Weekend update

Uncategorized

Weekend update

David Ermer–Congress, FDA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • While the House of Representatives is on recess this week, the Senate returns to Capitol Hill for Committee business and floor voting.
  • The Wall Street Journal reports,
    • “Senate Democrats angered by the deadly shooting in Minneapolis [on January 24] said they wouldn’t vote for a government funding package without major changes to its homeland security provisions, raising the possibility of a partial government shutdown this coming weekend. 
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) said Sunday that Republicans should work with Democrats to instead advance the other five funding bills in the package while lawmakers rewrite the Department of Homeland Security measure. Democrats are demanding constraints on DHS’s immigration enforcement activities and more oversight.
    • “Schumer said lawmakers need to overhaul immigration enforcement to “protect the public.” He said reworking the DHS bill while passing the remaining five—which include military and health funding—was the “best course of action, and the American people are on our side.”
    • “Republicans control the Senate 53-47, but 60 votes are needed to advance most legislation. Senate Appropriations Committee Chair Susan Collins (R., Maine) is exploring all options for the legislation, a spokeswoman said.
  • and
    • “This month has been tough for Republicans [who hold a narrow majority in the House of Representatives]. Following the death of Rep. Doug LaMalfa of California and the resignation of Rep. Marjorie Taylor Greene of Georgia, Republicans now hold 218 seats to Democrats’ 213. Democrats are expected to win a seat in Texas following a special election on Jan. 31, which would temporarily tighten the GOP majority to 218-214 once the new member is sworn in.
    • “The Republican members who voted Thursday included Rep. Steve Womack (R., Ark.), who was voting just a few days after his wife died. Rep. Jim Baird (R., Ind.) was present in a neck brace after his car accident earlier this month. Other GOP members, including Reps. Chip Roy, Nancy Mace and Julia Letlow, like Hunt, are campaigning for new jobs, which might create more pressures on their time. So far, 19 current Republican House members have announced campaigns for other offices, including for Senate and governor, compared with eight Democrats running for other offices. 
    • “Rep. Tom Emmer (R., Minn.), the party whip charged with counting votes, said recently that “outside of life-and-death circumstances, the whip’s office expects members to be here working on behalf of the American people.” It is a message Johnson and Emmer emphasized again in the House GOP’s weekly conference meeting on Wednesday, according to members.” 
  • Govexec notes,
    • “Federal agents on Saturday fatally shot a man protesting immigration enforcement activities in Minneapolis. The man was later revealed to be an employee of the Veterans Affairs Department, working as an intensive care unit nurse at the medical center in the city where he was killed. 
    • “Alex Jeffrey Pretti, 37, was taken to the ground by several federal agents before one of them shot him. Pretti gathered with other protestors as Border Patrol was conducting what it called a targeted operation to detain an individual it said was in the country illegally.”
  • Roll Call shares more details on this week’s activities on Capitol Hill.

From the Food and Drug Administration front,

  • STAT News informs us,
    • “Powdered whole milk used to make ByHeart infant formula could be a source of contamination that led to an outbreak of botulism that has sickened dozens of babies, U.S. health officials indicated Friday.
    • “Testing by the U.S. Food and Drug Administration found the type of bacteria that can cause the illness in two samples linked to the formula, officials said.” * * *
    • “Some formula companies do test raw materials and finished formula for evidence of the contamination, but such testing should be required, said Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, an advocacy group.
    • “FDA has not announced a plan to do testing, and that’s what we really want to see them do,” she said.
    • “Even if the contamination was traced to a milk supplier, the company remains responsible for the harm caused by its product, said Bill Marler, a Seattle food safety lawyer who represents more than 30 families of babies who fell ill.’

From the public health and medical / Rx research front,

  • MSN points out,
    • “The Georgia Department of Public Health says it would like to see lawmakers expand a state program aimed at bringing down the level of maternal and infant deaths.
    • “Georgia’s public health commissioner, Dr. Kathleen Toomey, recently told a legislative committee that her department has had a successful first couple of years for its Home Visit Program.
    • “According to the Georgia Department of Public Health website, “the DPH Home Visiting Program provides services by public health department nurses and trained staff, to expectant mothers from pregnancy until the first year of their baby’s life, at no cost to patients or providers.”
  • Medscape reports,
    • A 44-blood metabolite signature may help predict type 2 diabetes (T2D) beyond traditional risk factors, according to a new study based on data from more than 20,000 individuals without baseline diabetes.
    • “Integrating these data in large samples allowed us to identify early metabolic pathway changes that precede type 2 diabetes, providing new insights into disease mechanisms,” said Jun Li, MD, epidemiologist and assistant professor of medicine at Harvard Medical School in Boston.
    • “By further examining how genetics and modifiable lifestyle factors, such as diet, physical activity, and body weight, are related to these metabolites, our findings help shift the field toward more precise and potentially more effective strategies for preventing type 2 diabetes,” Li told Medscape Medical News.”
  • The American Journal of Managed Care tells us,
    • “Chronic inflammation and oxidative stress contribute to accelerated biological aging and increased skin cancer risk.
    • “Proinflammatory and pro-oxidative diets are associated with higher skin cancer risk, mediated by biological aging.
    • “The study used Dietary Inflammatory Index and Dietary Oxidative Balance Index to classify participants’ diets.
    • “Despite limitations, the findings highlight the need for further research on diet’s role in skin cancer development.”
  • The Washington Post relates,
    • “When Harith Rajagopalan considers the millions of patients who have taken a GLP-1 drug to treat diabetes or obesity, he sees a revolution that is failing to realize its promise. “We are literally lighting tens of billions of dollars on fire,” he said.
    • “Rajagopalan is referring to studies showing that most patients stop taking GLP-1 medications within a year or two, preventing them from reaping the long-term benefits like reducing cardiovascular risk. A cardiologist by training, Rajagopalan believes there’s a better way to harness the benefits of GLP-1 drugs: a gene therapy that, with a single infusion, can program the body to make more of the GLP-1 hormone naturally for years.
    • “Rajagopalan is the co-founder of a small biotech firm making a long-shot bid to disrupt the booming weight-loss industry. His publicly traded company, Fractyl Health, says it is on track to begin a human clinical trial later this year.” * * *
    • “The company has the attention of Wall Street and obesity researchers as it prepares to start its clinical trial for patients with Type 2 diabetes. Closer at hand, Fractyl plans to seek regulatory clearance this year for its other leading product: a procedure to help people maintain weight loss by removing the lining of part of the gut so that healthy tissue can regrow.
    • “So far, investors are more enthusiastic about other, more limited genetic approaches to treating obesity. Wave Life Sciences electrified Wall Street in December when it announced results from a small trial of an injectable drug that dials down the activity of a gene implicated in obesity. A single dose — designed to last at least six months — led participants to lose 9 percent of their visceral fat while increasing lean mass after 12 weeks. The company’s stock jumped almost 150 percent that day.
    • “Arrowhead Pharmaceuticals reported similar results from its own drug targeting the same gene, INHBE, by suppressing a protein that encourages the body to store energy rather than burn it.”
  • and
    • “If you are like a lot of people, you might be anxious about the risk of getting dementia as you age.
    • “The lifetime risk of developing dementia after age 55 is estimated at 42 percent, according to a 2025 study of over 15,000 participants. The number of Americans developing dementia each year is estimated to increase from 514,000 in 2020 to about 1 million by 2060.
    • “But there have been exciting strides in the diagnosis and treatments for Alzheimer’s disease, which accounts for 60 to 80 percent of dementia cases, as well as in understanding biological causes and development of dementia more broadly. About half of dementia cases may be preventable by addressing known risk factors, according to a 2024 Lancet Commission report.”
    • The article points out seven advances that occurred last year.

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

  • The Wall Street Journal reports,
    • Merck MRK is no longer in discussions to buy biotech Revolution Medicines RVMD, according to people familiar with the matter. 
    • Merck had recently been in talks to acquire RevMed in a deal that could have valued the cancer-drug biotech at around $30 billion. 
    • The talks cooled after the two couldn’t come to an agreement on price, some of the people said. 
    • It is always possible talks could restart or another suitor for RevMed could emerge. RevMed is expected to release closely watched testing data for its pancreatic and colorectal cancer drug candidates during the first half of this year.
  • The Rutland (N.D.) Herald lets us know,
    • “The North Dakota Insurance Department has approved the strategic affiliation between Blue Cross Blue Shield of North Dakota (BCBSND) and Cambia Health Solutions.
    • “The affiliation will enable greater capabilities for access to care that is simpler and more affordable while maintaining the strong local commitment that has served North Dakotans for more than 85 years. The affiliation will unify all operations and enable the organizations to share best practices for local plan innovation and services, deliver personalized member experiences and leverage Cambia’s robust technology infrastructure.” * * *
    • “The affiliation will take effect Feb. 1, 2026, making Cambia a five-state enterprise with North Dakota joining Cambia’s Regence health plans in Idaho, Oregon, Utah and Washington.”
  • Genetic Engineering and Biotechnology News observes,
    • “2026 kicked off with a stream of AI platform deals across pharma, signaling a cultural shift away from single-asset bets and toward investment in AI infrastructure for broad discovery.  
    • “The collaborations between AI start-ups, Chai Discovery, Noetik, and Boltz, and pharma giants, Eli Lilly, GSK, and Pfizer, respectively, will implement AI platforms across diverse applications, including biologics design, cancer clinical outcome prediction, and small molecule drug discovery.”  
  • MedCity News identifies “Five Collaboration Trends That Shaped Healthcare AI in 2025. Relationships between health systems, non profits, universities and public agencies are not new. The difference here is a nuance, the structure of the relationships are what stands out in these collaborations.”

Notable Obituaries

  • STAT News reports,
    • “William (Bill) Foege, credited by many for shepherding the smallpox eradication effort to completion, died Saturday at the age of 89. A towering figure, both literally — he was 6’ 7” — and figuratively, Foege epitomized all that was positive about an era of public health that saw enormous gains made both in the United States and abroad.
    • “He served as director of the Centers for Disease Control and Prevention from 1977 to 1983, capping 23 years of service with the agency. He was a founding member of the Task Force for Child Survival (now called the Task Force for Global Health), the first executive director of Carter Center — President Jimmy Carter’s human rights and global health focused alternative to a presidential library — and worked for a time as a senior medical adviser to the Gates Foundation.” * * *
      “Bill was a towering figure in global health — a man who saved the lives of literally hundreds of millions of people,” [Bill] Gates said in a statement. “He was also a friend and mentor who gave me a deep grounding in the history of global health and inspired me with his conviction that the world could do more to alleviate suffering. … The legacy of his career is that many of the remarkable developments to come will have his imprint all over them.”
    • “Though the list of his achievements was long, Foege — whose name was pronounced FEY-gee, with a hard G — was as well known for his unwillingness to claim credit as he was for the accomplishments themselves.” 

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Healthcare Dive reports,
    • “Republicans and Democrats in the House Budget Committee spent Wednesday blaming each other for the steep cost of healthcare, and arguing for diametrically opposed ideas to lower it. However, a few areas of bipartisan agreement emerged, including targeting healthcare consolidation — once an unheard-of view for members of the GOP.
    • “We got problems in Peoria with consolidation, with too much power and too many assets in too few market participants,” said Chairman Jodey Arrington, R-Texas, referring to a small community in Hill County. “You know how we feel about big government … but the most important thing here is, I think there’s common ground here.”
    • “We ought to huddle up at some point, probably not during a hearing, and figure out where we can deal with big medicine monopolies in pharma, hospital, insurance — the whole gambit. And I just want you to know I’m down with that,” Arrington continued.”
  • AHIP released two more healthcare cost articles today.
  • The Hill reports,
    • “Some of the nation’s top health insurance executives sought to deflect blame for the soaring cost of health care in the U.S., arguing that rising hospital and prescription drug prices were driving premiums higher and making health care less affordable for Americans.
    • “The CEOs of five major health insurers testified before a House Energy and Commerce subcommittee on Thursday, the first in a series of back-to-back hearings focused on finding the root causes driving unaffordability in the health care system, including skyrocketing premiums.”
  • and
    • “The House passed its final four appropriations bills Thursday afternoon, bringing Congress one step closer to avoiding a partial shutdown at the end of the month.
    • “A minibus package passed with a convincing 341-88 vote, funding the departments of Defense, Transportation, Housing and Urban Development, Health and Human Services, Labor, Education and other related agencies. The House separately passed legislation to fund the Department of Homeland Security with a 220-207 vote.”
  • The House of Representatives will be on recess next week while the Senate returns to Capitol Hill to tackle these appropriations bills.
  • Beckers Payer Issues raises three big questions about Trump’s healthcare policy plan.
  • On the bright side, Modern Healthcare relates,
    • “More than 40 hospitals have converted to rural emergency hospitals since 2023 [under a new federal program]. 
    • “The program has stabilized rural hospital finances but fewer hospitals converted last year.
    • “Hospitals have expanded services to their communities since joining the program.”
  • Federal News Network tells us,
    • “Agencies are getting more information on how to implement the recently finalized “rule of many.” The federal hiring strategy, several years in the making, aims to create broader pools of qualified job candidates while adding flexibility for federal hiring managers.
    • “A series of guidance documents the Office of Personnel Management published earlier this month outlined the steps agencies should take to begin using the “rule of many” when hiring. OPM’s new resources also detail how the “rule of many” intersects with other aspects of the federal hiring process, such as shared certificates, skills-based assessments and veterans’ preference.
    • “Under the “rule of many,” federal hiring managers score job candidates on their relevant job skills, then rank the candidates based on those scores. From there, hiring managers can choose one of several options — a cut-off number, score or percentage — to pare down the applicant pool and reach a list of qualified finalists to select from.”
  • Tammy Flanagan, writing in Govexec, answers “a litany of new questions on how to receive retirement benefits” coming from “an influx of federal retirees due to the Deferred Resignation Program and other separation programs.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Drugmakers developing experimental multiple myeloma drugs may have a quicker path to market under new guidance the Food and Drug Administration published this week.
    • “According to the new framework, the regulator may grant accelerated approvals in some settings based on a therapy’s ability to induce “minimal residual disease” or “complete responses,” both of which are achieved when drugs drastically reduce levels of dysfunctional blood cells in people with the disease.  
    • “The FDA has recently handed accelerated approvals to multiple myeloma drugs like Johnson & Johnson’s Tecvayli and Talvey based on the “objective response rate” — a measure of remissions determined by the presence of disease on a scan — observed in clinical testing.” 

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Despite gains in treatment, cardiovascular disease remains the leading cause of death in the United States, accounting for nearly three in 10 fatalities — 916,000 — in 2023, according to a report published Wednesday by the American Heart Association.
    • “It outnumbers deaths from the second and third leading causes — cancer and accidental injuries — combined.
    • “The statistics are a sobering reminder that there is “a lot of work to do” when it comes to prevention and treatment of heart disease and stroke, said Dr. Donald Lloyd-Jones, a professor of cardiology at Boston University and former president of the association, who was not involved in the new report.”
  • Cardiovascular Business adds,
    • “Cardiology has been shifting away from reactionary treatment strategies to a greater emphasis on prevention. With a shortage of heart failure specialists in the United States and hospitalization rates on the rise, reducing the number of advanced heart failure cases is a major target of such prevention efforts.
    • “A joint scientific statement from the Heart Failure Society of America (HFSA) and the American Society for Preventive Cardiology (ASPC) about prevention in heart failure was released online in 2025 and then published in the Journal of Cardiac Failure (JCF) to kick off 2026.[1] The goal of the statement is to raise awareness that prevention efforts to stop the advance of heart failure symptoms should start with primary care and general cardiologists before the symptoms of these patients becomes critical. This is part of a wider effort across cardiology and medicine to try and reduce heart failure hospitalizations.”
  • and
    • “Reducing the activity of a specific protein, RBM20, may provide significant relief for certain patients with heart failure, particularly those with preserved ejection fraction (HFpEF), according to a new analysis published in Cardiovascular Research.[1] 
    • “HFpEF is associated with stiff, rigid cardiac muscles. A team of researchers out of the University of Missouri School of Medicine believe they may be able to improve HFpEF symptoms by limiting RBM20’s influence in the heart and encouraging another protein, titin, to thrive. 
    • “Titin is a protein found in cardiac muscle cells and acts as a ‘spring,’ enabling the heart chamber to recoil and stretch sufficiently,” lead author Mei Methawasin, MD, PhD, said in a statement. “In HFpEF, it’s common for the titin to stiffen and no longer be as flexible. We learned that if we reduced the activity of a different protein, RBM20, it caused longer and more flexible filaments of titin and significantly improved heart filling in mice.”
    • “There are certain risks associated with too much RBM20 inhibition. Methawasin emphasized that it would be critical to find the “right balance” and not taking things too far.”
  • The Wall Street Journal relates,
    • “Colorectal cancer is on the rise among young people. Now it is the leading cause of cancer death in the U.S. for those under 50, according to a new analysis. 
    • “More than 1.2 million people under age 50 died of cancer in the U.S. from 1990 through 2023, American Cancer Society researchers reported Thursday.
    • “Some 3,905 people ages 20 to 49 died of colorectal cancer in 2023, according to Cancer Society statistics, compared with 3,809 for breast cancer and 2,086 for brain and other nervous system cancers.
    • “This is absolutely disconcerting,” said Dr. Madappa Kundranda, division chief of cancer medicine at Banner MD Anderson Cancer Center in Phoenix, who wasn’t involved in the research.” * * *
    • “As colorectal cancer among younger people has emerged as a bigger threat, medical groups have lowered the recommended age for colonoscopies that can detect the disease while there are good odds for effective treatment.
    • “Yet not enough people under 50 are getting the screenings, doctors said, prompting calls for a redoubling of efforts to educate doctors and nurses about the need to talk with patients.”
  • The New York Times points out,
    • “Is there a way to use the body’s way of fighting cancers to make a new drug?
    • “Perhaps, according to preliminary research studies.
    • “The idea is to exploit what is known about the growth of cancers. While many grow and spread and are deadly without treatment, some go away on their own or simply do not progress. They remain in the body, harmless and causing no symptoms. It’s contrary to conventional wisdom.
    • “But Dr. Edward Patz, who spent much of his career researching cancer at Duke, has long been intrigued by cancers that are harmless and has thought they might hold important clues for drug development.
    • “The result, after years of research, is an experimental drug, tested so far only in small numbers of lung cancer patients. The results are encouraging, but most promising experimental drugs fail after larger, more rigorous studies.
    • “That hasn’t stopped Dr. Patz from recently starting a company, Grid Therapeutics, hoping that the experimental drug will turn out to be a new type of cancer treatment.”
  • The Washington Post cautions,
    • Obesity in midlife may cause vascular dementia later in life by raising blood pressure over decades and quietly damaging brain vessels, according to new research released Thursday.
    • The danger could be significant. Having a higher body mass index increases the risk of vascular dementia by roughly 50 to 60 percent, according to the study, published in the Journal of Clinical Endocrinology & Metabolism. An association between obesity and dementia has long been the subject of study, and the new research strongly indicates there is indeed a link.
    • “We add a layer of evidence that suggests causality,” said Ruth Frikke-Schmidt, who was the study’s lead author and is a professor and chief physician at Copenhagen University Hospital Rigshospitalet and the University of Copenhagen. “For public health, this is an important message.”
  • Beckers Clinical Leadership informs us,
    • “Even as patient acuity climbed over the last several years, hospitals posted notable gains in mortality and reductions in two major hospital-acquired infections, a new Vizient report found.
    • “The Jan. 22 report is based on an analysis of the Vizient Clinical Data Base, which includes data from more than 1,000 hospitals nationwide. It compares trends from the fourth quarter of 2019 to the second quarter of 2025 across measures of acuity, mortality performance and select hospital-acquired infections.
    • “These improvements occurred during a period marked by workforce shortages, supply chain instability and rising case complexity, signaling that the system’s quality infrastructure is stronger, more adaptive and more scalable than often recognized,” the report said.”
  • Per MedPage Today,
    • “Ten-year follow-up results showed that 37.8% of patients who received antibiotics versus appendectomy had a true recurrence of appendicitis.
    • “Overall, cumulative complication rates at 10 years were significantly higher in the appendectomy group versus the antibiotic group.
    • “The analysis “reaffirms antibiotics as a safe and feasible alternative to appendectomy,” researchers said.”
  • Per Health Day,
    • “Even brief treatment with Ozempic can improve knee replacement outcomes among people with type 2 diabetes.
    • “Taking semaglutide for as little as two to three months improved a person’s odds of avoiding major surgery complications.
    • “Less than a month’s treatment lowered odds of minor complications.”
  • and
    • “Super agers are likely to have genetic advantages that protect their brain health.
    • “They are less likely to carry a gene linked to increased risk of Alzheimer’s.
    • “They also are more likely to have a gene that appears to protect against Alzheimer’s. * * *
    • “Super agers” are people whose brain power at 80 or older compares to that of people 20 to 30 years younger, researchers said.”
  • Truveta adds,
    • “As of December 2025, GLP-1 RA prescriptions account for more than 7% of all prescriptions.
    • “Tirzepatide continues to be the most prescribed anti-diabetic (ADM) and anti-obesity (AOM) medication (sold as Mounjaro and Zepbound, respectively) and showed the largest increase in total prescribing from September to December 2025.
    • “Overall prescribing rates (GLP-1 RA prescriptions per total prescriptions) increased slightly from September to December 2025 (+5.0%); however, first-time prescribing rates declined over the same period (-6.6%). These trends are consistent with first-time prescribing rates seen around the holidays in previous years.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Insurance technology company Sidecar Health is offering health plans to employers in Texas.
    • “The company, which launched in 2018, covers employees in 48 states who work for businesses headquartered in Ohio, Georgia, Florida and Texas.
    • “Insurance technology company Sidecar Health is offering health plans to employers in Texas.
    • The company, which launched in 2018, covers employees in 48 states who work for businesses headquartered in Ohio, Georgia, Florida and Texas. 
    • “Sidecar touts an alternative model promising no prior authorizations, referrals or specific networks. For covered services, the plan will pay for up to a maximum allowable amount based on local market prices, according to the company. If a service is below the benefit amount, members can keep half the savings, Sidecar said in the release. If they receive care that costs more than the benefit amount, members are required to pay the difference.”
  • and
    • “A unique marketing campaign from Blue Cross and Blue Shield of Vermont lays out price variations between specific providers for certain services. 
    • “Blue Cross and Blue Shield of Vermont unfavorably compares costs at the University of Vermont Medical Center to other hospitals.
    • “Industry watchers say it could represent a new era in contract negotiations between health insurance companies and providers.”
  • Beckers Health IT tells us,
    • Amazon’s One Medical and Cleveland Clinic have opened their second collaborative primary care office. 
    • The new office, located in Shaker Heights, Ohio, offers preventive care, chronic disease management and treatment for common illnesses such as colds and flu. Patients also have access to on-site lab services and same- or next-day appointments.
    • The office follows the October opening of the organizations’ first joint primary care site in Northeast Ohio, according to a Jan. 22 news release One Medical shared with Becker’s.
  • Fierce Pharma relates,
    • “As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade, the generic and biosim specialist sees a multibillion-dollar opportunity up for grabs. 
    • “The company detailed its outlook on the upcoming “‘golden decade’ of affordable medicines” at the J.P. Morgan Healthcare Conference last week. Tallying up expected losses of exclusivity across the industry over that period, the Swiss drugmaker sees a generic drug opportunity of up to $340 billion and a biosim opportunity totaling $322 billion.
    • “More than 50 biologic drugs are set to go off patent in the next seven years and have no biosimilars lined up to launch. This situation has created what’s been coined the “biosimilar void” among industry watchers.
    • “While fully dissipating the void will require participation from many biosim players, Sandoz is committed to the cause: The company boasts a plan to target some 60% of the total biosimilar opportunity in sight.
    • “Still, “we want to do more,” the company’s North American president, Keren Haruvi, told Fierce Pharma in an interview on the sidelines of JPM.”
  • MedTech Dive notes,
    • “Abbott’s fourth quarter sales came in below expectations, as the company navigated challenges in its nutrition and diagnostics businesses. Abbott also reported less growth than expected in its medical devices segment. 
    • “The company’s revenue of $11.46 billion for the quarter fell short of analysts’ consensus of $11.8 billion, Leerink Partners analyst Mike Kratky wrote in a research note on Thursday.”

From the artificial intelligence front,

  • Healthcare Dive shares a mixed bag of reports,
    • “Amazon is launching a health-focused artificial intelligence chatbot for members of its One Medical primary care chain, the tech giant said Wednesday. 
    • “The Health AI assistant uses One Medical members’ medical record information to answer health questions and provide guidance on symptoms and potential treatments. Users can also chat with the assistant to book appointments, decide between care settings and renew prescriptions.
    • “The chatbot is built with “multiple patient safety guardrails,” including protocols that connect patients with a provider through messages or an in-person appointment when their clinical judgment is needed, an Amazon spokesperson said.”
  • and
    • “Healthcare workers are using artificial intelligence tools that haven’t been approved by their organizations — a potential patient safety and data privacy risk, according to a survey published Thursday by Wolters Kluwer Health. 
    • “More than 40% of medical workers and administrators said they were aware of colleagues using “shadow AI” products, while nearly 20% reported they have used an unauthorized AI tool themselves, according to the survey by the information services and software firm.
    • “Those unapproved tools might be useful to individual workers, but their health systems haven’t vetted the products’ risks or considered governance processes, according to Dr. Peter Bonis, chief medical officer at Wolters Kluwer. “The issue is, what is their safety? What is their efficacy, and what are the risks associated with that?” he said. “And are those adequately recognized by the users themselves?”
  • and
    • “Misuse of artificial intelligence-powered chatbots in healthcare has topped ECRI’s annual list of the top health technology hazards.
    • “The nonprofit ECRI, which shared its list Wednesday, said chatbots built on ChatGPT and other large language models can provide false or misleading information that could result in significant patient harm.
    • “ECRI put chatbot misuse ahead of sudden loss of access to electronic systems and the availability of substandard and falsified medical products on its list of the biggest hazards for this year.”

Midweek update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, Medicare, OPM, Patient safety, SDOH, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Wall Street Journal reports
    • “The Senate plans two healthcare votes Thursday: one on a GOP bill that would put as much as $1,500 a year into health savings accounts in lieu of providing subsidies to cover premiums, and the second on a Democratic plan that extends ACA subsidies for three years. Neither is expected to reach the 60 votes needed to advance, but the willingness of some Republicans to consider any form of ACA extensions has opened the door to possible talks if the partisan measures fail.
    • “In the House, Speaker Mike Johnson (R., La.) said Republicans plan to put on the floor next week a package of healthcare proposals that doesn’t include extending subsidies. But other lawmakers see an ACA extension as the only way to prevent widespread pain ahead of the 2026 midterms and get a GOP-led Congress in position to make more sweeping changes.
    • “Rep. Jim Jordan (R., Ohio)—a onetime leader of the hard-line House Freedom Caucus—argued in a closed-door House Republican meeting that the party needed its own plan to temporarily extend the subsidies in tandem with more sweeping changes. If they didn’t, he warned, conservatives could be sidelined by centrists’ push to bring their own ACA extension to the floor.
    • “There’s a whole list of good things that we need to put in the legislation,” Jordan said in an interview. “But we also need to recognize reality, which is the cliff is coming in 21 days, and we have members who are very concerned about that. I think we all are.”
  • The Hill adds,
    • “The House on Wednesday easily passed the annual defense policy bill, sending the mammoth, $900 billion measure to the Senate ahead of the year-end deadline.
    • “The measure, known as the National Defense Authorization Act (NDAA), passed the lower chamber by a vote of 312-112. Ninety-four Democrats and 18 Republicans opposed the bill.
    • “The NDAA, a traditionally bipartisan bill that lays out defense priorities for the next year, would increase pay for service members, provide some military aid to Ukraine, restrict U.S. investment in China and fully repeal sanctions on Syria, among other things.”
  • Axios points out,
    • “Lab testing companies including giants Quest Diagnostics and LabCorp are pressing Congress to stop hundreds of millions of dollars of Medicare cuts for diagnostic tests that are due to take effect at the end of January.” * * *
    • “A 15% reduction to Medicare payments for nearly 800 lab tests is set to take effect Jan. 31, followed by additional cuts in following years.
    • “The change stems from 2014 legislation that aimed to align Medicare reimbursements for lab tests more closely with commercial payments.
    • “Medicare cuts that previously went into effect from the legislation cost labs nearly $4 billion over three years. Since then, the diagnostics industry has successfully argued the cuts are based on incomplete and outdated pricing information.” * * *
    • “Federal budget analysts previously used the Consumer Price Index as a proxy for lab payments. That measurement showed that delaying the changes appeared to save Medicare money. 
    • But the analysts have changed their model and now estimate that delaying the payment cuts will add to Medicare costs.”
  • Govexec tells us,
    • “The heads of the Office of Management and Budget and the Office of Personnel Management unveiled plans Wednesday to build a single information technology platform to manage all human capital data across the federal government. 
    • “In a joint memo, OMB Director Russ Vought and OPM Director Scott Kupor described a two-year plan to transition the federal government’s collection of disparate human resources networks onto a single system dubbed Federal HR 2.0.
    • “For too long, the Federal Government has lacked what is taken for granted at any other organization — a single system of record for personnel management. Instead, the Federal Government spends an inordinate amount each year on numerous costly, duplicative, and outdated core human capital management (“Core HCM”) systems,” the memo said. 
    • “As part of the plan, the memo said OMB and OPM officials will lead efforts “to procure a modern, best-in-class commercial Core HCM system” for governmentwide adoption by fiscal 2028.”
  • The Journal of Accountancy informs us,
    • “The IRS provided guidance Tuesday on new tax benefits for health savings accounts (HSAs) that include allowing bronze and catastrophic plans to be considered HSA-compatible under Sec. 223.
    • “The changes, which were part of H.R. 1, P.L. 119-21, commonly known as the One Big Beautiful Bill Act, generally expand the availability of HSAs under Sec. 223 and were outlined in Notice 2026-05.” * * *
    • “The IRS guidance also covered:
      • “Telehealth and remote care services: H.R. 1 made permanent the ability to receive telehealth and other remote care services before meeting the HDHP deductible while remaining eligible to contribute to an HSA, effective for plan years beginning on or after Jan. 1, 2025.
      • “Direct primary care (DPC) service arrangements: Beginning Jan. 1, 2026, an otherwise eligible individual enrolled in certain DPC service arrangements may contribute to an HSA. In addition, they may use their HSA funds tax-free to pay periodic DPC fees.”
    • “The IRS is seeking comments on Notice 2026-05 by March 6, 2026.”
  • Per Fierce Pharma,
    • “For more than two years, the U.S. Federal Trade Commission has been taking certain drugmakers to task over their alleged listing of “improper” patents in an FDA registry, a practice the agency says thwarts generic competition. 
    • “Now, after several prior wins with the effort, the agency is celebrating once again as Teva has agreed to remove more than 200 patents from FDA records, according to a Dec. 10 announcement.
    • “Following pressure from the FTC, Teva has asked the FDA to delist patents on certain products for asthma, diabetes, chronic obstructive pulmonary disease and for epinephrine autoinjectors, the FTC said. The removals from the FDA’s Orange Book registry will “pave the way for greater competition for generic alternatives” to more than 30 products, the agency explained.” * * *
    • “The AHA Board of Trustees has engaged WittKieffer to conduct a national search for Pollack’s successor as part of a planned transition. Pollack will remain fully engaged until the transition is complete.
    • “Recognizing Pollack’s commitment to the association, the AHA Board last month voted to bestow on him the title of AHA President and CEO Emeritus for when the transition is complete.”
  • The American Medical Association announced,
    • “AHA President and CEO Rick Pollack today announced his plans to retire by the end of 2026. A 43-year veteran of the association, Pollack has served as its chief executive for the past decade.
    • “Under Pollack’s leadership, the AHA steered hospitals through the COVID-19 pandemic, securing critical resources and regulatory flexibility to keep hospitals and health systems open and caring for patients during the most challenging public health crisis of recent time. Pollack launched bold initiatives to strengthen the health care workforce, advance quality and patient safety, and fortify cybersecurity defenses through partnerships with the FBI and other government agencies.
  • Per a Department of Justice news release,
    • “United States Attorney David Metcalf announced today that Recovery Centers of America (RCA) has agreed to pay $1,000,000 to resolve allegations that it failed to comply with provisions of the Controlled Substances Act (CSA) that are designed to prevent the diversion of controlled substances for illegal uses, and an additional $1,000,000 to resolve allegations that it violated the False Claims Act (FCA) by billing the government for drug and alcohol treatment services that it failed to adequately provide.
    • “The United States’ allegations under the CSA arise from audits and investigations the Drug Enforcement Administration (DEA) conducted at RCA facilities in Pennsylvania and Maryland between 2019 and 2024. Based on those audits and investigations, the United States contends that RCA dispensed controlled substances in an unlawful manner, that certain controlled substances were missing from the company’s records, and that the company failed to comply with additional recordkeeping requirements of the CSA.
    • “In addition, the United States alleges that, at certain facilities during a period from 2017 through 2019, RCA violated the FCA by billing the Federal Employees Health Benefits Program and Medicaid for the care of beneficiaries to whom it failed to provide and document the requisite treatment services.” * * *
    • “The resolution obtained in this matter was the result of a coordinated effort among the United States Attorney’s Office for the Eastern District of Pennsylvania, the DEA, the Office of Personnel Management Office of Inspector General, and the Department of Health and Human Services Office of Inspector General.
    • “The matter was handled in the U.S. Attorney’s Office for the Eastern District of Pennsylvania by Assistant U.S. Attorneys Peter Carr and Charlene Keller Fullmer and former auditor Dawn Wiggins.
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.
    • “GSK originally developed the drug, Augmentin XR, and won FDA approval for it in 2002. The British company then struck a deal in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics, which won the priority voucher.
    • “FDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often end up in shortages. The move “will strengthen domestic manufacturing and increase our national security,” Makary said in a statement Tuesday.”
  • Fierce Pharma adds
    • “The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the first therapy of its kind for the rare disease and making Italy’s Fondazione Telethon the first nonprofit to usher a gene therapy across the regulatory finish line in the U.S.
    • “Branded as Waskyra, the drug is specifically indicated for children 6 months and older, as well as adults who have a mutation in the WAS gene. To be eligible for the ex vivo gene therapy, patients must have no available human leukocyte antigen-matched related stem cell donor and be cleared for hematopoietic stem cell transplantation, the FDA said in its Dec. 9 announcement.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” director of the FDA’s Center for Biologics Evaluation and Research (CBER) Vinay Prasad, M.D., said in a release.”
  • and
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.”
  • Per Beckers Health IT,
    • “The FDA has qualified the first AI-based drug development tool to support metabolic dysfunction-associated steatohepatitis clinical trials.
    • “The cloud-based tool, AI-Based Histologic Measurement of NASH (AIM-NASH), is designed to assist pathologists in assessing liver biopsy images, according to a Dec. 8 news release. It evaluates disease activity by scoring steatosis, hepatocellular ballooning, lobular inflammation and fibrosis according to the NASH Clinical Research Network scoring system.
    • “AIM-NASH uses AI to analyze digital images of liver tissue, but human pathologists remain responsible for interpreting the results. They review the entire slide and AIM-NASH output before accepting or rejecting the scores.”
  • BioPharma Dive notes,
    • “Vinay Prasad and two other officials within the Food and Drug Administration office regulating many genetic medicines have outlined a stricter approval framework for the next CAR-T cell therapies developed for cancer. In an article published Monday in the Journal of the American Medical Association, the trio wrote that newer CAR-T treatments need to extend survival, or the time before a type of event occurs, in randomized, controlled trials. The control groups in those studies must also take into account the existing standard treatments, including other approved CAR-T therapies, and prove superior unless “adequately justified and discussed” with the FDA. The new protocol represents a higher approval bar for CAR-T therapies, which, historically, have been cleared based on their ability to induce responses in single-arm studies.” 

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today said the United States has 1,912 confirmed measles cases so far in 2025, an increase of 84 cases since last week and a bad sign as holiday gatherings, travel, and indoor activities is set to pick up in the final weeks of the year. 
    • “In January 2026, the United States is at risk of losing its measles elimination status because of ongoing transmission chains from a West Texas outbreak that began early last year and sickened roughly 800 people. The country first gained elimination status in 2000. 
    • “Eighty-eight percent of cases in the United States this year are outbreak-associated, and there have been 47 outbreaks recorded. Last year, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.
    • “Currently Utah, Arizona, and South Carolina are seeing large outbreaks that since Thanksgiving have pushed state totals well past 100 cases. Those outbreaks have been marked by exposures at schools and churches in communities with low vaccination levels.”
  • STAT News relates,
    • “Federal health officials on Wednesday [December 10] expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
    • “The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
    • ‘The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.
    • “No deaths have been reported in the outbreak, which was announced Nov. 8.
    • “Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. With the expanded definition, the CDC identified 10 additional cases that occurred from December 2023 through July 2025.”
  • and
    • “While extensive studies have found Covid-19 vaccines to be safe, effective, and to have saved millions of lives during the pandemic, these shots come with a rare but real risk of inflamed heart muscle, or myocarditis. Scientists on Wednesday reported that they have identified a pair of immune signals they believe drive these cases — and offered early evidence that these signals can be blocked.
    • Researchers sifted through previous Covid vaccine studies and identified a pair of immune signaling molecules, or cytokines, present at higher levels in the blood of vaccine recipients with myocarditis: CXCL10 and interferon-gamma (IFN-γ). The authors found that these signals could also be triggered in the lab when immune cells were exposed to the Pfizer and Moderna Covid vaccines, or when mice were inoculated.
    • “Scientists found that using antibodies to block CXCL10 and IFN-γ reduced signs of cardiac stress in vaccinated mice and in cardiac spheroids, three-dimensional growths of human cells meant to mimic some aspects of the heart’s structure and function. The authors also found they could block the cytokines’ effects with genistein, a compound found in soybeans and other legumes that has been linkedto reduced inflammation.
    • “The findings, published in the journal Science Translational Medicine, come as messenger RNA vaccines face scrutiny from the Trump administration and some lawmakers. That has forced researchers studying these shots to strike a tricky balancing act between reporting new insights on adverse events while making clear that the shots are safe overall.
    • “I want to emphasize this is very, very rare. This study is purely to understand why. In those rare cases, what’s going on? People talk about it, and here we provide a mechanism,” said Joe Wu, director of Stanford Cardiovascular Institute and the study’s senior author.”
  • Medscape tells us,
    • “As women age, they face several health risks related to the menopause transition. Treating these risk factors, which include obesity and high blood pressure, can reduce the risks for diabetes, cardiovascular disease (CVD), and other health problems.
    • “These risks also can be driven by age-related changes that occur around the time of menopause, said Marie K. Christakis, MD, MPH, assistant professor of obstetrics and gynecology and menopause and mature women’s health at the University of Toronto in Toronto, during a presentation at the Diabetes Canada and Canadian Society of Endocrinology and Metabolism (CSEM) Professional Conference 2025.
    • “Women at midlife are in what I term a cardiovascular storm,” she said. “More than 42% of American women between ages 40 and 59 years have a BMI over 30, and the prevalence of obesity is higher among women between ages 40 and 59 years. Generally, menopause occurs naturally between ages 46 to 54 years, and central adiposity is a particular issue.” 
  • MedPage Today notes,
    • “In a large phase III trial of adjuvant treatment for early-stage breast cancer, the investigational oral drug giredestrant reduced the risk of invasive disease recurrence by 30% versus standard endocrine therapy.
    • “Among more than 4,000 patients with hormone receptor (HR)-positive disease, 3-year invasive disease-free survival (IDFS) rates reached 92.4% with the next-generation oral selective estrogen receptor antagonist and degrader (SERD), as compared with 89.6% with standard of care (HR 0.70, 95% CI 0.57-0.87, P=0.0014).”
    • “The findings of the lidERA Breast Cancer trial mark the first benefit with a novel endocrine agent in early breast cancer in 20 years, not since the approval of aromatase inhibitors (AIs) in the 2000s, said Aditya Bardia, MBBS, MPH, of the University of California Los Angeles.
    • “Overall, the results support giredestrant as a potential standard endocrine option for patients with hormone receptor-positive breast cancer,” said Bardia, who presented the findings here at the San Antonio Breast Cancer Symposium.”
  • Fierce Pharma adds,
    • “Pfizer has rolled out detailed trial data suggesting Tukysa could be part of a new first-line treatment to delay the progression of HER2-positive breast cancer.
    • “The current standard of care for the disease includes induction chemotherapy in combination with Roche’s Herceptin and Perjeta, followed by a chemo-free maintenance phase with the two HER2 antibody drugs. Now, Pfizer has shown that adding Tukysa during the maintenance stage can improve patient outcomes.
    • “Specifically, addition of Tukysa to first-line maintenance therapy significantly reduced the risk of progression or death by 35.9%, according to investigator-assessed results from the phase 3 HER2CLIMB-05 trial, which were presented at the San Antonio Breast Cancer Symposium. Patients who received the Pfizer small molecule went 8.6 months longer without tumor progression, reaching 24.9 months at the median.
  • and
    • “A year after a clutch of major pharmas threw their weight behind a new campaign devoted to addressing the serious health disparities facing Black breast cancer patients, “Care for HER” has been shown to have a tangible positive impact on patients’ lives.
    • “Touch, The Black Breast Cancer Alliance and Unite for HER—the two nonprofit organizations behind the program—presented a study about that impact at the San Antonio Breast Cancer Symposium on Wednesday.
    • “The research centers ran a survey of 57 participants in the Care of HER program, all Black women who have been diagnosed with breast cancer, 93% of whom said they’d used the program’s resources.”
  • Per Cardiovascular Business,
    • “Intravascular lithotripsy (IVL) is a viable treatment option for patients with diabetes undergoing percutaneous coronary intervention (PCI), according to new findings published in The American Journal of Cardiology.[1]
    • “While IVL has demonstrated favorable procedural and clinical outcomes in general populations with calcified lesions, its performance in patients with diabetes mellitus remains insufficiently characterized,” wrote senior author Jose M. Montero-Cabezas, MD, PhD, a cardiologist with Leiden University Medical Center in The Netherlands, and colleagues. “Given the unique anatomical and pathophysiological features of coronary artery disease in diabetic patients, such as medial calcification, longer lesion length, and more frequent multivessel disease, there is a clear need to specifically evaluate the efficacy and safety of IVL in this higher-risk population.”
    • “Montero-Cabezas et al. tracked data from nearly 600 patients who underwent PCI with IVL from May 2019 to September 2024. All data came from the BENELUX-IVL registry, an international database open to all IVL patients. Patients with missing data were excluded.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS plans to launch a first-of-its-kind healthcare engagement platform, banking that perennial gripes about poor access and navigation will incentivize both consumers and rival companies to sign on.
    • “The platform will include data and services offered by CVS’ different health businesses — and those of participating industry partners. The goal is to create an integrated healthcare experience for consumers, hopefully enhancing their experience with the industry, lowering costs and improving outcomes, CVS executives said Tuesday during the healthcare giant’s investor day in Hartford, Connecticut. 
    • “CVS is also banking that the platform will also be a source of revenue by driving consumers to CVS products and services they might not know about otherwise.”
  • Kaufman Hall announced,
    • “Hospital volumes remained strong in October, while average length of stay declined, translating to a dip in net revenue per discharge. Bad debt and charity care continue to rise, and staffing levels are tightening.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • The American Journal of Managed Care lets us know,
    • “As states and federal programs accelerate the shift to value-based care, a new national survey suggests clinicians face a widening gap between policy expectations and the tools available to meet them.
    • “Tracking patient progress emerged as the biggest barrier—more than insurance—for mental health and primary care clinicians adapting to outcome-based payment models, according to October 2025 survey findings released by Twofold Health, an artificial intelligence (AI) clinical notetaking platform.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) targeting abnormal complexes of immunoglobulin for IgA nephropathy.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On December 17, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer, David Rind, MD, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on January 14, 2026.”
  • Per MedTech Dive,
    • “Teleflex has struck deals to sell its acute care, interventional urology and OEM businesses for a combined $2.03 billion, the company said Tuesday.
    • “Montagu and Kohlberg, two private equity firms, are buying the OEM business for $1.5 billion. Intersurgical, an anesthesia and respiratory care medtech company, is buying the acute care and interventional urology businesses for $530 million.
    • “Needham analysts said in a note to investors that the total sale price is at the low end of their estimates. Yet RBC Capital Markets analysts told investors they view the update positively.”
    • * * * “Selling the units will leave Teleflex focused on its vascular access, interventional and surgical businesses. The company picked the businesses as the focus of its ongoing operations because they serve attractive, primarily hospital-focused end markets. Teleflex framed the split as a way to simplify its operating model and manufacturing footprint.”

Tuesday Report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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.”

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Midweek update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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.”