Midweek report

CMS

Midweek report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Notable Death

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

Tuesday report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC

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

From the judicial front,

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

From the public health, medical and Rx research front,

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

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

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

Midweek report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Healthcare Dive reports,
    • “Overpayments to Medicare Advantage plans are causing seniors’ Medicare premiums to spike by billions of dollars, according to new report from congressional investigators.
    • “Medicare Part B premiums rose by $212 per enrollee in 2025, totaling $13.4 billion in higher premiums, due to health insurer practices like recording extra member diagnoses to inflate government reimbursement, the report from the Joint Economic Committee published Tuesday found. [FEHBlog note — CMS tells us that the Medicare premium rose $10.30 monthly from 2024 to 2025 or $123.60 annually]
    • “Health insurance groups argued that the report is based on flawed data and that MA saves money and drives better health outcomes for enrollees.”
  • Beckers Payer Issues relates,
    • “Elevance said it was “surprised and disappointed” by a recent CMS sanction threat, which would suspend enrollment in Medicare Advantage prescription drug plans, CFO Mark Kaye said March 10 at the Barclays 28th Annual Global Healthcare Conference in Miami.
    • “The executive claimed Elevance flagged provider-submitted diagnosis codes and shared information with CMS “in good faith.”
    • “The issues CMS raised relate to historical risk-adjustment processes. They do not reflect our current operating processes or practices,” he said.
    • “Mr. Kaye said he views the issue as a misalignment with policy interpretation.
    • “This is not simply a data submission issue. We view this as a broader policy and payments dispute about how retroactive corrections should be treated under the risk-adjustment framework that was in place during that period,” Mr. Kaye said. “This is a disagreement over the interpretation of policy. It’s not an unwillingness to correct inaccurate data.” He said the rules at the time were in line with Elevance’s conduct.” 
  • The Hill brings us up to date on the Department of Homeland Security shutdown.
  • Per CMS news releases,
    • “The Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS) is committed to improving health care and outcomes, and strengthening accountability, across the nation’s health- and long-term care systems.
    • “Over the next several years, CCSQ will focus on five strategic goals—Prevention, Quality and Safety, Coverage Innovation, Data and Technology, and Burden Reduction. These priorities build on CCSQ’s core mission to establish national health and safety standards; implement quality measurement, reporting and improvement; and support Medicare’s coverage determinations. Together, they represent a roadmap for health- and long-term care systems that are safer, stronger, and more transparent.”
  • and
    • The Centers for Medicare & Medicaid Services (CMS) today issued new guidance to strengthen public trust and ensure patients and their families are treated with dignity and care throughout the organ donation process. The guidance clarifies and reinforces the responsibilities of Organ Procurement Organizations (OPOs) and donor hospitals, both in providing patients full medical care regardless of potential donor status and allowing families the time to make decisions regarding organ donation without coercion. This action follows reports that some OPOs have rushed aspects of the organ donation and procurement process, pressuring families to make decisions during moments of grief. 
  • Govexec tells us,
    • “The No. 1 thing to know entering retirement: How much are you really spending?
    • “Many new retirees may overestimate how far their savings will go towards their budget. Having an idea of your cost of living can make them go further.”

From the Food and Drug Administration,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.  
    • “The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re fixing the problem through a major modernization initiative. Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”
  • Health Exec informs us,
    • “The U.S. Food and Drug Administration has released an early alert pertaining to patient safety, after the agency said it became aware of an issue with flexible cryoprobes—used to deliver extreme cold to a site on the body for a variety of medical purposes, including removing tissue tumors—manufactured by Erbe USA.
    • “According to the FDA, the company reported incidents of its cryoprobes “rupturing or bursting during activation,” leading to excessive pressure at sites of foreign bodies, mucus plugs, blood clots, necrotic tissue, or biopsies—essentially anything a provider is trying to remove.”

From the public health, medical and Rx research front,

  • The New York Times reports,
    • “In a survey by the health research group KFF and The Washington Post, released in September, 16 percent of parents said they had skipped or delayed at least one childhood vaccine other than for flu or Covid-19. And doubts about vaccines are increasingly spilling into refusal of other mainstays of pediatric medicine, including antibiotics, medications like Tylenol and diagnostic procedures like spinal taps.
    • “At a hospital in Boise, Idaho, for example, three infants died last year after their parents declined a shot of vitamin K, administered to newborns to prevent bleeding, said Dr. Amanda Lee, a pediatrician there.
    • “Parents have always had questions about vaccines, but Dr. Lee and other pediatricians say they are now finding their expertise to be sometimes powerless against the flood of misinformation.” * * *
    • “Conferences of pediatricians now routinely hold workshops on earning parents’ trust. They are training clinicians to be less authoritarian, less judgmental and more patient, said Dr. Brandan Kennedy, a pediatric hospitalist in Kansas.”
  • Medpage Today tells us,
    • “Semaglutide for weight loss (Wegovy) was associated with a significantly higher risk of ischemic optic neuropathy (ION) compared with the diabetes formulation (Ozempic) and other GLP-1 agonists.
    • “Added to the existing evidence base, the study suggests a dose-dependent risk of ION.
    • “Men treated with Wegovy had a threefold higher risk of ION versus women.”
  • and
    • “The COBRRA trial directly tested apixaban and rivaroxaban, the oral anticoagulants most frequently used to treat acute venous thromboembolism.
    • “The risk of clinically relevant bleeding came out significantly lower with apixaban than with rivaroxaban during the 3-month treatment period.
    • “The study-specific dosing regimen may have played a role in the results, however.”
  • and
    • “Over 40% of smokers who received one psilocybin dose quit by month 6 versus 10% of nicotine patch users in a pilot randomized trial.
    • “No serious adverse events were reported, and the most common side effects with psilocybin were temporary increases in blood pressure and nausea.
    • ‘Psilocybin works by increasing “mental flexibility,” allowing patients to reframe their relationship with addiction, researcher said.”
  • Health Day lets us know,
    •  “Women who have pregnancy complications might face a higher risk of heart disease, a new study has concluded.
    • “The stress of these complications increase a woman’s risk of high blood pressure for years after they deliver, researchers reported March 9 in the journal Hypertension.
    • “For women who were having babies for the first time and had complications, referred to as adverse pregnancy outcomes, we found that higher stress levels over time were associated with higher blood pressure levels two to seven years after delivery,” lead researcher Virginia Nuckols, a postdoctoral fellow at the University of Delaware, said in a news release.”
  • and
    • “An already-approved IV drug significantly reduces the symptoms of lupus, a new clinical trial showed.
    • “More than three-quarters of lupus patients taking obinutuzumab (Gazvya) had a significant improvement in their symptoms after a year on the drug, researchers reported March 6 in The New England Journal of Medicine.
    • “The drug also improved time between lupus flares, and had a more than doubled remission rate compared to placebo, researchers said.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Researchers headed by a team at the University of California San Diego have found that a novel blood-based biomarker can predict a woman’s risk of developing dementia as many as 25 years before symptoms appear. The study, involving more than 2500 women, showed that higher levels of phosphorylated tau 217 (ptau217)—a form of tau protein that reflects early brain changes associated with Alzheimer’s disease—were strongly associated with future mild cognitive impairment (MCI) and dementia among older women who were cognitively healthy at the start of the study, before any memory or thinking problems were detected.
    • “Our study suggests we may be able to identify women at elevated risk for dementia decades before symptoms emerge,” said Aladdin H. Shadyab, PhD, MPH, UC San Diego associate professor of public health and medicine at the Herbert Wertheim School of Public Health and Human Longevity Science and the School of Medicine. “That kind of long lead time opens the door to earlier prevention strategies and more targeted monitoring, rather than waiting until memory problems are already affecting daily life.”
  • MedPage points out,
    • “The nation’s safest hospitals, according to annual rankingsopens in a new tab or window from Healthgrades, represent the top 10% of hospitals nationwide for patient safety, with the lowest incidences of 13 preventable patient safety events.
    • “Patients treated at these 438 hospitals, located across 40 states, were significantly less likely to experience the four most common patient safety indicators, characterized as serious, preventable complications, which account for 78% of all safety events, including:
      • “In-hospital falls resulting in fracture: 52.4% less likely
      • “Collapsed lungs due to a procedure or surgery in or around the chest: 57.5% less likely
      • “Catheter-related bloodstream infections acquired in the hospital: 67.8% less likely
      • “Pressure sores or bed sores acquired in the hospital: 71.9% less likely
    • “The data behind this year’s Patient Safety Excellence Award highlights how measurable improvements in safety can prevent thousands of complications,” said Alana Biggers, MPH, medical advisor at Healthgrades, in a press release.
  • Per BioPharma Dive,
    • “Biogen on Wednesday unveiled updated data showing its spinal muscular atrophy drug salanersen slowed neurodegeneration and improved motor function in an early-stage study.
    • “The trial enrolled patients who had already been treated with the Novartis’ gene therapy Zolgensma, and found a reduction of 75% in neurofilament light chain levels, a measure used to evaluate neurodegeneration. Half of those patients also achieved a motor function milestone according to World Health Organization standards.
    • “As part of the update, Biogen also revealed the design for a late-stage study that includes three separate trials of salanersen in newborns, infants already treated with Zolgensma, and teens and older adults who have either not been treated or previously took another SMA drug, Roche’s Evrysdi.”
  • Per Fierce Pharma,
    • “After strutting its stuff against blockbusters in three head-to-head psoriasis trials, UCB’s Bimzelx has conquered another powerhouse product—AbbVie’s Skyrizi—in psoriatic arthritis (PsA).
    • “A phase 3b study of 553 adults with active psoriatic arthritis has achieved its primary objective, showing the “statistically significant superiority” of Bimzelx over Skyrizi in reducing disease activity as measured by the ACR50 endpoint at Week 16, the Belgian company said.”
    • “ACR50 is a composite efficacy measurement, specified by the American College of Rheumatology, which indicates 50% or greater improvement from baseline in tender or swollen joint counts in addition to 50% improvement in three of five other disease markers.”  

From the HIMSS conference front,

  • Fierce Healthcare reports,
    • “Epic is ramping up more artificial intelligence capabilities and features as it also touts how its AI tools drive measurable outcomes beyond just faster documentation time. 
    • “Health systems are reporting earlier diagnoses, fewer denials and improved patient experiences, the company said.
    • “At the 2026 Healthcare Information and Management Systems Society (HIMSS) Global Health Conference & Exhibition, which kicked off Monday, Epic teased its future AI road map with new features across clinical, patient-facing and operational workflows.”
  • and
    • “Samsung Electronics and digital health company b.well Connected Health are working together to toss out the traditional patient clipboard and replace it with smartphones.
    • “Samsung Galaxy smartphone users, through the Samsung Health app, will now have digital access to their complete health history and can share their medical record with participating providers via a QR code. That eliminates the intake paperwork patients fill out at nearly every healthcare visit, according to the two companies. 
    • “Despite advances with technology, patients typically still fill out the same paperwork at the doctor’s office and often have to repeat pertinent medical information from memory and log into multiple portals.”
  • Health Tech Magazine adds,
    • “Documentation overload, clinical burnout and rising operational costs are just some of the challenges healthcare organizations face today. This can have a major impact on clinician satisfaction and retention.
    • “Microsoft Dragon Copilot is one way health systems can address these concerns. The artificial intelligence-powered tool streamlines clinical documentation, giving clinicians more time in their day for seeing additional patients or other important tasks. In addition to improving clinical workflows, Dragon Copilot improves documentation, creates more accurate coding and improves the patient experience.
    • “At HIMSS26 in Las Vegas, HealthTech spoke with two Microsoft Dragon Copilot experts about what problems it solves, how it integrates with the electronic health record, how it can be used across departments and clinical specialties, and tips for implementation success.”
  • Healthcare Dive notes,
    • “Amazon is expanding access to its health-focused artificial intelligence chatbot, the technology giant said Tuesday. 
    • “The Health AI assistant first launched for members of Amazon’s primary care chain One Medical in January. The tool allows users to connect their health information and ask questions about their health, symptoms and potential treatments. 
    • “Now, the tool is rolling out to all U.S. consumers. “The desire to ask questions of an AI agent is enormous,” Dr. Andrew Diamond, chief medical officer at Amazon One Medical, told Healthcare Dive at the HIMSS conference Tuesday. “It is clearly the fastest way for people to get their basic health questions answered. And even basic is almost putting it too simply. They’re getting pretty in-depth questions answered.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “American hospitals saw expenses grow 7.5% in 2025, more than twice the rate of growth in hospital prices that year, according to the American Hospital Association’s annual “Costs of Caring” report.
    • “The findings, which were drawn from industry benchmark data compiled by Strata Decision Technology, point to a system under mounting strain: Hospitals are treating more patients, those patients are getting sicker and the cost of supplies from drugs to disposable gloves is increasing quicker than reimbursements can keep up with.
    • “Rising costs for labor, supplies, drugs, and administrative burdens caused by corporate insurers, combined with caring for sicker patients, have created challenges for hospitals and health systems,” AHA President and CEO Rick Pollack said in a March 11 news release shared with Becker’s. “These strains are jeopardizing hospitals’ ability to provide around-the-clock care and services that patients and communities need.”
  • and calls attention to ten hospital M&As finalized in 2026.
  • Fierce Healthcare relates,
    • “It’s not a secret that commercial payers are navigating an earnings slump.
    • “Weighed down by elevated member utilization and staring down stagnant proposed Medicare Advantage (MA) rates for 2027, insurers are looking to lessen the pain by securing more favorable network contracts with providers and increasing scrutiny of reimbursement claims.
    • “The former has recently led to some high-profile dustups in which MA contracts with health systems are permitted to expire, while the latter has forced hospitals to devote more resources toward combating denials. 
    • “However, for-profit hospital and ambulatory surgery center chain Tenet Healthcare isn’t viewing payer pushback as a major headwind. In last month’s earnings call, executives told analysts that its commercial rate updates are so far landing in a healthy range of 3% to 5%. The company is also almost entirely contracted for 2026, and about 80% contracted for 2027, they said.”
  • and
    • “Carrum Health, which offers value-based specialty care for employers, is teaming up with Virta Health on weight management.
    • “Virta offers virtual counseling, nutrition coaching and medication management with GLP-1s. Employers can customize Virta’s offering depending on their benefits. Meanwhile, Carrum has already provided bariatric surgeries for weight management. 
    • “Now, members can be referred and coordinated between the two as needed.”
  • Fierce Pharma tells us,
    • “Twelve months ago, drugmakers came roaring into 2025, fueled by a massive year of growth that peaked in the fourth quarter of 2024. Now, the momentum has dissipated, and most companies are bracing for a slowdown in sales heading into 2026. 
    • “In fact, over the last few weeks of earnings reports, drugmakers’ financial results were less noteworthy than their guidances. Of 25 companies with quarterly revenue of at least $2 billion that had reported through March 5, just five projected that their sales would grow at a higher rate in 2026 than in 2025, with each of those increases slight.
    • “The pharmas offered a variety of reasons—macro and micro—for their pessimistic 2026 projections. Several mentioned pricing effects related to the Inflation Reduction Act (IRA), as well as U.S. President Donald Trump’s most-favored-nation plan and his threats of tariffs on pharmaceutical products. An anticipated decline in vaccine sales, linked to a demand shortfall in the U.S., also plays into the computation for several companies, while many others are dealing with the loss of exclusivity (LOE) of blockbuster products.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “The U.S. Postal Service will run out of cash within a year unless Congress lifts a decades-old cap and allows the agency to borrow more money, the new postmaster general warned in an interview.
    • “If it doesn’t, the Postal Service might not be able to pay its employees or vendors by February 2027, with potentially dire consequences for mail delivery, Postmaster General David Steiner told The Associated Press.
    • “How long are employees going to work and vendors going to show up if we’re not paying them?” Steiner said in an interview on Wednesday.
    • “The postmaster general is scheduled to testify before Congress later this month about the Postal Service’s financial struggles and the need to change longstanding rules and regulations that he considers burdensome. He singled out the $15 billion cap on borrowing that has been in place since 1990.”
  • Per an HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced $69.1 million in funding opportunities for three grant programs: the Children’s Mental Health Initiative (CMHI), Implementing Zero Suicide in Health Systems (Zero Suicide) and Assisted Outpatient Treatment (AOT).
    • “Last month, I launched a comprehensive plan to strengthen prevention, expand treatment, and advance President Trump’s Great American Recovery Initiative,” said U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. “These grants will directly address the root causes of addiction — including homelessness and serious mental illness — and strengthen community safety by expanding treatment that prioritizes recovery, stability, and self-sufficiency.”
    • “Recovery is possible, and these investments help communities reach people earlier with the support and treatment that can change lives,” said Senior Advisor for Addiction Recovery Kathryn Burgum. “By expanding access to evidence-based mental health services and strengthening community partnerships, we are helping more Americans find a path to healing and stability.”
  • STAT News adds in an editorial piece,
    • “In a political moment defined by division, it is telling that former Rep. Patrick Kennedy (D) and health secretary Robert F. Kennedy Jr. are attempting to find common ground on on one issue: the urgent need to take mental health and addiction seriously as national priorities.” * * *
    • “The urgency for our nation’s leaders to act is underscored by sobering data. Suicide remains one of the leading causes of death for young people. Anxiety and depression among adolescents have risen sharply over the past decade. Alcohol-related deaths continue to climb while overdose deaths remain high, particularly in communities already facing economic and health disparities. The economic toll of mental illness and addiction now reaches hundreds of billions of dollars annually — costs borne by families, employers, health systems, and taxpayers.
    • “In the discussion about this crisis, one fact is routinely overlooked: These conditions are often preventable in the first place. If the health secretary is serious about making America healthier, preventing behavioral health disorders is one place to start.”
  • Earlier this week, Blue Shield of California Paul Markovich and others launched a healthcare political movement called Worthy. Check it out.
  • Fierce Healthcare relates,
    • “Just over 56 million people are enrolled in Medicare Part D, with the share of those securing coverage through Medicare Advantage Prescription Drug (MAPD) plans growing alongside the overall program.
    • “As of 2026, 24.9 million people were enrolled in standalone Part D plans, according to a new analysis from KFF, while 31.4 million were in MAPD plans. By comparison, overall enrollment in 2006 was just 21.8 million, with 15.8 million of those individuals with just Part D coverage.
    • “The data for 2026 do reflect slight growth year over year in the number of people with standalone Part D, as 23.2 million were enrolled in just the prescription drug coverage for 2025.
    • “The report found that enrollment in non-group MAPD plans has steadily risen over the past several years, while sign-ups for non-group standalone prescription coverage has plateaued.
    • “Meanwhile, it’s the opposite story in employer group Medicare, according to the report. Enrollment in employer group MAPD plans fell from 3.9 million to 2.7 million between 2025 and 2026, while sign-ups for group Part D plans rose from 5.1 million to 6.3 million.
    • “This marks the first time enrollment in employer group MAPD coverage has declined, the KFF researchers said.
    • “The researchers note that this shift may be in response to the Part D premium stabilization program, instituted last year, which is applicable only in standalone prescription plans and not MA plans. In employer Part D plans, the program would afford $10 per member per month in additional subsidies.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration’s controversial vaccines chief is leaving the agency.
    • “Dr. Vinay Prasad, who has led the FDA’s vaccines and biotech drugs division, will depart at the end of April, FDA Commissioner Marty Makary said Friday. Federal health officials are searching for his replacement, Makary said.”
  • Per an FDA press release,
    • “Earlier this week, the U.S. Food and Drug Administration held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer. The gathering was the latest step toward the FDA’s implementation of President’s Trump’s executive order on lowering drug prices. 
    • “The meeting provided a forum to exchange information, with the goal of making it easier for states that have expressed interest in the program to obtain authorization without sacrificing safety or quality. Representatives from HHS and the National Academy for State Health Policy also participated.
    • “We are committed to lowering prescription drug prices for Americans, building on recent MFN wins,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re moving forward to implement the president’s executive order as we continue the crucial work of helping states and Indian tribes import reduced cost prescription drugs, while protecting public health and safety.” * * *
    • “Presentations from yesterday’s meeting are available for download at: Section 804 Importation Program Policies and Authorizations.”
  • The American Hospital Association News points out,
    • “The Food and Drug Administration March 5 issued a request for information seeking public comments on potential new standards for in-home opioid disposal products. The FDA said it is considering whether to require opioid sponsors to make in-home disposal systems available through dispensers. Comments are due April 6.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration has approved a regimen involving Johnson & Johnson’s antibody drugs Tecvayli and Darzalex for relapsed multiple myeloma less than three months after the drugmaker presented study data suggesting the combination could have curative potential.   
    • “The regulator reviewed the drug under its new “national priority voucher” program, which it used “proactively” following J&J’s release of the findings at the American Society of Hematology meeting. The approval issued Thursday was the third under that program, following that of an older antibiotic and a lung cancer treatment from Boehringer Ingelheim. The review took a total of 55 days, according to the FDA.
    • “The decision also converts Tecvayli’s authorization from a conditional, “accelerated” approval to full clearance that’s based on its ability to improve survival in early disease.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) is sharing additional information about a series of recalls for certain electrophysiology (EP) and ultrasound catheters from Medline Industries. The agency emphasized that these devices should be destroyed immediately as opposed to being set to the side or returned to the manufacturer.
    • “Back in February, Medline Industries recalled several reprocessed catheters after discovering that they may contain small traces of residual material that could harm a patient. The catheters were originally made by a variety of vendors, but Medline Industries reprocessed the devices and then sold them again. Reprocessing single-use devices is a central component of the company’s business model, and it estimates this diverts more than 1 million pounds of waste from landfills each year. 
    • “Initial details about these recalls first appeared in an FDA database in February. However, this new advisory is the first time the agency has warned the public about these concerns.”

From the judicial front,

  • Govexec reports,
    • “A coalition of federal employee unions and other employee advocacy groups this week renewed their effort to block the implementation of President Trump’s plan to convert tens of thousands of federal workers into at-will employees who can be fired for virtually any reason, arguing that Trump exceeded his authority and violated federal law in advancing the policy.
    • “On Trump’s first day back in office last year, he signed an executive order reviving Schedule F, the abortive 2020 proposal to move feds in “policy-related” positions out of the competitive service and stripping them of most civil service protections, and renaming it “Schedule Policy/Career.” Final regulations implementing the policy are set to take effect next week, after which Trump is expected to sign an additional executive order formally converting the first tranche of positions into the new job category. Officials have estimated around 50,000 employees will be targeted for conversion.
    • “On Wednesday, the American Federation of Government Employees, the American Federation of State, County and Municipal Employees, the AFL-CIO, Public Employees for Environmental Responsibility and Democracy Forward filed an amended complaint in their lawsuit challenging Schedule Policy/Career, which began in January 2025 in the U.S. District Court for Maryland, incorporating new details that arose in the 14 months that the administration has spent preparing to launch the new excepted service job category.”

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 severity is not higher compared with recent seasons. This atypical season indicates 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
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing in most areas of the country 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 has started later than expected in most regions of the United States, though severity is not higher compared with recent seasons. This atypical season indicates 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.”
  • The University of Minnesota’s CIDRAP relates,
    • “Children under two years of age hospitalized for COVID-19 are more likely to die or become seriously ill than babies with respiratory syncytial virus (RSV), according to a study  published this week in Open Forum Infectious Diseases. 
    • “Babies can become sick and die from both respiratory viruses, even if they were healthy before becoming infected, according to the study, which was led by researchers from the US Centers for Disease Control and Prevention.” * * *
    • “Although RSV immunizations were approved in 2023, they were not yet widely available during the study. Only 5.5% of babies age six to 23 months were vaccinated against COVID-19 in the study.
    • “Research shows that vaccinations for both RSV and COVID-19 are safe and effective. The American College of Obstetricians and Gynecologists recommends women receive a COVID-19 vaccine at any time during pregnancy and an RSV vaccine between the 32nd and 36th week of pregnancy. Both vaccines can protect newborns too young to be vaccinated. 
    • “For babies whose mothers weren’t vaccinated against RSV, the American Academy of Pediatrics recommends newborns under 8 months receive an injection of lab-grown antibodies. The pediatric group also recommends babies age six to 23 months be vaccinated against COVID-19.”
  • The AHA News reports,
    • “The South Carolina Department of Public Health March 6 reported that the state’s measles outbreak is at 991 cases. The agency said the vaccination status of 925 cases is unvaccinated, 26 are fully vaccinated, 19 are partially vaccinated and the status of 21 cases is unknown. Additionally, the agency reported that more than 17,300 doses of the measles vaccine were administered statewide last month, a 70% increase compared to February 2025. Nationwide, 1,277 confirmed measles cases have been reported this year to the Centers for Disease Control and Prevention. Of those, 5% of all cases have been hospitalized and no deaths have been reported.” 
  • USA Today relates,
    • “International travel often comes with vaccine reminders, and the Centers for Disease Control and Prevention is now warning travelers to ensure their polio vaccinations are up to date.
    • “The CDC issued a level 2 travel advisory on March 3, warning that poliovirus has been detected in multiple destinations within the past 12 months – including parts of Africa, the Middle East and Europe.” 
  • Healio tells us,
    • “In-hospital mortality was significantly higher for younger women vs. younger men after a first heart attack, with women receiving fewer cardiac procedures and having more nontraditional cardiovascular risk factors, researchers reported.
    • “A study evaluating trends in first MI outcomes, both STEMI and non-STEMI, based on sex was published in the Journal of the American Heart Association.”
  • Health Day informs us,
    • “Regular cannabis users may be more likely to experience anxiety, depression or suicidal thoughts than non-users
    • “Rates of generalized anxiety and major depressive episodes among Canadians have nearly doubled since 2012
    • “Younger people show the strongest cannabis-mental health link.
  • Genetic Engineering and BioTechnology News notes,
    • “According to a new Stem Cell Reports paper, scientists have demonstrated that targeted delivery of mRNA can restore sperm production and fertility in genetically infertile male mice without introducing permanent changes to the germline. Full details are provided in a paper titled “Messenger RNA delivery into Sertoli cells restores fertility to congenitally infertile male mice.” The study was done by a team of scientists from Kyoto University, RIKEN, and elsewhere.  
    • “The findings represent a step forward in efforts to develop therapies that may help people affected by infertility.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “The Mayo Clinic ended 2025 with income over 13% higher than the year before, as the nonprofit health system was buoyed by increased volumes and demand for healthcare services, according to earnings documents released this week.
    • “The Rochester, Minnesota-based nonprofit health system said increases in its outpatient, hospital and surgical volumes accounted for the rise in revenue compared to the year prior.
    • “Still, as revenues rose, so too did expenses. Mayo’s increase in volumes drove supply and services expenses up, contributing to an over 8% year-over-year increase in operating costs, according to the health system.”
  • Modern Healthcare adds,
    • “Many large health systems are on the upswing financially — at least for now.
    • “Health systems are seeing improved margins as they benefit from higher volumes, investment returns and technology-driven efficiency efforts. They are betting that a stronger balance sheet will help offset the coming reimbursement cuts. 
    • “Nonprofit health systems addressed these issues in quarterly and full-year earnings reports released over the past few weeks. Here are five key themes from those reports.
      • “Systems are strengthening their margins
      • “Investment income is driving profits
      • “Cash on hand is improving
      • “Non-labor expenses are climbing, and
      • “Systems are bracing for what’s ahead.”
  • Beckers Hospital Review tells us,
    • “Fairfield, Calif.-based NorthBay Health has signed a letter of intent to acquire Providence Queen of the Valley Medical Center in Napa, Calif., a move that would expand the system to three hospitals.”
  • and
    • “Franklin, Tenn.-based Community Health Systems has signed a definitive agreement to sell four Arkansas hospitals to Freeman Health System for $112 million.” 
  • STAT News relates,
    • “Generic versions of Novo Nordisk’s blockbuster Wegovy and Ozempic medications could be mass produced for about $3 per person per month, a cost that could greatly widen access in low- and middle-income countries, according to a new analysis.
    • “After reviewing data for active pharmaceutical ingredients from the past two years, the researchers estimated a generic version of semaglutide — the key ingredient in the Ozempic diabetes treatment and Wegovy weight loss drug — could be made for $28 to $140 per person a year and then sold at low prices once patents expire this year in several countries.
    • “Specifically, patents for semaglutide are due to expire starting later this month in India, China, Canada, Brazil, and Turkey, along with three other countries later this year, which is expected to spark distribution of generic versions. This is especially true of India, where numerous generic makers are based and are seeking new markets.
    • “The standard dose of semaglutide is 2.4 milligrams per week as an injection, which is the equivalent of 10 mg per month. This is a very small amount of drug, which is why the cost of production is so low,” said Andrew Hill, a University of Liverpool pharmacology professor, who has previously analyzed production costs for HIV, cancer, and hepatitis drugs. “These low prices open the door to worldwide access to an essential medicine.”
  • Fierce Pharma informs us,
    • “As nonprofit-governed Servier continues to make gains with its IDH-mutant glioma med Voranigo, the drugmaker is wading deeper into the rare oncology arena with a new M&A play. 
    • “Servier on Friday unveiled a definitive agreement to acquire Day One Biopharmaceuticals—a commercial-stage company developing targeted therapies for pediatric cancers and other diseases—for $21.50 per share in cash. The total value of the deal, which is expected to close in the second quarter, comes to roughly $2.5 billion, the companies said in a March 6 release.” 
  • Per BioPharma Dive,
    • “Blackstone Life Sciences is widening its presence in drug development, announcing Tuesday a $400 million commitment over four years to support Teva Pharmaceutical’s work on a late-stage gut disease drug likely to be in a hotly contested class.
    • “Per deal terms, if the drug, called duvakitug, gains Food and Drug Administration approval, Teva will owe a milestone payment to Blackstone, along with additional payouts and royalties based on commercial sales. Blackstone has signed similar deals with Moderna, Alnylam Pharmaceuticals and Autolus Therapeutics.
    • “Duvakitug is in Phase 3 clinical trials that will enroll more than 3,000 people with ulcerative colitis or Crohn’s disease and follow them for up to 40 weeks. The deal will help subsidize Teva’s research and development spending, which topped $1 billion in 2025.”
  • Per MedTech Dive,
    • “MiniMed, Medtronic’s diabetes tech spinoff, made its debut on the public markets Friday. 
    • “The company started trading on the Nasdaq under the ticker “MMED.” MiniMed offered 28 million shares priced at $20 each, for a total value of $560 million.
    • “The amount was below the $25 to $28 per share suggested by the company in filings last month.
    • “MiniMed has a market capitalization of about $5.29 billion, according to Yahoo finance.” 

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.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “Republicans are renewing their push to fully fund and reopen the Homeland Security Department, suggesting the war the United States launched against Iran over the weekend has heightened the need to end the single-agency shutdown that entered its third week on Monday. 
    • “House Republicans will bring up another vote on a DHS appropriations bill this week, Majority Leader Steve Scalise, R-La., announced, saying it was dangerous for Democrats to continue holding up the funding due to concerns over the Trump administration’s immigration enforcement crackdown. 
    • “The legislation would “end the DHS shutdown so we can ensure agencies can protect America during this dangerous time,” Scalise said, noting the FBI has warned of an elevated threat of terrorist activity domestically.” * * *
    • “Most of the department’s employees have continued to work during the shutdown, with only about 8% of the workforce home on furlough. Many employees, such as law enforcement and other personnel at Immigration and Customs Enforcement and Customs and Border Protection, are receiving their normal paychecks thanks to funding Congress provided in the One Big Beautiful Bill Act. Others, such as Transportation Security Administration and Federal Emergency Management Agency workers, have started to receive partial paychecks or will do so this week. The U.S. Coast Guard is paying its uniformed personnel on time, but civilians will face delayed pay.” 
  • Healthcare Dive relates,
    • “The American Medical Association is overhauling how U.S. doctors report and bill for pregnancy services, bulldozing the current system of bundled payments and replacing it with more granular, itemized codes next year.
    • “The changes, shared exclusively with Healthcare Dive, could help improve poor maternity health outcomes in the U.S. But it’s also an acquiescence to specialty groups, which have long lobbied the powerful medical association that modern obstetric services are more complex than the current coding system is able to reflect.
    • “The move also represents a step back for value-based care, and could incentivize OB-GYNs and other doctors to provide unnecessary medical services at a time of skyrocketing health spending.
    • “But the changes shouldn’t result in OBGYNs, nurse-midwives or other maternity care specialists bringing in more revenue, according to the AMA, which argues the new coding system will benefit the entire healthcare industry.” * * *
    • “Global codes are normally billed when a baby is delivered, which can keep insurers in the dark about their members’ pregnancies. The new codes should give insurers more information, including when a member gets pregnant, that could help them ensure expecting mothers get adequate prenatal care, or know if mothers had complications during delivery that could necessitate follow-up services, according to Dr. Daniel Halevy, an executive at New York nonprofit insurer Healthfirst.”
  • and
    • “Sweeping reforms in the Consolidated Appropriations Act of 2026, signed into law by President Donald Trump earlier this month, included changes that could upend the traditional PBM model, while also turning attention back to drugmakers.” * * *
    • “With PBMs’ bargaining power facing stricter limits under the new reform [which takes effect later this decade to allow for necessary rulemaking], questions surrounding pricing could shift in a new direction.
    • “Be ready for the spotlight to swing back to drug manufacturers,” said Jesse Dresser, a partner in law firm Frier Levitt’s life sciences department and head of its pharmacy practice group.
    • “As PBMs lose traction in the coming years, the pressure on drugmakers to justify their own list prices could intensify.
    • “Now, the argument is going to be that PBMs have been handcuffed, limiting their ability to use some of these abusive tools,” Dresser suggested. “So, it’s going to be up to the drug manufacturers to make sure they’re taking the appropriate steps and not continuing in the old paradigm now that there should be a shift in financial incentives.”
  • Bloomberg Law reports,
    • “A group representing thousands of pharmacies across the US said its members are experiencing financial issues after the rollout of the government’s drug price negotiation program, urging the Centers for Medicare & Medicaid Services to immediately address cash flow concerns.
    • “A letter from the National Community Pharmacists Association is asking CMS Administrator Mehmet Oz to ensure pharmacies receive timely payments under the Medicare Drug Price Negotiation Program, finding in a survey that its members are facing cash flow issues after dispensing certain drugs and waiting for a refund from the manufacturer. 
    • “We need CMS to take all necessary steps to expedite the manufacturers’” refund payments to pharmacies, Ronna Hauser, senior vice president of policy and pharmacy affairs for NCPA, said in the letter to the CMS sent Thursday. “Pharmacies cannot continue to dispense these drugs with delayed payments unless the cash flow issues significantly improve.”
  • Per an Employee Benefits Research Institute news release,
    • “Rising health care costs are affecting household finances for many privately insured adults, with 4 in 10 reporting higher expenses in the past year and many cutting discretionary spending or reducing retirement contributions, according to results from the 2025 EBRI/Greenwald Research Consumer Engagement in Health Care Survey (CEHCS) released today by the Employee Benefit Research Institute (EBRI).
    • “Employment-based coverage remained the dominant source of private insurance, with 6 in 10 covered through their own job. Deductibles also remained widespread across plan types: More than three-quarters of enrollees had a medical deductible, including 70% of traditional plan enrollees. Enrollment in high-deductible health plans dipped slightly in 2025, while enrollment in consumer-directed health plans and health savings accounts (HSAs) appeared relatively stable.
    • “The annual survey also found that most enrollees spent relatively little time selecting coverage during open enrollment, with about half spending less than an hour reviewing options and most spending under two hours. While most adults reported being satisfied with the ease of plan selection and the information available, satisfaction with the availability of affordable plan options and the number of plans to choose from declined in 2025.”
  • Beckers Payer Issues tells us,
    • “CMS is sanctioning Elevance Health and plans to suspend enrollment into the insurer’s Medicare Advantage prescription drug plans, according to a Feb. 27 agency letter.
    • ‘The enrollment and communications pause is set to begin March 31 unless Elevance submits all data corrections and an attestation in advance. CMS said the intermediate sanctions stem from “substantial and persistent noncompliance with Medicare Advantage risk adjustment data submission requirements.” The sanctions will apply until Elevance resolves the issues.”
  • Per a Labor Department news release,
    • “The U.S. Department of Labor’s Wage and Hour Division announced [February 26] a proposed rule designed to help workers and employers better understand how to determine when a worker is an employee and when the worker may be classified as an independent contractor under the Fair Labor Standards Act and related federal laws. 
    • The proposed rule would rescind the department’s 2024 final rule addressing the classification of independent contractors and replace it with an analysis for employee classification similar to the one adopted by the department in 2021. Consistent with Supreme Court and federal circuit court precedent, the proposed rule would make it easier to properly differentiate between employees with the protections under the Fair Labor Standards Act and those workers who work as independent contractors.” * * *
    • “The department encourages all interested parties to submit comments on the proposed rule, which has a 60-day comment period that closes at 11:59 p.m. ET on April 28, 2026.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Ascendis Pharma said Friday the Food and Drug Administration granted accelerated approval to a treatment it’s developed for the most common type of dwarfism, ending what had been a monopoly for rival drugmaker BioMarin Pharmaceutical. 
    • “The new drug, previously known as TransCon CNP and now Yuviwel, is a once-weekly injection cleared for children aged two and older with achondroplasia and open growth plates. The treatment will compete with Voxzogo, a daily shot sold by BioMarin.”
  • MedTech Dive relates,
    • “Abbott has won approval for updated remote heart failure monitoring technology, the company said Friday.
    • “The Food and Drug Administration awarded approval to CardioMEMS Hero, a new version of the device that patients use to take daily pulmonary artery pressure readings.
    • “Abbott has made Hero smaller and 60% lighter than the previous reader, fitting the electronics into a device the size of a laptop case to make it easier to use and take on planes.”
  • and
    • “Unomedical, a subsidiary of Convatec and a supplier of insulin infusion sets to diabetes tech firms, received a warning letter from the Food and Drug Administration in January.
    • “Inspectors raised concerns with leaking infusion sets, which can pose a risk of insulin under-delivery, potentially leading to life-threatening complications like diabetic ketoacidosis.  “Regulators called for Unomedical to address problems with validating its devices, addressing complaints and providing timely adverse event reports to the FDA.
    • “The warning letter followed a remote regulatory assessment of Unomedical’s facility in Reynosa, Mexico, last summer.”

From the judicial front,

  • Bloomberg Law reports,
    • “The Justice Department said it won’t appeal the decision of a New York federal judge to throw out a murder charge against Luigi Mangione, which means he won’t face the death penalty if he’s convicted of killing UnitedHealth Group Inc. executive Brian Thompson.
    • “US District Judge Margaret Garnett ruled in January that prosecutors can’t pursuethe capital murder charge, but that a jury could determine if Mangione caused Thompson’s death under two federal stalking laws. If convicted of those crimes, he could face life in prison without possibility of parole. 
    • “In a one-page letter Friday to Garnett, a Justice Department lawyer said prosecutors won’t challenge the judge’s decision.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A report published March 2 by the American Cancer Society found that colorectal cancer rates among adults 65 and older continue to decline while rates for younger adults continue to increase. The study found that the increase is being driven by a higher prevalence of rectal cancer, which now makes up 32% of all colorectal cancer diagnoses, up from 27% in the mid-2000s. The study also projects 158,850 new cases of colorectal cancer in the U.S. in 2026, and that 55,230 individuals will die from the disease. Nearly one-third of deaths are estimated to be younger than age 65.” 
  • Cardiovascular Business tells us,
    • “Patients with type 2 diabetes who use GLP-1 receptor agonists (GLP-1 RAs) and make healthy lifestyle choices can significantly lower their risk of experiencing a heart attack or stroke, according to new data published in The Lancet Diabetes & Endocrinology.[1]
    • The study’s authors explored data from more than 98,000 participants from the U.S. Department of Veterans Affairs’ Million Veteran Program. These individuals were enrolled from 2011 to 2023. 
    • “Lifestyle habits explored in this analysis included getting a recommended amount of exercise, not smoking, sleeping well, drinking minimal alcohol, properly managing stress, connecting with others socially and avoiding opioids. Overall, adults on a GLP-1 RA and following six to eight of these healthy habits was associated with a 43% lower risk of experiencing a major adverse cardiovascular event (MACE) than those not taking GLP-1 RA or adhering to these habits. When adults followed all eight habits, meanwhile, the risk was approximately 60% lower.
    • “In addition, those using a GLP-1 RA had a 16% lower MACE risk than those who did not use a GLP-1. 
    • “Our findings underscore that, even in the era of highly effective GLP-1 pharmacotherapy, lifestyle habits remain central to diabetes management and cardiovascular risk reduction and can substantially amplify the benefits of modern medications,” corresponding author Frank Hu, MD, PhD, chair of the department of nutrition at the Harvard T.H. Chan School of Public Health, said in a statement.”
  • Contemporary OB/GYN informs us,
    • “The quadrivalent HPV vaccine is associated with a significantly reduced risk of invasive cervical cancer that persists for at least 18 years after administration.
    • “Vaccination before the age of 17 provides a 79% lower risk of cervical cancer, while those vaccinated at age 17 or older also experience significant long term risk reductions.
    • “Population level data shows that school based vaccination cohorts have significantly lower rates of invasive cervical cancer compared to earlier opportunistic vaccination cohorts.”
  • MedPage Today points out,
    • “The location and amount of brain microbleeds that a person has could be telling of their risk of dementia, according to an observational analysis.
    • “Compared with controls with no cerebral microbleeds detected on MRI, there was an increased dementia risk in older people with:
      • “Mixed subcortical and lobar microbleeds (HR 1.99, 95% CI 1.40-2.83)
      • “Lobar-only microbleeds, with or without cortical superficial siderosis (HR 1.96, 95% CI 1.30-2.97)
      • “Any cortical superficial siderosis (HR 2.57, 95% CI 1.36-4.89)
    • “Participants with three or more cerebral microbleeds of any pattern also had an increased risk of dementia (HR 1.92, 95% CI 1.35-2.72), as did peers with at least two subcortical microbleeds, according to Rebecca Gottesman, MD, PhD, of the National Institute of Neurological Disorders and Stroke in Bethesda, Maryland, and colleagues.
    • “Their report, based on the Atherosclerosis Risk in Communities-Neurocognitive Study, was published in Stroke.
  • and
    • “Chronic migraine patients who used GLP-1 receptor agonists to treat conditions like obesity or diabetes had fewer emergency department (ED) visits than those on topiramate (Topamax), a real-world data analysis showed.
    • “Compared with topiramate users, GLP-1 drug initiators were 10% less likely to visit the ED over the following year (RR 0.90, 95% CI 0.86-0.94), reported Hsiangkuo Yuan, MD, PhD, of Jefferson Headache Center at Thomas Jefferson University in Philadelphia, in an abstract released ahead of the American Academy of Neurologyopens in a new tab or window annual meeting.”
  • The Wall Street Journal asks whether Multi-Cancer Blood Tests Are Ready for Prime Time?
    • Early detection tests are already on the market, but without FDA approval or proof they reduce deaths some doctors urge caution
  • Per BioPharma Dive,
    • “Roche’s experimental pill fenebrutinib hit its main goal in a second Phase 3 trial in the most common form of multiple sclerosis, helping treatment recipients experience significantly fewer relapses than study volunteers who got Sanofi’s Aubagio, the company said Monday.
    • “However, Roche also reported a case of severe liver side effects in one enrollee who got fenebrutinib in the study. It also revealed a higher number of deaths among people who took its therapy in the two Phase 3 trials in relapsing MS, which prompted one analyst, Michael Leuchten of Jefferies, to question the drug’s approval prospects. Analysts have forecasted peak sales of more than 3 billion Swiss francs, or $3.8 billion, for fenebrutinib, Leuchten wrote.
    • “Fenebrutinib is part of a new crop of “BTK inhibitors” that drugmakers are now positioning as potential autoimmune disease treatments. The effort has yielded multiple setbacks in MS, though, as the Food and Drug Administration recently rejected a BTK drug from Sanofi, and other developers like Merck KGaA and Biogen have given up on prospective drugs.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealth Group has named Dennis Stankiewicz as chief accounting officer, effective March 2. 
    • “Tom Roos, who has served as CAO since 2015, has been named CFO at Optum Insight, the company said in regulatory filings.”
  • Healthcare Dive adds,
    • “UnitedHealth executive and former Optum leader Heather Cianfrocco is leaving the company, according to a post on LinkedIn.
    • “Cianfrocco was promoted to executive vice president of governance, compliance and information security at UnitedHealth in May, after serving for a year as CEO of Optum, the company’s health services arm. Patrick Conway, the former CEO of Optum Rx, replaced Cianfrocco.
    • “Cianfrocco is departing UnitedHealth after serving in a number of executive positions, including as CEO of Optum Rx and chief of UnitedHealthcare’s community and state division. “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she said in a post on LinkedIn. “I am leaving with so much pride in what we have accomplished together.”
  • Beckers Hospital Review notes,
    • “According to data gathered by Becker’s, Parkland Health and Hospital System [in Dallas, Texas] saw the highest number of emergency department visits in 2025. 
    • “The figures [shown in the article] represent the number of ED visits at individual hospital facilities, rather than the total visits across entire health systems. These self-reported totals were provided directly by hospitals.
  • Fierce Healthcare relates,
    • “Healthcare technology companies DoseSpot and Arrive Health have merged to combine an electronic prescribing platform with medical and pharmacy benefits data to advance real-time medication price transparency for providers and patients.
    • “The new company, called Interra Health, combines Arrive Health’s coverage and pricing network with DoseSpot’s e-prescribing capabilities to support prescribing decisions and help patients access the right medication at the lowest cost, according to the companies.
    • “Bain Capital Tech Opportunities is backing the deal and will serve as majority owner. PSG, the former majority owner of DoseSpot, will be a minority owner. Additional minority investors include Providence and UPMC Enterprises.
    • “The combined company is profitable, growing at approximately 40% annually and projected to exceed $100 million in revenue in 2026, executives said.”
  • Per BioPharma Dive,
    • “Privately held Candid Therapeutics will merge with Rallybio in a deal to take the inflammatory disease drugmaker public, the companies said Monday.
    • “The new entity will operate under Candid’s name, and trade on Wall Street under the ticker “CDRX.” As part of the deal, Candid raised $505 million from more than a dozen venture capital firms and mutual funds including Venrock, RA Capital Management and Janus Henderson Investors.
    • “Candid is developing bispecific antibodies known as T-cell engagers it acquired in two deals with Chinese biotechnology firms in 2024. One of Candid’s central goals is to show it can advance drugs that are similar to cell therapies targeting B cells, but easier to manufacture and administer. While bispecifics research has largely focused on cancer, startups like Candid — and even some pharmas — are now testing the applicability of these drugs against autoimmune conditions.”

Friday report

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, Telehealth, U.S. Healthcare–

From Washington, DC

  • Fierce Healthcare reports,
    • “The Trump administration has proposed flat rates in Medicare Advantage (MA) for 2027, and insurers argue in new commentary that those levels do not reflect the realities of the program.
    • “In late January, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed advance notice governing MA and Part D. 
    • “The proposal includes a net payment rate increase of 0.09% in MA, meaning levels will be essentially flat if the plan becomes final.
    • “The proposed rule drew immediate ire from the industry, which is already navigating significant financial challenges in this market. Multiple leading players have elected to exit certain MA markets. 
    • “In official comments (PDF) submitted Wednesday to the CMS, the AHIP said the proposed rule “risks undermining CMS’ goal of providing beneficiaries with stable, affordable choices during the annual enrollment period.”
    • “At a time of sharply rising medical costs and high utilization of medical services, the combined effect of the proposed policy changes and growth rates will not keep pace with the cost of caring for seniors in 2027,” the organization, which is the largest lobbying group representing insurers, said in its comment letter.”
  • MedPage Today relates,
    • A top health official at the Centers for Medicare & Medicaid Services (CMS) [Chris Klomp] hedged on payment reform, but committed to helping physicians address prior authorization challenges, during the American Medical Association’s (AMA) National Advocacy Conference.”
  • Per Beckers Health IT,
    • “CMS has rolled out an app directory for Medicare recipients as part of the agency’s push to digitize healthcare.
    • “The Medicare App Library seeks solutions that fall under one of three use cases: “kill the clipboard,” conversational AI assistants, or diabetes and obesity prevention and management.
    • “We are calling on health app developers, tech-enabled organizations, and innovators to voluntarily align around a shared framework for data and access that empowers people, improves care, and accelerates progress,” CMS stated Feb. 23. “This is a movement, not a mandate. It is a call to action, not a regulation. Let’s show what’s possible when we work together — and finally bring healthcare into the modern era.”
  • Federal News Network tells us
    • “Tens of thousands of federal employees at U.S. Customs and Border Protection are expected to continue receiving pay during the Department of Homeland Security’s current funding lapse, according to an email viewed by Federal News Network.
    • “CBP, a component of DHS, plans to use discretionary funding from the One Big Beautiful Bill Act to exempt and continue paying more than 57,600 agency employees who have been working throughout the partial shutdown this month. Details of the agency’s decision come from an email sent this week by the National Treasury Employees Union, obtained by Federal News Network.
    • “Under the current shutdown, CBP will “exempt” and provide pay to a large portion of its workforce, including law enforcement personnel and certain civilian agency employees. Some other CBP employees, however, are still considered “excepted” and will not receive pay until after the shutdown ends.”
  • MedTech Dive informs us,
    • “The Trump administration is imposing a six-month moratorium on Medicare enrollment for certain suppliers of durable medical equipment, prosthetics and orthotics, or DMEPOS, as part of a broader plan to combat fraud in healthcare.
    • “The administration said Wednesday that the nationwide halt on enrollment would give the government time to consider more actions “to further mitigate longstanding instances of fraud, waste, and abuse perpetrated by certain DMEPOS companies.”
    • “The temporary freeze applies to all applications for initial enrollment and changes in majority ownership for medical supply companies.
    • “Durable medical equipment includes items such as walkers, wheelchairs, oxygen equipment, hospital beds, continuous positive airway pressure machines and blood sugar monitors.”
  • NCQA, writing in LinkedIn, announced its “Advanced Primary Care Pilot Program” and invited readers to “Meet Our Primary Care Partners!”
  • The Labor Department’s Employee Benefits Security Administration let us know about extending the public comment period on its proposed Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure rule to April 15, 2026.

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “The Food and Drug Administration on Tuesday posted a warning letter sent to Beta Bionics in late January.
    • “The letter raised concerns with how the diabetes tech company handled complaints of severe low and high blood sugar associated with its automated insulin delivery system. The FDA also flagged problems with the company making modifications to its device without notifying regulators.
    • “In an annual report filed Tuesday, the company said it has already taken several corrective actions, including improvements to the processes identified in the warning letter. The company is also preparing a written response to the letter.”
  • Cadiovascular Business informs us,
    • “Cara Medical, a medtech company focused on advanced imaging technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its new platform that noninvasively visualizes a patient’s cardiac conduction system.
    • “The CARA System, which previously earned the FDA’s breakthrough device designation, was designed to help interventional cardiologists and electrophysiologists plan ahead before procedures and then guide them during treatment. It can be used for structural heart interventions such as transcatheter aortic valve replacement (TAVR) as well as pacing procedures.
    • “The newly cleared system includes two primary components. The CARA Metis Simulator is a preprocedural planning software that identifies the cardiac conduction axis on CT angiography results and generates a 3D map of the patient’s conduction system. The CARA Atlas Navigator, meanwhile, overlays that map onto live fluoroscopic images to assist with intraprocedural guidance. 
    • “Artificial intelligence (AI) algorithms play a role in both components, extracting metadata and detecting the user’s catheter for visualization, but all AI calculations can still be confirmed by a physician.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits and hospitalizations among infants and children 4 years and younger.
    • Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) has ended its investigation into the recent multistate infant botulism outbreak traced to ByHeart powdered formula and lowered the total case number by three. In a Public Health Alert issued earlier this week, California, CDC, and Food and Drug Administration scientists reported 51 infections, but yesterday the CDC said it has excluded three suspected cases, for a total of 48 (28 confirmed, 20 probable) in November and December 2025. While the outbreak is over, investigators continue to probe how Clostridium botulinum bacteria got into the formula, the CDC said.
    • “A report published yesterday in the CDC’s Morbidity and Mortality Weekly Report describes how officials used artificial intelligence (AI) to identify contaminated ice in a beer cooler as the source of a 2024 Salmonella enterica outbreak at a county fair. Ice is an uncommon vehicle for Salmonella spread at public events, noted author Katherine Houser, RN, of the Brown County Health Department in Mount Sterling, Illinois. The outbreak sickened 13 people (seven confirmed, six probable cases). AI tools helped synthesize background information to support and contextualize the environmental health team’s assessment, Houser said.”
  • The CDC also announced today,
    • “As of February 26, 2026, 1,136 confirmed* measles cases were reported in the United States in 2026. Among these, 1,130 measles cases were reported by 28 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New Mexico, New York City, New York State, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin. A total of 6 measles cases were reported among international visitors to the United States. 
    • “There have been 10 new outbreaks** reported in 2026, and 90% of confirmed cases (1,023 of 1,136) are outbreak-associated (152 from outbreaks starting in 2026 and 871 from outbreaks that started in 2025).”
  • MedPage Today informs us,
    • “Identical stool samples sent to seven direct-to-consumer microbiome testing companies produced substantially different bacterial profiles and health assessments.
    • “Across 18 commonly reported microbial genera, no company’s results matched the consensus; and only three genera of 1,208 identified taxa appeared in every report.
    • “Researchers attributed the discrepancies to differences in laboratory methods and analysis pipelines, and say the results underscore the need for standardized testing and quality controls.”
  • The Wall Street Journal considers
    • “Why All The Fuss About Bone Density?
    • “Like most of my peers, I’m being bombarded daily with hectoring advice about my bones. What’s a 40-something woman to do?” * * *
    • “For guidance, [the journalist] consult[s] with Dr. Karen Tang, the author of “It’s Not Hysteria: Everything You Need to Know About Your Reproductive Health (but Were Never Told),” who offers a more measured take.” 
  • Medscape adds,
    • “A low-dose, single pill that combines three antihypertensive treatments is as effective as standard-dose monotherapy — in some cases even better — for treating mild-to-moderate hypertension, according to the first phase 3 double-blind trials comparing the medications.
    • “Investigators for the HM-APOLLO-301 and HM-APOLLO-302 phase 3 clinical trials, which were published in the Journal of the American College of Cardiology, contend there is now concrete evidence to support the efficacy of the single-pill therapy.
    • “They argue that starting with the traditional single-agent therapy and then titrating up can delay blood pressure control, increase the possibility of adverse effects, and affect patient adherence.”
  • The University of Minnesota’s CIDRAP relates,
    • “The results of a randomized controlled trial (RCT) indicate that meningococcal B vaccine is not effective at preventing gonorrhea infection in high-risk groups.
    • “The results, presented this week at the Conference on Retroviruses and Infections by a team of Australian researchers, show that among gay and bisexual men with a history of gonorrhea infection who received either the 4CMenB vaccine or placebo, gonorrhea incidence was essentially the same—roughly 48% in both arms.
    • “The 4CMenB vaccine is designed to protect against four serogroups of Neisseria meningitidis, which can cause invasive meningococcal disease. But in recent years, observational studies have suggested 4CMenB might also provide moderate cross-protection against Neisseria gonorrhoeae, the bacterium that causes gonorrhea—one of the most common sexually transmitted infections (STIs) worldwide.” 
  • Genetic Engineering and Biotechnology News reports,
    • “CAR T cell therapy has revolutionized the treatment of many blood cancers, but has shown little success against solid tumors, which account for more than 85% of all cancers.
    • “Columbia University researchers have now developed a new form of highly sensitive CAR T cells, known as HIT T cells, that aims to overcome one of the biggest barriers in solid tumor immunotherapies, which is the way that solid tumors lack a single, widely shared surface target.
    • “Headed by Michel Sadelain, MD, PhD, director Columbia Initiative in Cell Engineering and Therapy (CICET), the researchers engineered an ultra-sensitive and highly selective chimeric antigen receptor called an HLA-independent T cell (HIT) receptor, which is capable of detecting even the smallest amounts of the protein CD70 on tumor cells.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance is consolidating control of its health insurance businesses under Felicia Norwood, its head of government benefits, as the company looks to improve coordination across its Medicaid, Medicare and commercial plans and — hopefully — bolster waning profits.
    • “Mark Kaye, Elevance’s CFO, will also take on leadership of health services division Carelon as current president Peter Haytaian leaves to spend more time with his family, according to a press release Thursday announcing the executive changes.
    • “Haytaian will leave the role effective May 4 and stay on as an advisor through the end of the year. The executive first joined Elevance in 2012 through its acquisition of Amerigroup before becoming president of Carelon in 2021.”
  • Beckers Payer Issues adds,
    • “Longtime UnitedHealth Group executive Heather Cianfrocco is leaving the company.
    • Ms. Cianfrocco has served as executive vice president of governance, compliance and information security at UnitedHealth since April 2025. She briefly served as CEO of Optum from 2024 to 2025 before being succeeded by Patrick Conway, MD, who previously led Optum Rx. 
    • “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she wrote on LinkedIn Feb. 27. “I am leaving with so much pride in what we have accomplished together. I’ve had the privilege of working alongside some of the most talented, mission-driven people who show up every day determined to make health care easier to navigate, more affordable and more human.”
  • Beckers Hospital Review notes,
    • “CVS Caremark is expanding its use of Surescripts’ Touchless Prior Authorization platform to accelerate approvals for select specialty medications.
    • “The prior authorization technology connects directly to patients’ EHRs to gather required clinical data and match it with prior authorization criteria, according to a Feb. 25 news release. When requirements are met, CVS Caremark can approve medications automatically in as little as 22 seconds.
    • “The platform is currently used for select specialty drugs, including Vivitrol and Epidiolex, which treat substance use disorder and epilepsy. These medications typically require complex approvals because of their high impact and specialized clinical use cases.”
  • Healthcare Dive tells us,
    • “Teladoc Health projects membership in its business-to-business integrated care unit will decline this year, in part due to the expiration of enhanced Affordable Care Act subsidies, management said during a fourth-quarter earnings call Wednesday.
    • “The company expects 97 million to 100 million members in U.S. integrated care in 2026, down from 101.8 million at the end of last year. 
    • ‘Teladoc expects the decline will be driven by enrollment reductions at some client health plans in government programs, which were impacted by the lapse of more generous financial assistance for ACA coverage, CEO Chuck Divita said on the call.”
  • Fierce Healthcare adds,
    • “Walgreens is wading into the self-pay GLP-1 space, going head-to-head with telehealth subscription offerings.
    • “The retail pharmacy giant launched a digital weight management service to offer access to personalized, clinician-guided support for weight loss. The service expands Walgreens’ virtual healthcare platform and provides patients with access to licensed doctors and nurse practitioners, FDA-approved medication options and ongoing virtual support, according to the company in a press release.
    • “Virtual visits through the weight management service cost $49 with no requirement for a monthly subscription. The program, currently available in 28 states, is intended for eligible overweight and obese adults ages 18-64 who plan to self-pay for their GLP-1 medication.”
  • Healthexec summarizes news from “the 2026 ViVE conference, part of HLTH, [which] just wrapped up in California. On the show floor, people from across the healthcare and health IT space gathered for four days of events, thought leader insights and product showcases on the floors of the Los Angeles Convention Center.