Thursday report

No Surprises Act

Thursday report

David Ermer–ACA, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News reports,
    • “The Senate April 23 adopted a budget resolution by a 50-48 vote, paving the way for a narrow reconciliation bill focused on immigration enforcement funding. Congressional Republicans are seeking to use the reconciliation process primarily to end the partial shutdown of the Department of Homeland Security. The resolution instructs the Senate Homeland Security and Governmental Affairs Committee, the Senate Judiciary Committee, and the House Homeland Security and Judiciary committees to write legislation by May 15 that provides up to $70 billion in funding.  
    • “The vote followed a lengthy “vote-a-rama” session overnight that consisted of multiple proposed amendments from Democrats that failed to pass. Both chambers must pass a common budget resolution to move forward with the reconciliation process. Legislative action is expected in the House as early as next week.”  
  • STAT News reports,
    • “President Donald Trump’s acting attorney general on Thursday signed an order reclassifying state-licensed medical marijuana as a less-dangerous drug, a major policy shift long sought by advocates who said cannabis should never have been treated like heroin by the federal government.
    • “The order signed by Todd Blanche does not legalize marijuana for medical or recreational use under federal law. But it does change the way it’s regulated, shifting licensed medical marijuana from Schedule I — reserved for drugs without medical use and with high potential for abuse — to the less strictly regulated Schedule III. It also gives licensed medical marijuana operators a major tax break and eases some barriers to researching cannabis.
    • “The Trump administration also said it was jump-starting the process for reclassifying marijuana more broadly, setting a hearing to begin in late June.”
  • The Wall Street Journal tells us “What to Know About the Health Risks of Marijuana.”
    • “Studies show the drug can exacerbate anxiety and teen use poses risks for developing brains.”
  • STAT News adds,
    • “President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
    • “Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.”
  • Tammy Flanagan, writing in Govexec, lets us know,
    • “I was planning to write about the number of TSP millionaires for this week’s column — until I started getting messages from former federal employees, all who retired on September 30, 2025, and are still waiting for their retirement benefit from the Office of Personnel Management (OPM) to be finalized.
    • “It is not completely surprising that retirement processing has slowed down, and for some former employees, they continue to wait for their retirement benefits to be finalized. But for the employees who have reached out for assistance, many have not received any money since their last paycheck was received in October 2025.
    • “It has been almost six months with very little or, in some cases, no money and little communication to help them understand how long they will have to continue to wait.” * * *
    • “In my experience, retirement processing is less like flipping a switch and more like closing out a file with dozens of tabs. One missing document or unresolved question can stop forward progress.
    • “Common culprits include late or incomplete payroll certifications, missing service history, unposted deposits or redeposits for prior service, unresolved military service credit, periods of leave without pay that need to be documented, name discrepancies, incomplete beneficiary or survivor elections, or court orders that require special handling.
    • “None of these problems are rare, and when thousands of cases arrive at once, the odds go up that more people land in the exception pile.”
    • Tammy then make suggestion on steps to take.

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
    • “The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
    • “The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.”
  • The Wall Street Journal relates,
    • “Children born deaf because of a rare condition can now take a drug to restore their hearing after a gene therapy was approved in the U.S., ushering in a new era for the treatment of an inherited form of hearing loss. 
    • “The Food and Drug Administration approved Regeneron Pharmaceuticals’drug Otarmeni for children born with a faulty gene that plays a role in hearing. It targets a rare condition affecting an estimated 20 to 50 newborns in the U.S. each year and could eventually be expanded to an even wider population if additional studies succeed.
    • “In my wildest dreams I never thought we’d be here in my lifetime,” said Lawrence Lustig, a hearing specialist at Columbia University Irving Medical Center who helped lead the trial.
    • “Regeneron said it would offer the drug free to people in the U.S.”
  • MedTech Dive tells us,
    • “Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
    • “The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. 
    • “Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. 
    • “The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release.
    • “The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday.” 
  • The New York Times points out “A $440,000 Breast Reduction: How Doctors Cashed In on a Consumer Protection Law.”
    • A law meant to end surprise medical billing accidentally created a multibillion-dollar industry that is making doctors richer.”
  • FEHBlog observation – This is happening. Why can’t Congress and the regulators fix the problem?

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk will seek regulatory approval for its semaglutide pill to treat Type 2 diabetes in children and adolescents after a late-stage trial showed it significantly reduced blood sugar in 10- to 17-year-olds.
    • “The once-daily semaglutide pill is currently marketed as Rybelsus in the EU and U.S. to treat diabetes in adults and will be available in the U.S. as Ozempic pill later in the second quarter. It is not currently approved for use in children or adolescents.
    • “The Danish drugmaker said Thursday that oral semaglutide has the potential to be the first oral GLP-1 to demonstrate a superior reduction in blood sugar levels compared with a placebo in children and adolescents with Type 2 diabetes, while maintaining the well-tolerated safety profile seen across other semaglutide trials.
    • “Over the past two decades, the prevalence of Type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need,” said Martin Holst Lange, Novo Nordisk’s chief scientific officer and head of research & development.”
  • MedPage Today relates,
    • “An investigational benzamide antipsychotic significantly improved symptoms in hospitalized adults with acute schizophrenia in a phase II trial.
    • “The drug, N-methyl amisulpride, is similar to its predecessor, amisulpride, but has some key differences in dosing and side effects.
    • “Because of the 4-week trial duration, long-term treatment durability wasn’t evaluated.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Diabetes affects over half a billion people globally. Along with direct consequences to those with the disease, it also contributes to and predisposes affected individuals to a host of other conditions. Specifically, it is a known contributing factor in the development of vascular disease, including peripheral artery disease. While therapies exist, they are not very effective, and peripheral artery disease can lead to restricted blood flow in peripheral limbs, which sometimes leads to amputation. Understanding the mechanism driving the connection at the tissue and cellular level has the potential to improve therapy options and the development of new treatments.
    • “Normal function of the peripheral vasculature requires communication and cooperation between the vascular endothelium and macrophages. “Monocytes patrol the vascular endothelium and remove damaged cells, and intimal-resident macrophages maintain a nonthrombogenic endothelial state,” wrote the authors of a study led by Zhen Chen, PhD, at City of Hope. They explained that under stress, macrophages can modulate vascular remodeling and in certain conditions, like cancer, they “can secrete inflammatory mediators to disrupt endothelial cell tight junctions and increase endothelial cell permeability.”
    • “The team decided to explore the cellular cross-talk between macrophages and endothelial cells, as well as the resulting vascular function, to better understand the mechanisms behind peripheral artery disease induced by diabetes.
    • “They published their work in a paper titled “Diabetes-induced TREM2–endothelial cell signaling impairs ischemic vascular repair” in Science Translational Medicine.“
  • Healio tells us,
    • “Influenza vaccination continues to protect children from influenza-related outpatient visits and hospitalizations, according to post-pandemic data published in Pediatrics.
    • “We have had really severe recent seasons for flu, particularly in children,” Samantha M. Olson, MPH, an epidemiologist in the CDC’s influenza division, told Healio in an interview. “This study really adds to the growing body of evidence showing how protective flu vaccines can be for infants, children and adolescents, and this includes even the most severe outcomes.”
  • and
    • “People taking GLP-1s had reduced risk for atrial fibrillation, regardless of whether they lost weight or how much they lost, according to findings presented at Heart Rhythm 2026.
    • “We were prompted to undertake this study by some encouraging data that … GLP-1 receptor agonists seem to have a favorable effect on reducing the incidence of atrial fibrillation, particularly in patients with metabolic risk factors,” Kenneth C. Bilchick, MD, MS, professor of cardiovascular medicine at the University of Virginia School of Medicine, who presented the findings, told Healio. “I think the results were expected, but they were even better than we thought they would be.”
  • Health Day informs us,
    • For many women, a sudden sneeze or a hearty laugh bring an unwelcome consequence: A small leak of urine. 
      Often dismissed as a normal part of aging or motherhood, new research suggests the real culprit may lie deep within the abdomen.
      A study from the Federal University of São Carlos (UFSCar) in Brazil found that hidden fat stored between internal organs is a major driver of stress-induced urinary incontinence.
      The research — published recently in the European Journal of Obstetrics & Gynecology and Reproductive Biology — suggests that where a woman carries her weight matters far more than the number on the scale.
      Stress urinary incontinence occurs when everyday actions like coughing, lifting or exercising put too much pressure on the bladder, causing urine to leak.
      “It’s that urinary leakage that occurs when pressure inside the abdomen increases and the pelvic floor can’t hold it in,” Patricia Driusso said in a news release. She’s a professor of physical therapy at UFSCar.

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

  • Healthcare Dive reports,
    • “Molina benefited from better controlled Medicaid spending in the first quarter, though steeper membership losses than expected raise questions about whether the insurer can keep costs in hand for the remainder of 2026.
    • “Molina posted better-than-expected first quarter earnings on Wednesday afternoon, sending the insurer’s stock up more than 10% in Thursday morning’s trade.
    • “Yet, unlike its peers UnitedHealth and Elevance, which both raised 2026 guidance after keeping medical spending in check, Molina elected to reaffirm its outlook.
    • “Executives said retaining the current 2026 guidance is prudent given it’s early in the year and the cost environment remains challenging. Still, they hinted Molina might update the outlook after the second quarter.”
  • Fierce Healthcare relates,
    • “Elevance Health’s top brass told investors Wednesday that the insurer is on pace to end the second quarter of 2026 with about 1.2 million members in its individual market plans.
    • “CEO Gail Boudreaux said on the company’s earnings call that the company saw “moderately stronger retention” in the Affordable Care Act segment through Q1, and that it was one of the contributing factors to its better-than-expected results in the quarter.
    • “The membership growth in the individual market plans reflected a shift toward bronze tier coverage following the expiration of enhanced premium tax credits at the beginning of this year, said Chief Financial Officer Mark Kaye. Part of why this trend contributed to lower medical costs is that utilization in these plans is frequently backloaded, he said.” * * *
    • “Kaye said that the company feels good about its position in the ACA market, and the shift to bronze tier plans has been positive in certain markets. However, the company is still taking a prudent approach to forecasting around the ACA market.”
  • Beckers Hospital Review identifies “eight health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2026.”
  • MedTech Dive tells us,
    • “Boston Scientific slashed its 2026 sales growth and earnings guidance on Wednesday as key businesses are facing challenges and setbacks.
    • “The medtech company expects full-year sales growth in a range of 7% to 8.5%, down from a range of 10.5% to 11.5% given in February. Boston Scientific also lowered its adjusted earnings per share guidance from a range of $3.43 to $3.49 to a range of $3.34 to $3.41.
    • “CEO Mike Mahoney told investors on an earnings call that the lowered guidance reflects challenges in several prominent businesses, including electrophysiology and the company’s Watchman franchise.
    • “This was a guide down that we, quite frankly, are not proud of, but we think it’s the right thing to do, and best reflects the current environment,” Mahoney said.”
  • Beckers Health IT informs us,
    • “OpenAI has introduced ChatGPT for Clinicians, offering free use of the tool to all verified U.S. physicians, nurse practitioners, physician assistants and pharmacists.
    • Here are [four] things to know from an April 22 news release and past Becker’s reporting:
      • “1. The AI developer said the solution can help clinicians with tasks like documentation, writing and medical research, freeing up time for patient care.
      • “2. OpenAI has previously launched ChatGPT for Healthcare, an enterprise solution for health systems, and ChatGPT for Health, a tool for users to ask health-related questions.
      • “3. The company also debuted HealthBench Professional⁠, a benchmarking application for three use cases: care consultation, documentation and writing, and medical research.
      • “4. OpenAI said its physician advisors review the AI’s healthcare responses “every few minutes” and before releasing ChatGPT for Clinicians tested nearly 7,000 conversations in their daily work, rating 99.6% of responses as accurate and safe.”
  • Healthcare Dive adds,
    • “The American Medical Association is urging Congress to create safety guardrails for artificial chatbots in mental healthcare, as Americans increasingly turn to the technology for health information and advice. 
    • “In letters sent Wednesday to the chairs of three congressional committees on digital health and AI, the major physician lobby said “well-designed, purpose-built” tools could help patients who would otherwise struggle to access mental healthcare, but that the lack of safety protocols poses serious risks.
    • “Privacy concerns, risks of emotional dependency on AI and reports the tools could encourage self-harm signal that “immediate attention is required to ensure these tools do not inadvertently harm individuals seeking mental health support or companionship,” AMA CEO Dr. John Whyte wrote.”

Midweek report

David Ermer–Congress, FDA, Generative AI, Mental health care, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • Per a House of Representatives news release,
    • “Today, the House Appropriations Committee met to consider the Fiscal Year 2027 Financial Services and General Government Appropriations Act. The measure was approved by the Committee with a vote of 34 to 28.” * * *
    • “A summary of the bill is available here.” * * *
  • Federal News Network adds,
    • “The prospects of a civilian federal pay raise next year are continuing to diminish, after House appropriators made no mention of a pay increase in their 2027 spending legislation.
    • “The House Appropriations Committee’s financial services and general government (FSGG) bill for fiscal 2027, which advanced along party lines Wednesday evening, says nothing on funding for a civilian pay raise. Although not yet final, that increases the chances federal employees will miss out on a salary increase next year.”
  •  A House Education and Labor subcommittee shared the testimony presented to its members during its PBM business model hearing today.
  • The Wall Street Journal offers seven takeaways from HHS Secretary Robert F. Kennedy Jr.’s numerous recent appearances before Congressional committees.
  • Healthcare Dive informs us,
    • “Prices for some healthcare services after arbitration under the No Surprises Act were much higher than the same in-network commercial prices before the law was passed, according to new research out this week.
    • “In 2024, prices for imaging after arbitration were 767% higher than average prices in Medicare. For comparison, the same imaging prices were roughly 200% higher than Medicare prices before the No Surprises Act was passed, according to an analysis published by the Brookings Center on Health Policy.
    • “Arbitration decisions in emergency care, imaging and pediatric critical care tended to skew more closely to amounts that providers offered during negotiations, rather than those offered by insurers, according to the analysis.” * * *
    • [This] Brookings research compliments other studies that have found the No Surprises arbitration process raises healthcare costs. One study published in Health Affairs last year found that IDR created an estimated $5 billion in costs between 2022 and 2024, which could eventually result in higher insurance premiums for consumers.”
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), is today announcing the first set of research teams for its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative, which will collectively fund up to $139.4 million to help spur new, effective therapies for behavioral health. As part of the Trump Administration’s Executive Order to Accelerate Medical Treatments for Serious Mental Illness, EVIDENT will allocate at least $50 million to match state government investments in psychedelic research for populations with serious mental illness.”
  • MedPage Today adds,
    • “From July 2022 [when the 988 mental health line was launched] through December 2024, 35,529 suicides among individuals ages 15 to 34 were observed compared with 39,901 expected suicides based on trends before the launch of the lifeline, corresponding to an 11% reduction (95% CI 8.7-13.1), reported Anupam B. Jena, MD, PhD, of Harvard Medical School in Boston, and co-authors in a research letter in JAMA.
    • “After replacing the previous 10-digit number for suicide and crisis services with the 3-digit number and investing more than $1.5 billion to expand crisis center capacity and workforce nationwide, “988 appears to be working where it matters most, in reducing suicide deaths among the young people who use it the most … saving lives, at scale, within a few years of launch,” said co-author Vishal R. Patel, MD, MPH, also of Harvard Medical School.
    • “Prior evidence for the lifeline was mostly indirect: higher call volumes, positive caller surveys, reductions in same-day distress,” Patel told MedPage Today. In contrast, this study shows that the lifeline actually affects suicide mortality at the population level, he noted.”
  • HR Dive relates,
    • “The U.S. Department of Labor’s Wage and Hour Division on Wednesday announced a proposed rule to streamline joint employer status under the Fair Labor Standards Act, the Family and Medical Leave Act, and the Migrant and Seasonal Agricultural Worker Protection Act, according to a department press release.
    • “The rule would create “a single nationwide standard that both derives from commonalities in federal court precedent where available and resolves significant differences among the circuit courts where they exist,” DOL said, to “ensure employees and employers have a clear, consistent understanding of when multiple employers are jointly responsible for protecting the wages and other rights of an employee.”

From the Food and Drug Administration front,

  • Fierce Pharma reports
    • ‘Merck is carving out its own place in the evolving HIV treatment space with an FDA approval for its Idvynso, a combination regimen that brings its novel islatravir to market for the first time and serves as the cornerstone of what could be a lucrative HIV franchise for the company. 
    • “Idvynso is a once-daily, two-drug oral pairing of Merck’s doravirine and islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that has been commercialized since 2018 as part of Merck’s Pifeltro and Delstrigo, while islatravir is a newer nucleoside reverse transcriptase translocation inhibitor (NRTTI) that represents the “anchor medicine” in a number of other HIV combos that the company is advancing.
    • “The doravirine and islatravir combo’s debut is specifically targeted at patients who are switching from other HIV treatments and will be available in pharmacies after May 11, Merck said in its April 21 press release.” 
  • STAT News relates,
    • “The Swiss drugmaker Roche on Tuesday presented the latest data for its experimental multiple sclerosis drug, setting the stage for the company to seek approval for a medicine that it believes can cut relapse rates and slow the progressive disability the disease causes.  
    • “Now the test is whether the drug, called fenebrutinib, can win the regulatory green light.
    • “While three late-stage trials of the drug have shown it to be effective, analysts have homed in on some potentially worrying liver safety signals, an issue that previously prompted the Food and Drug Administration to reject an MS therapy developed by Sanofi. In data released Tuesday, researchers also disclosed that there were two drug-related deaths among patients who took fenebrutinib.  
    • “Roche has touted the potential of fenebrutinib — an oral tablet — noting that it hit its efficacy mark across different types of MS and offers a new approach for treating the disease. It’s also sought to differentiate its therapy from Sanofi’s rejected drug, called tolebrutinib.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Revolution Medicines’ closely watched pancreatic cancer drug helped control tumors when administered early in a patient’s disease course, stimulating a response in at least half of those who got it either as a single treatment or alongside chemotherapy, according to trial results unveiled at a medical meeting Tuesday.
    • “The findings disclosed at the American Association for Cancer Research’s annual convention come from studies testing the therapy, daraxonrasib, in first-line pancreatic cancer. They follow, by a week, Phase 3 data showing the drug nearly doubled survival in people whose disease had progressed after an earlier treatment, sparking a share surge that has launched the company’s valuation past $30 billion.
    • “The Food and Drug Administration gave Revolution a special regulatory fast-pass that could lead to a clearance within weeks of an approval submission.”
  • and
    • “A three-drug combination involving Merck & Co.’s Welireg failed to significantly delay tumor progression or extend survival in a Phase 3 trial of patients newly diagnosed with the most common form of kidney cancer, setting back the big drugmaker’s plans to further expand use of the medication.
    • “The study evaluated Welireg alongside Merck’s immunotherapy Keytruda and Eisai’s Lenvima in first-line clear cell renal cell carcinoma and compared that regimen to the Keytruda-Lenvima tandem alone. Merck didn’t provide specifics but said that drug trio — as well as a separate one also tested in the trial — missed the study’s dual main objectives at an interim analysis.
    • “Merck noted how the findings don’t affect other ongoing studies in “Litespark,” the broad program it’s jointly conducting with Eisai and that includes other Welireg tests. The Food and Drug Administration is reviewing an application based on results from one Litespark study that would expand use of Welireg earlier in kidney cancer.”
  • MedPage Today relates,
    • “In a survey of roughly 45,000 U.S. adults representing more than 257 million people, 9% said they had obesity and drank heavily over the past month, while 3.8% said they had both obesity and met criteria for alcohol use disorder (AUD) over the past year, reported researchers led by Bryant Shuey, MD, MPH, of the University of Pittsburgh.
    • “Overlapping heavy drinking and obesity was most common among men ages 35 to 49 (13.6%), women ages 26 to 34 (11.9%), and Black individuals (11.9%). AUD and obesity overlap was highest for men and women ages 26 to 34 (6.2% and 5.1%), people without insurance, and those on Medicaid, the findings in JAMA Internal Medicine showed.
    • “Shuey and colleagues said the findings on this high-risk population call for public health and clinical interventions tailored to younger and middle-age adults, especially the uninsured and those on Medicaid, to prevent liver disease and liver-associated deaths.” * * *
    • “Given the effectiveness of GLP-1 drugs “for weight loss and metabolic dysfunction–associated steatohepatitis, expanding access for patients with co-occurring risky alcohol use and obesity may reduce liver disease burden,” they argued.”
  • Health Day tells us,
    • “Pregnancy-related deaths in the U.S. increased sharply during the COVID-19 pandemic, particularly among Black women, a new study reports.
    • “Deaths remain significantly higher today for Black mothers, even though they’ve returned to pre-pandemic levels for most other groups, researchers reported in the journal Obstetrics & Gynecology.
    • “We saw a dramatic increase in pregnancy-related deaths during the COVID-19 pandemic, but the recovery has not been equal across all groups,” said senior researcher Dr. Lindsay Admon, an associate professor of obstetrics and gynecology at the University of Michigan Medical School.
    • “We need to better understand what’s driving these differences so we can develop solutions that reduce maternal deaths and improve outcomes for everyone,” she said in a news release.”
    • * * * “Results showed that maternal deaths during or just after pregnancy rose more than 60% during the pandemic, from about 20 deaths per 100,000 live births in 2019 to 33 per 100,000 in 2021.
    • “Most of the pandemic increase was linked to COVID-associated deaths, researchers found. Early pregnancy death rates rose by 7.5 per 100,000 live births, and later pregnancy deaths by 3.7 per 100,000.
    • “By 2023 and 2024, early pregnancy deaths had returned to pre-pandemic levels, but those late in pregnancy and after pregnancy remained elevated.
    • “All death rates remained notably higher for Black mothers, researchers found.”
  • Per an NIH news release,
    • “In a National Institutes of Health (NIH)-funded study, researchers developed a cancer assessment tool that can identify high-risk patients and the tumor cells linked to that risk. The model, called scSurvival, uses a machine learning framework designed to analyze large-scale data at single-cell resolution. 
    • “With NIH support, Oregon Health & Science University (OHSU) tested the model on clinical data from more than 150 cancer patients. The tool predicted survival outcomes and linked specific cell populations to higher risk. 
    • “A risk assessment tool that not only tells you who may be at higher risk, but also provides clues as to why, could really help in these difficult cancers” said Anthony  Letai, M.D., Ph.D., director of NIH’s National Cancer Institute (NCI).”  

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

  • Beckers Hospital Review relates,
    • “Franklin, Tenn.-based Community Health Systems reported an operating income of $281 million (9.5% margin) on revenues of $3 billion in the first quarter of 2026, down slightly from a $284 million operating gain (9% margin) in the same period last year. 
    • “However, after interest payments on debt and other expenses, CHS reported a net loss of $58 million in the first quarter, compared to a $13 million loss in the first quarter of 2025. 
    • “We are pleased with the continued, tangible progress on our key priorities, demonstrated by improvements in quality scores, patient experience and physician satisfaction measures, and investments in growth opportunities,” CEO Kevin Hammons said in an April 21 news release. “In the face of a dynamic macroeconomic environment, we remain focused on the variables within our control and believe we are positioning the company for long-term success and value creation.”
  • and
    • “Optum Rx — the pharmacy benefit manager for UnitedHealth Group — claims its “PreCheck” prior authorization tool not only cuts prescription approval times but also reduces denials and appeals.
    • “UnitedHealth Group gave an update on the tool in an April 21 earnings call. Optum CEO Patrick Conway, MD, said denials due to missing information dropped by 68% and appeals were down 88%, thanks to PreCheck. He said PreCheck has been “easing interactions for clients, members and providers.”
    • “Dr. Conway reaffirmed that PreCheck has axed prescription approval time from eight hours to fewer than 30 seconds. 
    • “Optum Rx announced an expansion of PreCheck in November, alongside its decision to eliminate reauthorization requirements for 40 medications. In the November release, UnitedHealth Group said, as of this year, the PreCheck platform covers more than 45 medications and is leveraged across 20 health systems.”
  • Healthcare Dive tells us,
    • “Amazon is launching a weight management program with access to GLP-1s through its One Medical primary care chain, in a bid to help consumers more easily access the popular weight loss drugs alongside supportive care, the retail and technology giant said Tuesday. 
    • “Under the program, users work with a dedicated provider to receive a GLP-1 medication as well as follow-up care, so patients can adjust their treatment and address related health concerns like cardiovascular disease and diabetes. 
    • “Patients can also access prescriptions for “transparent pricing” on Amazon Pharmacy, the company said. New GLP-1 pills start at $25 per month with insurance or through cash-pay options as low as $149 per month.”
  • Fierce Pharma informs us,
    • “As pharma giants slash headcounts and routinely strike billion-dollar M&A deals, another trend is steadily playing out at many of the largest drugmakers: adoption of AI on a corporate scale.
    • “Mark Merck as a participant in this movement. On Wednesday, the company revealed a partnership with Google Cloud as it works to undergo an “agentic AI enterprise transformation.”
    • “As part of an investment in Google Cloud valued at up to $1 billion, Merck will get access to the tech giant’s agentic AI platform across its R&D operations, manufacturing, commercial teams and corporate functions.
    • “Notably, the deal involves Google Cloud engineers working directly with Merck’s teams to onboard the tech, according to the April 22 press release. In a statement, Dave Williams, Merck’s chief information and digital officer, noted that the AI push comes “as we enter one of the most significant launch periods in our company’s history.”
  • Beckers Health IT adds,
    • “UnitedHealth Group is betting big on AI in 2026 — $1.5 billion to be exact. 
    • “During the company’s Q1 earnings call, leaders fleshed out how that investment is materializing.
    • “Think about it this way: A third of this is explicitly invested into software products and platforms, accelerating Optum Insight’s transition of business models into an AI-first software and services firm. The remaining two-thirds is spent across signature end-to-end processes and functions across UnitedHealth Group,” Optum Insight CEO Sandeep Dadlani said. 
    • “Optum Insight, the technology-enabled services business under UnitedHealth, will manage internal AI use cases, which could eventually be translated and commercialized beyond the company. UnitedHealth expects a 2-to-1 return, much of it within the next 12 to 18 months.”
  • and
    • “Michael and Susan Dell have surpassed $1 billion in total giving to the University of Texas at Austin, becoming the university’s first billion-dollar donors, according to an April 21 news release.
    • “The latest investment will support development of the UT Dell Campus for Advanced Research, anchored by an AI-focused UT Dell Medical Center expected to open in 2030. The Dells’ investment will also support expanded supercomputing capabilities, student scholarships and housing.
    • “The medical center will integrate Houston-based University of Texas MD Anderson Cancer Center to provide cancer care as part of the new campus.
    • “The university plans to break ground on the medical center later in 2026.”
  • Fierce Pharma points out,
    • “After AbbVie earlier this year pledged a whopping $100 billion in U.S. R&D and capital investments over the next decade, the company is filling in more details on its expansion plans. And like with many other pharma giants, it’s putting down roots in North Carolina.
    • “The North Chicago-based drugmaker on Wednesday revealed its largest-ever capital investment in a single campus, plotting a 185-acre production hub in Durham. The project will cost some $1.4 billion and add more than 730 roles to the company’s headcount, according to an April 22 press release. The site will produce certain AbbVie medicines in its immunology, neuroscience and oncology portfolios.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. sought to distance himself from U.S. measles outbreaks on Friday at a House Education and Workforce Committee hearing on the administration’s fiscal 2027 budget request.
    • “The hearing, part of Kennedy’s weeklong tour of Congress on the budget, was relatively light on spending discussions, as Democrats who have repeatedly requested such a hearing with Kennedy looked to pin him down on a range of issues. The hearing was often combative, with Democrats drawing attention to issues such as vaccines and Kennedy’s focus on school nutrition.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services today announced the appointment of Casey B. Mulligan, PhD, as Chief Economist and Chief Regulatory Officer. Mulligan is a renowned University of Chicago economist who served as Chief Economist on the Council of Economic Advisers during the first Trump Administration. He most recently served as the U.S. Small Business Administration’s Chief Counsel for Advocacy.
    • “Mulligan will advise Health and Human Services Secretary Kennedy Robert F. Kennedy, Jr., and other agency leaders on policy development to continue to make health care more affordable for the American people. His portfolio will include cost-benefit analysis of regulation, econometric modeling, and program evaluation of major expenditures.”
  • Fierce Healthcare relates,
    • “Insurers hoping for a reprieve from an out-of-network billing system largely favoring healthcare providers will likely be left wanting as federal policymakers sit on their hands and one large payer’s bid to limit the claims faces an uphill battle, strategy firm Capstone concluded in a new report.” * * *
    • “Capstone expects any meaningful reversal of the IDR trend to most likely stem from direct action by payers. Chief among these is an administrative penalty Elevance Health implemented in 11 states for its Anthem BCBS commercial business. The policy levies a fee equal to 10% of the allowed amount on facility claims involving OON providers.
    • “The policy has faced substantial pushback from provider groups, though it still went into effect Jan. 1 in the 11 states with plans to expand similar fees in two more. Capstone noted that one of the initial states, Indiana, has already enacted legislation against the practice and that the broader policy is primed for legal challenges.
    • “However, if Elevance’s model is adopted more broadly, the OON ecosystem could shrink as facilities internalize the direct financial cost of hosting OON providers,” Capstone wrote. “In that scenario, provider groups would face pressure to either absorb the loss of facility relationships or accept often-lower in-network rates.” 
  • Bloomberg Law points out,
    • “The head of the Department of Labor’s employee benefits regulator defended how he’s changed the agency before lawmakers, saying he’s cut down on excessive litigation and enforcement.
    • “Daniel Aronowitz, leader of the Employee Benefit Security Administration, told members of a House Education and the Workforce subcommittee that the agency had reoriented its approach to follow the Employee Retirement Income Security Act, boasting that it was “the most pro-ERISA EBSA administration ever.” * * *
    • “The agency is revisiting a Biden-era [mental health] parity rule creating a comparative test to ensure employers are covering mental health equally with medical and surgical benefits. EBSA halted enforcement of the rule after The ERISA Industry Committee sued.
    • “Aronowitz noted that he didn’t believe the rule’s comparative analyses “got us anywhere. It just created cost and burden.”
    • “But he said EBSA is conducting investigations on medical necessity denials, exclusions for autism and opioid treatment, so-called “ghost networks” of unavailable doctors, and conflicts of interest.”
  • Thompson Reuters discusses this year’s obligation to provide notices of creditable coverage to Medicare Part D eligible individuals and to CMS.
    • “Sponsors of HRAs and other account-based plans, which are typically offered alongside major medical plans, will welcome the relief from providing burdensome and potentially confusing Part D creditable coverage notices. Sponsors of plans that remain subject to the disclosure requirements should use the 2027 parameters when determining whether their plans’ prescription drug coverage is creditable for that year.”
  • Healthcare Dive tells us,
    • “Employers, lawmakers, patient advocates, price transparency groups and more urged the Department of Labor to quickly finalize a rule that would force pharmacy benefit managers, shadowy middlemen in the drug supply chain, to share more pricing and compensation information.
    • “PBMs did not feel the same, according to industry comments on the proposed regulation.
    • “The rule has been caught up between two powerful industries — healthcare purchasers like employers and the PBMs they contract with to manage their drug benefits — since it was proposed in January, amid growing criticism of PBMs and a broader bet from the Trump administration that better price transparency will lower healthcare costs.”
  • and
    • “The CMS has proposed repealing the alternative pathway for new technology add-on payments, or NTAP, beginning in fiscal year 2028. The change is included as part of the 2027 Inpatient Prospective Payment Systems proposed rule. 
    • “Under the proposal, medical devices with breakthrough device designation would be required to meet the same eligibility criteria as other available technologies to receive the additional payments under the NTAP pathway.
    • “Industry trade group AdvaMed said the alternative pathway policy, implemented by the first Trump administration, has worked well. AdvaMed, in an emailed statement to MedTech Dive, said “it would be disappointing if this progress were rolled back.”

From the Food and Drug Administration front,

  • Healio reports,
    • “The FDA has cleared an HPV self-collection kit and approved a related HPV assay for at-home use, enabling patients to obtain their own sample for cervical cancer screening.
    • “The Onclarity HPV Self-Collection Kit (Waters Corp.) is tested with the BD Onclarity HPV Assay (Waters Corp.), which now supports specimens collected both in clinic and at home. The assay detects all high-risk, carcinogenic genotypes and is the only FDA-approved HPV assay to identify “six individually and three groups of pooled results,” according to a manufacturer press release.
    • “The at-home, self-collection kit could help reduce barriers for unscreened or underscreened individuals, who comprise nearly 60% of cervical cancer cases.”
  • MedTech Dive relates
    • “Philips has received Food and Drug Administration clearance for an artificial intelligence-enabled CT system.
    • “The 510(k) clearance, which Philips disclosed Thursday, covers a Verida device that the company claims reduces image noise by 80% and reconstructs scans twice as fast as its predecessor.
    • “Jie Xue, chief business leader for precision diagnosis at Philips, recently said Verida’s throughput sets it apart from photon-counting CT technology. GE HealthCare and Siemens Healthineers sell photon-counting devices.”
  • CVS Health informs us,
    • “New treatments take years of research, clinical trials, and regulatory review before reaching patients. Several therapies approaching FDA decisions this spring could expand treatment options for people managing a range of conditions.
    • “CVS Caremark’s Clinical Pipeline Services team — made up of licensed clinical pharmacists and analysts — monitors new therapies moving through the drug pipeline and evaluates what those approvals could mean for members. The team’s latest Drugs to Watch report identifies several notable therapies with decisions expected between April and June 2026, including:
      • “A new oral option for patients with treatment-resistant hypertension
      • ​​​”A more convenient, at-home format for early Alzheimer’s disease treatment that avoids lengthy IV infusions​​​​​​​​​​
      • “The first FDA-approved treatment for a chronic ​​​​liver infection
      • “An additional non-nicotine option for adults looking to quit smoking.”

From the judicial front,

  • Bloomberg Law reports,
    • “A wave of hospital bankruptcies has brought in its wake high-stakes lawsuits aiming to boost creditor payouts by targeting health insurers over allegedly systemic claim denials.
    • “At least nine different health insurers in the past six months have been sued by bankruptcy estates or trustees appointed under bankruptcy plans for three major health-care businesses, according to court documents reviewed by Bloomberg Law. 
    • “Lawsuits against insurers for Steward Health Care System LLC, CarePoint Health Systems Inc., and Jackson Hospital & Clinic Inc. seek a combined $427.9 million and represent 32,000 patient claims across 32 hospitals and providers and six states.
    • “The litigation is ramping up as hospital bankruptcies accelerate amid disputes over private equity ownership, real estate investment trust structures, and federal cuts.” * * *
    • “A trustee for CarePoint, which operated three New Jersey safety-net hospitals before it filed for Chapter 11 in November 2024, sued Cigna Health & Life Insurance Co. in February. It argued Cigna underpaid its hospitals for various services by more than $114 million.
    • “Steward’s trustee filed at least seven lawsuits against insurers, including Blue Cross of Florida, CareSource Ohio, and Aetna Health, seeking to recover more than $63 million and alleging they withheld valid reimbursements.
    • “Jackson Hospital took a different approach, bringing a more than $250 million antitrust suit against Blue Cross and Blue Shield of Alabama in December. The insurer used market domination to allow for a pattern of baseless claim denials for emergency care, the suit said.”

From the public health and medical / Rx research front,

  • The Centers for DIsease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is low in most areas of the country.
    • “Influenza
      • “Seasonal influenza activity continues to decrease. Influenza A activity is low across all HHS regions and influenza B activity continues to trend downward.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • “National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News reports,
    • “There are now 602 cases in the Utah measles outbreak, the state’s Department of Health and Human Services reported April 14. Of those, 405 cases have been diagnosed this year. The confirmed total of measles cases reported nationwide in 2026 has increased to 1,748, according to the latest data from the Centers for Disease Control and Prevention. There have been 19 reported outbreaks across 33 jurisdictions. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape adds,
    • Use of preexposure prophylaxis (PrEP) for HIV prevention in adolescents and young adults is “strikingly low,” though youth aged 13-24 years have nearly 1 in 5 new HIV infections in the US, according to a new study in JAMA Pediatrics. Use is particularly low in women and young people who live in the South and Midwest.
    • “Efforts to expand PrEP use among youths should address geographic disparities, legal and policy barriers, and clinician engagement to improve equitable access to HIV prevention,” the authors wrote, led by Nicholas Venturelli, MD, MPH, with Boston Children’s Hospital in Boston.
  • The University of Minnesota’s CIDAP relates,
    • “Historically, shigellosis cases in the United States have primarily been seen in young children in daycare settings and in people who’ve traveled to countries with poor sanitation. Infections with Shigella, a gut pathogen that causes diarrhea and vomiting, have also been fairly easy to treat.
    • “But the profile of who’s most at risk of shigellosis is changing, and the infections is becoming much harder to treat, according to a report published last week in Morbidity and Mortality Weekly Report, the flagship publication of the Centers for Disease Control and Prevention (CDC).
    • “In the report, researchers from the CDC and health departments across the country revealed that the vast majority of US Shigella infections from 2011 through 2023 were in adult men, a high proportion of whom (47%) had HIV. Analysis of nearly 17,000 Shigella isolates found that the proportion of isolates considered extensively drug-resistant (XDR) rose from 0% during 2011-2015 to 8.5% in 2023. 
    • “Approximately one-third of patients were hospitalized. And among patients with travel history, more than 80% reported no recent international travel.
    • “The report’s corresponding author said the findings reflect changes in epidemiology and resistance that are transforming Shigella from a primarily self-limiting infection that rarely required antibiotics into an emerging public health threat with limited treatment options. 
    • “Together, it’s a very concerning pattern of XDR Shigella strains that are being seen among vulnerable populations,” Naeemah Logan, MD, an epidemiologist with the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, told CIDRAP News.”
  • The AP informs us,
    • “The worrisome rise in colorectal cancer deaths in younger adults is concentrated in people with less education, suggesting socioeconomic factors could be driving the escalation, according to a new study.
    • “Celebrity deaths — including Chadwick Boseman in 2020 and James Van Der Beekearlier this year — have highlighted the increase in colorectal cancer deaths among younger adults, but the new paper was called the first to parse which people are most affected by the alarming rise. 
    • “The researchers found that over the last 30 years, the rise in colorectal cancer deaths in young adults occurred almost entirely among people without a four-year college degree.
    • “Of course, getting a college degree doesn’t protect you from getting colon cancer. Rather, experts say it’s a marker for other issues: People without degrees tend to earn less money, have poorer diets, exercise less and get less medical care.
    • “It’s not totally unexpected that the death risk is concentrated in the less advantaged, but the paper published Thursday in JAMA Oncology is the first national study to actually show the connection, said Dr. Paolo Boffetta, a researcher at Stony Brook Cancer Center in New York who wasn’t involved in the work.” 
  • The New York Times points out,
    • “Researchers at the University of Pittsburgh reported on Friday that they had trained the immune systems of a few patients to accept liver transplants without the drugs needed to avoid organ rejection.
    • “Three of eight patients have now been off the drugs for at least three years, perhaps an early step toward a new approach to transplantation that experts in the field have long hoped for. The study was published in Nature Communications.
    • “They’ve gone a long way toward proving a principle,” said Dr. William Jarnagan, chief of liver and transplant surgery at Memorial Sloan Kettering Cancer Center, who was not involved in the study.
    • “With further development, it could really be a game changer,” he added.
    • “Dr. Joohyun Kim, a liver transplant surgeon at Yale who was not involved with the study, said, “Even 10 years ago, people thought ‘tolerance induction’ was a dream.”
  • The Genetic Engineering and Biotechnology News adds,
    • “The American Association for Cancer Research (AACR) Annual Meeting kicks off this weekend in San Diego. A whirlwind of sessions, keynotes, fireside chats, posters, and exhibitors, the meeting is THE annual event for the cancer community.
    • “Before the conference, GEN spoke with AACR program chairs Paul S. Mischel, MD, Professor and Vice Chair for Research for the Department of Pathology at Stanford Medicine of Stanford University and Alice T. Shaw, MD, PhD, Chair of the Department of Medical Oncology and the Chief of Strategic Partnerships at Dana-Farber. In this interview, they share their perspectives on the event, what attendees should be looking out for, and what they, personally, are most looking forward to.”
  • and
    • “For pathogens like HIV, malaria, and rapidly evolving influenza strains, coaxing the immune system to produce the rare, highly potent antibodies needed for protection has long been a scientific bottleneck. Vaccines can train B cells to evolve such broadly neutralizing antibodies, but only under ideal conditions—and only in a small fraction of people. Even attempts to genetically edit mature B cells produced responses that faded as the cells died out.
    • “A team at The Rockefeller University has now taken a more upstream approach: programming hematopoietic stem and progenitor cells (HSPCs)—the source of all B lymphocytes—to carry permanent genetic instructions for therapeutic antibodies or other proteins. Because the immune system naturally amplifies rare, useful cells after vaccination, even a tiny number of edited stem cells can seed a durable, boostable immune response.
    • “The immune system is inefficient in that it produces a vast quantity of cells to protect itself,” said Harald Hartweger, a research assistant professor in Michel Nussenzweig’s Laboratory of Molecular Immunology. “We wanted to take advantage of the immune system’s ability to amplify useful, rare cells.”
    • “The study, published in Science and titled “B lymphocyte protein factories produced by hematopoietic stem cell gene editing,” demonstrates that CRISPR‑edited HSPCs can mature into B cells that express engineered antibodies upon vaccination. A standard vaccination then acts as the trigger: antigen exposure drives those edited B cells to expand, differentiate into plasma cells, and secrete high titers of the inserted antibody that last long-term.”

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

  • Fierce Healthcare reports,
    • “The Purchaser Business Group on Health has released new data that highlights some of the key healthcare priorities of its jumbo employer members, with—perhaps unsurprisingly—the escalating affordability crisis as the biggest challenge.
    • “Rounding out the top three priorities are data analytics and transparency, as well as an interest in advanced primary care. PBGH based the findings of a survey of more than two dozens of its members, which represent some of the largest employers in the United States.
    • “Elizabeth Mitchell, president and CEO of PBGH, said in an interview that the escalating cost pressures have driven “a much more proactive approach from our members to address these concerns, which are simply not being addressed by the industry.”
    • “The urgency of that concern is absolutely growing,” Mitchell said. There is “also a heightened focus on transparency and understanding prices, and we are enabling that because they cannot just keep writing blank checks to the healthcare system when they have poor outcomes and just no demonstrable improvement in quality or value.”
  • Beckers Hospital Review informs us,
    • “Little Rock, Ark.-based Baptist Health reached a definitive agreement to acquire Magnolia (Ark.) Regional Medical Center.
    • “The deal, subject to customary regulatory approvals, is expected to be completed by July 12, according to an April 16 Baptist news release. On that date, the hospital will be rebranded as Baptist Health Medical Center-Magnolia.
    • “While it is an extremely challenging time to operate community hospitals, we have a proven track record of operating rural hospitals successfully in Arkansas,” Baptist President and CEO Troy Wells said in the release.”
  • and
    • “Mark Cuban has a pitch for hospitals: Manufacture drugs in their own parking lot.
    • “Mr. Cuban’s Cost Plus Drugs previously launched a Dallas-based manufacturing facility to address supply issues, starting with epinephrine and norepinephrine production. More recently, Mr. Cuban said his facility can also produce Pitocin, pediatric cancer drugs and sterile water — and that generic tablets can be cheaper when made in Dallas versus purchased from India.
    • “During Becker’s Spring 2026 Chief Pharmacy Officer Summit, Mr. Cuban explained how Cost Plus — which includes pharmacy, contracting, procurement and manufacturing businesses — is “modularizing” its manufacturing facilities.
    • “We’ve been able to take the manufacturing facility we have in Dallas and not only make it much smaller than what everybody else has done to that point, but we’ve been able to modularize them and put them in a pod that is effectively a tractor trailer,” Mr. Cuban said. “The trailers that go on the back that you see going down the road — we can manufacture sterile injectables in that tractor trailer.”
    • “Cost Plus is selling these manufacturing pods, which can be deployed anywhere from hospital sites to disaster zones to research facilities. He said rare disease therapies that historically cost upward of $500,000 and took six months to produce can now cost roughly $50,000 and possibly take less time.
    • “That, literally, over the long term, is going to be our biggest business and will save the most lives and money,” he said. “The more efficient we become at using robotics and AI, the less expensive we can manufacture drugs.” 
  • BioPharma Dive relates,
    • “Through an acquisition announced Friday, Belgian drug company UCB is wagering more than $1 billion on a cutting-edge medicine that’s being tested as a potential therapy for a few seizure disorders as well as Alzheimer’s disease.
    • “UCB offered to buy privately held Neurona Therapeutics for $650 million up front while dangling another $500 million in future, milestone-based payments. If completed, the deal would hand UCB an experimental therapy that uses pluripotent stem cells engineered to calm the brain and repair neural networks.
    • “The therapy, codenamed NRTX‑1001, is currently being evaluated in clinical trials as a treatment for patients with hard-to-treat forms of a common epilepsy rooted in the “mesial temporal lobe” part of the brain.”
  • and
    • “Kailera Therapeutics, a high-profile drug startup aiming to compete with Novo Nordisk and Eli Lilly in obesity, said Thursday it banked $625 million in one of the sector’s largest-ever initial public offerings.
    • “The IPO haul far surpasses the $500 million it set out to raise in terms set earlier this week. Kailera sold more than 39 million shares at $16 apiece. It’ll begin trading on the Nasdaq stock exchange on Friday under the ticker symbol “KLRA.”
    • “Kailera’s offering is among the biggest, by total proceeds, raised by a venture-backed biopharmaceutical company, according to BioPharma Dive data. Its IPO eclipses Acelyrin’s $540 million stock sale in 2023, Sana Biotechnology’s $588 million issuance in 2021, and Moderna’s then-record $604 million pricing in 2018.”
  • MedTech Dive lets us know,
    • “GE HealthCare is expanding a mammography collaboration with RadNet subsidiary DeepHealth.
    • “The partnership brings more of DeepHealth’s artificial intelligence tools to GE HealthCare’s mammography machines, including a workflow for complex cases that may benefit from a secondary review.
    • “The companies announced the expanded initiative at the Society of Breast Imaging Annual Symposium on Thursday.”

Tuesday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “A prominent physician voice in the House of Representatives has introduced a new bill that would compel insurers to apply the cost for drugs purchased from direct-to-consumer platforms to deductibles and out-of-pocket maximums.
    • “North Carolina Republican Greg Murphy, M.D., on Tuesday unveiled the Every Dollar Counts Act, a bill that aims to lower patients’ out-of-pocket costs for pharmaceuticals. Murphy, a consistent critic of insurers and pharmacy benefit managers, notes in an announcement that consumers have increasingly embraced DTC offerings as costs rise.
    • “Using these platforms, patients can often find prices that cost far less out-of-pocket, especially for branded drugs, per Murphy’s office.”
  • The American Hospital Association News adds,
    • “The AHA and dozens of other organizations April 14 sent a letter of support to Reps. Suzan DelBene, D-Wash., and Mike Kelly, R-Pa., for their introduction of the Chronic Care Management Improvement Act. The bill would waive beneficiary cost-sharing requirements for Medicare beneficiaries receiving chronic care management services. Beneficiaries are currently required to pay a 20% coinsurance fee to receive such services. “This cost-sharing requirement creates a barrier to care, as beneficiaries are being billed for services that do not always include interfacing with their provider, thus creating confusion for patients,” the organizations wrote. “Also, many of these beneficiaries consider any additional out-of-pocket expense for healthcare services untenable.”
  • CMS has posted MMSEA Section 111 GHP User Guide Version 7.8 – April 13, 2026 (PDF)
    • “The GHP User Guide * * * is your primary source for Section 111 GHP reporting requirements.”
  • OPM Director Scott Kupor has added a new post titled “Merit Matters” to his Secrets of OPM blog.
    • “If we want the best talent in the federal government – which I think we do – we should not refuse to hire college dropouts, unless dropping out of college is somehow representative of their ability to work successfully on behalf of the American people. And, if they are in fact world-class engineers, then we should pay them at the level at which they are performing versus force-fitting them into a lower pay level because they have no prior work experience.
    • “Once again, merit matters.”
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Fox News’ Saturday in America with host Kayleigh McEnany to highlight the launch of EarlyCareers.gov, a new initiative to recruit more early career Americans into federal service and strengthen the government’s talent pipeline.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Even as Eli Lilly gets underway with its next major obesity launch in Foundayo, an FDA document related to the oral treatment shows lingering reservations about multiple “unexpected serious” risks potentially related to the drug.
    • “In the FDA’s approval letter (PDF) for GLP-1 pill Foundayo, the agency tasks Eli Lilly with obtaining more information about the med’s potential link to major adverse cardiovascular events and drug-induced liver injury. In addition, the agency wants to gain more info about delayed gastric emptying associated with the drug and its potential effects in lactating women.
    • “In its assessment of the medicine’s data, the FDA “determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events (MACE), drug-induced liver injury (DILI), and exposure to [Foundayo] during lactation,” the letter says.”
  • STAT News adds,
    • “In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
    • “FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
    • “In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, and this inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.”
  • MedTech Dive relates,
    • “Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected.
    • “Medline began the recall in February, and it was posted to the Food and Drug Administration’s website last week. The problem was the subject of a warning letter that Medline received in March, also recently posted to the FDA’s website.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies. When finalized, this guidance will provide recommendations for standardized methods for comprehensively assessing the safety of genome editing therapies to bring effective treatments to patients sooner.
    • “Genome editing holds extraordinary promise for treating previously incurable genetic diseases, and today’s announcement represents the FDA’s forward approach to drive innovation and advance the development of genome editing therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This guidance provides sponsors with clear, scientifically-grounded recommendations for evaluating off-target editing risks using state-of-the-art sequencing technologies. We are serious about moving this ball forward.”  
    • “The draft guidance, issued by the Center for Biologics Evaluation and Research, supports the FDA’s framework for accelerating development of individualized therapies for ultra-rare diseases launched in February. The framework revolutionizes how the FDA engages with industry and promotes a path for transformative rare disease treatments.
    • “The “Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing” guidance provides specific recommendations on sequencing strategies, sample selection, analysis parameters, and reporting.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal [magistrate] judge has tossed an Elevance subsidiary’s lawsuit against billing intermediary HaloMD and several California-based providers alleging they’re abusing the out-of-network billing dispute process set up by the No Surprises Act.
    • “[Magistrate] Judge Karen Scott of the Central District of California dismissed the suit on Monday, finding that Anthem Blue Cross, Elevance’s California subsidiary, failed to prove that the companies were gaming the law’s independent dispute resolution, or IDR, in order to inflate their reimbursement.
    • “It’s a major win for HaloMD, which is facing similar lawsuits from Elevance in three other states and has found itself in hot water over its status as the No. 1 submitter of IDR disputes. The Texas-based company cheered the court’s decision, while Elevance said it plans to appeal.”
    • Yesterday, Anthem Blue Cross did appeal the court’s decision to the U.S. Court of Appeals for the Ninth Circuit.
  • Bloomberg Law reports,
    • “A Delaware judge threw out lawsuits seeking to link the heartburn drug Zantac to cancer, freeing makers of the product from facing trials in the state over the cases.
    • “Superior Court Judge Francis “Pete” Jones concluded Monday lawyers for ex-Zantac users couldn’t produce legitimate evidence backing up claims the over-the-counter product caused cancer. Zantac is currently made by French drugmaker Sanofi.” * * *
    • Because former Zantac owners GSK Plc, Pfizer Inc., Sanofi and Boehringer Ingelheim Pharmaceuticals already have settled thousands of Zantac suits over the last several years, it’s unclear how many Delaware cases will be dismissed by Jones’ order. GSK paid more than $2 billion in 2024 to resolve what it said was more than 90% of its pending cases.

From the public health and medical / Rx research front,

  • Fierce Healthcare reports,
    • “Seven in 10 U.S. adults gamble, according to a survey from the National Council on Problem Gambling (NCPG). Commercial gaming revenue broke records at $78.7 billion in 2025, with over $18 billion in tax revenue going into state and local coffers. All gaming segments, from casinos to sports betting to online games (iGaming), are growing. Throw in prediction markets, which allow users to speculate on the outcome of real-world events but are not legally considered gambling platforms, and the betting buffet becomes basically limitless. 
    • “This menu of options is creating an addiction crisis yet to be widely recognized by the public, policymakers and the healthcare sector, experts caution. Current national problem gambling prevalence is unknown due to a lack of research and funding dedicated to the issue. States that measure and publish their own prevalence rates see anywhere from 1% to 6%. Those most at risk include young adults, men and online gamblers. Gambling-related harms can be dire, from financial stress to co-occurring behavioral health conditions to suicide, which a fifth of individuals with gambling addiction attempt.
    • “To understand problem gambling, what’s driving it and efforts underway to address it, Fierce Healthcare talked to two dozen providers, researchers, advocates and regulators. This story is also based on a review of research, as well as exclusive data from Komodo Health analyzed on Fierce Healthcare’s behalf.
    • “It’s a small but mighty group of us that have been in this field, treating,” said Jody Bechtold, L.C.S.W., president of the International Problem Gambling and Gaming Certification Organization (IPGGC). “We call it the next opioid epidemic.” 
  • Healio tells us,
    • “The risk for subsequent fractures is similar for older adults, regardless of whether they had an initial major osteoporotic fracture or nonmajor osteoporotic fracture, researchers reported.
    • “In findings published in Journal of Bone and Mineral Research, researchers found that sustaining a major or nonmajor osteoporotic fracture raises the risk for subsequent fractures and mortality.”
  • Infectious Disease Advisor informs us,
    • “Rhinovirus and enterovirus are associated with severe clinical outcomes among hospitalized patients, including mechanical ventilation and death, highlighting the need for expanded respiratory virus surveillance among high-risk patient populations.”
  • MedPage Today points out,
    • “A dual deprescribing intervention for proton pump inhibitors (PPIs) targeting patients and their primary care doctors proved effective in reducing potentially inappropriate use, a cluster-randomized trial in France found.
    • “At 1 year, the combined approach — where patients got educational material about reducing PPI use mailed to them and their physicians received a letter detailing a deprescribing algorithm — resulted in twice as many patients cutting their PPI use in half (14.9%) versus usual care (7%) or physician-targeted intervention alone (7.7%, P<0.001 for both).
    • “The results underscore “the value of prioritizing patient-facing deprescribing strategies,” wrote researchers led by Jean-Pascal Fournier, MD, PhD, of Nantes Université in France, in JAMA Internal Medicineopens in a new tab or window. Furthermore, the interventions were not associated with a resurgence in gastroesophageal reflux disease (GERD) symptoms.
    • “PPIs in the U.S. are frequently prescribed for inappropriate indications and sometimes prescribed indefinitely, according to Fournier and colleagues.” * * * Potentially unnecessary PPI spending — reimbursements in 2015 hit $12 billion in the U.S.

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

  • Modern Healthcare reports,
    • “The Purchaser Business Group on Health, which represents large companies, launched a project to combine federally required data with claims data culled from its biggest members to provide insight into costs and quality in employer-sponsored health plans.
    • “This has the potential to supply employers with unprecedented access to healthcare pricing data that could help curb escalating employee health benefit costs, said Purchaser Business Group on Health President and CEO Elizabeth Mitchell.
    • “There is employer demand for this information that is unmet in the market,” Mitchell said during a Purchaser Business Group on Health webinar on healthcare transparency in February.
    • “The Purchaser Business Group on Health has found that normal market forces that should be expected to link prices to quality don’t function in healthcare. Prices often fluctuate wildly based more on the size and market power of health systems or insurers than on the quality of services rendered.
    • “For instance, its data reveal prices at hospitals in the same markets do not correlate with scores from the Leapfrog Group, which assesses hospital quality and safety. Often, low-rated hospitals charge more. Or the same hospital charges vastly different prices for the same procedures depending on the insurance plans, not any differences in the service.” 
  • and
    • “Health systems are increasing their investments in concierge medicine to meet patient demand and keep burned-out doctors practicing.
    • “Though typically a small percentage of a health system’s operations, concierge medicine — where patients pay thousands of dollars in membership fees for increased access to primary care physicians — helps diversify revenue and creates growth opportunities in new and existing markets.
    • “Still, it’s a controversial model that raises questions about equal access to care because it historically has appealed to wealthier, often older individuals looking for more personalized primary care. Health systems say patient demand has expanded beyond that demographic.”
  • Fierce Healthcare relates,
    • “Anthem and Mount Sinai have reached a new multi-year contract agreement, restoring coverage for thousands after the system went out-of-network last month.
    • “Anthem Blue Cross and Blue Shield of New York said in a statement Monday that the three-year deal returns Mount Sinai’s hospitals, physicians and other providers to its network. The health plan said that the contract “reflects both organizations’ commitment to delivering quality care while helping control healthcare costs for New York workers, families, employers and taxpayers.”
    • “The contract also includes updated reimbursement models that aim to reward quality and outcomes, while continuing to support accurate billing and payment.”
  • The Wall Street Journal lets us know ,
    • Healthcare giant Johnson & Johnson JNJ reported nearly 10% revenue growth for the latest quarter on strong cancer drug sales that offset a steep decline from one of its bestselling drugs, Stelara.
    • J&J said its first-quarter sales rose to $24.06 billion, topping the mean estimate of $23.62 billion from analysts surveyed by FactSet. Adjusted quarterly earnings also beat Wall Street expectations.
    • On the back of those results, the drug and medical-device maker boosted its full-year financial forecast. So far, disruptions from the war in Iran haven’t materially hurt J&J.
    • “There’s a lot of macro uncertainty out there,” J&J Chief Financial Officer Joseph Wolk said in an interview. “We think the fact that we’re not only maintaining but raising” the forecast is a sign of the company’s strength, he added.
    • J&J has been working to ensure consistent growth after losing patent protection for Stelara, a treatment for skin and digestive conditions. Competitors introduced lower-cost alternatives last year, leading to a 60% drop in first-quarter sales of the brand-name version of the drug.
    • Strong sales of J&J cancer medications like multiple-myeloma treatment Darzalex helped make up for those declines. The company’s cancer-drug sales rose more than 22% for the quarter. J&J is in a stronger position than some of its peers, which face even bigger patent cliffs in coming years.
  • BioPharma Dive tells us,
    • “Eli Lilly is again turning to dealmaking to boost its oncology portfolio, reaching a deal Tuesday to acquire a biotechnology company, CrossBridge Bio, that’s developing newer types of targeted cancer medicines.
    • “Lilly will pay up to $300 million in cash for CrossBridge, a Houston-based startup making antibody-drug conjugates for cancer. That total includes an unspecified upfront payout and subsequent payment tied to a development milestone, CrossBridge said in a statement.
    • “The deal hands Lilly technological capabilities that have become increasingly desirable to major pharmaceutical firms. Antibody-drug conjugates, or ADCs, are now a pillar of cancer care, a method of precisely delivering a toxic blow to malignant cells. Over 20 ADCs are currently available to treat tumors of the breast, lung, bladder and more. Many are working their way into earlier treatment lines, in some cases supplanting decades-old chemotherapy approaches.”
  • MobiHealth informs us,
    • “New York-based virtual women’s health provider Maven Clinic announced a strategic collaboration with care concierge company Wellthy to combine clinical care and caregiving support for employees.
    • “Maven Clinic is a digital reproductive health and family platform that offers fertility and family planning services, pregnancy and postpartum care, parenting and pediatric support, and menopause-related care.
    • ‘Wellthy offers a care concierge service that connects employees with care teams to help them navigate the healthcare system, including finding in-home support, understanding benefits, accessing legal resources and obtaining financial assistance.
    • “The company also offers Backup Care services to help employees find emergency care for family members, including daycares, on-site childcare facilities and other community-based programs.    
    • “The aim of Maven and Wellthy’s partnership is to help employees in the “sandwich generation, – those in the period of starting a family and caring for an older loved one – navigate the process from fertility, growing a family and overseeing eldercare.
    • “This partnership is about building a system that reflects how people live, with clinical care and caregiving support together in one place. When technology makes that support intuitive, you don’t just improve outcomes – you make it possible for people to ask for help in the first place,” Kate Ryder, founder and CEO of Maven Clinic, said in a statement.”
  • The Wall Street Journal informs us,
    • “Novo Nordisk NOVO.B said it would work with ChatGPT maker OpenAI on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as healthcare companies seek to harness the technology to get ahead of the competition.
    • “The Danish drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients.
    • “The group said the partnership would boost efficiency across manufacturing, distribution, the supply chain and corporate, with pilot programs initially launching in research and development, manufacturing and commercial operations ahead of a full AI integration by the end of the year.” * * *
    • “Drugmakers are turning to AI companies and their increasingly powerful models to improve operations and cut repetitive tasks for employees, giving them more time to focus on R&D in a bet that advancements in the technology will help them identify promising new drugs and treatments.”
  • Modern Healthcare adds,
    • “Health systems and payers are making big investments in artificial intelligence to improve their operations by reducing administrative burden, beefing up clinical prediction capabilities and increasing access to care. 
    • “A case in point: This year alone, UnitedHealth Group is investing $1.6 billion into its AI efforts. Companies also are realigning executive roles by adding chief AI officers or adding AI responsibilities to C-suite executives overseeing data and innovation.” * * *
    • “Mike Baker, chief operating officer, UnitedHealthcare
    • “UnitedHealth Group, our parent, has embedded the use of AI across our business to simplify healthcare and improve how people access care, information and support. UnitedHealth Group is investing $1.6 billion this year with the aim of making experiences more personalized, reducing administrative friction for clinicians, increasing transparency around cost and coverage, and supporting better care decisions.” 

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.”

Friday report

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

Happy first day of Spring!!

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health, medical and Rx research front,

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

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

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

Midweek report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Notable Death

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

Monday report

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

From Washington, DC

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

From the judicial front,

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

From the public health, medical and Rx research front,

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

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

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

Thursday report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The New York Times reports,
    • “In his first week leading two of the nation’s health agencies, Dr. Jay Bhattacharya has been met with praise and gratitude from federal employees — an unexpected reception for a scientist who spent much of the last few years facing scorn from most other public health experts.
    • “Dr. Bhattacharya, director of the National Institutes of Health, was last week named the acting director of the Centers for Disease Control and Prevention. A medical economist and former Stanford University professor, he replaced Jim O’Neill, a Silicon Valley executive with no medical training.
    • “Like most officials in the Trump administration, Dr. Bhattacharya was staunchly opposed to mandates for Covid vaccines, but unlike many, he has not questioned the safety of childhood vaccines.
    • “In meetings with C.D.C. staff this week, Dr. Bhattacharya offered to publicly endorse immunizations in general and the measles vaccine in particular; extolled the importance of prevention efforts against H.I.V.; and promised to try to extend remote work accommodations, according to several C.D.C. employees with knowledge of the discussions.” 
  • Beckers Payer Issues informs us,
    • “HHS released its third annual report Feb. 9 that evaluates how the No Surprises Act has affected healthcare markets.
    • “The report was produced with analytical support from RAND, and extends claims data trends through 2022, the first full year after the law took effect.
    • “Because most self-insured employer plans were not previously subject to state surprise billing laws, the NSA represented a bigger regulatory change for them than for fully insured plans. Average out-of-network per-claim payments for emergency services in self-insured plans fell 41% during the period, compared to 22% for fully insured plans. Self-insured plans also saw steeper declines in out-of-network billing prevalence and out-of-pocket costs across the board.”
  • Avalere Health tells us,
    • “From 2025 to 2026, overall Part D enrollment increased from 55.4 million to 56.9 million (a 2.7% increase). Over this period, enrollment in PDPs grew by 7.2% while enrollment in MA-PDs decreased by 0.5%. This is a notable shift from trends in recent years. MA-PD enrollment had climbed from 26 million in 2022 to 31.8 million in 2025, with annual growth of 7.4% from 2023 to 2024 and 4.3% from 2024 to 2025. By contrast, PDP enrollment was stable at 23.4 million in 2022 and 23.5 million in 2025, before rising to 25.2 million in 2026.  
    • “PDP enrollees are increasingly selecting lower premiums plans. In 2026, 64% of PDP enrollees chose plans with premiums under $25, up from 49% in 2025. At the same time, the share selecting plans with premiums of $100 or more increased to 17% in 2026, up from 12% in 2025.” * * *
    • “Despite continued declines in the number of standalone PDPs offered in 2025 and 2026 relative to prior years, PDP enrollment has increased while MA-PD enrollment has largely leveled off. For plan sponsors, this divergence may signal changing beneficiary preferences around premium sensitivity, benefit offerings, pharmacy network design, and the value proposition of integrated MA coverage versus a standalone Part D product.” 
        
  • Federal News Network reports,
    • “The Agriculture Department is planning to sell one of its headquarters buildings, as part of an ongoing agency reorganization that will relocate more than half of its workforce in Washington, D.C. to regional hubs across the country.
    • “USDA announced Wednesday that it is turning the department’s South Building over to its landlord, the General Services Administration, which plans to sell the building.”
  • Tammy Flanagan, writing in Govexec, explains “How to make the most of FERS, Social Security and your TSP.”
    • “Understanding each part of your federal retirement can help you plan when and how to retire and avoid surprises.”
  • Govexec relates,
    • “Newly released data from the Government Accountability Office offers some of the most granular glimpses yet of how the Trump administration’s sprint to remake the federal workforce in the president’s image impacted agency headcounts.
    • “The report, published Tuesday, responds to a request by congressional Democrats to catalog data related to a variety of workforce changes undertaken shortly after President Trump returned to office last January, including reductions in force, the purge of recently hired or promoted employees with fewer civil service protections and the deferred resignation program.
    • “GAO said it relied upon data from the Office of Personnel Management and individual agencies in compiling its report. OPM has previously said that around 317,000 federal workers left government in 2025. The watchdog agency’s report captures the first six months of Trump’s second term, capturing a fraction of that throughput.
    • “Of the 134,122 employees who separated from the 23 CFO Act agencies during the period from January to June 2025, a substantial majority (around 77%) retired or resigned,” GAO found. “Another roughly 19% were terminated or removed from their positions. Of these, agencies reported that nearly 4,500 employees (or about 3%) were terminated during a probationary or trial period.”

From the Food and Drug Administration front,

  • ABC News reports,
    • “Frozen blueberries distributed in four states have been voluntarily recalled due to possible listeria contamination.
    • “Oregon Potato Company, which owns the Salem, Oregon-based Willamette Valley Fruit Company, voluntarily recalled 55,689 pounds of frozen blueberries on Feb. 12 over potential contamination with Listeria monocytogenes, according an enforcement report from the U.S. Food and Drug Administration.
    • “The recall was designated as a Class I recall on Feb. 24, the highest FDA classification, which indicates that “use of or exposure to” the affected product can cause “serious adverse health consequences or death.”
  • MedPage Today adds,
    • “The FDA approved dupilumab (Dupixent) for treating allergic fungal rhinosinusitis, a first for the condition, the agency announced on Wednesday.
    • “Approval stipulates use in individuals 6 years and older with prior sino-nasal surgery, as the condition has a high rate of post-operative recurrence.
    • “Allergic fungal rhinosinusitis is characterized by the production of thick, sticky mucus following an allergic reaction to fungi in the sinuses. Left untreated, the type 2 inflammatory disease can expand the sinuses, erode surrounding bone, and lead to vision problems, nerve damage, and even facial deformities.”

From the judicial front,

  • Govexec reports,
    • “A federal appeals court on Thursday declined to enforce a temporary decision blocking the Trump administration from stripping two-thirds of the federal workforce of their collective bargaining rights, dimming though not extinguishing the American Federation of Government Employees’ legal challenges against a pair of anti-union executive orders.
    • “A three-judge panel on the Ninth Circuit Court of Appeals ruled unanimously that it could not uphold a preliminary injunction that would have blocked the Trump administration from implementing a pair of 2025 executive orders that cite a seldom-used provision of the 1978 Civil Service Reform Act to ban collective bargaining at most federal agencies, under the auspices of national security. That injunction had itself been put on hold by the appellate judges since last August.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The last thing someone in their 30s or 40s should worry about is dying of a heart attack. But new research shows more are.
    • “The proportion of adults ages 18 to 54 who died in a hospital of a severe first heart attack rose 57% between 2011 and 2022, according to a new study published Thursdayin the Journal of the American Heart Association.
    • “Most of those who died were men, but women died at higher rates than men.
    • “The study offers the latest evidence of worsening health among younger U.S. adults, including deaths from conditions traditionally tied to aging, such as heart disease and cancer.”
  • The American Hospital Association News relates,
    • “Obesity rates for U.S. children and teenagers have reached record highs, while rates for adults had a slight decline, according to reports by the Centers for Disease Control and Prevention. Both reports examined historical trends using height and weight data from the National Health and Nutrition Examination Survey. From August 2021 to August 2023, an estimated 21.1% of children and teenagers ages 2-19 were obese, up from 19.3% from 2017-2018. Additionally, from 2021-2023, 7% of children and adolescents were severely obese and 15.1% were overweight. For adults, 40.3% were obese from 2021-2023, down from 42.8% in 2017-2018. In addition, from 2021-2023, 9.7% of adults were severely obese and 31.7% were overweight.”
  • BioPharma Dive tells us,
    • “Eli Lilly’s GLP-1 pill orforglipron was associated with greater weight loss and reductions in blood sugar levels than Novo Nordisk’s rival drug Rybelsus in a head-to-head trial in people with diabetes.
    • “The study results disclosed Thursday could help strengthen Lilly’s case for approval as well as orforglipron’s uptake in diabetes. But investigators also flagged higher rates of side effects in orforglipron recipients that led people to stop treatment. 
    • “The data highlight another potential threat to Novo, which has seen its shares tumble amid pricing pressure and competition from Lilly as well as drug compounders. The Denmark-based company markets the only oral GLP-1 medications for diabetes and obesity — Rybelsus and the Wegovy pill, respectively — but that could soon change. Lilly expects the Food and Drug Administration to decide whether to clear use of orforglipron in obesity sometime in the second quarter.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “A study by researchers at The Jackson Laboratory (JAX), the Broad Institute, and Yale University has identified how specific genetic changes function in cells to influence disease risk and other human health traits. By probing regions of DNA previously linked to disease, the scientists created high resolution maps of DNA variant activity, helping pinpoint the exact changes that shape blood pressure, cholesterol levels, blood sugar and other complex human traits.
    • “The study takes on a long-standing challenge in human genetics. Scientists have known for years that certain regions of the genome—often spanning tens of thousands to millions of DNA letters—are associated with diseases. But because these regions usually contain many variants that could potentially drive those associations, performing the necessary experiments to pinpoint which specific DNA changes truly matter has been difficult and time-consuming.
    • “The solution was scale. Using a massively parallel reporter assay (MRPA)—which is a high-throughput approach that simultaneously evaluates the regulatory activity of thousands of DNA sequences—the team tested more than 220,000 previously identified DNA changes in five different cell types. By doing so, they resolved about 20% of these regions across the genome, revealing new insights into what these variants do, which in turn could help improve risk prediction and guide the development of new therapies.
    • “Geneticist Ryan Tewhey, PhD, an associate professor who led the team at JAX, explained that previously making these connections was like searching for a single typo on one page of a massive book. The researchers’ new experimental approach is more akin to speed reading, scanning thousands of pages at once and flagging the exact letters that change meaning, dramatically accelerating genetic discovery.”
  • The Washington Post lets us know that “An all-or-nothing mindset could be hurting your exercise and health goals.
    • “If you’ve given up on your New Year’s resolutions to get fit, here are some tips for getting back in the saddle.”
  • MedPage Today adds,
    • “The cost of sunscreen with an SPF-50 rating varied by 17.5-fold per ounce and 100-fold per application in an economic analysis.
    • “Wearing more protective clothing could significantly reduce the amount of sunscreen needed and could lower application expenses.
    • “Standardization of sunscreen application to achieve desired thickness might influence annual cost.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Cigna has acquired CarepathRx, a large pharmacy backed by private equity that dispenses prescription drugs to nearly 10% of U.S. hospitals.
    • “The acquisition, discovered by STAT in a review of Cigna’s financial filings, reinforces the company’s push to control more of the lucrative flow of pharmaceuticals through the U.S. health care system. Cigna executives have repeatedly told investors that managing prescription drugs has been one of their highest priorities since the company acquired Express Scripts for $54 billion in 2018.”
  • Beckers Health IT relates,
    • “Two years after a merger that created a now $12.1 billion system, St. Louis-based BJC Health is rolling out fresh branding to solidify its market positioning and boost recruitment and retention, leaders told Becker’s.
    • “St. Louis-based BJC HealthCare and Kansas City, Mo.-based Saint Luke’s Health System joined forcesin early 2024, rebranding as BJC Health in late 2025. Now, the organization’s West region is in the midst of a new marketing campaign — “All For Kansas City” — and updating signage to bring the BJC brand to its market.
    • “The new logo puts an exclamation point behind the fact that the Saint Luke’s brand is here to stay, and, at the same time, connects us to BJC Health,” said Julie Quirin, president of BJC Health’s West region (aka Saint Luke’s Health System). “It tells the story that we’re stronger together, while leaning into that brand equity that we’ve built over the last 150 years here in Kansas City.”
  • Per Fierce Pharma,
    • “Already on a roll with its first-in-class FcRn blocker Vyvgart, argenx has reported successful trial results that could pave the way for the fast-rising blockbuster to reach a new indication—ocular myasthenia gravis.
    • “The phase 3 Adapt Oculus study, which is the first to specifically evaluate a targeted treatment for ocular myasthenia gravis (oMG), has achieved its primary endpoint, demonstrating that Vyvgart can improve vision by a statistically significant margin, argenx reported Thursday.
    • “The company hailed the victory the same day it unveiled its 2025 earnings, showing that Vyvgart sales came in at $1.3 billion in the fourth quarter and $4.2 billion for the full year.”
  • Per Healthcare Dive,
    • “Labcorp has expanded its collaboration with PathAI to use a digital pathology platform at its anatomic pathology labs and hospital sites.
    • “The agreement, which Labcorp disclosed Monday, supports the use of PathAI’s AISight Dx to enable digital workflows for case management, slide review, collaboration and annotation.
    • “Quest Diagnostics, Labcorp’s main rival, licensed AISight Dx in 2024 in conjunction with its $100 million acquisition of PathAI’s diagnostic laboratory in Memphis, Tennessee.”

Tuesday report

David Ermer–Congress, Employee Wellness Programs, FDA, Generative AI, NIH, No Surprises Act, Obesity, U.S. Healthcare–

From Washington, DC

  • Bloomberg Law reports,
    • “Another reconciliation bill represents a “tremendous opportunity”for Republicans to pass key policy priorities before the midterm elections, a House GOP tax-writer said Monday.
    • “Rep. Beth Van Duyne (R-Texas), a member of the House Ways and Means Committee, said at a Bloomberg Government roundtable that Republicans want a second shot at passing several provisions that were axed from their first reconciliation bill passed last year.
    • “It was a heavy lift to do reconciliation 1.0,” Van Duyne said. “But I think there’s a lot of parts of that bill that got washed out in the Byrd bath that we would like to be able to see put in reconciliation 2.0.” * * *
    • “Republican leaders including Ways and Means Chairman Jason Smith (R-Mo.) along with President Donald Trump have been cool to the idea of starting work on a second party-line bill given how challenging it was to pass the first bill, though a number of rank-and-file GOP lawmakers have clamored for it.
    • “There’s a lot of very strong bills that would be productive to be able to have passed and the only way that we can do that is put it in reconciliation,” Van Duyne said.”
  • and
    • “More than three dozen employers, insurers, and patient advocacy groups are askingthe Trump administration to intervene in the arbitration process for surprise medical bills. 
    • “Dysfunction under the No Surprises Act has flooded the courts with cases of alleged fraud on both sides. Insurers accuse providers of knowingly submitting ineligible claims to the arbitration process, while providers allege insurers are misleading arbitrators on key payment metrics.
    • “Health insurance companies and employers are losing the vast majority of cases under the law. Data from the Centers for Medicare & Medicaid Services, which oversees the arbitration process, show that providers are winning 88% of the time. But courts are largely siding with insurers when providers allege they aren’t paying up, saying that enforcement resides with the CMS.
    • “The Office of Management and Budget is reviewing a final rule to improve the independent dispute resolution process, which requires arbitrators to settle out-of-network bills between doctors and insurers. The rule has languished since the Department of Health and Human Services first proposed it in November 2023 as a series of legal challenges from the Texas Medical Association unfolded in the courts.
    • “More transparency and accountability is needed for companies that oversee arbitration, the ERISA Industry Committee, American Benefits Council, Business Group on Health, Elevance Health, union 32BJ Health Fund, and others said in a letter Tuesday.”
  • FEHBlog note — With regard to transparency, one of the factors that the arbitrators consider is patient acuity. A health plan can only guess at that factor. That’s unreasonable. The arbitration process should better align with American Arbitration Association rules for baseball arbitration.
  • Mobihealth News relates,
    • “Dr. Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services (CMS), said during an Action for Progress event focused on addiction and mental health that AI avatars are the best way to help rural communities access mental healthcare.
    • “We do not have enough practitioners for mental health support in these areas,” Dr. Oz said during the event.
    • “I’m telling you right now. There’s no question about it – whether you want it or not – the best way to help some of these communities is going to be AI-based avatars.”
    • “He proposed using agentic AI with the ability to conduct early mental health intakes, customize support to a patient’s needs and understand what a patient is “up to.”  
    • “[These tools] will pick up subtle little nuances in how you’re saying things – if you do it on purpose, it’s actually cool to find out – that will alert the avatar, but more importantly, the doctor they are going to report to that there is something going on,” Oz said. “And there will always be a doctor.”
    • “He framed the use of AI avatars to be used in conjunction with clinicians as, he said, humans are biologically designed to interpret facial cues, such as happiness, boredom, excitement and more, before a person verbalizes it.
    • “The key question is how do we use AI thoughtfully in that setting? If we do it right, we’ll build a much more sustainable healthcare system around mental health issues,” Oz said.”  

From the Food and Drug Administration front,

  • Fierce Pharma reports
    • “Four years after the FDA issued its most heavy-handed form of a rejection to the prior company behind pegzilarginase, the U.S. regulator has now given the treatment a thumbs-up.
    • “Scoring the accelerated nod is Immedica Pharma for Loargys as a therapy for hyperargininemia in the ultrarare genetic disorder Arginase 1 deficiency (ARG1-D). The approval covers patients age 2 and older, with the therapy to be used in conjunction with a protein-restricted diet. 
    • “Loargys, which is also known as pegzilarginase, is a recombinant human enzyme designed to lower levels of arginine in patients who are unable to break down the amino acid. It is the first treatment to address the elevated levels of plasma arginine associated with the disorder.”
  • and
    • “Sanofi and Regeneron’s megablockbuster immunology drug Dupixent has gained yet another FDA approval, this time in allergic fungal rhinosinusitis (AFRS).
    • “The U.S. regulator signed off on the drug as a treatment for adults and children ages 6 and older with AFRS based on late-stage trial data showing Dupixent reduced nasal signs and symptoms and systemic corticosteroid use or surgery compared to placebo, according to a Feb. 24 press release.” * * *
    • “Harmony Biosciences is rounding out the U.S. patient pool eligible for its sleep disorder pill Wakix after notching a pediatric nod from the FDA that positions the drug as a treatment for cataplexy in people ages 6 and older with narcolepsy.
    • “The new addition to Wakix’s label makes it the only non-scheduled treatment for both adult and pediatric narcolepsy patients in the U.S. with or without cataplexy. That non-scheduled classification represents an “important distinction that supports its clinical utility,” Harmony’s CEO, Jeffrey Dayno, M.D., commented in a press release. Cataplexy is a common symptom of narcolepsy that involves a sudden weakening of muscles, often when triggered by a strong emotion.” * * *
    • “Two months after Johnson & Johnson’s Rybrevant Faspro picked up its first FDA approval, the subcutaneous lung cancer drug has scored a label expansion to be given monthly.
    • “On Tuesday, J&J touted a “simplified” monthly dosing regimen for the drug’s combination with lazertinib for the first-line treatment of epidermal growth factor receptor EGFR-mutated advanced non-small cell lung cancer. Previously, the combo was approved as an every-two-week regimen.”
  • and
    • “Just three months after further scaling back its support for the struggling hemophilia A gene therapy Roctavian, the company is walking away altogether by pulling the treatment from the market. 
    • “The move follows a “comprehensive effort” to identify a potential buyer for the therapy, BioMarin explained Monday in its fourth-quarter earnings press release.” 

From the public health and medical / Rx research front,

  •  Health Day relates,
    • “You don’t need to look buff or tough, but muscle strength can influence how long you’ll live, a new study says.
    • “Older women with greater strength had a significantly lower risk of death during an eight-year follow-up, researchers recently reported in JAMA Network Open.
    • “The study measured women’s grip strength and ability to rise from a seated to standing position — two tests commonly used to determine seniors’ strength levels.
    • “Women had a 12% lower death rate for every 15 additional pounds of grip strength they exhibited during testing, researchers found.
    • “Likewise, they had a 4% lower death rate for every 6 seconds faster they could complete five sit-to-stand chair raises, results showed.”
  • and
    • “Teens who use weed are twice as likely to develop psychotic or bipolar disorders, a new study says.
    • “They also are more likely to have depression and anxiety, researchers reported Feb. 20 in JAMA Health Forum.
    • “As cannabis becomes more potent and aggressively marketed, this study indicates that adolescent cannabis use is associated with double the risk of incident psychotic and bipolar disorders, two of the most serious mental health conditions,” researcher Dr. Lynn Silver said in a news release. She’s a program director at the Public Health Institute in Oakland, California.
    • “More than 10% of 12- to 17-year-olds in the U.S. have used weed within the past year, researchers said in background notes. By their senior year in high school, about 26% of U.S. teenagers have tried it.”
  • and
    • “Side effects like nausea or vomiting are common among folks taking Ozempic/Wegovy, but they’ll grin and bear it if they think they’re losing weight, a new study finds.
    • “The drugs’ perceived effectiveness — lost weight, less appetite, fewer food cravings — outweigh GI side effects, researchers reported recently in the Journal of Medical Internet Research.”
  • MedPage Today informs us,
    • “Hepatitis B vaccination rates among U.S. newborns have fallen by more than 10 percentage points over the past 2 years.
    • “Those rates climbed steadily for 6 years, peaking at 83.5% in February 2023 before dropping to 73.2% by August 2025.
    • “The drop began months before the CDC’s Advisory Committee on Immunization Practices voted in December to stop universally recommending the birth dose.”
  • and
  • Per an NIH news release,
    • “A study funded by the National Institutes of Health (NIH) reduced new HIV cases by 70% in rural Kenya and Uganda by pairing digital tools with tailored HIV services delivered by community health workers and clinicians. This successful strategic implementation of existing healthcare infrastructure and available HIV prevention and treatment options could become a model for reducing HIV incidence in other countries, including the United States. The findings were presented today at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver.”  
  • Here’s a link to the latest edition of NIH’s Research Matters which covers the following topics:

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

  • The Wall Street Journal reports,
    • Novo Nordisk NOVO.B plans to slash U.S. list prices for its popular weight-loss and diabetes drugs Wegovy and Ozempic by up to half starting next year.
    • Under the changes, both Ozempic and Wegovy will list for $675 a month, effective Jan. 1, 2027. That is half of the current price tag for anti-obesity therapy Wegovy and a 34% cut for diabetes treatment Ozempic. The price cuts also will apply to pill versions of both injections, including one sold as Rybelsus.
    • The reductions escalate a price war with rival Eli Lilly LLY -1.40% in one of the fastest-growing, most hotly contested categories in pharmaceuticals.
  • Optum Rx, writing in LinkedIn, discusses the next phase of the GLP-1 revolution.
  • STAT News relates,
    • “In the last year and a half, direct-to-consumer telehealth company Hims & Hers has become a leading voice in the debate over compounded GLP-1 weight loss medications. On Monday, it announced earnings from the last quarter of 2025 after a whirlwind month that raised questions about the regulatory risks of the company’s compounding model and the threat of an investigation. 
    • “In the call, Hims & Hers CEO Andrew Dudum addressed the increased scrutiny on compounded GLP-1s and its impact on the business’s bottom line, emphasizing Hims’ other medications, including for weight loss. “We believe there’s a really durable weight business,” said Dudum, “even if you think you’re kind of in a draconian scenario of compounding GLP-1s not being there.”
  • Fierce Healthcare tells us,
    • “Employers are spending more on women’s and family health, but that is not always being felt by employees, a new report finds.
    • “The Maven Clinic released its fifth annual State of Women’s & Family Health Benefits report, which is based on responses from over 2,000 HR leaders and nearly 5,000 full-time employees across the U.S., U.K., Canada and India. The report highlights how rising healthcare costs are reshaping how employees seek care and what actions employers are considering to help address those costs.
    • “Though employers reported a 39% average increase in women’s and family health benefits offered year-over-year, the share of employees who felt their benefits support them “very well” dropped 10% on average. Globally, across all benefits, employers were slightly more likely to add or enhance benefits in the next year compared to those in the U.S.”
    • “From Maven’s perspective, all the report’s findings highlight the need for an integrated approach to benefits and care delivery.
    • “We think that the category continues to show importance, and that is a positive,” Stephanie Glenn, chief commercial officer at Maven, told Fierce Healthcare. 
    • “But the gap in what’s being offered and what employees are feeling exists because of a lack of thoughtful integration, she added. “Unless it’s a coordinated offering, if you get a one-time email about a new benefit, it’s very disjointed. You don’t understand what it looks like,” she said.”
  • Healthcare Dive tells us,
    • “Thirty-one thousand Kaiser Permanente nurses and other healthcare professionals in California and Hawaii ended a major strike Tuesday after about a month on the picket lines. 
    • “In a statement Monday, the workers’ union, the United Nurses Associations of California/Union of Health Care Professionals, said “significant movement” at the bargaining table over the past two days prompted leaders to end the strike.
    • “Returning members to their patients and their livelihoods is the clearest path to securing a final agreement and building on the progress achieved during the strike,” the UNAC/UHCP said.”
  • and
    • “Home health and hospice provider Enhabit has agreed to be taken private by private equity firm Kinderhook Industries in a deal worth $1.1 billion.
    • “Under the deal terms announced Monday, shareholders will receive $13.80 in cash per share, representing an almost 25% premium over Enhabit’s closing stock price on Feb. 20. 
    • “The Dallas-based provider — which has almost 250 home health locations and over 115 hospice locations in 34 states — will cease trading on the New York Stock Exchange when the deal closes, which the companies expect to happen in the second quarter this year.”
  • Beckers Hospital Review notes,
    • “For the first time, women now make up the majority of physicians in U.S. training programs, according to the Association of American Medical Colleges’ annual report on residency trends. 
    • “In the 2024-25 academic year, women accounted for 50.2% of residents and fellows across all specialties and subspecialties, per the report. The figure marks a stark contrast from the 1970s, when women comprised less than 10% of physicians, and reflects decades of steady growth in female representation in medical schools and training programs.”
  • and
    • “If healthcare IT were golf, CIOs would take a few mulligans.
    • “Choosing and installing an EHR is often one of the biggest, most complicated decisions IT leaders will ever make, and some executives told Becker’s they would do things differently if they could go back in time.”
  • Per MedTech Dive,
    • “Medtronic on Tuesday priced a planned initial public offering for its MiniMed diabetes spinoff at up to $784 million.
    • “MiniMed plans to price its IPO between $25 and $28 per share across 28 million shares. Underwriters will also have the option to buy an additional 4.2 million shares at the IPO price.
    • “Medtronic first announced plans to spin out its diabetes business into a separate, publicly traded company in May. The new firm would be the only company in the market that sells both insulin pumps and continuous glucose monitors.”