Friday report

Medicare

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, No Surprises Act, U.S. Healthcare–

Happy first day of Spring!!

From Washington, DC

  • Roll Call reports,
    • “Senators are sticking around Washington this weekend after a busy week on the Hill highlighted partisan divides, intraparty friction and growing tension between the two chambers. One thing is clear — everyone is ready for spring break.
    • “The Senate has largely been wrapped up in an extended debate on the GOP’s marquee voter ID legislation, dubbed the SAVE America Act. Debate on the bill began Tuesday and is anticipated to extend through the weekend, at least. 
    • “We’re in through this weekend,” Senate Majority Leader John Thune, R-S.D., said on Fox News on Friday morning. “There will be a vote on this bill. We will find out where everybody stands.” * * *
    • “After Senate appropriators of both parties held a face-to-face meeting Thursday with White House “border czar” Tom Homan — some of the first signs of progress in weeks — Thune set a deadline of next week for resolving the DHS funding standoff.”
  • Bloomberg Law relates,
    • “The Trump administration’s Medicare chief said the version of the program run by private insurers doesn’t do enough to control costs, raising questions about how much the US will pay companies in a crucial upcoming rate update.
    • “Chris Klomp, a top health official at the US Centers for Medicare and Medicaid Services, said the private Medicare Advantage program “does not sufficiently have control of costs,” in remarks at a STAT conference in New York on Thursday.”
  • STAT News adds,
    • “President Trump’s Medicare director said Thursday his team is considering a policy that would automatically enroll Medicare beneficiaries into Medicare Advantage plans, a controversial idea that was touted in the conservative Project 2025 policy blueprint. 
    • “Chris Klomp said the Centers for Medicare and Medicaid Services is mulling the feasibility of models that would either automatically enroll beneficiaries into the private form of Medicare or accountable care organizations, such as those that participate in the Medicare Shared Savings Program. Individuals could still opt into a different insurance arrangement. Right now, people who don’t make a choice are covered by traditional Medicare.
    • “Would either of those, in my view, be superior to a default enrollment into a fee-for-service arrangement, where there’s not this long-term, secular relationship between the beneficiary, the patient, and their provider? Yes,” Klomp said. 
    • “He made the comments in an interview with STAT reporter Mario Aguilar on the sidelines of STAT’s Breakthrough Summit East in New York.”
  • Health Affairs Forefront tells us,
    • “The only truly clear and formally stated goal of the MFN [most favored nation drug pricing] policies is to lower the prices that Americans pay for drugs. How can we begin to evaluate the extent and impact of this kind of change?
    • “It is notoriously difficult to know, precisely, what most Americans “pay” for drugs. We have a complicated system of confidential manufacturer rebates and arrangements with pharmacy benefit managers that often tie out-of-pocket payments to “list” prices that may or may not actually be paid by anyone. People far smarter than I have made careers of shedding light on the cost of drugs in the US, and ultimately, it will be up to them to track whether any person or entity ends up paying less for drugs (and for which drugs) than prior to the policies’ enactment. Until then, Observatory members are watching developments in a few key areas that could influence the reach of MFN policies in the US.
    • “First, they are watching the relationship of the MFN policies to the employer-based insurance market, which covers 160 million people, or more than 50 percent of those with health insurance in the US. To date, MFN policies have been announced for Medicare and Medicaid recipients and for individuals who purchase drugs out of pocket on TrumpRx. But even at discounted prices available through TrumpRx, many drugs will remain too costly for consumers unless they can use the insurance for which they already pay premiums.
    • “The reach of the new, “lower” prices will be limited if there isn’t a mechanism for those with employer-sponsored insurance to access those prices. Part of such “access” includes having purchases through TrumpRx (or other direct-to-consumer platforms) count toward the deductibles and out of pocket maximums that characterize private coverage. Without explicit mechanisms to enable this kind of accounting—or federal or state mandates to require it—the purchase of drugs at the MFN prices will likely be unappealing to more than half of the US population, significantly diluting the policies’ effectiveness and reach. Further, if employer-sponsored health plans cannot access the MFN prices, then those lower prices cannot be reflected in their overall premiums, which consistently rise far faster than both general inflation and wage growth with escalating pharmaceutical costs being an important contributor.”
  • and
    • “As reported by the Centers for Medicare and Medicaid Services (CMS) in supplemental tables and public use files, the volume of cases submitted into the [No Surprises Act Independent Dispute Resolution] IDR process continues to exceed all expectations and grew rapidly in the first six months of 2025. During that period, parties submitted 1.2 million new disputes to the IDR portal—more than double the volume of the first two quarters of 2024 when nearly 590,000 disputes were filed. This amounts to a total of 3.4 million disputes from 2022 through June 2025.
    • “And the number of disputes is only continuing to increase: Even more recent bi-monthly updates from CMS show that nearly 1.4 million cases were filed from July 2025 through December 2025. This has resulted in a whopping 4.8 million total cases through the end of 2025. As a reminder, federal officials expected approximately 17,000 disputes per year.” * * *
    • “Consistent with prior trends, providers continued to initiate (and win) the vast majority of disputes.” * * *
    • Four provider groups and provider representatives—mostly backed by private equity—initiated the majority of these disputes: HaloMD, Team Health, Radiology Partners, and SCP Health. HaloMD—a middleman organization that specializes in arbitration—initiated the most disputes, accounting for 17 percent of all disputes in the first quarter of 2025 and 22 percent of all disputes in the second quarter of 2025. For an organization that initiated a mere 1 percent of line-item claims in 2023, this is a rapid rise to prominence. The second most frequent initiator, Team Health, has long been a high-volume IDR participant and initiated 16 percent of all disputes in the first six months of 2025, a level that is consistent with prior years. Combined, the top four initiators accounted for more than half (56 percent) of disputes filed in the first two quarters of 2025.
    • Providers also won 88 percent of disputes—the highest provider win rate to date—as compared to 85 percent in 2024 and 81 percent in 2023. Radiology Partners prevailed most often, winning favorable IDR awards in 92 percent and 95 percent of its cases in the first two quarters of 2025, respectively. Team Health saw similar win rates of 94 percent across both quarters. HaloMD won slightly less often but still prevailed in 87 percent and 82 percent of its disputes in the first two quarters of 2025, respectively.
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) has finalized the Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures Final Rule (CMS-0053-F).
    • “This groundbreaking final rule establishes the first-ever Health Insurance Portability and Accountability Act (HIPAA)-adopted standards for health care claims attachments, enabling the secure electronic exchange of health care claims-related supporting clinical documentation such as medical records, x-rays and imaging, clinical notes, telemedicine visit documentation and laboratory results.
    • “The rule also establishes requirements for electronic signatures to ensure health care claims attachment transactions are secure, authenticated, and compliant with federal standards.” * * *
    • “Health care providers and payers should begin preparing to implement the finalized standards. This final rule is effective on May 26, 2026. The compliance deadlines for all requirements in this rule are set for 24 months from the effective date of the final rule. Stakeholders are encouraged to review the rule and begin implementing the new standards promptly. The final rule can be viewed at: https://www.federalregister.gov/.” * * *
    • To view the final rule fact sheet, visit: https://www.cms.gov/newsroom/fact-sheets/administrative-simplification-adoption-standards-health-care-claims-attachments-transactions.
    • For more information, visit: https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/hipaa/events-latest-news.
  • PCMA points out,
    • “The Pharmaceutical Care Management Association (PCMA) is urging the Labor Department to roll back a proposed rule aimed at boosting price transparency in pharmacy benefit management relationships now that Congress has passed industry reforms.”
  • Beckers Payer Issues informs us,
    • “Nine percent of people who had ACA Marketplace coverage in 2025 are now uninsured, with healthcare costs as a major reason many enrollees either switched Marketplace plans or dropped coverage, according to a KFF poll. 
    • “The KFF follow-up survey of Marketplace enrollees was conducted Feb. 12 to March 2 and included 1,117 U.S. adults who had Marketplace insurance in 2025. The sample was drawn entirely from respondents to KFF’s original 2025 Marketplace survey, which included 1,350 participants.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA issued a safety communication today warning of a potential increased risk of seizures tied to certain medications used to treat Parkinson’s disease.
    • “The agency will require manufacturers of carbidopa/levodopa products to update their labels with clearer warnings, to better inform patients and clinicians of this risk. The revised prescribing information will specify that these medications can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures.
    • “The warning also instructs healthcare professionals to assess baseline vitamin B6 levels before initiating carbidopa/levodopa therapy and to monitor these levels periodically during treatment, supplementing with vitamin B6 as needed.”
  • MedTech Dive adds,
    • “Intuitive Surgical has recalled stapler reload cartridges after receiving reports of four serious injuries and one death.
    • “The Food and Drug Administration communicated the recall in an early alert Wednesday, one week after Intuitive asked customers to quarantine and return all affected and unused reloads.
    • “An Intuitive spokesperson said in an email to MedTech Dive that the company is still investigating the root cause of rare reports of incomplete staple lines when using the recalled 8 mm SureForm gray reload cartridges.”
  • Fierce Pharma relates,
    • “Rhythm Pharmaceuticals is switching up the tempo for its melanocortin-4 receptor (MC4R) agonist Imcivree. After its initial approval more than five years ago to treat certain patients with genetic-driven obesity, the drug is moving into a different and broader realm with an FDA nod for acquired hypothalamic obesity (HO). 
    • “Acquired HO, for which Imcivree is the first approved treatment, represents an “expanded thinking” on the weight-regulating MC4R pathway that Rhythm’s product targets, Chief Scientific Officer Alastair Garfield, Ph.D., explained in a recent interview with Fierce. 
    • “Until now, all of Imcivree’s approved uses have centered around specific genetic causes. HO, on the other hand, is a result of a hypothalamic injury such as a tumor or stroke that impairs the MC4R pathway and causes weight gain and insatiable hunger (hyperphagia).”
  • Per an FDA news release,
    • “As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher pilot program. The agency also announced a public hearing on June 12, to allow stakeholders to present information and views about the program.
    • “The public hearing, consistent with 21 CFR § 15.1 et seq., will seek feedback about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation.” * * *
    • “The June 12 public hearing will be held at the FDA’s White Oak Headquarters with both an in-person and virtual option for participation. The FDA panelists will include subject matter experts from the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Oncology Center of Excellence, as well as a presiding officer. Requests to speak are due by May 1. The FDA is also soliciting written comments until June 27. For more information about the hearing: https://www.fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026.”

From the judicial front,

  • Fierce Healthcare reports,
    • “A federal judge has dealt a blow to the Trump administration’s push to restrict gender-affirming care for minors.
    • “Per the New York Times, Oregon [U.S.] District Court Judge Mustafa Kasubhai ruled Thursday that Department of Health and Human Services Secretary Robert F. Kennedy, Jr. overstepped his legal authority in issuing a declaration late last year that would bar hospitals from providing gender-affirming care to minors if they want to participate in Medicare and Medicaid.” * * *
    • “Restricting access to gender-affirming care for minors has been a key priority for the Trump administration, and NYT reports that legal experts believe Kasubhai’s decision will likely be appealed.”

From the public health, medical and Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. Seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. COVID-19 activity is decreasing in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing in most areas of the country.
    • “Influenza
      • “Overall seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. Influenza A activity continues to decrease while trends in influenza B activity vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • Vaccination
      • “RSV is a leading cause of hospitalization among U.S. babies.
      • “To help keep babies safe from severe RSV, babies younger than 8 months of age should get protection in their first RSV season (which usually starts in the fall) in one of these ways:
        • “The pregnant mother gets the RSV vaccine during pregnancy, or
        • “The baby gets an RSV antibody (nirsevimab or clesrovimab) just before the start of the RSV season or soon after birth, if born during the season.
      • “A CDC report showed that these protections are working. During the 2024–25 RSV season, infant RSV hospitalization rates were reduced by up to half compared to rates during seasons before when RSV prevention products were available.
      • “Interim estimates for the 2025–26 seasonal influenza vaccine show getting the vaccine reduced the risk of flu-related doctor visits and hospitalizations, supporting CDC’s vaccination recommendations. For children and teenagers, the vaccine was 38%–41% effective at preventing doctor visits and 41% effective at avoiding hospitalizations for the flu. For adults aged 18 and older, it was 22%–34% effective at preventing doctor visits and 30% effective for preventing hospital stays. Read more here: MMWR.
      • “Talk to your doctor or trusted healthcare provider about what may be recommended for you and your family.”
  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention announced today that there are now 1,487 confirmed measles cases nationwide so far this year. The CDC said 5% of cases have been hospitalized, and no deaths have been reported. The vaccination status of 92% of cases is unvaccinated or unknown. The South Carolina measles outbreak, which began in October 2025 and is currently the largest outbreak of any state, is at 997 cases. Utah, which has the second-largest outbreak, is now at 443 cases.” 
  • Health Day points out,
    • “Psychedelic-assisted therapy (PAT) is no more effective than traditional antidepressants (TADs) for treatment of major depression, according to a review published online March 19 in JAMA Psychiatry.” 
  • Medscape explains how “New Nanoparticles Can Destroy Undruggable Cancer Proteins.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Current schizophrenia (SZ) medications treat symptoms such as hallucinations and delusions, but do little for cognitive symptoms, such as disorganized thinking or executive dysfunction. As a result, many patients are unable to work, rely on family for lifelong support, become homeless or, in some cases, experience suicidal thoughts and actions.
    • “A study in humans and mice, headed by a team at Northwestern University, has discovered a novel biomarker of schizophrenia that could also serve as a new drug candidate to treat cognitive symptoms of the disorder. Their research in a mouse model of schizophrenia showed that treatment with a synthetic protein, SEAD1, corrected overexcited brain circuits. “A lot of people with schizophrenia cannot integrate well into society because of these cognitive deficits,” said Peter Penzes, PhD, professor of neuroscience, pharmacology and psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine. “Our discovery could solve these challenges by establishing the basis of a revolutionary and completely novel treatment strategy through a tandem biomarker-peptide therapeutic approach.”

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

  • BioPharma Dive reports,
    • “Novartis will pay $2 billion up front to acquire a drug that could improve upon existing treatments for patients with a particular form of breast cancer.
    • “Through a deal announced Friday, Novartis will purchase Pikavation Therapeutics, a subsidiary of privately held, Delaware-based Synnovation Therapeutics. The buyout hands Novartis an experimental pill called SNV4818, which targets tumors driven to growth by mutations to the PIK3CA gene. Alterations to this gene are implicated in a wide variety of cancers, including an estimated 40% of patients whose breast tumors are hormone-receptor positive, but don’t express the protein HER2, according to Novartis.”
  • Healthcare Innovation relates,
    • “Mary Bacaj, president of value-based care at Conifer Health Solutions, recently spoke with Healthcare Innovation about misconceptions around preventive care. She argues [in the interview found in the article] that self-insured employers should take a multi-year approach to assessing ROI rather than taking a single-year snapshot.” Check it out.
  • Beckers Hospital Review identifies and discusses six healthcare systems which are innovating primary care models to expand care.
  • Kaufman Hall informs us,
    • “Healthcare bankruptcy filings decreased for a second consecutive year, according to a recent report from Gibbons Advisors. The report finds a 21% decline in bankruptcy filings year-over-year, with the bulk of the 45 filings in 2025 occurring in the first quarter. The bankruptcy activity appears to be tempering, adjusting to pre-pandemic trends. By sector, senior care and pharmaceuticals comprise about half of the bankruptcies, with hospitals only accounting for 13.6% of all healthcare bankruptcy filings in 2025.”
  • The Withum CPA and consulting firm delves into “Artificial Intelligence and the Rise of Duplicate Claims: What Plan Sponsors Should Understand.”
    • “Artificial intelligence is fundamentally changing how healthcare claims are generated, submitted, and processed. As these technologies mature, both claim volume and complexity are likely to increase, placing additional pressure on traditional payment-integrity controls.
    • “While duplicate and near-duplicate claims are a visible result of this shift, AI also affects other aspects of the payment-integrity lifecycle, including coding accuracy, claim edits, resubmission behavior, and post-payment recovery.
    • “For plan sponsors, the question is no longer whether AI will influence claims administration, but whether current oversight frameworks have evolved to address these broader changes. Understanding duplicate-claim risk, evaluating vendor controls across the payment-integrity continuum, and ensuring transparency are increasingly important for prudent fiduciary governance in an AI-driven claims environment.
    • “As AI continues to reshape healthcare billing and claims processing, plan sponsors should periodically reassess whether their oversight frameworks and vendor controls remain aligned with an increasingly automated claims environment.”

Thursday report

David Ermer–CDC, CMS, Congress, Medical / Rx research, Medicare, Obesity, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC

  • Fierce Healthcare reports,
    • “Leading Senate Democrats are outlining their own healthcare policy priorities as they look to develop plans that could counter changes proposed by the Trump administration and included in the One Big, Beautiful Bill Act.
    • “In a letter (PDF) led by Finance Committee Ranking Member Sen. Ron Wyden, D-Oregon, the 12 senators establish three goals that will define their policymaking endeavors: reversing Republican policies that may drive up costs, simplifying the healthcare experience and taking on corporate profiteering.”
  • and
    • “Insurers and hospitals have come together to rebuke a Trump administration proposal to roll back limits of plan designs that may be listed on the Affordable Care Act’s (ACA’s) exchanges. 
    • “In February, the Centers for Medicare & Medicaid Services (CMS) included in its Notice of Benefit and Payment Parameters for 2027 Proposed Rule a plan to allow some non-network plans to obtain qualified health plan (QHP) status, which is necessary to be listed. 
    • “Non-network plans refer to offerings that do not have contracts in place with providers outlining specific services and rates, or conditions outlining different benefits for enrollees based on whether a provider is in network. CMS proposed that such plans could still obtain QHP status for plan year 2027 if they can ensure access to multiple providers who accept the non-network plan’s benefit amount as full payment.” * * *
    • “The plan does not appear to have landed with industry groups. In a rare move, groups representing health plans (AHIP, Association for Community Affiliated Plans and Alliance of Community Health Plans) as well as hospitals (Federation of American Hospitals and America’s Essential Hospitals) crossed the aisle to submit a joint comment letter to CMS calling on the administration to rethink its approach.”
  • Insurance NewsNet tells us,
    • “A new National Association of Insurance Commissioners working group aims to identify policy solutions to rising health care costs and insurance premiums, intending to produce a practical guide for state policymakers by the end of the year.
    • “The Health Care Affordability and Mitigation Working Group met for the first time last week. Members discussed a 2026 work plan, outlining a fast-paced schedule to develop affordability recommendations for regulators and lawmakers.
    • “The initiative will focus on examining factors that drive health care costs and insurance premiums, including expenses within the health system that ultimately flow into insurance pricing.”
  • STAT News relates,
    • “Chris Klomp, a top official at the federal health department, offered a reality check on President Trump’s drug discount platform, TrumpRx, while speaking at a STAT event on Thursday. 
    • “Even as Trump has spoken about the platform in grandiose terms, calling it “transformative” and promising the “largest reduction in prescription drug prices in history,” Klomp offered a more measured perspective on stage at STAT’s Breakthrough Summit East event in New York. He said it was never meant to be used by Americans with health insurance — which is the vast majority — and rejected the suggestion that Trump’s drug policies amount to price caps. 
    • “The goal was not actually some massive reach,” Klomp said, adding that “170 million Americans are commercially insured, 68 million Americans are on Medicare, the balance are on Medicaid and CHIP largely. TrumpRx is not for most of them, it’s cash pay.” 
    • “That said, the platform has shown lower prices for GLP-1s and fertility drugs, which often aren’t covered by health insurance, Klomp said. “But for many, your insurance benefit, where you already have insurance coverage, can be just as good so you may as well go there,” he said.” 
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is leading the historic $50 billion Rural Health Transformation Program, partnering with states to strengthen rural health systems, expand access to care, and tackle chronic disease. To advance that work, on March 18, 2026, CMS convened leaders from all 50 states for the first Rural Health Transformation Summit, bringing together state officials and experts to accelerate implementation of the program.
    • “State leaders highlighted practical approaches to strengthening local care delivery — including mobile care units, remote patient monitoring, community-based partnerships, and regional data-sharing platforms designed to improve coordination and expand access close to home. The summit also fostered cross-state dialogue, allowing participants to exchange best practices and build relationships that will support continued collaboration beyond the meeting itself.
    • “Participants emphasized that long-term success would depend on embedding these initiatives into durable financing and workforce structures, including alignment with Medicaid and Medicare payment models  and expansion of rural residency and training programs.”
  • Tammy Flanagan, writing in Govexec, reminds us “how federal retirement benefits have changed over the years.”
    • “From FERS to TSP to recent legislation, decades of policy shifts have reshaped how federal employees earn, save for and receive retirement benefits.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Novo Nordisk NOVO.B said the U.S. Food and Drug Administration approved a higher dosage of its Wegovy weight-loss medication, a boost for the Danish drugmaker as it faces growing competition in the obesity market.
    • “The group said Thursday that the FDA had expedited approval of the Wegovy injection with a higher dose based on results from a trial that showed 20.7% mean weight loss for participants with obesity.
    • “The company said its higher dosage Wegovy medication contains 7.2 milligrams of semaglutide, injected once weekly, and it complements Wegovy’s medication containing 2.4 mg semaglutide. The group expects to offer Wegovy HD in a single-dose pen in the U.S. next month.”
  • The New York Times adds,
    • “The blockbuster weight loss drug sold as Ozempic and Wegovy will soon go generic in countries that are home to 40 percent of the world’s population, significantly lowering the price of a costly medicine that had been largely unaffordable to nearly all but the wealthiest people.
    • “On Saturday, Novo Nordisk, the company that until now has had a monopoly on selling the drug, will lose patent protection in several of the world’s most populous countries. The first generic versions are expected to arrive in India as soon as this weekend. In the coming months, the generics are also expected to become available in China, Canada, Brazil, Turkey and South Africa.
    • “The availability of these drugs, which have been restricted to high-income countries to very wealthy people, will now be democratized by the generics,” said Leena Menghaney, an activist in New Delhi focused on treatment access.”
  • Beckers Hospital Review tells us,
    • “The FDA has launched a nationwide recall of children’s ibuprofen affecting nearly 90,000 bottles due to contamination concerns.
      “The recall involves children’s ibuprofen oral suspension, USP, 100 milligrams per 5 milliters, 4-fluid ounce or 120-milliter bottles manufactured for Taro Pharmaceuticals U.S.A., according to a March 16 FDA enforcement report.
    • “Strides Pharma recalled 89,592 bottles after receiving complaints of a gel-like mass and black particles in the product. The affected lots are 7261973A and 7261974A, with an expiration date of Jan. 31, 2027.
    • “The recall was initiated March 2 and remains ongoing, with products distributed nationwide.
      The FDA designated the event as a Class II recall, meaning exposure may cause temporary or medically reversible adverse health consequences with a low risk of serious harm.”
  • and
    • “The number of active drug shortages has declined sharply since June, according to the FDA’s database.
    • “As of March 19, 76 drugs are in shortage, down from 194 in mid-June.”
    • The article identifies eight recent drug shortages.

From the public health and medical research front,

  • USA Today reports,
    • “People who quit taking popular GLP-1 drugs such as Ozempic might not only gain back lost weight. They also might be jeopardizing their heart health, according to a new report.
    • “A study of Veterans Affairs patients published March 18 found those who quit the weight-loss medication reversed health gains from weight loss and had a higher risk for heart attack, stroke or death.
    • “Researchers tracked more than 330,000 VA patients with Type 2 diabetes over three years who took either a GLP-1 drug or another diabetes medication, sulfonylureas.
    • “Those who steadily took the GLP-1 medications over three years saw an 18% reduction in risk for heart attacks or strokes. Those who quit the medications for six months saw slightly higher risk. Those who halted the weight loss drugs for two years saw their risk rise 22%, according to a study published March 18 in the medical journal BMJ Medicine.”
  • BioPharma Dive adds,
    • “An experimental, triple-acting metabolic drug from Eli Lilly met the main goals of a Phase 3 study in people with Type 2 diabetes, helping treatment recipients significantly cut blood sugar levels and body weight compared to those who got a placebo. 
    • “Lilly said Thursday that the 40-week trial of retatrutide, which targets three gut hormones, showed the two highest doses lowered blood sugar an average of 1.9 percentage points from a baseline average of 7.9%. Those in the placebo arm, by comparison, had a 0.8 percentage point reduction from the study’s start. 
    • “The results are the first from a late-stage study of retatrutide in diabetes. In December, the company disclosed that retatrutide succeeded in a trial in people with obesity and arthritis-related knee pain, findings that were seen by Wall Street analysts as the most striking of any weight loss medication to date. Large studies in obesity are ongoing.” 
  • The American Hospital Association News relates,
    • “A JAMA study published March 18 found that women who experience premature menopause have a 40% higher lifetime risk of coronary heart disease. Approximately 15% of Black women in the study experienced premature menopause compared to about 5% of white women. The study found that Black women had a 41% higher risk of coronary heart disease compared to 39% for white women.” 
  • Medscape tells us,
    • “The American Headache Society (AHS) is recommending annual screening for migraine as part of routine preventive care for girls and women — from adolescence through menopause 
    • “Despite its high prevalence — especially among girls and women — and substantial negative impacts, migraine is “under diagnosed and under treated. Diagnostic screening for migraine enables more patients to receive timely, appropriate, and effective management,” said the guideline authors, led by Todd Schwedt, MD, with the Department of Neurology, Mayo Clinic, Phoenix. 
    • ‘The position statement was published in the February issue of Headache.” 
  • Health Day informs us,
    • “Want to figure out your heart health risk?
    • Look at your belly fat, not your body mass index, a new study says.
    • “Excess fat stored around the waist is more strongly associated with heart failure risk than BMI, an estimate of body fat based on height and weight, researchers will report at a meeting of the American Heart Association.
    • “This research helps us understand why some people develop heart failure despite having a body weight that seems healthy,” lead researcher Szu-Han Chen, a medical student at National Yang Ming Chiao Tung University in Taiwan, said in a news release.
    • “By monitoring waist size and inflammation, clinicians may be able to identify people with higher risk earlier and focus on prevention strategies that could reduce the chance of heart failure before symptoms begin,” Chen said.”
  • and
    • “Wastewater-based epidemiology is feasible as a community-level and population-level surveillance tool for colorectal cancer (CRC), according to a study published online March 17 in the Journal of Epidemiology & Community Health.” * * *
    • “This basic proof-of-concept for a novel wastewater surveillance application to track potential cancer burden demonstrates that CDH1, which is associated with CRC, is detectable in wastewater and may accelerate the field’s development for epidemiological studies,” the authors write. “The finding that CDH1 is detected is promising and needs an expanded research agenda and larger sample size for statistical power to enable more definitive findings.”
  • Medical Economics points out,
    • “Evidence links ZIP code–level poverty to higher utilization, costs, and striking life-expectancy gaps, reframing equity as a clinical and fiscal imperative. 
    • “Effective implementation requires health systems to pair screening with dependable community resources; absent housing, food, or transport supports, identifying needs rarely changes outcomes. 
    • “Grant-funded pilots show scalable models, such as food-pantry cardiometabolic screening clinics that expanded to multiple sites and revealed high rates of prediabetes and diabetes among food-insecure participants. 
    • “Clinicians can start by building trust and asking about social risk with empathy and respect, supporting referrals while recognizing SDOH work as integral to workforce sustainability.”
  • Per Genetic Engineering and Biotechnology News,
    • “The Trillion Gene Atlas, an initiative to generate and model biological data at the trillion-gene scale, has been launched by Basecamp Research in collaboration with Anthropic, Ultima Genomics, and PacBio. Powered by NVIDIA AI infrastructure, the Trillion Gene Atlas aims to expand known evolutionary genetic diversity 100-fold by collecting genomic data from more than 100 million species across thousands of sites worldwide. The initiative, which was unveiled during the Health Track at SXSW and the NVIDIA GTC conference in San Jose, is made possible by Basecamp’s growing network of global biodiversity partners.
    • “The initiative is built on three pillars: large-scale DNA sequencing, global data supply partnerships, and advanced computing. Together with AI systems capable of reasoning across complex data, these foundations can help turn vast datasets into therapeutic discoveries. By increasing the evolutionary data available to AI by another 100x, Basecamp Research aims to make drug design faster and more systematic.”

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

  • Kaufmann Hall reports,
    • “Hospital financial performance is challenged in early 2026 as rising bad debt and continued increases in expenses create ongoing pressure. Navigating this uncertain economic climate requires hospitals to be strategic about where to allocate resources.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.
    • “Key Takeaways
      • “Patient volume in January declined across inpatient and outpatient services. This decline could be due to postponing of elective procedures around the holidays, as well as a change in payer mix.
      • “Bad debt continues to increase. Carrying over from 2025, bad debt and charity care continue to go up.
      • “Expenses continue to put pressure on hospitals. In addition to the persistent increases in drugs and supplies, there was a big increase in labor expenses in January.
  • Radiology Business relates,
    • “GE HealthCare has officially completed its acquisition of imaging software provider Intelerad. 
    • “The health technology giant announced on Wednesday that the $2.3 billion purchase (base price) had been completed. GE previously said that the acquisition was a reflection of its “continued commitment to cloud-enabled and AI-powered solutions.” 
    • “In Wednesday’s announcement, Roland Rott, GE HealthCare’s president and CEO of imaging, shared his enthusiasm for how the move can further advance the company’s mission to improve radiology and data sharing workflows. 
    • “Intelerad’s cloud-enabled software will support GE HealthCare’s imaging technologies and AI capabilities by simplifying complex workflows, and providing patients and customers with more precise, connected care across the continuum,” Rott said. 
    • “Intelerad enhances our ability to deliver a cloud-first enterprise imaging platform at scale,” added Scott Miller, GE HealthCare’s CEO of solutions for enterprise imaging. “Together, we are connecting imaging across care settings with interoperable, AI-enabled solutions that simplify operations, improve clinical insight, and help our customers deliver more precise, personalized care.” 
  • and
    • “Radiologists spot significantly more suspicious lung nodules with the help of artificial intelligence support, a new study suggests. 
    • “New data shared in the American Journal of Roentgenology detail a comparison of interpretation times and detection rates of radiologists both with and without the help of AI. Though the study of AI in lung cancer screening is not new, prior retrospective research has made it challenging for to determine the real-world impact of such tools. This latest study addresses this shortcoming by offering prospective insight into how an AI-based lung nodule detection tool performs in clinical practice for asymptomatic patients undergoing lung cancer screening.” 
  • Modern Healthcare tells us,
    • “Perplexity is making its debut on the consumer health market. 
    • “The artificial intelligence-enabled search engine announced the launch of Perplexity Health, which looks to provide users with personalized responses to health questions.
    • “The AI tool relies on medical literature and user-provided patient records to answer health-related inquiries. It also offers an individualized dashboard with insight on users’ behavioral patterns such as their sleep and activity levels.
    • “Through a partnership with data network b.well Connected Heath, users can give Perplexity Health access to electronic health records from more than 1.7 million providers, the company said in a Thursday news release. Users can additionally integrate data from sources such as Apple Health and Fitbit.
    • “Perplexity Health is available to users of the company’s paid tiers, a spokesperson said in an email.”
  • Per a Google news release,
    • “Last year, we introduced the vision of a personal health coach built with Gemini to move beyond basic metrics and provide truly personalized guidance. Today at The Check Up, our annual health event, we’re taking the next step. We’re introducing significant updates to help you understand and improve your sleep, sharing how we’re advancing health through new research, and integrating clinical history to provide a more comprehensive view of your well-being.
    • We’re launching our most significant update yet, delivering an additional 15% increase in sleep staging accuracy for Public Preview users.
    • Trained on diverse, inclusive datasets, our models now better distinguish between when you are aiming to sleep and when you are asleep. These improvements more accurately capture interruptions, naps and transitions between stages, aligning with clinical gold-standard measurements.” * * *
    • “Starting next month for Public Preview users in the U.S., you’ll be able to link your medical records to the Fitbit app for a fuller picture of your health including your lab results, medications and visit history, all in one place and under your control.
    • “To make this possible, we’re collaborating with partners like b. well and CLEAR. You can search for your healthcare provider and then link to their portal, or simply verify your identity with CLEAR and we will search for records on your behalf. By using IAL2-certified standards — requiring only a selfie and a valid ID — this enhanced security allows the app to automatically locate and sync your records across different providers (availability varies per provider).”

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the HIMSS Conference 2026 front,

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

From the U.S. healthcare business front,

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

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.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, U.S. Healthcare–

Happy International Women’s Day!

From Washington, DC,

  • Roll Call outlines Congressional activities for the week.
  • The New York Times reports that “Health Care Has Become the Lifeblood of the Labor Market.”
    • “An aging population is drawing workers to medical and social care, creating reliable jobs and revealing weakness for the rest of the economy.”
  • CNN adds,
    • “Hiring at US businesses unexpectedly plunged last month as employers shed an estimated 92,000 jobs, according to new data released Friday by the Bureau of Labor Statistics.
    • ‘The unemployment rate edged higher to 4.4% from 4.3%.
    • “Economists were expecting job growth to slow somewhat after a surprisingly strong January – in part due a major labor strike by health care workers and a deep cold snap that hit many US states. The consensus estimates were for a net gain of 60,000 jobs and the unemployment rate to hold steady, FactSet estimates show.
    • “We had a labor market that nearly froze last year, and it seemed to show some signs of thawing, which made it slushy at best,” Diane Swonk, chief economist at KPMG US, told CNN in an interview.
    • “February’s report, however, showed how precarious the US jobs market is when the supporting “one-legged stool” of health care is kicked out, she said. The health care industry, which has driven the vast majority of the job gains in the past year, posted a loss of 28,000 jobs (31,000 of which were likely attributed to the mid-month Kaiser Permanente nurses and health care workers strike [which recently ended).”
  • Federal News Network offers guidance on how FEHB/PSHP work together for federal and postal annuitants.

From the judicial front,

  • Healthexec tells us,
    • “An alleged conspiracy involving two drug suppliers and several doctors tied to the diversion and resale of nearly $50 million in medications has led to a series of guilty pleas, the U.S. Department of Justice from the District of New Jersey announced Tuesday [March 3].
    • “The two men who most recently pleaded guilty—Frank Incognito, 46, and Stephen Corba, 50, both from New Jersey—were the operations manager and owner of a wholesale drug seller, respectively. The name of the company was not revealed.
    • “According to prosecutors, the duo worked with doctors to resell cancer and ophthalmology medications, purchasing them from licensed distributors under false pretenses. Because Incognito and Corba were unable to buy the pharmaceuticals themselves, they relied on physicians to make “straw purchases” in exchange for kickbacks.
    • “The doctors would promise manufacturers the drugs were being purchased for their patients. Instead, they slipped them to Incognito and Corba, who then resold the medications on the black market at significant profit.” * * *
    • “Three physicians—Anise Kachadourian, MD; Jon Paul Dadaian, MD; and Joel Lerner, MD—previously pleaded guilty for their roles in the conspiracy. The DOJ did not provide details about their sentencing status.” 

From the public health and medical / Rx research front,

  • Virtual Capitalist informs us,
    • “West Virginia has the highest diabetes prevalence in the U.S., with 15% of adults diagnosed.
    • “Vermont reports the lowest rate at 7.7%, nearly half the level of the highest states.
    • “Many Southern states report rates well above the national average of 10.3%.”
  • Point-Counterpoint. The Washington Post reports,
    • “The miracle of rapid weight loss has always come with fine print. Until recently, it read mostly like a list of digestive complaints —stomachaches, constipation — generally unpleasant but tolerable and rarely severe. New research presented this month suggests the drugs may affect something more structural: bone.
    • “In an analysis of nearly 150,000 patients, researchers found that people taking GLP-1 medications faced a significantly higher risk of skeletal disorders.
    • “Over five years, the risk of osteoporosis — a disease that weakens bones and makes them brittle — was nearly 30 percent higher. The risk of gout, a painful inflammatory arthritis which results from needlelike crystals forming in the joints, rose 12 percent. And the risk of osteomalacia, a softening of the bones caused by a low mineral-to-bone ratio that was rarer in the study, increased by more than 150 percent.
    • “It was a lot more than I expected,” said John Gabriel Horneff, one of the study’s authors and an associate professor of clinical orthopedic surgery at the University of Pennsylvania.
    • “The data was presented this month at the American Academy of Orthopaedic Surgeons’ annual meeting and drawn from electronic health records contained in a national database.”
  • Evidently, according to Health Day, another perspective on this issue was presented at this conference.
    • “Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for type 2 diabetes and obesity is independently associated with a significantly increased five-year risk for osteoporosis, gout, and osteomalacia compared with nonuse, according to a study presented at the annual meeting of the American Academy of Orthopaedic Surgeons, held from March 2 to 6 in New Orleans.
    • “Muaaz Wajahath, from the Michigan State University College of Human Medicine in East Lansing, and colleagues evaluated the five-year risk for osteoporosis, gout, and osteomalacia in adults with both type 2 diabetes and obesity treated with GLP-1 RAs (semaglutide, liraglutide, dulaglutide, or exenatide) compared with matched controls (73,483 per group).
    • The researchers found that at five years, patients exposed to GLP-1 RAs had a significantly increased risk for osteoporosis compared with controls (4.1 versus 3.2 percent; risk ratio, 1.29). Gout incidence also was elevated among GLP-1 RA users (7.4 versus 6.6 percent; risk ratio, 1.12). Osteomalacia had the greatest relative risk increase, with a five-year incidence of 0.2 percent among GLP-1 RA users compared with 0.1 percent in the control group (risk ratio, 2.55). There was statistical significance for all differences in absolute and relative risk.”
  • Healio adds,
    • “Women who start early menopausal hormone therapy after menopause have a lower risk for osteoporosis over a 5-year period, according to data presented at the American Academy of Orthopaedic Surgeons Annual Meeting.
    • “We know that with the aging population, fragility fractures are going to be a real problem in the future, and HRT is protective and may decrease the fracture burden,” James M. Barsi, MD, clinical associate professor in the department of orthopaedic surgery at Stony Brook University, told Healio.”
  • MedPage informs us,
    • “A machine learning model for prediction of preeclampsia risk using routinely collected data was feasible, according to a retrospective cohort study of pregnancies in late gestation.
    • “Patients who developed preeclampsia were older and more frequently Black.
    • “The most informative predictor in the model was blood pressure.”
  • Medscape points out,
    • “Chronic rhinosinusitis may be linked to an increased risk for cancer, according to a study of patients in Asia. 
    • “The study found that chronic rhinosinusitis was linked to an 18% increased risk for cancer in Korean patients and a 63% increased risk for cancer in patients from Japan. The results provide the first large-scale evidence for an association between chronic rhinosinusitis and the risk for cancer, suggesting a possible role for cancer surveillance in patients with the inflammatory condition, researchers said.
    • “This study suggests that certain chronic inflammatory conditions may be associated with an increased risk of cancer development and could warrant heightened cancer surveillance, particularly in middle-aged and older populations,” Seong H. Cho, MD, professor of medicine and pediatrics at the University of South Florida Health Morsani College of Medicine in Tampa, Florida, said. “While the consistency across both Asian populations strengthens the validity of the findings, confirmation in the US and other Western populations is essential before broad global application.”

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

  • The Health Information and Management Systems Society (HIMSS) Global Health Conference & Exhibition 2026 begins today in Las Vegas.
  • For example, Bloomberg informs us,
    • “Oura Health is buying a gesture-recognition startup, setting up the company to eventually add such controls to its popular line of smart rings.
    • “Oura said it is acquiring Helsinki-based Doublepoint Technologies Oy, which specializes in technology that allows users to control wearable devices with small hand movements using a combination of artificial intelligence and biometric data. The purchase will guide future versions of Oura’s smart rings, where hand gestures could play a central role to the experience, along with possibly voice control, Chief Executive Officer Tom Hale said in an interview. Terms of the deal were not disclosed.”
  • Beckers Payer Issues reports,
    • “Network Health, a Wisconsin-based insurer owned by Froedtert ThedaCare Health, grew 37% during this past annual enrollment period to 126,000 total Medicare Advantage members, its second consecutive year of record growth. The plan also posted a 98% member retention rate.
    • “The results make Network Health the second largest MA carrier in its 27-county service area, behind only UnitedHealthcare.” * * *
    • “One initiative that has distinguished Network Health nationally is its integration of Mark Cuban’s Cost Plus Drugs into its MA pharmacy network, making it one of the first plans in the country to do so when it first launched in early 2025. Ms. Dicus-Johnson [, the CEO,] said she first encountered Cost Plus Drugs four years ago and immediately wanted to bring the model to Network Health’s members. 
    • “Unlike coupon-based programs or out-of-pocket reimbursement models, Network Health built a fully electronic claims integration model with its PBM, Express Scripts, so prescriptions are processed in real time with no paper claims required. Mail-order benefits apply automatically, and eligible medications count toward members’ Part D accumulators.”
  • and
    • “Clover Health said it is the first health insurer to be live on a CMS-aligned network for patient-directed requests, according to a March 4 news release from the company.
    • “While CMS previously listed other payers as “early adopters” of CMS-aligned networks, a Clover spokesperson clarified the company was the first to fully integrate with a government-backed network. In this case, Clover integrated with Kno2, the patient information exchange. Kno2 is a qualified health information network under the Trusted Exchange Framework and Common Agreement, and it is also a CMS-aligned network.
    • “These networks are data exchanges that voluntarily follow CMS’ interoperability framework. By leveraging its AI physician-enablement platform Counterpart Health, Clover can respond to patient requests for claims and clinical data in real time, the release said.”
  • Beckers Hospital Review notes,
    • “Eight-four percent of primary care providers said they must play an essential role in meeting rising demand for mental and behavioral health treatment in the U.S, according to a Medscape survey published March 6. 
    • “The Health Resources and Services Administration’s Bureau of Health Workforce data found the number of designated mental health professional shortage areas rose from 6,418 to 6,807 in 2025, increasing pressure on primary care providers to address patients’ behavioral health needs.” 

Notable Death

  • The Washington Post reports,
    • “Paula Doress-Worters, who helped break the silence on postpartum depression, dies at 87
    • “She co-wrote “Our Bodies, Ourselves,” a 1970s touchstone conceived by and for women. The book offered information about abortion, pregnancy and postpartum life.”
  • RIP.

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.” 

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.