two years after products first launched.
    • “PFA sales grew by more than 300% year over year in the U.S. and outside the U.S. in the second quarter of Medtronic’s fiscal 2026, according to materials released ahead of Tuesday’s earnings call. The company did not report specific sales figures.
    • “The technology fueled growth for the company’s overall cardiac ablation solutions business, or CAS, where sales increased by 71% year over year organically in the fiscal second quarter. Medtronic’s CAS business is steadily climbing as PFA adoption continues: The unit’s sales grew by nearly 50% and 30% in the company’s previous two fiscal quarters.”

From the artificial intelligence and electronic health records front,

  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a new $2 million Caregiver Artificial Intelligence Prize Competition to support the 1 in 4 Americans serving as caregivers for older adults and people with disabilities.
    • “This initiative through HHS’ Administration for Community Living (ACL) recognizes the millions of caregivers who support aging relatives and loved ones with disabilities. Their compassion and commitment form the backbone of America’s long-term care system, helping older adults and people with disabilities live with dignity and independence at home and in their communities.” * * *
    • “For updates on the competition, visit ACL’s Caregiver AI Prize Competition page.”
  • Fierce Healthcare reports,
    • “Aetna is rolling out a new artificial-intelligence-powered, conversational tool designed to make it easier for members to understand and navigate their health and benefits.
    • “The AI assistant is embedded in the insurer’s website and member app to readily answer questions that they may have about benefits and coverage, with session awareness that makes the experience feel less like a traditional chatbot. And members do not need to use healthcare jargon to secure answers, according to the company.
    • “For example, a member is told by their doctor that they need surgery. They can ask the assistant about their coverage for the procedure and receive a full and personalized breakdown of their costs and options, including estimates for fees and copayments.”
  • Healthcare Dive relates,
    • “Humana and Epic are partnering to speed patient appointment check-in and coverage verification for Medicare Advantage beneficiaries, the companies said Tuesday. 
    • “The new features are included in the electronic health record vendor’s payer platform, which allows insurance details from Humana to be automatically shared with providers before patients arrive at appointments, according to a press release. 
    • “The collaboration is an early result of an initiative from the Trump administration that aims to boost health data sharing and reduce repetitive, paper-based processes in healthcare, the companies said.” 
  • Beckers Health IT tells us,
    • “Oakland, Calif.-based Kaiser Permanente recently completed one of the largest EHR consolidations in healthcare history, migrating about 40 million patient records.
    • “In early 2025, the 40-hospital system merged 12 instances of its Epic EHR into two: in its Northern California and Southern California markets. In each case, the health system transferred roughly 20 million patient records with less than three hours of downtime and no canceled appointments or delayed procedures.”
    • The article also features a Beckers interview with “Neil Cowles, chief information and technology officer of Kaiser Permanente, to learn more.”

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.”