FEHBlog

Midweek update

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

From Washington, DC

  • The American Hospital Association News reports,
    • “The House Budget Committee hosted a hearing Jan. 21 on health care affordability titled, “Reverse the Curse: Skyrocketing Health Care Costs and America’s Fiscal Future.”
  • The health subcommittee of the House Energy and Commerce Committee has posted the prepared testimony of the health insurance executives who will be testifying at tomorrow morning’s hearing.
  • The Health Care Cost Institute released a one pager explaining why healthcare has become unaffordable.
  • Healthcare Dive reports,
    • “Healthcare fraud settlements under the False Claims Act totaled over $5.7 billion for the 2025 fiscal year ended Sept. 30, the highest amount ever and more than triple last year’s total, the Department of Justice said Friday.
    • “The FCA settlements fueled $6.8 billion in total judgments across industries, the highest amount in a single year.
    • “In healthcare, settlements involved federal programs like Medicare, Medicaid and Tricare, the program for active and retired service members and their families. The Justice Department said it also expanded its enforcement in cases involving managed care, prescription drugs and medically unnecessary care.”
  • The AHA News informs us,
    • “The Centers for Medicare & Medicaid Services will host a webinar Feb. 11 at 2 p.m. ET on updated hospital price transparency requirements that were finalized in the hospital outpatient prospective payment system final rule for calendar year 2026. CMS will begin enforcement of the new and revised requirements April 1. During the webinar, the agency will review changes to the requirements, provide information on resources available to hospitals, and offer tips for ensuring that hospital machine-readable files conform to requirements finalized in the rule. Attendees with questions are advised to contact CMS at PriceTransparencyHospitalCharges@cms.hhs.gov.”
  • Healthexec observes,
    • “A study looking at healthcare pricing at Texas hospitals found that paying cash for services is typically a lot cheaper than the typical negotiated rate charged to insurance companies, calling into question the practicality of transparency regulations. 
    • “The research was conducted by market intelligence firm Trilliant Health, which based its analysis on reported rates coming from 327 hospitals in the state. Zooming in on 79 common procedures, the data revealed that four times out of five, the patients who paid cash received a discount larger than insurance companies were able to negotiate for reimbursement. 
    • “The federal government has pushed for transparency on service pricing. For example, a 2021 rule from the Centers for Medicare & Medicaid Services (CMS) that required the prices of “shoppable” services be prominently displayed. A machine-readable file containing all prices for common services—including cash and negotiated prices—also must be available. 
    • “However, the law does not standardize prices. Trilliant noted that healthcare is at odds with all other industries, because prices are locked into brackets determined by a person’s ability to pay, not the services themselves. So for those who are insured by their employer, costs will always be fundamentally different when compared to those paying strictly out of pocket.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first step to improve transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.”
  • STAT News reports,
    • “Bundling isn’t just for your streaming plans anymore. In radiology, new artificial intelligence tools are getting cleared by the Food and Drug Administration to check for multiple findings at once — sometimes more than a dozen in one go.
    • “On Wednesday, radiology AI company Aidoc announced the FDA has cleared a tool that can triage 14 critical findings in a single abdominal CT scan: liver injury, spleen injury, bowel obstruction, appendicitis, and more.” 

From the judicial front,

  • Modern Healthcare reports,
    • “Cigna may be on the verge of striking a deal with the Federal Trade Commission over allegations it artificially raised insulin prices.
    • “The FTC has suspended its administrative case against the Evernorth Health Services, Express Scripts and Ascent Health Services parent company while it considers a settlement, the FTC disclosed in a legal filing Tuesday.
    • “Attorneys for the agency and the company have “submitted a proposed consent agreement containing a proposed decision and order … that, if accepted by the commission, would resolve the claims against the [Cigna] respondents in their entirety,” FTC Secretary April Tabor wrote in the document.”

From the public health, medical and Rx research front,

  • Per a Centers for Disease Control and Prevention news release,
    • “Diabetes continues to affect millions of Americans and is among the major health threats facing the nation. New CDC data in the updated National Diabetes Statistics Report show:
      • “40.1 million people in the United States (12% of the population) have diabetes.
      • “11 million adults (more than 27% of adults with diabetes) are undiagnosed. 
      • “115.2 million adults (more than 43%) have prediabetes, and most don’t know they have it.
    • “The National Diabetes Statistics Report uses the latest technologies and methods to provide up-to-date data on the impact of diabetes and prediabetes. 
    • “It’s important that all people can take steps to prevent or delay type 2 diabetes and manage diabetes if they already have it.” 
  • Beckers Clinical Leadership points out,
    • “About a year after West Texas reported a large measles outbreak, South Carolina has the most measles cases of any U.S. state so far in 2026. 
    • “The state’s health department is counting 646 cases as of Jan. 20. Most cases are in Spartanburg County, a county in northwest South Carolina that is about 70 miles from Charlotte, N.C.
    • “This figure far surpasses the 145 cases reported in South Carolina by the CDC as of Jan. 13. Some jurisdictions report probable measles cases; however, the CDC only reports confirmed cases that jurisdictions have notified to CDC.” * * *
    • “South Carolina far exceeds other states, according to CDC data on confirmed measles cases. In 2026, eight other states have reported confirmed measles cases to the CDC: Utah with 14, Ohio (three), Florida (two), North Carolina (two), Oregon (two), Arizona (one), Georgia (one) and Virginia (one).” 
  • The AHA News notes,
    • “The American Red Cross Jan. 20 declared a severe blood shortage as the national blood supply fell approximately 35% within the last month. The organization is urging Americans to donate blood to alleviate the shortage. The current flu season and winter weather were cited as reasons for the decline.” 
  • Senior Living News relates,
    • “New research from Case Western Reserve University was recently heralded as a big step forward in the fight to not only slow but reverse the effects of Alzheimer’s Disease. Senior living memory care experts are encouraged by the results, but that there is still much left to be done to further that goal. 
    • “The study, published in December 2025 in Cell Reports Medicine, links Alzheimer’s progression to the brain’s inability to maintain healthy levels of NAD+, a molecule critical to cellular energy and resilience. In two studies, researchers restored NAD+ balances with an experimental compound that not only prevented further damage, but reversed disease characteristics.”
  • ‘The Washington Post offers “six daily habits to slow aging, from a Harvard brain expert. Harvard scientist Rudolph Tanzi shares his plan for brain health and aging well, including habits for sleep, stress and social interaction.” Check it out.
  • NBC News points out,
    • “Pregnant women’s exposure to wildfire smoke — particularly in the third trimester — may increase the risk of autism in their children, according to new research, which looked at hundreds of thousands of births in Southern California.
    • “The study, published Tuesday in the journal Environmental Science & Technology, is the first to examine a potential link between prenatal wildfire smoke exposure and autism. Earlier research has suggested that pregnant women’s exposure to air pollution more broadly, including smog spewed by vehicles, smoke stacks and lead, may be linked to the developmental disorder.”
  • Per Healio,
    • “Home-based self-sampling for squamous cell carcinoma of the anus could be a cost-effective way to increase screening among high-risk individuals.
    • “An evaluation of the randomized phase 2 Prevent Anal Cancer (PAC) Self-Swab Study showed higher screening rates for participants who sampled at home compared with those who went to a clinic. Each additional screen had a societal cost of approximately $25 and health care cost of about $130.
    • “Home-based screening promises to be a cost-effective option to enhance anal cancer screening participation,” Haluk Damgacioglu, PhD, assistant professor in the department of public health sciences in the College of Medicine at Medical University of South Carolina, and colleagues wrote.
    • “In addition, the lower [incremental cost-effectiveness ratio] from the societal perspective underscores the economic value of home-based screening by capturing time, travel and productivity costs associated with clinic-based screening.”
  • Per MedPage Today,
    • “Among kids with obstructive sleep-disordered breathing in a randomized trial, 29.5% had resolution of symptoms with an initial 6-week course of intranasal saline.
    • “For those with persistent symptoms, another 6 weeks of intranasal saline was as effective as switching to intranasal steroids.
    • “The researchers proposed that intranasal saline be used for 3 months before assessing the need for specialist referral for polysomnography and potential surgery.”
  • and
    • “A Finnish cohort study probed the long-term mortality, morbidity, recovery, and recurrence of stroke after maternal ischemic stroke.
    • “There was a greater risk of mortality after pregnancy-related stroke, particularly in the first year.
    • “Affected patients were also more prone to subsequent morbidities, though functional outcomes seemed good in the short and long term.”
  • Per BioPharma Dive,
    • “A regimen involving Moderna’s personalized cancer vaccine intismeran autogene and Merck & Co.’s immunotherapy Keytruda cut the risk of relapse or death in half over five years in study participants with melanoma when compared with Keytruda alone, the companies said Tuesday. Moderna and Merck reported three years ago that the Phase 2 study, which evaluated the vaccine-immunotherapy regimen after surgery, had met its primary endpoint. The partners have continued following trial enrollees to assess its impact on long-term health outcomes, though, and at the latest data check found that the shot maintained the survival benefit seen in 2023. The result is a “signal of durable tumor control,” wrote William Blair analyst Myles Minter. Moderna and Merck, which first partnered on cancer vaccines nearly 10 years ago, could announce Phase 3 results later this year. Merck paid Moderna $250 million to license intismeran autogene in 2022.”

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

  • The Wall Street Journal reports,
    • “Higher sales of drugs for cancer and autoimmune conditions more than offset the sales hit from a key drug patent loss and helped Johnson & Johnson JNJ -0.09%decrease; red down pointing trianglereport increased revenue and profit for the latest quarter.
    • “The New Brunswick, N.J., drug and medical-device maker also issued a forecast for the coming year that topped Wall Street expectations, despite the impact of tariffs and a recent deal with the Trump administration to cut some drug prices.
    • “J&J said Wednesday that net earnings rose 20.8% in the fourth quarter to $5.12 billion, or $2.10 a share, from $3.43 billion, or $1.41 a share, a year earlier. Adjusted to exclude certain items such as litigation costs, J&J earned $2.46 a share in the quarter, matching the mean estimate of analysts surveyed by Factset. 
    • “The company last year lost patent protection for one of its biggest-selling drugs, Stelara, a treatment for skin and gut conditions. Competitors introduced lower-cost versions of the drug, leading to sales declines for J&J’s. Stelara sales plunged nearly 48% for the fourth quarter.
    • “Yet strong sales growth for newer J&J drugs helped cushion the impact. Sales of Darzalex, a treatment for multiple myeloma, rose nearly 27% in the fourth quarter and sales of autoimmune drug Tremfya were up nearly 68%.”
  • Fierce Healthcare relates,
    • “In the past year, OpenEvidence, an AI-powered medical search engine, has seen breakneck growth, rapidly expanding its reach with doctors.
    • “OpenEvidence developed an AI-powered medical search engine and a generative AI chatbot exclusively for doctors that summarizes and simplifies evidence-based medical information.
    • “In December alone, the company claims it supported about 18 million clinical consultations from verified physicians in the U.S., up from about 3 million consultations per month a year ago. OpenEvidence is now actively used daily, on average, by more than 40% of physicians in the U.S., spanning more than 10,000 hospitals and medical centers nationwide, according to the company.” * * *
    • “The health tech company banked $250 million in series D funding to invest heavily in the R&D and compute costs associated with its multi-AI agentic architecture. OpenEvidence will also use the funding to continue to build out its content licensing partnerships.
    • “The lion’s share is training new models, training the next generation of digital intelligence, and compute costs,” Daniel Nadler, founder and CEO of OpenEvidence, told Fierce Healthcare.
    • “The series D round doubled its valuation to $12 billion, the company said.”
  • Kaufmann Hall offers five key takeaways from recent financial rating reports of hospitals.
    • “Hospital rating downgrades declined in 2025 while the number of upgrades increased, resulting in a lower ratio of downgrades to upgrades and tempering higher downgrade activity in recent years. Growing volumes, increased supplemental funding and better labor and expense management contributed to improved financial performance for many borrowers. Upgrades and downgrades included a wide swath of hospitals including academic medical centers, children’s hospitals and regional and national systems, as well as stand-alone hospitals. The overwhelming majority of ratings were affirmed, providing support for the rating agencies’ stable (Moody’s and S&P) and neutral (Fitch) outlooks for 2026.”
  • Healthcare Dive notes,
    • “Community Health Systems has agreed to sell an Alabama hospital for $450 million, the latest in a string of divestitures from the for-profit hospital operator as it looks to reduce its debt. 
    • “CHS said on Tuesday that a subsidiary has signed a definitive agreement to sell substantially all of the assets of its 180-bed Crestwood Medical Center in Huntsville, Alabama to Huntsville Hospital Health System. The deal includes Crestwood’s network of outpatient centers and medical practices, according to CHS’ release.
    • “The companies expects the deal to close in the second quarter this year.”
  • Per MedTech Dive,
    • “Medtronic has agreed to buy up to $90 million worth of shares in Anteris Technologies Global, developer of a transcatheter aortic valve replacement device for patients with severe aortic stenosis.
    • “The purchase, in a private placement, is contingent on Anteris completing a proposed $200 million public stock offering, the company said Tuesday.
    • “Anteris said it will sell the shares to Medtronic at a price per share equal to the public offering price, subject to a minimum purchase of 16% of the number of common shares outstanding after the offering and a maximum purchase of 19.99%.”

Tuesday report

David Ermer–ACA, Congress, FDA, Medical / Rx research, Medicare, Obesity, SDOH, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Appropriations Committee Jan. 20 released text of a three-bill minibus for fiscal year 2026 that includes funding for key health programs and other bipartisan health care provisions and extensions. The bill provides a discretionary total of $116.6 billion to the Department of Health and Human Services and maintains funding for key rural health, health care workforce and behavioral health programs. The bill has several priorities supported by the AHA, including one-year extensions of the Medicare-dependent Hospital and low-volume adjustment programs, a two-year extension of telehealth flexibilities, as well as a one-year delay of payment reductions for clinical laboratory services. It also includes a five-year extension of hospital at home flexibilities and eliminates Medicaid Disproportionate Share Hospital cuts until FY 2028. Additionally, the bill includes a provision requiring separate unique health identifiers for off-campus hospital outpatient departments, which the AHA says is redundant as hospitals already disclose care locations, and it would impose unnecessary costs and administrative burden by forcing changes to existing billing systems. The House is expected to vote on the bill this week, with the Senate expected to follow next week before the Jan. 30 funding deadline.”
  • STAT News notes,
    • “Th[is] bill would prohibit PBMs from linking their payments to drug prices in Medicare and increase transparency in that program. The bill would ban PBMs from charging Medicaid more than they pay for drugs, a practice called spread pricing. And in the commercial market, the bill would require PBMs to pass through 100% of rebates to employer-sponsored insurance plans. There also is a measure requiring that PBMs give pharmacies who want to be part of their network reasonable contracts. 
    • “However, some of those measures could be taken out if the nonpartisan Congressional Budget Office determines that they would cost money, Smolinski said. The commercial market requirements and Medicaid spread pricing measures are examples of measures that the CBO could determine would increase government spending.”
  • Per Beckers Hospital Review,
    • [This bill] does not extend the enhanced ACA subsidies that expired at the end of 2025, a point of concern for hospitals as insurance premiums rise for millions of people across the country.
  • Govexec adds,
    • “Negotiators in both chambers of Congress have reached an agreement to fund every federal agency in fiscal 2026, with appropriators announcing a final deal on Tuesday, giving lawmakers 10 days to get the remaining bills to President Trump’s desk before a shutdown would occur.
    • “The Senate last week passed a second “minibus” package of spending bills, sending the measure to Trump to clear out half of the 12 annual must-pass appropriations bills. The House has already passed a third package—funding the departments of State and Treasury, and other governmentwide oversight agencies—and the Senate is expected to pass it next week. 
    • “Lawmakers on Tuesday unveiled the fourth and final minibus, which would fund the departments of Defense, Labor, Health and Human Services, Education, Homeland Security, Transportation and Housing and Urban Development. Those agencies, as well as State and Treasury, are currently funded through a stopgap continuing resolution that is set to expire after Jan. 30. 
    • “The new package marks yet another breakthrough between Republicans and Democrats in both the House and Senate.” * * *
    • “The House is expected to approve the measure this week. The Senate would then take it up next week, when it returns from recess. Lawmakers will have to pass the bill and Trump would then have to sign it into law by Jan. 30 to avoid the second shutdown of the fiscal year.” 
  • Per an HHS news release,
    • The HHS Office of Inspector General released its annual report about “2025 Top Management & Performance Challenges Facing HHS.”
  • Per a CMS news release,
    • “January 20, 2026 – Medicare Secondary Payer and Certain Civil Money Penalties Group Health Plan Webinar Now Available 
    • “The presentation from the January 13th Medicare Secondary Payer and Certain Civil Money Penalties Group Health Plan Webinar is now available in the Download section below.”
  • Beckers Payer Issues ranks the States by Affordable Care Act enrollment change since 2025.
    • “New Mexico has seen the biggest increase in ACA enrollment from 2025 to 2026, while North Carolina has seen the largest decrease, according to KFF.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “French vaccine developer Valneva said it is voluntarily pulling the paperwork underlying the approval of its chikungunya virus shot in the U.S., ending a short-lived marketing run marred by safety concerns. 
    • “In a Monday statement, Valneva said it recently learned that the Food and Drug Administraiton placed a clinical hold on the vaccine, Ixchiq, pending an investigation of a newly reported serious adverse event that occurred outside the U.S. The company has responded by withdrawing its FDA applications altogether.”
  • MedTech Dive tells us,
    • “Boston Scientific has told customers to stop using certain stents linked to three deaths, the Food and Drug Administration said Friday.
    • “The FDA published an early alert about issues with deployment and expansion of certain Axios Stent and Electrocautery Enhanced Delivery Systems.
    • “Boston Scientific wrote to customers about the issues, which the FDA said were linked to 167 serious injuries, late last year to prevent further use of the products.”
  • Radiology Business informs us,
    • “A group of PET scanners manufactured by GE HealthCare are the subject of a new recall from the U.S. Food and Drug Administration (FDA). 
    • “On January 16, the FDA updated its list of medical device recalls to include certain Omni Legend systems from GE. The recall was issued due to the potential for the systems to produce artifacts during PET exams, which could skew readers’ ability to assess images accurately.” * * *
    • “More information regarding the specific systems impacted by the recall can be found here.”  

From the judicial front,

  • The AHA News reports,
    • “The federal government has dropped its appeal of a preliminary injunction blocking implementation of the Department of Health and Human Services’ 340B Rebate Model Pilot Program.
    • “The move comes after the 1st U.S. Circuit Court of Appeals Jan. 7 denied the government’s motion for a stay in a lawsuit filed by the AHA, the Maine Hospital Association and four safety-net health systems challenging the program.
    • “The 1st Circuit ruling follows a Dec. 29 decision from the U.S. District Court of Maine granting a preliminary injunction blocking implementation of the program, which was scheduled to go into effect Jan. 1. The district court held that the Health Resources and Services Administration’s approval of the nine manufacturer applications that collectively comprise the entire program likely violated the Administrative Procedures Act.
    • “In a court filing, the government has signaled it will restart the administrative process related to the program; however, it has not released specific details.” 

From the public health and medical / Rx research front,

  • Pulmonology Advisor reports,
    • “Increased risk for non-small cell lung cancer (NSCLC) in never-smokers is significantly associated with underlying chronic lung disease, a family history of lung cancer, and unemployment, researchers reported in Chest.” * * *
    • “These findings underscore the multifactorial nature of LCINS and highlight the need for a comprehensive, multifactorial risk-assessment approach to better identify high-risk populations among never-smokers,” the researchers concluded.”
  • The American Journal of Managed Care tells us,
    • Colorectal cancer (CRC) incidence is increasing among young adults, with significant survival disparities linked to socio-economic status (SES) and race.
    • Black patients and those from lower SES neighborhoods had poorer 3-year survival rates, but only SES remained significant after adjustment.
    • The study highlights the impact of structural inequities on survival outcomes, emphasizing the need for multilevel interventions.
    • Limitations include small sample sizes for certain racial groups and potential aggregation issues, affecting generalizability.
  • Health Day informs us,
    • “Fingertip blood oxygen monitors return false readings for people with darker skin tones.
    • “The devices might miss low blood oxygen levels among dark-skinned patients.
    • “The darker the skin tone, the more inaccurate the devices become.” * * *
    • “In the linked editorial, Valley and colleagues agreed that for the time being, doctors will have to do their best, while understanding the devices’ flaws.
    • “The goal is not to abandon pulse oximetry but to understand its limits and make it equitable, ensuring that the technology designed to measure oxygen does not itself perpetuate inequalities in those who receive it,” the editorial said.”
  • STAT News points out,
    • “In a new secondary analysis of the larger trial published Monday in the Annals of Internal Medicine, [Mary Elizabeth] Patti [MD] and her colleagues asked how different social determinants of health affected outcomes after bariatric surgery compared to medical therapy for people with type 2 diabetes and obesity.
    • Bariatric surgery was better than medical therapy across all social backgrounds, they found, and not just in areas of higher deprivation. The ancillary study was smaller, and some of the participants randomized in earlier stages crossed over from medical to surgical treatment, and the reverse. The authors acknowledged and accounted for these limitations, along with the rapid development of more powerful obesity drugs not fully captured in the study. 
    • Still, “bariatric surgery remains an underutilized approach. Even in comparison to these really wonderful medications that we now have access to, it is still better,” Patti, director of the hypoglycemia clinic at Joslin Diabetes Center in Boston, told STAT. “I’m not a surgeon, but I think we need to keep in mind that surgery offers an approach which can be a durable therapy for type 2 diabetes and obesity.”
  • and
    • “Corvus Pharmaceuticals reported updated results Tuesday from an early-stage study of an oral treatment for eczema that has the potential to be more effective than currently approved drugs, including the blockbuster therapy Dupixent.
    • “After eight weeks, 75% of participants treated with the Corvus pill, called soquelitinib, achieved at least a 75% improvement in the extent and severity of skin lesions — an efficacy metric known as EASI 75 — compared to 20% of participants offered a placebo, the company said.
    • “The study also found that 33% of treated participants achieved clear or almost clear skin after eight weeks, as assessed by physicians, compared to none of the participants in the placebo group. 
    • “Side effects, all mild, were reported in 42% of participants treated with soquelitinib and did not result in any dose modifications or interruptions. No serious side effects were reported, Corvus said.”
  • The American Medical Association lets us know what doctors wish patients knew about hepatitis A, B and C.
    • “Chronic viral hepatitis affects millions of people worldwide. But the tricky part is that people infected with hepatitis viruses may not show symptoms, causing many to be unaware they have this condition. 
    • “While many patients with an acute infection fully recover after a few weeks, others develop chronic infection. That is why it is vital that patients know the ABCs of viral hepatitis and understand when to seek help.”
  • Genetic Engineering and Biotechnology News relates,
    • “An international team of scientists, headed by a team at Nanyang Technological University, Singapore (NTU Singapore), has discovered a new way that could speed up the healing of chronic wounds infected by antibiotic-resistant bacteria.
    • “Collaborating with researchers at the University of Geneva, the team’s preclinical study showed how a common bacterium, Enterococcus faecalis, actively prevents wound healing. The results of their collective studies in mice and in human cells showed that, unlike other bacteria, which produce toxins when they infect wounds, E. faecalis produces reactive oxygen species (ROS), which impairs the healing process of human skin cells.
    • “The team identified extracellular electron transport (EET) as a previously unrecognized mechanism by which E. faecalis generates ROS, which, in turn, activates the unfolded protein response (UPR) in epithelial cells and impedes their migration following wounding. The study also demonstrated how neutralizing this biological process can allow skin cells to recover and close wounds.
    • “Establishing a direct link between bacterial metabolism and host cell dysfunction, the study points to a potential new therapeutic strategy for chronic wounds. Co-senior and co-corresponding author, NTU associate professor Guillaume Thibault, PhD, at the School of Biological Sciences, and colleagues reported on their findings in Science Advances, in a paper titled “Enterococcus faecalis redox metabolism activates the unfolded protein response to impair wound healing,” in which they concluded, “Our findings establish EET as a virulence mechanism that links bacterial redox metabolism to host cell stress and impaired repair, offering new avenues for therapeutic intervention in chronic infections.”

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute posted its reports about “The Shifting Landscape of Employment-Based Health Benefits: Long-Term Resilience, Small-Employer Erosion, and the Threat of Higher Premiums,” and its “2025 Workplace Wellness Survey.”
    • “Employers’ commitment to worker health dates back to the late 1800s, but it was during World War II that employers began to offer more formal health coverage. Employers today offer health coverage because of their belief that offering it has a positive impact on the overall success of the business. It can be argued that the Employee Retirement Income Security Act of 1974’s (ERISA’s) preemption of state law has created an environment of nationally uniform standards for employee benefit plans, thus giving employers the regulatory means to continue to offer health benefits as they do today. Despite predictions spurred by the Patient Protection and Affordable Care Act of 2010 (ACA) that employers would stop offering coverage, employment-based health insurance remains resilient.”
    • “This edition of the Workplace Wellness Survey found that American workers’ average level of concern about their physical, mental, and workplace well-being was a 5.8 out of 10, up from 5.5 in 2024. Some other the key conclusions in the survey were that 56 percent of workers were very or extremely satisfied with their current job, with a few expressing dissatisfaction; top suggestions for improvement to benefits were a greater employer contribution and more flexibility of benefits to choose from; and half of the workers were open to using AI as a tool to help with benefits, but significant shares remained skeptical.”
  • Beckers Payer Issues informs us,
    • “Sustained GLP-1 use slows medical cost growth, according to findings published Jan. 13 from professional services firm Aon.
    • “The firm analyzed 192,000 GLP-1 users from July 2022 to March 2025, comparing outcomes to non-users, through commercial medical and pharmacy claims data. This research builds off 2025 analyses.
    • “These results provide employers a much clearer view of how GLP‑1 therapies can change the trajectory of both health risks and longer-term costs in their workforce,” Aon North America Health Solutions Leader Farheen Dam said in a news release. “The real impact comes when employers consider not just coverage, but also how these medications are used, supported and sustained over time. By pairing thoughtful GLP-1 strategies with programs that encourage adherence and total well-being, organizations can improve outcomes for their workforce.”
  • Fierce Pharma notes,
    • “Five weeks after telling investors to expect a revenue decline in 2026, Pfizer has found a quick funding fix, selling off its stake in GSK’s ViiV Healthcare.
    • “The New York powerhouse has agreed to surrender its 11.7% interest in the HIV-focused company for $1.875 billion. Under terms of the agreement, Shionogi will pick up Pfizer’s shares for $2.125 billion, with GSK gaining a special dividend of $250 million.
    • “The deal allows majority owner GSK to retain its 78.3% interest in ViiV, while Osaka, Japan-based Shionogi will boost its stake in ViiV from 10% to 21.7%. The companies expect to close the deal in the first quarter of this year.”
  • and
    • “With star checkpoint inhibitors like Keytruda and Opdivo now sporting subcutaneous formulations, GSK has struck a deal aimed at ensuring its own PD-1 stalwart doesn’t miss out on the action.
    • “GSK, through its oncology subsidiary Tesaro, is handing over $20 million upfront to Alteogen for global rights to the Korean biotech’s novel hyaluronidase enzyme ALT-B4. Tesaro plans to use the tech to develop and potentially market a subcutaneous form of Jemperli (dostarlimab).
    • “To sweeten the deal, GSK and Tesaro are offering up to $265 million more tied to certain development, regulatory and sales milestones, Alteogen said in a Jan. 20 press release. Alteogen will also be in line to earn royalties on sales of subcutaneous Jemperli, should it win approval and go to market.”
  • BioPharma Dive adds,
    • GSK on Tuesday said it’s agreed to buy Rapt Therapeutics for $2.2 billion, gaining access to a drug that promises to help a wider population of patients avoid allergic reactions to food.
    • The medicine, ozureprubart, targets the immunoglobulin E, or IgE antibodies that are produced when a patient’s immune system overreacts after encountering allergens. Once released, the IgE antibodies help trigger allergic reactions that can sometimes be deadly for patients. 
    • Ozureprubart is currently in Phase 2b testing, and Rapt believes it has the potential to be administered every eight to 12 weeks, instead of the two-to-four week regimens currently used for Roche and Novartis’ Xolair. The company also expects the drug to be used by a bigger pool of patients, including those with high levels of IgE or a body weight that makes them ineligible to take Xolair.
  • Per Radiology Business,
    • “[Last] week iSono Health—a company that specializes in developing solutions catered to women’s health—announced the commercial launch of its wearable breast ultrasound system.  
    • “ATUSA is an artificial intelligence-enabled ultrasound device that delivers 3D automated imaging of the breast at the point of care. ISono Health developed the system to address the diagnostic gap between women with dense breast tissue and challenges accessing supplemental imaging. The company believes the product has the potential to address shortages of skills sonographers by putting the easy-to-use technology directly in the hands of providers in clinic. 
    • “ATUSA is a systemwide upgrade for women’s breast health,” Neda Razavi, CEO of iSono Health, said in an announcement. “We are putting the power of a world-class radiology suite into the hands of local clinicians, replacing slow, manual workflows with real-time diagnostic images at the point of care.” 

MLK Holiday Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, NIH, OPM, U.S. Healthcare–

Happy Martin Luther King, Jr., Day. This is the 40th anniversary of holding a federal holiday to celebrate the life and legacy of this great American leader.

From Washington, DC,

  • This week’s main event on Capitol Hill, at least from the FEHBlog’s perspective is Thursday’s afternoon’s House Ways and Means Committee hearing with Health Insurance CEOs.
  • Federal News Network reports,
    • “The Office of Personnel Management extended the deadline to apply for the U.S. Tech Force, due to what it said has been “tremendous interest and a recent surge in applications.”
    • “The Tech Force program initially launched in December, as a way to temporarily hire technologists into government for two-year stints to work on critical tech challenges across agencies. Those interested now have until Feb. 2 to apply for a spot in the program, according to a Thursday social media post. OPM is targeting 1,000 recruits to the program by March.
    • “It’s not clear how many individuals have so far submitted applications to Tech Force. But OPM Director Scott Kupor said more than 35,000 people expressed initial interest in the program.
    • “We’re working through our funnel now of how many of those people will give us a resume, how many people will do the application,” Kupor said Wednesday during an event hosted by Washington AI Network. “From my perspective, the interest is phenomenal.”
  • Per a National Institutes of Health news release,
    • “Effective Jan. 31, 2026, Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH), is retiring from federal service. Dr. Gibbons has led NHLBI since 2012, dedicating his time to championing research research in the prevention and treatment of heart, lung, and blood diseases and sleep diseases and disorders.” * * *
    • “David Goff, M.D., Ph.D., will serve as Acting NHLBI Director while a search for a new director is conducted.”

From the Food and Drug Administration front,

  • Beckers Hospital Review points out,
    • “UnitedHealth Group’s Optum Rx is monitoring three notable drug candidates that might be approved in the next few months, according to its winter 2026 report published Jan. 2.
    • “Two of the medications Optum Rx is tracking are also on GoodRx’s list of 11 upcoming FDA approval decisions to watch in 2026 — Anaphylm for anaphylaxis and Sotyktu for psoriatic arthritis. 
    • “Here is a breakdown of the three FDA decisions Optum Rx is closely watching:
      • “1. Anaphylm (dibutepinephrine) is under FDA review for the treatment of severe allergic reactions, including anaphylaxis. If approved, the sublingual films will be the first oral epinephrine product for allergic reactions.” * * *
      •  “2. Bristol Myers Squibb is seeking another indication for Sotyktu (deucravacitinib), an FDA-approved pill for adults with moderate to severe plaque psoriasis. The potential new indication is the treatment of adults with active psoriatic arthritis, a chronic autoimmune condition that affects about 1 million U.S. adults.” * * *
      •  “3. Novo Nordisk resubmitted an application for FDA approval of insulin icodec, a once-weekly basal (long-acting) insulin to improve glycemic control in patients with Type 2 diabetes.”
  • Per MedPage Today,
    • “Meals and snacks with “GLP-1 Friendly” labels on the packaging are becoming more common in U.S. supermarkets as a growing number of Americans try obesity drugs like semaglutide (Wegovy) and tirzepatide (Zepbound) to lose weight.
    • But the labels aren’t regulated by the FDA, unlike the popular medications themselves. Dietitians say people taking GLP-1 drugs need to read ingredient lists and talk to experts about what nutrients they need — and don’t need.
    • “A drug does not educate you on how to eat properly,” said Suzy Badaracco, MS, a registered dietitian and president of the food trends forecasting firm Culinary Tides. “You’re not magically going to be educated — without a doctor’s help — to eat healthy.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A new study helps explain why you get sick from a common cold virus. The secret, it turns out, lies inside your nose.
    • “Winter brings a surge of respiratory illnesses, including rhinoviruses, the most frequent cause of the common cold. How your nasal-passage cells respond to the rhinovirus helps determine whether you get sick and how bad you feel, according to a new study published Monday in the journal Cell Press Blue.
    • “This study offers a more detailed picture of what’s going on during common cold infections than we ever had,” said Dr. Ellen Foxman, an immunologist at the Yale School of Medicine and senior author of the new research.”
  • The Washington Post informs us,
    • “Since the inception of antibiotics in 1910 with the introduction of salvarsan, a synthetic drug used to treat syphilis, scientists have been sounding the alarm about resistance. As a microbiologist and biochemist who studies antimicrobial resistance, I [André O. Hudson] see four major trends that will shape how we as a society confront antibiotic resistance in the coming decade.” * * *
      • “Faster diagnostics are the new front line” * * *
      • “Expanding beyond traditional antibiotics” * * *
      • “Antimicrobial resistance outside hospitals” * * *
      • “Policies on what treatments will exist in the future” * * *
    • “Antibiotic resistance is sometimes framed as an inevitable catastrophe. But I believe the reality is more hopeful: Society is entering an era of smarter diagnostics, innovative therapies, ecosystem-level strategies and policy reforms aimed at rebuilding the antibiotic pipeline in addition to addressing stewardship.
    • “For the public, this means better tools and stronger systems of protection. For researchers and policymakers, it means collaborating in new ways.
    • “The question now isn’t whether there are solutions to antibiotic resistance — it’s whether society will act fast enough to use them.”
  • and
    • “As more continues to be understood about the health benefits associated with GLP-1 drugs, a growing body of science is aiming to answer whether the popular weight-loss medication can help with one of the world’s leading causes of death: cancer.
    • “Research into the effects of GLP-1 drugs on the risks of developing and surviving cancer is early, and results so far have been somewhat of a mixed bag. While some studies suggest the medication could be linked to a lower chance of developing certain cancers and better outcomes after being diagnosed, researchers have also found little to no effect on other types. In some cases the drugs have been tied to a slight increase in risk. Experts also noted that the medication’s potential long-term effects are not yet well understood.
    • “We don’t know all the good effects, but we don’t know all the bad effects either,” said Sherry Shen, a medical oncologist specializing in breast cancer at Memorial Sloan Kettering Cancer Center.”
  • Per MedPage Today,
    • “Patients with acute mpox infections experienced persistent physical, behavioral, and psychosocial side effects more than a year after illness, a cohort study suggested.
    • “Among 154 people with clade II mpox infections, 58% had at least one persistent sequelae, 56% of which were related to appearance, 11 to 18 months after illness, reported Preetam Cholli, MD, of the CDC, and colleagues in the Annals of Internal Medicine. 
    • “Specifically, 51% had sequelae at one to two sites, 8% were affected at 10 or more sites, 83% had persistent skin discoloration, and 51% had scars. Most had fewer than 10 scars (82%) or discrete pigmented areas (86%). Persistent physical or appearance-related sequelae were more likely in those with 10 or more acute lesions, merged lesions 2 cm or larger, or bacterial superinfection.
    • “Our findings suggest that clinicians should consider more aggressive monitoring and treatment or early dermatology consultation to try to mitigate the possibility of long-term scarring for lesions at or exceeding 2 cm in size,” Cholli and team wrote.”
  • Genetic Engineering and BioTechnology News lets us know,
    • “Learning to read and write is the beginning of literacy, a progression now mirrored in modern genomics. Scientists first read the human genome, a three-billion-letter biological book, in April 2003. Since then, researchers have steadily advanced the ability to write DNA, moving far beyond single-gene construction. New technologies enable the synthesis of viral, bacterial, and yeast genomes. Now, cutting-edge projects are building the tools needed for large-scale chromosome engineering, with the long-term goal of constructing the first human genome from scratch.
    • “In the U.K., a Wellcome-funded five-year proof-of-concept project, Synthetic Human Genome (SynHG), is taking aim at developing the foundational and scalable technologies to achieve reliable genome construction. The £10 million (~$13 million in U.S.) project established a consortium consisting of five university teams from Cambridge, Kent, Oxford, Manchester, and Imperial. Embedded within the ambitious scientific undertaking is also a research wing designed to address socio-ethical implications. According to Wellcome, “Achieving reliable genome design and synthesis–i.e., engineering cells to have specific functions—will be a major milestone in modern biology.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “Bloomington, Minn.-based HealthPartners launched its copay-only health plan, Simplica NextGen Copay, this year. The plan sets prices for in-network care without a deductible or coinsurance.
    • “Moe Suleiman, senior vice president of commercial business, and Maggie Helms, senior vice president, chief data, AI and digital officer, sat down with Becker’s to unpack the effort — and how to do it the right way.
    • “The pair said there can be misconceptions surrounding copay-only plans. Some may believe copay-only plans must replace all existing other plan types in a portfolio, when that is not necessarily the case. Copay-only plans can also stand alongside familiar options, such as a tax-advantaged health savings account, so members can have a choice.”
  • KFF offers a table of “Hospital Expenses per Adjusted Inpatient Day by Ownership Type” from 1999 through 2024.
  • Radiology Business relates,
    • “The Society of Interventional Radiology and other members of a coalition of imaging industry stakeholders are pointing to a new analysis from the Progressive Policy Institute. It notes that, between 2019 and 2023, the share of physician practices owned by hospitals and other corporate entities leapt from 39% to 59%.
    • “Meanwhile, the proportion of docs employed by such entities increased from 62% to 78%. SIR, AdvaMed, the American College of Radiation Oncology, Philips, Abbott and others in the Office-Based Facility Association (OBFA) contend more must be done to reverse these trends and protect private practices.
    • “Office-based facilities are a cornerstone of affordable, patient-centered care—but they’re under pressure like never before,” Robert Tahara, MD, policy chair of the association and a Pennsylvania-based vascular surgeon, said in a Jan. 15 announcement. “We urge policymakers at all levels to act now to support payment policies and competitive practices that keep healthcare accessible, affordable, and rooted in community practice.”
  • Per HR Dive,
    • “Organizations in 2026 are facing culture dissonance as companies expect more from employees without offering more in return, according to a recent workplace trend report from business and technology firm Gartner.
    • “Negative psychological impacts resulting from the pervasiveness of artificial intelligence, as well as poor quality work resulting from an “overwhelming focus on AI adoption” were also among the findings reported in the research, which identified nine trends that CHROs will need to address in 2026. 
    • “Another aspect of AI’s influence has been job seekers’ use of the tech to make their applications easier and more appealing, even as organizations use AI to sift through a high volume of resumes. In the coming year, CHROs will need to focus on the human aspect of recruiting to counteract this trend, per Gartner.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • The Wall Street Journal reports,
    • “Federal lawmakers next week are expected to revive efforts to renew lapsed cybersecurity legislation aimed at fostering collaboration between Washington and private-sector companies in chasing down state-sponsored hackers.
    • “We’re making a hard push,” Rep. Andrew Garbarino, a New York Republican, said about extending the Cybersecurity Information Sharing Act, which provides liability and antitrust protections to companies sharing cyberattack intelligence with the federal government.
    • “Garbarino at a congressional hearing Tuesday said House and Senate lawmakers on both sides of the aisle are committed to fully reauthorizing the decade-old legislation, known as CISA, beyond a reprieve passed in Novemberand set to expire at the end of January. Congress failed to approve a long-term extension before last year’s government shutdown in October.”
  • Cyberscoop tells us,
    • “President Donald Trump re-nominated Sean Plankey to lead the Cybersecurity and Infrastructure Security Agency on Tuesday, after Plankey’s bid for the position ended last year stuck in the Senate.
    • “It’s not clear whether or how Plankey’s resubmitted nomination will overcome the hurdles that left many observers convinced his chance of becoming CISA director had likely ended, but it does definitively signal that the Trump administration still wants Plankey to have the job.
    • “Plankey’s nomination was included in a batch sent to the Senate announced on Tuesday [January 13].
  • Cybersecurity Dive informs us,
    • “In an attempt to help critical infrastructure operators protect themselves from hackers, the U.S. and six other countries have published security guidance for organizations that run operational technology, offering advice on everything from network segmentation to activity logging.
    • “Exposed and insecure OT connectivity is known to be targeted by both opportunistic and highly capable actors,” the authoring agencies — representing the U.S., Australia, Canada, Germany, the Netherlands, New Zealand and the United Kingdom — wrote in the document, “Secure connectivity principles for Operational Technology.”
    • “Improving OT cybersecurity, the agencies added, “can challenge attackers’ efforts and raise the threshold necessary to cause physical harm, environmental impact, and disruption.”
  • and
    • “The Department of Homeland Security is preparing to introduce a new system for holding sensitive discussions with critical infrastructure operators, replacing a framework that the Trump administration abruptly eliminated in its early days.
    • “The new program, currently dubbed Alliance of National Councils for Homeland Operational Resilience (ANCHOR), will streamline the process through which federal agencies and infrastructure providers meet to discuss cyber and physical security threats, according to multiple people familiar with the matter, who requested anonymity to speak freely.”
  • Cyberscoop relates,
    • “A 40-year-old Jordanian national pleaded guilty Thursday [January 15, 2026] to operating as an access broker, selling access to at least 50 victim company networks he broke into by exploiting two commercial firewall products in 2023, according to the Justice Department.
    • Feras Khalil Ahmad Albashiti, who lived in the Republic of Georgia at the time, sold an undercover FBI agent unauthorized access to the victim networks on a cybercrime forum under the moniker “r1z” in May 2023, authorities said in court records.
    • The undercover FBI agent continued communicating with Albashiti for the next five months, uncovering evidence of additional alleged crimes. He’s accused of selling malware that could turn off endpoint detection and response products from three different companies.
    • Albashiti proved the malware worked when, unbeknownst to him, the FBI observed him use the EDR-killing malware on an FBI server the agency granted him access to as part of its investigation. 

From the cybersecurity breaches and vulnerabilities front,

  • Cybersecurity Dive reports,
    • “The healthcare sector experienced twice as many breaches in 2025 as it did in 2024, but the number of exposed patient records dropped precipitously, according to a new report from Fortified Health Security.
    • “Ransomware attacks and third-party risk are powering the surge in breaches, with many of those intrusions now threatening operations more than data privacy.
    • “The industry has shifted from major, headline events to a more taxing state of constant disruption,” Fortified said in its report.”
  • and
    • “Cybersecurity remained the top risk concern among corporate leaders for a fifth year in a row, but AI jumped into the number two position, according to a report released Wednesday from Allianz Commercial. 
    • “AI rose sharply from the number 10 spot to the second biggest concern, indicating growing interest in how the technology might improve productivity, while also creating novel security challenges, according to the annual Allianz Risk Barometer. 
    • “Companies increasingly see AI not only as a powerful strategic opportunity, but also as a complex source of operational, legal and reputational risk,” Allianz chief economist Ludovic Subran told Cybersecurity Dive. “In many cases, adoption is moving faster than governance, regulation and workforce readiness can keep up.”
  • CISA added two known exploited vulnerabilities to its catalog this week.
  • Dark Reading informs us,
    • “Linux systems may soon be facing a new threat with an advanced, cloud-first malware framework developed by China-affiliated actors that’s aimed at establishing persistent access to cloud and container environments.
    • “Check Point Research discovered the framework, called VoidLink, which is comprised of cloud-focused capabilities and modules, including custom loaders, implants, rootkits, and modular plug-ins, according to a blog post published Tuesday [January 13]. Calling it an “impressive piece of software,” Check Point researchers said the framework is far more advanced than any current Linux-oriented malware.”
  • and
    • “The year has barely begun, but 2026 is already in familiar territory for Fortinet customers, as a new vulnerability has come under attack.
    • “On Jan. 13, Fortinet disclosed a critical flaw in its FortiSIEM platform, tracked as CVE-2025-64155 and assigned a 9.4 CVSS score. The OS command injection vulnerability allows an unauthenticated attacker to achieve remote code execution (RCE) on FortSIEM instances through crafted TCP requests.
    • “Yesterday, cybersecurity vendor Defused warned in a post on X that CVE-2025-64155 had been exploited in the wild. Much of the threat activity observed by Defused’s honeypots came from different IP addresses, including three from Chinese providers.
    • “In a LinkedIn post, Simo Kohonen, Defused founder and CEO, said the company’s honeypots had received a “good amount” of targeted exploitation activity that began almost immediately after public disclosure. China-nexus threat groups have heavily targeted Fortinet, along with other edge device vendors, in recent years.”
  • Cyberscoop points out,
    • “Predator spyware operators have the ability to recognize why an infection failed, and the tech has more sophisticated capabilities for averting detection than previously known, according to research published Wednesday [January 14].
    • Jamf Threat Labs found from an analysis of a Predator sample that it has an error code system that can alert operators to why an implant didn’t stick, with “error code 304” signifying that a target was running security or analysis tools.
    • “This error code system transforms failed deployments from black boxes into diagnostic events,” Shen Yuan and Nir Avraham wrote for the company. “When an operator deploys Predator against a target and receives error code 304, they know the target is running security tools — not that the exploit failed, not that the device is incompatible, but specifically that active analysis is occurring.
    • “This has direct implications for targeted individuals: if security analysis tools like Frida are running, Predator will abort deployment and report error code 304 to operators, who can then troubleshoot why their deployment failed,” they continued.
  • Bleeping Computer notes,
    • Security researchers have discovered a critical vulnerability in Google’s Fast Pair protocol that can allow attackers to hijack Bluetooth audio accessories, track users, and eavesdrop on their conversations.
    • The flaw (tracked as CVE-2025-36911 and dubbed WhisperPair) affects hundreds of millions of wireless headphones, earbuds, and speakers from multiple manufacturers that support Google’s Fast Pair feature. It affects users regardless of their smartphone operating system because the flaw lies in the accessories themselves, meaning that iPhone users with vulnerable Bluetooth devices are equally at risk.
    • Researchers with KU Leuven’s Computer Security and Industrial Cryptography group who discovered it explain that the vulnerability stems from the improper implementation of the Fast Pair protocol in many flagship audio accessories.
  • Per SC Media,
    • “A vulnerability in the AI-powered Cursor integrated development environment (IDE) could have enabled an attacker to conduct stealthy remote code execution (RCE) attacks via indirect prompt injection, Pillar Security reported Wednesday.
    • “The flaw, tracked as CVE-2026-22708, arose from implicit trust in certain shell built-ins including “export” and “typeset,” which would allow them to be executed without any notification of or approval from the user, even when the user’s allowlist was empty.”

From the ransomware front,

  • The HIPAA Journal reports,
    • “The threat from ransomware is greater than ever, according to a new report from GuidePoint Security. The cybersecurity firm recorded a 58% year-over-year increase in victims, making 2025 the most active year ever reported by GuidePoint Security. In 2025, GuidePoint Security tracked 2,287 unique victims in Q4, 2025 alone – the largest number of victims in any quarter tracked by the GuidePoint Research and Intelligence Team (GRIT). December was the most active month in terms of claimed victims, which increased 42% year-over-year to 814 attacks. On average, 145 new victims were added to dark web data leak sites every week in 2025, with the year ending with 7,515 claimed victims.
    • “Law enforcement operations have targeted the most active groups, and there have been notable successes; however, they have had little effect on the number of victims, which continues to increase. Rather than the ransomware-as-a-service (RaaS) landscape being dominated by one or two major actors, law enforcement operations have helped create a highly fragmented ecosystem, with smaller groups conducting attacks in high volume, using repeatable operations. In 2025, GRIT tracked 124 distinct named ransomware groups – a 46% increase from 2024 and the highest number of groups ever recorded in a single year.
    • “While ransomware attacks are conducted globally, as in previous years, ransomware actors are primarily focused on the United States, where 55% of attacks were conducted last year, followed by Canada, which accounted for 4.5% of attacks. The manufacturing sector was the most heavily targeted, accounting for 14% of attacks, followed by the technology sector (9%), and retail/wholesale (7%). Healthcare ranked in fourth spot, with more than 500 victims in 2025.”
  • Symantec adds,
    • “The cyber-extortion epidemic reached new heights in 2025, with a record number of attacks recorded. As outlined in our new whitepaper, this increase is being powered by a new breed of attackers who eschew encryption and rely solely on data theft as leverage for extortion. By using zero-day vulnerabilities or exploiting weaknesses in the software supply chain, attackers can steal data from even the best-defended organizations before they become aware of the issue. 
    • Meanwhile, there has also been no decline in the number of attacks involving encryption. This is despite significant levels of disruption among key players, such as the collapse of LockBit in late 2024 and the closure of RansomHub in April 2025. Instead, other ransomware operators such as Akira, Qilin, Safepay and DragonForce expanded rapidly in the wake of those departures, quickly winning over affiliate attackers who previously worked with the departing actors. 
  • The Register calls our attention to
    • “Researchers at Group-IB say the DeadLock ransomware operation is using blockchain-based anti-detection methods to evade defenders’ attempts to analyze their tradecraft.
    • “First spotted in July 2025, the DeadLock group has attacked a wide range of organizations while almost managing to stay under the radar.
    • “It abandons the usual double extortion approach in which cybercrooks steal data, encrypt systems, and threaten to post it online for all to see if the victim refuses to pay a ransom.” * * *
    • “But for the researchers at Group-IB, the old-school encryption-only model is not the most notable aspect of the DeadLock operation. Its use of Polygon smart contracts to obscure its command-and-control (C2) infrastructure is an unusual move that’s slowly gaining popularity.
    • “Once a victim’s systems are encrypted, DeadLock drops an HTML file that acts as a wrapper for the decentralized messenger Session. This file replaces an instruction for the victim to download Session to communicate with DeadLock.
    • “By using blockchain-based smart contracts to store the group’s proxy server URL – the one victims connect to before communicating with the criminals – it allows DeadLock to rotate this address frequently, making it difficult for defenders to permanently block its infrastructure.”

From the cybersecurity business and defenses front,

  • Dark Reading reports,
    • “CrowdStrike continues its shopping spree, announcing plans to acquire browser security startup Seraphic Security. The acquisition will bring browser telemetry to the endpoint detection company’s flagship Falcon security platform.
    • “Seraphic Security’s platform, which includes a secure Web gateway, zero-trust network access, and cloud access security browser, provides protection and detection capabilities to browsers. Enterprises can use the platform to provide their users with secure access to software-as-a-service and private Web applications. Security teams get a consistent secure browser experience across both managed and personal devices without the complexity or cost of deploying virtual desktop infrastructure or a virtual private network.” * * *
    • “CrowdStrike plans to combine Seraphic’s “continuous in-session browser protection” with the identity protection and authorization capabilities from SGNL (announced last week) and Falcon’s existing endpoint telemetry and threat intelligence, according to the release announcing the acquisition. The combination will provide next-generation identity security that protects every interaction across endpoints, browser sessions, and the cloud, the company said.”
  • Bleeping Computer relates,
    • “Microsoft announced on Wednesday [January 14] that it disrupted RedVDS, a massive cybercrime platform linked to at least $40 million in reported losses in the United States alone since March 2025.
    • “Microsoft filed civil lawsuits in the United States and the United Kingdom, seizing malicious infrastructure and taking RedVDS’s marketplace and customer portal offline as part of a broader international operation with Europol and German authorities.
    • ‘Two co-plaintiffs joined Microsoft in this action: H2-Pharma, an Alabama pharmaceutical company that lost $7.3 million in a business email compromise scheme, and the Gatehouse Dock Condominium Association in Florida, which lost nearly $500,000 in resident funds.”
  • Federal News Network tells us,
    • “As the Defense Department moves to meet its 2027 deadline for completing a zero trust strategy, it’s critical that the military can ingest data from disparate sources while also being able to observe and secure systems that span all layers of data operations.
    • “Gone are the days of secure moats. Interconnected cloud, edge, hybrid and services-based architectures have created new levels of complexity — and more avenues for bad actors to introduce threats.
    • “The ultimate vision of zero trust can’t be accomplished through one-off integrations between systems or layers. For critical cybersecurity operations to succeed, zero trust must be based on fast, well-informed risk scoring and decision making that consider a myriad of indicators that are continually flowing from all pillars.
    • “Short of rewriting every application, protocol and API schema to support new zero trust communication specifications, agencies must look to the one commonality across the pillars: They all produce data in the form of logs, metrics, traces and alerts. When brought together into an actionable speed layer, the data flowing from and between each pillar can become the basis for making better-informed zero trust decisions.”
  • Security Week notes,
    • “Tracked as CVE-2025-20393 (CVSS score of 10/10), the security defect was disclosed on December 17, one week after Cisco’s Talos researchers observed its in-the-wild exploitation as a zero-day.
    • “This attack allows the threat actors to execute arbitrary commands with root privileges on the underlying operating system of an affected appliance,” Cisco said at the time.
    • “The company said the attacks targeted only a small set of appliances, and attributed the campaign to UAT-9686, a China-linked APT.
    • “On Thursday, Cisco updated its advisory to provide information on the flaw, the affected products, and the available patches.
    • “The flaw affects the Spam Quarantine feature of the AsyncOS software running on Secure Email Gateway and Cisco Secure Email and Web Manager, and exists due to insufficient validation of HTTP requests.’
  • SC Media considers,
    • “The concerning cyber-physical security disconnect”
  • and
    • “Five questions to ask about email whitelists.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, OPM, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Beckers Payer Issues offers three takeways from the President’s healthcare plan that was announced yesterday.
    • “President Donald Trump released a sparsely detailed healthcare policy framework Jan. 15 that calls on Congress to codify voluntary drug pricing agreements with major pharmaceutical companies, direct payments to Americans over extending enhanced ACA subsidies, and expand price transparency requirements for insurers and providers. The proposal does not identify how most of its provisions would be implemented or enforced.”
  • Rick Pollack, the American Hospital Association’s President, points the healthcare cost increase finger at health insurers.
  • Healthcare Dive adds,
    • “The federal government will pay an estimated $76 billion more to cover Medicare Advantage seniors this year than it would if those same seniors were in traditional Medicare, according to new estimates from an influential advisory group.
    • “It’s a smaller sum than last year thanks to the continued phase-in of a new risk adjustment model. Overpayments were estimated to reach $84 billion in 2025.
    • “Still, the report released Friday by the Medicare Payment Advisory Commission is likely to add more fuel to concerns about overpayments in the privatized Medicare program, which has grown to cover more than half of all Medicare enrollees.”
  • The American Hospital Association News tells us,
    • “The Medicare Payment Advisory Commission Jan. 15 voted to recommend that Congress update Medicare payment rates for hospital inpatient and outpatient services by the current law amount for 2027 and reiterated its recommendation to distribute an additional $1 billion to safety-net hospitals by transitioning to a Medicare safety-net index policy. The AHA Jan. 9 urged the commission for higher updates.
    • In other action, MedPAC recommended that Congress update 2027 Medicare payments for physicians and other health professional services by current law plus 0.5%. The commission also recommended reducing the 2027 payment rates for home health agencies by 7%, skilled nursing facilities by 4% and inpatient rehabilitation facilities by 7%.
  • and
    • The White House hosted a roundtable on rural health Jan. 16 that included health care leaders, legislators and administration officials. The event included discussion on the Rural Health Transformation Fund and the “The Great Healthcare Plan,”with a focus on “most favored nation” prescription drug pricing and other topicsimpacting rural health. Speakers included President Trump, CMS Administrator Mehmet Oz, M.D., Andrew McCue, M.D., a cardiologist at AdventHealth, Senator Dan Sullivan, R-Alaska, Gov. Jim Pillen, R-Neb., Reps. Rob Bresnahan, R-Pa., Mike Lawler, R-N.Y., and Secretary of Agriculture Brooke Rollins.”
  • Per Medical Economics,
    • “Telehealth adoption did not increase overall office visit volumes among traditional Medicare patients, with visit volumes remaining stable or declining through mid-2024.
    • “Researchers categorized specialists into low, medium and high telehealth usage groups, finding declines in outpatient office visits across all groups.
    • “The study suggests telehealth serves as a substitute for in-person visits, not increasing total utilization among Medicare fee-for-service beneficiaries.
    • “Congress must decide on extending Medicare’s telehealth coverage standards, impacting patient access to virtual care.”
  • Per a Senate news release,
    • “U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Maggie Hassan (D-NH) support the Trump administration taking action to implement the No Surprises Act, which protects patients from surprise medical bills and ensures they know the cost of care before receiving it.
    • “Since the bipartisan legislation, led by Cassidy and Hassan, was signed into law by President Trump in 2020, the No Surprises Act has protected American patients from more than 25 million surprise medical bills. This would not be possible without the work of the Departments of Health and Human Services, Labor, and the Treasury.
    • “We are writing to express our support of the Department’s efforts to improve the implementation of the No Surprises Act and encourage the pursuit of additional solutions to ensure that the process established under the law to resolve payment disputes between providers, facilities, and health plans is effective,” wrote the senators. “We look forward to continuing to work with the Department and stand ready to assist to ensure that the implementation of the No Surprises Act continues to be successful.”
  • An HHS news release informs us,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today [January 13] a $231M funding opportunity to administer the 988 Suicide & Crisis Lifeline. The 988 Lifeline is comprised of a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded 988 network administrator. In 2025, 988 received more than 8 million contacts from help seekers via call, text, chat and ASL videophone.”
  • NCQA calls our attention to its 2026 trends.
    • “Re-Thinking Our Approach to Population Health”
    • “Understanding Health Differences Within Populations and Communities”
    • “Shaping the Future of Primary Care”
    • “Integrating Primary Care and Behavioral Healthcare”
    • “Advancing the Transition to Digital Quality Measurement”
    • “Expanding Use of Clinical Data in HEDIS®”
    • “Improving Quality of Care for Patients with Cardiovascular-Kidney-Metabolic Syndrome”
    • “Defining High Quality Diabetes Care”
    • “Reducing the Administrative Burden of Utilization Management”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court agreed to hear Bayer AG’s appeal taking aim at thousands of lawsuits targeting its top-selling Roundup weedkiller for causing cancer. 
    • “The high court agreed Friday to hear Bayer’s challenge to a $1.25 million Missouri jury verdict against the company’s Monsanto unit over Roundup on the grounds some of the claims in the 2023 case were preempted by federal law. Bayer officials hope the justices’ ruling will help knock out thousands of Roundup cases that include failure-to-warn claims.”
  • and
    • “The US Supreme Court will hear generic drug maker Hikma Pharmaceuticals USA Inc.’s challenge of an appeals court holding that it induced doctors and pharmacists to prescribe its heart medicine for off-label treatments that would infringe a rival’s patents. (Case no.
      24-1068)
    • “The government urged the high court to reverse the US Court of Appeals for the Federal Circuit’s ruling reviving a lawsuit from Amarin Pharma Inc. Amarin claimed that Hikma infringed its patents despite the generic company’s use of a “skinny label” instructing users only to take the drug to treat severe hypertriglyceridemia, a method-of-use no longer covered by any Amarin patent.” (Case No. 24-889).

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. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old and RSV hospitalizations are highest among infants less than 1 year 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, but influenza activity has decreased or remained stable for two consecutive weeks. CDC will continue to monitor closely. A second period of increased influenza activity does often occur after the winter holidays.
      • “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, including emergency department visits among infants under 1 year and children 1-4 years old and hospitalizations among infants less than 1 year 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 Hospital Review offers five notes about dipping numbers of hospital admissions for flu.
  • The University of Minnesota’s CIDRAP relates,
    • “Two new analyses, one from France and one from China, suggest that seasonal influenza vaccination provided moderate protection during the early months of the 2025–26 flu season, despite the rapid spread of influenza A(H3N2) subclade K viruses, which differ from the strains anticipated during vaccine development for the current flu season.”
  • STAT News notes,
    • “Reported measles cases in South Carolina surged by almost 30% in the last few days, state health officials said Friday.
    • “The South Carolina health department reported 124 new cases since Tuesday, bringing the state’s total to 558 in a wave of infections centered around an outbreak in Spartanburg County.”
  • The AP informs us,
    • “Wastewater testing can alert public health officials to measles infections days to months before cases are confirmed by doctors, researchers said in two studies published Thursday by the Centers for Disease Control and Prevention.
    • “Colorado health officials were able to get ahead of the highly contagious virus by tracking its presence in sewer systems, researchers wrote. And Oregon researchers found wastewater could have warned them of an outbreak more than two months before the first person tested positive.
    • “The findings add to evidence that wastewater testing is a valuable weapon in tracking disease, including COVID-19, polio, mpox and bird flu.”
  • The American Hospital Association News points out,
    • “The AHA has published a webpage that highlights facts, causes, effects and solutions that hospitals and health systems can use for reducing the risk and severity of postpartum hemorrhage. Resources include how to prepare for, train, measure and support the workforce and patients during maternal care. LEARN MORE“
  • The Washington Post reports,
    • “A sweeping new study of psychiatric and genetic records has the potential to change treatment for millions of psychiatric patients, finding that many conditions involve similar genes and may not need to be treated as distinct illnesses.
    • “In essence, the study suggests that bolstering the traditional emphasis on patient behavior with a deeper understanding of the biology of mental illness could lead to better treatment.
    • “Published in Nature, the paper addresses the boundaries psychiatry uses to separate similar conditions like bipolar disorder and schizophrenia. The research also suggests that linking genes to the brain processes they influence will provide psychiatrists with greater insight into their patients, and guide researchers toward new therapies.”
    • “The findings could also spare patients the burden of carrying multiple different diagnoses that require an assortment of different pills.”
  • Per Healio,
    • “People with hypertension who meet guideline-directed levels of weekly physical activity in just 1 or 2 days may derive similar mortality benefit vs. those who are consistently active, researchers reported.
    • “The 2020 WHO guidelines on physical activity and sedentary behavior, published in the British Journal of Sports Medicine, recommended 150 minutes or more of moderate to vigorous physical activity per week for people with chronic conditions such as hypertension.”
  • Per Fierce Pharma,
    • “Just days after AbbVie unveiled a major new oncology play in the form of its high-dollar RemeGen collab, the Illinois drugmaker closed out the week with some mixed news for its marketed cancer offering Epkinly.
    • “Friday afternoon, the company and its partner Genmab shared word that the phase 3 Epcore DLBCL-1 trial missed on its primary endpoint of overall survival. Specifically, the partners’ Epkinly failed to mount a statistically significant OS benefit among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Despite ongoing pushback, the University of Nebraska Board of Regents on Jan. 15 unanimously approved a proposed deal to bring jointly operated Nebraska Medicine under its full ownership and governance.
    • The deal would see co-owner Clarkson Regional Health Services offload its 50% share of the independently run system for $500 million plus another $300 million for owned land and buildings. Nebraska Medicine’s board is staunchly opposing the plan, and launched a public messaging campaign warning that sole governance, among other possibilities, would allow the university to redirect healthcare funds to cover its own budget gaps.
  • Beckers Hospital Review tells us,
    • “Nashville, Tenn.-based Vanderbilt Transplant Center completed 960 solid organ transplants in 2025 — the most ever performed by a single center in one year — making it the largest transplant center by volume in the U.S. 
    • “In addition to the record number of solid organ transplants, the center set a world record for the performing 210 adult and pediatric heart transplants in 2025, according to a Jan. 14 news release from Nashville-based Vanderbilt University Medical Center.” 
  • MedTech Dive informs us,
    • “Intuitive Surgical executives said this week that general surgery, particularly in after-hours care, drove procedure growth for the da Vinci robotic platform. U.S. procedures increased 15% in the fourth quarter compared with a year ago.
    • “After-hours procedures such as gallbladder removal and appendectomy using a da Vinci robot grew 35% in the fourth quarter, CFO Jamie Samath said in a presentation at the J.P. Morgan Healthcare Conference.
    • “Intuitive has been ramping up the launch of its latest system, da Vinci 5, making it broadly available in the U.S. in the third quarter of 2025. Da Vinci 5 is also cleared in Korea, Japan and Europe. 
    • “The strong launch has exceeded the company’s expectations, with about 1,200 da Vinci 5 systems installed and 270,000 procedures performed globally, CEO Dave Rosa said at the conference.”

Thursday report

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

From Washington, DC,

  • By a vote of 82-15, the Senate passed H.R.6938, Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations. This means that Congress has passed half of the twelve required appropriations bills for fiscal years 2026.
  • President Trump unveiled his healthcare plan today.
    • Here is a link to the related fact sheet.
  • AHIP posted a “Health Care Costs 101” explanation of “What’s Driving Premiums Higher and How to Make Coverage More Affordable.” FWIW, the FEHBlog finds AHIP’s explanation credible.
    • “Health plans are doing everything in their power to shield Americans from the high and rising costs of medical care, and we welcome any opportunity to discuss common-sense solutions to lower costs for everyone.
    • “Health plans are the only part of the health care system whose profits and administrative costs are capped under federal law. Health plans’ profit margin was 0.8% in 2024, NAIC data show. In 2023, the net income of health plans accounted for about 0.5% of U.S. health expenditures ($4.9 trillion that year, per CMS data). By comparison, the pharmaceutical industry averages 15-20% margins.”
  • Fierce Healthcare reports
    • The Trump administration has released new estimates on improper payments in key government insurance programs.
    • The Centers for Medicare & Medicaid Services (CMS) said late Thursday that the estimated improper payment rate in traditional Medicare was 6.55%, or $28.83 billion, in 2025. That’s down from $31.7 billion, or a 7.66% rate, the year prior.
    • The CMS said in a fact sheet that this marks the ninth year in a row in which this figure has been below the 10% threshold required by statute. 
  • STAT News relates,
    • “Last week, the Trump administration unilaterally cut the number of recommended pediatric vaccines, removing shots for diseases like rotavirus, influenza, and hepatitis A from the schedule.
    • “Health secretary Robert F. Kennedy Jr. said the changes were intended to restore trust in public health. But major health systems and clinicians told STAT they plan to ignore the new federal guidelines, placing their trust instead in guidance from the American Academy of Pediatrics, which is similar to previous U.S. policy.” 
  • FEHBlog note — This doesn’t matter to insurers because regardless of whether it’s CDC or AAHP approved, it will be covered without cost sharing when administered in-network.
  • Tammy Flanagan, writing in Govexec, discusses “How federal retirement benefits are calculated and where estimates go wrong. High-three pay, length of service and overlooked reductions can significantly change retirement payouts.”
  • Federal News Network reports,
    • “The Postal Service’s regulator is setting limits on how often the agency can set higher prices for its monopoly mail products.
    • “The Postal Regulatory Commission ruled on Tuesday that the USPS, starting in March, can only raise mail prices once a year. This limit will remain in place through Sept. 30, 2030.
    • “The commission eased restrictions on USPS mail prices in December 2020, when the agency was reeling from the COVID-19 pandemic, and was months away from running out of cash.
    • “Since then, USPS has generally raised mail prices every January and July. Despite setting higher prices, the mail agency is seeing deeper net losses each year, and is far from achieving the “break-even” goal of its 10-year reform plan. In July 2025, USPS raised the price of a first-class stamp to 78 cents.
    • “Members of the commission wrote in their order that the Postal Service’s long-term financial problems “cannot be resolved by using pricing authority alone.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • The Food and Drug Administration quietly removed webpages saying cellphones aren’t dangerous as the Department of Health and Human Services under Robert F. Kennedy Jr. launches a study on cellphone radiation. 
    • Kennedy and some of his allies have long pointed to cellphones as a potential source of illnesses including cancer. Many mainstream scientific institutions, including the FDA, previously concluded that there isn’t adequate proof to link health problems to cellphones or other wireless devices. A vocal group of scientists have said there is reason to worry and to take more precautions, and Kennedy has echoed their concerns.
  • HCPLive tells us,
    • “The FDA approved a new carrying case for OTC naloxone nasal spray, enhancing portability and reducing stigma.
    • “A survey showed 74% of consumers prefer discreet packaging, with higher preference among college students.
    • “Despite OTC approval, naloxone carry rates are low, highlighting the need for increased accessibility and preparedness.
    • “Synthetic opioids in products like THC vapes necessitate immediate availability of naloxone and readiness for repeated dosing.”
  • Cardiovascular Business relates,
    • “Imricor Medical Systems, a Minneapolis-based medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its Vision-MR Diagnostic Catheter. This represents the company’s first FDA clearance since opening its doors in 2006.
    • “The Vision-MR Diagnostic Catheter was built to be provide real-time electrophysiological mapping during under MRI guidance. According to Imricor, this helps electrophysiologists “harness the unmatched soft tissue imaging of the MRI” to visualize a patient’s cardiac anatomy prior to ablation procedures.”
  • Fierce Pharma tells us,
    • “The steady stream of FDA untitled letters that began in September is showing no signs of letting up in the new year.
    • “The regulator’s Office of Prescription Drug Promotion (OPDP) has already sent out two letters alleging “false or misleading” promotional materials in 2026, both dated Jan. 7 and sent to ImmunityBio and BeOne Medicines. BeOne is also the subject of another letter from December that was belatedly uploaded to the FDA website this month.”

From the public health and medical / Rx research front,

  • AAMC informs us about “10 things to know about this year’s surprisingly fierce flu season.”
    • “At least 15 million Americans have come down with the flu — and 7,400, including 17 children, have died from the illness — during the 2025-26 flu season so far, making it one of the most brutal in recent memory.”
  • MedPage Today lets us know,
    • “The FDA and CDC are investigating a multistate outbreak of Salmonella Typhimurium infections linked to Live it Up brand Super Greens dietary supplement powder. A total of 45 people were infected and 12 people were hospitalized.”
  • and
    • “President Donald Trump signed a bill Wednesday allowing schools participating in the National School Lunch Program to serve whole milk again. (AP)”
  • The American Hospital Association News informs us,
    • “A Centers for Disease Control and Prevention report found a drastic increase in alcohol-related emergency department visits from 2003-2004 to 2021-2022. The report said visits rose 101% for males and 96% for females. Visits were for diagnoses that included alcohol-induced psychosis, alcohol abuse, myopathy and liver disease, among others. Additionally, the report said that alcohol was the most common substance involved in substance-related ED visits from 2021-2023, outpacing opioids and cannabis.” 
  • Medscape points out,
    • “The GLP-1 drugs widely prescribed for diabetes and weight loss might also help reduce the risk for colorectal cancer and possibly improve outcomes in people who have the disease, according to a series of studies presented at ASCO Gastrointestinal Cancers Symposium 2026.
    • “In one study, researchers observed a 36% lower risk for colorectal cancer among people who used GLP-1 receptor agonists vs those who used aspirin — a drug long investigated for colorectal cancer primary prevention.
    • “While aspirin has shown “modest efficacy” in that regard, it also carries a bleeding risk that limits its use, Colton Jones, MD, a hematology and oncology fellow with The University of Texas San Antonio, told conference attendees.”
  • Per Health Day,
    • “As teens transition to adulthood, many begin to skip yearly wellness visits with a primary care provider, according to a study published online Dec. 19 in the Journal of Adolescent Health.
    • “Morayo Akande, Ph.D., from Johns Hopkins School of Medicine in Baltimore, and colleagues explored adolescents and young adults’ (AYAs’) longitudinal patterns for annual well-visit attendance (WVA) and associations with WVA. The analysis included data from 2,766 participants in the NEXT Generation Health Study followed annually for seven years (ages 15 to 23 years).
    • “The researchers found that among male participants, 66 percent were “engaged,” 17.7 percent were “engaged with decline,” and 17 percent were “persistently disengaged.” A similar pattern was seen for female participants: 67 percent were “engaged” and 19 percent were “engaged with decline,” but 13 percent were “gradually reengaged.” 
  • Per MedPage Today,
    • “Patients randomized to a self-administered electronic intervention had a significantly greater likelihood of complete benzodiazepine cessation compared with those who received treatment as usual.
    • “However, there was no difference in the second primary endpoint of at least a 25% dose reduction, or in secondary endpoints including self-reported anxiety symptoms and sleep quality.
    • “Experts noted that this intervention may be of interest only to patients already motivated to decrease use, though the findings are encouraging given the prevalence of benzodiazepine dependence.”
  • Genetic Engineering and Biotechnology News relates,
    • “Mucosal surfaces that line the body are embedded with defensive molecules that help keep microbes from causing inflammation and infections. Among these molecules are lectins, proteins that recognize microbes and other cells by binding to sugars found on cell surfaces.
    • “Researchers headed by a team at the Massachusetts Institute of Technology (MIT) have now found that one of these lectins, known as intelectin-2 (hItln2), has broad-spectrum antimicrobial activity against bacteria found in the gastrointestinal tract. Their preclinical studies showed that this lectin binds to sugar molecules found on bacterial membranes, trapping the bacteria and hindering their growth. Additionally, the study found that intelectin-2 can crosslink molecules that make up mucus, helping to strengthen the mucus barrier.”
  • and
    • “Candida auris is an emerging threat, primarily to hospital patients and residents of nursing homes. The fungus easily spreads, colonizes surfaces and objects where it can survive for weeks to months, is often resistant to standard disinfectants, and can cause life-threatening infections. Although those infections, in principle, can be treated with several antifungal medications, strains of the pathogen that have developed antimicrobial resistance (AMR) against those drugs have become a difficult challenge for hospital physicians.
    • “Clinicians need a much more effective diagnostic approach to accurately quantify the abundance of the pathogen in patients and assess its antifungal resistance in order to better respond to C. auris infections in their patients and help prevent future hospital-associated outbreaks,” said Justin Rolando, PhD, a postdoc in the Walt lab at the Wyss Institute. “Current diagnostic methods for detecting C. auris are too costly, slow, and dependent on complex equipment and trained personnel in order to effect real change.”
    • “A new study presents a diagnostic approach that enables fast and accurate quantification of C. aurisstrains from swab samples, as well as the quantification of AMR-causing mutations in fungal populations with mixed antifungal susceptibility.
    • “The findings are published in Nature Biomedical Engineering in the paper, “Digital CRISPR-based diagnostics for quantification of Candida auris and resistance mutations.”
  • Per BioPharma Dive,
    • “Johnson & Johnson’s Tecvayli helped people with multiple myeloma live longer than those who’d received standard drug combinations in a Phase 3 trial, the company said Wednesday. 
    • “J&J enrolled who’d relapsed after receiving frontline therapies and administered either Tecvayli — a dual-targeting antibody drug — or widely used regimens involving medicines like Velcade and Kyprolis. Trial enrollees who got Tecvayli were 71% less likely than those in the comparator group to die or have their disease progress during the trial, J&J said. 
    • “This trial builds on evidence supporting early use of Tecvayli in multiple myeloma. At a medical meeting last year, J&J presented results showing a combination of Tecvayli and another drug it sells called Darzalex might be curative when administered early in a patient’s disease course.”

From the J.P. Morgan healthcare conference which wrapped up today,

  • Fierce Healthcare reports,
    • “Ascension’s $3.9 billion deal to acquire AmSurg and its 34-state footprint is a doorway for the massive nonprofit system to enter 25 additional markets and strike new partnerships with independent physicians and other health systems, President and CEO Eduardo Conrado said this week at the 2026 J.P. Morgan Healthcare Conference.
    • “The newly minted top executive, speaking in a presentation to attendees and in a subsequent interview with Fierce Healthcare, affirmed that the portion of AmSurg’s 250-plus managed ambulatory surgery centers (ASCs) already in Ascension’s 10 existing markets will help the system build out its networks.
    • “This will allow Ascension to capture and serve more patients, shift low-acuity cases out of the hospital to sites that are lower cost and often preferred by patients, and increase case mix index among hospitals where the company is spending big to update its clinical programs and equipment, he said. Ascension’s plans to build new wholly owned ASCs on its home turf also provide an opportunity to better serve the likely influx of uninsured patients on the horizon, he added.”
  • and
    • “Medicare Advantage (MA) insurer Clover Health is leaning on strong performance in the annual enrollment period and financial growth to turbocharge the company in the coming months.
    • “The insurtech presented at the J.P. Morgan Healthcare Conference on Thursday morning, and CEO Andrew Toy told investors that achieving earnings before interest, taxes, depreciation and amortization profitability is a key turning point on the company’s broader goal of reaching net income profitability.
    • “The company announced Wednesday in advance of the session that it is on track for full-year general accepted accounting principles profitability in 2026 for the first time. This is on the back of 53% year-over-year membership growth in the annual enrollment period and high quality scores under the star ratings.
    • “Clover kicks off the year with about 153,000 members, with 97% of them enrolled in the insurer’s central PPO plan, which has a No. 1 ranking nationally on core HEDIS quality measures.”
  • Per Modern Healthcare,
    • “Talkspace plans to launch a mental health support AI agent that is HIPAA protected, and incorporates clinically recognized standards of care.
    • “Mental health support requires something much more specialized and nuanced, including challenging distorted thinking, recognizing delusions and identifying risk in real time,” CEO Dr. Jon Cohen told attendees.
    • “The company has identified depression screening, risk monitoring and additional support between therapy sessions as possible use cases. Its AI agent is in beta testing mode, and is slated to go live in the first half of 2026, Cohen said.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Novo Nordisk started marketing its Wegovy weight loss medication in pill form this month.
    • “Employers which are struggling to manage spending on glucagon-like peptide-1 agonists, or GLP-1s, such as Wegovy, could face higher demand from workers for the pill.
    • “The price for Wegovy pills is comparable to the cost of injectable GLP-1s.
    • “Employers are scaling back GLP-1 coverage as spending rises amid mixed evidence of improved health and lower spending.”
  • and
    • “Sutter Health plans to form new partnerships outside its home base of California. 
    • “The system named Scott Nordlund to lead this initiative as the executive vice president of corporate development and partnerships. 
    • “Nordlund was previously the executive vice president and chief strategy and growth officer for Banner Health.”
  • Kaufmann Hall informs us that “Despite a decline in hospital performance and volume this month, year-to-date revenue, volume, and margins are still strong compared to prior years. The latest issue of the National Hospital Flash Report covers these and other key performance metrics.” and offers a review of 2025 hospital and healthcare system merger and acquisition activities.
  • MedTech Dive relates,
    • “Boston Scientific plans to acquire Penumbra for about $14.5 billion, the companies announced Thursday.
    • “Penumbra makes heart devices to remove clots from blood vessels, treating conditions including pulmonary embolism, stroke and deep vein thrombosis. It also makes an embolization system, designed to stop blood flow to control bleeding.
    • ‘Boston Scientific CEO Mike Mahoney sees an “opportunity to enter new, fast-growing segments within the vascular space,” he said in a statement.”
  • and
    • “Medtronic has partnered with Precision Neuroscience to pair a brain computer interface with its neurosurgical platform.
    • “The agreement, which the companies disclosed Monday, supports co-development of a system that integrates Precision’s Layer 7 cortical interface with Medtronic’s StealthStation surgical navigation system.
    • “Precision said the alliance will shorten the path to widespread clinical use of Layer 7 by enabling surgeons to use its high-resolution electrode technology with a familiar Medtronic system.”

Midweek report

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

From Washington DC

  • The House of Representatives approved an appropriations bill (HR 7006) that includes OPM appropriations by a 341-79 votes this afternoon. The bill now moves onto the Senate for its consideration.
  • Roll Call offers more details on the state of the Congressional effort to pass the twelve appropriations bills in regular orde.
  • Beckers Payer Issues reports,
    • “A bipartisan group of senators working to revive the ACA enhanced tax credits that expired at the end of 2025 said they won’t have their proposal ready until the end of January, Politico reported Jan. 13. 
    • “Sen. Bernie Moreno, R-Ohio, a lead negotiator, previously said the legislative text could be ready as early as Jan. 12, but told Politico, “[W]e have to make sure we get this right.”
    • “Mr. Moreno said Republicans and Democrats involved in the discussions have not yet resolved how to address the Hyde Amendment, which bars federal funding from covering abortions, according to the report. Under the law, ACA marketplace insurers must segregate funds that go toward abortion services from funds that go to all other health services. Republicans and Democrats disagree on whether that segregation complies with the Hyde Amendment.” 
  • Axios adds,
    • “Long-stalled bipartisan priorities that are in play include an overhaul of pharmacy benefit manager practices, as well as a measure that would place more controls on Medicare outpatient spending. 
    • “They’d likely be combined with a renewal of health programs due to expire Jan. 30, including certain Medicare telehealth flexibilities and funding for community health centers.”
  • Healthcare Dive tells us,
    • “National healthcare spending reached $5.3 trillion in 2024 as Americans continued to ravenously consume healthcare coming out of the coronavirus pandemic, according to a new report from CMS actuaries.
    • “Growth in healthcare spending continued to outpace that of the overall economy. As a result, healthcare’s share of the U.S. gross domestic product increased from 17.7% in 2023 to 18% in 2024, researchers said in the report released Wednesday in Health Affairs.
    • “The sharp health spending growth was not driven by increasing costs for goods and services. Instead, it was fueled by intense consumer demand for medical care, and changes in what types of medical care was consumed, CMS actuaries said.
    • “Prices are a factor. They’re part of the equation. But non-price factors were the driver,” Micah Hartman, a statistician with the CMS’ Office of the Actuary, said in a call with press on Wednesday.”
  • Modern Healthcare adds,
    • “Health insurers struggling with rising medical expenses may have less of a cushion in 2026. 
    • “Companies such as UnitedHealth Group reaped gains on their investments over the past several years that bolstered their finances and offset narrowing profit margins or losses from operations.
    • “Broader economic factors are at work though. The Federal Reserve signaled last month that it intends to cut the benchmark interest rate for the fourth time since the beginning of 2025. In addition, Standard & Poor’s Global Ratings projects that yields on 10-year Treasury bonds will continue to decline, which would indicate waning investor confidence in the economy. 
    • “These circumstances would squeeze health insurance company finances at a time when many of the companies are struggling to restore profit margins, said Whit Mayo, senior managing director and senior research analyst at investment bank Leerink Partners.
    • “It’s not a helpful headwind in the context of the challenging, persistent elevated-cost-trend environment,” Mayo said.” 
  • MedPage Today points out,
    • “There’s a reason that the ACA specifies the [U.S. preventive services] task force as the organization insurers must pay attention to, according to Aaron Carroll, MD, president and CEO of AcademyHealth. “No one else has the rigorous transparency in process that the USPSTF has,” he said in an online interview at which a public relations person was present. “They are very clear and transparent in how they gather the evidence, how they grade the evidence, what was actually included, and how they are deliberating. Other organizations may do that, but they do not do it as consistently … which is why the ACA is pegged to them and not to each individual society.”
    • “However, the Trump administration has taken actions recently that have slowed the task force’s work. A planned meeting of the task force in July was canceledopens in a new tab or window, and its November meeting was postponedopens in a new tab or window. No new meeting dates have been announced, according to the New York Timesopens in a new tab or window. In addition, the Timesreported, the terms of five members of the 16-member task force expired on Dec. 31, with no plans announced for their replacements, even as four draft guidelines are set to be finalized. Those guidelines address screening adults for unhealthy alcohol use, self-swabs for cervical cancer screening, counseling for women at increased risk for perinatal depression, and the use of vitamin D supplements to prevent fractures and falls in older people (the task force’s draft guideline recommended against the latter preventive measure).” * * *
    • “Last week, the Health Resources and Services Administration (HRSA) issued guidelines in support of self-swabs to screen for cervical cancer. However, although the ACA also requires insurers to cover preventive services recommended by HRSA, “the difference is in the rigor of the process with high transparency and public input at every stage of the process that the USPSTF adheres to, as opposed to the HRSA process,” Melissa Simon, MD, MPH, vice chair of obstetrics and gynecology research at Northwestern University in Chicago, said in an email. “It is through that highly rigorous and successful methodology that USPSTF adheres to for the decades it has been in existence that lends itself to [being] one of the most trusted preventive services [recommendation bodies] for the U.S.”
  • Fierce Healthcare informs us,
    • “The Paragon Health Institute, a conservative health policy think tank, has launched an AI Initiative that will deliver market-based policy recommendations to the Trump administration and Congress on AI in healthcare. 
    • “Paragon already has an ear with the administration. Its president, Brian Blase, was an economic advisor to President Donald Trump during his first term and formerly worked at the Heritage Foundation. Moreover, several Paragon directors and advisers joined the second Trump administration to lead health policy. Some of the think tank’s proposals, including limits on states’ use of federal Medicaid funds, also made it into the text of last summer’s One Big Beautiful Bill Act.
    • “The Health AI initiative will be led by Kev Coleman, a technologist and healthcare researcher, who has already published several policy papers on the topic as a research fellow at Paragon.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration is expected to decide on approval of Eli Lilly’s obesity pill orforglipron in the second quarter of 2026, Lilly CEO David Ricks said Tuesday, giving it a chance to quickly follow to market an oral version of Wegovy that rival Novo Nordisk launched last week. 
    • “The FDA granted Lilly a “national priority” voucher for orforglipron that could significantly accelerate the agency’s evaluation. While no statutory deadline exists under that program because it’s never been authorized by Congress, Ricks said he expects a “rapid review” that is “moving at pace.”
    • “A second-quarter launch would be well-timed for Lilly to begin selling orforglipron to the millions of people enrolled in Medicare, which will have broad access to obesity medications beginning in April.”
  • MedPage Today relates,
    • “Modern Warrior is recalling all lots of its Modern Warrior Ready supplement, marketed for boosting brain function, after the detection of undeclared 1,4-DMAA, aniracetam, and tianeptine, the latter of which has been linked to suicidal ideation or behavior in kids and young adults, according to the FDA. (The Hill)”
  • and
    • “The FDA requested that manufacturers of GLP-1 receptor agonists remove information regarding risks of suicidal behavior and ideation from drug labels following a detailed review of existing data, the agency announced on Tuesday.
    • “Affected products include those indicated for weight management, including tirzepatide (Zepbound), semaglutide (Wegovy), and liraglutide (Saxenda).
    • “Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 receptor agonist medications,” the agency said in a statement.”
  • and
    • “The FDA told influenza vaccine makers they should add a warning about an increased febrile seizure risk in babies and preschoolers the day after flu vaccination.
    • “The agency made the announcement opens in a new tab or windowin safety labeling notification letters sent Jan. 9 to the manufacturers of six flu vaccines.
    • “The new language in the label would state, “In two separate postmarketing observational studies, an increased risk of febrile seizures was observed during the first day following vaccination with standard dose trivalent (2024-2025) and quadrivalent (2023-2024) influenza vaccines in children 6 months through 4 years of age.”
  • MedTech Dive notes,
    • “Boston Scientific has received Food and Drug Administration approval for a new pulsed field ablation catheter that is indicated for use as an adjunctive device in a type of ablation that is performed when treating persistent atrial fibrillation.
    • “Called Farapoint, the device can deliver linear and focal lesions across complex heart anatomies in a single catheter while preserving surrounding cardiac tissue, the company said in an emailed statement Tuesday. The catheter can be combined with the company’s Faraview software module on the Opal HDx mapping system to enhance visualization of the catheter and lesion formation.
    • “Boston Scientific said clinical data supporting the approval, in cavotricuspid isthmus ablation, demonstrated the device was safe and effective, and showed high effectiveness in preventing atrial flutter recurrence.”

From the judicial front,

  • Beckers Payers Issues discusses ten recent healthcare billing fraud cases.
  • It’s worth adding that the GAO announced today,
    • “The federal government loses hundreds of billions of dollars annually to fraud. We issued the Fraud Risk Framework in 2015 to help managers prevent, detect, and respond to fraud.
    • “However, agencies aren’t doing enough to evaluate their antifraud efforts. In 2023, we surveyed 24 federal agencies and found
      • a third didn’t have regular monitoring or evaluation activities
      • half didn’t regularly make changes based on evaluation results
    • “We are issuing this technical appendix to our framework to help managers evaluate and adapt their antifraud efforts. These efforts can aid program integrity, protect taxpayer dollars, and maintain public trust.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “South Carolina health officials yesterday said the state now has 434 measles cases after 124 new cases have been confirmed. 
    • “There are currently 409 South Carolinians in quarantine and 17 in isolation, with some quarantines extending to February 6. Mobile vaccine units will be active this week, and officials urge local residents to get vaccinated.” * * * 
    • “In other measles news, Utah has 25 new cases, raising the state total to 201. Southwest Utah has the most cases, at 147, followed by Utah County with 24 cases, and Wasatch County with 9 cases. 
    • “Arizona officials yesterday confirmed three new measles cases in the state, all from this year. All three are in Mohave County, which has seen a lingering cross-border outbreak with Southwest Utah for several months. Arizona’s outbreak has now reached 217 infections.”
  • STAT News reports,
    • “U.S. overdose deaths fell through most of last year, suggesting a lasting improvement in an epidemic that had been worsening for decades.
    • “Federal data released Wednesday showed that overdose deaths have been falling for more than two years — the longest drop in decades — but also that the decline was slowing.
    • “And the monthly death toll is still not back to what it was before the Covid-19 pandemic, let alone where it was before the current overdose epidemic struck decades ago, said Brandon Marshall, a Brown University researcher who studies overdose trends.
    • “Overall I think this continues to be encouraging, especially since we’re seeing declines almost across the nation,” he said.”
  • Per Cardiovacular News,
    • “In many ways, cardiovascular health throughout the United States has improved significantly over the years. However, thanks in part to an aging population and the impact of the COVID-19 pandemic, there are certain areas where patient outcomes are trending in the wrong direction.
    • “To learn more about this topic, researchers performed the first comprehensive report of its kind, tracking the latest data on a variety of risk factors and cardiovascular conditions. They published their findings in JACC, the flagship publication of the American College of Cardiology (ACC).[1] 
    • “Progress in cardiovascular health depends on knowing where we stand,” wrote first author Rishi K. Wadhera, MD, MPP, MPhil, associate director and section head of health policy at Richard A. and Susan F. Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center, and colleagues. “To improve, we must measure—not occasionally, but consistently, transparently and with purpose.”
    • “One key takeaway from the report is that there is still plenty of room for improvement in terms of patient outcomes.
    • “Across all risk factors and conditions, persistent disparities by race, geography, and socioeconomic status emerge as a central finding—one that demands focused attention and action,” the authors wrote. “The report also reveals other critical gaps: places where information is incomplete, where our collective understanding falls short, and where new data are urgently needed.”
  • CNN reports,
    • “The Defense Department has spent more than a year testing a device purchased in an undercover operation that some investigators think could be the cause of a series of mysterious ailments impacting US spies, diplomats and troops that are colloquially known as Havana Syndrome, according to four sources briefed on the matter.
    • “A division of the Department of Homeland Security, Homeland Security Investigations, purchased the device for millions of dollars in the waning days of the Biden administration, using funding provided by the Defense Department, according to two of the sources. Officials paid “eight figures” for the device, these people said, declining to offer a more specific number.
    • “The device is still being studied and there is ongoing debate — and in some quarters of government, skepticism — over its link to the roughly dozens of anomalous health incidents that remain officially unexplained.
    • “CNN has asked the Pentagon, HSI and the DHS for comment. The CIA declined to comment.”
  • MedPage Today points out,
    • “Nearly 76% of households with prediabetes patients had additional members who had diabetes risk factors.
    • “Many of these household members had overweight or obesity.
    • “EHR data could identify at-risk households and help target family-centered diabetes prevention strategies, the researchers suggested.”
  • and
    • “Physicians viewed 17% of patient encounters as difficult, according to a meta-analysis.
    • “Patient characteristics associated with perceived difficulty included personality disorders, depression, anxiety, and chronic pain.
    • “The researchers suggested a need for more training in handling difficult encounters.”
  • Healio notes,
    • “Bystander CPR as depicted on TV frequently did not align with correct real-world procedures and experience.
    • “These inaccuracies may skew lay perceptions of cardiac arrest and negatively influence bystander CPR.”

From the. J.P. Morgan healthcare conference,

  • Genetic Engineering and Biotechnology News reports,
    • “They met for the first time in 2018. David A. Ricks, a year into his tenure as Eli Lilly’s Chair and CEO, hosted Jensen Huang at Lilly’s Indianapolis headquarters campus, where the Nvidia founder and CEO gave a talk to the pharma giant’s management team about a new technology called artificial intelligence (AI) and its potential in reshaping drug discovery.” * * *
    • “The two CEOs recalled their first meeting on Monday, when they entertained a packed ballroom at the Fairmont San Francisco hotel, a hilly half-mile north of where the J.P. Morgan 44th Annual Healthcare Conference is taking place. The occasion was a Huang-hosted “fireside chat” in which he and Ricks discussed the companies’ latest partnership, and extolled the promise and potential of AI to reshape not just drug discovery but the development of new treatments and their uptake by patients.
    • “The Silicon Valley microprocessing giant and pharma powerhouse announced a five-year, $1 billion partnership to create a “Co-Innovation AI Lab” designed to address key challenges in AI drug discovery.”
  • STAT News lets us know,
    • “Pfizer CEO Albert Bourla said earlier this week that “the goal in obesity is to become a leading player.” No surprise. But he was also asked about his prediction a year ago that President Trump would be a net positive for the pharmaceutical industry.
    • “Yes,” he said, “but I have to say that I got scared big time” along the way. The big win, from his perspective: The United Kingdom agreeing to raise prices for medicines as part of a trade deal with the U.S. This, he said, changed the dynamic between European companies and the pharmaceutical industry and would not have happened without Trump, who, Bourla also reiterated, deserved a Nobel Prize for supporting the development of Covid vaccines.
    • “But Bourla also expressed some worries about elements of the administration. He continued to say that the pressure it was putting on vaccines is “an anomaly that will correct itself” and reiterated that Pfizer is doing its own vaccine research, including developing a Lyme disease inoculation.
    • “He also expressed concern about developments at the Food and Drug Administration, including the departure of former top official Richard Pazdur. Bourla called Pazdur “a legend in regulatory work globally” and said that he was “very concerned” when Pazdur resigned after only two weeks on the job.”
  • Fierce Healthcare reports,
    • “Surescripts is teaming up with Good Rx to surface key prescription discounts to consumers.
    • “The health information network announced Tuesday at the J.P. Morgan Healthcare Conference that it would launch Script Corner, a new patient experience platform. Script Corner unites key benefit data, medication management tools and personalized engagement to smooth out their medication experience.
    • “The tool is also being built with price transparency in mind, in part through offering discounted cash prices in an exclusive partnership with GoodRx.
    • “Frank Harvey, CEO of Surescripts, said at the conference that while many apps and tools aim to arm patients with key transparency data, but the Script Corner platform is the first to put that in the palm of their hands.”
  • Fierce Healthcare also offers more stories from day 3 of the conference.

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

  • Fierce Healthcare reports,
    • “Insurance giant UnitedHealthcare is rolling out a new program that aims to support the finances of cash-strapped rural hospitals.
    • “Through the pilot, UHC will accelerate the payment timelines in its Medicare Advantage plans by 50% over the next six months, lowering the time from an average of less than 30 days to less than 15 days, according to an announcement from the company.
    • “The insurer said in the announcement that the program is designed to “deliver immediate cash‑flow relief and support the sustainability of these important rural hospitals.” * * *
    • “The pilot will initially launch in four states: Oklahoma, Idaho, Minnesota and Missouri. UnitedHealth said the first participants were selected based on their potential to “maximize impact” and support the future of this initiative and the development of additional interventions in rural healthcare.”
  • Beckers Hospital Review shares “McKinsey’s 2026 healthcare predictions: 5 takeaways for hospital leaders.” 
  • Fierce BioTech relates,
    • “Still riding the high of last year’s twice-yearly HIV PrEP approval of lenacapavir as Yeztugo, Gilead Sciences is approaching dealmaking from a “position of strength” as a more mature biopharma, according to CEO Daniel O’Day.
    • “When you’re a company that’s cured a disease and showed curative potential in another disease and are on the verge of ending an epidemic, you’re kind of bold about your aspirations,” said O’Day, referring to the company’s hepatitis C and HIV medicines.
    • “Since O’Day joined Gilead from Roche in 2018, the California company has built three primary focus areas: virology, cancer and inflammation. In all three, Gilead’s recent successes have given the pharma the luxury of being selective in the external assets it considers, O’Day explained.
  • Healthcare Dive calls attention to the “Top healthcare AI trends in 2026.”
    • “While health systems will continue their AI rollout, use of the technology could evolve amid intensifying competition from EHRs, fragmented regulations and growing M&A opportunities.”

Tuesday report

David Ermer–CDC, Congress, Electronic health records, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Tomorrow, the House of Representatives will vote on the appropriations bill that funds the FEHB and PSHB, among other programs, H.R. 7006 – Financial Services and General Government and National Security, Department of State, and Related Programs Appropriations Act, 2026
  • Beckers Hospital Review tells us whether the ACA healthcare premium subsidies stand.
  • Fierce Healthcare adds,
    • “The Trump administration has released a new update on enrollment on the Affordable Care Act’s exchanges, with signups lagging notably behind figures for the 2025 plan year.
    • “Per the latest snapshot report, nearly 22.8 million people have signed up for coverage across the exchanges through Jan. 3. By comparison, 23.6 million people had enrolled in ACA plans through Jan. 4, 2025, according to a report from a year ago.
    • “Of that total, the Centers for Medicare & Medicaid Services said 2.8 million individuals are new enrollees, while nearly 20 million are returning customers. Close to 15.6 million people signed up for coverage through Healthcare.gov, and 7.2 million used a state-based exchange, according to the report.
  • Beckers Payer Issues provides us with eleven No Surprises Act updates.
  • BenefitsLink calls our attention to a November 2025 IRS notice that provides for inflation adjustments to qualifying payment amounts issued in 2026 under the No Surprises Act. According to BenefitsLink, the notice was not well publicized.
  • Milliman assesses “Medicare drug price negotiation: Navigating the next wave of maximum fair prices.”
  • BioPharma Dive adds,
    • AbbVie is the latest among more than a dozen of the world’s largest drugmakers to sign a drug pricing deal with the White House, announcing late Monday a deal to invest $100 billion in U.S. pharmaceutical research and manufacturing and lower some product costs in return for tariff relief. 
    • As with the many other deals revealed between the Trump administration and large pharma companies, the agreement is short on details as well as its potential impact on AbbVie’s earnings. AbbVie only said that it will provide “low prices” to Medicaid and boost efforts to sell through a government portal widely used medicines like Humira, Alphagan, Combigan and Synthroid — all of which are off-patent and face competition from lower-cost biosimilars or generics. 
  • Per an HHS news release,
    • The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of two new members to the CDC Advisory Committee on Immunization Practices (ACIP). These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to transparency, gold standard science, and diverse expertise in guiding the nation’s immunization policies. In June 2025, Secretary Kennedy reconstituted ACIP to restore public trust in vaccines.
    • The new members are Adam Urato, MD, and Kimberly Biss, MD.
  • MedPage Today offers backgrounds on the new members.
  • Federal News Network notes that “A sea of challenges opens up with 105,000 feds retiring.”
    • “The one-year drop in the number of GS-14s and GS-15s across government is causing some to be concerned about the future of federal management.”

From the Food and Drug Administration front,

  • MedTech Dive points out,
    • “Medtronic said Monday it received 510(k) clearance from the Food and Drug Administration for an app to connect its smart insulin pens with a glucose sensor made by Abbott.
    • “The app, called MiniMed Go, provides alerts for missed insulin doses, a dose calculator and guidance on what to do if a person misses a dose. It also includes software reporting for providers.
    • “The pairing is part of a partnership Medtronic struck in 2024 for Abbott to make an integrated continuous glucose monitor sold exclusively by Medtronic.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The five-year survival rate for all cancers in the U.S. has reached 70% for the first time, according to a report published Jan. 13 by the American Cancer Society. The study analyzed diagnosed cases of cancer in the U.S. from 2015-2021. Among the findings, the study said that since the mid-1990s, there have been notable gains in the survival rates for more fatal cancers, such as myeloma (from 32% to 62%), liver (7% to 22%) and lung cancers (15% to 28%). The cancer mortality rate declined by a total of 34% since peaking in 1991, averting 4.8 million deaths since then.”
  • and
    • “A study released Jan. 12 by the Journal of the American College of Cardiology analyzed the current state of heart health in the U.S., highlighting the burden of disease, quality of care and mortality trends of risk factors and conditions that can lead to heart disease. The study found no change in the prevalence of hypertension among U.S. adults from 2009-2023 but found that hypertension-related cardiovascular deaths nearly doubled from 23 per 100,000 in 2000 to 43 per 100,000 in 2019. The prevalence of diabetes in U.S. adults increased from 11.9% in 2009-2010 to 14.1% in 2021-2023. Deaths related to type 2 diabetes increased from 30.4 per 100,000 adults in 2009 to 54 per 100,000 adults in 2023. The study analyzed other risk factors and conditions such as obesity, cigarette smoking and stroke, among others.”
  • STAT News adds,
    • “46% of U.S. counties don’t have a cardiologist. ARPA-H’s new agentic AI program could bring them specialized care.”
      • “The Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) program will support the development of Food and Drug Administration-authorized full-stack solutions that use agentic artificial intelligence to autonomously provide specialty care for every American living with advanced heart disease.”
  • The Washington Post explains how to know when to keep your kids out of school.
  • Per Genetic Engineering and BioTechnology News,
    • “Tahoe Therapeutics, Arc Institute, and Biohub have each made a multi-million dollar commitment to fill the massive data gap for virtual cell models. The teams exclusively told GEN Edge that more than 120 million single cell data points across 225,0000 perturbations will be generated using Tahoe’s Mosaic technology for mapping how drug molecules interact with biology.
    • “All three organizations lead a field that builds AI models trained on transcriptome data to predict how cell gene expression changes with cell states. In therapeutics, these virtual cells could gleam insight into new drugs capable of shifting cells from “diseased” to “healthy” with fewer off target effects.” 

From the J.P. Morgan Healthcare Conference,

  • Healthcare Dive reports
    • “JPM26: Dr. Oz, CMS leaders make their pitch to hospitals, payers on Trump admin healthcare policies.
  • and
    • “JPM26: CommonSpirit CEO teases new divestures, outlines AI wins and pitfalls”
  • Fierce Pharma offers a potpourri of biopharma stories from day 2.
  • STAT News adds,
    • It will be hard for OpenEvidence to top its 2025. The company announced nearly $500 million in funding last year and seemingly overnight became a go-to tool in the medical profession. A slide during the company’s Monday JPM presentation claims that queries to the company’s clinical evidence chatbot grew from 2.6 million in 2024 to 17.9 million in December 2025, with well over 100 million queries for the year.
    • “The company also revealed it will be launching “medical super-intelligence.” What does that mean? Katie Palmer explains in a new story.”

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

  • Beckers Hospital Review reports,
    • San Antonio-based University Health is investing $1.7 billion in a five-year expansion, including two new community hospitals and two multispecialty clinics.
  • and
    • “Skilled nursing facility operating capacity dropped by 5% in the U.S. between 2019 and 2024, according to a study published Jan. 12 in JAMA Internal Medicine.” 
  • STAT New relates,
    • “Illumina became a genomics juggernaut by developing machines that could read large amounts of DNA accurately and quickly. But the company’s betting the next phase of its growth will be accelerated by helping customers better understand genetic data and apply it to drug development.
    • “The San Diego firm took a step in that direction on Tuesday, when it unveiled what it says will be the world’s largest dataset of its kind, the Billion Cell Atlas. The atlas is based on the results of turning on or off genes across 200 cell lines, including lines used to study heart disease, neurologic disorders, immune conditions, and cancer.”
    • “Data on how these genetic perturbations affect cells could in principle help drug companies validate drug targets or create “virtual cells,” artificial intelligence-powered models of cell behavior. Thus far, Illumina has generated data from about 150 million cells and expects to reach a billion by the end of the year. The company’s already offering the atlas as a resource for pharmaceutical companies, with Merck, AstraZeneca, and Eli Lilly as its first customers. Several others have expressed interest, too, according to CEO Jacob Thaysen.”
  • Per MedCity News,
    • “If there’s any single company that understands or should understand the value of health data and its importance in patients’ lives, it’s Wisconsin-based EHR company Epic.
    • “And yet, while the company announced a whole host of future AI efforts last August, including a digital companion for patients called Emmie, it was OpenAI — which announced ChatGPT Health last week — that has actually given people the power to query their medical records and gain insights. Anthropic is announcing a similar capability for Pro and Max users of its Claude generative AI platform. Like Epic, other companies that demonstrated an understanding of that broad patient need also missed the boat.
    • “But in an interview on Friday, Epic’s chief medical officer pushed back on the notion that this was a “missed opportunity” for the EHR company.
    • “I would categorize it, instead of a missed opportunity, as thoughtfully developed over multiple years on top of other non-AI MyChart development and AI that’s actually going to be more thoughtful and tuned to your medical history and your personal medical care,” declared Dr. Jackie Gerhart, also a practicing family physician and vice president of clinical informatics.
    • “Gerhart, who has been with Epic for seven years, and another Epic R&D expert took some pains to describe how the company is developing the capabilities of Emmie, the digital concierge, deeply embedded within the EHR and able to not only handle simple queries like “create an exercise plan”or “explain my lab results” but also nudge you to do the things that you should do for better health.”

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.” 

Weekend Update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • Tomorrow, the Senate will take a final vote on H.R. 6938, Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026, which the House of Representatives already has passed. When as expected, the Senate passes this bill, Congress will have passed half of the twelve appropriations bills in regular order.
  • Roll Call offers more insights into the state of the appropriations process.
    • “The House, meanwhile, looks to move forward with a bundle of two more spending bills, including funding for the State Department, the Treasury and an assortment of related agencies including the White House itself.”
    • While the Senate has scheduled a recess for next week, “[t]he House is expected to be in session next week except for Jan. 19, which is Martin Luther King Jr. Day.”
  • Per a Senate news release,
    • “On Thursday, January 15, [at 10 am ET] the Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on several bipartisan bills to improve American families’ health.
    • “The bills under consideration include:
      • “S. 1157, Women and Lung Cancer Research and Preventive Services Act
      • “S. 921, Tyler’s Law
      • “S. 2169, Rural Hospital Cybersecurity Enhancement Act
      • “S. 272, Protect Infant Formula from Contamination Act.” * * *
    • “Click here to watch live.”
  • Per a House news release,
    • “Ways and Means Committee Chairman Jason Smith (MO-08) and Energy and Commerce Committee Chairman Brett Guthrie (KY-02) announced the details for an upcoming hearing with five of the biggest health insurance company CEOs to answer questions on making health care more affordable for all Americans.” * * *
    • “The date of the hearing will be January 22, 2025, with the panel appearing before the House Committee on Energy and Commerce Subcommittee on Health in the morning, and the House Committee on Ways and Means in the afternoon. 
    • “Company CEOs in attendance will be UnitedHealth Group, CVS Health, Elevance Health, The Cigna Group, and Ascendiun (the parent company of Blue Shield of California).”
  • Govexec tells us,
    • “The Trump administration is bringing back an awards program for senior executives after canceling it for fiscal 2025. 
    • “In a Jan. 5 memo, Office of Personnel Management Director Scott Kupor asked agencies to nominate up to nine percent of their highest-ranking career employees for the fiscal 2026 presidential rank awards. The program was established in 1978 to honor civil servants who have exhibited consistent achievement.”
  • BioPharma Dive reports,
    • Johnson & Johnson on Thursday [January 8] became the latest pharmaceutical company to agree to “most favored nation” pricing in return for a reprieve on pharmaceutical tariffs. The company didn’t provide many specifics in its announcement. But it’ll participate in a government online channel for drug purchasing; enable U.S. patients to access drugs at comparable prices to what’s paid in foreign countries; and give the same prices to Medicaid, which already has best-price guarantees. J&J will also build a cell therapy plant in Pennsylvania and a facility in North Carolina as part of its $55 billion commitment to boost U.S. manufacturing capacity.

Frrom the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT). The agency’s more flexible approach has been, and is expected to continue to be, helpful in expediting product development and will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission.  
    • “Regulatory flexibility must be tailored for cell and gene therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “These are common-sense reforms that will address the unique characteristics of cell and gene therapies and foster more innovation.”
  • The Washington Post explains the problem that the FDA seeks to resolve.
    • “Genetic therapies could be used to treat hundreds of diseases. The path to patients is tricky.”
  • STAT News notes,
    • “Stoke Therapeutics and the Food and Drug Administration were unable to reach agreement on an expedited submission for the company’s severe epilepsy treatment, the company said Sunday. 
    • “Following a meeting in December, the FDA did not shut the door on Stoke’s request to submit zorevunersen, a treatment for Dravet syndrome, later this year, rather than wait for the completion of an ongoing Phase 3 study in the middle of 2027, Stoke CEO Ian Smith told STAT in an interview.
    • “Instead, regulators asked the company to submit more information, and further discussions are planned. Stoke expects to make a decision on a regulatory path for zorevunersen by the middle of the year.” 

From the public health and medical / Rx research front,

  • Medscape relates,
    • “Different subgroups of patients with adult-onset diabetes showed different rates of comorbidities and mortality outcomes. Patients with severe insulin-resistant diabetes (SIRD), a high-risk subtype, were most likely to have kidney, liver, and heart diseases despite having only mild hyperglycemia, and some of these conditions were present even before diabetes was diagnosed.”
  • Healio points out,
    • “Between 50% to 75% of children struggle with adhering to health care regimens.
    • “Rebecca Liu, a senior at UCLA, described her idea for a game that could educate children about their health and improve adherence.”
  • The Wall Street Journal considers,
    • “What Time Should You Wake Up? Probably Not 5 a.m.
    • “Sleep experts warn against rising too early if you’re not naturally a morning person, and provide tips for a better night’s sleep.” * * *
    • “Your ideal rise time is linked to your chronotype, your genetic predisposition to waking at a certain time. (If you need help understanding yours, take Breus’s quiz, which requests your name and email address.)”
  • MedPage Today reports,
    • “An immuno-oncology (IO) regimen for intermediate-stage hepatocellular carcinoma (HCC) significantly extended treatment benefit versus transarterial chemoembolization (TACE), according to an interim analysis of a randomized trial.
    • “Time to failure of treatment strategy (TTFS) increased from 9.5 months with TACE to 14.6 months with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin). Treatment-related adverse events (TRAEs), including grade ≥3 TRAEs, occurred more often with the systemic therapy, but no unexpected or excess fatal events occurred.
    • “The results provided justification to continue enrollment and follow-up to a second planned interim analysis later this year, reported Peter R. Galle, MD, of University Medical Center Mainz in Germany, at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.”

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

  • Modern Healthcare reports,
    • “The 44th annual J.P. Morgan Healthcare Conference kicks off Monday, drawing more than 8,000 healthcare executives and investors to San Francisco. 
    • “At a time of widespread uncertainty for the industry’s profit potential, companies will unpack their latest financial results while touting capital projects, technology advancements and merger and acquisition plans to private equity firms, venture capitalists and other potential investors. More than 500 public and private companies are expected to discuss a range of topics including artificial intelligence, biotechnology, personalized medicine, digital health, healthcare funding, regulation and glucagon-like peptide-1 drugs that treat diabetes and obesity.”
  • The Wall Street Journal adds,
    • “When Health Secretary Robert F. Kennedy Jr. released his MAHA Report in May, a who’s who of the wellness world convened at the White House for the occasion. There was the influential physician Mark Hyman, who co-founded the direct-to-consumer testing company Function Health, recently valued at $2.5 billion. Also in attendance: Alex Clark, the host of the popular Turning Point USA podcast “Culture Apothecary.” Longevity influencer Gary Brecka, who’d recently had Kennedy over to get intravenous drips and use Brecka’s hyperbaric chamber, was present, along with the “medfluencers” Dr. Will Cole and Dr. Paul Saladino.
    • “All of them support Kennedy’s ascent to the nation’s top health job. And all of them stand to gain from the spotlight he’s placed on alternative health. That’s because each of them has ties to the business of supplements, a $70 billion, lightly regulated U.S. market that could benefit from his support. On Brecka’s podcast, recorded after their wellness treatments, Kennedy vowed to end “the war on vitamins.”
  • Fierce Pharma lets us know,
    • As Novartis turns the calendar on a new year, the Swiss drugmaker is elaborating further on plans for the $23 billion U.S. investment it unveiled last April.
    • Next on the docket will be a new, 35,000-square-foot radioligand therapy (RLT) facility in Winter Park, Florida, Novartis reported Friday. 
    • Joining established plants in Novartis’ American RLT network in Indiana, New Jersey and California, the new facility will boost the company’s radiopharmaceutical manufacturing to “optimize the delivery” of the cutting-edge cancer treatments to patients across the southeastern United States, Novartis said in a Jan. 9 press release. The upcoming site is expected to come online by 2029, the company added. 
  • Buiness Insider relates,
    • “Anthropic is rolling out a major expansion of its healthcare and life-sciences offerings, as AI companies race to embed large language models more deeply into regulated medical workflows.
    • “The company on Sunday announced Claude for Healthcare, a product that allows healthcare providers, insurers, and consumers to use Claude for medical purposes through HIPAA-ready infrastructure. 
    • “The launch builds on Anthropic’s earlier release of Claude for Life Sciences, which focused on research and drug discovery, and reflects the company’s broader effort to position its AI models as practical tools for regulated industries.”

Notable Obituary

  • The New York Times reports,
    • “Dr. Joel Habener, an American endocrinologist who discovered GLP-1, the protein fragment that became the basis of Ozempic, Wegovy and other blockbuster weight-loss and diabetes drugs that are transforming 21st-century medicine, died on Dec. 28 in Newton, Mass. He was 88.
    • “His death, in a retirement community, was confirmed by his brother, Stephen, who said the cause was a heart attack.” * * *
    • “Dr. Habener’s discovery of GLP-1, in 1987, came about almost by accident. “It was a eureka moment,” he said in a 2023 interview, “which rarely happens in science.”
    • “He was a researcher at the time at Massachusetts General Hospital, where he arrived in 1971 and remained until his retirement in 2023.”