Tuesday report

Mental health care

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Weekend update

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

Happy Super Bowl Sunday!

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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, Medicare, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports.
    • “Speaker Mike Johnson (R., La.) faces a tougher-than-expected vote to end a partial government shutdown this week, after House Democrats pushing for sweeping changes to immigration enforcement signaled they wouldn’t help Republicans pass any funding measures through the narrowly divided chamber.
    • “Johnson, with a 218-213 majority, will need to keep almost all Republicans on board or risk the shutdown that started Saturday stretching deep into the week. The measure, endorsed by President Trump, funds swaths of the government for the rest of the fiscal year, while providing a two-week extension for the Department of Homeland Security—which contains immigration-enforcement agencies. The extension is intended to jump-start talks on reining in enforcement officials’ practices.
    • “I’m very optimistic that we will get everyone back in town,” Johnson said Sunday in an interview, referring to GOP lawmakers. “We will convince them that we need to implement the president’s play call,” giving the White House time to discuss changes to DHS with Democrats.” * * *
    • “Johnson’s tiny vote margin gives any one or two GOP members powerful leverage if they want changes or concessions. Johnson as soon as Monday is expected to swear in Christian Menefee, a Democrat who just won a Texas special election to represent Texas’ 18th Congressional District after former Rep. Sylvester Turner’s death last year. That will bring the majority to 218-214.”
  • Here’s a link to Roll Call’s take on what to expect to occur on Capitol Hill this week.
  • The American Medical Association tells us,
    • “The influential Medicare Payment Advisory Commission (MedPAC) voted in January to address inadequate payment for Medicare physician services under current law, once again underscoring a longstanding policy failure that is widely recognized but remains unresolved.
    • “MedPAC voted to recommend an additional 0.5% update on top of the updates specified in current law—0.25% and 0.75%—and will forward that recommendation to Congress. 
    • “The AMA appreciates that last year’s reconciliation bill provided a temporary 2.5% update for 2026; however, that increase expires in 2027. Absent meaningful reform, physicians again will face payment cuts, and Congress will once more be forced into last-minute efforts to avert further disruption,” AMA Board Chair David H. Aizuss, MD, said in a statement.
    • “The AMA is leading the charge to reform the Medicare payment system. That includes strongly urging MedPAC to recommend to Congress that they update 2027 physician payment rates so that they keep pace with the Medicare Economic Index (MEI).” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today began accepting requests to participate in the FDA PreCheck pilot program. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.
    • “After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.”
    • “The agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the U.S. market.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “There’s been a small but “alarming” bump in aortic stenosis (AS) deaths among people ages 45 to 74 in recent years, according to nationwide trends.
    • “In this younger group, age-adjusted AS mortality rates had been relatively stable until 2019, when they started climbing from a rate of 3.33 per 100,000 to 3.57 per 100,000 in 2023 — a statistically nonsignificant change that is notable nonetheless, according to Sameer Hirji, MD, MPH, of Brigham and Women’s Hospital in Boston.
    • “In comparison, those ages 75 and older showed a consistent decline in age-adjusted AS mortality rates from 2012 (112.3 per 100,000) to 2023 (104.1 per 100,000) based on the CDC WONDER database, Hirji reported at the Society of Thoracic Surgeons (STS)opens in a new tab or window annual meeting.
    • “This emerging trend — spanning sex, race, and geography — demands urgent evaluation of existing screening practices, timely diagnosis, and equitable access to both transcatheter and surgical therapies,” he concluded.”
  • The Washington Post relates,
    • “For years, scientists have been working to unravel the mystery of patients with failing kidneys dying from heart-related complications.
    • “Researchers now say they’ve uncovered a clue that explains why people with chronic kidney disease have such a high risk of heart failure — and it could have major implications for the diagnosis and treatment of the two common health conditions.
    • “A new study found that diseased kidneys released tiny particles that were toxic to the heart, according to findings published recently in the peer-reviewed journal Circulation.” * * *
    • “That molecular discovery is helping to shed light on one way the kidney and heart are linked — and, in this case, to dangerous effect, said Susmita Sahoo, the study’s senior author and an associate professor of medicine at the Cardiovascular Research Institute at the Icahn School of Medicine at Mount Sinai.
    • “No one has shown this causal relationship before,” Sahoo said.” * * *
    • “Sahoo said her team’s findings could help identify heart disease in kidney patients earlier, before they show symptoms.
    • “By measuring these cardiotoxic microRNAs, you can actually predict or identify or diagnose the patient who are on the way to developing a failing heart,” she said.
    • “The research can also influence treatment recommendations, said Erdbrügger, the study co-author who is also a practicing kidney doctor. For instance, Erdbrügger said if she knew one of her kidney patients had a higher risk of heart disease, she would consider treating more aggressively by increasing drug dosages or using more combinations of medications.”
  • The Wall Street Journal tells us,
    • “Federal regulators issued a safety warning, telling used-car owners in the U.S. to examine their vehicles’ maintenance histories regarding air-bag safety.
    • “NHTSA said nine people have died and two were injured in otherwise-survivable crashes after DTN inflaters ruptured.
    • “NHTSA urged drivers who find that their vehicles experienced an air-bag deployment to have an inspection.” * * *
    • “If a DTN inflater is found, the vehicle should not be driven until you are able to have it replaced with genuine parts,” NHTSA said.
  • NPR Shots informs us,
    • “Building strength and muscle comes with huge payoffs for health and longevity, but most Americans still don’t lift weights or regularly practice any muscle-strengthening activity.
    • “Why? People often blame a lack of time.
    • “Exercise physiologist David Behm says often when he talks to people about resistance training they seem to think they’d need hours in the gym to get results, working through rows of machines targeting each muscle.
    • “They’re like ‘my God, I’m going to be in there for an hour and a half or longer,” says Behm, a professor at Memorial University of Newfoundland in Canada.” * * *
    • “The evidence shows you can make real gains in strength and muscle with as little as one or two quick workouts a week — depending on the approach, you might be able to get away with as little as a half hour in the gym (or even less).
    • “The key is focusing on what are called multi-joint exercises, or compound lifts.”
  • The New York Times points out,
    • “A study published this week in the journal JAMA Pediatrics found that a close, nurturing relationship with parents during middle and high school was associated with a variety of positive social metrics up to two decades later.
    • “Researchers looked at six outcomes, such as having three or more close friends or socializing at least once a week. They found that high social connection in adulthood was more than twice as common among those who had felt the strongest family ties in youth, compared with those who had felt the weakest.
    • “We tend to think of adult loneliness or low social connectedness as byproducts of individual choice or adult social structures,” said Dr. Andrew Garner, a pediatrician and researcher at Case Western Reserve University, who was not involved in the research. This study, on the other hand, “forces us to think developmentally.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “2026 is an “execution year” for Teladoc Health, CEO Chuck Divita told Healthcare Dive.
    • “The telehealth company has spent the past year focusing on a strategy shift, prioritizing international expansion, improving operating efficiency, better leveraging its mental health assets and enhancing its integrated care business.
    • “The goal is to deliver sustainable long-term growth at Teladoc, which has seen its stock price decline significantly from the heights reached during the COVID-19 pandemic. To that end, the virtual care giant completed multiple acquisitions last year, launched new products and began accepting insurance coverage at its direct-to-consumer mental health arm BetterHelp. 
    • “I believe that we have the right strategy, the right priorities, and it’s really about execution now,” said Divita, who took up the role as Teladoc’s chief executive about a year and half ago.”
    • For the full interview, read the article. 
  • McKinsey & Co. discusses the changing contours of health and wellness.
    • “As 2026 takes shape, long-held notions of health and wellness, both in and out of the workplace, are evolving—expanding beyond disease prevention to focus on longevity, performance, and quality of life.
    • “Advances in healthspan science are driving biomedical innovations that contribute to healthy longevity, while the rapidly evolving wellness economy reflects shifting consumer expectations around fitness, nutrition, and healthy aging. McKinsey Health Institute research from Barbara Jeffery, Jacqueline Brassey, Lucy Pérez, and Darshini Mahadevia also shows that workplace health interventions can deliver measurable gains for both individuals and organizations. 
    • “As you navigate your own wellness journey this year, explore these insights on what it means to live a healthier, more fulfilling life.”
  • Per Fierce Healthcare,
    • “Maven Clinic launched a research institute on Thursday to rally further research and collaboration in digital health.
    • “The Clinical Research Institute is based on what Maven claims is the largest public evidence base measuring the impact of virtual care on women’s and family health. Maven has published over 40 peer-reviewed publications. A clinical research team, including Maven’s chief medical officer, is part of the center and driving its research and collaborations with partners.
    • “The goal is to serve as a platform for partnerships across academia and industry while expanding the scope of women’s and family health research. Current and past research partners include Harvard Medical School, Brown University, Posterity and OURA, with additional studies planned.
    • “The Institute also advances research through Maven’s Visiting Scientist program. Visiting Scientists work part-time with Maven for up to one year, contributing to research that informs care delivery and helps translate evidence into practice.”
  • and
    • “Nourish, a virtual nutrition provider, is launching a program that gives patients access to free cardiometabolic lab testing. 
    • “Nourish Labs will integrate blood testing into personalized nutrition care. The free basic panel will include key cardiometabolic markers like cholesterol, A1C and thyroid-stimulating hormone. An enhanced lab panel for insights into heart and hormone health will be available for a small add-on cost. 
    • “The objective measurement will improve treatment plans and strengthen patient engagement, executives say.
    • “We had just really wanted to, for a long time, bring it in-house and to be able to do this ourselves,” Aidan Dewar, co-founder and CEO of Nourish, told Fierce Healthcare in an exclusive advanced interview.”

Tuesday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Republicans and the White House were trying to broker a last-minute deal Tuesday with Democrats who are demanding changes to immigration enforcement in a sprawling funding package, with an agreement seen as critical to averting a partial government shutdown.
    • “The Senate is set to consider a $1.3 trillion package of six spending bills, including one that would fund the Department of Homeland Security. Lawmakers need to send the measures to President Trump’s desk by the end of this week to avoid a funding lapse. Democrats have said they would pass five of the bills, but insisted on separating or reworking the DHS funding legislation, arguing that any changes to immigration enforcement must be written into law. 
    • “An administration official said the White House is offering to change its immigration-enforcement operations to get the final appropriations bills passed, pointing to steps already taken such as removing Border Patrol commander Gregory Bovino from Minneapolis. But the White House doesn’t want to alter the funding bills, the official said, seeing such a move by the Senate as effectively guaranteeing a shutdown this weekend by requiring the House—currently on recess until Monday—to take action.”
  • Fierce Pharma relates,
    • “Even as the Trump administration works to implement its “most favored nation” pricing system, the U.S. government continues to advance efforts to negotiate Medicare drug prices as enabled by the Inflation Reduction Act. 
    • “On Tuesday, the Centers for Medicare & Medicaid Services unveiled the next 15 high-spend medicines up for price negotiations under the program. 
    • “Meds up for first-time Medicare price negotiations this year include GSK’s inhaler Anoro Ellipta, Gilead’s HIV blockbuster Bitkarvy, AbbVie’s Botox and Botox Cosmetic brands, Takeda’s inflammatory bowel disease drug Entyvio and Johnson & Johnson prostate cancer medicine Erleada, according to a Jan. 27 release from the CMS.
    • “In addition, Novartis’ breast cancer medicine Kisqali, Eisai’s cancer therapy Lenvima, Lundbeck and Otsuka’s atypical antipsychotic Rexulti, Eli Lilly’s diabetes drug Trulicity and its breast cancer treatment Verzenio are also due up for first-time negotiations, according to the government.
    • “Rounding out the list are Roche and Novartis’ Xolair for food allergies, chronic hives and other uses, plus immunology biologics Cosentyx, Cimzia, Orencia and Xeljanz from Novartis, UCB, Bristol Myers Squibb and Pfizer, respectively.
    • “Also for the first time, the government will renegotiate a drug’s price under the IRA system, tagging Boehringer Ingelheim’s diabetes med Tradjenta for renegotiations. The drug was previously included in last year’s batch of pricing talks.”
    • “After the negotiation process for the drugs kicks off this year, their new Medicare prices will become effective in early 2028, according to the CMS. Drugmakers have until the end of February to decide whether to participate in the process.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients — including Medicare and Medicaid enrollees — in a manner that’s low risk under the federal anti-kickback statute, so long as key safeguards are met. * * *
    • “The guidance, issued as a bulletin [PDF] by the HHS Office of Inspector General (OIG), supports efforts to make medically necessary drugs more affordable while protecting patients and federal health care programs from fraud and abuse. It also aligns with the Trump Administration’s broader effort to lower drug prices, increase transparency across the prescription drug market, and expand the availability of affordable direct-to-consumer pharmaceuticals as part of the TrumpRx program. * * *
    • “The guidance issued today provides pharmaceutical manufacturers with assurance that they may sell prescription drugs directly to patients who choose to pay cash — including patients enrolled in federal health care programs — when the arrangement meets specific conditions. These include ensuring the drug is not billed to Medicare, Medicaid, or other federal programs, is not used to market other federally reimbursable products, and is not tied to future purchases or referrals.
    • “Importantly, the guidance does not change the federal anti-kickback statute itself, which remains a criminal law enforced on a case-by-case basis. It also does not address financial relationships between manufacturers and other parties such as physicians, pharmacies, pharmacy benefit managers, or marketers. HHS OIG has indicated it will seek additional public input on those arrangements separately.”
  • Healthcare Dive tells us,
    • “The Trump administration’s top Medicare official is coming to the defense of the 2027 Medicare Advantage rate notice, after the rule sparked a wave of backlash from the health insurance sector.
    • “The CMS proposed a flat rate update for next year, which won’t adequately cover higher spending on seniors in the privatized Medicare program, insurers say. Regulators also proposed reforms to MA risk adjustment that would restrict insurers’ ability to inflate members’ risk scores and, correspondingly, their reimbursement from the federal government.
    • “The rule sent a shockwave down Wall Street, which had expected a much higher update from the historically pro-business Trump administration.”
  • Yesterday, CMS released proposed Medicare Part D payment policies for 2027. The American Hospital Association News notes,
    • “CMS plans updates to the Part D risk adjustment model. Out-of-pocket prescription drug costs for individuals with Medicare Part D are proposed to be capped at $2,400 in 2027, up from $2,100 in 2026. Comments on the [two] CY 2027 proposals are due Feb. 25. The agency expects to publish a final rate announcement on or before April 6.” 

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Amid a deregulatory push by the Trump administration, the Food and Drug Administration is scrutinizing its digital health policies. The agency suddenly issued a pair of guidances earlier this month, intended to clarify its approach to wellness devices and medical software. 
    • “The updates reflect changes to the agency’s thinking about what counts as a wellness device, but also raise new questions and pose challenges to consumers, experts said. 
    • “FDA Commissioner Marty Makary announced the pair of guidances — issued without any prior notice or public comment period — at the Consumer Electronics Show in early January. Makary said the agency has 27 different guidances that deal with software and digital health, and he aims to cut that number by at least half, while updating them to be more clear, modern and consistent.
    • “Despite Makary’s framing, attorneys viewed the updates as less of a major change to regulations, and more as tweaks and examples. 
    • “He was talking about cutting red tape and deregulating, and that’s not really what these are,” said Amanda Johnston, a partner at Gardner Law. “The law itself has not changed.” 
  • BioPharma Dive informs us,
    • “Shares for Intellia Therapeutics climbed by about 10% early Tuesday after the company said the Food and Drug Administration cleared it to resume one of two Phase 3 trials evaluating its experimental CRISPR-based treatment against the rare genetic disease transthyretin amyloidosis.   
    • “U.S. regulators halted two studies of Intellia’s nexiguran ziclumeran, or nex-z, last October following the occurrence of serious liver toxicity that resulted in the death of a trial participant. Intellia said Tuesday that the FDA has allowed it to restart “MAGNITUDE-2,” a trial testing nex-z in people with a form of the disease that affects the nerves, by incorporating new risk mitigation measures. It’s also enrolling about 10 more patients in that study. Intellia aims to begin testing again “as quickly as possible.” 
    • “Intellia also revealed, however, that a pause in the “MAGNITUDE” trial in patients with the “cardiomyopathy” form of the disease is ongoing. The company will provide an update once aligned with regulators on the program’s path forward there.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “The South Carolina measles outbreak has surpassed the recorded case count in Texas’ 2025 outbreak, as health officials have logged almost 600 new cases in just over a month.
    • “The outbreak centered in northwestern Spartanburg County is showing little sign of slowing down, with health officials saying Tuesday that 789 cases have been confirmed since September. Last year in Texas, 762 cases were reported, although experts believe that was likely an undercount.
    • “A large outbreak on the Utah-Arizona border is also ongoing, and the United States’ measles elimination status is at risk.”
  • ABC News informs us,
    • “Long-term alcohol use has been linked to higher risks of colorectal cancer, according to a study published Monday in the journal Cancer.
    • “Researchers found that those with heavy lifetime alcohol consumption have up to a 91% higher risk of developing colorectal cancer compared with those who drank very little. That risk significantly increased with consistent heavy consumption, whereas those who quit drinking may have demonstrated decreased risk of precancerous tissue.
    • “The longer someone drinks, the longer their colon and rectum are exposed damage and impaired repair, both major mechanisms of cancer,” Dr. Lynn M O’Connor, section chief of colon and rectal surgery at Mercy Medical Center and St. Joseph Hospital in New York, told ABC News.
    • “The study followed more than 88,000 adults with no prior history of cancer. Participants reported their alcohol use beginning in early adulthood and were followed for nearly a decade to track cancer outcomes.
    • “Compared with those who averaged one drink or less per week over their lifetime, those who consumed over 14 drinks a week had a 25% higher risk of developing colorectal cancer. The link was even stronger for rectal cancer, where one’s risk nearly doubled.”
  • and
    • “Reducing the sodium in pre-packaged and prepared foods may prevent thousands of cases of heart disease, stroke and death, according to two new studies.
    • “The studies, published early Monday in the journal Hypertension, took place in France and the United Kingdom, countries where food giants have subtly reduced salt levels in store-bought foods.
    • “Using national diet and health data, researchers in France estimated that modest decreases in bread salt content could cut adults’ daily salt intake by 0.35 grams, lower their blood pressure and prevent more than 1,100 deaths.
    • “Researchers from the U.K. estimated that similar salt reductions in packaged foods and takeout meals could lower daily British sodium intake by 17.5%, preventing more than 100,000 cases of heart disease and 25,000 cases of stroke over 20 years.
    • “Sodium plays important health roles, like helping blood vessels hold water. However, about 90% of Americans consume too much of it, according to the American Heart Association. Excessive sodium raises the risk of high blood pressure, a risk factor for issues such as cardiovascular disease, long-term kidney disease and cognitive decline.”
  • The New York Times considers whether “Intermittent Fasting Live Up to the Hype? The diet has been linked to weight loss, longer life span and even a lower risk of cancer — in mice. What about humans?” For example.
    • “The most common claim about intermittent fasting is that it’s a better way to lose weight than other diets. Early mouse and rat experiments suggested that something interesting was going on beyond simple calorie restriction. The animals lost weight and stayed healthier than mice that ate normally, no matter how many calories they binged between fasts.
    • “But in humans, the idea that intermittent fasts offer special weight loss benefits “really hasn’t been borne out by the data,” said James Betts, a professor of metabolic physiology at the University of Bath in the United Kingdom.”
  • Per an NIH news release,
    • “A study funded by the National Institutes of Health (NIH) provides the clearest evidence to date to link severe chronic traumatic encephalopathy (CTE) to dementia risk. CTE is a degenerative brain disorder in some people who have had repeated head impacts over time. It can only be diagnosed after death by examining brain tissue. While researchers were able to link severe CTE (stages III and IV) to dementia risk, they did not find any measurable link between less severe CTE (stages I and II) and changes in thinking, mood, or daily functioning.
    • “The research, led by scientists at Boston University CTE Center and the U.S. Department of Veterans Affairs Boston Healthcare System, analyzed 614 donated brains from people with known exposure to repetitive head impacts. None of the donors had Alzheimer’s disease, Lewy body disease, or frontotemporal lobar degeneration, three of the most common neurodegenerative diseases that cause dementia.”
  • NIH released its latest edition of Research Matters which covers the following topics:
    • “Testing risk-based breast cancer screening
      • “In a large clinical trial, risk-based breast cancer screening was as safe and effective as annual mammograms.
      • “This approach could help reduce anxiety, costs, and unnecessary follow-up testing.”
    • “ADHD medications stimulate alertness, motivation”
      •  “Researchers found that prescription stimulants for ADHD act on brain networks that control wakefulness and reward, but not attention as previously thought.
      • “The study suggests that stimulants and additional sleep affect the brain in similar ways, and that getting enough sleep could help in managing ADHD.”
    • “Cellular mitochondria transfer prevents pain”
      • “Studies in mice and human cells revealed that power-hungry sensory neurons get mitochondria for energy production from nearby supporting cells.
      • “The results point to potential new treatments for nerve pain caused by drugs or health conditions that harm mitochondria.”
  • Per MedPage Today,
    • “Postmenopausal women on the GLP-1 medication tirzepatide (Zepbound) for obesity lost more weight if they were also using menopause hormone therapy, a retrospective cohort study indicated.
    • “Among 120 women with overweight or obesity on tirzepatide, hormone therapy users lost 19.2% of their body weight, while those not using hormone therapy treatment lost 14% (P=0.0023), reported Maria Daniela Hurtado Andrade, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and colleagues.
    • “Women in the hormone therapy group lost 35% more body weight than those in the no hormone therapy group and showed notable improvements in key cardiometabolic parameters, supporting a potential enhancing effect of hormone therapy on tirzepatide’s therapeutic effect,” the researchers wrote in Lancet Obstetrics, Gynaecology, & Women’s Health.”
  • The Wall Street Journal points out,
    • “Roche ROG Holding said an experimental injection achieved positive results in a midstage clinical trial by helping patients shed weight, paving the way for the start of the company’s first late-stage obesity study.
    • “Eli Lilly and Novo Nordisk’s GLP-1 drugs currently dominate the obesity-drug market, but big drugmakers including Roche, Pfizer and Amgen, as well as smaller players, are trying to come up with new treatments to challenge them.” * * *
    • “The Swiss pharmaceutical company said Tuesday that a once-weekly injection of a drug candidate known as CT-388—one of its experimental drugs bought from Carmot—resulted in a weight loss of 22.5% when adjusting for placebo at 48 weeks.
    • “The reduction was achieved at the highest dose tested, 24 milligrams, without reaching a weight-loss plateau, the company said. Roche said 54% of trial participants on the 24 mg dose achieved resolution of obesity.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Wall Street believed the Trump administration was going to take a friendly approach to Medicare insurers. Now, investors think the industry might be in for a rough ride.
    • “Shares of big insurers plunged after The Wall Street Journal first reported that the Medicare agency was proposing 2027 Medicare insurer rates well below analysts’ expectations.
    • “UnitedHealth Group’s shares were down nearly 20% on Tuesday, while Humana’s dropped 21%. CVS Health and Elevance Health both fell 14%.”
    • “Among those large companies, $96 billion in market capitalization was wiped out Tuesday.” 
  • Beckers Payer Issues informs us,
    • “UnitedHealth Group reported fourth-quarter and full-year 2025 earnings Jan. 27. Profits took a hit, with the company attributing drops to Medicare funding reductions, the Inflation Reduction Act, steeper medical costs and remaining Change Healthcare cyberattack costs.”
  • Modern Healthcare adds,
    • “United Health Group plans to reduce Optum Health’s footprint by 20%.
    • “Optum Health will focus on its profitable segments as UnitedHealth Group navigates a multiyear recovery.
    • “Optum Health lost $278 million from operations in 2025. 
    • “Optum Financial Services will be incorporated into Optum Insight.”
  • Beckers Hospital Review lets us know,
    • “Nashville, Tenn.-based HCA Healthcare reported a net income of $6.8 billion in 2025, a 17.8% increase year over year, according to its Jan. 27 financial report.” 
  • and
    • “Healthgrades published its annual “America’s Best Hospitals Awards” Jan. 27, recognizing 250 hospitals across the country for strong quality performance.
    • “The list recognizes the top 50, 100 and 250 best hospitals, representing the top 1%, 2% and 5% of hospitals in the country for clinical excellence, respectively, the consumer platform said in a news release. For the ranking, Healthgrades analyzed clinical performance for 4,500 hospitals across 30 common procedures and conditions. It covers Medicare data from 2022 through 2024. Full details on the methodology can be found here.”
    • The article lists the top 50 hospitals organized by State.
  • Fierce Pharma informs us,
    • “Pfizer again heads up a physician ranking of vaccine manufacturers, beating Merck & Co. and Moderna to complete an unchanged top three from the last edition of the survey. But, while the rankings held steady, the operating environment has changed quickly to reinforce the value of being in good standing with physicians.
    • “ZoomRx generated the league table by asking 58 U.S.-based healthcare professionals (HCPs) about 14 vaccine manufacturers. Respondents graded the companies’ innovation, patient centricity, reputation, HCP centricity and promotions, generating data that ZoomRx used to give each manufacturer a score out of 100. 
    • “As happened when ZoomRx ran a similar survey in 2024, Pfizer took the top spot after achieving strong scores across all five dimensions. The Big Pharma scored 83 out of 100 after HCPs praised its innovation, reliability and sales execution in particular.”
  • Per MedCity News,
    • “Purchasers are increasingly seeking performance-based contracts — in which payment is tied to outcomes — with digital health solutions. However, implementing these contracts is difficult, especially for employers who have limited resources.
    • “That’s why the Peterson Health Technology Institute (PHTI) released a playbook last week for purchasers on how to effectively execute performance-based contracts. The playbook was created in collaboration with health plans, vendors, brokers, consultants, data warehouses and other stakeholders.
    • “We have consistently heard from both health plans and employers that the process of negotiating performance-based contracts remains very arduous. … We would really like to see purchasers coming to the table as a customer with high standards, we want to raise the bar on purchasing,” said Caroline Pearson, executive director of PHTI, in an interview. “Every payer should be holding their partners accountable for outcomes that really matter.” 

Monday report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Patient safety, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “The Senate inched closer to triggering a partial government shutdown Monday as GOP leaders pushed forward with a $1.33 trillion funding package that includes a Homeland Security bill Democrats vowed to oppose.
    • “With only four days left before current funding for most federal agencies runs out, both parties sought to find an exit ramp from the road to a shutdown that neither side wants.”
  • The Wall Street Journal reports,
    • “The Trump administration is proposing a .09% average payment increase for Medicare Advantage plans in 2027, significantly below Wall Street’s roughly 4% to 6% expectations.
    • “The proposal also includes eliminating payments tied to diagnoses from insurer medical chart reviews not linked to specific medical visits, reducing the 2027 payment rate by 1.53 percentage points.
    • “Overall payments are projected to increase by 2.54% for 2027, combining the proposed rate changes with an additional 2.45% from underlying billing trends.”
  • Per another CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) today issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking public feedback on potential approaches to strengthen the American-made supply chain for personal protective equipment (PPE) and essential medicines. Building on lessons learned during the COVID-19 public health emergency, the agency is exploring ways to reduce reliance on foreign-made medical supplies and enhance the nation’s readiness for future emergencies while supporting American workers and manufacturers.” * * *
    • “Information on how to submit comments is available via the Federal Register at: https://www.federalregister.gov/public-inspection/current. There is a 60-day comment period.”
  • The American Hospital Association (AHA) News notes,
    • The AHA Jan. 26 urged the Health Resources and Services Administration to take immediate action to stop a new Eli Lilly and Company policy from taking effect on Feb. 1, including by “assessing civil monetary penalties for intentionally overcharging 340B hospitals.”  
    • On Jan. 15, Lilly issued a notice to all 340B covered entities that the company was updating its data requirements for its 340B distribution program. The policy would require 340B covered entities to submit claims data for all dispensations of all Lilly drugs, regardless of setting.  
    • “All told, Lilly’s draconian new policy is a case of ‘déjà vu all over again,’” the AHA wrote. “Once more, we have a drug company taking unilateral action against 340B hospitals based on flawed legal and policy reasoning, testing the limits of the law and challenging HRSA’s authority over the 340B Program. Much like its 2021 contract pharmacy restrictions and its 2024 unilateral rebate policy, Lilly seeks to boost its bottom line at the expense of 340B hospitals and the vulnerable patients they serve.” 
  • Healthcare Dive reports,
    • “Providers and health insurers submitted almost 1.2 million cases to a federal portal meant to resolve disputes over surprise medical bills in the first half of 2025 — almost 40% more than in the last six months of 2024, according to new data from the CMS.
    • “Arbiters are handling the rising volume while cutting into the existing backlog, processing more than 1.3 million disputes in the first half of the year, the CMS said. That’s up almost 50% from the prior six months.
    • “Still, despite faster closures, the independent dispute resolution process remains dogged by problems. Many submitted disputes are actually ineligible for IDR, and parsing through those is the primary cause of delays, the CMS said. And, the lion’s share of disputes continue to be submitted by a handful of mostly private equity backed-provider groups, raising concerns IDR is being exploited for profit.”
  • The AHA News adds,
    • “The Departments of Health and Human Services, Labor, and the Treasury have added Dane Street, LLC as a new independent dispute resolution entity, bringing the total number to 16. IDR arbitrators help make payment determinations in disputes between providers, group health plans and health insurance issuers under the No Surprises Act.” 
  • OPM Director Scott Kupor writes in his Secrets of OPM blog about “the performance management priorities and actions the Trump Administration is taking on behalf of the American people.”

From the Food and Drug Administration front,

  • Fierce Healthcare relates,
    • “Aidoc has secured 11 new indications from the Food and Drug Administration (FDA), bringing a comprehensive body CT triage solution to emergency departments and ambulatory settings to reduce patient backlogs. 
    • “Aidoc, a clinical artificial intelligence company, is trying to solve the root issue of overcrowding in emergency departments and provider offices. The company argues that providers’ operational workflows, which mostly prioritize patients on a “first come, first serve” basis, don’t work well.
    • “Instead of first-in, first-out, Aidoc’s AI triage solution can prioritize scans based on its initial review of the images. Those scans are then moved up in the queue for radiologists to review, allowing acutely ill patients to receive care more quickly.”
  • MedTech Dive points out,
    • “Intuitive Surgical on Monday provided more details about its new cardiac surgery initiative for the da Vinci 5 robot, including specifying nine procedures that received U.S. clearance.
    • “Among those are mitral and tricuspid valve repair, mitral valve replacement, and left atrial appendage closure — procedures that comprise key businesses for heart device companies such as Boston Scientific, Abbott and Edwards Lifesciences.
    • “Intuitive said cardiac procedures with da Vinci 5 can enable surgeons to operate through small incisions without splitting the breastbone, which is typically required in open heart surgery.” * * *
    • “The update comes after Intuitive executives told analysts on an earnings call last week that the Food and Drug Administration had cleared the robot for cardiac surgery.”
    • “Intuitive said it plans to begin working with a limited number of U.S. sites through 2026 to establish da Vinci 5 cardiac programs.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The American Academy of Pediatrics recommends children be vaccinated against 18 diseases, more than the U.S. government directs after it overhauled its schedule.
    • “The doctors group, which released its recommendations Monday, kept its guidance largely unchanged from its previous version from last year. The group said it doesn’t endorse the Centers for Disease Control and Prevention’s childhood-vaccine schedule. The agency now recommends all children get vaccinated against 11 diseases.”
  • A commentator, writing in STAT News, observes,
    • “The recent overhaul of the U.S. pediatric vaccine schedule under Health and Human Services Secretary Robert F. Kennedy Jr. touched off a firestorm of criticism — most of it for demoting six vaccines from routinely recommended to “shared clinical decision-making” (SCDM). The implication was that these six vaccines are optional, less safe, or less useful than the routinely recommended ones.
    • “Like nearly everyone in public health, I agree that the evidence for the safety and efficacy of the six vaccines is robust and hasn’t changed.
    • “But in its urge to say what Kennedy gets wrong, the public health and medical community is actively resisting something he gets right: Vaccination decisions belong to patients and their parents, guided by candid advice from health care professionals.”
  • The American Medical Association lets us know what doctors wish their patients knew about polio.
  • The New York Times relates,
    • “For years, the nonprofit groups that coordinate transplants in the United States regularly ignored federal rules — skipping patients at the top of waiting lists and sending organs to those who weren’t as sick and hadn’t waited as long.
    • “But new federal data shows that the rate of skipped patients has dropped by more than half in recent months, a change that reflects a far-reaching effort to make the transplant system fairer and safer.
    • “This is truly great news for patients and the system,” said Dr. Jesse Roach of the National Kidney Foundation. “We need to continue to monitor it, to ensure the system is fair, efficient and transparent. But this is a win.”
  • Beckers Clinical Leadership informs us,
    • “The Joint Commission and the National Quality Forum are aligning their serious safety event reporting frameworks in an effort to reduce redundancy and ease the administrative burden on healthcare providers.
    • “Effective Jan. 1, 2027, The Joint Commission will adopt the NQF’s Serious Reportable Events, or SRE List, across all accredited domestic and international organizations, according to a Jan. 26 news release from the organizations. Three workplace safety events — homicide, sexual abuse or assault, and physical assault of staff — will be retained as part of the revised SRE list.
    • “Leaders of both organizations said consolidating around the NQF list will simplify reporting for clinicians and hospitals while providing a more consistent, standardized framework for measuring and tracking patient safety events across states and health systems.”
  • Genetic Engineering and BioTechnology News notes,
    • “It is known that inflammatory bowel disease (IBD) increases the risk of colorectal cancer (CRC). But the underlying mechanism—and the genetic drivers—between this link remain yet to be determined. Genetic variants in TNFSF15, encoding tumor necrosis factor (TNF)-like cytokine 1A (TL1A), are associated with both severe IBD and advanced CRC.
    • “Now, a new study points to immune reactions in the gut—driven by a key signaling protein and a surge of white blood cells from the bone marrow—to help explain why people with inflammatory bowel disease have a higher risk of colorectal cancer.
    • “This work is published in Immunity in the paper, “Innate lymphoid cells activated by the cytokine TL1A link colitis to emergency granulopoiesis and the recruitment of tumor-promoting neutrophils.”
  • Per Healio,
    • “Researchers compared the outcomes of more than 40,000 infants who were immunized through nirsevimab or maternal RSV vaccination.
    • “Nirsevimab was associated with fewer severe outcomes than the maternal vaccine.” * * *
    • “Our results should not be interpreted as evidence against maternal RSV vaccination,” Marie Joelle Jabagi, PharmD, PhD, MPH, said. “Instead, they underscore that clinicians should individualize prevention strategies based on clinical context, access to care and timing within the RSV season. Both approaches remain valuable and may be complementary, particularly in efforts to maximize population-level protection against RSV.”
  • Per Health Day,
    • “Childhood ADHD can set a person up to have poor health in middle age, a new study says.
    • “People with ADHD traits at age 10 are likely to have chronic illness and disability at age 46, researchers reported Jan. 21 in JAMA Network Open.
    • ‘The study said these health problems can include asthma, migraines, back problems, cancer, epilepsy, hearing problems, GI disorders, kidney disease and diabetes.
    • “We have added to the concerning evidence base that people with ADHD are more likely to experience worse health than average across their lifespan,” said lead researcher Joshua Stott, a professor of aging and clinical psychology at University College London in the U.K.
    • “People with ADHD can thrive with the right support, but this is often lacking, both due to a shortage of tailored support services but also because ADHD remains underdiagnosed, particularly in people in midlife and older, with needs unaddressed,” Stott said in a news release.”

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

  • The Street reports
    • “The Centers for Medicare & Medicaid Services (CMS) recently published some in-the-weeds datasets on the use of, and spending for, drugs prescribed to Medicare beneficiaries. 
    • “There’s the Medicare Quarterly Part B and Part D Drug Spending Datasets and the annual version of the Medicare Part B and Part D Drug Spending datasets.”
    • The Street feature a 13 minute webinar with a consultant who has used the data sets (plus a transcript of that webinar).
  • Beckers Hospital Review tells us,
    • “More than 500,000 providers prescribed GLP-1s in 2025, with wide variation between specialties, according to a Jan. 22 article from IQVIA, a clinical research firm. 
    • “GLP-1 medications are approved for several conditions, including Type 2 diabetes, obesity, cardiovascular disease, chronic kidney disease, liver disease and sleep apnea. Among GLP-1 drugs approved for weight loss — Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound — adoption and prescribing trends differed across provider specialties.
    • “Endocrinologists stand out as both quick adopters of Wegovy and subsequent high writers for Zepbound, leveraging their expertise in managing complex metabolic conditions to integrate new treatments earlier,” according to IQVIA. “Their readiness to prescribe is shaped by familiarity with the mechanisms of GLP-1 therapies and a patient base that often presents with comorbidities where these drugs deliver added value.”
    • “Primary care providers account for the largest share of GLP-1 prescriptions due their broad patient base. However, in contrast to endocrinologists, they have been slower to adopt GLP-1s, which IQVIA defines as prescribing a GLP-1 within the first 1.75 years of the drug entering the market.”
  • Per BioPharma Dive,
    • “Children with Duchenne muscular dystrophy who received Sarepta Therapeutics’ gene therapy Elevidys in a clinical trial continued to perform better on tests of motor function than historical data suggests they should, and the benefits appear to compound with time, the company said Monday.
    • “According to Sarepta, patients in the study, Embark, had greater reductions on three measures of function than a matched historical control group, with the gap “significantly widening” between two and three years after treatment. Doug Ingram, Sarepta’s CEO, said the data is an opportunity to “rebalance the discussion” surrounding Elevidys, sales of which have slowed amid safety concerns and newly restrictive labeling. 
    • “In research notes published Monday, multiple Wall Street analysts viewed the data as a positive development for the company. They also noted, though, that investors will be more focused on whether the results translate to sales growth. Sarepta shares, which have lost much of their value over the last year, rose by double digits in morning trading.” 
  • MedCity News considers “what does OpenAI and Anthropic’s healthcare push mean for the industry?”
    • “As OpenAI and Anthropic move deeper into healthcare, experts say AI chatbots are becoming the new front door to medicine. This shift is shaking things up for some health tech startups, redefining the patient-provider relationship, and intensifying debates over safety, privacy and accountability.:

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.”

Friday report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Midweek report

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

From Washington DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the. J.P. Morgan healthcare conference,

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

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

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