Midweek report

CDC

Midweek report

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

From Washington, DC,

  • The New York Times reports,
    • “The director of the National Institutes of Health, Dr. Jay Bhattacharya, will take on the additional role of acting director of the Centers for Disease Control and Prevention, two administration officials said on Wednesday.
    • “Dr. Bhattacharya will continue to run the N.I.H., according to the officials, who insisted on anonymity to speak about personnel decisions before President Trump announces them. He will serve until Mr. Trump appoints a permanent director — a position that now requires confirmation by the Senate.
    • “The C.D.C. has run through a series of leaders since Mr. Trump returned to the White House last year.
    • “A physician and medical economist who left Stanford University to join the Trump administration, Dr. Bhattacharya has no formal training in public health. But his research has focused on the well-being of populations, which is the core mission of public health, and thus the C.D.C.”
  • Bloomberg Law relates,
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz said Tuesday that potential legislation to codify the Trump administration’s plan to link US drug prices to lower prices in other countries would need to take into account the needs of the pharmaceutical industry. 
    • “I think we’ve established a deep passion to preserve innovation,” Oz said at an annual forum hosted by the Pharmaceutical Research and Manufacturers of America, as he discussed the Trump administration’s most-favored-nation proposal. “If it’s not done right, a future administration will take more drastic, draconian steps in ways that would hurt this industry.”
    • “Oz also said during his fireside chat at the PhRMA forum with Pfizer Inc. CEO Albert Bourla that he wanted to “codify MFN in a way that industry finds is reflective of what was signed in the contracts.”
  • The American Hospital Association tells us,
    • “The Department of Health and Human Services Office for Civil Rights Feb. 13 announced the launch of a program to implement and enforce statutory and regulatory requirements under 42 CFR Part 2, which protect the confidentiality of substance use disorder patient records. As of Feb. 16, the program uses a range of civil enforcement mechanisms, including civil money penalties, to ensure compliance with new provisions from section 3221 of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. This section aligns federal privacy standards for SUD records more closely with those under HIPAA and strengthens confidentiality protections. In compliance with the provisions, HHS OCR has begun accepting complaints of alleged confidentiality violations and SUD record breach notifications.”
  • Adam Fein, writing in his Drug Channels blog, let us know,
    • “The Centers for Medicare & Medicaid Services (CMS) has just released its initial 2026 data on enrollment in Medicare Part D prescription drug plans (PDPs).
    • “DCI’s exclusive analysis shows that 83% of seniors remain enrolled in PDPs with preferred pharmacy networks—essentially unchanged from 82% in 2025, but sharply lower than the 99% peak in 2023. Meanwhile, the number of major Part D plans offering preferred networks has fallen to a record-low eight.
    • “The new enrollment data reveal a clear shift in competitive positioning: Albertsons and Publix are now preferred in every major plan. Walgreens is holding strong. Walmart—the company that invented the Part D preferred network model—has slipped to the middle of the preferred pack.
    • “Meanwhile, smaller pharmacies have fully abandoned PDPs’ preferred networks in 2026. 
    • “At the same time, the IRA’s expansion of the Low-Income Subsidy (LIS) means a growing share of beneficiaries have little financial incentive to use a preferred pharmacy at all. Add in the PBM reforms in the Consolidated Appropriations Act of 2026, and the preferred network model will gradually lose relevance.” 

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration reversed course and agreed to begin a review of Moderna’s MRNA 6.08%increase; green up pointing triangle application to sell a new seasonal flu shot after the vaccine maker agreed to conduct additional testing in the elderly.
    • “The move means that Moderna’s experimental flu shot is largely back on track after the FDA’s surprise decision earlier this month to refuse to start a review of its application. The decision came after discussions with White House and health department officials, people familiar with the matter said. Moderna said it also met with the FDA and proposed a revised approach. 
    • “Now, the FDA will review the application and is expected to make a decision by August, though approval isn’t guaranteed. If approved, Moderna’s flu shot, mRNA-1010, could become available for the 2026-27 flu season.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration has accepted Bristol Myers Squibb’s approval application for its experimental multiple myeloma drug iberdomide, setting a decision deadline of Aug. 17, the company said Tuesday. The drug, from a new class of protein-degrading treatments, is intended for use in combination with Johnson & Johnson’s Darzalex and the steroid dexamethasone in people whose disease has advanced or become resistant to early lines of treatment.” 
  • MedTech Dive informs us,
    • “Medtronic has received Food and Drug Administration clearance for a next-generation spine surgery system that combines artificial intelligence-based planning, real-time navigation and robotic assistance.
    • “The Stealth AXiS system has a modular design that can be used in both hospital settings and ambulatory surgery centers and can accommodate a range of surgeon preferences, Medtronic said Friday.
    • “The underlying architecture can also support cranial applications and ear, nose and throat surgeries, pending 510(k) clearance, according to the device maker.”
  • and
    • “Medtronic said Tuesday that a surgeon completed the first U.S. procedure for its Hugo robotic surgery system, shortly after the company received Food and Drug Administration clearance for the platform.
    • “The first surgery was a prostatectomy procedure performed at the Cleveland Clinic. Along with the Cleveland Clinic, Duke University Hospital and Atrium Health Wake Forest Baptist High Point Medical Center are among the first hospitals in the U.S. to install Hugo, with Atrium Health being the first hospital in the U.S. to do so that was not part of the investigational device exemption clinical study.”
  • Beckers Hospital Review notes,
    • “The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy.
    • “Filkri is indicated for patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia undergoing induction or consolidation therapy, bone marrow transplant recipients, individuals with severe chronic neutropenia and patients exposed to myelosuppressive radiation.
    • “The biosimilar marks the sixth FDA-approved product in Accord BioPharma’s biosimilar portfolio and the seventh overall, according to a Feb. 17 news release.”

From the judicial front,

  • Bloomberg Law reports,
    • “A prominent US physicians group is suing the Trump administration, alleging it violated its free-speech rights over its public support of gender-affirming care for minors.
    • “The American Academy of Pediatrics said it was hit in January with a Federal Trade Commission civil investigative demand for a “sweeping array of information” that includes comments the group has made about gender dysphoria treatment and communications with other groups regarding the development of clinical guidance on gender-affirming care.
    • “Filed Tuesday in the US District Court for the District of Columbia, the complaint is the latest turn in an ongoing battle between the AAP and the Trump administration.
    • “The parties are fighting in another federal court over Trump administration vaccine policy under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr.”

From the public health and medical / Rx research front,

  • Progeny Health released its “2026 Progeny Health Trends Report — your essential guide to the evolving landscape of maternal and infant health in America.” Check it out.
  • Cardiovascular Business reports,
    • “Reducing the activity of a specific protein, RBM20, may provide significant relief for certain patients with heart failure, particularly those with preserved ejection fraction (HFpEF), according to a new analysis published in Cardiovascular Research.[1] 
    • “HFpEF is associated with stiff, rigid cardiac muscles. A team of researchers out of the University of Missouri School of Medicine believe they may be able to improve HFpEF symptoms by limiting RBM20’s influence in the heart and encouraging another protein, titin, to thrive. 
    • “Titin is a protein found in cardiac muscle cells and acts as a ‘spring,’ enabling the heart chamber to recoil and stretch sufficiently,” lead author Mei Methawasin, MD, PhD, said in a statement. “In HFpEF, it’s common for the titin to stiffen and no longer be as flexible. We learned that if we reduced the activity of a different protein, RBM20, it caused longer and more flexible filaments of titin and significantly improved heart filling in mice.”
    • “There are certain risks associated with too much RBM20 inhibition. Methawasin emphasized that it would be critical to find the “right balance” and not taking things too far.” 
  • Per a National Institutes of Health news release,
    • “A study in mice found that after a bone fracture, the nerves that sense pain also promote healing by signaling for bone repair and wound healing.
    • “The findings could lead to new treatments that stimulate bone repair and might be used to drive bone formation in bone disorders such as osteoporosis.”  
  • Per Healio,
    • “Less than 2 extra hours of walking per week could help mitigate the increased mortality risk among women with breast cancer who also have a higher genetic predisposition to obesity.
    • “An analysis of more than 4,000 women with breast cancer found those who have the highest value of genetic score genes linked to obesity had a 15% greater risk for death than those with the lowest value.
    • “However, if women in that highest tertile of the genetic score walked approximately 15 additional minutes per day, their mortality risk would be similar to those with lower scores.”
  • Per Health Day,
    • “A new advance might help doctors improve movement in people with Parkinson’s disease by tracking their gait-related brain waves in real time.
    • “An experimental brain implant can capture the signals of movement-related brain regions while Parkinson’s patients perform daily activities like walking to the kitchen or strolling through a park, researchers reported Feb. 13 in the journal Science Advances.
    • “What’s more, researchers have figured out how to read those brain recordings, allowing a deeper understanding of the gait problems associated with Parkinson’s, researchers said.”
  • Per Fierce Pharma,
    • “With their blockbuster obesity drugs, Eli Lilly and Novo Nordisk have uncovered a variety of ailments the incretin treatments can combat.
    • “Chalk up another new potential expansion for Lilly as it has found in a phase 3b trial that combining Zepbound and its autoimmune treatment Taltz can provide added benefits for psoriasis patients who are obese or overweight.” 
  • and
    • “Less than half a year after winning an inaugural green light in chronic hives, Novartis’ oral BTK inhibitor Rhapsido is jockeying to expand its urticaria reach into a new indication where it has the potential to become the first targeted therapy. 
    • “In top-line results issued Wednesday, Novartis revealed that a phase 3 trial of Rhapsido (oral remibrutinib) met its primary endpoint in patients with the three most prevalent types of chronic inducible urticaria (CIndU): symptomatic dermographism, cold urticaria and cholinergic urticaria. 
    • “Specifically, the company’s BTK inhibitor helped patients achieve “significantly higher complete response rates” compared with placebo after 12 weeks of treatment, Novartis said in a Feb. 18 press release.” 

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

  • Beckers Payer Issues points out
    • “Paul Markovich, president and CEO of Ascendiun, the parent company of Blue Shield of California, is not one to sugarcoat the state of the healthcare system.
    • “I don’t see how you can look at it and say there isn’t a fundamental problem. It’s systemic in nature,” Mr. Markovich said on the Becker’s Healthcare podcast.
    • “Mr. Markovich was one of five health insurance CEOs who testified before House lawmakers in January over the broad topic of rising healthcare costs. The hearings lasted more than nine hours and covered industry consolidation, prior authorization and executive compensation. Most people would be nervous to be summoned before Congress in general, much less to speak to lawmakers about controversial topics — but not Mr. Markovich.” * * *
    • “His message to the industry is blunt: Stop asking for more money.
    • “This is our new normal. We have to, as many other industries have, figure out how to make an impact and do better with fewer resources and be more productive. That has not been the mindset of the industry for most of my career,” he said.
    • “We have to get into a different mindset: How do we make healthcare affordable? We all have to be financially viable, but how do we make healthcare affordable and worthy of our family and friends? That means we have a cost problem that we need to address,” he added. “I’m hopeful that creating that kind of budgetary, top-down pressure helps create that mindset and gets us into a much more innovative phase in healthcare, one where we really are focused on how to make things better for the patient and more efficiently.”
    • “To listen to the full conversation with Mr. Markovich about PBM reform, the company’s efforts to unbundle pharmacy benefits and keep Blue Cross Blue Shield plans competitive, plus his scathing rebuke of fax machines, you can tune in here.“
  • Modern Healthcare reports,
    • “More than 20 health systems have teamed up in a bid to use technology to improve access to care in rural and underserved areas. 
    • “The National Specialty Care Access Coalition, which launched Wednesday, will prioritize standardizing care models, reforming policy and deploying pilots to speed innovation, a news release said.
    • The model enables shared learning and a unified perspective, among other advantages, according to its website.
  • MedCity News tells us,
    • “Daffodil Health, an AI platform for health plan administration and claims processing, has raised $16.3 million in Series A funding to help scale the company, it announced on Tuesday.
    • “The San Francisco-based startup provides AI-based software for U.S. health plans and third-party administrators to manage claims pricing and payment integrity. Its platform allows payers to handle out-of-network repricing in-house, using transparent benchmarks and real-time reporting. This work has historically been outsourced to vendors that have built “multi-billion dollar businesses sitting between providers and payers,” according to Navin Nagiah, CEO and co-founder of Daffodil Health. It offers a SaaS pricing model, versus a percentage-of-savings pricing model that companies like MultiPlan and Zelis use.
    • “We have automated that entire workflow end-to-end,” he said. “When a claim comes in, we benchmark it against market data, Medicare rates, historical allowed amounts by MSA, percentile distributions, and even provider-specific acceptance history. It takes minutes to configure, and then the system runs automatically claim by claim. Our goal is to give plans control, automation, and transparency at a fraction of the historical cost.”
  • Fierce Healthcare adds,
    • “Optum is rolling out a new AI tool that aims to address some of the key barriers to value-based care, from data fragmentation to administrative burden.
    • “The company said in an announcement on Wednesday that the Value Connect platform supports both payers and providers in value-based care work, leaning on artificial intelligence to surface ways to improve and identify areas where programs are underperforming. The tool can also identify and quickly facilitate interventions that improve outcomes, either directly or embedded within other platforms, Optum said. 
    • “The goal of Value Connect, per the company, is to make it easier for payers and providers to collaborate as well as improve the performance of value-based care programs.
    • “We’re accelerating the shift to value-based care by meeting payers and providers where they are in their journey,” said Beth Merle, senior vice president of provider enablement at Optum Insight, in the announcement. “The solution empowers organizations to proactively manage risk and costs while improving outcomes for the people they serve.”
  • Health Data Management informs us,
    • “Clinician turnover and burnout have been two of the core issues threatening healthcare, with staffing trends already having been exacerbated by the COVID-19 pandemic. 
    • “However, there are growing indications that some of the churn caused by revolving-door policies to staffing are abating. But a recent report suggests that some of the negative effects of staffing upheaval remain, including restrictions on access, rising cost pressures and inconsistent outcomes. 
    • “Still, the suggestion that staff churn is abating suggests that healthcare organizations are improving efforts to find appropriate clinicians and staff, and then keeping them happier and willing to stay where they are.” 
  • Per MedCity News,
    • “Eli Lilly has been scouting for drugs to follow the trail blazed by its blockbuster cardiometabolic medicines. Its latest pipeline-building deal has the pharmaceutical company paying $100 million for rights to a clinical-stage CSL Limited drug addressing an increasingly competitive target associated with chronic inflammation.
    • “Under deal terms announced late Tuesday, CSL retains rights to the drug, clazakizumab, for prevention of cardiovascular events in patients with end-stage kidney disease while Lilly gains rights in other indications. Lilly has not disclosed its plans for the antibody but cardiovascular disease has become a particular area of interest for the company and it’s also the focus of clinical-stage programs in clazakizumab’s drug class.
    • “Clazakizumab is a monoclonal antibody designed to bind to and block IL-6, a signaling protein that in excessive amounts plays a role in inflammation. While FDA-approved antibody drugs that block this target have already reached the market in certain inflammatory disorders, there’s renewed industry interest in expanding this approach to more diseases, particularly the inflammation that drives cardiovascular conditions.”
  • Per Fierce Pharma,
    • “With $55 billion earmarked to bolster its U.S. operations, Johnson & Johnson is the latest drugmaker to zero in on expansion plans that are aimed, at least in part, at abating the Trump administration’s pharmaceutical tariff threats. 
    • “J&J will spend more than $1 billion to build out a next-generation cell therapy production plant in Montgomery County, Pennsylvania, the company said in a Feb. 18 release. Once up and running, the facility will create some 500 new permanent biomanufacturing positions, not to mention more than 4,000 construction jobs while the plant is being developed, J&J said. 
    • “J&J did not lay out a timeline for the plant’s expected completion, nor did the company specify the types of “cutting-edge cell therapy technologies” it plans to employ at the new site. 
    • “Still, Wednesday’s announcement adds more color to J&J’s overall $55 billion U.S. investment plan, unveiled last March, which came with a pledge to construct three new domestic manufacturing sites and expand others in the company’s existing drug and medtech network.” 

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Roll Call tells us,
    • “As Congress spent months arguing over COVID-19-era enhanced premium tax credits that many people on the Affordable Care Act used to subsidize their health insurance, a relatively narrow debate over a single policy grew into a much broader and more complicated discussion about how to lower health care costs. 
    • “Concerns about those costs are a top issue for voters ahead of this year’s midterms. But whether Congress can meaningfully address the issue and how candidates communicate that idea to voters depends on the type of cost increases and what is driving them. 
    • “A main reason is that health-related costs mean different things to different people, such as higher insurance premiums, more expensive drugs, co-pay increases, surprise charges or unexpected gaps in coverage.
    • “Health care is probably the most complicated sector of the economy,” said Jonathan Burks, executive vice president of health and economic policy at the Bipartisan Policy Center. “I think when policymakers are talking about affordability, the reason that they can say ‘affordability’ and yet be nowhere near agreement on what they specifically want to do is because of that complexity.”
  • Federal News Network reports,
    • “The Trump administration is telling most agencies to proceed with terminating their collective bargaining agreements and derecognizing their federal unions in response to a pair of 2025 executive orders, despite ongoing litigation.
    • I”n a memo issued Thursday, Office of Personnel Management Director Scott Kupor advised all agencies covered by President Donald Trump’s orders to move forward with either amending or fully canceling their collective bargaining agreements. The president’s orders last year directed a majority of agencies to cancel their union contracts, citing “national security” concerns.
    • “For various reasons, including litigation, implementation of these executive orders at certain agencies and agency subdivisions has been delayed,” Kupor wrote in the Feb. 12 memo. “[OPM] now advises agencies and agency subdivisions covered by [the orders] that they should proceed to terminate or modify collective bargaining agreements.”
    • “The OPM memo tells agencies to notify their federal unions that the agreements are being terminated. It adds, though, that federal employees and agencies not covered by the two executive orders [here and here] can continue collective bargaining procedures as normal.”
  • NCQA announced the draft measurement year 2027 changes to its HEDIS quality measures. The public comment period ends on March 13, 2026 at 5 pm ET. HEDIS measures form a major part of OPM’s FEHB/PSHB plan performance assessment.
  • The American Hospital Association News relates,
    • “The Department of Health and Human Services Feb. 13 issued a request for information on a new 340B rebate model program. The RFI said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, will accept comments through March 19.
    • “The RFI asks 340B stakeholders to provide answers to a long list of questions so that HRSA can evaluate whether it should implement a 340B rebate model pilot program and how such a program might be designed. HRSA expressly encourages commenters to “include supporting facts, research, and evidence.”
    • “In a statement, Aimee Kuhlman, AHA vice president of advocacy and grassroots, said, “The AHA welcomes HRSA’s attempt to gather detailed information about the impact of a rebate model. We look forward to working with the agency to answer the many specific questions it has posed to 340B hospitals and other stakeholders. We hope that after careful consideration of comments from 340B hospitals and other stakeholders, HRSA will recognize that imposing hundreds of millions of dollars in costs on hospitals serving rural and underserved communities is not a sound policy.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration on Friday rejected bitopertin, a therapy developed by Disc Medicine to treat the rare blood disorder porphyria, which makes patients extremely sensitive to sunlight. 
    • “It’s the first experimental drug to go through FDA Commissioner Marty Makary’s new program to fast-track drug reviews. The agency previously approved a generic antibiotic through the new drug review program in December.
    • “The FDA, in its letter rejecting bitopertin, cited “uncertainties” about the correlation between the blood-based biomarker used as the efficacy goal in Disc’s clinical trials and clinical benefit for patients.” 
  • Fierce Pharma informs us,
    • “With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna. 
    • “Late Thursday, PTC revealed that it withdrew its FDA application for Translarna in nonsense mutation DMD after receiving feedback on its filing from the regulator. 
    • “FDA shared that based on its review to date, the data in the [New Drug Application] submission are unlikely to meet the Agency’s threshold of substantial evidence of effectiveness to support approval of Translarna,” Matthew Klein, M.D., PTC’s chief executive, explained in a statement. 
    • “PTC is “disappointed that FDA approval cannot be achieved,” Klein said, citing the decades of development work that have gone into the company’s protein restoration therapy. 
    • “In a letter to the U.S. DMD community, PTC cited unresolvable “differences in data interpretation” with the FDA, Pharmaphorum reports.” 
  • and
    • “It’s déjà vu all over again. Just as the kidney disease space becomes increasingly competitive, Novartis has found itself intending to turn a statistical miss into a regulatory win.
    • “Despite the phase 3 Align trial narrowly failing to hit its kidney function endpoint, Novartis announced Friday that it will pursue traditional FDA approval for Vanrafia (atrasentan) in IgA nephropathy (IgAN).” * * *
    • “For its part, Novartis is leaning on a “positive difference” with Vanrafia versus placebo in eGFR change from baseline at Week 136, as well as a “clinically meaningful” improvement for the drug at Week 132, when study treatment ended.” 

From the judicial front,

  • The AHA News reports,
    • “The U.S. District Court for the Eastern District of Texas Feb. 12 vacated a final rule by the Federal Trade Commission that changed premerger notification rules, form and instructions under the Hart-Scott-Rodino Antitrust Improvements Act. The rule had increased reporting requirements on the HSR form. The final rule was challenged by the U.S. Chamber of Commerce in 2024.
    • “First, the Final Rule exceeds the FTC’s statutory authority because the agency has not shown that the Rule’s claimed benefits will ‘reasonably outweigh’ its significant and widespread costs,” Judge Jeremy D. Kernodle wrote in his opinion. “Though the FTC asserts that the Rule will detect illegal mergers and save agency resources, the FTC fails to substantiate these assertions. The Final Rule is therefore not ‘necessary and appropriate,’ and the statute ‘does not authorize [the FTC] to promulgate [the Final Rule].’”
    • “The AHA filed an amicus brief in the case last year, explaining that the changes made by the FTC under the HSR Act were “unnecessary and unlawful.” Key aspects of yesterday’s decision, including the court’s rejection of the FTC’s reliance on a study regarding hospital mergers, were based on arguments made in the AHA’s amicus brief.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally. 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. RSV hospitalizations are highest among infants less than 1 year old. COVID-19 activity is elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country; however, trends vary by region.
      • “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. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP adds,
    • “Six more US children died of influenza last week, for a total of 66 pediatric deaths this respiratory illness season, as flu rates remained moderate to very high in different regions of the country, per the weekly FluView update from the Centers for Disease Control and Prevention (CDC).
    • “Of all pediatric deaths this season, 90% who were eligible for vaccination were unvaccinated. This age-group has been particularly vulnerable, with high-severity illness, while both adults and older adults are currently categorized as having moderate-severity illness. 
    • “The 2024-25 influenza season saw 289 pediatric deaths—the most reported in a non-pandemic flu season since the CDC began tracking child flu deaths in 2004.
    • “COVID-19 rates are still elevated and are growing in some states, but ED visits for the virus are decreasing.”
  • The AHA News tells us,
    • “The South Carolina measles outbreak has grown to 950 cases, the state’s Department of Public Health reported Feb. 13. Of those, 246 cases are under age 5, 611 cases are from age 6-17, 82 cases are age 18 or older, and the ages of 11 cases are unknown. Since Jan. 1, 910 confirmed measles cases nationwide have been reported to the Centers for Disease Control and Prevention. The vaccination status of 94% of cases is classified as unvaccinated or unknown.”
  • The UMN CIDRAP again adds,
  • Radiology Business informs us,
    • “A novel artificial intelligence model could improve the identification of a potentially deadly pregnancy complication that often goes undetected. 
    • “Placenta accreta spectrum happens when the placenta improperly attaches, typically too deeply, to the uterine wall. Due to its potential to trigger life-threatening hemorrhage during or after delivery, it is considered a high-risk complication of pregnancy and is a leading cause of maternal mortality and morbidity. 
    • “Despite the dangers associated with the condition, its presence often (up to half the time) evades detection during pregnancy. With instances of PAS on the rise, there is a critical need for methods of identifying the condition prior to delivery. 
    • “This week, during the Society for Maternal-Fetal Medicine (SMFM) 2026 Pregnancy Meeting, researchers shared new data on a novel AI tool they believe could help improve the diagnosis of PAS. 
    • “Our team is very excited about the potential clinical implications of this model for accurate and timely diagnosis of PAS,” researcher Alexandra L. Hammerquist, MD, a maternal-fetal medicine fellow at Baylor College of Medicine in Houston, said during the presentation. “We are hopeful that its use as a screening tool will help decrease PAS-related maternal morbidity and mortality.”   
  • Fierce Healthcare informs us,
    • “While Generation Z and millennial workers still account for fewer claims than their baby boomer counterparts, claims in these populations are rising fast, according to a new report.
    • “UnitedHealthcare and the Health Action Council (HAC) earlier this month released their annual white paper digging into key trends impacting the employer market and found that the number of claims for lower-aged workers are increasing more quickly than they did for baby boomers.
    • “Between 2023 and 2025, the year-over-year growth rate in claims was nearly double that of baby boomers. The study also found that younger individuals were developing conditions like diabetes or obesity earlier in life and were less likely to be engaged with a primary care provider (PCP), instead frequenting the emergency room.
    • “All of these factors can drive up medical costs for employers in the long term, according to the report.” * * *
    • “For employers or plan sponsors that identify this trend, the challenge is how to best engage this population around their health. One approach, Kurtzweil said, is to try and incentivize them to develop a primary care relationship through education and communication programs that make clear the value of a PCP.
    • “Or, plan sponsors can consider alternative options like on-site clinics or virtual care that can connect people to the healthcare system without necessarily leaning on primary care, he said.”
  • The Health Care Cost Institute lets us know,
    • “Nearly half of adults in the US have high blood pressure or high cholesterol, which are key risk factors of heart disease – the leading cause of death in the US.  HHS estimates about 30 million adults in the US have blood pressure at levels where medication use is recommended but are untreated. The American Heart Association estimates the direct and indirect costs of cardiovascular disease in the US is more than $414B. Commonly used, low-cost medications can effectively treat high blood pressure and high cholesterol and prevent more serious and costly heart-related conditions like heart attack or stroke.” 
  • Medscape adds,
    • “Patients worried about potential side effects of statins can rest easy, according to a new large-scale study: The vast majority of adverse effects listed on statin medications simply never occur.
    • “The study, published in The Lancet, analyzed individual patient data from 154,000 patients in 23 large, randomized controlled trials conducted by the Cholesterol Treatment Trialists’ Collaboration.”
  • Healio points out,
    • “Night shift workers and individuals who regularly achieve fewer than 6 hours of sleep demonstrate an increased risk for osteoarthritis, according to findings published in Arthritis Care & Research. 
    • “We chose to study the associations of shift work and sleep with osteoarthritis because accumulating laboratory evidence had indicated that maintenance of daily circadian rhythms are critical for homeostasis of articular cartilage and other joint tissues,” Elizabeth Yanik, PhD, ScM, assistant professor in the department of orthopedic surgery at Washington University, St. Louis, told Healio. “However, few studies had investigated the relationships between circadian clock disruption, sleep and osteoarthritis risk in humans.”
  • The Wall Street Journal adds,
    • “Attention lapses from sleep deprivation result from the brain’s efforts to clean itself, a process usually occurring during sleep, research suggests.
    • “A study in Nature Neuroscience found sleep-deprived brains experience fluid pulses during wakefulness, causing brief attention reductions.
    • “During these attention lapses, cerebrospinal fluid surges through the brain, and study participants experienced slower reactions and missed cues.”

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

  • The Wall Street Journal reports,
    • “Annual inflation slowed in January, falling more than economists expected, helped by declining prices for gasoline and used vehicles.
    • “Cooler price increases overall are positive news for the economy, easing concerns that the Trump administration’s steep tariffs will lead to broader ongoing inflation. Yet price increases in January for items like computers and washing machines suggest inflation is continuing to weigh on Americans exhausted by price hikes.
    • “Consumer prices rose 2.4% in January from a year earlier, cooler than 2.7% in December and below the 2.5% economists surveyed by The Wall Street Journal had expected. Core prices, which exclude volatile food and energy items, rose 2.5% from a year earlier, in line with expectations.” * * *
    • “Analysts and economists have focused on the rising price of goods as a way to measure tariff impact, but the report also showed higher costs for an array of services, including airline tickets and hospital care. Overall, costs for services rose at their fastest monthly clip in a year, a frustrating data point for economists who have warned that lingering services inflation will be hard to slow.” 
  • Modern Healthcare relates,
    • “Health systems are investing billions of dollars into inpatient facilities, driven by an aging population and increasing demand for specialized care. 
    • “In recent years, providers have largely focused their investing on extensive outpatient projects. They also face ongoing cost pressures and regulatory uncertainty.
    • “Still, several are looking to add to their inpatient footprint. 
    • “Mark Pascaris, senior director at credit ratings agency Fitch Ratings, said demand for inpatient projects is particularly strong in competitive markets with growing populations.
    • “I think we have and will continue to see plenty of big-ticket hospital constructions,” Pascaris said. “We can’t ignore the inpatient footprint. The [COVID-19] pandemic taught all of us that we still need ICUs. We still need inpatient surgery suites.” 
  • Per Beckers Payer Issues,
    • “Humana is in talks with Sarasota, Fla.-based MaxHealth — a primary care network and platform focused on adults and seniors — regarding an acquisition, Bloomberg reported Feb. 12.
    • “According to Bloomberg sources, MaxHealth, owned by private equity firm Arsenal Capital Partners’ Best Value Healthcare, could have been valued at about $1 billion.
    • “Humana President and CEO Jim Rechtin previously said the company is looking to expand its primary care footprint.
    • “We also hope to soon announce a strategic acquisition in the primary care space,” Mr. Rechtin saidon a Feb. 11 earnings call.” 
  • The Employee Benefits Research Institute prepared a report titled “Cell and Gene Therapies in Employment-Based Health Insurance: Financing the High-Cost, High-Impact Future.” Check it out.
  • MedCity News considers “From Claims Payer to Care Partner: What AI Really Changes in Health Insurance, and What It Doesn’t.”
    • “AI can help health plans reduce friction, speed revenue-cycle throughput, and improve member experience, but only when it is deployed with strong data discipline, modern integration patterns, and a governance model that treats AI as “augmented intelligence,” meaning powerful, assistive, and accountable.”
  • The Wall Street Journal notes,
    • “In one experiment, offering human contact to loan applicants during the approval process made them much more likely to eventually accept a loan if offered.
    • “A study found that providing access to a human, even if unused, boosts customer satisfaction and confidence in sensitive online transactions.
    • “Only about 10% of customers offered human assistance actually use it, suggesting the cost of providing the option is lower than perceived.”
  • Fierce Pharma points out,
    • “Determined to avoid a repeat of the supply shortfalls that plagued early GLP-1 rollouts for obesity, Eli Lilly has amassed a sizable store of its oral weight loss candidate orforglipron. 
    • “Specifically, Lilly had secured “pre-launch inventories” worth $1.5 billion as of Dec. 31, with most of that supply tied to orforglipron, the company said in a securities filing this week. 
    • “The update on Lilly’s pending launch inventory comes after the Indianapolis drugmaker said last February that it had built up nearly $550 million in early inventory that was again primarily related to orforglipron.” 
  • BioPharma Dive informs us,
    • “Moderna reported better-than-expected fourth quarter sales and affirmed revenue growth estimates for 2026 despite soft demand for its COVID-19 vaccine and recent, high-profile pushback from the Food and Drug Administration.
    • “The biotechnology company said Friday it recorded revenue of $678 million over the final three months of last year and $1.9 billion for all of 2025, figures that came at the higher end of a projected forecast from November. U.S. sales more than halved between the third and fourth quarters, but still made up more than 60% of Moderna’s full-year revenue, in part because of the successful launch of the COVID shot mNEXSPIKE and a strong U.S. retail COVID vaccine market.”
  • Per MedTech Dive,
    • “Dexcom is watching for expanded Medicare coverage of its continuous glucose monitors to people with Type 2 diabetes who don’t take insulin. 
    • “New CEO Jake Leach told investors on Thursday that the company has been “sitting here waiting for a coverage decision” from the Centers for Medicare and Medicaid Services. Dexcom expects CMS to propose a coverage expansion in the first half of 2026, BTIG analyst Marie Thibault wrote in a note to clients Thursday. 
    • “Dexcom started to see commercial coverage unlock for Type 2, non-insulin users toward the end of last year, Leach said. He expects broader Medicare coverage for that group would allow nearly 12 million people to access CGMs. 
    • “In the meantime, the American Diabetes Association updated its guidelines last year to recommend clinicians consider using CGMs for Type 2 diabetes when patients are taking glucose-lowering medications other than insulin. Leach said that real world data the company has been generating supports that decision, and that Dexcom has launched a registry for non-insulin users.”

Thursday report

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

Happy Lincoln’s Birthday

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Department of Homeland Security is on the verge of a shutdown after Senate Democrats voted to block a bill to fund the agency, saying negotiations with Republicans to put new restrictions on immigration enforcement hadn’t made enough progress.
    • “A bill to fund DHS through September failed to advance with 52 in favor and 47 opposed, short of the 60 votes required. Republicans control the Senate 53-47 but need Democratic support to pass most bills due to the longstanding filibuster rule.
    • “Democratic Sen. John Fetterman of Pennsylvania voted with Republicans to advance the bill, while Senate Majority Leader John Thune (R., S.D.) switched his vote from yes to no to preserve his ability to bring the bill up again. Sen. Mitch McConnell (R., Ky.) was absent.
    • “DHS oversees Immigration and Customs Enforcement and Customs and Border Protection as well as the Federal Emergency Management Agency, the Transportation Security Administration and the U.S. Coast Guard. While the failed vote sets the stage for funding to lapse at DHS for at least a week, there isn’t expected to be any significant impact on border enforcement from the shutdown.”
  • The Washington Post adds,
    • “The Senate is not expected to hold any more votes before a shutdown starts at 12:01 a.m. Eastern time on Saturday, and many senators were set to leave town Thursday to travel to the Munich Security Conference. Schumer and Thune have said they are prepared to bring senators back early if a deal comes together.” * * *
    • “This shutdown would affect only DHS — but it would not shutter U.S. Immigration and Customs Enforcement or Customs and Border Protection, because Republicans sent those agencies tens of billions of dollars in additional funding last year that would allow them to continue to operate.
    • “Instead, the brunt of a shutdown would fall on the Transportation Security Administration, the Federal Emergency Management Agency, the Coast Guard and other agencies within DHS. It would affect about 13 percent of the federal civilian workforce, most of whom would be forced to work without pay, according to data from DHS and the Office of Personnel Management.”
  • The Wall Street Journal tells us
    • “The White House and Health Secretary Robert F. Kennedy Jr. have shaken up the top ranks at his department, a move meant to install more disciplined messengers and smoother operations ahead of the midterm elections.
    • “Kennedy and White House officials tapped Chris Klomp, the head of Medicare and a former healthcare executive, to lead the department as its No. 2 under Kennedy, administration officials said. Klomp will have responsibility for operations and messaging, and he will be aided by at least three other agency lieutenants to take senior counselor roles under him, the officials said.
    • “We’re structuring in such a way that we can move faster and we can make sure the quality is uniform,” Klomp said in an interview.” * * *
    • “The three other senior advisers tapped to help Klomp include John Brooks, who currently heads policy at the Centers for Medicare and Medicaid Services; Grace Graham, who leads the Food and Drug Administration’s policy office; and Kyle Diamantas, who heads FDA’s food division. Brooks will oversee CMS matters, while Graham and Diamantas will have roles managing the FDA.”
  • Beckers Payer Issues informs us,
    • “Fourteen health insurers have voluntarily committed to CMS’ “Advancing Chronic Care with Effective, Scalable Solutions” model, according to a Feb. 12 CMS news release shared with Becker’s.
    • “The insurers that are on board will work toward achieving alignment with the model by 2028. The plans represent 165 million Americans.
    • “With a decade-long evaluation period beginning in July, ACCESS will explore whether linking payments to clinical outcomes can facilitate technology in chronic disease management, focusing on Medicare beneficiaries. Targeted conditions include high blood pressure, diabetes, chronic musculoskeletal pain and depression. The agency began accepting applications, which are due in April, on Jan. 12.
    • “The FDA’s “Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot” will operate in conjunction with ACCESS, allowing expanded availability of relevant devices.”
  • The Internal Revenue Service issued a draft of Publication 969 Health Savings Accounts and Other Tax-Favored Health Plans For use in preparing 2025 Returns.
  • The American Hospital Association News lets us know,
    • “A bipartisan letter supported by the AHA was sent by members of Congress Feb. 11 to the Department of Homeland Security, urging the agency to grant health care workers an exemption from the $100,000 filing fee for H-1B visas. The letter, led by Reps. Yvette D. Clarke, D-N.Y., and Michael Lawler, R-N.Y., was signed by 100 lawmakers. “Imposing a $100,000 fee for new H-1B visa petitions will exacerbate hospitals’ existing staffing challenges and could push chronically underfunded hospitals to their financial brink,” the legislators wrote. “If these hospitals cannot petition for new H-1B visas to address their staffing needs without also having to pay this fee, it will further damage their financial viability. Critically needed open positions will simply go unfilled, leaving rural and high-poverty urban areas without adequate access to care.”
  • and
    • “The Administration for Strategic Preparedness and Response has launched a $100 million competition to support the development of antiviral drug therapies targeting viruses in the Togaviridae and Flaviviridae families, such as dengue, Zika, West Nile and Chikungunya. The initiative, called the Small Molecule Approaches for Rapid and Robust Treatment Prize, will be coordinated by ASPR’s Biomedical Advanced Research and Development Authority. BARDA plans to include input from experts in drug development, virology, artificial intelligence, medicinal chemistry and public health for the program. A series of virtual information sessions will be held in the coming weeks on the initiative, which has a May 11 application deadline.” 
  • Federal News Radio interviews Tammy Flanagan about federal employee retirement benefits.
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC), together with the Office of Personnel Management (OPM), today provided federal agencies with a joint technical assistance document addressing telework as a reasonable accommodation for federal employees with disabilities.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “In an hour-long meeting in January, Food and Drug Administration career staff laid out their objections to a plan to block a new flu shot from vaccine maker Moderna. They argued that refusing to even consider the vaccine was the wrong approach to address any concerns about the product.
    • “Vinay Prasad, the head of the FDA vaccine and biologics division, overruled them—despite the agency earlier signing off on Moderna’s approach to studying the shot. Prasad told Moderna earlier this month he wouldn’t review its flu application, arguing that its clinical trial was inadequate.
    • “The Moderna decision is part of a pattern of regulatory U-turns and overruling of FDA staff by Prasad, a Covid-vaccine critic elevated by FDA Commissioner Marty Makaryand Health Secretary Robert F. Kennedy Jr. At least nine companies, many of them focused on rare or hard-to-treat diseases, have said Prasad’s team has surprised them in recent months with rapid shifts in its decisions, in some cases rejecting their products after previously blessing their approaches.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue.”
  • and
    • “The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning,” the agency’s most prominent safety-related warning.”

From the judicial front,

  • Fierce Pharma reports,
    • “In response to last month’s list of the 15 drugs chosen by the Centers for Medicare & Medicaid Services (CMS) for upcoming price cuts under the Inflation Reduction Act (IRA), AbbVie is the latest to join the flood of industry litigation over the law.
    • “While AbbVie’s lawsuit contends that the CMS pricing negotiations mandated for Botox step on the company’s constitutional rights—a common thread woven into much of the industry’s legal complaints about the program—the Illinois-based drugmaker also takes a unique position that specifically relates to the formulation of its offering.”
    • “When the IRA was signed into law by former President Joseph Biden in 2022, the law made clear that only certain products are eligible to make the list of drugs that will go through negotiations to determine maximum fair prices paid under Medicare. The IRA specifically excludes “low-spend drugs,” or those with Medicare spending of less than $200 million, certain orphan rare disease drugs and plasma-derived products. 
    • “AbbVie is hedging its argument around the IRA’s “express statutory exclusions” for plasma-derived products, it said in its complaint, which was filed in a Washington D.C. District Court on Feb. 11 and names the Department of Health and Human Services (HHS), CMS and their respective leaders, Robert F. Kennedy Jr. and Mehmet Oz, M.D.”

From the public health, medical and Rx research front,

  • Cardiovascular Business reports,
    • “Interest in lipoprotein(a), or Lp(a), is on the rise thanks to mounting evidence that the genetically inherited lipid particle may be a key missing link in unexplained heart attacks and strokes. While current treatments are limited, experts say that will likely change in the near future when new drugs begin to enter the market.
    • :Nathaniel Lebowitz, MD, who leads preventive cardiology at Hackensack University Medical Center and serves as an assistant professor of internal medicine at Hackensack Meridian School of Medicine, has spent two decades studying this biomarker. He is now part of the American Heart Association (AHA) Lp(a) Discovery Project, a national initiative aimed at expanding physician and patient awareness as new therapies move closer to market. Lebowitz spoke with Cardiovascular Business at length about this important topic.
    • “Lp(a) is a major, major killer. And most of the population, and even most doctors, don’t know the exact degree of how dangerous it really is,” he explained.
    • “Lebowitz noted that Lp(a) is often responsible when patients suffer cardiovascular events despite not showing any of the normal warning signs.
    • “When somebody who you wouldn’t expect to have a stroke or a heart attack has one and does not have traditional risk factors to speak of, check Lp(a), because it will be positive,” he said.
    • “Lp(a) is genetic and present in about 20% of the general population. Guidelines from the AHA, American College of Cardiology and National Lipid Association now emphasize screening in individuals with a family history of premature heart disease, as well as cascade screening of first-degree relatives when Lp(a) is identified. Levels typically do not fluctuate significantly, so testing once is believed to be generally sufficient.
    • “I consider it a risk elevator. It’s a risk multiplier,” Lebowitz said. “So if somebody is considered low risk for cardiovascular disease, but they have Lp(a) now, I would consider them intermediate risk. If they’re intermediate risk, but they have Lp(a), I would now consider them high risk and treatment should ensue accordingly.”
    • “Currently, there are no approved therapies specifically targeting Lp(a), but that may soon change. Several investigational agents are in late-stage clinical trials, including small interfering RNA (siRNA) therapies designed to silence the gene responsible for producing Lp(a).”
  • The New York Times provides a look at what alchohol does to your body.
    • “Dry January has come and gone, but Americans’ relationship with drinking is undergoing a more lasting change. According to one recent poll, just 54 percent of U.S. adults said they consume alcohol, the smallest percentage in nearly 90 years of data collection. That may be because more people are taking alcohol’s negative health consequences seriously.
    • “Drinking alcohol can have profound effects on the brain and body. In the moment, some of those effects can be pleasurable. But in the long term, especially when it’s consumed in large quantities, alcohol can cause serious health harms.”
  • and tells us,
    • “Fertility experts know that the more eggs retrieved from a woman, the better the chances that one of them will lead to a viable embryo that will result in the birth of a baby.
    • “Now, a new study suggests something startling, even to many in the field: the conventional method of searching for eggs often fails to find all of them, and a new technology that automates the process may significantly increase the number recovered.
    • Using the conventional method, embryologists use high-powered microscopes to search the follicular fluid extracted from women in fertility clinics. The fluid is then discarded. The study, published in Nature Medicine on Thursday, reported that a device that uses microfluidic technology to sift through follicular fluid found additional eggs for more than half of the patients.
    • “It’s very, very surprising,” said Dr. Mitchell Rosen, who directs the reproductive laboratories at the University of California, San Francisco and was not involved in the study. “They were finding eggs that we wouldn’t otherwise have had the potential to use.”
  • MedPage Today informs us,
    • “Receiving an mRNA SARS-CoV-2 vaccine during or shortly before pregnancy had no impact on kids’ neurodevelopmental outcomes, a multicenter prospective observational study found.
    • “Kids between ages 18 and 30 months scored similarly on the Ages & Stages Questionnaire, 3rd Edition (ASQ-3) (adjusted median difference -3.4, 95% CI -9.7 to 3.0) as well as in each of the five specific ASQ-3 domains, reported George Saade, MD, of Eastern Virginia Medical School in Norfolk, Virginia, during a presentation at the Society for Maternal-Fetal Medicine (SMFM) annual meeting.
    • “Scores on other neurodevelopment assessments that evaluated emotional and behavioral problems, risk for autism spectrum disorder, and temperament were also similar between groups.
    • “We conclude that the primary neurodevelopmental outcome was equivalent between children of mothers who received and did not receive mRNA SARS-CoV-2 vaccination during or immediately prior to pregnancy, and there was no association with secondary neurodevelopmental outcomes,” Saade said during his presentation.
    • “Our results provide reassurance regarding the safety of mRNA SARS-CoV-2 vaccination and pregnancy,” he added.
    • “Indeed, much research has found no link between COVID vaccination in pregnancy and adverse outcomes for children, including at least two studies showing no increase in birth defects.”
  • BioPharma Dive observes,
    • “An experimental medicine from BridgeBio Pharma, the San Francisco-area biotechnology company, has succeeded in a late-stage clinical trialas a treatment for the most common type of dwarfism, results which could tee up an approval and greater competition for two other closely watched therapies.
    • “The trial enrolled around 110 children with achondroplasia, who, over a main treatment period of a year, were given either a placebo or BridgeBio’s drug, called infigratinib. On Thursday, BridgeBio announced that those in the drug arm were growing taller faster. Depending on the measure, this “annualized height velocity” was, on average, between 1.74 and 2.1 centimeters greater per year than what researchers observed in the control group.
    • “Not only did infigratinib meet the trial’s central goal, it also scored so well on a couple other height and growth tests that BridgeBio said it set records for a randomized study of achondroplasia patients. The drug was well tolerated, too, as no serious adverse events were tied to it. No one dropped out of the trial because of side effects either. BridgeBio did disclose three cases of patients having abnormally high levels of phosphate in their blood, but all were mild, transient, asymptomatic, and didn’t require the dose given to be changed or stopped.”
  • Beckers Hospital Review notes,
    • “The number of active drug shortages has declined sharply since June, according to the FDA’s drug shortage database.
    • “Eighty drugs were in shortage as of Feb. 12, down from 194 in mid-June.
    • “The decline reflects updates to the FDA’s database, which is modified daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
    • The article also points out “12 recent drug shortages, according to the FDA database.”

From the U.S. healthcare business front,

  • Per an Institute of Clinical and Economic Review news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Medication for Smoking Cessation
    • “Independent appraisal committee votes reflect a net health benefit for cytisinicline alone, but uncertainty when compared to varenicline; Manufacturer setting a price for cytisinicline to align with value would help ensure public health goals for smoking cessation are met.”
    • Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • Beckers Payer Issues reports,
    • “Most of the country’s largest insurers reported year-over-year increases in medical cost ratios in 2025.
    • “Centene reported the highest medical loss ratio at 91.9%, driven by higher marketplace medical costs, Medicaid cost pressures in behavioral health and home health, and program changes in the Medicare prescription drug plan business.”
    • The article provides the largest insurers MLRs for 2023, 2025 and 2025.
  • Healthcare Dive relates,
    • “Hospital operator Tenet Healthcare expects the expiration of more generous Affordable Care Act subsidies to lower its earnings growth this year by about $250 million.
    • “Still, Tenet’s expected loss is smaller than those of some of its peers, including HCA Healthcare, which last month said it expects to lose up to $900 million from the lapse of the enhanced tax credits in 2026.
    • “Excluding the ACA headwind and the impact of some Medicaid state supplemental payments, Tenet anticipates it will grow adjusted earnings before taxes and other non-operating expenses by about 10% this year compared to 2025, executives said on a Wednesday call with investors.”
  • BioPharma Dive tells us,
    • “Sanofi on Thursday announced the ouster of CEO Paul Hudson after a six-year tenure that included a major transformation of the French drugmaker and the rise of Dupixent into one of the world’s best-selling medicines.
    • “Hudson will be replaced by current Merck KGaA CEO Belén Garijo, who is leaving her post at the German company at the end of April as part of a planned transition. Olivier Charmeil, executive vice president for general medicines, will serve as interim CEO after Hudson’s departure at the close of business on Feb. 17, Sanofi said.
    • “Belén Garijo will bring an increased rigor to the implementation of Sanofi’s strategy and accelerate the preparation of the group’s future,” Sanofi said. “Her priority will be to strengthen the productivity, governance and innovation capacity of research & development.”
  • Fierce Healthcare informs us,
    • “Maven Clinic, a virtual women’s and family health provider, is teaming up with health tech company Color Health to support family building after a cancer diagnosis. 
    • “The partnership’s goal is to expand access to oncofertility care, helping patients of childbearing age going through the cancer journey to understand and preserve their fertility options. Members will receive access to oncologists, dietitians, mental health providers, fertility preservation specialists and care advocates. The services will be available to cancer patients through employers and payers to start. 
    • “Both of us have seen the attention being paid by employers to what it really looks like for their team members going through a cancer diagnosis, because it’s happening at such a rapid clip now,” Caroline Savello, president at Color, told Fierce Healthcare. A quarter of Color patients are between the ages of 18 and 45.”
  • and
    • “Specialty care company Lantern revealed it will expand its cancer care navigation platform through a new partnership with AccessHope.
    • “Through the partnership, Lantern’s platform will now include expert review at each point in a patient’s care journey, preventing misdiagnoses and ensuring treatments meet clinical guidelines. Reviews will be conducted by experts at National Cancer Institute (NCI)-designated cancer centers, according to the announcement.
    • “Lantern said the reviews will be available for both adult and pediatric cancers as well as solid tumors and blood-based disease.
    • “Dickon Waterfield, president of Lantern, told Fierce Healthcare that the “beauty of this partnership” lies in the ability to allow people to seek care in their local communities while also providing them supports at the standard of an NCI-designated facility.”

Midweek report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Republicans and Democrats sparred Wednesday on the potential real-world harms of a partial shutdown for the Department of Homeland Security, as Congress marched toward a funding deadline for the agency amid a dispute over immigration enforcement policies.
    • “The House Homeland Security Appropriations Subcommittee held a hearing with officials from five national security and emergency management agencies to highlight what would happen if a continuing resolution expires Saturday without further action from Congress.”
  • and
    • “Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. 
    • “At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries.
    • “But Guthrie stressed that further changes could be forthcoming.
    • “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.”
    • “Rep. Morgan Griffith, R-Va., chair of the Health Subcommittee, said after the hearing that he hopes to mark up affordability legislation before Memorial Day, but acknowledged the appetite for bipartisan cooperation will be “tough” given the political climate.” 
  • Beckers Payer Issues adds,
    • “Sens. Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., have introduced legislation that would ban health insurers and pharmacy benefit managers from owning medical providers, and would force companies in violation to divest within one year of the bill’s enactment.
    • :The “Break Up Big Medicine Act” would also prohibit a parent company of a prescription drug or medical device wholesaler from owning a medical provider or management services organization.”
  • The American Hospital Association tells us,
    • “The Senate Special Committee on Aging held a hearing Feb. 11 on issues impacting physician burnout. The AHA provided a statement for the hearing and urged Congress to pass legislation to address burnout, including the Improving Seniors’ Timely Access to Care Act (H.R. 3514/S. 1816), legislation that would streamline prior authorization requirements under Medicare Advantage plans by making them simpler and more uniform, and the Save Healthcare Workers Act (H.R. 3178/S. 1600), a bill that would make it a federal crime to assault a hospital employee. The AHA also urged Congress to pass the Resident Physician Shortage Reduction Act of 2025 (H.R. 3890/S. 2439), which would add 14,000 Medicare-funded residency positions over seven years.”
  • Per OPM news releases,
    • [On February 10, 2026], the US Office of Personnel Management (OPM) convened senior administration officials, federal agency leaders, and industry executives at the White House for a US Tech Force (Tech Force) roundtable focused on strengthening the federal government’s technology workforce and accelerating innovation across agencies.
  • and
    • “US Office of Personnel Management (OPM) Director Scott Kupor appeared on Fox Business to discuss the administration’s launch of the U.S. Tech Force, a new initiative aimed at strengthening the federal workforce with top technical talent and modernizing critical government systems.” You can watch the Director’s appearance here.
  • Govexec discusses the tax implications of making Roth IRA conversions in the Thrift Savings Plan.
    • “Beginning Jan. 28, the Thrift Savings Plan now allows participants to convert traditional (pre-tax) balances into Roth (after-tax) balances inside the TSP itself. This long-awaited change gives federal employees and retirees more flexibility over how and when they pay taxes on retirement savings.
    • “While the mechanics of the change are straightforward, the implications are not. A Roth in-plan conversion is a tax event and not just a retirement planning decision. Once it is made, it cannot be reversed. Knowing this beforehand helps you choose effective planning tools and avoid costly errors.”
  • Per an HHS news release,
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “ASTP/ONC released the draft USCDI v7 on January 29, 2026, proposing 29 new data elements and one significantly revised element to strengthen nationwide interoperability. Draft USCDI v7 expands standardized health data to support more efficient adverse event reporting, nutrition information exchange, and quality improvement, ultimately modernizing how health information is used across the entire health care system to Make America Healthy Again.”
    • “In the coming days, ASTP/ONC will launch the EHIgnite Challenge, a two-phase prize competition to improve the usability, readability, and actionability of single-patient electronic health information (EHI) exports. The EHIgnite Challenge will catalyze the development of tools and workflows, focused on the application of AI, that transform raw EHI into clear, usable information to better support care transitions, provider onboarding, and patient understanding and engagement. Awards will support both concept development and prototype solutions through 2027.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For all its success across a wide range of cancer types, Merck’s PD-1 superstar Keytruda has never been able to crack the code for one of the toughest-to-treat indications in oncology—ovarian cancer.
    • “But now, 13 years after the FDA initially blessed it for skin cancer, the U.S. regulator has approved Keytruda as a second- or third-line treatment for patients with a certain type of ovarian cancer.
    • “With the green light, Keytruda becomes the first immune checkpoint inhibitor approved for this indication. 
    • “Keytruda is to be used in combination with the chemotherapy paclitaxel and with or without Roche’s targeted cancer therapy Avastin. The endorsement covers those with platinum-resistant recurrent ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1-positive tumors. 
    • “The nod also covers infused Keytruda and its subcutaneous version, Keytruda Qlex, which the FDA blessed five months ago.” 

From the public health and medical / Rx resarch front,

  • STAT News reports,
    • “Food fights pitting low-carbohydrate diets against low-fat diets are off the mark when they aim at heart health, a large new study suggests. To reduce heart disease risk, it’s the quality, not the quantity, of those carbs or fats that matter. Diets high in plant-based foods, whole grains, and unsaturated fats led to better heart health, the researchers found. Low-fat dairy also got a nod when part of a diet featuring whole grains, vegetables, and fruits.
    • “Not all carbs are created alike; nor are all fats. Whole grains, fruits, vegetables, nuts, legumes, and olive oil are associated with lower risk of coronary heart disease (CHD), whether they contain carbohydrates or fats. But diets high in refined carbohydrates and animal proteins and fats were associated with a higher risk of heart disease, according to the new study, published Wednesday in the Journal of the American College of Cardiology.” 
  • MedPage Today relates,
    • “The CDC excludes homicide, suicide, and overdose in defining “maternal mortality,” instead focusing on more medical causes.
    • “An analysis of 2018-2023 data showed that drug overdoses, homicides, and suicides accounted for more than a quarter of all deaths among pregnant and postpartum women.
    • “Violence and overdose accounted for 2,018 deaths, while cardiovascular causes, hypertension, infection, and hemorrhage together accounted for 2,141 deaths [over the period 2018-2023].” * * *
    • “Maeve Wallace, PhD, MPH, of the Mel & Enid Zuckerman College of Public Health at the University of Arizona in Tucson, told MedPage Today that the results were not surprising.
    • “Research dating back decades finds that rates of violent death exceed obstetrical causes of death for pregnant women,” Wallace said. “What is disheartening is that this continues to be the case.”
    • “This analysis “can help policymakers concerned with maternal health understand pregnancy as a dangerous condition,” and can encourage policy-level solutions to promote women and girls’ health and safety, she added.”
  • and
    • “A meta-meta-analysis of randomized trials showed exercise reduced depression and anxiety symptoms.
    • “Group aerobic exercise appeared to be most effective for depression, while exercise of shorter duration and lower intensity was most associated with reductions in anxiety symptoms.
    • “The researchers concluded that tailored exercise programs are an “accessible and cost-effective” treatment option for depression and anxiety.”
  • Healio informs us,
    • “Statin use had a statistically significant protective effect against acute asthma exacerbations in mild asthma among Black adults and adults with obesity, according to data published in Annals of Allergy, Asthma & Immunology. 
    • “The pleiotropic effects of statins may extend beyond cholesterol control due to their anti-inflammatory and immunomodulatory properties, prompting interest in their potential use for chronic airway diseases, William Crawford, MD, physician with the department of allergy, Kaiser Permanente Southern California, and colleagues wrote.
    • “But mixed results in prior research including beneficial and null effects in asthma outcomes indicate that determining the patient subgroups that may benefit most from treatment is vital in determining the role that statins may have in asthma management.” 
  • The American Journal of Managed Care observes,
    • “More than half of patients with long-term conditions (LTCs) surveyed said they preferred a remote consult vs an in-person visit with their referring physician, particularly for discussion of results and medication renewal, according to a new study
       published in JAMA Network Open.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The U.S. economy added 130,000 jobs in January, its strongest growth in over a year, and a sign that the labor market may be shaking off its recent stagnation.
    • “January’s robust gains surprised forecasters, blowing far past consensus expectations, while solidifying expectations the Federal Reserve will keep rates on hold for the foreseeable future. The unemployment rate dipped to 4.3% from 4.4% in December, the Labor Department said Wednesday. And workers’ wages rose.
    • “The gains were highly concentrated in healthcare and social-assistance fields, which includes jobs like home health aides and residential care workers. Such jobs tend to grow regardless of the economy’s health and have long been an engine of U.S. job growth.”
  • Fierce Healthcare relates,
    • “Humana CEO Jim Rechtin acknowledged the noise around the latest Medicare Advantage rate notice and said that while the flat proposal is a concern, the company will continue to push forward on its performance improvements.
    • “He said that part of the challenge for policymakers, regardless of political alignment, is managing the program as it “sits at the intersection of U.S. fiscal pressures and a program that is incredibly popular with seniors.”
    • “Every administration wrestles with how to balance these two forces,” Rechtin said.
    • “We are committed to always protecting our consumers the best we can, and we are very aware that we must do that within the constraints of the annual funding environment,” he continued. “If that funding environment cannot fully support our benefit structure, then we will adapt as we have in the past.” * * *
    • “Humana reported a $796 million loss in the fourth quarter of 2025, with its losses growing year over year as increased utilization continues to drag Medicare Advantage (MA) plans.
    • “By comparison, Humana reported a $693 billion loss in the fourth quarter of 2024. The company did post a profit for the full year of $1.2 billion, flat from the company’s $1.2 billion haul in 2024.”
  • and
    • “Hinge Health’s shares were up 13% in after-hours trading Tuesday after the digital health company reported a strong fourth quarter and a bright outlook for 2026.
    • “The digital musculoskeletal (MSK) care provider, which went public in late May, brought in fourth-quarter revenue of $171 million, up 46% from the same period a year ago and easily topping Wall Street analyst estimate of $155 million for fourth-quarter revenue. The company posted fourth-quarter adjusted earnings of 49 cents per share, significantly exceeding analyst estimates of 14 cents per share. Hinge Health’s non-GAAP income from operations increased 124% to $48 million during quarter.
    • “Free cash flow for the quarter was $61.5 million, representing a free cash flow margin of 36%.
    • “The company’s full-year 2025 revenue jumped 51% year over year to reach $588 million compared to revenue of $390 revenue in 2024, according to its fourth-quarter and full-year financial results.” 
  • KFF lets us know,
    • “National spending on health has increased rapidly over time—rising to $5.3 trillion and 18% of GDP in 2024—and is projected to continue to do so into the future. Growth in health spending contributes to higher costs for families, employers, Medicare, Medicaid, and other payers. In 2025, average annual premiums for employer-sponsored family coverage reached $26,993, with workers paying $6,850 for their coverage, according to KFF’s annual survey of employers.  Hospital care accounted for nearly one-third of national health expenditures in 2024, and more than doubled in nominal terms over the preceding two decades, making hospitals a major driver of health spending growth over time.” * * *
    • “National health expenditures increased by $692 billion between 2022 and 2024, from $4.6 trillion to $5.3 trillion. During this period, spending on hospital care alone accounted for $277 billion of spending growth, or 40% of the total increase in national health spending (Figure 1). The large contribution of hospital care to overall health spending growth reflects the fact that hospital spending accounted for nearly a third of national health expenditures in 2022 (30%) and grew more quickly than national health expenditures overall in both 2023 (10.6% versus 7.4%) and 2024 (8.9% versus 7.2%).”
    • FEHBlog note — Hospitals and health systems are not included in the Break Up Big Medicine bill discussed above.
  • Beckers Hospital Review tells us,
    • “Dallas-based Tenet Healthcare reported $21.3 billion in revenue in 2025, up from $20.7 billion in 2024, as the system posted strong fourth-quarter results and outlined a positive outlook for 2026. For the fourth quarter, Tenet reported net operating revenue of $5.5 billion, compared to $5.1 billion during the same period in 2024.
    • “2025 extended Tenet’s track record of strong revenue growth, disciplined operations, improved margins and robust free cash flow generation,” Tenet Chair and CEO Saum Sutaria, MD, said in a Feb. 11 news release. “We see continued demand for acute care and ambulatory surgical services in our markets and are confident in our ability to execute on our strategy and achieve our full-year 2026 expectations.”
  • and
    • “There are 417 rural hospitals that are vulnerable to closure, according to a Feb. 10 report from Chartis, a healthcare advisory services firm. 
    • “Chartis’ Rural Hospital Vulnerability Index assesses more than a dozen indicators to identify which are statistically significant for determining the likelihood of closure.
    • “The number of overall rural hospitals vulnerable is down from 432 last year, but Chartis said there are “notable shifts at the state level.” In Tennessee, the percentage of vulnerable hospitals increased from 44% to 61%. In South Dakota, the percentage increased from 28% to 42%. Mississippi, which Chartis said has long been a “weak spot in the rural health safety net,” saw an improvement from 49% to 42%. Kansas also saw an improvement from 47% to 44%. 
    • “”Chartis’ analysis found that 17 states have 10 or more rural hospitals vulnerable to closure this year. Texas has the most with 50, followed by Kansas (44), Tennessee (27), Georgia (25), and Mississippi (24). These states are receiving a combined $1.1 billion in the first round of CMS’ Rural Health Transformation Fund initiative.”  
  • BioPharma Dive informs us,
    • “Shares of Gilead Sciences slid after the stock market closed Tuesday in spite of a fresh earnings report in which the company’s top products beat Wall Street forecasts.
    • “Gilead recorded $7.9 billion in product sales over the final three months of 2025, a 5% increase from the same period a year prior. Brian Abrahams, an analyst at RBC Capital Markets, called it a “strong commercial quarter” with “major beats” in Gilead’s HIV business, which was up 6% year-over-year.
    • “Biktarvy, a three-in-one pill for HIV treatment, and Descovy, a daily tablet often used to stave off infections from the virus, respectively brought in $4 billion and $819 million during the quarter. That’s higher than the roughly $3.84 billion and $720 million the average analyst had penciled in, according to Abrahams.”
  • MedTech Dive notes,
    • “Edwards said study data supporting earlier use of its Sapien heart valves to treat patients who have severe aortic stenosis without symptoms is changing clinical practice and helping to accelerate sales of the devices.
    • “The company on Tuesday posted a second consecutive quarter of double-digit sales growth in its transcatheter aortic valve replacement business.
    • “CEO Bernard Zovighian said momentum is coming from long-term data presented last fall confirming the durability of the Sapien valves and the “practice-changing” EARLY TAVR trial results that showed asymptomatic patients who had the procedure fared better than those who remained under clinical surveillance alone. Edwards is the only TAVR system with asymptomatic approval.”

Tuesday report

David Ermer–CDC, FDA, Medical / Rx research, Mental health care, NIH, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “Republicans on the House Judiciary Committee have subpoenaed eight insurers for documents outlining their measures to head off fraud related to Affordable Care Act subsidies.
    • “The information demands follow an attempt from the Trump administration over the summer to enact new guardrails on improper enrollments, which was paused by the courts amid ongoing litigation. The Republican committee heads said their inquiries could help unstuck that regulatory effort.: * * *
    • “The insurers who were sent a subpoena are: Blue Shield of California, Centene Corporation, CVS Health, Elevance Health, GuideWell, Health Care Service Corporation, Kaiser Permanente and Oscar Health.”
  • STAT News relates,
    • “File this under “If at first you don’t succeed…”
    • “The Trump administration is planning another attempt at creating a pilot program that would alter payments for medicines purchased through a controversial federal drug discount program.
    • “In a little-noticed posting, the Health Resources and Services Administration indicated it is pursuing a rule for a rebate model, although details were not disclosed.”
  • The American Hospital Association News tells us,
    • “The AHA Feb. 10 released its 2026 Rural Advocacy Agenda, laying out the association’s key priorities for Congress, the administration, regulatory agencies and courts. The agenda is focused on flexible payment models; ensuring fair reimbursement and access to capital; commercial insurer accountability; bolstering the workforce; and protecting the 340B Drug Pricing Program.”
  • The Washington Post informs us,
    • “The American Medical Association and a leading public health research group focused on vaccines are teaming up to create a system to review vaccine safety and effectiveness, mirroring a role long played by the Centers for Disease Control and Prevention.
    • “The groups, which will operate independently from the federal government, say their work is needed because the CDC’s vaccine review process has “effectively collapsed.” The parallel effort will initially focus on reviewing immunizations for influenza, covid-19 and respiratory syncytial virus, or RSV, ahead of the coming fall respiratory season.
    • “The groups will not be making vaccine recommendations but will provide the evidence reviews to state health officials, clinicians and others making vaccine decisions.
    • “The nation’s largest physician organization and the Vaccine Integrity Project at the University of Minnesota will convene leading medical professional societies, public health groups and health care organizations to “ensure a deliberative, evidence-driven approach to produce the data necessary to understand the risks and benefits of vaccine policy decisions for all populations — the approach traditionally used by the federal government,” according to a joint statement announcing the effort Tuesday.”

From the Food and Drug Administration front,

  • Radiology Business lets us know,
    • “A new MRI system designed specifically for imaging of neonates and infants has just been cleared by the U.S. Food and Drug Administration. 
    • “Cincinnati-based Eyas Medical Imaging announced the clearance of its Ascent3T on Thursday. Eyas cited the clearance as the first in the world for a 3T neonate-specific MRI system.  
    • “Cincinnati Children’s Hospital played a pivotal role in the scanner’s design and development. Experts there observed over 1,700 infant MRI scans on prototypes to get a better idea of how to design the system so it could achieve diagnostic quality in real-world settings.
    • “We took great care in the design of the Ascent3T. Our goal is to transform neonatal care by bringing an unprecedented level of MR imaging and access to the most vulnerable patients when and where they need it,” MR physicist Charles Dumoulin, PhD, a professor of pediatrics and radiology at Cincinnati Children’s and the founder of Eyas Medical Imaging, said in an announcement.”
  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration refused to review Moderna’s application to sell a new seasonal flu vaccine.
    • “The FDA sent Moderna a “refusal-to-file” letter earlier this month, saying the company’s study testing the vaccine wasn’t sufficient, and the agency wouldn’t take up the company’s request for approval to sell the shot, Moderna said Tuesday.
    • “In the letter, the FDA said Moderna failed during testing to compare its experimental flu vaccine to the best available vaccine on the market.
    • “Moderna said the FDA didn’t identify any concerns about the safety or effectiveness of the company’s experimental vaccine. The company said it was asking the agency for a meeting to discuss the matter.”
  • Fierce Pharma adds,
    • “A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi.”
  • Per an HHS news release,
    • “The U.S. Food and Drug Administration today launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food. The review will consider whether BHA is safe under its current conditions of use in food and as a food contact substance, based on the latest scientific information. As part of this re-assessment, the agency issued a Request for Information (RFI) on the use and safety of BHA.
    • “This is part of the FDA’s broader efforts to proactively review chemical additives in the food supply. In May 2025, the FDA launched a strengthened program to review chemicals currently in the food supply. FDA identified BHA as a top priority for review. The FDA’s post-market assessment of BHA used in food is one of several ongoing post-market assessments under the agency’s enhanced systematic process for scrutinizing chemicals in our food supply.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “There are 933 cases in the South Carolina measles outbreak, the state’s Department of Public Health reported Feb. 10. Of those, 859 cases are unvaccinated, 20 are partially vaccinated, 25 are vaccinated and the status of 29 cases is unknown. The agency said last week that in January there were more than 16,800 doses of the measles vaccine administered, a 72% increase compared to January 2025. The department said vaccination continues to be the best way to prevent measles and end the outbreak.”
  • The Wall Street Journal asks “Why Doctors Can’t Agree on How to Diagnose Alzheimer’s Disease.”
    • “Divergent diagnostic criteria is raising concerns that some patients are being misdiagnosed and unnecessarily treated.” * * *
    • “Dr. Gayatri Devi, director of Park Avenue Neurology in New York City, is a neurologist who says over the past year she has seen an increasing number of patients who were told they had Alzheimer’s disease when they didn’t. One patient, a human-resources executive, had erroneously been diagnosed with Alzheimer’s based on a faulty PET scan of his brain that had read positive for amyloid and his own fears of memory issues because he had missed an important meeting.” * * *
    • “Dr. Reisa Sperling is a neurology professor at Harvard Medical School who runs studies testing antiamyloid drugs in asymptomatic people with amyloid in their brain. She says the goal is early intervention. * * *
    • “She says the International Working Group’s criteria requiring cognitive impairment to diagnose Alzheimer’s disease is problematic, likening it to requiring someone with diabetes to wait until they have blindness or kidney failure to be diagnosed. “All disease begins before symptoms, and most diseases are better treated before people walk into your office with clear impairment,” Sperling says. 
    • “Devi says the psychological impact of being told you have Alzheimer’s when you don’t is profound. Until the medical community can better agree on how to both diagnose early Alzheimer’s disease and determine whether early treatment helps, patients should avoid unnecessary testing—especially with the advent of easily accessible blood tests.”
  • MedPage Today tells us,
    • “A large-scale, automated urinary incontinence (UI) screening and education program increased awareness, diagnosis, and treatment of the condition, researchers found.
    • “In a quality improvement study known as Identify, Teach, and Treat (IT2), Sarah Collins, MD, of the University of Chicago Pritzker School of Medicine, and colleagues asked women presenting for routine annual primary care visits a single question: “Do you have bothersome leakage of urine?”
    • “Those who answered “yes” were given the option to engage in an educational and interactive computer-based tool about UI and treatment options. Using the tool led to significant increases in practice-level rates of UI diagnosis and treatment, the researchers reported in JAMA Internal Medicine.”
  • Healio informs us
    • “Adolescents and young adults with type 1 diabetes who reported receiving help with managing their disease may have better glycemic outcomes as they transition from pediatric to adult care, researchers reported.
    • “In a study published in Diabetic Medicine, researchers analyzed baseline data from adolescents and young adults who enrolled in a randomized clinical trial to assess a behavioral intervention to support the transition from pediatric to adult care. After conducting four multiple regression models, researchers found that participants who said they received more help with managing their diabetes had better self-management skills and lower HbA1c.”
  • Per NIH news releases,
    • “National Institutes of Health (NIH) researchers have developed a digital replica of crucial eye cells, providing a new tool for studying how the cells organize themselves when they are healthy and affected by diseases. The platform opens a new door for therapeutic discovery for blinding diseases such as age-related macular degeneration (AMD), a leading cause of vision loss in people over 50.
    • “This work represents the first ever subcellular resolution digital twin of a differentiated human primary cell, demonstrating how the eye is an ideal proving ground for developing methods that could be used more generally in biomedical research,” Kapil Bharti, Ph.D., scientific director at the NIH’s National Eye Institute (NEI).”
  • and
    • “The National Institutes of Health (NIH) has stopped an investigational treatment arm of the Comparison of Anti-coagulation and Anti-platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) study ,following a regular review by the Data Safety and Monitoring Board (DSMB).
    • The DSMB is an independent group of experts that regularly check if the study is safe. NIH’s National Institute of Neurological Disorders and Stroke, the trial’s funder, accepted the DSMB recommendation that CAPTIVA discontinue the low-dose rivaroxaban arm of the trial due to an increase in safety events and evidence of futility, a pre-specified stopping point to enable the study to end if early results showed the treatment is unlikely to help people. Rivaroxaban is a U.S. Food and Drug Administration-approved anticoagulant medication used to treat or prevent blood clots.
    • All study sites that have active participants randomized to the discontinued arm have received instructions for drug discontinuation. Study participants who have completed their evaluation of the discontinued arm will be contacted by the site where they received treatment. Participant safety remains NIH’s top priority.
  • Per BioPharma Dive,
    • “In experimental eczema shot from Nektar Therapeutics helped trial enrollees who’d already benefited from treatment maintain and even deepen their response over one year after being switched to a longer-lasting maintenance dose, the company said Tuesday.
    • “The data, if confirmed in additional testing, could give Nektar’s shot a competitive advantage over Regeneron and Sanofi’s Dupixent and Eli Lilly’s Ebglyss by offering deepening effects with less-frequent dosing. But Nektar also faces competition from many others advancing different types of injectables and oral medicines for the condition. 
    • “Nektar is planning a Phase 3 trial with a similar design that will allow responders to transition to a maintenance dose while others continue on with the initial regimen. If successful, the company expects to ask the Food and Drug Administration for approval in 2029.”
  • and
    • “An experimental, dual-acting weight loss pill from Hengrui Pharma and Kailera Therapeutics will advance into further testing after succeeding in a mid-stage study in China.  
    • “The drug is an oral version of ribupatide, an injectable therapy the two have already brought into Phase 3 development. In a Phase 2 study in 166 participants, that pill helped spur an average of as much as roughly 12% weight loss over 26 weeks, compared to about 2% for placebo recipients. More than half of those on the highest dose lost at least 10% of their body weight, and around 38% achieved at least 15% weight loss.
    • “Most treatment-related side effects were gastrointesinal and mild to moderate in nature. At the top two doses tested, vomiting was reported in as many as 11.4% and 7.5% of recipients, and nausea in 22.7% and 20%, respectively. Hengrui will “rapidly” move the drug into a Phase 3 trial in China, while Kailera plans to start a global mid-stage trial this year, the companies said.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS beat Wall Street’s expectations in the fourth quarter, but investors — unhappy that the healthcare giant didn’t change its outlook for 2026 — still sent CVS’ stock down after the company released results early Tuesday morning.
    • “Executives defended CVS’ 2026 guidance as achievable and indicative of the success of the company’s turnaround plan during a difficult time for insurers. The financial growth CVS outlined contrasts with some of its managed care peers, which expect revenue and earnings to contract this year.
    • “CEO David Joyner also said that CVS is in talks with the Federal Trade Commission in the agency’s high-profile lawsuit against major pharmacy benefit managers, following the FTC’s recent settlement with Cigna.” * * *
    • “Moreover, legislation passed earlier this month requiring more transparency and delinking compensation from drug prices in Medicare’s prescription drug benefit is manageable, and could lead to greater adoption of Caremark’s rebate-free model, Joyner said.
    • “What we’ve seen now is more clarity in terms of where the reform is coming from. The good news is, we know at least with the legislation how to operate and how to run our business,” Joyner said. “At least consistent with the PBM legislation, the tools that we’ve seen are essentially leaning into what we’ve been doing over the last couple years.”
  • Fierce Healthcare relates,
    • “With 2025 marking a “reset year for the industry,” Oscar Health put a focus throughout the year on setting the company up for the future, its top brass told investors Tuesday.
    • “Oscar’s insurance business is concentrated in the Affordable Care Act exchange market, and CEO Mark Bertolini said during the company’s fourth-quarter earnings call that plans across this space felt the squeeze as more Medicaid lives entered the pool and integrity measures drove changes in market dynamics.
    • “With that backdrop, Oscar priced its plans for 2026 to account for those program integrity changes, elevated utilization trends and higher morbidity among its membership, Bertolini said. He said the team also baked in an expectation that the advanced premium tax credits would run out as scheduled, which they did Jan. 1.
    • “We took decisive actions with a disciplined pricing, distribution and product strategy to go after profitable growth as competitors pulled back or exited the market,” he said.”
  • Kaufmann Hall tells us,
    • “Hospital performance settled into a “new normal” in 2025. Patient volumes continue to grow, and a persistent gap between gross and net operating revenue indicates an eroding payer mix and more uninsured patients.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.
    • “Key Takeaways
      • “Hospital performance settled into a “new normal” in 2025. While margins in 2025 were stronger compared to prior years, hospitals need to be strategic about diversifying services and managing expenses.
      • “Patient volumes continue to grow across all services. While outpatient volumes continue to increase, hospitals will likely have a greater proportion of high acuity patients with elevated costs of care.
      • “There is a persistent gap between gross and net operating revenue, alongside a rise in bad debt and charity care. This imbalance indicates an eroding payer mix, likely a higher proportion of government vs. private payers, and more uninsured patients.”
  • Beckers Hospital Review adds,
    • “The same financial pressures hospitals are facing are increasingly evident at the physician enterprise level, according to Kaufman Hall’s latest quarterly “Physician Flash Report,” which is based on data from more than 200,000 employed providers — physicians and advanced practice providers — across more than 100 specialties.
    • “Provider productivity continues to climb, even as reimbursement and compensation lag behind, according to the report. Provider productivity — measured by work relative value units per full-time equivalent — has increased 7% since 2023. Over the same period, provider compensation rose 6%, while reimbursement declined 1%, as measured by net patient revenue per provider wRVU.
    • “The imbalance is driving higher practice subsidies. 
    • “The median investment — or subsidy — per physician reached $315,358 in the fourth quarter of 2025, a 4% increase since 2023. Labor expenses also remain elevated, accounting for 84.4% of total physician practice costs.
    • “The amount of downstream revenue that a provider needs to generate to cover a practice’s investment is increasingly unsustainable in this current financial environment,” Matthew Bates, managing director and physician enterprise service line leader at Kaufman Hall, said in a Feb. 10 news release. “Providers are working more but are being paid less for their work. Patient demand is up, yet reimbursement is falling.”
  • Fierce Pharma points out,
    • “After ending 2025 with a strong fourth quarter, AstraZeneca management has doubled down on its ambitious “$80 billion by 2030” revenue target, outlining a roadmap to have more than 25 blockbuster medicines by the end of the decade.
    • “During AZ’s Q4 earnings call, CEO Pascal Soriot highlighted an “unprecedented catalyst-rich period.” With more than 100 ongoing phase 3 trials and over 20 late-stage readouts slated for 2026, AZ’s exec team used a big chunk of their time on the call taking inventory of key clinical programs.
    • “That large portfolio shows the value of diversification, again highlighting what Soriot called “low concentration risk.”
    • “It’s great to have one or two big products. [It] makes you very profitable and makes you look good,” Soriot said. “But if you lose one of those, as we’ve seen happen to some actors in the industry lately, it really becomes very painful, very quickly. So this diversification, both product-wise, but also geographically, is suddenly becoming more apparent as we drive growth through therapy areas but also through regions.”
    • “AZ capped 2025 with fourth-quarter revenues of $15.5 billion, which arrived slightly above analysts’ expectations, thanks mainly to the company’s oncology portfolio.”
  • Beckers Payer Issues ranks States by share of mental health treatment facilities that accept commercial insurance.
    • “Overall, 83% of mental health treatment facilities accept private insurance in the United States. 
    • “Wyoming has the greatest percentage of centers that take commercial insurance, whereas California and the District of Columbia have the lowest. 
    • “KFF reported the rate of mental health treatment facilities that accept various insurance types, relying on 2024 data from respondents. While a facility may report participation, not all facilities may be accepting new patients.”

Monday report

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

From Washington, DC,

  • The Hill reports,
    • “The Trump administration on Monday proposed stripping the power of an independent board to review challenges from fired federal workers while barring employees from taking the matter to court.
    • “The new proposed rule would impact federal workers fired through a Reduction in Force (RIF), the process used at 22 different agencies last year as the Trump administration conducted widespread layoffs.
    • “If finalized, any federal worker fired in a future RIF would not be able to plead their case before the quasi-judicial Merit Systems Protection Board (MSPB), which last year found that some agencies had “engaged in a prohibited personnel practice” in firing the workers. 
    • “Instead, any challenges would be reviewed by the Office of Personnel Management (OPM), which last year alongside the Office of Management and Budget instructed agencies to begin RIFs.”
  • Per a CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) proposed regulations to lower health care costs, promote competition, and strengthen program integrity in the Federal and State-Based Health Insurance (Exchanges). The proposed Notice of Benefit and Payment Parameters for 2027 would crack down on fraud and misleading practices by agents and brokers, restore accountability for taxpayer-funded subsidies, and remove federal barriers that have limited plan innovation and driven up premiums—helping ensure coverage is more affordable and works better for consumers, taxpayers, and states.” * * *
    • “To review the proposed rule, visit https://www.federalregister.gov/d/2026-02769. 
    • “Public comments must be submitted by March 11, 2026. 
    • “To review the proposed rule fact sheet, visit https://www.cms.gov/newsroom/fact-sheets/hhs-notice-benefit-payment-parameters-2027-proposed-rule.” 
  • Bloomberg Law adds,
    • “The Notice of Benefit and Payment Parameters from the Centers for Medicare & Medicaid Services would allow certain plans that offer preset dollar amounts for care—such as indemnity plans—to meet the requirements of a “qualified health plan” under the ACA if they demonstrate a sufficient number of doctors would accept the plan’s payment terms.” * * *
    • “The rule likewise expands hardship exemptions to permit more individuals to buy “catastrophic” plans with the lowest level of cost-sharing and coverage, and allows catastrophic plan issuers to offer multi-year terms. The proposal would also permit plans with low deductibles and higher out-of-pocket costs
    • “The rule also reverses changes made under the Biden administration, including requiring insurers to offer standardized plan options that were meant to simplify choices.”
  • Healio observes,
    • “A voluntary program designed to help Medicare Part D beneficiaries manage drug costs[, which took effect last year,] could provide considerable benefit to people with cancer, according to study results.
    • “The Medicare Prescription Payment Plan (M3P) provides flexibility that may ease financial distress — particularly for those with limited or fixed incomes — and reduce the potential for cost-related treatment nonadherence, researchers concluded.”
    • “However, many patients and health care professionals are unaware of the program, according to Aryana Sepassi, PharmD, MAS, assistant professor of clinical pharmacy at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “The Food and Drug Administration’s breakthrough program has made a steady start to the 2026 financial year, granting designations at the same pace as in the two prior years.
    • “After years of growth that peaked in 2021, designations have settled at a lower rate in recent years. The agency awarded 164 to 166 designations per financial year three times from 2022 to 2025.
    • “The FDA is on course to grant a similar number of breakthrough designations in its 2026 financial year. After one quarter, the agency had awarded 42 designations, a pace that would result in 168 breakthrough statuses if maintained across the full financial year.”
  • MedPage Today tells us,
    • “Oncology specialists should inform patients about a risk of serious toxicity related to dihydropyrimidine dehydrogenase (DPD) deficiency and should test for DPYD variants before starting treatment with capecitabine (Xeloda) and fluorouracil, the FDA announced.
    • “In a safety update communicationopens in a new tab or window, the agency noted that DPYD encodes DPD, which breaks down more than 80% of fluorouracil. Certain homozygous or compound heterozygous DPYD variants result in complete or near-complete absence of DPD activity, increasing the risk for serious, potentially fatal toxicities when exposed to capecitabine or fluorouracil, which are widely used in cancer treatment. Potential adverse reactions include mucositis, diarrhea, neutropenia, and neurotoxicity. The reactions also can occur in patients who have partial DPD activity.
    • “Capecitabine and fluorouracil, or 5-FU, are routinely used in treatment regimens for breast, colorectal, gastric, and pancreatic cancers.”
  • STAT New informs us,
    • “The Food and Drug Administration has rejected a rare-disease gene therapy from Regenxbio, the company said Monday. 
    • “The one-time treatment, called RGX-121, is designed to replace a malfunctioning gene that causes mucopolysaccharidosis type II, also known as Hunter syndrome, an ultra-rare disorder that causes physical and cognitive impairments.”
    • “Regenxbio had applied for accelerated approval, a type of conditional market clearance, based on RGX-121’s ability to significantly reduce in the short term a specific biomarker in cerebrospinal fluid believed to correlate with longer-term cognitive improvements in patients with the severe form of Hunter syndrome. 
    • “But the FDA, in its letter rejecting the therapy, raised questions about the appropriateness of using the surrogate biomarker, called CSF HS D2S6, as a predictor of clinical benefit. The agency also questioned the eligibility criteria  Regenxbio used to enroll patients into its clinical trial and the use of a natural history comparator arm, the company said.”  

From the judicial front,

  • Bloomberg Law reports,
    • “Medical providers are testing a new legal strategy to recoup unpaid arbitration awards as health insurers rack up victories in surprise billing disputes.
    • “The shift underscores the difficulties both sides face in arbitration under the No Surprises Act, which requires doctors and insurers to settle most unexpected out-of-network bills themselves rather than balance-billing the patient. The volume of disputes has exposed cracks in the system, leading to a series of lawsuits around ineligible claims, fraud, and unpaid awards.
    • “Courts have largely concluded that the law doesn’t grant doctors the right to sue over unpaid awards in most circumstances. Most recently, the US Supreme Court denied two air ambulance companies’ petition to hear their case after the US Court of Appeals for the Fifth Circuit ruled against them.
    • “Providers are now adapting their legal strategy by arguing insurance companies are guilty of improper denial of benefits under the Employee Retirement Income Security Act and unjust enrichment under common law. Hundreds of cases in the US District Court for the District of New Jersey were paused last month pending a decision on the amended claims in Rowe Plastic Surgery of NJ LLC v. Aetna Life Insurance Co .
    • “But the doctors are likely to face problems, at least in overcoming ERISA preemption on their unjust enrichment claims, said Leslie Howard, co-founder of Cohen Howard, a firm representing out-of-network providers.”
  • The American Hospital Association News relates,
    • “The 5th U.S. Circuit Court of Appeals Feb. 9 affirmed a district court ruling upholding Louisiana’s 340B contract pharmacy law. The state law prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. Three drug companies — AbbVie, PhRMA and AstraZeneca — challenged the law, arguing that it was unconstitutional in several ways. “Rejecting those arguments, the appeals court held that Louisiana’s law was not preempted by federal law, did not violate the Fifth Amendment’s Takings Clause, did not violate the Constitution’s Contract Clause and was not unconstitutionally vague. “States regulate pharmacies — and the distribution of drugs to those pharmacies — every day,” the 5th Circuit explained. “Act 358 fits comfortably within that tradition.
    • “The AHA filed friend-of-the-court briefs supporting Louisiana’s law last year.” 
  • The Society for Human Resource Management notes,
    • “On Feb. 6, a federal appeals court vacated a preliminary injunction of two executive orders (EO) — EO 14151 on “Ending Radical and Wasteful Government DEI Programs and Preferencing” and EO 14173 on “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” — finding they were not unconstitutional on their face. The court had previously stayed the injunction, pending appeal. This ruling was the first by a federal appeals court to find the two EOs facially constitutional. Both EOs focused on infrastructure inside the federal government with an emphasis on contracts and grants.
    • “EO 14173, issued Jan. 21, 2025, “was the most significant EO for the private sector” last year, said W. John Lee, an attorney with Morgan Lewis in Philadelphia. Established on May 19, 2025, the U.S. Department of Justice’s Civil Rights Fraud Initiative “is a direct result of the EO and is a prominent example of how it is reshaping federal enforcement of civil rights law.” EO 14151, issued Jan. 20, 2025, set the tone for EO 14173. EO 14173 reshaped compliance obligations for federal contractors and grantees. It also revoked EO 11246, ending EO-based affirmative action programs for women and minorities.
    • “On Jan. 21, 2025, U.S. Equal Employment Opportunity Commission (EEOC) Chair Andrea Lucas made it clear that the EEOC’s enforcement priorities had shifted in alignment with President Donald Trump’s EOs.
    • “While the 4th U.S. Circuit Court of Appeals vacated the injunction, it sent the case back to the district court for further proceedings and left open the possibility of challenges based on individual application of the EOs.”
  • The Wall Street Journal points out,
    • “A lawsuit that drugmaker Novo Nordisk filed on Monday against telehealth firm Hims & Hers shows how fierce the maneuvering over the booming obesity-drug market has become.
    • “In the lawsuit filed in a federal court in Delaware, Novo Nordisk accused Hims & Hersof violating the patents covering its Ozempic and Wegovy drugs used for weight loss by trying to sell custom-made versions of those medicines.
    • “The pill from Hims & Hers threatened to undermine Novo Nordisk’s efforts to recapture momentum in the $70 billion weight-loss drug market by providing a lower-cost alternative to a Wegovy pill the Danish company recently launched.
    • “Novo Nordisk has been pulling out the stops to reclaim the momentum it lost to Eli Lilly in the booming market.” 

From the public health and medical / Rx research front,

  • Health Day tells us,
    • “Americans could be facing an uphill battle when it comes to protecting their heart health as they age, a new Cleveland Clinic poll reveals.
    • “Nearly 3 of 4 Americans (72%) feel confident in their ability to maintain heart health as they age, the survey found.
    • “But nearly as many (69%) also report that they have at least one known risk factor for heart disease.
    • “Worse, nearly 1 in 4 (24%) aren’t sure whether they are at increased risk for heart disease, according to the survey.
    • “Healthy aging is about prevention,” said Dr. Samir Kapadia, chair of cardiovascular medicine at the Cleveland Clinic.
    • “Heart disease often develops silently over decades, which is why staying active, understanding your risk factors, and addressing them early can make a profound difference in both quality of life and longevity,” Kapadia said in a news release.”
  • The American Medical Association lets us know “what doctors wish patients knew about the shingles virus.”
    • “If you’ve ever had chickenpox, then the virus that causes shingles is present in your body and can resurface at some point in the future. Find out more.”
  • The New York Times relates,
    • “If you think your daily doses of espresso or Earl Grey sharpen your mind, you just might be right, new science suggests.
    • “A large new study provides evidence of cognitive benefits from coffee and tea — if it’s caffeinated and consumed in moderation: two to three cups of coffee or one to two cups of tea daily.
    • “People who drank that amount for decades had lower chances of developing dementia than people who drank little or no caffeine, the researchers reported. They followed 131,821 participants for up to 43 years.
    • “This is a very large, rigorous study conducted long term among men and women that shows that drinking two or three cups of coffee per day is associated with reduced risk of dementia,” said Aladdin Shadyab, an associate professor of public health and medicine at the University of California, San Diego, who wasn’t involved in the study.”
  • NBC News relates,
    • “Bad,” or LDL, cholesterol is a major risk factor for heart disease and most people are screened for it as part of their yearly physicals.
    • There’s another marker in the blood that may be a better predictor of heart disease risk, a recent large review suggests. But it’s not part of routine blood testing.
    • “Apolipoprotein B (apoB) is a protein that attaches to harmful fat particles in the blood. The apoB protein is found on the surface of harmful lipoproteins like low density lipoprotein, or LDL, that contribute to heart disease. Since each one of the harmful particles contains one apoB molecule, testing for it essentially captures the overall number of harmful plaque-producing compounds.” * * *
    • “ApoB testing is hot among health influencers and increasingly touted in the commercial blood testing market. Recently, the Sweetgreen salad chain — which has tied itself to anti-seed-oil influencers — launched a collaboration with the testing company Function Health and is promoting apoB screening along with its menus.
    • “Dr. Michael Shapiro, a preventive cardiologist and the chair of the American Heart Association Council on Lipidology, Lipoprotein, Metabolism & Thrombosis, said that he typically uses an apoB test in select patients.” * * *
    • “In some cases, insurance may cover the test. If not, it typically costs around $70 at a lab.
    • “There aren’t clear guidelines for what target apoB levels should be. In healthy people, apoB values less than 90 mg/dL are typically considered acceptable, with some saying lower targets closer to 70 mg/dL may be more optimal for preventing heart disease.”
  • MedPage calls attention to
    • “Most women said they preferred clinic-based cervical cancer testing over at-home self-sampling, with demographics and life experiences shaping those preferences, a cross-sectional study indicated.
    • “In a nationally representative survey, 20.4% of women said they would prefer to do their own at-home self-sampling for cervical cancer screening, while 60.8% said they prefer clinic-based testing and 18.8% said they were uncertain on their preference, reported Sanjay Shete, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues in JAMA.
    • “The survey showed that women who had experienced prejudice or discrimination while receiving medical care had higher odds of preferring self-sampling at home (adjusted OR 1.94, 95% CI 1.16-3.22), while Black women had lower odds of preferring at-home self-sampling compared with their white peers (aOR 0.45, 95% CI 0.21-0.96).
    • “When women were asked why they preferred at-home self-sampling, privacy was the most common reason (54.9%), followed by time constraints (35.1%) and fear of embarrassment (33.4%).”
  • and
    • “The CDC’s Advisory Committee on Immunization Practices recently voted to stop recommending a universal dose of the hepatitis B vaccine at birth.
    • “An evidence review found that universal hepatitis B vaccination at birth is safe, effective, and protective for individual and public health.
    • “There was no improvement in safety or effectiveness with a delayed first dose of the hepatitis B vaccine.”
  • Per Genetic Engineering and Biotechnology News,
    • “In a study using gut microbiome samples from over 11,000 people across 39 countries, a single group of bacteria (CAG-170) has been found in higher numbers in the gut microbiomes of healthy people. CAG-170 remain unculturable in the lab, and are only identifiable from their genetic fingerprints.
    • “Further analysis of CAG-170 revealed the bacteria have the capacity to produce high levels of Vitamin B12 and enzymes that break down a wide range of carbohydrates, sugars, and fibers in our gut. The researchers suggest that Vitamin B12 supports other species of gut bacteria, rather than supporting the humans whose guts it is being produced in. CAG-170 could, in the future, be used as an indicator of our gut microbiome health or serve as the basis for the development of probiotics specifically designed to support and maintain healthy levels of CAG‑170 in the gut.”
  • Per Cardiovascular Business,
    • “An oral PCSK9 inhibitor from Merck is associated with significant reductions in low-density lipoprotein (LDL) cholesterol, according to new data published in The New England Journal of Medicine.[1] All PCSK9 inhibitors on the market today are injectable—an oral option that does not require needles could make a major impact on patient care. 
    • “Fewer than half of patients with established atherosclerotic cardiovascular disease currently reach LDL cholesterol goals,” lead author Ann Marie Navar, MD, PhD, an associate professor of cardiology at the University of Texas Southwestern Medical Center in Dallas, said in a statement. “An oral therapy this effective has the potential to dramatically improve our ability to prevent heart attacks and strokes on a population level.”
    • “Back in November, researchers presented initial findings from this study at the American Heart Association’s Scientific Sessions 2025 conference. Now, however, the analysis can be read in full.
    • “The CORALreef Lipids trial focused on nearly 3,000 heart patients with high LDL cholesterol who were randomized to either receive enlicitide, Merck’s experimental oral PCSK9 inhibitor, or a placebo. Two patients received the new drug for every one patient treated with a placebo.”
  • Per Radiology Business,
    • “A new MRI-specific artificial intelligence tool could significantly improve the diagnosis of neurological conditions in busy settings. 
    • “Developed by researchers at the University of Michigan, the tool can read brain scans in just seconds. The tool, named Prima, is a video language model that can simultaneously process video, images and text in real time. Experts involved in its development are hopeful it can help address the rising imaging volumes.
    • “As the global demand for MRI rises and places significant strain on our physicians and health systems, our AI model has potential to reduce burden by improving diagnosis and treatment with fast, accurate information,” said senior study author Todd Hollon, MD, a neurosurgeon at U-M Health. 
    • “Researchers trained Prima using more than 200,000 MRI exams collected at the university over several decades. Imaging data were included alongside patients’ medical histories and clinical indications for the scans. The team tested the model on more than 30,000 brain studies over a one-year period. Unlike earlier AI tools that focus on just one disease, Prima was designed to analyze all available imaging and clinical information at once, similar to how a radiologist reviews a case, giving it broad applicability.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Kaiser Permanente nearly tripled its operating income last year, even as the integrated healthcare conglomerate weathered rising expenses.
    • “Kaiser, which recorded results alongside its subsidiary Risant Health, recorded operating income of $1.4 billion last year, up from $569 million in 2024 as the nonprofit continued to invest in operational improvements, according to earnings results released last week. 
    • “Still, expenses rose by more than $11 billion last year as Kaiser said rising medication costs and other line items made providing care more expensive.”
  • Beckers Hospital Reviews identifies eleven rapidly growing health systems.
  • BioPharma Dive relates,
    • “Eli Lilly will acquire biotechnology startup Orna Therapeutics, saying Monday it will pay up to $2.4 billion to buy the privately owned company and a technology able to reprogram immune cells within the body.
    • “The Indiana-based drugmaker didn’t disclose how much upfront cash it’s shelling out for Orna, which specializes in “circular” RNA medicines that are believed to be more stable and easier to pair with the lipid nanoparticles used for delivery. But it noted in its statement that it intends to use Orna’s technology to develop cell therapies for autoimmune conditions.
    • “In announcing the deal, Lilly cited its interest in Orna’s lead project, which instructs immune cells to latch onto B cells that are attacking patients’ tissue in inflammatory diseases. The company presented data from preclinical studies at the American Society for Hematologymeeting in December that it’s using to support advancing into Phase 1 studies.”
  • and
    • “Japan’s largest drug company is teaming up with an artificial intelligence specialist to find new medicines for cancer and other diseases, through a deal that could be worth more than $1.7 billion.
    • “Announced Monday, the multiyear collaboration grants Takeda Pharmaceutical access to two technologies at Iambic Therapeutics. The first is an AI-driven platform used to discover and develop new drugs. The second is a model meant to predict how proteins will interact with certain receptors.
    • “The companies haven’t disclosed the deal’s upfront cost, nor any specific disease targets. The focus, though, will be on small molecule drugs for cancers and conditions rooted in the digestive or immune systems. Iambic will get milestone payments based on the partnership’s level of success, and is also eligible to receive royalties on net sales of any products it generates.”
  • Per Beckers Payer Issues,
    • “Patients who take advantage of zero-cost preventive screenings see better health outcomes and reduced spending, according to January research from BCBS Association and Blue Health Intelligence.
    • “The groups reviewed claims data of BCBS members with breast or colorectal cancer. The research pointed to lower likelihood of invasive tests and treatment.
    • “Eighty-one percent of members who were diagnosed with colorectal cancer through a preventive screening were classified in an early stage, compared to a 73% rate overall. For breast cancer, that figure was 86% during preventive screening. The early-stage rate was 82% overall.” 
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
    • “IgA nephropathy has historically been thought of as a relatively benign form of kidney disease, but it has become increasingly recognized that it frequently progresses to end-stage kidney disease,” said ICER’s Chief Medical Officer, David Rind, MD. “Management of progressive disease has typically included treatments targeted at B-cells, but such therapies, such as systemic glucocorticoids, have serious side effects. New therapies offer the possibility of better outcomes with fewer harms.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on February 26, 2026. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.”

Weekend update

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

Happy Super Bowl Sunday!

  • The House Energy Commerce Committee health subcommittee holds a hearing on February 11 with Pharma and PBM executives.
  • Fierce Healthcare adds,
    • “In the $1.2 trillion budget package signed Tuesday, a little-known healthcare provision was reauthorized that will allow millions of people on Medicare to access diabetes prevention education online. 
    • “As part of the budget package, Congress passed the PREVENT DIABETES Act, which extends the ability for digital health companies (virtual suppliers) to participate in the Medicare Diabetes Prevention Program (MDPP) through the end of 2029. 
    • “Medicare Part B patients who are at risk for Type 2 diabetes can participate in the program for free, if they meet certain clinical thresholds for weight, blood pressure or blood glucose. The program lasts for a year and consists of 22 sessions on lifestyle changes to prevent diabetes. 
    • “Since the COVID-19 pandemic, virtual providers like Omada Health, 9am Health and Amwell have entered the business on temporary authority, much like other Medicare telehealth services.” 
  • Under the budget package, the Homeland Security appropriations bill remains under a continuing resolution which expires on February 13.
  • Roll Call lets us know,
    • “With no signs of tangible progress in negotiations over changes to immigration enforcement policies, the main question may be whether House members and senators can muster the votes needed for another short-term funding extension just for DHS.
    • “Both chambers of Congress are expected to be on recess next week for Presidents Day. The holiday weekend overlaps with the annual Munich Security Conference, which runs Feb. 13-15 and typically attracts a large congressional delegation.
    • “Senate Majority Leader John Thune, R-S.D., who is not traveling to Munich this week, suggested the Senate may need to be in session if the Homeland Security funding is not resolved.”

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “Hims & Hers has abandoned plans to sell a compounded version of Novo Nordisk’s weight loss pill following backlash from U.S. regulators and the threat of a federal investigation. 
    • “In a short statement posted on the social media platform X Saturday, Hims said that, after “constructive conversations with stakeholders across the industry,” it “decided to stop offering access” to the treatment. “We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.” 
    • “The sudden turn quickly ends, for now, plans by the telehealth company to launch a copycat form of Novo’s “Wegovy” pill. Hims had announced those plans on Thursday and, in doing so, quickly drew legal threats from Novo as well as swift action from the Food and Drug Administration.” 

From the public health and medical / Rx research front,

  • Clinical Advisor reports,
    • “Measles is now extending beyond families with young children, with outbreaks reported on college campuses and communities across the country.
    • “At least 12 people have tested positive for measles at Ave Maria University in Florida, near Naples, since January 29, according to local officials. Three people were taken to the hospital.
    • “A student at the University of Wisconsin-Madison also tested positive after traveling overseas.
    • “Earlier this year, Clemson University in South Carolina confirmed a measles case linked to someone with ties to the school.
    • “It takes only 3 cases of measles for health officials to declare an outbreak.
    • “So far in 2026, at least 17 states have reported infections, according to the US Centers for Disease Control and Prevention (CDC).”
  • CNN tells us,
    • “We often discuss depression and dementia separately, although scientists have long observed a connection between the two: People with depression appear to have a higher likelihood of developing dementia later in life.
    • “A new study published in The Lancet Psychiatry adds an important twistin untangling that relationship and looks beyond depression as a single diagnosis. By focusing on specific symptoms, the research raises a more precise and potentially more useful question: Could certain symptoms in midlife signal greater vulnerability to dementia decades later? And if so, what should people and clinicians do with that information now?”
    • The CNN reporter interviews CNN wellness expert Dr. Leana Wen about the study.
  • Medscape informs us,
    • “As GLP-1s continue to surge in demand, older patients in your practice may inquire about these medications for their weight-loss efforts. Although they are known to improve conditions such as high cholesterol and obesity and help with the management of type 2 diabetes, certain precautions should be considered for patients older than 65 years.
    • “Older adults often do their own research on wellness trends. If they ask about GLP-1 medications, knowing clinical and science-based facts can keep them informed and safe. Some experts say these medications and this patient population should be carefully considered.
    • “[In the article,] Yuval Pinto, MD, DABOM, assistant professor of medicine and part of the Healthful Eating, Activity & Weight Program at Johns Hopkins School of Medicine in Baltimore, laid out some of the risks.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Two years ago, a GLP-1 prescription could cost an uninsured patient more than $1,000 a month. Today, Novo Nordisk’s NOVO.B Wegovy pill starts at just $149 through cash-pay programs. 
    • “In the world of Big Pharma, this is unheard of. 
    • “Typically, drug prices climb or plateau until generics arrive years later. That trend should be even stickier in a duopoly. Yet the obesity market has turned traditional pharma economics upside down. As Leerink analyst David Risinger notes, there isn’t a comparable precedent for this level of price erosion in the industry’s history.” * * *
    • The question both companies [Novo and Lilly] are now racing to answer is just how elastic consumer demand is in the obesity market. Lower prices are clearly unlocking growth in demand, especially in the cash-pay market. As Novo Nordisk Chief Financial Officer Karsten Munk Knudsen argued in an interview this week, this isn’t a price war, so much as a search for the price points that open the floodgates of access.
  • The New York Times lets us know “How to Tell if You Will Save Money Using TrumpRx.”
    • “People may be able to pay less for prescriptions with their insurance rather than via the new government website. The Trump drugstore is meant to help people buy medications using their own money.”
  • Beckers Payer Issues notes,
    • “Elevance Health bid on 11 national accounts in competing Blue Cross Blue Shield markets last year and won nine of them, the company said on its 2025 earnings call with investors, offering the first look at how a landmark antitrust settlement is reshaping competition within the Blues ecosystem.
    • “This is the first year that we’ve had the opportunity for employers in competing geographies against us who could actually quote with our organization if they wanted,” Morgan Kendrick, Elevance’s president of commercial and specialty health benefits, said Jan. 28.
    • “The provision, known as the “second blue bid,” stems from a $2.67 billion settlement that resolved allegations dating back to 2012 that BCBS companies conspired to divide up markets and avoid competing with one another, thereby driving up costs for consumers. Among other changes, the settlement struck down a rule that required large employers to work with the BCBS insurer covering the geography where the employer is headquartered.
    • “Now, for certain large national accounts, employers can solicit bids from any BCBS plan in the country, not just the one licensed in their service area. Elevance’s 9-for-11 record is the first concrete data point on how the settlement is reshaping competition among Blues plans, but industry observers say the effects could stretch beyond one selling season.
    • “Ari Gottlieb, a consultant to insurers and owner of A2 Strategy, told Becker’s the provision will primarily benefit BCBS plans with the existing scale and technology to compete nationally.”

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, Generative AI, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Mehmet Oz arrived on Capitol Hill last week to pitch Republicans on an idea to codify into law President Trump’s drug-pricing model, which ties U.S. pharmaceutical costs to lower prices typically paid abroad.
    • “Oz, the Centers for Medicare and Medicaid Services administrator, could sense the skepticism from GOP senators—members of the Finance Committee—as they raised concerns about industry backlash and a potential chilling effect on innovation.
    • “You read the room,” Oz said in an interview. “When’s the right time to tell them they need to do something different?”
    • “The move marked the opening effort of the administration’s push to advance the president’s planahead of the midterm elections, as healthcare costs have become a top voter concern. While Trump has proposed sending money directly to Americans through Health Savings Accounts to ease those costs, that discussion was absent from Oz’s talks with Republicans, he said.
    • “That’s not the most important issue for us,” said Oz, the former television host and celebrity surgeon widely known as Dr. Oz. He emphasized making sure that pricing deals reached under Trump with more than a dozen pharmaceutical companies endure beyond his time in office.”
  • and
    • “The White House on Thursday launched its drug-pricing website, dubbed TrumpRx, the culmination of efforts by the administration to bring down pharmaceutical costs for some consumers.
    • “When it launched, it had roughly 40 drugs available, including obesity treatments Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound and infertility treatments such as Gonal-F from EMD Serono. The prices for the drugs on TrumpRx were generally much lower than their sticker price, with President Trump touting some discounts of hundreds of dollars a month. The website, TrumpRx.gov, allows customers to search for specific medicines and purchase them through a manufacturer’s direct-to-consumer site, or in some cases gives users coupons that they can present at certain pharmacies.” * * *
    • “The website likely won’t have a substantial impact on the amount most Americans pay for their prescriptions, as most of Americans are insured—either through private or government plans—and are likely to get a better deal on the drugs via their coverage. The roughly 27 million Americans who are uninsured are those most likely to benefit from the direct-to-consumer offerings.” 
  • Here is a link to the White House’s fact sheet on TrumpRx.
  • Govexec tells us,
    • “The U.S. Postal Service on Thursday reported that it experienced a net loss of nearly $1.3 billion in the first quarter of fiscal 2026, as there continues to be a lack of consensus among postal leaders, stakeholders and lawmakers about how to fix the agency’s longstanding financial challenges. 
    • “Officials attributed the loss to a $634 million increase to workers’ compensation, among other spending hikes, paired with a $264 million reduction in operating revenue. In comparison, USPS saw a net income of $144 million during the first quarter of fiscal 2025. 
    • “USPS, however, experienced a net loss of $9 billion in fiscal 2025, and officials have projected that the postal agency will continue to operate in the red for fiscal 2026. 
    • “At a USPS Board of Governors meeting on Thursday, Postmaster General David Steiner and the board reiterated their argument that legislative and administrative reforms, such as raising the postal agency’s $15 billion statutory debt limit, are necessary to reverse these losses.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With online health and wellness company Hims & Hers opening a new front in the GLP-1 compounding showdown Thursday, the United States’ top drug regulator has taken notice.
    • “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” FDA commissioner Marty Makary, M.D., said in a Feb. 5 post on X. “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
    • “Makary’s comments mark a clear and sharp rebuttal to Hims’ announcement earlier in the day that it had launched a compounded version of Novo Nordisk’s new Wegovy (semaglutide) pill for obesity, which starts at just $49 per month.”
  • and
    • “The FDA removed a prior “limitations of use” restriction it had placed on Gilead Sciences’ CAR-T Yescarta, allowing it to be used in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).
    • “Yescarta is approved for R/R large B-cell lymphoma, but previously wasn’t permitted to treat those with the rare, fast-growing PCNSL subtype. Prognoses related to this disease, which originates in the brain, spinal cord, eye, or cerebrospinal fluid, are typically poor, with a five-year survival rate of about 30%. The cancer type has no standard-of-care treatment options and an estimated 1,500 cases are diagnosed annually in the U.S.
    • “Dana-Farber Cancer Institute ran a phase 1 study to evaluate the safety of Yescarta in patients with PCNSL, as those with the disease had previously been excluded from the clinical trials supporting Yescarta’s initial approval, global head of development at Gilead’s Kite unit, Gallia Levy, M.D., Ph.D. explained in a company release.” 
  • MedTech Dive relates,
    • “Johnson & Johnson is recalling certain Cerepak detachable coil systems due to a higher-than-expected failure to detach rate that has been associated with four serious injuries and one death. The events were reported as of Oct. 14.
    • “The failure to detach could result in hemorrhagic and ischemic stroke, procedural delays or the need for additional surgical intervention, according to the Food and Drug Administration, which posted the recall on Thursday.
    • “J&J issued a letter to customers on Oct. 2 recommending they remove certain Cerepak products from where they are used or sold.”
  • Cardiovascular Business tells us,
    • “Zydus Pharmaceuticals, a New Jersey-based distributor of generic drugs, has recalled nearly 23,000 bottles of its icosapent ethyl capsules due to leakage issues that may have weakened their effectiveness. The prescription-strength capsules were manufactured by Softgel Healthcare in India and are sold in the United States as a more affordable option to name-brand treatment options.
    • “Icosapent ethyl is primarily used to help treat patients with high triglyceride levels in their blood. Taken together with a statin, it can also help significantly reduce the risk of heart attack, stroke or other cardiac complications in certain patient populations.
    • “Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” according to the Food and Drug Administration (FDA).”

From the judicial front,

  • Fierce Healthcare reports,
    • “The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals.
    • “Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand. 
    • “The filing acknowledged the preliminary injunction plaintiffs had secured and the government’s failed bid to have the the temporary pause overturned by the appellate court. Both reflected judges’ belief that the hospitals were likely to succeed on the merits of their claims based on at least two administrative issues—”a failure to provide a reasonable explanation or address significant reliance interests and a failure to consider relevant costs.” 
    • “As such, HHS does not believe providing more administrative documents to the court would change any decisions, according to the joint motion.”
  • The Wall Street Journal relates,
    • “Luigi Mangione will face murder and weapons charges in a Manhattan court in June for the killing of UnitedHealthcare CEO Brian Thompson, three months before jury selection in his federal trial for crimes related to the same killing.
    • “New York state court Judge Gregory Carro set a June 8 trial date during a snap hearing Friday, prompting an outburst from Mangione, who claimed he was being denied double-jeopardy protections.” * * *
    • “The Manhattan district attorney’s office argued the state case should go first because the killing occurred in Manhattan and local prosecutors—working with many NYPD detectives—led the investigation that resulted in Mangione’s arrest.
    • “The State has an overriding interest in trying this defendant for the cold-blooded execution of Brian Thompson on December 4, 2024. It resulted in the tragic death of a guest to our city on our streets,” Assistant District Attorney Joel Seidemann said in a letter to the judge.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally with most areas of the country reporting stable or decreasing trends. Emergency department visits are stable and highest among children 5-17 years. Hospitalizations trends continue to decrease overall and are highest among those 65 years and older. 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. RSV hospitalizations are highest among infants less than 1 year old.
    • “COVID-19
      • COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally with most areas of the country reporting stable or decreasing trends; however, activity continues to increase in the Pacific Northwest.
      • “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. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • The University of Minnesota CIDRAP adds,
    • “The effectiveness of this season’s flu vaccine in Canada is 40% against medically attended infection with influenza A(H3N2) viruses, 37% against newly emerged and predominant subclade K of the H3N2 strain, and 31% against the H1N1 influenza A strain, an interim analysis estimates.
    • “Researchers from the Canadian Sentinel Practitioner Surveillance Network (SPSN) conducted the test-negative study, which evaluated samples from patients aged one year or older who had acute respiratory illness. Community-based sentinel health care providers in Alberta, British Columbia, Ontario, and Quebec collected the specimens from October 26, 2025, to January 10, 2026, and the findings were published yesterday in Eurosurveillance.”
  • The AP reports,
    • “During the early years of the COVID-19 pandemic, experts worried that disruptions to cancer diagnosis and treatment would cost lives. A new study suggests they were right.
    • “The federally funded study published Thursday by the medical journal JAMA Oncology is being called the first to assess the effects of pandemic-related disruptions on the short-term survival of cancer patients.
    • “Researchers found that people diagnosed with cancer in 2020 and 2021 had worse short-term survival than those diagnosed between 2015 and 2019. That was true across a range of cancers, and whether they were diagnosed at a late or early stage.
    • “Of course, COVID-19 itself was especially dangerous to patients already weakened by cancer, but the researchers worked to filter out deaths mainly attributed to the coronavirus, so they could see if other factors played a role.”
  • Healio informs us,
    • “As the number of home hazards increased, so did the effect of visual function on the odds of falling.
    • “Home safety evaluations and environmental adaptations could be helpful for adults with low vision.”
  • and
    • “Use of SGLT2 inhibitors was associated with lower 5-year risk for chronic kidney disease and AKI compared with GLP-1 receptor agonists for adults with type 2 diabetes, according to data published in JAMA Internal Medicine.”
  • Radiology Business lets us know;
    • “New research suggests that photon-counting computed tomography scans outshine conventional contrasted chest CT for follow-up imaging of lung cancer. 
    • “Patients who have been diagnosed with the disease require routine imaging to monitor treatment effectiveness and ensure their cancer has not progressed or recurred. This is typically done via standard contrast-enhanced CT scans. Though effective, the standard of care comes with caveats, including increased exposure to both radiation and contrast media. What’s more, image quality can vary based on patient size, which can negatively affect lesion detection and characterization. 
    • “Experts believe that emerging photon-counting technology can help address these shortcomings. Published in RSNA’s flagship journal, Radiology, a new paper details numerous benefits photon-counting CT scans have over conventional CTs, including reduced radiation exposure and enhanced lesion visualization. Experts involved in the study went as far as to suggest that the advanced technology could replace conventional CTs in certain settings soon.”
  • Genetic Engineering and Biotechnology News observes,
    • “If you zoomed in far enough on a new experimental HIV vaccine, you wouldn’t see the usual protein shell that most vaccines rely on. Instead, you’d find tiny geometric structures folded from strands of DNA—molecular origami designed not to be noticed at all. This “invisible” scaffold may be the key to awakening some of the rarest and most sought‑after cells in immunology: the B cells capable of maturing into broadly neutralizing antibody producers.
    • “Many next‑generation vaccines use virus‑like particles (VLPs)—nanostructures that mimic the outer shape of a virus but contain no genetic material. By displaying many copies of a viral antigen on their surface, VLPs can activate B cells far more effectively than free‑floating proteins. The paper is titled “DNA origami vaccines program antigen-focused germinal centers,” and was published recently in Science. 

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

  • Fierce Healthcare reports,
    • “Centene is “laser-focused” on improving the performance of its Medicaid business following a difficult 2025.
    • “CEO Sarah London told investors Friday morning on the company’s earnings call that the team made headway in this effort in later part of 2025, with it’s Q4 medical loss ratio of 93% on par with expectations set for analysts in October and showing notable improvement from the second quarter of 2025.
    • “She said that utilization trend patterns seen in the third quarter largely carried into Q4, with behavioral health as the largest driver. Home health services and high-cost pharmaceuticals were also key factors in cost and utilization trends seen in the back half of the year, she said.
    • “And while a spike in flu and other respiratory illnesses generated headlines late in the year, London said that utilization patterns in its Medicaid population were on par with expectations.
    • “As an organization, we have been laser-focused on restoring our Medicaid business to sustainable profitability while maintaining our focus on quality outcomes for our members and the communities we serve,” London said.”
  • and
    • “Molina Healthcare’s share price plunged on Friday as it posted a $160 million loss in the fourth quarter as well as guidance for 2026 that fell short of analysts’ expectations.
    • “Shares in the company were down by about 28% at 11:30 a.m. ET, with its stock tumbling out of the gate at market open on Friday. By comparison, Molina earned $251 million in profit for the fourth quarter of 2024.
    • “For the full year, Molina has posted $472 million in profit, down from $1.2 billion in 2024.
    • “In the earnings report, Molina revealed that it will exit the Part D space in the 2027 plan year due to financial pressure, including Medicare Advantage prescription drug (MAPD) plans. The company will focus on its existing dual-eligible business in Medicare, according to the announcement.”
  • Healthcare Dive relates
    • “Primary care physicians spend a significant amount of time on work in their electronic health records, even when they decrease the number of appointments they schedule with patients, according to new research published in Health Affairs.
    • “Physicians who cut back appointments saw their visit volume decline by 32.6% compared with other doctors. But their EHR time fell by just 21.2% — meaning the number of minutes spent in their records systems actually increased per visit by more than 20%, according to the study. 
    • ‘Primary care physicians need to handle a lot of tasks outside appointments, like responding to patient messages, researchers wrote. So reducing visits doesn’t necessarily eliminate a host of EHR tasks — though it does have repercussions for physicians’ pay and patients’ access to care, they noted.” 
  • and
    • “Epic rolled out an artificial intelligence tool this week that drafts clinical notes, setting up the nation’s largest electronic health record vendor as a major competitor in the ambient scribe market. 
    • “AI Charting, part of Epic’s AI tool called Art geared toward clinicians, listens during patients’ appointments with providers and can suggest orders based on the conversation. The product also allows clinicians to personalize the note’s structure using voice commands, like asking the tool to format current conditions as a bulleted list, according to a press release. 
    • “Epic plans to expand beyond documentation to make the tool “an active assistant in the room,” Corey Miller, Epic’s vice president of research and development, said via email. “This is really just the start for Art,” he said.”
  • Fierce Healthcare adds,
    • “Infinitus has launched a new suite of agentic artificial intelligence tools for healthcare payers that aim to improve member engagement through personalized communications.
    • “Infinitus is an AI company that helps call centers better handle inbound call volumes. For payer organizations, pressured to control costs as call volumes rise and ratings of members demand a modern consumer experience, AI is positioned to solve both issues. 
    • “With the Agentic AI Member Services Suite, health plan members have 24/7 access to an AI agent that can answer simple administrative questions, onboard members, triage questions and navigate care. Through messaging and calling capabilities, Inifinitus’ AI agents can proactively reach out to patients and scale member services without adding team members.”
  • and
    • “Aetna is continuing to build out its digital member experience with the launch of a new onboarding program designed to ease the process.
    • “The insurer said Thursday that the platform will be available to 4 million new members during the welcome period for their enrollment. The program leads on Rich Communication Services, or RCS, to support navigation and connect members with key information and resources they may need after enrolling in a new plan through text messaging.
    • “Nathan Frank, senior vice president and chief digital and technology officer for Aetna, told Fierce Healthcare that building trust with the member requires an end-to-end experience, and tech like the new onboarding program can play a key role in that effort.
    • “Onboarding isn’t just about administration and signing people up and making sure that you have the right information,” he said. “It’s the moment when members decide whether their health plan feels simple, or is it overwhelming?” 

Midweek report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Senate negotiators said an effort to renew expired healthcare subsidies had effectively collapsed, likely ending the hopes of 20 million Americans that the tax-credit expansion could be revived and lower their monthly insurance premiums.
    • “Talks had centered on a proposal from Sens. Bernie Moreno (R., Ohio) and Susan Collins (R., Maine) to extend a version of the enlarged Affordable Care Act subsidies for at least two years, while cutting off higher-income people from participating and eventually giving enrollees the option of putting money into health savings accounts. It also would eliminate zero-dollar premium plans. But lawmakers from both parties now say the chances of a deal have all but evaporated.
    • “It’s effectively over,” Moreno said Wednesday. Sen. Bill Cassidy (R., La.)—the architect of an adjacent plan—agreed. While Collins declined to be as definitive, she did say that it was “certainly difficult.”
  • Federal News Network tells us,
    • “Following a year of the Trump administration’s overhauls to the civil service, a bicameral group of lawmakers on Wednesday launched a congressional caucus focused on the federal workforce.
    • “Sens. Chris Van Hollen (D-Md.) and Tim Kaine (D-Va.), along with Reps. James Walkinshaw (D-Va.), Steny Hoyer (D-Md.) and Suhas Subramanyam (D-Va.) joined federal unions and good government organizations to announce the newly formed Federal Workforce Caucus. The group aims to more cohesively advocate for federal employees.” * * *
    • “Members of the new Federal Workforce Caucus, which includes at least some bipartisan support, are expected to meet regularly with leaders from federal unions, employee groups and other organizations. The group plans to propose legislation and workforce policies focused on long-term improvements to the career civil service.
    • “The Partnership for Public Service, American Federation of Government Employees, National Federation of Federal Employees and National Active and Retired Federal Employees Association, among several others, are also partners in the new caucus.”
  • OPM Director Scott Kupor has added another post to his Secrets of OPM blog.
  • Per a CMS news release,
    • “CMS continues to bring accountable care to more people with Medicare in 2026, expanding the benefits of high-quality, whole-person health care to achieve better health outcomes for millions of older Americans.
    • “As of January 2026, 14.3 million Medicare beneficiaries are estimated to receive care coordinated by Accountable Care Organizations (ACOs), up from 13.7 million in 2025, representing a 4.4% increase. This includes patients whose health care providers are in Medicare Shared Savings Program (Shared Savings Program) ACOs and entities participating in Center for Medicare and Medicaid Innovation (CMS Innovation Center) accountable care models, as well as other CMS Innovation Center models focused on total cost of care, advanced primary care, and specialty care.
    • “ACOs are groups of doctors, hospitals, and other health care providers who collaborate and provide coordinated, high-quality care to people with Medicare, and they are a critical tool to help Make America Healthy Again by supporting whole person care that addresses prevention, chronic illness and the root causes of disease.
    • “In addition to improving health care, ACOs save billions of dollars for the Medicare program by focusing on delivering the right care at the right time while avoiding unnecessary services and medical errors. ACOs achieve savings because health care providers are held accountable for saving money and improving health care quality, delivering a win for both patients and the Medicare Trust Funds.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Johnson & Johnson’s Abiomed has sent an urgent medical device correction about a malfunction risk linked to 22 reports of serious injuries.
    • “The Food and Drug Administration, which published an early alertabout the devices on Tuesday, said sensor values in Impella RP heart pumps may drift over time.
    • “Erroneous information on automated Impella controllers has caused users to make inaccurate adjustments to the devices and unnecessary pump exchanges, the FDA said.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors by Abbott Diabetes Care due to incorrect glucose readings that are lower than actual blood glucose levels. The FDA said patients with impacted sensors should immediately discontinue use and dispose of any affected products. Abbott has reported 860 serious injuries and seven deaths associated with the issue since Jan. 7.” 
  • USA Today relates,
    • “A shortage in estrogen patches because of manufacturing issues and some brand discontinuation has been exacerbated by an increase in prescriptions for estrogen since the Food and Drug Administration removed its black-box warning label last fall. The shortage has left women exhausted, frustrated and scrambling each month to call pharmacies for the medicine they need to treat their menopause symptoms.
    • Some women have switched from generic medication to available brand names, which costs them as much as $300 a month and are not covered by insurance. Others have been forced to use a different brand of estrogen each month, leading to inconsistent care. Women have driven 45 miles to pick up a coveted box of the tiny plastic patch they place near their belly button and change twice a week to help with their symptoms, from frozen shoulders to vaginal dryness.”
  • STAT News adds,
    • “Vertex executives warned that Casgevy, its curative treatment for sickle cell disease, would be slow to reach patients. But few expected it to be this slow.
    • “More than two years after its approval, only about 60 patients across the U.S., Middle East, and Europe have been treated with the gene-editing therapy. Specialists at four sickle centers told STAT they’ve been surprised by one of the key stumbling blocks to faster rollout: They can’t collect enough cells to create the treatment.

From the judicial front,

  • Healthcare Dive reports,
    • “The Federal Trade Commission has agreed to what it called a “landmark” settlement with Express Scripts, allowing the company to bow out of the agency’s lawsuit against major pharmacy benefit managers for allegedly inflating the cost of U.S. insulin.
    • “In return, Express Scripts, which is owned by Cigna and is one of the largest PBMs in the country, has agreed to make major changes to its drug benefit designs, including no longer preferring drugs with high list prices on its standard formularies when there are cheaper equivalents and delinking its compensation from the savings it negotiates with drugmakers, the FTC announced Wednesday.
    • “Express Scripts has also agreed to increase transparency, including reporting more data on drug spending and disclosing any kickbacks to brokers that help employers choose PBMs.
    • “Notably, the company also agreed to reshore its group purchasing organization Ascent from Switzerland back to the U.S.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The measles outbreak in South Carolina has increased to 876 cases, the state’s Department of Public Health reported Feb. 3. Last week, the South Carolina outbreak surpassed last year’s outbreak in Texas, which had 762 cases. The agency said the number of public exposure sites indicates community spread is occurring, increasing the risk of exposure and infection for individuals who are not immune due to vaccination or natural infection. “Vaccination continues to be the best way to prevent measles and stop this outbreak,” the department said.” 
  • MedPage Today informs us,
    • “In this self-controlled case series, myocardial infarction rates were nearly 9 times greater in the week after an RSV-related hospitalization compared with a control period prior to infection.
    • “Stroke rates were more than 7 times higher compared with the control period.
    • “Recent research has suggested that RSV vaccination lowers the risk of cardiorespiratory hospitalizations.”
  • and
    • The effectiveness of last season’s COVID vaccines among immunocompetent adults reached 40% against hospitalization and 79% against invasive mechanical ventilation or death.
    • Those levels of protection were similar among seniors and sustained through 6 months post-vaccination.
    • This study is a reminder that “vaccines still have a role, even in the current epidemiological landscape,” an expert said.
  • Per an NIH news release,
    • The National Institutes of Health (NIH) has opened the East Palestine Train Derailment Health Research Program Office to assess and address the long-term health outcomes stemming from the 2023 train derailment in East Palestine, Ohio. The new office is the hub of a five-year, $10 million research initiative funded by NIH.
    • “Federal research experts will engage directly with the community, coordinate studies, and help enroll residents in federally supported health research through the new office.” * * *
    • Three years ago, on Feb. 3, 2023, a Norfolk Southern freight train derailment involving 38 railcars carrying hazardous chemicals — including vinyl chloride, butyl acrylate, ethylene glycol and benzene residue — resulted in prolonged fires and controlled burns in East Palestine. Several railcars burned for more than two days, and emergency responders conducted controlled burns that raised concerns about the potential airborne release of hydrogen chloride and phosgene.
    • “Local residents reported a range of initial health symptoms, including headaches and respiratory, skin and eye irritation. These reports prompted concerns about potential longer-term effects on maternal and child health, as well as psychological, immunological, respiratory and cardiovascular health.”
    • “This research program is designed to bring rigorous, independent science directly to the community,” said NIH Director Jay Bhattacharya. “By establishing a local presence, we can better engage residents, support enrollment in studies, and ensure the research reflects the real experiences and concerns of the people affected.”
  • Genetic Engineering and BioTechnology News observes,
    • “As drug‑resistant hospital infections continue to rise worldwide, a team of Australian researchers has identified a surprising new bacterial vulnerability: a sugar that only microbes make. By designing antibodies that recognize this sugar, the scientists were able to clear lethal infections in mice—offering a potential new strategy for tackling multidrug‑resistant pathogens.
    • “The work, published in Nature Chemical Biology, describes the development of monoclonal antibodies that target pseudaminic acid, a carbohydrate found on the surface of many dangerous bacteria but absent from human cells. The study, titled “Uncovering bacterial pseudaminylation with pan‑specific antibody tools,” demonstrates that this sugar may serve as a highly selective molecular flag for immunotherapy.”
  • Per Healio,
    • “Once-weekly subcutaneous tirzepatide may not raise risk for depression compared with placebo, according to a post hoc analysis of the SURMOUNT trials.
    • “As Healio previously reported, in January the FDA requested that risk for suicidal ideation and behaviors be removed from labels for liraglutide (Saxenda, Novo Nordisk), injectable semaglutide 2.4 mg (Wegovy, Novo Nordisk) and tirzepatide (Zepbound, Eli Lilly). 
    • “In data published in Obesity, researchers found adults receiving tirzepatide in three SURMOUNT trials did not experience worsening of depression throughout the studies.
    • “The low occurrence of these events with tirzepatide is similar to that observed in pooled analyses of semaglutide 2.4 mg and liraglutide 3 mg, both GLP-1 receptor agonists approved for weight management,” Thomas A. Wadden, PhD, professor of psychology in psychiatry at Perelman School of Medicine, University of Pennsylvania in Philadelphia, told Healio. “The present report provides the first detailed analysis of the risk of these psychiatric events with tirzepatide.”

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

  • BioPharma Dive reports,
    • “Eli Lilly shares jumped early Wednesday after the company reported better-than-expected fourth-quarter revenue and shared higher forecasts for 2026, buoyed by its obesity and diabetes medicines.
    • “Fourth-quarter revenue soared 43% to $19.3 billion, Lilly said Wednesday. That’s 7% above the Wall Street consensus, Leerink Partners analyst David Risinger wrote in a note to clients. Earnings per share beat estimates by 9% and operating income came in 13% higher than analysts expected, he said.
    • “This year, Lilly expects revenue of between $80 billion and $83 billion, with non-GAAP earnings of $33.50 to $35 a share. Analysts had been expecting midpoint forecasts of $78.5 billion for revenue and $33.30 for EPS, according to Risinger.”
  • Fierce Pharma tells us,
    • “Novartis CEO Vas Narasimhan is doubling down on a growth forecast for 2026, even as the Swiss drugmaker’s fourth-quarter results start to show the impact of the “largest patent expiry” in its history. And while a $4 billion revenue hole awaits, Narasimhan insisted that a wave of newer blockbusters will pull the company back into growth by year-end.
    • “The steep patent cliff that Narasimhan was referring to follows the 2025 U.S. entry of generic rivals to heart failure treatment Entresto, blood disorder drug Promacta and cancer therapy Tasigna.”
  • MedTech Dive informs us,
    • “Boston Scientific has been one of the big winners of the pulsed field ablation revolution. Over the past two years, the company has reported strong electrophysiology sales growth — sometimes in the triple digits — and declared itself the clear market leader in PFA.
    • “However, on a Wednesday morning earnings call, analysts questioned executives on the electrophysiology unit’s potential after U.S. sales growth stalled in the fourth quarter compared with the third quarter.
    • “CEO Mike Mahoney told investors that the company remains confident in PFA’s potential, even as the market becomes more penetrated and competition in the space ramps up. Mahoney said that the electrophysiology market should grow about 15% in 2026, and the company expects to grow above that rate.
  • Beckers Clinical Leadership notes,
    • [Nurse] workforce projections from HHS’ Health Resources and Services Administration indicate “the gap between the demand for and supply of RN services is expected to shrink over the next decade from 10% in 2027 to 6% in 2037,” according to a January report from the council. 
    • “This forecast is partly due to an increase in first-time examinees of the National Council Licensure Examination, according to the report. 
    • “By comparison, the U.S. supply of licensed practical nurses and licensed vocational nurses is projected to decrease a whopping 36% by 2037, HRSA data shows. These workforces have declined in labor participation and absolute licensure statistics across most states, the report said. 
    • “Although the projected outlook for the RN workforce is more favorable than it is for LPNs/LVNs, maldistribution of providers remains a critical issue, with nonmetropolitan areas projected to face significantly higher shortages than metropolitan areas in the coming years,” the report said. “These issues exacerbate the broader projected shortfall owing to the dual trends of increasing demand due to an aging population and an aging workforce.”
  • Cardiovascular Business lets us know,
    • “Early adopters have been using robotics to perform cardiac surgeries in the United States for years now, but multiple factors—including high costs and early concerns about patient outcomes—have held back widespread implementation.   
    • “According to a new commentary in The Annals of Thoracic Surgery, however, robotic cardiac surgery has gained considerable momentum in the last year. Is now the time for this trend to truly take off?
    • “A convergence of improved training frameworks, maturing technology and increasingly standardized quality processes have supported a broader and more sustainable growth,” wrote co-authors Andrea Amabile, MD, a cardiothoracic surgery resident with the University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute, and Johannes Bonatti, MD, director of the cardiac robotic surgery at the UPMC Heart and Vascular Institute. “In this context, the past year has brought forward a set of notable global milestones that collectively illustrate the evolving capabilities of robotic cardiac surgery.”
  • Per Beckers Health IT,
    • “KLAS Research released its annual “Best in KLAS” report Feb. 4, ranking healthcare technology vendors and service providers across more than 140 market segments based on feedback from the clinicians and administrators who use them.
    • “The report, now in its 28th year, draws on tens of thousands of provider evaluations to identify the top-performing solutions in categories spanning electronic health records, revenue cycle, cybersecurity, AI and other areas. This year’s edition arrives as AI — particularly ambient speech technology — continues to reshape clinical workflows, and as health systems navigate tightening finances alongside growing vendor competition.
    • “For the 16th consecutive year, Epic was named the top Overall Health System Suite. Epic also won Best in KLAS recognition in 11 market segments.
    • [The article lists] the winners in some of the report’s most closely watched categories. The full report is accessible from KLAS Research here.
  • Per Beckers Payer Issues,
    • “Optum has launched a pair of AI-driven prior authorization products, one designed to speed up submissions on the provider side and another to accelerate clinical reviews for payers.
    • “The provider-facing product, Digital Auth Complete, went live in January in collaboration with digital health company Humata Health. The payer-facing product, InterQual Auth Accelerator, began piloting with two large health plans in late 2025, with the first payer expected to be fully live by April.
    • “It’s a combination of three things,” John Kontor, MD, senior vice president of clinical technology at Optum Insight, told Becker’s, explaining why the products are coming to market now. “It is the policy changes, including CMS-0057, that have accelerated everyone’s urgency to get this figured out. Two, it’s the readiness now of technology to be able to support solving many of these administrative, burdensome problems in healthcare. And third, the policy changes really reflect both industry frustration and impatience and the public’s real desire to get real and better answers to the problems of prior authorization.”
  • Per Fierce Healthcare,
    • “Epic is rapidly building out artificial intelligence tools integrated into its electronic health record solution as health IT companies strive to keep up with the dizzying speed of AI innovation.
    • “This week, the EHR giant released AI Charting, a built-in feature that ambiently listens during patient visits and drafts the clinician’s note. The AI charting feature also queues up orders based on the conversation. 
    • “Epic CEO Judy Faulkner announced the AI Charting technology during the company’s Users Group Meeting (UGM) in August as part of its collaboration with longtime partner Microsoft.
    • “AI models are advancing at a rapid pace; we continue to work with Microsoft on AI Charting and use a variety of different models through the Microsoft Azure platform,” an Epic spokesperson said Wednesday.”

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump demanded Monday that House lawmakers back the bipartisan spending deal passed by the Senate last week and set aside policy demands in an effort to quickly end a partial government shutdown. 
    • “We need to get the Government open, and I hope all Republicans and Democrats will join me in supporting this Bill, and send it to my desk WITHOUT DELAY,” Trump posted on Truth Social. “There can be NO CHANGES at this time.”
    • “House Speaker Mike Johnson (R., La.) is trying to pass as soon as Tuesday the $1.2 trillion package that funds large parts of the federal government through the end of the fiscal year while funding the Department of Homeland Security for just two weeks. That short-term extension is designed to provide time for a bipartisan deal to be reached on stricter policies for immigration-enforcement agents.” 
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services today announced a new behavioral health initiativeto assist homeless individuals with substance use treatment and recovery. The program, called the Safety Through Recovery, Engagement, and Evidence-based Treatment and Supports, or STREETS, will focus on psychiatric care, medical stabilization and crisis intervention, HHS said. The initiative is tied to an executive order issued by the administration last week on substance use.” 
  • In January 2024 OPM proposed to create to advance the FEHB / PSHB eligibility date to the first day of employment.  AFHO, the trade association that the FEHBlog represents, used the public comment period to advocate for the HIPAA 820.  Today, in a welcome deregulatory step, OPM withdrew the proposed rule.
  • MedCity News considers whether “It is Time to Change the Independent Dispute Resolution Process of the No Surprises Act.” The FEHBlog thinks so because the current process is opaque.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Grail has filed for Food and Drug Administration approval of its multi-cancer early detection test, the company said Thursday.
    • “The premarket approval filing for Grail’s Galleri test focuses on a U.S. study of more than 25,000 people and a randomized, controlled trial the company is running in the United Kingdom.
    • “Grail President Josh Ofman said at an event in January that approval will be a “major trigger” for evidence-based decisions with U.S. payers and could enable Medicare coverage.”
  • Cardiovascular Business relates,
    • “eMurmur, an Ontario-based artificial intelligence (AI) startup, has received U.S. Food and Drug Administration (FDA)clearance for its suite of algorithms designed to evaluate heart recordings captured by digital stethoscopes. 
    • “The newly approved offering, eMurmur Heart AI, was designed to detect both the presence and absence of heart murmurs. In addition, it can provide hemodynamic data that helps care teams as they develop patient management strategies. eMurmur Heart AI can be accessed through the company’s own standalone software—available as a web platform or mobile app—or through a third-party system.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The Centers for Disease Control and Prevention released its annual progress report on health care-associated infections Jan. 29, which found continued decreases in hospitalizations from multiple infections last year. Among the findings, there was an 11% decrease in hospital-onset Clostridioides difficile, or C. difficile, infection; a 10% decrease in catheter-associated urinary tract infections, or CAUTI; a 9% decrease in central line-associated bloodstream infections, or CLABSI; and a 7% decrease in hospital-onset methicillin-resistant Staphylococcus aureus, or MRSA. 
    • “Among inpatient rehabilitation facilities, there was an 18% decrease in hospital-onset C. difficile infections and an 8% decrease in CAUTI. For long-term care hospitals, there was a 23% decrease in ventilator-associated events and a 15% decrease in hospital-onset C. difficile. The report recommended providers continue reinforcing prevention practices, review HAI surveillance data to identify areas for improvement and address any gaps in prevention practices.”
  • Cardiovasular Business relates,
    • “Researchers have developed a new injectable therapy that could help protect a patient’s brain after they experience a stroke. The team behind this new treatment shared a look at its early progress in Neurotherapeutics.
    • “The therapy in question was built to cross the blood-brain barrier and help repair brain tissue, limiting the risk of permanent brain damage and encouraging a healthy recovery following an ischemic stroke. Co-author Samuel Stupp, PhD, founding director of Northwestern University’s Center for Regenerative Nanomedicine, previously found that supramolecular therapeutic peptides (STPs) technology could reverse paralysis and repair tissue in mice after a single injection. This analysis took those observations related to the potential benefits of STPs and transferred them to a new area of medicine. 
    • “Current clinical approaches are entirely focused on blood flow restoration,” co-author Ayush Batra, MD, an associate professor with the Northwestern University Feinberg School of Medicine and co-director of the NeuroVascular Inflammation Laboratory at Northwestern, said in a statement. “Any treatment that facilitates neuronal recovery and minimizes injury would be very powerful, but that holy grail doesn’t yet exist. This study is promising because it’s leading us down a pathway to develop these technologies and therapeutics for this unmet need.”
  • MedPage Today informs us,
    • “Use of single maintenance and reliever therapy (SMART) for moderate-to-severe asthma saved money by improving outcomes, according to a meta-analysis.
    • “While SMART is recommended by guidelines, combination inhalers aren’t FDA approved for both rescue and maintenance therapy, and thus insurance coverage has been a struggle in the U.S.
    • “Finding an economic advantage should influence payer decisions, the researchers suggested, calling for broader formulary inclusion of SMART.”
  • and
    • “All hypertensive disorders of pregnancy were tied to increased long-term cardiovascular risk, but superimposed preeclampsia carried the highest risk.
    • “All subtypes were significantly associated with higher risks of heart failure and stroke, and most were associated with higher risk of cardiovascular death.
    • “Unspecified hypertension was associated with myocardial infarction, while chronic and unspecified hypertension were both associated with atrial fibrillation.”
  • The Endocrinology Advisor lets us know that “the fit-fat index (FFI), which calculates the ratio of cardiorespiratory fitness to various adiposity measures (BMI, WHR, or WHtR), is significantly associated with lower risks for cardiovascular and all-cause mortality.”
  • Genetic Engineering and BioTechnology News points out,
    • “Evidence has been rising over the past few years that the gut microbiome can significantly influence how well cancer treatments work, especially immunotherapies. But the underlying mechanism has remained unclear. Now, a new study reveals how bacteria in the gut can help determine whether the amino acid asparagine (obtained from diet) will increase tumor growth or activate immune cells against the cancer​.
    • “The findings, published in Cell Microbe and Host in the paper, “Microbiota utilization of intestinal amino acids modulates cancer progression and anticancer immunity,” could lead to a novel cancer treatment approach and monitoring strategy; instead of targeting tumors directly, clinicians may one day be able to reshape the gut microbiome or diet to starve tumors while supercharging immune cells.
    • “Our study suggests that we need to think about how the interplay of diet, gut microbiota and tumor-infiltrating immune cells could affect cancer growth and response to therapy. We can’t overlook this key level regulation,” said Chunjun Guo, PhD, associate professor of immunology at Weill Cornell.”
  • Per BioPharma Dive,
    • “Novo Nordisk’s experimental combination shot CagriSema helped people with diabetes and obesity lower their blood sugar and lose more weight than the blockbuster drug Wegovy in a Phase 3 trial, the company said Monday, building the case for regulatory approval.
    • “The results come from one of several studies Novo has underway in obesity and diabetes for CagriSema, which adds a second metabolic drug to the active ingredient from Wegovy in a fixed-dose injection. The Denmark-based drugmaker has already asked the Food and Drug Administration to approve the shot in obesity.
    • “The data could sharpen Novo’s rivalry with Eli Lilly and its obesity drug Zepbound, which has overtaken Wegovy to become the biggest-selling obesity treatment in the world. Looking at all participants enrolled in the trial, CagriSema’s weight loss and blood-sugar reductions fall numerically short of Zepbound’s, but a head-to-head trial comparing the two hasn’t been completed yet.”
  • and
    • “An experimental rare disease drug from Sanofi succeeded against one so-called lysosomal storage disorder but failed against another, the French pharmaceutical company said Monday.
    • “According to Sanofi, the drug, dubbed venglustat, missed its primary objective in a Phase 3 study testing it against Fabry disease. However, in another study in a form of Gaucher disease, the drug met its main goal and three out of four key secondary endpoints. Sanofi didn’t provide details — they’ll be shared at medical meeting this week — but said it intends to submit the Gaucher results to global regulatory authorities.”

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

  • MedCity News reports,
    • “Access to primary care is collapsing in the U.S., creating an opening for new models that lower costs and improve outcomes.
    • “This week, Premise Health and Crossover Health moved to capitalize on that opportunity, announcing an agreement to merge into a single company focused on scaling primary care access. The combined organization will provide onsite, nearsite and virtual care for more than 400 employers with millions of members, operating nearly 900 wellness centers across the country.
    • “The new entity will be led by Premise CEO Stu Clark. He framed the deal as a convergence of two companies with the same thesis: advanced primary care is the lever to disrupt U.S. healthcare. Both companies define advanced primary care as an integrated bundle of primary care, behavioral health, pharmacy services and care navigation.
    • “Crossover and Premise have proven that a few things happen when you deploy our advanced primary care models: access goes up, health improves and costs go down. Costs go down for the employer as well as for the family,” Clark stated.
    • “The company’s target customers will be large self-insured employers, mainly Fortune 1000 companies, unions, Native tribes and government entities, he said.”
  • Healthcare Dive relates,
    • “Tenet has regained full ownership of Conifer Health Solutions, acquiring the remaining stake in its revenue cycle management business from CommonSpirit Health.
    • “CommonSpirit will pay Tenet almost $1.9 billion over the next three years to get out of its existing services contract, according to the deal announced Monday. That’s offset by $540 million that Conifer will pay CommonSpirit for its almost 24% equity stake and to eliminate CommonSpirit’s capital account.
    • “All told, Tenet executives said the deal creates almost $2.7 billion in total value to the system through the cash payments, the reduction of liability on its balance sheet and the value of the additional Conifer equity. Tenet’s stock rose 2% in morning trade Monday following the news.”
  • Fierce Healthcare informs us,
    • “Community Health Systems (CHS) has wrapped a deal to divest its 80% interest in two joint ventures to Vanderbilt University Medical Center (VUMC), the organizations announced Monday morning.
    • “The joint ventures own and operate Tennova Healthcare – Clarksville, a 270-bed hospital with 1,100 staff, and other ancillary businesses in the major Tennessee city. CHS received $623 million before certain transaction expenses for the interests, with CHS also paying $23 million of owed balances to the subsidiaries upon completion of the transaction. 
    • “VUMC, in its announcement, said it will be renaming the hospital and a freestanding emergency room to Vanderbilt Clarksville Hospital and Vanderbilt Emergency Sango, respectively. It also highlighted physician practices in Clarksville plus nearby Dover, Pleasant View and Tiny Town that were included in the deal.”
  • and
    •  “Community Health Systems (CHS) has sold its Commonwealth Health system to nonprofit Tenor Health Foundation, the for-profit chain announced.
    • “The sale, effective Feb. 1, comes just days after the parties received regulatory clearance from the state and in the wake of community and government efforts to keep the facilities open despite financial losses (see that story below). 
    • “The announcement also makes public the three-hospital system’s price tag: $33 million of cash plus a $15 million promissory note from Tenor, with additional cash considerations possible depending on collections of certain patient accounts receivable during the following 90 days.”
  • Healthcare Dive adds,
    • “Healthcare bankruptcies declined in 2025, even as the sector faces financial headwinds on the horizon, according to an analysis published last week by restructuring advisory firm Gibbins Advisors.
    • “The industry recorded 45 bankruptcy filings for debtors with liabilities of at least $10 million last year, down 21% from 2024 — and a steep drop from the 79 cases logged in 2023. However, hospital bankruptcies rose. 
    • “Another year of falling Chapter 11 bankruptcy filings doesn’t necessarily signal financial health in the sector, the report cautioned. Healthcare remains under “significant pressure” as the industry faces looming challenges like historic cuts to Medicaid, according to Gibbins.” 
  • The New York Times tells us,
    • If you wind up at an urgent care center in America, it’s increasingly likely you will be treated by a P.A. For a long time, P.A. meant the same thing everywhere: “physician assistant,” a licensed medical professional who can perform patient care, including prescribing medicine, under the supervision of a doctor.
    • But that might be changing. In Oregon, New Hampshire and Maine, P.A. now means “physician associate,” and other states may follow this year.
    • “Assistant” versus “associate” might sound like a trivial semantic debate, but to many practitioners, and to the American Academy of Physician Associates (which changed its own name in 2021), it’s an important part of the expanding role of P.A.s in health care. * * *
    • “Since 2000, the number of P.A.s has quadrupled, while many parts of the country face a shortage of doctors. That means P.A.s are becoming more numerous — and visible — in all fields of medicine, from primary care to dermatology. And along with the name change, they are seeking the ability to operate more independently from doctors.”
  • Per The Wall Street Journal,
    • “Eli Lilly plans to open a $3.5 billion weight-loss drug manufacturing plant in Pennsylvania’s Lehigh Valley, creating 850 permanent jobs.
    • “Pennsylvania is investing $100 million in tax credits and grants for the project, plus $5 million for a pharmaceutical training center.
    • “Lehigh Valley manufacturing jobs have grown by 28.8% since 2010, triple the national rate, despite recent U.S. manufacturing job contractions.”
  • Per Beckers Health IT,
    • “Oracle Health is expanding its Clinical AI Agent to help clinicians automate the creation of clinical orders during patient appointments.
    • “The tool now supports automated order creation for laboratory tests, imaging and diagnostic studies, new and refilled prescription medications, follow-up appointments and referrals. Oracle Health said in a Feb. 2 news release that the update builds on the product’s existing note-generation feature and uses ambient listening during visits to draft clinical orders for physician review and approval.
    • “The technology is designed to reduce the administrative burden of repetitive manual tasks, such as order entry, which can pull providers away from direct patient care and contribute to burnout.”