Monday report

OPM

Monday report

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

From Washington, DC

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    • “Kupor wrote that the program is outdated and rarely used, with less than 0.2% of the federal workforce participating.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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

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.”

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.”

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.”

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Weekend update

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medicare, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services (CMS) hosted health tech leaders at a Health Tech Ecosystem Connectathon event in Washington, D.C., Thursday [November 13, 2025] to showcase progress on its interoperability pledge.
    • “In late July, the CMS and the White House jointly announced a new focus on driving healthcare interoperability and getting health data into Medicare patients’ hands. The push for innovative products that ease health data transfer stems not from regulation, but from voluntary commitments made by industry to uphold new standards set out by the CMS. 
    • “The announcement was sprawling and included several spokes: a new CMS Interoperability Framework and a Health Tech Ecosystem that committed to working on conversational AI, modern digital identity verification and diabetes apps. 
    • “The CMS also committed to improving Medicare beneficiaries’ digital experience with CMS websites.” * * *
    • “The CMS debuted a beta prototype of its new national provider directory, multiple attendees said. The directory will allow Medicare beneficiaries to find providers that accept Medicare and will be available via a free FHIR API. 
    • “One participant noted that the CMS will update the public on its progress online and via a GitHub repository, an open-access cloud repository for projects that also tracks changes.  
    • Multiple companies also demonstrated products that meet the standards set out by the CMS in July for its so-called CMS Aligned Networks.”
  • Federal News Network shares OPM Associate Director for Healthcare and Insurance Shane Stevens views on the Open Season and the FEHB / PSHB program generally.

From the public health and medical / healthcare research front,

  • The Wall Street Journal offers women information about the Food and Drug Administration’s recent removal of a black box warning from all forms of menopausal hormone therapy.
  • Wired reports,
    • “GLP-1s are being studied for a wide range of conditions. Now, scientists will test whether their anti-inflammatory properties can help alleviate symptoms of long Covid.”
  • and
    • “The Aedes aegypti mosquito that can carry dengue, yellow fever, and Zika was thought to be too reliant on a hot and wet climate to survive in the Mountain West. But now, a population is thriving in Western Colorado.
  • The Washington Post adds,
    • “When Susan Akin first started injecting a coveted weight-loss drug early this year, the chaos in her brain quieted. The relentless cravings subsided — only they’d never been for food.
    • “The medication instead dulled her urges for the cocaine and alcohol that caused her to plow her car into a tree, spiral into psychosis and wind up admitted to a high-end addiction treatment center in Delray Beach, Florida.
    • “Doctors at Caron Treatment Centers tried a novel approach for the slender 41-year-old by prescribing her Zepbound, part of a blockbuster class of obesity and diabetes medications known as GLP-1s. Federal regulators have not approved the drugs for behavioral health, but doctors are already prescribing them off-label, encouraged by studies suggesting that they could reshape addiction treatment.
    • “Scientists caution that the research remains nascent. Health insurers do not cover the pricey drugs for that purpose. Addiction specialists say the medications might not be a cure but may work as a tool to quell addictive behaviors.”
  • MedPage Today informs us,
    • “Blood Test May Be a ‘Viable Alternative’ in Liver Cancer Surveillance. Investigational multi-target test more sensitive than ultrasound, but fell short in specificity.
  • The New York Times points out the best foods and drinks to resolve constipation.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health’s operations saw year-over-year improvement for the quarter ended September 30, but the nonprofit health system continues to be weighed down by rising expenses and reimbursement challenges.
    • “Despite strong volume, salary cost management, length-of-stay improvements and higher productivity, CommonSpirit’s financial performance continues to be impacted by expenses growing at a faster pace than revenue,” management said in a press release issued Friday.
    • “A significant impact to the organization’s revenue comes in the form of challenges with payers on denials and timely payments, and payment increases from both government and non-government payers that do not keep up with inflation,” management said.
    • “The 138-hospital system reported an as-recorded operating loss of $396 million (-4.0% operating margin) for the quarter ended September 30, its first fiscal quarter in 2026, as compared to the prior year’s $331 million operating loss (-3.5% operating margin).”
  • and
    • “Maven Clinic is expanding its maternity program to make pregnancy care more precise and personalized.
    • “The expansion includes remote monitoring to identify risks earlier and help address complications. Maven is also adding a NICU program to help get babies home faster through parent preparedness. New features begin rolling out this month.
    • “There’s no typical pregnancy; it’s not a thing. And it’s 2025, and it’s time to not have a cookie-cutter approach,” Neel Shah, M.D., chief medical officer at Maven, told Fierce Healthcare in an advanced interview.
    • “Maven clients trust the company to take care of an entire population, per Shah. That requires providing the right care for the right person, which is now being enabled by a new level of access to data. A year ago, Maven still relied on what members shared about themselves and claims data, Shah said. Now, Maven also has insights from wearables.”
  • Per a November 11, 2025, company news release,
    • “Doc.com, a pioneering healthcare technology company, proudly announces the launch of its new telemedicine platform and services. The platform combines artificial intelligence and blockchain-based technologies to enhance patient access, data security, and care coordination. Through a seamless mobile experience, patients can connect with licensed healthcare professionals within their state to receive quality care conveniently and securely. As part of its introductory rollout, new users may access up to 15 minutes of complimentary teleconsultation, available in eligible jurisdictions and subject to applicable regulations. These minutes may be used across one or multiple sessions as part of an initial trial experience. Subsequent consultations will be available at standard rates.
    • “Doc.com’s United States application rollout begins today with Phase 1 launching in West Virginia, followed by Virginia soon after. The company will then expand to the remaining U.S. states in three additional phases throughout 2026, concluding with full nationwide availability by early 2027. In addition to its United States rollout, Doc.com is introducing a blockchain component, designed to ensure secure, transparent, and efficient transactions across the healthcare ecosystem. This technology supports telemedicine consultations, medical record management, and AI-driven diagnostics, creating a fully integrated platform.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor reflects on the shutdown in his Secrets of OPM blog.
  • CMS announced 2026 Medicare Parts A & B Premiums and Deductibles and 2026 Medicare Part D Income-Related Monthly Adjustment Amounts. Of note,
    • “The standard monthly premium for Medicare Part B enrollees will be $202.90 for 2026, an increase of $17.90 from $185.00 in 2025. The annual deductible for all Medicare Part B beneficiaries will be $283 in 2026, an increase of $26 from the annual deductible of $257 in 2025. 
    • “The increase in the 2026 Part B standard premium and deductible is mainly due to projected price changes and assumed utilization increases that are consistent with historical experience. If the Trump Administration had not taken action to address unprecedented spending on skin substitutes, the Part B premium increase would have been about $11 more a month. However, due to changes finalized in the 2026 Physician Fee Schedule Final Rule, spending on skin substitutes is expected to drop by 90% without affecting patient care.”
  • Federal News Network reports,
    • “The Postal Service is seeing deeper financial losses than expected this year, but does not expect to veer much from a 10-year reform plan that it is nearly midway through completing.
    • “USPS, however, is far from the plan’s “break-even” goal, and is calling on Congress and the Trump administration to take a familiar wish list of reform efforts that are outside the agency’s control.
    • “The agency saw a $9 billion net loss in fiscal 2025 — significantly higher than the nearly $7 billion net loss it expected.
    • “USPS said it saw increased compensation costs, including offering early retirement incentives to more than 10,000 of its employees, which contributed to higher operating expenses this year.”
  • and
    • “More than 30,000 federal insurance enrollees may be in for some sticker shock next year, if they choose to do nothing during Open Season.
    • “With eight plan options being discontinued in the Federal Employees Health Benefits (FEHB) program, participants currently enrolled with those carriers — most of whom are enrolled in plans from the National Association of Letter Carriers — will, in some cases, face more than a 200% spike in premium costs, if they accept the auto-enrollment plan option for 2026.
    • “Typically, participants whose plans leave the FEHB program are automatically enrolled in the lowest-cost nationwide plan the following year. But for 2026, the Office of Personnel Management chose a different path forward.
    • “The specifics behind OPM’s decision remain unclear, but an OPM spokesperson told Federal News Network the agency chose a plan that’s not the lowest-cost nationwide plan “because we determined it was in the best interest of the program to do so.” * * *
    • “For 2026, the lowest cost nationwide plan that fits the statutory requirements is GEHA Elevate. But OPM made the decision to “exercise its authority” to make GEHA High the auto-enrollment plan instead.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “Withings, a French medtech company, has received U.S. Food and Drug Administration (FDA) clearance for BeamO, a new artificial intelligence (AI)-enabled device it describes as the “thermometer of the future.” BeamO includes electrocardiogram sensors, a stethoscope and a thermometer, providing users with a single check-up tool that evaluates a body temperature, cardiac health and pulmonary health in less than one minute—all from the comfort of home.
    • “BeamO is equipped with highly innovative sensors, meeting the challenge of miniaturization to bring together so many functionalities in such a small device,” Xavier Debreuil, product research director at Withings, said in a statement. “These sensors record the heart’s electrical activity as well as measure infrared light to interpret body temperature. On the other hand, they capture acoustic waves to study the activity of the heart and lungs. All the data is analyzed by artificial intelligence algorithms to identify anomalies.”
    • “BeamO brings access to key vital signs, typically measured during medical consultations, into everyday life,” added Eric Carreel, founder and president of Withings. “All this new data on the heart, lungs, and temperature provides an overview of the state of each user’s health. This data promotes a much more precise and reliable diagnosis, and it marks a revolution in telemedicine, transforming it into a true medical consultation by integrating the data collection component.”
    • “With FDA clearance now secured, BeamO is officially for sale in the United States. The price is $249.95. 
    • ‘By early 2026, the new-look thermometer will be available on Amazon and a variety of other retail partners.” 
  • Per Fierce Pharma,
    • “As Roche works to switch certain patients with breast cancer over to a fixed-dose combination of two medicines, its 13-year-old drug Perjeta is inching toward the end of its exclusive run in the U.S.
    • “The FDA said Thursday that it has approved Poherdy as an interchangeable biosimilar to Perjeta. The agency’s endorsement covers the Roche drug’s existing HER2-positive breast cancer indications. 
    • “Perjeta’s label currently includes its use in combination with trastuzumab and chemo for first-line HER2-positive metastatic breast cancer and as a neoadjuvant or adjuvant treatment for early-stage disease.”
  • and
    • “The FDA has officially limited the label of Sarepta Therapeutics’ Elevidys, putting an end to a whirlwind few months that saw the abrupt departure—and reinstatement—of top agency official Vinay Prasad, M.D.
    • “Duchenne muscular dystrophy (DMD) patients who are no longer able to walk independently can no longer receive the one-time gene therapy, the FDA said Friday. In addition, the drug’s indication now only covers ambulatory DMD patients who are at least 4 years of age.
    • “The official label restriction comes five months after Sarepta and its ex-U.S. partner Roche voluntarily suspended giving Elevidys to non-ambulatory patients following the report of a second recipient who died after developing acute liver failure.
    • “The updated label now includes a new boxed warning, the FDA’s most serious safety warning, describing the potentially deadly risks of serious liver injury and acute liver failure.”

From the judicial front,

  • The New York Times reports,
    • “The drugmaker Purdue Pharma, which along with its owners came to symbolize greedy indifference to surging opioid overdose deaths, will soon cease to exist, after a bankruptcy judge said Friday that he would give final approval to a plan to settle thousands of lawsuits against the company.
    • “The agreement comes more than two decades after the first legal actions were filed against Purdue over its aggressive sales tactics and promotion of the opioid painkiller OxyContin as largely nonaddictive. It requires members of the billionaire Sackler family to relinquish ownership of the company and pay as much as $7 billion over 15 years to states, communities, tribes and others harmed in what became a decades-long national opioid addiction crisis.
    • “I will tell you now that I’m going to confirm the plan,” Judge Sean H. Lane of the United States Bankruptcy Court for the Southern District of New York said Friday afternoon at the conclusion of three days of testimony. He said he would issue a formal ruling on Tuesday.
    • “Purdue will immediately contribute $900 million and then be dissolved. It will be reborn as a public benefit company called Knoa Pharma, which will manufacture limited quantities of opioid painkillers and also opioid overdose-reversal medications. Profits will go to programs to remediate the continuing devastation related to opioids.”

From the public health and medical / Rx research front,

  • Guess what’s back now that the shutdown is over? The Centers for Disease Control and Prevention announced today,
  • Beckers Hospital Review identifies the hospitals that received the best and the worst patient safety grades from the LeapFrog Group this week.
  • CNN Health tells us,
    • “As colon and rectal cancers in young people are on the rise globally, especially in the United States, consumption of ultraprocessed foods has been in lockstep. The fare now makes up roughly 70% of the US food supply and nearly 60% of US adult caloric intake, and several studies have linked this growing trend with the risk of such cancers.
    • “A new, first-of-its-kind study adds to the growing evidence by suggesting eating ultraprocessed foods may significantly raise the odds of developing early-age noncancerous colorectal adenomas — growths, or polyps, in the colon and rectum that can lead to cancer.”
    • “In the new study, ultraprocessed food intake was primarily from ultraprocessed breads and breakfast foods; sauces, spreads and condiments; and sugar- or artificially sweetened beverages.
    • “Participants with the highest intake of ultraprocessed foods — about 10 servings daily — had a 45% higher risk of developing those growths by age 50 when compared with those with the lowest consumption, a bit over three servings daily. The study, which followed more than 29,100 female nurses for a median period of 13 years, published Thursday in the journal JAMA Oncology.”
  • NBC News points out,
    • “One of the most common viruses in the world could be the cause of lupus, an autoimmune disease with wide-ranging symptoms, according to a study published Wednesday.
    • “Until now, lupus was somewhat mysterious: No single root cause of the disease had been found, and while there is no cure, there are medications that can treat it.
    • “The research, published in the journal Science Translational Medicine, suggests that Epstein-Barr virus — which 95% of people acquire at some point in life — could cause lupus by driving the body to attack its own healthy cells.
    • “It adds to mounting evidence that Epstein-Barr is associated with multiple long-term health issues, including other autoimmune conditions. As this evidence stacks up, scientists have accelerated calls for a vaccine that targets the virus.”
  • MedPage Today adds,
    • “Low levels of vitamin D and its principal circulating form 25-hydroxyvitamin D (25-OH-D) have been linked to many types of adverse outcomes beyond bone health, such as cardiovascular disease.
    • “How vitamin D levels may affect outcomes in lupus patients has not been well studied, especially over the long term.
    • “This prospective cohort study, with many years of follow-up, showed markedly increased risk for all-cause mortality and cardiovascular events in lupus patients with low levels at enrollment.”
  • Per Health Day,
    • “People facing a major surgery might understandably think they need to conserve their energy, both for the procedure as well as the rehabilitation to follow.
    • “But they’d be better off if they engaged in “prehabilitation.” And a new study found prehab works best if a patient receives some one-on-one attention.
    • “Patients who got a personalized prehab program with twice-weekly coaching wound up better prepped for surgery than those offered standard pre-surgery advice without any direct guidance, researchers reported Nov. 12 in the journal JAMA Surgery.
    • “Those who got personal coaching improved significantly on every test of physical and mental fitness prior to their procedure, researchers found.
    • “The patients also experienced changes in their immune system that aided their post-surgery recovery and wound up with fewer major complications.”
  • Per Medscape,
    • “The first global randomized trial of the PCSK9 inhibitor evolocumab for the prevention of a primary major adverse cardiovascular event (MACE) found a relative reduction in risk similar in magnitude to that previously seen for secondary prevention. 
    • “The VESALIUS-CV trial showed a risk reduction over a median of 4.6 years of follow-up of 19% and 25% (P < .001 for both) for the dual composite primary MACE endpoints. These were accompanied by a 20% reduction (P = .0005) in all-cause death, a result characterized as “nominal” because it was not among the prespecified composite endpoints.
    • “The reduction in MACE in this trial supports intensive LDL-C lowering in high-risk patients whether or not they have had a prior event,” said Erin A. Bohula, MD, DPhil, an associate physician in cardiovascular medicine at Brigham and Women’s Hospital in Boston, who led the study.
    • “The findings were presented at the 2025 Scientific Sessions of the American Heart Association and published simultaneously in The New England Journal of Medicine.”
  • Per MedPage Today,
    • “In patients with angina but no obstructive arteries on angiography, further testing with stress cardiac MRI improved diagnosing the cause of angina, resulting in better management and quality of life, the CorCMR trial showed.
    • “Reclassification of the initial angiogram-based diagnosis occurred in 53% of patients after cardiac MRI (95% CI 46.6-59.3, P<0.001), meeting the primary outcome of the diagnostic phase of the study, reported Colin Berry, MBChB, PhD, of the University of Glasgow in Scotland, at the American Heart Association (AHA)opens in a new tab or window annual meeting.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb and Johnson and Johnson have stopped early the first of trio of late-stage trials testing an experimental anticoagulant they hope will become a future blockbuster. 
    • “Trial monitors determined that a regimen involving the drug, milvexian, and standard medications wasn’t likely to be superior to those typical treatments alone at preventing cardiovascular complications in people who’d recently had a heart attack. Despite the failure, the two companies noted that two other large studies are ongoing and milvexian still has “multibillion-dollar potential.” 
    • “Still, the result is the latest setback for drugs in milvexian’s class, called Factor XIa inhibitors and viewed as potentially safer alternatives to widely used medicines like Eliquis and Xarelto. It’s also another recent negative readout for Bristol Myers, which has reported late-stage stumbles for drugs in cancer, mental health conditions and other diseases this year.” 

From the U.S. healthcare business front,

  • Kaufman Hall reports,
    • “The number of physicians exiting traditional Medicare has accelerated, especially since the Covid-19 pandemic, with the annual exit rate climbing from less than 1% in 2013 to nearly 5% in 2023, a new JAMA study has found. The study, a review of Medicare fee-for-service claims data, found that while the total number of physicians in fee-for-service Medicare rose modestly over the decade, from about 586,000 to 622,000, departures have accelerated sharply in recent years. Participation peaked in 2019, then began a steady decline that has continued. Researchers found higher exit rates among older doctors, women, primary care physicians and those practicing in rural or underserved areas but stopped short of making a claim about the impact of the pandemic. The trend raises concern that access to care for Medicare beneficiaries could erode even as the overall physician workforce grows; these patterns could exacerbate existing access gaps for older and rural Americans.”
  • The American Hospital Association News lets us know,
    • Aetna’s new “level of severity inpatient payment” policy is now set to take effect Jan. 1, 2026, the company recently announced, along with providing additional details about the policy. The policy was supposed to take effect Nov. 15. 
    •  Aetna earlier this year said it was creating a new type of inpatient reimbursement for so-called “low severity” inpatient stays that it has said will be “comparable” to observation rates. This policy will take the place of Aetna’s (and essentially every other insurer’s) long-standing approach of denying inpatient stays it deems medically unnecessary and then, in most instances, downgrading them to outpatient observation status. Instead, Aetna will approve these inpatient stays but reimburse hospitals at a lower rate it determined unilaterally outside of the good faith contract and rate negotiation process. This policy only will apply to Aetna’s Medicare Advantage and dual eligible lines of business. 
    •  In its Nov. 6 announcement, Aetna clarified that:
      • The level of severity review will apply only to urgent/emergent inpatient stays of at least one midnight but less than five midnights.
      • Stays of five midnights or greater will not be subject to level of severity review and will be paid at the inpatient DRG (diagnosis related group) rate.
      • For inpatient stays of at least one midnight but less than five midnights that do not meet MCG criteria, providers may request a severity review and engage in a severity discussion with an Aetna medical director.
    • The AHA appreciates Aetna’s decision to delay implementation of its level of severity policy for inpatient hospital admissions from November to January,” the AHA said. “This pause provides additional time for hospitals and health systems to prepare and for continued dialogue on the policy’s impact.” 
  • BioPharma Dive informs us,
    • “Merck & Co. is spending billions of dollars to gain rights to a new kind of preventive flu medicine, hoping that the treatment is poised to become a top seller in the years ahead. 
    • “The pharmaceutical giant on Friday agreed to acquire Cidara Therapeutics, the San Diego-based developer of that medicine, in a deal worth $9.2 billion. Merck is paying $221.50 per share for the company, a 109% premium to its closing price on Thursday. 
    • “News of the pending buyout was first reported by The Financial Times on Thursday.
    • “The deal revolves around a prospect currently known as CD388. It’s an antiviral that combines a small molecule with a protein fragment. Cidara has been evaluating it as a long-acting, preventive therapy for seasonal influenza, one of the world’s most common respiratory infections.”
  • and
    • “Last month, Avadel Pharmaceuticals agreed to sell to fellow Dublin-based drugmaker Alkermes in a deal potentially worth around $2.1 billion. Terms held that Avadel investors would receive $18.50 per share up front, but could eventually take home another $1.50 per share if the company’s main asset — a marketed narcolepsy drug called Lumryz — also gets approved within the next few years to treat a different sleep disorder known as idiopathic hypersomnia. “Wall Street analysts described Lumryz as a “clear” strategic fit for Alkermes, which has been developing its own narcolepsy medicine that’s part of an emerging drug class expected to generate billions of dollars.
    • “But that deal may not materialize, now that another company has submitted a bigger, unsolicited proposal to buy Avadel.
    • “Lundbeck, a Danish drug developer, is offering to pay $21 up front, in cash for each Avadel share, while also providing a “contingent value right” that could be worth as much as $2 per share if certain milestones are met. With that right, half of the value would come from the combined annual net sales of Lumryz and another Avadel asset, valiloxybate, reaching at least $450 million in the U.S. by the end of 2027. The other half would come if annual net sales from those drugs hit $700 million in the U.S. by the end of 2030.”
  • Per Beckers Payer Issues,
    • “As part of the ongoing enterprise-wide recalibration effort to improve financial performance, UnitedHealth Group leadership shared in late October that it would be moving its finance business at Optum under the umbrella of Optum Insight, the company’s data and analytics arm.
    • “We are realigning Optum Financial Services within our Optum Insight Services platform. Many of these actions are underway, and we believe they will improve both our focus and long-term performance,” CEO Stephen Hemsley told investors on the company’s third quarter earnings call.
    • “Optum Financial offers a portfolio of financial products and solutions, including health savings accounts (HSAs), flexible spending accounts (FSAs), payment and claims management services and financial education tools. 
    • “The business unit includes Optum Bank, which serves around five million customers. In 2023, the bank recorded more than $400 million in brokered deposits and almost $600 million in interest income.”
  • Per Fierce Healthcare,
    • “Fabric, a healthcare tech and care enablement company, inked its fifth acquisition in less than three years, acquiring UCM Digital Health.
    • “The deal adds 400 new payer and employer customers and 1 million covered lives across all 50 states. Fabric executives said the acquisition will integrate its AI-enabled virtual care technology and nationwide clinical network with UCM’s deep expertise in serving payers and employers.
    • “For Fabric, it’s about making healthcare more accessible,” said Aniq Rahman, CEO and Founder of Fabric, in a statement. “We’ve already made meaningful progress in the payer and employer markets, and this acquisition allows us to deepen that impact. By bringing more payers and employers onto our platform, we’re creating a connected experience that streamlines workflows, reduces friction and costs, and ultimately drives better outcomes for members and our partners.”

Midweek update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Monday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Hill reports,
    • “The Senate on Monday is holding a series of votes to possibly pass the proposal that could reopen the federal government. 
    • “Monday’s series, which will include up to eight votes, kicked off shortly before 6 p.m. and will conclude with a vote on final passage.
      • FEHBlog note — The Senate did pass a Sen. Susan Collins substitute to the HR 5371 which will go back to the House for a vote perhaps as early as Wednesday. Here is a link to a later Monday Hill report.
    • “Speaking at the White House earlier Monday, President Trump indicated he would back the Senate deal. The bill will still need to pass the House if the Senate votes to advance it.”
  • Federal News Network adds,
    • “The Senate’s initial agreement toward ending the longest-ever government shutdown includes provisions that would secure back pay for all federal employees, as well as reverse the Trump administration’s recent reductions in force.” * * *
    • “The Senate’s legislation over the weekend would also compel agencies to reverse all reduction-in-force actions that have taken place since the shutdown began. About 4,200 federal employees across government received RIF notices in mid-October, following guidance from the White House that encouraged agencies to move forward with layoffs in the event of a funding lapse.
    • “Most, but not all, of those RIF actions are currently on hold due to a preliminary injunction granted by a district court judge last month. Federal unions are suing the Trump administration over the layoffs, alleging that they violate the Administrative Procedure Act.”
    • “The Senate’s tentative agreement would also temporarily bar the Trump administration from conducting further RIFs until late January.”
  • Healthcare Dive tells us,
    • “House Democrats introduced a bill on Friday to repeal a CMS innovation center payment model that will add artificial intelligence-backed prior authorization for some services in Medicare. 
    • “The Wasteful and Inappropriate Service Reduction, or WISeR, model will implement prior authorization in six states starting in January. The CMS last week announced health technology companies that will administer the model.
    • “The six Democrat representatives behind the legislation say WISeR will add red tape and limit access to care for Medicare seniors. “It is not an exaggeration to say that the requirement of prior authorization for traditional Medicare services will kill seniors,” said Rep. Mark Pocan, D-Wis. “Not only that, but the use of AI in determining whether or not treatment is necessary is extremely reckless.”
  • Govexec informs us,
    • “The federal government’s backlog of pending retirement claims hit the highest level since the COVID-19 pandemic last month, as tens of thousands of federal workers who accepted the Trump administration’s so-called deferred resignation program.
    • “While January and February are traditionally the busiest months for processing federal employees’ retirement applications, the deferred resignation program, stemming from Elon Musk’s controversial “fork in the road” email, created a new logjam last month, as most who agreed to leave federal service through the initiative did were paid through Sept. 30. A second tranche is expected next January, as some DRP participants were allowed to remain on paid leave through the end of the calendar year in order to reach retirement eligibility.”
    • “All told, OPM received 20,344 new retirement claims in October. The agency processed 8,751 applications during the same time period—an increase over September’s 7,902 despite the ongoing government shutdown—causing the agency’s backlog to balloon to 34,587 pending claims.”
  • Kevin Moss, writing in Govexec, offers advice on how to assess choices created by the Federal Benefits Open Season, which began today.
    • “From rising premiums to fewer plan choices, this guide walks you through reviewing benefits, checking provider networks and using tax-advantaged accounts to keep your healthcare costs in check next year.”
  • OPM Associate Director for Healthcare and Insurance Shane Stevens also gives Open Season advice on You Tube.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration said manufacturers should remove black box warnings on hormone-replacement therapy drugs, citing clinical trials showing no association with increased breast cancer risk.
    • “The black box warnings may have kept many women away from what life-changing treatment could be, the head of the FDA said Monday in an opinion piece published in The Wall Street Journal.”
  • MedTech Dive lets us know,
    • “MMI said the Food and Drug Administration approved an investigational device exemption to study a microsurgical intervention for Alzheimer’s disease using the company’s Symani robotic platform.
    • “The REMIND study will evaluate the safety and feasibility of the procedure to improve drainage of neurotoxins, such as amyloid beta and phosphorylated tau, from the brain in patients with mild to moderate Alzheimer’s disease and obstruction in the deep cervical lymph nodes of the neck.
    • “The study’s primary endpoint is device-related serious adverse events through 30 days after the procedure. Additional endpoints include biomarker and imaging changes, and cognitive assessments through six months.”

From the public health and medical / Rx research front,

  • PlanSponsor reports,
    • Four industry experts attending the Milken Institute’s Future of Health Summit 2025 noted that as Americans live longer, the challenge is not just adding years to their lives, but making sure that time includes quality, health and financial security.
    • During the panel, “The Longevity Equation: Integrating Healthspan and Wealthspan,” the speakers explored innovative strategies and systems intended to help close the gap between what people need and what the current system delivers, given today’s demographic realities.
    • “It’s great that people are living longer, but it’s important to acknowledge the disparities between their wealth span, lifespan and health span,” said Alberto Casellas, the executive president and CEO of health and wellness at Synchrony Financial. “We haven’t spoken enough about saving for [their] health.”
  • The American Medical Association lets us know what doctors wish their patients knew about sleep apnea.
  • Per Health Day,
    • “Women diagnosed with advanced breast cancer can now expect to live an extra six or seven months compared to about a decade ago, researchers report.
    • “This increase in survival time coincides with the development of more effective treatments for advanced breast cancer, as well as wider improvements in diagnosis and quality of care, researchers said.
    • “In particular, women with breast cancers driven by known biological factors have seen a dramatic improvement in their outlook, thanks to better targeted therapies.
    • “Survival time for patients with advanced breast cancer, where the cancer has spread to other parts of the body, is much lower compared to early breast cancer,” senior researcher Dr. Fatima Cardoso said in a news release. She’s president of the Advanced Breast Cancer Global Alliance in Lisbon.
    • “The major treatments for this stage of breast cancer are systemic therapies, like hormone therapy, chemotherapy and targeted therapy, that aim to kill cancer cells wherever they are growing in the body,” Cardoso said. “In the last 15 years, we have seen a number of new systemic therapies developed and become available to some patients.”
  • Biopharma Dive relates,
    • “An experimental and closely watched drug for multiple sclerosis has delivered positive results in two late-stage clinical trials, giving its developer confidence it could change how the disease is treated.
    • “Roche said Monday that the drug, called fenebrutinib, hit the main goal of a trial focused on the most common, “relapsing” form of MS. According to Roche, participants taking fenebrutinib as opposed to Sanofi’s Aubagio showed a significant decrease in the average number of relapses — periods where neurological symptoms flare up or worsen — experienced in a year. A second, similarly designed experiment should produce results in the first half of 2026.
    • “Additionally, fenebrutinib succeeded in a separate study that enrolled nearly 1,000 people with “primary progressive” MS. The drug was “non-inferior” at slowing the disease compared to Roche’s Ocrevus, a blockbuster product and the only approved therapy for this more severe kind of MS.”
  • Per MedPage Today,
    • “In a phase I trial, an intranasal adjuvanted recombinant influenza vaccine appeared to result in response to a range of H5N1 clades.
    • “The adjuvanted vaccine elicited seroconversion against clade 2 subclades, including the avian influenza H5N1 clade.
    • “Post-dose reactogenicity symptoms to the adjuvanted vaccine were common and mostly mild.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente and its subsidiaries posted a $218 million operating income, or a 0.7% operating margin, for the third quarter of 2025, the country’s largest nonprofit health system shared Friday in a release.
    • “The integrated care organization painted its operating performance as below average for nonprofit healthcare entities. Still, the tally is still well ahead of its $608 million operating loss (-2.1% operating margin) from the third quarter of 2024, when higher-than-expected utilization, pharmacy costs and other factors triggered a push to reduce spending.
    • “Kaiser also benefited from a strong financial market conditions that fueled a $2.4 billion nonoperating income for the quarter. This gave the organization a bottom-line net income of $2.6 billion, again much stronger than the prior year’s $845 million.
    • “Consolidated operating revenues for the quarter hit $31.8 billion, up about 99.7% year over year, while operating expenses hit $31.6 billion, a roughly 6.8% increase. Membership across Kaiser and its Risant Health affiliates was more than 13.1 million as of Sept. 30, roughly the same as when it closed its second quarter June 30.”
  • Beckers Payer Issues recounts that “health insurers spent the third quarter resetting pricing models and narrowing their product portfolios as medical cost trends remained elevated and Medicare Advantage headwinds intensified heading into 2026.”
  • Beckers Hospital Review points out,
    • “Twenty-seven labor and delivery units at rural hospitals have shuttered in 2025, up from 21 in 2024, according to a new report from the Center for Healthcare Quality and Payment Reform.
    • “The report found that since year-end 2020, 116 rural hospitals have ended deliveries or planned to do so by year-end 2025. Rural L&D units have closed in most states over the last five years, and in three states, at least one-quarter of rural hospitals with maternity services have ended deliveries. Only 41% of U.S. rural hospitals provide L&D services, with less than one-third offering them in 12 states. 
    • “The findings highlight a concerning trend, driven by limited alternative revenue streams or inadequate reimbursement, which suggests that more rural communities could be at risk of losing maternity care due to the financial uncertainties of offering the services.”
  • and
    • “Since June, Jacksonville, Fla.-based Nemours Children’s Health has cared for more than 120 children with complex medical conditions at home through a first-of-a-kind program.
    • “The Advanced Care at Home program is designed for children who are medically stable but require ongoing advanced care. It is the nation’s first at-home care model operated by a freestanding children’s hospital, according to a Nov. 10 news release from Nemours.
    • “Since its launch, the program has helped avoid 177 inpatient days, 27 hospital readmissions and 91 emergency department visits, Nemours said.” 
  • MedTech Dive notes,
    • “Laborie Medical Technologies has struck a deal to buy a post-childbirth medical device from Organon for $440 million upfront, the companies said Friday.
    • “The acquisition covers the Jada system, a treatment for abnormal postpartum uterine bleeding or hemorrhage, and around 100 employees who will transfer to Laborie as part of the deal.
    • “Organon acquired the system in 2021 for an initial $219 million. The women’s health specialist grew sales from $20 million in 2022 to $61 million in 2024 as more hospitals stocked the system.”