Midweek report

NIH

Midweek report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, NIH, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News reports,
    • “America’s hospitals and health systems are deeply committed to providing high-quality, accessible and affordable care, AHA President and CEO Rick Pollack March 18 told the House Committee on Energy and Commerce Subcommittee on Health during a hearing focused on lowering health care costs. 
    • “Pollack shared several efforts that hospitals are leading to make care more affordable, including increasing efficiencies, adopting innovative technologies and rethinking how they deliver care. 
    • “Many are investing in preventive care and care coordination programs that help patients better manage chronic diseases, avoid unnecessary hospital visits and stay healthier at home,” Pollack said. “These efforts improve outcomes, and they help lower costs for patients, families and the entire health care system.” * * *
    • “Pollack also said that there is more work to do to make health care more affordable for Americans and outlined several solutions focused on improving the health of individuals and communities; advancing value through care transformation; reducing regulatory and administrative waste; and innovating to improve care quality and outcomes. 
    • “We also know that to truly make care affordable for Americans, all stakeholders, including government, commercial health insurers, drug companies, providers and patients, must work together,” Pollack said.” 
  • MedPage Today relates,
    • “NIH Director — and CDC Acting Director — Jay Bhattacharya, MD, PhD, had little trouble Tuesday responding to questions from House members during an oversight hearing.
    • “While the promise of the NIH is strong, we must reflect upon policies and evolve with changing technology,” Bhattacharya told members of the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. “And reform is already underway. A new office within the [Office of the Director] will support rigorous analysis of the NIH portfolio to strengthen performance management, accountability, and promote reproducibility of our research, because … it’s vital that the research that we do is reproducible, that an independent team looking at the same result find the same answer.”
    • “Committee members on both sides of the aisle seemed generally pleased with the way Bhattacharya was running things.” 
  • Noah Peters, an OPM senior advisor, writing in the OPM Director’s Substack blog, explains why “Modernization is Essential to Effectively Manage the Executive Branch.”
  • The Wall Street Journal tells us,
    • “The Trump administration, which has been skeptical of vaccines that prevent infections, is going all in on a new initiative to deploy novel vaccines against cancer.
    • “The Department of Health and Human Services, through the National Cancer Institute, has initiated a potential $200 million public-private partnership to fund clinical trials of vaccines that spark an immune attack on tumors. These vaccines may ward off cancer in patients who have been treated for the disease, but are at high risk for recurrence. 
    • “Dr. Anthony Letai, who became NCI director in September, said he wants to finance larger trials of vaccines that in smaller studies have shown potential to keep aggressive cancers at bay.
    • “What’s exciting about this is that there are early signals from clinical trials that we can actually have an impact even in some very difficult settings where we have very little to offer patients,” he said. 
    • “Instead of protecting against infection, these vaccines train the immune system to fight tumors. And unlike flu or Covid-19 shots, which are injected into healthy people, these vaccines would be used in patients who have been treated for cancer.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Johnson & Johnson said Wednesday it won Food and Drug Administration approval to sell what it calls a “game-changing” pill to treat psoriasis.
    • “The drug is part of a class of medicines that work by blocking the action of a protein called IL-23, a key player in the body’s inflammatory response. It’s an approach that has proved extremely effective, spurring a generation of blockbuster injectable medicines including AbbVie’s Skyrizi and J&J’s own Tremfya.
    • “J&J’s new entry is the first in the class that can be taken orally, offering patients the convenience of a once-daily pill. The drug, icotrokinra, will be sold as Icotyde and is available to treat moderate-to-severe plaque psoriasis in patients over the age of 12 who weigh at least 40 kilograms, or 88 pounds.”
  • MedTech Dive relates,
    • “MiniMed, the diabetes tech firm spun out of Medtronic earlier this month, received Food and Drug Administration clearance for a smaller insulin pump.
    • “The device, called MiniMed Flex, is about half the size of the company’s previous 780G pump and is controlled using a smartphone.
    • “The new insulin pump is MiniMed’s first launch since the company went public in early March.”
  • and
    • “JenaValve has received premarket approval from the Food and Drug Administration for its transcatheter heart valve to treat symptomatic, severe aortic regurgitation in patients who are at high risk for surgical valve replacement.
    • “The Trilogy valve is now the first transcatheter device with a dedicated indication for the condition, the company said Wednesday. 
    • “Edwards Lifesciences in January canceled its planned acquisition of JenaValve after the Federal Trade Commission challenged the $945 million deal, arguing it would combine the only two companies conducting U.S. clinical trials for transcatheter aortic valve replacement devices to treat aortic regurgitation.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued a draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on human-centric data.  
    • “This marks another major milestone in the implementation of the FDA’s roadmap to reducing animal testing, and reflects the FDA’s commitment to moving away from using animal testing as the default method for gaining drug safety information. The draft guidance describes the Center for Drug Evaluation and Research’s (CDER’s) general recommendations to consider for validating NAMs when nonclinical NAMs data are provided in support of a drug application or regarding an order issued under section 505G of the FD&C Act for an OTC monograph.”
  • A National Institutes of Health news release adds,
    • “The National Institutes of Health (NIH) today announced more than $150 million to develop and scale research methods that better simulate human biology and reduce reliance on animal models, a priority of the Trump Administration. The funding marks the first awards under the Complement Animal Research in Experimentation (Complement-ARIE) program, an initiative to develop, implement, and standardize lab or computer-based methods, also known as new approach methodologies (NAMs). Research teams across the United States will lead projects designed to produce more predictive models of human disease. 
    • “This is an exciting opportunity to create a repertoire of human-focused methods that are so sophisticated and comprehensive that successful clinical translation will rise and we will be able to answer questions beyond our reach with current research models,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives. “These new projects are key steps in expanding and strengthening our scientific toolbox. NIH’s investment in NAMs is critical to our mission to carry out gold-standard research.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Leapfrog Group is withdrawing safety grades for nearly 500 hospitals dating back to fall 2024. 
    • “A federal judge this month ordered Leapfrog to unpublish the grades for five Tenet hospitals that alleged in a 2025 lawsuit they received worse grades from the watchdog group after they stopped participating in its surveys as of the fall 2024 report.
    • “Although the judge’s order only applied to the five hospitals, Leapfrog is applying it to all hospitals that did not participate in the surveys during the same period.” * * *
    • “Leapfrog will not assign grades in its spring 2026 report to any hospital that has not participated in the survey in the past two years, Binder said. The next report is expected to be released by early May.
    • “The group plans to develop new methodology applicable to all hospitals in time for its fall 2026 report, she said.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Little Rock, Arkansas, is the No. 1 most overweight city in the United States, according to a new WalletHub report. McAllen, Texas, came in at No. 2, followed by Memphis, Tennessee, at No. 3.
    • “WalletHub compared a total of 100 U.S. metro areas for this report, focusing on obesity rates among adults and children, cardiovascular health, food access and physical fitness levels. The final results reinforced trends that have been identified again and again: Americans in some parts of the country—particularly southern states and the Midwest—face an especially high risk of developing cardiovascular disease.  
    • “Click here for the full report.
    • “What can cardiologists living in these parts of the country do for their patients? According to Romit Bhattacharya, MD, a preventive cardiologist with Massachusetts General Hospital and member of the American College of Cardiology’s Prevention of Cardiovascular Diseases Council, it is critical for clinicians to consider proactive patient care whenever possible.”
  • and
    • “New early clinical data from a study using artificial intelligence (AI) to monitor widely available consumer wearables may help transform how heart failure patients are monitored and managed outside the hospital.
    • “At the THT 2026 meeting in Boston, Afnan Tariq, MD, JD, an interventional cardiologist and assistant clinical professor of medicine at the University of California, Irvine, presented first-in-man results from a passive, device-agnostic AI platform designed to turn data from consumer wearables into actionable clinical insights. The technology was able to lower the number of hospitalizations required over time thanks to earlier interventions.” 
  • STAT News adds,
    • “CAR-T cells, immune cells engineered to fight cancer, are one of oncology’s most powerful tools. But making them is arduous, as the patient’s immune cells must be extracted, manipulated in a lab, then returned to the patient’s body. Instead, scientists at Azalea Therapeutics, a spinout from the lab of Nobel laureate Jennifer Doudna, are seeking to make the engineered cells right in the patient’s own body.
    • “In a new paper published in Nature on Wednesday, the researchers showed some early signs of success with the process, known as in vivo CAR-T. With an infusion of gene editing particles, scientists were able to create CAR-T cells that could clear both solid and blood tumors in mice, a step forward for the field.
    • “Azalea Therapeutics isn’t the only group developing in vivo CAR-T. But, said Justin Eyquem, a cancer researcher at the University of California San Francisco and senior author on the paper, what makes their method unique is the ability to reliably genetically edit the right cells and the right part of those cell’s genomes. The method should practically eliminate the chances of accidentally editing the wrong cell or the wrong part of the genome, Eyquem said, both of which could pose serious risks to the patient.”
  • The American Journal of Managed Care tells us,
    • “Maintaining or improving a healthy lifestyle after a hypertension diagnosis significantly lowers the risk of developing cardiovascular disease (CVD) and type 2 diabetes (T2D), according to a new study.
    • “This prospective, population-based cohort study is published in JAMA Network Open.“
  • Pulmonology Advisor points out,
    • “Women experience more frequent asthma attacks, and prior attack history is a statistically stronger predictor of future attacks in men vs women, according to study findings published in Chest.” * * *
    • “The overall annualized asthma attack rate was higher in women than men,” the investigators stated, concluding, “Prior attack history had stronger prognostic value for future attacks in men, while other clinical risk factors and type-2 biomarkers (blood eosinophils and FeNO) showed no major sex differences.”
  • Healio notes,
    • “More than 80% of patients implanted with a transvenous phrenic nerve stimulation device for central sleep apnea had at least 4 hours of usage per night for 70% of nights at follow-up visits, according to study findings.
    • “The percentage of patients receiving adequate [transvenous phrenic nerve stimulation] therapy, based on the CMS CPAP adherence definition, appears to be higher than that for mask-based therapies reported in the literature,” Rami Khayat, MD, director of Penn State Health sleep services and division chief of pulmonary, allergy and critical care medicine at Penn State College of Medicine, and colleagues wrote in the Journal of Clinical Sleep Medicine.”

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

  • The Peterson KFF Health System Tracker identifies eight trends shaping health care costs in 2026.
    • 1. Healthcare costs remain top of mind for many Americans.
    • 2. Premiums have increased across commercial and individual marketplaces.
    • 3. The public and private sectors are looking for solutions as U.S. spending on prescription drugs continues to increase.
    • 4. Price transparency for healthcare prices has momentum.
    • 5.  Federal and state policymakers show interest in addressing the impacts of healthcare consolidation.
    • 6. The use of artificial intelligence in healthcare is likely to accelerate coding intensity, placing upward pressure on healthcare spending.
    • 7. States are responding to funding and program implementation pressures with changes to Medicaid beginning in 2027, and
    • 8. Effective distribution of the Rural Health Transformation Funds will require rapid state action.
  • MedCity News reports,
    • “San Diego-based startup Turquoise Health closed a $40 million Series C financing round on Tuesday, bringing the company’s overall fundraising total to $95 million.
    • “The round was led by Oak HC/FT, with participation from Andreessen Horowitz, Adams Street Partners and Yosemite.
    • “Turquoise, founded in 2020, originally built its business around collecting and analyzing price transparency data from hospital and payer disclosures. Providers used that data primarily for benchmarking and contract negotiations, said CEO Chris Severn.”
    • With its new funding, the startup plans to move beyond analyzing healthcare prices and into facilitating the transactions themselves, he stated. The goal is to enable guaranteed upfront prices for patients while reducing administrative waste between payers and providers.
  • STAT News informs us,
    • “Today, 13 years, a sprawling mansion, a private jet, and a five-day Italian wedding later, Alla and Scott LaRoque are living lavishly. It’s all funded by their long-running strategy of squeezing as much money as possible from the health care system. 
    • “While they portray themselves as Robin Hood-esque heroes helping doctors take on big insurance, their story is emblematic of an American health care system that’s rife with profit-seekers who critics say repeatedly test the lines of legality. Each effort by lawmakers to rein in the excesses is met with retooled tactics.
    • “The LaRoques own a little-known middleman called HaloMD, which helps providers navigate a new federal arbitration process to resolve billing disputes with insurance companies. HaloMD is fighting lawsuits from four different Blue Cross Blue Shield insurers accusing it of rigging the system and triggering huge payouts for itself and its provider clients.” 
    • “HaloMD’s strategy works like this, according to lawsuits from health insurers: It floods the overburdened federal arbitration system with thousands of disputes, many of them ineligible, and demands much more money than providers had originally charged. Disputes aren’t eligible if they should go through state arbitration, if the patients are covered by Medicare and Medicaid, or if the parties didn’t negotiate beforehand. 
    • “This new tactic is possibly even more lucrative for providers than surprise billing was, said Chris Whaley, an associate professor of health services, policy, and practice at Brown University. 
    • “If you were balance-billing patients, you had to chase money down from patients,” Whaley said. “Now, you have a means to get that money directly from insurers.”
  • Fierce Healthcare points out,
    • “Maven Clinic has introduced Maven Intelligence, an artificial intelligence-powered infrastructure embedded across its virtual clinic, care programs and benefits platform. 
    • “The company refers to Maven Intelligence as an orchestration layer that integrates agentic AI with longitudinal data and clinical expertise to personalize care. The layer is built on over 1 billion structured data points from Maven care journeys and will begin rolling out to members in March.
    • “Women’s health has [long been] a major gap in healthcare,” Jaya Savkar, senior vice president of product at Maven, told Fierce Healthcare. “We really believe that we have an opportunity to help close the gap … We’re the largest virtual clinic for women and families, and by coupling that with women’s health-focused AI, we believe that humans and AI can do more together.”

Notable Death

  • Cardiovascular Business reports,
    • “Amir Lerman, MD, a veteran cardiologist with Mayo Clinic, died unexpectedly on Feb. 23. He was 69 years old. 
    • “Lerman was known as a leading voice in interventional cardiology, writing nearly 1,000 peer-reviewed publications and holding several leadership positions during his long tenure with Mayo Clinic. He helped found the hospital’s Chest Pain and Coronary Physiology Clinic, for example, and served as the director of its Cardiovascular Research Center at the time of his death. He has also been cited more than 69,000 times, highlighting the critical impact his work had on generations of cardiologists. 
    • “Lerman’s research covered a variety of subjects, but he is perhaps best known as a pioneer in the treatment of nonobstructive coronary artery disease (CAD), particularly those with coronary microvascular dysfunction (CMD).”
  • RIP

Tuesday report

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

From Washington, DC

  • MedCity News reports,
    • “In a letter to lawmakers on Monday, employer advocacy groups applauded the introduction of the Healthy Competition for Better Care Act, a bill that aims to increase competition in healthcare.
    • “The letter was signed by the American Benefits Council, the ERISA Industry Committee, the National Alliance of Healthcare Purchaser Coalitions, the Purchaser Business Group on Health, the Silicon Valley Employers Forum and the Small Business Majority.
    • “The bill was introduced in the Senate last week by Jon Husted (R-Ohio). Reps. Jodey Arrington (R-Texas), Rick Allen (R-Georgia), Donald Davis (D-North Carolina) and Chuck Edwards (R-North Carolina) previously introduced a companion bill in the House.
    • “Specifically, the Healthy Competition for Better Care Act aims to improve competition in healthcare by banning several types of anticompetitive contracts between insurers and healthcare providers. It would prohibit all-or-nothing clauses that force insurers to include every provider in their network, anti-steering and anti-tiering clauses that limit employers’ ability to direct patients to lower-cost or higher-quality providers, most-favored-nation clauses that require insurers to receive the lowest price and can drive prices up overall and gag clauses that restrict sharing cost information.”
  • Federal News Network relates,
    • “After more than four weeks of a shutdown across the Department of Homeland Security, many federal unions and employee organizations are calling for relief for the impacted agency employees.
    • “Out of more than 260,000 DHS personnel, tens of thousands of employees have been feeling financial strain after working over a month without pay. That includes workers at the Transportation Security Administration, FEMA, Coast Guard, Secret Service and Cybersecurity and Infrastructure Security Agency. Many employees missed a full paycheck last Friday — the first entirely skipped payday since the shutdown began.
    • ‘Despite no real progress by lawmakers toward a DHS spending agreement, National Treasury Employees Union President Doreen Greenwald demanded Congress find a way to reach a bipartisan solution to immediately end the funding lapse, which started Feb. 14.
    • “These frontline employees have had to wonder whether they’ll be able to pay their mortgage or buy groceries; a month of not knowing how long this shutdown will last,” Greenwald wrote in a recent letter to Congress. “Yet even with such uncertainty hanging over their heads, they still come to work every day to keep our country safe.”
  • and
    • “The Postal Service is less than a year away from running out of cash and is calling on Congress to increase its limit to borrow money from the Treasury Department.
    • “Postmaster General David Steiner told members of the House Oversight and Government Reform Committeeon Tuesday that USPS is set to run out of cash in less than 12 months and that lawmakers need to act soon to keep the agency running.” * * *
    • “A Government Accountability Office report released Tuesday said the Postal Service’s business model is “unsustainable,” and that “urgent action” is needed to get ahead of a looming cash crisis.
    • “It’s highly unlikely that USPS will be able to fix its financial condition on its own. Congress will need to act,” David Marroni, GAO’s director of physical infrastructure, told lawmakers.”
  • Per a U.S. Office of Personnel Management (“OPM”) news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of its new HR Shared Service Center,  a governmentwide initiative designed to modernize and streamline human resources service delivery across federal agencies.  
    • “Building on the Federal HR 2.0 vision, the Shared Service Center will deliver high quality, cost effective HR operations and strategic advisory services that strengthen agency mission delivery and improve efficiency. Services will be available to agencies on a voluntary, fee for service basis through OPM’s revolving fund authority.” * * *
    • “Agencies can view a full list of services or initiate onboarding by visiting opm.gov/sharedservice or contacting sharedservice@opm.gov.”  
  • The Secrets of OPM blog written by OPM Director Scott Kupor has moved from OPM’s website to Substack. The Director added a new blog post today titled “Pulse Check.”
  • WEDI has released the results of its latest survey of payers and providers about coming into compliance with new CMS rules on prior authorizations.
    • “The Workgroup for Electronic Data Interchange (WEDI) released results of its recent survey assessing industry readiness to meet the requirements of the Centers for Medicare & Medicaid Services (CMS) Advancing Interoperability and Improving Prior Authorization Final Rule, also known as CMS-0057-F. With just under a year until the compliance deadline, the new survey results demonstrate that while the industry has made some progress, there is more work remaining in implementing, testing, and training to meet the regulatory requirements. This survey, conducted in February, is a follow up to the first two conducted by WEDI in October 2025 and January/February 2025.
    • “CMS-0057-F mandates the use of Patient Access, Provider Access, Payer-to-Payer, and Prior Authorization Application Programming Interfaces (APIs) with the goal of increasing data sharing to streamline prior authorization and patient data exchange. Once implemented, these new data exchange methodologies are expected to deliver much-needed reduction in overall payer, provider, and patient burden. Impacted entities are required to implement the API requirements by January 1, 2027. The rule also requires covered payers to publicly report designated prior authorization metrics by January 1, 2026.”

From the judicial front,

  • The New York Times reports,
    • “When a federal judge on Monday blocked the changes in vaccine policy set in motion by Health Secretary Robert F. Kennedy Jr. over the last year, public health groups hailed the ruling as a victory for science and evidence-based government recommendations.
    • “Their jubilation may be short-lived. The Trump administration is planning to appeal the decision, and if it does so quickly enough, an appeals court could overturn Monday’s ruling before the end of the week.
    • “The ruling revoked the authority of advisers appointed to the Advisory Committee on Immunization Practices by Mr. Kennedy to make vaccine recommendations, and ordered a return to the childhood vaccine schedule from before their appointment.
    • “On Tuesday, experts in public health, law and government said they were still trying to understand its ramifications.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “People who eat around nine servings a day of ultraprocessed foods like chips and doughnuts have about a 67% higher risk of heart attacks, strokes and dying from heart disease compared with those who eat about one serving a day, according to a new study.
    • “The risks rose with each additional serving a person ate, according to the study published Tuesday in JACC: Advances, a journal of the American College of Cardiology.
    • “The findings add to a growing body of research linking diets high in ultraprocessed foods to a range of health problems. They were released as the Department of Health and Human Services under Secretary Robert F. Kennedy Jr. takes steps to discourage eating junk foods, including issuing new dietary guidelines advising Americans to avoid highly processed foods with added sugars and salt, such as packaged chips, cookies and candy.”
  • STAT News relates,
    • “The cigarette smoking rate among U.S. adults fell below 10% for the first time in recorded history in 2024.
    • “That’s a big deal in itself. Also remarkable is how everyone is finding out about it. 
    • “Reports of the historic dip in smoking didn’t come from the U.S. government, which had collected the data. Instead, the news came via an analysis in the digital journal NEJM Evidence by Israel Agaku, the founder and CEO of research technology company Chisquares.” 
  • MedScape tells us,
    • “In patients without diabetes being treated with GLP-1s for overweight/obesity, persistence rates (rates of patients remaining on the drugs without treatment gaps) have significantly improved over the last 5 years, results from two new studies showed.
    • “This real-world analysis of high-potency, weight loss-indicated GLP-1 products among individuals without diabetes found that 1-year treatment persistence has nearly doubled from 2021 to the first half of 2024,” reported the authors of the first of the two studies, recently published in the Journal of Managed Care & Specialty Pharmacy.”
  • MedPage Today adds,
    • “An earlier diagnosis and intervention strategy for Alzheimer’s disease is on the horizon, signaling a need to overhaul current detection methods and patient care protocols, experts at the Alzheimer’s Association Research Roundtable (AARR) said.
    • “Advances in biomarker technology, digital cognitive assessments, and amyloid-targeting therapies have redefined the opportunities for accurate and early diagnosis and care of Alzheimer’s disease,” reported Christopher Weber, PhD, of the Alzheimer’s Association in Chicago, and co-authors in Alzheimer’s & Dementia: Translational Research & Clinical Interventionsopens in a new tab or window.
    • “These advances create new possibilities to intervene before the onset of cognitive impairment, Weber and colleagues wrote. Targeting the earliest stages of Alzheimer’s, Weber said, “is similar to how doctors treat other diseases like heart disease and some cancers, where early detection and prevention are key parts of care.”
  • Health Day informs us,
    • “Loneliness can impact a woman’s brain health as she begins menopause, a new study says.
    • “Loneliness and social isolation are both linked to the cognitive decline a woman feels as she begins to transition into menopause, researchers recently reported in the journal Menopause.
    • “Further, women experiencing both loneliness and social isolation are at greatest risk for brain decline, researchers found.” * * *
    • “These findings highlight the importance of psychosocial factors in cognitive health during the menopause transition,” researchers added.”
  • and
    • “It’s long been known that exercise improves a person’s brain health – and researchers now think they better understand at least one of the factors at play.
    • “Just one 15-minute session of aerobic exercise floods the brain with brain-derived neurotrophic factor (BDNF), a protein known to support the health of new and existing brain cells, researchers will report in the June 2026 issue of the journal Brain Research.
    • “What’s more, as a person’s fitness increases, so does the amount of BDNF released following exercise, researchers found.”
  • Genetic Engineering and Biotechnology News points out,
    • “The explosion of mRNA vaccines brought on by the COVID-19 pandemic have proven that the delivery vehicles for those vaccines work incredibly well. Despite that, researchers are still working on improvements: to increase efficacy and reduce side effects from the vaccination. Now, researchers report modifications to lipid nanoparticles (LNPs) that outperform leading, commercially available formulations while reducing common vaccine side effects in preclinical tests of human cells and mouse models.
    • “Changing the structure of the ionizable lipid of the LNPs boosted the metabolism of key immune cells, providing the energy necessary to gird the body’s defenses while dialing down the inflammatory signals that often cause fever and fatigue. The chemical tweak also enhanced on-target delivery of the nanoparticles to immune organs like the lymph nodes.
    • “This work is published in Nature Materials in the paper, “Crosslinked ionizable lipids reprogram dendritic cell metabolism for potent mRNA vaccination.”
    • “This is an early step, but it opens the door to a new generation of mRNA vaccines that are more potent and better tolerated,” says Michael J. Mitchell, PhD, associate professor in bioengineering at the University of Pennsylvania. “Instead of accepting a trade-off between efficacy and side effects, we’re beginning to see that chemistry can help us improve both.”
  • Per BioPharma Dive,
    • “Pfizer on Tuesday said a key experimental medicine helped stave off disease progression in a Phase 2 trial of patients with metastatic breast cancer.
    • “Atirmociclib is designed as a next-generation improvement on Pfizer’s Ibrance, the pioneer in a class known as cyclin-dependent kinase, or CDK 4/6 inhibitors. The drugs, which block proteins that tumors use to grow and multiply, have become a pillar of care for a common type of breast cancer known as HR+/HER2-.
    • “The new study, dubbed Fourlight-1, tested atirmociclib in patients who had previously tried CDK4/6 inhibitors. Researchers found that those given the experimental drug in combination with a widely used hormone therapy called fulvestrant had a 40% reduction in the risk of disease progression or death compared with those on another combination of medicines.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “The health insurance industry’s credit outlook for the year remains negative as medical costs continue to rise, according to a new report from Moody’s Ratings.
    • “The Moody’s analysts said that in the current environment, payers will have “limited prospects for profitable growth” this year. Given the margin pressures facing the industry, plan redesigns, benefit cuts and exits from low-performing markets remain likely, per the report.
    • “Medical cost inflation has impacted every business line insurers have—Medicare Advantage (MA), Medicaid, the Affordable Care Act exchanges and commercial plans—and that trend is set to carry through the coming months. In addition, reimbursement rates have generally lagged these inflation rates, putting further pressure on plans, according to Moody’s.
    • “Key cost drivers range from pricey pharmaceuticals, increased intensity alongside higher utilization and higher coding intensity from providers, according to the report.
    • “Making improvements to earnings and margins has been a key focus for the major companies in this space, according to the report, making for a pivot from the growth mindset that was central for many of these firms.”
  • and
    • “Highmark and Blue Cross and Blue Shield of Kansas City have secured the necessary regulatory approvals to move their affiliation plans forward, the insurers announced Tuesday.
    • “The deal secured an O.K. from the Missouri Department of Insurance and is set to close on March 31, according to the announcement. Through the affiliation, Blue KC aims to improve outcomes and accelerate key innovations to support its members in the Kansas City region.
    • “The affiliation was first announced in December. Once it closes, the two insurers expect that integration will “take place over a phased period of time.” At present, nothing will change for members of either plan, according to the announcement.”
  • Chief Health Executive informs us,
    • “Long known for its rankings of America’s best hospitals, U.S. News & World Report has been examining providers of outpatient care in recent years.
    • “Today, U.S. News released its list of the 2026 Best Ambulatory Surgery Centers. Working in partnership with Arcadia, a healthcare analytics firm, U.S. News examined 4,421 ambulatory surgery centers in specialties including colonoscopy & endoscopy; ophthalmology; orthopedics and spine; and urology.
    • “In its analysis, U.S. News named 911 surgery centers as worthy of recognition as the best, about one in five (21%) of those reviewed. Last year, 733 ambulatory surgery centers, or about 17% of those examined, earned U.S. News honors as the nation’s best performers.
    • “Ben Harder, chief of health analysis and managing editor at U.S. News, said the analysis of top surgery centers comes as more complex procedures are being done in outpatient facilities.
    • “Overall we found that ambulatory surgical care continues to be a very safe option for the vast majority of patients, even as utilization grows,” Harder said in an email to Chief Healthcare Executive®. “That’s reassuring for patients and suggests that the ongoing shift of care from hospitals to ASCs is likely to continue and, if anything, gather steam.”
  • Beckers Hospital Review lets us know,
    • “Sacramento, Calif.-based Sutter Health and Minneapolis-based Allina Health have signed a letter of intent for Allina to join the health system, creating a combined nonprofit organization spanning California, Minnesota and Wisconsin.
    • :The proposed transaction would create a system with 39 hospitals and more than 400 care sites, serving more than 5 million patients, according to a joint news release.
    • “Upon closing, the combined system would include 18,000 physicians and 88,000 employees across Northern and Central California and Minnesota and Wisconsin.
    • “Based on 2025 revenues, the combined organization would generate about $26 billion.”
  • and
    • “The top 15 U.S. pharmacies accounted for nearly 75% of the nation’s $751 billion of prescription dispensing revenue in 2025, according to Drug Channels.
    • “CVS Health led all dispensing organizations with $119 billion in revenue, followed by Walgreens at $90.8 billion and Cigna’s Express Scripts at $80.5 billion. GLP-1 medications drove nearly 60% of retail revenue growth over the last five years and contributed significantly to a 10% year-over-year increase in total prescription spending.
    • “Centene entered the top 15 for the first time, reflecting its expanding presence in specialty pharmacy. Rite Aid’s continued store closures and bankruptcy reshaped market dynamics, while CVS and Walgreens have acquired more than 6,000 pharmacy locations since 2010.”

Monday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, No Surprises Act, Obesity, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “President Donald Trump is directing nearly a dozen federal agencies that provide public-facing benefits and services to crack down on fraudulent payments.
    • “Trump signed an executive order on Monday launching a task force to crack down on fraudulent payments across the federal government.” * * *
    • “Vice President J.D. Vance will serve as chairman of the fraud task force. The head of the Federal Trade Commission, Andrew Ferguson, will serve as its vice chairman.”
  • Bloomberg Law adds,
    • Lawmakers and the administration are stepping up scrutiny of overpayments in Medicare Advantage plans in a sign that Republicans increasingly could be willing to crack down on how much insurers are reimbursed for seniors’ health care. 
    • Medicare Advantage plans can offer additional benefits that traditional Medicare doesn’t cover, like dental, vision, or fitness classes, which have likely contributed to the rising popularity of the program among seniors. The Trump administration in January proposed keeping the private health insurance plans funded at an essentially flat rate of 0.09% for 2027. The proposal sent a shock through the health care market, and insurers warned without more funding, the program won’t cover sharply rising medical costs for seniors in 2027.
    • While the administration controls the annual funding rate, Congress established Medicare Advantage’s funding framework and still has power to overhaul the payment system, which lawmakers are looking into. 
  • Here’s the background on this Wednesday’s Congressional hearing about “Lowering Health Care Costs for All Americans: An Examination of the U.S. Provider Landscape.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services March 16 announced it will transition later this year to a new centralized platform for managing federal independent dispute resolution operations related to the No Surprises Act. CMS will move from single-use web forms to the platform, called the IDR Gateway, which the agency said will allow users to start and respond to disputes; access dispute dashboards and reports associated with their organization; track dispute information, including disputes assigned to a certified IDR entity; monitor assigned disputes by process phase; and review notifications regarding dispute activity. CMS said the platform would also include new security features, including identity verification processes and protocols that would permit only U.S.-based users to access the federal IDR process.” 
  • FedSmith offers federal and postal retirees practical tips about controlling rising healthcare costs.
  • Beckers Hospital Review tells us,
    • “The third round of the Medicare Drug Price Negotiation Program is moving forward with full manufacturer participation.
    • “The program, created under the Inflation Reduction Act, allows CMS to directly negotiate prices for high-expenditure, single-source drugs covered by Medicare Part B and Part D that lack generic or biosimilar competition. The negotiated prices are scheduled to take effect in 2028.
    • “The manufacturers of all 15  drugs selected for the third round have agreed to participate in the negotiation program, along with the manufacturer of one drug selected for renegotiation, according to a March 13 news release from CMS.”
  • and
    • “CMS will award up to $100 million to fund as many as 30 pilot programs through its voluntary initiative focused on lifestyle medicine.
    • “[The first two of] six things to know:
      • 1. The agency plans to award up to 30 three-year cooperative agreements totaling as much as $100 million to organizations focused on “evidence-based, whole-person functional or lifestyle medicine interventions” to launch programs that enhance conventional healthcare, according to a March 13 CMS news release shared with Becker’s.
      • 2. The funding opportunity is part of the Make American Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence, or ELEVATE, model, which CMS unveiled in December. The initiative will fund up to 30 chronic disease prevention and health promotion pilot projects aimed at integrating lifestyle and evidence-based functional medicine into original Medicare. 
  • Fierce Pharma informs us,
    • “The White House’s direct-to-consumer (DTC) platform, TrumpRx, is steadily expanding its catalogue, with products from GSK and Amgen the latest to join the collection of drugs offered through the program. 
    • “Amgen’s Humira biosimilar Amjevita, migraine med Aimovig and cholesterol drug Repatha became available through TrumpRx on Monday. GSK, meanwhile, is offering DTC discounts on several of its Ellipta inhalers and its flu treatment Relenza through the platform. 
    • “Amjevita can be purchased by cash-paying patients for $299 per month, an 80% discount to the med’s list price of $1,484. Aimovig and Repatha are discounted by 62% off their respective list prices, according to the website.” * * * 
    • “The new additions bring the total of medications offered through TrumpRx to 54 drugs.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal judge on Monday blocked the Trump administration from implementing its pared-down list of recommended childhood vaccines.
    • “The new guidelines were part of Health and Human Services Secretary Robert F. Kennedy Jr. overhaul of the country’s immunization policies. But Judge Brian E. Murphy, a Biden appointee in Massachusetts, said the government appeared to have improperly bypassed the vaccine advisory panel to change the recommendations. 
    • “Murphy said that was “both a technical, procedural failure itself and a strong indication of something more fundamentally problematic: an abandonment of the technical knowledge and expertise embodied by that committee.” 
    • “Murphy said the government also improperly replaced all the committee members with new appointees, who made other changes last year to vaccine recommendations. Murphy blocked the votes taken by the Advisory Committee on Immunization Practices from taking effect and put on hold the new committee appointments. 
    • “He didn’t block the panel from meeting as planned on Wednesday and Thursday, but said the meeting in practice won’t be able to take place. The committee “as currently constituted cannot meet, for how can a committee meet without nearly the entirety of its membership?” he said.”
  • Per a Justice Department news release,
    • “Two owners of a pharmaceutical wholesale company were sentenced Friday to a total of 38 years in prison for orchestrating a complex, nationwide drug diversion scheme that harmed vulnerable HIV-positive patients, placed countless others at risk, and corrupted the supply chain for prescription drugs in the United States.
    • “Patrick and Charles Boyd did not just commit fraud and cost taxpayers millions of dollars, they preyed upon some of the most vulnerable members of our society: HIV patients who depend on life-saving treatments to manage their disease,” said Assistant Attorney General A. Tysen Duva of the Justice Department’s Criminal Division. “Fraud schemes like this one undermine the integrity of our supply chain for necessary prescription drugs. These defendants will rightly spend years in prison for their reprehensible conduct, which took advantage of people for illicit profit. This case is another example of how the Criminal Division, our United States Attorney partner in the Southern District of Florida, and law enforcement will pursue and seek convictions of those who defraud our systems, endanger our citizens, and seek to line their pockets with fraud proceeds.”

From the public health, medical and Rx research front,

  • The Wall Street Journal reports,
    • “Cyndy Dowling struggled with her weight for decades until she found what she thought was a lifelong solution: a monthly injection of one of the popular new weight-loss drugs.
    • “The 69-year-old easily lost 60 pounds in the span of a year and a half. But in early 2025, something changed.
    • “The food noise started creeping back. Her weight began edging up. She had to start “dieting” again. Here’s the twist: She never stopped taking Wegovy, one of the so-called GLP-1 drugs.
    • “A year later, Dowling has regained 10 pounds and is back to relying on protein shakes for some meals, all while continuing her weekly injections. “I’m fighting it as much as I can,” says the retired government employee. “I feel like I’m trying to hold the reins on something I can’t really control.”
    • “We’ve all heard that stopping taking a GLP-1 medication for weight loss—such as semaglutide (marketed as Wegovy) and tirzepatide (sold as Zepbound)—often leads to rapid weight gain, with people returning to baseline in as little as 18 months.
    • “What you might not have heard: For some people, the return of hunger and thoughts of food come back leading to potential weight gain—even while they are still taking the drug, which mimics naturally occurring gut hormones, suppressing appetite and making people feel full faster.
    • “Most obesity doctors say they’ve seen patients in this boat. They say it’s not that the weight-loss medications become less effective. Rather it’s that the body’s biological pressure to regain weight kicks in.”
  • BeckMedPage Today notes,
    • “For patients with obesity and atrial fibrillation (Afib), GLP-1 receptor agonist drugs may be the weight loss approach that better addresses their arrhythmia, observational data suggested.
    • “People who came out of catheter ablation and got bariatric surgery, as opposed to initiating GLP-1 drug therapy postablation, had significantly higher odds of Afib readmission at 2 years (36.4% vs 45.3%, HR 1.37, 95% CI 1.21-1.56), according to Rutvij Patel, MD, of Creighton University in Omaha, Nebraska, and colleagues.
    • “Their analysis of a large trove of U.S. electronic medical records also showed other clinical endpoints favoring GLP-1 drugs over bariatric surgery:
      • Heart failure (HF) readmission (HR 1.51, 95% CI 1.23-1.84)
      • All-cause readmission (HR 1.55, 95% CI 1.32-1.82)
      • All-cause mortality (HR 2.53, 95% CI 1.33-4.80)
    • “These findings were notable given that the GLP-1RA [receptor agonist] cohort had a higher baseline prevalence of diabetes, hypertension, HF, and chronic kidney disease,” study authors reported in JACC: Clinical Electrophysiologyopens in a new tab or window. “These findings highlight the potential role of GLP-1RAs as an adjunct in rhythm management strategies and support the need for prospective randomized trials.”
  • Beckers Hospital Review adds,
    • “Since late 2022, rising uptake of GLP-1 medications for obesity has coincided with a decline in bariatric surgeries, according to a growing body of research.
    • “A study published March 4 in JAMA Surgery found the swelling popularity of GLP-1 drugs for obesity, such as Wegovy and Zepbound, is not slowing — unlike bariatric surgery volumes. More patients are preferring GLP-1 therapies over bariatric operations, according to past research.” * * *
    • “Between the fourth quarter of 2018 and the third quarter of 2025, GLP-1 prescriptions increased from 0.22% to 24.17%. The percentage of bariatric surgeries among adults declined from 0.17% in the fourth quarter of 2022 to 0.09% in the third quarter of 2025 — which equals a 46.4% decrease.”
  • and
    • Little Rock, Ark., topped WalletHub’s 2026 ranking of the most overweight and obese U.S. cities, while Honolulu ranked lowest on the list.
    • The personal finance website compared 100 of the most populated U.S. metropolitan areas across three dimensions: obesity and overweight, health consequences, and food and fitness.
    • WalletHub evaluated these dimensions using 19 metrics, ranging from the share of physically inactive adults to healthy-food access. Each metric was graded on a 100-point scale, with 100 representing the most overweight and obese. Each metropolitan area’s overall score was then based on the weighted average across all metrics.
    • The article identifies the ten U.S. cities with the highest rates of overweight and obesity and the ten U.S. cities with the lowest rates thereof.
  • The American Medical Association lets us know what doctors wish their patients knew about at home blood pressure measurement.
  • Per a National Institutes of Health news release,
    • “In a clinical trial supported by the National Institutes of Health (NIH), a research team found that administering weekly injectable extended-release buprenorphine for treatment of opioid use disorder (OUD) during pregnancy led to higher rates of abstinence from illicit opioids than buprenorphine given daily under the tongue (sublingual), one of the standard methods of treatment. Additionally, serious adverse events were less common in those receiving extended-release treatment. The findings, which support the use of this formulation of buprenorphine for treating OUD during pregnancy, were published in JAMA Internal Medicine.  
    • “These findings are clinically valuable for they show us that this injectable extended-release buprenorphine formulation is safe to use in pregnancy and results in better opioid abstinence outcomes compared to sublingual buprenorphine,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “This is especially relevant in the context of the ongoing opioid overdose crisis and public health emergency.” 
  • MedPage Today informs us,
    • “Although most sexually active adolescents within a large primary care network had received human papillomavirus (HPV) vaccination before sexual debut, 12% had not received any doses of the vaccine, and 9% had not completed the series.
    • “Young people who had not been vaccinated were disproportionately non-Hispanic white (49%) and commercially insured (59%).
    • “Factors at play might have included vaccine hesitancy and delayed decision-making rather than lack of access.”
  • Health Day points out,
    • “The secret to a healthy heart in your 50s might actually be found in the dental records of your 10-year-old self.
    • “A massive study from the University of Copenhagen found that poor oral health during childhood is a significant predictor of cardiovascular issues later in life.
    • “By tracking more than 568,000 Danish children born between 1963 and 1972, researchers discovered that those who suffered from multiple cavities or severe gum disease (gingivitis) as children were much more likely to experience heart attacks, strokes and clogged arteries as adults.
    • “Specifically, children with high rates of tooth decay had a 45% higher rate of heart disease as adults compared to those with healthy teeth.
    • “The study — being published April 1 in the International Journal of Cardiology — suggests that the link isn’t just about poor habits, but rather how the body reacts to long-term infection.”
  • and
    • “People who eat more ultra-processed foods tend to have lower bone density and a higher risk of hip fractures, researchers recently reported in The British Journal of Nutrition.
    • “For every 3.7 extra servings eaten per day, a person’s risk of hip fracture increases by nearly 11%, researchers found.
    • “That means every slice of frozen pizza, every bowl of breakfast cereal, every sugary soda and every ready-to-heat meal adds to a person’s risk of brittle, easily broken bones, researchers said.
    • “Ultra-processed foods can be easily found on any trip to the grocery store, and these findings add to concerns of how they may affect our bone health,” researcher Dr. Lu Qi, a professor of public health at Tulane University in New Orleans, said in a news release.” 
  • STAT News relates,
    • “A brain implant could help people type — using just their minds. 
    • “Two people with paralysis were able to type strokes on a virtual keyboard using an implant that decodes attempted finger movement, with one patient typing up to 80% as quickly as an able-bodied person, according to a new study. 
    • “Brain-computer interfaces have been shown to help patients communicate, often by tracking their eye movement or by decoding brain activity associated with speech or handwriting. However, researchers say that some patients are more familiar with a typical keyboard and may prefer to use that to communicate. That’s what researchers from Mass General Brigham Neuroscience Institute and Brown University attempted in their new study, published in Nature Neuroscience.
    • “What’s really important is having this array of options for every individual such that we can best fit where they’re placed, what diseases they have,” said Justin Jude, study author and postdoctoral researcher at Brown University.”
  • Per BioPharma Dive,
    • “A pill from Structure Therapeutics helped people in a Phase 2 trial in obesity lose as much as 15% of their body weight over 44 weeks, results that suggest the drug, aleniglipron, could be competitive with rival medications from Eli Lilly and Novo Nordisk. 
    • “Treatment was also associated with a lower rate of study discontinuations than what had been seen earlier, after Structure incorporated a new strategy involving a slower step-up in dosing. Structure said that only one enrollee who got a dose of 120 milligrams daily or higher dropped out because of a side effect.
    • “Structure shares rose as much as 6% in morning trading. Leerink Partners analyst David Risinger characterized the results as “best-in-class weight loss” data, while RBC Capital Markets analyst Trung Huynh wrote that the pill looks like “another potential oral option to the market that will be competing for share in the future” with Novo’s Wegovy pill and Lilly’s orforglipron, the latter of which could be cleared in the U.S. within weeks.”
  • and
    • “San Francisco-based CytomX Therapeutics impressed investors Monday with the latest results for its experimental antibody-drug conjugate in hard-to-treat, late-stage colorectal cancer.
    • “The fresh data come from a so-called expansion portion of an ongoing Phase 1 study, which has been testing CytomX’s “masked” ADC. This portion evaluated three doses of the drug, dubbed Varseta-M, and found the two highest had response rates of 20% to 32% and extended progression-free survival by 6.8 and 7.1 months. The most common treatment-related adverse event was diarrhea, which, CytomX said, was generally manageable and reversible. However, despite an updated prophylactic regimen, 10% of a group of 20 patients still experienced severe diarrhea.
    • “The company said more data will be announced at upcoming medical meetings this year, and plans to engage with the Food and Drug Administration to determine a study design to evaluate the medicine as a monotherapy in advanced colorectal cancer.”

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

  • The Wall Street Journal reports,
    • “Employer healthcare costs are projected to surge around 9.5% this year, the largest increase in at least 15 years.
    • “Companies are weighing options like self-insurance, changing plan designs, and pushing more costs to employees to manage rising expenses.
    • “Higher prices for care, expanding use of services and expensive prescriptions are driving cost increases.”
  • Fierce Healthcare relates,
    • “As hospitals reduced their spending on oncology treatments due to the increasing availability of biosimilars, the reimbursements they received from insurers did not drop at the same rate—allowing hospitals to claim greater margins as they increased their use of the treatments, according to a recent analysis published in JAMA. 
    • “The observational study linked the Blue Cross Blue Shield insurance data of more than 66,000 cancer patients receiving care with the average acquisition and actual reimbursement payments of more than 1,500 hospitals. Additional analyses took into account hospital characteristics, such as eligibility for 340B drug discounts, that could affect purchasing and reimbursement.” * * *
    • “The editorial’s authors wrapped their critiques with calls for policy interventions that would “lower spending more automatically, rather than leaving it to the discretion of insurers and hospitals,” such as those proposed by MedPAC in its June 2023 report.”
  • and
    • “UnitedHealthcare is expanding its doula benefit to employer plans nationwide, the insurance giant announced Monday.
    • “The company said in the announcement that it intends to continue expanding the reach of its Doula Support program to additional employer groups throughout this year and expects that 7.2 million members would be eligible by Jan. 1, 2027. 
    • “Through the program, patients can connect with doulas who provide additional emotional, physical and education support during a pregnancy and postpartum. Doulas can offer key guidance to prepare for delivery and during labor as well as supports for newborn care, UnitedHealth said.”
  • Fierce Pharma tells us,
    • “Eli Lilly scored $408 million in U.S. sales of eczema treatment Ebglyss in its first full year on the market in 2025. Now, with positive results from a phase 3 trial of the IL-13 inhibitor, the Indianapolis drugmaker is set up to make it available to a younger group of patients.
    • “The study, which included 363 patients ages 6 months to 18 years with moderate to severe atopic dermatitis, met its primary and key secondary endpoints by alleviating disease symptoms, while providing skin clearance and itch relief at Week 16, Lilly reported Monday. Participants received placebo or a weight-based dose of Ebglyss and were on topical steroids beginning two weeks before randomization and throughout the study.
    • “The trial achieved its primary endpoint as 63% of patients on Ebglyss achieved meaningful skin improvement compared to 22% of those on placebo, according to Lilly. The Eczema Area Severity Index (EASI) was used as a measurement tool, with 75% improvement from baseline considered “meaningful.” As a secondary measure, 39% of those on Ebglyss reached 90% improvement on the EASI index compared to 11% of the patients on placebo.” * * *
    • “Lilly said it plans to submit these data to U.S. and global regulators for a potential label update.” 
  • MedCity News informs us,
    • “Isaac Health, a virtual memory clinic, unveiled a new eight-week virtual group series on Wednesday to reduce the risk of dementia.
    • “The New York City-based startup works with healthcare organizations to provide screening, assessment, treatment and care management for people living with dementia. It’s in network with Medicare and major insurers across all 50 states, including UnitedHealthcare, Aetna and Humana.
    • “The new program — called the Lifestyle Medicine and Better Brain Health program — is intended for those proactively seeking to reduce dementia risk or slow cognitive decline, particularly those prone to dementia and their caregivers.
    • “The weekly sessions are led by clinicians and are available in individual, couple or family formats. They’re focused on a variety of strategies for brain health, including sleep, nutrition, physical activity, cognitive engagement, vascular risk factor reduction and stress management. The program can be covered by most insurers but depends on individual plan benefits.”
  • Kaufmann Hall offers an “Executive Dialogue: AI in action: Separating the hype from real value in strategy and planning.”
    • “Following a period defined by operational strain, workforce disruption and financial pressure, healthcare leaders are now turning their focus toward technologies that can help rebuild stability as they prepare for the future. Artificial intelligence is a central point of exploration for health systems seeking greater efficiency, improved patient experience and sustainable clinical operations.
    • “To gather real-world perspectives, the American Hospital Association’s Society for Health Care Strategy & Market Development (SHSMD) hosted an executive dialogue focused on the practical realities of AI adoption. Leaders from academic centers, community hospitals and Federally Qualified Health Centers shared insights on governance, workforce expectations, vendor strategy and how best to measure value in a technology environment evolving faster than most organiza­tions can absorb.
    • “As dialogue participants reflected on the evolving role of artificial intel­ligence across their organizations, four major themes emerged. The first was the growing need for clear AI governance, as health systems work to balance rapid innovation with responsible oversight. The sec­ond was workforce adoption, with leaders noting that even the most promising tools succeed or fail based on how well they fit into clinical and operational workflows. Third was the shifting vendor landscape, as organizations navigate the tension between emerging third-party solu­tions and rapidly advancing EHR-embedded capabilities. The fourth was the question of value — how to define, measure and communicate the impact of AI in a way that captures both operational gains and the broader transformation of care delivery.”

Midweek update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, NIH, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC

  • The Hill reports,
    • “The House on Wednesday advanced a GOP-backed Department of Homeland Security (DHS) funding bill, an effort by Republicans to pressure Democrats to end the partial government shutdown in the wake of the U.S. launching strikes against Iran.
    • “The panel voted 211-209 to pass the rule, which tees up debate and a vote on the final passage of the measure. The bill is expected to pass the lower chamber on Thursday.”
  • Roll Call relates,
    • “The White House tentatively aims to release President Donald Trump’s fiscal 2027 budget proposal the week of March 30, according to multiple sources with knowledge of the plan.
    • “That timing would put budget delivery some eight weeks after the statutory due date of the first Monday in February, though presidential budgets often miss that deadline.
    • “Office of Management and Budget staff couldn’t immediately be reached for comment.”
  • Federal News Network tells us,
    • “Agencies would make layoff decisions based more highly on federal employees’ performance, rather than how long they have been working in government, according to a new proposal from the Trump administration.
    • “If finalized, proposed regulations that the Office of Personnel Management (OPM) is expected to publish Thursday morning would reorder the factors that agencies consider when determining which employees to retain or remove during a reduction in force (RIF).
    • “When it comes to personnel decisions during RIFs, current federal regulations tell agencies to first look at employees’ tenure and length of service, before considering their performance ratings. The new proposed regulations seek to reverse that order, making employee performance the top priority.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) and the National Aeronautics and Space Administration (NASA) today announced the launch of NASA Force, a dedicated talent track within the US Tech Force initiative designed to recruit and deploy the nation’s top engineers and technologists to support America’s space program.
    • “NASA Force will identify and place high-impact technical talent into mission-critical roles supporting NASA’s exploration, research, and advanced technology priorities, ensuring the agency has the cutting-edge expertise needed to maintain US leadership in space.”
  • Healthcare Dive informs us,
    • “Federal regulators received a record number of comments on their proposal to keep Medicare Advantage rates flat next year, Trump administration officials said Tuesday during an industry event, as insurers continue to lobby heavily for higher reimbursement.
    • “We appreciate all the input. I mean, obviously there’s been a little bit more input this year than we typically get,” John Brooks, the CMS’ chief policy and regulatory officer, said during the Better Medicare Alliance’s summit in Washington, D.C.
    • “In January, the Trump administration proposed an average rate bump of less than 0.1% for MA plans in 2027, along with tighter guardrails around how plans adjust for the health risks of their members.” * * *
    • “Regulators received almost 47,000 comments on the rule during the input period ended Feb. 25 — an all-time high, according to Brooks.
    • “In their comments, major MA carriers like UnitedHealth along with industry associations like the BMA and AHIP argued that the CMS ignored rising costs, resulting in a payment proposal underfunding MA.”
  • and
    • “The CMS innovation center is exploring more mandatory payment models as the Trump administration brainstorms how to get more providers to participate in value-based care, health officials said Tuesday.
    • “Mandatory models are going to have to be part of the equation,” CMMI Director Abe Sutton said at a conference hosted by value-based care advocacy group Accountable for Health.
    • “The CMMI tests ways of injecting more value-based care into federal programs through its models, which can be mandatory or voluntary. Mandatory models require all eligible participants — usually providers — to take part. Participants generally can’t exit the model before the testing period is up.
    • “That’s opposed to voluntary models, in which accountable care organizations or other actors can opt into participation.” * * *
    • “The CMMI started trialing more mandatory models during the first Trump administration, a direction that continued under President Joe Biden. Now, the second Trump administration is once again reiterating its support of expanded mandatory tests.”
  • Cardiovascular Business points out,
    • “The U.S. Centers for Medicare and Medicaid Services (CMS) has released a list 2,600 cardiologists who will be required to participate in a new Ambulatory Specialty Model (ASM) payment model for heart failure starting on Jan. 1, 2027.
    • “CMS said the new program aims to improve prevention and upstream management of high-cost chronic diseases with an initial push in heart failure and lower back pain. The new payment model is an attempt to reduce avoidable hospitalizations and unnecessary procedures. Heart failure is a major driver of Medicare expenses, and currently costs the U.S. health system about $179.5 billion annually.[1]
    • “Participation in the ASM will be mandatory for certain specialists who commonly treat these conditions in Medicare patients in an outpatient setting. The ASM will begin on Jan. 1, 2027, and run for five performance years through Dec. 31, 2031.”
  • Beckers Hospital Review notes,
    • “For the third time since March 2025, HHS has postponed a planned meeting for the U.S. Preventive Services Task Force, which provides clinical preventive health recommendations to Congress every year. 
    • “The USPSTF, which is a volunteer panel of national experts that was launched in 1984, usually meets three times a year. The group did not meet in July or in November of 2025, with the latter tied to a government shutdown. * * *
    • “An HHS spokesperson confirmed the March 2026 meeting’s postponement to Becker’s, adding that the meeting “will be rescheduled in the coming months.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Food and Drug Administration officials are giving Prime Medicine new hope for a gene-editing treatment the company was forced to shelve last year.
    • “The therapy, PM359, is designed to treat chronic granulomatous disease, or CGD, a potentially deadly condition that leaves patients highly susceptible to bacterial and fungal infections. A study of two patients released last year suggested PM359 could correct the genetic anomaly that causes the disease, offering the possibility of a cure.
    • “But the condition is so rare that Prime opted not to continue development of the therapy amid a cash crunch. Even as it announced the promising early results, Prime said it would deprioritize PM359 and focus on other programs after cutting a quarter of its staff. On Tuesday, Prime said it now sees the possibility of approval based on the two-patient study alone.”

From the judicial front,

  • STAT News reports,
    • “For the fourth time, federal auditors have turned up improper or potentially improper Medicaid payments in every sample of autism therapy records they audited. This report, focused on Colorado, yielded the highest improper payment amount yet. 
    • “The Department of Health and Human Services’ Office of Inspector General uncovered $285.2 million in improper and potentially improper payments in 2022 and 2023 to clinicians who provide a popular form of autism therapy called applied behavior analysis, or ABA. The payments, administered under Colorado’s Medicaid program, come from the state and federal governments. 
    • “HHS OIG announced in 2022 it would conduct reviews of Medicaid payments to ABA providers in seven states. The first was Indiana, then Wisconsin, and Maine. ABA is a commonly used therapy for managing autism symptoms, but a 2022 STAT investigation found that a rapid influx of private equity investment in the industry has contributed to a crisis of providers routinely overbilling insurers while providing substandard treatment to vulnerable children and families.” 

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • Heard about a lot of people getting flu this winter but not much about covid?
    • It’s not just you. For the second winter in a row, the United States has faced a punishing flu season, with covid as a more muted threat.
    • Early in the covid pandemic, coronavirus proved far more transmissibleand deadly as it ripped through the world than the flu typically was. Flu was almost nonexistent that first pandemic winter in 2020-2021.
    • Now that SARS-CoV-2 is no longer a novel virus sweeping through a population with little immunity, covid and influenza illnesses are becoming more similar, with a key difference: Coronavirus circulates year-round and ticks up in the summer, when flu is gone.
    • “Does that mean flu is now the woe of the winter, and covid is the scourge of the summer? It’s complicated and too soon to say.”
  • The American Hospital Association relates,
    • “The U.S. maternal mortality rate fell to 17.9 deaths per 100,000 live births in 2024, statistically similar to the 2023 rate of 18.6 per 100,000, according to data from the Centers for Disease Control and Prevention. The CDC reported that the maternal mortality rate for Black women in 2024 was 44.8 deaths per 100,000 live births, significantly higher than rates for white (14.2), Hispanic (12.1) and Asian (18.1) women. 
    • “The AHA is committed to safeguarding mothers and babies by eliminating maternal mortality and reducing maternal morbidity. For more on members’ efforts, including case studies, podcasts, webinars and other resources, visit the AHA’s Better Health for Mothers and Babies Initiative webpage.” 
  • The New York Times tells us,
    • “The doctor kept hearing the same story from his patients. After taking GLP-1 weight-loss drugs and finally shedding those excess pounds, some had gone a bit rogue. They began spacing out the shots instead of injecting themselves every week.
    • “And it seemed to be working, said Dr. Mitch Biermann, an obesity and internal medicine specialist at Scripps Clinic in San Diego.
    • “By the time the third person told me they were taking it every second or third week and still maintaining their weight, I started recommending it to other patients,” he said.
    • “Dr. Biermann also conceived a study to test the strategy. Now the results of that research are in: After 36 weeks of follow-up, most of the patients who spaced out their GLP-1 injections kept the weight off and also maintained health benefits like reduced blood pressure and better blood sugar control.
    • “Only four patients gained weight after making the switch, and they quickly reverted back to weekly injections, the report said.
    • “The study was small, only 34 patients in a relatively homogeneous group — mostly white and privately uninsured. And it was done by analyzing their existing medical charts.
    • “Still, the research, published in February in the journal Obesity, provides a potentially appealing new option for patients who are loath to commit to lifelong weekly injections of a costly medication that may not be covered by insurance and that some fear could have unknown side effects.”
  • Medscape informs us,
    • “Viral and bacterial infections’ overlapping symptoms and signs can complicate RSV diagnosis and lead to unnecessary antibiotic prescriptions.
    • “In this study, children who had RSV detected via a rapid antigen test had a 48% lower likelihood of receiving antibiotics within 14 days of diagnosis.
    • ‘Overall, 20% of the kids who tested positive for RSV received at least one antibiotic prescription compared with 40% of those testing negative.”
  • and
    • “Alzheimer’s brain changes progressed up to 20 times faster in women with Alzheimer’s and alpha-synuclein co-pathology compared with men, a cohort study showed.” * * *
    • “The findings suggest that when alpha-synuclein — a protein associated with Parkinson’s and other Lewy body diseases — accumulates alongside Alzheimer’s pathology, it may drive faster Alzheimer’s progression in women.”
  • Health Day points out,
    • “A frequently prescribed atrial fibrillation drug might interact with blood thinners
    • “Diltiazem had a higher rate of serious bleeding events when taken with blood thinners like apixaban or rivaroxaban
    • “Diltiazem interacts with enzymes that play a role in the metabolism of the blood thinners.”
  • Per an NIH news release,
    • “A research team funded by the National Institutes of Health (NIH) has developed a versatile machine learning model that could one day greatly expand what medical scans can tell us about disease. Scientists used their tool, named Merlin, to assess 3D abdominal computed tomography (CT) scans, accomplishing tasks as simple as identifying anatomical features to as complex as predicting disease onset years in advance. Despite being developed as a general-purpose CT model, Merlin surpassed a gauntlet of similar automated tools in tasks they were specifically built to handle.
    • “The team trained their model on a unique set of patient CT scans linked to radiology reports and medical diagnosis codes collected from the Stanford University School of Medicine. The researchers note that it is the largest collection of abdominal CT data to date.  
    • “Rich datasets like this are necessary to push the limits of what artificial intelligence models can accomplish in medicine,” said Bruce Tromberg, Ph.D., director of NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). “This work exemplifies how meticulously crafted training data can enable remarkable insights that significantly streamline workflows and assist in clinical decision-making.” 
  • Genetic Engineering and BioTechnology News adds,
    • “Life is governed by tiers of gene regulation, driven by modulation of RNA polymerase (RNAP) by transcription factors. The second tier is composed of cell signaling cascades and feedback loops. Dissecting gene regulation requires distinguishing transcription factor targets from indirect network effects. 
    • “A new study by The Rockefeller University published in Molecular Cell titled, “Cell-free genomics reveals fundamental regulatory principles of the Mycobacterium tuberculosis transcription cycle,” has revealed fundamental features of the transcription cycle in the bacteria that causes tuberculosis. The study informs the development of new drugs.
    • “Gaining a deep understanding of how transcription works reveals central principles in biology that have huge significance for human health,” said Elizabeth Campbell, PhD, head of the Laboratory of Molecular Pathogenesis at The Rockefeller and corresponding author of the paper. “We can more precisely design therapeutics to target a process if we truly understand it.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “In recent months, payers across the country have tried tightening policies to get a better grip on evaluation/management coding.
    • “While payers often say the policies aim to control costs or combat fraud, these more restrictive policies are often met with provider backlash. [You will find in the article] three insurer policies from the past few months — and where they stand.
  • Fierce Healthcare relates,
    • “Even as its inpatient occupancy surged near the end of 2025, the nation’s largest for-profit hospital system said it has generally managed to avoid revenue-limiting capacity constraints and should continue to do so through 2026 even as its volumes grow. 
    • “HCA Healthcare, with its stock sitting at an all-time pricing high, pleased investors earlier this year when announcing a better-than-expected fourth-quarter performance and bullish 2026 guidance despite hundreds of millions in expected headwinds due to changes in Medicaid policy. 
    • “But, while that quarter’s same-facility equivalent admissions rose 2.5% over the prior year, in line with expectations, its inpatient surgeries remained flat while its outpatient surgical volume dipped by about 1.5%. At the same time, its hospitals were filled to about 73% to 74% capacity, a historical high point that could place strains on the operating efficiency of hospitals pulling the average upward.”
  • Beckers Hospital Review tells us,
    • “Grand Forks, N.D.-based Altru has acquired CHI St. Alexius Health Devils Lake (N.D.) — a 25-bed critical access hospital — from Chicago-based CommonSpirit. The hospital is now known as Altru Hospital Devils Lake, according to a March 2 Altru news release. 
    • “This transition represents an opportunity to make a meaningful difference in the lives of those we serve,” Altru CEO Todd Forkel said in the release. “Over the next several months, we will be expanding services and enhancing care offerings to better meet the needs of this important community.” 
    • “Altru is also in the process of acquiring three more hospitals from CommonSpirit. In January, Altru signed a nonbinding agreement to acquire CHI St. Alexius Health in Bismarck, CHI St. Alexius Health Turtle Lake and CHI St. Alexius Health Garrison (N.D.). If finalized, the move would expand Altru’s footprint further west in North Dakota.
    • “CommonSpirit is also in talks with Pittsburgh-based UPMC to sell Trinity Health System — a three-hospital network based in Steubenville, Ohio. CommonSpirit CFO Michael Browning said on the system’s March 2 investor call that both deals, if approved, could close in 2026.”
  • and
    • “Academic health systems posted a wide range of operating performance in 2025 and early fiscal 2026, with margins spanning from negative territory to double digits. While strong investment returns buoyed bottom lines at many organizations, core operations remain under strain from rising labor, supply and drug costs.
    • “Across these systems, operating margins spanned from -2.6% to 10.7%, highlighting the uneven financial recovery taking shape in academic healthcare. Many organizations saw stronger net income driven by investment returns and nonoperating gains, even as core operating performance remained thin. Expense growth — particularly labor, supplies and drug costs — continues to pressure margins, while scale, integration and restructuring efforts are increasingly shaping financial trajectories across academic healthcare.
    • “{The article shows] how 12 major academic and nonprofit systems stack up based on their most recent financial reports. 
  • Health Day informs us,
    • “Telemedicine appointments aren’t only more convenient, but actually save money for both patients and health care systems, a new study says.
    • “Telemedicine visits are five times less costly than in-person appointments for the most common conditions, researchers recently reported in JAMA Network Open.
    • “On average, telemedicine patients are billed $400 less, researchers found, and are less likely to need follow-up visits after their first appointment.
    • “Before we did this study, there was a common concern that telemedicine might serve only as an easy source of ‘first aid,’ just delaying in-person care and increasing costs overall,” said co-senior researcher Dr. David Asch, senior vice president for strategic initiatives at the University of Pennsylvania.
    • “But we found that wasn’t true, and our work suggests that for many patients, telemedicine can be a complete solution, not just a temporary band-aid,” he said in a news release.”
  • Per Fierce Pharma,
    • “The primary growth drivers in Bayer’s pharma sector—Nubeqa and Kerendia—are performing even better than the company anticipated and their momentum is expected to continue in 2026. But that won’t lead to growth of Bayer’s pharma business overall this year as two contraction drivers—Xarelto and Eylea—are working in the opposite direction. 
    • “This will be the last year of the sector’s “resilience phase,” Bayer’s pharma president Stefan Oelrich said during a quarterly conference call, which will set it up for growth in 2027.”
    • “In a way, Bayer’s pharma business is the company in a microcosm. As the German conglomerate absorbs massive litigation charges related to its disastrous acquisition of Monsanto a decade ago and eyes a potential $7.25 billion settlement of Roundup lawsuits, a rebound is finally in sight.”
  • Per Fierce Healthcare,
    • “Eldercare company Papa is rolling out a new program that leans on its existing companion care services to support quality improvements for health plans.
    • “Called Papa Plus, the company’s network of vetted “Pals” will be able to provide key services that insurers need in addition to their work in addressing social needs of members. These tasks could include assisting a member in scheduling a key wellness visit and then accompanying them to the appointment, providing support after hospital discharge or helping an individual use a telehealth visit.
    • “This builds a direct engagement channel to some of the most vulnerable—and least reachable—patients, Papa said in the announcement, which was shared exclusively with Fierce Healthcare.”

Tuesday report

David Ermer–Congress, Employee Wellness Programs, FDA, Generative AI, NIH, No Surprises Act, Obesity, U.S. Healthcare–

From Washington, DC

  • Bloomberg Law reports,
    • “Another reconciliation bill represents a “tremendous opportunity”for Republicans to pass key policy priorities before the midterm elections, a House GOP tax-writer said Monday.
    • “Rep. Beth Van Duyne (R-Texas), a member of the House Ways and Means Committee, said at a Bloomberg Government roundtable that Republicans want a second shot at passing several provisions that were axed from their first reconciliation bill passed last year.
    • “It was a heavy lift to do reconciliation 1.0,” Van Duyne said. “But I think there’s a lot of parts of that bill that got washed out in the Byrd bath that we would like to be able to see put in reconciliation 2.0.” * * *
    • “Republican leaders including Ways and Means Chairman Jason Smith (R-Mo.) along with President Donald Trump have been cool to the idea of starting work on a second party-line bill given how challenging it was to pass the first bill, though a number of rank-and-file GOP lawmakers have clamored for it.
    • “There’s a lot of very strong bills that would be productive to be able to have passed and the only way that we can do that is put it in reconciliation,” Van Duyne said.”
  • and
    • “More than three dozen employers, insurers, and patient advocacy groups are askingthe Trump administration to intervene in the arbitration process for surprise medical bills. 
    • “Dysfunction under the No Surprises Act has flooded the courts with cases of alleged fraud on both sides. Insurers accuse providers of knowingly submitting ineligible claims to the arbitration process, while providers allege insurers are misleading arbitrators on key payment metrics.
    • “Health insurance companies and employers are losing the vast majority of cases under the law. Data from the Centers for Medicare & Medicaid Services, which oversees the arbitration process, show that providers are winning 88% of the time. But courts are largely siding with insurers when providers allege they aren’t paying up, saying that enforcement resides with the CMS.
    • “The Office of Management and Budget is reviewing a final rule to improve the independent dispute resolution process, which requires arbitrators to settle out-of-network bills between doctors and insurers. The rule has languished since the Department of Health and Human Services first proposed it in November 2023 as a series of legal challenges from the Texas Medical Association unfolded in the courts.
    • “More transparency and accountability is needed for companies that oversee arbitration, the ERISA Industry Committee, American Benefits Council, Business Group on Health, Elevance Health, union 32BJ Health Fund, and others said in a letter Tuesday.”
  • FEHBlog note — With regard to transparency, one of the factors that the arbitrators consider is patient acuity. A health plan can only guess at that factor. That’s unreasonable. The arbitration process should better align with American Arbitration Association rules for baseball arbitration.
  • Mobihealth News relates,
    • “Dr. Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services (CMS), said during an Action for Progress event focused on addiction and mental health that AI avatars are the best way to help rural communities access mental healthcare.
    • “We do not have enough practitioners for mental health support in these areas,” Dr. Oz said during the event.
    • “I’m telling you right now. There’s no question about it – whether you want it or not – the best way to help some of these communities is going to be AI-based avatars.”
    • “He proposed using agentic AI with the ability to conduct early mental health intakes, customize support to a patient’s needs and understand what a patient is “up to.”  
    • “[These tools] will pick up subtle little nuances in how you’re saying things – if you do it on purpose, it’s actually cool to find out – that will alert the avatar, but more importantly, the doctor they are going to report to that there is something going on,” Oz said. “And there will always be a doctor.”
    • “He framed the use of AI avatars to be used in conjunction with clinicians as, he said, humans are biologically designed to interpret facial cues, such as happiness, boredom, excitement and more, before a person verbalizes it.
    • “The key question is how do we use AI thoughtfully in that setting? If we do it right, we’ll build a much more sustainable healthcare system around mental health issues,” Oz said.”  

From the Food and Drug Administration front,

  • Fierce Pharma reports
    • “Four years after the FDA issued its most heavy-handed form of a rejection to the prior company behind pegzilarginase, the U.S. regulator has now given the treatment a thumbs-up.
    • “Scoring the accelerated nod is Immedica Pharma for Loargys as a therapy for hyperargininemia in the ultrarare genetic disorder Arginase 1 deficiency (ARG1-D). The approval covers patients age 2 and older, with the therapy to be used in conjunction with a protein-restricted diet. 
    • “Loargys, which is also known as pegzilarginase, is a recombinant human enzyme designed to lower levels of arginine in patients who are unable to break down the amino acid. It is the first treatment to address the elevated levels of plasma arginine associated with the disorder.”
  • and
    • “Sanofi and Regeneron’s megablockbuster immunology drug Dupixent has gained yet another FDA approval, this time in allergic fungal rhinosinusitis (AFRS).
    • “The U.S. regulator signed off on the drug as a treatment for adults and children ages 6 and older with AFRS based on late-stage trial data showing Dupixent reduced nasal signs and symptoms and systemic corticosteroid use or surgery compared to placebo, according to a Feb. 24 press release.” * * *
    • “Harmony Biosciences is rounding out the U.S. patient pool eligible for its sleep disorder pill Wakix after notching a pediatric nod from the FDA that positions the drug as a treatment for cataplexy in people ages 6 and older with narcolepsy.
    • “The new addition to Wakix’s label makes it the only non-scheduled treatment for both adult and pediatric narcolepsy patients in the U.S. with or without cataplexy. That non-scheduled classification represents an “important distinction that supports its clinical utility,” Harmony’s CEO, Jeffrey Dayno, M.D., commented in a press release. Cataplexy is a common symptom of narcolepsy that involves a sudden weakening of muscles, often when triggered by a strong emotion.” * * *
    • “Two months after Johnson & Johnson’s Rybrevant Faspro picked up its first FDA approval, the subcutaneous lung cancer drug has scored a label expansion to be given monthly.
    • “On Tuesday, J&J touted a “simplified” monthly dosing regimen for the drug’s combination with lazertinib for the first-line treatment of epidermal growth factor receptor EGFR-mutated advanced non-small cell lung cancer. Previously, the combo was approved as an every-two-week regimen.”
  • and
    • “Just three months after further scaling back its support for the struggling hemophilia A gene therapy Roctavian, the company is walking away altogether by pulling the treatment from the market. 
    • “The move follows a “comprehensive effort” to identify a potential buyer for the therapy, BioMarin explained Monday in its fourth-quarter earnings press release.” 

From the public health and medical / Rx research front,

  •  Health Day relates,
    • “You don’t need to look buff or tough, but muscle strength can influence how long you’ll live, a new study says.
    • “Older women with greater strength had a significantly lower risk of death during an eight-year follow-up, researchers recently reported in JAMA Network Open.
    • “The study measured women’s grip strength and ability to rise from a seated to standing position — two tests commonly used to determine seniors’ strength levels.
    • “Women had a 12% lower death rate for every 15 additional pounds of grip strength they exhibited during testing, researchers found.
    • “Likewise, they had a 4% lower death rate for every 6 seconds faster they could complete five sit-to-stand chair raises, results showed.”
  • and
    • “Teens who use weed are twice as likely to develop psychotic or bipolar disorders, a new study says.
    • “They also are more likely to have depression and anxiety, researchers reported Feb. 20 in JAMA Health Forum.
    • “As cannabis becomes more potent and aggressively marketed, this study indicates that adolescent cannabis use is associated with double the risk of incident psychotic and bipolar disorders, two of the most serious mental health conditions,” researcher Dr. Lynn Silver said in a news release. She’s a program director at the Public Health Institute in Oakland, California.
    • “More than 10% of 12- to 17-year-olds in the U.S. have used weed within the past year, researchers said in background notes. By their senior year in high school, about 26% of U.S. teenagers have tried it.”
  • and
    • “Side effects like nausea or vomiting are common among folks taking Ozempic/Wegovy, but they’ll grin and bear it if they think they’re losing weight, a new study finds.
    • “The drugs’ perceived effectiveness — lost weight, less appetite, fewer food cravings — outweigh GI side effects, researchers reported recently in the Journal of Medical Internet Research.”
  • MedPage Today informs us,
    • “Hepatitis B vaccination rates among U.S. newborns have fallen by more than 10 percentage points over the past 2 years.
    • “Those rates climbed steadily for 6 years, peaking at 83.5% in February 2023 before dropping to 73.2% by August 2025.
    • “The drop began months before the CDC’s Advisory Committee on Immunization Practices voted in December to stop universally recommending the birth dose.”
  • and
  • Per an NIH news release,
    • “A study funded by the National Institutes of Health (NIH) reduced new HIV cases by 70% in rural Kenya and Uganda by pairing digital tools with tailored HIV services delivered by community health workers and clinicians. This successful strategic implementation of existing healthcare infrastructure and available HIV prevention and treatment options could become a model for reducing HIV incidence in other countries, including the United States. The findings were presented today at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver.”  
  • Here’s a link to the latest edition of NIH’s Research Matters which covers the following topics:

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

  • The Wall Street Journal reports,
    • Novo Nordisk NOVO.B plans to slash U.S. list prices for its popular weight-loss and diabetes drugs Wegovy and Ozempic by up to half starting next year.
    • Under the changes, both Ozempic and Wegovy will list for $675 a month, effective Jan. 1, 2027. That is half of the current price tag for anti-obesity therapy Wegovy and a 34% cut for diabetes treatment Ozempic. The price cuts also will apply to pill versions of both injections, including one sold as Rybelsus.
    • The reductions escalate a price war with rival Eli Lilly LLY -1.40% in one of the fastest-growing, most hotly contested categories in pharmaceuticals.
  • Optum Rx, writing in LinkedIn, discusses the next phase of the GLP-1 revolution.
  • STAT News relates,
    • “In the last year and a half, direct-to-consumer telehealth company Hims & Hers has become a leading voice in the debate over compounded GLP-1 weight loss medications. On Monday, it announced earnings from the last quarter of 2025 after a whirlwind month that raised questions about the regulatory risks of the company’s compounding model and the threat of an investigation. 
    • “In the call, Hims & Hers CEO Andrew Dudum addressed the increased scrutiny on compounded GLP-1s and its impact on the business’s bottom line, emphasizing Hims’ other medications, including for weight loss. “We believe there’s a really durable weight business,” said Dudum, “even if you think you’re kind of in a draconian scenario of compounding GLP-1s not being there.”
  • Fierce Healthcare tells us,
    • “Employers are spending more on women’s and family health, but that is not always being felt by employees, a new report finds.
    • “The Maven Clinic released its fifth annual State of Women’s & Family Health Benefits report, which is based on responses from over 2,000 HR leaders and nearly 5,000 full-time employees across the U.S., U.K., Canada and India. The report highlights how rising healthcare costs are reshaping how employees seek care and what actions employers are considering to help address those costs.
    • “Though employers reported a 39% average increase in women’s and family health benefits offered year-over-year, the share of employees who felt their benefits support them “very well” dropped 10% on average. Globally, across all benefits, employers were slightly more likely to add or enhance benefits in the next year compared to those in the U.S.”
    • “From Maven’s perspective, all the report’s findings highlight the need for an integrated approach to benefits and care delivery.
    • “We think that the category continues to show importance, and that is a positive,” Stephanie Glenn, chief commercial officer at Maven, told Fierce Healthcare. 
    • “But the gap in what’s being offered and what employees are feeling exists because of a lack of thoughtful integration, she added. “Unless it’s a coordinated offering, if you get a one-time email about a new benefit, it’s very disjointed. You don’t understand what it looks like,” she said.”
  • Healthcare Dive tells us,
    • “Thirty-one thousand Kaiser Permanente nurses and other healthcare professionals in California and Hawaii ended a major strike Tuesday after about a month on the picket lines. 
    • “In a statement Monday, the workers’ union, the United Nurses Associations of California/Union of Health Care Professionals, said “significant movement” at the bargaining table over the past two days prompted leaders to end the strike.
    • “Returning members to their patients and their livelihoods is the clearest path to securing a final agreement and building on the progress achieved during the strike,” the UNAC/UHCP said.”
  • and
    • “Home health and hospice provider Enhabit has agreed to be taken private by private equity firm Kinderhook Industries in a deal worth $1.1 billion.
    • “Under the deal terms announced Monday, shareholders will receive $13.80 in cash per share, representing an almost 25% premium over Enhabit’s closing stock price on Feb. 20. 
    • “The Dallas-based provider — which has almost 250 home health locations and over 115 hospice locations in 34 states — will cease trading on the New York Stock Exchange when the deal closes, which the companies expect to happen in the second quarter this year.”
  • Beckers Hospital Review notes,
    • “For the first time, women now make up the majority of physicians in U.S. training programs, according to the Association of American Medical Colleges’ annual report on residency trends. 
    • “In the 2024-25 academic year, women accounted for 50.2% of residents and fellows across all specialties and subspecialties, per the report. The figure marks a stark contrast from the 1970s, when women comprised less than 10% of physicians, and reflects decades of steady growth in female representation in medical schools and training programs.”
  • and
    • “If healthcare IT were golf, CIOs would take a few mulligans.
    • “Choosing and installing an EHR is often one of the biggest, most complicated decisions IT leaders will ever make, and some executives told Becker’s they would do things differently if they could go back in time.”
  • Per MedTech Dive,
    • “Medtronic on Tuesday priced a planned initial public offering for its MiniMed diabetes spinoff at up to $784 million.
    • “MiniMed plans to price its IPO between $25 and $28 per share across 28 million shares. Underwriters will also have the option to buy an additional 4.2 million shares at the IPO price.
    • “Medtronic first announced plans to spin out its diabetes business into a separate, publicly traded company in May. The new firm would be the only company in the market that sells both insulin pumps and continuous glucose monitors.”

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.”

Friday report

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

From Washington, DC,

  • The Washington Post reports,
    • The Senate passed a bill Friday to fund most of the federal government and buy more time to debate new accountability measures for immigration agents, but many agencies will still shutter this weekend.
    • The vote was 71-29. Five Republicans and 23 Democrats voted against the bill, as did Sen. Bernie Sanders (Vermont), an independent who caucuses with Democrats.
    • The House will not consider the spending legislation until early next week, setting off a partial shutdown just past midnight. The effect of the lapse in funding is expected to be relatively limited compared with the 43-day government shutdown last fall, the longest in history.
  • Govexec adds,
    • “We have been sending guidance to agencies this week, including today, on the likely lapse in funding,” an Office of Management and Budget spokesperson said on Friday. They added that OMB was following the “normal shutdown process” and would send a memorandum later on Friday instructing them to kick off shutdown procedures. Agencies would then notify employees who will be deemed excepted—and would therefore have to work during the shutdown—and who will be furloughed.” * * *
    • “All federal employees who would normally report to work on Feb. 2 would be expected to do so anyway, as is standard practice on the first working day after a funding lapse to initiate “orderly shutdown activities.” Depending on when the House acts, OMB could advise furloughed employees to remain at work or to go home and await an update.” 
  • Per a House of Representatives news release,
    • “U.S. Representative James Walkinshaw (D-VA-11) and U.S. Senator Tammy Duckworth (D-IL)  called on Donald Trump—who has repeatedly failed to deliver on his promise to provide free IVF for all Americans—to prove his self-proclaimed support for IVF by expanding coverage for the millions of hardworking Americans in our federal workforce. In their letter, the lawmakers called on the Office of Personnel Management (OPM) to require all Federal Employees Health Benefits (FEHB) Program insurance carriers to cover IVF and other fertility treatments to at least the same level of coverage that Members of Congress and their staff currently enjoy.”* * *
    • “Since many FEHB carriers also offer plans through the DC Health Link, these insurance carriers have already invested time and resources improving their plan designs to comply with the DC Health Link’s excellent IVF benchmark requirements,” the lawmakers continued. “The bottom line is that OPM setting FEHB’s required IVF benefit at an identical or equivalent level to the DC Health Link IVF benefit requirements would bring fairness to the Federal workforce; strengthen recruitment and retention; and provide clarity, consistency, and improved IVF access across FEHB.”
  • Today, the Department of Health and Human Services announced certain information from the 2027 Notice of Benefits and Payment Parameters required for administering the Affordable Care Act. Of interest to FEHB and PSHB plans,
    • Maximum Annual Limitation on Cost Sharing for 2027
    • Under 45 CFR 156.130(a)(2), for the 2027 calendar year, cost sharing for self-only coverage may not exceed the dollar limit for calendar year 2014 increased by an amount equal to the product of that amount and the premium adjustment percentage for 2027. For other than self-only coverage, the limit is twice the dollar limit for self-only coverage. Under § 156.130(d), these amounts must be rounded down to the next lowest multiple of $50. Using the premium adjustment percentage for 2027 of 1.8916224814, and the 2014 maximum annual limitation on cost sharing of $6,350 for self-only coverage, which was published by the Internal Revenue Service on May 2, 2013,6 the 2027 maximum annual limitation on cost sharing is $12,000
    • for self-only coverage and $24,000 for other than self-only coverage. This represents an approximately 13.2 percent increase from the 2026 parameters of $10,600 for self-only coverage and $21,200 for other than self-only coverage.
  • The American Hospital Association (AHA) News tells us,
    • “The White House issued an executive order Jan. 29 to address substance use and addiction. The order establishes the White House Great American Recovery Initiative, a federal effort tasked with coordinating the administration’s efforts on the matter. The initiative will be led by the Department of Health and Human Services, which will work in conjunction with other federal agencies and officials. The initiative would advise federal agencies on how to implement programs regarding substance use prevention, early intervention, treatment, recovery support and re-entry, among other efforts. Additionally, the program would advise federal agency leaders on how to direct grants supporting addiction recovery.”
  • and
    • The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology released a request for information Jan. 29 on the potential adoption of diagnostic imaging interoperability standards for health IT under ONC’s Health IT Certification Program. Comments on the request are due March 16. 
  • The Labor Department posted a fact sheet about the proposed ERISA PBM transperency rule published in today’s Federal Register.

From the judicial front,

  • Beckers Payer Issues reports,
    • “A federal judge has ruled that Luigi Mangione will not face the death penalty in the federal case stemming from the killing of UnitedHealthcare CEO Brian Thompson.
    • “On Jan. 30, U.S. District Judge Margaret Garnett dismissed two of the four federal counts against Mangione, including a murder charge that would have made him eligible for capital punishment. Judge Garnett found the charge was technically flawed because it required an underlying “crime of violence,” and she ruled that the government’s stalking allegation did not meet that legal standard under Supreme Court precedent. Attorney General Pamela Bondi directed federal prosecutors to pursue the death penalty in April.
    • “The remaining stalking-related charges carry a maximum sentence of life in prison without parole. Mangione, 27, has pleaded not guilty to both federal and state murder charges.
    • “In a win for prosecutors, Judge Garnett denied the defense’s motion to suppress evidence seized from Mangione’s backpack during his December 2024 arrest at a McDonald’s in Altoona, Pa. Authorities said the backpack contained a handgun and a notebook describing his intent to target an insurance executive.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally and increased this week after three weeks of decreasing trends. Emergency department visits among children 5-17 years are increasing. Hospitalization trends continue to decline overall. However, they are increasing among infants less than 1 year old. They remain stable in children 5-17 years old. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old.
    • “COVID-19
      • COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally and increased this week after three weeks of decreasing trends.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • National vaccination coverage for COVID-19, influenza, and RSV vaccines remains suboptimal for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • The AHA News informs us,
    • “The South Carolina Department of Public Health announced Jan. 30 that the state’s measles outbreak now has 847 cases. The agency said most cases are close contacts of known cases, but the number of public exposure sites indicate that the disease is circulating through community spread, increasing the risk of exposure and infection for individuals who are not immune due to vaccination or natural infection. The state’s outbreak began in October. Nationally, 588 cases have been reported since Jan. 1 across 17 jurisdictions, according to datafrom the Centers for Disease Control and Prevention. Of those cases, 94% are outbreak-associated. Additionally, the vaccination status of 94% of cases is classified as unvaccinated or unknown.” 
  • Per an HHS news release,
    • “The Centers for Disease Control and Prevention (CDC) today announced that its Traveler-Based Genomic Surveillance (TGS) program has surpassed one million voluntary participants, marking a significant milestone in the United States’ ability to detect and respond to emerging public health threats at our borders.
    • “TGS is one of many tools the United States uses to strengthen disease surveillance and protect the American people. Through voluntary and anonymous sample collection from arriving international travelers at select U.S. airports, the program provides early insight into emerging pathogens and variants before they spread broadly within the United States
    • “The United States is the world’s leading authority in public health,” said HHS Deputy Secretary and Acting CDC Director Jim O’Neill. “The broad participation of travelers enhances our ability to safeguard the nation using tools that are developed, operated, and governed here at home without reliance on unaccountable global bureaucracies.”
  • Per a National Institutes of Health news release,
    • “National Institutes of Health (NIH)-supported investigators have developed a blood test to find pancreatic ductal adenocarcinoma, one of the deadliest forms of cancer. The new test could improve survival rates from pancreatic cancer, which tends to be diagnosed at late stages when therapy is less likely to be effective. The findings were published in Clinical Cancer Research.
    • “Overall, only about 1 in 10 pancreatic cancer patients survive more than five years from diagnosis. However, experts expect that when the cancer is found and treated at an earlier stage, survival would improve. While finding the cancer early is key, there are no current screening methods to do so.”
  • The University of Minnesota CIDRAP informs us,
    • “Researchers and clinicians in Michigan have developed new guidance for triage and management of suspected urinary tract infections (UTI) symptoms in patients seeking care via telehealth and virtual visits. * * *
    • “The result is two algorithms for uncomplicated UTI management—one for non-pregnant women and one for men—that clinicians can use in any setting to determine whether urine testing, empiric antibiotics, and further examination are needed. The guidance also addresses patients with more complicated health conditions and symptoms that could indicate a more serious health issue.
    • “The authors of the paper say the guidance is needed because UTIs are one of the most common reasons for antibiotic use in outpatient settings, but far fewer patients are being seen in a setting where a urine sample can be collected to confirm an infection.
    • “We hope that this guide will help both patients and providers be aware that even though they’re now able to take a questionnaire or interact with a provider completely virtually, that alone may not be enough to get the right diagnosis or treatment,” first author Jennifer Meddings, MD, MSc, a clinician and patient safety researcher at VAAAHS and Michigan Medicine, said in a press release.”
  • Per MedPage Today,
    • “Risk of recurrent major adverse limb events was lower in diabetes patients taking GLP-1 agents compared with DPP-4 inhibitors.
    • “Reduction of limb events was most significant for major amputations, where the risk was reduced by 41%.
    • “Researchers suggested the findings support preferential use of GLP-1 drugs for preventing recurrent limb events.”

From the U.S. healthcare business front,

  • Beckers Payer Issues “connected with 17 health plan leaders to learn how their organizations are shifting their priorities in response to continued medical cost trends and affordability concerns.”
  • OptumRx writing in LinkedIn shares its notable new drug report
    • “In our latest edition of this ongoing series that highlights anticipated new drugs, we’ll review:
      • “Anaphylm™ (dibutepinephrine), the first oral drug for emergency treatment of severe allergic reactions.
      • “Sotyktu® (deucravacitinib) for treatment of psoriatic arthritis. This is a new indication for Sotyktu, which is currently approved for plaque psoriasis.
      • “Insulin icodec, the first once-weekly basal (or long-acting) insulin for treating type 2 diabetes mellitus.
    • “These drugs are expected to receive Food and Drug Administration (FDA) approval during the first quarter of 2026.”
  • BioPharma Dive reports,
    • “Amgen is backing out of a deal for an eczema drug it spent considerable resources developing, handing rights back to Kyowa Kirin for a medication called rocatinlimab that completed its first Phase 3 studies more than a year ago
    • “Amgen’s decision was based on a “strategic portfolio prioritization,” the Japan-based drugmaker said Friday, adding that it plans to seek regulatory approvals in the first six months of the year. Kyowa Kirin is “confident in the potential of rocatinlimab,” said Abdul Mullick, the company’s president, in a statement.
    • “While the two rocatinlimab trials in eczema achieved their primary goals, investors and Wall Street analysts have viewed them as disappointing compared to leading treatments like Regeneron and Sanofi’s Dupixent. Sanofi, though, is still planning regulatory submissions for a drug in the same class despite results that fell short of expectations.”
  • Modern Healthcare relates,
    • “Clinical teams are increasingly using wearables from consumer companies such as Apple, Fitbit and Samsung.
    • “Involving clinical teams before implementation of these tools has helped combat skepticism.
    • “There’s room for greater collaboration between clinicians and device manufacturers.
    • “Brigham and Women’s Hospital is using Apple Watches to study the connection between physical activity and heart health.”

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.” 

MLK Holiday Weekend Update

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

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the J.P. Morgan Healthcare Conference,

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

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

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