Tuesday report

CDC

Tuesday report

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Avalere Health breaks down yesterday’s CMS Medicare Advantage premium announcement.
  • Per an HHS news release,
    • “The Health Resources and Services Administration (HRSA) today announced more than $135 million in new funding opportunities to expand nutrition services and strengthen the rural health workforce. Secretary of Health and Human Services Robert F. Kennedy, Jr., alongside HRSA Administrator Tom Engels and Representative Juan Ciscomani (AZ-06), announced this important investment during a Preventative Care Roundtable with key stakeholders.
    • “Preventative care cuts costs, improves outcomes, and drives our mission to Make America Healthy Again,” said Secretary Kennedy. “These investments expand access to high-quality, affordable care—especially in rural communities that need it most.”
    • “HRSA is committed to strengthening the health workforce, advancing preventative care, and expanding access to essential nutrition services,” said HRSA Administrator Engels. “By supporting new rural residency programs to deliver evidence-based nutrition services, we are creating a stronger, more sustainable system of care that helps prevent chronic disease, improves health outcomes, and advances HHS and Make America Healthy Again priorities for communities across the country.”
  • Beckers Hospital Review tells us,
    • AbbVie and Genentech are the latest drugmakers to sell prescription medications on TrumpRx, CBS News reported April 6.
    • “They are the 10th and 11th drugmakers to offer discounted medications on the website. 
    • TrumpRx now lists AbbVie’s best-selling anti-inflammatory drug Humira — in syringe or pen form — for $950, representing an 86% discount off the list price. Genentech’s antiviral medication Xofluza is also available for $50, down from a list price of $168.” * * *
    • “Since launching in February, TrumpRx’s list has expanded from 43 medications to 69. Amgen also recently added its arthritis treatment Enbrel and plaque psoriasis drug Otezla to the platform.”
  • Bloomberg Law reports,
    • “President Donald Trump is in no hurry to tap a permanent attorney general to replace Pam Bondi following her ouster, according to people familiar with the matter, allowing Todd Blanche time to settle into his role as the US Justice Department’s acting chief.”
  • NewsNation relates,
    •  “Acting Attorney General Todd Blanche revealed key details Tuesday about the Department of Justice’s newly created National Fraud Enforcement Division.
    • “Our vision is to build a robust fraud-fighting squad capable of investigating and prosecuting the full spectrum of fraud against taxpayer dollars,” Blanche explained. 
    • “Blanche said the division will be staffed with some of the DOJ’s “best prosecutors,” including experts in health care, tax, benefits and corporate fraud.
    • “There will be an additional 93 prosecutors in every district across the country devoted to the mission of combating fraud,” Blanche added.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “One year into his tumultuous tenure as the FDA’s commissioner, Marty Makary, M.D., has laid out ambitious internal goals and perhaps a more ambitious legislative wish list in his fiscal year 2027 budget proposal (PDF) to Congress.
    • “Alongside the justification of a $7.2 billion budget request, including $3.3 billion from congressional appropriations and $3.9 billion in industry-paid user fees, Makary is asking for a broad set of legislative actions. 
    • “The proposed changes would, among other things, create a new clinical trial initiation pathway as an alternative to the existing Investigational New Drug (IND) pathway, allow the FDA to disclose more information to the public in complete response letters, remove the interchangeability determination for biosimilars, give domestic generic manufacturers an upper hand and permanently authorize the rare pediatric disease priority review voucher program.”
  • The Wall Street Journal relates,
    • “Novo Nordisk NOVO.B launched its higher-dose Wegovy weight-loss shot in the U.S. after the new treatment gained regulatory approval there last month.
    • ‘The Danish drugmaker said Tuesday that Wegovy HD is now available nationwide through more than 70,000 pharmacies, its online pharmacy, certain telehealth providers and other outlets.
    • “Wegovy HD is a once-weekly injection that contains 7.2 milligrams of active ingredient semaglutide, offering the highest weight-loss of any Wegovy injection so far, the company said.” * * *
    • “In a trial of adults with obesity but without diabetes, patients taking a 7.2 milligram dose of Wegovy over about a year and a half lost 21% of their body weight on average, while around one in three people lost 25% or more of their body weight.
    • “Prior to the launch of Wegovy HD, the highest available injectable dose was 2.4 milligrams of semaglutide, which has shown to help patients lose around 18% of their body weight on average.
    • “The higher dose of Wegovy was approved by the Food and Drug Administration nearly three weeks ago under an accelerated approval process based on the results of the trial.”
  • Beckers Hospital Review tells us,
    • “Pfizer and BioNTech have halted a U.S. study of their updated COVID-19 vaccine in adults ages 50-64 due to slow enrollment, a Pfizer spokesperson confirmed to Becker’s.
    • “We can confirm our communication to the FDA about the status of the Pfizer-BioNTech COVID-19 vaccine postmarketing activities, including our intent to stop study C4591081,” the spokesperson said. “Notably, this study is not ending as a result of any safety or benefit-risk concerns.”
    • “The spokesperson added that the companies “intend to stop the study due to slow enrollment and therefore the inability to generate relevant postmarketing data.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A Centers for Disease Control and Prevention report published April 7 found that 47.2% of all U.S. adults met federal guidelines for aerobic physical activity in 2024. The report found that 52.3% of men and 42.4% of women met the standards. The CDC found that the prevalence of meeting the guidelines increased with education level. Aerobic physical activity was higher among adults without disabilities (49.8%), those with a healthy weight (54.8%), and those with excellent or very good health (57.8%). The analysis was based on data from the 2024 National Health Interview Survey.” 
  • Healio adds,
    • “Modest real-world weight loss may significantly reduce a person’s risk for cancer, according to results of a retrospective observational study.
    • “The risk reduction conferred by nonsurgical weight loss appeared consistent over multiple time intervals.
    • “The benefits became apparent quickly, with each 1% reduction in BMI equating to an approximately 1% reduction in cancer risk after as little as 3 years of follow-up.
    • “I definitely was surprised by the results, especially that we saw them as early as we did,” Daniel M. Rotroff, PhD, chairman of the department of quantitative health sciences and Eddie J. Brandon Endowed Chair for Diabetes Research at Cleveland Clinic, told Healio. “A 1% BMI reduction for a 1% reduction in risk may not sound like a lot but, when you think about some interventions achieving 5% weight loss pretty rapidly — and [some GLP-1 or dual GLP-1/GIP receptor agonists] achieving 10% or greater — that is a really meaningful reduction in cancer risk.”
  • Infectious Disease Advisor points out,
    • “The significant burden of respiratory syncytial virus-associated hospitalization in older adults, particularly those with underlying conditions, underscores the need for targeted vaccination strategies.”
  • MedPage Today adds,
    • “Influenza vaccines were effective in preventing related hospitalizations and outpatient visits among U.S. kids in recent years, but vaccine uptake remained low.
    • “Vaccine effectiveness against hospitalization ranged from 28% during the 2021-2022 flu season to 67% in the 2023-2024 season, and against outpatient visits ranged from 28% during the 2021-2022 season to 56% in the 2023-2024 season.
    • “Experts pointed to a need to properly communicate the benefits of influenza vaccines, especially as “distrust in vaccines grows.”
  • Health Day tells us,
    • “Cancer risk is higher for people battling autoimmune diseases, but the danger declines after they start taking anti-inflammatory medications, a new report finds.
    • “Italian researchers reporting in the journal Cancers found a 32% increase in the odds for cancer in the first year after a diagnosis for an autoimmune disease such as lupus, rheumatoid arthritis or psoriasis.
    • “However, after patients start taking drugs to ease the runaway inflammation that characterizes these illnesses, their cancer risk declines.
    • “The peak risk observed in the early stages suggests that chronic inflammation, rather than treatments, is a key factor in cancer development,” said Daniela Marotto, co-senior author of the study. She is head of rheumatology at the Local Health Authority of Gallura, in Italy.”
  • Health Day adds,
    • “Catching tumors early is crucial to lung cancer survival
    • “New robotic technologies, along with other innovations, is making early detection safer and easier on patients
    • “Often, detection, staging and treatment are done during the same procedure.”
  • Per STAT News,
    • “For some advanced cancers, sequencing the tumor genome should be one of the first steps patients and physicians take. But a new study finds that many patients never receive genomic testing and so never get the chance to know if they might have benefitted from newer, more targeted therapies.
    • “The study, published on Tuesday in JAMA Network Open, examined how many patients diagnosed with one of five different metastatic cancers received genetic sequencing for the cancers. For most cancers in the study, roughly half of patients in the cohort received genetic sequencing. Patients with low income, Medicare or Medicaid coverage, and Black or Hispanic race or ethnicity were also less likely to receive sequencing.”
  • MedPage informs us,
    • “Under physician supervision, 26% of older adults successfully stopped levothyroxine while maintaining stable thyrotropin and free thyroxine levels for a year.
    • “Discontinuation was more common in patients taking lower levothyroxine doses at baseline.
    • “Researchers urged clinicians to reassess thyroid therapy in older adults to avoid overtreatment and its associated risks.”

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

  • Fierce Healthcare reports,
    • “Last summer, the insurance industry broadly agreed to reform a major healthcare pain point: prior authorization.
    • “Now, two of the industry’s leading organizations are offering a look at progress toward those goals. AHIP and the Blue Cross Blue Shield Association released a report on Tuesday that found leading health plans reduced prior authorizations for an array of services by 11% since the pledge was made.
    • “This equates to 6.5 million fewer prior auth requests for patients, according to the report. Reductions in Medicare Advantage specifically were 15%, it reads.
    • “Health plans have taken important initial steps to support patients and are working toward the shared goal of delivering answers at the point of care whenever possible—a goal that will require both plans and providers to eliminate manual processes and adopt real-time electronic data sharing,” said Mike Tuffin, AHIP President and CEO, in the announcement.”
  • Physicians’ Practice adds,
    • “Access to affordable health care has displaced administrative burden as the single biggest policy concern among U.S. physicians, according to athenahealth’s fifth annual Physician Sentiment Survey. The shift signals the industry’s growing concern over systemic cost and coverage pressures, stretching well beyond the exam room.
    • “The survey, conducted online by The Harris Poll in October 2025 among 1,045 primary care physicians and specialists nationwide, found that 52% of physicians now consider access to affordable health care to be the most pressing issue they want policymakers to address. That figure was 44% in the 2025 survey and 38% in 2024, a 14-point climb in just two years. For the first time in the survey’s five-year history, the issue overtook minimizing excessive documentation requirements, which fell to 46% from 49% in 2024.”
  • The Wall Street Journal charts the weight loss drug frenzy ongoing in our country.
    • “The market for weight loss drugs is exploding and patients may have several new options in coming years.”
  • The Journal also relates,
    • “Gilead Sciences GILD agreed to buy German biotechnology company Tubulis for $3.15 billion to expand its portfolio of a cancer technology that aims to better guide chemotherapies to tumors.
    • “Tubulis’s lead drug is a targeted cancer therapy known as an antibody-drug conjugate. It is in mid-stage trials for ovarian and lung cancers. The German company has another antibody-drug conjugate in earlier stages of development that is being tested across several tumor types.”
    • “The deal, announced Tuesday, is expected to close by the end of June and includes up to $1.85 billion in potential milestone payments. Gilead already had a two-year research partnership, signed in 2024, with Tubulis.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi) for the protection against Covid-19, including both the short- and long-term effects of the infection. 
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
  • Per Fierce Healthcare,
    • “Alloy Health, a virtual platform serving women in midlife, is expanding its weight care program with two new offerings: micro-dosing and the Wegovy pill.
    • “Micro-dosing will allow for more personalized dosing for women who, for whatever reason, do not tolerate the manufacturer-made doses. The Wegovy pill introduces a daily oral GLP-1 option for women who prefer an alternative to injections. The company hopes to keep adding more brand-name products, including the Zepbound KwikPen, as they become available. 
    • “The products build on Alloy’s existing weight care program, launched last year, which aims to offer menopause-specialized weight care. The program offers physician-led hormonal expertise with personalized care plans designed for midlife women. Alloy is an entirely asynchronous, text-based provider.” 
  • and
    • “Artificial intelligence-enabled virtual care company Counsel Health is building out its clinical offerings to include lifestyle and chronic condition services. 
    • “The expansion will first focus on lifestyle conditions, including hair loss and sexual health, with plans to broaden its scope to chronic conditions later in 2026, including services to address high cholesterol and obesity. 
    • “If its chatbot recommends consultation with a physician, users can pay $29 to schedule follow-up care. Counsel Signature members, the company’s annual membership plan, will be able to use the expanded capabilities at no extra cost, according to a company announcement.”
  • Beckers Payer Issues lets us know,
    • “Cigna Healthcare offers the best digital experience to commercial members, while UPMC Health Plan provides the best experience to Medicare Advantage enrollees, according to J.D. Power’s 2026 U.S. Healthcare Digital Experience Study. Both plans topped their respective segments in last year’s ranking as well.
    • “Overall, the segment average for commercial plan digital experience is 658 on a 1,000-point scale. For MA, the segment average is 645. Both figures represent an improvement over the 2025 study, which recorded averages of 653 for commercial plans and 597 for Medicare Advantage.
    • “The study measured satisfaction across visual appeal; navigation; information/content; speed; and telehealth. The 2026 study included evaluations from 7,687 members of the 17 largest MA plans and 16 largest commercial plans, fielded from August through December 2025.”
    • More results are available in the article.
  • Modern Healthcare reports,
    • “Health systems and health plans are embracing performance-based contracts with digital health vendors. 
    • “In 2025, 75% of health plans and 61% of health systems implemented performance-based contracts with digital health vendors, according to a 2025 survey conducted by Peterson Health Technology Institute. In addition, the majority of the organizations that didn’t use performance-based contracts last year expressed interest in doing them.
    • “The contracts can ensure that payment is tied to return on investment and measurable outcomes. That makes formulating them tricky.”

Friday report

David Ermer–CDC, CMS, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) released its Plan Year 2027 Carrier Call Letter for the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) Programs, outlining a clear shift toward prevention, wellness, and long-term health outcomes.
    • “The guidance calls on FEHB and PSHB carriers to help advance a healthcare approach that prioritizes prevention, improves health outcomes, and supports long-term affordability.
    • “The Plan Year 2027 priorities emphasize empowering individuals to take a more active role in their health while encouraging carriers to expand access to non-pharmaceutical interventions and digital therapeutics, promote cost-effective sites of care, and reduce unnecessary or low-value services. Over time, these changes are expected to prevent chronic conditions and drive meaningful cost savings.
    • “This year’s carrier letter reflects this administration’s commitment to WellCare and prioritizing the health and longevity of federal workers,” OPM Associate Director for Healthcare and Insurance Shane Stevens said. “Today’s health decisions shape outcomes for years to come.  By focusing on prevention and giving individuals the tools to take ownership of their health our participants have enhanced opportunities to improve their health while ensuring a more sustainable program for federal employees, retirees, and taxpayers.”
    • “OPM will continue working with carriers to implement these changes and strengthen a healthcare system centered on wellness and prevention. Read the letter to carriers here.”
  • FEHBlog Observation — While the call letter does include a boatload of new mandates, those mandates sit on topic of ideas from the Obama and Biden administrations because OPM rarely looks back. It’s high time to offset new spending by cleaning house on earlier mandates.
  • The American Hospital Association reports,
    • “President Trump April 3 submitted to Congress his budget request for fiscal year 2027. The top-line request proposes a 10% decrease ($73 billion) in non-defense discretionary spending. The budget requests $111.1 billion in discretionary funding for the Department of Health and Human Services, a 12.5% ($15.8 billion) reduction from FY 2026 enacted. The HHS proposal does not include any new mandatory spending proposals. While this proposal is not binding, it serves as a preliminary framework for both Congress and the administration as they determine federal funding levels and shape health care policy this year.”  
  • STAT News relates,
    • “The Trump administration is slashing the number of quality and care measures that Medicare Advantage plans will be graded on, a move that will funnel an extra $18.6 billion toward health insurers over the next decade.
    • “The final regulation, released Thursday by President Trump’s Centers for Medicare and Medicaid Services, is significantly more beneficial for the insurance industry than originally expected. CMS previously estimated these changes to star ratings would cost $13.2 billion between 2028 and 2036 when the rule was proposed in November.
    • “The extra funding from star ratings provides a sizable buffer for Medicare Advantage insurers, which are awaiting final payment rates for 2027 and experiencing higher medical claims. Insurers have lobbied Trump officials for more money in their baseline payments, and to scale back changes in how they record the sicknesses of their members. The government is supposed to release that regulation no later than April 6.”
  • Bloomberg Law adds,
    • “President Donald Trump’s plan to cover weight-loss medications for some people in the Medicare program for the elderly would cost the health insurers billions in its first year, a new analysis found. 
    • “The Trump administration has argued that the lower prices it negotiated with drugmakers last year would offset the cost of adding coverage for millions of new patients. The plan will “expand access and lower prices for obesity GLP-1 medication without passing the bill to taxpayers,” Mehmet Oz, director of the Centers for Medicare and Medicaid Services, said in a video promoting the plan. 
    • “But a new analysis undercuts that claim. Savings of more than $900 million during the program’s first year would only cover the costs for an estimated 4.4% of the patients who would become newly eligible for the drugs, according to researchers led by Vanderbilt University Professor of Health Policy Stacie Dusetzina.
    • “The findings published in the Journal of the American Medical Association come ahead of a crucial April 20 deadline for health insurers to decide whether they will join the optional program next year. The Trump administration has said it won’t proceed with the plan unless insurers covering 80% of the Medicare population join.
    • “All of the major insurers participating in Medicare’s drug benefit program would need to opt-in to hit that threshold. Dusetzina said she doesn’t see any clear path for the plans to increase access without a significant financial hit.”
  • FEHBlog Observation: This Medicare program would benefit the FEHB and PSHBP which currently covers these GLP-1 drug expenses for federal and Postal annuitants over age 65.
  • Fierce Pharma notes,
    • “The U.K. can officially declare itself free of tariffs on drug exports to the U.S. after its government signed off on the landmark U.S.- U.K. pharmaceutical partnership that first came to be in December. 
    • “In exchange for the tariff reprieve, the U.K. will boost the net price its National Health Service (NHS) pays for novel treatments by 25%. The arrangement lasts at least three years and makes the U.K. the first in the world to secure 0% tariffs on U.S. pharma exports, U.K. officials said in a Thursday press release. 
    • “First announced in December, the partnership protects a UK pharmaceutical industry that added £28.5 billion to the UK economy in 2025, employs over 50,000 people in highly skilled, well-paid jobs, and exported almost £21 billion in pharmaceutical products worldwide last year,” the government explained.” 

From the public health, medical and Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “US flu activity keeps trending downward, according to the latest FluView report from the Centers for Disease Control and Prevention (CDC).
    • “Flu cases are declining across most of the country, the CDC said, with influenza A viruses waning and influenza B viruses showing varying levels of activity. That trend follows the typical seasonal flu virus patterns. The proportion of tests that were positive for flu fell to 9.8%, down from 11.5% the previous week, and the proportion of outpatient visits for flu remained below the national baseline for the second straight week, falling from 2.8% to 2.6%.
    • “For the season overall, influenza A viruses have been the most frequently reported. Of the influenza A viruses collected so far, 92.7% have belonged subclade K, which contains mutations that developed after this season’s flu vaccine strains were selected.
    • “Weekly hospital admissions for flu also declined, dropping from 5,640 the previous week to 3,050 this week. But an additional four pediatric deaths were reported this week, bringing the total for the season to 127. Although the CDC has classified the current flu season as moderate for adults, for children it’s been a high severity season.
    • “The CDC estimates there have been 30 million illnesses, 370,000 hospitalizations, and 23,000 deaths from flu so far this season.”
    • “Overall, the amount of acute respiratory illness causing Americans to seek health care is low, the CDC said in its respiratory illness update. But respiratory syncytial virus (RSV) activity picked up later than normal this year and is currently at elevated levels, though it appears to have peaked in most regions, and the virus isn’t making people sicker than in previous seasons. Emergency department visits and hospitalizations for RSV are highest among children aged 4 and under.
    • “COVID-19 levels are low across most of the country.
    • “The CDC also noted that human metapneumovirus (HMPV) activity is rising across the country, which is typical for this time of year. Symptoms of HMPV include cough, fever, nasal congestion, and shortness of breath.“
  • Beckers Clinicial Leadership adds,
    • “The new “Cicada” variant identified in more than half of U.S. states may be more likely to infect children than adults, CNN reported April 2.
    • “The variant, BA.3.2, earned its nickname because it has largely remained undetected or “underground” — like its insect namesake — since first discovered in a five-year-old boy in South Africa in November 2024.” 
  • The American Hospital Association relates,
    • “Cases in the Utah measles outbreak have increased to 559, the state’s Department of Health and Human Services reported March 31. The agency said 362 cases have been diagnosed so far this year during the outbreak, which began in June 2025. The Centers for Disease Control and Prevention reported today that there are 1,671 measles cases nationwide across 33 jurisdictions. There have been 17 outbreaks reported this year, with 94% of confirmed cases being outbreak-associated. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • KFF Health News points out,
    • “This week, the Centers for Disease Control and Prevention posted online its first large tranche of advanced genetic data from measles viruses spreading last year. Scientists with knowledge of the operation expect the agency to post heaps more in weeks to come, revealing whether the U.S. has lost its hard-won measles elimination status.” * * *
    • “The CDC did not answer queries from KFF Health News on its timeline for publishing measles data or analyses. However, once all the data is public, researchers can run quick initial analyses that will signal whether outbreaks across the U.S. last year resulted from the continuous spread of the disease between states, rather than separate introductions from abroad.
    • “If there was continuous transmission for a year, that means the U.S. has lost its status as a country that has eliminated measles. That status, which the U.S. has held since 2000, reflects a country’s vaccination rates: Two doses of the measles-mumps-rubella vaccine prevent most infections and so stop outbreaks from growing.
    • “More careful analyses take weeks.”
  • Reuters tells us,
    • “Medetomidine, which is also known as ‘rhino tranq,’ or ‘dex’, is ​not approved for human use but is approved for sedation ​and analgesia in dogs.
    • “The agencies said it has increasingly been detected in law enforcement drug seizures, drug product and paraphernalia samples and wastewater samples, ​with the highest concentrations in the Northeast region.
    • “The CDC said ​stopping medetomidine after regular use can trigger severe withdrawal, with symptoms including hypertension, ‌anxiety, ⁠nausea, vomiting and fluctuating alertness, which may require emergency or intensive care. It can also cause profound sedation, slow heart rate and hypotension.
    • “Because fentanyl is involved in most overdoses involving medetomidine, opioid ​overdose reversal medications ​like naloxone ⁠should be administered to restore normal breathing, the agencies said.”
  • Health Day tells us,
    • “A new rapid urine test could lead to more targeted and effective treatment of urinary tract infections (UTI), researchers say.
    • “It currently takes labs two to three days to determine which antibiotic would work best against an individual’s UTI.
    • “But the new test can turn around results in just under six hours, creating the potential for same-day antibiotic prescriptions for a UTI, researchers reported in this month’s issue of the Journal of Antimicrobial Chemotherapy.”
  • Medscape informs us,
    • “A group of diabetes professionals is proposing a change from the term prediabetes to the use of a three-stage classification of type 2 diabetes (T2D), with the aim of promoting earlier treatment and risk reduction.
    • “When is it too early to start to intervene in the process of diabetes?” said Moshe Phillip, MD, director of the Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center, Petah Tikva, Israel, co-author of a comment paper on the topic published earlier this year in the Lancet Diabetes & Endocrinology.
    • “One of the mistakes that “we as a community have done in the past” is to label people as having prediabetes “because ‘prediabetes’ means that you are healthy,” he told Medscape Medical News.
    • “Actually, many of those that are defined as having prediabetes have a higher risk for all complications, mainly cardiovascular, he explained.” * * *
    • “Yet there is no drug approval process for prediabetes, despite the evidence that agents such as metformin, pioglitazone, and GLP-1 drugs can prevent progression to T2D and reduce cardiovascular risk.”

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

  • Modern Healthcare reports
    • “Elevance Health will apply its policy deducting pay from hospitals that refer some members to out-of-network providers to facilities in New York.
    • “Starting July 1, Elevance Health’s Anthem Blue Cross Blue Shield subsidiary may reduce New York hospitals’ pay by 7.5% or terminate facilities from its network if hospitals refer commercial members to inpatient or outpatient providers without a contract.
    • “Hospitals cannot pass the monetary penalty onto patients, according to an April 1 notice sent to providers.
    • “Rural, critical access and safety-net hospitals are exempt. Hospitals will also not be penalized for referring patients to emergency services or an out-of-network pre-approved provider. Additionally, the penalty will not apply when no in-network providers are available to provide the same care within the same geographic area.”
  • Healthcare Dive offers a commentary from Dr. Catherine Gaffigan is the president of health solutions at Elevance Health in which Dr. Gaffigan explains how this practice holds down health care costs.
  • Medical Economics relates,
    • “Medical Economics spoke with Shannon Sims, M.D., Ph.D., FAMIA, chief product officer at Vizient, and Matthew Bates, M.P.H., managing director at Kaufman Hall, about Vizient’s 2026 State of the Industry Report and what it describes as a reset moment for U.S. health care. When asked what changes physicians will feel first, both pointed to the same two shifts: artificial intelligence (AI) moving into everyday workflow and advanced practice providers (APPs) taking on a larger share of clinical care.
    • “Bates framed the AI transition as a move out of the hype cycle and into practical use. Ambient listening — tools that generate clinical notes from recorded patient encounters — is the clearest example. “It is moving from a niche to really changing the way we practice, particularly in clinic and office settings,” Bates said.
    • “Sims explained that, “what most physicians will see day to day is the use of AI tools to automate or reduce the burdens they feel,” pointing specifically to documentation, billing, medication refills and patient access as areas where meaningful improvement is already within reach. Now, he says the window for sitting it out is closing. “If [physicians] do not [embrace these tools], they risk falling behind and losing some of the relevance and ability to practice in the way they would like to.”
    • “On APPs, Bates was equally blunt. The physician shortage is real, it isn’t resolving quickly, and APPs are filling the gap. How health systems build effective, high-quality teams around that reality, rather than just plugging holes, is one of the central operational questions of the moment.”
  • Radiology Business adds,
    • “A Harvard University economist claims that imaging volumes are falling in the U.S., blunting the need for more radiologists. 
    • “David M. Cutler, PhD, a noted researcher and professor, shared the thought in an editorial published Thursday by JAMA Health Forum. He cited research including 2019 study published by the Radiological Society of North America showing that imaging use stabilized or declined between 2010 and 2016.
    • “Dipping utilization combined with lower reimbursement per procedure has led to a “sustained slowdown in imaging spending growth,” Cutler wrote. 
    • “In addition to helping with cost concerns, the reduction in imaging use has helped to minimize a potential shortage of radiologists,” he wrote April 2. “For some time, economists were worried about a looming radiologist shortage. The decrease in imaging has allowed the U.S. to meet the need for imaging without an increase in radiologists.”
    • “The claims appear to contradict both anecdotal and numerous published academic reports stating the contrary. Another RSNA-published study last year found that emergency departments’ use of CT imaging has increased substantially since 2013. Another JACR study published in January estimated that radiology exam caseloads climbed 31% since 2018. A third shared by Health Affairs in 2024 said overall spending on radiology services leapt almost 36% between 2010 and 2021.”  

Notable Death

  • The Wall Street Journal reports,
    • “By the time patients seek therapy for post-traumatic stress disorder, many have spent years suppressing their worst memories and avoiding the places and situations they associate with the most difficult moments of their lives. 
    • “Edna Foa asked them to get closer to those moments.
    • “She asked women who had survived rape to recount what happened, and encouraged soldiers to explain what they had seen in war. It wasn’t an easy ask, but patients had been avoiding so many things for so long that their worlds had gotten smaller and many were willing to try something, even if it felt drastic. 
    • “At first, revisiting memories and places that they feared could be distressing. Over time—typically eight to 15 sessions—the prolonged exposure therapy could make the memories of the traumatic events approachable and turn them into something they could emotionally process and ultimately take power over.
    • “Foa, a clinical psychologist who died March 24 at the age of 88, didn’t just pioneer prolonged exposure therapy, one of the most effective, evidence-based therapies used for treating PTSD in the U.S.; she also created an ecosystem to get it into practice. She trained thousands of healthcare professionals on how to treat patients, and trained others how to do the training. She also wrote books, manuals and patient workbooks to make sure that the training was implemented correctly.”
  • RIP

Thursday report

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

From Washington, DC

  • Govexec reports,
    • “President Trump on Thursday said he plans to sign an executive order to pay all Homeland Security Department workers, after the House failed again to pass legislation ending the partial government shutdown, now in its 48th day.” * * *
    • “TSA workers were granted four weeks’ worth of back pay Monday following the signing of the more targeted edict last week, while ICE and CBP workers have been paid on time since the beginning of the department-wide appropriations lapse using funds from the One Big Beautiful Bill law. Still working without pay within the department are employees at the Federal Emergency Management Agency along with support staff and other non-immigration-related DHS components. 
    • “Observers had anticipated Thursday to serve as the potential end of the six-week impasse. After the House rejected a Senate-passed bill to fund DHS—minus ICE and CBP—through the end of September last week, senators again passed the bill with the expectation that the House would approve it via unanimous consent that morning. But when the House convened its pro forma session, lawmakers did not bring the measure up for consideration, reportedly due to pressure from conservative GOP members.
    • “The next possible opportunity for Speaker Mike Johnson to advance the DHS legislation would be Monday. The House is not set to return to Washington until April 14.”
  • Roll Call relates,
    • “President Donald Trump ousted Pamela Bondi as attorney general Thursday, closing out a tumultuous tenure punctuated by rolling controversies and attacks against the Justice Department’s traditional independence from the White House.
    • “Trump, who made the announcement in a social media post, said his former personal attorney, Deputy Attorney General Todd Blanche, would lead the department as acting attorney general. The president described Bondi as a “loyal friend.”
    • “Bondi, in a statement on social media, said that over the next month she would be working to transition the office of attorney general to Blanche “before moving to an important private sector role.”
    • “She said she would continue “fighting for President Trump and this Administration” in the new role.”
  • The Wall Street Journal tells us,
    • “The U.S. will impose tariffs of as much as 100% on branded pharmaceuticals, the White House said Thursday, though nations or drugmakers that strike deals with the Trump administration or commit to build manufacturing facilities in the U.S. can receive lower levies. 
    • “The 100% tariff will apply to patented imported pharmaceuticals from companies that haven’t committed to invest in the U.S. and haven’t entered into “most favored nation” agreements to match their U.S. prices to the lowest they charge in other developed countries, a senior administration official said Thursday.
    • “But the full 100% tariff might apply to only a few drugmakers or none at all. If a company pledges to invest in U.S. drug manufacturing in the coming years, its tariff rate will fall to 20%, the senior administration official said. The company would have to complete the factory by the end of President Trump’s term in the White House, the official said, or tariffs could be increased.
    • “Additionally, if a company that has made a U.S. manufacturing pledge also strikes a most-favored-nation agreement with the Trump administration, its tariffs can fall to zero, the official said.”
  • Lotsa Medicare news today. Bloomberg Law reports,
    • “The Trump administration announced changes to patient cost-sharing in Medicare’s prescription drug benefit and will update the methodology used to rate private Medicare Advantage plans.
    • “The final rule (RIN 0938-AV63), released Thursday by the Centers for Medicare & Medicaid Services, implements changes to Part D enacted under the Inflation Reduction Act in 2022 and will update the methodology used to calculate insurers’ “star ratings,” which are quality scores that determine bonuses and marketing privileges. The changes would take effect in 2027.
    • “The new rule finalizes the Inflation Reduction Act’s elimination of Medicare Part D’s coverage gap as part of a broader overhaul of how the program is financed. The law’s $2,000 annual out-of-pocket cap for prescription drugs took effect last year.
    • “The agency chose to hold off on finalizing a previous proposal that would have allowed Medicare Advantage members a special enrollment period when their doctor leaves their network.”
  • and
    • “The Trump administration proposed new transparency measures for hospices under Medicare amid a focus on fraud led by Centers for Medicare & Medicaid Services Administrator Mehmet Oz.
    • “The proposed rule (RIN 0938-AV78), released Thursday by the CMS, also includes updates to the hospice wage index, which adjusts daily Medicare hospice payments based on differences in labor costs across geographic regions. 
    • “The measure proposes a new analysis of non-hospice spending in an effort to better identify fraud and overutilization, as well as to require hospices to list for patients what services are not covered under Medicare’s hospice benefit.
    • “Hospices exist to help Americans die peaceful, dignified deaths, not to line the pockets of fraudsters,” Oz said in a statement. “These new transparency measures will make it easier for CMS and others to identify hospice providers that misuse Medicare dollars, cut off their funding, and refer them to law enforcement for criminal prosecution.”
    • “The proposal would also increase payment rates in fiscal year 2027 by 2.4%, or $785 million, and seeks comment on developing a hospice-specific wage index.”
  • The American Hospital Association News informs us,
    • The Centers for Medicare & Medicaid Services April 2 issued a proposed rule for the skilled nursing facility prospective payment system for fiscal year 2027. The proposal would increase aggregate payments by 2.4%, which reflects a 3.2% market basket update and a 0.8 percentage point cut for productivity. CMS also included in this proposed rule a request for information on how to address perceived case-mix upcoding. For the SNF Quality Reporting Program, CMS proposes to remove two measures focused on COVID-19 vaccination for patients and health care personnel. CMS also proposes to shorten the timeframe for data submission at the end of each quarter from 4.5 months to 45 days beginning with FY 2029. CMS suggests this change would reduce the lag in public reporting and give SNFs access to more timely data for quality initiatives. CMS will accept public comments on the proposed rule through June 1, 2026. 
  • and
    • The Centers for Medicare & Medicaid Services April 1 released the fiscal year 2027 prospective payment system proposed rule for inpatient rehabilitation facilities. The rule would increase payments by 2.8% overall, which includes a 3.2% market basket update, reduced by a 0.8 percentage point productivity adjustment. CMS is also proposing a slight decrease in the outlier threshold, which would increase payments by 0.4 percentage points. Further, CMS proposes changes and clarifications to the IRF coverage rules, including that all therapies must be initiated within 36 hours of admission to the IRF, current functional status be documented at admission, and the initial interdisciplinary team meeting occur on or before the fourth day of admission. Finally, CMS has also included a request for information on modernizing the IRF PPS, including more closely aligning methodologies with those used for skilled nursing facilities. 
  • and
    • “The Centers for Medicare & Medicaid Services April 2 issued a proposed rule for the inpatient psychiatric facility prospective payment system for fiscal year 2027. CMS proposes to increase IPF payments by a net 2.3%, equivalent to $50 million, in FY 2027. The payment update reflects a proposed market basket update of 3.1% minus a productivity adjustment of 0.8 percentage points. CMS also proposes to update the outlier threshold so that estimated outlier payments remain at 2.0% of total payments. 
    • “For the IPF Quality Reporting Program, CMS proposes to remove two measures focused on alcohol and tobacco use screening and treatment effective with the calendar year 2026 reporting/FY 2028 payment periods. CMS also proposes to implement the standardized IPF Patient Assessment Instrument that is mandated by the Consolidated Appropriations Act of 2023. IPFs would be required to collect IPF-PAI data on all patients age 18 years and older regardless of payer beginning Oct. 1, 2027. CMS will accept public comments on this rule through June 1.”
  • and
    • “The Centers for Medicare & Medicaid Services March 31 released a request for applications for its new accountable care organization model, the Long-term Enhanced ACO Design Model, or LEAD. The model is designed to accommodate a wide range of health care providers, including those who have not previously participated in an ACO and providers who care for specialized patient populations. CMS said ACOs interested in the voluntary, 10-year payment model must apply by May 17. The model will launch Jan. 1, 2027.” 
  • Tammy Flanagan writing in Govexec asks “Traveling soon? What federal health plans actually cover.”
    • “Peak travel season is here, but most federal workers don’t know what happens if they need care abroad. From upfront costs to medical evacuations, here is what your FEHB plan does and doesn’t cover when you are out of the country.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced a cross-government hiring action to recruit Project Managers for critical roles across federal agencies.
    • “Project management has long been identified as an area where the federal government faces a critical skills gap. OPM is tackling that skills gap with this cross-government hiring action. Selected candidates will lead major initiatives in areas such as artificial intelligence, healthcare, defense, energy, financial technology, and infrastructure, increasing on-time, on-budget delivery through professionalized project management practices. Applicants will be screened for qualifications and must complete project management and writing assessments to determine skills levels.
    • “Like the Tech Force program, OPM will use a shared certificate allowing several agencies to hire qualified candidates from the same pool for one year. The effort supports a goal to hire about 250 professionals in project management and data science roles across government.
    • “Delivering on complex national priorities requires strong project management at every level of government,” OPM Director Scott Kupor said. “This effort helps agencies identify and hire professionals who can drive execution, manage risk, and ensure results for the American people.”
    • “Click here to view the job posting and contact CrossGovHiring@opm.gov for more information.”
  • Per an ARPA-H news release,
    • “New STOMP program will uncover how microplastics build up in the body—and drive new ways to protect people from their potential health impact
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced STOMP: Systematic Targeting Of MicroPlastics, a nationwide $144 million program to create the definitive toolbox for measuring, researching, and affordably removing microplastics and nanoplastics (MNPs) in the human body. 
    • “Today, HHS is taking decisive action to confront microplastics as a growing threat to human health,” said HHS Secretary Robert F. Kennedy, Jr. “Americans deserve clear answers about how microplastics in their bodies affect their health. Through ARPA-H’s STOMP program, we will measure microplastic exposure, identify sources of risk, and develop targeted solutions to reduce it.”  

From the judicial front,

  • Thompson Reuters reports,
    • “Whittemore v. Cigna Health & Life Ins. Co., 2026 WL 777418 (1st Cir. 2026)
    • “The First Circuit has affirmed the dismissal of a lawsuit challenging a health plan’s exclusion of weight-loss drugs, holding that a participant did not plausibly allege she had a disability simply by stating she had been diagnosed with obesity and prescribed medication to treat it. The participant filed a proposed class action lawsuit against a health insurer, alleging disability discrimination under Affordable Care Act (ACA) Section 1557. The participant asserted that her obesity was a disability and that the insurer discriminated against her by designing and administering health plans that categorically excluded coverage for prescription weight-loss medications. (Section 1557 prohibits discrimination on grounds specified in several federal laws, including Section 504 of the Rehabilitation Act, which bars discrimination based on disability.) The district court dismissed the case, ruling that the participant had not plausibly shown that she was disabled merely as a function of her body mass index, nor that the insurer had ever regarded her as disabled.
    • “The First Circuit affirmed the dismissal, but on different grounds. The court explained that to state a disability discrimination claim, the participant had to show she was disabled as defined by the Americans with Disabilities Act (ADA). The ADA defines disability as a physical or mental impairment that “substantially limits one or more major life activities.” The participant’s complaint alleged that her obesity substantially limited her in major life activities such as walking, standing, and sleeping. The court, however, concluded that these allegations were conclusory “threadbare recitals of the elements of a cause of action.” The court also rejected the participant’s argument that any individual diagnosed with obesity and prescribed medication for it is, by definition, substantially limited in the operation of major bodily functions, reasoning that such general statements about obesity’s potential health impacts do not plausibly support an inference that every person in that category is disabled under the ADA.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “Flu and COVID-19 vaccination rates among all health care workers for the 2024-25 respiratory virus season was 76.3% and 40.2%, respectively, according to a Centers for Disease Control and Prevention report released April 2. Coverage was higher for personnel whose employers offered on-site flu and COVID-19 vaccinations, at 73% and 42.9%. Lower figures were found among personnel with employers that did not offer on-site vaccinations, at 41.4% and 19.8%. The CDC said that increasing vaccination coverage by implementing workplace policies, including offering on-site vaccinations, could increase coverage and reduce flu- and COVID-19-related morbidity among health care providers.” 
  • The University of Minnesota CIDRAP adds,
    • “Respiratory syncytial virus (RSV) vaccination coverage among older US adults remained low through the end of the 2024–25 respiratory virus season, according to a new study published in Vaccine. In 2024, the Advisory Committee on Immunization Practices recommended RSV vaccination for adults aged 60 to 74 years who are at increased risk of severe RSV and for all adults aged ≥ 75 years.
    • “Analyzing data from approximately 64,000 adults surveyed from September 2024 through April 2025, researchers from the Centers for Disease Control and Prevention found that, by the end of the 2024–25 respiratory virus season, 38.3% of adults ages 60 to 74 who were at increased risk of severe RSV and 41.5% of those 75 and older had received an RSV vaccine.”
  • Cardiovascular Business shares “Key clinical takeaways from ACC.26” * * * “in New Orleans highlighted advances that will likely impact patient care for years to come. Key topics included pulmonary embolism (PE), lipid management and noninvasive coronary assessment.”
  • Genetic Engineering and Biotechnology News relates,
    • “The ALS Therapy Development Institute (ALS TDI), LifeArc, and Axol Bioscience launched the Patient induced pluripotent stem cell (iPSC)-based Research to Improve Sporadic ALS Modeling (PRISM) initiative, a collaborative effort to expand access to patient-derived stem cell models.
    • ‘ALS is a heterogeneous disease. While 10-15% of cases are linked to inherited mutations, nearly 85% are sporadic, according to a PRISM ALS official, who adds that much of ALS drug discovery has relied on models representing a limited number of rare genetic subtypes. This mismatch has constrained target discovery, limited therapeutic testing across patient populations, and contributed to the high failure rate of clinical trials, maintains the spokesperson.
    • “This initiative plans to provide a high-quality and accessible source of sporadic ALS/MND models for use in research. PRISM ALS aims to develop, evaluate, and make available a diverse panel of well-characterized, patient-derived induced pluripotent stem cell (iPSC) models that capture both genetic and sporadic forms of ALS.
    • “For researchers and drug developers, those standardized, human-relevant models are expected to allow them to better understand disease mechanisms, identify therapeutic targets, and evaluate treatments across distinct biological subtypes. For people living with ALS, it might lead to the development and testing of therapies in models that more closely mirror their own biology, increasing the likelihood that discoveries will translate into meaningful treatments.”
  • Per Healio,
    • ‘A short walk around the block, a 30-minute bike ride, or an intense 1-hour lifting session at the gym each can benefit patients with breast cancer undergoing chemotherapy.
    • “A meta-analysis of more than 20 clinical trials showed women randomly assigned to exercise interventions, whether aerobic, strength or a combination of both, during treatment had more than a 60% greater likelihood of reporting improved quality of life than those who received standard care alone.”
  • Per Fierce Pharma,
    • “Another green light appears increasingly within reach for AstraZeneca’s Emerald program after a combo regimen featuring the company’s immunotherapy duo, Imfinzi and Imjudo, showed benefit in certain liver cancer patients. 
    • “Results from the phase 3 Emerald-3 trial showed that the combination, paired with transarterial chemoembolizaton (TACE) and Lenvima, significantly improved progression-free survival (PFS) versus TACE alone in patients with unresectable locoregional hepatocellular carcinoma. Lenvima is a multikinase inhibitor sold by Merck & Co. and Eisai.
    • ‘But whether AZ has struck gold with Emerald-3 remains to be seen. Overall survival (OS), a secondary endpoint that will be a key consideration for the FDA, was immature at the interim analysis, although AZ highlighted a trend toward improvement in its April 2 announcement.”

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

  • Modern Healthcare reports,
    • “Henry Ford Health is adding to its rapid expansion across Southeast Michigan with the acquisition of Clinton Township-based Cornerstone Medical Group. 
    • “Terms of the deal were not disclosed, but Cornerstone’s 25 locations across the region will be rolled into Henry Ford Medical Group, which employs 3,400 physicians and researchers.
    • “The locations — which include family and internal medicine, pediatrics, endocrinology, hospitalist care, podiatry and colorectal surgery — have been renamed Henry Ford Cornerstone.”
  • Radiology Business point out.
    • nterventional radiology vendor Merit Medical is acquiring a rival imaging-focused firm for $140 million, the two announced Wednesday. 
    • The South Jordan, Utah-based company plans to merge with View Point Medical, which manufactures the OneMark Detection Imaging System. Cleared by the U.S. Food and Drug Administration in 2024, the device uses ultrasound guidance to detect and remove cancer. 
    • Merit Medical—a leading manufacturer of disposable devices such as catheters and guide wires—said it made the move to help expand its portfolio of therapeutic oncology products. 
    • View Point’s ultrasound-based technology is “highly innovative,” it noted, allowing physicians to localize more lesions at the time of biopsy. This represents a market opportunity of 1.3 million procedures annually in the U.S. alone, Merit estimated. 
  • and
    • “The chief executive of America’s largest public hospital system says he is prepared to start replacing radiologists with artificial intelligence in some circumstances, once the regulatory landscape catches up. 
    • ‘Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, recently spoke during a panel discussion held by Crain’s New York Business. The trained internal medicine specialist noted how AI is increasingly being used to interpret mammograms and X-rays. 
    • “This presents an opportunity to save on how much hospitals spend on radiologists, who have become more costly amid rising demand for imaging, Crain’s reported Thursday. 
    • “We could replace a great deal of radiologists with AI at this moment, if we are ready to do the regulatory challenge,” Katz said at the forum, held on March 25.” 
  • Healthcare Dive relates,
    • “Community Health Systems has closed the sale of another hospital as the for-profit health system makes progress paying down its debt.
    • “On Wednesday, nonprofit Huntsville Hospital Health System acquired Huntsville, Alabama-based Crestwood Medical Center from CHS for $459 million.
    • “The purchase price is higher than the initial $450 million deal proposed in January, when the two health systems signed a definitive agreement. The final amount was subject to a post-closing working capital adjustment, according to a release, an amount that can fluctuate based on the acquisition target’s assets and liabilities.”
  • Beckers Hospital Review tells us,
    • “Oakland, Calif.-based Kaiser Permanente has broken ground on a new hospital tower at Kaiser Permanente Sunnyside Medical Center in Clackamas, Ore.
    • “The seven-story, 615,000-square-foot tower is slated to open in 2029 and will be Oregon’s first fully electric hospital, according to an April 2 health system news release. The facility is also targeting LEED Gold certification and will become Kaiser Permanente’s 87th LEED-certified building.
    • “Features will include private patient rooms; in-room telemedicine capabilities, advanced robotics and image-guided surgical equipment; expanded emergency department capacity to reduce wait times; and green spaces, walking paths and healing gardens.”
  • and
    • “Farmington, Conn.-based UConn Health has shared plans to integrate Middletown, Conn.-based Solnit Hospital, a children and adolescent psychiatric facility, into a satellite location of its UConn John Dempsey Hospital in Farmington.
    • “This collaboration reflects our shared commitment to delivering exceptional, high-quality, and specialized care for Connecticut’s youth while optimizing resources across agencies,” UConn Health CEO, Andrew Agwunobi, MD, said in an April 2 statement shared with Becker’s. 
    • “Solnit Hospital is a state-administered psychiatric facility for children ages 13 to 17. It offers care to children and adolescents with “severe mental illness and related behavioral and emotional problems who cannot be safely assessed or treated in a less restrictive setting,” according to  the state’s website.” 
  • Fierce Healthcare informs us,
    • “Sunfish, a family-building software platform, is launching what it says is the first AI-powered egg-freezing success program in the fertility space.
    • “The goal of the program is to solve the uncertainty that comes with fertility preservation, from a lack of financial transparency to outcomes that are unknown and not guaranteed. Based on a patient’s biodata, Sunfish’s proprietary algorithm predicts the optimal amount of matured eggs that should be frozen as well as the cost of the cycle. 
    • “Sunfish is really focused on helping people to navigate the full fertility journey,” Angela Rastegar, co-founder and CEO of Sunfish, told Fierce Healthcare in an advanced interview. “Patients shouldn’t have to be an unpaid project manager for their own family planning.” 

Midweek update

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump on Wednesday endorsed a two-part plan to quickly fund most of the Department of Homeland Security and then use a special procedure to pay for immigration enforcement with only GOP votes, stepping in to resolve a standoff between Republican congressional leaders.” * * *
    • “Congress could now pass a bill funding most of DHS that the Senate approved last week, and Trump set a goal of June 1 for funding the rest of the department using a process called budget reconciliation. The maneuver requires a simple majority for budget-focused bills, rather than the 60 votes typically required in the Senate, which Republicans control 53-47.
    • [Senate Majority Leader John] Thune [(R., SD)] and House Speaker Mike Johnson (R., La.), who had publicly disagreed over the best way to end the DHS shutdown, issued a joint statement backing Trump’s directive and saying they agreed on the two-step path to fully fund the department in “coming days.”
  • Healthcare Dive reports,
    • “Elevance avoided steep sanctions against its Medicare Advantage plans that were set to kick in on Wednesday, after the CMS granted the insurer an extension to make up for incorrect risk adjustment data reporting stretching back years.
    • “Earlier this year, the CMS notified Elevance that it planned to prevent the insurer’s MA plans from enrolling new members, along with other sanctions, starting on March 31 after finding that Elevance failed to comply with federal data submission requirements. Elevance asked regulators for more time to comply, and the CMS granted the company’s request in mid-March, according to a disclosure from Elevance.
    • “Elevance now has until May 30 to correct its data reporting before sanctions kick in. The CMS also exempted several of Elevance’s MA plans that weren’t impacted by the noncompliance from the potential penalties.”
  • The Labor Department issued a “Frequently Asked Question (FAQ) regarding implementation of certain provisions of Title I (the No Surprises Act)(1) of division BB of the Consolidated Appropriations Act, 2021. This FAQ has been prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM).”
    • The FAQ 73 concerns an ongoing Qualifying Payment Amount dispute long pending before the U.S. Court of Appeals for the Fifth Circuit.
    • “Q1: Are the Departments and OPM extending the enforcement relief regarding the use of QPAs announced in FAQs Part 71?
      • “Yes. The Departments and OPM extend the exercise of enforcement discretion, originally provided in FAQs Part 62 and extended in FAQs Parts 67, 69, and 71, under the relevant No Surprises Act provisions for any plan or issuer, or party to a payment dispute in the Federal IDR process, that uses a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026, the first day of the calendar month that begins after 6 months from the issuance of these FAQs. This exercise of enforcement discretion applies to QPAs for purposes of calculating patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment,(14) and providing required disclosures and submissions under the Federal IDR process.
      • “HHS similarly extends its exercise of enforcement discretion under the relevant No Surprises Act provisions for a provider, facility, or provider of air ambulance services that bills, or holds liable, a participant, beneficiary, or enrollee for a cost-sharing amount based on a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026.”
  • Per an OPM March 31, 2026, news release,
    • “Today, the Office of Personnel Management (OPM) announced the President’s Commission on White House Fellowships is now accepting applications for the 2026-27 class of White House Fellows.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS), through the CMS Innovation Center, announced that organizations participating in certain Innovation Center models may begin offering a new Substance Access Beneficiary Engagement Incentive (BEI) starting April 1, 2026. Through this optional incentive, eligible hemp-derived products can be incorporated into patient care plans under clinician guidance, consistent with model requirements and applicable law.
    • “This milestone reflects the Administration’s broader efforts to expand access to innovative, patient-centered care. It also aligns with President Trump’s Executive Order supporting research and innovation related to hemp-derived products. It marks a meaningful step as CMS begins testing how emerging care tools can be integrated into coordinated care to improve outcomes and quality of life. 
    • “CMS is committed to innovation that meets patients where they are while maintaining strong safeguards and clinical oversight,” said CMS Administrator Dr. Mehmet Oz. “Under the President’s leadership, we’re expanding the tools available to improve patients’ health while generating important insights into how providers can use these tools safely and effectively in real-world care settings.” * * *
    • “More information about the Substance Access Beneficiary Engagement Incentive, including eligibility criteria and program requirements, is available at: https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services March 30 announced that C2C Innovative Solutions will replace Maximus in reviewing and processing appeals of adverse organization determinations and reconsiderations made by Medicare Advantage plans as of May 1. Maximum will continue to process appeals requests received on or before April 30. CMS said there will be a short period when both Maximus and C2C are issuing decisions. Updates on procedures for submitting appeal case files and other communications will become available on C2C’s website beginning April 1.” 
  • The Wall Street Journal informs us,
    • “The latest Census Bureau data show the broad effects of a big immigration slowdown in the U.S., and a lot more.
    • “The numbers for the year through June 2025 also show fewer people bailing on America’s tech epicenter, a modest Midwest rebound and rising appeal for small southern metros.” 

From the Food and Drug Administration front,

  • In the biggest healthcare news of the day, the Wall Street Journal reports,
    • “The weight-loss pill wars start now. 
    • “Eli Lilly’s once-daily pill for weight loss got approval from U.S. drug regulators Wednesday. The all-clear sets up a battle with rival Novo Nordisk, which has been selling a pill version of its Wegovy since the start of this year.
    • “The Wegovy pill has had one of the best drug launches in history. Now that the Food and Drug Administration has approved its pill, Lilly will seek to overtake the rival, and further its dominance of the booming $70 billion-plus market for weight-loss and diabetes drugs known as GLP-1s.
    • “It will be a battle royal for GLP-1 pill leadership between Novo and Lilly,” Leerink Partners analyst David Risinger said.
    • “Lilly has won a weight-loss fight before: While Novo Nordisk pioneered the use of GLP-1 drugs for weight loss with its Wegovy and Ozempic weekly injections, Lilly’s Zepbound and Mounjaro injections now outsell them.
    • “Yet Novo Nordisk plans to avoid the mistakes that hurt it during the last round, and will seek to hold on to its early lead by emphasizing the effectiveness of its pill.
    • “Analysts are betting on Lilly, expecting its pill, named Foundayo, to generate about $21 billion in global sales by 2030, compared with $4 billion for the Wegovy pill, according to pharmaceutical commercial intelligence firm Evaluate.”
  • Fierce Pharma relates,
    • “The FDA has delayed its target decision date for Orca Bio’s blood cancer cell therapy candidate Orca-T by three months to July 6.
    • “The review extension comes after the company submitted additional data related to chemistry, manufacturing and controls (CMC) a couple of weeks ago upon request by the agency, Orca Bio’s CEO Nate Fernhoff, Ph.D., told Fierce.
    • “Fernhoff wouldn’t specify the exact nature of the FDA’s questions but said the company doesn’t believe “any of these to be fundamental or unaddressable.”
  • MedTech Dive tells us,
    • “Distalmotion has submitted a 510(k) application to expand the label of its Dexter robotic surgery system in the U.S., the company said Wednesday.
    • “The company aims to expand use of Dexter in gynecological indications, strengthening its push to support ambulatory surgical centers that want to perform more outpatient procedures.  
    • “Distalmotion has identified ASCs, which may have less space, resources and infrastructure than hospitals, as sites of care where Dexter could have an advantage over existing surgical robots.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) has confirmed a new recall of the purge cassettes sold with certain Johnson & Johnson MedTech Impella heart pumps. The alert covers individually packaged Generation 1 Purge Cassettes as well as the ones sold with certain Impella RP, Impella 2.5, Impella CP, Impella CP with Smart Assist, Impella 5.0 and Impella 5.5 with Smart Assist heart pumps. 
    • “The FDA issued this recall due to a risk of the purge cassettes leaking. Purge cassettes play a critical role in patient care, delivering a rinsing fluid to the catheter that prevents blood from flowing back into the motor.
    • “A purge leak may lead to low purge pressure if it goes unaddressed,” according to Johnson & Johnson MedTech. “This can lead to biomaterial ingress, which may lead to an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death.”
    • “The leaks have been linked to four serious injuries and no deaths.”

From the judicial front,

  • ABHW reports,
    • “The Association for Behavioral Health and Wellness (ABHW), the national voice for payers that manage behavioral health insurance benefits for 200 million people, issued the following statement in response to the Trump Administration’s announcement that they will issue a new proposed rule on the Mental Health Parity and Addiction Equity Act (MHPAEA), including anticipated significant revisions to the provisions of the Rule, as ABHW had requested. The Administration has indicated through court documents that it intends to include this rulemaking on the 2026 Spring Regulatory Agenda, and to issue a notice of proposed rulemaking no later than December 31, 2026.”

From the public health and medical / Rx research front,

  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a novel, highly potent opioid that shows potential as a therapy for both pain and opioid use disorder. In a study published in Nature, the team observed the new drug’s effect in laboratory animals. They showed that it has high pain-relieving effects without causing respiratory depression, tolerance or other indicators of potential for addiction in humans.
    • “Opioid pain medications are essential for medical purposes, but can lead to addiction and overdose,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “Developing a highly effective pain medication without these drawbacks would have enormous public health benefits.”
    • “The team investigated formulations of an understudied class of synthetic opioid compounds, known as nitazenes. Nitazenes selectively engage mu-opioid receptors, primary targets for opioid drugs in the brain and peripheral nervous system. However, nitazenes had been shelved in the 1950s due to their excessive potency. The scientific team revisited this class of compounds with a focus on harnessing their selectivity for the mu opioid receptor and engineering new nitazenes with a safer pharmacological profile.
    • “Our goal was to study the profile, or pharmacology, of these drugs,” said Michael Michaelides, Ph.D., senior author and NIDA investigator. “We wanted to decrease the potency and create a potential therapeutic. What we discovered exceeded our expectations.”
  • STAT News reports,
    • “Few things will give a man as much of an insight into the female body as growing up with sisters. Painful, irregular periods, body hair, skin trouble: Al Barrus, a 43-year-old veteran and communications specialist from New Mexico, heard all about it growing up, the only male of three siblings. He’s also known for a while that one of his sisters had been diagnosed with polycystic ovary syndrome, an endocrinological disorder and leading cause of infertility associated with a range of issues including high androgen levels, insulin resistance, and enlarged ovaries. His other sister, too, had some PCOS symptoms. 
    • “Recently, he’s begun to wonder: Could he have it, too? 
    • “Not exactly PCOS but a “male form.” Where women with PCOS’ levels of androgen are too high, his are too low; rather than hirsutism (excess body hair), he has sparse body and facial hair and began going bald as a teenager. He has other issues similar to the ones that can appear in women with PCOS: high levels of the hormone prolactin, suspected insulin resistance, obesity, mental health struggles.” * * *
    • “It took more than a decade, but at last, there is a name, though it is still tightly under wraps “pending submission to a journal for publication,” said Robert Norman, a professor emeritus of reproductive and periconceptual medicine at Adelaide University and one of the experts who worked on selecting a new name. He declined an interview request: “I think you would find it frustrating talking with us when we are not going to reveal the new name yet!” 
  • The American Hospital Association News relates,
    • “The Centers for Disease Control and Prevention has temporarily paused rabies and pox virus testing, according to an update on its website March 30. The pox virus family consists of several viruses, including smallpox and mpox. The CDC typically confirms infections for rabies and pox viruses, among several other infectious diseases.”
  • MedPage Today tells us,
    • “Significant incidental findings detected on low-dose CT lung cancer screening were associated with an increased risk of an extrapulmonary cancer diagnosis over the following year.
    • “Risk differences were significantly higher for urinary cancers, as well as lymphoma and leukemia.
    • “Certain significant incidental findings should be assessed as potential indicators of undiagnosed cancers, researchers said.”
  • Healio informs us,
    • “Incidence of fractures among women begins to rise at age 35 years and increases dramatically starting at age 45 years, whereas men have their highest rates of fracture at age 35 to 45 years, according to data from the UK Biobank.
    • “Our findings reveal a previously underrecognized trajectory of increasing fracture risk in women beginning as early as age 35 years old, with a marked acceleration from the mid-40s,” Catherine Rolls, MSc, research associate in the musculoskeletal research unit and translational and applied research group at University of Bristol in the U.K., and colleagues wrote in a study published in Journal of Bone and Mineral Research. “This female-specific pattern resembles the postmenopausal risk profiles traditionally seen in older populations and suggests that skeletal vulnerability begins earlier than often assumed.”
  • Health Day points out,
    • “Teenagers might be known for being night owls, but they’ll be healthier if they can get to bed earlier, a new study says.
    • “Teens who stay up late and sleep the morning away are more likely to eat more and be less physically active, especially when school is in session, researchers report in the April issue of the journal Sleep Health.
    • “Sleep timing — when teens go to bed and wake up — had the biggest influence on sedentary and eating behavior in teens,” senior researcher Julio Fernandez-Mendoza, a professor of psychiatry and behavioral health at Penn State College of Medicine, said in a news release.
    • “It’s something parents need to pay attention to — and protect — during critical developmental years like adolescence,” he said.”
  • Per MedTech Dive,
    • “Medtronic said it will support a new study of its Symplicity Spyral procedure in patients with uncontrolled high blood pressure and multivessel artery disease who are undergoing percutaneous coronary intervention. Global guidelines indicate patients with both conditions need more aggressive hypertension management, the device maker said this weekend at the American College of Cardiology’s annual meeting.
    • “Medtronic’s Symplicity Spyral renal denervation device won Food and Drug Administration approval in late 2023 to treat patients whose high blood pressure cannot be controlled by drugs. The new study, called EMBRACE, will evaluate renal denervation performed in the same procedure as PCI, a treatment to remove plaque buildup and open blocked coronary arteries.
    • “Separately, Medtronic released results from a pooled analysis of the SPYRAL HTN ON and OFF MED trials showing that patients who underwent a renal denervation procedure to improve their blood pressure had a significantly lower rate of hypertensive emergencies (40%) at three years than those who received a sham treatment.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The combination of technology and alternative care options is slowing the growth rate of healthcare spending.
    • “In January, the Centers for Medicare and Medicaid Services said healthcare expenditures rose 7.2%, to $5.3 trillion, in 2024. Healthcare spending accounted for 18% of gross domestic product in 2024, less than the 21.2% the agency projected.
    • “Advances in care delivery, reduced pricing on some treatments and payer restrictions on care utilization drove down spending, according to a recent study by public policy organization Brookings Institute. 
    • “The healthcare spending growth rate relative to GDP from 2010 to 2024 is the lowest in a 14-year period since 1960, the study said. 
    • “While we’re documenting that the healthcare cost curve has bent and we think that there are reasons that it will continue to be bent, it could still bend more,” said Lev Klarnet, one of the study’s authors and a doctoral student in business economics at Harvard University.
    • “Here are three takeaways from the research.
      • Cost sharing, prior authorizations reduce demand
      • Outpatient procedures are saving money, and
      • “Technology is lowering costs by improving health.”
  • and
    • “The Leapfrog Group will expand its rating system for ambulatory surgery centers.
    • “Starting in July, Leapfrog plans to use publicly reported Centers for Medicare and Medicaid Services data to compare safety and quality measures across nearly 4,000 ASCs, similar to how the independent watchdog group rates hospitals, according to a Tuesday news release. 
  • Beckers Payer Issues reminds us,
    • “For the first time, payers must publicly post data on how often they deny prior authorization requests, how quickly they process them and how often denials are overturned on appeal. The first reports are due March 31 under a rule CMS finalized in 2024.” 
  • Fierce Healthcare tells us,
    • “It’s been seven years since the American Medical Association (AMA) launched its Joy in Medicine program to address physician burnout. 
    • “The issue is far from resolved, with burnout peaking during the COVID-19 pandemic. Recent estimates have found that more than half of surgeons are still burned out. Amid pressing financial challenges and as organizations struggle to recruit clinicians, the need for joy in medicine has never been more pressing.
    • “The AMA’s voluntary program is meant to serve as a guide to health systems looking to assess and address their institutions’ levels of burnout. Organizations must apply and it is free to participate. About 1,800 organizations have participated to date.”
  • BioPharma Dive informs us,
    • “Merck and Co. has signed an agreement with California-based Infinimmune to develop multiple antibodies for various disease targets, the companies announced Tuesday.
    • “Per deal terms, Merck could load Infinimmune with up to $838 million in upfront and milestone payments if any of the drug candidates make it into clinical testing and onto the market. Neither company disclosed how much was offered as an upfront payment. Merck will hold exclusive rights to develop and commercialize drugs that are discovered through the collaboration.”
  • Beckers Hospital Review shares “the big bets 20 pharmacy leaders are making right now.”
  • The Wall Street Journal points out,
    • “The nation’s costliest autism therapy provider will shut down by mid-May, the company’s human resources chief said in an email to employees one week after the state of Indiana said it would bar the firm from billing Medicaid.
    • “The autism-therapy provider, Piece by Piece Autism Centers, received $340,000 in Medicaid payments per patient in 2023, the highest level in the country, The Wall Street Journal reported last month in an article examining how some providers had outpaced regulators in their fast-growing businesses.
    • “Once Piece by Piece—which state officials have said abused the taxpayer-funded program for low-income people—closes, its centers will be operated by a rival autism-therapy provider, Applied Behavior Center for Autism, emails show. Applied Behavior Center settled federal civil fraud allegations over billing issues just three years ago without admitting wrongdoing, the Justice Department announced at the time.”

Tuesday report

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

From Washington, DC

  • OPM Director Scott Kupor created another post in his Secrets of OPM blog today. This post is titled “Trust but verify,” which has always been the FEHBlog’s favorites Reaganism. Director Kupor concludes,
    • “We have a lot of work to do to ensure the federal government can continue to attract all of the skills needed to deliver on our promises to the American people. While “In America we trust,” in federal hiring we will “trust, but verify.”
  • Modern Healthcare informs us,
    • “A bipartisan House bill that lawmakers plan to introduce this week would cap annual Medicare physician reimbursement cuts at 2.5% while giving regulators more leeway to set annual payment updates.
    • “The Provider Reimbursement Stability Act of 2025 is far from the Medicare payment system overhaul doctors have failed to win for years and it does not include a raise for 2027. But the measure would address underlying aspects of the rate-setting process that medical societies say contributed to pay cuts and modest increases in recent years. 
    • “Under the legislation, CMS would gain financial flexibility, could consider medical inflation in narrow circumstances when calculating fees, and would make changes to the base values it uses to set rates and correct errors that the American Medical Association estimates have cost doctors billions.”
  • STAT News tells us,
    • “Sellers of health savings accounts see an opening for expanding their market, and they’re ramping up lobbying efforts to seize the opportunity.
    • “A group of companies and organizations tied to the HSA industry this year formed a nonprofit called the Great American Health Alliance, or GAHA, a riff on Make America Healthy Again, or MAHA. * * *
    • “Members of GAHA include HealthEquity, one of the largest administrators of HSAs, and the American Bankers Association, which represents institutions holding about 90% of HSAs. GAHA is run by brothers Keith Nahigian, who is the group’s president and has worked for multiple GOP presidential campaigns, and Ken Nahigian, who led the Trump transition in 2017 and was health secretary Robert F. Kennedy Jr.’s liaison to senators during his confirmation process.”
  • American Hospital Association News reports,
    • “The Department of Health and Human Services March 31 announced that it is reverting a 2024 reorganization of health IT leadership and services. The dually titled Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT will now restore ONC as a singularly titled office. The HHS Chief Technology Officer, HHS Chief Artificial Intelligence Officer and HHS Chief Data Officer roles and responsibilities will move back under the HHS Office of the Chief Information Officer. HHS said the changes reinforce OCIO’s responsibility for enterprise IT, cybersecurity and data operations, while ONC will focus on health IT policy, standards and certification.”
  • and
    • “The Centers for Medicare & Medicaid Services March 20 released a memorandum reinforcing hospital nutrition service obligations for hospitals. The memo reminds hospitals of the Medicare conditions of participation that require hospitals to ensure menus and diets meet individual patient nutritional needs in accordance with recognized dietary practices. It also asks hospitals to review and revise their food and nutrition service policies, standard menus, therapeutic protocols and other practices to align with the recently released 2025-2030 Dietary Guidelines for Americans. CMS makes several recommendations for hospital inpatient menus, including limiting ultra-processed foods; eliminating sugar-sweetened beverages unless clinically appropriate in limited scenarios; eliminating refined grains and replacing them with 100% whole grains; prioritizing minimally processed protein sources, including plant-based options; and emphasizing vegetables, fruits, legumes, nuts, seeds, seafood and healthy fats.” 
  • The Wall Street Journal adds,
    • “New nutrition guidance from the American Heart Association advises getting protein from plants rather than meat, choosing low-fat or fat-free dairy and using olive, soybean and canola oils instead of beef tallow and butter. 
    • “The recommendations, released Tuesday by the association, contrast with dietary guidelines that the Trump administration introduced earlier this year.
    • “The differences add to disagreements between the federal government and mainstream medical groups on medicine and nutrition advice, after the Health and Human Services Department under Health Secretary Robert F. Kennedy Jr., for instance, sought to dial back vaccine recommendations and President Trump told pregnant women to minimize Tylenol use.
    • * * * “The association’s latest recommendations are mostly unchanged from the guidelines that it released in 2021 and that the federal government had issued before this year.
    • “Like the federal government, the AHA defines a healthy diet as rich in vegetables and fruits and low in added sugars and ultraprocessed foods. 
    • “Dr. Stacey Rosen, AHA’s president, who is a cardiologist and a senior vice president of women’s health at Northwell Health in New York, said the government’s encouragement to eat red meat and full-fat dairy products could hurt people’s health. “It has been shown repeatedly to be a not healthy way to eat,” she said.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Amgen’s rare disease drug Tavneos is under mounting regulatory scrutiny, with the FDA warning of serious liver injuries, including some fatalities, among patients who received the drug. 
    • “From the drug’s approval in 2021 through October 2024, 76 cases of drug-induced liver injury with “reasonable evidence” of a causal association to Tavneos were reported to the FDA Adverse Event Reporting System (FAERS), according to a Tuesday safety communication.
    • “The medicine is available as an adjunct treatment for severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. But the FDA is looking to change that with a request for Amgen to withdraw the product, which the company has so far resisted.”
  • Reuters relates,
    • “The U.S. Food and Drug Administration has approved a higher dose of Biogen’s (BIIB.O), opens new tab spinal muscular atrophy drug Spinraza, the company said on Monday, after rejecting it last year.
    • “The approval for a potentially ​more effective treatment marks a boost for the U.S. drugmaker battling intensifying competition ​from therapies such as Roche’s (ROPC.S), opens new tab oral drug Evrysdi and Novartis’ (NOVN.S), opens new tab gene therapies ⁠Zolgensma and Itvisma.”
  • Cardiovascular Business tells us,
    • “Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has secured U.S. Food and Drug Administration (FDA) clearance for its advanced pulmonary hypertension (PH) algorithm. The algorithm, which previously received the FDA’s breakthrough device designation, was designed to detect signs of PH in standard 12-lead electrocardiograms (ECGs).
    • “PH is a life-threatening condition that can be difficult for care teams to diagnose. It directly impacts the arteries in a patient’s lungs as well as the right side of their heart. While there is no cure, treatments are available once a diagnosis is confirmed. 
    • ‘Anumana’s newly cleared AI model was built with data from more than 250,000 de-identified Mayo Clinic patients. It runs entirely within the care team’s own hospital or health system environment.
    • “According to Anumana, the algorithm was linked to a sensitivity of 73% and specificity of 74.4% in adult patients presenting with dyspnea. A separate study found that it was able to identify more than 85% of patients presenting with pulmonary arterial hypertension as well as 78% of patients presenting with chronic thromboembolic pulmonary hypertension.”
  • and
    • “A new-look embolic protection device for reducing the risk of stroke after transcatheter aortic valve replacement (TAVR) is associated with clinical outcomes comparable to Boston Scientific’s Sentinel Cerebral Protection System, according to new data presented at ACC.26 in New Orleans.
    • “The device in question is the Emboliner Embolic Protection System from California-based Emboline. Features include a double-wall, cylindrical mesh filter made of Nitinol and a self-sealing port that allows devices such as TAVR delivery systems to pass through when necessary. 
    • “The ProtectH2H clinical trial was a head-to-head comparison of the Emboliner and Sentinel devices. It is believed to be the first head-to-head analysis of any two embolic protection devices for TAVR. More than 500 TAVR patients with a mean age of 79 years old were enrolled out of the United States, Germany and Brazil. Patients were excluded if they had experienced a stroke in the previous six months.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention reminds us,
    • “Chronic kidney disease (CKD) affects more than 37 million U.S. adults. That’s more than 1 in 10 people. The risk is even higher for people with diabetes or high blood pressure. Nearly 4 in 10 adults with diabetes and 2 in 10 adults with high blood pressure have CKD. 
    • “Most people with CKD—about 9 in 10—do not know they have it. CKD often has no early symptoms, but simple blood and urine tests can help find it early. Knowing your risk and getting tested could help protect your kidneys.”
  • Avalere Health marks “National Kidney Month with An Outlook in the 2026 Kidney Care Policy, Payment, and Treatment Landscape.”
    • “Evolving kidney transplant regulations, payment reforms, and accelerated innovation in treatments are opening new opportunities across the kidney care landscape.”
  • This week’s issue of NIH Reseach Matters covers the following topics:
    • SuperAgers show unique cell signatures in the brain
      • “Researchers linked neuron creation to exceptional recall and memory in older adults.
      • “Understanding how new neurons are created in adulthood could help lead to interventions that promote healthy aging.”
    • Scientists identify proteins tied to food tolerance
      • “Scientists identified parts of proteins that interact with immune cells and allow mice to tolerate certain foods rather than have an allergic reaction.
      • “The findings enhance our current understanding of food tolerance and may lead to new therapies for people with food allergies.”
    • Using RNA to treat heart attacks
      • “An RNA-based lipid nanoparticle therapy helped the heart recover from a heart attack in animal studies.
      • “The results suggest a new strategy for treating heart attacks and repairing damage to the heart.”
  • MedPage tells us,
    • “Significant incidental findings detected on low-dose CT lung cancer screening were associated with an increased risk of an extrapulmonary cancer diagnosis over the following year.
    • “Risk differences were significantly higher for urinary cancers, as well as lymphoma and leukemia.
    • “Certain significant incidental findings should be assessed as potential indicators of undiagnosed cancers, researchers said.”
  • Healio adds,
    • “MRIs may be a reasonable option for high-risk patients with extremely dense breasts.
    • “A simulation study found MRIs moderately reduced breast cancer mortality in this group but increased rates of false positives.”
  • and
    • “In stable patients without heart failure, discontinuing beta-blockers 1 year after a heart attack was noninferior to continued use for all-cause death, recurrent MI or HF hospitalization, researchers reported. 
    • “The SMART-DECISION trial is the first randomized study to demonstrate the noninferiority of beta-blocker discontinuation in post-MI patients without left ventricular systolic dysfunction or heart failure,” Joo-Yong Hahn, MD, a cardiologist at Samsung Medical Center in Seoul, South Korea, said during a press conference at the American College of Cardiology Scientific Session. The results were simultaneously published in The New England Journal of Medicine.”
  • The Wall Street Journal reports,
    • “AstraZeneca AZN reported mixed results from three late-stage clinical trials of an experimental treatment for a rare metabolic disease, but remains confident the drug can generate annual peak sales of $3 billion to $5 billion.
    • “The U.K. drugmaker expects to be able to launch the medicine, efzimfotase alfa, in more markets than its predecessor treatment, Strensiq, the chief executive of AstraZeneca’s rare-disease unit Alexion, Marc Dunoyer, said in an interview Tuesday. It plans to submit data to regulators as soon as possible, Dunoyer added.
    • “AstraZeneca said the results of the studies support the drug’s potential to transform the treatment of hypophosphatasia, a rare, chronic disease caused by deficient activity of an enzyme that is important for building healthy bones and supporting proper muscle function.”

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

  • Modern Healthcare reports,
    • “Kurt Small has been named as president and CEO of CareFirst BlueCross BlueShield, effective May 4. 
    • “Small is the president of Medicaid for Elevance Health. 
    • He will succeed Ja’Ron Bridges, who has been serving as interim president and CEO since Brian Pieninck left the company in September to become president and CEO of GuideWell and its insurer subsidiary Florida Blue, a CareFirst spokesperson said Tuesday. * * *
    • “Bridges will return to his former role as CareFirst’s executive vice president and chief financial officer. 
    • “Small held several leadership roles at Blue Cross and Blue Shield of Minnesota, Highmark and Aetna prior to joining CareFirst, an independent licensee of the Blue Cross Blue Shield Association.”
  • Healthcare Dive adds,
    • “Elevance announced a slate of mid-level executive appointments on Tuesday as the company continues to shuffle its leadership roster to try to combat waning profits.
    • “The insurer named two new executives to its health benefits division, including a new president of government business after the previous president was promoted to lead Elevance’s broader insurance arm.
    • “Carelon, Elevance’s health services division, added four new executives, including its first chief growth and strategy officer as the company seeks to accelerate Carelon’s expansion.”
    • “The appointments are effective immediately.”
  • The Wall Street Journal informs us,
    • “Eli Lilly LLY has agreed to buy clinical-stage company Centessa Pharmaceuticals CNTA for an initial payment of about $6.3 billion in a deal that expands the drugmaker’s neuroscience portfolio and capabilities into sleep medicine.
    • “Eli Lilly on Tuesday said it will pay an initial $38 a share in cash for Centessa, a 38% premium to Monday’s closing price of $27.58 for the U.K.-based company.
    • “Centessa investors will also receive nontransferrable contingent value rights worth up to an additional $9 a share, bringing the total potential deal consideration to about $7.8 billion, or $47 a share.
    • “The deal is slated to close in the third quarter.’
  • Fierce Pharma adds,
    • “Despite a healthy roster of late-stage assets and a revenue turnaround in 2025, it’s no secret that Biogen has been seeking near-term sales drivers ahead of its planned product rollouts later in the decade. 
    • “Now, the company is responding by bulking up in immunology—and paving the way for its future ambitions in kidney diseases—with an M&A play that adds two ongoing launches to its marketed drugs portfolio.
    • “On Tuesday, Biogen unveiled a deal to acquire Apellis Pharmaceuticals for $41 per share in cash, representing a total transaction value of roughly $5.6 billion. For Biogen, the deal grants access to the approved Apellis meds Syfovre for the eye condition geographic atrophy (GA) and Empaveli, approved by the FDA last year in the rare kidney diseases complement 3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).” 
  • The Wall Street Journal notes,
    • “Big drugmakers are pursuing smaller acquisitions, typically under $10 billion, reflecting a more cautious approach to dealmaking.
    • “Deals between $1 billion and $10 billion represent 76% of pharmaceutical transactions by value this year to date.
    • “Companies like Eli Lilly and Biogen are making smaller deals to bolster pipelines and avoid risks associated with large acquisitions.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today releaseda Final Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
    • “ICER’s report on this therapy was the subject of the February 2026 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations“
  • Beckers Hospital Review informs us,
    • “Retail and e-commerce giants are rapidly expanding their presence in pharmacy services, prompting new concerns among hospital and health system leaders about losing ground in patient access and workforce recruitment.
    • “Amazon, for example, is significantly scaling its pharmacy footprint. The company plans to expand its same-day prescription delivery service to 4,500 U.S. cities and towns by the end of 2026 — adding nearly 2,000 new communities as it targets patients affected by pharmacy closures, staffing shortages and transportation barriers.
    • “Walmart is taking a different approach, focusing heavily on its workforce. The retailer recently promoted 3,000 pharmacy technicians into pharmacy operations team lead roles while also increasing pay. Technician wages now average $22 per hour, with some earning as much as $40.50 depending on certification and location. The newly created team lead roles average $28 per hour, with potential earnings up to $42.”
  • and
    • “Novo Nordisk has launched a multimonth subscription program for Wegovy, which claims to offer more predictable, lower pricing for eligible self-pay patients who enroll through select telehealth providers.
    • “The program is currently available through Ro, WeightWatchers and LifeMD. Additional platforms, including Hims & Hers and Sesame, are expected to join, according to a March 31 news release from Novo. Patients can choose three-, six- or 12-month subscriptions, with longer terms offering lower monthly costs.
    • “Under the program, Wegovy injections are priced at $329 per month for a three-month subscription, $299 per month for six months and $249 per month for 12 months — representing savings of up to $1,200 annually. Oral formulations are priced at $289, $269 and $249 per month across the same timeframes, respectively, with savings of up to $600 annually.
    • “The subscription model aims to reduce cost uncertainty and support adherence for patients managing obesity, a chronic condition that requires ongoing care, according to the release.”
  • Healthcare Innovation considers the “Link Between Ambient Scribes and Increased Coding Intensity.”
    • “Allison Oakes, Ph.D., Trilliant’s chief research officer, discusses how AI-enabled documentation may intersect with coding activity.”
    • “According to Trilliant, AI scribing tools have been associated with an increase in high-intensity outpatient billing codes across six health systems.
    • “The increase in higher-intensity billing codes may reflect improved documentation accuracy rather than intentional overbilling.
    • “Enhanced transparency and auditability of AI-driven billing are crucial for detecting potential issues and ensuring fair reimbursement practices.”
  • Radiology Business has a different outlook.
    • “Imaging interpretation times have more than doubled over the course of a decade, according to new Neiman Health Policy Institute research published Tuesday. 
    • “Current workforce shortages in the specialty are being spurred by increasing per-patient demand for imaging, an aging population and the limited supply of radiologists. As hiring challenges persist, there are growing concerns about the impact on patient care, experts write in JACR. 
    • “Researchers recently aimed to assess how turnaround times—or the period between when a scan is performed and a radiologist reads the images—have changed in recent years. They found that the length of this window leapt by 113% between 2014 and 2023, with worsening wait times beginning two years after the COVID-19 pandemic. 
    • “The potential negative clinical impact of growing turnaround time for the interpretation of imaging must be closely monitored, especially if the trend worsens,” study co-author Cindy Yuan, MD, with the Indiana University School of Medicine, said in a statement March 13. “We think these results are an early indicator of a worsening problem. If the sudden change in 2022 reflects that there is no remaining capacity for the radiology workforce to absorb new workload, then continued imaging growth will eventually impact patients.”
  • MedTech Dive points out,
    • “Whoop, the wearable company that sparked a debate on wellness regulations, has raised $575 million.
    • “The series G round values Whoop at $10.1 billion, the company said on Tuesday. Abbott joined as a strategic investor.
    • “Whoop plans to put the funds toward its U.S. and international growth, as well as personalized health features.”
  • Fierce Healthcare relates,
    • “eMed pocketed $200 million in funding to build out its AI agentic platform and offer new models for employers, including programs for GLP-1 medications.
    • “The funding round boosts the company’s valuation to $2 billion. AON Consulting led the round along with prominent investors former NFL player Tom Brady, founding chief wellness officer, Jeff Aronin, founder, chairman and CEO of Paragon Biosciences; Ara Cohen, co-founder and co-managing Member of Knighthead Capital Management; Antonio Gracias, founder and CEO of Valor Equity Partners; Joe Lonsdale, founder and managing partner at 8VC and co-founder of Palantir; R.J. Melman, CEO, Lettuce Entertain You Restaurants; Tom Ricketts, chairman of the Chicago Cubs; and former X CEO and current eMed CEO Linda Yaccarino. 
    • “The company plans to use the fresh capital to support and fund a new capitated model designed to help employers bend the healthcare cost curve. GLP-1 medications are the most requested workplace benefit, yet only one in five companies provide the benefit, according to the company.”

Monday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–
  • Happy National Doctors’ Day!
    • “National Doctors’ Day is a nationwide observance dedicated to honoring physicians for their expertise, responsibility, and continued commitment to patient care. Observed annually on March 30, it creates a natural point of recognition for the role doctors play in the health and well-being of individuals, families, and communities, often during critical and life-changing moments.”

From Washington, DC.

  • Roll Call reports,
    • “President Donald Trump wants Congress to nix a two-week recess and return to the Capitol to address the ongoing Department of Homeland Security shutdown, his top spokesperson said Monday.
    • “The president is also encouraging Congress to come back to Washington to permanently fix this problem and to fund and reopen the Department of Homeland Security entirely,” White House press secretary Karoline Leavitt told reporters.”
  • Govexec adds,
    • “Most Transportation Security Administration officers received a paycheck Monday covering four weeks of back wages that were held up by the funding lapse at the Homeland Security Department, a TSA spokesperson said, [due to an Executive Order].
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM), in partnership with the White House, today announced the launch of a new Early Career Talent Network designed to connect emerging professionals with full-time career opportunities across the federal government.
    • “The new network, available at EarlyCareers.gov, will help build a stronger pipeline of talent into critical mission roles across government, including finance, human resources, engineering, project management, and procurement. The initiative supports broader administration efforts to modernize federal hiring and strengthen the next generation of public servants.
    •  “Building a strong pipeline of early-career talent is essential to the future of the federal workforce,” OPM Director Scott Kupor said. “We are making it easier for talented individuals to connect with meaningful careers in public service while helping agencies efficiently identify the talent they need to deliver results for the American people.”
  • OPM Director Scott Kupor made another management-oriented post to his Secrets of OPM blog now available on Substack. The post discusses the Earlycareers.gov initiative.
  • The American Hospital Association News tells us,
    • “Average out-of-pocket premiums for Health Insurance Marketplace enrollees increased $65 per month in 2026 compared to 2025, going from $113 to $178, according to a report released March 27 by the Centers for Medicare & Medicaid Services. The figures represent costs after accounting for the enhanced premium tax credits, which expired at the end of 2025. CMS also found that 40% of 2026 enrollees selected bronze plans, up from 30% in 2025. Silver plan selection dropped from 56% to 43%, while gold plan selection increased from 13% to 17%. Additionally, CMS said 23.1 million consumers selected or re-enrolled in Marketplace coverage for 2026, marking a 5% decrease from 2025.” 
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) today has chosen 15 scientific teams from across the nation as cash prize winners for their submissions to a national crowdsourcing challenge designed to generate innovative ideas that integrate diet and nutrition into autoimmune disease research. Winning submissions investigated the effectiveness of dietary interventions; microbiome, immune system and multi-omic approaches; personalized and data-driven predictive nutrition; and community and patient-center research frameworks. 
    • “Autoimmune diseases affect more than 8% of the U.S. population, impacting between 23 and 50 million Americans. Despite the prevalence and significant economic burden of autoimmune diseases, the role of diet and nutrition in this area remains largely underexplored. NIH invited researchers, clinicians, patients, caregivers, advocacy groups, and interdisciplinary teams to submit feasible, scalable approaches to better understand how dietary interventions may influence autoimmune disease onset, progression, flares, and symptom management. 
    • “The challenge, known as the Nutrition for Our Immune System Health (NOURISH): Autoimmunity Challenge and led by NIH’s Office of Autoimmune Disease Research, yielded many highly competitive submissions, and resulted in 15 prize awards, totaling $10,000 to each team. The winners showed thoughtful planning and designs that, with further development, could result in innovative solutions to benefit Americans affected by autoimmune diseases. Each winning entry contributed innovative, scientifically rigorous, and patient-centered ideas to advance the science of autoimmune disease research and care in one of four thematic areas.”
  • and
    • “The National Institutes of Health (NIH) announced that Elisabeth Armstrong, DBe, has been named chief of staff in the NIH Office of the Director.  As chief of staff, Dr. Armstrong will oversee the Office of the Director. She will provide strategic counsel to the NIH Director and other key leaders within NIH, in addition to managing process, operations, and information flows.    
    • “Dr. Armstrong is an outstanding addition to NIH’s leadership team. Her unique background and range of public and private sector experience will help drive positive action and innovation at NIH,” said NIH Director Jay Bhattacharya, M.D., Ph.D.” 

From the Food and Drug Administration front,

  • BioPharma Dive points out five FDA decisions to watch in the second quarter of 2026, which starts on Wednesday.
  • Per Fierce Pharma,
    • “With a second phase 3 win for Tyvaso in idiopathic pulmonary fibrosis (IPF), United Therapeutics is padding the case for an expansion and putting more color on its filing plans with the FDA. 
    • “In the wake of the “overwhelmingly positive” pair of late-stage readouts, multiple analysts are sharing in United’s optimism that Tyvaso (treprostinil) could change the treatment landscape in the lung scarring disease, which is estimated to affect more than 100,000 people in the U.S.” 
  • MedTech Dive reports,
    • “Medtronic has received 510(k) clearance for its Stealth AXiS surgical system for cranial and ear, nose and throat procedures.
    • “The clearances, which Medtronic disclosed Friday, expand the label of a system that combines surgical planning, navigation and robotics to improve surgeons’ workflows.
    • “Medtronic said cranial surgeons can use the system to create patient-specific brain maps, while the benefits for ENT teams include visualization tailored to the sinuses and skull base.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “A “highly mutated” COVID variant that flew under the radar for years has been detected in a growing number of U.S. states, health officials said this week.
    • “The Centers for Disease Control and Prevention (CDC) said in a March 19 report that it was tracking variant BA.3.2, nicknamed “Cicada,” after routine surveillance noted an increase in U.S. cases. The World Health Organization (WHO) likewise listed the strain on its “variants of monitoring” record, as it has been detected in at least 23 countries.
    • “Cicada still accounts for only a small number of cases in the United States, but has ballooned to represent up to 30% in some European countries. Still, the CDC said its monitoring of the spread “provides valuable information about the potential for this new SARS-CoV-2 lineage to evade immunity from a previous infection or vaccination.” * * *
    • “The CDC’s latest data from Feb. 11 used wastewater collected by its National Wastewater Surveillance System and Stanford University’s WastewaterSCAN Dashboard. A pathogen’s existence and prominence can be measured by testing wastewater samples collected from sources such as sewage, industrial waste and stormwater runoff.
    • “The testing tracked the presence of BA.3.2 in 25 states, including: California, Connecticut, Florida, Hawaii, Idaho, Illinois, Louisiana, Maine, Michigan, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Vermont, Virginia and Wyoming.”
  • Stony Brook (NY) Medicine adds,
    • “The Cicada variant (BA.3.2) is a newer Omicron-related subvariant identified through global and U.S. monitoring systems. Like other recent strains, it has evolved with mutations that may influence how easily it spreads and how the immune system responds.” * * *
    • “Overall, while the Cicada variant may contribute to seasonal increases in cases, it does not currently appear to dramatically change the risk landscape.
    • “Health experts say that the BA.3.2 “Cicada” variant doesn’t seem to cause any new or unusual symptoms compared to other Omicron COVID‑19 variants. Right now, health organizations are mostly tracking how the virus spreads and changes, rather than listing new symptoms.”
  • The Wall Street Journal relates,
    • “Measuring cholesterol levels has long been the main way doctors assess the risk of heart disease. Increasingly, people are opting, too, for a simple, relatively affordable test: a coronary artery calcium scan, or CAC.
    • “The tests recently got a boost from influential clinical guidelines issued earlier this month by leading cardiology groups. These guidelines also included, for the first time, recommended levels of LDL—known as low-density lipoprotein or “bad” cholesterol—based on calcium scores from the scans.
    • “Why does this matter to you? The more calcium you have in your heart, the lower your LDL cholesterol should be to help reduce your risk of having a heart attack or stroke. So the scans give doctors and patients a more precise picture of your risk and whether you need to take action.”
  • The American Medical Association lets us know “what doctors wish patients knew about the deadly risk of stroke.”
    • “Every 40 seconds, someone in the U.S. has a stroke, which is a medical emergency that demands swift action. Meanwhile, every three minutes and 14 seconds, someone dies of stroke in this country. Stroke is the fifth leading cause of death in the U.S. and a major cause of long-term disability for adults, but it is preventable and treatable. That is why patients and families need to know more about preventing and identifying stroke. 
    • “More than 795,000 people in the U.S. have a stroke every year. About 610,000 of these are first or new strokes. Meanwhile, nearly 25% of strokes are in people who have had a previous stroke. And about 87% are ischemic strokes in which blood flow to the brain is blocked, according to the Centers for Disease Control and Prevention (CDC).”
  • Health Day tells us,
    • “For parents of a child with obesity, a normal lab report from the pediatrician may suggest that their weight isn’t yet a problem.
    • “But even if the child’s blood pressure is steady and their sugar levels are fine, those encouraging results — called metabolically healthy obesity or MHO — might be a deceptive snapshot of a much riskier future.
    • ‘Researchers at the Karolinska Institute in Sweden followed more than 7,200 children aged 7 to 17 who were in treatment for obesity. They were followed until age 30. 
    • “Over that period, researchers compared those with metabolically healthy test results to those with early warning signs, and to a control group of more than 35,000 from the general population.
    • ‘The study published March 23 in JAMA Pediatrics found that even kids with MHO — meaning they had normal blood pressure, liver values and blood fats — were at a disadvantage compared to their peers over the long term.”
  • CNN informs us,
    • “Calls to poison centers in the United States about the widely available herb kratom increased more than 1,200% between 2015 and 2025, new research has found.
    • “This data reflects a concerning trend,” study coauthor Dr. Christopher Holstege , director of the Blue Ridge Poison Center at the University of Virginia, said in a news release.
    • “The research was published Thursday in the US Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
    • “Kratom is an herb from the leaves of the tropical tree Mitragyna speciosa native to Southeast Asia. It has both stimulant and sedative effects and carries a risk of addiction due to how it interacts with the brain, Dr. Oliver Grundmann , a leading kratom researcher and clinical professor in the department of medicinal chemistry at the University of Florida, told CNN in an August story.
    • “The psychoactive herb isn’t federally regulated and thus isn’t “lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food,” according to the US Food and Drug Administration. But in states that haven’t banned kratom, it’s sold at gas stations, smoke shops and convenience, grocery and health food stores in various forms, including powders, loose-leaf teas, capsules, tablets and concentrates. Some states allow people of any age to buy it.”
  • Neurology Advisor notes,
    • “Among multiple healthy dietary patterns, higher adherence to the DASH diet was associated with the greatest reduction in risk for subjective cognitive decline, supporting diet quality as a modifiable factor for cognitive health.”
  • Per Fierce Pharma,
    • “After notching a phase 2 trial win, Idorsia’s insomnia med Quviviq (daridorexant) is one step closer to potentially becoming a first-in-class treatment for children.
    • “The drug, a dual orexin receptor antagonist (DORA), was studied in children with insomnia between the ages of 10 and 17 years old, including those with neurodevelopmental disorders such as autism spectrum disorder and attention-deficit/hyperactivity disorder (ADHD). 
    • “As measured through a two-week polysomnography sleep study, 165 patients who received a 10-, 25- or 50-mg dose of Quviviq experienced dose-dependent improvements in total sleep time from baseline, Idorsia reported on Monday.”
  • Per MedTech Dive,
    • “Boston Scientific’s Watchman FLX left atrial appendage closure device worked as effectively as blood thinners to lower stroke risk and death at three years in patients with non-valvular atrial fibrillation, study data unveiled Saturday showed.
    • “The study also demonstrated a 45% relative reduction in non-procedural bleeding risk in patients who received the Watchman FLX implant. The findings of the closely watched CHAMPION-AF clinical trial were presented at the American College of Cardiology’s annual meeting and published in the New England Journal of Medicine.
    • “The 3,000-patient study met all of its safety and efficacy endpoints. Boston Scientific said it will seek to expand the indication and Medicare coverage for the device as a first-line stroke risk reduction option based on the results.

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

  • Beckers Hospital Review reports,
    • “Cigna’s Express Scripts continued its lead in the U.S. pharmacy benefit manager market for the second year in a row, processing nearly one-third of all prescription claims, according to a March 30 report from the Drug Channels Institute.
    • “The PBM handled 31% of total equivalent prescription claims last year, up from 30% in 2024. CVS Caremark, which dominated the sector until 2024, saw its share fall to 26% amid volume losses tied to major client transitions. Optum Rx, a subsidiary of UnitedHealth Group, maintained a 23% share for the second straight year.
    • “Despite ongoing scrutiny from regulators and rising competition from smaller firms, the same three PBMs as last year still control 80% of the market.
    • “The rankings are based on Drug Channels Institute’s analysis of total equivalent prescription claims processed across the industry.”
  • and
    • “CVS Pharmacy will open its first pharmacy-only location in Chicago on March 30.
    • “The store, located at 2628 W. Pershing Road in the city’s West End, is part of a planned rollout of nearly 20 pharmacy-only, apothecary-style CVS Pharmacy locations expected to launch in select communities in 2026, according to a March 24 statement from CVS shared with Becker’s. The format reflects CVS’ shift toward smaller, pharmacy-focused stores amid declining retail sales.
    • “CVS is in the early stages of launching the new model, the first locations under which will average less than 5,000 square feet — about half the size of a traditional CVS store. The sites will stock health-related products but exclude general consumer goods like greeting cards and groceries.
    • “The launch comes as CVS repositions its pharmacy footprint. The company closed 270 locations in 2025 but plans to open nearly 100 new sites, including more than 60 acquired from Rite-Aid. According to CVS Health’s October 2025 “Rx Report,” 80% of patients prefer in-person pharmacy care and 84% view pharmacies as credible sources of healthcare. The small-format stores aim to meet these expectations while expanding access in underserved areas.”
  • BioPharma Dive relates,
    • “Obesity drugmaker Kailera Therapeutics plans to test investor appetites for another biotechnology initial public offering, according to a Friday securities filing.
    • “If successful, the company, which has several experimental weight loss medicines in testing, could join a short list of newly public biotechs that have raised more than $1.7 billion in proceeds so far this year.
    • “Kailera’s most advanced prospect, ribupatide, is a weekly GLP-1/GIP agonist in late-stage testing. So far, Kailera and its partner Hengrui Pharma have published data from a 48-week Phase 3 trial in Chinashowing that ribupatide helped people with obesity, on average, lose 18% of their body weight.
    • “The drugmaker expects to publish data from an earlier study of an increased dose next year, and findings from its global Phase 3 study in 2028.”
  • A MedCity News opinion piece explains why
    • “AI Can Expand Access to Healthcare — But Only With Human Action
    • “Health systems can turn insights into action, ensuring that preventive care actually happens by combining accurate risk prediction with human outreach and careful planning.”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of lorundrostat (Mineralys Therapeutics, Inc.) and baxdrostat (AstraZeneca) for hypertension.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in October 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, the manufacturers, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.  
    • “All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to publiccomments@icer.org and must be received by 5 PM ET on April 17, 2026.”

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, HSA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “President Trump directed federal officials to pay Transportation Security Administration workers, bypassing a gridlocked Congress after the latest proposal to fund the broader Department of Homeland Security ran aground Friday.
    • “The move, which Trump had previewed a day earlier, came as House Republican leaders rejected a Senate-passed bill that would fund most of DHS, including the TSA. A standoff in Congress over immigration enforcement and funding has led to missed paychecks for airport-security workers and long lines for travelers.
    • “The executive action instructs the Homeland Security secretary and the White House budget director to use federal funds that have a “reasonable and logical nexus to TSA operations” to pay the TSA workers. The memo, signed Friday afternoon by Trump, described the situation at the airports as an “unprecedented emergency.”
    • “TSA officers should begin getting paychecks as early as Monday, DHS said.”
  • STAT News tells us,
    • “The White House has drafted legislative text for its drug pricing policy, and officials are in the process of sharing it with more than a dozen major pharmaceutical companies, according to people familiar with the meetings.
    • “The legislative text, according to a White House official, closely follows the outlines of the voluntary deals the administration made with pharma companies. The draft includes a policy that would allow drugs purchased in cash to count toward a patient’s deductible.
    • “The Trump administration’s push for drug price legislation is part of a larger effortto get health reforms signed into law. The president’s focus on his affordability agenda in an election year has heightened the profile of the effort.
    • “Still, despite the White House digging in to get Congress to pass its plan, lawmakers have little appetite for major changes — and there’s no clear path to passage.”
  • The AP relates,
    • “Vice President JD Vance on Friday held the inaugural meeting of a new anti-fraud task force he’s leading as the Trump administration seeks to show it’s cracking down on potential misuse of social programs.
    • “Vance, speaking Friday before the task force held a closed-door meeting, said that the federal government, for decades, had not taken the issue of fraud seriously and that it needed to be tackled with “a whole-government approach.”
    • “This is not just the theft of the American people’s money,” Vance said. “It is also the theft of critical services that the American people rely on.” * * *
    • “Joining the task force was Colin McDonald, a top aide to the Justice Department’s second in command. He was recently confirmed as the assistant attorney general overseeing the department’s new division focused on prosecuting fraud.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration has released an advisory examining innovative solutions to close gaps in behavioral health care deserts. It highlights how more than 60% of rural Americans live in designated behavioral health shortage areas. The advisory details how integrating additional community health workers and peer support specialists can enhance care. It also explains the strengths of both and includes strategies for recruitment and retention.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “Food and Drug Administration officials briefed senators on the agency’s plans for food policy for 2026, according to a person familiar with the meeting.
    • “The agency plans to focus on infant formula safety, updating food labels, defining ultra-processed foods, expanding inspections of food processing plants, and bolstering seafood safety programs, according to a document shared with lawmakers, obtained by STAT.
    • “The meeting comes amid a shift in the administration’s health agenda toward food issues and away from vaccine policy. In recent polls, food reforms have been more popular than the vaccine agenda, catching the attention of administration officials looking to sharpen their message for the midterms.”
  • Fierce Pharma relates,
    • “The FDA signed off on a new insulin from Novo Nordisk, marking the U.S.’s first once-weekly basil insulin for adults with Type 2 diabetes. 
    • “Novo’s Awiqli offers a new long-acting option compared to standard daily basil insulin injections, representing an “important advancement that meets a real need,” the company’s VP of clinical development, medical and regulatory affairs, Anna Windle, Ph.D., commented in a release. 
    • “The FDA based its decision on Novo’s Onwards Type 2 diabetes phase 3a clinical trial program, which consisted of four randomized, active-controlled, treat-to-target trials that enrolled 2,680 adults with uncontrolled Type 2 diabetes. The studies showed that once-weekly Awiqli achieved efficacy in reducing A1C over daily basal insulin, with a safety profile consistent with the daily basal insulin class. 
    • “Awiqli is administered using Novo’s FlexTouch pen and will be available across the country in “the coming months,” the company said.”
  • MedTech Dive tells us,
    • “Philips said Thursday it has received 510(k) clearance for a heart procedure visualization tool it developed with Edwards Lifesciences.
    • “The system, called EchoNavigator R5.0 with DeviceGuide, uses artificial intelligence to enable surgeons to track and visualize mitral valve repair devices during minimally invasive heart procedures. 
    • “Philips said the system is intended for use with Edwards’ Pascal Ace mitral valve repair system, which competes with Abbott’s MitraClip for the transcatheter edge-to-edge repair market.”
  • MedPage Today informs us,
    • “The FDA on Thursday granted accelerated approval to marnetegragene autotemcel (Kresladi) as the first gene therapy for treating kids with severe leukocyte adhesion deficiency type I (LAD-I), an ultra-rare inherited immune deficiency.
    • “Approval stipulates use in LAD-I cases caused by biallelic variants in the ITGB2 gene and in which no human leukocyte antigen (HLA)-matched sibling donor is available for allogeneic hematopoietic stem cell transplant.
    • “LAD-I has an estimated incidence of 1 per 100,000-200,000 live births, and the disorder brings substantial morbidity and mortality in a child’s first decade of life. Roughly two-thirds of patients have the severe form of the disease, which is characterized by recurrent, life-threatening infections that don’t respond well to antimicrobials and time spent in and out of hospitals.”

From the public health and medical/Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “After a tough flu season, today’s respiratory virus update from the Centers for Disease Control and Prevention (CDC) offers a bit of good news: Doctors are seeing fewer people with influenza.
    • “Cases of flu are declining in most of the country. While influenza A is on its way out, rates of influenza B—which tends to peak later in flu season—vary by region. Levels of influenza A in wastewater are low. Influenza B is not monitored in wastewater.
    • “Most flu viruses reported this week were influenza A(H3N2) and influenza B. Nearly 93% of influenza A(H3N2) viruses since late September belong to subclade K, a new strain that was not included in this year’s flu shots.
    • “About 5,640 people were admitted to the hospital for flu in the past week, nearly 2,000 fewer than the previous week, according to the CDC’s FluView report. Eight additional flu deaths were reported in children, bringing the total number for this season to 123. Among children who were eligible for a flu shot and whose vaccination status is known, 85% of children who died from flu were not fully vaccinated.
    • “The CDC estimates that there have been at least 29 million illnesses, 360,000 hospitalizations, and 23,000 deaths from flu so far this season.
    • “Although respiratory syncytial virus (RSV) levels remain high, the country seems to have gotten past the worst of RSV season, which has peaked in many regions of the nation. Levels of RSV in wastewater are low.
    • “The number of COVID-19 infections is low, with low levels in wastewater. Although COVID-related emergency room visits remain low across the country, they are likely increasing in Florida and Massachusetts. According to the CDC, 2.3% of tests for COVID-19 were positive, along with 7.5% for RSV and 11.5% for the flu.”
  • The American Hospital Association News relates,
    • “A measles outbreak in Utah is now at 486 cases, with 107 reported in the last three weeks, according to datafrom the state’s Department of Health and Human Services. The outbreak began in June 2025. Nationally, 1,575 measles cases have been reported so far this year to the Centers for Disease Control and Prevention. A South Carolina measles outbreak, which began in October 2025, remains at 997 cases, the state’s Department of Public Health reported today. No new cases have been reported by the state since March 17.” 
  • and
    • “The Centers for Disease Control and Prevention March 26 released a report on U.S. child vaccination coverage by age 2. The report found that coverage among children born from 2021-2022 was similar to those born in 2019-2020 but noted decreases for five vaccines. The CDC found declines in vaccinations for the flu (7.4 percentage points), the birth dose of the hepatitis B vaccine (1.8 percentage points), rotavirus (1.7 percentage points), the pneumococcal conjugate vaccine (1.5 percentage points) and the primary series of the Haemophilus influenzae type b conjugate vaccine (1 percentage point). The report also found that coverage varied by race and ethnicity, poverty status, urbanicity and jurisdiction. 
    • “Vaccines have substantially reduced severe illness, hospitalization, and death and have saved approximately $2.7 trillion in societal costs,” the CDC wrote. “Although national vaccination coverage remained stable for most vaccines, lower coverage among certain population subgroups and in some jurisdictions is creating an increased risk for outbreaks of vaccine-preventable diseases.” 
  • The Washington Post identifies “13 surprising ways GLP-1s may benefit the body, according to science.”
  • Beckers Hospital Review points out four ways GLP-1s are changing care patterns, patient behavior
  • Medscape adds,
    • “When individuals with overweight or obesity discontinue GLP-1 receptor agonists (RAs), they regain approximately 60% of their weight within 1 year following GLP-1 RA discontinuation.
    • “Approximately 25% of the weight loss achieved with these medications appears to persist with long-term findings, with significant implications for how clinicians counsel patients at the point of discontinuation.
    • “These are the two central findings of a meta-analysis of 48 studies, including 36 randomized controlled trials, conducted by British researchers led by medical students Brajan Budini and Steven Luo from the School of Clinical Medicine, University of Cambridge, Cambridge, England. The results were published in eClinical Medicine, which is a part of The Lancet Discovery Science.
  • MedPage Today tells us,
    • “While mammography use did not significantly decline overall from 2002 to 2022, there was a significant drop in certain subgroups.
    • “Declines were significant among young women without health insurance, current smokers, unmarried women, and white women.
    • “The prevalence of mammography use among women ages 40-49 fell by almost 10 percentage points from 2010 to 2022 following guideline changes.”
  • Helio informs us,
    • “Global early-onset cancer incidence has risen slightly since 1990, but mortality has decreased significantly.
    • “Deaths related to obesity have gone up substantially in the past 3 decades.”
  • Per BioPharma Dive,
    • “AstraZeneca said Friday its experimental antibody drug tozorakimab met its main goal in two Phase 3 trials in chronic obstructive pulmonary disease, helping reduce flare-ups in a broad range of people with the condition.
    • “The data could help AstraZeneca’s drug reach more patients than the currently available biologics for COPD, Dupixent and Nucala, both of which are limited to those with high levels of white blood cells called eosinophils. The U.K.-based drugmaker said the trials “included former and current smokers, and patients across all blood eosinophil counts and all stages of lung function severity.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “One or two health systems controlled the entire inpatient hospital care market in 47% of metropolitan areas in 2024, a March 27 KFF Health News report found.”
  • Fierce Healthcare relates,
    • “A new oral GLP-1 therapy and the first preventive option for COVID-19 are among the pipeline drugs that payers and plan sponsors should be watching this spring, according to a new report.
    • “The pipeline surveillance team at Optum Rx has released its latest report on notable drugs that are set for an imminent Food and Drug Administration review. The spring edition includes:
    • Icotyde, or icotrokinra, an oral therapy for moderate-to-severe plaque psoriasis that secured FDA approval in March.
      • “Orforglipron, the second oral GLP-1 treatment, which is set for an April review.
      • “Ensitrelvir, or Xocova, a preventative therapy for COVID-19 exposure, with an FDA decision expected in June.
    • “Icotyde and orforglipron both fit within high-priority areas for many insurers: psoriasis and obesity. In the latter case, it would follow an oral Wegovy to market, but orflorglipron is the first oral GLP-1 that does not have meal-time restrictions.”
  • Lively shares its 2026 healthcare savings account spend report.
    • Healthcare is changing — and HSA spending tells the story.
    • In 2025, where and how people use their health savings accounts (HSAs) reveals a clear shift.
    • Consumers are no longer relying solely on hospitals and traditional providers. They are increasingly turning to retail brands, digital platforms, direct-to-consumer healthcare companies, and connected health technology.
    • HSAs are evolving from long-term savings tools into active, everyday healthcare wallets.
  • Fierce Pharma tells us,
    • “New drug manufacturer Neion Bio has emerged from stealth after incubating a novel way to cook up biologic drugs. After its founding two years ago, the company is cracking open a multi-product commercial biosimilar partnership with an unnamed drugmaker.
    • “Using its Raptor platform to produce recombinant biologics in eggs, the company is teaming up with an unnamed pharma company to co-develop and supply up to three monoclonal antibodies in a deal that includes upfront and milestone payments, plus profit sharing upon potential commercialization. 
    • “Neion Bio’s platform removes the capital intensity and process constraints of traditional biomanufacturing, enabling highly scalable and resilient production while materially lowering the cost of development and supply,” CEO and co-founder Dimi Kellari said in a company release.”
  • BioPharma Dive informs us,
    • “One of the largest drug companies in Japan is looking to, through a $700 million buyout, take control of an experimental medicine that could be useful for treating post-traumatic stress disorder and other psychiatric conditions.
    • “On Friday, Otsuka Pharmaceutical announced that its American subsidiary plans to acquire privately held, New York-based Transcend Therapeutics. In addition to the upfront payment, Otsuka offered up to $525 million more if Transcend’s assets ultimately hit certain sales milestones. The companies expect to complete their deal sometime between April and the end of June.
    • “If finalized, the acquisition would hand Otsuka a drug meant to rapidly restore and improve “neuroplasticity,” or the brain’s ability to rewire and adjust the connections between neurons. Neuroplasticity impairment is a fundamental component of many psychiatric conditions — including PTSD, where chronic stress and trauma can keep brain cell networks stuck in a fear-based survival mode.
    • “The active ingredient in Transcend’s “TSND-201” is methylone, an analog of MDMA that was first synthesized three decades ago and widely used as a “designer drug.”  TSND-201 engages with certain transporter proteins that regulate neurotransmitters like serotonin, norepinephrine and dopamine, which, according to Transcend, results in “rapid and sustained enhancement of neuroplasticity.”
  • and
    • “Novartis will acquire Excellergy, a young allergy drugmaker, to gain access to an experimental therapy that could improve upon the widely used medication Xolair. 
    • “The deal announced Friday could be worth as much as $2 billion overall when including the unspecified upfront payment as well as future payouts. It’s expected to close in the second half of the year, the companies said in a statement.
    • “At the heart of the acquisition is a drug called Exl-111, which targets the antibody immunoglobulin E, or IgE. In certain cases, IgE can mistakenly react to substances — like food, pollen or pet dander — that wouldn’t otherwise be harmful. The antibody then binds to cells, triggering the release of histamines and in turn, an allergic reaction.” * * *
    • “It’s the holy grail of what people are trying to accomplish,” Geoff Harris, Excellergy’s chief scientific officer, told BioPharma Dive in October. “If you can turn off this access to the immune system, you can completely control a wide swath of different allergy-driven diseases.”

Thursday report

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump announced Thursday night he would immediately begin paying Transportation Security Administration workers through an emergency executive order.
    • “The order promised to end long delays at the nation’s airports and allow TSA workers to get paychecks they have been denied during a partial shutdown of the Department of Homeland Security that has persisted for more than 40 days. 
    • “It also offered a partial reprieve for Congress, which has been locked in a bitter partisan standoff over immigration enforcement policies that has kept the department unfunded for weeks. Long lines at airport checkpoints and complaints from TSA workers had become critical pressure points in a search for an end to the shutdown.”
  • Per a White House fact sheet,
    • Today, President Donald J. Trump signed an Executive Order eliminating racially discriminatory “diversity, equity, and inclusion” (DEI) practices by Federal contractors and their subcontractors, ensuring merit-based and efficient contracting and employment.
      • The Order requires that all Federal contracts that are subject to the Federal Property and Administrative Services Act include a clause prohibiting contractors and their subcontractors from engaging in racially discriminatory DEI activities.
      • The Order directs the Office of Management and Budget to issue guidance to contracting agencies to ensure compliance and identify economic sectors that pose a particular risk of engaging in racially discriminatory DEI activities.
      • The Order authorizes contracting agencies to cancel, terminate, or suspend contracts — and to suspend or debar contractors — for failure to comply.
      • The Order directs the Attorney General to prioritize potential claims under the False Claims Act against contractors or subcontractors that are in violation of the contractual terms prohibiting racially discriminatory DEI activities, and ensure the prompt review of related civil actions brought by private persons.
      • The Order directs the Federal Acquisition Regulatory Council to amend Federal Acquisition Regulations to include this clause and remove any conflicting provisions.  
  • Per a CMS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) announced the members of the Healthcare Advisory Committee, a new federal advisory body comprised of leaders from across the healthcare system to provide expert advice on improving, strengthening and modernizing U.S. healthcare.
    • “The Committee will advise HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz on ways to improve how care is financed and delivered across Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace.
    • “This Administration is bringing leaders together to tackle the challenges facing American patients and the health care system, putting prevention front and center,” said HHS Secretary Robert F. Kennedy, Jr. “This committee will help us shift from a sick care system to a true health care system by delivering practical solutions that drive real change.”
    • “We received an overwhelming response from highly qualified candidates across the country,” said CMS Administrator Dr. Mehmet Oz. “These members bring deep expertise across care delivery, financing, innovation, and patient engagement. Their insights will help us advance higher-quality care, reduce administrative burden, and strengthen the sustainability of our programs, while supporting efforts to transform our healthcare system and restore a stronger focus on patients.” * * *
    • “The Committee will convene its first meeting later this year. Additional information, including meeting notices and opportunities for public engagement, will be published in the Federal Register and on the CMS website.
    • “For more information, visit: www.cms.gov/priorities/healthcare-advisory-committee/overview“
  • Federal News Network tells us,
    • “Thrift Savings Plan participation is at an all-time high — and nearly 90% of Federal Employee Retirement System (FERS) participants are contributing enough to receive a full match from the government. The TSP board is also reporting that participant satisfaction with the agency’s customer service center is at nearly 94%. Satisfaction scores have remained at that level, now for more than a year. (Federal Retirement Thrift Investment Board – TSP monthly report, March 2026)”

From the judicial front,

  • Bloomberg Law reports,
    • “The government can lawfully limit federal health carriers from covering certain gender transition procedures, the EEOC said in a new ruling.
    • “The Republican-controlled commission on Thursday rejected claims from a group of transgender current and former federal employees that the Office of Personnel Management’s health coverage policy violated anti-discrimination laws. 
    • “The ruling in Sam T. v. Kupor adds to the Equal Employment Opportunity Commission’s efforts under the Trump administration to chip away at transgender rights in the private and federal sectors.”
  • An OPM news release adds,
    • “The EEOC’s landmark ruling reinforces OPM’s duty to manage the FEHB Program responsibly and protect taxpayer-funded benefits for federal employees and retirees,” Associate Director for Healthcare and Insurance Shane Stevens said. “Federal health benefits must be administered in a way that is fiscally responsible, legally sound, delivers high-quality care, and works toward improved health outcomes.”
  • The next step for this lawsuit is federal district court.
  • The Wall Street Journal relates,
    • “The Justice Department filed an antitrust lawsuit against the prominent hospital system NewYork-Presbyterian, alleging that it used restrictions in its contracts with insurers to limit price competition and block lower-cost healthcare options.
    • “The suit, first reported by The Wall Street Journal, was filed Thursday in the U.S. District Court for the Southern District of New York. It is the latest development in a broader Justice Department effort focused on whether hospital systems use hidden contracts to protect their market position and maintain high prices.”

From the public health and medical / Rx research front.

  • The American Hospital Association News reports,
    • “An American Heart Association study published March 25 found that children born to mothers with premature placental separation could be at higher risk of heart disease by age 28. They also are nearly three times more likely to be hospitalized for heart-related complications, such as heart failure, ischemic heart disease, heart attack, blocked arteries or general cardiovascular disease. The study examined nearly three million pregnancies and found that approximately 1% were impacted by placental abruption. Although limited in scope and not focused on interventions, the study highlights the importance of postpartum and postnatal monitoring for maternal and infant complications.” 
  • The Washington Post points out “five things you need to know about meningitis.”
    • “Two people died in an outbreak of bacterial meningitis in England. The infection, which is rare, requires prompt medical treatment to avoid severe complications.”
  • MedPage Today tells us,
    • “After peaking at over 185,000 courses in 2015, prescriptions for direct-acting antivirals (DAAs) for hepatitis C virus infections dropped 63% by 2025.
    • “While those older than 61 years accounted for over 40% of DAA-treated patients in 2015, that percentage shrank to roughly 25% by 2025.
    • “Specialists wrote two-thirds of DAA prescriptions in 2015, but their share fell to 28% by 2025.” * * *
    • “These are “sobering numbers” that reflect the need for a national HCV elimination plan such as the Cure Hepatitis C Act of 2025, Debika Bhattacharya, MD, of the University of California Los Angeles, told MedPage Today. “We must expand access to DAAs.”
  • and
    • “Patients with a history of depression or anxiety were less likely to see their mental health decline while on GLP-1 medications.
    • “The link between GLP-1 drug use and lower risk of psychiatric decline was more pronounced for semaglutide than for other agents.
    • “The data may allay prior concerns about suicidality, which prompted an FDA investigation in 2023.”
  • and
    • “Alzheimer’s can be detected early with p-tau blood biomarkers, but some tests can lead to overdiagnosis.
    • “Combining p-tau217 and eMTBR-tau243 may refine diagnostic accuracy and reduce false-positives.
    • “Plasma eMTBR-tau243 also could help identify people with high tau burden.”
  • NPR adds,
    • “Babies under 6 months old still have one of the highest rates of hospitalization from COVID-19 infections compared to other age groups, but no COVID vaccine is available for these infants.
    • “That’s one reason the American College of Obstetricians and Gynecologists, or ACOG, recommends COVID vaccination during pregnancy.
    • “There are a number of studies that show one of the benefits of COVID vaccination during pregnancy is the passage of antibodies to the newborn, and then that protects the newborn against COVID,” says Dr. Kevin Ault, a professor of obstetrics and gynecology at Western Michigan University Homer Stryker M.D. School of Medicine in Kalamazoo, Mich.”

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

  • MedCity News reports,
    • “Affordability is top of mind for executives at AHIP as Americans battle skyrocketing healthcare costs.
    • “We are laser-focused on affordability at AHIP,” said Mike Tuffin, president and CEO of AHIP. “That’s, of course, the issue at every kitchen table. … We see the cost of hospital care, certainly the cost of brand prescription drugs, specialty care, imaging, down the line, just continuing to rise faster than wages, faster than inflation. That’s driving up premiums across all markets. Premiums directly reflect the underlying cost of medical care.”
    • “Tuffin made these comments during a press briefing on Tuesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. AHIP is an advocacy organization for health insurers.
    • “As for what’s leading to the rising cost of care, Tuffin pointed the finger at hospital consolidation, as well as actions by drug manufacturers like patent thickets (in which there is a dense web of multiple patents around one medication). 
    • “Tuffin added that AHIP is focused on improving affordability across four zones:
      • “More competition, especially for prescription drugs, and addressing hospital consolidation
      • “Site of service reforms, and increasingly using the home as a site of service. According to Tuffin, too much care is delivered at the costliest sites of care, like the emergency room
      • “Tackling administrative burden, as the healthcare system is still “far too dependent on fax machines”
      • “Aligning incentives around patient care outcomes and driving value across the system.”
  • The Wall Street Journal assesses the “Weight Loss Drug Frenzy: What’s Here and What’s Likely Coming Next.”
    • “The market for weight loss drugs is exploding and patients may have several new options in coming years.”
  • Beckers Payer Issues relates,
    • “Centene has named Kate Casso senior vice president of finance operations and innovation and Theodore Pienkos corporate controller and chief accounting officer.
    • “Ms. Casso has been with Centene for more than two decades and has served as the company’s corporate controller and chief accounting officer since April 2021, according to a March 24 regulatory filing. 
    • “Ms. Casso will focus in part on enterprise and finance innovation while continuing to lead data analytics, medical economics, payment integrity, finance shared services and financial planning and analysis. 
    • “Mr. Pienkos has been with Centene since 2011 and has served as the company’s deputy corporate controller since August 2024. He previously served as vice president of finance and accounting.
    • “Both appointments were effective March 18.”
  • BioPharma Dive informs us,
    • “Merck’s deal for Terns [mentioned in yesterday’s FEHBlog post] sparks debate over a possible biotech bidding war
    • “Some analysts argue the $6.7 billion offer undervalues biotech’s lead cancer drug, although investors may be happy with one-year returns.”
  • and
    • “Shares of Maze Therapeutics, a San Francisco-area biotechnology company, fell over 30% Wednesday despite positive clinical trial results for a progressive kidney disease drug that could potentially compete with a rival therapy from Vertex Pharmaceuticals.
    • “Maze said that, in a mid-stage trial, treatment with its experimental drug, “MZE829,” led to a “clinically meaningful” reduction of protein levels in urine by an average of almost 36% in people with a kidney disease caused by mutations in a gene called APOL1. Maze said it will continue enrollment for its Phase 2 trial and plans to meet with regulators to advance MZE829 into pivotal testing for AMKD, or APOL1-mediated kidney disease.
    • “Full results from the Phase 2 trial will be presented at a future medical conference, Maze added.”
  • Beckers Payer Issues informs us that “UnitedHealthcare has launched Avery, a generative AI companion that helps members navigate healthcare services.”
  • Health Exec adds,
    • “U.S. patients wait an average 31 days to see a doctor, so it’s no wonder 65% of surveyed consumers have consulted AI specifically because it’s faster and easier.
    • “Meanwhile 77% of clinicians appreciate the technology’s contributions to healthcare—yet 1 in 5 patients have tried to hide their use of AI from their doctors. 
    • “Most who admit to the secrecy chalk it up to a fear of being judged. 
    • “The findings are from a survey report released March 24 by Zocdoc, a digital appointment-booking service that has markedly increased its use of AI.”
  • Fierce Healthcare notes,
    • “OpenEvidence released an artificial intelligence-powered medical coding feature embedded in its clinical AI assistant.
    • “The new feature, called Coding Intelligence, provides automatic Current Procedural Terminology (CPT) code suggestions, evaluation and management (E/M) level recommendations with supporting medical decision-making rationale written directly into the note and ICD-10 diagnoses, according to the company.
    • “The tool, available in OpenEvidence Visits, provides coding derived from the clinical documentation and it automatically applies at the end of every doctor-patient visit, executives said.
    • “Without any extra work, OpenEvidence is able to generate concise rationale for their CPT + E/M suggestions. It truly captures the complexity of the encounter and saves me hours when I’m at the ER,” said Ania Bilski, M.D., vice president of clinical AI at OpenEvidence.”

Midweek report

David Ermer–CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
  • Federal News Network reports,
    • “Following more than a year of sweeping reductions across the federal workforce, Office of Personnel Management Director Scott Kupor told House lawmakers on Wednesday that he would be open to hiring more federal employees — with one crucial caveat.
    • “Kupor said he would be “perfectly happy” to see an increase in federal workforce staffing if it meant that the number of federal contractors went down. The OPM director described contractors as a “shadow” workforce and argued that creating that type of shift would save taxpayer costs and improve government services.
    • “Contractors, I think, can be very valuable where you have temporary assignments, or you have skill gaps where potentially the government can’t recruit those,” Kupor told the House Appropriations Committee’s subcommittee on financial services and general government. “Instead, we have people who are contractors for five, 10, 15, 20 years. They are basically full-time employees in disguise, and they get paid anywhere from 25% to 100% higher than what a federal employee would.”
  • Payment accuracy.gov commends OPM for being one of the three highest performing agencies. OPM’s annual agency financial report for FY 2025 (p. 112) adds the following detail
    • “In FY 2025, FEHB ERC [experience rated carriers, which includes all nationwide plans] activity is reporting a statistically valid improper and unknown payment estimated amount and rate. The ERC activity reports one year in arrears, based on the time necessary to collect, test, report and aggregate the data. Because the ERC activity reports in arrears, PSHB data is not included in the IP estimate being reported in 2025.
    • “Independent public accountants (IPAs) provide the data by conducting sampling, testing and reporting of transactions performed by carriers as required in the Financial Reporting and Audit Guide’s Agreed Upon Procedures.” * * *
    • Based on the results of the sampling and testing for 2024, the FEHB ERCs properly paid 99.86 percent of payments. The FEHB ERCs had an improper and unknown payment rate of 0.14 percent.
  • That information shows that carriers have strong controls over benefit payments.
  • The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20. 
  • The Wall Street Journal points out,
    • “Indiana is barring Piece by Piece Autism Centers from billing its Medicaid program after a Journal article detailed the company’s practices.
    • “Piece by Piece received the highest per-patient payments in 2023, averaging $340,000, in part by raising list prices up to $640 an hour.
    • “Indiana’s Medicaid director, Mitch Roob, issued an ultimatum to providers to self-report abuses by April 3 or face federal scrutiny.”
  • Modern Healthcare relates,
    • “The Republican congressional majority is weighing further cuts to health programs a year after taking $1 trillion out of the system.
    • “The GOP would use an expedited process called budget reconciliation to prevent Senate Democratic filibusters.
    • ‘The measure could be a vehicle for cuts that didn’t make it into last year’s tax law and for President Donald Trump’s health proposals.
    • “Trump’s demands for Iran war funding and voting restrictions provide the GOP with an opportunity to advance more spending cuts.”
  • Federal News Network further notes,
    • “The U.S. Postal Service is adding a temporary surcharge to most of its standard package shipping options, citing higher fuel and transportation costs.
    • “USPS told its regulatory agency on Wednesday that it plans to implement an 8% across-the-board increase in prices for its core package and shipping services on April 26, and would remain in place until Jan. 17, 2027.
    • “At that time, the Postal Service can determine if a different long-term approach is needed,” USPS said in a press release.
    • “Previously, USPS has only sought limited-time price increases on its package services during its busy holiday peak season, which runs from October through December. But agency officials told the Postal Regulatory Commission that this surcharge is now necessary to account for the higher cost of fuel and contracted transportation services.”
  • Beckers Hospital Review tells us,
    • “The White House has delayed nominating a new CDC director, allowing Jay Bhattacharya, MD, director of the National Institutes of Health, to continue leading the agency past the March 26 deadline, The Washington Post reported March 25.
    • “Dr. Bhattacharya has served as acting CDC director since Feb. 18. Although he will no longer hold that title due to federal rules, he will retain authority over the agency’s delegable duties, an HHS spokesperson told the Post.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20.” 
  • Fierce Pharma relates,
    • “The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates.
    • “In approving Denali’s tividenofusp alfa, now known as Avlayah, the FDA has greenlit the first treatment for Hunter syndrome that can address the condition’s pernicious cognitive symptoms. 
    • “Avlayah is the first product approved to address neurologic complications of Hunter syndrome,” Tracy Beth Høeg, M.D., Ph.D., acting director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a March 25 release. “This accelerated approval was based on a surrogate endpoint: reduction of cerebrospinal fluid heparan sulfate, which the review team determined was reasonably likely to predict Avlayah’s clinical benefit.”
  • and
    • “With a new U.S. green light in certain ovarian cancer patients, Corcept Therapeutics has redeemed its lead asset relacorilant after stumbling at the finish line in a separate indication late last year. 
    • “The FDA has given the all-clear to Corcept’s class-first selective glucocorticoid receptor antagonist (SGRA) to treat adults with platinum-resistant ovarian cancer. Patients must have tried one to three prior lines of systemic treatment, at least one of which had to include bevacizumab (Avastin). 
    • “The FDA approval covers a regimen of relacorilant, to be sold as Lifyorli, alongside the chemotherapy nab-paclitaxel (Abraxane), according to a March 25 press release. The drug is taken orally the day before, of and after treatment with the regimen’s chemotherapy component, Corcept explained.” “

From the public health and medical / Rx research front,

  • Infectious Disease Advisor relates,
    • “The high rate of persistent physical and psychosocial sequelae of mpox suggests clinicians should consider screening affected individuals for symptoms of depression as well as social and occupational disruptions following acute illness.”
  • Health Day adds,
    • “New fathers might be proud poppas, but their mental health might be shaky as they adapt to their increased responsibilities, a new study says.
    • “Men have a 30% increased risk of depression and stress disorders by the end of their first year of fatherhood, researchers reported March 23 in JAMA Network Open.
    • “This follows a mental health boost among men during pregnancy and the first few months following birth, researchers found.”
  • Healio tells us,
    • “Limiting sedentary time and increasing light-intensity physical activity may reduce risk for developing a hypertensive disorder of pregnancy, according to study findings.
    • “Clinicians should consider counseling pregnant patients not only about exercise, but also about their everyday movement patterns. Based on our findings, limiting sedentary time to no more than 10 hours per day, and ideally closer to 8 hours, may help reduce the risk of developing a hypertensive disorder of pregnancy. Encouraging frequent light-intensity movement throughout the day appears to be an important and achievable target for improving pregnancy health,” Kara M. Whitaker, PhD, MPH, FAHA, associate professor in the department of health, sport and human physiology at University of Iowa, told Healio.”
  • Pharmacy Time adds,
    • “Compositional modeling of sedentary time, light activity, moderate-to-vigorous physical activity (MVPA), and sleep quantified insulin-resistance impacts of time reallocation while adjusting for sociodemographic and seasonal covariates. 
    • “Replacing 30 sedentary minutes with MVPA correlated with approximately 15% lower the homeostatic model assessment of insulin resistance, a clinically meaningful shift in a validated proxy for type 2 diabetes risk. 
    • “Shifting sedentary time to sleep also improved insulin resistance, supporting sleep duration as a metabolic cotarget alongside physical activity in adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck MRK has reached a nearly $6 billion cash deal to buy the cancer biotech Terns Pharmaceuticals TERN and its promising leukemia treatment.
    • If it proves to work safely, the experimental drug would give Merck a boost as the company prepares for its top-selling drug, Keytruda, to lose patent protection [in 2028].
    • Under the terms, Merck would pay $53 a share for Terns, Merck said Wednesday. The deal is worth $5.7 billion including the cash that Terns has on hand.” * * *
    • “Merck said it expects the deal to close by the end of June and result in a second-quarter charge of about $5.8 billion, or about $2.35 a share.”
  • MedTech Dive relates,
    • “Thermo Fisher Scientific said Tuesday that it has closed the $8.9 billion takeover of Clario, expanding its capabilities for handling clinical trial endpoint data.
    • “The buyout, which was announced in October, gives Thermo Fisher a platform for capturing and managing safety data, efficacy results and patient-reported outcomes in clinical trials.
    • “Thermo Fisher will integrate Clario’s platform with its existing capabilities for analyzing biological samples to create a high-growth business, CEO Marc Casper said at a recent investor event.”
  • BioPharma Dive informs us,
    • “Sarepta Therapeutics shares jumped 25% Wednesday morning after the company unveiled promising early clinical data for two medicines that it gained rights to through a deal with Arrowhead Pharmaceuticals worth more than $1 billion.
    • “The experimental drugs, dubbed SRP-1001 and SRP-1003, aim to treat two rare, genetic conditions that cause dangerous muscle deterioration. The therapies work by delivering small interfering strands of RNA, or siRNA, into muscle tissue to target the genetic abnormalities.
    • “Results from two Phase 1/2 studies released Wednesday show both medicines achieved high muscle concentrations without severe side effects, according to Sarepta. The company said it also has proof-of-concept data showing these treatments can hit their genetic targets.”

Tuesday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Oklahoma Republican Gov. Kevin Stitt on Tuesday selected Alan Armstrong, an energy executive, to fill the seat being vacated by Sen. Markwayne Mullinuntil a new election takes place in November.
    • “The announcement came a day after Mullin was confirmed Monday by the Senate as secretary of the Department of Homeland Security. The appointment of Armstrong as a temporary seat holder keeps the Senate’s GOP majority at 53-47.
    • “Armstrong, the chairman of Williams Companies, focused in remarks Tuesday morning on permitting reform, the cost of energy and infrastructure.” * * *
    • “President Trump has endorsed Oklahoma Rep. Kevin Hern for the Senate seat in the coming election, calling him a “true friend of MAGA.” The Republican primary in the deep-red state is scheduled for June 16.
    • “Armstrong said he had a positive meeting with Trump before his selection. Oklahoma state law prohibits Senate appointees from running for the seat in a subsequent election.” 
  • and
    • “Senate Republicans offered Tuesday to fund all of the Department of Homeland Security except for the unit that carries out immigrant arrests and deportations, moving to end a nearly six-week funding standoff that has caused security snarls at airports nationwide. 
    • “Democrats reacted coolly to the proposal, which didn’t include the new restrictions on immigration enforcement practices they have demanded, but said that they were engaged in negotiations. President Trump indicated he wasn’t pleased with the direction of the talks, muddying the prospects of a quick resolution.”
  • The Hill adds,
    • “House Republicans are pushing back stiffly against the idea of splitting up legislation to fund the Department of Homeland Security (DHS), despite the White House and Senate Republicans saying President Trump is open to doing just that.”
  • Roll Call notes,
    • “As a deadline arrives this week to nominate a Centers for Disease Control and Prevention director, some Republicans are skeptical the administration will find someone who can check all the boxes necessary for confirmation.
    • “The candidate will need the “Make America Healthy Again” mindset of Secretary Robert F. Kennedy Jr.’s Health and Human Services Department, while also appeasing a set of stick-to-science senators increasingly unhappy with Kennedy’s direction.” * * *
    • “HHS senior adviser Chris Klomp, in an interview last week with Stat News, said the agency has interviewed “dozens” of potential candidates. Though there is a structured process to name top candidates, Kennedy will ultimately make the final decision.
    • “Klomp also said that if the White House hasn’t named a nominee Wednesday, HHS would shift to delegate responsibilities, but getting a qualified nominee “is a top priority.”
  • The Washington Post points out,
    • “The nascent Make America Healthy Again movement got one of its biggest wins last spring: Casey Means was selected to be the nation’s top doctor.
    • :But more than 10 months later, the controversial surgeon general pickhas yet to assume the position advising Americans on how to improve their health. Her nomination has stalled as some Republicans question her stance on vaccines, her medical credentials and her pushes against the medical establishment.
    • “Means probably cannot afford to lose the support of a single Republican on the Senate health committee, which has yet to schedule a vote to advance her nomination to the full Senate. The panel’s chairman, Sen. Bill Cassidy (R-Louisiana), repeatedly pressed Means on her views on immunizations during a late February hearing — questions she largely dodged — and Sens. Susan Collins (R-Maine) and Lisa Murkowski (R-Alaska) afterward publicly said they still have questions.”
  • The New York Times relates,
    • “Dr. Robert Malone, vice chair of the federal committee that recommends vaccines to Americans, angrily resigned his position on Tuesday.
    • “The panel, called the Advisory Committee on Immunization Practices, or ACIP, is currently in judicial limbo. A federal judge ruled last week that the advisers, appointed by Health Secretary “Robert F. Kennedy Jr., did not have the expertise needed to make vaccine recommendations and prevented them from meeting as planned this month.
    • “The judge also blocked all of the committee’s actions to date, including decisions to rescind recommendations for some childhood vaccines.
    • “The Department of Health and Human Services has indicated that it will appeal the ruling but has not said when. Dr. Malone indicated that he would not rejoin the committee even if the ruling were to be overturned or if Mr. Kennedy announced a new slate of advisers.”
  • FedManager observes,
    • “With the cancellation of the Federal Employee Viewpoint Survey (FEVS) for 2025, the Partnership for Public Service conducted its own version of FEVS. The goal: check the pulse of the workforce in a year of major workforce changes, including deferred resignations, returns to office, the cancellation of union contracts, and other changes. 
    • “The revamped survey was modeled after FEVS but was developed and deployed by the Partnership. While it’s not directly comparable, it contained similar questions. The survey was conducted on a smaller scale with 11,000 feds responding, compared to the 500,000 or so who respond to the official FEVS. Responses were collected in November and December 2025.
    • As for the results, employee engagement and satisfaction governmentwide was measured at a score of 32 out of 100, with 58 percent of respondents saying engagement has gotten worse since 2024. 
    • “We have every red light blinking across the federal government,” said Partnership President and CEO Max Stier. “Morale is as low as imaginable.”
  • Govexec informs us,
    • “As the U.S. Postal Service contemplates service cuts due to the prospect of running out of money as soon as fall 2026, President Donald Trump recently nominated three additional individuals to the postal agency’s Board of Governors. Several unions and other stakeholders, however, reported that they are largely unfamiliar with his picks. 
    • “[The National Association of Letter Carriers] is closely monitoring these unknown nominees and will actively work to ensure they have the best interests of the employees and the network before they are confirmed,” the union said in a press release responding to the nominations announcement. 
    • “The postal board nominees are: Robert Steffens of Texas, Jeffrey Brodsky and William Gallo, both of Florida.” * * *
    • “There are currently four governors on the USPS board — two Democrats, one Republican, one independent — leaving five vacancies. No more than five of them can be from the same political party. 
    • “NALC noted that the Senate has traditionally advanced postal nominees in bipartisan pairs, but all of Trump’s picks, so far, have been Republicans. The president has attempted to remove Democratic members of several bipartisan agency boards, prompting legal challenges that have reached the Supreme Court.” 
  • Modern Healthcare lets us know,
    • “The Accelerating State Pediatric Innovation Readiness and Effectiveness, or ASPIRE, Model is designed for children and young adults with complex physical and behavioral health needs.
    • “The demonstration will test wraparound Medicaid and Children’s Health Insurance Program payments to promote care coordination.
    • “CMS will distribute $125 million to up to five states over 10 years.”
  • KFF analyzes the BALANCE Model for GLP-1s in Medicare and Medicaid.
    • “GLP-1s, a class of drugs used to treat type 2 diabetes, obesity, cardiovascular disease, and other conditions, have exploded in popularity in recent years due to their demonstrated effectiveness, but are often not covered by insurance, particularly for the treatment of obesity. According to KFF polling, about half (56%) of GLP-1 users say these drugs were difficult to afford, including one in four who say they were “very difficult” to afford.
    • “The Trump administration is pursuing various approaches to lowering the cost and expanding coverage of these medications. These approaches include striking “most-favored nation” deals with GLP-1 manufacturers Novo Nordisk and Eli Lilly, providing access to discounted prices for GLP-1s through TrumpRx, and implementing a new demonstration program called the BALANCE (Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth) Model to expand Medicare and Medicaid coverage of GLPs for obesity, which is currently subject to statutory limitations (prohibited in Medicare, permissible but not required in Medicaid). In addition, the GLP-1 drug semaglutide (branded as Ozempic, Wegovy, and Rybelsus) was selected for Medicare drug price negotiation in 2025, with a negotiated price set to take effect in 2027.
    • “This brief describes current coverage of GLP-1s in Medicare and Medicaid, the Centers for Medicare & Medicaid Services’ (CMS) efforts to expand access and lower costs for GLP-1s through temporary demonstration programs including the BALANCE Model, and potential impacts on beneficiaries and program budgets.”
  • The American Hospital Association tells us,
    • “The Administration for Strategic Preparedness and Response March 24 announced an investment to expand the domestic manufacturing of propofol and metoprolol. Propofol is a sedative used for anesthesia and intensive care unit sedation, while metoprolol is a medication used to treat cardiovascular conditions such as arrhythmias and hypertension, and can also reduce lung inflammation in ICU settings. ASPR said the API Innovation Center, based in St. Louis, was awarded $8.3 million to produce both ingredients. The investment is the latest in a series of projects by ASPR and the Department of Health and Human Services to reduce reliance on foreign resources and increase the domestic production of essential medications and their active pharmaceutical ingredients.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “GE HealthCare has received 510(k) clearance for its spectral photon-counting CT technology, the company said Monday.
    • “The Food and Drug Administration clearance positions GE HealthCare to compete with Siemens Healthineers’ Naeotom Alpha, the first photon-counting CT machine to reach the U.S. market.
    • “Citi Research analysts said in a note to investors that GE HealthCare’s Photonova Spectra is differentiated by its use of a detector designed to produce high-contrast spectral images with detailed visualization.”
  • Cardiovascular Business adds,
    • “Medtronic has received an expanded U.S. Food and Drug Administration (FDA) approval for its OmniaSecure defibrillation lead. 
    • “The lead was originally approved for placement in the right ventricle in April 2025. This expanded indication covers the left bundle branch (LBB) area, meaning it can now be used for conduction system pacing and even LBB optimized cardiac resynchronization therapy (LOT-CRT). This is the first time the FDA has approved a defibrillation lead for placement in the LBB area.
    • “Conduction system pacing is a rapidly growing therapy for patients who need a pacemaker,” Trevor Cook, vice president and general manager of Medtronic’s defibrillation solutions business, said in a statement. “Now, patients who require a defibrillator and pacing have an option that can safely deliver life-saving defibrillation therapy and activate the heart’s natural electrical system to enable a more synchronous, physiologic pattern. This approval underscores the versatility of the OmniaSecure defibrillation lead and supports its use across a variety of implant approaches to best serve a broad range of patients.”

From the judicial front,

  • Healthcare Dive reports,
    • “CVS Health has reached a proposed settlement with the Federal Trade Commission in the agency’s sweeping case against major pharmacy benefit managers for allegedly inflating the cost of U.S. insulin.
    • “The proposed consent agreement was disclosed Monday in a joint motion from the FTC and CVS for the company’s subsidiaries, PBM Caremark and group purchasing organization Zinc, to withdraw from the case while antitrust regulators consider the deal.
    • “The filing did not include the terms of the potential settlement, but analysts expect it would be similar to the deal the FTC secured with Cigna’s PBM Express Scripts earlier this year. If CVS reaches a settlement, that would leave UnitedHealth as the lone holdout in the high-profile suit.”

From the public health, medical research and Rx research front,

  • The AP reports,
    • “Whether they’re using weekly shots or daily pills, more Americans than ever are turning to anti-obesity drugs to lose weight and boost health.
    • “About 1 in 8 U.S. adults say they are taking a GLP-1 drug, according to a recent surveyby the health research group KFF.
    • “Just since January, more than 600,000 prescriptions have been written for Novo Nordisk’s new Wegovy pill, the company said. Early analysis suggests that more than a third of users are new to the drugs, according to Truveta, a health care data company. 
    • “But medication alone isn’t the answer, experts caution. It also takes lifestyle changes — healthy diet, exercise, adequate sleep and stress management — to reap the biggest benefits from the drugs known as GLP-1s.
    • “The biggest mistake people make with GLP-1 medications is thinking the prescription is the treatment,” said Dr. Katherine Saunders, an obesity medicine expert at Weill Cornell Medicine and co-founder of FlyteHealth, a weight-loss treatment company.
    • “GLP-1s can spur weight loss and health benefits on their own, but the effects are larger and last longer when the drugs are combined with lifestyle changes, a recent review of nearly three dozen studies found.”
  • Beckers Clinical Leadership relates,
    • “The CDC is tracking a new SARS-CoV-2 variant — BA.3.2 — that has been identified in 23 countries, including the U.S.
    • “Here are [four] things to know:
      • “1. The variant was first identified in South Africa in November 2024. Detections began increasing in September 2025, with the highest number reported during the week of Dec. 7, 2025.
      • “2. BA.3.2 was first detected in the U.S. in June 2025 at San Francisco International Airport through traveler-based surveillance. As of mid-February, it had been found in clinical samples from five patients across four states and 132 wastewater samples from 25 states. Prevalence among sequenced specimens remains low at 0.19%. Two of the five patients were hospitalized older adults with comorbidities, and all five survived.
      • “3. BA.3.2 carries about 70 to 75 mutations in its spike protein compared to JN.1 and its descendant LP.8.1, the antigens used in the most current COVID-19 vaccine. Lab studies show BA.3.2 evades antibodies more effectively than other circulating variants. The 2025–26 COVID-19 vaccine demonstrated the lowest antibody neutralization against BA.3.2 among seven variants tested. The CDC said real-world vaccine effectiveness data is still needed and that current vaccines continue to protect against the predominant circulating strains.
      • “4. Data from several European countries show BA.3.2 has not rapidly overtaken other strains. Instead, the strain has cocirculated with other JN.1 descendent lineages at 10% to 40% prevalence. Two lab studies also found BA.3.2 had reduced lung cell entry compared with other variants, potentially limiting its ability to become dominant. However, further evolution or seasonal transmission increases could enable broader circulation, the CDC noted.”
  • The American Journal of Managed Care tells us,
    • “AMD [Age related macular degeneration] affected more men than women and was higher in White vs Black individuals; Rhode Island reached ~7214 per 100,000. 
    • “Diabetic retinopathy clustered in Black and Hispanic populations and in southern states, with Mississippi ~3607 per 100,000 and marked male predominance. 
    • “DME [diabetic macular edema] prevalence remained low overall yet disproportionately higher in Black individuals (712 per 100,000) than Hispanic (578) and White (155), supporting targeted screening within diabetes care. 
    • “RVO [retinal vein occlusion] was least prevalent but showed higher rates in White individuals and in Rhode Island; analyses assumed age-related increases, potentially influencing estimates. 
    • “Specialist access and costs were substantial: California had 918 retina specialists vs 3 in Wyoming; annual payer costs were ~$13.4B AMD, $6.2B DR, $4.4B DME, $6.4B RVO.”
  • Cardiovascular Business informs us,
    • “Exercise and using medications to reduce a patient’s cardiovascular risk factors are not associated with significant improvements in cognitive function, according to new findings published in JAMA Neurology. The study’s authors focused on older patients with a family history of dementia and/or self-reported signs of possible cognitive decline. 
    • “Exercise combined with pharmacological management of cardiovascular risk factors is the evidence-based strategy for maintaining cardiovascular health,” wrote first author Rong Zhang, PhD, a researcher with the University of Texas Southwestern Medical Center and Texas Health Presbyterian Hospital Dallas, and colleagues. “However, its effects on cognitive function remain unknown.”
  • “Today’s issue of Research Matters from the National Institutes of Health discusses Treating addiction.”
    • “Alcohol and drug addiction can cause many harms. This Research in Context feature looks at research into the causes of addiction and new ways to treat it.”
  • Per Health Day,
    • “Higher combined consumption of fruits, vegetables, legumes, and potatoes may reduce the risk for Crohn disease (CD), according to a study published in the March issue of the American Journal of Gastroenterology.
    • “Antoine Meyer, M.D., Ph.D., from Université Paris-Saclay in France, and colleagues assessed the risk for developing CD and ulcerative colitis (UC) based on intake of individual fruits, vegetables, legumes, and potatoes. The analysis included 341,519 individuals completing food frequency questionnaires who were followed for a median 13.4 years.”

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

  • Plan Advisor reports,
    • “Rising health care costs are reshaping how employees choose workplace benefits, even when those selections expose workers to significant future financial risk.
    • “Nearly two-thirds of employees reported cost as their top priority during open enrollment, according to Securian Financial’s annual workplace benefits study, “The Affordability Trap: Why Cheaper Choices Cost Employees More.” The focus on cost leads many employees to choose lower-premium plans with higher deductibles; skip supplemental coverage; or scale back voluntary benefits, a pattern identified by the report as an “affordability trap.”
    • “While these decisions may reduce payroll deductions in the short term, the study found they often leave employees vulnerable to sizable out-of-pocket expenses when medical events occur.”
  • Per Healthcare Dive,
    • “Cencora has agreed to acquire EyeSouth Partners’ retina business for $1.1 billion as the drug distributor continues to expand its specialty medical arm.
    • “Once the transaction closes, EyeSouth’s physicians will join Cencora’s management services organization Retina Consultants of America, according to the Monday announcement.
    • “Cencora expects the deal to close after the company’s fiscal year ends on Sept. 30 and be slightly accretive to Cencora’s earnings.”
  • Fierce Healthcare relates,
    • “Highmark posted a $175 million net loss in 2025 as its insurance arm weathered cost pressures that strained the industry nationwide.
    • “The company said Tuesday morning that full-year revenue $32.4 billion, up 11%. Revenues were up across business units, with Highmark Health Plans posting a 12% increase, Allegheny Health Network reporting an 11% increase in revenue and the diversified business unit—which includes United Concordia Dental and its stop-loss business, HM Insurance Group—seeing revenue up 7%.
    • “The insurance division posted a $609 million operating loss in 2025, and executives told reporters during a briefing that the performance of other businesses helped to offset some of that downturn. Allegheny Health Network, the company’s provider arm, posted $90 million in operating income, up from $237 million in 2024.”
    • “We are not immune to the strong headwinds experienced across the entire insurance industry,” Carl Daley, Highmark’s chief financial officer, said during the briefing. “About half of the industry has had credit ratings or outlooks downgraded, including some of the largest players.”
  • BioPharma Dive tells us,
    • “Gilead Sciences will acquire autoimmune drugmaker Ouro Medicines, the companies said Monday afternoon, spending nearly $1.7 billion on the young startup and a T cell engager it licensed from a Chinese biotechnology firm.
    • “Ouro launched in early 2025, backed by GSK and Monograph Capital. Its bispecific antibody, called OM336 or gamgertamig, is designed to bind to a pair of immune cell proteins, BCMA and CD3, that have been popular targets for drugmakers.
    • “Many bispecific antibodies have been approved for cancers, but over the past decade, a flurry of research has shown these treatments hold promise in autoimmune diseases as well. The multipronged drugs eliminate B cells much like cell therapies, but cost less to manufacture, don’t require harsh chemotherapy conditioning and can be dosed multiple times.”
  • Fierce Pharma informs us,
    • “UCB plans to build a $2 billion manufacturing facility near its U.S. headquarters in Atlanta, Georgia. It will become the first plant in the U.S. for the Belgium-based company and will produce biologics.  
    • “The 460,000-square-foot factory will sit on a 79-acre plot of land in the Rowen innovation district, a mixed-use development designed to attract corporate investment. The project is modeled after North Carolina’s Research Triangle Park (RTP). 
    • “Officials from Gwinnett County signed off on UCB’s application on Tuesday afternoon. It becomes the largest investment a company has made in county history, according to the Atlanta Journal-Constitution. The site is near Dacula, Georgia, which is 35 miles northeast of downtown Atlanta. UCB’s U.S. headquarters is in Smyrna, which is in Atlanta’s northwest suburbs, about 45 minutes away.”
  • The Wall Street Journal lets us know,
    • “Finance chiefs once questioned the returns on investing in artificial intelligence. Those days are gone.
    • “Speaking at The Wall Street Journal’s CFO Council Summit in Palo Alto, Calif., finance chiefs from the tech, retail and financial services sectors said their companies are seeing big gains in efficiency and productivity—in some cases worth millions of dollars—from their investments in generative AI. Nudging employees to embrace AI also has yielded new ideas about how to accomplish time-consuming tasks, CFOs said.
    • “Finance chiefs say they are playing a leading role in their company’s AI transformation efforts, evaluating performance, pushing for productivity gains and clearly articulating the value to reluctant employees.”