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%.”

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