Monday report

FDA

Monday report

David Ermer–CMS, Congress, FDA, Generative AI, HSA, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Washington Post lets us know,
    • “The White House will make the case Monday to Congress — and to voters — that it has developed a strategy to address frequent frustrations involving U.S. medical care, such as too few physicians and too much paperwork.
    • “The Trump administration casts its physician-focused agenda as a fix for a strained health care system — pointing to a $50 billion funding program for rural health it contends will boost the number of doctors in remote areas, efforts to reduce payment distortions that favor hospitals rather than doctors, and regulatory changes intended to speed insurance approvals for tests and follow-up care.
    • “Together, these reforms will enable faster, more affordable, and higher-quality physician services for Americans,” the White House writes in the Economic Report of the President [WhiteHouse.gov link], an annual document previewed with The Washington Post and set to be transmitted to Congress on Monday.
    • “The economic report, which does not offer new proposals, is best understood as a distillation of White House economists’ thinking ahead of this year’s midterm elections, in which voters’ frustrations regarding health care costs and access are set to play a central role. Past administrations have often used the report, which is written by the president’s Council of Economic Advisers, as a messaging document to rally support for their initiatives. This year’s report addresses health care affordability, a key focus for President Donald Trump and his advisers, and says it is working to “unleash” more competition in health care markets to lower costs and improve quality.”
  • Bloomberg Law informs us,
    • “Senate Republicans aren’t planning to include Medicare and Medicaid changes in the next partisan spending package—instead focusing it largely on ending the partial government shutdown.
    • “Top Republicans plan to use a bill that advances through the simple-majority budget reconciliation process to fund immigration enforcement and US Border Patrol and would not require Democrats’ support.
    • “Though some Republicans have been pushing for including Medicare and Medicaid policies in the package, the narrow focus does not leave room for other priorities, Senate Majority Leader John Thune (R-S.D.) said Monday. He said budget instructions will not be sent to the Senate Finance Committee.” * * *
    • “But he didn’t rule out returning to other health care policies. For instance, he mentioned a provision blocking federal Medicaid payments from going to Planned Parenthood, which was included in the 2025 tax-and-spending law and sunsets in July, as a possible candidate for inclusion.”
  • Beckers Hospital Review reports,
    • “CMS on April 10 proposed a 2.4% pay increase for hospitals under the fiscal 2027 Inpatient Prospective Payment System, but hospitals are concerned that the update does not keep pace with the mounting financial challenges.
    • “CMS has proposed another inadequate update to inpatient payment rates, another extremely high productivity cut, and reductions to disproportionate share payments — in the face of rising need for care and higher uninsured rates,” Ashley Thompson, the American Hospital Association’s vice president of public policy analysis and development, said in an April 10 statement. 
    • “Beth Feldpush, America’s Essential Hospitals’ senior vice president of policy and advocacy told Becker’s in an April 11 statement that the proposed DSH payment cuts “fails to acknowledge the growing number of uninsured individuals due to recent Congressional actions.” 
    • ‘Charlene McDonald, president and CEO of the Federation of American Hospitals, said in an April 10 statement that CMS’ proposal is a step in the right direction, but added it “does not negate the compounding effects of rising inflation, record levels of uncompensated care and a growing uninsured population.”
    • “National hospital group leaders also raised concerns about another aspect of the proposal: the introduction of the first mandatory nationwide episode-based payment model.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare and Medicaid Services picked 150 digital health companies and healthcare providers to participate in the launch of its tech-enabled chronic care model.
    • “The Center for Medicare and Medicaid Innovation (CMMI) announced in December the Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model as a 10-year payment program to encourage the use of technology to treat chronic diseases. CMS aims for the ACCESS Model to provide stable, recurring payments for technology used to treat diabetes, hypertension, chronic kidney disease, obesity, depression and anxiety. The model will help pay for telehealth software, wearables and wellness apps that address the conditions.
    • “The CMMI plans to use outcome-aligned payments to cover the cost of technology for Medicare providers if a patient with a qualifying chronic condition achieves clinically significant outcomes, such as lowering their blood pressure.” 
  • Citeline points out,
    • An April 1, 2026, proposal [Federal Register link] from the US Treasury Department would allow whistleblowers who alert the government to certain financial crimes to collect 10%-30% of any monetary penalties collected, creating a new risk for healthcare firms – especially those with overseas business partners. The public comment period ends on June 1, 2026.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For the first time, the FDA has approved generics for AstraZeneca’s Type 2 diabetes blockbuster Farxiga. The U.S. regulator has given thumbs up to 14 companies, including Teva, Sandoz and a host of Indian drugmakers including Aurobindo, Biocon, Cipla, Lupin and Zydus to produce 5 mg and 10 mg tablets of dapagliflozin.
    • “The treatment is indicated for glycemic control and to reduce the risk of hospitalization for heart failure for those with Type 2 diabetes who also have established cardiovascular disease or multiple cardiovascular risk factors.Farxiga generated sales of $8.5 billion last year, including $1.7 billion in the U.S.
    • “The FDA originally approved the SGLT2 inhibitor in 2014. Generic versions of Farxiga became available (PDF) in the U.K. and Japan in the second half of last year.”
  • and
    • “From a negative phase 3 readout and a seemingly tightening regulatory climate to a grueling three-month review extension, the path for Travere Therapeutics in its first-in-disease bid was anything but certain. Yet, the company has defied the odds, securing Filspari a landmark FDA approval in focal segmental glomerulosclerosis (FSGS) and delivering the first treatment for the rare kidney disease.
    • “Monday’s FDA approval makes Filspari the first therapy specifically indicated for FSGS, a condition that represents a $1 billion-plus sales opportunity, according to Leerink Partners analysts. The drug was originally approved in 2023 for the treatment of IgA nephropathy, another kidney disease.
    • “FSGS is estimated to affect more than 40,000 patients in the U.S. The disorder is characterized by scarring in the kidney’s filtering units as protein keeps leaking into the urine, often leading to further disease progression and kidney failure, sometimes quite rapidly.” 
  • Cardiovascular Business relates,
    • “Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has received U.S. Food and Drug Administration (FDA) clearance for a new algorithm designed to detect signs of cardiac amyloidosis (CA). This represents Anumana’s second FDA clearance in just two weeks, highlighting the company’s growing impact in the world of cardiovascular care. 
    • “CA is a life-threatening condition that often leads to heart failure complications, but it remains critically underdiagnosed. Anumana sees this clearance as a way to help care teams identify CA early so patients can receive timely treatment.
    • “The newly cleared algorithm, which previously received the FDA’s breakthrough device designation, was designed to evaluate standard 12-lead electrocardiograms (ECGs) and flag patients at increased risk of CA. 
    • “Each of our FDA-cleared algorithms addresses a specific and frequently missed cardiovascular condition, and cardiac amyloidosis represents an important addition to that portfolio,” Maulik Nanavaty, CEO of Anumana, said in a prepared statement. “The more conditions we can identify from a single ECG, the more valuable the test becomes in clinical practice. That’s what Anumana is working toward with each new clearance as we continue to advance our rigorous clinical evidence approach.”

From the census front,

  • The Wall Street Journal reports,
    • “The first of the youth-obsessed baby boomers turn 80 this year, including President Trump, and they want to shake up old age.
    • “Having reached octogenarian levels, a generation that shaped much of our past is shaping the future of aging for themselves and those who follow. They want better healthcare and housing, cures for dementia and a say in when to die. New professions and products will appear. Their massive spending will shift and innovators will follow.
    • “They are reinventing old age,” says Joseph Coughlin, director of the Massachusetts Institute of Technology AgeLab. Unlike the patient Silent Generation, boomers had high expectations and used their sheer numbers as well as financial and political clout to make them happen, which isn’t necessarily a bad thing.
    • “If you don’t have expectations of getting better, then you simply become satisfied with what is,” says Coughlin.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Protein-hungry shoppers are buying more meat with their health top of mind. Health experts, however, wish they’d think beyond the butcher counter.” * * *
    • “Meat is indeed packed with protein, but it comes with some well-established health drawbacks.
    • “Saturated fat we’ve known about for decades,” said Dr. Sarah C. Hull, a cardiologist at Yale Medicine. It’s common in red meat and contributes to increasing LDL cholesterol levels, hardening the blood vessels and, in turn, raising the risk of heart attack or stroke.” * * *
    • “Hull said that many common plant-based proteins are particularly high in fiber, which 95% of Americans don’t get enough of, and they’re generally associated with better overall health outcomes than animal proteins. Her research suggests that increased consumption of certain plant-derived nutrients may help counter some negative effects of red meat and ultra-processed foods.”
  • Health Day relates,
    • “Influenza vaccination may offer cardiovascular protection even when it does not prevent infection, according to a study published online April 2 in Eurosurveillance.” * * *
    • “Hospital admissions for heart attack and stroke were more frequent in the first week after testing positive for influenza than during any other period in the year before and after their test,” the authors write. “This increased risk was about half as high among people who tested positive for influenza but had received the influenza vaccine that season.”
  • and
    • “Children with ADHD are more apt to have a bright future if they’re diagnosed in their early elementary years rather than as high schoolers, a new study says.
    • “Kids diagnosed with ADHD at an earlier age are more likely to have better grades and go on to college, researchers reported April 8 in JAMA Psychiatry. They’re also less likely to drop out of school.
    • “ADHD diagnosis during the first years of school was associated with better school performance, more academic track choices and lower probability of school dropout,” concluded the research team led by Lotta Volotinen, a doctoral researcher at the University of Helsinki in Finland.
    • “The findings support the recommendations for earlier diagnosis, and screening for ADHD before age 12 years should be considered,” the team wrote.”
  • The American Medical Association lets us know “what doctors wish patients knew about managing food allergies.”
    • Once a food allergy is diagnosed, learning how to avoid triggers, recognize warning signs and when to seek medical care are key. Two physicians share more.
  • Per Cardiology Advisor,
    • “Maternal stroke is associated with significantly higher rates of maternal mortality and severe delivery complications, including cardiac arrest and acute renal failure.”
  • Per Pulmonology Advisor,
    • “The increased risk for asthma attacks among those using marijuana was consistent regardless of whether individuals vaped or smoked cannabis or did both.”
  • Per an Oregon State University news release,
    • “Researchers at Oregon Health & Science University have uncovered a key reason why immunotherapy has largely failed in pancreatic cancer — and identified a promising strategy to overcome that resistance. 
    • “The study, published in the journal Immunity, shows that pancreatic tumors actively reshape their immune environment by co‑opting regulatory immune cells that normally shut down tumor-killing cells. By reprogramming those cells, the research reveals a potential pathway to make immunotherapy effective against one of the deadliest and most treatment‑resistant cancers. 
    • “Pancreatic cancer is incredibly resistant to most therapies,” said the study’s senior author, Katelyn Byrne, Ph.D., assistant professor of cell, developmental and cancer biology in the OHSU School of Medicine and member of the OHSU Brenden‑Colson Center for Pancreatic Care. “Even when we know the immune system is capable of long‑lasting protection, it’s been very difficult to get that response to work in this disease.” 
    • “In the new study, Byrne and team tested an experimental immunotherapy in mouse models known as agonistic CD40, which works differently from standard checkpoint inhibitors. Rather than targeting a single immune signal, the therapy broadly activates the immune response upstream. 
    • “Byrne said the researchers were surprised to find out that activating the immune system this way didn’t just stimulate tumor‑killing cells — it also reprogrammed regulatory T cells, converting them from immune suppressors into cells that support anti‑tumor activity. 
    • “We didn’t expect this,” Byrne said. “The therapy doesn’t directly target Tregs, but as a secondary effect of turning on the immune response, those Tregs changed their behavior. Cells that were shutting down the immune reaction suddenly started supporting tumor killing.” 
    • “The team’s findings help explain one reason why many immunotherapies haven’t worked in pancreatic cancer and point to a possible solution: Treatments may need to both turn on the immune system and overcome the tumor’s own ability to shut it down.” 
  • Per an NIH news release,
    • “A National Institutes of Health (NIH)-funded research team has discovered an enhanced CRISPR gene-editing system that could enable targeted delivery inside the human body — a key step toward broader clinical use. Researchers identified a naturally occurring enzyme, Al3Cas12f, that is small enough to fit into adeno-associated virus vectors, a leading targeted delivery method for gene therapies. They then engineered an enhanced version that dramatically improved gene-editing performance in human cells. 
    • “The advance addresses a major limitation in CRISPR technology. Commonly used gene-editing proteins are too large for targeted delivery systems, restricting clinical applications to cells modified outside the body, such as blood and bone marrow. 
    • “Smart delivery of gene editing systems is a powerful notion with broad clinical implications, and this basic science finding takes us a significant step toward that future,” said Erica Brown, Ph.D., acting director of NIH’s National Institute of General Medical Sciences (NIGMS).” 
  • BioPharma Dive adds,
    • “Revolution Medicines said Monday its experimental pancreatic cancer drug hit every goal at an early checkpoint in a Phase 3 trial, helping people who got it live nearly twice as long as those who got standard chemotherapy.
    • “Enrollees who got daraxonrasib lived a median of 13.2 months after treatment, compared with 6.7 months for those who got chemo, a finding that equates to a 60% reduction in the risk of death among those who got the experimental drug. Daraxonrasib achieved its other objectives at an interim look at the results, findings so striking that the company ended the trial early. Revolution enrolled people whose metastatic pancreatic cancer had returned after an earlier treatment.
    • “The Food and Drug Administration has already awarded daraxonrasib a “national priority” voucher that could help Revolution gain an approval within weeks of an official submission. Revolution shares rose nearly 40% in early trading, adding $7 billion to the company’s already hefty valuation.”
  • BioPharma Dive also informs us,
    • “An experimental therapy from Allogene helped eliminate signs of cancer better than standard treatment in a Phase 3 trial in first-line large B-cell lymphoma, results suggesting the biotechnology company may have found a role to use donor-derived cell therapy against the deadly blood cancer.  
    • “After 45 days of treatment, seven of the 12 patients given Allogene’s therapy in the study were negative for “minimal residual disease,” meaning that diagnostic tests could no longer detect signs of cancer. By comparison, only 2 of 12 placebo recipients hit that mark, a roughly 42-percentage-point difference that clears an important bar published literature has suggested is crucial for delaying a relapse. 
    • “The results come from an early “futility” analysis. Allogene is enrolling 220 people in the study and expects to report in 2027 results showing whether treatment staved off cancer’s return.
  • and
    • “In experimental drug from Spyre Therapeutics helped lower signs of disease activity and improve remission rates in a Phase 2 study of people with ulcerative colitis. 
    • After 12 weeks of treatment, patients who received “SPY001” in the trial had a statistically significant, 9.2-point reduction on a scoring system that assesses the severity of their disease, meeting the study’s primary objective. Notably, treatment was also associated with a 40% remission rate and a 51% improvement on endoscopic imaging. One severe adverse event was reported — chest pain in a 68-year-old male with a history of cardiovascular disease — but was deemed unrelated to treatment.
    • Spyre said the findings were “clinically meaningful” and support SPY001’s “best-in-class profile.” The drug is one of multiple therapies the company is evaluating in Phase 2 trials in inflammatory bowel disease. Proof-of-concept data for two other therapies in the trial are expected later this year. Data from a placebo-controlled portion of the study are on track for 2027.” 
  • Per Fierce Pharma,
    • “Eli Lilly has chalked up another victory in the chronic lymphocytic leukemia (CLL) space, as its BTK inhibitor Jaypirca delivered its fourth positive phase 3 readout in the blood cancer. 
    • “Monday, Lilly said its phase 3 Bruin CLL-322 trial in patients with previously treated CLL or small lymphocytic lymphoma (SLL) has met its primary endpoint. In an industry first, the study showed that adding Jaypirca to a fixed-duration regimen of venetoclax and rituximab significantly extended progression-free survival (PFS) compared with the standard combo alone. 
    • “As Lilly pointed out, Bruin CLL-322 is the first phase 3 in CLL to utilize and outperform a venetoclax-based regimen. Roche and AbbVie sell venetoclax, an oral BCL-2 inhibitor, under the brand name Venclexta.” 

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

  • Beckers Payer Issues reports,
    • “Houston-based Memorial Hermann Health System and BCBS Texas agreed on a contract April 11, bringing the health system back in network.
    • “The agreement ensures “access to quality care at cost-effective prices,” BCBS Texas said in an April 13 statement shared with Becker’s. It covers both commercial and Medicare Advantage members. The previous contract expired April 1, affecting commercial members. The health system had beenout of network for Medicare Advantage plans since Jan. 1.”
  • Fierce Healthcare offers a look at how Evernorth’s new Delaware specialty pharmacy facility highlights a broader care coordination approach.
  • Beckers Hospital Reports ranks 83 health systems by their most recent revenue.
    • “Revenue growth continued across the hospital industry in 2025, with many of the nation’s largest health systems posting mid- to high-single-digit gains fueled by stronger patient volumes, improved payment rates and the expansion of ambulatory and pharmacy operations. 
    • “But the gains were far from uniform. Some systems grew revenue by double digits through mergers, acquisitions and new payer arrangements, while others saw declines as they shed hospitals and restructured their portfolios.”
  • and tells us,
    • “The world’s two main GLP-1 drug manufacturers, Eli Lilly and Novo Nordisk, are taking different approaches with rolling out their recently approved GLP-1 pills for weight loss. 
    • “Two oral GLP-1s, two very different commercial strategies. Health systems operating metabolic programs or making formulary decisions need to understand both.
    • “While both companies offer their recently approved GLP-1 pills through pharmacies and direct-to-consumer platforms that circumvent pharmacy benefit managers, they are diverging in other routes. 
    • “Eli Lilly is betting on retail and digital access, as it’s offering its weight loss GLP-1 pill through GoodRx, telehealth firm Ro and same-day delivery with Amazon Pharmacy. 
    • “By contrast, Novo Nordisk launched a Wegovy subscription program through WeightWatchers, LifeMD, Ro and Hims & Hers — with which the drugmaker previously had a strained relationship. With the 12-month subscription plan, Novo Nordisk said patients can save up to $600 per year on the Wegovy pill.” 
  • and informs us,
    • “Large language models may help identify drug safety signals in clinical notes, though their performance remains below thresholds required for clinical decision support.
    • “Researchers evaluated three models — GPT-3.5, GPT-4 and GPT-4o — using clinical notes from 100 patients at Nashville, Tenn.-based Vanderbilt Health, 70 patients at the University of California—San Francisco and 272 patients from seven Roche-sponsored trials, according to an April 6 Vanderbilt news release.
    • “For detecting immune-related adverse events at the patient level, GPT-4o achieved F1 scores of 56%, 66% and 62% across the respective datasets. The F1 score reflects how well a model balances correctly identifying real safety issues while avoiding false alarms. At the individual note level, the model reached an average F1 score of 57% across 667 notes.
    • “An F1 score of 90% or more is considered excellent, while 80% or higher may support clinical decision-making.”
  • STAT News points out,
    • “Every day, more than 40 million people ask ChatGPT about health care, according to OpenAI. They’re asking questions about diet, exercise, insurance — and in some cases, serious symptoms that would typically get discussed on a 911 call or in a doctor’s office.
    • “For some health systems, that’s creating an imperative. A small number of hospitals are trying to recapture some of those clinical conversations from commercial large language models like ChatGPT, Claude, and Gemini. They’re implementing their own patient-facing chatbots, ones that draw directly from their existing medical records and can funnel patients toward care in their own system. 
    • “Hartford HealthCare this week will launch PatientGPT, a chatbot engineered by clinical AI company K Health, to its patients in Connecticut. Two health systems — California-based Sutter Health and Reid Health, serving Indiana and Ohio — have announced pilot versions of Emmie, the chatbot built by medical record mammoth Epic. The list is likely to grow rapidly.
    • “Health systems need to do this, either through a vendor or building it themselves,” said Mount Sinai chief AI officer Girish Nadkarni, the senior author of a recent study that found ChatGPT Health missed high-risk emergencies when used to triage patients.”
  • The Wall Street Journal cautions,
    • “The artificial intelligence gold rush is rapidly drying up the supply of computing power, leading to product issues and reliability problems.
    • “Anthropic experiences frequent outages and limits user token usage, while OpenAI scrapped its Sora app to free up compute.
    • “CoreWeave raised prices over 20% and extended contracts, as spot-market Nvidia GPU rental costs rose 48% in two months.” * * *
    • “All of it points to a classic problem that has popped up in technology booms throughout history, from the 19th-century railroad expansion to the telecom and internet explosion of the early 2000s. Demand is growing far faster than companies are able to access resources and build out infrastructure. Historically, price increases have been among the only ways to address a supply crunch, but such a move could be perilous for frontier AI companies, which are in a ferocious competition to gain users.”
  • Per MedTech Dive,
    • “Stryker said Monday that it has agreed to buy intravascular lithotripsy firm Amplitude Vascular Systems. The companies did not disclose the terms of the acquisition. 
    • “Intravascular lithotripsy is a procedure to treat artery disease. Boston-based Amplitude Vascular Systems, or AVS, uses pressure waves generated by carbon dioxide through a balloon catheter to break up calcified plaque.
    • “The acquisition is expected to bolster Stryker’s peripheral vascular portfolio once AVS’ device is cleared in key markets.”
  • and
    • “GE HealthCare has provided an update on the integration of its bkActiv intraoperative ultrasound technology with Medtronic’s Stealth AXiS surgical navigation system.
    • “The integrated product is now available commercially, GE HealthCare said Thursday. Medtronic said it had integrated bkActiv into Stealth AXiS when the surgical system received regulatory clearance last month.
    • “Integrating the technologies gives surgeons real-time ultrasound images, helping them to assess mid-procedure anatomy changes that could affect the preoperative plan.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network offers an interview with Tammy Flanagan about how “health‑coverage decisions in retirement can shape when and how federal retirees tap their money.”
  • Govexec reports,
    • “The percentage of federal employees who are classified as “thriving” decreased by 10 points between 2024 and 2025, according to a recent report from Gallup, which sheds light on how civil servants are reacting to cuts and other reforms that President Donald Trump has made to agencies since the start of his second term. 
    • “By taking the average of responses from quarterly surveys conducted respectively in both years, the analytics firm found that the percentage of “thriving” feds dropped from 58% in 2024 to 48% in 2025.” * * *
    • “While the “thriving” rate for federal employees held steady at around 60% from 2022 to 2024, the latest data puts them on par with the average for U.S. workers in general, which also stood at 48% in 2025. That broader group, however, saw a smaller decline, going from 51% in 2024.”
  • OPM has brought the Director’s Secrets of OPM blog posts up to date on the agency’s website, which may be more easily accessible than Substack.
  • Per a CMS email,
  • This reporting requirement applies to FEHB and PSHB plans.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services April 9 held a demonstration showcasing the first series of products intended to push the health care industry toward a more connected ecosystem. The event highlighted tools and applications from more than 50 companies supporting the Medicare App Library that was initially announced in February. Tools intended to promote digital data access and eliminate manual check-in forms were featured, along with personalized health apps providing tailored guidance for nutrition, wellness and chronic disease management.” 
  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services has proposed a 2.4% payment rate bump for inpatient services for fiscal year 2027 as well as the first mandatory, nationwide test of an episode-based payment model. 
    • “The plans were outlined Friday in the annual release of CMS’ Inpatient Prospective Payment Systems (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System proposed rule. 
    • “Other planned changes, according to a fact sheet from the agency and the proposed rule’s summary, include various measure additions or modifications to measures in the Hospital Inpatient Quality Reporting Program; adjustments to the Transforming Episode Accountability Model (TEAM) alternative payment model controversially finalized in last year’s rule; and changes to graduate medical education payments to implement discrimination requirements aligned with the administration’s view of diversity, equity and inclusion practices.” 
  • A CMS news release adds,
    • “Medicare beneficiaries undergoing knee, hip, and ankle replacements, among the most frequent surgeries for people with Medicare, could soon experience more coordinated care and lower costs under a new Centers for Medicare & Medicaid Services (CMS) proposal. CMS is looking to implement these improvements by expanding the Comprehensive Care for Joint Replacement (CJR) Model nationwide through the Fiscal Year (FY) 2027 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule.
    • “Every year, Medicare funds thousands of knee, hip, and ankle replacements that help seniors keep up with their speedy little grandkids,” said CMS Administrator Dr. Mehmet Oz. “This proposed expansion of our successful joint replacement pilot program would better align financial incentives with improved health outcomes—protecting taxpayer dollars while ensuring patients get the care they need before, during, and after surgery.” * * *
    • “To learn more about the CJR-X Model, including independent evaluation reports, visit: https://www.cms.gov/priorities/innovation/innovation-models/cjr-x“
    • “The FY 2027 IPPS and LTCH PPS proposed rule can viewed on the Federal Register at: https://www.federalregister.gov/public-inspection/current. 
    • “For a fact sheet on FY 2027 IPPS and LTCH PPS proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/fy-2027-hospital-inpatient-prospective-payment-system-ipps-long-term-care-hospital-prospective.”
  • Fierce Healthcare relates,
    • “The Trump administration has issued a proposed rule that aims to significantly overhaul prior authorization for pharmaceuticals.
    • “Through the Interoperability Standards and Prior Authorization for Drugs rule, the Centers for Medicare & Medicaid Services said it would establish deadlines for payers in government insurance plans, setting the timeline at 24 hours for urgent requests and 72 hours for standard determinations.
    • “In addition, the rule would require insurers to publicly report certain metrics around prior authorization, including approval and denial rates; outcomes for appeals; and decision timeframes, according to an announcement from the agency.”
    • “The rule also builds on a 2024 regulation that took aim at prior authorization for non-drug services as well as payers’ 2025 pledge to significantly overhaul their approach to prior auth, an agreement brokered in part by CMS officials.” * * *
    • “CMS would also push to adopt Fast Healthcare Interoperability Resources (FHIR)-based standards for the small number of plans still using older models, making it easier for real-time electronic workflows to thrive.”
  • and
    • “Despite encountering a legal roadblock last month in his effort to rework the U.S. vaccine infrastructure, HHS secretary Robert F. Kennedy Jr. is continuing to reshape the Centers for Disease Control and Prevention’s vaccine advisory panel in a way that’s setting off alarm bells for some experts.
    • “In the new charter for the Advisory Committee on Immunization Practices (ACIP), the focus of the group—which helps advise the CDC on vaccine schedules and recommendations—seems to be shifting more toward concerns around vaccine safety and side effects. 
    • “In particular, the panel will now work on identifying “gaps in vaccine safety research, including adverse effects following vaccination.” The language is new in the updated charter and will likely appease the vaccine skeptic crowd, which has long used the potential for vaccine injuries and erroneous links to the development of neurological disorders like autism to further their cause.
    • “The group will also now specifically be tasked with reviewing new vaccine platforms such as mRNA shots, which have become a frequent bugbear in anti-vaccine rhetoric following the COVID-19 pandemic.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has, for the second time, turned back a medicine for a tough-to-treat skin cancer in a decision that marks a major setback for the therapy and its developer, biotechnology company Replimune.
    • “The agency on Friday rejected the treatment, vusolimogene oderparepvec or “RP1,” which had been under review for people whose advanced melanoma progresses despite treatment with a widely used cancer immunotherapy. In a letter made public Friday, the agency claimed that the review team, as well as multiple agency leaders and subject matter experts, determined the data are “insufficient to conclude substantial evidence of effectiveness.”
    • “The decision comes eight months after U.S. regulators spurned RP1, arguing that the company’s findings couldn’t be “adequately interpreted.” Replimune claimed to have been blindsided by the rejection and afterwards provided the FDA with additional information and analyses to boost its case. The agency, though, argued in its letter that its feedback to Replimune has remained consistent through years of communications and that its issues weren’t addressed.”
  • The Wall Street Journal relates,
    • “GSK withdrew its application for a drug touted last year by President Trump as a potential treatment for autism symptoms, just months after the company submitted it at the request of health officials.
    • “The U.K. drugmaker asked the Food and Drug Administration to pull its application for the drug leucovorin calcium because it doesn’t market the medicine, according to a regulatory filing posted Thursday. 
    • “The FDA had just approved leucovorin last month. Generic forms of the medicine will still be available. * * *
    • “GSK hadn’t sold the drug since 1999. At the request of the Food and Drug Administration, GSK said in September it would submit its application for patients with cerebral folate transport deficiency—a rare genetic condition with similarities to autism—in a move that allowed the agency to update the label for the drug and its generic counterparts. 
    • “FDA officials last month announced they had approved the drug for that condition based on a review of existing studies, but said in a call with reporters that they hadn’t found enough evidence to merit OK’ing the drug’s use to treat autism more broadly.
    • “Senior FDA officials said they examined scientific studies to see whether they could approve leucovorin to treat autism, but didn’t come up with enough strong scientific evidence to do so.
    • “A spokesman for HHS said GSK’s withdrawal on Thursday doesn’t affect generic versions of the drug, which already have updated labels for the genetic condition.”
  • Cardiovascular Business tells us,
    • :The U.S. Food and Drug Administration (FDA) is warning the public that certain sizing catheters from Indiana-based Cook Medical should no longer be used due to an increased risk of cracking or breaking.
    • “The agency’s warning covers specific lots of Cook Medical’s Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters and Beacon Tip Centimeter Sizing Catheters. These devices are used for a variety of angiographic procedures, aortic interventions, peripheral interventions and vascular interventions. They are made in a variety of sizes and multiple configurations.
    • “Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation and vessel injury,” according to the FDA. “In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death.”
    • “At this time, the FDA noted, no serious injuries or deaths have been linked to this issue. The agency is still reviewing the situation.
    • “The FDA’s early alert can be read in full here. It also includes a full list of all affected product lots.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “Even as the US respiratory illness season continues to ebb, it remains deadly, with the Centers for Disease Control and Prevention (CDC) documenting 12 more pediatric deaths in its FluView update today. 
    • “So far this season, 139 children have died from the virus, and about 85% with a known vaccination status were unvaccinated. While the CDC has classified this flu season as moderate for adults, it’s been high-severity for children.
    • “For comparison, in the previous three flu seasons the CDC logged 187, 210, and 296 flu-related deaths for the complete season. The 289 pediatric deaths in 2024-25 was the most since the 2009-10 H1N1 flu pandemic.
    • “Only four jurisdictions were reporting moderate flu activity last week, and none saw high activity. Flu accounted for 8.2% of viral respiratory diseases, down from 9.8% the previous week. A total of 2,589 people were hospitalized, compared with 3,050 the week before. The proportion of outpatient visits for flu declined to 2.4% from 2.6% the previous week.” * * *
    • “The level of acute respiratory illness causing people to seek medical attention is very low. Rates of respiratory syncytial virus (RSV) remain elevated, but the virus is past peak in many areas of the country, the CDC said in its weekly respiratory virus activity update today.
    • “COVID-19 levels are low in most parts of the country, and viral wastewater concentrations are low for RSV and very low for COVID-19 and influenza A.” 
  • The American Hospital Association adds,
    • “The Utah measles outbreak has increased to 583 cases, the state’s Department of Health and Human Services reported April 7. Of those, 386 cases have been diagnosed this year. Nationwide, there have been 1,714 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 94% of cases are outbreak-associated and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • Harvard Professor of Pediatrics Dr. David S. Ludwig opines in STAT News
    • “Targeting ultra-processed foods would make packaged foods less tasty and appealing, but no less fattening.
    • “Ironically, many products now emblematic of ultra-processed foods were developed in response to calls from nutrition scientists and government to replace dietary fat with carbohydrates, a misguided campaign that did more harm than good. We can’t afford another sweeping restructuring of the food supply based on imprecise interventions and uncertain science.
    • “Instead, focusing on processed carbohydrates offers a more precise and pragmatic solution, one that could invite collaboration with, rather than opposition from, the food industry.
    • “Delicious, calorie-rich food — whether home-prepared or packaged — isn’t the problem. What matters is how long we stay satisfied (satiety) relative to calories consumed. A 100-calorie snack or a sugary beverage isn’t better for our waistline than 200 calories from nuts if the lower-calorie option leaves us hungry and craving more soon after.
    • “By targeting the dietary drivers of weight gain, rather than misleading notions about food palatability and pleasure, we can have our (low-carb) cake and eat it, too.”
  • STAT News also tells us,
    • “With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavoredvapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem. 
    • “Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette sellers to a list of unauthorized businesses, according to the report from the Government Accountability Office. The second-most common type of enforcement actions (20 out of 88) noted in the report were injunctions to stop legal violations. 
    • “The GAO report was focused on actions that involved the DOJ, so those tallies do not take into account enforcement actions like the seizure of more than 6 million illegal products by the Food and Drug Administration and U.S. Customs and Border Protection between 2024 and 2025. To put those seizures in context, a large seizure of $76 million worth of products in 2024 — 3 million vapes — equated to about 4% of China’s e-cigarette exports to the U.S. in a single month, said Steven Xu, an adjunct assistant professor at the University of Waterloo who studies e-cigarettes.
    • “Sen. Dick Durbin (D-Ill.), who requested the report, said it shows that much more work needs to be done to combat the public health threat posed by illegal vapes.”
  • Health Day informs us,
    • “Standard cognitive tests may fail to capture early brain changes in women 
    • “Women’s brains often show a steeper and more widespread decline than men’s when moving from mild impairment to Alzheimer’s
    • “Sex-specific standards may be needed to interpret brain scans and screening results accurately.”
  • and
    • “Cardiovascular health may impact fracture risk in women after menopause, according to a study published online March 27 in The Lancet Regional Health-Americas.” * * *
    • “Many of the same factors that protect your heart — regular physical activity, a balanced diet rich in calcium and vitamin D, not smoking and managing conditions like diabetes and high blood pressure — also help protect your bones,” Hossain said in a statement. “If you’ve been told you have intermediate or high cardiovascular risk, particularly if you are a postmenopausal woman, it may be worthwhile to talk to your doctor about bone health screening, given the many effective treatments available that reduce fracture risk.”

From the U.S. healthcare business front,

  • Beckers Payer Issues shares a boatload of Blue Cross Blue Shield updates.
  • Healthcare Dive reports,
    • “Menopause has come out of the shadows and into the public spotlight in recent years. Celebrities have become more eager to dish about hot flashes and night sweats, and a flurry of telehealth start-ups promising relief from a broad constellation of symptoms have given rise to a $17 billion menopause market.
    • “But demand for treatments still far outpaces the science, as persistent structural barriers confound the women’s health space. 
    • “People have taken up the charge and are trying to make an impact in a specific area,” said Kim Dalla Torre, an EY Global and Americas Health leader.” * * *
    • “More also needs to be done to raise women’s awareness that menopausal symptoms shouldn’t be something they need to tolerate in silence, Dalla Torre said. Some 80% of women experiencing these symptoms don’t reach out to their doctors for help, according to the Mayo Clinic. Drugmakers also need to play a role.” 
       
  • Cigna, writing in LinkedIn, tells us,
    • “Mental fitness is essential for stress management, resilience, and workplace productivity, helping employees achieve work/life harmony.
    • “When organizations truly care about mental fitness, employees feel more supported and valued—which leads to higher engagement, fewer days missed from work, and meaningful reductions in healthcare costs for everyone.
    • “By thoughtfully weaving together mental and physical wellness programs, organizations can nurture a more vibrant and supportive workforce—leading to lasting success, greater employee retention, and the ability to attract exceptional talent.”
  • Healthcare Innovation points out,
    • “Sentara Health’s navigators are trained professionals with expertise in behavioral health, community resources, and motivational interviewing, working closely with ED teams and patients.
    • “The program started with pilot phases at select hospitals, expanding to 10 sites over a year, with ongoing data collection to measure impact and guide future improvements.
    • “Early results indicate significant reductions in readmission rates, demonstrating the program’s effectiveness in connecting patients to appropriate community-based care.”
  • Radiology Business informs us,
    • “In a bid to offer more services outside of Manhattan, Weill Cornell Medicine is planning to build a $57 million new radiology clinic in Brooklyn.
    • “The New York City academic system officially applied for the necessary state Department of Health approvals on Monday. Located in South Brooklyn’s Bay Ridge neighborhood on 86th Street, the clinic is expected to include three MRI machines, a CT scanner and ultrasound and mammography offerings, Crain’s New York Business reported. 
    • “The outpatient radiology clinic will be housed inside the NewYork-Presbyterian Bay Ridge Primary Multispecialty center and marks a significant expansion for the hospital system outside of Manhattan.
    • “While it’s premature to talk about the services of this location, we are always striving to meet the healthcare needs of New Yorkers in their own neighborhood,” Robert J. Min, MD, radiology chair and president and CEO of the Weill Cornell Physician Organization, told Radiology Business by email April 9. “We are still in the planning stages and will share details in the coming months.”
    • “Weill Cornell hopes the new center will help alleviate demand for radiology services in Brooklyn and the surrounding communities, according to the state application. The project is part of a bigger push by Weill Cornell and NewYork Presbyterian to expand their outpatient footprint across the city, local news outlet Hoodline reported Thursday.” 

Thursday report

David Ermer–CDC, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “The Postal Service is temporarily suspending payments to a governmentwide pension plan, after warning Congress that it’s less than a year away from running out of cash.
    • “USPS told the Office of Personnel Management on Thursday that it will hold off paying its contributions to the Federal Employees Retirement System (FERS), a move that’s expected to conserve cash in the near term.
    • “The mail agency, which has posted billion-dollar net losses almost every year since 2007, has relied on these extraordinary measures before to conserve cash.”
  • and
    • “The Postal Service received approval to add a temporary surcharge to most of its standard package shipping options. The Postal Regulatory Commission approved an 8% across-the-board price increase for its core package and shipping services. The surcharge will go into effect on April 26 and will remain in place until Jan. 17, 2027. USPS said the surcharge is necessary to keep up with higher fuel and transportation costs. Before this, USPS only added a package surcharge during its busy holiday peak season, which runs from October through December.”
  • OPM Director Scott Kupor explains how to chart your HR career path in his latest Secrets of OPM blog post which is available on Substack.
  • Tammy Flanagan writing in Govexec discusses “How to ensure your federal retirement benefit is correct.”
    • “OPM processed more than 33,000 retirement claims in early 2026. Learn how your FERS benefit is calculated and how to verify your creditable service.”
  • Federal News Network adds,
    • “More than 55,000 federal retirement applications are still pending finalization at the Office of Personnel Management. That’s after OPM managed to shave off about 10,000 applications from its total case inventory last month. During March, OPM received close to 15,000 incoming retirement applications, but processed over 22,000. Roughly half of those claims were completed digitally through OPM’s new processing system, which OPM said can finalize retirements at about double the speed as the traditional system.”

From the census front,

  • Per a U.S. Census Bureau news release,
    • “The nation turns 250 this year and Americans’ median age — the age at which half of the population is younger and half is older — continues to rise, climbing from 39.2 in 2024 to 39.4 in 2025.
    • “We use population estimates released today to examine changes in the U.S. age structure by sex from 2001, when the median age was 35.6, to 2025.
    • “One striking shift is that while women continued to outnumber men at older ages, the gap between the sexes narrowed in the past 25 years.
    • “In 2001, there were 70.6 males for every 100 females age 65 and older. By 2025, the ratio had increased substantially to 81.6.
    • “The gap among those age 80 and older narrowed even more dramatically — from 50.9 males per 100 females in 2001 to 68.3 in 2025.
    • “Mortality rates for older men have been decreasing faster than for women and, as a result, men’s share of the older population has increased,” said Marc Perry, senior demographer in the U.S. Census Bureau’s Population Division. “But the mortality gap between men and women is still there. In fact, the current mortality rate for men age 65 and older is roughly where the equivalent rate for women was 50 years ago.”
  • The Wall Street Journal reports,
    • “The nation’s fertility rates hit record lows in 2025 as childbearing continued to shift toward older women, according to new federal data released Thursday. For the sixth straight year, the number of children born in the U.S. remained at roughly 3.6 million.
    • “The number of births per 1,000 women ages 15 to 44—the general fertility rate—reached a record low of 53.1 in 2025, according to provisional data from the Centers for Disease Control and Prevention. The rate has mostly headed down since 2007, a prerecession peak when millennial women started to enter their prime childbearing years.
    • “One long-term trend driving the slide: a sharp decrease in birthrates for teens and women in their 20s. In 2025, birthrates for women in their late 30s exceeded those for women in their early 20s for the first time.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Despite a mandate from the Trump administration to remove barriers for health artificial intelligence companies, the Food and Drug Administration has denied a proposal that would have made it easier for large developers of AI-enabled medical devices to put their products on the market.”
  • Modern Healthcare reports,
    • “The Food and Drug Administration has sent a warning letter to Medline Industries over reported issues with syringes used in cardiac procedures and the company could face regulatory action if the issues are not corrected.
    • “The company received the letter March 25 following a December inspection of its facility in Glen Falls, New York. The agency said the Namic angiographic control syringes, which are packaged into Medline’s cardiovascular procedure kits, were disconnecting from the hub that controls the flow of fluids. The letter was made public Tuesday.”
    • “In the warning letter, the agency said there were 221 complaints about the syringes and 177 medical device reports, including one involving air being injected into a patient and another exposing a clinician to a biohazard.”
  • MedTech Dive relates,
    • The Food and Drug Administration’s device center launched an innovation challenge Tuesday to give patients access to home medical devices to reduce hospital readmissions.
    • The Center for Devices and Radiological Health plans to select nine devices from different manufacturers by Dec. 4 for the challenge. Selected companies will have opportunities for early engagement with the FDA, including feedback to help refine device design and testing, and the chance to demonstrate their technology at FDA research facilities. 
    • The program, called the Reducing Readmissions through Device Innovation for the Home Innovation Challenge, is part of the device center’s Home as a Healthcare Hub initiative, which started in 2024. The initiative is intended to support innovation for medical devices used in the home, while considering diverse perspectives and people’s living environments.
  • and
    • “Philips sent an urgent field safety notice to customers in March instructing them to no longer use non-pneumatic nebulizers, including vibrating mesh nebulizers, with its Trilogy Evo ventilators.
    • “The Food and Drug Administration posted the action in its database last week as a Class I recall. It applies to Philips’ Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 ventilators.
    • “A Philips spokesperson wrote in an email to MedTech Dive that the ventilators may be used safely by following the revised instructions.”
  • Radiology Business tells us,
    • “Experts are sounding the alarm on a newly approved use of dermal filler in the décolleté area, citing concerns over its potential effect on breast cancer screening exams. 
    • “Radiesse, manufactured by Merz Aesthetics, is a subdermal filler used to smooth wrinkles and decrease the visibility of fine lines. The U.S. Food and Drug Administration on April 8 approved its use for the décolleté area—the upper chest above the breasts—in adults 22 and older. 
    • “The filler contains hydroxylapatite microspheres, which may be visible on medical imaging. Given the location of the implant and its close proximity to imaged area, experts are concerned it could affect the visibility of breast tissue on mammograms, masking small lesions. Experts voiced these concerns to the FDA during an advisory meeting about the product last August. 
    • “As a breast imager, my focus is to find a cancer as small as possible,” Sandra Shuffett, MD, of Baptist Health Medical Group in Lexington, Kentucky, explained during the panel. “That is my concern, with the fillers potentially obscuring a cancer on a mammogram until it grows larger and then requires more serious treatment.” 
    • “Merz Aesthetics has refuted these claims, maintaining the safety and efficacy of the product. As a precautionary measure, however, the FDA is requesting that the company conduct a postmarket assessment of 30 individuals to determine whether the filler affects breast imaging. The study will require participants receiving the injections to undergo baseline breast imaging before completing three filler treatments six weeks apart; they will complete additional breast imaging one month after all the treatments have been administered.” 

From the public health, medical and Rx research front,

  • Per an Epic news release,
    • “Epic Research now monitors health conditions across the U.S. at the county level and publishes Health Alerts when elevated rates are detected. The alerts use statistical models applied to real-world medical records to detect when the rate of a health condition in a county is higher than expected. Each alert is reviewed by the Epic Research team before it is published.
    • “You can view active Health Alerts here. You can also subscribe to receive Health Alerts by email. Subscribers receive new alert notifications when an elevated rate is first detected in a state and weekly summaries of all active, new, and resolved alerts.”
  • NBC News reports,
    • “Regular exercise and about seven hours of sleep a night could protect brain health in the long term, a study published Wednesday in the journal PLOS One found. Long bouts of sedentary behavior may increase dementia risk.
    • “It’s the latest data to show that people don’t need elaborate and expensive longevity hacks to stay mentally sharp as they age. Simple lifestyle changes could reduce a person’s risk of late-onset dementia by as much as 25%, according to the study. 
    • “About 1 in 9 people in the United States will develop Alzheimer’s disease, according to the Alzheimer’s Association, meaning a person’s overall risk is about 11%. With the suggested changes in lifestyle, the average person’s risk decreases to about 8%.
    • “The reduction is “fairly comparable to the effect sizes sometimes seen with medications for chronic diseases,” said Akinkunle Oye-Somefun, a researcher at York University in Toronto, who led the study. 
    • “Breaking up longer periods of sitting had the greatest effect, the study found.” 
  • MedPage Today adds,
    • “People who followed a high-quality plant-based diet had a lower risk of Alzheimer’s disease and other dementia, while those with a low-quality plant-based diet had a higher risk, prospective data showed.
    • “At baseline, people who ate the most plant foods overall had a 12% lower risk of dementia over nearly 11 years of follow-up compared with those who ate the least (HR 0.88, 95% CI 0.85-0.92), reported Song-Yi Park, PhD, of the University of Hawaii at Manoa in Honolulu, and co-authors.
    • “However, not all plant-based diets performed equally well. People with a high-quality plant-based diet at baseline had a lower dementia risk (HR 0.93, 95% CI 0.89-0.97), while those with a low-quality plant-based diet had a higher dementia risk (HR 1.06, 95% CI 1.01-1.10), Park and colleagues wrote in Neurology.”
  • BioPharma Dive relates,
    • “Invivyd said Thursday it has discovered and is preparing for human testing an antibody drug for measles, infections of which have spiked as of late in the U.S. due in part to rising vaccine hesitancy.  
    • “The Connecticut-based biotechnology company also provided an update for its lead program, an antibody for COVID-19 prevention, alongside its plans for the new drug’s development. Invivyd sees the antibody, known as VMS063, as a possible treatment for the disease or a preventive option for those who can’t, or won’t, get vaccinated. 
    • “VMS063 uses a similar strategy as approved antibody drugs for respiratory syncytial virus, which work by latching onto a surface “fusion” protein and blocking entry into cells. Invivyd said VMS063 could be the “first precision therapy” for measles and address the “immunity gap” emerging due to lower vaccination rates.” 
  • Health Day notes,
    • “In pediatric patients, influenza vaccine effectiveness (VE) varied across 2021 to 2024 seasons, but did help prevent influenza-associated hospitalizations and outpatient visits, according to a study published online April 6 in Pediatrics.” * * *
    • “Our study shows influenza VE ranged, but overall, was effective at preventing influenza-associated hospitalizations and outpatient visits in children aged 6 months to 17 years,” the authors write. “Higher pediatric influenza vaccine coverage could amplify the benefits of vaccination among children.”
  • Genetic Engineering and Biotechnology News tells us,
    • “The biological connection between a pregnant woman and her developing baby—the human maternal–fetal interface—is a specialized, transient organ composed of uterine cells from the mother and fetal cells that acts as a barrier, supports fetal growth, and maintains the mother’s health. The cellular complexity of the maternal-fetal interface has limited scientists’ ability to study how healthy pregnancies develop and why complications arise. The underlying cellular, molecular, and spatial programs of the interface—which forms about a week after fertilization and lasts until birth—has remain incompletely defined.
    • “Now, the human maternal–fetal interface has been mapped in unprecedented detail by scientists at the University of California, San Francisco (UCSF), revealing new cell types and providing insights into conditions such as preeclampsia, preterm birth, and miscarriage.
    • “By examining this tissue cell by cell across pregnancy, we can begin to understand both normal development and what may go wrong,” said Susan J. Fisher, PhD, professor of obstetrics, gynecology, and reproductive sciences at UCSF.”
  • Endocrinology Advisor notes,
    • “Elevated BMI in infancy and early childhood has a nearly null effect on pubertal timing. In contrast, high BMI in mid-childhood (starting around 6 years of age) and late childhood shows a strong, direct association with earlier onset.”

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

  • STAT News reports,
    • “At first blush, it might seem like Charleston, W.Va., New York, N.Y., and Janesville, Wis., have little in common. 
    • “But those three metros were flagged in a new report as having some of the country’s highest per-person health care spending. And there are other surprises, too. Three metros in California — a state known for its high prices — are among the lowest spenders, and two in West Virginia are among the highest. 
    • “The Health Care Cost Institute, a nonprofit, independent research group, released the report today along with a new data tool called Health Cost Landscape, which allows users to search for specific U.S. metro areas and examine the factors behind health spending there.  
    • “The tool and accompanying report rely on 1.3 billion medical claims from 2018 to 2022 from employer-sponsored health plans, representing more than 38 million people with employer sponsored insurance each year. 
    • “The fact that there’s not a consistent theme among the 10 highest and lowest spending metros speaks to the “irrationality” of health care spending in the U.S., said Katie Martin, HCCI’s CEO. Spending will always be a combination of price and utilization, but figuring out why each region landed on the list requires drilling down into its specific characteristics.” 
  • KKaufman Hall released its National Hospital Flash Report for February 2026.
    • “Key Takeaways
      • “Cost pressures are driving a tenuous financial outlook. Hospital expenses are elevated in early 2026 compared to 2025, while revenues are pressured by an eroding payer mix and remain below sustainable levels.
      • “Hospital performance is bifurcating. There is significant variation in hospital performance by size, geography, and market position.
      • “Softer, uneven volumes reflect shifting care patterns. Patient days have softened in early 2026 while the average length of stay remains relatively steady, reflecting both demographic shifts and changes in where care is delivered.
      • “Outpatient revenue is rising in early 2026. Outpatient care offers significant benefits to both patients and health systems, though hospitals must manage both revenue dilution and a greater concentration of high-acuity patients as a result.”
  • Kaufman Hall also posted its “M&A quarterly activity report: Q1 2026.”
    • “The Q1 2026 trends reflect an industry undergoing transformation. Health systems are repositioning by withdrawing from underperforming or non-core markets, building capital to invest in new capabilities, proactively seeking partners to increase resilience or enhance access to care and services, and placing big bets on new combinations of resources and capabilities. A return to more robust levels of deal-making is a sign that organizations remain well aware of the need to seek combinations and partnerships to face the challenges and opportunities that lie ahead.”
  • Fierce Healthcare tells us,
    • “Advocate Health notched a strong 2025 with more revenue, patients, operating income and bottom line gains than the year prior. 
    • “The nation’s third-largest nonprofit health system reported Wednesday over $38.9 billion in total revenue during the year ended Dec. 31, 2025, a nearly 12% increase over the year before. 
    • “Total expenses rose a hair slower, by about 11%, to $37.4 billion, leaving the organization with more than $1.5 billion in operating income (4.0% operating margin). It had reported a $1.2 billion operating income (3.5% operating margin) in 2024.” 
  • Beckers Hospital Review points out four hospitals that closed in the first quarter of 2026.
  • The Wall Street Journal reports,
    • “Eli Lilly’s Foundayo weight-loss pill is now available in the U.S. following the Food and Drug Administration’s approval.
    • “The drug is available through Eli Lilly’s direct sales platform, telehealth providers, and is shipping to retail pharmacies.
    • “Foundayo’s starting dose costs $149 a month, matching the price of Novo Nordisk’s competing GLP-1 pill.”
  • Beckers Hospital Review adds,
    • “Novo Nordisk’s recently approved high-dose Wegovy formulation has entered the U.S. market and is available for $399 per month for self-paying patients, the drugmaker said April 7. 
    • “In March, the FDA approved Wegovy HD, a 7.2-mg injection of semaglutide, as a weight loss medication. Prior to the approval, the highest dose of injectable Wegovy was 2.4 milligrams. 
    • “Wegovy HD’s launch comes days after the FDA approved Eli Lilly’s GLP-1 pill, Foundayo, which is the second FDA-approved GLP-1 pill for weight loss — the first is Novo Nordisk’s Wegovy pill. 
    • “Novo Nordisk’s direct-to-consumer platform offers self-paying patients to fill injectable Wegovy prescriptions for $199 per month’s supply of the 0.25-, 0.5-, 1-, 1.7- or 2.4-mg dosages. Wegovy HD is offered for $399 per month’s supply.” 
  • Per Fierce Healthcare,
    • “Humana is teaming up with digital health company b.well Connected Health to make it easier for members to access their health data across multiple providers, health plans, pharmacies and digital health apps. 
    • “The partnership aligns with a broader push by the Trump administration to give patients easier access to their health information.
    • “As part of the partnership with b.well, Humana will also be able to access its members’ data in real-time at the point of claims processing and securely respond to data requests from providers and other health plans, supporting care coordination and quality improvement, the insurer said in an April 9 press release.”
  • and
    • “Amazon is expanding its health conditions program with two recently announced partnerships focusing on nutrition therapy and sleep care. 
    • “The retail giant launched its Health Benefits Connector program in January 2024, which aims to help connect customers with virtual care benefits. Teladoc, Rula Health, Talkspace, Omada Health and Hinge Health are several of the organizations involved with the program.
    • “The most recent to join is virtual sleep clinic Dreem Health.
    • “Eligible customers can enroll in the care provider’s sleep services, which include sleep diagnostics using Sunrise Group’s FDA-approved home sleep test. Dreem Health will be the first sleep health provider on the platform, according to the April 9 announcement. 
    • “Artificial intelligence-driven nutrition therapy platform Berry Street also announced March 31 it would be joining Amazon’s program. The platform has a network of more than 1,500 registered dietitians providing nutrition therapy for weight loss, diabetes, cardiovascular disease and maternal health.”
  • MedTech Dive informs us,
    • “One year after President Donald Trump’s “Liberation Day” declaration in a White House Rose Garden ceremony unleashed a tariff policy targeting top U.S. trading partners, medtech companies are still absorbing the shocks.
    • “Tariffs on imports from China, Mexico, Canada, the European Union and other key trade partners were meant to boost domestic manufacturing, but in the medtech sector, where integrated global supply chainsdesigned for efficiency can take years to establish, reshoring has not been the primary response. That’s in contrast to the pharmaceutical industry and certain other sectors, where companies are pouring billions of dollars into building new production facilities in the U.S.
    • “To manage the extra expenses brought by tariffs, medtech companies have tried to avoid raising prices for hospitals and health systems or cutting R&D budgets, according to industry advisers and analysts. Instead, they are accelerating efforts to drive down costs across their organizations.
    • “They have to find levers elsewhere,” said Glenn Hunzinger, PwC’s U.S. health industries leader. “They’re not passing the prices on to customers. They’re just bearing the brunt of it and trying to find efficiency, which was always the focus.”

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.”

Midweek update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Monday report

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

From Washington, DC.

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Friday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical/Rx research front,

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

From the U.S. healthcare business front,

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

Midweek report

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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