FEHBlog

Friday report

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

Delving into aspects of recent CMS Medicare rules,

  • Healthcare Dive reports,
    • “The CMS is proposing to overhaul the Medicare Advantage star ratings system, including by culling a dozen quality measures and removing a health equity reward. 
    • “In a proposed rule released Tuesday, the agency said it wanted to cut 12 metrics that focus on administrative processes where health plan performance is typically high and beneficiaries can’t easily distinguish between offerings, like customer service and appeal timeliness. Most of the cuts would go into effect in the 2029 star ratings. 
    • “The CMS is also proposing to not implement the Excellent Health Outcomes for All reward, designed to incentivize plans to improve care for enrollees who are low-income or disabled. Additionally, the agency wants to add a quality measure on depression screening and follow-up.”
  • Modern Healthcare tells us,
    • “A new Medicare policy on complex surgical procedures could drive a deluge of patients to outpatient facilities. But while some view the change as a win for beneficiaries and taxpayers, others see clinical risks.
    • “The Centers for Medicare and Medicaid Services will phase out the Medicare Inpatient-Only List over the next three years under the Hospital Outpatient Prospective Payment System final rule for 2026, which it published Friday. The first stage is allowing outpatient providers to bill for 285 musculoskeletal codes that currently are only reimbursable for inpatient hospitals.
    • “The Ambulatory Surgery Center Association welcomed the relaxed rules. “The elimination of the Inpatient-Only List provides Medicare beneficiaries the ability to work with their surgeon to best determine the appropriate site of care,” Chief Advocacy Officer Kara Newbury wrote in an email.
    • Similarly, the Medical Group Management Association believes this policy will enhance access and reduce costs, said Senior Vice President of Government Affairs Anders Gilberg.
    • Yet the American Hospital Association stands firmly against ending the Inpatient-Only List. “The AHA opposes CMS’ proposal to eliminate the [Inpatient-Only List] over three years. Instead, the AHA recommends that CMS continue with its standard process for removing procedures from the [Inpatient-Only List],” Ashley Thompson, senior vice president of public policy analysis and development, wrote CMS on Sept. 15.
    • “We are concerned that, given the depth and breadth of the 1,731 procedures on the [Inpatient-Only List], it would be reckless to eliminate them all,” Thompson wrote. “We are concerned that CMS is proposing a blanket policy to essentially remove all procedures without an examination of any safety or other implications.”
  • MedTech Dive informs us,
    • “The Centers for Medicare and Medicaid Services has finalized a payment policy that covers cardiac catheter ablation procedures in ambulatory surgery centers for the first time.
    • “The Heart Rhythm Society’s advocacy arm representing electrophysiologists called the final rule, which is effective Jan. 1, 2026, a milestone for the field. “This change expands Medicare beneficiary access to EP services and represents one of the most significant federal advancements in how and where EP care is delivered in more than two decades,” the group said. 
    • “Wall Street analysts said the new ASC reimbursement payment could boost atrial fibrillation procedure volumes, potentially benefiting Abbott, Boston Scientific, Johnson & Johnson and Medtronic.”

From the public health and medical / Rx research front,

  • The Washington Post lets us know “Ozempic 2.0 is on the way, and it could be even more transformative. A new weight loss pill could come within months, and other experimental treatments with more potency are not far behind.”
    • “A new wave of the medicine is coming that could be even more transformative for human health: pills, more potent injectables and new compounds that might have fewer side effects or could be taken just once a month.
    • “With this newer generation of medications, we’re not just focusing on weight loss,” said David Lau, an endocrinologist and professor emeritus at the University of Calgary Cumming School of Medicine. “We’re talking about changes beyond what you see on the scale.”
  • NBC News relates,
    • “As we age, the human brain rewires itself. 
    • “The process happens in distinct phases, or “epochs,” according to new research, as the structure of our neural networks changes and our brains reconfigure how we think and process information.
    • “For the first time, scientists say they’ve identified four distinct turning points between those phases in an average brain: at ages 9, 32, 66 and 83. During each epoch between those years, our brains show markedly different characteristics in brain architecture, they say.
    • “The findings, published Tuesday in the journal Nature Communications, suggest that human cognition does not simply increase with age until a peak, then decline. In fact, the phase from ages 9 to 32 is the only time in life when our neural networks are becoming increasingly efficient, according to the research.”
  • Cancer Advisor points out,
    • “Overweight and obesity are both associated with a greater risk of developing pancreatic cancer by the age of 50 years, according to research published in the European Journal of Cancer.
    • “These findings indicate that even modest excess weight in early adulthood, including overweight and mild obesity, may represent an independent and modifiable risk factor for young-onset pancreatic cancer,” study researchers wrote.
    • “Although the incidence of pancreatic cancer among adults under the age of 50 years has risen in recent years, the risk factors driving young-onset pancreatic are not well defined, the researchers noted. In this study, they evaluated the dose-response relationship between body mass index (BMI) and the risk of developing pancreatic cancer by the age of 50 years.”
  • Per Medscape, “Chronic Gut Pain’s Elusive Cause Found — and Possibly Fixed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance mergers and acquisitions picked up in the third quarter as companies seek to gain scale, modernize operations and stay competitive in a difficult regulatory and cost environment. 
    • “Insurers announced 10 M&A deals during the third quarter, up from seven in the year-ago period, according to data compiled by the Levin Associates, and more have emerged during the fourth quarter.
    • “This month, MVP Health Care and Independent Health announced a deal, Medica proposed buying UCare’s exchange and Medicaid operations, and Cambia Health Solutions and Arkansas Blue and Cross and Blue Shield inked an agreement to affiliate.
    • “It definitely seems to have a new momentum behind it. Payers are definitely more active,” said Dan Farrell, a partner and health services deals leader at the consulting firm PricewaterhouseCoopers. “It’s accelerating at all levels, and I think that will continue through the end of 2025 and into the first half of ‘26.” 
  • McKinsey & Company evaluates the “Future of US healthcare: Gathering storm 2.0 or a golden age?”
    • “Health industry economics continue to be roiled in the postpandemic era, and the outlook for funding suggests continuing relentless pressure. Healthcare industry EBITDA as a proportion of national health expenditure (NHE) was 200 basis points lower in 2024 compared with 2019. From 2024 through 2027, it is expected to fall another 100 basis points, with marginal recovery expected by 2028 through targeted interventions, according to McKinsey research.
    • “Nonetheless, the potential opportunity from advances in AI, automation, efficient sites of care, medical science, and care model innovation is staggering. We estimate that the available improvement opportunity is 9 to 15 percent of NHE on a run-rate basis.1
    • “As always, the opportunity to improve healthcare outweighs the headwinds if healthcare leaders can unlock the transformation required to seize the opportunity.”
  • Fierce Healthcare informs us,
    • “Three drugs treating chronic conditions are set for Food and Drug Administration review by the end of the year, and a new report from Optum Rx digs into why payers should be watching these decisions.
    • “According to the report, the FDA is set to review an oral formulation of Novo Nordisk’s GLP-1 Wegovy as well as depemokimab, a drug that treats eosinophilic asthma, and remibrutinib, a therapy for chronic spontaneous urticaria under the brand name Rhapsido.
    • “Sara Guidry, senior director of pipeline and drug surveillance at Optum Rx, told Fierce Healthcare in an interview that these drugs target weight and chronic inflammatory conditions, both segments that are significant cost drivers for payers and plan sponsors.
    • “They are two topics we are consistently discussing with payers and clients,” Guidry said.”
  • and
    • “WellTheory, a virtual platform for autoimmune care, is partnering with Instacart to embed grocery stipends into its care model. The partnership addresses a critical gap in autoimmune care: access to nutritious, anti-inflammatory foods, according to the companies.
    • “By integrating Instacart’s Health Fresh Funds, more than 300,000 eligible WellTheory members can purchase clinically recommended groceries to support healthier nutrition decisions.
    • “Autoimmune patients often face significant barriers to accessing the right foods — from affordability and availability to the daily friction of turning dietary guidance into actionable shopping decisions. The new Instacart partnership supports WellTheory’s mission to fill the gaps left behind by traditional healthcare and provide whole-person care that addresses the root causes of autoimmunity, executives said.
    • “Instacart reaches more than 98% of U.S. households, including 95% of those located in food deserts and nearly 98% of households enrolled in SNAP, the grocery technology company said.”

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.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • “The Trump administration’s top cybersecurity official on Tuesday [November 18, 2025,] previewed the contours of the administration’s cyber strategy, saying it would focus heavily on countering foreign adversaries and reducing regulatory burdens on industry.
    • “We are striving as an administration to make sure that there is a single coordinated strategy in this domain in a way that hasn’t happened before,” National Cyber Director Sean Cairncross said at the Aspen Cyber Summit. “We are working in very close partnership with our interagency colleagues to develop this strategy and get it out the door.”
    • “Like its Biden administration predecessor, the new cyber strategy will be accompanied by an action plan that lists lines of effort under six pillars of activity. “It’s going to be a short statement of intent and policy,” Cairncross said.
    • “One of the pillars will focus on shaping the behavior of Russia, China, ransomware gangs and other adversaries by imposing costs when they attack the U.S. In emphasizing the need for consequences, Cairncross repeated a frequent criticism of the government’s approach to cyber defense, saying policymakers have failed to deter adversaries’ malicious cyber activity.
    • “We need to do that,” he said, “because it is scaling, and it is becoming more aggressive every passing day.”
  • and
    • “The Cybersecurity and Infrastructure Security Agency will increase its hiring efforts in 2026 as it seeks to rebuild from the Trump administration’s deep cuts and prepare for a potential U.S. conflict with China.
    • “The recent reduction in personnel has limited CISA’s ability to fully support national security imperatives and administration priorities,” acting CISA director Madhu Gottumukkala said in a Nov. 5 memo to staff obtained by Cybersecurity Dive. The agency has “reached a pivotal moment,” he added, but it remains “hampered by an approximately 40% vacancy rate across key mission areas.”
  • The American Hospital Association tells us,
    • U.S. and international agencies Nov. 19, 2025, released a guide on mitigating potential cybercrimes from bulletproof hosting providers. A BPH provider is an internet infrastructure provider that intentionally markets and leases their infrastructure to cybercriminals. The agencies said they have recognized a notable increase in cybercriminals using BPH resources for cyberattacks on critical infrastructure and other targets. Mitigating malicious activity from BPH providers requires a nuanced approach, as BPH infrastructure is integrated into legitimate internet infrastructure systems, and actions from internet service providers or network defenders could impact legitimate activity. 
    • “Bulletproof hosts have long been used to facilitate cybercrime,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “They hide in plain sight, looking like other legitimate providers. They do not cooperate with law enforcement investigations, providing cybercriminals cover for their activities.” 
  • Cyberscoop relates,
    • “The Securities and Exchange Commission on Thursday [November 20, 2025,] dropped its case against SolarWinds and its chief information security officer over its handling of an alleged Russian cyberespionage campaign uncovered in 2020, an incident that penetrated at least nine federal agencies and hundreds of companies.
    • “The SEC’s decision brings to a halt one of the more divisive steps under the Biden administration to hold companies’ feet to the fire over their security failings, a groundbreaking suit that a judge last year dismissed in significant measure.
    • “It comes the same day the Federal Communications Commission rescinded Biden-era cyber regulations the FCC wrote in response to another major cyberespionage campaign that saw alleged Chinese hackers infiltrate telecommunications carriers.
    • Two years ago, the SEC took action against SolarWinds and its CISO, Tim Brown, over claims that it didn’t adequately disclose the Sunburst attack that began in 2019, as well as over other security assertions the company made.
    • “The SEC litigation notice Thursday didn’t explain why it had dropped the case. An SEC spokesperson declined to comment beyond the notice.
    • ‘A SolarWinds spokesperson said the company welcomed the SEC decision. The mere threat of SEC action two years ago had panicked some cyber executives who said it could create a chilling effect to disclose cyber information.”

From the cybersecurity vulnerabilities and breaches front,

  • Security Week informs us,
    • “Outages hit a wide range of online services, including ChatGPT, X, Dropbox, Shopify, and the game League of Legends. The incident has also reportedly caused some disruptions to websites and other digital services associated with critical organizations such as New Jersey Transit, New York City Emergency Management, and the French national railway company SNCF.
    • “Cloudflare initially reported seeing a “spike in unusual traffic”, which led some to believe that the outage may be the result of a cyberattack.
    • “However, Cloudflare CTO Dane Knecht pointed out on Tuesday morning [November 18, 2025,] that it was not an attack.
    • “Instead, Knecht said, “a latent bug in a service underpinning our bot mitigation capability started to crash after a routine configuration change we made. That cascaded into a broad degradation to our network and other services.”
    • “That issue, impact it caused, and time to resolution is unacceptable. Work is already underway to make sure it does not happen again, but I know it caused real pain today,” he added.
  • Cybersecurity Dive adds,
    • “Microsoft said Monday [November 17, 2025,] it was able to neutralize a record breaking distributed denial of service attack against its Azure service in late October. 
    • “The multivector attack, measuring 15.72 Tbps and almost 3.64 billion packets per second, was the largest single attack in the cloud ever recorded, according to the company.
    • “The company traced the attack to the Aisuru botnet, which often targets compromised home routers and cameras. Most of the threat activity linked to Aisuru involved residential internet service providers in the U.S., but also includes other countries, according to Microsoft.”
  • Dark Reading points out,
    • “In a near replica of a separate campaign this summer, hackers connected to the ShinyHunters extortion operation have once again breached many organizations’ Salesforce instances via a third-party integration.
    • “Following a spring vishing campaign targeting organizations’ Salesforce environments, a ShinyHunters-adjacent threat group hit Salesforce again in August. The threat actors performed a supply chain breach through Salesloft’s Drift, an integrated application that uses artificial intelligence (AI) to automate marketing and sales processes. They broke into Salesloft, stole OAuth tokens that connect Drift and Salesforce, and used them to reach hundreds of organizations’ Salesforce environments, with all of the powers and permissions within Salesforce that those organizations had granted the Drift app.” * * *
    • “Researchers from the Google Threat Intelligence Group (GTIG) have publicly attributed the attack to hackers tied to ShinyHunters, and said that more than 200 customer instances have been impacted. DataBreaches.net directly contacted the group, which confirmed responsibility, claiming that between Drift and Gainsight the group has gained access to Salesforce data for nearly 1,000 organizations. 
    • “Dark Reading has not independently confirmed that these organizations have been affected.”
  • and
    • “For more than half a decade now, a Chinese state-aligned threat actor has been spying on Chinese organizations by infecting their trusted software updates.
    • “When the SolarWinds breach was unearthed in 2020, it might have seemed like a uniquely devious event in cybersecurity history. But cyberattackers and cybersecurity researchers have been finding other, novel ways of poisoning software updates since then.
    • “PlushDaemon” is one such group that has quietly, for quite a while now, been taking its own approach to the update hijack. Like Chinese advanced persistent threats (APTs) often do, it infects organizations through their edge devices. But where most APTs use edge devices as initial entry points to deeper network compromise, researchers at ESET have found that PlushDaemon uses them in its own way. It hijacks network traffic using a specially designed implant, re-routes legitimate software update requests to its own infrastructure, and then serves victims malicious substitutes.”
  • Cyberscoop adds,
    • “Federal, state, and local government agencies face a critical vulnerability hiding in plain sight: outdated web forms collecting citizen data through insecure channels. While agencies invest in perimeter security and threat detection, many continue using legacy forms built years ago without modern encryption, authentication, or compliance capabilities. These aging systems collect Social Security numbers, financial records, health information, and security clearance data through technology that cannot meet current federal security standards.
    • “The scope of the problem is substantial. Government agencies allocate 80% of IT budgets to maintaining legacy systems, starving modernization efforts while feeding outdated technology. The federal government’s 10 most critical legacy systems—ranging from 8 to 51 years old—cost $337 million annually to operate and maintain, with total projected spending on legacy systems reaching $2.4 billion by 2030. Meanwhile, government data breaches cost an average of $10.22 million per incident in the United States—the highest globally.” * * *
    • “Legacy government web forms that do implement encryption often use outdated protocols that no longer meet regulatory requirements. Older systems rely on SHA-1 hashing and TLS 1.0, which are vulnerable to known exploits and don’t meet NIST, CJIS, or HIPAA requirements. Without HTTP Strict Transport Security enforcement, browsers don’t automatically use secure connections, allowing users to access unencrypted form pages.”
  • Per Bleeping Computer,
    • “American cybersecurity company SonicWall urged customers today [November 20, 2025,] to patch a high-severity SonicOS SSLVPN security flaw that can allow attackers to crash vulnerable firewalls.
    • Tracked as CVE-2025-40601, this denial-of-service vulnerability is caused by a stack-based buffer overflow impacting Gen8 and Gen7 (hardware and virtual) firewalls.
    • “A Stack-based buffer overflow vulnerability in the SonicOS SSLVPN service allows a remote unauthenticated attacker to cause Denial of Service (DoS), which could cause an impacted firewall to crash,” SonicWall said.
  • and
    • “American cybersecurity firm CrowdStrike has confirmed that an insider shared screenshots taken on internal systems with hackers after they were leaked on Telegram by the Scattered Lapsus$ Hunters threat actors.
    • “However, the company noted that its systems were not breached as a result of this incident and that customers’ data was not compromised.
    • “We identified and terminated a suspicious insider last month following an internal investigation that determined he shared pictures of his computer screen externally,” a CrowdStrike spokesperson told BleepingComputer today.
    • “Our systems were never compromised, and customers remained protected throughout. We have turned the case over to relevant law enforcement agencies.”

From the ransomware front,

  • Bleeping Computer reports,
    • “An in-development build of the upcoming ShinySp1d3r ransomware-as-a-service platform has surfaced, offering a preview of the upcoming extortion operation.
    • “ShinySp1d3r is the name of an emerging RaaS created by threat actors associated with the ShinyHunters and Scattered Spider extortion groups.
    • “These threat actors have traditionally used other ransomware gangs’ encryptors in attacks, including ALPHV/BlackCat, Qilin, RansomHub, and DragonForce, but are now creating their own operation to deploy attacks themselves and their affiliates.
    • “News of the upcoming RaaS first came to light on a Telegram channel, where threat actors calling themselves “Scattered Lapsus$ Hunters,” from the names of the three gangs forming the collective (Scattered Spider, Lapsus$, and ShinyHunters), were attempting to extort victims of data theft at Salesforce and Jaguar Land Rover (JLR).”
  • eSecurity Planets adds,
    • “A fast-moving ransomware group known as “The Gentlemen” has emerged as one of 2025’s most aggressive cybercrime operations, rapidly scaling its attacks across Windows, Linux, and ESXi environments. 
    • “First observed in July 2025, the group has already listed 48 victims on its leak site and continues to release new, highly capable ransomware variants. 
    • “Cybereason researchers said the group “… blends mature ransomware techniques with RaaS features, dual‑extortion, cross‑platform (Windows/Linux/ESXi) lockers, automated persistence, flexible propagation, and affiliate support, allowing it to scale attacks and evade basic defenses quickly.
    • “The Gentlemen ransomware group relies on tried-and-true tactics borrowed from other successful RaaS operations. Organizations can stay ahead by validating their defenses against these established methods before attackers utilize them,” said Hüseyin Can Yüceel, Security Research Lead at Picus Security.”
  • Cyber Press relates,
    • “The notorious Clop ransomware gang, also tracked as Graceful Spider, has escalated its latest extortion campaign by listing Oracle Corporation on its dark web leak site. 
    • “The group claims to have successfully breached the tech giant’s internal systems using a critical zero-day vulnerability in Oracle E-Business Suite (EBS), designated as CVE-2025-61882. 
    • ‘This marks a significant development in supply chain attacks, with Oracle potentially falling victim to a flaw in its own software.​”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports
    • “Palo Alto Networks PANW is buying the observability platform Chronosphere for $3.35 billion, the latest acquisition by the cybersecurity company to capitalize on an AI-intensive economy.
    • The Santa Clara, Calif.-based company said Wednesday the cash-and-stock deal will address demands for observability in the rapidly expanding artificial-intelligence data center market, combining Chronosphere’s observability architecture with Palo Alto Networks’ AI-powered AgentiX tool.
    • “Once we leverage AgentiX with Chronosphere, we will take observability from simple dashboards to real-time, agentic remediation,” Palo Alto Networks Chief Executive Nikesh Arora said. “We are excited to not just enter this space, but to disrupt it.”
    • “The deal is expected to close in the second half of Palo Alto Networks’ fiscal 2026.
    • “The deal came as Palo Alto Networks posted higher revenue in its latest quarter and raised its top-line view for the year.”
  • CISA announced a #SecuretheSeason campaign promoting online shopping safety.
  • Per Dark Reading,
    • “Editors from Dark Reading, Cybersecurity Dive, and TechTarget Search Security break down the depressing state of cybersecurity awareness campaigns and how organizations can overcome basic struggles with password hygiene and phishing attacks.”
  • and
    • “Securing the Win: What Cybersecurity Can Learn from the Paddock. A Formula 1 pit crew demonstrates the basic principles of how modern security teams should work.”
  • Here is a link to Dark Reading’s CISO Corner.

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.”

Midweek update

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Roll Call reports,
    • “GOP health panel leaders in the Senate on Wednesday seemed intent on quickly implementing a health savings account proposal to replace expiring health care tax credits that subsidize insurance plans used by millions of Americans, despite increased skepticism from Democrats and even some House Republicans.
    • During a Senate Finance Committee hearing on health care affordability, lawmakers largely stuck to party-line questioning over skyrocketing costs for Affordable Care Act health plans, suggesting no easy compromise is imminent.”
  • Fierce Healthcare tells us,
    • “Democrats didn’t necessarily discount their counterparts’ ideas during the hearing but said lawmakers need to extend the subsidies as-is for at least one year to allow for significant time to actually have a back-and-forth on healthcare policy and for those policies to be implemented.” * * *
    • “Ranking member Ron Wyden, D-Ore,, said that once a “clean” extension is in place, he and his Democratic colleagues would gladly join Republicans in curbing “insurance company abuses.” That extends to a long-discussed reform of the pharmacy benefit management industry, he said.”
  • The American Hospital Association News informs us,
    • “The House Ways and Means Subcommittee on Health held a hearing Nov. 19 to discuss improvements to care coordination and delivery to prevent and treat chronic disease. Health care and pharmaceutical experts testified before the committee, including Michael Hoben, M.D., chief medical officer of population health services at Novant Health.” 
  • Roll Call adds,
    • “Congress’ schedule for next year is set after the Senate rolled out its 2026 calendar Wednesday, a day after the House unveiled its own version. 
    • “The Senate calendar, made public by Majority Leader John Thune’s office, contains a few notable differences from the schedule set by the House for the midterm election year.”
    • The article identifies those differences. 
  • Per a U.S. Office of Personnel Management news release,
    • “The U.S. Office of Personnel Management (OPM) today issued a memo to agencies announcing the launch of two new executive development programs: the Senior Executive Development Program (SEDP) and Leadership for an Efficient and Accountable Government (LEAG). These programs aim to equip Senior Executives, Senior Professionals, GS-15s, GS-14s, and their non-Title 5 equivalents with the skills and knowledge to advance the administration’s priorities and drive transformational change across federal agencies.” * * *
    • “These programs are a bold step toward building a federal workforce that is agile, accountable, and ready to deliver results for the American people,” OPM Director Scott Kupor said. “By investing in our leaders, we’re ensuring they have the tools to advance President Trump’s vision for a more efficient and effective government.”
    • “Read the memo here.”
  • Kevin Moss, writing in Govexec, offers Open Season advice for annuitants.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Just a few months after Boehringer Ingelheim broke into the oncology space with the first drug that can target a rare tumor type in patients with non-small cell lung cancer (NSCLC), the FDA has given its stamp of approval to a competitor in Bayer’s Hyrnuo (sevabertinib).
    • “Hyrnuo, a tyrosine kinase inhibitor (TKI), is specifically indicated for patients who have previously received treatment for nonsquamous NSCLC and whose tumors are confirmed to have relatively rare HER2 activating mutations in the tyrosine kinase domain (TKD).
    • “The twice-daily oral med was cleared through the FDA’s accelerated approval pathway, meaning it still needs to prove its worth in a confirmatory study. Nonetheless, the FDA saw preliminary evidence of clinical benefit in Bayer’s phase 1/2 Soho-01 trial.”
  • Per Radiology Business,
    • “The U.S. Food and Drug Administration has just granted De Novo marketing authorization for an at-home prenatal ultrasound platform that allows patients to scan themselves. 
    • “Israel-based Pulsenmore Ltd. announced the authorization for its Pulsenmore ES on Monday [November 3]. The product is an at-home prenatal ultrasound system physicians can prescribe to women so they can scan themselves under remote guidance via in-app instructions or a physician. Images captured are transmitted securely to the Pulsenmore app, where the provider can read them and inform the patient of any findings that might warrant an in-person visit. 
    • “Experts are hopeful the complementary tool can expand access to vital prenatal care, offering expectant mothers an added layer of reassurance.” * * *
    • “Learn more about the system here.” 

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “A pair of new Pew Research Center surveys finds that while nearly two-thirds of US adults view childhood vaccines as effective, confidence in their safety and in vaccine policy is increasingly shaped by political affiliation. At the same time, changes to federal COVID-19 vaccine recommendations appear to have had little impact on willingness to receive an updated shot. 
    • “In a nationally representative survey of more than 5,100 adults, 63% say they are extremely or very confident that routine childhood vaccines are effective at preventing serious illness.” * * *
    • “A separate Pew survey examined whether recent changes to US Centers for Disease Control and Prevention (CDC) vaccine guidelines have influenced Americans’ decisions to receive an updated COVID-19 vaccine. 
    • “According to the survey, the new recommendations have had little effect on public uptake. A majority of adults (59%) say they do not plan to receive the updated vaccine, similar to 2024 levels. Thirteen percent of respondents had already received the vaccine as of late October, and just 26% say they want to get it.”
  • and
    • “The results of a large clinical trial, published today in the New England Journal of Medicine, show that researchers are making progress on experimental mRNA flu shots, even if they aren’t yet ready to be rolled out to consumers.
    • “In the study, people randomly assigned to receive a flu shot made with modified mRNA were 29% less likely to be diagnosed with a lab-confirmed case of influenza by the end of winter than people given a conventional flu shot.
    • “The experimental mRNA vaccine prevented 60% to 67% of flu infections, while the conventional vaccine prevented 44% to 54% of infections, said Kelly Lindert, MD, vice president of clinical research and development at Pfizer and senior author of the new study.
    • “Authors of the study, which was funded by Pfizer, tested the experimental mRNA vaccine in more than 18,000 adults age 18 to 64 during the 2022-2023 flu season.
    • “This really is exciting and promising,” said Bill Hanage, PhD, a professor of epidemiology at the Harvard T.H. Chan School of Public Health., who was not involved in the new study. The modified mRNA vaccine “is plainly capable of protecting for at least a season and doing so better than the one with which it was being compared.”  * * *
    • “Mild to moderate side effects were much more common in those who received the mRNA shot, however.
    • “Researchers will need to reduce the number of side effects to make mRNA shots palatable, Hanage said.
    • “While there’s no evidence of an excess of really serious adverse events, there are clearly more of the moderate and not-pleasant adverse events,” Hanage said. “For many folks, this has been their dominant memory of COVID shots, and people will be reluctant to get vaccines on an annual basis which make them feel rotten.”
  • Yale New Haven Health System discusses what causes lung cancer in non-smokers.
  • JAMA Network lets us know,
    • “Annual lung cancer screening (LCS) reduces LC mortality and is recommended by the US Preventive Services Task Force (USPSTF). Recent state-level data showed LCS uptake is low (9%-31%), but true nationally representative estimates are lacking. This study estimated the current national prevalence of up-to-date LCS and deaths prevented and life-years gained from LCS at current and 100% screening uptake.” * * *
    • “Only approximately 1 in 5 eligible individuals in the US underwent LCS in 2024. Increasing current uptake to 100% could increase deaths prevented and life-years gained 3-fold. Efforts to increase uptake include improving awareness of LCS recommendations and access to LCS facilities, and targeting subgroups in whom LCS maximizes life-years gained. Unscreened eligible individuals in this study with fewer comorbidities had similar life-years gained because they were less likely to die of comorbid causes. Revisiting current eligibility recommendations is warranted. In 2023, the American Cancer Society eliminated the years-since-quit requirement and the National Comprehensive Cancer Network followed suit in 2025″
  • Per Cardiovascular Business,
    • “Financial incentives appear to double consistent hypertension medication use, according to a study led by NYU Langone Health and presented as a late-breaker at the American Heart Association (AHA) 2025 Scientific Sessions.
    • “Financial incentives clearly worked during the study—people in the rewards group took their medication much more consistently,” said John A. Dodson, MD, MPH, principal investigator and lead author of the study in a statement. Dodson is the director of NYU Langone’s Geriatric Cardiology Program and an associate professor in the Department of Medicine’s Leon H. Charney Division of Cardiology at NYU Langone Health.” * * *
    • “Researchers found that about 71% of patients in the rewards group opened their blood pressure medication on 80% of days. But the control group only opened the bottles on about 34% of days. Interestingly, both groups saw similar drops in blood pressure, with average systolic pressure falling by 6.7 mm Hg in the rewards group and 5.8 mm Hg in the control group.
    • “We were surprised that this didn’t lead to significantly better blood pressure control,” Dodson said. “It’s unclear whether participants opened the bottles without taking the medication, or if other untracked factors, like different medications or lifestyle behavior, affected their blood pressure.”
    • “Also, once the rewards ended, so did improvements in blood pressure, as medication habits returned to pre-study noncompliance levels.
    • “Dodson said the team was also surprised that adherence to medication dropped when the rewards ended. He said this shows how complex behavior change really is.”
  • Incentives can be complicated.
  • Per Health Day,
    • “The risk for hearing loss is significantly higher for patients with type 2 diabetes versus controls, according to a review published in the November issue of Otolaryngology-Head and Neck Surgery.”
  • Per MedPage Today,
    • “Overall cesarean birth rates decreased from 2012 to 2021, but racial disparities for Black women widened.
    • “Cesarean delivery can be vital but can also contribute to undue morbidity and mortality.
    • “Strategies to target racial disparities in cesarean delivery are warranted.”
  • Genetic Engineering and Biotechnology News relates,
    • “Typically, bone marrow research relies heavily on animal models and oversimplified cell cultures in the laboratory. Now, researchers from the Department of Biomedicine at the University of Basel and University Hospital Basel have developed a realistic model of bone marrow engineered entirely from human cells. Derived using human induced pluripotent stem cells (hiPSCs) and macro-scale porous hydroxyapatite scaffolds, the engineered vascularized osteoblastic niche (eVON) model may become a valuable tool not only for blood cancer research, but also for drug testing and potentially for personalized therapies. The researchers suggest the novel system could reduce the need for animal experiments for many applications.
    • “The research team, headed by Professor Ivan Martin, PhD, and Andrés García-García, PhD, reported on their achievement in Cell Stem Cell. In their paper, titled “Macro-scale, scaffold-assisted model of the human bone marrow endosteal niche using hiPSC-vascularized osteoblastic organoids,” the team stated, “The described eVON model addresses some of the current limitations in the development of uniform, durable, and reproducible human organoids toward enhanced relevance in disease modeling and drug screening.”
  • Per an NIH news release,
    • “Researchers gained new insights into the changes in the brains of young athletes that may lead to chronic traumatic encephalopathy. 
    • “The findings suggest that repetitive head impacts cause brain changes much earlier than previously thought.” 
  • Fierce Pharma informs us,
    • “In its mission to grow the reach of its pyruvate kinase (PK) activator Pyrukynd (mitapivat), Agios Pharmaceuticals has come up short of producing an unequivocal win in the key indication of sickle cell disease (SCD).
    • “Attempting to capture a “broad assessment” of the potential benefits of the drug across “multiple aspects of the disease,” the company ran the 52-week Rise Up study, with primary endpoints assessing hemoglobin responses and the annualized rate of sickle cell pain crises (SCPCs) compared to placebo. The study further examined five secondary endpoints, including other biomarker responses, patient fatigue and the annualized rate of hospitalizations for SCPCs.
    • “Rise Up met one primary endpoint by demonstrating an improved hemoglobin response, Agios said on Wednesday, with 40.6% of patients on the drug meeting hemoglobin response criteria, versus 2.9% on placebo. On the other primary measure, however, Pyrukynd showed a “reduction” in SCPCs but did not ultimately achieve statistical significance.”

From the U.S. public health front,

  • MedCity News explains how forward-thinking health plans are designing utilization management systems that are clinically sound, operationally efficient, and aligned with enterprise goals.
  • Healthcare Dive reports,
    • “Cleveland Clinic finished the quarter ended Sept. 30 on a high note, growing its operating income more than 375% year over year to total $206.2 million.
    • “Total revenue climbed to $4.5 billion, fueled largely by higher patient volumes, strong demand for outpatient services and favorable Medicare Advantage delegated premium and risk agreements that took effect at the beginning of the year. 
    • ‘Still, like many of its peers, the Ohio-based academic medical center is contending with rising costs. Operating expenses rose 10.2% year over year to total $4.1 billion as inflation and higher patient volumes pushed up spending on labor and pharmaceuticals.” 
  • Per Beckers Hospital Review,
    • “New York City-based NYU Langone Health reported an operating income of $482.8 million on $15.4 billion in revenue for the fiscal year ended Aug. 31, 2025, maintaining a steady operating margin of 3.1%, according to financial documents published Nov. 17.
    • “The financial results represent a 9.6% increase in operating revenue compared to the prior year, when the seven-hospital system posted a $431.4 million operating gain on $14 billion in revenue. Growth was driven by a 5% increase in inpatient discharges, a 10.8% increase in outpatient surgical volume and a 3.4% rise in emergency department visits, according to the system.”
  • Per Fierce Pharma,
    • “Facing the fact that Lundbeck’s unexpected offer for Avadel Pharmaceuticals was sweeter, Alkermes has come back to the negotiating table with a higher bid it believes can seal the deal.
    • “Alkermes and Avadel have reached an accord on a new offer that would see Alkermes pay up to $22.50 per Avadel share to acquire the company, according to a Nov. 19 press release. The upgraded bid features $21 per Avadel share in cash as well as a $1.50 per share contingent value right (CVR) tied to the potential FDA approval of Avadel’s narcolepsy drug Lumryz in idiopathic hypersomnia by the end of 2028.
    • “All told, the souped-up bid values Avadel at $2.37 billion, contingent upon the Lumryz milestone paying out, Alkermes said in its release.”
  • and
    • “Amid the pharma industry’s breakneck onshoring push this past year, North Carolina has been a major beneficiary as investment announcements rolled in from the likes of Roche, Biogen and Amgen. Now, Novartis is ready to significantly boost its presence in the state.
    • “Wednesday, the Swiss pharma giant rolled out a plan to establish a “flagship manufacturing hub” in the Tar Heel State. While Novartis already operates a gene therapy production site in Durham, the company plans to expand that site and add two more in the same city. In addition, Novartis plans to establish a new plant in Morrisville, North Carolina, the company said in a Nov. 19 announcement.
    • “Specifically, the company plans to build two new facilities in Durham for biologics and sterile packaging, according to the release. Novartis’ new site in Morrisville will specialize in solid dosage tablets and capsules, including packaging capabilities.”
  • and
    • “With a $140 million investment, Moderna will bring its drug product manufacturing to the United States, joining a parade of drugmakers looking to strengthen their supply chains and reduce exposure to potential tariffs on U.S. pharmaceutical imports. 
    • “Moderna’s project centers on the buildout of a new facility at its manufacturing campus in Norwood, Massachusetts, 20 miles south of its headquarters in Cambridge. The new plant will allow the company to execute end-to-end clinical and commercial stage production of its mRNA medicines. 
    • “By onshoring drug product manufacturing to our campus in Norwood, Massachusetts, we have completed the full manufacturing loop under one roof in the U.S.,” Moderna CEO Stéphane Bancel said in a Nov. 19 press release. “As an American company committed to building and producing in America, we are proud to strengthen our domestic footprint while bringing meaningful new jobs to the community.”

From the artificial intelligence front,

  • Beckers Health IT identifies ten “big” AI themes for healthcare as we head toward 2026.
  • MedTech Dive reports,
    • “Philips said Monday it has collaborated with Edwards Lifesciences to develop a tool that uses artificial intelligence to help physicians visualize and navigate mitral transcatheter edge-to-edge repair, or TEER, procedures.
    • “Called DeviceGuide, the technology tracks the repair device in real time as it moves through the heart. Philips said the system marks a shift in the use of AI from diagnostic imaging and patient monitoring into support for clinical decision-making during live procedures.
    • “DeviceGuide is available in some European markets through a limited release and has been submitted to the Food and Drug Administration for review, a Philips spokesperson said in an email.”

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.”