Monday report

Medicare

Monday report

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

From Washington, DC,

  • Federal News Network reports,
    • “Congressional appropriators are seeking less aggressive budget cuts for the IRS than what the Trump administration has proposed.
    • ‘Members of the House and Senate appropriations committees, in the latest package of spending bills for fiscal 2026, are also renewing efforts to shrink federal office space.
    • “Funding for the State Department remains relatively unchanged, despite a massive reorganization carried out last year.
    • “Meanwhile, lawmakers want agencies to use artificial intelligence tools to speed up the delivery of public-facing benefits and services.
  • Govexec adds,
    • “Lawmakers in Congress appear to have abandoned a plan to bar insurers participating in the federal government’s employer-sponsored health care program from covering gender affirming care for federal workers and their family members, though the development changes little, practically speaking.
    • ‘When the House first unveiled its draft of the fiscal 2026 Financial Services and General Government appropriations package last September, it included language barring federal funds being used to cover the cost of “surgical procedures or puberty blockers or hormone therapy” as part of gender affirming care under the Federal Employees Health Benefits Program.
    • “But a new version of the bill unveiled Sunday, negotiated with Senate appropriators and containing three of the 12 traditional appropriations packages, strikes that language, issuing no prohibition on gender-affirming care for FEHBP participants.
    • “Despite the recent reversal, the measure, if passed, on its own would not restore access to gender affirming care for federal workers and their families. That’s because the Office of Personnel Management last year instructed insurance carriers who participate in FEHBP to cease covering those treatments.”
  • Here is a link to the House Appropriations Committee’s January 11 news releases on these new appropriations bills.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services has released a request for information seeking input on replacing its Medicare claims processing system with a real-time, cloud-based platform. Under the program, called ClaimsCore, CMS is seeking vendors already capable of supporting more than 2 million active members on a single production instance and processing more than 100,000 claims per day. CMS said the program would provide faster, more transparent claims, strengthen fraud protection and provide near real-time explanations of benefits, among other improvements.” 

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.” * * *  
    • “Menkes disease is a neurodegenerative disorder caused by a genetic defect that impairs a child’s ability to absorb copper. The disease is characterized by seizures, failure to gain weight and grow, developmental delays, and intellectual disability. It leads to abnormalities of the vascular system, bladder, bowel, bones, muscles, and nervous system. Children with classical Menkes (90% of those with the disease) begin to develop symptoms in infancy and typically do not live past three years. It affects approximately one in every 100,000-250,000 live births worldwide and is more common in boys.”
  • and
    • “The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective treatments to patients sooner. 
    • “Bayesian methodologies help address two of the biggest problems of drug development: high costs and long timelines,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Providing clarity around modern statistical methods will help sponsors bring more cures and meaningful treatments to patients faster and more affordably.”
    • “Bayesian approaches use a different framework from traditional statistical approaches. In a Bayesian analysis, data from a study are combined with relevant prior information to form a new distribution that can be used for inference and to draw conclusions about safety and efficacy.” 

From the judicial front,

  • Bloomberg Law lets us know,
    • “The US Supreme Court rejected a case seeking to force health insurers to pay arbitration awards that medical providers win in disputes over surprise medical bills, ending a long-running fight for a pair of air ambulance companies.” * * *
    • “Courts have so far mostly ruled for insurers in determining that oversight of the process resides with the Department of Health and Human Services, though providers have notched a couple of victories in district court.
    • The petition sought the high court’s input on whether the law grants parties the private right to sue, as well as whether breaching the relevant plan terms constitutes an injury to an enrollee under the Employee Retirement Income Security Act.” * * *
    • “The case is Guardian Flight LLC v. Health Care Serv. Corp. , U.S., No. 25-441, decision issued 1/12/26.”
  • STAT News reports,
    • “The Trump administration has signaled plans to drop its appeal of a court order that blocked a pilot program from changing payment terms for a controversial federal drug discount program.
    • “In a Monday court document, the Department of Justice indicated talks are underway with the American Hospital Association and several hospital systems, which filed a lawsuit challenging a plan that allowed drug companies to pay rebates — instead of discounts — for some medicines purchased under the 340B Drug Pricing Program.
    • “The parties are engaged in discussions about returning the [rebate] approvals challenged in this litigation to the agency for reconsideration. The agency intends to resolve such proceedings promptly. Therefore, the parties do not believe that expediting this appeal is warranted at this time and plan to dismiss the appeal in short order,” the DOJ wrote.”
  • MedTech Dive informs us,
    • “Edwards Lifesciences said Friday it has dropped plans to acquire JenaValve Technology after a U.S. district court granted the Federal Trade Commission’s motion for an injunction blocking the transaction.
    • “Edwards said it disagrees with the ruling, in the U.S. District Court for the District of Columbia, and believes the acquisition would have been in the best interest of a large underserved group of patients.”

From the public health and medical / Rx research front

  • The Wall Street Journal reports,
    • “If everyone you know seems to have the flu, there is a reason for that: Influenza climbed to unusually high levels across the country, thanks to a flu strain that caught us off guard.
    • “There have already been an estimated 15 million cases of the flu, according to the Centers for Disease Control and Prevention, along with 180,000 hospitalizations and 7,400 deaths.
    • It is the worst flu season in recent years though numbers are starting to decline yet remain high. But there are two things making things easier for some folks.
    • One, we all became familiar with at-home rapid tests for Covid-19 during the pandemic so more people are comfortable taking such tests at home for influenza. This results in more timely diagnoses.
    • That makes it easier to take antivirals, which make people feel better sooner, provided they are started within two days of getting sick. While most people are familiar with Tamiflu (oseltamivir phosphate), there is another antiviral, Xofluza (baloxavir marboxil) making the rounds on social media.
  • The AP related last Friday,
    • “South Carolina’s measles outbreak exploded into one of the worst in the U.S., with state health officials confirming 99 new cases in the past three days. 
    • “The outbreak centered in Spartanburg County grew to 310 cases over the holidays, and spawned cases in North Carolina and Ohio among families who traveled to the outbreak area in the northwestern part of the state.
    • “State health officials acknowledged the spike in cases had been expected following holiday travel and family gatherings during the school break. A growing number of public exposures and low vaccination rates in the area are driving the surge, they said. As of Friday, 200 people were in quarantine and nine in isolation, state health department data shows.
    • “The number of those in quarantine does not reflect the number actually exposed,” said Dr. Linda Bell, who leads the state health department’s outbreak response. “An increasing number of public exposure sites are being identified with likely hundreds more people exposed who are not aware they should be in quarantine if they are not immune to measles.”
  • The American Medical Association lets us know what doctors wish their patients knew about donating blood.
    • “When caring for patients, physicians and other health professionals rely on blood donation to support care ranging from trauma response to cancer treatment. But ongoing blood shortages mean many hospitals and health systems struggle to keep an adequate supply on hand. With the need for donating blood rising during seasonal shortages or public health crises, a single donation of blood can help up to three people. Donating blood when you can is vital because maintaining an adequate blood supply is a shared responsibility that strengthens patient care across the country.”
  • The Washington Post informs us,
    • “An estimated quarter of traditional Medicare beneficiaries with dementia are prescribed risky, brain-altering drugs despite years of clinical guidelines cautioning against the practice, a new study shows.
    • “The drugs fall into five broad categories — including antidepressants, antipsychotics, antidepressants and barbiturates — that may leave older adults in a drowsy, confused fog that can make them less steady on their feet and more prone to falls. And while the study published Monday in JAMA found that overall prescriptions for these types of drugs for traditional Medicare beneficiaries fell from 2013 to 2021, their “potentially inappropriate” use was significantly higher for people who are cognitively impaired or have dementia compared to people whose cognition was normal.
  • Per Genetic Engineering and Biotechnology News,
    • “Many of us will recognize being in a situation where it’s really hard to get started on a task—whether it’s making a difficult phone call or preparing a presentation that’s stressful just to think about. We understand what needs to be done, yet taking that very first step feels surprisingly hard.
    • “When this difficulty becomes severe, it is known medically as avolition. People with avolition are not lazy or unaware. They know what they need to do, but their brains seem unable to push the “go” button. Avolition is commonly seen in conditions such as depression, schizophrenia, and Parkinson’s disease, and it can seriously disrupt a person’s ability to manage daily life and maintain social functions.
    • “Working with macaque monkeys trained to perform certain tasks, scientists at Kyoto University applied chemogenetics techniques to identify a pathway between the ventral striatum (VS) and ventral pallidum (VP) in the brain that functions as a “motivation brake,” suppressing this internal “go” button, particularly when facing stressful or unpleasant tasks. The results showed that chemogenetic suppression of this VS–VP pathway restored motivation in the animals under aversive conditions.
    • “The team, headed by Ken-ichi Amemori, PhD, an associate professor at the Institute for the Advanced Study of Human Biology (WPI-ASHBi), and colleagues, suggests that the discovery of this VS–VP motivation brake may shed light on conditions such as depression and schizophrenia, where severe loss of motivation is common, and point to interventional strategies.”

From the J.P. Morgan Healthcare Conference 2026,

  • Per BioPharma Dive,
    • “JPM26: US biotech’s ‘Sputnik moment,’ Pfizer’s obesity ambitions and Bristol Myers’ big year.
    • “Four recent deals fueled more angst about China’s biotech progress, while Pfizer, Bristol Myers and Sarepta all worked to appease jittery investors.”
  • Fierce Healthcare reports,
    • “Abridge is partnering with real-time health information network Availity to fire up AI-powered prior authorization, expanding the reach of real-time coverage approval to more providers.
    • “The two companies announced a partnership, timed to the annual J.P. Morgan Healthcare Conference, to scale up real-time prior authorization. The integration of the two companies’ technologies could significantly speed up prior auth, from months to minutes. The use of Abridge’s ambient AI and Availity’s data exchange tech can compress a weekslong process that occurs post-visit to one that happens in real-time during the patient exam.
    • “Rather than create disparate AI systems, Abridge and Availity decided to team up to share information between providers and health plans at the point of care, making the process of medical necessity review more efficient, the companies said in a press release.”
  • and
    • “Teladoc is improving its 24/7 virtual urgent care for health plans by upskilling providers through real-time specialist consultations and offering care for a broader set of conditions, the company announced at the 2026 J.P. Morgan Healthcare Conference.
    • “The company hopes to save health plans money by reducing the number of follow-up appointments a patient may need to have after a virtual urgent care visit. 
    • “Teladoc’s virtual urgent care, which has been operational for over 20 years, will now be treating back and joint pain, hair loss and sleep issues, in addition to acute conditions like colds, coughs and ear infections.” 
  • Fierce Pharma offers a potpourri of stories from day one of the conference.

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Boston Scientific said Monday it has agreed to acquire Valencia Technologies, a developer of treatments for bladder dysfunction, for an undisclosed sum.
    • “Valencia makes the eCoin tibial nerve stimulator, which received Food and Drug Administration approval in 2022 to treat urinary urge incontinence. The leadless device is implanted near the ankle.
    • “The deal will allow Boston Scientific to expand into a high-growth area that complements the company’s existing pelvic health product line, Meghan Scanlon, Boston Scientific’s president of urology, said in a statement.” 
  • Beckers Payers Issues points out,
    • Administration and automation are not the only AI use cases payers should be focused on this year, according to McKinsey Senior Partner Adi Kumar, who broke down his 2026 predictions for insurers in a Jan. 12 report.
      • “1. Payers are at a place to look beyond AI administrative use cases. Care management is one opportunity where payers can assert more control.
      • “2. Mr. Kumar said healthcare has been slow to reach a technological revolution, but payers can harness technology to better engage with consumers.
      • “3. The One Big Beautiful Bill Act will raise the bar for payer performance, affecting how much money insurers get from the federal level. Payer financials could either take a hit — hurting risk pools — or payers could play the “productivity game” to get ahead.
      • “4. Mr. Kumar encourages payer CEOs to consider what types of business they want to focus on as the line between payers, providers and services get more blurred.
      • “5. CEOs also need to think about productivity and “how to do more with less.”
  • BioPharma Dive calls attention to five questions facing biopharma this year.
    • “The biopharmaceutical sector finally regained its footing in 2025. Here are five issues that could determine whether the renewed optimism will carry over into the new year.”
  • Beckers Hospital Review relates,
    • “In recent years, a swell of states has adopted laws to lessen the requirements for foreign-trained physicians to join the U.S. workforce.  
    • “The laws aim to combat the nation’s growing physician shortage, which is becoming more urgent as patient acuity rises, more physicians approach retirement age and a plethora of other factors. One tactic to staunch the shortage is reducing or eliminating residency requirements for internationally trained medical school graduates to gain employment in the U.S.
    • “Eighteen states have laws allowing internationally trained physicians to gain full licensure, three states grant limited licensure, three other states have pending bills related to limited licensure and another six state legislatures are considering pathway bills in 2026.
    • “International medical graduates account for about one-fourth of physicians practicing in the U.S., according to the American Medical Association, which supports these pathway laws.” 

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Beckers Payer Issues tells us,
    • “CMS has become more aggressive with its rollout of new payment and care delivery models.
    • To provide healthcare leaders with an outlook for 2026, research firm ATI Advisory compiled observations from 2025 to gain a sense of CMS’ plans for its Innovation Center.” 
  • Modern Healthcare reports,
    • “Safety-net providers got a reprieve from a controversial plan to replace discounts with rebates under the 340B Drug Pricing Program, but they aren’t in the clear.
    • “The Health Resources and Services Administration intended to launch a pilot program this month that would allow nine pharmaceutical companies to give 340B providers rebates on 10 prescription drugs, rather than upfront discounts, for at least a year.”
    • “340B providers cried foul, and the American Hospital Association sued to block the initiative, which it contends would enrich drugmakers at its members’ expense. Last month, the U.S. District Court for the District of Maine directed HRSA to suspend the program while it considers the case. The U.S. Court of Appeals for the 1st Circuit upheld that preliminary injunction Wednesday.” * * *
    • “Yet even if the AHA wins the case, the rebates plan could resurface. 
    • “Separate court rulings last year affirmed that HRSA has the authority to institute rebates under 340B, so the agency could simply try another approach. “Congress clearly gave defendants that option,” Walker wrote.
    • “HRSA remains committed to the rebates pilot and other actions on 340B, and the pharmaceutical industry aims to do its part to fight back against the lawsuit and against what it views as a bloated program that has grown beyond its original scope. The Health and Human Services Department declined to comment on ongoing litigation.”
  • Per an NCQA news release,
    • “The National Committee for Quality Assurance (NCQA) today announced the appointment of Sarah E. Saxton, MBA, as Senior Vice President of Quality Services. Saxton brings more than 20 years of experience advancing quality, performance measurement, and large-scale transformation across public and private health systems.
    • “In this role, Saxton will lead NCQA’s Quality Solutions Group, driving research and implementation efforts that underpin NCQA’s evidence-based standards and performance measures. She will also deepen collaboration with federal agencies to advance initiatives that deliver measurable improvements in healthcare systems and patient outcomes.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “A biotechnology firm hatched by two prominent researchers publicly debuted on Friday, aiming to use a new regulatory framework to quickly develop many gene editing treatments for rare diseases.
    • “Called Aurora Therapeutics, the startup was co-founded by Nobel laureate Jennifer Doudna and genetic medicine expert Fyodor Urnov and seeded by Menlo Ventures. It intends to simultaneously work on multiple therapies for the same condition, each of which target different genetic mutations, and quickly advance them with the help of the Food and Drug Administration’s recently unveiled “plausible mechanism” pathway.“
  • Cardiovascular Business relates,
    • “AccurKardia, a New York-based medtech company, has received U.S. Food and Drug Administration (FDA) clearance for the latest version of its AccurECG Analysis Software, a fully automated platform that delivers rapid electrocardiogram (ECG) interpretations.
    • “AccurECG 2.0 was designed to interpret a total of 13 different rhythm classifications, including atrial fibrillation, atrial flutter and ventricular tachycardia. According to AccurKardia, it was developed to be used by cardiac monitoring companies, device makers, hospitals and independent diagnostic testing facilities alike. 
    • “AccurECG 2.0 was designed to be device agnostic, meaning these artificial intelligence (AI) algorithms can be utilized by a wide range of stakeholders. The software can interpret test results originating from patches or any other traditional ECG devices.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. RSV activity is elevated in many areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. COVID-19 activity is low but increasing nationally.
    • “COVID-19
      • “COVID-19 activity is low but increasing nationally.
    • “Influenza
      • “Seasonal influenza activity remains elevated across the country.
      • “Although some indicators have decreased or remained stable this week compared to last, this could be due to changes in the number of people seeking healthcare, testing or reporting during the holidays rather than an indication that influenza activity has peaked. The country is still experiencing elevated influenza activity and elevated influenza activity is expected to continue for several more weeks.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity is elevated in many areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains suboptimal for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • Beckers Clinical Leadership offers “four things to know from the CDC’s latest FluView report.”
    • Flu positivity dipped but remains high.
    • Pediatric deaths increased.
    • A(H3N2) continues to dominate.
    • Hospitalizations continue to climb.
  • and
    • “The annual number of deaths in the U.S. is projected to exceed the annual number of births beginning in 2030, according to a January report from the Congressional Budget Office.
    • “The projections are based on existing laws and policies as of Sept. 30, as well as recent demographic trends, and serve as a benchmark for assessing how potential legislation could affect the size and structure of the U.S. population.” * * *
    • “The population is expected to become older on average between 2026 and 2056. The cohort of Americans 65 and older is expected to grow through 2036 at an annual average rate of 1.6% — faster than the average growth rates projected for younger cohorts. The group ages 24 and younger is expected to decrease in each of the next 30 years.
    • “An older population presents a dual challenge for hospitals and health systems: increasing demand for more complex care and exacerbating workforce shortages as more Americans retire.
    • “The aging trend is driven by longer life expectancies and baby boomers reaching age 65 or older by 2030, according to Maria Ansari, MD, co-CEO of The Permanente Federation and CEO of three of Oakland, Calif.-based Kaiser Permanente’s medical groups.”
  • The American Hospital Association News lets us know,
    • “A study published Jan. 7 by the University of Minnesota Rural Health Research Center examined the availability of hospital-based obstetric services in the U.S. by county from 2010-2023. It found 293 counties (8.6%) nationwide lost all hospital-based obstetric services during that period. Among those, 26 counties experienced a recent loss between 2022 and 2023, 21 of which are rural counties. Among the 148 rural counties with a town population of 10,000 or fewer people, 11% lost all hospital-based obstetric services from 2010-2023. Overall, 60% of rural counties and 38% of urban counties did not have any hospital-based obstetric services by 2023.” 
  • The University of Minnesota’s CIDRAP tells us,
    • “The influenza and tetanus, diphtheria, and pertussis (whooping cough; Tdap) vaccines are an estimated 69.7% and 88.6% effective against flu- or pertussis-related hospitalizations or emergency department (ED) visits, respectively, among the infants of vaccinated mothers, although with considerable uncertainty, per an observational study published yesterday in JAMA Network Open.”
  • Per HCPLive,
    • “Exercise is as effective as psychological therapy in alleviating depressive symptoms, with no significant difference in outcomes.
    • “Moderate-intensity exercise, especially between 13 and 36 sessions, provides the greatest benefit for reducing depressive symptoms.
    • “Many trials exhibited biases, emphasizing the need for more high-quality, large-scale studies with clinically diagnosed participants.
    • “The study suggests exercise could complement or serve as an alternative to traditional depression treatments, though further research is necessary.”
  • Per the Genetic Engineering and BioTechnology News,
    • “Some parts of the body can recover from injury fairly rapidly. The cornea, for example, can heal from minor scratches within a single day. The human brain, however, is not one of these fast-healing tissues or organs. Adult brain cells are stable and last for a lifetime— barring trauma or disease—while some cells lining the gut last only five days and must be continually replaced.
    • “Scientists would like to use stem cell therapy to boost the brain’s ability to regenerate following damage resulting from concussion or stroke. To date, such treatments have been stymied due to injury-related changes in the brain, as well as with difficulties integrating regenerated cells into existing brain circuits to restore functions such as memory retention or motor skills.
    • “Scientists headed by a team at Sanford Burnham Prebys Medical Discovery Institute and Duke-National University of Singapore (NUS) Medical School now report the results of testing a regenerative therapy derived from human stem cells. Their studies showed that when transplanted into mice, the cells matured, integrated into existing circuits and restored function. By tracing the cells and sequencing their gene expression patterns, the researchers also revealed how transplanted cells find where they need to go and form connections with the nervous system. The studies showed that the cells contain their own intrinsic codes for navigation, and once they become neurons, this code instructs the cell to send its axons to a specific area of the brain.
    • “Headed by Su-Chun Zhang, MD, PhD, the Jeanne and Gary Herberger Leadership chair in neuroscience and the director of and professor in the Center for Neurologic Diseases at Sanford Burnham, the researchers reported their findings in Cell Stem Cell, in a paper titled “Transcriptional code for circuit integration in the injured brain by transplanted human neurons.” In their paper the team concluded, “Our finding opens a promising strategy for treating neurological diseases through promoting regeneration and neural transplantation.”

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

  • The Wall Street Journal reports,
    • “Merck MRK is in talks to acquire Revolution Medicines in a deal that could value it at around $30 billion, according to people familiar with the matter. 
    • “A deal for the cancer-drug biotech could come as soon as later this month, the people said, cautioning the talks could still fall apart or another suitor could prevail. 
    • “Merck has been discussing a deal valued between $28 billion and $32 billion, the people added.” * * * 
    • “Revolution is developing drugs that target a molecular driver of cancers known as RAS. Revolution’s experimental drugs seek to block the driver, thereby thwarting cancers including lung, pancreatic and colon. 
    • “If it proves to work safely, the pancreatic-cancer drug candidate could generate $10 billion in 2035 worldwide sales, Mizuho Securities analysts estimate.” 
  • Digital Commerce 360 informs us,
    • “CVS Health has outlined a broad digital and artificial intelligence (AI) strategy aimed at simplifying health care delivery.
    • “The strategy deepens consumer engagement and supports multiyear earnings growth. It positions technology as a core driver of the company’s next phase rather than a back-office function.
    • “At its 2025 investor day in December, the health care and pharmacy company introduced what it described as an AI-native consumer engagement platform. It designed the platform to connect interactions across CVS Pharmacy, CVS Caremark, Aetna and its health care delivery businesses into a single digital interface. Executives said the company intends for the platform to reduce friction for consumers by navigating prescriptions, benefits, and care, while also improving operational efficiency across the enterprise.”
  • Per a LinkedIn post by a Memorial Sloan Kettering Cancer Center executive,
    • “Memorial Sloan Kettering Cancer Center has entered into a one-year trial partnership with OpenAI on its new HIPAA-compliant version of hashtag#ChatGPT, “ChatGPT Healthcare”. This collaboration is designed to accelerate responsible AI adoption at MSK by providing new a range of tools and access to expertise in support of our clinical, research, and operational workflows. As an early launch partner, we’re also looking forward to shared learning alongside peer institutions across the country. Importantly, this partnership reflects a strong, shared commitment to rigorous governance, privacy, and security. We see this as a meaningful opportunity not only to advance our own work, but also to help shape the broader conversation on how AI can thoughtfully and responsibly enhance cancer care and research.”
  • Fierce Healthcare points out,
    • “Pittsburgh-based insurer Highmark is further expanding its drug offerings through CivicaScript and leaning on biosimilars as pharmaceutical costs continue to rise for many.
    • “Highmark is a founding member of the drug company, which manufactures lower-cost alternatives to high-cost generic products. CivicaScript is a sister to Civica Rx, a drugmaker cofounded by health systems that makes key products for care facilities, which are often in short supply.
    • “The insurer first made abiraterone acetate, a drug for treating prostate cancer, available through CivicaScript in 2023, and found that members are saving $90 each month on average thanks to this partnership and its relationship with specialty pharmacies.
    • “Highmark said that more than 300 members are benefiting from the savings—across both individual and group customers, the plan has collectively saved $8 million.
    • “And as of September 2025, Highmark is now offering four additional CivicaScript products: dimethyl fumarate and dalfampridine, which are both used to treat multiple sclerosis; droxidopa, which is used for neurogenic orthostatic hypotension; and capecitabine, a cancer drug.”
  • Per MedTech Dive,
    • “Haemonetics will acquire Vivasure Medical, an Ireland-based firm that makes a patch device for percutaneous vessel closure, the companies announced Friday.
    • “Haemonetics will pay 100 million euros upfront ($116.3 million), or about 52 million euros when including the value of certain previous investments and loans. Vivasure will be able to get an additional 85 million euros if it meets certain sales growth and other milestones.
    • “The acquisition is expected to bolster Haemonetics’ presence in the large-bore closure market, giving the company a bigger impact in fast-growing structural heart and endovascular procedures, Ken Crowley, general manager of interventional technologies at Haemonetics, said in a statement.”
  • Per MedCity News,
    • “Health tech may be getting a new heavyweight — though the deal is still in its early stages.
    • “Last month, reports emerged that Matt Holt, former managing director and president of private equity at New Mountain Capital, had left the New York City firm to start a new venture combining five of its health tech portfolio companies in a deal valued at more than $30 billion. 
    • “The creation of the new company — apparently to be named Thoreau after essayist and naturalist Henry David Thoreau — is not yet finalized, but steps are underway to move the process forward, an anonymous source familiar with the transaction told MedCity News. The source said significant diligence, analysis and capital-raising efforts are still underway.
    • “The five New Mountain-backed startups that Holt is in discussion to acquire are Datavant, Machinify, Office Ally, Smarter Technologies and Swoop. Anonymous sources close to the deal told media outlets that the new entity, called Thoreau, is being backed by London-based alternative asset manager ICG Strategic Equity.” * * *
    • “Though Thoreau is not yet a done deal, experts think the move represents a major bet on scale and integration in the health tech sector.”

Weekend update

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

From Washington, DC

  • Congress is out of session again this week. The House of Representatives begins its 2026 session on January 6 while the Senate begins its 2026 session on January 5.
  • The American Bazaar tells us,
    • “Around 25,000 people have expressed interest in joining the “Tech Force,” a cadre of engineers to be hired by the Trump administration as it looks to install staff with artificial intelligence expertise in federal roles.
    • “The Trump administration will use that list to recruit software and data engineers, in addition to other tech roles, said Scott Kupor, director of the U.S. Office of Personnel Management, in a post on X. The 25,000 figure has been provided by a senior Trump administration official, according to a Reuters report.”
  • Beckers Hospital Review informs us,
    • “The Department of Homeland Security will replace the random lottery used to select H-1B visa recipients with a system that gives greater weight to applicants with higher skills.”
    • The article lets us know five things about this change.

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “It’s been a long time coming: Four years after Omeros came up short in its bid to gain an FDA approval for stem cell transplant drug narsoplimab, the Seattle biotech has finally scored its long-awaited nod.
    • “With a Christmas Eve thumbs-up for narsoplimab, the FDA has delivered Omeros its first U.S. approval in its 31 years. Taking on the commercial name Yartemlea, it also becomes the first treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The first-in-class lectin pathway inhibitor is for patients age 2 and older.
    • By selectively inhibiting MASP-2, which is the effector enzyme of the lectin pathway, Yartemlea blocks activation while preserving complement functions important for host defense.”

From the public health and medical / Rx research front,.

  • The Washington Post reports,
    • “When Marc and Cristina Easton’s son was diagnosed with autism at 20 months, the Baltimore couple left the doctor’s appointment in confusion. Their toddler — who was very social — didn’t resemble the picture of the condition they thought they knew. And the specialists could offer little clarity about why or what lay ahead.
    • “It wasn’t until four years after their child’s diagnosis that the Eastons finally began to get answers that offered them a glimmer of understanding. This summer, a team from Princeton and the Flatiron Institute released a paper showing evidence for four distinct autism phenotypes, each defined by its own constellation of behaviors and genetic traits. The dense, data-heavy paper was published with little fanfare. But to the Eastons, who are among the thousands of families who volunteered their medical information for the study, the findings felt seismic.
    • “This idea that we’re seeing not one but many stories of autism made a lot of sense to me,” Cristina said.”
  • The New York Times relates,
    • “The egg has become a dominant source of anxiety for many women. Human eggs are finite, declining in both quality and quantity with age. In a woman’s 30s, this starts to make it harder to get pregnant, and by menopause, a woman is without functional eggs. Growing awareness of this reproductive reality has led to a surge in egg freezing, as women aim to preserve the vitality of their younger eggs.
    • “But there’s more to infertility than old eggs. Recent research is bringing greater attention to the ovaries.
    • ‘An expanding body of evidence suggests that the age of an ovary, not just the eggs it contains, is important to reproduction and healthy aging. That includes the cells and tissues that make up the environment around a woman’s eggs, such as support cells, nerves and connective tissue.
    • “The tissues surrounding the follicles — fluid-filled sacs that contain an immature egg — can change with age, even becoming fibrotic. Research has shown that this can harm the quality of eggs, reduce the number that mature each month and block ovulation. Fibrosis is common in many aging organs as thick, scarlike tissue builds up. But it occurs decades earlier in the ovaries.”
  • The Wall Street Journal lets us know,
    • “Approved by the Food and Drug Administration decades ago for seizures and nerve pain from shingles, gabapentin is now the seventh-most widely prescribed drug in the U.S., according to the Iqvia Institute for Human Data Science. About 15.5 million people were prescribed gabapentin in 2024, according to an analysis by Centers for Disease Control and Prevention researchers. 
    • “Studies show that most of the prescriptions are written to treat conditions that it wasn’t approved for—a practice that is legal and common, but means the FDA hasn’t vetted its risks and benefits for those purposes.
    • “Some doctors say gabapentin can be helpful for certain types of neuropathic pain, a condition resulting from nerve damage. But doctors also give it to patients with other types of chronic pain, anxiety, migraines, insomnia, distorted sense of smell and hot flashes in menopause. Veterinarians dispense it to calm or treat pain in cats and dogs.
    • “A growing body of research shows it isn’t as safe or effective as doctors have long thought. Gabapentin has been associated in studies with greater risk of dementia, suicidal behavior, severe breathing problems for people who have lung disease, and edema, in addition to well-known side effects like dizziness.
    • “A study published this year found giving gabapentin to surgery patients didn’t reduce complications or get them out of the hospital any faster, and more of them reported pain four months after surgery. Doctors for years had touted gabapentin as a way to use fewer opioids. 
    • ‘While the medical establishment has mostly maintained that gabapentin isn’t habit-forming, some patients have reported debilitating adverse effects when they try to taper off it. They say the withdrawal symptoms make it clear to them they have developed a dependence to the drug taking it as prescribed.”
  • and
    • summarizes “The Future of Everything’s top stories of the year, including a formula for aging, fruit-picking robots and the car of the future.”
      • “This longevity doctor has a formula for aging better. Dr. Eric Topol’s research suggests lifestyle impacts longevity more than genes. The cardiologist believes more people can become “super agers” by embracing regular exercise and digital health technology.”
      • “Inflammaging” leads to cancer, but allergy drugs could help fight it. Dr. Miriam Merad is testing whether allergy drugs and other seemingly unlikely medications can help reduce chronic inflammation—or inflammaging—and thereby slow cancer in older patients.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Mail-order pharmacies filled just 9% of Medicare prescriptions in the three-year period examined by the Journal, but accounted for 37% of the excess dispensing, the analysis showed. Such pharmacies often send 90-day refills automatically when patients near the end of their earlier supplies.” * * *
    • “The Journal’s analysis counted as excess only dispensed prescription drugs that exceeded a month’s supply over up to three years’ worth of prescriptions.” * * *
    • “The Journal analysis is based on Medicare prescription records accessed under a research agreement with the federal government. The records include details of each individual prescription for more than 50 million Medicare recipients between 2021 and 2023, but don’t identify individuals. 
    • “Doctors and patients said such earlier-refilling practices aren’t limited to Medicare patients, and that it also happens with people covered by employer-sponsored plans. The Journal analysis doesn’t cover those private plans.”
  • Beckers Payer Issues identifies six insurer moves in 2025 that signal a heightened PBM focus.
  • Fierce Healthcare offers a 2026 outlook based on parting thoughts from dozens of healthcare CEOs retired in 2025.
  • HR Dive shares its “top 10 learning stories of 2025. Workers sounded off about the need for more training and just how great a role the onboarding experience plays in their retention.”

Tuesday report

David Ermer–CMS, FDA, HSA, Medical / Rx research, Medicare, OPM, Patient safety, Rx coverage, U.S. Healthcare–

The FEHBlog will be on hiatus following today until next December 27 Cybersecurity Saturday. Merry Christmas and Jingle Bells to all.

From Washington, DC,

  • Federal News Network reports,
    • “There’s an old adage that tells someone to “put your money where your mouth is.” Well, Don Bauer is going all in at the Office of Personnel Management.
    • “Bauer wrote a column for Federal News Network criticizing OPM’s plans to consolidate and modernize human resources systems across the government. In his Oct. 30 column, Bauer wrote that OPM’s initial plan was “not modernization; it’s madness.”
    • “Now Bauer is in charge of that madness. Federal News Network has learned Bauer will join OPM on Jan. 12 as its new deputy associate director for workforce standards and data center (WSDC) in the HR Solutions (HRS) office. He will be leading the HR Line of Business, the quality service management office (QSMO) and human capital management core modernization effort.”
  • Good luck, Mr. Bauer.
  • Mercer tells us,
    • “In Notice 2026-5, IRS and the Treasury Department provide key details about health savings account (HSA) enhancements passed as part of the One Big Beautiful Bill Act (OBBBA) (Pub. L. No. 119-21), clearing the way for employers to continue offering telehealth and to begin offering direct primary care service arrangements (DPCSAs) to otherwise HSA-eligible employees.
    • “Effective for the 2025 plan year, OBBBA reinstated and made permanent COVID-19-era telehealth relief allowing HSA-compatible high-deductible health plans (HDHPs) to cover telehealth and other remote care services before the statutory minimum deductible is satisfied.
    • “Beginning Jan. 1, 2026, OBBBA also allows individuals enrolled in DPCSAs to remain eligible to make or receive HSA contributions and treats certain bronze and catastrophic plans as HDHPs.
    • “This article summarizes the Notice 2026-5 question-and-answer guidance, addressing significant topics such as which services the IRS will treat as “telehealth and other remote care services;” whether a DPCSA can separately bill for primary care services or offer services beyond primary care; and whether a bronze or catastrophic plan can be an HDHP if purchased using an employer-sponsored individual coverage health reimbursement account (ICHRA).
    • ‘Comments about the guidance are due March 6, 2026.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today a new voluntary test of a model that is designed to enable Medicare Part D plans and state Medicaid agencies to cover GLP-1 medications used for weight management and metabolic health improvement, while helping control costs for patients and taxpayers.
    • “The Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model builds on emerging evidence that combines access to GLP-1 medications with access to evidence-based lifestyle supports to achieve better long-term health outcomes. The model represents a major step toward potential expanded access and affordability for millions of Americans. 
    • “Today’s announcement builds upon our historic Most Favored Nations drug pricing deals’ goal of democratizing access to weight-loss medication, which has been out of reach for so many in need,” said CMS Administrator Dr. Mehmet Oz. “These actions further the administration’s bold plan to reform our country’s health systems and Make America Healthy Again. With the BALANCE Model, we’re pairing breakthrough science with healthy living to cut costs while empowering Americans to take control of their health.”
    • “Under the model, CMS negotiates directly with pharmaceutical manufacturers of GLP-1 drugs for lower net prices and standardized coverage terms. Negotiation areas include: 
      • “Guaranteed net pricing and potential out-of-pocket limits for beneficiaries;
      • “Standardized coverage criteria; and
      • “Evidence-based lifestyle support offerings.”
    • “To learn more about the BALANCE Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/balance.” * * * 
    • “Prior to the launch of the BALANCE model, CMS also plans to implement a new Medicare GLP-1 payment demonstration beginning in July 2026, which will serve as a short-term bridge to the model. This additional payment demonstration means that Medicare beneficiaries can start accessing these important medications at prices negotiated by the Administration as soon as possible.
    • “The GLP-1 payment demonstration will operate outside of the Medicare Part D benefit’s coverage and payment flow, which means that Part D Plan Sponsors will not carry risk for eligible GLP-1 products furnished under the demonstration. Beneficiaries enrolled in Medicare Part D who meet the negotiated access criteria will have access to these drugs. Under the demonstration eligible Medicare beneficiaries will pay $50 for a month of GLP-1 medications.
    • “CMS will provide additional information on the design and implementation of the GLP-1 payment demonstration in early 2026.
  • The Wall Street Journal points out,
    • “About half of 20 million Americans with FSA [healthcare flexible spending] accounts let some of their money expire each year.
    • “The average forfeited amount per individual is over $400, and unused FSA money generally returns to employers.
    • “FSAs offer tax savings; a worker in the 22% tax bracket contributing $1,500 could save as much as around $500 in taxes.”
  • Per an AHIP news release from December 18,
    • “AHIP’s Board of Directors has elected Jim Rechtin, President and CEO of Humana, as Board Chair effective January 1, 2026. Rechtin succeeds Pat Geraghty, who announced his retirement after 14 years leading GuideWell and Florida Blue effective December 31, 2025.
    • “I was proud to be part of AHIP’s work this year to unite our industry around voluntary commitments to simplify prior authorization – an important ongoing effort that shows what’s possible when health plans work together to deliver for patients. As Board Chair, I look forward to taking the same cooperative approach to helping health consumers navigate the system and access high-quality, affordable care,” Rechtin said.

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • “The FDA has expanded the indication of ferric maltol (Accrufer) capsules for the treatment of iron deficiency to include adolescents.
    • “The approval makes the drug the first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older. It was first approved in 2019 for adults with iron deficiency.
    • “The expanded indication was supported by the phase III FORTIS trialopens in a new tab or window in which 24 patients ages 10-17 received age-based dosing of ferric maltol twice daily, and showed a clinically meaningful average increase in hemoglobin of 1.1 g/dL at 12 weeks. This would be the expected average increase in hemoglobin with one blood transfusion, the agency noted.”
  • MedTech Dive reports,
    • “Edwards has received Food and Drug Administration approval for its Sapien M3 mitral valve replacement system, the company said Tuesday.
    • “The device is intended for people with moderate to severe mitral regurgitation, a heart condition where the valve between the left heart chambers doesn’t fully close, allowing blood to leak back through. Sapien M3 is indicated for people who are deemed unsuitable for surgery or transcatheter edge-to-edge repair therapy, a minimally invasive procedure to fix a valve by clipping its leaflets together.”
  • and
    • “The Food and Drug Administration said Monday it has issued a Class I recall notice regarding Medtronic’s removal of heart vent catheters.
    • “Medtronic previously asked customers to quarantine lots of its DLP Left Heart Vent Catheters in response to an issue linked to three serious injuries. The FDA published an early alert about the recall in August.
    • “The agency updated its notice this week to inform the public that it has classified the issue as a Class I recall.” 

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Infants given the monoclonal antibody nirsevimab, which provides temporary immunity to respiratory syncytial virus (RSV), had lower risks of related hospitalizations and severe outcomes than those whose mothers got the RSVpreF vaccine, according to a population-based study.
    • “The study may be the first to compare the two interventions in a real-world setting in a national population.
    • “The study and two others reported alongside it join a growing body of real-world evidence demonstrating the effectiveness of RSV products in protecting against severe outcomes related to RSV in the youngest kids.”
  • Health Day informs us,
    • “People on the verge of type 2 diabetescan cut their risk of death from heart disease by more than 50% if they bring their blood sugar levels back to normal, a new study says.
    • “Patients with prediabetes reduced their heart risk by up to 58% when they successfully lowered their blood sugar, researchers reported in The Lancet Diabetes & Endocrinology.
    • “This is an important finding, given that recent studies have concluded people with prediabetes can’t lower heart disease risk through lifestyle changes like exercise, weight loss and a healthy diet, researchers said.
    • “Essentially, reversing prediabetes by lowering blood sugar matters more to your heart than any healthy habits you adopt, researchers said.
    • “This study challenges one of the biggest assumptions in modern preventative medicine,” said lead researcher Dr. Andreas Birkenfeld, a reader in diabetes at King’s College London.
  • Medscape points out,
    • “A trio of large observational studies reported at the San Antonio Breast Cancer Symposium (SABCS) 2025 suggest that GLP-1 receptor agonists may improve outcomes in some women with breast cancer.
    • “Two studies reported an overall survival benefit of GLP-1 use in certain patients with breast cancer, including those with ductal carcinoma in situ (DCIS) and invasive hormone receptor (HR)-positive nonmetastatic disease, and a third found improvements in a range of toxicities among patients receiving chemotherapy.
    • “These studies, presented during a poster session, add to other emerging research indicating that GLP-1 drugs could have implications across the breast cancer trajectory, including prevention, active therapy, and posttreatment survivorship, explained study discussant Jasmine S. Sukumar, MD, with University of Texas MD Anderson Cancer Center in Houston.”
  • Fierce Pharma relates,
    • “Just days after an upbeat R&D event, Neurocrine Biosciences has found itself having to report a phase 3 failure.
    • “The company’s Ingrezza (valbenazine), approved to treat certain uncontrolled movement conditions, failed to make a significant difference in a phase 3 trial for patients with dyskinesia due to cerebral palsy (CP), Neurocrine announced Monday.
    • “Ingrezza didn’t outperform placebo on improving involuntary, jerky movements of the body after 14 weeks of treatment, causing the phase 3 trial to miss its primary endpoint. The study, dubbed Kinect-DCP, also did not meet key secondary endpoints, according to Neurocrine.”
  • and
    • “A patient in an open label extension study of Pfizer’s hemophilia treatment Hympavzi has died, the company and several hemophilia advocacy groups confirmed this week.
    • “Pfizer is now working with its trial investigator and independent data monitoring committee to accrue more information and better understand the circumstances behind the incident, the New York drugmaker wrote in a letter to the hemophilia community, which was posted online (PDF) by the World Federation of Hemophilia (WFH) on Dec. 22.”
  • STAT News reports,
    • “Oncologists have been moving away from the notoriously unpopular neutropenic diet. It requires nearly all food to be cooked to high temperatures — or, as some have described it, “boiled to death” — to reduce the risk of food-borne illnesses. But since evidence in recent years suggested the diet didn’t actually help ward off infections, doctors started leaning away from a strict neutropenic diet.
    • “Now, a new study published last week in the Journal of Clinical Oncology is giving some physicians pause about fresh fruits and vegetables for patients whose treatment involves heavy suppression of the immune system, particularly neutrophils, white blood cells that are key to preventing infection. Contrary to research in the past, the trial found that certain blood cancer patients who were allowed a less restrictive or liberalized diet had 11% more infections than patients who were prescribed the neutropenic diet.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Analysts expect health insurance companies to be better positioned for 2026 after adjusting their offerings.
    • “Medicare Advantage offers the sector the largest potential for improvement because companies will receive a significant increase in federal pay. 
    • “Federal changes to Medicaid and the exchanges will pressure health insurance companies’ finances.”
  • Ernst & Young informs us,
    • “A changing healthcare landscape is shifting economic returns, leading organizations to rethink their value chain position.
    • “Expansion in lower-acuity care and opportunistic mergers and acquisitions can accelerate long-term growth.
    • “Implementing new benefit cost containment strategies and investing in innovative AI solutions can elevate efficiency and performance.”
  • Per a Harvard Business Review article,
    • “U.S. employers are grappling with surging healthcare costs as healthcare prices and service volumes rise. Provider consolidation, high drug prices, labor shortages, and growing chronic disease are fueling the cost increases. Employer have largely responded by shifting expenses to workers. Their track record in pursuing aggressive options—including collective purchasing, tiered plans, value-based care, and advocating for changes in government policies—is poor. The big question is whether they have the will to become more aggressive in pursuing remedies. The outlook is not promising. The reasons include the complexity of the problem, employee resistance to some solutions, and the fact that most employers just don’t have sufficient “skin in the game” to take on the disruption and risk that would be required to bend the healthcare cost curve significantly or sustainably.”
  • The FEHBlog has more confidence in employers.

FEHBlog response to public comment

  • A commenter called into question the statistices upon which AHIP relied in this recent news release which the FEHBlog quoted. In response the FEHBlog notes that the AHIP news release was generated in response to the Affordable Care Act marketplace subsidy controversy and 2020 was an outlier year for all health insurers as it was the first year of the Covid pandemic. Health plans did make MLR rebates in that year according to CMS.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Nine pharmaceutical companies including Bristol-Myers Squibb, GSK and Merckagreed to lower the prices that certain federal government programs and patients pay, in a new round of industry pacts with the Trump administration.
    • “The companies said they would reduce U.S. prices on drugs to levels comparable with prices charged in other wealthy countries, which are generally much lower. In return, the companies get administration-backed reprieves from potential new U.S. tariffs for three years.
    • “President Trump announced the deals Friday at the White House, joined by top executives of the nine companies. * * *
    • Under the terms, the “most-favored nation” prices offered by companies would apply to the U.S. Medicaid program for lower-income patients, direct-to-patient services including the planned TrumpRx.gov and to newly launched drugs in the future.
    • “Merck said it would make diabetes drugs Januvia and Janumet available to eligible American patients at a cash price that is 70% off the current list price through a direct-to-patient program. 
    • “Amgen said it would sell its migraine drug Aimovig for $299 a month, nearly 60% off the list price.
    • “Some of the companies in the new round of deals also agreed to donate the main ingredients for certain medicines to a national stockpile, to be available in the event of a national emergency. 
    • “GSK is donating six-months’ supply of a respiratory inhaler, and Bristol-Myers will donate six-months’ worth of the blood thinner Eliquis.
    • “Bristol-Myers said it would provide Eliquis free to Medicaid programs.”
  • The Hill adds,
    • “Medicare enrollees could save roughly half of what they usually pay for certain drugs next year, according to a study from the AARP.
    • “The study, published Thursday, found that the out-of-pocket cost of 10 drugs included in the first round of Medicare drug price negotiation will decrease substantially in five states with high enrollment in the program — California, Florida, New York, Pennsylvania and Texas — once negotiated prices go into effect on Jan. 1, 2026.” 
  • Roll Call sums up Congress’s activities in the final week of this term of Congress and looks forward to January.
    • “The Senate followed the House in leaving for the Christmas break on Thursday, clearing another batch of President Donald Trump’s nominations but kicking to January the fate of the next handful of spending bills.
    • “The Senate confirmed, 53-43, an en bloc package of 97 nominations. Senators also by unanimous consent confirmed the nomination of Kevin E. Lunday to be commandant of the Coast Guard. And they reached an agreement to set up confirmation of additional Trump nominees when they return in January.” * * *
    • “[T]he aspiration of Thune and Senate Republican appropriators to get the ball rolling on a package of fiscal 2026 spending bills was not to be. The rules require unanimous consent to combine more than one regular appropriations measure into a single bill — and that agreement proved elusive despite talks that went on throughout the day Thursday.
    • “That sets the stage for January, when lawmakers will have less than a month to figure out how to fund the government and avoid another partial government shutdown. Thune said he thought another shutdown would be “toxic” for Democrats and Republicans alike.
    • “I don’t think either side wants to see that happen,” Thune said. “So I’m hoping that there will be goodwill and we’ll figure out how to fund the government.”
  • Per a Centers for Medicare and Medicaid Service press release,
    • “The Centers for Medicare & Medicaid Services (CMS), in partnership with the Department of Labor and the Department of the Treasury (collectively, the Departments), today jointly proposed major updates to the historic health care price transparency rules established during President Trump’s first term.” * * *
    • “In line with Executive Order 14221, this proposed rule reflects the Department’s commitment to ensuring that health care pricing data is not only public but maximally impactful and actionable.
    • “Key improvements include:
      • “Requiring plans and issuers to exclude from the In-network Rate Files certain data for services providers would be unlikely to perform.
      • “Reorganizing In-network Rate Files by provider network rather than by plan, cutting redundancy, and aligning with how most hospitals report data pursuant to the Hospital Price Transparency requirements.
      • “Requiring Change-log and Utilization Files so users can easily identify what has changed from one In-network Rate File to the next and have clear information on which in-network providers are actively furnishing which items and services.
      • “Reducing reporting cadence for In-network Rate and Allowed Amount Files from monthly to quarterly, significantly reducing burden while maintaining meaningful transparency.
      • ‘Increasing the amount of out-of-network pricing information reported by reorganizing Allowed Amount files by health insurance market type, reducing the claims threshold to 11 or more claims, and increasing the reporting period from 90 days to 6 months and the lookback period of data from 180 days to 9 months. 
    • “The Departments seek feedback from stakeholders during the 60-day comment period on all elements of the proposed rule, including opportunities for further standardization and burden reduction. The deadline to submit comments is February 21, 2026.
    • “To access the proposed rule, visit: https://www.federalregister.gov/public-inspection/2025-23693/transparency-in-coverage
    • “To read the CMS fact sheet, visit: cms.gov/newsroom/fact-sheets/transparency-coverage-proposed-rule-cms-9882-p” 
  • Beckers Payer Issues informs us,
    • “CMS has proposed two new models aimed at curbing Medicare drug spending by linking payments to international benchmarks. The proposals — GUARD for Part D drugs and GLOBE for Part B — are the latest in the CMS Innovation Center’s efforts to make prescription drugs more affordable for beneficiaries while preserving the long-term sustainability of the Medicare program.” * * *
    • “The models were published via a notice of proposed rulemaking and are now open for public comment [for sixty days] through the Federal Register.” 
  • MedCity News delves into “CMS’ new ACCESS model [mentioned in yesterday’s post and], slated to begin on July 1, aims to shift traditional Medicare fee-for-service toward value-based care by tying payments to patient outcomes and encouraging tech-enabled, preventive care. Experts say it could benefit digitally mature, value-focused providers first, but its overall success will hinge on clear metrics, better data sharing and sustained participation.”
  • Per a Commitee for a Responsible Budget news release,
    • “Health care spending represents about 18% of the nation’s economy and the largest area of federal spending. High and rising health care costs are driven in part by the prices for medical care, which have risen 130% since 2000, compared to 93% for overall inflation.1 This is particularly true in commercial insurance – including large employers, the Affordable Care Act marketplaces, and public employers such as states and the federal government – where rising costs place a growing burden on workers, employers, and the federal government.2 To manage costs, many employers attempt to work with insurance plans to reduce spending, but many lack the market power to command lower prices from providers, such as hospitals.3
    • “Some public employers have looked to reference pricing to address rising employee health care costs in state plans. Under a reference pricing approach, the employer sponsoring the plan establishes a maximum price for certain services. States that have launched reference pricing programs for state employees have been able to reduce costs for state budgets, as well as for enrollees.
    • “In order to reduce health care costs more broadly, policymakers could consider adopting or encouraging reference pricing for federally subsidized insurance. A possible place to start would be the Federal Employees Health Benefits (FEHB) program, which is the largest employer-sponsored commercial insurance program in the country and costs the federal government roughly $50 billion per year.4
    • “In this brief, we discuss an option to adopt a version of reference pricing for hospital reimbursement rates in FEHB, with the reference price based on Medicare rates. Doing so could save billions of dollars for enrollees and the federal government.”
  • Tammy Flanagan, writing in Govexec, discusses “key decisions every federal employee [nearing retirement] must make. From survivor benefits and health coverage to leave payouts and TSP choices, federal employees nearing retirement face deadlines that can permanently shape their finances.”
  • The New York Times lets us know that “President Trump on Thursday ordered cannabis to be downgraded to a lower category of drugs, a change that would allow for more widespread use by patients and permit cannabis producers to take advantage of standard business tax breaks.” The article explains why “moving cannabis to a category of drugs that includes some common medicines will have implications for research, businesses and patients.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Seven years after the FDA’s accelerated approval of bleeding reversal agent Andexxa, which was then under the ownership of Portola Pharmaceuticals, the drug’s round trip on the U.S. market is coming to an end. 
    • “Andexxa, now under AstraZeneca’s stewardship, is slated to be pulled from the U.S. market next week, according to a Dec. 18 update from the FDA. 
    • “In the FDA communication, the agency notes that it has “received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa.” Based on the available data, the agency “considers the risks of the product to outweigh its benefits,” it said.”
  • BioPharma Dive relates,
    • “The Food and Drug Administration has put a partial clinical hold on one of Merck & Co. and Daiichi Sankyo’s antibody-drug conjugates following an unexpected number of deaths in a late-stage clinical trial.
    • “Daiichi initiated a voluntary pause recruiting and enrolling the trial, called IDeate-Lung02, after “higher than anticipated incidence of grade 5 interstitial lung disease events,” a spokesperson for Merck and Daiichi said in a statement to BioPharma Dive. Following the pause, the FDA verbally placed the trial on a partial clinical hold in October. The spokesperson did not say the number of deaths recorded.
    • “During the hold, Daiichi, along with the FDA and an independent committee will review the safety data and “decide on any necessary further actions.” Trial enrollees will be able to continue treatment, but no new participants will be recruited.
    • “The experimental drug, called ifinatamab deruxtecan, or I-DXd, is one of three ADCs Merck gained the rights to through a major licensing deal with Daiichi in 2023. ADCs, which link an antibody to a toxic payload, are meant to more effectively target and destroy cancer cells while sparing the surrounding healthy tissue.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for American patients.
    • “The products are:
      • Enlicitide decanoate — an oral PCSK9 inhibitor for lowering LDL cholesterol
      • Sacituzumab Tirumotecan — a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate
    • “High health care costs and prescription drug prices threaten to undermine all the technological advancements we see in the medical field,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re pleased to grant these vouchers to two products that may significantly contribute to our goal of improving the accessibility and affordability of healthcare in America.”
    • “With these awards,18 products have now received a voucher under the CNPV pilot program since it was established in June 2025. On December 9, the agency announced its first review decision under the program, achieving significant time savings compared to a typical review timeline.”
  • and
    • “The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and America’s most innovative companies. 
    • “The FDA recognizes that many breakthrough technologies and innovative solutions relevant to its public health mission — including artificial intelligence, biotechnology, medical devices, and regulatory technology — are being developed by firms within venture capital portfolios. However, longstanding challenges, have limited engagement with innovative companies. Many existing federal contracting mechanisms favor large systems integrators and intermediaries that focus on labor-based work rather than scalable technologies. In addition, small business set-aside programs can be difficult for early-stage companies to access and have faced concerns about misuse.  
    • “We should be harnessing the incredible talent of America’s innovators, instead of relying on middlemen and D.C. insiders,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA is exploring a new approach that enables us to harness innovative capabilities and work directly with American entrepreneurs.”
  • Per Cardiovascular Business,
    • “Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for its Amplatzer Piccolo Delivery System. The device was developed for clinicians to use when implanting the company’s Amplatzer Piccolo Occluder in a premature baby with a patent ductus arteriosus (PDA).
    • “PDAs are holes between two blood vessels that typically close when a baby is born. In rare instances, however, the hole stays open after birth, directing too much blood toward the lungs and impacting the neonate’s ability to breathe.
    • “The Amplatzer Piccolo Occluder first secured FDA approval and CE mark approval in 2019. It is the first transcatheter treatment to gain FDA clearance for closing a PDA in a premature infant. The device is smaller than a pea and delivered through a tiny incision in the child’s leg before it is guided to the heart using the newly cleared Amplatzer Piccolo Delivery System.
    • “We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier,” Sandra Lesenfants, senior vice president of Abbott’s structural heart business, said in a prepared statement. “With the Amplatzer Piccolo Occluder, which is the world’s smallest heart device, and now with the new delivery system to complement it, we’re continuing to advance how we meet the needs of our tiniest patients with structural heart disease.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity continues to increase across the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • Beckers Clinical Leadership tells us,
    • “Flu hospitalization cases are evenly split between children and older adults, Northwell said, and its Cohen Children’s Medical Center in New York City is at capacity. 
    • “Flu is rising a lot faster than it did last year,” Dwayne Breining, MD, senior vice president of lab services at Northwell, said during a Dec. 18 news conference. 
    • “The other two [COVID-19 and RSV] are rising but not as fast as they did last year,” Dr. Breining said. “That’s driven by a couple of things. What’s very concerning for us is the cases of flu are rising at like 35% per week; the hospitalizations are rising at 75% per week. So we’re keeping a close eye on that trend. It could mean the flu is more severe.”
    • “Experts have said a mutated version of H3N2, “subclade K,” could be fueling the current uptick in flu activity amid earlier and more intense outbreaks abroad. The strain is a version of the influenza A virus, which is generally known to cause more severe illness, particularly in older adults and young children.
    • “At Northwell, more than one-third of flu tests for the week ending Dec. 14 were positive for influenza A’s H3 subtype. The same week period in 2024 saw a 10% flu positivity rate.”
  • Per a National Institutes of Health news release from its Director Dr. Jay Bhattacharya,
    • “At the National Institutes of Health (NIH), engendering trust and confidence in the research we support is one of our top priorities. Three things guide these efforts: engaging in open, honest dialogue, acting in transparency, and delivering on our commitment to advancing science and improving health.
    • “To help guide this work, the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) recently undertook a multi-year effort to provide the NIH with a roadmap for incorporating public voices in clinical research (see NExTRAC report).  Deliberations were informed by a team of multi-disciplinary experts and community conversations across the country, specifically asked to think about strategies for incorporating public voices at every stage of the clinical research process.
    • “I am pleased to endorse these recommendations, which focus on:
      • “providing a clear vision and framework for maximally involving patients and communities in clinical research;
      • “ensuring that people and communities have meaningful input into the agenda and direction of research that is relevant and impactful for them; and
      • “increasing transparency for how research participant data are utilized in moving the scientific enterprise forward.
    • “NIH is eager to begin implementing this roadmap, starting in 2026.”
  • The University of Minnesota’s CIDRAP adds,
    • Today [December 17] the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and NEJM Evidencelaunched their new Public Health Alerts initiative with reports on potential local transmission of clade 1b mpox virus (MPXV) in California and on influenza viruses circulating during the 2024-25 flu season.
    • Public Health Alerts is designed to deliver information and early warnings about emerging health threats, enabling swift, informed responses across the United States and globally.
    • “The new collaboration between NEJM Evidence and CIDRAP fills a gap in reliable data, offering expert-reviewed reports that translate frontline observations into actionable public health evidence. An NEJM Evidence editorial today explains the initiative further.
    • “Access to emerging public health data saves lives,” said infectious disease doctor Eric J. Rubin, MD, Editor-in-Chief of the New England Journal of Medicine and NEJM Group, publisher of NEJM Evidence, in a news release. “By providing this new, rigorous pathway for public health information, NEJM Group is delivering on its commitment to equip physicians with reliable information to support evidence-based care.”
    • “Rapid, credible communication has always been essential to an effective public health response,” added CIDRAP Director Michael Osterholm, PhD, MPH. “With this new collaboration, we hope to restore and strengthen that early-warning function, providing timely, evidence-based alerts that can help local and state health leaders act quickly to protect the health of people in their communities.” 
  • Health Day informs us,
    • “It’s beside the point to debate whether vaping or nicotine pouches can be more healthy than smoking a cigarette, a major new report argues.
    • “Nicotine is toxic to the heart and blood vessels regardless of how it’s consumed, according to an expert consensus report published today in the European Heart Journal.
    • “Nicotine is not a harmless stimulant; it is a direct cardiovascular toxin,” said lead researcher Dr. Thomas Münzel, a senior professor of cardiology at University Medical Center at Johannes Gutenberg University in Mainz, Germany.
    • “Across cigarettes, vapes, heated tobacco and nicotine pouches, we consistently see increased blood pressure, damage to blood vessels and a higher risk of heart disease,” Münzel said in a news release. “No product that delivers nicotine is safe for the heart.”
  • and
    • “Young adults are inheriting a world filled with turmoil and unrest, and this instability is leaving its mark on their mental and emotional health.
    • “A single half-hour course, however, could help them feel less anxious and depressed, by helping them increase their tolerance of uncertainty, a new study says.
    • “Young adults who took the course titled “Uncertainty-Mindset Training” continued to feel better a month after taking it, researchers reported Dec. 15 in the journal Psychological Medicine.
    • “Young people today are coming of age amid great climate, economic, social and health uncertainty,” senior researcher Susanne Schweizer, an associate professor with the University of New South Wales in Sydney, said in a news release.”
  • The Washington Post points out that “feeling wonder every day improves our health and explains how to do it.
  • Health Day calls attention to
    • “A new rapid test [that] could improve treatment of urinary tract infections (UTIs), by identifying the most effective antibiotic for each individual patient.
    • “The test applies different antibiotics to bacteria found in urine samples, to see which one best suppresses bacterial growth, researchers recently reported in the journal Microbiology Spectrum.
    • “This new method could cut a full day off the time between testing and prescription, researchers said, and arm a patient with the best means of clearing their infection.
    • “The sooner we know which antibiotic is effective, the more targeted our treatment can be,” senior researcher Oliver Hayden, a professor of biomedical electronics at the Technical University of Munich in Germany, said in a news release.”
  • Beckers Hospital Review lets us know about GLP-1 drugs that are poised to enter the U.S. market.
  • Per BioPharma Dive,
    • “An experimental anti-inflammatory drug being developed by Belgium-based Galapagos met its main goal in one Phase 2 clinical trial but missed in another, the company said Thursday.
    • “The drug, which blocks an inflammation-signaling enzyme called TYK2, helped significantly improve disease signs and symptoms in people with a muscle and skin condition called dermatomyositis. But it didn’t help people with lupus, missing statistical significance on a broad measure of clinical response.
    • “Called GLPG3667, the drug is Galapagos’ biggest remaining asset following a decision to wind down the company’s cancer cell-therapy business after an unsuccessful attempt to sell it. Galapagos may seek a partner to help further develop GLPG3667, which has some competition in the form of a Roivant medicine that could be under Food and Drug Administration review for dermatomyositis early next year.”
  • Per the Genetic Engineering and Biotechnology News,
    • “As the number of antibiotic-resistant infections continues to rise, scientists are looking to bacteriophages (“phages”), viruses that infect bacteria, as an approach to tackling antibiotic resistance. A new study by researchers at the Hebrew University of Jerusalem has revealed how bacteriophages use a tiny piece of genetic material to hijack bacterial cells and make more copies of themselves.
    • “Focusing on infection of Escherichia coli by phage lambda, a bacteriophage that scientists have been studying for decades, research lead Sahar Melamed, PhD, and colleagues identified a virus-encoded small RNA molecule (sRNA) called phage replication enhancer sRNA (PreS) that acts like a hidden genetic “switch.” The team’s research indicated that this switch rewires bacterial genes to help the virus copy its DNA more efficiently and boost viral replication.
    • “The team said that understanding how phages control bacterial cells is important both for basic science and to help inform future medical applications. By uncovering how phages use tools such as PreS to take control of bacterial cells, the newly reported study provides important basic knowledge that could help scientists design new phage-based therapies targeting drug-resistant bacteria.”

From the U.S. healthcare business front,

  • Kaufman Hall discusses “key health system enterprise strategy trends in 2025… and our predictions for 2026.”
  • Radiology Business reports,
    • “Commercial insurer Anthem is defending a controversial new plan to penalize hospitals who use out-of-network radiologists and other physicians. 
    • “Word of the new administrative policy first surfaced in October and is slated to take effect Jan. 1 across 11 states. Anthem plans to punish hospitals by charging a 10% penalty of the allowed amount for claims that involve docs outside of its networks. 
    • Radiologists and other physicians have roundly criticized the change, labeling the policy as “deeply flawed and operationally unworkable.” The American Hospital Association also joined the chorus on Wednesday with its own sternly worded letter, calling for Anthem parent Elevance Health to rescind the policy. 
    • “However, the Indianapolis-headquartered conglomerate is standing its ground and refusing to honor such requests. Radiologists have charged that the No Surprises Act and its independent dispute resolution process already addresses concerns raised by Elevance. 
    • “We agree that the federal NSA has fulfilled its intent of protecting patients from unexpected medical bills at the point of care,” Catherine Gaffigan, MD, president of health solutions for Elevance Health, detailed in a Dec. 9 response letter to the American Medical Association and others who wrote to the company in November. “At the same time, our experience shows it has also created incentives for many care providers to remain out-of-network due to extremely high, unsustainable IDR awards—on average around nine times in-network commercial reimbursement rates—resulting from the NSA’s IDR arbitration process.” 
  • Amen to that.
  • Fierce Pharma relates,
    • “Pharma marketers enter 2026 asking where DTC fits in the DTP era. 
    • “That question, which few foresaw 12 months ago, reflects the fast rise of direct-to-patient (DTP) programs. In the last few months alone, Amgen, Bristol Myers Squibb, AstraZeneca, Genentech, Novartis and Boehringer Ingelheim have all launched DTP services with discounts for self-pay patients on certain popular medications, joining earlier adopters Eli Lilly, Pfizer and Novo Nordisk.
    • “The programs are changing how patients access medicines—and how patients hear about medicines could therefore evolve to reflect the emerging sales channel.” 
  • and
    • “Sixteen months after luring former Roche dealmaker James Sabry, M.D., Ph.D., out of retirement and signaling a shift in its business development approach, BioMarin has announced the largest transaction in the company’s 28-year history.
    • “In a merger of rare disease specialists, BioMarin has agreed to acquire Amicus Therapeutics for $4.8 billion. The California biopharma will pay $14.50 per share, which is a 33% premium on the $10.89 Thursday closing price of the New Jersey-based biopharma and a 46% premium on its 30-day average.
    • “With the deal, BioMarin gains two rapidly growing products—Fabry disease drug Galafold and Pompe disease combination treatment Pombiliti-Opfolda. BioMarin also acquires the U.S. rights to DMX-200, a potential first-in-class small molecule in phase 3 development for the rare kidney disease focal segmental glomerulosclerosis (FSGS).”
  • and
    • “Regeneron has had its hands full this year contending with regulatory setbacks, Amgen’s marketed Eylea biosimilar and Roche’s hard-charging ophthalmology rival Vabysmo. Next year, the biosimilar competition to the New York drugmaker’s blockbuster eye drug Eylea is only likely to ratchet up.
    • “Regeneron has inked another settlement related to Eylea biosimilars, this one with Alvotech and Teva, enabling the partners to launch their product “in the fourth quarter of 2026, or earlier under certain circumstances,” according to a Dec. 19 press release from Alvotech.”

Thursday report

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

From Washington, DC,

  • The Society for Human Resource Management tells us,
    • “In an address to the nation on Dec. 17, President Donald Trump spoke about the economy, efforts to lower prescription drug prices, and his plans for the year ahead. He noted the pending launch of a new website, TrumpRx.gov, in January 2026, highlighted economic progress, and announced a bonus payment of $1,776 to every military service member as a “Warrior Dividend.” He also touted his economic record and predicted the country is “poised for an economic boom the likes of which we’ve never seen.”
  • STAT News adds,
    • When HCA Healthcare, one of the largest hospital systems in the U.S., recently told employees it would stop covering blockbuster obesity drugs Zepbound and Wegovy next year, it pointed them to an alternative way to get the treatments: Buy them themselves.
    • In a notice viewed by STAT, HCA said use of the GLP-1 weight loss drugs surged 90% this year, “significantly” raising costs. It instead suggested employees enroll in discount programs introduced by the drugs’ manufacturers, Eli Lilly and Novo Nordisk, which allow patients to buy the medicines without using insurance at cash prices that are lower than the list prices.
  • The Wall Street Journal reports,
    • “Millions of Americans are facing higher healthcare premiums and lingering uncertainty about whether help might still arrive, with Congress set to break for the rest of the year without renewing enhanced Affordable Care Act subsidies. 
    • “Supporters of the subsidies insist the fight isn’t over. But prospects of a bipartisan deal remain slim, even as some lawmakers and people close to the Trump administration signaled that voter pressure could lead to a retroactive fix when Congress reconvenes in the new year.
    • “I’m not ruling anything out,” Senate Majority Leader John Thune (R., S.D.) told reporters Thursday.”  
  • Modern Healthcare adds,
    • “Health insurance exchange shoppers facing huge premium hikes are scrambling for deals during this sign-up season.
    • “Insurance brokers report high interest in bottom-tier, lower-cost Bronze plans, policies only available outside the exchanges and alternatives such as short-term plans. Some of those consumers are downgrading from Silver or higher amid skyrocketing prices tied to the expiration of enhanced subsidies at the end of the year.
    • “Yet enrollment in Affordable Care Act of 2010 plans was outpacing last year as of Dec. 5, when sign-ups reached 5.8 million, a 7% increase from the same period in 2024, the Centers for Medicare and Medicaid Services reported. Notably, 950,000 enrollees were new to the exchanges. Open enrollment began Nov. 1 and runs until Jan. 15 in most states, although Monday was the last day to choose a plan that would be in place on Jan. 1.
    • ​“All of the attention that has been paid to the market has actually helped enrollment,” said Wesley Sanders, founder and principal consultant at the health insurance consulting firm Evensun Health.” 
  • Govexec informs us,
    • “President Trump on Thursday issued an executive order implementing his plan to provide civilian federal workers with a 1% across-the-board pay raise next month.
    • “As first proposed in August, the increase is entirely being applied to buttress federal workers’ basic pay, with no changes to locality pay rates coming next year. Though the White House skipped outlining its pay raise plans as part of its annual budget proposal, officials initially planned on issuing a pay freeze for 2026. * * *
    • “The administration published pay tables outlining the 2025 pay raise across the General Schedule, along with tables for VA health workers, senior executives, and military service members on the White House website.”
    • [The executive order further states “Additionally, the Director of the Office of Personnel Management (Director) is directed to assess whether to provide up to a total increase of 3.8 percent (inclusive of the increase provided under Section 1) to the rates of pay of certain Federal civilian law enforcement personnel, as determined by the Director following coordination with agencies and consistent with 5 U.S.C. 5305.”}
  • and
    • “President Donald Trump in an executive order on Thursday gave the federal workforce a holiday on Dec. 24 and 26. Because Christmas falls on a Thursday this year, this provides government workers with a five-day weekend. 
    • “According to the directive, agency heads can require certain offices to remain open on either day due to national security, defense or other public need.” 
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services announced Dec. 18 that it will launch a voluntary payment model designed to broadly reach more health care providers who have not joined accountable care organizations, including those with specialized patient populations and others such as small, independent or rural-based practices. The Long-term Enhanced ACO Design Model will begin Jan. 1, 2027, and continue for 10 years. CMS said ACOs can apply for participation in March following the release of a request for applications.”
  • and
    • “The Department of Health and Human Services Dec. 18 announced three regulatory actions related to the practice of “sex-rejecting procedures” on children.
    • “The Centers for Medicare & Medicaid Services issued a proposed rule that would prohibit hospitals participating in the Medicare and Medicaid programs from performing SRPs on individuals under 18 years of age. The proposed condition of participation defines SRPs as “any pharmaceutical or surgical intervention that attempts to align an individual’s physical appearance or body with an asserted identity that differs from the individual’s sex …” and would include procedures that would intentionally disrupt, suppress or alter the development of an individual’s biological functions, physical appearance or body. The proposed rule provides exceptions for the treatment of an individual with a verifiable disorder of sexual development, for uses other than attempting to align an individual’s physical appearance or body with an identity other than the individual’s sex, or to treat complications arising from, or exacerbated by, previous performance of an SRP. The proposed rule did not specify how the proposed prohibitions would be enforced.
    • “Separately, CMS published a proposed rule that would prohibit states from receiving federal matching funds for SRPs provided to Medicaid and separate Children’s Health Insurance Program beneficiaries under the age of 19. CMS notes that these proposed changes would not prevent states from providing coverage for SRPs with state-only funds. The exceptions outlined in the COP proposed rule are also applied to the Medicaid/CHIP rule.
    • “Comments on the proposed rules are due Feb. 16.
    • “HHS’ Office for Civil Rights also proposed to revise its regulations implementing Section 504 of the Rehabilitation Act of 1973 to clarify that the definitions of “disability” and “individual with a disability” exclude “gender dysphoria” not resulting from physical impairments. Comments on HHS OCR’s rule are due Jan. 20.”
  • Per Healthcare Dive,
    • “The Federation of American Hospitals has tapped Charlene MacDonald as its next CEO, the for-profit hospital association said Tuesday.
    • “MacDonald is succeeding Chip Kahn, who announced his retirement earlier this year. Kahn is stepping down after almost 25 years at the helm of the FAH.
    • “MacDonald previously led the FAH’s lobbying, public affairs and communications efforts, and oversaw its finance and operations teams. She’ll start as CEO on Jan. 1.”

From the Food and Drug Administration front,

  • BioPharma Dive lets us know,
    • “Eli Lilly’s experimental obesity pill orforglipron helped people maintain their weight following a 72-week course of the GLP-1 shots Zepbound or Wegovy in a Phase 3 clinical trial, opening up a potential new use for drugs of its kind.
    • “People taking orforglipron after Wegovy gained less than one kilogram over the span of a year, while those who got Zepbound regained five kilograms. Both ended up at the same average at the end of the study period, however, and placebo recipients regained more than nine kilograms before being offered “rescue” orforglipron.
    • ‘Lilly also said it has officially asked the Food and Drug Administration to approve orforglipron. The pill was awarded one of the FDA’s new “national priority” vouchers, making a decision likely within weeks rather than the standard six to 10 months.”
  • Fierce Pharma reports,
    • “A year after an FDA rejection, Johnson & Johnson has won approval for a more convenient version of its lung cancer drug Rybrevant to better challenge AstraZeneca’s Tagrisso.
    • “Rybrevant Faspro, a subcutaneous formulation of Rybrevant, is now cleared in the same indications as the original intravenous infusion, including its use alongside J&J’s Lazcluze for the first-line treatment of EGFR-mutated metastatic non-small cell lung cancer (NSCLC).
    • “Compared with the original Rybrevant, the under-the-skin version reduces the antibody drug’s administration time from several hours to about five minutes, which J&J suggests is more convenient for patients and less burdensome for healthcare resources.
    • “This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment,” Joelle Fathi, chief healthcare delivery officer at GO2 for Lung Cancer, a patient support group, said in a Dec. 17 statement.”
  • MedTech Dive points out,
    • “Pulse Biosciences said Thursday it got the Food and Drug Administration’s go-ahead to begin an investigational device exemption study of its cardiac catheter ablation system to treat drug-resistant paroxysmal, or intermittent, atrial fibrillation.
    • “The company has developed technology that delivers nanosecond electrical pulses to treat the heart rhythm condition. Nanosecond pulses are briefer in duration than the microsecond pulses used in other pulsed field ablation systems, which could offer advantages. The Pulse Biosciences catheter is designed to deliver a complete lesion in a single energy application.
    • “Pulse Biosciences will evaluate the safety and effectiveness of its nPulse ablation catheter in the single-arm, multicenter NANOPULSE-AF study.:
  • and
    • “CMR Surgical said Tuesday it received 510(k) clearance from the Food and Drug Administration for its next-generation robotic system to perform gallbladder removal procedures.
    • “The Cambridge, England-based company said more than 40,000 surgical procedures have been completed with its robotic platforms outside of the U.S., across multiple specialties and care settings.
    • “CMR said it is on track to begin launching the new system, called Versius Plus, in the U.S. in 2026.”

From the judicial front,

  • ABC News reports,
    • “The evidence suppression hearing in the case against accused CEO killer Luigi Mangione concluded Thursday after the defense signaled it would call no witnesses.
    • “The defense rests,” defense attorney Karen Agnifilo said after prosecutors indicated they, too, rested.
    • “The nine-day hearing will determine what evidence will be used against Mangione when he goes on trial on charges of gunning down UnitedHealthcare CEO Brian Thompson on a Manhattan sidewalk last year.
    • “New York Judge Gregory Carro gave the defense until Jan. 29 to make its final argument about the evidence in writing.  Prosecutors have until March 5.  The defense then has two weeks after that to submit a reply.
    • “Carro said he expected to issue his decision about what, if any, evidence to exclude on May 18, at which point he would also set a date for trial.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The Los Angeles wildfires of nearly a year ago took an unexpectedly heavy toll on residents’ health, a new study found. 
    • “An unusually large number of people suffered from heart attacks, lung conditions and a perplexing rise in unexplained illnesses, according to an analysis by researchers of emergency-department data at Cedars-Sinai, the largest hospital in Los Angeles County. 
    • “Their findings offer clues into the potential cost to human health of massive wildfires that spread quickly from wild lands into urban areas, said Dr. Susan Cheng, vice chair for research affairs at Cedars-Sinai’s Smidt Heart Institute and senior author of the study.
    • “Such wildfires are increasing in frequency and scope, and release heavy metals and other toxins into the air as they engulf homes and cars. 
    • “You have a much greater magnitude and a much greater complexity of toxins being produced by the disaster affecting a very large, large population of people,” she said.” 
  • NBC News relates,
    • “As of Dec. 6, the Centers for Disease Control and Prevention had logged 26,632 cases of whooping cough in 2025. The last time the U.S. saw so many cases was more than a decade ago, in 2014, according to CDC data.
    • “But an NBC News/Stanford University investigation has found that DTaP vaccination rates are plummeting across the country, as part of a larger, troubling trend of growing vaccine hesitancy that is fueling a resurgence of preventable diseases, including measles.”
  • Managed Healthcare Executive adds,
    • “While most (82%) primary care physicians (PCPs) in the United States understand the risk factors for shingles, far fewer (29%) are fully aware of current shingles vaccine recommendations, according to a recent study published in Human Vaccines and Immunotherapeutics. The study was sponsored by GSK, the manufacturer of the recombinant zoster vaccine (RZV).”
  • BioPharma Dive notes,
    • “An experimental drug Takeda acquired in a multibillion-dollar deal has succeeded in a pair of late-stage trials, positioning the company to seek clearance of a therapy it expects to become a future blockbuster.
    • “The therapy, known as zasocitinib, met its co-primary and top secondary objectives in two Phase 3 studies testing it against a placebo or Amgen’s Otezla in patients with plaque psoriasis. Without disclosing specifics, Takeda said Thursday that, after four months, zasocitinib demonstrated “superiority” on both top study goals, which involved meaningfully reducing disease severity on two different measures. Respiratory tract infections, colds and acne were the most common side effects, according to the company.
    • “Takeda will provide detailed results at an upcoming medical meeting and intends to file for approvals in the U.S. and elsewhere during its 2026 fiscal year. Zasocitinib is also being evaluated in multiple other indications, as well as in a head-to-head study testing it against Bristol Myers Squibb’s similar, rival drug Sotyktu.”
  • and
    • “A streak of positive news that pushed Insmed into the ranks of the most valuable biotechnology companies ended this week with the announcement of a failed clinical trial.
    • “The company’s share price dropped almost 17% to about $165 early Thursday, following the announcement late Wednesday. The stock, which was worth around $25 a year and a half ago, had vaulted above $200 in trading this week.
    • “The Phase 2b study focused on a drug called brensocatib, which Insmed already sells under the brand name Brinsupri to treat a lung disease known as non-cystic fibrosis bronchiectasis. The company had hoped to expand use of the medicine to include a chronic nasal condition, but researchers found no benefit for either of the two doses they tested.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “All community pharmacies in Optum Rx’s network have transitioned over to a cost-based reimbursement model as the massive pharmacy benefit manager tries to reduce variation in how pharmacies are paid.
    • “Optum Rx first launched the model across roughly 1,400 community pharmacies in March. Now, the PBM, which is owned by healthcare conglomerate UnitedHealth, has notched agreements with three additional pharmacy services administration organizations representing more than 17,000 community pharmacies to transition them to cost-based contracts, Optum Rx said Thursday.
    • “Optum Rx aims to move all of its pharmacy partners to the new model, which should result in pharmacies being paid more for brand-name drugs and less for generics, by January 2028. The PBM is still working on those owned by retail chains and grocers, a network contracting executive said.”
  • Beckers Payer Issues tells us,
    • “UnitedHealthcare is delaying a coverage policy that would have sharply restricted remote physiologic monitoring services for most chronic conditions.
    • “The policy, which had been scheduled to take effect Jan. 1, will now be implemented later next year, the insurer confirmed to Becker’s.
    • “After listening to feedback from care providers, medical societies and other stakeholders, we are postponing the Remote Physiologic Monitoring (RPM) policy scheduled to take effect on Jan. 1, 2026. We still intend to implement this policy in 2026 and will share an updated timeline once it is finalized,” a UnitedHealthcare spokesperson said.”
  • BioPharma Dive notes,
    • “Moderna said Thursday its experimental bird flu vaccine, which was cut from federal funding earlier this year, will receive up to $54.3 million from a global coalition to advance the candidate.
    • “The Coalition for Epidemic Preparedness Innovations, or CEPI, a public-private global partnership working to develop vaccines against pandemics, agreed to fund Moderna’s candidate mRNA-1018 against H5 avian influenza into Phase 3 testing. As part of the agreement, if the shot is approved and in the event of an influenza pandemic, Moderna will allocate 20% of its production capacity for low- and middle-income countries, “at affordable pricing.”
    • “Under the Biden administration, the experimental vaccine was awarded over $700 million in government contracts from the Biomedical Advanced Research and Development Authority, or BARDA. Those contracts were later canceled by the Department of Health and Human Services under Secretary Robert F. Kennedy Jr., a major critic of messenger RNA technology.”
  • MedTech Dive relates,
    • “Editor’s note: This is the fourth article in a series of stories profiling medtech companies that are changing the field of robotic surgery. You can read the first three stories here, here and here.
    • “XCath is developing a robot-assisted approach to brain aneurysm treatment that could bring greater precision to procedures and enable more physicians to perform them.
    • “A cerebral aneurysm is a bulge in a weakened area of an artery in the brain. To prevent a life-threatening rupture of the vessel wall, endovascular interventions that access the aneurysm from inside the artery are increasingly preferred over traditional open surgery.
    • “While less invasive than open surgical repair, the intricate procedures are not free from complications and require significant technical skills to perform. A global shortage of neurointerventionists with expertise to perform the procedures has raised concerns about limited patient accessto critical stroke care.
    • “XCath, a Houston-based startup, is working on a robotic system that it expects to standardize endovascular brain aneurysm treatment. The goal is to facilitate consistent performance among a wider field of physicians, minimize complications and improve clinical outcomes.”

Monday report

David Ermer–CDC, CMS, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News informs us,
    • “Approximately 950,000 consumers who currently do not have health insurance coverage through the federally facilitated Health Insurance Marketplace have signed up for a 2026 health plan, the Centers for Medicare & Medicaid Services announced Dec. 5. More than 4.8 million returning consumers have selected 2026 plans. The open enrollment period began Nov. 1 and continues through Jan. 15. Today is the final day for consumers to enroll in coverage that would begin Jan. 1. For those enrolling after Dec. 15, coverage would begin Feb. 1.”
  • and
    • “The Centers for Medicare & Medicaid Services Dec. 15 published the Measures Under Consideration List for 2025. These are measures that CMS is considering adopting through the federal rulemaking process for use in Medicare programs. This year’s list comprises 24 unique measures, with some under consideration for multiple CMS programs and others already in use but undergoing substantial change to their specifications. Notably, several measures address topics consistent with the Department of Health and Human Services’ Make America Health Again priority framework, such as chronic illness and nutrition, and all 24 measures rely on data submissions using at least one digital source. In addition, CMS is promoting the early review of five measures that align with the MAHA initiative and are currently in the development stage. 
    • “CMS will convene a consensus-based multidisciplinary group, on which the AHA sits, to provide recommendations to the agency on these measures by Feb. 1. In addition, CMS will seek input through public comments from Dec. 16 through Jan. 6.” 
  • Per a CMS fact sheet,
    • “All seven of CMS’ A/B Medicare Administrative Contractors (MACs) will issue updated Final Local Coverage Determinations (LCDs) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers that will be effective January 1, 2026.”
  • Per HHS news releases,
    • “Ralph Abraham, M.D., was sworn in today as Principal Deputy Director of the Centers for Disease Control and Prevention (CDC) by Health and Human Services Secretary Robert F. Kennedy, Jr. He will begin his duties at CDC headquarters in Atlanta on January 5, 2026.
    • “Dr. Abraham has nearly 30 years of experience as a medical practitioner, most recently as Surgeon General of the state of Louisiana. As CDC Principal Deputy Director, he will help realign the agency with its mission as America’s frontline defender against infectious disease.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today convened Lyme disease patients, clinicians, and researchers for a roundtable on diagnostics and clinical needs moderated by HHS Secretary Robert F. Kennedy, Jr. The event fulfills commitments made in the Make America Healthy Again Commission Strategy Report [PDF, 21.85 MB] to address chronic and often unseen illnesses that affect millions of Americans.
    • “For decades, Americans suffering from Lyme disease have been denied the accurate diagnostics and meaningful care they deserve,” said Secretary Kennedy. “Today’s actions push us decisively toward reliable testing and treatment grounded in the real-world experiences of patients. We are committed to delivering the tools that families have waited far too long to receive.”
    • “Participants shared their experiences and recommendations on improving care and advancing research. Senator Susan Collins (R-ME) and Representatives Morgan Griffith (R-VA) and Chris Smith (R-NJ) also engaged in the discussions.
    • “As part of today’s event, HHS announced the renewal of the LymeX Innovation Accelerator with the Steven & Alexandra Cohen Foundation that began during President Trump’s first term. Established in 2020, LymeX is the largest public-private partnership ever built to improve Lyme disease diagnostics and care. The $10 million initiative will advance artificial intelligence tools that support earlier and more accurate detection across stages of infection.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM), in coordination with the Office of Management and Budget (OMB), the General Services Administration (GSA), the White House Office of Science Technology and Policy (OSTP), and agency leaders across the administration, today announced the establishment of the United States Tech Force (Tech Force)– a new, cross-government program to recruit top technologists to modernize the federal government.” * * *
    • “OPM is proud to announce the initial private sector partners for Tech Force: Adobe, Amazon Web Services, AMD, Anduril, Apple, Box, C3.ai, Coinbase, Databricks, Dell Technologies, Docusign, Google Public Sector, IBM, Meta, Microsoft, Nvidia, OpenAI, Oracle, Palantir, Robinhood, Salesforce, SAP, ServiceNow, Snowflake, Synopsys, Uber, Workday, xAI, and Zoom. OPM welcomes the opportunity to expand this list of partners over time.
    • “In addition, Tech Force is partnering with NobleReach Foundation – a nonpartisan talent platform that brings together America’s best and brightest across industry, academia, and government via initiatives such as its NobleReach Scholars Program – to recruit technologists and support the program.
    • “Read more of what government and tech world leaders have to say about Tech Force here.
    • “For further information, please see OPM’s memo to agencies here. To learn more or apply for Tech Force and for FAQ’s visit TechForce.gov. And follow US Tech Force on X.”  

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. In new guidance for certain types of medical device submissions, the agency states it will accept RWE without requiring that identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission. The FDA similarly intends to consider updating its guidance for drugs and biologics.”
  • and
    • “The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation, especially for recalls involving foods for our country’s most vulnerable populations –infants and young children. Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. These warning letters highlight a concerning problem with recall effectiveness at the retail level. Last year, the FDA sent a similar warning letter to a retailer who failed to adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves.”
  • Fierce Pharma reports,
    • “Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has given Milestone Pharmaceuticals its first FDA approval in its 22-year history.
    • “The U.S. regulator has signed off on Cardamyst (etripamil) to quell symptomatic episodes from paroxysmal supraventricular tachycardia (PSVT), which is a type of abnormal heart rhythm. Cardamyst becomes the first self-administered treatment patients can use to manage their PSVT symptoms.
    • “The calcium channel blocker is a convenient alternative to an emergency room visit, where patients receive an intravenous dose of a drug that “basically reboots your heart,” Milestone CEO Joe Oliveto said in an interview.
  • and
    • “LIB Therapeutics has scored an FDA approval for its cholesterol-lowering, third-generation PCSK9 inhibitor, lerodalcibep-liga.
    • “The injected treatment, which will carry the commercial name Lerochol, is approved to be used along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
    • “Lerochol arrives on the market with a convenience edge over other PCSK9 drugs, as it is self-administered once monthly and doesn’t need refrigeration because it retains its stability for up to three months at room temperature. By comparison, Amgen’s Repatha and Sanofi and Regeneron’s Praluent are dosed between every two to four weeks, depending on patient needs, and have a shorter shelf life at room temperature.”
  • and
    • “Johnson & Johnson’s Akeega is opening new fronts in prostate cancer treatment with a fresh FDA approval, making it the first precision medicine combo for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
    • “Akeega, a dual-action tablet made up of J&J’s androgen-directed prostate cancer med Zytiga (abiraterone acetate) and the PARP inhibitor niraparib—sold by GSK as Zejula in other indications—is added to corticosteroid medication prednisone to delay disease progression of the aggressive form of prostate cancer.  
    • “J&J’s Amplitude study was the first showing that a PARP inhibitor-androgen receptor pathway inhibitor treatment combination could delay both radiographic and symptomatic disease progression in the disease type, Dana-Farber Cancer Institute’s Bradley McGregor, M.D., noted in a company press release.“
  • and
    • “The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority Voucher pilot (CNPV), the agency said Monday.
    • “The voucher was granted to J&J for its proposed combination of Tecvayli and Darzalex for previously treated multiple myeloma.
    • “With the voucher, the FDA aims to deliver a decision within one to two months following submission of an application. Normally, FDA drug reviews take up to 10 months, starting from the acceptance of an application.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A new drug has been saturating the fentanyl supply in Philadelphia and moving to other cities throughout the East and Midwestern United States: medetomidine, a powerful veterinary sedative that causes almost instantaneous blackouts and, if not used every few hours, brings on life-threatening withdrawal symptoms.
    • “It has created a new type of drug crisis — one that is occasioned not by overdosing on the drug, but by withdrawing from it.
    • “Since the middle of last year, Philadelphia’s hospitals have been strained by patients coming in with what doctors have identified as medetomidine withdrawal. Although the heart rate slows drastically right after use, in withdrawal the opposite occurs: The heart rate and blood pressure become catastrophically high. Patients experience tremors and unstoppable vomiting. Many require intensive care.”
  • The Wall Street Journal relates,
    • “People susceptible to developing heart issues benefit the most from reducing their consumption of saturated fats, according to a review of research that comes as the federal government prepares to revise dietary recommendations.
    • ‘A paper published Monday in the Annals of Internal Medicine found that people at high risk of developing cardiovascular problems saw a reduction in major health issues including heart attack and stroke when they cut back on saturated fats. The picture was different for people without those same cardiovascular risks. Within five years, cutting saturated fats didn’t yield the same benefits for that group, the review said.”
  • The Washington Post tells us,
    • “Why some people experience long-lasting physical and mental effects from covid-19 could be linked to chronic inflammation, according to new research that experts say could help develop new treatments for the confounding condition that continues to afflict millions.
    • “Some early research on the condition has suggested that long covid’s symptoms linger because the virus persists in people’s bodies. But the new study published Friday in Nature Immunology found that people with long covid had activated immune defenses and heightened inflammatory responses for more than six months after initial infection compared with those who fully recovered.
    • “The latest research “leads to a hypothesis that there might be therapeutic targets related to inflammation that might be worth exploring in clinical studies,” said Dan Barouch, the study’s lead author and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.
    • “The study’s findings signal progress in understanding a condition that is estimated to affect more than 400 million individuals around the world as the coronavirus continues to infect people every day, said Ziyad Al-Aly, a clinical epidemiologist at Washington University in St. Louis who studies long covid. There are no drugs approved for treatment of long covid, leaving doctors to tackle individual symptoms with various therapies.”
  • The American Medical Association lets us know “What doctors wish parents knew about fall prevention for kids.
    • “Rabia Nagda, MD, of Texas Children’s Pediatrics, emphasizes that every environment where kids spend time should be built with fall risk in mind.”
  • Per MedPage Today,
    • “Cannabis use in pregnancy is associated with health risks including preeclampsia and low birthweight.
    • “In this secret shopper study, one in five cannabis retailers told callers that cannabis use was safe in pregnancy.
    • “The findings support a need for more public education about the risks of prenatal cannabis use and for guidance to discuss its use with physicians.”
  • Per Health Day,
    • “‘Dual use’ of vaping and smoking might help smokers cut back or quit.
    • “Smokers who also vaped were 4.5 times more likely to quit within a year.
    • “Dual users were also more likely to cut their smoking by half.”
  • and
    • “People could learn within 15 minutes whether they are infected with hepatitis C, thanks to a rapid test developed by Northwestern University.
    • “The test will allow doctors to diagnose infections during an office visit and kickstart patients’ treatment before they leave, researchers said.
    • “This test could revolutionize HCV care in the U.S. and globally by dramatically improving diagnosis, accelerating treatment uptake and enabling more people to be cured faster,” researcher Dr. Claudia Hawkins said in a news release. She’s director of Northwestern’s Institute for Global Health’s Center for Global Communicable and Emerging Infectious Diseases in Chicago.”
  • STAT News reports,
    • “Gene therapy researchers were converging on a holy grail. A few years ago, researchers at labs and companies reported they had engineered viruses that could ferry corrective genes deep into the brain, giving potential entry to a new world of treatments for Alzheimer’s, Parkinson’s, and a slew of rare genetic diseases.
    • “This summer, after years of careful study, the first person underwent gene therapy using one of the new viruses. The patient, a young child, died two and a half days later.
    • “The death has sent concern and uncertainty rippling through labs and companies developing gene therapies for the brain, along with rare disease groups who hoped these tools could deliver long-sought cures. They worry that Capsida Biotherapeutics unearthed a broader risk for other viruses designed to travel like a messenger pigeon to our brains, one that could derail years of progress. 
    • “Capsida has declined to answer questions about the death beyond a brief statement. Its CEO has departed. The information that has leaked out is troubling. The child died of cerebral edema — brain swelling — a clinical course distinct from other deaths tied to gene therapy over the last decade, according to a person familiar with the matter.
    • “Most disturbingly, none of the animal and lab studies Capsida presented indicated such a calamity was possible, making it unclear how other researchers and companies would test for such a risk.” * * *
    • “The best path ahead may be to start new trials in very low doses. But that’s challenging in gene therapy, where patients can only ever receive one dose of a virus in their lifetime, before they develop immunity to it. Still, “we may have to be a bit more conservative,” said Miguel Sena-Esteves, a gene therapy researcher at the UMass Chan Medical School 
    • “Alternatively, companies may have to move forward first in diseases otherwise immediately fatal, where the risk-benefit calculus shifts dramatically. The prion disease that shadows Sonia Vallabh, a researcher at the Broad Institute, is one. 
    • “Whichever way it goes, the gene therapy field has lost the assurance — already tenuous — that tests in animals can predict the toxicities for us. 
    • “In some way,” Vallabh said, “our only safety species is humans.”
  • The Wall Street Journal adds,
    • “Sanofi said its tolebrutinib drug candidate didn’t meet the primary goal in a late-stage clinical trial for multiple sclerosis. It separately said talks with the U.S. Food and Drug Administration had indicated a regulatory review for tolebrutinib in a different form of the disease would take longer than previously expected.
    • “The updates deal a blow to one of the most advanced drugs in Sanofi’s pipeline as the company seeks to move past recent disappointments in clinical trials. Sanofi has turned to dealmaking this year, using funds raised from the sale of a controlling stake in its consumer-healthcare business to replenish its pipeline.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark released its third quarter earnings report on Monday, where its top brass said the insurer expects to see elevated utilization trends persist into 2026.
    • “The Pittsburgh-based organization, which includes Highmark Health Plans and health system Allegheny Health Network, reported a $69 million net loss and a $204 million operating loss alongside $24.6 billion in revenue through the first nine months of 2025. The bulk of that loss came from the health insurance unit, which is continuing to be pressured by care use.
    • “Carl Daley, chief financial officer and treasurer at Highmark Health, told Fierce Healthcare that the company had expected utilization to normalize over the course of the year, and priced plans accordingly. It’s made adjustments in its pricing strategy for 2026 to adapt to the expectation that utilization remains high.”
  • MedTech Dive tells us,
    • “Philips has agreed to acquire SpectraWAVE, a firm making tools to help diagnose and guide treatment of coronary artery disease, the companies announced Monday. They did not disclose the terms of the deal.
    • “SpectraWAVE makes an intravascular imaging system for the coronary arteries. The Bedford, Massachusetts-based company also makes an AI-enabled solution that calculates fractional flow reserve from a single coronary angiogram to support treatment decisions. 
    • “Philips expects the acquisition will expand its portfolio of intravascular imaging and physiological assessment devices. CEO Roy Jakobs said in a statement that the company is “doubling down on image-guided therapy” and expanding its coronary intervention portfolio with the planned purchase.”
  • Cardiovascular Business adds,
    • “Ambulatory surgical centers (ASCs) and office-based labs (OBLs) are poised to play a growing role in cardiovascular care as payment policies shift and health systems look for more efficient ways to manage procedural volume. That trend, and the guardrails needed to ensure patient safety, was the focus of an educational session at TCT 2025 in San Francisco. 
    • “Cardiovascular Business spoke with one of the presenters, Arnold Seto, MD, cath lab director at the Long Beach VA Medical Center, professor of medicine at Charles Drew University, Society for Cardiovascular Angiography and Interventions (SCAI) treasurer and chair of the SCAI Advocacy Committee, to find out more.
    • “Seto said there is wide expectation that lower-acuity interventional cardiology and peripheral procedures will migrate into the ASC environment. This is partly due to better cost effectiveness and the fact that larger centers want to expand into more complex and structural heart procedures without building out their hospital cath labs to be bigger.
    • “The consultants tell us that as many as 25% to 50% of cardiology procedures will be migrating to the ASC environment. The government would prefer that because they pay about two-thirds of the hospital outpatient costs compared with an ASC reimbursement,” he said. He added that the Center of Medicare and Medicaid Services (CMS) is clearly signaling interest in this shift. “We’ve already seen CMS effectively remove all the PCI codes from the inpatient only list, and actually talk about removing everything from the inpatient only list.”
  • Per a Leapfrog news release,
    • “Today, The Leapfrog Group, a national watchdog organization of employers and other purchasers focused on health care safety and quality, announced the 2025 recipients for their elite annual Top Hospital Award and Top Ambulatory Surgery Center (ASC) Award. This national recognition is one of the most competitive honors U.S. hospitals and surgery centers can earn for excellence in patient safety and quality of care. Selected hospitals and ASCs will be celebrated today as part of Leapfrog’s 2025 Annual Meeting and Awards Dinner.” * * *
    • “The award honors hospitals and ASCs that demonstrate the highest performance in the nation on quality and patient safety, including ethical billing and informed patient consent procedures, lower infection rates, prevention of medication errors and surgical safety. To see the full methodology and list of institutions honored as 2025 Top Hospitals, please visit www.leapfroggroup.org/tophospitals. To see the full list of institutions honored as 2025 Top ASCs, please visit www.leapfroggroup.org/ratings-report/top-ascs.” 
  • Genetic Engineering and Biotechnology News points out,
    • “As Eli Lilly (NYSE: LLY) and Novo Nordisk (Nasdaq Copenhagen: NOVO-B) scramble to bring an oral glucagon-like peptide 1 (GLP-1) receptor agonist to market for obesity, a much smaller potential rival spotlighted positive mid-stage clinical data that captivated investors enough to send its share price more than doubling this past week.
    • “Structure Therapeutics (NASDAQ: GPCR) shares soared 102% after it reported positive data from its Phase II ACCESS clinical program assessing its oral GLP-1 candidate aleniglipron in people with obesity and/or overweight with at least one weight-related co-morbidity. Aleniglipron (formerly GSBR-1290) is designed to be a biased G protein-coupled receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway.”
    • “If approved, Structure would compete with oral GLP-1s for weight management by the leading obesity drug developers, whose candidates could both win FDA approval in the new year.”
  • MedCity News notes,
    • “This Year’s Hottest Healthcare Company Isn’t Even a Healthcare Company
    • “Nvidia has quietly become one of the most influential players in healthcare technology by supplying the accelerated computing and AI infrastructure that powers everything from imaging to drug discovery. The company’s restraint — focusing on enabling the ecosystem rather than owning it — has helped cement its role as the indispensable backbone of the healthcare industry’s AI transformation.”

Weekend update

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

From Washington, DC,

  • Roll Call lets us know,
    • “The last week of the congressional session before Christmas could feature a flurry of activity on unfinished business for both the House and Senate, from spending bills and health care costs to nominations.
    • “House Republican leaders released draft legislation Friday afternoon consisting of a package of health proposals aimed at reducing health care costs in 2026, aiming to lay down a marker ahead of the midterm election year as Democrats continue to hammer them over the pending expiration of Affordable Care Act premium tax credits.
    • “The House Rules Committee is scheduled to meet Tuesday afternoon to consider the GOP bill for floor action.” * * *
    • “Senate Majority Leader John Thune, R-S.D., has set up a busy getaway week, having last week filed multiple motions to limit debate on various measures. First on the Senate floor agenda is the final House-Senate agreement on the fiscal 2026 National Defense Authorization Act, with a cloture vote scheduled for 5:30 p.m. Monday.”
    • “Beyond the NDAA, the other percolating legislative business is a much awaited agreement on a second package of fiscal 2026 appropriation bills. The objective remains to pass as many of the regular spending measures as possible before the current continuing appropriations law expires at the end of January. The Senate is scheduled to be out of session the week of Jan. 19. [Here is a link to the 2026 House of Representatives calendar.]
    • “President Donald Trump and Republicans in the Senate are set up for a year-end victory on nominations, again taking advantage of the rules change the Senate GOP enacted earlier this year to allow expedited consideration of bundles of nominations through executive branch resolutions. A package on track for confirmation this week includes 97 nominations for roles across federal departments and agencies, with at least two additional individual nominees also slated for floor action.”
  • Per a House news release,
    • “On Wednesday, December 17, 2025, at 9:00 a.m. ET, the Committee on Oversight and Government Reform will hold a Member Day hearing. The hearing will convene in room HVC 210 of the U.S. Capitol Visitor Center. Members of Congress, regardless of Committee assignment, are invited to testify on issues within the Committee’s jurisdiction, including specific legislation or topics of importance to them, their district, and their constituents.”
  • STAT News reports,
    • “The federal government has sent a record $16 billion to health insurers that sell Medicare drug plans, a flashing red sign that prescription drug spending is blowing up far beyond what government officials and insurance experts had expected.” * * *
    • “Every year, Medicare looks at drug spending data and calculates whether the insurers’ drug plans, known as Part D plans, spent more or less than what they had projected at the start of the year. If insurers’ costs were more than expected, the government gives them an infusion to help subsidize the losses, known as reconciliation payments.
    • “The new $16 billion payout — which was for drug spending in 2024 — was by far the largest reconciliation payment since the Part D program went into effect in 2006, according to Medicare data. It was nearly four times more than the $4.3 billion that Part D plans got in 2023. The closest was $11.1 billion in 2014, when the Affordable Care Act was phasing out the so-called donut hole coverage gap in Part D plans.” * * *
    • “In November, the CBO called for more research into Part D spending “to help explain the unexpected growth in costs.” The group wants to understand if the changes to things like the out-of-pocket cap are driving more people to fill prescriptions if they know their financial exposure is limited.” 
  • MedTech Dive tells us,
    • “The Food and Drug Administration has created a pathway for unauthorized digital health devices to access a new Medicare payment option.
    • “In a policy published last week, the FDA said it will consider waiving typical market access rules for companies that want to join a new Centers for Medicare and Medicaid Services program.
    • ‘The pathway could enable device developers to collect data through real-world use in the CMS’ Advancing Chronic Care with Effective, Scalable Solutions, or ACCESS, program.”
  • Per a National Science Foundation news release,
    • “The U.S. National Science Foundation Directorate for Technology, Innovation and Partnerships (NSF TIP) on Friday announced the launch of a new initiative designed to launch and scale a new generation of independent research organizations. These organizations will focus on technical challenges and bottlenecks that traditional university and industry labs cannot easily solve on their own. NSF seeks feedback on this initiative through a Request for Information (RFI).
    • “As scientific challenges have become more complex and dependent upon the work of cross-disciplinary teams of experts, our nation must expand its scientific funding toolkit to adapt,” said Erwin Gianchandani, NSF TIP Assistant Director. “Tech Labs will provide entrepreneurial teams of proven scientists the freedom and flexibility to pursue breakthrough science at breakneck speed, without needing to frequently stop and apply for additional grant funding with each new idea or development.” * * *
    • “To learn more, read the RFI and plan to join a webinar on Wednesday, Dec. 17, 2025, at 11 a.m. EST. Please register in advance for the webinar.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Flu hospitalizations are at the third-highest level seen at this point in the season in 15 years, according to the CDC’s latest FluView report [released December 11, 2025].
    • “The cumulative flu hospitalization rate for the week ending Dec. 6 reached 6.9 per 100,000, ranking third highest for week 49 since the 2010–11 flu season. Only the 2022–23 season (36.1) and 2023–24 season (9.5) reported higher rates at this point. Meanwhile, the weekly flu hospitalization rate increased to 2.2 per 100,000, up from 1.7 the week prior.”
  • The New York Times explains what menopause does to a woman’s body from head to toe.
  • MedPage Today adds,
    • “Menopausal hormone therapy (MHT) did not increase breast cancer risk in women with BRCA mutations, according to a study reported here.
    • “In fact, women who used estrogen-only MHT had a significantly lower risk of breast cancer compared with a matched cohort of women who did not use MHT (42.% vs 24.9%). An analysis of different types of estrogen showed either a lower risk of breast cancer or no effect. MHT that included estrogen and progesterone had no effect on breast cancer risk.
    • “The findings added to a growing body of literature showing the safety of MHT, reported Joanne Kotsopoulos, PhD, of Women’s College Hospital and the University of Toronto, at the San Antonio Breast Cancer Symposium. 
  • Medscape tells us,
    • “Semaglutide, a GLP-1 receptor agonist (RA), was associated with a significantly lower risk for adult-onset epilepsy in patients with diabetes than other glucose-lowering drugs (GLDs). Notably, this risk reduction appeared largely independent of improvements in glycemic control or weight.
    • “Approved for type 2 diabetes and obesity management, semaglutide has shown neuroprotective effects in stroke and dementia, but these new findings suggest it may also have a unique neuroprotective mechanism specific to seizure prevention.
    • “If a patient has type two diabetes and a high risk or likelihood of a seizure disorder, it would be beneficial to consider using semaglutide with overall brain health in mind, not just for stroke prevention and cardiovascular health,” Yong Eun, MD, primary care attending, Department of Medicine, NYC Health, Columbia University, New York City, told Medscape Medical News.”

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

  • Fierce Healthcare explains “why health plans need to bridge the member trust gap to fully harness technology.”
  • Beckers Payer Issues summarizes “major payer acquisitions have closed or were announced in 2025. 
  • Beckers Hospital Review ranks twenty health systems by operating margins.
    • “As policy uncertainties, reimbursement pressures and continued cuts and closures weigh on hospitals and health systems heading into 2026, third-quarter operating margins showed wide variation. 
    • ‘Several systems, including UnityPoint, Montefiore Health System and Providence, reported operating losses or near-break-even results, while others, such as Allegheny Health Network, UPMC and Northwell Health, recorded only modest gains. On the stronger end, Tenet Healthcare led all systems with a 16.8% operating margin, followed by HCA Healthcare at 12.6% and Universal Health Services at 11.6%.”
  • Per HR Dive, “2026 may mean an extra biweekly pay period. This article explains how HR can prepare. The phenomenon occurs approximately every 11 to 12 years for affected employers, necessitating a 27th pay day.”

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S.healthcare business front,

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