Tuesday Report

Obesity

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.”

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.”

Weekend update

David Ermer–CDC, Congress, COVID treatment, FDA, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call adds,
    • Both the House and Senate come back from recess this week to begin a busy three-week period that’s expected to focus on Republicans’ budget reconciliation agenda, including extending and expanding tax cuts and tightening immigration policy.
    • The top items on the House agenda this week, meanwhile, will include more measures to overturn Biden administration rules. And the Senate will continue to vote on more of President Donald Trump’s nominations. The headliners this week are the nominees to lead the National Institutes of Health and the Food and Drug Administration.
    • With a stopgap spending law now in effect through Sept. 30, the Republican majorities in both the House and Senate can fully turn their attention to their budget reconciliation agenda.
    • This work period on Capitol has just three weeks, followed by the traditional two-week recess that coincides with Easter and Passover. By then, House and Senate Republicans will want to make progress on resolving differences on how to execute the process that allows them to pass legislation without the risk of filibusters in the Senate.
  • Roll Call also gives us the 119th Congress in numbers, mid-March edition.
  • On Tuesday morning at 10 am, the House Oversight and Government Reform Committee will mark up the following batch of bills,
    • H.R. 1295, the Reorganizing Government Act of 2025; 2) H.R. 1210, the Protecting Taxpayers’ Wallet Act; 3) H.R. ___, the Preserving Presidential Management Authority Act; 4) H.R. 2174, the Paycheck Protection Act; 5) H.R. 2193, the FEHB Protection Act of 2025; 6) H.R. ___, the Federal Accountability Committee for Transparency (FACT) Act; 7) H.R. 2056, District of Columbia Federal Immigration Compliance Act; 8) H. Res. 187, Of inquiry requesting the President to transmit certain information to the House of Representatives referring to the termination, removal, placement on administrative leave, moved to another department of Federal employees and Inspectors General of agencies; 9) H. Res. 186, Of inquiry requesting the President to transmit certain documents to the House of Representatives relating to the conflicts of interest of Elon Musk and related information.
  • Healthcare Dive tells us,
    • “A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place in April, a spokesperson for the Department of Health and Human Services confirmed.
    • “The Advisory Committee on Immunization Practices, or ACIP, had originally been scheduled to meet Feb. 26 to Feb. 28, but was unexpectedly delayed soon after Robert F. Kennedy Jr., a longtime critic of U.S. vaccination policies, took office as health secretary. At that time, an HHS spokesperson said the rescheduling was to allow extra time for public comment.” * * *
    • “ACIP, which includes outside vaccine experts as well as federal health officials, will now convene on April 15 and April 16, Andrew Nixon, HHS’ director of communications, wrote in an email to BioPharma Dive.” 
    • “A notice posted Friday ahead of publication Monday in the federal register indicated that advisers will discuss the current measles outbreak, as well as vaccines for COVID-19, human papillomavirus, monkeypox, respiratory syncytial virus and other pathogens.”
  • The New York Times reports,
    • “Robert F. Kennedy Jr., the nation’s health secretary, on Saturday instructed leaders of the nonprofit he founded to take down a web page that mimicked the design of the Centers for Disease Control and Prevention’s site but laid out a case that vaccines cause autism.
    • “The page had been published on a site apparently registered to the nonprofit, the anti-vaccine group Children’s Health Defense. Mr. Kennedy’s action came after The New York Times inquired about the page and after news of it ricocheted across social media.
    • “The page was taken offline Saturday evening.” 
  • Pharmacy Practice News informs us,
    • “The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video.
    • “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.”
    • “These activities can result in “a thousand fraudulent prescriptions using an unsuspecting doctor’s DEA number within a 14-hour time frame,” Ms. Hager said.”

From the public health and medical research front,

  • The New York Times reports, “Dementia May Not Always Be the Threat It Is Now. Here’s Why. The number of cases will increase, but the rates seem to be declining with every birth cohort that reaches advanced ages, researchers said.”
    • Eric Stallard, an actuary and co-director of the Biodemography of Aging Research Unit at Duke University, read the [recent dementia] study and thought the team “seemed very competent at their analysis” of individual risk.
    • But when it came to the projection that cases would double, which assumed that the incidence of dementia would remain stable over the next 40 years, “I don’t believe it,” Mr. Stallard said.
    • “The notion that the number of people with dementia will double over the next 25, 30 or 35 years due to the aging of baby boomers is widespread, it’s pervasive — and it’s wrong,” he added.
    • “He and two other Duke researchers recently published a commentary in JAMA pointing out that the age-specific prevalence of dementia in this country had steadily declined for 40 years.
    • “If your risks are lower than your parents’ risks and this trend continues, you won’t see the doubling or tripling of dementia that’s been projected,” said Dr. Murali Doraiswamy, director of the Neurocognitive Disorders Program at Duke and a co-author of the JAMA article.
    • “To be clear, experts agree that the number of people with dementia will climb in coming decades, simply because the disorder rises so steeply with age and the number of older adults in the United States will increase.
    • “But Mr. Stallard estimates that the increase will be more like 10 to 25 percent by 2050. “It will still be a significant challenge for the health system in the U.S.,” he said.”
  • The University of Minnesota CIDRAP lets us know,
    • Another study is raising questions about whether compliance with a federally mandated hospital protocol aimed at improving sepsis care and management is associated with better outcomes.
    • The study, published this week in JAMA Network Open, found that sepsis patients who received care that was noncompliant with the Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) tended to be older, have more comorbidities, and have more complex clinical presentation than those who received compliant care. When those factors were accounted for, SEP-1 compliance was no longer associated with improved mortality.
    • The study comes on the heels of a systematic review and meta-analysis, published last month in the Annals of Internal Medicine, that found no evidence that SEP-1 compliance was associated with improved mortality.
  • and
    • “People who started taking the antiviral drug ensitrelvir within 72 hours after a household member tested positive for COVID-19 were significantly less likely to be infected, according to results from an international phase 3 clinical trial presented last week at the Conference on Retroviruses and Opportunistic Infections in San Francisco.
    • “Made by Japanese pharmaceutical firm Shionogi, ensitrelvir is approved in Japan for the treatment of mild to moderate COVID-19.  * * *
    • “In addition to vaccination, post-exposure prophylaxis with timely use of an oral antiviral would be a valuable way to help prevent COVID-19 illness in people who have been exposed, especially people at high risk for severe disease,” Frederick Hayden, MD, a University of Virginia School of Medicine professor emeritus who helped design the trial and presented the findings, said in a university news release.
    • “This is the first clinical trial of an oral antiviral drug to show significant protection against COVID-19 [infection],” he added. “If approved by the [US] Food and Drug Administration for this purpose, it would be an important addition to current preventive strategies.”
  • A Wall Street Journal reporter tells us “A Year After I Stopped Taking a [GLP-1} Weight-Loss Drug, I’ve Lost 20 More Pounds. I’m one of the millions of people trying to keep the weight off without taking expensive drugs like Mounjaro or Ozempic for life. It wasn’t easy, but I found ways.”
    • “My first mistake in stopping the medicine [after reaching his target weight in five months] was that I didn’t wean myself off it more slowly. I stopped cold turkey, and my hunger pangs and food noise came back with a vengeance. Some doctors and researchers have begun to recommend stopping more gradually, as well as taking appetite suppressants like phentermine to ease the transition. This has helped reduce weight regain in some patients.
    • “My second mistake was not having a structured nutrition plan at the ready. The medicine had helped winnow my bad habits down to a number I could actually manage, from perhaps 25 or 30 entrenched eating behaviors (really!) down to more like five or six (I still can’t shake my addiction to impulsive runs to the 7-Eleven, for example). But even a few bad habits—when they meet with what feels like insatiable hunger—can do a lot of damage.
    • “After a few months, I found a highly structured nutrition program, one with expert coaching that focused on a low-carb diet. While the transition was difficult, it eventually helped me bring my cravings under control. 
    • “Virta Health, a startup I turned to for a few months, has users test their blood daily. The results, which measure glucose levels and another indicator of dietary compliance, are beamed through an app to a nutrition coach. Being aware that someone was watching—and would know if I had cheated—was immensely helpful as I sought to improve my nutrition and manage hunger.
    • “Without wading into the nutrition wars over the keto or Atkins or Mediterranean diet or any other, I’ve found that I have generally been far less hungry when I’ve eaten more protein, fiber and healthy fats. Meanwhile, drastically limiting carbohydrates has had another benefit: forcing me to eat more vegetables. Gobs and gobs of them.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The Longevity Business Is Booming—and Its Scientists Are Clashing. The antiaging movement has raced ahead amid fierce debates; critics of a grandfather of the field, Leonard Guarente, include former protégés and rivals.”
  • and
    • “Doctors Are Just as Frustrated as You by Our Messed-Up Healthcare System. Trust between doctors and patients is fraying, but there are ways to mend it.”
      • “One of doctors’ biggest gripes: largely corporate institutions that effectively set patient quotas and require extensive documentation. One physician said he and other doctors are allowed 15 minutes with patients; exceeding that leads to poor performance reviews and “being out of compliance.”
      • “These doctors think patients lose trust because they don’t understand who or what is in control. “Physicians have lost autonomy,” says Dr. Corinne Rao, an internal medicine physician and hospitalist. “Their decisions are subject to the financial interests of their employer.” 
      • “Doctors also say that trust—and respect—go both ways. “It’s like a marriage,” says Dr.  James Schouten, a family physician. Each side has to give 100%. Implying that a loss of trust is entirely the doctor’s fault, he says, suggests the patient has no role in establishing or maintaining trust.
      • “They do, he and others say.”

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.”

Tuesday Report

David Ermer–Congress, COVID-19 testing, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC

Capitol Hill News

  • The Wall Street Journal reports,
    • The House [of Representatives] narrowly approved a Republican proposal to fund the government into the fall, as GOP lawmakers remained largely united following a last-minute push from the White House, overcoming Democratic opposition and setting up a fight in the Senate. 
    • Funding for the federal government expires this weekend. The GOP proposal would extend funding through Sept. 30 at fiscal 2024 spending levels, but it includes $13 billion in cuts in nondefense spending and $6 billion in increased military spending. It allocates additional money for border enforcement and forces Washington, D.C., to cut $1 billion from its budget. 
    • The measure passed 217-213, with Rep. Thomas Massie of Kentucky being the only Republican to vote against it. Democrats were largely united in opposition, with one Democrat, Rep. Jared Golden of Maine, voting yes. * * *
    • “The matter now heads to the Senate, where Republicans will need Democratic support to advance the bill. Senate Democrats were wrestling over the matter Tuesday. Some saw the funding deadline as their only leverage to push back against GOP efforts to dismantle federal programs, while others were wary of playing hardball and triggering a government shutdown. 
    • The House left town after Tuesday’s vote, effectively giving the Senate the option of approving or blocking the House measure—but not revising it.” 
  • Fierce Healthcare adds,
    • “Rep. Greg Murphy, M.D., R-N.C., posted on X Monday night that Johnson and Senate Majority Leader John Thune have agreed to include a doc pay fix in Congress’ budget reconciliation, which is expected to be finished in May to align with President Donald Trump’s first 100 days.
    • “A doc pay fix, which would counteract a 2.83% cut to Medicare physicians’ payment rates that went into effect Jan. 1, has been a central focus for provider lobbying groups as well as for physician members of the legislature. It was seen as the driving force behind passing an expanded healthcare package.
    • “The Energy and Commerce committee has an $880 billion deficit reduction target. E&C will identify those cuts from programs within its jurisdiction like Medicaid and other healthcare programs. It could identify some of those savings from items in the December healthcare package that did not make it into last year’s funding bill, such as PBM reform.”
  • Per Govexec,
    • “Also on Tuesday, Sen. Jerry Moran, R-Kan., who chairs the Senate Veterans Affairs Committee, announced during a hearing he will put forward legislation that will also seek to put some constraints on the Trump administration’s efforts to remake the Veterans Affairs Department’s workforce. He said VA must work closely with Congress and stakeholders such as veterans service organizations when seeking to make staffing cuts. The Republican chairman added he has voiced his reservations to VA Secretary Doug Collins.”

HHS News

  • The Washington Post reports,
    • Robert F. Kennedy Jr. is making one of his first official moves aimed at increasing oversight of the chemicals found in the nation’s food supply — a key component of his “Make America Healthy Again” agenda to root out chronic disease and childhood illness.
    • On Monday, Kennedy, who serves as the nation’s top health official, announced he was directing the Food and Drug Administration to “explore potential rulemaking” to tighten a decades-old loophole allowing food companies to put chemicals in their products without notifying the nation’s food regulators.
    • The practice Kennedy is targeting, known as “generally recognized as safe” (GRAS), can occur when companies self-certify the safety of a food additive. Companies aren’t required to tell the FDA when they include some chemicals and substances in their products, meaning there are probably hundreds of such ingredients added to the food supply without government oversight.
  • Per a March 10, 2025, CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule to address the troubling amount of improper enrollments impacting Affordable Care Act (ACA) Health Insurance Marketplaces across the country. CMS’ 2025 Marketplace Integrity and Affordability Proposed Rule includes proposals that take critical and necessary steps to protect people from being enrolled in Marketplace coverage without their knowledge or consent, promote stable and affordable health insurance markets, and ensure taxpayer dollars fund financial assistance only for the people the ACA set out to support.” * * *
    • “View the 2025 Marketplace Integrity and Affordability Proposed Rule (CMS-9884-P) here: https://www.cms.gov/files/document/MarketplacePIRule2025.pdf
    • “For additional information on the rule and its proposals, view the CMS fact sheet:  https://www.cms.gov/newsroom/fact-sheets/2025-marketplace-integrity-and-affordability-proposed-rule” 
  • Per Modern Healthcare,
    • “The U.S. Department of Health and Human Services increased its voluntary buyout offer for some employees for further layoffs this week as the agency faces pressure to reduce headcount, according to an email viewed by Bloomberg. 
    • “In addition to a $25,000 lump-sum buyout offer, some HHS workers would also receive around two months of paid administrative leave if they chose to accept the buyout. * * *
    • “The buyout offer was available to employees this week and expires Friday. The original buyout offer was extended to a “broad population of HHS employees,” according to an email. However, the Food and Drug Administration told staff Monday that employees responsible for reviewing drugs, medical devices and tobacco products aren’t eligible for the buyout program. 
    • “The HHS buyout offers are in addition to an early retirement program that relaxed service requirements for retirement.”
  • The U.S. Preventive Services Task Force issued a final recommendation on screening for food insecurity which received an inconclusive “I” grade.
    • “For children, adolescents, and adults:
      “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.”
  • Per Axios,
    • “The federal government’s free at-home COVID test distribution program has been suspended and is no longer accepting orders” as of March 9, 2025.
    • “For some previously distributed tests, expiration dates were extended to account for data that revealed a longer-than-expected shelf life.
    • “A full list of approved tests and their revised expiration dates is posted on the FDA website.”

FDA News

  • Per Cardiovascular Business,
    • “Google has received U.S. Food and Drug Administration (FDA) for Loss of Pulse Detection, a new smartwatch feature that detects when a person’s heart stops beating and then automatically alerts emergency services. 
    • “Loss of Pulse Detection asks the user if they are OK when it first detects the loss of pulse. If no response is provided, it triggers an audio alarm and countdown to when emergency services will be notified. If the countdown reaches zero, the alert is officially sent out.
    • “This feature is already available in 14 different countries. It will be made available in the United States for Google’s Pixel Watch 3 in the weeks ahead.”
  • Per Modern Healthcare,
    • “Siemens Healthineers has received clearance from the Food and Drug Administration for its Naeotom Alpha class of photon-counting computed tomography scanners.
    • “The company unveiled the two scanners in December, touting the Naeotom Alpha.Pro and Naeotom Alpha.Prime as more affordable options to its original Naeotom Alpha photon-counting CT, which received FDA clearance in September 2021.
    • “Photon-counting CT is a new technology that uses lower radiation doses than conventional CT and produces clearer images with fewer distortions.
    • “Siemens Healthineers’ photon-counting CTs are the only commercially available scanners of their kind available for clinical use but competitors are working to bring their versions to market.”

From the judicial front,

  • Govexec reports,
    • “A federal judge has ordered the acting head of the Office of Personnel Management to testify at a court hearing examining the legality of the Trump administration’s mass firings of federal employees, but the key workforce official has informed the court he will ignore the order. 
    • “Acting OPM Director Charles Ezell was slated to appear in a U.S. District Court in San Francisco on Thursday after Judge William Alsup ruled Monday on Monday that he must do so, but he will now face a to-be-determined sanction. The Trump administration had sought to block his testimony, saying it would raise constitutional concerns, but the judge rejected the argument. Ezell has already submitted written testimony, Alsup said, and now must be subject to cross examination. 
    • “After initial publication of this story, the Trump administration Tuesday evening informed the court Ezell would not testify and withdrew his written declaration suggesting he did not order the probationary firings across government. It called live testimony “not necessary” for Ezell or any other official. The plaintiffs in the case are seeking testimony from human resources personnel throughout government.” 

From the public health and medical research front,

  • Healio lets us know,
    • “The diabetes mortality rate in the U.S. dropped from 28.1 deaths per 100,000 people in 2000 to 19.1 deaths per 100,000 in 2019.
    • “Reductions in diabetes mortality were observed for all racial and ethnic groups.”
  • The Wall Street Journal reports,
    • “GLP-1s, including Ozempic, show promise in preventing age-related conditions like Alzheimer’s, osteoarthritis and certain cancers.
    • “GLP-1s work by suppressing appetite and reducing inflammation, potentially contributing to their preventive health benefits.
    • “While promising, more robust studies are needed to confirm the causal effects of GLP-1s on longevity and healthspan.”
  • The National Institutes of Health offers a research bulletin on the following topics: “Predicting preeclampsia | Liver gene editing | Mapping MS-like brain lesions.”
  • MedPage Today tells us five things that patients with low back pain need from their doctors and
    • “BMI was lower in kids whose mothers received a responsive parenting intervention in the INSIGHT randomized clinical trial.
    • “Across ages 3 to 9 years, children in a responsive parenting group had a lower mean BMI than those in a control group.
    • “The impact appeared significant only for girls.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of brensocatib (Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “The assessment will be publicly discussed during a meeting of the CTAF in September 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The National Cancer Institute informs us,
    • “For men with metastatic castration-resistant prostate cancer, an initial treatment that combines enzalutamide (Xtandi) and talazoparib (Talzenna)may help them live longer than just getting enzalutamide alone, according to updated results from a large clinical trial. Enzalutamide is a type of drug known as an androgen receptor antagonist and talazoparib is part of a group of drugs called PARP inhibitors.” * * *
    • “More information about the trial, which was funded by Pfizer, the maker of talazoparib, is available in this Cancer Currents story.”
  • Fierce Pharma adds,
    • “After Gilead Sciences’ lenacapavir made waves with stellar clinical results as a twice-yearly HIV prevention candidate, the drug has shown promise being dosed even further apart at only once a year.
    • “Two different once-yearly formulations of lenacapavir achieved blood concentrations that exceeded those associated with the strong HIV prevention efficacy that twice-yearly lenacapavir showed in phase 3 preexposure prophylaxis (PrEP) studies.
    • “The pharmacokinetic results came from a small phase 1 trial presented at the Conference on Retroviruses and Opportunistic Infections and simultaneously published in The Lancet.
    • “Based on the early-stage data, Gilead plans to start a phase 3 program for once-yearly lenacapavir in the second half of this year, with the potential for regulatory filings in 2027, Jared Baeten, M.D., Ph.D., Gilead’s vice president of HIV clinical development, told Fierce Pharma.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Hinge Health filed Monday for a proposed initial public offering.
    • “The virtual musculoskeletal health company, which contracts with employers, pharmacy benefit managers and large insurance companies to provide physical therapy and pain relief services, has been considered a potential IPO candidate since last year.”
  • and
    • “Tampa General Hospital and Mass General Brigham are teaming up to open a radiation oncology center in Florida.
    • “The 10,000-square-foot facility in Palm Beach Gardens will be co-branded and jointly owned. Tampa General will handle daily operations, while Mass General Brigham will provide oversight on quality and safety, according to a Tuesday news release.
    • “The center is scheduled to open in early 2026, the release said.”
  • Per Fierce Pharma,
    • “At its sprawling complex in Durham, N.C., Merck has opened a new $1 billion, 225,000-square-foot manufacturing plant slated to produce bulk substance for its megablockbuster HPV vaccine Gardasil.
    • “Merck built the new plant on the 262-acre campus it has occupied since 2004, where the pharma giant produces a variety of vaccines including shots to prevent chickenpox, measles and rubella.
    • “The complex manufactured more than 70 million doses last year, with the figure expected to increase this year, a Merck spokesperson said in an email. The campus now employs more than 1,000 people.”
  • Per STAT News,
    • “In the last two years, hundreds of businesses have cropped up to meet the surge in demand for the obesity and diabetes medications known as GLP-1s. The majority prescribe compounded copies of the drugs — a tenuous business strategy as shortages of the branded versions of the medications have come to an end. 
    • “Now, some businesses are setting their sights on another opportunity in compounding: hormones.
    • “Dozens of wellness and direct-to-consumer telehealth companies offering GLP-1s have begun marketing cash-pay hormone replacement therapy to women in perimenopause and menopause, and testosterone replacement therapy to men. Noom, best-known for its weight loss app and more recent GLP-1 offering, launched an HRT program for menopause in late February, and telehealth company Hims & Hers plans to roll out at-home testing over the next year to enable care for low testosterone, perimenopause, and menopause.
    • “Patients and physicians have long advocated for better access to hormone-based care. Men with low testosterone levels due to hypogonadism can face stigma as they seek care, and many women struggle to receive medically appropriate estrogen and progesterone to address serious hot flashes and help prevent osteoporosis. But clinicians and health policy researchers expressed concern that the emerging commodification of hormone replacement therapies — often marketed as a personalized fix for low energy, libido, and other age-related concerns — could lead to inappropriate prescriptions and put patients at risk.” 
  • Beckers Hospital Review points out,
    • “In August, Kaiser Permanente embarked on the largest rollout of generative AI in healthcare to date.
    • “The Oakland, Calif.-based health system offered Abridge, an ambient AI listening tool that drafts clinical notes for the EHR, to tens of thousands of providers.
    • “Becker’s caught up with Brian Hoberman, MD, executive vice president of IT and CIO at the Permanente Federation, at the HIMSS conference in Las Vegas to find out how the implementation is going.”
    • Here’s a link to that interview.
  • The Wall Street Journal adds,
    • “Last year, some cancer patients in Tennessee and Mississippi got a startling offer: Instead of videoconferencing with oncology specialists located hours away, they could see a hologram doctor, courtesy of the same special effects that have projected the Jonas Brothers and other celebrities at concerts and live events.
    • “The offer came from West Cancer Center & Research Institute, a health system that employs about 61 doctors and serves about 19,240 new patients a year across 12 locations in Tennessee, Mississippi and Arkansas. The system’s main clinic is in Germantown, Tenn., a suburb of Memphis.
    • “Its doctors typically spend hours on the road each week getting to the satellite clinics to see patients in more rural locations, while also relying heavily on videoconferencing for check-ins. Now, however, two of those clinics are replacing the video calls with life-size hologram-like displays, part of a cross-industry push to take videoconferencing to the next level.”

Weekend Update

David Ermer–CDC, Congress, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC,

  • Committee hearings of note this week:
    • Senate Committee on Health, Education, Labor, and Pensions March 5 10:00 AM (EST) | 562 Dirksen Senate Office Building, Washington, D.C. Meeting: Hearings to examine the nomination of Jayanta Bhattacharya, of California, to be Director of the National Institutes of Health, Department of Health and Human Services.
    • Senate Committee on Health, Education, Labor, and Pensions March 6 10:00 AM (EST) | 562 Dirksen Senate Office Building, Washington, D.C. Meeting: Hearings to examine the nomination of Martin Makary, of Virginia, to be Commissioner of Food and Drugs, Department of Health and Human Services.
  • USA Today observes,
    • President Trump on Tuesday [March 4] will deliver his first address to a joint session of Congress since his reelection. While the speech shares many characteristics with a State of the Union address, this presentation is slightly different in nature.
    • Trump’s speech to Congress is expected to outline his legislative priorities for the upcoming term and highlight the work his administration has accomplished since taking office.
    • But since this is his first address in his second nonconsecutive term, the speech is not classified as a State of the Union.
  • The FEHBlog noticed today that on February 12, the Congressional Research Services released a legal sidebar titled Rescission of Executive Order 11246, Employment Opportunity”: Legal Implications.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care received Food and Drug Administration clearance for its Control-IQ+ algorithm in Type 2 diabetes. The automated insulin delivery (AID) system can pull data from glucose monitors and integrate with Tandem’s insulin pumps, automatically calculating how much basal insulin patients should receive. 
    • “The expanded indication increases access for people with Type 2 diabetes who use Tandem’s t:slim X2 tubed pump and Tandem Mobi, a smaller form-factor pump.
    • “CEO John Sheridan told investors in a Wednesday earnings call that the expanded indication covers all people with Type 2 diabetes who take insulin, more than doubling Tandem’s total addressable market in the U.S.”

From the public health and medical research front,

  • The Washington Post reports,
    • Hospitals across the country have reported an increase in pediatric flu cases this season, with many children experiencing severe complications such as pneumonia, dehydration and organ failure. Hospital admissions for flu in children ages 5 to 17 increased by 145 percent, from 959 on Jan. 4 to 2,348 on Feb. 1, according to an analysis from the American Academy of Pediatrics.”
    • “Death is obviously the most severe outcome, but there is a huge spectrum between well and not well,” Patel said. “The flu can take a previously healthy kid and land them on a ventilator.”
    • “Doctors say early symptoms like dehydration or difficulty breathing should not be ignored, as they can indicate a more severe infection.
    • “Patel added that while cases at her hospital have started to decline, the tail end of this flu season could last a few more months.”
  • The Wall Street Journal discusses “The New Thinking on Concussions in Sports. Elite athletes are learning that the best way to recover from a sports-related concussion isn’t to shut down all physical activity. It’s to get back in a workout routine—and quickly.”
  • NPR Shots offers patient perspectives on two Alzheimer’s drugs — Leqembi and Kisunla. The FDA has approved “since 2023 that can clear the brain of sticky amyloid plaques, one of the hallmarks of Alzheimer’s.”
  • Fortune Wells points out “Nutritionists offer these six ways to get back to a healthy diet.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Prime Healthcare completed its acquisition of eight Ascension Illinois hospitals.
    • “The transaction closed March 1 and involves more than half of Ascension’s Illinois hospital network, along with several skilled nursing, home health and senior living facilities. Federal and state regulators signed off on the $375 million deal last year.
    • Prime, a for-profit system based in Ontario, California, pledged to invest $250 million in the facilities.
  • MedTech Dive lets us know,
    • “Teleflex will split into two publicly traded companies, with the new entity comprising its urology, acute care and OEM businesses. The remaining company will consist of the hospital-focused vascular access, interventional and surgical businesses.
    • “The separation positions each organization to accelerate growth under a simplified operating model and increased management focus, with a streamlined manufacturing footprint and better allocation of resources, Teleflex said in a Thursday announcement.
    • “In addition, Teleflex said it agreed to pay about 760 million euros (about $791 million) to acquire nearly all of Biotronik’s vascular intervention division. The company also announced the planned retirement of CFO Thomas Powell.”

Happy Presidents Day

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Mount Rushmore Photo by Laura Nyhuis on Unsplash

From Washington, DC

  • Milliman explains how to navigate the new mental health parity rules which are under a legal challenge before the U.S. District Court for the District of Columbia.
  • Per Fierce Pharma,
    • “Pfizer’s two-year run with the only 5-in-1 meningococcal vaccine on the U.S. market has come to an end. Now, GSK is ready to play catch-up after nabbing its own FDA approval. 
    • “The FDA approved the British drugmaker’s Penmenvy vaccine to protect people ages 10 to 25 against meningococcal serogroups A, B, C, W and Y (MenABCWY), which together cause the most invasive meningococcal disease (IMD) cases globally. The shot mixes the antigenic components of GSK’s established meningococcal vaccines Bexsero and Menveo, which target MenB and MenACWY, respectively, to offer broader coverage in fewer doses.”
  • MedPage Today adds,
    • “The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday [February 14].
    • “Like its reference counterpart, insulin aspart (Novolog), the biosimilar helps lower mealtime blood sugar spikes to improve glycemic control. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.
    • “For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research (CDER), in a statement.

From the U.S. public health and medical research front,

  • Beckers Clinical Leadership identifies America’s priciest health conditions.
  • Medscape notes,
    • “The CDC recommends everyone age 6 months or older get a flu vaccine, although so far this year, fewer adults have gotten the shot, compared to last year. The adult flu vaccination rate this season is 44%, down from 48% last season. According to the National Foundation for Infectious Diseases, “as long as influenza (flu) viruses are circulating in your community, it’s not too late to get vaccinated against flu.”
  • The New York Times offers “New Insights into Older Hearts. Heart disease is more common in people over 65, but treatments are better than ever. That can complicate decision-making for older heart patients.”
  • Consumer Reports, writing in the Washington Post, explains “How to keep your eyes healthy and your vision sharp. Cataracts, dry eyes, glaucoma and other eye problems become more common with age. Knowing the early signs and acting fast can make a difference.”
  • Per Healio,
    • There is evidence that GLP-1s can ameliorate psychiatric and neurologic symptoms.
    • More clinical trials on the direct and indirect effects of GLP-1s and their mechanisms of action are needed.
  • and
    • “American Indian and Alaska Native women face substantially higher risk for heart disease, particularly during reproductive-age years.
    • “Generational trauma, violence and racism have compounded [pregnancy] risks.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit Health’s quarterly net patient revenue dipped for the first time in months.
    • “The health system saw net patient revenue of $8.9 billion in the second quarter of fiscal 2025, a 5% drop from the year-ago period, according to its earnings report released Friday. Net patient revenue, or revenue from providing healthcare services after contractual discounts, makes up most of providers’ total operating revenue and can have a big impact on the bottom line.
    • “The results were markedly different from last year, when CommonSpirit was one of several systems that saw big increases in net patient revenue due to higher utilization and improved payer rates.
  • Beckers Hospital Review shares more insights on CommonSpirit Health’s second quarter report.
  • Beckers Payer Issues discusses the adverse impact of the Inflation Reduction Act on payers.
  • Fierce Healthcare relates,
    • “As obesity rates rise across the U.S., a new study from UnitedHealthcare and the Health Action Council examines the financial costs that this growing “epidemic” may cause for employers.
    • “The report (PDF) notes that 75% of adults in U.S. are either overweight or obese, up from 50% in 1990. Obesity rates grew fastest among younger adults, according to the report.”The HAC represents about 230 self-funded employers, and, among its members, about a quarter (26%) have been diagnosed with obesity. The obese population accounts for 46% of the employers’ medical spend, according to the report.
    • “Per member per month costs for obese employees were more than double on average compared to those who were not obese, the study found. Per member per month costs for those with obesity averaged $973, compared to $421 for non-obese workers.”
  • and
    • “As both regulatory and market forces are pushing the industry toward more transparency in healthcare pricing, MultiPlan sees opportunities to be a bigger player in data and tech for providers, payers and employers.
    • “The data analytics company, which has been in the market for 45 years, launched a rebrand at the ViVE 2025 digital health conference on Monday.
    • “Rebranded Claritev, the company is focused on developing new products and technologies that provide data insights to a broader swath of the healthcare market. Providing “actionable insights” to healthcare organizations will be a key part of the company’s growth, Travis Dalton, chairman, CEO and president, told Fierce Healthcare in an interview in the lead-up to the ViVE 2025 event.”
  • MedTech Dive informs us,
    • “Medtronic has bought nano surface technology from Nanovis for use in its next-generation spine fusion implants.
    • “Nanovis, which disclosed the deal Tuesday [February 11], has developed nanotechnology to improve the speed and consistency of bone growth. The company has its own portfolio of spine devices.
    • “Medtronic will use the technology to develop PEEK interbody spine fusion devices that enhance implant fixation. The technology could help bone grow and fuse with the implant.”
  • The Wall Street Journal reports,
    • “If you need a prescription filled in the coming years, don’t be surprised if it flies in and lands in your backyard. 
    • “Hospitals and doctors are increasingly experimenting with the use of drones to deliver medications, lab tests and supplies to patients being treated at home. Some are testing whether drones can be used to deliver organs for transplant more quickly and cheaply. And in some cities, a 911 call today could set off a drone carrying a defibrillator, Narcan spray or tourniquet to the scene of an emergency ahead of the arrival of paramedics.” * * *
    • “One of the challenges in this space five to 10 years ago was that there wasn’t a really clear regulatory framework. Over the last 18 months this has solidified, especially in the U.S. There is now a clear path to scale,” says Adam Woodworth, chief executive officer of Wing, the drone-service unit of Google’s parent Alphabet GOOGL.

Tuesday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

Capitol Hill news

  • Roll Call reports,
    • “House Republicans are plowing ahead with a budget resolution markup on Thursday before the chamber’s scheduled one-week recess begins the following day. 
    • “The blueprint wasn’t finalized yet and leadership also has some work to do in preparation for the floor, with key holdouts looking for assurances on things like spending cuts and raising the statutory debt ceiling. 
    • “But Speaker Mike Johnson, R-La., said after the GOP conference’s weekly meeting Tuesday that the “intention” was to mark up the blueprint in committee on Thursday after hammering out the details Tuesday. “We’ll be rolling out the details of that probably by tonight,” Johnson said. “We are right on the schedule that we need to be on.”
    • “The Budget panel has a 24-hour notice rule for posting text before bringing the resolution up for a committee vote.
    • “By the end of the day, we’ll be able to have the final pieces to put the budget resolution along with the reconciliation instructions in play, because we have to communicate that in some detail when we mark it up,” House Budget Chairman Jodey C. Arrington, R-Texas, said Tuesday after the conference meeting.”
  • The House Budget Committee has scheduled “a markup for the Concurrent Resolution on the Budget for Fiscal Year 2025 which will be held on February 13, 2025, at 10 am.

White House news

  • The Washington Post reports,
    • “President Donald Trump on Tuesday signed an executive order that calls on federal agencies to work with the U.S. DOGE Service in a bid to cut their existing workforce and limit future hiring. Ahead of the signing, Trump was joined in the Oval Office by Elon Musk, his billionaire ally who is overseeing DOGE, an agency that Trump has empowered to find government efficiencies.”
  • The Office of Personnel Management has updated its Fork in the Road website for the legal developments that occurred yesterday

Medical Coding news

  • The ICD10 Monitor alerts us that 50 new ICD 10 PCS codes will become effective on April 1. 2025.
  • Per a recent government bulletin,
    • The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (hereafter ASTP) Standards Bulletin 2025-1 (SB25-1) describes the development of the Draft United States Core Data for Interoperability Version 6 (Draft USCDI v6), which ASTP released on January 14, 2025. 
    • The USCDI sets the technical and policy foundation for the access, exchange, and use of electronic health information to support nationwide interoperable health information exchange and is a standard stewarded and adopted by ASTP on behalf of the U.S. Department of Health and Human Services (HHS). ASTP publishes new versions of USCDI annually, with a draft version released in January and a final version released in July to keep pace with clinical, technology, and policy changes that influence the use of clinical and related terminology. Draft USCDI v6 includes new data elements that seek to advance interoperability for patient care.
    • SB25-1 describes ASTP’s continued expansion of USCDI, following the same prioritization approach applied to USCDI Version 5. SB25-1 also reflects ASTP’s consideration of submissions for new data elements, comments on previously submitted data elements, and the evolving maturity of data elements through the USCDI+ Program.

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “COVID-19 vaccination averted more than 5,000 US in-hospital deaths, 13,000 intensive care unit (ICU) admissions, and 68,000 hospitalizations in 7 months in 2023-2024, researchers from the US Centers for Disease Control and Prevention (CDC) estimated late last week in Vaccine, although with considerable uncertainty.
    • “The investigators estimated COVID-related deaths, ICU admissions, and hospitalizations prevented by vaccination from October 1, 2023, to April 21, 2024, using a novel multiplier model that used causal inference, conditional probabilities of hospitalization, and correlations between data elements in simulations.
    • “The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has used estimates of the potential benefits and risks to inform vaccine policy decisions, and burden averted estimates can be used to evaluate vaccine policy,” the study authors wrote.”
  • STAT News lets us know,
    • “We’ve talked a lot about how hospitals have been recording a lot more patient visits throughout 2024. One major component of that: There’s been a lot more little bundles of joy lately.
    • “Analysts at investment bank Leerink Partners looked at birth data across four states (Arizona, Colorado, Florida, and North Carolina) and found births in December were up almost 4% year over year. 
    • “There’s an especially interesting trend in Florida: 53% of all births are covered by commercial health insurance (either from the parents’ workplace or the Affordable Care Act exchanges). 
    • “Usually, Medicaid covers the majority of births, but this reversal is “a reflection of redeterminations,” in which states kicked people off Medicaid if they no longer met eligibility requirements that were loosened during the pandemic, Leerink analysts wrote to investors.”
  • The Washington Post reports,
    • “California-based Tri-Union Seafoods has issued a voluntary recall of canned tuna sold at Trader Joe’s, Safeway, Harris Teeter, Walmart, Costco and other major grocery stores in dozens of states.
    • “The recall centers on concerns that a manufacturing defect in the cans may cause “a potentially fatal form of food poisoning,” the company said in a statement Friday.
    • “Tri-Union Seafoods said the defect, located on the cans’ pull-tab lid, may compromise the integrity of the product seal, especially over time, causing it to leak or become contaminated with the clostridium botulinum bacterium, which causes botulism.
    • “While Tri-Union Seafoods has said no illnesses linked to the recalled products have been reported, the company warned consumers not to use the product, “even if it does not look or smell spoiled.” The manufacturing company asked consumers to instead return the recalled tuna for a full refund, throw it away or contact Tri-Union directly for a retrieval kit and a coupon for a replacement product.” * * *
    • “Tri-Union Seafoods issued the recall notice Friday on all tuna products sold under the Genova, Van Camp’s, H-E-B and Trader Joe’s brand names.” * * *
    • “Tri-Union’s statement includes UPCs, can codes and best-by dates you can check to determine if your tuna is affected by the recall. Consumers can contact Tri-Union Seafoods at support@thaiunionhelp.zendesk.comor 833-374-0171 to request a replacement product.”
  • The Wall Street Journal lets us know,
    • “We all know cigarettes cause cancer. The memo on booze hasn’t reached everyone.
    • “Doctors say many people are surprised to learn alcohol raises the risk of certain cancers, such as liver, colorectal and breast cancer. And cancer patients say they aren’t always aware of the increased risk until after they have been diagnosed.
    • “As awareness increases—the former U.S. surgeon general recently called for adding warning labels on alcoholic beverages—more people are rethinking their drinking habits. On social-media sites like Reddit, cancer patients talk about replacing alcohol with cannabis, although this, too, has health issues. Others opt for mocktails or nothing at all.”
  • Per Beckers Hospital Review,
    • “A phase 3 trial found that a combination of a Pfizer and Astellas drug, enfortumab vedotin, and Merck’s drug, pembrolizumab, has significantly improved survival rates for patients with advanced bladder cancer. 
    • “The latest results from the trial, which focused on patients with untreated, locally advanced or metastatic urothelial cancer, showed that the combination therapy reduced the risk of death by 49% compared to traditional chemotherapy.” 
  • Healio tells us,
    • “Women prescribed a GLP-1 receptor agonist up to 2 years before conception were less likely to develop hypertensive disorders of pregnancy, gestational diabetes, have a preterm birth or cesarean delivery, researchers reported.
    • “Relatively little is known how preconception GLP-1 receptor agonist use may impact pregnancy outcomes,” Christopher T. Nau, MD, assistant professor in the department of reproductive biology at Case Western Reserve University School of Medicine and the division of maternal fetal medicine at University Hospitals Cleveland Medical Center, told Healio. “This study suggests that [GLP-1s] may have potential to be a powerful tool to optimize preconception health.”
    • “The findings were published in the American Journal of Obstetrics and Gynecology.”
  • MedPage Today notes,
    • “[A] Plasma p-tau217 [blood test] successfully identified Alzheimer’s pathology in several neurodegenerative syndromes.
    • “This included disorders not typically associated with Alzheimer’s disease, like frontotemporal dementia.
    • “Alzheimer’s pathology in syndromes related to frontotemporal lobar degeneration correlated with worse cognitive performance.”
  • Per an NIH news release,
    • “National Institutes of Health (NIH) scientists and their colleagues report that a single dose of a broadly neutralizing antibody (bnAb) administered prior to virus exposure protects macaques from severe H5N1 avian influenza. Highly pathogenic avian influenza (HPAI) H5N1 viruses have sporadically spilled over from birds into many other animals, including humans and dairy cows, in recent years. Although it has not yet acquired the capacity to spread readily between people, H5N1 has pandemic potential, which has spurred efforts to develop effective treatments and other countermeasures.
    • “The investigators studied a bnAb called MEDI8852, which was discovered and developed by Medimmune, now part of AstraZeneca. MEDI8852 targets a portion of a key flu protein that is less prone to change than other parts of the virus and thus is capable of conferring protection against a wide range of flu viruses. In the new study, a group of macaques received an injection of MEDI8852 and were exposed to aerosolized HPAI H5N1 virus three days later. All the pre-treated animals survived and experienced no or very limited signs of disease. In contrast, a group of control macaques developed severe or fatal illness within a short time after virus exposure.
    • “Of note, the scientists determined that MEDI8852 remained in the body for a prolonged time after the injection. According to scientists, protection from severe disease would extend to weeks beyond antibody infusion, providing a realistic preventative window in the face of an H5N1 outbreak.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana brought in profit of $1.2 billion in 2024, down more than half from $2.5 billion in 2023 due to significantly higher spending on its members’ care in Medicare and Medicaid, according to financial results released Tuesday.
    • “Still, Humana’s performance in the fourth quarter capping off the year was better than expected given ongoing cost pressures in the government programs, analysts said.
    • “Humana said it expects to lose 550,000 members in privatized Medicare Advantage plans this year — roughly one-tenth of its individual MA footprint — from cutting unprofitable plans to improve margins. The size of the membership loss is notably larger than Humana’s prior expectations.”
  • STAT News adds,
    • “The most important number in health insurance, at least to Wall Street and the companies themselves, is the medical loss ratio.” * * *
    • Here’s how fourth-quarter MLRs have looked for insurers so far, and how they compared to Wall Street’s consensus estimates: Molina Healthcare (90.2% actual vs. 88.7% consensus), Oscar Health (88.1% actual vs. 86.9% consensus), Cigna (87.9% actual vs. 84.7% consensus), UnitedHealth (87.6% actual vs. 86.5% consensus).
    • “Centene (89.6% actual vs. 90% consensus) and Elevance Health (92.4% actual vs. 92.6% consensus) each barely had lower fourth-quarter MLRs than expected.”
  • Per BioPharma Dive,
    • “Novartis is wagering more than $3 billion that a startup it helped launch six years ago has developed a better blood thinner than what’s now available.
    • “The Swiss drugmaker on Tuesday announced a deal to acquire Anthos Therapeutics, a Boston-based startup it formed with Blackstone Life Sciences in 2019. Novartis will pay $925 million upfront,and could pay up to $2.15 billion more should the drug at the center of the deal hit certain regulatory and sales milestones. The deal should close in the first half of 2025.
    • “Through the acquisition, Novartis will regain a blood-thinning drug, called abelacimab, that’s currently in late-stage testing. Novartis originally discovered the compound, but in 2019 licensed it to Anthos, a startup Blackstone Life Sciences launched with $250 million. That deal gave Novartis a minority stake in Anthos, which went on to advance the drug into Phase 3 testing.
  • Fierce Pharma notes,
    • “Some two years into Leqembi’s launch, Eisai continues to go all-in on its Alzheimer’s disease-fighting antibody, which the company believes could be finally nearing a “growth expansion phase” despite slow sales so far in the U.S.
    • “All told, Leqembi brought home around 13.3 billion Japanese yen ($87 million) in the third quarter of Eisai’s 2024 fiscal year, which will wrap up on March 31. In the U.S. specifically, Leqembi grew roughly 30% quarter-over-quarter to 7.7 billion yen (nearly $51 million), Eisai said in a recent earnings presentation (PDF).
    • “Cumulatively, the antibody has generated total sales of 29.6 billion yen (about $194 million) over the last nine months of 2024, putting Leqembi on track to reach a 12-month sales target of 42.5 billion yen ($279 million), Eisai’s chairman and CEO, Tatsuyuki Yasuno, said in an interview with Fierce Pharma.”
  • Per Beckers Hospital Review,
    • “Warner Robbins and Perry, Ga.-based Houston Healthcare’s bid to join Emory Healthcare was approved by both boards, according to a Feb. 10 news release.
    • “Both boards finalized the terms of a definitive agreement outlining the specific details and provisions of Houston Healthcare to integrate into Atlanta-based Emory. The two organizations have been working on an agreement since August 2024, when they signed a nonbinding letter of intent to combine.
    • “Emory and Houston Healthcare are now focused on finalizing the regulatory reviews and approvals before closing the transaction in the “coming months,” according to the statement.”