FEHBlog

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.”

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Trump administration will raise payments to Medicare insurers by 2.48% next year, a dramatic increase after a preliminary proposal holding the line on payments drew fierce criticism from the industry and torpedoed shares of the largest companies.
    • “The final 2027 rates for Medicare Advantage, the private-insurer version of the federal program for seniors and the disabled, came in above some analysts’ expectations. Several had suggested a rate increase would likely be finalized at around 1% or slightly higher, with a “bull” case closer to 2% to 3%. 
    • “The final increase represents about $13 billion in additional payments to the insurers.
    • “The announcement marks a stunning turnaround for an industry that has been battered by a series of financial setbacks across multiple lines of business, particularly in the Medicare plans that had long been a major engine of growth.” * * *
    • “Chris Klomp, the Medicare program director, said in an interview with The Wall Street Journal that the Centers for Medicare and Medicaid Services is trying to balance the interests of enrollees and taxpayers. 
    • “We have to be wise stewards of the tax dollar,” said Klomp, who is also now a top official at the Department of Health and Human Services. But “we need to make sure that plans aren’t pulling out of markets, that they’re not cutting benefits that beneficiaries are relying on.”
    • “Trends in Medicare plans’ billing will raise the overall 2027 payment increase to 4.98% with the final rate changes added in, the agency said.”
  • AHIP adds,
    • “AHIP issued the following statement after the Centers for Medicare and Medicaid Services (CMS) issued the final 2027 Medicare Advantage (MA) and Part D rate notice.
    • “More than 35 million seniors and Americans living with disabilities choose Medicare Advantage because it provides them with better care at lower costs than fee-for-service. As health plans incorporate the policies released in recent days, they will continue to focus on keeping coverage and care as affordable as possible during this time of sharply rising medical costs.” – Chris Bond, AHIP spokesperson.”
  • and
    • “A new report by The Wall Street Journal examines why “Americans spend more on health care than anyone else in the world,” underscoring “the high prices Americans pay for surgeries and drugs” compared to consumers in other nations. Some key excerpts: 
    • “Americans spend more on healthcare than anyone else in the world. Just insuring a family here costs nearly $27,000 a year, enough to buy a car. The main cause: Prices are far higher in the U.S. for the same medical products and services, from surgeries to drugs.”
    • “Big hospitals can charge higher rates because of consolidation … Many cities and communities are now dominated by a single hospital system, partly because hospitals have been merging in recent years. The consolidation has given hospital systems leverage to command higher rates during negotiations with health insurers. The insurers would lose business if powerful hospitals shut them out.”
    • “Of note, an analysis  by KFF provides some additional context on the significance of pricing: “The U.S.’s higher spending on providers is driven more by higher prices than higher utilization of care. Patients in the U.S. have shorter average hospital stays and fewer physician visits per capita, while many hospital procedures have been shown to have higher prices in the U.S.” 
  • On a related note, MedPage Today offers an interview with “William Schpero, PhD, a healthcare economist at Weill Cornell Medicine in New York City, explains — among other things — why he thinks consumer-focused price transparency in healthcare won’t work, but putting the onus on physicians might.”
  • Modern Healthcare informs us,
    • “The Federation of American Hospitals’ new President and CEO, Charlene MacDonald, has her work cut out. 
    • “MacDonald, who succeeded longtime CEO Chip Kahn in January, is charged with steering a trade group that supports more than 1,000 for-profit hospitals and health systems as they navigate steep funding cuts and a rapidly evolving care delivery landscape.
    • “MacDonald joined the federation in 2023 as executive vice president of public affairs and oversaw government affairs, advocacy, communications, finance and operations. 
    • “In an interview, MacDonald said the changes coming in the next two years are dire for hospitals, and members can play a critical role in shaping policy. The interview has been edited for length and clarity. 
    • “What are your top priorities for 2026 and beyond?
    • “The first is affordability. That’s not just premiums, but out-of-pocket costs and whether coverage translates into access. The second is stability in coverage programs. Medicaid financing is obviously critical, but so is the stability of the individual market. The third is transparency and accountability on how premium dollars are being used.
    • “Our role is to bring that on-the-ground perspective to the policy conversation and ensure the conversations we’re having are not just academic but are reflective of the patient experience.”
  • Govexec and Federal News Network discuss OPM’s March 31, 2026, call letter for 2026 benefit and rate proposals from FEHB and Postal Service Health Benefits carriers. It is unfortunate that OPM continues to pile new benefit mandates on top of the many older ones.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “VDyne said the Food and Drug Administration approved an investigational device exemption for a pivotal clinical trial of its transcatheter tricuspid valve replacement system. The approval, announced last week, moves VDyne a step closer to competing with Edwards Lifesciences’ Evoque tricuspid valve replacement device.
    • “The TRIVITA trial will evaluate the safety and efficacy of the VDyne device to treat symptomatic severe tricuspid regurgitation, where the valve fails to close properly and leaks, making the heart work harder to pump blood. The artificial valve is intended to restore normal blood flow.
    • “VDyne said there is a significant unmet need for minimally invasive tricuspid regurgitation treatments, noting most of the 1.5 million patients in the U.S. with the condition are too frail for open heart surgery. Tricuspid valve surgery is associated with high mortality and poor outcomes, the company added.”
  • Fierce Pharma relates,
    • “In response to a warning letter from the FDA that accused the company of making “false or misleading” claims about its bladder cancer drug Anktiva, ImmunityBio is implementing enhanced measures aimed at ensuring that all promotional communications relating to the drug are “accurate, balanced and compliant with FDA regulations,” the company said in a release.
    • “Among the measures ImmunityBio has implemented are “expanded promotional review protocols,” executive training and external regulatory oversight, the company said. The moves follow a “comprehensive review of all promotional materials and external communications” with its legal and regulatory teams, ImmunityBio explained.
    • “ImmunityBio added that it has removed from its corporate website a podcast identified by the U.S. regulator in its March warning letter. The company has also requested the removal of the podcast from all third-party platforms, it said.” 

From the public health, medical and Rx research front,

  • HealthDay reports,
    • “Many folks think it’s OK to belt back a few extra rounds on Saturday night if they stay mostly sober during the week.
    • “But saving up your drinks for a single sitting could be a recipe for liver problems, new research suggests.
    • “A team at the University of Southern California’s Keck School of Medicine linked occasional heavy drinking to triple the risk of advanced liver fibrosis — a dangerous type of scarring that can lead to liver failure. 
    • “Their findings — published April 2 in Clinical Gastroenterology and Hepatology — indicate that the way you drink may be just as important as how much.
    • “Occasional binge drinking could be changing liver tissue in profound ways.
    • “This study is a huge wake-up call because traditionally, physicians have tended to look at the total amount of alcohol consumed, not how it is consumed, when determining the risk to the liver,” lead author Dr. Brian Lee, a hepatologist at Keck Medicine, said in a news release.”
  • The American Medical Association lets us know “what doctors wish patients knew about rheumatoid arthritis.”
    • “Among chronic conditions, one stands out for its enigmatic nature and debilitating impact: rheumatoid arthritis (RA). 
    • “This condition presents an array of challenges and wreaks havoc on the lives of those who live with it. And while there are effective treatments that can prevent or slow the progression of rheumatoid arthritis, many questions remain unanswered, leaving patients and their families searching for better strategies to manage this life-altering condition.”
  • Drug Topics relates,
    • A growing body of evidence suggests that the choice of glucose-lowering therapy may play a critical role in colorectal cancer prevention.
    • For pharmacists managing the complex needs of patients with type 2 diabetes (T2D), a growing body of evidence suggests that the choice of glucose-lowering therapy may play a critical role in colorectal cancer prevention. A trial emulation published in Diabetology and Metabolic Syndrome reveals that dual therapy combining sodium-glucose cotransporter-2 (SGLT2) inhibitors with glucagon-like peptide-1 (GLP-1) receptor agonists is associated with a 21% lower risk of colon cancer in high-risk patients with a history of polypectomy. This finding, derived from a large-scale analysis of over 57,000 patients, suggests that the combination of these 2 drug classes may offer additive chemopreventive effects that surpass the benefits of monotherapy alone.
  • MedPage Today adds,
    • “Commonly prescribed antibiotics and non-antibiotic drugs were associated with significantly increased odds of Clostridioides difficile infection in a case-control study.
    • “Non-antibiotic drugs with the greatest observed risks for C. difficile infection were antidiarrheals, analgesics, and corticosteroids.
    • Considering how frequently these medications are used, prudent prescribing decisions are needed, researchers said.
  • Healio notes,
    • “Approximately half of patients with the highest-risk brain metastases did not receive palliative care consultations, according to results of a study of nearly 500 patients.
    • “Those who received palliative care had significantly higher rates of advance directive completion and hospice enrollment, without any compromise in overall survival.
    • “Palliative care consultation is not end-of-life consultation,” Rohit Singh, MD, medical oncologist and assistant professor at University of Vermont Larner College of Medicine, told Healio. “It should be a part of patients’ multidisciplinary team.”
  • Genetic Engineering and BioTechnology News tells us,
    • “Biomedical researchers headed by a team at the Lampe Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill/North Carolina State University, have developed an injectable microgel to help reduce bleeding in infants who require surgical care. Tests in an animal model showed that the hemostatic microgels, known as B-knob-triggered microgels (BK-TriGs), reduced bleeding by at least 50%.
    • “Research lead Ashley Brown, PhD, who is the Lampe Distinguished Professor of Biomedical Engineering, is co-corresponding author of the team’s published paper in Science Advances, titled “Hemostatic B-knob-triggered microgels (BK-TriGs) to address bleeding in neonates.” In their paper the team concluded “This study highlights the potential of BK-TriGs, designed for neonatal-specific clotting mechanisms, to address the heightened bleeding and thrombosis risks in neonates, who face 4.4 times higher postsurgery mortality … Our findings support BK-TriGs as a promising approach for improving hemostasis in neonates, offering a tailored, effective solution for this vulnerable patient population.”
  • BioPharma Dive informs us,
    • “Amgen said an injectable version of its blockbuster eye disease drug Tepezza hit both goals in a key late-stage trial that could help the company fend off competition from an emerging rival. 
    • “According to Amgen, a form of the thyroid eye disease drug Tepezza that’s delivered via an on-body injector instead of an intravenous infusion met its main objective as well as a key secondary endpoint in the study. Notably, the newer version, Tepezza OBI, appeared comparable to the marketed medicine, displaying “IV-like efficacy,” said research chief Jay Bradner, in the statement.”  

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

  • Healthcare Dive reports,
    • “Centene has created two new executive leadership positions to consolidate oversight of its Medicaid, Medicare and Affordable Care Act businesses as the insurer copes with rising costs and looming policy challenges.
    • “Centene has hired longtime health insurance executive Daniel Finke as its inaugural group president of markets and commercial, the company announced Monday. Centene also named Michael Carson, the CEO of its Medicare business, as group president of Medicare and specialty.
    • “Both executives will report to Centene CEO Sarah London. Centene did not respond to a request for comment about when the appointments are effective.”
  • Per a recent Health Care Cost Institute issues brief,
    • “Imaging services made up 24% of outpatient visits and were the second largest category of outpatient spending (17%) in 2022. The most common imaging services were for screening mammography and chest x-rays, which are used for routine screening and diagnosing certain conditions. Other imaging services such as CT scans of the abdomen, echocardiography (ultrasound for the heart), and MRI of the brain occurred less often but had higher costs, making them some of the highest spending imaging services.
    • “One way to better understand prices in employer-sponsored insurance is to compare negotiated rates paid in ESI to Medicare payments for the same services. On average the commercial prices of x-rays were 314% of Medicare, MRIs were 307% of Medicare, CT scans were 257% of Medicare, and Ultrasounds were 245% of Medicare. HCCI estimated that, if commercial prices were equal to Medicare prices, ESI spending would be $6B lower for MRIs, $3.1B lower for CT scans, $2.7B lower for ultrasounds, $1.5B lower for nuclear imaging, and $1.2B lower for x-rays.”
  • MedCity News relates,
    • A new report is providing some much needed validation for those in the women’s health industry.
    • Women’s health has long been under-represented, under-researched and under-funded. About 5% of total healthcare R&D and investment funding goes towards women’s health. But a shift is taking place as research shows that increasing investor dollars are starting to flow into women’s health, and not just reproductive health, according to a report released this month from consulting firm PwC. Which means a wholesale modification of the very categories that define women’s health — traditionally thought of only as reproductive health and women specific-conditions such as menopause or endometriosis — is in order.
    • The traditional definition of women’s health only represents a $195-205 billion market, according to PwC. But there are medical conditions that affect women differently — like asthma, cardiovascular diseases, diabetes and mental health. Then there are conditions that affect women disproportionately, including Alzheimer’s, autoimmune diseases and migraines.
    • “When this broader definition is considered that includes a woman’s entire life cycle through all its varied stages, the women’s health industry represents a $430-440 billion global market across pharmaceuticals, devices and diagnostics, providers, payers and consumer health solutions, according to PwC. 
    • “And this is projected to reach $600 billion by 2030, and that’s “if we do nothing,” according to Glenn Hunzinger, PwC’s health industries leader.
    • “If we continue to have a focus, I could see those opportunities getting much wider and much bigger,” he said in an interview.
    • “Investors, advocates and entrepreneurs were encouraged by the report’s call to action.”
  • MedTech Dive tells us,
    • “Boston Scientific has closed its acquisition of incontinence device maker Valencia Technologies, the company said on LinkedIn last week.
    • “The buyout gives Boston Scientific control of eCoin, a tibial nerve stimulator that competes with Medtronic’s Altaviva for the urge urinary incontinence market. Boston Scientific announced the deal in January.
    • “RBC Capital Markets analysts welcomed the deal in a note to investors in January, explaining that the takeover moves Boston Scientific into a high-growth area.”
  • Fierce Pharma informs us,
    • “Neurocrine Biosciences, forever a possible M&A target in the biopharma industry, is making a major acquisition itself.
    • “Neurocine has reached a deal to acquire Soleno Therapeutics for $2.9 billion, bagging recently FDA-approved Vykat XR (diazoxide choline), the first therapy for hyperphagia in patients with the rare genetic neurodevelopment disorder Prader-Willi syndrome (PWS).
    • “Hyperphagia is an insatiable hunger, which can lead to co-morbidities such as obesity and other cardiometabolic diseases and death.
    • “The announcement of the Soleno deal comes a few months after Neurocrine unveiled an obesity pipeline led by a preclinical CRF2 agonist.” 
  • Fierce BioTech points out,
    • “AI powerhouse Anthropic is continuing its push into the healthcare arena with the acquisition of previously stealth AI biotech startup Coefficient Bio in a $400 million stock deal, according to reporting from The Information and Eric Newcomer.
    • “TechCrunch also confirmed the acquisition through sources close to the deal, and Coefficient’s PitchBook page reflects the $400 million transaction as well. Anthropic and Coefficient have not yet responded to Fierce Biotech’s requests for confirmation.”
  • MedCity News adds “Uma Veerappan of Flare Capital Partners thinks the healthcare AI startups that will come out on top will be companies that integrate seamlessly into workflows, build proprietary datasets and quickly determine how to sell their technology.”

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare–

Happy Easter!

From Washington, DC,

  • Congress remains on a State/District work break this week. Both Houses of Congress return to Capitol Hill on April 13.
  • Govexec reports,
    • “President Trump’s fiscal 2027 budget proposal, released Friday morning, would freeze federal civilian employees’ pay in 2027, all while granting a sizeable raise for members of the armed services.
    • “An Office of Management and Budget spokesperson told Government Executive that under Trump’s budget, civilian workers would receive no pay increase next January. But under the plan, members of the military would receive between a 5% and 7% pay increase, with the highest raises going to the lowest ranked personnel.”
  • The U.S. Office of Personnel Management has released its Fiscal Year 2027 Congressional Budget Justification.
    • Worth noting on page 84
      • The FEHB Protection Act of 2025 (FPA) requires OPM to strengthen eligibility verification and oversight of the FEHB Program. OPM is directed to issue regulations and implement verification processes by July 4, 2026, conduct a comprehensive family member eligibility audit between July 4, 2026 – July 4, 2029, and establish a process for removal of ineligible individuals (completed in December, 2025 per statutory deadline).
    • FEHBlog observation — Any improvement in eligibility verification should begin with adding the HIPAA 820 electronic enrollment roster transaction to OPM’s enrollment system. That transaction would allow carriers to reconcile premium payments to individual enrollments. What is the sense of performing this family member audit if carriers don’t know if the individual with self and family or self and family coverage (or half of the enrollment with self only coverage) is paying the correct premium?
  • Healthcare Dive reports,
    • “Antitrust regulators are warning Tennessee not to terminate an agreement giving its health department oversight of Ballad Health, a hospital monopoly in the state.
    • “The Tennessee legislature is considering bills that would allow Ballad’s certificate of public advantage, or COPA, to expire in 2028. Balled was formed in 2018 under the COPA, a controversial mechanism that allows potentially anticompetitive hospital mergers to go through in exchange for increased state oversight for a period of time.
    • “Without the COPA, all state supervision of Ballad’s care quality, availability and access, along with population health initiatives, would end.
    • “That could have steep consequences for Tennessee patients, including higher healthcare costs and poorer quality of care, the Federal Trade Commission said in the letter sent Wednesday.”
  • MedTech Dive relates,
    • “The Trump administration is adjusting how Section 232 tariffs on steel, aluminum and copper imports and derivative products are calculated, according to a proclamation President Donald Trump signed Thursday. 
    • “Under the new rules, which go into effect April 6, goods made almost entirely of aluminum, steel or copper, including steel coils and aluminum sheets, will face a 50% tariff for the value of the item. 
    • “However, derivative articles “substantially made” of steel, aluminum or copper will incur a 25% levy, per a White House fact sheet. Such goods include steel cooking appliances, silverware, diesel-engine trains and semi-trailer hauling trucks, according to a list provided by the White House.” 

From the public health, medical / Rx research front,

  • The Washington Post reports,
    • “Uri Alon was long puzzled by a textbook statistic: longevity, the thinking went, was about 20 percent in our genes.>” * * *
    • “The original studies that were used to estimate how much of lifespan was inherited were studies of Scandinavian twins from the tail-end of the 19th century.
    • “During that era, “extrinsic” mortality was high — deaths that aren’t related to the deterioration of aging, such as accidents, violence or deaths from infections that are now uncommon because of better nutrition, therapies and hygiene.
    • “His team examined a database of Swedish twins born later, between 1900 and 1935, and found that these extrinsic deaths were masking the inherited component of lifespan. When they applied their model, designed to remove extrinsic deaths, to databases of Scandinavian twins and the siblings of centenarians who lived to at least 100, the heritability of lifespan markedly increased — to about half.” * * *
    • “Thomas Perls, a longevity researcher at Boston University and the founding director of the New England Centenarian Study, agrees that genetics play a major role in lifespan, but that it depends on what age you are talking about.
    • “At the very extremes of old age — people who live to 105 or even 110 — genetics play a major role in lifespan. But Perls points to a 2018 study in the journal Circulation that suggests that even without winning the genetic lottery, an average person can probably get to about 88 years old as a man, and 93 years old as a woman. That depends on embracing good health-related behaviors. He also notes that socioeconomic advantages contribute — access to health care, education, healthy food.”
  • and
    • “Joseph Buxbaum was initially unconvinced. When early hints of a connection between autism and Alzheimer’s began to appear in the medical literature a few years ago, they struck him as implausible — one a condition of early brain development, the other driving decline in old age.
    • “But the signals kept accumulating, and over time, his skepticism gave way to a new line of inquiry that could transform scientists’ understanding of the two diseases.
    • “I came to this kicking and screaming. I didn’t want to believe it,” Buxbaum, a professor of psychiatry, neuroscience, and genetics/genomic sciences at the Icahn School of Medicine at Mount Sinai, said.” * * *
    • “The idea that two conditions at opposite ends of life might be biologically linked is beginning to upend long-standing assumptions in brain science, blurring a divide that has shaped the field for decades. Now, some researchers have begun to see the two as intertwined: that understanding Alzheimer’s may require looking back to how the brain develops, and that insights into autism might, in turn, reshape how we understand Alzheimer’s itself.”
  • Medscape tells us,
    • “For decades, clinical dietetics has been based on standardized nutritional recommendations for the general population: food pyramids, and Italy’s nutrient reference values, and dietary indications applied uniformly for conditions such as hypercholesterolemia or hypertension.
    • “In routine practice, however, physicians have increasingly observed that patients with the same caloric intake and physical activity can show different outcomes in terms of weight change, glycemic control, or lipid profile.
    • “This interindividual variability, once considered a clinical anomaly, is now supported by scientific literature. Response to diet does not depend exclusively on energy balance but also on a series of individual biological characteristics that influence nutrient metabolism and the interaction between diet and the body’s physiology.”
    • “Precision nutrition frames diet from a simple quantitative tool of nutrients to a personalized metabolic intervention.
    • “Applications of precision nutrition extend beyond body weight management. It has potential relevance in numerous clinical conditions, including gastrointestinal disorders such as irritable bowel syndrome, food intolerances, kidney stones, and various cardiometabolic conditions.”
  • and
    • “Analysis of real-world pharmacovigilance data shows that GLP-1s demonstrate distinct adverse event patterns across indications, primarily related to metabolic, nutritional, gastrointestinal, and psychiatric disorders, with different profiles observed across treatments.” * * *
    • “As millions of patients are taking GLP-1s for weight control and obesity treatment worldwide, clinicians should be vigilant in monitoring for unanticipated long-term adverse effects,” the authors of the study wrote.”
    • “The study was led by David Stone, Departments of Oncological Sciences and Biomedical Informatics, University of Utah, Salt Lake City. It was published online in Obesity.”

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

  • Beckers Payer Issues reports,
    • “The Blue Cross Blue Shield Association submitted a wide-ranging letter to CMS on March 30 in response to the agency’s information request on its Comprehensive Regulations to Uncover Suspicious Healthcare, or CRUSH, initiative. 
    • [Three of] Seven BCBSA Recommendations
      • “1. CMS should notify Medicare Advantage plans in real time when it suspends payments to a provider over suspected fraud because bad actors are exploiting the current information gap by shifting billing from original Medicare to MA after CMS acted on suspected fraud in fee-for-service.
      • “2. CMS should remove any contractual or policy language that requires MA plans to continue paying claims when fraud is suspected, regardless of whether CMS has paid its portion. The association also recommends that suspect claims be tagged with a unique code or priced at zero member liability at the time of a CMS payment suspension, so MA plans can identify those claims before payment.” * * *
      • “6. Overall, the association says the independent dispute resolution process under the No Surprises Act is broken and needs structural fixes. BCBSA recommends CMS launch the IDR Gateway as soon as possible, implement baseline eligibility screening before payment or review, establish an upfront eligibility fee to deter bad-faith submissions, and create performance metrics.”
  • The Health Care Cost Institute relates,
    • “The prevalence of depression and anxiety has increased steadily since 2019. Previous research, including a report from HCCI,  has identified a concurrent steady increase in the use of antidepressant and anxiolytic medications. Previous studies have found that most people receive prescriptions for psychotropic medications from their primary care providers. This finding describes national prescribing patterns, but few analyses have examined sub-national patterns and whether there is variation at a state level.” * * *
    • “Nationally, approximately three quarters of antidepressant and anxiolytic prescription fills are prescribed by a primary care provider. The remaining quarter of fills are prescribed by psychiatrists and psychiatric NPs, and a small fraction (<1%) are prescribed by other mental health professionals.” * * *
    • “At the state level, there is variation in the proportion of antidepressant and anxiolytic fills prescribed by each provider type. The proportion of fills prescribed by a PCP range from 55% in Washington, D.C. to nearly 86% in West Virginia.  Likewise, Washington D.C. has the highest proportion of fills prescribed by a psychiatrist or psychiatric NP (44%) while West Virginia has the lowest (14%).  The proportion of prescriptions from other mental health providers is highest in Rhode Island (5%) and lowest in Mississippi (0.2%).”
    • “At a national level, the proportion of antidepressant and anxiolytics prescribed by a psychiatrist or psychiatric NP increased by about 2 percentage points from 2018-2022.”
    • “More research is needed to understand the implications of high levels of PCP prescribing. One study found that patients who are treated by PCPs were less likely to be adherent to antidepressant treatment than patients who are treated by psychiatrists, and that patients treated by multiple providers had lower odds of nonadherence than patients treated by a single provider. Future studies should investigate why patients are receiving antidepressant and anxiolytic prescriptions from PCPs. This phenomenon could be related to mental health provider shortages or could indicate integration of mental health care into primary care, which is an objective of collaborative care models. Additional areas of research should include the role of other mental health providers, including allied health professionals, in prescribing medication, and outcomes associated with these prescribing provider types. Understanding how and why people are prescribed medications to treat mental health conditions is foundational for making informed decisions and effective policy to promote mental health care access.”
  • “The Wall Street Journal explains how a consumer can obtain healthcare advice from a AI tool.  The journalist does so in consultation with a human doctor.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iranian war front,

  • Industrial Cyber reports,
    • “New data from KELA recognizes that Iranian state-sponsored threat actors have moved well beyond traditional espionage, increasingly blurring the line between nation-state operations and financially motivated cybercrime. Rather than running large-scale ransomware cartels of their own, these groups have embedded themselves into the existing criminal ecosystem, acting as initial access brokers, collaborating with ransomware affiliates, and deploying pseudo-ransomware to mask destructive attacks as extortion campaigns.
    • “A key example is Pay2Key, an Iran-linked ransomware operation that has resurfaced as a professionalized RaaS platform operating on the anonymous I2P network, actively recruiting affiliates from Russian cybercrime forums and offering an elevated profit share, bumping the affiliate cut from 70% to 80%, for attacks on U.S. and Israeli targets. The model creates a significant compliance risk for victim organizations: paying what appears to be a routine ransom demand could unknowingly funnel money to OFAC-sanctioned Iranian entities, exposing companies to severe legal and financial penalties.
    • “The KELA Cyber Intelligence Center identified in its Monday [March 30] post that one of the more concerning developments is the growing collaboration between Iranian state-linked actors and the broader ransomware ecosystem.”
  • Security Week relates,
    • The FBI has confirmed that threat actors have gained access to an email account belonging to FBI Director Kash Patel, but said no government information has been compromised. 
    • “The Iran-linked hacker group Handala on Friday [March 27] claimed to have hacked Patel’s email account, releasing files allegedly representing photos, emails, and classified documents taken from the FBI director’s inbox.
    • “The so-called ‘impenetrable’ systems of the FBI were brought to their knees within hours by our team,” the hackers wrote. 
    • However, the account does not appear to be hosted on FBI systems; it is a personal Gmail account. In addition, the stolen information does not seem to be recent.
    • It’s unclear when the account was hacked, but it may have been one of the many targeted by Iranian hackers back in 2024 as part of an operation targeting Donald Trump’s presidential campaign.” 
  • Cyberscoop tells us,
    • “Medtech company Stryker says it’s back to being “fully operational,” three weeks after it became the most prominent victim to date of Iranian hackers, who said they attacked the Michigan-based company in retaliation over the conflict with the United States and Israel.
    • “A March 11 wiper attack from the pro-Palestinian, Iranian government-connected group Handala damaged the company’s order processing, manufacturing and shipping.” * * *
    • “Production is moving rapidly toward peak capacity with discipline and stability, supported by restored commercial, ordering and distribution systems,” the company wrote in an update on its website Wednesday. “Overall product supply remains healthy, with strong availability across most product lines, as we continue to meet customer demand and support patient care.”
    • “Stryker said it continues to work with outside cyber experts, government agencies and industry partners on its investigation and recovery.” * * *
    • “Iranian hackers have been busy since the U.S.-Israel strikes began, but have claimed few successes in the United States. Handala boasted this week about an attack on St. Joseph County, Indiana, where officials said they were investigating a hack of its external fax service.”

From the cybersecurity policy front,

  • Cybersecurity Dive reports,
    • “President Donald Trump on Friday [April 3] proposed significantly slashing the Cybersecurity and Infrastructure Security Agency’s budget.
    • “The White House’s fiscal year 2027 budget would reduce CISA’s funding by $707 million, roughly 30% of its FY2025 budget of $2.4 billion.
    • “The administration said its proposal “refocuses CISA on its core mission” of protecting federal networks and helping critical infrastructure operators defend themselves from cyberattacks and physical threats.”
  • Per a March 31 HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced that it is reversing a 2024 reorganization that: (1) dually titled the Office of the National Coordinator for Health Information Technology (ONC) as the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), headed by the Assistant Secretary for Technology Policy, dually titled as the National Coordinator for Health IT; (2) moved three HHS-wide technology roles to ONC from the Office of the Chief Information Officer (OCIO); and (3) shifted specific cybersecurity functions out of OCIO.
    • “Today’s action restores a unified, Department‑wide technology leadership model by returning these enterprise responsibilities to OCIO while sharpening ONC’s mission focus on nationwide health IT interoperability and data liquidity.
    • “Under this alignment, HHS has ended the Biden administration’s dual management title for the Assistant Secretary for Technology Policy, restored ONC as a singularly titled office, and shifted the roles, responsibilities, and offices of the HHS Chief Technology Officer (CTO), HHS Chief Artificial Intelligence Officer (CAIO), and HHS Chief Data Officer (CDO) back under the HHS Chief Information Officer’s leadership. This structure reinforces OCIO’s statutory responsibility for enterprise IT, cybersecurity, and data operations, while enabling ONC to concentrate on health IT policy, standards, and certification that support better care and lower costs.
    • “To better integrate policy and operations, OCIO will organize enterprise roles around three core functions: (1) strategic technology leadership and innovation, led by the CTO; (2) responsible, trustworthy artificial intelligence, led by the CAIO; and (3) enterprise data governance and analytics, led by the CDO. These leaders will work as a unified team under the CIO to deliver secure, scalable platforms and common services that support ONC’s policy work and the Department’s mission programs.
    • “This structure allows OCIO to provide an integrated backbone for cloud, cybersecurity, data, and AI that every HHS component can rely on,” said HHS Chief Information Officer Clark Minor. “By bringing CTO, CAIO, and CDO functions together under one roof, we can move faster on shared platforms, protect our systems more effectively, and support ONC and the operating divisions with the technology capabilities they need to innovate for patients.”
  • Cybersecurity Dive informs us,
    • “Federal government leaders are prioritizing cybersecurity improvements as they sketch out their technology-modernization agendas for the year, consulting firm EY said in a survey released this week.
    • “Roughly half of survey respondents (56%) said cybersecurity was one of their top modernization priorities, with roughly a third saying that growing cybersecurity threats “are a barrier for their agencies to achieve their modernization goals,” the survey found.
    • “EY also presented data on government leaders’ impressions of their agencies’ current security postures and their hopes for AI.”
  • Bleeping Computer points out,
    • “The U.S. Federal Bureau of Investigation (FBI) warned Americans against using foreign-developed mobile applications, particularly those created by Chinese developers.
    • “In a public service announcement (PSA) issued via its Internet Crime Complaint Center (IC3) platform this Tuesday [March 31], the FBI warned of privacy and data security risks associated with these apps.
    • “As of early 2026, many of the most downloaded and top-grossing apps in the United States are developed and maintained by foreign companies, particularly those based in China,” the bureau warned.”

From the cybersecurity breaches and vulnerabilities front,

  • Health Exec reports on April 2,
    • “A hospital in Texas revealed that it’s fallen victim to a data breach that exposed the personal information of more than 257,000 patients to hackers.
    • “Nacogdoches Memorial Hospital—an independent health system in Texas consisting of one emergency-capable facility, several affiliated provider practices, and a rehabilitation center—made the breach public this week.
    • “The incident occurred on Jan. 31—or at least, that’s when Nacogdoches Memorial staff became aware of an ongoing cyberattack.
    • “At that time, the hospital said it notified law enforcement, initiated an “incident response plan” and began an investigation to find out what happened. As for details such as the nature of the breach and who was responsible, neither a statement from Nacogdoches Memorial nor a report filed with the Office of the Maine Attorney General contain those details.
    • “To date, no known listing of the data trove on the dark web exists, and no hacker group has claimed responsibility for the cyberattack. Whether or not the data will eventually end up leaked onto the Internet or put up for sale remains unknown—but given the scope of the breach and the black market value of the stolen information, it’s not out of the realm of possibility.”
  • Bleeping Computer relates,
    • “Telehealth giant Hims & Hers Health is warning that it suffered a data breach after support tickets were stolen from a third-party customer service platform.” * * *
    • “It is one of the most successful U.S. brands in the online pharmacy and telehealth space, with strong marketing presence, and annual revenues close to $1 billion.” * * *
    • “BleepingComputer learned last month that the ShinyHunters extortion gang conducted the breach.
    • “The data was stolen as part of a widespread campaign in which threat actors compromised Okta SSO accounts to gain access to third-party cloud storage services and SaaS platforms to steal data.
    • “In this particular attack, BleepingComputer was told that the threat actors used the Okta SSO account to access the His and Hers Zendesk instance, where they stole millions of support tickets.”
  • Dark Reading notes,
    • “The impact of TeamPCP’s high-profile supply chain attacks is rapidly expanding — in more ways than one.
    • “Following last month’s spree of compromised open source projects, two victim organizations disclosed breaches related to the attacks this week. On Tuesday, AI startup Mercor said on social media platform X that it was “one of thousands of companies impacted by a supply chain attack involving LiteLLM.”
    • “And on Thursday, the EU’s Computer Emergency Response Team (CERT-EU) disclosed that a recent attack on the European Commission’s cloud and Web infrastructure stemmed from the previously reported Trivy supply chain attack,also attributed to TeamPCP. According to CERT-EU, the EC inadvertently installed a compromised version of the Trivy code-scanning security tool, which allowed threat actors to harvest credentials and secrets that they later used to access the organization’s Amazon Web Services (AWS) cloud environment.”
  • The American Hospital Association News tells us,
    • “The Cybersecurity and Infrastructure Security Agency released an alert March 27 on a vulnerability in F5 BIG-IP Access Policy Manager software that is being exploited for malicious cyber activity. F5 devices and software, used widely by health care and other critical infrastructure, provide app security and management services. The vulnerability was previously disclosed in October 2025 as a denial-of-service issue but was reclassified this month due to new information that found the vulnerability allows malicious actors to perform remote code execution, according to an alert from F5. 
    • “F5 has determined that this issue is much more severe than previously thought,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “The original patch released last year fixes the larger issue, so if you are using F5’s BIG-IP software, a very common app delivery and security service, ensure that you patch the system as soon as possible.” 
       
  • Cybersecurity Dive informs us,
    • “Security researchers warn that chaining two critical vulnerabilities in Progress Software’s ShareFile service could allow an attacker to achieve remote code execution.
    • “The flaws exist in ShareFile Storage Zones Controller, which helps users manage files while they are using the ShareFile software-as-a-service interface, according to researchers at watchTowr Labs.
    • “The vulnerabilities include an authentication bypass flaw, tracked as CVE-2026-2699, and a remote code execution flaw, CVE-2026-2701. The vulnerabilities have severity scores of 9.8 and 9.1, respectively.
    • “Progress Software warned in a security bulletin released Thursday [April 2] that an attacker could access on-premises Storage Zones Controller configuration pages, allowing them to make changes in system configuration or achieve remote code execution.
    • “There is no immediate evidence of exploitation, but researchers urged users to immediately apply security updates.”
  • and
    • “A North Korean threat actor is suspected to be behind a major supply chain attack against a
      Axios, a JavaScript library that is downloaded more than 100 million times per week, according to security researchers. 
    • “Earlier this week, an attacker compromised the node package manager account for an axios maintainer and introduced a malicious dependency plain-crypto-js. The malicious versions were deleted within a few hours, but, with the widespread use of axios, there was a risk that a large number of users could have downloaded the poisoned version.
    • “Researchers from Google Threat Intelligence Group said the malicious dependency is an obfuscated dropper that deploys a backdoor called Waveshaper.v2 across Windows, Linux and Mac environments.” 
  • Bleeping Computer notes,
    • “Threat actors are exploiting the recent Claude Code source code leak by using fake GitHub repositories to deliver Vidar information-stealing malware.
    • “Claude Code is a terminal-based AI agent from Anthropic, designed to execute coding tasks directly in the terminal and act as an autonomous agent, capable of direct system interaction, LLM API call handling, MCP integration, and persistent memory.
    • “On March 31, Anthropic accidentally exposed the full client-side source code of the new tool via a 59.8 MB JavaScript source map included by accident in the published npm package.”
  • and
    • “Device code phishing attacks that abuse the OAuth 2.0 Device Authorization Grant flow to hijack accounts have surged more than 37 times this year.
    • “In this type of attack, the threat actor sends a device authorization request to a service provider and receives a code, which is sent to the victim under various pretexts.
    • “Next, the victim is tricked into entering the code on the legitimate login page, thus authorizing the attacker’s device to access the account through valid access and refresh tokens.
  • Per Cyberscoop,
    • “A new malware-based credential-stealing campaign, which researchers are calling “DeepLoad,” has been infecting enterprise business IT environments.
    • “In a report released Monday, ReliaQuest AI researchers Thassanai McCabe and Andrew Currie say the most relevant feature of this attack is the way it uses artificial intelligence and other engineering “to defeat the controls most organizations rely on, turning one user action into persistent, credential-stealing access.”
    • “DeepLoad is delivered to victims via “QuickFix” social-engineering techniques, such as fake browser prompts or error pages. If the user falls for the scheme, the malware developers — or more likely their AI tools — put a lot of work into building evasion of security technology “at every stage” of the attack chain.
    • “The loader “buries functional code under thousands of meaningless variable assignments,” and the payload runs behind a Windows lock screen process that is “overlooked by security tools” monitoring for threats. ReliaQuest said “the sheer volume” of code padding likely rules out human-only involvement.”
  • Info Security discusses,
    • “A new malware-as-a-service (MaaS) platform dubbed Venom Stealer that automates credential theft and continuous data exfiltration has been identified by cybersecurity researchers.
    • “The platform is being sold on cybercrime networks and is designed to go beyond traditional credential harvesting tools by maintaining ongoing access to stolen data even after the initial infection.”

From the ransomware front,

  • Cisco Talos reflects on ransomware trends in 2025.
  • Cyberscoop reports,
    • “The Akira ransomware group has compromised hundreds of victims over the past year with a well-honed attack lifecycle that has whittled down the time from initial access to encryption of data in less than four hours, according tocybersecurity firm Halcyon.”
  • Security Week relates,
    • “Like an inverted pyramid, the range of different attack modes are now built on top of the single point of identity abuse.
    • “Stolen credentials are a major threat. Legitimate credentials illegitimately acquired provide legitimate access to illegitimate actors. Once inside the network, these bad actors have greater ability to move and act in stealth. The continuing rise in ransomware attacks bears testament.
    • “The theft and resale of credentials operates on an industrial scale. Fueled by the rise of increasingly more sophisticated infostealers, stolen credentials are packaged into ‘logs’ and sold to criminals on the black market. Ontinue reports, “Listings tied to LummaC2 alone surged by 72%, with high-privilege cloud console credentials selling for $1,000–$15,000+.”
    • “Ransomware has been one of the primary beneficiaries of stolen credentials. More than 7,000 incidents and 129 active groups were tracked through 2025. At the same time, ransom payments decreased slightly from $892M in 2024 to $820M in 2025. This apparent contradiction is actually logical.
    • “Larger targets, with larger payout potential, will have seen the most aggressive corporate investment (process and technology) mitigating exposure to this attack pattern,” explains Trey Ford, chief strategy and trust officer at Bugcrowd. These larger targets are also more susceptible to government pressure to not pay ransoms, and ransomware income has consequently declined. The ransomware groups have responded with more attacks demanding smaller payments from more but smaller companies.” 

From the cybersecurity defenses front,

  • Dark Reading reports,
    • “After some delay, Apple has patched the vulnerabilities associated with the DarkSword exploit chain for all affected customers, even those who aren’t updated to iOS 26 — a boon for organizations trying to get users updated to a new version all at once, and for those with patch management policies that preclude such updates.”
  • and
    • “Joseph Izzo, chief medical information officer for San Joaquin General Hospital, received ransomware training during a downtime period. He practiced responding and maintaining patient care in the event that the facility is forced to operate offline. But when the hospital where he was working was actually hit with ransomware, he realized very quickly how “different it was under pressure.” 
    • “Izzo shared his story at RSAC 2026 Conference and provided key incident response (IR) recommendations for healthcare organizations, a sector frequently targeted by ransomware gangs due to highly sensitive information. Ransomware doesn’t always cripple hospitals, but partial attacks happen frequently, Izzo explained. Either way, a rapid response is necessary when serving a vulnerable population.
    • “Recommendations ranged from identity protection to being prepared to operate with pen and paper in a digital world. Preparation is what really “makes the difference” when healthcare facilities are trying to get past a ransomware incident, Izzo emphasized.” 
  • Cybersecurity Dive tells us,
    • “Cybersecurity is one of the leading risks influencing corporate executives’ decisions about AI adoption, the consulting firm KPMG said in a quarterly AI pulse survey released on Tuesday.
    • “Three-quarters of senior leaders at large corporations told KPMG that they were worried about the cybersecurity and privacy risk associated with AI tools, according to the report.
    • “The survey also asked questions about governance approaches and agentic AI, offering a window into how businesses around the world are wrestling with new security challenges.”
  • Here is a link to Dark Reading’s CISO Corner.

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.”

Weekend update

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

From Washington, DC,

  • Congress left town late last week on two weeklong recess which wraps around the upcoming Passover and Easter holidays.
  • Beckers Payer Issues reports,
    • “Healthcare took center stage in governors’ 2026 “State of the State” addresses.
    • “The National Governors Association compiled excerpts from across the country that focused on healthcare, ranging from technology use to the Rural Health Transformation Program to insurance reforms.”
  • The FEHBlog expects that OPM’s call letter for 2026 FEHB and PSHB benefit and rate proposals will be released this week, and the sooner the better.

From the public health and medical / Rx research front,

  • ABC News reports on how online gambling has become a public health crisis for our Nation’s youth.
    • “[T]he link between gambling early and gambling addiction has become increasingly clear. While only 1% of adults who gamble report addictions, the Journal of Behavioral Addictions reports that between 2% and 7% of young people who place bets report gambling addictions. 
    • “Young people’s brains are particularly susceptible to this because … the parts of their brains that respond to these rewards develop more quickly,” said Dr. Nasir Naqvi, the director of Columbia University’s gambling disorders clinic. “So they become sensitive to these awards and to that dopamine release before the part of their brain that helps them to control these behaviors.” 
    • “Naqvi says he now routinely hears about children as young as 13 seeking support for possible addictions to gambling. 
    • “I don’t want to overstate the problem. But yes … it’s a looming public health crisis,” Naqvi told ABC News. “In fact, it’s already here.” 
  • Medscape reports,
    • “Going into 2026, widespread shortages of most major diabetes medications had largely stabilized: The shortages of Humulin and lispro insulin vials, and therefore medications, that dogged Indianapolis-based Eli Lilly in spring and summer 2024 have resolved, and it, like other manufacturers, has largely caught up with much of the demand for its GLP-1 products as well. 
    • “However, experts from the advocacy group T1D Strong say that shortages of GLP-1 receptor agonists, basal and rapid-acting insulin analogues, and several frontline oral agents are expected to persist into 2026 as the supply chain remains unstable, and especially in certain geographic pockets. 
    • “When shortages occur, it often falls to primary care clinicians to improvise substitutions and bridge strategies, while hospitalists see the downstream effects of shortages in real time in patients who show up with conditions like dehydration, medication errors, and avoidable admissions. The challenge has shifted from simply locating medication to building structured, risk-based strategies that prevent treatment gaps and protect the most vulnerable patients.” “
  • and
    • “Repeating the same meals and keeping calorie intake steady produced more weight loss than eating a more varied diet among individuals living with overweight or obesity, a short-term trial showed.
    • “Conventional wisdom around dieting says you should incorporate a lot of different foods to avoid getting bored and that you should splurge on the weekends or special occasions so you don’t feel as deprived,” lead author Charlotte Hagerman, PhD, of the Oregon Research Institute, Springfield, Oregon, told Medscape Medical News. “This contradicts research showing that consistency makes your behavior more habitual, that is, more automatic or effortless.
    • “We wanted to formally test these competing ideas in a group of people trying to lose weight,” she explained. “Maintaining a healthy diet in today’s food environment requires constant effort and self-control. Creating routines around eating may reduce that burden and make healthy choices feel more automatic.”

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

  • Modern Healthcare reports,
    • “Insurers and providers are locked in more messy contract disputes than in previous years
    • “A convergence of economic pressures across nearly all business lines has raised the stakes.
    • “Reimbursement disagreements are just one factor as providers object to insurance company practices.
    • “Both sides are equipped with unprecedented access to price transparency data.”
  • STAT News reports,
    • “Alex Zhavoronkov, CEO of Insilico Medicine, can’t stop complimenting Eli Lilly. “Lilly is better in AI than Insilico, and no other company is better in AI than us … except for these guys,” he said. 
    • “He insisted he wasn’t saying nice things about Lilly just because the pharma giant has signed a new deal with Insilico that’s worth $115 million up front and approximately $2.75 billion in biobucks, which are contingent on achieving regulatory and commercial milestones. After calling Lilly’s tirzepatide, which he is on, “the best drug ever invented by humans,” he said he’s been consistently singing Lilly’s praises for a year. “Mounjaro makes me so happy every day. I want to develop the next one.
    • “It looks like Zhavoronkov might have the opportunity to do just that — his AI drug development company’s new deal with Lilly, announced on Sunday, includes rights for the Mounjaro and Zepbound manufacturer to develop, manufacture, and commercialize some of Insilico’s preclinical AI-discovered candidates for oral therapeutics. Though he declined to say which assets Lilly licensed, he said that the company is the “absolutely best partner” for the candidates and that “nobody is better than them” in these disease areas. Insilico’s pipeline webpage recently was updated to note that a candidate targeting GLP-1 has been out-licensed to an undisclosed partner.” 
  • Beckers Hospital Review relates,
    • “Hospitals and health systems have continued to close maternity units, citing ongoing financial challenges, workforce shortages and declining birth rates. However, in rural Kansas, AdventHealth Ottawa — part of Altamonte Springs, Fla.-based AdventHealth — recently restored labor and delivery services to Franklin County.
    • “The AdventHealth Ottawa Family Birth Place temporarily closed in 2023 and reopened in September 2025 with a fully staffed labor and delivery team. As of August 2025, the hospital had hired 11 full-time staff for the unit, with additional providers joining in 2026.
    • “Maternity care challenges remain significant. A report reflecting data stretching into 2026 from the Center for Healthcare Quality and Payment Reform found that fewer than half of U.S. rural hospitals still offer labor and delivery services. In a dozen states, fewer than one-third do.
    • “Becker’s has reported similar trends, including 29 maternity service closures in 2025 and seven in 2026. Against that backdrop, AdventHealth Ottawa’s reopening stands out.
    • “What’s unique about Ottawa is that we’re an OB desert that does not sit in a population desert, so there’s a lot of population around us that doesn’t have OB services,” AdventHealth Ottawa President and CEO Brendan Johnson said in a hospital video. “But within a large circumference, there’s about 400 to 500 births a year that didn’t have a place to go.”
  • and
    • “Defining return on investment for healthcare technology has never been more consequential — or more contested. As health systems face mounting financial pressure, workforce strain and the rapid proliferation of AI-driven tools, the question of what truly constitutes a return on a technology investment has grown more complex than a simple cost-benefit calculation. The old metrics — uptime, deployment speed, license cost — no longer tell the full story. 
    • ‘”Across the industry, a new framework is emerging, one that measures ROI not just in dollars saved or revenue gained but in time restored to clinicians, cognitive burden lifted, outcomes improved, and trust strengthened between technology and the people who use it. From community hospitals to academic medical centers, health system leaders are redefining what it means for technology to deliver value. Becker’s asked 50 healthcare leaders how they define ROI for a technology they invest in.” [The answers are found in the article.]