Friday report

Uncategorized

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Govexec.com reports,
    • “While the Homeland Security Department is shut down, the vast majority of employees—about 92%—are still reporting to work. In some cases, however, workers are finding creative solutions to get out of their regular duties and save money while their paychecks hang in the balance. 
    • “My unit is rotating voluntary furlough days,” said one DHS staffer.  “Workers in that office are taking turns to take time off work, which, during a shutdown, entails being placed in an unpaid furlough status. 
    • “[We] conserve finances by not commuting, since we’re only allowed to telework in emergency situations,” the employee said, noting some employees in the unit commute 80 miles per day and are therefore seeing significant savings on gas when they do not go to work. The employees who accept the furloughs have used the time to schedule medical appointments, handle errands or tackle home projects.” * * *
    • “Most DHS employees will not miss a full paycheck until the beginning of March. Craig Carter, president of the Federal Managers Association, said the impacts are already being felt across the DHS workforce.” 
  • The OPM Office of Inspector General has posted its semi-annual report to Congress for the period ended September 30, 2025. Here is a link to the OPM management’s response to this report.
  • Legistorm tells us about GAO report number GAO-26-107169 which was issued yesterday.
    • “What GAO Found
      • “The No Surprises Act, among its provisions, generally prohibits providers from balance billing in certain circumstances—such as emergency services—for individuals with private health insurance. Balance billing is when insured patients receive a bill from an out-of-network health care provider for the amount above any applicable cost-sharing that exceeds the health plan or issuer’s payment. An unexpected balance bill is referred to as a surprise bill.
      • “GAO analyzed the percentage of claims that were in-network for selected specialties to examine potential changes in network participation after the act’s implementation. Increases in the percentage of in-network claims may indicate increases in provider participation, while decreases may indicate reduced participation.
      • “Among specialties likely to be affected by the No Suprises Act protections—emergency medicine, radiology, anesthesiology, and air ambulance—the percentage of in-network claims increased for three of the four specialties after the act took effect. For example, GAO found the percentage of in-network facility claims (typically submitted by hospitals) and professional claims (typically submitted by physicians) for emergency medicine declined before the No Surprises Act took effect, then increased afterward.
      • “Payment changes for the selected services largely reflected continuations of trends prior to the No Surprises Act taking effect. For example, the inflation-adjusted payment for in-network emergency medicine services billed by facilities increased in 2022 and 2023, continuing the trend since 2019. Meanwhile, the inflation-adjusted payment for in-network emergency services billed by physicians or their practices decreased in 2022 and 2023, continuing previous trends.”
    • FEHBlog note: This is encouraging news.
  • NCQA writes in LinkedIn
    • “NCQA has updated its State of Health Care Quality Report to include data for HEDIS® Measurement Year (MY) 2024. This free resource, available on the NCQA website, offers valuable insight into healthcare quality performance nationwide.
    • “You can use this report to:
      • “Learn more about each quality measure, how it is defined and why it matters.
      • “Access national averages and historical trends for over 90 measures of clinical quality and patient satisfaction.
      • “Compare performance across different products, like Commercial, Medicare and Medicaid.
      • “We will add data for MY 2025 in February 2027, or you can get it sooner through NCQA’s Quality Compass®.
    • “The report is available through this link. You can also find a link to the report on the HEDIS Measures and Technical Resources web page.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Tracy Beth Høeg, the top drug regulator at the Food and Drug Administration, indicated in her first address to staff that she’ll scrutinize antidepressants and the shots used to protect babies from RSV.
    • “Høeg told employees on Thursday that her top priorities include two issues she’s focused on in the recent past: evaluating the safety of antidepressants taken by pregnant women and of monoclonal antibodies that protect infants against RSV.
    • “I’ve been interested to learn we really haven’t been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job,” Høeg said. “I actually think that there’s agreement about that, and among the CDER staff that I’ve been working with on this issue, so I’m excited to see that.”
    • “Høeg also discussed her interest in vaccine policy, and mentioned she’d like to “bring that interest” into the drug center.”
  • Radiology Business relates,
    • “GE HealthCare has secured three notable new MRI clearances from the U.S. Food and Drug Administration. 
    • “On Thursday, the company announced the clearance of two MRI systems, Signa Sprint with Freelium and Signa Bolt, and one artificial intelligence-enabled workflow platform. Each of the three cleared produts were designed with the rising demand for MR imaging in mind, according to the company’s president and CEO of MR, Kelly Londy. 
    • “Achieving FDA clearance of our next-generation Signa MRI technology underscores our commitment to expanding access to high-quality imaging and elevating the standard of care for patients everywhere,” Londy said in an announcement. “As MRI demand continues to rise across clinical areas, providers need solutions that deliver greater efficiency without compromising diagnostic precision.”
  • BioPharma Dive informs us,
    • “Roche said Friday that the Food and Drug Administration will decide by Dec. 18 whether to approve its experimental drug giredestrant in breast cancer, setting the stage for a verdict that could intensify the competition surrounding a new class of oral, tumor-fighting medications.  
    • “Roche’s submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies at keeping people with a certain type of advanced breast cancer alive without their disease getting worse. The pill has also since proven helpful to people in the “adjuvant” setting after surgery. 
    • “If approved, giredestrant would become the third new oral “SERD” on the market, following clearances for Menarini Group’s Orserdu and Eli Lilly’s Inluriyo. Roche believes giredestrant has the potential to stand out from its competitors, but faces persistent doubts about the class’ commercial outlook.”

From the judicial front,

  • The American Hospital Association News reports,
    • The Supreme Court Feb. 20 ruled [in a 6-3 opinion written by the Chief Justice] that the International Emergency Economic Powers Act [of 1977] does not authorize the imposition of global tariffs. The court held that IEEPA does not provide the president with “the independent power to impose tariffs on imports from any country, of any product, at any rate, for any amount of time.” The court did not address whether the government will have to refund the tariff revenue or what other legal authorities the president may have to impose similar tariffs. [The Court remanded those decisions to the lower courts.]
  • Bloomberg Law reports,
    • “The FTC has asked a federal appeals court to revive requirements for companies to divulge more information to US antitrust regulators ahead of potential mergers.
    • “The Federal Trade Commission Wednesday appealed a Feb. 12 decision from a US district court judge in Texas blocking a 2024 Biden-era rule. The case is pending in the US Court of Appeals for the Fifth Circuit.
    • “The regulation updated a decades-old US pre-merger notification program to require companies share more about overlapping business lines and ownership structures, among other details. Companies seeking combinations valued at $133.9 million or more must undergo an initial 30-day review by the FTC and Justice Department under the notice system.”
  • and
    • “The [U.S. Court of Appeals for the] First Circuit rejected a lawsuit accusing Cigna Health & Life Insurance Co. of obesity discrimination, shutting down an attempt to broaden coverage of blockbuster GLP-1 weight-loss drugs.
    • “Pressure to cover the drugs is growing for insurers and employers as their uptake among the general public increases. One in five adults has taken a GLP-1 drug at some point, according to a November 2025 poll from health-care think tank KFF.
    • “The US District Court for the District of Maine previously dismissed Jamie Whittemore’s case, along with a similar case against Elevance Health Inc. The district judges determined that Whittemore didn’t prove that obesity qualified her as disabled.” * * *
    • “Here, even if Whittemore plausibly alleged that obesity is a physical impairment, she failed to allege sufficient facts to support an inference that her obesity substantially limits her major life activities,” Judges Lara E. Montecalvo, Sandra L. Lynch, and Ojetta Rogeriee Thompson wrote in their opinion Thursday.”
  • Per a Justice Department news release,
    • “The Justice Department’s Antitrust Division, together with the Attorney General of Ohio, filed a civil antitrust lawsuit today challenging OhioHealth Corporation’s (OhioHealth) anticompetitive contract restrictions that force Ohio patients to pay higher prices for healthcare.
    • “The complaint, filed in the U.S. District Court for the Southern District of Ohio, seeks to enjoin OhioHealth, the largest healthcare system in central Ohio, from enforcing its anticompetitive contractual terms and continuing to suppress healthcare competition.”
  • Per Beckers Payer Issues,
    • “An insurance brokerage president and the CEO of a marketing company were each sentenced to 20 years in prison for their roles in a scheme to fraudulently enroll individuals in subsidized ACA plans to obtain commission payments from insurers.”

From the public health, medical and Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits for RSV are highest among infants and children less than 4 years old. RSV hospitalizations are highest among infants and children less than 4 years old. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains 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 and children 4 years and younger. 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.
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Feb. 19 released a report on the low use of COVID-19 antiviral drugs among individuals age 65 and older, a population at high risk of severe illness from the disease. The report found that from June 2023 through September 2025, 16%-23% of COVID-19 patients older than 65 received an antiviral prescription during low occurrences of COVID-19, compared to 37%-38% during higher occurrences. Adults ages 75-84 and 85 and older were more likely to receive an antiviral prescription than those ages 65-74. “COVID-19 vaccination and treatment can prevent severe COVID-19 among older adults,” the CDC wrote. “Efforts to improve health care provider and patient knowledge regarding the benefits of COVID-19 vaccination and antivirals, especially for older adults, are needed to reduce the risk for severe illness and death.”
  • The University of Minnesota’s CIDRAP adds,
    • “Two studies examined the effects of COVID-19 vaccination in pregnancy, with one estimating that full vaccination and a booster dose reduce the risk of preeclampsia (PE) by 15% and 33%, respectively, and the other finding no elevated risk of miscarriage before 20 weeks’ gestation among pregnant or soon-to-be-pregnant recipients of the Pfizer/BioNTech or Moderna vaccines.”
  • The CDC also announced,
    • “As of February 19, 2026, 982 confirmed* measles cases were reported in the United States in 2026. Among these, 976 measles cases were reported by 26 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New York City, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin. A total of 6 measles cases were reported among international visitors to the United States. 
    • “There have been 7 new outbreaks** reported in 2026, and 89% of confirmed cases (870 of 982) are outbreak-associated (73 from outbreaks starting in 2026 and 797 from outbreaks that started in 2025).”
  • The University of Minnesota’s CIDRAP adds,
    • “Utah has confirmed 300 measles cases in an ongoing outbreak, with the virus now spreading in Salt Lake County and new exposures at high schools in that county, according to an update yesterday from the Salt Lake County Health Department (SLCoHD).
    • “The first measles symptoms are often cold- or flu-like, with cough, runny nose, red/watery eyes, and fever, so you may think you have a common respiratory illness and can continue engaging in normal activities,” said Dorothy Adams, executive director of SLCoHD. “But please stay home if you have any signs of illness, especially now that we know measles is actively circulating in our community.”
  • Per the AHA News,
    • “The ongoing measles outbreak in South Carolina has reached 973 cases, the state’s Department of Public Health reported Feb. 20. Of those, 906 cases are unvaccinated, 26 are fully vaccinated, 20 are partially vaccinated and the vaccination status of 21 cases is unknown. Nationally, 982 confirmed measles cases across 26 jurisdictions have been reported to the Centers for Disease Control and Prevention since Jan. 1. The CDC said there have been seven outbreaks reported in 2026 and that 89% of confirmed cases are outbreak-associated.” 
  • Cardiovascular Business informs us,
    • “The American College of Cardiology (ACC) and American Heart Association (AHA) have developed their first clinical practice guidelines focused on the treatment and management of acute pulmonary embolism (PE). The new document, published in full in JACC and Circulation, highlights the importance of diagnosing patients as quickly as possible and determining the best course of action.
    • “A PE is a potentially fatal blood clot that travels through the heart and then becomes lodged in an artery in the lungs. Treating PEs quickly—and effectively—can help minimize the patient’s risk of death and cardiac arrest. Anticoagulants are the most common PE treatment, but catheter-based interventions and surgery may be necessary for more severe cases.
    • “There have been significant advances in the understanding of PE and treatments to effectively manage this condition,” Mark A. Creager, MD, chair of the document’s writing committee and director emeritus of the Heart and Vascular Center at Dartmouth Health, said in a statement. “This guideline is a road map to help clinicians navigate these advances for the safest and most effective approaches to care for people with this condition.”
  • Per Radiology Business,
    • “New research highlights the potential for a PET- and MRI-based imaging approach for differentiating a new type of dementia from Alzheimer’s disease. 
    • “Limbic-predominant age-related TDP-43 encephalopathy, also known as LATE, was recently recognized as a type of dementia that occurs in older adults, typically presenting as memory-related cognitive decline. Due to its impact on memory, it is often mistaken for AD. 
    • “However, both LATE and Alzheimer’s present differently on imaging. While AD is identified due to the accumulation of amyloid and tau proteins on the brain, LATE involves clumps of the protein TDP-43 in the limbic system. It is important to differentiate between the two due to the differing treatment methods for each. 
    • ‘A new paper in the Journal of Nuclear Medicine describes how combining PET and MRI imaging data can help distinguish between the two in living patients. 
    • “The distinction in the causes of these types of dementia is critical, especially in the era of anti-amyloid therapies,” Satoshi Minoshima, MD, PhD, professor of radiology and imaging sciences at the University of Utah, Salt Lake City, said in a news release. “Because LATE has a different underlying pathology and a seemingly different prognosis, it cannot be diagnosed or treated in the same way as Alzheimer’s disease.” 
  • The University of Connecticut, the FEHBlog’s alma mater, writes in LinkedIn about research on Parkinson’s Disease treatments.
  • Per BioPharma Dive,
    • “Grail’s multi-cancer early detection test failed to meet its primary endpoint in a key study, sending the company’s shares tumbling about 50% in Friday trading.
    • “The NHS-Galleri trial evaluated annual screening with the Galleri MCED test in England’s National Health Service over three years in 142,000 asymptomatic participants aged 50 to 77.
    • “Grail said the study aimed to show testing could help reduce late-stage cancer diagnoses and increase detection rates to support national screening in England. A U.S. premarket approval application for Galleri, submitted earlier this month, includes data from the trial on test performance, clinical validation and benefit of detection at stages I through III, including reduction in stage IV cancer diagnoses, the company said.”
  • Per Health Day,
    • “An ancient Chinese mind-body practice can lower a person’s blood pressure as well as medication or a program of brisk walking, a new study says.
    • “Baduanjin is a widely practiced eight-movement sequence that combines slow, structured movement, deep breathing and meditation.
    • “The practice lowered people’s blood pressure by about 3 to 5 points, similar to benefits sustained by people asked to take up walking, according to clinical trial results published Feb. 18 in the Journal of the American College of Cardiology.”
  • Per Genetic Engineering and Biotechnology News,
    • “Stanford Medicine researchers and collaborators have developed a universal vaccine candidate that studies in mice suggest protects against a wide range of respiratory viruses, bacteria, and even allergens. Unlike any vaccine used today, the new vaccine, delivered intranasally, was found to provide broad protection in the lungs for several months. The novel vaccination strategy integrates the two branches of immunity—innate and adaptive—creating a feedback loop that sustains a broad immune response.
    • “The research team, headed by Bali Pulendran, PhD, the Violetta L. Horton Professor II, director of the Institute for Immunity, Transplantation and Infection, and a professor of pathology, microbiology and immunology at Stanford University, demonstrated that vaccinated mice were protected against SARS-CoV-2 and other coronaviruses,  Staphylococcus aureus and Acinetobacter baumannii (common hospital-acquired infections), and house dust mite allergen. Pulendran said the new vaccine has worked for a remarkably wide spectrum of respiratory threats that the researchers tested. Speaking to GEN, Pulendran emphasized that the reported work is preclinical, and the team’s goal is to translate their research carefully and responsibly. “If it ultimately proves safe and effective in humans, the potential impact could be transformative: simplifying seasonal vaccination and improving readiness for emerging respiratory threats,” Pulendran said.”

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

  • Beckers Payer Issues reports,
    • “Medicare Advantage now covers about 55% of eligible beneficiaries nationwide — more than 35 million people — but health systems are confronting a question that until recently felt almost taboo: What happens when participation in the country’s fastest-growing Medicare program no longer makes financial sense?
    • “Over the past three years, Becker’s has reported on roughly 90 hospitals and health systems that have terminated some or all of their commercial Medicare Advantage contracts. In 2026 alone, at least 15 systems have gone out of network with one or more Medicare Advantage plans, and the trend is showing no signs of slowing down. 
    • ‘This year, 1 in 10 Medicare Advantage enrollees — about 2.9 million people — will be forced to disenroll from their plan following a spike in plans exiting the market, according to a Feb. 18 study published in JAMA.
    • “Behind many of those decisions lies what Scripps Health CFO Brett Tande describes as a classic “sunk-cost” dilemma: after years of building infrastructure, staffing and strategy around Medicare Advantage, can systems realistically walk away — even when contracts are losing money?
    • “For a growing number of health systems, the answer is becoming clearer.
    • “Becker’s connected with executives from Providence, Scripps Health, Ascension, MemorialCare and Mayo Clinic to understand how they are reassessing their participation in Medicare Advantage and what that shift could mean for providers, payers and patients.”
  • Kaufmann Hall notes,
    • “Partnerships, like all relationships, are de facto collaborative. Certain success factors are well known, including the importance of cultural alignment, constant communication and effective post-closing integration. Based on our collective experience assisting health systems with the negotiation of strategic partnerships, we share other lessons learned that are important considerations. These are tangible steps that require intentional focus and may require hard choices during the partnership development process but are important for ensuring long-term success. We hope these “inside baseball” lessons and case studies are useful for organizations when negotiating their next strategic partnership.”
  • and
    • “Amazon last week announced it would expand its same-day pharmacy delivery service to 4,500 cities nationwide. The move expands Amazon’s market share against other drug delivery providers like Walmart and CVS Caremark. It adds same-day delivery services to 2,000 communities, including remote areas in Alaska, the Navajo Nation and islands only accessible by ferry and only navigable by horse-drawn carriage. The expansion demonstrates the retail giant’s ability to scale its logistics network in healthcare, offering faster access to medications compared with traditional mail-order pharmacies, which can take up to 10 days to deliver drugs.”
  • Behavioral Health Business relates,
    • “Madison Health Group (MHG) has announced its plans to purchase managed behavioral health provider Magellan Health.
    • “This comes roughly five years after payer giant Centene Corporation (NYSE: CNC) bought Magellan Health at a valuation of $2.2 billion.
    • ​”Magellan Health manages behavioral health services for health plans, employers and government agencies.
    • ​”Following the deal, Magellan will become an independent organization, with MHG’s backing to support innovation. Specifically, the new funds will be used to expand its clinical programs into new markets, leveraging “enhanced technology, AI, data and analytical solutions” for its clients, according to social media posts.”
  • Fierce Healthcare tells us,
    • “Carrot is expanding its parenting benefits with on-demand virtual pediatric care through Blueberry Pediatrics. 
    • “Carrot, a fertility and family-building benefits platform working with payers and employers, will offer Blueberry as an add-on. The new offering will be available to families with kids under 12. It is expected to roll out in the next few months. The offering will be covered by the plan sponsor, and members are not expected to incur out-of-pocket costs.
    • ‘Parents will have 24/7 access to on-demand virtual visits with board-certified pediatricians from Blueberry for common issues like ear infections, rashes, colds and the flu. Families can connect with pediatricians around the clock via secure messaging, video or audio. Members will also get a home medical kit with a wireless digital ear scope, pediatric pulse oximeter and thermometer. This will help Blueberry clinicians remotely assess children.”
  • Per Modern Healthcare,
    • “Early lessons are emerging as the digital health sector’s ambient AI focus shifts from clinical documentation to prior authorization.
    • “Companies such as Abridge, Suki and Cohere say their solutions can do for prior authorization what ambient AI has done for documentation and clinician burnout. The importance of partnerships become an integral part of their efforts in this area.
    • “In August, Abridge announced a partnership with Pittsburgh-based insurer Highmark Health and its integrated health system Alleghany Health Network to develop a tool that would approve prior authorization requests at the point of care. Prior authorization was the logical next step for Abridge after clinical documentation, said Clinical Strategy Principal Matt Troup.
    • “Six months in, the collaboration has shown the importance of building connections with providers and payers when developing ambient AI for prior authorization.
    • “[Our partnership] just gave us access to bring everyone to the table, to figure out, what we can possibly do in this space,” Troup said. “Is it actually possible to get these approvals in real-time, upstream in the conversation, if both the payer and provider are aligned on the impact that this can have in healthcare.” 

Thursday report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC

  • The U.S. Office of Personnel Management promulgated a final rule
    • to amend its career and career-conditional employment regulations. The revision is necessary to implement section 1108 of the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019, which requires OPM to issue regulations implementing hiring authorities that allow agencies to hire certain post-secondary students into positions at specified grades in the competitive service. The intended effect of the authority is to provide additional flexibility in hiring eligible and qualified individuals.
  • Federal News Network adds,
    • “Some senior political appointees, including the vice president, will continue to see a long-standing freeze on their salaries. The Office of Personnel Management announced that pay rates will continue to be capped for certain Executive Schedule employees. Political appointees in Schedules C and G, however, are exempted from the pay freeze. Certain higher-paid positions have continued to see their salary capped for more than a decade. For 2026, the pay ceiling sits at about $197,000.(Updated guidance — pay freeze for certain senior political officials – Office of Personnel Management)
  • and
    • “The Office of Personnel Management will make job offers to the first participants in the TechForce initiative as soon as March 1. OPM Director Scott Kupor said the agency is in the final stages of reviewing the applications for software engineers and data scientists to join the government for two to four years and work on specific modernization projects. Kupor said OPM will soon open up applications for cybersecurity and web design positions. OPM plans to hire 1,000 technologists to work with agencies and private sector companies to solve specific agency technology challenges.(First set of TechForce hires to come in early March – OPM)”
  • Tammy Flanagan writing in Govexec tells us, “Federal workers delay retirement as savings gaps persist.A survey shows most workers expect to retire at 65 or later, but many haven’t calculated savings for health care or emergencies.”
  • JAMA informs us,
    • “Every year over the last 2 decades, the share of Medicare beneficiaries enrolling in Medicare Advantage has increased.1 The number of plans available to Medicare Advantage beneficiaries has also increased year after year, doubling in number over the last 7 years.2 As a result, Medicare Advantage beneficiaries have rarely had to contend with disruptions resulting from Medicare Advantage plans exiting the market (forced disenrollment), which may include adjustment to different provider networks, plan benefit packages, and supplementary benefits. However, recent reports suggest that many insurers will stop offering plans in 2026.3,4 This study characterized the scale and impact of Medicare Advantage plan exits for beneficiaries.”
  • STAT News reports,
    • “After years of grand ambitions, the federal government disclosed that it is months away from rolling out a centralized list of doctors and hospitals filled with up-to-date contact and insurance information.
    • “Details of how the national provider directory will work are scant — federal officials buried the development in a document intended for health insurance companies. The directory will be in a testing phase to start. * * *
    • “The agency plans to conduct an initial beta launch of the National Provider Directory later this year, with iterative improvements and expansions to follow,” federal officials said in the guidance document for Medicare Advantage plans.”

From the Food and Drug Administrationm

  • BioPharma Dive reports,
    • “Going forward, the Food and Drug Administration will generally only require one pivotal trial to support the approval of new medicines, top agency officials announced Wednesday.
    • “Writing in the New England Journal of Medicine, FDA Commissioner Marty Makary and top deputy Vinay Prasad said they are ending the “two-trial dogma,” a standard set in the 1960s to ensure the safety and efficacy of medical products. Technological advancements mean the FDA and sponsors can now focus on designing one high-quality trial that can better assess results, they said.
    • “In practice, many drugs in recent years have sped to market with only one pivotal study, thanks to changes Congress made in 1997. But Makary and Prasad argued that a new official standard is needed. “Default options anchor individuals and institutions psychologically, and we believe that formally articulating the FDA’s new position will spur biomedical innovation,” they wrote.”
  • CNBC adds,
    • “Food and Drug Administration Commissioner Marty Makary told CNBC that he believes “everything should be over the counter” unless a drug is unsafe, addictive or requires monitoring – doubling down on a push that some in the pharmaceutical industry have questioned. 
    • “In an interview Wednesday in Washington, D.C., Makary said the FDA aims to make changes this year that allow more companies to offer their prescription medicines over the counter, or OTC. He noted that the agency is going through “the proper regulatory processes” to update OTC monographs –  the rulebooks that determine which drugs can be sold without a prescription. 
    • “Makary said the FDA is looking at “basic, safe” prescription drugs like nausea medications and vaginal estrogen, which is used to treat menopausal symptoms like dryness and pain. 
    • “In my opinion, everything should be over the counter and not requiring a prescription, unless it’s unsafe, unless you need laboratory tests to monitor how it’s being received by your body, or if it could be used for some nefarious purpose or it’s addictive,” Makary told CNBC after the PhRMA Forum, a one-day event organized by the pharmaceutical industry’s largest lobbying group.” 
  • Per MedTech Dive,
    • “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
    • “The Food and Drug Administration posted an early alert Tuesday for a problem with certain Trividia Health blood glucose monitors linked to 114 injuries and one death.
    • “Earlier this month, Trividia issued a correction for four versions of its True Metrix blood glucose system. The company updated the devices’ instructions for use to clarify that patients should seek medical attention if they have symptoms of high glucose and receive an error code.
    • “The affected products may issue an error code in the case of a very high blood glucose result (higher than 600 mg/dL) or in the event of a test strip error, according to the FDA alert.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “Data from the National Vital Statistics System
      • “After increasing from 2016 (77.1%) to 2021 (78.3%), prenatal care beginning in the first trimester decreased to 75.5% in 2024.
      • “From 2021 to 2024, care beginning in the second trimester increased from 15.4% to 17.3%, and late or no care increased from 6.3% to 7.3%.
      • “From 2021 to 2024, prenatal care beginning in the first trimester decreased, while care beginning in the second trimester and late or no care increased, for all maternal age groups.
      • “First trimester prenatal care decreased, while second trimester prenatal care and late or no care increased, for nearly all race and Hispanic-origin groups from 2021 to 2024.
      • “From 2021 to 2024, late or no care increased in 36 states and the District of Columbia.”
  • Cardiovascular Business adds,
    • Hypertensive disorders during pregnancy are being recognized more and more as early warning signs of what is yet to come.
    • “We’ve increasingly come to appreciate that pregnancy can really be seen as a red flag or a risk signal of long-term maternal cardiovascular risk when certain complications emerge,” said Michael Honigberg, MD, MPP, a preventive cardiologist and researcher at Massachusetts General Hospital.
    • These complications include preeclampsia and gestational hypertension. He said clinicians have known for more than 25 years that these hypertensive pregnancy disorders are associated with higher, long-term cardiovascular risks. However, widespread integration of this knowledge into daily practice has lagged behind. In fact, only recently have these ideas been embraced by the broader cardiovascular community.
    • “I think the lack of that next step in terms of what do as a cardiologist with that information has sort of hindered people,” Honigberg explained.
    • He emphasized that asking a woman about about pregnancy history takes one second and can yield critical insight into a patient’s future risk.
  • and
    • “After years of implanting left atrial appendage occlusion (LAAO) devices in atrial fibrillation (AFib) patients, an interventional cardiologist with the University of Chicago Medical Center (UChicago Medicine) has developed a new device that could be a more affordable alternative to Boston Scientific’s Watchman and Abbott’s Amplatzer Amulet LAA Occluder. 
    • “Atman P. Shah, MD, a professor of medicine and co-director of the cardiac cath lab at UChicago, found that the currently available devices for LAAO were still associated with significant limitations. Their round shape is a poor fit for many patients, for example, and they require active fixation. With these issues in mind, Shah developed a minimally-invasive device that seals the LAA using a gel that adapts to the AFib patient’s anatomy and then hardens. A catheter delivers the gel, and an umbrella-like piece at the end of that catheter protects the heart during treatment. 
    • “Shah believes this device will reduce the risk of stroke in these patients while also limiting the likelihood of adverse complications while it is being implanted by an interventional cardiologist.” 
  • The Washington Post reports,
    • “Scientists showed in a new study published Thursday that they could use blood draws to build a “clock” for Alzheimer’s disease that could roughly predict when symptoms will develop, findings that could eventually transform how the illness is diagnosed and treated.
    • “A simple blood test can help diagnose Alzheimer’s, but the study in the journal Nature Medicine shows how these kinds of tests could one day play a greater role in preventing the insidious, memory-robbing illness.In the new study, researchers built a model that could use blood test results to forecast symptom onset within a margin of three to four years.
    • “The technique is not yet precise enough to predict the course of a patient’s trajectory. But it could be used to identify which patients would benefit if companies are able to develop drugs to treat the disease before symptoms develop.
    • “In the short term, the approach could accelerate the research to identify such treatments by recruiting the ideal study participants: people withno symptoms, but who are at high risk for developing them soon.” * * *
    • “Suzanne E. Schindler, a dementia specialist at Washington University School of Medicine in St. Louis who helped lead the study, said she’s been involved with research studies that are attempting to test treatments before people have cognitive impairment. When those people receive a positive test, she said, they immediately ask: “So how long do I have before I develop symptoms?”
  • Medscape relates,
    • “Current research supports the idea that remission of type 2 diabetes is increasingly achievable.
    • “A 2023 study published in Diabetes Care showed that an intensive low-energy total diet replacement program in Australian primary care led to diabetes remission at 1 year in about half of the participants with recently diagnosed type 2 diabetes, with higher remission rates tracking with greater weight loss. Meanwhile, a September 2025 systematic review and meta-analysis in the same journal pooled 18 nonsurgical randomized controlled trials and found that structured interventions, particularly those producing substantial weight loss, consistently achieved clinically meaningful remission rates.
    • “Evidence from other journals points in the same direction.”
  • and
    • “The therapeutic variations among patients with chronic obstructive pulmonary disease (COPD) present ongoing treatment challenges. However, the two currently approved biologics, dupilumab and mepolizumab, have shown success for a subset of patients with type 2 inflammation, and more biologics are in the pipeline for COPD, said Don D. Sin, MD, a pulmonologist at the University of British Columbia, Vancouver, Canada, in a presentation at the 2025 GOLD International COPD Conference.
    • “Both dupilumab and mepolizumab were originally approved for asthma but were subsequently studied in patients with COPD who continue to experience symptoms and moderate-to-severe exacerbations despite other treatments and who demonstrate type 2 inflammation based on high blood eosinophil counts, Sin said. The biologics target inflammatory pathways to get to the root of the problem, he added.”
  • Per Health Day,
    • “Cumulative lead exposure is suggested as a potential dementia risk factor, according to a study published online Feb. 12 in Alzheimer’s & Dementia.
    • “Xin Wang, Ph.D., M.P.H., from the University of Michigan in Ann Arbor, and colleagues examined prospective associations between lead exposure and incident Alzheimer disease (AD) and all-cause dementia. Blood lead was measured at baseline and patella and tibia lead were estimated for 6,217 and 5,865 participants, respectively, from the National Health and Nutrition Examination Survey (NHANES)-III (1988 to 1994) and 8,038 and 4,824 participants, respectively, from continuous NHANES (1999 to 2016), and was then linked to Medicare and the National Death Index for incident AD and all-cause dementia.
    • “In continuous NHANES, the researchers found that when comparing quartile 4 with quartile 1, estimated patella lead was associated with AD and all-cause dementia (hazard ratios, 2.96 and 2.15, respectively). Weaker associations were observed in NHANES-III. No association was seen for blood lead.”
  • and
    • “Pain during pregnancy and after delivery can significantly increase a woman’s risk of postpartum depression, a new evidence review has concluded.
    • “Further, there are specific pain-related risk factors that influence the odds of postpartum depression among women in racial and ethnic minorities, researchers reported in the journal Current Psychiatry Reports.
    • “There are multiple interrelated factors that contribute to pain, particularly childbirth-related pain,” researcher Sudhamshi Beeram, a graduate student at the University of Illinois Urbana-Campaign, said in a news release.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “There’s “a hunger for a different kind of dialogue” when it comes to relations between payers and providers, according to Aetna President Steve Nelson.
    • “Mr. Nelson laid out a vision for Aetna that centers on rebuilding trust in the industry, an effort he said is already producing measurable results with some of the country’s largest health systems and that informed Aetna’s recognition as Press Ganey’s inaugural health plan of the year earlier this month.
    • “I can tell you firsthand that the provider community and provider organizations wake up every day trying to do good work. And so do payers,” Mr. Nelson told Becker’s. “I think if we can start with positive intent and change the dialogue — if we can focus on the patient and the member as opposed to our own issues — we end up in a better place.”
    • Mr. Nelson, who took the helm at Aetna in late 2024 after leading UnitedHealthcare and value-based primary care company ChenMed, said the insurer’s strategy rests on three themes: better navigation to help members move through a complex system, an advocacy mindset that treats member interactions as more than transactions, and stronger partnerships with providers.
    • “That last theme, he said, is one the industry needs to focus on getting right. The payer-provider dynamic “has not always been super constructive,” Mr. Nelson said, “and that needs to change. This idea that we can’t work together is not true.”
  • Fierce Healthcare relates,
    • “Despite a string of recent selloffs, executives told analysts Thursday that hospital deals are still likely on the table for Community Health Systems in 2026. 
    • “The Franklin, Tennessee-based for-profit, currently owns or leases 65 affiliated hospitals. It’s cut down its portfolio by about 35% since 2019, with a string of divestitures announced or executed in the past handful of months alone. 
    • “The dealmaking has helped the company turn its first cashflow-positive year in some time, and is fueling both increased investment into CHS’ remaining core hospitals as well as efforts to deleverage. 
    • ‘As of the end-of-year earnings call, Kevin Hammons, CHS director and CEO, told curious analysts that the company is “getting closer to the end of our programmatic divestitures,” but that it was still in the “early stages of discussions” for “a couple transactions” that aren’t guaranteed reach the finish line. CHS is still getting inbound interest on some of its other hospitals in strong markets, he said, but the company is less eager to let those facilities go.”
  • and
    • “In a fourth-quarter conference call, Insmed CEO Will Lewis admitted that it was “audacious” that his company would project sales of newly approved respiratory drug Brinsupri to reach $1 billion in 2026. Then he laid out the case of why the forecast isn’t so cheeky at all. 
    • “We have a number of different data sources we examine,” Lewis said on Thursday morning. “Across all the metrics, we’re seeing [numbers] at or above our targets and that’s very much behind why we have a conviction that we’ll do at least $1 billion in revenue in Brinsupri this year.”
    • “Approved in August with much fanfare as a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, Brinsupri was pegged by analysts at Mizuho Securities for a peak sales potential of $6.6 billion, but even they were surprised by its dynamic launch. Last month at the J.P. Morgan Healthcare Conference, Insmed revealed sales of $145 million in the fourth quarter, promptingMizuho to call it “a ginormous result.” 
    • “On Thursday, Lewis added that the launch “surpassed even our most ambitious expectations,” which were based on “a basket of historically strong respiratory launches as our guide.”
  • Healthcare Dive tells us,
    • “Telehealth use in primary care has held fairly stable in recent years, suggesting the sector has reached an equilibrium after a boom in virtual care amid the COVID-19 pandemic, according to an analysis by Epic Research. 
    • “Telehealth visits accounted for over 8% of primary care encounters in July 2022, according to the research published on Tuesday. By October 2025, telehealth made up just under 6% of visits — a roughly 30% decline. 
    • “But since 2023, the share of virtual care visits in primary care has held relatively steady at around 6% to 7% of appointments.”
  • Per Beckers Hospital Review,
    • “With cancer care growing beyond hospital walls and more cancer patients surviving than ever before, health systems in the U.S. are doubling down on their oncology infrastructure commitments.
    • “Cancer care can no longer be designed around treatment alone. We must intentionally redesignoncology as a continuum of care, where survivorship is not an afterthought but a core clinical strategy,” Robert Stone, CEO at Duarte, Calif.-based City of Hope, told Becker’s.
    • “As breakthroughs in precision diagnostics and cellular therapies accelerate at a rapid pace, leaders are tasked with balancing lifesaving but expensive cancer care investments with other system priorities.
    • “Hospital and health system leaders often underestimate the complexity of patient selection, treatment timing and site-of-care decisions,” Armin Ghobadi, MD, bone marrow transplant specialist and medical oncologist at St. Louis-based Siteman Cancer Center, told Becker’s. “Ultimately, successful immunotherapy programs depend on tight alignment between clinical expertise, operational authority and sustainable financial models — recognizing immunotherapy as an enduring service line rather than a one-time therapeutic event.”
  • and
    • “Select Medical, which operates more than 100 critical illness recovery hospitals in the U.S., plans to close its hospital in Meridian, Miss., by March 13. 
    • “In an online statement, Regency Hospital-Meridian said it is no longer accepting new admissions and will close on or before March 13.
    • “Regency Hospital-Meridian is a 40-bed facility on the second floor of Baptist Anderson Regional Medical Center-South, according to a Feb. 19 report from The Meridian Star. A Select Medical spokesperson told the Star the planned closure is an operational business decision and patients can receive care at Ochsner Specialty Hospital, also in Meridian.”

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.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI, Uncategorized–

From the cybersecurity policy front,

  • The Wall Street Journal reports,
    • “After months of partisan wrangling, a temporary extension on Tuesday of legislation aimed at encouraging firms to share cyberattack intelligence with Washington might be too little, too late for corporate cybersecurity leaders. 
    • “The seesaw effect we saw last year has eroded the trust that intel sharing needs to be built on,” said Timothy Youngblood, an investor who led cybersecurity teams at T-Mobile, McDonald’s and Kimberly-Clark. Before providing sensitive details of a data breach or ransomware attack, companies need to be assured “they will not have the information used against them,” Youngblood said.
    • “The Cybersecurity Information Sharing Act, or CISA, provides liability and antitrust protections for companies that share attack data with federal agencies. Created in 2015 with a 10-year sunset clause, the act lapsed twice over the past four months as lawmakers clashed over proposed revisions. It was extended this week [to September 30, 2026] as part of a broader spending bill approved by Congress and signed by President Trump.  
    • “But an eight-month shelf life—and on-again off-again status—is unlikely to encourage hacked companies to risk legal or reputational damage by sharing sensitive data, especially in the wake of costly downtime, cybersecurity experts said. Staffing and resource cuts over the past year at the federal Cybersecurity and Infrastructure Security Agency, which shepherds private-public intelligence sharing, is adding to their concerns, they said.
    • “Temporary extensions are Band-Aids,” said Kevin Greene, public sector chief cybersecurity technologist at security firm BeyondTrust. Prolonged uncertainties, he said, will “absolutely create some friction in information sharing.”
  • Cyberscoop relates,
    • “The Trump administration needs help from industry to reduce the cybersecurity regulatory burden and to back important cyber legislation on Capitol Hill, among other areas, National Cyber Director Sean Cairncross said Tuesday.
    • “You know your regulatory scheme better than I do: Where there’s friction, where there’s frustration with information sharing, what sort of information is shared, the process through which it’s shared,” he said. “It is helpful for us to hear that and have that feedback so that we can address it, engage it and try to make it better.”
    • “The Trump administration is interested in being a partner with industry rather than a “scold,” Cairncross said at an Information Technology Industry Council event. The Biden administration sought to impose more cybersecurity rules on the private sector than prior administrations.”
  • Cybersecurity Dive adds,
    • “Cairncross’s comments come as the White House prepares to unveil its five-page national cybersecurity strategy, which will focus heavily on streamlining regulations to reduce the burden on industry, including critical infrastructure organizations.
    • “The White House wants to revise the current patchwork of cybersecurity regulations “so that form follows function rather than [the rules being] a compliance checklist,” said Cairncross, who has led the relatively new Office of the National Cyber Director since August.” * * *
    • “Cairncross did not provide a timeline for the strategy’s release, but he said the White House would publish it “sooner rather than later.” The goal of the brief document, he explained, is “to point a direction for the USG to go so resources and effort can be lined up.”
  • and
    • “Governments should work closely with the private sector when designing and detailing their national cybersecurity strategies, a prominent think tank said in a report published on Monday.
    • “Active participation from the private sector, particularly large technology, telecommunications, and cybersecurity firms, is critical throughout the strategy’s development,” the Center for Cybersecurity Policy and Law (CCPL) said in its white paper. “The private sector can help not only support but also deliver on the government’s cybersecurity objectives and is key to a secure and resilient nation.”
  • and
    • “The Trump administration is making progress on creating an information sharing and analysis center for the AI industry to improve its ties with the government as AI cyber threats proliferate, a U.S. official said on Tuesday.
    • “The administration is absolutely committed to making sure that we’re supporting this industry, making sure that we’re going to foster information sharing,” Nick Andersen, executive assistant director for cybersecurity at the Cybersecurity and Infrastructure Security Agency, said during a talk at an event hosted by the Information Technology Industry Council. “We just want to make sure we take the opportunity to get that relationship right.”
  • Federal News Network shares five updates on the Trump Administration’s cybersecurity agenda.
    • Six-pillar national cyber strategy
    • CIRCIA update
    • AI-ISAC in development
    • AI security policy framework
    • CIPAC replacement coming soon?
  • DefenseScoop notes,
    • “Marine Corps Maj. Gen. Lorna Mahlock was confirmed by the Senate on Friday evening [January 30] as deputy commander of U.S. Cyber Command, where she could have an outsized influence as the organization prepares for new leadership and other major changes.
    • “She was nominated for the position by President Donald Trump.
    • “Her Senate confirmation, which happened via voice vote, means she’ll also pin on a third star and become a lieutenant general.
    • “Mahlock brings deep cyber knowledge and background to her new role.”
  • Per Cybersecurity Dive,
    • “The Federal Communications Commission is warning telecommunications companies to regularly patch their systems, enable multifactor authentication and segment their networks to avoid falling victim to ransomware attacks.
    • “Recent events show that some U.S. communications networks are vulnerable to cyber exploits that may pose significant risks to national security, public safety, and business operations,” the FCC’s Public Safety and Homeland Security Bureau said in a Jan. 29 alert.”

From the cybersecurity vulnerabilities and breaches front.

  • Cyberscoop reports,
    • “Cybersecurity and Infrastructure Security Agency order published Thursday [February 4, 2026] directs federal agencies to stop using “edge devices” like firewalls and routers that their manufacturers no longer support.
    • “It’s a stab at tackling one of the most persistent and difficult-to-manage avenues of attack for hackers, a vector that has factored into some of the most consequential and most common types of exploits in recent years. New edge-device vulnerabilities surface frequently.
    • “Under the binding operational directive CISA released Thursday, federal civilian executive branch (FCEB) agencies must inventory edge devices in their systems that vendors no longer support within three months, and replace those on a dedicated list with supported devices within one year.”
  • The American Hospital Association News tells us,
    • “The National Institute of Standards and Technology Feb. 2 published details on a critical vulnerability that impacted Notepad++, a free, open-source text and source code program widely used by several industries, including health care. The vulnerability impacted an update component affecting iterations of the program prior to version 8.8.9, and allowed attackers to gaining access to and disrupt the update process. According to the program’s developer, attacks that occurred from June to November 2025 were likely executed by a sophisticated nation-state threat actor.”
  • Cybersecurity Dive informs us,
    • “Cybercrime “began its shift toward an AI-driven future” in 2025, the security firm Malwarebytes said in a report published Tuesday that charted AI’s influence on the rapidly growing hacking ecosystem.
    • “AI is making cyberattacks faster and more effective through deepfakes, vulnerability discovery, autonomous ransomware attacks and growing connectivity between AI models and penetration testing tools, according to the report.
    • “Malwarebytes urged businesses to “shrink their attack surfaces, harden identity systems, close blind spots, accelerate remediation, and adopt continuous monitoring.”
  • and
    • “Hackers working for an Asian government have breached at least 70 government agencies and critical infrastructure organizations in 37 countries over the past year as part of an espionage campaign likely aimed at collecting information about rare earth minerals, trade deals and economic partnerships, Palo Alto Networks said in a reportpublished on Thursday.
    • “While this group might be pursuing espionage objectives,” researchers with the company’s Unit 42 group wrote in the report, “its methods, targets and scale of operations are alarming, with potential long-term consequences for national security and key services.”
    • “The security firm provided indicators of compromise and described the threat actor’s techniques and infrastructure.”
  • CISA added six known exploited vulnerabilities to its catalog this week.
    • February 3, 2026
      • CVE-2021-39935 GitLab Community and Enterprise Editions Server-Side Request Forgery (SSRF) Vulnerability
        • Cyber Press discusses this KVE here.
      • CVE-2025-40551 SolarWinds Web Help Desk Deserialization of Untrusted Data Vulnerability
        • Cybersecurity Dive discusses this KVE here.
      • CVE-2019-19006 Sangoma FreePBX Improper Authentication Vulnerability
      • CVE-2025-64328 Sangoma FreePBX OS Command Injection Vulnerability 
        • The Hacker News discusses these KVEs here.
    • February 5, 2026
      • CVE-2025-11953 React Native Community CLI OS Command Injection Vulnerability
        • Security Wek discusses this KVE here.
      • CVE-2026-24423 SmarterTools SmarterMail Missing Authentication for Critical Function Vulnerability
        • Bleeping Computer discusses this KVE here.
  • Dark Reading points out, “CISA Makes Unpublicized Ransomware Updates to KEV Catalog
    • “A third of the “flipped” CVEs affected network edge devices, leading one researcher to conclude, ‘Ransomware operators are building playbooks around your perimeter.'”
  • Cyberscoop adds,
    • “Attackers are again focusing on a familiar target in the network edge space, actively exploiting two critical zero-day vulnerabilities in Ivanti software that allows administrators to set mobile device and application controls. 
    • “The vulnerabilities — CVE-2026-1281 and CVE-2026-1340 — each carry a CVSS rating of 9.8 and allow unauthenticated users to execute code remotely in Ivanti Endpoint Manager Mobile (EPMM). Ivanti did not say when the earliest known date of exploitation occurred but warned that a “very limited number of customers” were attacked before it disclosed and addressed the defects Thursday [January 29, 2026]. * * *
    • “The Cybersecurity and Infrastructure Security Agency has flagged 31 Ivanti defects on its known exploited vulnerabilities catalog since late 2021. At least 19 defects across Ivanti products have been exploited in the past two years. 
    • “The agency added CVE-2026-1281 to the catalog Thursday, but not CVE-2026-1340. Both defects have been exploited, according to watchTowr. Yet, a spokesperson for Ivanti said the vulnerabilities have not been chained together for exploitation.
    • “The latest code-injection vulnerabilities demonstrate attackers are focusing on EPMM in particular of late. Ivanti disclosed a separate pair of vulnerabilities in the same product in May 2025.” 
  • Cybersecurity Dive informs us,
    • “Two months after a critical vulnerability was disclosed in React Server Components, researchers warn of a significant change in threat activity targeting the flaw. 
    • “The original vulnerability, tracked as CVE-2025-55182, allows an unauthenticated attacker to achieve remote code execution due to unsafe deserialization of payloads. 
    • “The initial wave of attacks in December led to hundreds of systems being compromised as state-linked threat groups and other actors engaged in widespread exploitation. The vulnerability, dubbed React2Shell, has been targeted in a wide range of industries since it was discovered in late November.
    • “Researchers from GreyNoise on Monday reported a distinctive change over the prior seven days, as more than half of the threat activity now emanated from only two IP addresses, according to a blog post. Before the change, there were 1,083 unique sources linked to threat activity, according to researchers.
    • “GreyNoise said its sensors detected more than 1.4 million attempts to exploit CVE-2025-55182 during the seven-day period.
    • “Researchers warned the exploitation appears to be focused on the developer community.” 
  • Per Dark Reading,
    • “Threat actors are using a forensic tool’s Windows kernel driver to kill security products, despite the fact the driver’s digital certificate was revoked more than a decade ago.
    • “In a blog post Wednesday, security researchers at Huntress detailed how the company responded to an intrusion earlier this month in which the threat actor used compromised SonicWall SSL VPN credentials for initial access to the victim’s network. But the real kicker was how the attacker avoided detection: they weaponized the Windows kernel driver of a legitimate forensic toolset called EnCase to disable security products across the network.”
    • “The attack technique is known as bring-your-own-vulnerable-driver (BYOVD), which involves taking advantage of the elevated privileges and kernel-level access of a driver to terminate security processes before an intrusion is detected. Threat actors have increasingly used drivers to disable endpoint detection and response (EDR) platforms, often in ransomware attacks; these tools are commonly known as EDR killers.”  
  • Per SC Media,
    • “More than 300 malicious OpenClaw skills hosted on ClawHub spread malware including the Atomic macOS Stealer (AMOS), keyloggers and backdoors, Koi Security reported Sunday.  
    • “OpenClaw, formerly known as Moltbot and Clawdbot, is an open-source AI agent that has recently gained significant popularity as a personal and professional assistant.
    • “ClawHub is an open-source marketplace for OpenClaw “skills,” which are tools OpenClaw agents can install to enable new capabilities or integrations.
    • “Koi Security Researcher Oren Yomtov discovered the malicious skills in collaboration with his own OpenClaw assistant named Alex, according to Koi Security’s blog post, which is written from Alex’s perspective.
    • “Yomtov and Alex audited all 2,857 skills available on ClawHub at the time of their investigation, and discovered that 341 were malicious, with 335 seemingly tied to the same campaign.”
  • Per Security Week,
    • “The big takeaway from 2026 onward is the arrival and increasingly effective use of AI, and especially agentic AI, that will revolutionize the attack scenario. The only question is how quickly.
    • ‘Michael Freeman, head of threat intelligence at Armis, predicts, “By mid-2026, at least one major global enterprise will fall to a breach caused or significantly advanced by a fully autonomous agentic AI system.”
    • “These systems, he continues, “use reinforcement learning and multi-agent coordination to autonomously plan, adapt, and execute an entire attack lifecycle: from reconnaissance and payload generation to lateral movement and exfiltration. They continuously adjust their approach based on real-time feedback. A single operator will now be able to simply point a swarm of agents at a target.”

From the ransomware front,

  • Bleeping Computer reports today,
    • “A major U.S. payment gateway and solutions provider says a ransomware attack has knocked key systems offline, triggering a widespread outage affecting multiple services.” * * *
    • “BridgePay Network Solutions confirmed late Friday that the incident disrupting its payment gateway was caused by ransomware.
    • “In an update posted Feb. 6, the company said it has engaged federal law enforcement, including the FBI and U.S. Secret Service, along with external forensic and recovery teams.
    • “Initial forensic findings indicate that no payment card data has been compromised,” the company said, adding that any accessed files were encrypted and that there is currently “no evidence of usable data exposure.”
  • The Rhode Island Current tells us,
    • “A state vendor and major provider of workers’ compensation insurance in Rhode Island confirmed it was the victim of a cyberattack in January.   
    • “The Beacon Mutual Insurance Company posted about the Jan. 14 incident to its website around noon Thursday, following inquiries from Rhode Island Current earlier in the day. The requests for comment were prompted by Beacon’s appearance on public websites that list and track recent reports of ransomware — a genre of malware characterized by making users’ files encrypted and inaccessible unless they pay a price.
    • “Yes, this was a ransomware attack,” Michelle N. Pelletier, the assistant vice president of marketing and communications at the Warwick company, confirmed over email late Thursday afternoon.
    • “But Pelletier added that not all was lost, and that the company’s production environment — or the live systems that users interact with directly — remained safe from harm.  
    • “Fortunately, our production environment was not encrypted, and we were able to resume normal operations on January 20,” Pelletier wrote.”  
  • Security points out,
    • “If battling ransomware isn’t challenging enough, these attacks have undergone a significant metamorphosis, with attackers shedding their encryption-based model for one of pure exfiltration. The result? A more stealthy, discreet approach that successfully bypasses traditional defenses to snatch sensitive data and employ a double or triple extortion scheme. 
    • “With pure exfiltration, businesses don’t realize they’re a victim until it’s too late.” 
  • Security Week adds,
    • “Data allegedly pertaining to over 5 million Panera Bread customers has emerged online after hackers failed to extort the US bakery-cafe chain.
    • “The ShinyHunters extortion group has claimed the theft of roughly 14 million records from Panera Bread, after compromising a Microsoft Entra single-sign-on (SSO) code.
    • “The attack falls in line with recent ShinyHunters attacks that rely on voice phishing (vishing) and SSO authentication to access victim organizations’ cloud-based software-as-a-service (SaaS) environments.
    • “Last week, ShinyHunters published on its Tor-based leak site a 760GB archive allegedly containing the sensitive information stolen from Panera Bread.
    • “According to the data breach notification site Have I Been Pwned, the data was leaked after the hackers failed to extort the food chain.
    • “The archive includes 5.1 million unique email addresses and likely impacts as many Panera customers. Associated information such as names, addresses and phone numbers was also present in the leak.”
  • Security.com lets us know,
    • “A recent Black Basta attack campaign was notable because the ransomware contained a bring-your-own-vulnerable-driver (BYOVD) defense evasion component embedded within the ransomware payload itself.
    • “Normally the BYOVD defense evasion component of an attack would involve a distinct tool that would be deployed on the system prior to the ransomware payload in order to disable security software. However, in this attack, the vulnerable driver (an NsecSoft NSecKrnl driver) was bundled with the ransomware itself. 
    • “BYOVD is by far the most frequently used technique for defense impairment these days. Generally, attackers will deploy a signed vulnerable driver to the target network, which they then exploit to elevate privileges and disable security software. Since the vulnerable drivers operate with kernel-mode access, they can be used to terminate processes, making them an effective tool for disrupting security measures. In most cases, the vulnerable driver is deployed along with a malicious executable, which will use the driver to issue commands.”
  • Bleeping Computer relates,
    • “Ransomware operators are hosting and delivering malicious payloads at scale by abusing virtual machines (VMs) provisioned by ISPsystem, a legitimate virtual infrastructure management provider.
    • “Researchers at cybersecurity company Sophos observed the tactic while investigating recent ‘WantToCry’ ransomware incidents. They found the attackers used Windows VMs with identical hostnames, suggesting default templates generated by ISPsystem’s VMmanager.
    • “Diving deeper, the researchers discovered that the same hostnames were present in the infrastructure of multiple ransomware operators, including LockBit, Qilin, Conti, BlackCat/ALPHV, and Ursnif, as well as various malware campaigns involving RedLine and Lummar info-stealers.”
  • Per Dark Reading,
    • “The operators of DragonForce, a ransomware-as-a-service outfit that first surfaced in 2023, appear to be drawing heavily from the organized crime playbook, creating a cartel and attempting to bring mafia-style territorial organization — and a bit of muscle — to the ransomware ecosystem.
    • “A detailed analysis by LevelBlue showed the group has recently shifted its business model to one where customers — or affiliates — of its service can create their own brands while still operating under a blossoming DragonForce cartel umbrella.” * * *
    • “DragonForce has established itself as a relatively major player in the ransomware ecosystem since launching activities in 2023. Though not as big as rivals like Akira and Qilin, it has commanded some attention for its aggressive marketing and outreach. As of July 2025, the company had notched at least 250 victims based on its data leak site, according to Check Point Research.”

From the cybersecurity defenses front,

  • Cyberscoop reports,
    • “Following a series of high-profile cyberattacks, boards of directors are now requiring their organizations to take greater responsibility for the risks posed by enterprise resource planning (ERP) systems pose after a series of high-profile cyberattacks. The Jaguar Land Rover (JLR), incident in Sept. 2025 illustrates the severe consequences of such attacks. The cyberattack forced JLR to halt production for six weeks, making it the costliest cyberattack in Britain’s history. The company’s revenue declined 24 percent that quarter, accounting for potentially over a  $1.2 billion drop in earnings, and subsequently reported a 43.3% wholesale sales volume drop the following quarter.
    • “For decades, organizations have treated ERP systems like SAP as back-office workhorses. However, the JLR incident—carried out by executed by the cybercrime group ShinyHunters —has thrust ERP systems into the spotlight. That shift in attention is critical: today, 90% of the Fortune 500 use SAP, making these systems “crown jewel” assets that require the highest level of protection.
    • “The threat is escalating. A recent Google Cloud Security report forecasts that ransomware operations specifically designed to target critical enterprise applications such as ERP systems will emerge in 2026, forcing organizations to make quick ransom payments and sacrifice business resilience. 
    • “In our roles as board members, advisers, and cybersecurity CEOs, we’re witnessing a fundamental shift in how organizations approach ERP security: the conversation has moved from compliance to survival. Organizations are grappling with critical question: Who owns the risk? What is our recovery time? Can we patch critical ERP vulnerabilities within 72 hours? Do we have visibility inside the application?”
  • Help Net Security explains where NSA zero trust guidance aligns with enterprise reality.
  • This HHS Inspector General’s report points out “Security Controls to Enhance Its Ability to Prevent and Detect Cyberattacks.”
  • Tech Target describes “five steps to ensure HIPAA compliance on mobile devices.”
  • Here is a link to Dark Reading’s CISO Corner.

Tuesday report

David Ermer–Congress, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NCQA, Patient safety, SCOTUS, Uncategorized–

From Washington, DC,

  • Federal News Network reports,
    • “The House [of Representatives] passed a spending package to end a short-term partial government shutdown and fund most federal agencies through the end of the fiscal year.
    • “The spending deal, which includes a two-week continuing resolution for the Department of Homeland Security, was passed by the Senate last Friday.
    • “President Donald Trump signed the spending package into law on Tuesday afternoon.” * * *
    • “The spending package includes language guaranteeing back pay to federal employees who were briefly furloughed during the partial shutdown.” * * *
    • “After Trump signed the spending plan into law, OPM directed furloughed employees to return to work.”
  • The Wall Street Journal notes,
    • Twenty-one Republicans voted against the package [on the final vote [217-214] for passage], largely hard-liners who wanted to use the spending package as a vehicle to tighten election procedures. Twenty-one Democrats—mostly a collection of appropriations-committee members and centrists—voted for it.
  • Fierce Healthcare adds,
    • “The legislation finalizes several key healthcare extenders including provisions of the Medicare telehealth program and Acute Hospital Care at Home waiver as well as major supplementary funding programs for rural hospitals and those with high proportions of government-covered patients. The bill provides a five-year extension of the Acute Hospital Care at Home program and a two-year extension for Medicare telehealth flexibilities. The telehealth provisions in the bill include removing Medicare’s geographic requirements for telehealth and expanding the types of practitioners able to furnish telehealth services for the government health program.
    • “The bill also introduces reforms to pharmacy benefit manager (PBM) practices, including elements that would prevent PBMs from tying compensation in Part D to the list price of drugs, and boost price transparency for employers in their PBM contracts.
    • “Other provisions in the bill require that Medicare Advantage plans provide accurate provider lists, addressing so-called “ghost networks” that have come under fire in recent years. It would also require that health systems establish unique identification numbers for outpatient services, allowing the Centers for Medicare & Medicaid Services to track pricing in these facilities.”
  • Rep. Jodey Arrington (R TX), the chairman of the House Budget Committes, writing in Real Clear Health, shares his vision of a second reconciliation bill that would focus on healthcare.
  • The HHS Office of Inspector General posted “Medicare Advantage Industry Segment-Specific Compliance Program Guidance.”
  • Per an AHIP news release,
    • “Public and private payers are delivering greater value to Americans and the health care system by advancing value-based care (VBC). AHIP, in collaboration with the Centers for Medicare & Medicaid Services (CMS), today released the results of the 2025 Alternative Payment Model (APM) Adoption Survey. The findings reaffirm the commitment of the federal government and private health plans to advance VBC and APM models that shift away from fee-for-service (FFS) models toward payment arrangements that reward quality, efficiency and improved patient outcomes.
    • “This year’s survey highlights how health plans continue to work hand-in-hand with providers to advance value-based care and drive meaningful improvement for patients. These innovative payment models reward outcomes, resulting in patient-centered, high-quality, coordinated care that is more affordable for Americans,” said Danielle Lloyd, MPH, AHIP’s senior vice president of private market innovations and quality initiatives for Clinical Affairs.” * * *
    • To view the full 2025 survey findings, click here.
  • NCQA announced today,
    • “Every year, NCQA seeks public comment about proposed changes to HEDIS Volume 2.
    • “Public comment is your opportunity to weigh in on the relevance, scientific soundness and feasibility of new and revised measures for HEDIS. Your feedback helps us determine changes to our programs, procedures and processes.
    • “This year’s public comment is open February 13–March 13.
    • We’d like input on:
      • Seven new HEDIS measures.
      • Revising three HEDIS measures.
    • “This year’s public comment will go live Friday, February 13, at 9:00a.m. ET.
    • “We’ll post the link and more details here, so check back on February 13.”
  • The Washington Post relates,
    • “The American Society of Plastic Surgeons has issued a broad recommendation against gender transition surgeries for youths, becoming the first major medical association in the United States to narrow its guidance on pediatric gender care amid a crackdown by the Trump administration.
    • “A statement sent Tuesday to the group’s 11,000 members and obtained by The Washington Post recommends surgeons delay gender-related chest, genital and facial surgery until a patient is at least 19 years old. Fewer than 1,000 minors in the United States receive such surgeries every year, according to research published in JAMA, the American Medical Association’s journal, and the vast majority of the procedures are mastectomies, not genital surgeries.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products. The agency said Abiomed found its Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices could display inaccurate information due to a malfunction of the differential pressure sensors. The company reported 22 injuries associated with the issue since Jan. 15.” 
  • MedTech Dive relates,
    • “Abbott received a warning letter from the Food and Drug Administration related to its FreeStyle Libre continuous glucose monitors.
    • “The warning letter, dated Jan. 23 and posted to the FDA’s website on Tuesday, concerns performance specifications and testing for the glucose sensors’ accuracy. An Abbott spokesperson wrote in an email that the company is implementing corrective actions and providing ongoing updates to the FDA.
    • “The warning letter does not affect Abbott’s ability to manufacture, market or distribute Libre products, wrote Leerink Partners analyst Mike Kratky and J.P. Morgan analyst Robbie Marcus.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN said the U.S. Food and Drug Administration rejected an initial submission for its Saphnelo lupus drug in injection form, and vowed to work with the regulator to move forward with an updated application.
    • “The U.K. pharmaceutical company said Tuesday that the FDA issued a complete response letter, which indicates that a new drug application can’t be approved in its present form, regarding Saphnelo for subcutaneous administration. The company said it subsequently provided information requested in the letter and that it was committed to working with the FDA to progress the application as quickly as possible.
    • “A decision on the updated application is expected in the first half of 2026, AstraZeneca said.
    • “The drug, a treatment for the autoimmune disease systemic lupus erythematosus, is already approved as an intravenous infusion and that form of administration remains commercially available, AstraZeneca said.”
  • Fierce Biotech tells us,
    • “As the first CAR-T treatment for an autoimmune disease draws ever closer, officials at the FDA have signaled a willingness to support the development of these novel cell therapies with a flexible regulatory approach.
    • “While interested in CAR-T therapies’ potential to achieve durable, drug-free remission in serious autoimmune conditions, the FDA is equally wary of their “unpredictable long-term toxicity,” according to an article published Monday in the Annals of Internal Medicine.
    • “In the article, Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research, and two other regulators said that, recognizing the complexity of autoimmune conditions in terms of seriousness and type, the agency will work with CAR-T makers “on a case-by-case basis to encourage appropriate study populations in rheumatologic autoimmune disease.”
    • “Simultaneously, citing a need to monitor a drug’s effect on fertility, the FDA officials recommended that industry conduct long-term follow-up studies for CAR-T products in the autoimmune setting, “as is standard for genetic therapies and CAR T-cells for oncologic indications.”
    • “While the FDA “shares enthusiasm for this class of products,” it will “carefully shepherd” the advancement of clinical studies “focused on the development, durability, and long-term safety of CAR T-cell therapies,” the regulators wrote.”
  • STAT News lets us know, “AI could soon renew prescriptions without clinician help. Should the FDA make sure it’s safe? Doctronic claims its AI doctor doesn’t need FDA approval. Experts aren’t so sure.”

From the public health and medical / Rx research front,

  • Nature reports,
    • “Nearly 40% of new cancer cases worldwide are potentially preventable, according to one of the first investigations1 of its kind, which analysed dozens of cancer types in almost 200 countries.
    • “The study found that in 2022, roughly seven million cancer diagnoses were linked to modifiable risk factors — those that can be changed, controlled or managed to reduce the likelihood of developing the disease. Overall, tobacco smoking was the leading contributor to worldwide cancer cases, followed by infections and drinking alcohol. The findings suggest that avoiding such risk factors is “one of the most powerful ways that we can potentially reduce the future cancer burden”, says study co-author Hanna Fink, a cancer epidemiologist at the World Health Organization’s International Agency for Research on Cancer in Lyon, France.
    • “The study was published today in Nature Medicine.”
  • The American Journal of Managed Care relates,
    • “The majority (57.5%) of commercially insured patients had at least 1 chronic condition in 2024. The average allowed amount1 for a patient with no chronic conditions was $1590, whereas the average allowed amount for a patient with 1 chronic condition was nearly double ($3039). Of 44 common chronic conditions studied, hyperlipidemia, or high cholesterol, was the most common, with a crude prevalence2 of 21.2%. These and other findings are reported in a new FAIR Health white paper: Chronic Conditions in the United States: A Study of Commercial Claims.” * * *
    • “Many patients had more than 1 chronic condition. For example, 11.5% of patients had 2 conditions, and 9.1% had 3.
    • “Some chronic conditions frequently co-occur. In the commercially insured population, 33.4% of patients had hyperlipidemia, hypertension, obesity, or some combination of these, and 4.3% had all 3.3 Half the patients with any one of these conditions had more than 1.” * * *
    • “For the complete white paper, click here“
  • CNN tells us,
    • “Men develop a greater risk of cardiovascular disease years earlier than women — starting at around age 35, according to a new long-term study.
    • “The report, published Wednesday in the Journal of the American Heart Association, followed more than 5,000 adults from young adulthood and found that men reached clinically significant levels of cardiovascular disease about seven years earlier than women.
    • “Experts advise both men and women to monitor their heart health in early adulthood and to see their doctor regularly.
    • “Heart disease doesn’t happen overnight; it develops over years. One of the things I think oftentimes people aren’t aware of is that it can start really early in your 30s or 40s,” said study coauthor Dr. Sadiya Khan, professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine in Chicago.
    • “Even if you don’t have heart disease at that time, your risk can start at that time.”
  • MedPage Today adds,
    • “National data showed 79% of adults with hypertension didn’t have their blood pressure within the blood pressure goal recommended by guidelines.
    • “Most of those uncontrolled hypertension cases went untreated by blood pressure medication.
    • “These findings highlight a large gap in hypertension control that treating hypertension earlier and more intensively could address.”
  • The New York Times observes,
    • “For much of the 20th century and beyond, social scientists attributed a range of chronic mental health problems to dysfunction between infants and their mothers, who were categorized as overbearing, rejecting, domineering or ambivalent.
    • “But a team of researchers from Pennsylvania State University has found that at times the early parenting behavior of fathers may have a greater impact on children’s health.
    • “For a study published recently in the journal Health Psychology, the scientists observed three-way interactions between 10-month-old infants, their fathers and their mothers, and then checked in on the families when the children were 2 and 7.
    • “They found that fathers who were less attentive to their 10-month-olds were likely to have trouble co-parenting, instead withdrawing or competing with mothers for the children’s attention. And at age 7, the children of those fathers were more likely to have markers of poor heart or metabolic health, such as inflammation and high blood sugar.
    • “Mothers’ behavior did not have the same effect, said Alp Aytuglu, a postdoctoral scholar at Penn State’s College of Health and Human Development and an author of the paper.
    • “We of course expected that family dynamics, everybody in the family, fathers and mothers, would impact child development — but it was only fathers, in this case,” Dr. Aytuglu said.”
  • Per Health Day,
    • “More than one-quarter of young children experience persisting symptoms after concussion (PSaC), according to a study published online Jan. 26 in Pediatrics.
    • “Sean C. Rose, M.D., from The Ohio State University in Columbus, and colleagues assessed the frequency of PSaC after early childhood concussion and identified potential predictors of PSaC. The analysis included 235 young children (ages 6 months to <6 years) with concussion, 108 with orthopedic injury, and 75 community controls.
    • “The researchers found that at one month postinjury, PSaC were documented in 28 percent of children with concussion, higher than in the orthopedic injury group (10 percent) and the community control group (2 percent). PSaC were documented in just under one-quarter of children at three months postconcussion (24 percent) and 16 percent at 12 months. PSaC at one month postconcussion was predicted by total symptom burden in the emergency department (odds ratio, 1.108). There were no associations for age, loss of consciousness, receiving brain imaging in the emergency department, attending daycare or school, or parent education with PSaC.”
  • and
    • “The symptoms women experience on the verge of menopause could be vastly different from what they might expect, a new study says.
    • “Women in perimenopause – the time leading up to their final period, as well as the year after – expect to be plagued with hot flashes and night sweats.
    • “However, these women reported symptoms like exhaustion and fatigue far more frequently than those typically associated with menopause, researchers reported Jan. 28 in the journal Menopause.
    • “This study shines a light on how little we still understand about perimenopause and how much it affects people’s daily lives,” lead researcher Dr. Mary Hedges said in a news release. She’s a community internal medicine physician at the Mayo Clinic in Jacksonville, Florida.”
  • Per BioPharma Dive,
    • “An experimental obesity shot Pfizer got through a buyout of Metsera helped enrollees in a mid-stage trial lose significantly more weight than a placebo, spurring up to an 11% reduction over 28 weeks using a regimen that switched from a weekly to monthly dose after 12 weeks.
    • “When including only participants who completed the trial, the shot helped people lose up to 12 percentage points more of their body weight than those who received a placebo. Though cross-trial comparisons can be misleading, the results “look slightly inferior” to what was seen in testing of Eli Lilly’s blockbuster Zepbound at a similar timepoint, wrote Leerink Partners analyst David Risinger.
    • “Pfizer executives noted on a conference call that, going forward, they intend to test a far higher dose than they did in Phase 2 testing. Phase 3 trials starting later this year will involve a dose that’s double the highest one used in the Phase 2.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente and Renown Health have wrapped the paperwork on a deal forming an insurance and outpatient care joint venture in northern Nevada. 
    • “The arrangement announced last September (see below) represents an entry into the geographic market for Kaiser, the country’s largest nonprofit health system. It brings Hometown Health—an existing health plan run by Renown Health, a Reno-based, two-hospital nonprofit system—plus an existing primary care medical office under joint ownership. The partners have plans to open two more facilities in 2026, plus retail pharmacies in 2027. 
    • “This joint venture with Renown Health allows us to extend our value-based care model and nation-leading health outcomes to northern Nevada, in collaboration with Renown Health’s trusted local teams,” Greg Adams, chair and CEO of Kaiser, said in a Tuesday announcement. “Together, we will improve health outcomes; expand access to affordable, high-quality care; and serve the needs of this growing community.”
    • “Financial terms of the transaction were not disclosed.” 
  • and
    • “Primary care company Carbon Health filed for Chapter 11 bankruptcy relief in Texas. 
    • “The company, which offers both in-person care at nearly 100 clinics and virtual care services, said Monday it reached a restructuring agreement with its existing lenders that establishes a “clear path to recapitalization and new ownership.”
    • “Carbon Health intends to pursue a dual-track, court-supervised process that allows it to enter a Chapter 11 plan premised on a debt-for-equity exchange, and a post-petition marketing and sale process for all or a portion of its assets, the company said in a press release issued Monday.
    • “This structure is intended to maximize value while preserving flexibility as the process moves forward,” Carbon Health executives said.
    • “To implement the restructuring, Carbon Health and certain affiliates have filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas.”
  • Healthcare Dive relates,
    • “Humana is launching an artificial intelligence tool that aims to help its call center workers answer beneficiaries’ questions about their coverage, the insurer said Tuesday. 
    • “Agent Assist, developed in partnership with Google Cloud, can summarize conversations between workers and enrollees in real time while highlighting relevant information, like the member’s benefit and eligibility details and important context from the call, Chris Sakalosky, vice president of strategic industries at Google Cloud, said via email.
    • “The insurer began rolling out Agent Assist in October, and plans to implement the tool across Humana’s service centers this year.”
  • Per MedCity News,
    • “About 50 million people in the U.S. are affected by autoimmune disease, and about 80% of them are women. When women give birth, they often experience significant hormonal changes that can trigger new diagnoses or symptoms of autoimmune disease.
    • “That’s why WellTheory, a platform focused on autoimmune disease, launched a new program last week aimed at supporting women in the postpartum period.
    • ‘Atherton, California-based WellTheory treats autoimmune conditions such as Addison’s disease, celiac disease, multiple sclerosis and lupus. Using a collaborative care model, it partners with patients’ physicians to deliver personalized plans focused on nutrition, stress, sleep and movement. The company offers video sessions, unlimited expert messaging and diagnostics. It serves both employers and health plans.
    • “The new postpartum program includes personalized care plans and one-on-one support with autoimmune and hormonal health experts. WellTheory also provides advanced hormonal testing if appropriate, including assessment of sex hormones, cortisol levels and metabolites. This helps identify root causes of conditions like postpartum depression.”
  • Adam Fein writing in his Drug Channels blog lets us know,
    • “The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which track all U.S. spending on healthcare. (Links below.)
    • “We spent an astounding $5,278,588,000,000 on healthcare in 2024. Yes, that’s $5.3 trillion!
    • “Retail outpatient prescription drugs accounted for less than 9% of that total. More than half of net outpatient drug spending was paid by federal, state, and local government programs. Below, we delve into the spending trends, which reveal the impact of the Inflation Reduction Act (IRA) on Medicare spending, the boom in healthcare marketplaces, and the post-pandemic bust in Medicaid. 
    • “Contrary to what you might read, the government’s data show that drug spending growth was not driven by purportedly “skyrocketing” drug prices. In reality, nearly all of the increase in drug spending reflected higher utilization—more people treated, more prescriptions dispensed, and shifts among drugs dispensed—rather than higher net prices.”
  • Per Fierce Pharma,
    • “Armed with what CEO Robert Davis called the “broadest and widest pipeline we’ve had in years,” Merck is preparing for its post-Keytruda future with what it foresees as a host of major sales opportunities over the next decade.
    • “Thanks in part to its recent acquisitions of Verona Pharma and Cidara Therapeutics, the company sees new growth drivers delivering potential annual revenue of more than $70 billion by the “mid-2030s,” Merck said in its fourth-quarter and full-year earnings presentation (PDF).
    • “To put the $70 billion number into context, Davis pointed to the figure as being more than double the $35 billion Keytruda is expected to pick up during its peak sales year in 2028. The oncology superstar is slated for a loss of exclusivity (LOE) in 2028, and a growing pipeline of Keytruda biosimilars is already lining up to take a shot at the drug’s massive market.
    • “Our belief in our ability to have substantial growth once we get closer to the LOE is as high as it’s ever been,” Davis emphasized on a conference call. “And we’re not done.”
  • and
    • “During the first six months of Maziar Mike Doustdar’s tenure as Novo Nordisk’s CEO, the company enjoyed a run of positive momentum highlighted by the launch of its Wegovy pill and a recent stock-price runup. But investor optimism came to a sudden halt Tuesday as the company warned of significant sales and earnings declines in 2026.
    • “Tuesday, Novo put out word that it’s expecting sales and earnings to slide between 5% and 13% this year. In 2025, Novo generated sales growth of 10% and operating profit growth of 6%, the company said.
    • “A few factors are playing into the 2026 guidance. For one, the company said it’s expecting sales to decline in the U.S. amid “intensifying competition” and lower prices in some areas of its business. Novo is also warning of a sales hit from the recent “Most Favored Nation” pricing deal it struck with the Trump administration.
    • “The company is also forecasting a currency hit as the U.S. dollar has lost value against the Danish krone, Novo’s local currency.”
  • Per MedTech Dive,
    • “Medtronic plans to acquire CathWorks, which makes tools to help detect coronary artery disease, the companies announced on Tuesday. Medtronic will pay up to $585 million, with the potential for undisclosed earn-out payments after the acquisition closes.
    • “The companies have worked together since 2022, when Medtronic agreed to co-promote CathWorks’ FFRangio System in the U.S., Europe and Japan.
    • “The FFRangio System uses artificial intelligence and computational science to provide an assessment of the entire coronary tree using routine angiograms, a type of X-ray for imaging blood vessels. The system can provide fractional flow reserve, or FFR, values that help detect what lesions are causing a reduction in blood flow. The system can also help physicians measure the dimensions of a lesion during an operation.”
  • Per Radiology Business,
    • “RadNet Inc. is entering the Midwest by acquiring a 60-year-old private practice’s outpatient imaging assets. 
    • “The Los Angeles company has reached a deal to acquire six freestanding centers, all operated by Indianapolis-based Northwest Radiology, for an undisclosed sum. 
    • “Founded in 1967, NWR is one of Indiana’s largest independent imaging groups, employing 18 physicians. They will continue to provide contracted services across the practice’s former locations. 
    • “The centers are primarily located in Carmel, a growing northern suburb of Indianapolis recently recognized by Travel & Leisure magazine for its livability. RadNet—which, as a publicly traded company, will eventually disclose the purchase price in a future regulatory filing—expects to net $18 million in annual revenue from the sale. 
    • “Steve Forthuber, president and CEO of Eastern Operations for RadNet, said the practice has built “remarkable trust and confidence” among the local physician community. The company plans to work closely with NWR radiologists to further expand their “clinical reach and capabilities.” 

Weekend update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Notable Obituaries

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

Thursday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Midweek update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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