Tuesday Report

CMS

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, NIH, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “The Trump administration began broad staff cuts at the Health and Human Services Department, locking some workers out of federal buildings and reassigning others to new agencies including the Indian Health Service.
    • “Emails notifying employees of cuts and reassignments flooded inboxes on Monday night and Tuesday morning. The move is part of Health and Human Services Secretary Robert F. Kennedy Jr.’s strategy to shrink and reshape the nation’s health agencies.
    • “The cuts extend far and wide, from the Food and Drug Administration and the National Institutes of Health to the Centers for Disease Control and Prevention. 
    • “On the social-media platform X, Kennedy said what the government had been doing wasn’t working: “We must shift course. HHS needs to be recalibrated to emphasize prevention, not just sick care. These changes will not affect Medicare, Medicaid, or other essential health services.” 
    • “An HHS spokesman said the cuts wouldn’t affect drug or food reviewers or inspectors. “This critical work continues,” he said.”
  • Per a Senate committee press release,
    • “Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Bernie Sanders (I-VT), ranking member of the HELP Committee, sent a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., inviting him to participate in a[n April 10, 2025,] HELP Committee hearing on the reorganization of HHS.”
  • Federal News Network adds,
    • “The departments of Agriculture, Defense, Energy, Transportation and Housing and Urban Development, as well as the Small Business Administration and the General Services Administration, have all restarted their deferred resignation programs, Federal News Network has confirmed.
    • “The “fork in the road” relaunch at those seven agencies comes at the same time many agencies are beginning to take on plans for conducting reductions in force (RIFs).”
  • Fierce Healthcare discusses what’s going on with Dr. Mezmet Oz’s efforts to be confirmed as CMS Director.
  • Healthcare Dive reports,
    • “Sens. Chuck Grassley, R-Iowa, and Ron Wyden, D-Ore., sent letters to HHS officials last week demanding the CMS and the Health Resources and Services Administration look into the growing problem of “line skipping” in organ donation, after media reports suggested patients were being passed over in the organ donation process in favor of less sick recipients.
    • “Reports from The New York Times, cited by the senators, found line skipping occurred in nearly 20% of transplants from deceased donors last year. For comparison, patients received out of order organ donations in about 2% of such donations in 2016, the letter said.
    • “The senators have charged the CMS and HRSA, which oversee organ procurement organizations, with explaining their process for monitoring organ distribution, and asked officials to provide transparency into any complaints the agencies might have received about line skipping since 2019.”
  • Per a Justice Department news release,
    • Today, Attorney General Pamela Bondi released the following statement:
      • “Luigi Mangione’s murder of Brian Thompson — an innocent man and father of two young children — was a premeditated, cold-blooded assassination that shocked America. After careful consideration, I have directed federal prosecutors to seek the death penalty in this case as we carry out President Trump’s agenda to stop violent crime and Make America Safe Again.”
      • “As alleged, Luigi Mangione stalked and murdered UnitedHealthcare executive Brian Thompson on Dec. 4, 2024. The murder was an act of political violence. Mangione’s actions involved substantial planning and premeditation and because the murder took place in public with bystanders nearby, may have posed grave risk of death to additional persons.   
      • “Following federal murder charges handed down on Dec. 19, 2024, Attorney General Bondi has now directed Acting U.S. Attorney Matthew Podolsky to seek the death penalty in this case.
      • “This is in line with Attorney General Bondi’s Day One Memo as Attorney General entitled Reviving The Federal Death Penalty And Lifting The Moratorium On Federal Executions.”

From the patient safety front,

  • The American Hospital Association News lets us know,
    • “As part of the AHA’s Patient Safety Initiative, a dedicated webpage features case studies showing how hospitals and health systems across the nation are implementing effective and innovative programs to create a culture of safety, improve staff well-being and connect with their communities. READ NOW.”

From the public health and medical research front,

  • Cardiovascular Business reports, “Embracing a healthy plant-based diet can help patients with obesity, diabetes and heart disease live longer, according to new research presented during ACC.25, the annual conference of the American College of Cardiology (ACC).”
  • Per MedPage Today,
    • “A diet involving fasting on three nonconsecutive days per week yielded a 6.37 lbs greater weight loss after a year than a daily caloric deficit.
    • “Both groups aimed for a total weekly energy deficit of 34%.
    • “Weight-loss differences were likely due to greater adherence to the intermittent fasting diet.”
  • This week’s issue of NIH Research Matters discusses “Diet and healthy aging | Peptide eye drops | Bacteria use antimicrobial agent.”
  • The Washington Post takes “a closer look at vitamin D’s role in gut health. Health-care providers often recommend meeting your vitamin D requirements through food rather than sun exposure.”
  • Per an NIH news release,
    • “A new form of tumor infiltrating lymphocyte (TIL) therapy, a form of personalized cancer immunotherapy, dramatically improved the treatment’s effectiveness in patients with metastatic gastrointestinal cancers, according to results of a clinical trial led by researchers at the National Institutes of Health (NIH). The findings, published April 1, 2025 in Nature Medicine, offer hope that this therapy could be used to treat a variety of solid tumors, which has so far eluded researchers developing cell-based therapies.”
  • Health Day informs us,
    • “Surgery might not be needed in breast cancer patients whose tumors are wiped out by chemotherapy and radiation therapy
    • “31 women who had surgery after successful chemo and radiation treatment remained cancer-free five years later
    • “As many as 60% of early-stage breast cancers are completely eliminated by chemo and radiation prior to surgery, researchers noted.”
  • Consumer Reports, writing in the Washington Post, discusses “How to keep your memory sharp as you age. Simple habits can reduce your risk of memory loss and dementia — and slow cognitive decline.”
  • Per MedPage Today,
    • “A new blood-based test reflected Alzheimer’s tau tangle pathology.
    • “The assay measured a new plasma tau species known as endogenously cleaved MTBR-tau243.
    • “The test distinguished various stages of Alzheimer’s and separated it from non-Alzheimer’s tauopathies.” * * *
    • “This blood test clearly identifies Alzheimer’s tau tangles, which is our best biomarker measure of Alzheimer’s symptoms and dementia,” [Dr. Randall] Bateman said in a statement. The test also provides a good indication about whether a patient’s symptoms are due to Alzheimer’s or another disorder, he noted.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Hims & Hers is expanding its weight-loss offering on its telehealth platform with the addition of Eli Lilly’s LLY  Zepbound prescription and generic liraglutide.” * * *
    • “The telehealth-consultation platform on Tuesday said its aim is to bring customers more treatment options that best suit their needs.
    • “We’ve now expanded that choice even further by adding access to generic liraglutide and branded tirzepatide through our platform,” the company said.
    • “Hims & Hers’ platform already offers weight-loss brands including Novo Nordisk’s NOVO.B Ozempic and Wegovy.
    • The company said it plans to continue expanding its weight loss offering to deliver a more personalized experience to its customer base.
  • Per Beckers Hospital Review,
    • “Eli Lilly is broadening its direct-to-consumer approach by partnering with a digital health company, Noom, which is focused on weight management. 
    • “The collaboration connects Noom users with Eli Lilly’s pharmacy provider, GiftHealth, to facilitate access to Zepbound single-dose vials for individuals with a prescription, according to a March 31 Noom news release. 
    • “The integration also allows users to track prescription fill statuses and shipping dates within an app. Eli Lilly’s decision to offer Zepbound in a single-dose vial format for cash-paying patients is part of a broader effort to increase access to the weight loss drug.”
  • and
    • “Durham, N.C.-based Duke University Health System has completed its $284 million acquisition of Lake Norman Regional Medical Center and related businesses in Mooresville, N.C., from subsidiaries of Franklin, Tenn.-based Community Health Systems.
    • “Duke finalized the acquisition April 1. The 123-bed acute care hospital will be renamed Duke Health Lake Norman Hospital, according to a Duke Health news release.
    • “This is an exciting day for Duke Health and the Lake Norman team,” DUHS CEO Craig Albanese, MD, said in the release. “We have a bright future ahead and look forward to bringing the excellence and innovation of Duke Health to enhance the care offered at Duke Health Lake Norman Hospital and clinics.” 
  • Modern Healthcare relates,
    • “Novant Health, with MedQuest Associates, has signed an agreement to acquire 18 OrthoCarolina imaging centers in the Carolinas.  
    • “The deal, which closed March 31, involves 13 locations in the Charlotte region in North Carolina, three locations in the Winston-Salem region in North Carolina and two locations in South Carolina. MedQuest, which is owned by Novant, will manage day-to-day operations at the sites, according to a Tuesday news release.
    • “Financial details of the deal were not disclosed. 
    • “Winston-Salem-based Novant operates more than 900 care locations in the Carolinas, including 19 hospitals, about 750 physician clinics and other outpatient facilities. MedQuest operates more than 50 outpatient centers and mobile radiology units.”

Weekend Update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, OPM, Telehealth–
Texas bluebonnets now blooming in central Texas

From Washington, DC,

  • On April 3, 2025, at 10 am, ET, the Senate Homeland Security and Governmental Affairs Committee will hold a confirmation hearing for Scott Kupor, the President’s nominee for the position of OPM Director. The FEHBlog looks forward to Mr. Kupor’s confirmation.
  • Fierce Healthcare reports,
    • “Over three dozen healthcare associations and organizations penned a letter this week calling on House and Senate leaders for action on a bill bolstering foreign-born physician recruitment to underserved regions.
    • “The letters—which include the American Medical Association, the American Hospital Association and the Association of American Medical Colleges as signatories—speak to the Conrad 30 Waiver Program and its role in alleviating the nation’s worsening clinical workforce shortage.
    • “It allows foreign students who come to the U.S. for medical training immediately begin practicing in the U.S. by foregoing visa requirements that would force them to return to their home country for at least two years. In exchange, program participants are required to work full-time for at least three years in a medically underserved community.” * * *
    • “A pair of bills introduced in the House and Senate late last month and referred to their respective judiciary committees would reauthorize and “make necessary updates to strengthen the program,” the groups said.”
  • CMS is holding a virtual town hall meeting on April 30, 2025, from 10 am to 3 pm ET “for clinicians and researchers as well as other interested parties, such as patient advocacy organizations, patients, and caregivers, to share input relevant to the clinical considerations related to drugs selected for the second cycle of negotiations [under the Inflation Reduction Act].”

From the judicial front,

  • Govexec reports,
    • “President Trump can once again fire a key appointee who hears appeals of firings and suspensions of federal employees, putting the board on which she sits at risk of losing its functionality as the administration is pushing out large swaths of the federal workforce. 
    • “Cathy Harris, a Democrat nominated to the Merit Systems Protection Board by President Biden, was fired by Trump last month but quickly won reinstatement from a district judge. On Friday, a panel on the U.S. Court of Appeals for the D.C. Circuit in a 2-1 decision paused the lower court’s decision and said Trump could fire Harris. 
    • “The decision also applied to Gwynne Wilcox, a member of the National Labor Relations Board who Trump had fired, and a district court also reinstated. 
    • “If Harris is removed, MSPB would be left without a quorum. From 2017 to 2022, the board also lacked a quorum, which created a 3,500-case backlog that was only just recently eliminated. Due to an interim final rule established that same year, MSPB can conduct some actions without a quorum, though it cannot issue final decisions appealed to its central board.
    • “Zac Kurz, an MSPB spokesman, confirmed Friday evening that that the central board no longer has a quorum. While regional administrative judges can still issue initial rulings, the central board can no longer hear appeals of those rulings.”  

From the public health and medical research front,

  • The New York Times reports,
    • “As many as one in five people — an estimated 64 million in the United States — have elevated levels of a tiny particle in their blood. It can greatly increase the risk of heart attacks and strokes.
    • “But few know about it, and almost no doctors test for it, because there was not much to be done. Diet does not help. Neither does exercise. There have been no drugs.
    • “But in the near future, that may change.
    • “On Sunday [today], cardiologists announced that an experimental drug made by Eli Lilly, lepodisiran, could lower levels of the particle, Lp(a), by 94 percent with a single injection. The effects lasted for six months and there were no significant side effects.
    • “But it is not yet confirmed that reducing Lp(a) levels also reduces the risk of heart attacks and strokes. That awaits large clinical trials that are now underway.
    • “The Lilly research was presented Sunday at the annual meeting of the American College of Cardiology and simultaneously published in the New England Journal of Medicine. At least four other companies are also testing innovative drugs that block the body’s production of Lp(a), a mix of lipids and a protein.
    • “Dr. David Maron, a preventive cardiologist at Stanford not involved in the Lilly research, said the evidence of profound and long-lasting reduction in lipoprotein levels with lepodisiran was “thrilling.”
    • “Dr. Martha Gulati, a preventive cardiologist at Cedars-Sinai Medical Center also not involved in the trial, said the study was “really elegant.”
  • and
    • “Many people use a smartwatch to monitor their cardiovascular health, often by counting the number of steps they take over the course of their day or recording their average daily heart rate. Now, researchers are proposing an enhanced metric, which combines the two using basic math: Divide your average daily heart rate by your daily average number of steps.
    • “The resulting ratio — the daily heart rate per step, or DHRPS — provides insight into how efficiently the heart is working, according to a study conducted by researchers at the Feinberg School of Medicine at Northwestern University and published today in the Journal of the American Heart Association.
    • “The study found that people whose hearts work less efficiently, by this metric, were more prone to various diseases, including Type II diabetes, hypertension, heart failure, stroke, coronary atherosclerosis and myocardial infarction.
    • “It’s a measure of inefficiency,” said Zhanlin Chen, a third-year medical student at the Feinberg School of Medicine at Northwestern University and lead author of the new study; his coauthors included several Feinberg faculty physicians. “It looks at how badly your heart is doing,” he added. “You’re just going to have to do a tiny bit of math.”
  • NPR Shots tells us,
    • “As a measles outbreak in West Texas and New Mexico continues to grow, and other states report outbreaks of their own, some pediatricians across the U.S. say they are seeing a new trend among concerned parents: vaccine enthusiasm.
    • “Our call center was inundated with calls about the MMR [measles, mumps, rubella] vaccine,” says Dr. Shannon Fox-Levine, a pediatrician in Broward County, Fla. She says parents are asking if their child is up to date on their vaccinations. Or “should they get another vaccine? Should they get an extra one? Can they get it early?” * * *
    • “Interest in vaccinations has ramped up ahead of the spring break travel season, says Dr. Susan Sirota, a primary care pediatrician in the Chicago area.
    • “We have many patients calling us because they are traveling to either Texas or places near Texas, or states where they suspect that vaccination rates are lower than we have in Illinois,” Sirota says. “Many families are requesting early MMR [vaccines].” 
  • MedPage Today lets us know, “Transcatheter aortic valve replacement (TAVR) continued to hold its own against surgery for younger patients at low surgical risk, with the Evolut Low Risk trial now halfway to its goal of 10-year follow-up.”
  • Per Medscape,
    • “GSK said on Tuesday that it is studying a group of more than a million older adults in the UK to examine whether its best-selling shingles vaccine lowers the risk of dementia.
    • “The British drugmaker is using the health data of some 1.4 million people, aged 65 to 66, some of whom received its Shingrix shot and some who did not. 
    • “GSK’s chief scientific officer Tony Wood said the data, from the state-run National Health Service’s (NHS) large database, is a unique set of information because due to a tweak in the UK’s shingles immunization program there is effectively a naturally randomized trial already taking place.”
  • and
    • “High-dose oral cholecalciferol (vitamin D3) supplementation significantly reduced disease activity in patients with clinically isolated syndrome (CIS) suggestive of multiple sclerosis (MS) in the randomized, controlled D-Lay MS trial.
    • “Combined with data from previous studies on vitamin D as an add-on therapy, the results of the D-Lay MS trial, which show a stronger effect of vitamin D in patients with vitamin D deficiency compared to others, strongly suggest that patients with vitamin D deficiency should be supplemented, regardless of whether they are already under disease-modifying therapy,” Eric Thouvenot, MD, PhD, University Hospital of Nimes, Neurology Department, Nîmes, France, told Medscape Medical News.
    • “The study was published online on March 10 in JAMA.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health Care Service Corp. was limited to selling Blue Cross and Blue Shield policies, including Medicare Advantage plans, in Illinois, Montana, New Mexico, Oklahoma and Texas before the deal.
    • “After the Cigna acquisition, Health Care Service Corp. has a much bigger footprint and can offer Medicare Advantage in 25 more states and the District of Columbia, Part D nationally, and Medigap in 48 states and the District of Columbia. The insurer now counts 830,000 Medicare Advantage members, about four times as many as prior to the Cigna purchase.” * * *
    • “Moving up a weight class means facing dominant for-profit Medicare Advantage carriers such as UnitedHealth Group subsidiary UnitedHealthcare, Humana and CVS Health subsidiary Aetna head on. Those three insurers collectively cover 57% of Medicare Advantage enrollees, according to an analysis of Centers for Medicare and Medicaid Services data the investment bank Stephens published in February.”
  • Beckers Payer Issues adds,
    • “Moody’s has downgraded Health Care Service Corporation’s insurance financial strength rating to A3 from A2 following the company’s acquisition of Cigna’s Medicare business on March 19.
    • “Moody’s cited likely challenges with the integration of the MA business into the company’s primarily commercial insurance operations, along with ongoing headwinds within the MA industry more broadly.  
    • “Another concern is the limited experience the company has with making and integrating major acquisitions in the recent past,” analysts wrote. “The company expects to invest an estimated $1 billion over the next two years into updating systems and for working capital to ensure its success, but this may prove to be insufficient.”
  • Kauffman Hall explains how health systems can create a sustainable approach to corporate shared services.

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Fierce Healthcare lets us know,
    • Bipartisan lawmakers have introduced a bill that aims to more closely align Medicare insurers’ prior authorization denials with medical need, as determined by board-certified specialist physicians.
    • The Reducing Medically Unnecessary Delays in Care Act of 2025 was introduced in the House Thursday by Rep. Mark Green, M.D., R-Tennessee, and referred to committee. It is a reintroduction of similar bills brought by the lawmaker in 2023 and 2022.
    • Green—along with Reps Greg Murphy, M.D., R-North Carolina, and Kim Schrier, M.D., D-Washington, who also backed the bill—said the legislation will help streamline necessary care and reduce administrative burden and burnout among providers.
  • Roll Call tells us,
    • “President Donald Trump on Friday threw his support behind the funding fix needed to allow the District of Columbia’s government to avoid $1.1 billion in budget cuts squeezed in the remaining half of the fiscal year, all but ensuring House passage of legislation the Senate passed two weeks ago.
    • “The full-year stopgap spending law, drafted by House Republicans, did not include the typical provision that would allow the D.C. government to tap into its fiscal 2025 budget for operating costs. This would force D.C. to go back to the previous year’s funding levels for the remainder of the fiscal year, which runs through Sept. 30, which local officials say would require steep cuts in critical services like law enforcement and education.”
  • STAT News reports,
    • “Peter Marks, the top Food and Drug Administration official who oversaw vaccines, gene therapies, and the blood supply, resigned Friday after being told by Trump administration officials he would be fired if he did not step down, according to people familiar with the situation.”
  • and
    • “President Trump has selected Sara Carter, a conservative journalist and Fox News contributor, as the nation’s next drug czar.” * * *
    • “If confirmed by the Senate, Carter would oversee the White House Office of National Drug Control Policy, an executive office housed across the street from the West Wing that makes policy recommendations and coordinates efforts between various federal agencies focused on substance use, both from a law enforcement and public health perspective.” 
  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today joined West Virginia Governor Patrick Morrisey for a press conference at the St. Joseph School in Martinsburg, WV, to celebrate the signing of new legislation banning seven types of harmful food dyes from school lunches beginning August 2025. Governor Morrisey announced at the event that he intends to request a waiver to restrict taxpayer funds from being used to purchase soda through the SNAP program.”

From the judicial front,

  • Healthcare Dive points out,
    • “The Department of Justice agrees that Claritev, formerly known as MultiPlan, conspired with health insurers to underpay doctors for medical care, according to a statement of interest filed by antitrust regulators on Wednesday in the consolidated lawsuit from providers against the cost management firm.
    • “Lawyers for the providers said the DOJ’s position affirms the validity of their case, while Claritev reiterated that it believes the lawsuits are without merit.
    • “The DOJ’s interest in the case signals antitrust regulators, including in the Trump administration, are still closely scrutinizing exchanges of potentially sensitive information between companies, along with their use of pricing algorithms.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “After much delay, Novartis has finally won a key FDA go-ahead for Pluvicto, opening up the radioligand therapy to a much broader prostate cancer population.
    • “The new approval, which triples Pluvicto’s eligible patient population, allows the radiopharmaceutical to treat PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) before taxane-based chemotherapy, Novartis said Friday. Patients will have to have been treated with an androgen receptor pathway inhibitor (ARPI) to be considered.
    • “Pre-chemo mCRPC represents the most important indication in Novartis’ plan for Pluvicto to achieve more than $5 billion in peak sales. Initially cleared by the FDA in 2022 in the post-chemo setting, Pluvicto’s revenue is currently annualizing at about $1.5 billion based on its most recent quarterly number.”
  • and
    • Over the last three years, the FDA has approved six new hemophilia drugs, including three gene therapies.
    • Into this crowded treatment landscape comes another new medicine as the FDA has signed off on Sanofi’s Qfitlia (fitusiran), which sets itself apart as the only treatment for all types of hemophilia.
    • Not only is Qfitlia for those with hemophilia A and B, but unlike most treatments for the disorder, it also can be used by patients regardless of their inhibitor status.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test. This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test is intended for females with or without symptoms and delivers results in approximately 30 minutes.
    • “Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health. “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.” * * *
    • “This announcement follows last year’s authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV.”
  • Per Managed Health Executive,
    • “Fresenius announced today [March 27, 2025] that the FDA has approved the biologics licensing applications (BLA) for denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht), according to a news release. Prolia, the reference product for Conexxence, and Xgeva, the reference product for Bomyntra, were both developed by Amgen. As a result of a global settlement between Fresenius and Amgen, both biosimilars are expected to launch in the United States in mid 2025 and in the second half of 2025 in Europe.
    • “Bomyntra and Conexxence are the fourth pair of denosumab biosimilars. Other Prolia biosimilars include Jubbonti, Ospomyv and Stoboclo. Additional Xgeva biosimilars include Wyost, Xbryk and Osenvelt.
    • “Although the active drug ingredient in Conexxence and and Bomyntra is deosumab, they have different indications.
    • ‘Conexxence is approved for patients at high risk for fractures, including osteoporosis patients and patients undergoing cancer treatments that affect bone density. It comes as a 60 mg/mL single-dose prefilled injection to be administered every six months via subcutaneous injection. Adverse reactions varied by indication.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is declining nationally to low levels. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity continues to decline; however, CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The American Hospital Association News adds,
    • “There are 483 confirmed cases of measles in 19 states across the country, according to the latest data from the Centers for Disease Control and Prevention. The agency said 93% of the cases are outbreak-associated. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • NBC News adds,
    • “We are experiencing an extremely concerning decline in measles vaccination in the very group most vulnerable to the disease,” said Benjamin Rader, a computational epidemiologist at Boston Children’s Hospital, an assistant professor at Harvard Medical School and the author of a recent study that looked at children’s vaccination rates.” * * *
    • “Rader said that the true MMR vaccination rate among young children can be misrepresented by publicly reported numbers, because MMR surveillance is drawn from older children who are already in kindergarten.
    • “Younger children under the age of 5 are not fully captured in surveillance data because they have not reached kindergarten age — although a 2021 estimate from the CDC notes a subset of younger children, namely those who received at least one MMR dose by 24 months, were 90.6% vaccinated for measles.
    • “In Rader’s study, published online in February in the American Journal of Public Health, his team surveyed approximately 20,000 parents of children under 5 from July 2023 through April 2024, finding only 71.8% reported that their children received at least 1 dose of MMR vaccine — much lower than CDC estimates.
    • “The researchers used a digital surveillance platform that the CDC has used to estimate things like at-home Covid testing, he said.  
    • “Rader downplayed the difference in numbers between his findings and the CDC data, emphasizing that, while accurate, the CDC data does not provide a complete picture — despite its best intentions.
    • “Dr. Scott Roberts, associate medical director of infection prevention at the Yale School of Medicine in New Haven, Connecticut, who was not part of the research, called the findings “worrisome.”   
  • Health Day relates,
    • “Tobacco control measures like anti-smoking campaigns and cigarette taxes have prevented nearly 4 million lung cancer deaths during the past five decades, a new American Cancer Society study estimates.
    • “More than 3.8 million lung cancer deaths were averted due to substantial reductions in smoking, gaining a little more than 76 million years of extra life among Americans, researchers say in CA: A Cancer Journal for Clinicians.
    • “The substantial estimated numbers of averted lung cancer deaths and person-years of life gained highlight the remarkable effect of progress against smoking on reducing premature mortality from lung cancer,” lead investigator Dr. Farhad Islami, the ACS’ senior scientific director for cancer disparity research, said in a news release. 
    • “In fact, the number of averted lung cancer deaths accounts for roughly one-half of all cancer deaths that were prevented in recent decades, researchers said.
    • “However,” Islami added, “Despite these findings, lung cancer is still the leading cause of cancer death in the United States, and smoking-attributable morbidity and mortality from other cancers or diseases remain high.”
  • Per Healio,
    • “There were 69 nonfatal fentanyl exposures in 2015 and 893 in 2023.
    • “Two-thirds of adolescents who were exposed to fentanyl used it intentionally.” * * *
    • “According to the researchers, nearly 39.4% of all overdoses and 65.7% of those among adolescents involved intentional misuse or abuse. In contrast, 81.7% of overdoses among younger children were reported to be unintentional.
    • “It was surprising that a large portion of adolescents used fentanyl intentionally,” Palamar said. “We often think of pediatric exposures to fentanyl as being unintentional.”

From the AI front,

  • Per an NSF news release,
    • “Powered exoskeletons that enable humans to move faster or lift heavy objects more easily have been envisioned for decades. In science fiction, advanced exoskeletons such as the power loader in the movie “Aliens” or Marvel Comics’ Iron Man’s suit provide the wearer with superhuman capabilities with nearly zero limitations.
    • “There are exoskeletons in use today, but current technology falls short of the vision laid out in science fiction, and widespread use of exoskeletons is hampered because to work properly, a suit must be tested and adapted to work with each user individually, a complicated and lengthy process.
    • “Now, engineering researchers supported by the U.S. National Science Foundation have made a breakthrough, creating a new method that takes advantage of artificial intelligence and computer simulations to improve the process of enabling users and exoskeletons to work together. This framework is compatible with a variety of assistive devices and could improve the lives of millions of able-bodied and mobility-impaired individuals.
    • “This marks a major advance in exoskeleton engineering by eliminating one of its biggest hurdles: individualized calibration,” said Alexander Leonessa, program director for the NSF Mind, Machine and Motor Nexus program. “Using AI and human-robot simulations, the team developed a scalable, adaptable system that assists a wide range of users without lengthy setup. It is a key step toward making exoskeletons practical, versatile and accessible for both industry and mobility-impaired individuals – smart, human-centered engineering at its best.”

From the U.S. healthcare business front,

  • FiercePharma reports,
    • “A rival bidder has emerged to acquire struggling gene therapy specialist bluebird bio.
    • Ayrmid has offered to buy bluebird for $4.5-apiece upfront, plus a one-time contingent value right (CVR) of $6.84 per share tied to a sales milestone, bluebird said Friday.
    • “The upfront tag is 50% higher than the $3-per-share selling price that bluebird has previously penned with Carlyle and SK Capital Partners. That private equity duo’s buyout offer also includes a $6.84-per-share CVR.
    • “For now, bluebird’s board has not changed its mind and the company remains bound by the original merger agreement. But it’s willing to look at the new unsolicited non-binding written proposal.
    • “Consistent with its fiduciary duties, the bluebird Board of Directors is carefully reviewing the Ayrmid proposal in consultation with its legal and financial advisors,” the Massachusetts biopharma said Friday.”
  • Beckers Hospital Review tells us,
    • “Insight Hospital and Medical Center Trumbull and Hillside Rehabilitation Hospital, both in Warren, Ohio, paused all inpatient, outpatient and emergency room services March 27 due to ongoing bankruptcy and financial disruptions from former owner Dallas-based Steward Health Care.
    • “Tom Connelly, local president of the American Federation of State, County and Municipal Employees, told NBC affiliate WFMJ March 28 that the hospitals also laid off the director of nursing, the assistant director of nursing, the administrative secretary and the human resources coordinator.
    • “A spokesperson for Insight Health refuted the claims to Becker’s and denied upper management layoffs.
    • “Existing patients at both Insight hospitals are being transferred, with appointments being canceled to protect patient safety, an Insight Health spokesperson said in a March 27 statement shared with Becker’s.
  • Beckers Payer Issues informs us,
    • “Enrollment in provider-sponsored Medicare Advantage plans declined by nearly 60,000 members for 2025, according to a report from Chartis. 
    • “The healthcare consulting firm published an analysis of CMS Medicare Advantage enrollment data March 25. 
    • “Overall, Medicare Advantage plans gained 1.3 million new enrollees, a smaller growth rate than the program has seen in previous years. 
    • “Kaiser Permanente saw the largest membership growth for 2025 among provider-sponsored plans, gaining 58,000 new members. Trinity Health and UPMC Health Plan each added 11,000 MA members.” 

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call lets us know,
    • “Senate Majority Leader John Thune told GOP senators Wednesday that a compromise budget resolution could hit the floor for a “vote-a-rama” as soon as next week, which would allow the House to adopt it the following week before the two-week April recess.
    • “This accelerated time frame, if both chambers can adhere to it, would let Republicans hit the ground running after the recess to write the “big, beautiful” budget reconciliation bill that President Donald Trump wants.
    • “Speaker Mike Johnson, R-La., has set an informal deadline of Memorial Day to send the measure to Trump, including a massive tax cut package, more money for defense and border security, domestic energy incentives, a debt limit increase and trims to mandatory spending.
    • “As recently as Tuesday, Thune, R-S.D., had been telling colleagues that Senate consideration could slip to the week of April 7, which likely wouldn’t give the House time to act before the recess.
    • “But discussions made a big leap on Wednesday with a new strategy: provide a different, lower set of spending cut targets for Senate committees than their House counterparts. Under this scenario, the final budget resolution adopted by both chambers would “instruct” House and Senate committees differently.” * * *
    • “Both sets of instructions would be in the final budget resolution, and then the two chambers could hammer out differences later on what the actual reconciliation details look like.
    • “What needs to ultimately be reconciled is the final bill. The resolution’s looking different in two chambers, I don’t think anybody’s getting worked up about that,” Sen. Eric Schmitt, R-Mo., said Wednesday. “But eventually everybody does kind of need to unlock the process, which is what the resolution is for.”
    • “The working theory is that eventually what matters for “Byrd rule” enforcement in the Senate is whether that chamber’s reconciliation instructions are adhered to.”
  • and
    • “President Donald Trump on Thursday announced he would withdraw the nomination of New York Rep. Elise Stefanik to be U.S. ambassador to the United Nations, citing a need for Republicans to keep her seat amid narrow margins in the House. 
    • “With a very tight Majority, I don’t want to take a chance on anyone else running for Elise’s seat,” Trump posted on his Truth Social platform. “The people love Elise and, with her, we have nothing to worry about come Election Day. There are others that can do a good job at the United Nations.”
  • The American Hospital Association News tells us,
    • “The AHA March 27 voiced opposition to the Physician Led and Rural Access to Quality Care Act (H.R. 2191), a bill that would lift the ban on the establishment of physician-owned hospitals in certain rural areas and permit the unfettered expansion of POHs nationwide, regardless of location. In place since 2010, current law includes an exceptions process that allows existing POHs to expand if they accept Medicaid patients and are located in areas where beds are needed. 
    • “By performing the highest-paying procedures for the best-insured patients, physician-owners inflate health care costs and drain essential resources from community hospitals, which depend on a balance of services and patients to provide indispensable treatment, such as behavioral health and trauma care,” AHA wrote in comments to Rep. Morgan Griffith, R-Va., the bill’s author. “By increasing the presence of these self-referral arrangements, H.R. 2191 would only further destabilize community care.” 
  • Per a news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced a dramatic restructuring in accordance with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.”
    • “The restructuring will address this and serve multiple goals without impacting critical services. First, it will save taxpayers $1.8 billion per year through a reduction in workforce of about 10,000 full-time employees who are part of this most recent transformation. When combined with HHS’ other efforts, including early retirement and Fork in the Road, the restructuring results in a total downsizing from 82,000 to 62,000 full-time employees.
    • “Secondly, it will streamline the functions of the Department. Currently, the 28 divisions of the HHS contain many redundant units. The restructuring plan will consolidate them into 15 new divisions, including a new Administration for a Healthy America, or AHA, and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. Regional offices will be reduced from 10 to 5.
    • “Third, the overhaul will implement the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins. These priorities will be reflected in the reorganization of HHS.
    • “Finally, the restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact.” * * *
    • For more detailed information, please visit our fact sheet.
  • The HHS reorganization is worth a shot in view of the thirty yearlong federal budget outlook from the Congressional Budget Office.
  • Tammy Flanagan, writing in Govexec, offers federal retirement advice in these uncertain times.

From the public health and medical research front,

  • Medpage Today informs us,
  • and
    • “A flea-borne disease that was once largely eradicated from the U.S. may be making a resurgence, CDC researchers said during a clinician-focused call on Thursday.
    • “Murine typhus became so rare after public health efforts against it in the 1940s that it eventually stopped being a nationally notifiable disease.
    • “But now, cases are on the rise in two states that actively monitor the disease — Texas and California — and the illness may be going undiagnosed, experts said.”
  • Per a National Cancer Institute news release,
    • “Scientists have long been exploring ways to kill cancer cells by starving them of the nutrients they need to survive. A new study suggests that genetically modified fat cells could help researchers realize this goal.
    • “In the study, researchers genetically engineered white fat cells—the most common type of fat in the body—to aggressively consume nutrients such as glucose and fatty acids. When the engineered fat cells were implanted near tumors in mice, the tumors grew more slowly than tumors in mice without the engineered cells.
    • “The approach slowed the growth of cancer in mice even when the engineered fat cells were implanted far from a tumor, the researchers reported in Nature Biotechnology on February 4. 
    •  “We believe the engineered cells are outcompeting tumors for essential nutrients, suppressing the proliferation of cancer cells,” said study leader Nadav Ahituv, Ph.D., director of the University of California, San Francisco (UCSF) Institute for Human Genetics. “The findings suggest that engineered fat cells could be a new form of cellular therapy.”
  • Per Healio,
    • “Survivors [of metastatic breast cancer] who participated in [telephone-delivered] acceptance and commitment therapy reported less fatigue interference with functioning.
    • “Researchers are studying the approach for people with advanced gastrointestinal cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare tells us,
    • “Nonprofit hospitals’ 2024 financial performances are beating the prior year’s tough numbers, though even the stronger organizations remain “well below pre-pandemic levels,” Fitch Ratings said.
    • “In a Thursday brief describing the financial profiles of its rated nonprofit hospitals, the agency attributed the year-to-year improvements to stronger revenues and volumes as well as slightly mitigated, but still pressured, labor spending.
    • “Fitch said the median operating margin among hospitals with early fiscal year ends (often June 30) was 1.2%, a flip from the prior year’s -0.5%. The agency said it expects the calendar year 2024 median margin for the remainder of its rated hospitals “will at least be in line” with the former group.”
    • “Persistent” labor pressures continue to push base salary and wage expenses upward by a median 6.9% among the rated hospitals, which Fitch said “would have been even higher without the sector’s ongoing efforts to recruit and retain talent, streamline operations and optimize supply chains.”
  • Beckers Hospital Review notes,
    • “Doylestown (Pa.) Health will officially join the University of Pennsylvania Health System on April 1, marking a significant expansion of Penn Medicine’s reach into Philadelphia’s northern suburbs. 
    • “The transaction follows regulatory reviews and approvals from the Pennsylvania Attorney General’s Office and the Federal Trade Commission.
    • “Under the new structure, Doylestown Health and its affiliates will be rebranded as Penn Medicine Doylestown Health. The integration combines one of the country’s leading academic health systems with a regional health system.” 
  • and
    • “Four blockbuster GLP-1 medications are expected to be among the 10 best-selling drugs in 2026, accounting for $66.8 billion in global sales, according to market research company Statista
    • “Statista predicts Ozempic will yield $22.3 billion in 2026, followed by Mounjaro with $19.8 billion, Wegovy with $13.4 billion and Zepbound with $11.3 billion.” 
  • Modern Healthcare reports,
    • “When Florida Blue wanted its call center employees to demonstrate greater emotional intelligence when dealing with customers, the nonprofit health insurance company enlisted a tutor incapable of emotion.
    • “A generative artificial intelligence, or genAI, chatbot instructs 30 Florida Blue customer service representatives on how to behave like human beings when interacting with other human beings. The chatbot guides workers on human behaviors, such as when to slow their speech, when to hasten a call to its conclusion and what to recommend to policyholders. The company plans to expand this pilot program to its entire 1,600-person call center team this year.
    • “A lot of the time, people carry emotion into calls with health insurers. When you’re upset, it just comes out. One of the prompts is to remind the advocate, ‘Hey, this member appears to be stressed. Make sure you’re pausing and listening to them,’” said Anne Hoverson, vice president of digital transformation at Florida Blue, a subsidiary of Guidewell.
    • “Insurance companies already used genAI for processing claims, predicting clinical needs and performing administrative functions, but this latest trend is different, said Josh Streets, a senior consultant at the International Customer Management Institute, which advises business on call centers.”
  • and
    • “GE HealthCare announced Thursday the commercial launch of Flyrcado, its PET imaging agent that assesses blood flow to the heart muscle, in select U.S. markets.
    • “The Centers for Medicare and Medicaid Services granted Flyrcado pass-through status starting April 1, allowing separate payments for the imaging agent and the PET/CT scan in hospital outpatient settings.
    • “In late September, the company announced that Flyrcado received Food and Drug Administration approval to detect coronary artery disease. It provides more accurate diagnostics than SPECT imaging, the current standard in cardiac nuclear medicine imaging, according to GE HealthCare.
    • “Since Flyrcado has a half-life of 109 minutes, which is significantly longer than other similar PET imaging agents, healthcare facilities don’t need to produce it on-site. Instead, it can be manufactured at off-site pharmacies and delivered as needed.”

Midweek Update

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, SCOTUS, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • It turns out that at yesterday’s markup meeting, the House Oversight and Government Reform Committee did clear HR 2193, the FEHB Protection Act of 2025, for floor consideration, along with the other bills considered during the markup.
  • The Senate confirmed James Bishop to be Deputy Director of the Office of Management and Budget by a 53-43 vote.
  • CMS today released a “Revised Final 2026 Actuarial Value (AV) Calculator Methodology.”
    • “The only changes that are being made to the Final 2026 AV Calculator as part of this Revised Final 2026 AV Calculator are the following:
      • “The de minimis range for bronze, silver, gold and platinum plans was expanded to +2
      • percentage points to -4 percentage points;
      • “The de minimis range for expanded bronze plans was expanded to +5 percentage points
      • to -4 percentage points;
      • “The de minimis range for income-based silver CSR plans was expanded to +1 percentage
      • points to -1 percentage points;
      • “The MOOP limit was updated to $10,600; and
      • “The AV Calculator version number was updated, and the AV Calculator label was
      • updated to “Revised Final 2026 AV Calculator”.
    • “These changes do not affect the AV calculation methodology. All AV calculations are the same
    • in both the Final 2026 AV Calculator and the Revised Final 2026 AV Calculator.”
  • The Congressional Research Service has summarized the federal requirements on private health insurance plans.
  • Per the American Hospital Association (“AHA”) News,
    • “The FBI March 26 advised that, after extensive investigation and intelligence review, they have not identified any specific credible threat targeted against hospitals in any U.S. city. The FBI advised if they receive credible threat information, they will immediately advise any identified potential targets and, if appropriate, alert the broader health care sector through the AHA, the Health-ISAC (Information Sharing and Analysis Center) and other appropriate channels. 
    • “On March 18, the AHA and Health-ISAC received multiple reports from the field regarding a public social media post alleging active planning of a coordinated, multi-city terrorist attack targeting hospitals in the coming weeks. 
    • “Out of an abundance of caution, the AHA and Health-ISAC notified the field of the potential threat, indicating that no further information was available to either corroborate the threat or dismiss it as not credible. The AHA and Health-ISAC today distributed an updated bulletin to members with the latest update from the FBI.” 

From the judicial front,

  • Bloomberg Law informs us,
    • “The US Supreme Court suggested [during an oral argument today] it’s likely to uphold a federal program that uses more than $8 billion in fees imposed on phone bills to subsidize the cost of telecom services for poor people, rural residents, schools and libraries.
    • “Hearing arguments in Washington on the decades-old Universal Service Fund, some conservative justices voiced concern that Congress had unconstitutionally handed off its taxing power to the Federal Communications Commission without imposing sufficient limits [also known as the non-delegation doctrine].”

In Food and Drug Administration news,

  • BioPharma Dive relates,
    • “The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease Prader-Willi syndrome, a long-awaited decision that follows an unorthodox pitch from the drug’s developer.
    • “The agency on cleared Vykat XR, from biotechnology company Soleno Therapeutics, for this hyperphagia that’s caused by Prader-Willi. Treatment has specifically been approved for adults and children at least four years of age. Soleno hasn’t yet disclosed the drug’s list price. 
    • “The approval is a milestone for research into a disease that’s proven difficult to target. Prader-Willi affects an estimated 10,000 to 20,000 people in the U.S. and causes multiple cognitive and behavioral symptoms.”
  • Per a National Cancer Institute (NCI) news release,
    • “The Food and Drug Administration (FDA) has given an accelerated approval to zenocutuzumab (Bizengri), making it the first drug that targets tumors with a very rare genetic alteration called an NRG1 fusion. Under the approval, zenocutuzumab can be used to treat people with pancreatic or non-small cell lung cancer (NSCLC) whose tumors have an NRG1 fusion and whose disease has gotten worse despite standard treatments.
    • “The approval was based on the results of a clinical trial in which one-third of patients treated with zenocutuzumab had sustained tumor shrinkage of at least 30% that lasted a median of 11 months. Most of the patients in the study had either NSCLC or pancreatic cancer.
    • “This is a patient population that has a very high unmet need,” said the study’s lead investigator, Alison Schram, M.D., of the Memorial Sloan Kettering Cancer Center. “This approval gives these patients, who have very few effective therapeutic options, a new treatment option.”
    • “Because it’s an accelerated approval, Partner Therapeutics, which licensed zenocutuzumab from Merus, must conduct additional studies to confirm that the drug helps patients clinically, which can include helping them live longer than with other treatments.’

From the public health and medical research front,

  • The New York Times reports,
    • Measles cases in Kansas more than doubled in the last week, bringing the tally to 20, while another outbreak in Ohio has sickened 10 people, local public health officials reported on Wednesday.
    • There have been several large outbreaks in the United States this year, including one in West Texas that has spread to more than 320 people and hospitalized 40. Health officials have worried that the Texas outbreak may be seeding others.
    • More than 40 measles cases have been reported in New Mexico, and seven have been identified in Oklahoma. In both states, health officials said the infections were connected to the Texas outbreak.
    • In Kansas, the virus has mainly infected unvaccinated children in the southwest corner of the state. Genetic sequencing has suggested a link to the Texas and New Mexico outbreaks, state health officials told The New York Times on Wednesday.
  • Per the AHA News,
    • “A study published March 26 by the National Institutes of Health and the University of Oxford found that individuals who engaged in light and moderate-to-vigorous daily physical activity had a lower cancer risk than those with more a sedentary lifestyle. The study found that higher daily step counts, but not pace, was also associated with a lower cancer risk. In comparison to cancer risk for individuals taking 5,000 steps per day, risk was 11% lower for those taking 7,000 steps per day and 16% lower for those taking 9,000 steps per day. Risk reduction plateaued beyond 9,000 steps.”
  • This week’s Cancer Information Highlights from the NCI discuss “Quit Smoking | Metastatic Prostate Cancer | Kidney Cancer.”
  • The National Institute of Standards and Technology informs us,
    • “A rare but painful disorder can make it difficult for people to swallow food. The symptoms include weight loss and chest pain after eating. Scientists are working to better understand this condition, known as corkscrew esophagus, in hopes of finding more treatment or prevention options.
    • “We are working to contribute to that effort with an approach you may not associate with medical research. It involves math, physics and computer modeling.”
  • Medscape points out,
    • “In a recent final analysis of a phase 3 trial, the bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine [which are FDA approved] maintained high efficacy and a favorable safety profile against RSV-associated lower respiratory tract illness (RSV-LRTI) over two seasons in people aged ≥ 60 years.”
  • STAT News tells us, “Study suggests mRNA vaccine could make humans resistant to ticks that transmit Lyme bacteria. New tool shows how the human immune system responds to components of ‘tick cement.’”
    • “Ticks, once latched onto a fleshy target with their barbed, needle-like mouths, are ready for almost anything. They glue themselves to the skin using a complex, cement-like substance. And then, like a “little pharmacological company,” they dole out proteins to keep the blood flowing, make it relatively painless, and hamper any immune response that might reveal their parasitic presence, Yale University researcher Erol Fikrig says.
    • “It’s in those days of quiet blood-thirst that ticks pass along bacteria that causes conditions like Lyme disease, a growing problem driven in the U.S. by black-legged ticks (or Ixodes scapularis). Researchers have been trying for decades to understand just how the tiny tick is able to evade the human body’s defenses and pass along pathogens. 
    • “A new study by Fikrig and other researchers, published Wednesday in Science Translational Medicine, uses a powerful monitoring system to reveal how the human immune system is responsive to a litany of tick triggers — some of which might be leveraged to create a protective mRNA vaccine.” 
  • Per Fierce Pharma,
    • “Johnson & Johnson has produced the most convincing data to date that its combination of Rybrevant and Lazcluze could replace AstraZeneca’s Tagrisso as the new standard of care in first-line EGFR-mutated non-small cell lung cancer—proof it could extend patients’ lives.
    • “The Rybrevant-Lazcluze combo significantly reduced the risk of death by 25% versus Tagrisso in patients with newly diagnosed advanced EGFR-mutated NSCLC, according to data from the phase 3 Mariposa trial presented at the European Lung Cancer Congress (ELCC) 2025.
    • “While the median overall survival time was not yet reached for the combo, investigators expect that the J&J regimen could offer at least an extra year of life versus Tagrisso, on which patients have logged a median 36.7 months of survival.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Fewer physicians are considering leaving the profession in 2025 than in 2024, according to a new survey from the Harris Poll and electronic health record provider Athenahealth.
    • “Part of physicians’ improved job satisfaction was driven by increased adoption of artificial intelligence, the researchers said. Fewer physicians reported the technology was over-hyped this year, and they saw the most promise in transcription services and capabilities.
    • “Still, physicians shared concerns about the fate of the industry long-term and only 3 in 10 physicians were optimistic about the direction of U.S. healthcare generally. Respondents were most concerned about interoperability challenges, their organization’s financial health and meeting regulatory requirements.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec (Nanoscope Therapeutics) for the treatment of advanced retinitis pigmentosa.”
      • Key Clinical Findings
        • “For adults with advanced retinitis pigementosa and severe vision loss, ICER rated the current evidence on sonpiretigene isteparvovec as promising but inconclusive (“P/I”) due to concerns about durability of benefits and unknown short-term and long-term harms.
      • Key Cost-Effectiveness Findings
        • “Sonpiretigene isteparvovec has not yet been approved by the FDA for retinitis pigmentosa, and the manufacturers have not yet announced a US price for the therapy if approved. 
        • “ICER has calculated a health benefit price benchmark (HBPB) to be between $67,400 and $101,300 for treatment in one eye.”
  • The Brown & Brown consulting firm has posted an executive summary of its 2025 Employee Health and Benefits Strategy Survey.
  • Beckers Health IT survey notes,
    • “Amazon is testing a generative AI-powered health assistant, dubbed Health AI, on its website and mobile app, CNBC reported March 25.
    • “The chatbot is designed to answer health and wellness questions, suggest common care options for various medical needs, and recommend products. Some responses are marked with a “clinically verified” badge, indicating that the information has been reviewed by U.S.-based licensed clinicians, according to Amazon.
    • “In addition to providing health guidance, Health AI directs users to Amazon’s online pharmacy and clinical services from One Medical, the primary care provider Amazon acquired for $3.9 billion in 2022.”

Tuesday Report

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

From Washington, DC,

  • Bloomberg Law tells us,
    • “The Senate voted to confirm Jay Bhattacharya, a Stanford University health economist and physician, to lead the National Institutes of Health. 
    • “Senators confirmed him Tuesday evening 53-47 on a party line vote.” 
    • “The Senate also confirmed Marty Makary, a surgeon at Johns Hopkins Medicine, to oversee the Food and Drug Administration. Unlike many of President Donald Trump’s nominees for health positions, a few Democrats chose to support Makary as well. The Senate confirmed him by a 56-44 vote.
  • The American Hospital News informs us,
    • “The Senate Finance Committee March 25 advanced Mehmet Oz’s nomination for administrator of the Centers for Medicare & Medicaid Services by a vote of 14-13. Oz, a doctor and former television show host, will soon be considered by the full Senate for confirmation.” 
  • Govexec relates,
    • “[The] House Oversight and Government Reform Committee on Tuesday debated legislation that would set up a process for Congress to approve President Donald Trump’s overhauls of federal agencies. 
    • “The Reorganizing Government Act of 2025 (HR 1295), which is scheduled to receive a panel vote at 6:30 p.m., would resurrect a lapsed authority enabling the president to submit a plan for restructuring agencies that Congress must vote on within 90 days. Such a plan is not subject to the filibuster, meaning the Senate can clear it with a simple majority instead of the usual 60-vote threshold. 
    • “Still, the bill itself would need 60 votes for the Senate to pass it, which is unlikely.” 
  • At this markup session, the Oversight and Reform Committee was poised to approve HR 2193, the FEHB Protection Act of 2025 in a bipartisan fashion, but due to the length of the markup session, the Chairman postponed roll call votes until a later date. HR 2193 would tighten oversight over FEHB family member eligibility.
  • Federal News Network lets us know,
    • “Former Postmaster General Louis DeJoy avoided several third-rail issues, as part of his plans to modernize the Postal Service — including privatizing the agency, closing post offices or cutting the number of delivery days each week.
    • “Leaders of three USPS unions say they aren’t so sure DeJoy’s successor or the Trump administration will agree to the same red lines, as the White House envisions major changes for the independent mail agency.”

From the judicial front,

  • Roll Call points out,
    • “The Supreme Court is set to hear arguments in a pair of cases Wednesday over how much power Congress can give to executive agencies without running afoul of the Constitution, which could end up shaping how legislation is written.
    • “The arguments center on whether Congress handed over too much power to the Federal Communications Commission when it created the Universal Service Fund. The fund collects money from telecommunications companies and distributes funds intended for telecommunications services nationwide.
    • “Several experts said the cases come as a majority of the members of the conservative-controlled Supreme Court have expressed interest in imposing new limits on what’s called the “nondelegation doctrine” — or how much legislative power Congress can cede to other entities. Depending on how the justices handle the complicated case, experts said, it could have wide-ranging impacts on federal agencies.”

From the public health and medical research front,

  • Medscape delves into “Avian Influenza: What Infectious Disease Physicians Need to Know.”
  • FiercePharma reports,
    • “GSK is opening the door to a new era in urinary tract infection (UTI) treatment with its Blujepa, the first in a new class of oral antibiotics for the condition in nearly 30 years.
    • “Blujepa, also known as gepotidacin, has been cleared by the FDA to treat uncomplicated UTIs (uUTIs) that can be tied to E. coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus or Enterococcus faecalis in women 12 years of age and older. “These types of UTIs are the most common infection for women, with more than half of all women experiencing one in their lifetime, making the antibiotic a much-needed new option for the up to 16 million U.S. women who are impacted annually. 
    • “GSK tested the antibiotic in the phase 3 Eagle-2 and Eagle-3 trials, pitting its twice-daily option against longtime standard-of-care nitrofurantoin for five days.” 
  • JAMA Online considers
    • “Question   Which health conditions, types of care, and counties are associated with the highest levels of spending?
    • “Findings   This observational study showed considerable variation in spending across health conditions, types of care, age groups, payers, and counties—with spending being greatest for type 2 diabetes. Across counties, there was more variation in utilization rates rather than price and intensity of care.
    • “Meaning   Further investigation into unexplained variation in spending, focusing on the health conditions with the most spending, could help inform health care policies aimed at lowering costs and improving access to care.
  • The NIH Research Matters Bulletin discusses “Norovirus antibodies | Non-opioid pain relief | Tardigrades & cancer care.”
  • Per Cardiovascular Business,
    • “A new drug has shown early potential to slow the progression of aortic stenosis (AS) and potentially limit the number of heart patients who require transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). 
    • “The team behind this breakthrough, a group of healthcare researchers out of Mayo Clinic, shared its early progress in Circulation.
    • “The drug in question, ataciguat, is able to reactivate oxidized soluble guanylate cyclase, which then limits signals in the body that can lead to fibrocalcific aortic valve stenosis (FCAVS). After observing this phenomenon in action in animal models and in vitro, the Mayo Clinic researchers performed a phase I clinical trial that showed ataciguat is well tolerated in patients with FCAVS. The group then compared ataciguat with a placebo in a phase II clinical trial, finding that six months of treatment with the drug was associated with a significant reduction—nearly 70%—in the progression of aortic valve calcification in patients who presented with moderate FCAVS. Treatment with ataciguat also “tended to slow other changes in valvular and ventricular dysfunction, reflective of disease progression,” in these patients.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Demand for GLP-1 drugs is causing spending on traditional drugs to grow at a faster clip than spending on specialty drugs, according to new research. That could put further stress on employers and health plans struggling to contain already sky-high spending on prescription drugs.
    • “Spending growth for traditional drugs — simple-to-administer medications used to treat common health problems — outstripped spending growth for specialty drugs — pricey medications used to treat complex and chronic conditions — for the first time in 2023, according to a report released Tuesday by Evernorth, the health services division of national insurer Cigna.
    • “The trend isn’t expected to revert, at least in the next few years, amid sustained demand for GLP-1s for weight loss and as the drugs become approved for more conditions, Evernorth said.”
  • Fierce Pharma adds,
    • “Novo Nordisk has quickly expanded its discounted Wegovy program, now offering all eligible cash-paying customers its popular weight-loss med at $499 per month.
    • “Novo had only launched the cheaper Wegovy option earlier this month originally through its own NovoCare Pharmacy and at that time indicated an expansion to traditional retail channels “in the near future.”
    • “Now, less than three weeks later, all cash-paying patients can purchase any Wegovy injection doses—from 0.25mg to 2.4mg—at their local pharmacies for $499 for a 28-day supply, Novo said Monday. The new price tag marks a further cut from Novo’s previous policy that offered self-pay patients Wegovy at a cost of $650 per month.”
  • Per STAT News,
    • “The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — rose a modest 0.4% in last year’s fourth quarter, but that compared unfavorably with a 3% decline in the same period a year earlier, according to the latest data from SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends.
    • “A key reason was that net prices rose for so-called protected oncology medicines, one of six classes of drugs for which Medicare Part D generally covers an entire category. Typically, these six classes have smaller and more stable discounts compared with other medicines in the marketplace. As a result, net prices rose faster for protected classes, but it is not clear why this occurred more so with cancer drugs.
    • “Tugging in the other direction was a type of medicine known as disease-modifying antirheumatic drugs, such as Humira, which are used to treat rheumatoid arthritis and other maladies. Ongoing pricing pressure caused by a growing number of biosimilars — nearly identical variants of brand-name biologic medicines that yield the same health outcomes but at a lower cost — stifled further rises in net prices.
    • “Meanwhile, list prices for all drugs grew 1.4% in the first quarter of the year compared with 5.4% a year earlier. Most of the slower growth rate was traced to major insulin makers — Eli Lilly, Novo Nordisk, and Sanofi — that lowered prices for many patients with private insurance, but also to comply with the Inflation Reduction Act, which required capping monthly out-of-pocket costs at $35 for Medicare beneficiaries.”
  • The American Benefits Council has posted a detailed report titled “Destination 2030: A Road Map for the Future of Employer-Provided Benefits.” “This 2030 strategic plan describes the five most pressing challenges facing employer-sponsors today, provides four goals to address each challenge and then offers detailed policy recommendations for meeting those goals.”

Monday Report

David Ermer–CDC, CMS, Congress, HIPAA Privacy and Security Rules, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network reports,
    • “Postmaster General Louis DeJoy will leave the Postal Service’s top job by the end of the day Monday, after he announced plans to leave the agency last month.
    • “I have today informed the Postal Service Board of Governors that today will be my last day in this role,” DeJoy said in a statement.
    • “DeJoy announced last month he was preparing to step down as postmaster general and urged the USPS Board of Governors to begin the search for his successor.
    • “Deputy Postmaster General Doug Tulino will lead USPS until its Board of Governors selects a new postmaster general.”
  • The Wall Street Journal informs us,
    • “President Trump nominated the acting director of the Centers for Disease Control and Prevention to lead the agency permanently, after dropping his first pick for the job.  
    • “Susan Monarez was named acting director of the CDC early in the Trump administration and has worked closely with Health Secretary Robert F. Kennedy Jr.’s leadership team to fight a measles outbreak in Texas.
    • “Dr. Monarez will work closely with our GREAT Secretary of Health and Human Services, Robert Kennedy Jr. Together, they will prioritize Accountability, High Standards, and Disease Prevention to finally address the Chronic Disease Epidemic and, MAKE AMERICA HEALTHY AGAIN!” Trump wrote Monday on Truth Social.
    • “Monarez has a Ph.D. in microbiology and immunology from the University of Wisconsin-Madison and subsequently studied at Stanford University.
    • “She would be the first CDC director without a medical degree in more than 70 years. She must be confirmed by the Senate.”
  • The Wall Street Journal also seeks to explain how the Medicaid program works in charts.
  • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will mark up the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator during an executive session on Tuesday, March 25, at 9:30 AM.” 

From the judicial front,

  • The Wall Street Journal lets us know,
    • “The Justice Department asked the Supreme Court on Monday to block a judge’s order requiring it to reinstate more than 16,000 federal employees, as administration officials vow to seek the justices’ intervention in clearing away lower-court rulings that have slowed Trump policies. 
    • “Earlier this month, a federal district judge in San Francisco ordered the government to reinstate probationary employees fired at a half dozen agencies under the Trump administration’s fast-moving plan to shrink the federal government. U.S. District Judge William Alsup found that the administration had failed to comply with legal procedures required for the layoffs. 
    • “Alsup’s order, and a similar one from a federal judge in Maryland, require agencies to offer the employees their jobs back while litigation over the legality of the layoffs proceeds. 
    • “In her Supreme Court brief, acting Solicitor General Sarah Harris argues that the case should have been thrown out of court because it was filed by labor unions and other organizations rather than the terminated employees themselves. Federal law requires government employees to raise complaints through an internal process before going to court, Harris said.” 
  • Bloomberg Law tells us,
    • “A group of former Wells Fargo employees failed to prove the bank neglected its fiduciary duties over its health plan’s prescription drug costs because they could not prove concrete harm, a federal judge in Minnesota ruled Monday.
    • “The workers sued in July in the US District Court for the District of Minnesota, alleging the plan paid excessive administrative fees and prescription drug prices compared to other large employer plans. Wells Fargo & Co. also violated the Employee Retirement Income Security Act by allowing pharmacy benefit manager Express Scripts to keep drug manufacturer rebates instead of passing them back to the plan, the employees argued.
    • “The high-profile case is part of a wave of legal challenges to rising employer health plan costs, with workers suing employers and employers suing their benefit administrators. The lawsuits follow legislative and regulatory changes strengthening transparency and fiduciary requirements for insurers and employers—scrutiny that is expected to continue from lawmakers and the Trump administration.
    • “The court agreed with the plaintiffs “in theory” that they could be injured by Wells Fargo’s PBM contract. But the former employees ultimately failed to prove standing because the plan covers a broad range of drugs beyond those cited in the complaint, and because the plan picks up costs after the plaintiffs hit their deductibles, the court concluded.
    • “There are simply too many variables in how Plan participants’ contribution rates are calculated to make the inferential leaps necessary to elevate Plaintiffs’ allegations from merely speculative to plausible,” Judge David T. Schultz wrote in his order dismissing the case.”
    • FEHBlog note — Judge Laura M. Provinzino wrote the decision, not Judge Schultz.

From the public health and medical research front,

  • The AP relates,
    •  “Tuberculosis continued to rise again in the U.S. last year, reaching its highest levels in more than a dozen years. 
    • “More than 10,300 cases were reported last year, an 8% increase from 2023 and the highest since 2011, according to preliminary data posted this month by the Centers for Disease Control and Prevention. 
    • “Both the number of cases and the rate of infections rose. Rates were up among all age groups, and 34 states reported an increase. 
    • “CDC officials say the rise is the mainly due to international travel and migration. The vast majority of U.S. TB cases are diagnosed in people born in other countries. Other illnesses that weaken the immune system and allow latent TB infections to emerge may also be at play.”
  • NBC News reports,
    • “Cervical cancer is one of the most preventable cancers, although recent research suggests that the United States is backsliding in efforts to detect the disease early, when it is most curable.
    • “A new study shows that the percentage of women screened for cervical cancer fell from 47% in 2019 to 41% in 2023.
    • “Rural women are 25% more likely to be diagnosed and 42% more likely to die from cervical cancer than women who live in cities, a trend that likely reflects lower screening rates in less populated areas, according to the study, published in JAMA Network Open this month.” 
  • Consumer Reports, writing in the Washington Post, explains “How to find a home health aide. Having the right person can make caring for a loved one much easier. Here are tips for finding and affording the help.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have developed eye drops that extend vision in animal models of a group of inherited diseases that lead to progressive vision loss in humans, known as retinitis pigmentosa. The eye drops contain a small fragment derived from a protein made by the body and found in the eye, known as pigment epithelium-derived factor (PEDF).  PEDF helps preserve cells in the eye’s retina. A report on the study is published in Communications Medicine.
    • “While not a cure, this study shows that PEDF-based eye drops can slow progression of a variety of degenerative retinal diseases in animals, including various types of retinitis pigmentosa and dry age-related macular degeneration (AMD),” said Patricia Becerra, Ph.D., chief of NIH’s Section on Protein Structure and Function at the National Eye Institute and senior author of the study. “Given these results, we’re excited to begin trials of these eye drops in people.”

From the healthcare business front,

  • The Wall Street Journal reports,
    • “Novo Nordisk agreed to pay up to $2 billion for the rights to a developmental weight-loss and obesity drug from Chinese pharmaceutical company the United Bio-Technology (Hengqin) Co., as it looks to boost its pipeline of next-generation drugs.
    • “Novo Nordisk, which earlier Monday lost its crown as Europe’s most valuable company, said it signed an exclusive global licensing deal for UBT251, a drug that targets three different hormones to treat obesity, type 2 diabetes, and other diseases.
    • “The Danish pharmaceutical company will pay $200 million up front and potential milestone payments of up to $1.8 billion, as well as tiered royalties.
    • “Novo Nordisk has exclusive rights to develop, manufacture, and commercialize UBT251 globally, excluding the Chinese mainland, Hong Kong, Macau and Taiwan.
    • “UBT251 differs from Novo Nordisk’s current portfolio as it takes a three-pronged approach to weight-loss and blood-sugar control. It combines a GLP-1–the same class of drugs as Novo Nordisk’s blockbuster Wegovy and Ozempic–with GIP to reduce appetite and blood sugar, and glucagon to prevent low blood-sugar levels.”
  • The Wall Street Journal adds,
    • 23andMe has filed for bankruptcy but assures customers that their genetic data will remain protected and managed in accordance with applicable laws.
    • Consumers can delete their 23andMe account data and destroy any stored genetic material by following the instructions provided in the article [and quoted below].
    • In the event of a bankruptcy sale, consumer data may be sold as part of the transaction, but protections may be in place to ensure responsible handling of sensitive information.
      • “Log in to your 23andMe account and go to the “Settings” section of your profile. Then scroll to a section labeled “23andMe Data” at the bottom of the page. Click “View” next to “23andMe Data.” You can download your genetic data if you want a copy for personal storage.
      • “After that, scroll to the “Delete Data” section and click “Permanently Delete Data.” You will receive an email from 23andMe. Follow the link in the data to confirm your deletion request. 
      • “Some customers who tried to delete their data Monday said they received error messages. Those trying to resolve the issue reported long customer service wait times. A company spokesman didn’t immediately respond to requests for comment.”
  • Fierce Healthcare fills us in one the latest Match Day for medical school seniors.
    • “Match Day 2025 has come and gone with the largest-ever total of applicants and positions as well as upticks in primary care and emergency medicine.
    • “The 73-year-old National Resident Matching Program’s (NRMP’s) breakdown of the annual event also outlined ongoing interest in obstetrics and gynecology—despite shifting reproductive care policies in the wake of the Dobbs decision—and a jump in participation among non-U.S. citizen international medical graduates.
    • “Applicants learned of their matches at 12:00 p.m. ET on Friday.
    • “All told, there were 52,498 total applicants, up 4.1% over last year, competing for 43,237 positions, up 4.2%.”

  • Beckers Payer Issues ranks payers by 2025 Part D membership
    • “Centene’s Medicare Part D enrollment is nearing 8 million members.
    • “According to CMS enrollment data from March 2025, Centene leads the nation in Medicare Part D membership with 7.92 million enrollees. The company has gained nearly 1 million members since the end of 2024, when its Part D enrollment was 6.93 million.”

Monday Report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg Law reports,
    • “Mehmet Oz, President Donald Trump’s nominee to lead the Centers for Medicare & Medicaid Services, used his Senate confirmation hearing Friday to tout the benefits of artificial intelligence to help streamline the prior approval process for Medicare managed care plans.
    • “But consumer policy watchers were immediately leery, noting the string of recent legal challenges stemming from AI-influenced coverage denials by Medicare Advantage plans.
    • “We are very concerned that increasing the use of AI will only make the prior authorization situation worse,” Alice Bers, litigation director at the Center for Medicare Advocacy, said in a statement.” * * *
    • “Sen. Tina Smith (D-Minn.) expressed similar concerns about lawsuits against MA insurers alleging use of AI to determine length of hospital stays and to deny claims. “This is a big concern,” Smith told Oz. “My view is that a human needs to have a final say in these decisions.”
    • “Oz said he agreed with Smith about the need for humans to make final coverage decisions. But Oz maintained that he thinks “AI can play a vital role in accelerating pre-authorization.”
    • “He also said the CMS should be using AI to identify insurers that are misusing the technology.”
  • Beckers Hospital Review adds,
    • “CMS will not change the Biden administration’s plan to negotiate prices for 15 previously named prescription drugs, and the agency’s next potential leader says he will defend the program in court.
    • “In January, CMS selected Ozempic, Rybelsus, Wegovy, Trelegy Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo, Breo Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet, and Otezla to be included in the second round of negotiations aimed at reducing drug costs for Medicare beneficiaries. 
    • “On March 14, CMS said it had signed agreements with manufacturers, who will now participate in meetings and roundtables throughout 2025 to negotiate maximum fair prices for the 15 drugs, with final agreements due by Nov. 1.
    • “Mehmet Oz, MD, President Donald Trump’s pick for CMS administrator, told the Senate Finance Committee March 14 he would defend the negotiation program in court.
    • “It’s the law. I’m going to defend it and use it,” he said, adding that it is one of multiple approaches he would pursue to lower drug costs.
    • “The selected drugs account for approximately $41 billion in total spending under Medicare Part D between November 2023 and October 2024, or about 14% of Medicare Part D’s prescription drug costs, according to CMS. The negotiated prices for the drugs will take effect in 2027.”
  • HUB International tells us,
    • “Following on the enactment late last year of two bills to simplify employer reporting under the Affordable Care Act (“ACA”), the IRS has now released its first bit of guidance in the form of Notice 2025-15. The notice provides guidance on how employers can avoid providing individual Forms 1095-C to their employees. Perhaps unsurprisingly, it essentially piggybacks on existing guidance that applies to insurance carriers and other coverage providers.”
  • STAT News adds, “FTC highlights new concern over ‘pay-to-delay’ deals that determine when generics are sold. The agency noted restrictions on how many drugs a generic company may sell as part of a patent settlement.”
  • Per MedTech Dive,
    • “The Food and Drug Administration warned healthcare providers Friday about interruptions to the supply of hemodialysis bloodlines.
    • “The letter said the disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.
    • “The FDA linked to a letter B. Braun sent to customers in January. B. Braun said “additional supply and labor constraints over the holidays” had reduced production and it would run out of product on Jan. 20.”
  • Per Fierce Pharma,
    • “A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.
    • “The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls.” 

From the judicial front,

  • A panel of the U.S. Court of Appeals for the Ninth Circuit denied the Justice Department’s request for an immediate stay of the lower court’s decision to reinstate terminated probationary employees from six federal agencies. The panel set a briefing schedule on the Justice’s Department’s underlying motion to stay.
  • Bloomberg Law reports,
    • “Walmart Inc. is suing many of the nation’s largest pharmaceutical companies, alleging they colluded to inflate the price of hundreds of generic drugs and caused the retailer to pay more for the medications than it should have.
    • “Mylan Inc., Teva Pharmaceuticals USA Inc., and Glenmark Pharmaceuticals Inc. are among the defendant companies that exchanged drug price points and bid information as part of a conspiracy that specifically targeted Walmart, according to a nearly 700-page complaint filed Friday in the US District Court for the Eastern District of Pennsylvania.
    • “Walmart is one of the largest pharmacy providers in the US, purchasing hundreds of millions of dollars of prescription drugs every year. 
    • “The suit adds to similar cases against pharma companies brought by independent pharmacies, hospitals, and federal and state law enforcers.”
    • “The case is Walmart v. Actavis Elizabeth LLC, E.D. Pa., No. 2:25-cv-01383, 3/14/25″ 

From the public health and medical research front,

  • The Washington Post reports,
    • “By 2050, there will be an estimated 25.2 million people living with Parkinson’s disease worldwide, a 112 percent increase from 2021, according to a new study published in the journal BMJ.
    • “The World Health Organization estimated that 8.5 million people worldwide were living with Parkinson’s disease in 2019.
    • “Researchers used data from the 2021 Global Burden of Disease Study, pulling information from 195 countries and territories. They identified aging and population growth as the main contributors to the projected increase in Parkinson’s numbers, noting that growth rates would differ at regional and national levels.”
  • The American Medical Association lets us know what doctors wish their patients knew about pertussis.
  • MedPage Today tells us,
    • “A probiotic mixture reduced fever duration by 2 days versus placebo among children with upper respiratory tract infections.
    • “Probiotics have emerged as a new potential approach to managing infectious diseases.
    • “Adverse events were mild, and did not significantly differ between the two groups.
  • and fills us in on which adults need a measles booster in the U.S.
  • Beckers Hospital Review identifies the “10 most, least overweight and obese cities in the U.S.”
    • “McAllen, Texas, topped WalletHub’s 2025 ranking of the most overweight and obese cities in the U.S., published March 17, while Honolulu is the healthiest-weight city.”
  • Per a press release,
    • “The National Institute of Standards and Technology (NIST) has released a human stool reference material that will help scientists accurately measure the gut microbiome. The initiative aims to speed progress in a cutting-edge field of medical research targeting some of humanity’s most serious and intractable diseases.
    • “The human gut microbiome is a rich, teeming ecosystem of microorganisms and their byproducts that line the human gastrointestinal tract. Over the last decade, scientists have linked activity in the gut microbiome to obesity, diabetes, mental illness, cancer and other medical conditions. Researchers believe that a new class of drugs targeting the gut microbiome can treat many of these conditions.”
  • Per National Institutes of Health news releases,
    • “Surgical removal of enlarged tonsils and adenoids in children with mild sleep-disordered breathing (SDB) appears to significantly reduce the frequency of medical office visits and prescription medicine use in this group, according to a clinical study supported by the National Institutes of Health (NIH). The findings, published in JAMA Pediatrics, show that the surgery, called adenotonsillectomy, was tied to a 32% reduction in medical visits and a 48% reduction in prescription use among children with a mild form of the condition.”
  • and
    • In a preclinical study, rodents treated with uric acid showed improved long-term outcomes after acute ischemic stroke. The findings suggest that the treatment may work as an add-on therapy to standard stroke treatments in humans. The study was funded by the National Institutes of Health (NIH) and published in Stroke.
  • Consumer Reports, writing in the Washington Post, informs us about “Everything you need to know to keep your teeth healthy. Toothpaste matters, and you might want to consider adding a tongue scraper to your routine.”
  • Per BioPharma Dive,
    • “An experimental cellular medicine developed by Orca Bio outperformed a standard stem cell transplant in treating people with several types of blood cancer by helping avert a potentially dangerous side effect. 
    • “According to clinical trial results announced by Orca on Monday, about three-quarters of people treated with the company’s T cell immunotherapy did not experience moderate-to-severe chronic graft-versus-host disease through one year, compared to only 38% of those given the standard transplant. 
    • “Graft-versus-host disease, or GvHD, is a serious complication of transplants involving cells sourced from matched donors. Orca aims to develop its therapy, which uses a purified mix of donor-derived T cells and stem cells, as a safer transplant alternative in cancers like acute myeloid leukemia.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Median hospital margins remained stable to kick off 2025, as many reported higher service volumes and expenses.
    • “Kaufman Hall’s “National Hospital Flash Report” revealed January median operating margins hit 4.4%, up from 3.7% in December and 0.6% last January. Without allocations, the median operating margin grew to 8%, a 12-month high. the averages are based on data from more than 1,300 hospitals and gathered by Strata Decision Technology. 
    • “January was a relatively stable month for hospitals, as more people received care due in part to seasonal challenges like flu and other respiratory diseases. Hospitals are also experiencing more rapid revenue growth from inpatient than outpatient services. Expenses are also rising, driven primarily by drug costs, though the rate of cost growth has slowed,” said Erik Swanson, managing director and group leader, data and analytics, of Kaufman Hall.”
  • Fierce Healthcare notes,
    • “Highmark Health reported $29.4 billion in revenue and $50 million in net income for 2024 as the organization continues to weather notable headwinds that have battered health insurers.
    • “Highmark also posted $209 million in operating losses, according to its earnings report released last week. The full year results “reflect the negative operating performance of Highmark Health Plans,” the company said in a press release, as the team faced cost pressures throughout the year.
    • “United Concordia Dental and HM Insurance Group, the company’s stop-loss division, were bright spots with steady performance. Highmark said that trend was backed by growing dental membership and a disciplined pricing approach.
    • “Its health system, Allegheny Health Network, also saw improvements as patient volumes increased across “all delivery areas.”
    • “While our consolidated revenue improved, we continue to face significant industry headwinds and medical cost trends, including high costs for prescription drugs, especially GLP-1s, the impact of Medicaid redeterminations and nationwide high utilization, especially within the Medicare Advantage portfolio,” said Carl Daley, chief financial officer and treasurer of Highmark Health.” 
  • Fierce Pharma points out “the top 10 drugs losing US exclusivity in 2025.”
    • “While each year features high-profile losses of exclusivity in the pharma industry, this year’s list is something of a doozy.”
  • The Wall Street Journal reports,
    • “Pfizer PFE had a problem. Doctors weren’t prescribing its migraine drug Nurtec because they assumed insurance coverage would be too much of a hassle.
    • “So last year the company created a phone line for doctors and patients to call Pfizer directly for help. Pfizer now credits that and other changes for a 31% increase in Nurtec’s U.S. sales last year.
    • “The beleaguered drugmaker’s shares still haven’t recovered from their post-Covid slump, and shareholders are wary. But sales of products such as Nurtec and the vaccine Abrysvo that the company has been counting on are rising, and an activist shareholder’s push has lost steam. 
    • “Pfizer did it by shaking up its U.S. sales strategy, shifting where it deploys its sales representatives, how they market to doctors and how the company helps patients pay for their prescriptions.”
  • Per Modern Healthcare,
    • “Scripps Health plans to build a $1.2 billion medical campus that will include a 200- to 250-bed hospital and outpatient facilities.
    • “The San Diego-based health system’s board last week approved the 13-acre development in San Marcos, California. The first phase of the project will feature space for specialty and primary care offices, ambulatory surgery, cancer care, imaging, lab and other services, and the second phase includes the hospital, according to a Monday news release.
    • “The outpatient center will be built in two to three years, and the hospital will take about six years, a spokesperson estimated.”
  • and
    • “Sharon Regional Medical Center is set to reopen Tuesday, about two months after the former Steward Health Care facility in Pennsylvania closed.
    • “On Friday, the Pennsylvania Department of Health approved Pasadena, California-based Tenor Health Foundation’s plans to reopen the 163-bed hospital. In January, Judge Christopher Lopez of the U.S. Bankruptcy Court for the Southern District of Texas in Houston signed off on the hospital management company’s takeover of the facility, which employed more than 800 workers“
  • From BioPharma Dive,
    • “AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to $1 billion for a biotechnology startup making treatments that reprogram cells inside the body.
    • “The British drugmaker is buying EsoBiotech, a Belgian startup, for $425 million in cash upfront. EsoBiotech’s investors, among them Invivo Partners and UCB Ventures, could receive up to $575 million in additional payouts should the startup’s programs hit certain development and regulatory milestones, AstraZeneca said in a statement.”

Happy Pi Day!

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “The Senate March 14 approved by a vote of 54-46, a continuing resolution to fund the government through Sept. 30. The House passed, by a vote of 217-213, the bill earlier in the week. President Trump is expected to sign the measure.
    • “The bill extends certain key health care provisions that were set to expire at the end of March, including eliminating Medicaid disproportionate share hospital cuts, and extending the enhanced low-volume adjustment and Medicare-dependent hospital programs; key telehealth waivers; the hospital-at-home program; the Work Geographic Index Floor program; and add-on payments for ambulance services.”
  • Upshot — No government shutdown.
  • Fierce Healthcare adds,
    • “A last-ditch effort to pass a bipartisan healthcare package pushed aside at the end of 2024 that includes telehealth extensions and pharmacy benefit manager reform, reverses doc pay cuts and addresses the opioid crisis has failed.
    • “That legislation was brought to the floor by Senators Ron Wyden, D-Oregon and Bernie Sanders, I-Vermont, March 14 ahead of a key procedural vote [on the continuing resolution]. The senators’ bill required unanimous consent, or it would not advance. Sen. Rick Scott, R-Florida, quickly rejected the bill.”
  • Per a Senate news release,
    • “Today, the Senate overwhelmingly voted to pass the Halt All Lethal Trafficking of (HALT) Fentanyl Act. The bipartisan legislation, led by Judiciary Chairman Chuck Grassley (R-Iowa), Health, Education, Labor and Pensions Chairman Bill Cassidy, M.D. (R-La.) and Sen. Martin Heinrich (D-N.M.), would permanently classify fentanyl-related substances before their temporary Schedule I status expires on March 31, 2025. 
    • “Last month, the HALT Fentanyl Act was passed out of the Senate Judiciary Committee by a bipartisan vote of 16-5. Attorney General Pam Bondi has endorsed the legislation. President Trump’s Office of Management and Budget has confirmed that, if Congress passes the bill in its current form, the president will sign it. The legislation now heads to the House of Representatives.
    • “The HALT Fentanyl Act is a critical step towards ending the crisis that’s killing hundreds of thousands of precious American lives. I thank my Senate colleagues for passing this bill with broad, overwhelming support. I urge my House colleagues to swiftly pass the Senate version of this battle-tested, bipartisan bill to save lives, advance research and support our brave men and women in blue,” Grassley said.: * * *
    • “Download bill text HERE and a fact sheet HERE.”
  • The AHA News tells us,
    • “The Senate Finance Committee March 14 held a confirmation hearing on Mehmet Oz’s nomination for administrator of the Centers for Medicare & Medicaid Services. Oz, a doctor and former television show host, indicated that some of his priorities in the position, if confirmed, would be to reduce health care spending by improving poor health, increasing use of technology, incentivizing providers, and stopping wasteful spending, fraud and abuse. The committee will soon schedule a vote on whether to advance his nomination to the full Senate.”
  • The Wall Street Journal adds,
    • “Mehmet Oz, the Trump administration’s nominee to lead the Medicare agency, said some actions by private insurers in the Medicare Advantage program amounted to fraud and cheating, and he intended to go after them as head of the Centers for Medicare and Medicaid Services. 
    • “His comments, during his Senate confirmation hearing on Friday, were focused on industry practices that can boost insurers’ Medicare Advantage payments by documenting more diagnoses in their patients. Medicare Advantage insurers get higher payouts when patients have certain conditions. 
    • “There’s a new sheriff in town,” said Oz, a heart surgeon known for his long-running television show. He criticized “upcoding” in Medicare Advantage and said, “I pledge if confirmed I will go after it.”
  • Per Senate news releases,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, laid out his health care priorities during a hearing to consider Dr. Mehmet Oz’s nomination to be Administrator of the Centers for Medicare and Medicaid Services (CMS). Oz committed to supporting Grassley’s efforts to lower prescription drug costs, strengthen rural health care, help kids with exceptional medical needs, preserve transitional health plans and improve the agency’s responsiveness to Congress.”
  • and
    • “At a U.S. Senate Finance Committee hearing to consider the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator, Chairman Mike Crapo (R-Idaho) highlighted Dr. Oz’s wealth of firsthand experience as an accomplished physician and his clear vision for creating a healthier nation.  Crapo and Dr. Oz discussed how he would address the nation’s chronic disease epidemic, as well as how he might approach reforming payment programs to improve efficiency.
    • “Crapo concluded the hearing with, “There is no doubt you are qualified to serve as the next Administrator of [CMS], and I look forward to voting in favor of your nomination and am urging all of my colleagues to do the same.”
  • The AHA News informs us,
    • “The Medicare Payment Advisory Commission March 13 released its March report to Congress that includes recommendations for hospital and other Medicare payment systems for fiscal year 2026. Among the recommendations, MedPAC urged Congress to update the base payment rate for hospitals by current law plus 1%.  
    • “An update above current law is necessary given the combination of providers’ continued financial pressures, and almost two decades of sustained and substantial negative Medicare margins,” AHA wrote in a January letter to MedPAC. “Simply put, even after the recommended payment update, Medicare’s payments to hospitals would remain inadequate.” 
  • Per a Food and Drug Administration news release,
    • “Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.
    • “The new study, published in the peer-reviewed scientific journal American Journal of Preventive Medicine, found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.”

From the judicial front,

  • Politico reports,
    • “A federal appeals court has given President Donald Trump’s administration the go-ahead to enforce a pair of controversial executive orders that seek to root out diversity, equity and inclusion efforts in federal agencies and government contractors.
    • “The three-member appeals panel — including two judges appointed by Democratic presidents — lifted a lower court’s injunction that had put the policy on hold last month.
    • The ruling Friday from the panel of the Richmond, Virginia-based 4th Circuit Court of Appeals is not a final decision on the legality of Trump’s anti-DEI policy. It merely allows the government to administer the policy while litigation continues.
    • “In separate opinions explaining their votes, the three judges suggested the Trump administration should be allowed to demonstrate that it will abide by anti-discrimination laws and respect First Amendment rights as it implements the executive orders, which Trump issued on the first two days of his new term.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota’s CIDRAP reports,
    • “The measles outbreak in Texas has risen by 36 cases, pushing the US case count for the year past the number for all of 2024.
    • “The outbreak of the highly contagious virus, which began in late January and is centered in the western part of the state, now stands at 259 cases, according to the latest update from the Texas Department of State Health Services (DSHS). Of those patients, 257 are either unvaccinated or have unknown vaccination status, and 201 are children ages 17 or younger. Thirty-four patients have been hospitalized, with one death in an unvaccinated child who had no known underlying conditions.
    • “Eleven counties to date have reported cases, but two thirds of the cases (174; 67%) are in Gaines County, which has one of the highest rates of school-aged children in Texas who have opted out of at least one vaccine. The county is home to a large Mennonite community with low vaccination rates.
    • “DSHS officials said they have determined that three of the case-patients previously listed as vaccinated were not vaccinated. Two had received their measles, mumps, and rubella (MMR) vaccine doses 1 to 2 days before their symptoms started and after they had been exposed to the virus. The third had a vaccine reaction that mimicked a measles infection and has been removed from the case count.”
  • The University of Minnesota CIDRAP also notes,
    • “The US Food and Drug Administration (FDA) yesterday announced the strains it recommends manufacturers include in seasonal flu vaccines for the 2025-26 flu season, and [as usual] they mirror recommendations announced by the World Health Organization (WHO) last month.” 
  • Gallup reports,
    • “Americans’ assessments of their mental and physical health are the least positive they have been in Gallup’s 24-year trend, reflecting a decadelong decline that began around 2013 and accelerated sharply with the onset of the COVID-19 pandemic in 2020.
    • “Three in four U.S. adults in Gallup’s latest annual reading rate their mental health (75%) and, separately, their physical health (76%) as either “excellent” or “good.” This contrasts with a record-high 89% rating their mental health positively as recently as 2012, and a high of 82% for physical health in 2003.
    • “As fewer Americans have rated their mental and physical health positively, most of the change has been in the percentages rating each aspect “excellent” — shrinking to 31% for mental health and 24% for physical health.”
  • The National Science Foundation points out,
    • “A team of researchers led by the recipient of a U.S. National Science Foundation Faculty Early Career Development grant has developed a new storage method for protein-based drugs that could potentially eliminate the need for refrigeration of important medicines. Using an oil-based solution and a molecule acting as a coating to enclose the proteins in these drugs, researchers demonstrated a technique to prevent the proteins from degrading rapidly — a protection that traditionally requires refrigeration.
    • “The research is led by Scott Medina at Pennsylvania State University and published in Nature Communications. It demonstrates a possible practical application to eliminate the need to refrigerate hundreds of life-saving medicines like insulin, monoclonal antibodies and viral vaccines.
    • “The work could eventually reduce the cost of refrigerating such drugs throughout the supply chain and enable greater use of protein-based therapies where constant refrigeration isn’t possible, including military environments. 
    • “Over 80% of biologic drugs and 90% of vaccines require temperature-controlled conditions. This approach could revolutionize their storage and distribution, making them more accessible and affordable for everyone,” says Medina.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have determined that dermatitis resulting from topical steroid withdrawal (TSW) is distinct from eczema and is caused by an excess of an essential chemical compound in the body. Scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) identified treatments that could be studied in clinical trials for the condition based on their potential to lower levels of the chemical compound—called nicotinamide adenine dinucleotide (NAD+), a form of vitamin B3. The findings were published today in the Journal of Investigative Dermatology.
    • “Dermatitis is characterized by inflammation, itching, or burning sensations on the skin, and can result from various conditions including TSW and eczema. Eczema, also known as atopic dermatitis, is a common cause of dermatitis and affects 10 to 30% of children and 2 to 10% of adults each year in the United States. Topical steroids—specifically glucocorticoids or topical corticosteroids—have long been used as a first-line treatment for dermatitis caused by eczema because the drugs are safe, effective, easy to apply, and considered well-tolerated.” * * *
    • “The scientists provisionally established criteria that can be used by health care providers to identify TSW in people. People who have stopped topical steroid treatment and meet the criteria may be diagnosed by practitioners as having TSW. The researchers suggest that patients identified as having TSW could be treated using the proposed mitochondrial complex I-blocking drugs.
    • “The results of this study may help practitioners identify TSW in patients and work towards developing safe and effective treatments. According to the researchers, more research is needed to determine whether all patients with TSW have an excess of NAD+, or if there are other features that define TSW. Additionally, the diagnostic criteria will help health care providers and researchers to better understand the prevalence of TSW and evaluate the effects of using topical steroids.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.
    • “But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?
    • “The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.
    • “To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)”
  • Per STAT News,
    • “Biotech company Altimmune announced in an investor call yesterday that it will study its obesity drug, which targets receptors of the GLP-1 and glucagon hormones, in alcohol use disorder, as mounting evidence supports the potential of GLP-1 drugs to help with addiction.
    • “Altimmune executives think that their molecule, called pemvidutide, could be particularly helpful for liver conditions, since there are glucagon receptors located in the liver. The company has already been studying the drug in weight loss and in the liver disease MASH, and are now expanding into alcohol-related conditions.
    • “The company plans to start a study in alcohol use disorder in the second quarter of this year, and another study in alcohol-related liver disease in the third quarter.
    • “Eli Lilly has also started studying mazdutide, a GLP-1/glucagon drug it’s developing with Chinese biotech Innovent, in alcohol use disorder. Lilly CEO Dave Ricks has said the company also plans to test obesity drugs in other areas of addiction, like nicotine and drug use disorders.
    • “Novo Nordisk is running a study of its obesity drugs in alcohol-related liver disease but has not yet started any trials in addiction.”
  • Per Beckers Hospital CFO Report,
    • As healthcare organizations continue to navigate shifting financial and operational landscapes, new data from Kaufman Hall and Strata highlights significant trends in physician productivity, compensation, and costs.
    • In the fourth quarter, median work relative value units per full-time physician varied across specialties, with medical specialties leading at 7,139 wRVUs. Physician compensation followed a similar pattern, with surgical specialists earning the highest median paid compensation at $491,000 per FTE.
    • Despite an encouraging increase in net revenue per physician, rising expenses remain a challenge. These figures underscore the mounting financial pressures and workforce challenges facing healthcare organizations. For executives, balancing rising costs, evolving productivity demands, and compensation structures will be critical in sustaining financial stability and operational efficiency.
  • Beckers Hospital Review points out ten drugs poised to be top sellers next year.

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) threw a wrench into a Republican plan to avert a government shutdown this weekend, saying there wasn’t enough Democratic support to advance the measure funding federal agencies through Sept. 30.
    • “Republicans “do not have the votes in the Senate,” to move the resolution forward, Schumer said on the Senate floor, indicating that his party was prepared to block it. He blamed Republicans, saying they “chose a partisan path” in their bill without any input from congressional Democrats.  
    • “As an alternative, Schumer floated a shorter-term plan that would fund the government for a month. “I hope my Republican colleagues will join us to avoid a shutdown on Friday,” he said.
    • “Government funding will lapse at 12:01 a.m. Saturday if Congress doesn’t act. The GOP-led House left town after it approved Republicans’ resolution on Tuesday, effectively giving the Senate no time to revise the bill—but to simply pass it or reject it.”
  • The Hill adds,
    • Some Democrats floated the idea that an amendment vote on the 30-day CR, which would fail, could be won in exchange for the requisite number of votes to advance the GOP bill. Some Republicans could support it, according to Sen. Tim Kaine (D-Va.), but not enough that it would be adopted. 
    • “It remains unclear whether Republicans would go along with that though. Senate Majority Leader John Thune (R-S.D.) did not fully shoot down the idea. 
    • “I think there would have to be some understanding,” he told The Hill on Wednesday evening. “We’ll see. I’m not sure exactly what their demand is — if they just need a vote on that, and if in exchange for that they’ll give us the votes to fund the government.”
    • “Thune added that discussions are “going on right now” on a path forward, but he also panned the idea of a full shift to a 30-day CR in order to finish 2025 appropriations bills.”
  • The Wall Street Journal further tells us,
    • “The Centers for Medicare and Medicaid Services plans to terminate four demonstration projects at the end of 2025, closing out models affecting primary care, kidney care and healthcare payments in the state of Maryland.
    • “The agency will also make changes to other projects, including dropping a planned initiative that would offer certain generic drugs to Medicare enrollees for $2. CMS said its planned terminations would save nearly $750 million, and an agency official said the projects would affect millions of patients.”
  • Per Modern Healthcare,
    • “Johnson & Johnson MedTech said Wednesday its Monarch Quest robotic platform received clearance from the Food and Drug Administration.
    • “Robotic-assisted bronchoscopy is a minimally invasive technique that allows surgeons to reach airways and suspicious lung nodules.”

From the public health and medical research front,

  • The New York Times reports,
    • “Measles continues to spread in West Texas and New Mexico, with more than 250 people infected — many unvaccinated school-age children. Two cases in Oklahoma, for which state officials have not provided a location, have also been linked to these outbreaks. Twelve other states have reported isolated measles cases, typically linked to international travel.”
  • The American Medical Association lets us know what doctors wish patients knew about measles.
  • STAT News reminds us,
    • “The 2020s have inarguably been Covid-19’s decade. 
    • “Since the coronavirus outbreak was acknowledged as a pandemic exactly five years ago, the pandemic has killed well over 1 million Americans, derailed the global economy, and sparked political upheaval that continues today. It also yielded what many hail as the greatest scientific accomplishment in human history: the development of effective vaccines in under a year. 
    • “Yet in dominating the early 2020s, Covid-19 also distracted from what is arguably a more significant public health emergency. Even at the height of the pandemic, more young Americans died of drug overdose than Covid. And in the last year, the overall death toll from the country’s drug crisis has exceeded the Covid-19 pandemic as the deadliest health event this generation.”
  • MedPage Today notes,
    • “Using only targeted models of syphilis screening in the emergency department (ED) would miss large proportions of active syphilis cases as well as new HIV diagnoses and acute HIV cases, according to new research.
    • “Only screening patients for syphilis who came to the ED for gonorrhea and chlamydia testing would have missed 76.4% of positive syphilis screens as well as 68.7% of new HIV diagnoses, reported Kimberly Stanford, MD, MPH, of the University of Chicago Medical Center.”
  • Healio informs us,
    • “An increase in depressive symptoms was observed among U.S. teenagers without, rather than with, behavioral risk factors, underscoring the need for greater screening in this population, data show. 
    • “Over the last decade, national survey data has revealed a sharp rise in depressive symptoms among U.S. adolescents,” Tanner J. Bommersbach, MD, MPH, child and adolescent psychiatrist and assistant professor at the University of Wisconsin School of Medicine and Public Health, told Healio regarding the research presented in The Lancet Regional Health Americas. “Yet, surprisingly little is known about what is driving this increase and which adolescents are most affected.”
  • Consumer Reports, writing in the Washington Post, explains what to do about ear pain.
  • Per a National Institutes of Health press release,
    • “The antiviral drug tecovirimat used without other antivirals did not reduce the time to clinical resolution of clade II mpox lesions or improve pain control among adults in an international clinical trial sponsored by the National Institutes of Health (NIH). The trial enrollment was stopped in late 2024 when an interim analysis showed that tecovirimat monotherapy was ineffective in the study population. Detailed results were presented at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.
    • “This study brought us a step forward in better understanding mpox disease and potential treatment strategies,” said Jeanne Marrazzo, M.D., M.P.H., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which sponsored and funded the trial. “We are grateful to the study team and participants for their contributions to groundbreaking research on a disease that we still do not know enough about.”
  • The National Cancer Institute’s Cancer Information Highlights cover the following topics this week: “AI and Immunotherapy | Breast Reconstruction | Multiple Myeloma Research.”
  • Food Safety Magazine alerts us,
    • “The U.S. Centers for Disease Control and Prevention (CDC) has released a summary analyzing the causes of foodborne illness outbreaks that occurred between 2014 and 2022. Data included in the analysis was drawn from the Foodborne Disease Outbreak Surveillance System (FDOSS), via the National Outbreak Reporting System (NORS).
    • “According to CDC, approximately 800 foodborne illness outbreaks occur in the U.S. each year, causing an estimated 15,000 illnesses, 800 hospitalizations, and 20 deaths, annually.
    • “An overall trend revealed in the FDOSS data for 2014–2022 included that many foodborne illness outbreaks occur because of contamination of food by an animal or environmental source before arriving at the point of final preparation. Additionally, most viral outbreaks are caused by contamination from ill food workers. The data showed that common contributing factors to bacterial outbreaks are 1) allowing foods to remain out of temperature control for a prolonged period, and 2) inadequate time and temperature control during cooking.”
  • The American Hospital Association News relates,
    • “The AHA and Press Ganey March 12 released a new report showing hospital and health system patients reporting improvements in overall care experience and perception of safety alongside gains in key safety outcomes. It also shows that the health care workforce has had a rebound in their reported experience, resilience and perceptions of safety culture.
    • “The insights report, “Improvement in Safety Culture Linked to Better Patient and Staff Outcomes,” highlights how hospitals that foster a strong culture of safety also report a better experience for patients and the health care workforce.
    • “Key report findings include: 
      • “13 million patients surveyed after hospital stays report improvements in their overall care experience and perception of safety.
      • “Surveys of 1.7 million members of the health care workforce show a rebound in their reported experience, resilience and perceptions of safety culture, following the enormous strain of the COVID-19 pandemic.
      • “Improvements in key safety outcomes like falls and infections across more than 25,000 units in 2,430 hospitals.”
  • Per MedTech Dive,
    • “Capstan Medical says it has notched a first in the treatment of structural heart disease, employing a robot to implant two people with mitral valve replacement devices.
    • “Current treatment options for heart valve disease exclude too many patients who are not good candidates for existing procedures, said Capstan CEO Maggie Nixon, and the company hopes its approach will provide them with a new alternative.
    • “The Santa Cruz, California-based startup is developing a valve implant, catheter and robotic delivery platform to expand structural heart intervention to a broader group of people.
    • “There need to be more percutaneous, minimally invasive options to help treat valve disease,” Nixon said in an interview.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Blue Shield of California President and CEO Lois Quam is out at the company two months after taking the helm.
    • “The company declined to explain the circumstances of Quam’s immediate departure.
    • “Chief Financial Officer Mike Stuart will serve as interim president and CEO until the board names a permanent successor, the company said in a news release Tuesday. Stuart has worked at the nonprofit insurer for more than a decade, the company said.
    • “Quam joined the company as president in August after having served as CEO of Pathfinder, a nonprofit global health organization. She was named CEO in early January as part of a corporate restructuring and was touted as its first female CEO.”
  • Fierce Healthcare reports,
    • “Health technology company Innovaccer launched a new platform that seeks to make it easier for insurers to manage risk adjustment and quality improvements.
    • “On Wednesday, Innovaccer unveiled the 360-Degree Gap Closure Solution, which assist payers in improving coding accuracy and patient outcomes. The tool comes at a time when the industry is under significant scrutiny from regulators over coding practices.
    • “The platform enables better engagement across different care settings, greater automation and data governance, Innovaccer said. Health plans can deploy one-click campaigns that address care gaps in a way that reaches provider offices, pharmacies and home healthcare.”
  • Per BioPharma Dive,
    • “Roche has raised its bet on obesity, agreeing to pay Zealand Pharma $1.65 billion to license an experimental shot the Danish company put into a Phase 2b trial in December, Zealand said Wednesday.
    • “Per deal terms, Roche will pay $1.4 billion immediately and $250 million in anniversary payments to license petrelintide. With further milestone payments, Zealand could receive up to $5.3 billion. Roche and Zealand will co-commercialize the shot in the U.S. and Europe, and share in any profits and losses.
    • “The deal gives Roche access to a type of experimental drug known as an amylin analog, a class the Swiss pharmaceutical company didn’t obtain when it acquired Carmot Therapeutics 15 months ago. Roche plans on testing petrelintide with one of those drugs, for which Zealand could reimburse Roche $350 million.”
  • Per MedTech Dive,
    • “Labcorp will pay up to $225 million to acquire the oncology diagnostics businesses of BioReference Health, a subsidiary of Opko Health, to expand its portfolio of tests used in cancer care.
    • “The deal, announced Tuesday, includes $192.5 million to be paid at closing and a payment of up to $32.5 million based on performance. 
    • “The assets, including certain customer accounts, generate about $85 million to $100 million in annual revenue, according to the announcement. Labcorp expects the acquisition to be accretive to earnings in the first year after closing.”
  • Healthcare Dive relates,
    • “Hospital operator Landmark Holdings of Florida filed for Chapter 11 bankruptcy protections on March 9, becoming the latest in a growing number of embattled providers to restructure amid financial headwinds. 
    • “In first day court filings, Landmark, which owns or operates six long-term acute care hospitals across three states, said rising labor and pharmaceutical costs, as well as stagnating Medicare reimbursements, had dinged Landmark’s profitability and threatened the provider’s ability to make timely loan repayments.”
    • “Still, Landmark told the court it expects to have enough cash on hand to keep its hospitals open through the bankruptcy process.:
  • STAT News lets us know,
    • While there are no official statistics on the number of end-of-life doulas in the United States as this emerging field is still largely unregulated, Fortune reports that the National End-of-Life Doula Alliance (NEDA) has significantly grown its membership, especially after the pandemic. In 2024, NEDA had over 1,500 registered members, compared to about 250 in 2019. 
    • “The term “end-of-life-doula” was first formally used in the early aughts. In 2001, the Jewish Board of Family and Children’s Services launched the “Doula to Accompany and Comfort Program,” a pilot program that trained volunteers to aid and support people who would otherwise die alone. 
    • “Sometimes known as “death doulas,” [these] professionals * * *help people navigate what can be a confusing and overwhelming time.”