Midweek report

OPM

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.”

Friday report

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

From Washington, DC,

  • STAT News informs us,
    • “White House officials are steering the Trump administration away from vaccine reform, fearing the political consequences of emphasizing a relatively unpopular issue in a key election year.
    • “But the Make America Healthy Again movement, led by Robert F. Kennedy Jr. — a health secretary with a history of anti-vaccine activism — isn’t going along without a fight.”
  • FedWeek reports,
    • “The House government operations subcommittee has scheduled hearings next week on the state of USPS finances and operations, including, in the words of the announcement, “whether USPS is reliable enough for Congress to allow it to borrow more money from the Department of the Treasury.”
    • “USPS is rapidly losing money and becoming more unreliable each year and is dire need of a course-correction. While some progress has been made to improve USPS operations, there is still much more work to be done to reform the agency and make up for the billions it has already lost,” the subcommittee said in scheduling Postmaster General David Steiner and the GAO as witnesses.”
    • The hearing will be held next Tuesday March 17 at 2 pm ET.
  • Federal News Network relates,
    • As the Trump administration’s Schedule Policy/Career nears finalization, Office of Personnel Management Director Scott Kupor reaffirmed his view that the pending personnel change is centered on “accountability,” rather than politicization.
    • The OPM director pushed back against criticisms from the federal community, after many warned of a return to a patronage system in the career civil service if the new federal employment classification is finalized.
    • “I think most federal employees know this — and certainly all the ones I’ve encountered have had no problem with this — your job is ultimately to effect lawful actions that the president determines are the appropriate objectives for the organization,” Kupor said during a March 5 event hosted by Federal News Network. “That’s what this does — basically codify what essentially has always been the practice of the executive branch.”
    • Tens of thousands of federal employees are on track to soon be converted to the new Schedule Policy/Career category, leaving them with limited appeal rights and making it easier for agencies to fire them.
    • FEHBlog note — This rule became effective on March 9, 2026.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS), through its Office on Women’s Health (OWH), today announced a formal Memorandum of Understanding (MOU) with the American Urological Association, the American Urological Education and Research, and the Urology Care Foundation (together, the AUA) to promote the appropriate and evidence-based use of local estrogen therapy in postmenopausal women, particularly those experiencing genitourinary syndrome of menopause (GSM) and recurrent urinary tract infections (UTIs).
    • “The collaboration reflects a unified commitment by both institutions to improving women’s health, preventing disease, and enhancing quality of life through safe and effective therapies. Together, HHS and the AUA will exchange information, develop educational resources, and work collaboratively to reach health care providers and women across the country.
    • “This collaboration represents an important step forward in addressing a significant and often undertreated women’s health concern,” said Dorothy A. Fink, M.D., Principal Deputy Assistant Secretary for Health and Director of the HHS Office on Women’s Health. “Many postmenopausal women are not aware that local estrogen therapy is a safe and effective treatment for GSM and recurrent UTIs. By joining forces with the AUA, we can ensure that clinicians and patients alike have access to clear, evidence-based guidance.”
  • Kaiser Family Foundation (KFF) tells us,
    • “A new KFF analysis examines Medicare Advantage coverage options in 2026 for the 2.6 million enrollees whose Medicare Advantage plan with prescription drug coverage was terminated at the end of 2025. Plan termination affected 13% of all enrollees in such plans in 2025, more than double the 6% affected the year before.
    • “Medicare Advantage insurers have warned that recent and prospective changes to the Medicare Advantage payment system are driving plan terminations and reductions in benefits. The analysis finds, however, that almost all of the enrollees whose plans were terminated have at least one Medicare Advantage plan with drug coverage (MA-PD) available in 2026, and on average they have more than two dozen plan options to choose from in their area. Most beneficiaries affected by the termination of a plan that had a zero-premium MA-PD option in 2025 also had a zero-premium MA-PD option for 2026.
    • “Just 1.1% of those who were in terminated plans nationwide, or fewer than 30,000 people, have no option for a Medicare Advantage plan with drug coverage for 2026.”
  • KFF also updated its key facts about the CMS drug negotiation program.

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP tells us,
    • :British drugmaker GSK said today that the US Food and Drug Administration (FDA) has expanded the approved use of its respiratory syncytial virus (RSV) vaccine for younger adults at risk of complications from the virus.
    • “In a news release, the company said the FDA approved Arexvy for use in adults aged 18 to 49 who are at increased risk of lower respiratory tract disease (LRTD) caused by RSV. The vaccine was previously approved for all adults aged 60 and over and those aged 50 to 59 at increased risk of LRTD caused by RSV.”
  • BioPharma Dive informs us,
    • “For the first time, the Food and Drug Administration is allowing a certain kind of cell therapy for epilepsy to be tested in humans.
    • “The therapy, created by Shanghai-based Unixell Biotechnology, is designed to curb the excessive electrical activity that triggers seizures in epileptic patients. It uses donor-derived — or “allogeneic” — stem cells reprogrammed so that they ultimately produce the main chemical messenger, “GABA,” responsible for calming the brain and nervous system.” * * *
    • “Yet, Unixell will likely also face newer competition. Decades of research into ion channels — cellular tunnels that often play a role in epilepsy — has finally started to bear fruit.”
  • Cardiovascular Business notes,
    • “Vena Medical, a Canada-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its Vena MicroAngioscope System—advertised as the “world’s smallest camera”—to be used for intravascular imaging in the peripheral arteries.
    • “The device was designed to help care teams evaluate a patient’s peripheral vasculature without the use of X-ray fluoroscopy. It connects to standard endoscopy equipment and is used in tandem with a balloon distal access catheter to provide real-time color images. The balloon occludes the vessel temporarily and the segment is flushed with saline to enable the camera to directly image the interior of the vessel.
    • ‘In Canada, more than 100 patients have already been treated with the Vena MicroAngioscope System. With this FDA clearance in place, the company now plans to enter the hospitals and health systems in the United States.”
  • Per Fierce Pharma,
    • “The FDA has rejected Hyloris Pharmaceuticals antiviral valacyclovir, an oral suspension for infections caused by herpes simplex and varicella zoster viruses. 
    • “In a complete response letter (CRL), the FDA said it identified issues in an inspection of Hyloris’ third-party manufacturer. The U.S. regulator did not specify the problems in the CRL, explaining that they were itemized to a representative of the production facility.
    • “The CRL was not a surprise. In a release last month, Belgium-based Hyloris explained (PDF) that the FDA had assigned an official action indicated (OAI) classification to the Greek facility after an inspection.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. Seasonal influenza activity remains elevated nationally. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Overall seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. Influenza A activity continues to decrease while trends in influenza B activity vary by region.
      • Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • “RSV is a leading cause of hospitalization among U.S. babies.
      • “To help keep babies safe from severe RSV, babies younger than 8 months of age should get protection in their first RSV season (which usually starts in the fall) in one of these ways:
        • “The pregnant mother gets the RSV vaccine during pregnancy, or
        • “The baby gets an RSV antibody (nirsevimab or clesrovimab) just before the start of the RSV season or soon after birth, if born during the season.
      • “A CDC report showed that these protections are working. During the 2024–25 RSV season, infant RSV hospitalization rates were reduced by up to half compared to rates during seasons before when RSV prevention products were available.
      • “Interim estimates for the 2025–26 seasonal influenza vaccine prove getting the vaccine reduced the risk of flu-related doctor visits and hospitalizations, supporting CDC’s vaccination recommendations. For children and teenagers, the vaccine was 38%–41% effective at preventing doctor visits and 41% effective at avoiding hospitalizations for the flu. For adults aged 18 and older, it was 22%–34% effective at preventing doctor visits and 30% effective for preventing hospital stays. Read more here: MMWR.”
  • The American Hospital Association News reported today,
    • “There have been 1,362 confirmed measles cases nationwide this year, according to the latest data published today by the Centers for Disease Control and Prevention. Of those, 94% are associated with outbreaks. South Carolina and Utah currently have the largest ongoing measles outbreaks in the country. The South Carolina outbreak, which began in October 2025, has slowed in recent weeks and is at 996 cases as of today. Utah’s outbreak, which began in June 2025, has risen to 405 cases as of March 10, marking an increase of 47 cases since last week.” 
  • The Wall Street Journal relates,
    • “Adults should be screened and treated for high cholesterol starting at age 30, if not sooner, according to new clinical guidelines, lowering the age by at least a decade at a time when heart attacks are becoming more common in younger adults. 
    • “The goal is to shift to a more proactive approach to head off problems in younger years, rather than starting lifestyle changes and medical treatment in middle age when a patient may already have damage in their arteries, said Dr. Roger Blumenthal, chair of the committee of cardiologists that wrote the new guidelines. 
    • “Growing research shows how much damage can be done when levels of LDL, or “bad,” cholesterol stay high in the blood for years, he said. At the same time, more medicineshave become available to lower cholesterol, along with screening tests and a new online tool that allows people 30 and older to calculate their risk of cardiovascular disease.
    • “We need to pay attention much earlier,” said Blumenthal, director of preventive cardiology at Johns Hopkins Medicine.  
    • “The guidelines, published Friday in two leading cardiology journals, were issued by 11 medical associations, including the American College of Cardiology and American Heart Association. These organizations set standards for medical professionals from family doctors to cardiologists.”
  • Per a National Institutes of Health news release,
    • “A team of researchers funded by the National Institutes of Health (NIH) have developed an artificial intelligence (AI) tool that provides decision support to clinicians by predicting if patients are at risk of intimate partner violence (IPV). Using data routinely collected during medical visits, the team trained a machine-learning model, a type of AI, that was highly accurate in detecting IPV among patients in a study. 
    • “IPV refers to abuse from current or former partners that results in serious effects such as potentially life-threatening injuries, chronic pain and mental health disorders. It affects millions of people in the United States — both men and women — at some point in their lives. However, many cases go undetected, because patients can be hesitant to disclose abusive relationships due to safety concerns, fear and stigma. 
    • “In their study, the research team led by researchers from Harvard Medical School, Boston, introduced three AI models for IPV detection in healthcare settings, comparing their performance in predicting it.  
    • “This clinical decision support tool could make a significant impact on prediction and prevention of intimate partner violence,” said Dr. Qi Duan, Ph.D., director of the Division of Health Informatics Technologies at NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). “Given the prevalence of cases, the tool could be a game-changing asset to public health.” 
  • Health Day informs us,
    • “People frequently switch between different weight-loss drugs, swapping Ozempic for Zepbound and vice versa within the first year of treatment, a new study reports.
    • “What’s more, those patients who do swap GLP-1 drugs are more likely to stick with the drugs, researchers reported March 10 in JAMA Network Open.
    • “Switching between GLP-1RA medications should be viewed as a normal part of long-term obesity care,” said senior researcher Sarah Messiah, a professor of epidemiology and pediatrics at UT Southwestern Medical Center in Dallas.
    • “Persistence should not be judged by staying on a single drug indefinitely, but by maintaining engagement in care and working with clinicians to find sustainable, effective treatment strategies over time,” she said in a news release.”
  • and
    • “Vitamin D3 supplementation does not change the four-week incidence of health care utilization or COVID-19-related outcomes among adults with newly diagnosed COVID-19 but may reduce the risk for long COVID, according to a study published online March 12 in the Journal of Nutrition.”
  • Per BioPharma Dive,
    • “Vima Therapeutics announced Wednesday it has raised $100 million in the hopes of bringing to market a new oral therapy that might help people with certain neurological disorders regain control of movement.
    • “The company was hatched by biotechnology investor Atlas Venture more than three years ago. It’s since advanced a combination drug called VIM0423 to the precipice of mid-stage studies in Parkinson’s disease and dystonia. Both trials are expected to read out in 2027.
    • “Vima estimates that about 160,000 people in the U.S. have isolated dystonia, a chronic and disabling neurological condition that causes involuntary muscle contractions that can worsen as a person moves. For a larger share, dystonia is a symptom of other brain diseases, among them Parkinson’s.”
  • Per Genetic Engineering and Biotechnology News,
    • “Lipid nanoparticles (LNPs) act as carriers for mRNA and CRISPR payloads across a wide range of therapeutic applications, from cancer to inflammatory and genetic diseases. The same delivery system used in COVID‑19 vaccines is now being adapted for other, more complex targets, but one challenge persists: LNPs transfer their cargo into cells far more readily in the lab than in the body. What makes in vivo delivery so much harder?
    • “A new study from Biohub may have uncovered a surprisingly simple way around this barrier. From Science Translational Medicine, in a paper titled “Amino acid supplementation enhances in vivoefficacy of lipid nanoparticle‑mediated mRNA delivery in preclinical models,” the team reports that co‑injecting three common amino acids with LNPs dramatically boosts both mRNA delivery and CRISPR gene editing efficiency.
    • “Gene editing and mRNA‑based therapies will play increasing roles in the medicine of the future, but they require LNPs to reach and enter cells,” said Shana O. Kelley, PhD, president of bioengineering at Biohub and head of Biohub Chicago, in a press release. “Any LNP formulation being developed today could potentially benefit from our approach.”
    • “Rather than redesigning the nanoparticles themselves—a major focus of the field—the researchers asked: Could the body’s own metabolic environment be making cells less receptive to LNP fusion?
    • “By asking why LNPs perform so differently in the physiological milieu of the body, we found a surprisingly simple answer that could make a wide range of mRNA and gene editing therapies substantially more effective,” said Daniel Zongjie Wang, PhD, who leads Biohub’s Spatiotemporal Omics Group.”

From the HIMSS Conference 2026 front,

  • While the conference ended yesterday, the FEHBlog ran across some interesting stories from the conference today.
  • Healthcare IT News tells us,
    • “Digital transformation demands accurate, trusted identity data
    • “Identity is part of foundational infrastructure and should be strengthened so digital transformation initiatives can truly deliver, says MDM tech exec Rachel Blum at HIMSS26.”
  • Healthcare Dive informs us,
    • “The CMS wants to deploy artificial intelligence tools to Medicare beneficiaries to help navigate their care, CMS officials said at the HIMSS conference Thursday. 
    • The agency is already using the technology to detect fraud. But the CMS also hopes to get the technology into patients’ hands, both to assist seniors and to hopefully bring down rising healthcare spending, which continues to outpace the rest of the economy. 
    • “The fundamental problem right now is that other sectors of the U.S. economy have advanced and been deflationary with their use of technology,” CMS Administrator Dr. Mehmet Oz said during a panel discussion. “Healthcare has remained inflationary.”
  • Beckers Hospital Review offers six notes from the conference.
  • Beckers Health IT adds,
    • “As healthcare AI moves beyond the pilot phase, health systems need to build the infrastructure to enable the technology for the long term, according to a recent panel discussion at New York City-based Columbia Business School.”

From the U.S. healthcare business front,

  • Kaufmann Hall reports,
    • The latest Vizient Research Institute study, The access imperative: Reimagining care delivery for a more complex patient population, concludes that the bulk of hospitalizations in the United States are due to chronic illness. Patients with chronic conditions generate roughly 10 times more inpatient admissions and emergency department visits and more than six times as many office visits compared with those without chronic care needs. On a per capita basis, they generate about 17 times more inpatient days. With more than 80% of hospitalizations involving Americans with at least one chronic condition, chronic care drives most of the healthcare utilization. The findings underscore that healthcare leaders cannot afford siloed care, and the future belongs to organizations that strategically prioritize integrated chronic care models to meet rising demand and manage complexity.
  • McKinsey & Co. points out that “With aging populations and rising chronic disease, improving health span is becoming a societal and economic priority. Here’s what drives it and what can be done.”
  • NAVA Benefits notes,
    • “Women’s health is a career-long conversation, but most benefit packages treat it as a single moment. This piece breaks down six areas where employer coverage still falls short, from menstrual and hormonal health to menopause and chronic conditions, and highlights what leading companies are doing differently. Whether you’re an HR leader benchmarking your benefits or an employee who’s felt the gaps firsthand, it’s a look at what genuinely inclusive coverage can look like.”
  • Per Beckers Hospital Review,
    • “Hospitals and health systems had a rocky start to 2026. Patient demand and revenue growth slowed while expenses intensified, leading to an operating margins dip, according to Strata’s Monthly Healthcare Industry Financial Benchmarks report.”

Thursday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Lawmakers boarded planes Thursday and headed home for the weekend, passing through security checkpoints manned by agents working without pay, as Democrats and Republicans blamed each other for the monthlong impasse over funding the Department of Homeland Security.
    • “Funding for DHS lapsed on Feb. 14, held up over demands from Democrats that new restrictions be placed on Immigration and Customs Enforcement operations as a condition for funding its parent agency. Since then, lawmakers have made no progress in resolving the standoff.
    • “The shutdown has forced a swath of federal workers—including Transportation Security Administration officers at airports—to continue working without pay, contributing to staffing shortages and long security lines at some airports across the country. TSA employees received partial paychecks earlier this month and are due to miss a full paycheck in coming days, just as spring break travel is kicking off. 
    • “Democrats again blocked a measure to fund DHS on Thursday afternoon. Earlier in the day, Republicans blocked a proposal by Democrats to fund individual parts of DHS, including the TSA and Coast Guard but not ICE.”
  • Bloomberg Law relates,
    • “Senate Health, Education, Labor and Pensions Chair Bill Cassidy has a wide range of health care affordability priorities he wants to pursue in 2026, including addressing drug costs and price transparency. 
    • “In terms of the [health care] affordability, it is a campaign issue,” the Louisiana Republican said in an interview at an exclusive Bloomberg Government event on Tuesday.
    • “You can tell Tony Fabrizio is in Donald Trump’s ear, right?” referring to the president’s longtime pollster who has released a survey that shows high drug prices top voter concerns, and many have unfavorable views of pharmaceutical companies. 
    • “Some policies Cassidy thinks could help with affordability are price transparency, site-neutrality in Medicare, which equalizes payments between hospitals and off-site physician offices, and pre-funding health savings accounts to help lower-income people buy insurance. 
    • “There are ways in which the cost of health care is affecting the average American that sometimes flies below the radar,” Cassidy continued.”
  • Beckers Hospital Review tells us,
    • “Sen. Ron Johnson, R-Wis., said he is opening an investigation into the FDA’s rejection of treatments for rare diseases, including ataluren, a drug used by some patients with Duchenne muscular dystrophy.
    • “Mr. Johnson, who chairs the Senate Permanent Subcommittee on Investigations, announced the inquiry at a news conference March 11. He said the FDA should allow patients access to high-risk treatments with clear disclosures rather than remove those options altogether, according to a report from Spectrum News 1.”
  • Federal News Network reports,
    • “Federal annuitants who have been waiting for weeks on a key tax document from the Office of Personnel Management should keep an eye on their mailboxes in the coming days.
    • “In an email sent Wednesday, OPM informed federal retirees who requested physical copies of their 1099-R forms that the remaining paper documents were being sent out this week, and should be delivered in the next three to five days.
    • “If retirees who requested a physical copy of their 1099-R form do not receive it by March 18, they should email OPM, “so that we can look into it and help get you your form,” OPM wrote Wednesday in its message to annuitants, viewed by Federal News Network.
    • “OPM Director Scott Kupor further confirmed on social media that the remaining paper tax documents would be delivered shortly. He said about 93% of annuitants have either downloaded digital copies of their documents, or already received a copy of the tax form in the mail.”
  • Tammy Flanagan, writing in Govexec, tells us,
    • “Women in federal service still face retirement gaps.
    • “Lifetime earnings, career interruptions and caregiving responsibilities continue to shape retirement outcomes for women in federal service.” * * *
    • “While challenges exist, federal employment offers tools that women can leverage so they can prepare for retirement.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration is cracking down on telehealth companies’ marketing of compounded versions of weight loss drugs. In recent months, the agency has warned them against implying that their products are FDA approved, or that they themselves manufacture the products.
    • “But those companies may not be the only ones under the microscope. 
    • “The telehealth companies that have been warned — with names like Lovely Meds, Hello Cake, and MEDVi — don’t directly prescribe the medications, which are not approved by the FDA or evaluated for safety and efficacy. That falls to the clinicians in medical groups affiliated with the companies. And a STAT analysis shows that cited companies can share clinical DNA.
    • “Among more than 70 telehealth companies warned by the FDA in the last six months, at least 30% have publicly stated affiliations with just four nationwide medical groups: Beluga Health, OpenLoop, MD Integrations, and Telegra. 
    • “These “white label” telehealth practices, which allow brands to quickly plug into a stable of clinicians often licensed to practice medicine across the country, have helped telemedicine companies grow rapidly. But in doing so, they are now closely tied to an industry attracting government regulators’ scrutiny.” 
  • Fierce Pharma adds,
    • “Though it’s hard to say exactly what the future holds for mass GLP-1 compounding, the pressure is mounting from multiple angles in the U.S. as drugmakers and the FDA alike seek to crack down on the practice. 
    • “Now, Eli Lilly—which has already staged multiple efforts in court to protect sales of its diabetes and obesity meds Mounjaro and Zepbound from compounders, medical spas and telehealth firms—is launching a new salvo focused on the potential safety risks behind a common compounding tactic. 
    • Lilly cautioned Thursday that through its own testing, it has “uncovered significant levels of an impurity” in certain compounded products marketed in the U.S., which seem to stem from a chemical reaction between vitamin B12 and tirzepatide, the active ingredient in Mounjaro and Zepbound. 
    • “Lilly called the impurity “concerning” given what little is known about its short- or long-term effects in humans, as well as its potential to interact with the GLP-1 itself or how it is absorbed, distributed, metabolized and eliminated from the body. 
    • “The Indianapolis pharma stressed that tirzepatide has never been studied in combination with B12 and warned that the compounders making these products, who are beholden to different regulations than branded drugmakers are, aren’t required to monitor and report potential negative reactions to their medicines.” 
  • Cardiovascular Business lets us know,
    • “Toro Neurovascular, a California-based medtech company focused on developing new treatments for stroke and other neurovascular conditions, has secured U.S. Food and Drug Administration (FDA) clearance for its new Toro 88 Superbore Catheter.
    • “The large-bore device was built to provide support, trackability and stability during the treatment of time-sensitive stroke patients. According to Toro Neurovascular, the company worked closely with physicians to ensure it can deliver value to care teams treating even the most challenging cases. 
    • “Satoshi Tateshima, MD, PhD, a professor of interventional neuroradiology at UCLA, performed the first clinical use case with the Toro 88 device in the United States.”

From the public health, medical and Rx research front,

  • Cardiovascular Business reports,
    • “The U.S. cardiovascular mortality rate decreased dramatically from 2000 to 2011. Since then, however, it has remained relatively unchanged, according to new findings published in JACC.
    • “Cardiovascular mortality in the United States declined steadily for more than five decades; yet, progress slowed beginning around 2010,” wrote first author Adith S. Arun, BS, a research fellow with Yale New Haven Hospital and Yale School of Medicine, and colleagues. “Recent work has described this pattern as a ‘disquieting plateau,’ a period in which gains in cardiovascular outcomes have stalled despite major advances in therapies and an expanding clinical armamentarium. At the same time, national healthcare spending has reached historic levels.” * * *
    • “The researchers did note that the growth in spending is somewhat expected due to an aging patient population and the high costs associated with emerging technologies. At the same time, they wrote, “the value of these technologies depends on both their clinical effectiveness and their pricing.”
    • “The group also highlighted the importance of prevention efforts and lifestyle interventions as health systems look to keep healthcare costs down and potentially get cardiovascular mortality to start dropping again. 
    • “Click here to read the full study in JACC, the flagship journal of the American College of Cardiology.”
  • Beckers Hospital Review relates,
    • “West Virginia had the highest rate of fatal opioid overdoses of any state in 2024, according to a new analysis from KFF. 
    • “The analysis is based on finalized 2024 opioid overdose death totals from the CDC’s WONDER database, which uses ICD-10 codes to identify deaths where synthetic and prescription opioids are listed as a contributing cause. Rates are age-adjusted per 100,000 population using the 2000 U.S. standard population distribution. The data includes both deaths involving illegally manufactured and pharmaceutical fentanyl.
    • “The national opioid overdose death rate was 16 per 100,000 residents in 2024. More broadly, the U.S. recorded its largest-ever annual decline in overall drug overdose deaths, with the national rate falling from 31.3 per 100,000 in 2023 to 23.1 per 100,000 in 2024.”
  • MedPage Today tells us,
    • “This season’s influenza vaccine effectiveness rates against outpatient visits and hospitalizations may be lower than last season’s, according to an interim CDC analysis.
    • “During the current flu season, 88% of subtyped influenza A-positive specimens have been H3N2, 93% of which have been an antigenically drifted subclade K version that’s different from the 2025-2026 flu vaccine virus.
    • “These national trends were mirrored in the nation’s most populous state, California.”
  • and
    • “In cancer patients with brain metastases and type 2 diabetes, those using GLP-1 drugs had a 37% lower risk of death over 3 years.
    • “Significant mortality benefits were linked to semaglutide and dulaglutide, but not with liraglutide.
    • “The risk of all-cause mortality was consistently lower with GLP-1 drugs among patients with primary cancers of the lung, breast, and melanoma.”
  • Infectious Disease Advisor informs us,
    • “Human papillomavirus (HPV) vaccination may provide strong protection among men, highlighting its role in comprehensive disease prevention and gender-neutral control of HPV-related morbidity and mortality.”
  • Health Day notes,
    • “Providing support to stressed-out parents might help their children avoid obesity, a new study says.
    • “Children were more likely to eat healthy and not gain weight if their parents participated in training to help manage stress, researchers reported March 6 in the journal Pediatrics.
    • “We already knew that stress can be a big contributor in the development of childhood obesity,” senior researcher Rajita Sinha, director of the Yale Interdisciplinary Stress Center in New Haven, Connecticut, said in a news release.
    • “The surprise was that when parents handled stress better, their parenting improved, and their young child’s obesity risk went down,” Sinha said.”
  • Science points out,
    • “Scientists have plenty of ideas about why aging impairs memory. Reductions in blood flow in the brain, shrinking brain volume, and malfunctioning neural repair systems have all been blamed. Now, new research in mice points to another possible culprit: microbes in the gut.
    • “In a study published today in Nature, scientists show how a bacterium that is particularly common in older animals can drive memory loss. This microbe makes compounds that impair signaling along neurons connecting the gut with the brain, dampening activity in brain regions associated with learning and memory, the team found.
    • “This is a tour de force,” says Haijiang Cai, a neuroscientist at the University of Arizona who studies gut-brain communication and was not involved in the work. “They define the pathway all the way from aging and bacteria … to cognitive function—it’s really impressive.” However, he and others emphasize it remains to be seen whether a similar mechanism exists in humans—and if so, how important it is compared with other drivers of cognitive decline.”
  • STAT News relates,
    • “Jim Wells, a biologist at the University of California San Francisco, was studying proteins on the surface of cancer cells when he noticed one that wasn’t supposed to be there. This protein, called Src, should only be tucked inside cells.
    • “An accident,” he said, and a serendipitous one. Wells and his team report in Science that they have found Src on the surface of malignant cells, not healthy donor tissue.  This discovery may bring scientists closer to a long-sought goal: finding an ideal immunotherapy target for solid tumors.
    • “It was certainly provocative and exciting to see this cancer-associated Src kinase now presented on the cell surface,” said Kathleen Yates, a biologist at the Broad Institute of MIT and Harvard University who did not work on the study. But, she added, it’s still too early to know how much clinical benefit there will be from targeting Src on the cell surface. “They’ve accomplished a great deal. It is an outstanding question as to whether this will be translationally impactful,” she said.”
  • Genetic Engineering and Biotechnology News adds,
    • “After becoming the world’s first patient treated with a bespoke base editing therapy, baby KJ Muldoon is now healthy and free from the toxic ammonia buildup caused by his rare genetic metabolic disorder that initially presented a 50% mortality rate in infancy. While his story highlights the life-changing potential of gene editing, it also underscores a major challenge for the field: expanding these therapies to benefit broader patient populations.  
    • “KJ’s urea cycle disorder stemmed from a single disease-causing mutation that could be precisely targeted. However, many genetic disorders arise from numerous mutations scattered across a gene, making individualized corrections far too resource-intensive to scale.
    • “Ben Kleinstiver, PhD, associate investigator at Massachusetts General Hospital (MGH) and co-author of the NEJM study describing KJ’s case, told GEN that insertion of large DNA sequences at programmable locations in the genome holds tremendous promise as a generalizable medicine that could treat patients regardless of their underlying disease-causing mutations. His team has recently taken one step closer to making large gene insertions safer for therapeutic applications. 
    • ‘In the new study published in Nature titled, “Immune evasive DNA donors and recombinase license kilobase-scale writing,” Kleinstiver and colleagues, in collaboration with Full Circles Therapeutics, have developed a circular single stranded DNA donor (ssDNA) that enables kilobase-scale integration while remaining non-toxic to cells.”

From the HIMSS Conference 2026,

  • Fierce Healthcare reports,
    • “The Department of Health and Human Services (HHS) is ramping up major federal interoperability initiatives on several fronts.
    • “As part of this interoperability work, the Trump administration unveiled in July a sweeping health tech initiative that aims to modernize Medicare and advance next-generation digital health for patients, including conversational artificial intelligence, digital IDs and easier ways to access health data.
    • “The Centers for Medicare & Medicaid Services (CMS) is spearheading an API-focused data exchange framework to enable sharing of patient medical records through a new initiative called the CMS Aligned Network. This work is meant to accelerate data sharing at a faster pace than can be achieved through regulations alone, according to Amy Gleason, acting administrator, U.S. DOGE Service, and strategic advisor to the CMS.”
  • The Wall Street Journal adds.
    • “Microsoft MSFT is betting on healthcare as a path to become more competitive in artificial intelligence. The company’s biggest push yet: a new tool it describes as an AI concierge doctor—one that can access your medical records and health data, with your consent. 
    • “The company on Thursday unveiled Copilot Health, a feature within the Copilot app that lets the chatbot dispense personalized healthcare advice informed by the user’s disease history, test results, medications, doctors’ visit notes and biometric data as recorded by wearable devices. 
    • “Health data imported into the feature will be encrypted and firewalled from the rest of the app to address the privacy concerns of handing over one’s medical records to a generative AI platform, Microsoft AI Chief Executive Mustafa Suleyman said in an interview.
    • “It’s something that Microsoft is uniquely placed to do with our scale, with our regulatory experience, with the kind of trust and confidence that people have in our security and the history that we have as a mature, stable player,” Suleyman said.”

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

  • Modern Healthcare reports,
    • “North Dakota rural hospitals are showing they don’t need the help of a large health system to provide more primary care while driving down costs.
    • “In 2023, more than 20 critical access hospitals formed the Rough Rider High-Value Network, seeking to share data and collective resources to standardize care and improve financial performance.
    • “It’s been less than three years, but the network’s early results are a good sign for the concept given the pressure on margins at all hospitals, and especially those in far-flung communities. Rural providers in five other states have since banded together in similar coalitions of independent hospitals while many of their peers join larger health systems.” 
  • Beckers Health IT relates,
    • “More than 80% of physicians use artificial intelligence in their professional practice — more than double the share in 2023, according to a March 12 survey from the American Medical Association.
    • “AMA polled 1,692 U.S. physicians across various specialties, practice settings and career stages about their use and perception of AI. Responses were collected between Jan. 15 and Feb. 2. About 38% of participants practiced in group settings and 24% in hospitals.” 
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (Takeda Pharmaceutical Co., Ltd.) for narcolepsy type 1.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “Register for ICER’s Early Insights Webinar
    • “On March 24, as part of ICER’s Early Insights Webinar Series, ICER’s Senior Vice President of Research, Foluso Agboola, MBBS, MPH, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “Submit a Public Comment
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on April 7, 2026. * * *
    • “ICER’s Patient Portal and Manufacturer Engagement Guide  provide additional detail on what types of information may be most informative to the report.”

Tuesday report

David Ermer–CDC, Congress, Employee Wellness Programs, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Washington Post reports on the continuing shutdown of the Department of Homeland Security.
  • Federal News Network reports,
    • “Agencies are closing in on an opportunity to hire talent for temporary technology jobs, after the Office of Personnel Management released its first two shared certificates on Tuesday for the Trump administration’s “Tech Force” program.
    • “Lists of eligible candidates for software engineering and data engineering positions are now available for participating agencies to review and potentially hire, an OPM spokesperson confirmed to Federal News Network. If hired, selected employees would move into two-year roles to temporarily work on technology-related initiatives.
    • “Candidates who are listed on the new shared certificates have already passed three rounds of hiring evaluations, including a technical assessment, a resume review and a screening interview, said OPM Director Scott Kupor.”
    • “We hope to have several hundred people now who passed all three phases of that, where we will put them on a shared certificate, and then we will start to push that certificate out to all the participating agencies,” Kupor said during a March 5 event hosted by Federal News Network. “The agencies then have an opportunity, if they so choose, to do an additional round of interviews, if they want to make sure the person is the right fit for their organization.”
  • MedTech Dive tells us,
    • “The Advanced Research Projects Agency for Health, or ARPA-H, launched a new program on Tuesday to support development of biosensors that can track multiple signals such as inflammation markers, hormones or drug levels within the body.
    • ‘The program, called Delphi, will focus on using electronic “chiplets,” with the goal of being able to “mix and match” features across wearables and ingestible sensors.
    • “The initiative comes as Health and Human Services Secretary Robert F. Kennedy Jr. has emphasized a role for wearables in tracking health habits. Last year, the secretary said he wanted all Americans to use wearables, and the Food and Drug Administration’s device center launched a pilot that would allow the agency to waive premarket requirements for certain digital health devices while they collect real-world data under a Medicare program.”
  • Kevin Moss, writing in Federal News Network, points out special features of FEHB and PSHB plans.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “About five months after U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. touted leucovorin as “an exciting therapy that may benefit large numbers of children who suffer from autism” during a White House press conference, the FDA has approved the decades-old drug for a rare genetic condition with “autistic features” that represents a small subset of autism patients.
    • “The FDA has approved GSK’s brand-name leucovorin calcium tablets, Wellcovorin, to treat cerebral folate deficiency (CFD) but only in patients who have a confirmed variant in the folate receptor 1 (FOLR1) gene.”
  • and
    • “Issues at a former Catalent plant now owned by Novo Nordisk have derailed another FDA application, with Incyte announcing Friday that the FDA handed over a complete response letter for its PD-1 inhibitor Zynyz as a first-line treatment for non-small cell lung cancer (NSCLC).
    • “The rejection was not related to any efficacy or safety concerns but rather inspection findings at a fill-finish facility—specifically, the former Catalent plant in Bloomington, Indiana, which is now owned by Novo as part of Novo Holdings’ $16.5 billion acquisition of the CDMO in 2024.
    • “The setback comes more than a year after Incyte detailed a 25% reduction in the risk of death for a combination of Zynyz and chemotherapy versus chemo alone among patients with newly diagnosed metastatic NSCLC in the phase 3 Pod1um-304 trial.” * * *
    • “In a March 9 statement to Fierce Pharma, a Novo spokesperson said the company is “actively engaging with the agency to address its findings.”
  • Beckers Hospital Review informs us,
    • “Ipsen, a Paris-based drugmaker, is removing its cancer drug Tazverik (tazemetostat) from the U.S. market because of safety concerns. 
    • “An ongoing Tazverik clinical trial has reported adverse events of secondary hematologic malignancies — which are blood cancers — indicating “the risks may outweigh potential benefits for patients,” Ipsen said in a March 9 news release. 
    • “The FDA granted Tazverik accelerated approval in 2020. The drug is approved to treat epithelioid sarcoma, a rare, aggressive soft tissue cancer that affects a few hundred patients each year, and relapsed or refractory follicular lymphoma, a form of non-Hodgkin lymphoma.
    • “The company said it is voluntarily withdrawing Tazverik in all indications.”

From the judicial front,

  • Beckers Payer Issues reports,
    • “On March 8, a judge for the U.S. District Court in Connecticut approved a preliminary injunction against Aetna, ordering the insurer to alter its gender-affirming care policy for two plaintiffs.
    • “Several transgender women sued Aetna in 2024 over denied gender-affirming facial reconstructions. The complaint pointed to Aetna’s Clinical Policy Bulletin 0615, which outlines parameters for gender-affirming care.” * * *
    • “Under the preliminary injunction, Aetna must individualize coverage for Jamie Homnick, PhD, and Gennifer Herley, PhD, two of the plaintiffs. Both women lack access to this coverage and have been facing depressive symptoms due to gender dysphoria, a court document said.
    • “Aetna has a strong track record as a proud ally of the LGBTQ+ community and is committed to meeting the healthcare needs of all our members. As a third-party administrator for self-funded plan sponsors, our role is to administer benefits in accordance with the specific terms set forth by each plan,” Aetna said in a statement shared March 10 with Becker’s. 
    • “Many employer benefit plans may include customized coverage for gender-affirming procedures. We work closely with our plan sponsors to meet their unique needs and preferences while complying with all applicable regulations and legal requirements,” the statement continued. “We strongly disagree with the allegations in this lawsuit and will defend ourselves vigorously.” 
  • Here’s a link to the Leapfrog CEO Leah Binder’s statement about the Tenet Healthcare decision mentioned in yesterday’s post.
  • Per a Justice Department news release,
    • “The Department of Justice released today the first-ever Department-wide corporate enforcement policy for criminal matters, promoting uniformity, predictability, and fairness in how it pursues white-collar cases to protect the American people.”

From the public health and medical / Rx research front,

  • Bloomberg Law reports,
    • “South Plains, Texas, had long declared its measles outbreak over when in January wastewater testing picked up what Zachary Holbrooks called “a blip, a spike.”
    • “The testing found measles after months without traces of the virus, which by the 2025 West Texas outbreak’s end infected over 750 people, hospitalized nearly a hundred, and two children died.
    • “With samples sent to Baylor University weekly, subsequent testing hasn’t picked up further traces, said Holbrooks, executive director for the South Plains Public Health District. The goal is to “test long-term” and see “if anything shows up.”
    • “With the Centers for Disease Control and Prevention reporting over 1,200 confirmed measles cases and 12 new outbreaks in 2026, states across the US are taking similar steps to those taken in West Texas to manage infections, mounting outreach strategies, easing access to vaccines, and more.
    • “Working against such efforts are low vaccination rates in pockets of states where misinformation and distrust of government spur outbreaks.
    • “Any state should be looking across its communities and identifying areas where the vaccination rates are lower than 95%. Those are the places that are very ripe for outbreaks,” said Jennifer Nuzzo, director of Brown University’s Pandemic Center.”
    • “Given 2025’s outbreak cycle, states should’ve been better prepared, Nuzzo said. Now, they’ll need to undertake “the very slow, laborious ground game of building trust” in communities to encourage vaccination.”
  • The latest issue of NIH’s Research Matters covers the following topics:
  • Healio relates
    • “Adults with type 2 diabetes who adhered to eight healthy lifestyle habits had a 60% lower risk for cardiovascular events than those who reported zero or one healthy lifestyle habits, researchers reported.
    • “In a prospective cohort study of adults with type 2 diabetes enrolled in the U.S. Veterans Affairs Million Veteran Program, researchers assessed the risk for major adverse CV events according to the number of self-reported healthy lifestyle habits for each participant. The risk for CV events declined with each additional lifestyle habit a person reported, and the findings were similar regardless of whether adults were using a GLP-1 receptor agonist.”
  • and
    • “Risks for cognitive impairment increased with more advanced chronic kidney disease (CKD) stages. 
    • “Associations were strongest for higher urinary protein-to-creatinine ratio plus lower eGFR. ***
    • “Our findings suggest that measures of CKD severity may be relevant to consider in combination with known dementia risk factors, such as age or comorbid conditions,” [Tanika} Kelly [PH.D, MPH] told Healio. “Cognitive screenings should be considered if a patient or family member notice cognitive or behavioral changes.”
  • Health Day informs us,
    • “People think of aging as a steady decline, with seniors gradually losing their physical abilities and mental agility as the years wear on.
    • “But a new study suggests that seniors can – and often do – improve over time, with the right mindset.
    • “Nearly half of seniors 65 and older showed measurable improvement in their brain health, physical function or both over time, researchers reported in the journal Geriatrics.
    • “Many people equate aging with an inevitable and continuous loss of physical and cognitive abilities,” lead researcher Becca Levy, a professor of social and behavioral sciences at the Yale School of Public Health, said in a news release.
    • “What we found is that improvement in later life is not rare, it’s common, and it should be included in our understanding of the aging process,” Levy said.”
  • and
    • “Smoking weed, taking a hit of cocaine or popping some amphetamines can raise a person’s risk of stroke – even if they’re a younger adult.
    • “Coke and amphetamines can double or triple the risk of stroke for any adult, researchers reported in the International Journal of Stroke.
    • “Weed also increases stroke risk, but to a lesser extent, British researchers said.
    • “This is the most comprehensive analysis ever conducted on recreational drug use and stroke risk and provides compelling evidence that drugs like cocaine, amphetamines, and cannabis are causal risk factors for stroke,” lead researcher Megan Ritson said in a news release. She’s a postdoctoral research associate with the University of Cambridge.”
  • Cigna, writing in LinkedIn, discusses how employers can help improve the mental health of their male employees.
    • “Men face unique barriers to seeking mental health support, including stigma, societal expectations, and concerns about confidentiality at work.
    • “Untreated mental health conditions among men contribute to higher healthcare costs, absenteeism, and turnover.
    • “Employers that normalize mental health conversations, protect privacy, and offer tailored support men’s mental health can improve outcomes for employees and business performance.”
  • STAT News notes
    • “Several years ago, nephrologists attempted a first-of-its-kind effort: remove race from a key clinical algorithm, and attempt to undo the harms of the race-based equation for those who were still being negatively affected by it. 
    • “Until 2021, eGFR, which is used to measure kidney function, was inflated by around 16% to 21% for Black patients — which could mask severe kidney disease and delay urgently needed transplants. Not only was the equation phased out in 2022, but the Organ Procurement and Transplantation Network mandated that transplant programs submit modifications for Black patients waiting for transplants. 
    • Several years ago, nephrologists attempted a first-of-its-kind effort: remove race from a key clinical algorithm, and attempt to undo the harms of the race-based equation for those who were still being negatively affected by it. 
    • Until 2021, eGFR, which is used to measure kidney function, was inflated by around 16% to 21% for Black patients — which could mask severe kidney disease and delay urgently needed transplants. Not only was the equation phased out in 2022, but the Organ Procurement and Transplantation Network mandated that transplant programs submit modifications for Black patients waiting for transplants. 
  • and
    • “Vertex said Monday that a drug it secured as part of a $4.9 billion acquisitionsuccessfully reduced by half a key marker of a kidney disease known as IgA nephropathy.
    • “The results, from a Phase 3 trial, match data from a study of Otsuka’s recently approved Voyxact and are numerically superior to data released last year by Vera Therapeutics.
    • “All three companies have been racing to treat a disease that affects 330,000 people across the U.S. and Europe, according to Vertex’s estimates, putting many at risk of developing end-stage renal disease. Analysts have projected Vertex’s drug could eventually bring in $4 billion or more in annual sales.” 

From the HIMSS conference front,

  • Health Tech Magazine reports,
    • The HIMSS Global Health Conference and Exhibition is back in Las Vegas this year, with the tagline “Expert Insights, Exceptional Impact.” 
    • The annual conference kicks off Tuesday with an opening keynote from venture capital leader Jon McNeill (whose experience includes Tesla and Lyft) and Dr. John Halamka, the Dwight and Dian Diercks President of the Mayo Clinic Platform. 
    • Other notable keynote speakers throughout the week include Sumbul Ahmad Desai, vice president of health and fitness at Apple, on Wednesday; and Dr. Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, on Thursday (the final day of the conference). 
    • Before HIMSS 2026 began in full swing, Monday saw a day of preconference sessions organized around topics such as artificial intelligence in healthcare, cybersecurity, interoperability and health information exchanges, among others. 
    • The AI in healthcare preconference track saw healthy attendance with a focus on tangible use cases and lessons on how to deploy AI into improved or better-integrated workflows.
  • Heathcare Dive digs into regulation of artificial intelligence issues.
  • MedCity News adds,
    • “Verily and Samsung are teaming up to accelerate clinical research using wearable data, the companies announced Monday at the HIMSS conference in Las Vegas. 
    • “The companies are integrating user data from Samsung Galaxy smartwatches into Verily’s precision health platform, Verily Pre, so pharma companies and government agencies can run studies and monitor participants remotely.
    • “Researchers will be able to collect continuous health data from study participants wearing Samsung watches, including metrics such as heart rate, sleep and physical activity. The information will flow back into Verily’s data platform, allowing pharma companies and regulators to track patients’ health over time and quickly analyze real-world data.
    • “Consumer wearables are becoming “real, bonafide research-grade instruments,” according to Myoung Cha, Verily’s chief product officer.” 
  • In related news, “Ratnakar Lavu, chief digital information officer at Elevance Health, sat down with MobiHealthNews for an in-person interview to discuss the framework the health insurance company uses to validate and scale AI in healthcare.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Centene’s stock took a nosedive on Tuesday as the company’s top brass offered further color on the marketplace headwinds battering its performance.
    • “CEO Sarah London said during the Barclays Global Healthcare Conference that membership in its Affordable Care Act exchange plans was down to 3.6 million as of February, from 5.5 million at the end of 2025. She said the team expects that to decline further to about 3.5 million by the end of Q1.” * * *
    • “The company had braced for a likely downturn in enrollment following the expiry of the enhanced premium tax credits and the planned implementation of program integrity measures that proved controversial in the industry.” * * *
    • “Given that these shifts are driven in part by the end of the enhanced subsidies, London said that the member mix in the bronze tier does look different than in years past. Prior to the rollout of the enhanced subsidies in response to the pandemic, the bronze tier was largely made up of younger, healthier individuals.
    • “Now, the insurer is seeing people select a bronze plan because it’s a lower cost option to ensure they maintain coverage, even if they were previously in a silver or gold plan, she said.”
  • Modern Healthcare relates,
    • “Elevance Health is expanding [to California] a policy to penalize hospitals that refer patients to out-of-network providers. [The purposes of this sensible policy is to reduce No Surprises Act claims.}
    • “The insurance company has introduced the policy in at least 11 other states. 
    • “The American Hospital Association and Federation of American Hospitals have pushed back against the policy.”
  • Beckers Hospital Review tells us,
    • “Private equity firms have become a major force in healthcare, investing more than $1 trillion over the last ten years, according to a recent report from New York University’s Stern Center for Business and Human Rights.
    • “The report, published March 10 and authored by Michael Goldhaber, examines how private equity’s investments have impacted patient care, hospital finances and medical access.
    • “There is a healthcare crisis in the United States. Costs are rising, driven by market consolidation, increased insurance premiums, escalating drug prices and other changes,” the report said. “Many hospitals and healthcare facilities are experiencing staffing shortages. These and other factors mean that the poorest people in the U.S. have worse health outcomes than those in other high-income countries, despite the high level of spending.”
  • Fierce Healthcare adds,
    • “Highly concentrated—and, by extension, less economically competitive—hospital markets are ubiquitous across the country and the norm in rural states Wyoming, North Dakota and South Dakota, according to a market analysis tool unveiled this week by Yale University’s recently launched Health Care Affordability Lab.
    • “Every hospital in those three states operates in a market deemed to be highly concentrated or even monopolistic based on their Herfindahl-Hirschman Index (HHI), a metric used by the “Federal Trade Commission (FTC) and the Department of Justice (DOJ) to determine when it should intervene in a deal on competitive grounds. 
    • “More broadly, the tool shows that 94% of the nation’s hospitals operate in markets with HHIs above 1,800, reflecting a highly concentrated market.” 
  • BioPharma Dive lets us know,
    • “Ugur Sahin and Özlem Türeci, who co-founded BioNTech and led its rise to prominence as a COVID-19 vaccine maker, are leaving the company to establish a new startup focused on mRNA technology. 
    • “BioNTech said Tuesday that Sahin and Türeci, who’ve been serving as CEO and Chief Medical Officer, respectively, will step down by the end of the year. Afterwards, they’ll steer a startup working on “next-generation mRNA innovations.” BioNTech will grant that unnamed biotech certain rights to its mRNA technology in exchange for a minority stake, but won’t provide ongoing capital support, the company said.
    • “BioNTech, meanwhile, will focus on advancing a late-stage portfolio that now includes several different cancer medicines. The company said its supervisory board has initiated a search to identify successors for Sahin and Türeci and ensure a “smooth transition.” It’ll provide more details on the partnership with the new startup once an official deal is signed. Paperwork should be completed by the end of the first half.”
  • Beckers Hospital Review points out,
    • “Statista, a global data company that publishes insights for 170 industries, projects four cancer therapies will be among the top 10 best-selling pharmaceutical products in the U.S. this year. 
    • “The company projects Merck’s cancer drug Keytruda will earn $12.7 billion in U.S. revenue in 2026 — nearly twice that of the second top-selling medication, according to data shared March 9 with Becker’s. 
    • “[The article identifies] the medications Statista projects will be the 10 best-selling U.S. pharmaceutical products in 2026.”
  • Fierce Pharma notes,
    • “Sandoz has not minced words about the massive yet largely untapped opportunity biosimilar makers are presented with as dozens of branded medicines inch toward the patent cliff in the next decade. 
    • “Now, in an effort to fully capitalize on what the company recently referred to as a potential “‘golden decade’ of affordable medicines” after 2030, Sandoz is committing even further to its biosimilar business with plans to launch a dedicated unit that will operate separately from the company’s remaining small molecule generics division.”
    •  “The new biosimilar unit, focused on development, manufacturing and supply of copycat biologic drugs, will be led by Armin Metzger, most recently chief technical operations officer at fellow Swiss drugmaker Ferring Pharmaceuticals.”
  • Per MedTech Dive,
    • “Medtronic said Tuesday it agreed to acquire neurovascular technology company Scientia Vascular for $550 million, with the potential for undisclosed milestone payments after the acquisition.
    • “Scientia’s neurovascular access devices are used to navigate the brain’s complex vasculature to treat conditions such as strokes and aneurysms.
    • “The Scientia proposal is Medtronic’s second deal of the year, after the company announced an acquisition of CathWorks for up to $585 million in February.”

Thursday report

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

From Washington, DC

  • The House of Representatives today passed the Department of Homeland Security Appropriations Act, 2026 (HR 7744) by a 221 to 209 vote. The Senate , however, failed to invoke cloture on a similar bill (HR 7147) by a 51-45 vote (60 votes required), meaning the ongoing DHS shutdown will continue.
  • Per a Senate news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, delivered remarks during today’s hearing on how the U.S. Office of National Coordinator for Health Information Technology (ONC) is improving health outcomes using patient health information.
    • “Click here to watch the full hearing.”
  • Govexec reports,
    • “The Trump administration will continue working to shrink the size of the federal workforce after already shedding more than 300,000 employees, a White House official said on Thursday, who suggested a leaner civil service will be more effective as a result of its reduced stability. 
    • “Continuing to reduce the size of the federal government and its workforce remains “priority number one,” Office of Management and Budget Deputy Director for Management Eric Ueland said at a government efficiency conference in Washington, adding it would contribute to the goal of tackling waste, fraud and abuse. He pledged that individual agencies would ensure consistent and transparent communication on their plans, so employees would at least have a clear roadmap of what is to come even if they disagree with the destination.” * * *
    • “Scott Kupor, the Office of Personnel Management [OPM] Director who also spoke at the panel, said his agency is not giving agencies any specific targets for workforce reduction.” * * *
    • “He added the needs of government will continue to grow, but agencies must find ways to add to their portfolios without adding staff.” 
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the Attorney Talent Network.
    • “The Attorney Talent Network enables attorneys from across the United States to connect directly with federal recruiters and explore career opportunities in the federal government. By joining the network, attorneys can make their resumes searchable, receive notifications about job openings, and be alerted to upcoming hiring events.” * * *
    • “Attorneys interested in joining can create or log in to their USAJOBS account, upload their resume, and opt in to share their profile with federal recruiters through the here.
    • “For more information or to join the Attorney Talent Network, click here.”
  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services and Education March 5 announced a new initiative to increase nutrition education in medical schools beginning this fall for the next academic year. The agencies announced commitments from 53 schools for the program, which will provide at least 40 hours of nutrition education or a 40-hour competency equivalent for medical students. HHS also announced $5 million in funding for a multi-phase education challenge by the National Institutes of Health to support medical schools, nursing residency, nutrition science and dietitian programs that integrate nutrition education into their curricula. Additionally, HHS said that Public Health Service officers will be required to complete nutrition-focused continuing education hours as part of their career development.”
  • Newfront offers RxDC reporting considerations for 2026 filings.
  • Per an AHIP news release,
    • “A new national survey finds American workers hold consistently positive views of employer-provided health care coverage, with nearly nine in 10 expressing satisfaction with their plans and strong majorities valuing the financial security and peace of mind their coverage provides.
    • “Employer-provided coverage is the backbone of our nation’s health care system, delivering high-quality, affordable health care and financial security to more than 180 million Americans. These findings confirm once again that Americans strongly value their employer-provided health coverage and want policymakers to support the longstanding partnership between employers and health plans,” said AHIP president and CEO Mike Tuffin.
  • Modern Healthcare points out,
    • “A health insurance industry-backed coalition is going after hospitals in a bid to capitalize on Washington’s bipartisan focus on affordability and rising healthcare costs.
    • “Better Solutions for Healthcare launched its “Hospital Watch” campaign last month. The organization’s website links to news articles and data that are unflattering to the hospital sector. A banner on the home page reads, “Shining a Light on Corporate Hospital Systems’ Role in Driving America’s Healthcare Cost Crisis.”
    • “The effort could prove well-timed. Over the past few years, Congress has focused on drug prices and pharmacy benefit managers — as has President Donald Trump — and on health insurance premiums and industry practices. Their attention may be shifting to providers.”

From the Food and Drug Administration front,

  • The Wall Street Journal lets us know,
    • “Federal health officials, facing criticism from lawmakers for recent rejections of rare-disease drugs, attacked an Amsterdam-based biotech company seeking approval of a Huntington’s disease treatment and accused it of lying.
    • “The public criticism of Uniqure by officials at the Food and Drug Administration and Health and Human Services department was unusual for agencies that normally shy away from commenting on products still under consideration.
    • “The attacks risk further angering members of Congress who have been pressing the Trump administration to be more open to approving rare-disease therapies, after FDA officials rejected or delayed some applications for approval of some new drugs.”
  • STAT News explains,
    • “Is it better to approve a drug with undetermined or debatable benefits that is later found not to be effective?
    • “Or, is it better to reject or block a drug with undetermined or debatable benefits that is later found to be effective?
    • “These are two fundamentally different regulatory philosophies. Peter Marks, the former FDA regulator of cell and gene therapies, was firmly in the “approve now” camp. He believed in maximal flexibility, one might even call it absolute permissiveness.
    • “If there was a chance a treatment could help a patient with a rare disease, even if the data were equivocal, Marks was willing to approve it. Rejecting that drug and later learning that it was effective is a far worse outcome, in Marks’ view.
    • “Vinay Prasad, Marks’ successor at the FDA, takes a maximalist approach in the other direction. He wants to approve drugs that work with certainty. The regulatory bar is high.
    • “Uncertainty — anything outside the statistical fence — is a disqualifier. For Prasad, approving a drug without proven benefit is false hope. Approving a drug that later ends up being ineffective is the worst outcome.
    • “Two regulators, two extreme regulatory philosophies, one replacing the other.
    • “The rare disease community is suffering whiplash. Drugmakers are frustrated. Investors are sitting on their wallets.”
  • Fierce Pharma reports,
    • “Since discontinuing its two branded versions of asthma inhaler Flovent at the start of 2024, GSK has still produced “authorized generic” versions of the treatment, which are the same products with different labels distributed by another firm.
    • “Now, true competition has finally arrived for GSK’s Flovent in the form of an FDA approval for Glenmark’s fluticasone propionate inhalation aerosol. The inhaled corticosteroid, which reduces inflammation in the lungs, is a maintenance treatment and can be used by patients ages 4 and older to prevent wheezing and shortness of breath.
    • “As the first company to gain FDA approval for a Flovent generic, Glenmark receives 180 days of exclusivity before other makers of generics can enter the market. Glenmark will begin distributing fluticasone this month, the company said in a release.”
  • Radiology Business reports,
    • “The U.S. Food and Drug Administration has approved the first artificial intelligence-powered imaging device for breast cancer surgery. 
    • “Manufacturer Perimeter Medical Imaging announced the news on Tuesday after earning premarket approval for “Claire” (formerly the Perimeter OCT B-Series). The product also has received Breakthrough Device designation, with it designed to enhance surgeon’s ability to detect difficult-to-see cancers during surgery. 
    • “This could potentially reduce the need for repeat operations and save excess healthcare costs, the company contends. 
    • “Repeat breast cancer surgeries due to residual disease remain a significant clinical, health and economic burden,” Perimeter CEO Adrian Mendes said in a statement March 3. “Claire’s FDA approval marks a major milestone in breast cancer care, as we advance our goal of reducing repeat surgeries so that no patient has to be told ‘we didn’t get it all.’”
    • “Mendes said the Dallas-based company plans to roll out the product nationwide in the coming weeks. Claire combines proprietary AI with wide-field OCT imaging, enabling high-res, real-time evaluation of excised tumor margins. The system purportedly can deliver 10 times higher resolution when compared to standard X-ray and ultrasound.” 
  • BioPharma Dive adds,
    • “PepGen is in a holding pattern on its request to include U.S. patients in a Phase 2 trial of a muscle disorder treatment after the Food and Drug Administration put a partial halt on the study.
    • “The agency did not raise any questions about the company’s data in patients with the condition known as myotonic dystrophy type 1, or DM1, instead focusing on previously submitted preclinical work, PepGen said Wednesday. Specifically, the FDA seems concerned about drops in blood pressure in a study of mice that have not been seen in humans, analysts wrote.
    • “PepGen said it’s working with the FDA to address the concerns as quickly as possible. The company is continuing its Phase 2 work elsewhere and recently got permission to open the “Freedom2” studyto patients in New Zealand, Australia and South Korea.” 

From the judicial front,

  • Per a Justice Department news release,
    • “Brad D. Schimel, United States Attorney for the Eastern District of Wisconsin, announced today that Kinex Medical Company, LLC, agreed to pay $6,925,000 to resolve allegations that it violated the False Claims Act by submitting false claims to Medicare, TRICARE, and other federal programs.
    • “Based in Waukesha, Wisconsin, Kinex sells and distributes durable medical equipment, including knee, shoulder, and hip braces, to patients across the United States. After receiving information from a whistleblower, the United States investigated and alleged that the company submitted false claims to Medicare, TRICARE, the Federal Employees Health Benefits Program (FEHBP), and the Office of Workers Compensation Programs of the Department of Labor (OWCP). 
    • “Specifically, the United States alleged that from 2019 through 2024, Kinex provided patients covered by these programs with medical braces that the patients did not need and then billed Medicare, TRICARE, FEHBP, and OWCP as if the braces had been necessary. The United States also alleged that Kinex convinced the patients to accept the braces by waiving costs like patient co-pays and by giving the patients other equipment for free.
    • “In addition to paying nearly $7 million to resolve the allegations concerning these false claims, Kinex also entered into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General (HHS-OIG), to ensure compliance with applicable regulations going forward.”
  • Fierce Healthcare relates,
    • “The Federal Trade Commission (FTC) may be nearing settlements with the remaining two pharmacy benefit managers involved in a lawsuit over insulin pricing.
    • “In a court filing (PDF) posted this week, the agency disclosed that it is making “significant progress” in talks with both CVS Health’s Caremark and UnitedHealth Group’s Optum Rx on the heels of a broad settlement with Cigna’s Express Scripts.
    • “In late January, the FTC suspended the administrative case against Express Scripts, indicating a settlement was in the works. That settlement was later confirmed Feb. 4, with the PBM agreeing to a slew of changes to resolve allegations that it unlawfully and artificially inflated the price of insulin.
    • “In the filing, the agency pushed back the date for an evidentiary hearing and oral arguments in the case by 21 days, to late March, to allow for greater negotiation time.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Initiation of a GLP-1 receptor agonist was tied to lower risks of several substance use disorders (SUDs) in adults with type 2 diabetes, according to a target trial emulation using data on veterans.
    • “In patients without a history of any SUD, those who started a GLP-1 drug versus an SGLT2 inhibitor had a reduced risk of a composite outcome of all SUDs, including alcohol, cannabis, cocaine, nicotine, opioid, and other SUDs (HR 0.86, 95% CI 0.83-0.88), reported Ziyad Al-Aly, MD, of the VA Saint Louis Health Care System, and colleagues.
    • “Benefits also extended to those with pre-existing SUDs, the researchers wrote in The BMJ.” 
  • The AAMC shares information about
    • GLP-1 pills for weight loss are here. How will they change obesity care?
  • and
    • What you need to know about the updated childhood vaccination schedule.
  • Cardiovascular Business informs us,
    • “A new implantable artificial intelligence (AI) device that modulates venous pressure to increase renal perfusion in diuretic-resistant heart failure patients was associated with positive 90-day data in the first-in-human RELIEF-FIH study. Researchers presented the data at the THT 2026 conference in Boston.
    • “The Relief System from Relief Cardiovascular is a first-of-its-kind device. The goal of the device is to better manage heart failure congestion at home. It is one of many new heart failure technologies aimed at finding new ways to reduce heart failure rehospitalizations, which are a major driver for healthcare costs.
    • “The Relief System incorporates a valve and sensor implant that uses AI to intelligently modulate venous pressure using hemodynamic data. The system actively adjusts flow in the inferior vena cava (IVC), which lowers venous pressure to drive durable decongestion in heart failure. It uses a daily transmission of hemodynamic data to adjust the valve through a cloud-enabled interface.”

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

  • Beckers Payer Issues reports,
    • “Excellus BlueCross BlueShield ended 2025 with a 1.4% operating loss totaling $108 million, as medical and drug claims climbed 16% year over year to nearly $7 billion. The insurer said March 5 the results are its largest annual claims increase in nearly 20 years.
    • “Last year, Excellus spent roughly $19 million daily on medical and drug benefits for its 1.5 million members. The company’s 2025 medical loss ratio was 92%, and it recorded a 2% net margin and $150 million in net income. Reserves closed the year at $1.7 billion, which is equal to less than three months of claims and operating expenses.
    • “Medicare Advantage drove most of the cost increase.”
  • and
    • “Three of four Regence health plans ended 2025 with operating losses as medical and drug costs climbed across Oregon, Washington, Idaho and Utah, according to results published by the organizations on March 2.
    • “The Washington plan was the hardest hit. Regence BlueShield reported an operating loss of nearly 8% on total revenue of $2.38 billion and a net loss of 3.1%. The plan paid $2.17 billion in care for its fully insured members, with per-member costs rising more than 15% year over year. Total membership at the end of 2025 was 1.58 million.
    • “In Oregon, Regence BCBS posted a 1.3% operating loss on revenue of $3.18 billion, though investment returns pushed the plan to 1.5% net income. The plan paid $2.9 billion in care for fully insured members, at $6,022 per member, up 15% from 2024. Total membership was roughly 950,000 at the end of 2025.
    • ‘Regence BlueShield of Idaho also ran an operating loss, at 0.5% on revenue of $752 million, but finished with net income of 2.5% because of the strength of investment returns. Per-member costs rose more than 22%, the steepest increase among the four plans. The plan had more than 350,000 members at year’s end.
    • “Regence BCBS of Utah reported net income of 3.5% on total revenue of $1.45 billion, slightly above its 10-year average of 3%, driven by strong member retention and investment income. The plan paid $1.31 billion in care for fully insured members, with per-member costs rising nearly 5%. Membership held at roughly 740,000.”
  • The Commonwealth Fund tells us,
    • “Changing how we pay for primary care can incentivize clinicians to deliver the right care at the right time. Historically, clinicians have been retroactively paid a fee for each service they provide. Known as fee-for-service (FFS), this practice encourages clinicians to provide more services, rather than efficiently deliver comprehensive care. Although it can lead to more care, it may not lead to better health outcomes.
    • “Instead, we could use payment to encourage primary care clinicians to deliver appropriate, efficient care in coordination with other clinicians. An increasingly common way to do this — value-based payment (VBP) — ties clinicians’ payments to their performance on outcomes, including the cost and quality of care. Specific outcomes include the way clinicians manage patients’ chronic conditions or the minimization of avoidable hospitalizations. The evidence shows that changing how we pay for primary can improve patients’ outcomes, including reducing avoidable hospitalizationsand increasing access to coordinated care.
    • “Despite the promise of VBP, some primary care practices have been left behind, and their patients haven’t been able to benefit. Policymakers and payers are particularly worried about low participation among rural, small, and independent practices, as well as community health centers (CHCs) that face unique barriers to participation.
    • “In this blog post, we assess current rates of primary care physician (PCP) participation in VBP, using data from the 2025 Commonwealth Fund International Health Policy Survey of Primary Care Physicians. We also highlight opportunities to design value-based models to account for the needs of different practice settings, such as small or rural practices.”
  • STATNews relates,
    • “Digital chronic care company Omada reported a quarterly profit for the first time since going  public less than a year ago, the company revealed while announcing  its full year 2025 earnings Thursday. 
    • “Omada also provided earnings guidance for 2026, suggesting the company will continue to grow as it capitalizes on the demand for popular GLP-1 obesity medications.
    • ‘Omada earned $260 million in revenue in 2025, 53% more than the year before — above top-end preliminary results the company announced at the J.P. Morgan Healthcare Conference in January. In August, shortly after it went public, it projected top-end earnings of $241 million for the year.
    • “Notably, the company reported $5 million in net income in the fourth quarter of 2025 — the first time the company has turned a net profit. 
    • “We’re pretty ahead of schedule on a lot of positive financials,” Omada CEO Sean Duffy told STAT.”
  • Modern Healthcare tells us,
    • “CVS Health plans to launch a health technology subsidiary later this year that will offer an artificial intelligence-based platform designed to help consumers access healthcare information and services. 
    • “The platform will allow patients to find providers, compare costs of care and centralize their health records and information, CVS said. It also will make recommendations for the next steps of care for patients with chronic conditions and offer care management through a digital health portal between visits.
    • “The Health100 consumer platform, slated to launch midyear, will use agentic AI and be powered by Google Cloud technology, including Gemini AI programs.
    • “It will be rolled out first to CVS Health customers and not all features will be available upon launch, a spokesperson said. It will be expanded to other consumers, and outside providers and other companies can opt in to participate, the spokesperson said.”
  • Healthcare Dive adds,
    • “Amazon Web Services rolled out a suite of agentic artificial intelligence tools Thursday that aim to handle a range of healthcare tasks, like helping patients schedule appointments and summarizing medical data for clinicians. The product, called Amazon Connect Health, includes five capabilities: verifying patients’ identities; handling appointment scheduling; creating summaries of patient medical histories; creating clinical notes based on conversations between clinicians and patients; and generating medical codes from clinical documentation. 
    • “Amazon Connect Health should help patients more easily access care and assist with clinicians’ administrative work, according to Naji Shafi, general manager and director of healthcare AI at AWS. “Our healthcare workers are overburdened, drowning in administrative complexity, and it’s costing everyone,” he said.” 
  • Per Beckers Health IT,
    • “Optum is expanding its collaboration with Microsoft to introduce new AI-powered capabilities within Optum Real, a real-time claims platform designed to connect payers and providers and streamline reimbursement workflows.
    • “In a March 5 news release, the companies said the new capabilities combine Optum’s healthcare data and analytics expertise with Microsoft technologies including Azure, Dragon Copilot and Microsoft Foundry. The platform aims to give providers a unified view of clinical and operational data while helping teams identify coverage issues, automate documentation tasks and address prior authorization requirements earlier in the care process.”
  • Fierce Healthcare informs us,
    • “Eli Lilly has officially launched Employer Connect, its direct-to-employer platform for its obesity medications, after teasing the rollout late last year.
    • “The drugmaker said in an announcement that the program is aimed at supporting employer choice and enabling them to build the solution that works best for them and their workforces. It will launch with more than 15 independent program administrators as partners, which allows employers to select multiple models.
    • “Coverage for GLP-1s remains a key challenge for employers to navigate, as there is significant demand for the drugs that often come at a high cost. Within the program, Lilly will offer Zepbound KwikPen to network pharmacies at a discounted $449 price.
    • “What the patient ultimately pays could vary based on the employer’s cost sharing model and which partner they lean on, per the announcement.”
  • Fierce Pharma points out,
    • “Galderma has significantly raised its peak annual sales estimate for Nemluvio (nemolizumab) to more than $4 billion, doubling its previous projection of more than $2 billion. The update follows what CEO Flemming Ørnskov described as an “outstanding launch trajectory” for the inflammatory skin condition drug in its first full year on the market. 
    • “Driven by strong adoption in its existing indications of atopic dermatitis and prurigo nodularis (PN), Nemluvio posted $452 million in 2025 sales. Growth accelerated sharply in the second half of the year, with the period contributing $321 million to the total. It comes as real-world experience with the IL-31 receptor inhibitor exceeded initial expectations, Ørnskov said on Galderma’s fourth-quarter earnings call Thursday.”
  • and
    • “After delivering solid sales growth in a difficult 2025, Germany’s Merck KGaA may have a tougher go of things this year, which the company is crediting in part to a predicted onslaught of U.S. generics to its multiple sclerosis blockbuster Mavenclad. 
    • Approved by the FDA in 2019, Mavenclad delivered its third straight year of blockbuster sales in 2025, charting nearly 17% growth over the previous year to 1.2 billion euros ($1.4 billion) worldwide, Merck KGaA reported Thursday. In North America specifically, the drug reeled in 635 million euros ($735 million) last year, Merck noted in a detailed earnings report issued(PDF) March 5.” * * *
    • “[I]n an unfortunate turn for Merck, recent efforts to stave off Mavenclad patent challenges in the U.S. have fallen short, prompting the drugmaker to more or less throw in the towel on future growth for the MS med stateside. 
    • “In particular, Merck’s guidance for the year—anticipating sales between 20 billion euros and 21 billion euros, or -1% to 2% growth— “assumes no U.S. sales of Mavenclad from March 2026 amid generic competition.”  

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

From Washington, DC

  • The Hill reports,
    • “Top Democrats are whipping against the Department of Homeland Security (DHS) funding bill expected to come to the floor this week, even as Republicans press them to support it in the wake of the U.S. attacks on Iran. 
    • “The White House and Democrats have been locked in an impasse over a deal to reopen DHS, as the minority party calls for the administration to overhaul Immigration and Customs Enforcement (ICE) following the killings of two U.S. citizens in Minnesota by federal agents.” 
  • Per a CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released Medicare.gov Enhanced Login options. By providing people with Medicare these options, Medicare.gov is helping users better manage their health care information by delivering more login choices. People with Medicare do not need to create an account to access general Medicare information or their individualized Medicare information. If someone chooses to create an account, Medicare is providing new and free options with enhanced security to help protect their Medicare information.”
  • Beckers Payer Issues adds,
    • “Medicare Advantage plans looking to maintain no-premium models could face 50% cuts to supplemental benefits and $1,000 more in older adults’ cost exposure in 2027, according to February reports commissioned by health insurance trade association AHIP.
    • “Wakely Consulting Group conducted the research. The groups evaluated how CMS’ proposed 0.09% 2027 payment increase for MA would play out for insurers and their beneficiaries. AHIP sent the findings to CMS in a Feb. 25 letter.”
  • The Paragon Health Institute notes,
    • “The [Medicare] primary base hospital payment rate for inpatient services—known as the Inpatient Prospective Payment System (IPPS) operating base rate—has increased by 30 percent since 2016, mainly because of statutory formulas.  The outpatient services base rate—known as the Outpatient Prospective Payment System (OPPS) conversion factor—has increased by 26 percent since 2016, also mainly because of statutory formulas. Meanwhile, the physician base payment rate—known as the Physician Fee Schedule (PFS) conversion factor—has declined by 7 percent over the same period.
    • “The declining PFS conversion factor and the rising hospital base rates are not an accident but a result of policy choices made by Congress.” * * *
    • “To reduce distortions, hospital payments in Medicare should be subject to similar fiscal sustainability pressures as physician payments. Policymakers should consider proposals that address distortions and, in particular, site neutral payment policies that equalize payments for the same services across all providers.” 
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted a Special Report on Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.) for the treatment of ulcerative colitis and Crohn’s disease. This report will be submitted to the Centers for Medicare & Medicaid Services (CMS) as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2028. 
    • “Downloads: Final Report
    • “Over three million people in the United States suffer from inflammatory bowel diseases like ulcerative colitis and Crohn’s disease. Our special report focuses on the medical evidence for and value of Entyvio, which is commonly used to treat both conditions,” said ICER’s President and CEO Sarah K. Emond, MPP. “We recognize that our report will be one of many inputs CMS may consider, and we hope that it will support their ongoing efforts to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced Kurt Dykstra as General Counsel.
    • “Dykstra is an accomplished attorney with nearly three decades of experience handling complex workforce issues, regulatory compliance, internal investigations, and governance. His career spans corporate law, higher education, financial services, and public service, including leadership roles as a law firm shareholder, university counsel, college president, bank executive, mayor, and Major in the US Army Reserve.
    • “As OPM’s Chief Legal Officer, Dykstra will lead the Office of the General Counsel and advise the director and agency leadership on legal and policy matters.
    • “Kurt is a proven leader with the judgment and experience to help guide OPM through complex legal and workforce challenges,” said OPM Director Scott Kupor. “He understands how strong governance, accountability, and sound legal strategy support effective government. I am confident his leadership will help ensure OPM continues to serve federal employees and the American people with integrity and excellence.”
  • The Wall Street Journal relates,
    • “Patient Advocate Foundation and Patient Access Network Foundation merged, creating a nonprofit with over $800 million in assets.
    • “Kevin Hagan is chief executive of the combined Patient Advocate Foundation, which aims to serve patients facing rising costs.
    • “The combined foundation will launch a TotalAssist program in July and offer more than 130 disease-specific financial assistance funds.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration has been talking a big game about bringing artificial intelligence to patients. In January, when it announced relaxed rules for certain AI products, Commissioner Marty Makary said the agency is “developing a new regulatory framework for AI.” 
    • “How the agency will regulate rapidly-evolving uses of generative AI is one of the big questions facing health technology developers. Large language models’ wide-ranging applications evade simple measures of safety and efficacy, challenging the FDA’s longstanding approach to device validation — and the agency has yet to authorize a device that relies on generative AI. But a recent breakthrough designation from the FDA could offer hints about its approach to regulating patient-facing chatbots that fall under its purview. 
    • “In November, the FDA quietly handed one of its breakthrough device designationsto a chatbot for patients recovering from joint replacement surgery. Under development by RecovryAI, which is coming out of stealth as it announces the designation, the LLM-powered device would be prescribed to patients to use in the 30 days after surgery. It will encourage them to check in twice a day about their sleep, activity, diet, and other elements of recovery, answering questions and escalating to a care team when necessary.” 
  • Radiology Business adds,
    • “An artificial intelligence-enabled tool capable of accurately predicting an expectant mother’s delivery date has received the U.S. Food and Drug Administration’s De Novo clearance. 
    • “Ultrasound AI—a company that specializes in medical imaging AI applications—on Monday announced the clearance of its flagship Delivery Date AI technology. The product is a cloud-based software as a medical device that predicts delivery dates using ultrasound imaging alone. This could help to better prepare both patients and providers for potential complications, reducing the likelihood of preterm birth. 
    • “It was trained on a diverse dataset of over 1 million ultrasound images and evaluated via a peer-reviewed study, published in the Journal of Maternal-Fetal & Neonatal Medicine. The study, which included nearly 6,000 patients, determined AI could achieve an accuracy of 0.92 R² value for predicting the day a mother would deliver her child using only standard ultrasound images. 
    • “Delivery Date AI can be easily integrated into most ultrasound systems. Ultrasound AI indicates that installation takes just a few minutes and offers organizations scalability while also potentially reducing long-term costs by improving maternal outcomes.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. 
    • “It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”
    • “This is the second group of warning letters sent to telehealth firms since the agency launched in September a crackdown on misleading direct-to-consumer pharmaceutical advertisements. Over the past six months, the agency has sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads, more than had been sent over the entire preceding decade.”
  • Per BioPharma Dive,
    • “Pierre Fabre Pharmaceuticals has asked the Food and Drug Administration for an urgent meeting to discuss why the agency rejected a cell therapy for a post-organ transplant malignancy, the company said Tuesday, following claims by partner Atara Biotherapeutics that the agency contradicted its previous guidance.” * * *
    • “The regulatory dispute over Ebvallo is one of a series of recent squabbles between drugmakers and the FDA related to previous agreements on approval standards. On Monday, UniQure learned it will have to conduct another trial of a Huntington’s disease gene therapy. Last month, the agency initially refused to review a flu vaccine from Moderna before quickly changing course.”

From the judicial front,

  • Medical Economics tells us,
    • “Advanced analytics and multi-agency coordination are shortening investigative timelines and expanding parallel civil FCA, criminal, administrative, and state litigation exposure from a single operational issue. 
    • “Enterprise-level FCA theories are emphasizing systems, governance, and vendor relationships, with sustained focus on managed care, prescription drugs, and medically unnecessary services. 
    • “Medicare Advantage risk adjustment scrutiny is extending to incentive design, retrospective addenda, chart review vendors, and documentation tools that may be construed as rewarding coding intensity. 
    • “Telehealth platforms face continued controlled-substance risk despite extended prescribing flexibilities, with enforcement targeting clinical legitimacy, marketing representations, cross-state compliance, and decision-making controls. 
    • “Cybersecurity and privacy failures are becoming enforcement multipliers via FCA cyber-fraud theories, CCPA actions, and HIPAA tracking-technology scrutiny involving adtech and analytics data sharing.”
  • STAT News reports,
    • “Moderna has agreed to pay Roivant up to $2.25 billion to settle claims that the mRNA vaccine developer infringed on Roivant’s patents in its Covid-19 shot.
    • “Roivant will receive $950 million and then another $1.3 billion if Moderna’s attempts to have parts of its liability offloaded to the federal government fail upon appeal. If the full amount is paid, it will be among the largest patent settlements in history. 
    • “It is probably the largest ever,” said Jacob Sherkow, a professor of law and medicine at the University of Illinois Urbana-Champaign.
    • “The settlement comes less than a week before the two companies were set to go to a jury trial in Delaware, where legal experts say Moderna may have faced an uphill battle.\

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • To live long, be strong.
    • That’s the poetic implication of a new study of longevity and mortality in a large group of women aged 63 to 99.
    • “In the study, published in February in JAMA Network Open, researchers checked the women’s health, fitness, grip strength and lifespans. By analyzing that data, they hoped to tease out the importance of muscular strength for healthy aging.
    • “The results “were a bit of a surprise,” said Michael J. Lamonte, lead author of the study and a professor of epidemiology and healthy aging at the University of Buffalo in New York. Strength turned out to be a key — and singular — contributor to longer lives, he said, reducing the risk for early death by a third or more, even when the researchers took into account people’s aerobic fitness, health, age and exercise habits.”
  • The American Medical Association lets us know what doctors wish their patients knew about cystic fibrosis.
  • MedPage tells us,
    • “A meta-analysis found that women lost more weight than men while taking a GLP-1 receptor agonist.
    • “Biological differences, such as estrogen levels and body composition, may explain why women respond more to these agents.
    • “Weight loss was consistent across many other patient subgroups broken down by age, race and ethnicity, body mass index, and HbA1c.”
  • and
    • “Lithium carbonate might have slowed decline in verbal memory in a pilot study.
    • “However, the treatment did not meet a prespecified threshold for the trial’s primary outcomes.
    • “Earlier research suggested lithium may offer neuroprotective benefits in Alzheimer’s and dementia.”
  • Genetic Engineering and BioTechnology News points out,
    • “Immune monitoring is useful to monitor processes like vaccination and during diseases like infectious disease, cancer, and autoimmunity. However, detection of antigen-specific lymphocytes is challenging given that are low in frequency and have a dispersed distribution.
    • “Now, the first bandage-like, painless, microneedle patch that can sample the body’s immune responses from the skin has been developed. The device detects inflammatory signals within minutes and collects specialized immune cells within hours without the need for blood draws or surgical biopsies.
    • “The study appears in Nature Biomedical Engineering in the paper, “Leveraging tissue-resident memory T cells for non-invasive immune monitoring via microneedle skin patches.”
    • “The patch is helping researchers and clinicians study immune responses in aging and skin autoimmunity, including vitiligo and psoriasis. In the future, it could make it easier to track how people respond to vaccines, infections, and cancer therapies by complementing traditional blood tests and biopsies while being far easier on patients.”
  • Per BioPharma Dive,
    • “Shares of Aardvark Therapeutics lost more than half their value after safety worries led the biotechnology company to halt testing of its most advanced drug prospect. 
    • “Aardvark said Friday that, “out of an abundance of caution,” the company has voluntarily paused dosing and enrollment in a Phase 3 trial of ARD-101, an experimental drug it’s been developing for the rare genetic disease Prader-Willi syndrome. According to Aardvark, trial monitors detected “reversible cardiac observations” during a routine safety check in a study of healthy volunteers.” 
  • and
    • “Kyowa Kirin will stop all trials of an eczema drug once seen as a possible future blockbuster, claiming a new safety review has led the company to believe that the treatment’s risks may outweigh its benefits.
    • “In a Tuesday statement, the company said a planned evaluationconducted by the company and former development partner Amgen in recent weeks unearthed “emerging concerns of malignancies” related to treatment with a therapy known as rocatinlimab. These concerns included one new confirmed case and another suspected case of Kaposi’s sarcoma, a cancer that forms around skin lesions.”
    • “The findings suggest a potential link between onset of the cancer and the drug’s mechanism of modulating an immunogical pathway called OX40. While the overall number of cases is below expected background rates, the “characteristics” involved “raised a plausible biological concern that cannot be excluded,” the company said.
    • “All studies will be discontinued after study participants complete their required safety follow-up visits, Kyowa Kirin added.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Rochester, Minn.-based Mayo Clinic recorded an income from current activities of $1.5 billion (6.8% margin) in 2025, up from $1.3 billion (6.5% margin) in 2024.”
  • and
  • and
    • “Nacogdoches County Hospital District in Nacogdoches, Texas, unanimously approved a new lease agreement with Dallas-based Tenet Healthcare on Feb. 27, The Nacogdoches Daily Sentinel reported March 2.
    • “The 15-year lease agreement designates Nacogdoches Memorial Hospital and Cecil R. Bomar Rehabilitation Center as campuses of Nacogdoches Medical Center. Tenet, which operates Nacogdoches Medical Center, will assume daily operations of Nacogdoches Memorial Hospital.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare and Ascension are planning competing freestanding emergency departments in Fairview, Tenn., a fast-growing community in western Williamson County.”
  • Fierce Healthcare tells us,
    • “Health systems interested in preserving their operating margins will need to be proactive in addressing a growing minority population responsible for an outsized share of care utilization: patients with multiple chronic conditions. 
    • “In a newly released analysis of 2025 claims data, Vizient found that 11% of the U.S. population with multiple chronic conditions accounted for 52% of inpatient admissions. These patients also represented 35% of emergency department visits and 32% of office visits.
    • “To put it another way—compared to those without any chronic disease, these patients have about 10 times more inpatient admissions and ED visits, as well as six times as many office visits. Further, ED and office visits among those with multiple chronic conditions are projected over the next decade to grow at nearly double the rate of those with a single chronic condition, who are also higher care utilizers.
    • These patients pose a major financial challenge for providers due to their unfavorable payer mix. Specifically, Vizient found that 72% of inpatient admissions for those with multiple chronic conditions were covered by Medicare and another 10% by Medicaid. 
  • and
    • “Grow Therapy, a hybrid mental health provider, has clinched $150 million to build out physician and employer relationships.
    • “The series D round was led by TCV and Growth Equity at Goldman Sachs Alternatives, with participation from new investors BCI and Menlo Ventures. 
    • ‘Physicians and employers are newer customer types for Grow but have been the focus of the platform’s growth over the past five years. The capital will also be used to strengthen the tech powering Grow and enhance the user experience for patients, therapists and other partners.
    • “Grow has amassed a range of partners that today includes 125 payers, provider groups like Circle Medical, health systems like Kaiser Permanente and employers. Primary care docs are of particular focus to Grow right now, given they deliver 60% of the nation’s mental healthcare.” 
  • MedTech Dive informs us,
    • “RadNet has struck a 230 million euros deal to buy radiology artificial intelligence company Gleamer.
    • “The takeover, which the companies disclosed Monday, gives RadNet control of devices that are used in more than 25 indications and are forecast to generate about $30 million in annualized recurring revenue this year.
    • “Buying Gleamer will expand the capabilities RadNet acquired through the DeepHealth buyout in 2020, particularly in X-ray, and accelerate its expansion outside the U.S. Gleamer will be integrated into DeepHealth, a full-owned subsidiary of Radnet.”

Thursday report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The New York Times reports,
    • “In his first week leading two of the nation’s health agencies, Dr. Jay Bhattacharya has been met with praise and gratitude from federal employees — an unexpected reception for a scientist who spent much of the last few years facing scorn from most other public health experts.
    • “Dr. Bhattacharya, director of the National Institutes of Health, was last week named the acting director of the Centers for Disease Control and Prevention. A medical economist and former Stanford University professor, he replaced Jim O’Neill, a Silicon Valley executive with no medical training.
    • “Like most officials in the Trump administration, Dr. Bhattacharya was staunchly opposed to mandates for Covid vaccines, but unlike many, he has not questioned the safety of childhood vaccines.
    • “In meetings with C.D.C. staff this week, Dr. Bhattacharya offered to publicly endorse immunizations in general and the measles vaccine in particular; extolled the importance of prevention efforts against H.I.V.; and promised to try to extend remote work accommodations, according to several C.D.C. employees with knowledge of the discussions.” 
  • Beckers Payer Issues informs us,
    • “HHS released its third annual report Feb. 9 that evaluates how the No Surprises Act has affected healthcare markets.
    • “The report was produced with analytical support from RAND, and extends claims data trends through 2022, the first full year after the law took effect.
    • “Because most self-insured employer plans were not previously subject to state surprise billing laws, the NSA represented a bigger regulatory change for them than for fully insured plans. Average out-of-network per-claim payments for emergency services in self-insured plans fell 41% during the period, compared to 22% for fully insured plans. Self-insured plans also saw steeper declines in out-of-network billing prevalence and out-of-pocket costs across the board.”
  • Avalere Health tells us,
    • “From 2025 to 2026, overall Part D enrollment increased from 55.4 million to 56.9 million (a 2.7% increase). Over this period, enrollment in PDPs grew by 7.2% while enrollment in MA-PDs decreased by 0.5%. This is a notable shift from trends in recent years. MA-PD enrollment had climbed from 26 million in 2022 to 31.8 million in 2025, with annual growth of 7.4% from 2023 to 2024 and 4.3% from 2024 to 2025. By contrast, PDP enrollment was stable at 23.4 million in 2022 and 23.5 million in 2025, before rising to 25.2 million in 2026.  
    • “PDP enrollees are increasingly selecting lower premiums plans. In 2026, 64% of PDP enrollees chose plans with premiums under $25, up from 49% in 2025. At the same time, the share selecting plans with premiums of $100 or more increased to 17% in 2026, up from 12% in 2025.” * * *
    • “Despite continued declines in the number of standalone PDPs offered in 2025 and 2026 relative to prior years, PDP enrollment has increased while MA-PD enrollment has largely leveled off. For plan sponsors, this divergence may signal changing beneficiary preferences around premium sensitivity, benefit offerings, pharmacy network design, and the value proposition of integrated MA coverage versus a standalone Part D product.” 
        
  • Federal News Network reports,
    • “The Agriculture Department is planning to sell one of its headquarters buildings, as part of an ongoing agency reorganization that will relocate more than half of its workforce in Washington, D.C. to regional hubs across the country.
    • “USDA announced Wednesday that it is turning the department’s South Building over to its landlord, the General Services Administration, which plans to sell the building.”
  • Tammy Flanagan, writing in Govexec, explains “How to make the most of FERS, Social Security and your TSP.”
    • “Understanding each part of your federal retirement can help you plan when and how to retire and avoid surprises.”
  • Govexec relates,
    • “Newly released data from the Government Accountability Office offers some of the most granular glimpses yet of how the Trump administration’s sprint to remake the federal workforce in the president’s image impacted agency headcounts.
    • “The report, published Tuesday, responds to a request by congressional Democrats to catalog data related to a variety of workforce changes undertaken shortly after President Trump returned to office last January, including reductions in force, the purge of recently hired or promoted employees with fewer civil service protections and the deferred resignation program.
    • “GAO said it relied upon data from the Office of Personnel Management and individual agencies in compiling its report. OPM has previously said that around 317,000 federal workers left government in 2025. The watchdog agency’s report captures the first six months of Trump’s second term, capturing a fraction of that throughput.
    • “Of the 134,122 employees who separated from the 23 CFO Act agencies during the period from January to June 2025, a substantial majority (around 77%) retired or resigned,” GAO found. “Another roughly 19% were terminated or removed from their positions. Of these, agencies reported that nearly 4,500 employees (or about 3%) were terminated during a probationary or trial period.”

From the Food and Drug Administration front,

  • ABC News reports,
    • “Frozen blueberries distributed in four states have been voluntarily recalled due to possible listeria contamination.
    • “Oregon Potato Company, which owns the Salem, Oregon-based Willamette Valley Fruit Company, voluntarily recalled 55,689 pounds of frozen blueberries on Feb. 12 over potential contamination with Listeria monocytogenes, according an enforcement report from the U.S. Food and Drug Administration.
    • “The recall was designated as a Class I recall on Feb. 24, the highest FDA classification, which indicates that “use of or exposure to” the affected product can cause “serious adverse health consequences or death.”
  • MedPage Today adds,
    • “The FDA approved dupilumab (Dupixent) for treating allergic fungal rhinosinusitis, a first for the condition, the agency announced on Wednesday.
    • “Approval stipulates use in individuals 6 years and older with prior sino-nasal surgery, as the condition has a high rate of post-operative recurrence.
    • “Allergic fungal rhinosinusitis is characterized by the production of thick, sticky mucus following an allergic reaction to fungi in the sinuses. Left untreated, the type 2 inflammatory disease can expand the sinuses, erode surrounding bone, and lead to vision problems, nerve damage, and even facial deformities.”

From the judicial front,

  • Govexec reports,
    • “A federal appeals court on Thursday declined to enforce a temporary decision blocking the Trump administration from stripping two-thirds of the federal workforce of their collective bargaining rights, dimming though not extinguishing the American Federation of Government Employees’ legal challenges against a pair of anti-union executive orders.
    • “A three-judge panel on the Ninth Circuit Court of Appeals ruled unanimously that it could not uphold a preliminary injunction that would have blocked the Trump administration from implementing a pair of 2025 executive orders that cite a seldom-used provision of the 1978 Civil Service Reform Act to ban collective bargaining at most federal agencies, under the auspices of national security. That injunction had itself been put on hold by the appellate judges since last August.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The last thing someone in their 30s or 40s should worry about is dying of a heart attack. But new research shows more are.
    • “The proportion of adults ages 18 to 54 who died in a hospital of a severe first heart attack rose 57% between 2011 and 2022, according to a new study published Thursdayin the Journal of the American Heart Association.
    • “Most of those who died were men, but women died at higher rates than men.
    • “The study offers the latest evidence of worsening health among younger U.S. adults, including deaths from conditions traditionally tied to aging, such as heart disease and cancer.”
  • The American Hospital Association News relates,
    • “Obesity rates for U.S. children and teenagers have reached record highs, while rates for adults had a slight decline, according to reports by the Centers for Disease Control and Prevention. Both reports examined historical trends using height and weight data from the National Health and Nutrition Examination Survey. From August 2021 to August 2023, an estimated 21.1% of children and teenagers ages 2-19 were obese, up from 19.3% from 2017-2018. Additionally, from 2021-2023, 7% of children and adolescents were severely obese and 15.1% were overweight. For adults, 40.3% were obese from 2021-2023, down from 42.8% in 2017-2018. In addition, from 2021-2023, 9.7% of adults were severely obese and 31.7% were overweight.”
  • BioPharma Dive tells us,
    • “Eli Lilly’s GLP-1 pill orforglipron was associated with greater weight loss and reductions in blood sugar levels than Novo Nordisk’s rival drug Rybelsus in a head-to-head trial in people with diabetes.
    • “The study results disclosed Thursday could help strengthen Lilly’s case for approval as well as orforglipron’s uptake in diabetes. But investigators also flagged higher rates of side effects in orforglipron recipients that led people to stop treatment. 
    • “The data highlight another potential threat to Novo, which has seen its shares tumble amid pricing pressure and competition from Lilly as well as drug compounders. The Denmark-based company markets the only oral GLP-1 medications for diabetes and obesity — Rybelsus and the Wegovy pill, respectively — but that could soon change. Lilly expects the Food and Drug Administration to decide whether to clear use of orforglipron in obesity sometime in the second quarter.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “A study by researchers at The Jackson Laboratory (JAX), the Broad Institute, and Yale University has identified how specific genetic changes function in cells to influence disease risk and other human health traits. By probing regions of DNA previously linked to disease, the scientists created high resolution maps of DNA variant activity, helping pinpoint the exact changes that shape blood pressure, cholesterol levels, blood sugar and other complex human traits.
    • “The study takes on a long-standing challenge in human genetics. Scientists have known for years that certain regions of the genome—often spanning tens of thousands to millions of DNA letters—are associated with diseases. But because these regions usually contain many variants that could potentially drive those associations, performing the necessary experiments to pinpoint which specific DNA changes truly matter has been difficult and time-consuming.
    • “The solution was scale. Using a massively parallel reporter assay (MRPA)—which is a high-throughput approach that simultaneously evaluates the regulatory activity of thousands of DNA sequences—the team tested more than 220,000 previously identified DNA changes in five different cell types. By doing so, they resolved about 20% of these regions across the genome, revealing new insights into what these variants do, which in turn could help improve risk prediction and guide the development of new therapies.
    • “Geneticist Ryan Tewhey, PhD, an associate professor who led the team at JAX, explained that previously making these connections was like searching for a single typo on one page of a massive book. The researchers’ new experimental approach is more akin to speed reading, scanning thousands of pages at once and flagging the exact letters that change meaning, dramatically accelerating genetic discovery.”
  • The Washington Post lets us know that “An all-or-nothing mindset could be hurting your exercise and health goals.
    • “If you’ve given up on your New Year’s resolutions to get fit, here are some tips for getting back in the saddle.”
  • MedPage Today adds,
    • “The cost of sunscreen with an SPF-50 rating varied by 17.5-fold per ounce and 100-fold per application in an economic analysis.
    • “Wearing more protective clothing could significantly reduce the amount of sunscreen needed and could lower application expenses.
    • “Standardization of sunscreen application to achieve desired thickness might influence annual cost.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Cigna has acquired CarepathRx, a large pharmacy backed by private equity that dispenses prescription drugs to nearly 10% of U.S. hospitals.
    • “The acquisition, discovered by STAT in a review of Cigna’s financial filings, reinforces the company’s push to control more of the lucrative flow of pharmaceuticals through the U.S. health care system. Cigna executives have repeatedly told investors that managing prescription drugs has been one of their highest priorities since the company acquired Express Scripts for $54 billion in 2018.”
  • Beckers Health IT relates,
    • “Two years after a merger that created a now $12.1 billion system, St. Louis-based BJC Health is rolling out fresh branding to solidify its market positioning and boost recruitment and retention, leaders told Becker’s.
    • “St. Louis-based BJC HealthCare and Kansas City, Mo.-based Saint Luke’s Health System joined forcesin early 2024, rebranding as BJC Health in late 2025. Now, the organization’s West region is in the midst of a new marketing campaign — “All For Kansas City” — and updating signage to bring the BJC brand to its market.
    • “The new logo puts an exclamation point behind the fact that the Saint Luke’s brand is here to stay, and, at the same time, connects us to BJC Health,” said Julie Quirin, president of BJC Health’s West region (aka Saint Luke’s Health System). “It tells the story that we’re stronger together, while leaning into that brand equity that we’ve built over the last 150 years here in Kansas City.”
  • Per Fierce Pharma,
    • “Already on a roll with its first-in-class FcRn blocker Vyvgart, argenx has reported successful trial results that could pave the way for the fast-rising blockbuster to reach a new indication—ocular myasthenia gravis.
    • “The phase 3 Adapt Oculus study, which is the first to specifically evaluate a targeted treatment for ocular myasthenia gravis (oMG), has achieved its primary endpoint, demonstrating that Vyvgart can improve vision by a statistically significant margin, argenx reported Thursday.
    • “The company hailed the victory the same day it unveiled its 2025 earnings, showing that Vyvgart sales came in at $1.3 billion in the fourth quarter and $4.2 billion for the full year.”
  • Per Healthcare Dive,
    • “Labcorp has expanded its collaboration with PathAI to use a digital pathology platform at its anatomic pathology labs and hospital sites.
    • “The agreement, which Labcorp disclosed Monday, supports the use of PathAI’s AISight Dx to enable digital workflows for case management, slide review, collaboration and annotation.
    • “Quest Diagnostics, Labcorp’s main rival, licensed AISight Dx in 2024 in conjunction with its $100 million acquisition of PathAI’s diagnostic laboratory in Memphis, Tennessee.”

Midweek report

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

From Washington, DC,

  • Healthcare Dive reports,
    • “America has entered its “golden age,” President Donald Trump argued in a lengthy State of the Union address Tuesday night that glossed over the biggest achievements of the president’s second term so far but was notably light on healthcare.
    • “The economy is improving, prices are coming down, illegal immigration is under control and crime is plummeting, the president said, while lauding guests in attendance like Erika Kirk and the Olympic gold medal-winning U.S. men’s hockey team. Trump’s remarks — the longest State of the Union speech in recorded history, at an hour and 47 minutes — were often met with chants of “U.S.A! U.S.A!” from Republicans in the gallery, and come as the president seeks to reverse plummeting approval ratings.
    • “However, Trump didn’t use the State of the Union to introduce many new policy ideas. He also didn’t devote much time to healthcare, spending only about five minutes of his speech on the sector.”
  • Per an HHS news release,
    • “Today at the White House, Vice President J.D. Vance, Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr., and Administrator of the Centers for Medicare & Medicaid Services (CMS) Dr. Mehmet Oz announced new steps to crack down on fraud in Medicare and Medicaid to protect patients and taxpayers and improve affordability. The actions include deferring $259.5 million of quarterly federal Medicaid funding in Minnesota to prevent payment of questionable claims while further investigation is completed; a nationwide moratorium on Medicare enrollment for certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers; and a nationwide call to action for Americans to support fraud prevention, including stakeholder input on how CMS can continue to expand and strengthen its efforts. Together, these steps reflect a coordinated, data-driven strategy to prevent fraud before it occurs, hold bad actors accountable, and protect taxpayer dollars.”
    • * * * “CMS is looking to stakeholders to provide input, based on their experience and knowledge, on additional ways the agency can tackle fraud prevention to help inform the development of a possible future rule under CMS’ Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative. The CRUSH request for information (RFI) seeks input from a broad range of stakeholders – including states, providers, suppliers, payers, technology companies, patient advocates, beneficiaries, and others – on ways to strengthen CMS’ ability to prevent, detect, and respond to fraud, waste, and abuse, and program inefficiencies in Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.” * * * 
    • “Comments on the CRUSH Request for Information must be submitted by March 20, 2026, via the Federal Register at: https://www.federalregister.gov/public-inspection/2026-03968/request-for-information-comprehensive-regulations-to-uncover-suspicious-healthcare (refer to CMS-6098-NC).
    • “More information on CMS’ fraud prevention efforts is available at: www.cms.gov/fraud.”
  • Govexec offers five things to watch concerning the Department of Homeland Security shutdown.
  • The Wall Street Journal relates,
    • “President Trump’s nominee for surgeon general aligned herself with the administration’s moves on vaccines so far, including shrinking the number of recommended vaccines for children, as she told lawmakers in her confirmation hearing that her focus is fighting chronic disease. 
    • “Dr. Casey Means told the Senate health committee on Wednesday that she believes vaccines save lives but declined to promise recommending measles and flu shots for children. 
    • “I’m not an individual’s doctor, and every individual needs to talk to their doctor before putting medication in their body,” Means said, in response to a question about whether she would recommend other mothers get measles vaccines for their children.” 
  • Per an OPM news release,
    • “The US Office of Personnel Management today issued a memorandum to federal agencies providing updated guidance ending use of the Administrative Careers with America (ACWA) assessment. This step reinforces the administration’s ongoing efforts to streamline hiring and ensure agencies recruit the most qualified applicants based on merit.
    • “From the beginning, ACWA (which was developed in response to the Luevano consent decree) was criticized by hiring managers and applicants alike as ineffective in identifying quality candidates for federal service. In light of OPM’s development of validated, state-of-the-art assessment tools (particularly the USA Hire platform), there is no longer a need for ACWA.”
    • * * * “Read the memo here and Director Kupor’s blog on this here.”
  • Govexec also explains why “Why your federal benefits may not protect your family the way you think.”
    • “While federal employee benefits can assist beneficiaries in the event of a loved one’s death, it’s important to understand the rules of those plans and how to best seamlessly apply them to your survivors.”
  • The American Hospital Association (AHA) News tells us,
    • “The Health Resources and Services Administration Feb. 25 said it will extend the deadline to April 20 to receive comments on its request for information on whether to implement a 340B rebate model program. Comments on the RFI were originally due March 19. The AHA, joined by several other national groups representing 340B hospitals, last week urged HRSA to extend the original deadline to allow stakeholders to provide feedback to HRSA’s detailed questions in the RFI.  
    • “HRSA also indicated that it may expand the 340B rebate model pilot program to all drugs included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program through 2027.”   
  • Per a Federal Register notice,
    • The Centers for Disease Control announced a meeting of its Advisory Committee on Immunization Practices.
    • “The meeting will be held on March 18, 2026, from 8 a.m. to 5 p.m., EST, and March 19, 2025, from 8 a.m. to 5 p.m., EST, (times subject to change; see the ACIP website for updates: https://www.cdc.gov/vaccines/acip/index.html). The meeting is expected to be held at the Centers for Disease Control and Prevention, with virtual option. Written comments must be received between March 2 – 12, 2026.”
  • Mercer lets us know,
    • “Mercer projects the 2027 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs), and excepted-benefit health reimbursement arrangements (HRAs) will increase from 2026 levels. These unofficial 2027 amounts are determined using the Internal Revenue Code (IRC)’s cost-of-living adjustment methods, the US Bureau of Labor Statistics (BLS) published Chained Consumer Price Index for All Urban Consumers (C-CPI-U) values through January 2026, and Mercer’s projected C-CPI-U values for February and March.
    • ‘The table [in the article] shows the projected HSA, HDHP, and excepted-benefit HRA amounts for 2027, along with the 2026 and 2025 values for comparison. The HSA catch-up contribution limit is set by statute and hasn’t changed since 2009.
  • The Government Accountability Office notes,
    • “Mental health, suicide, and substance misuse issues have increased in the U.S. The federal agency that oversees such issues saw its budget more than double in FY21 due to increased COVID-19 and 988 Lifeline funding. This Q&A examines the use of that funding.
    • “The agency received $8.5 billion for COVID-19. It awarded about $8.3 billion in grants for activities such as community mental health. Recipients spent about $6.9 billion as of July 2025.
    • “The agency got $1.6 billion in FY21-24 for the 988 Lifeline, a call, text, and chat hotline supporting those in crisis. It awarded $1.2 billion to funding recipients, who had spent about $906.3 million.”

From the Food and Drug Administration front,

  • MedPage Today informs us,
    • “Assorted flavors of cream cheese were recalled by Made Fresh Salads due to possible Listeriacontamination, according to an FDA notice.”
  • The FDA issued today an “Early Alert: Heart Pump Purge Cassette Issue from Abiomed.”

From the judicial front,

  • Healthcare Dive reports,
    • “Frustrated by a recent, dramatic overhaul of the U.S. childhood immunization schedule, 15 Democrat-led states have sued the Trump administration in a bid to undo those changes as well as what they alleged to be an “unlawful replacement” of a key vaccine panel. 
    • “The lawsuit, filed by 14 attorneys general and the governor of Pennsylvania [in the U.S. District Court for the Northern District of California], seeks to rescind the new schedule adopted by the Department of Health and Human Services and vacate the committee, known as ACIP, reformed last year by Secretary Robert F. Kennedy Jr. Kennedy, the Centers for Disease Control and Prevention and the agency’s acting director, Jay Bhattacharya, are named as defendants in the suit.” 

From the public health, medical and Rx research front,

  • The AHA News reports,
    • “An American Heart Association study published Feb. 25 found that 6 in 10 U.S. women are projected to develop a form of cardiovascular disease by 2050. The report found a growing prevalence of heart disease, heart failure, atrial fibrillation and stroke and projected increases of conditions leading to cardiovascular disease, such as high blood pressure, obesity and diabetes. Additionally, the study found that nearly 32% of girls age 2-19 may be obese by 2050.”
  • Cardiovascular Business adds,
    • “Metabolic and bariatric surgery (MBS) is associated with better long-term cardiovascular protection than glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes and obesity, according to a new meta-analysis. The findings were published in full in Obesity Surgery.”
  • Healio tells us,
    • “Cervical cancer incidence has declined close to 30% among women aged 20 to 31 years since the start of the millennium, but certain states have achieved significantly greater reductions.
    • “Washington, D.C., Rhode Island, Michigan and Hawaii all achieved decreases of more than 50%, but incidence in Vermont, West Virginia, Idaho, Arkansas and Alabama remained unchanged.
    • “Researchers observed an association between increased HPV vaccination rates and faster decline in incidence, as well.
    • “A decline of more than 50% observed in several states within such a relatively short period is rarely seen in cancer epidemiology, making these findings particularly striking,” Chenxi Jiang, MPH, associate scientist in surveillance, prevention and health services research at American Cancer Society, told Healio. “At the same time, they are highly encouraging, demonstrating what is achievable when prevention efforts are effectively implemented.”
  • Cigna Healthcare, writing in LinkedIn, points out
    • “Proactive mental health care helps lower overall medical costs.
    • “Untreated mental illness leads to higher health expenses and lost productivity.
    • “Investing in treatment for depression and anxiety yields a fourfold return.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies five forces reshaping pharmacy economics this year.
  • Fierce Healthcare reports,
    • “There’s been a flurry of recent activity in the direct-to-consumer space as drug costs and spending continue to rise.
    • “It’s with that backdrop that GoodRx announced Tuesday it would launch Employer Direct, a new program that allows employers to offer workers lower costs on branded products, which often carry the highest prices. Through the program, these firms can select branded drugs and subsidize the cost for the cash-pay price available through GoodRx.
    • “Employers in the program can also tap into GoodRx’s telemedicine solutions, which bring together the clinical care with the prescription fulfillment to ensure patients get the drugs they need.”
  • Modern Healthcare adds,
    • “Employers tired of dealing with health insurers now have another option at their disposal: Go through a different intermediary instead.
    • “Third-party vendors such as Lantern, Nomi Health and Transcarent are making a play for the employer market as businesses wage a perpetual struggle to manage rising health benefit costs. These platforms tout savings, flexibility and a seamless experience to enable direct contracting with providers at scale.
    • “Their reach, once limited, is now national and includes all types of medical services. Transcarent has more than 20 million members after it acquired care navigation company Accolade last year. Nomi Health serves 19 million members. Lantern’s specialty care platform has grown from 100,000 members to more than 12 million in the last decade.”
  • Fierce Healthcare notes,
    • “Uber Health is rolling out a new feature that allows patients who are comfortable with its platform to book their own rides.
    • “Uber’s healthcare platform has traditionally been a back-end option for providers and other partners to book rides to and from appointments on the behalf of the patient. Through this approach, Uber supported processes like transportation benefits and discharge planning for its partners.
    • “However, the company heard feedback from clients that the administrative time to do this was not insignificant, and that there were many patients who were familiar enough with Uber to book trips themselves, Cory Warner, global head of growth and operations for Uber Health, told Fierce Healthcare in an interview at ViVE on Tuesday.
    • “We’re really excited, because we’ve been able to advance the technology to meet the needs of some of our customers who’ve been sharing with us that, while we have a lot of folks that may not have a smartphone, we do have a number of patients and members who have the Uber app in their everyday life,” she said.”
  • Fierce Pharma informs us,
    • “Novartis is wasting little time sketching out the radiopharmaceutical details of its $23 billion U.S. investment push. Shortly after announcing a new manufacturing facility for the class of cancer meds in Florida, the pharma giant is revealing its intention to build another site in Texas. 
    • “The forthcoming 46,000-square-foot radioligand therapy (RLT) production plant will be set upin Denton, Texas—part of the greater Dallas-Fort Worth area—and becomes the fifth existing or planned radiopharmaceutical manufacturing site in Novartis’ U.S. network, the company said in a Feb. 25 release. 
    • “Construction is slated to kick off this year, with the site expected to come online in 2028, Novartis said. 
    • “The plant will generate jobs in fields like bioengineering, advanced manufacturing, quality and operations, although Novartis did not specify how many new hires it has planned.” 
  • Per BioPharma Dive,
    • “Novo Nordisk announced Wednesday a collaboration with startup Vivtex that’ll give it access to technologies that could yield new oral biologics for obesity and other metabolic diseases.
    • “The companies did not disclose the amount of guaranteed cash going from Novo to Vivtex in the deal. But the Boston biotechnology startup stands to gain as much as $2.1 billion, as well as sales royalties, if drugs emerging from the alliance progress and are eventually commercialized.”
  • and
    • “GSK is scooping up a promising experimental medicine for a dangerous type of high blood pressure through a $950 million acquisition of private Canadian drugmaker 35Pharma.
    • “The drug, HS235, has already completed Phase 1 testing in healthy volunteers and, according to GSK, should soon enter studies focused on either pulmonary arterial hypertension or a different pulmonary hypertension caused by a certain kind of heart failure. The company added that this medicine has potential to fight cardiovascular disease, deliver metabolic benefits and offer a lower risk of bleeding — a key limitation of current PH treatments.
    • “HS235 is a so-called activin signaling inhibitor, designed to fight the over-proliferation of cells that can thicken blood vessel walls. This drug class has already seen success; Merck & Co. won approval for one member, Winrevair, in 2024, and chalked up sales of more than $1.4 billion from it last year. Merck is looking to expand its usage as well.”
  • Per MedTech Dive,
    • “Quantum Surgical, which specializes in medical robotics for cancer treatment, said Tuesday that it has acquired NeuWave Medical from Johnson & Johnson.
    • “Quantum, based in Montpellier, France, with an office in Miami, said the deal supports its strategy of expanding robot-assisted tumor ablation treatment to reduce cancer mortality.
    • “Last year, J&J informed customers that it planned to discontinue the NeuWave business, before announcing in September that it had received a binding offer from Quantum to buy NeuWave.”