Midweek Update

NIH

Midweek Update

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

From Washington, DC,

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

From the judicial front,

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

In Food and Drug Administration news,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

David Ermer–CDC, COVID-19, FDA, NIH, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us,
    • “President Trump on Thursday issued a presidential memorandum aiming to expand the power of the Office of Personnel Management to fire federal employees, alarming experts and federal employee groups.
    • “The memo, quietly published Thursday night alongside an executive order mandating agencies share data, particularly with Elon Musk’s Department of Government Efficiency, delegates to OPM the authority to fire federal employees based on “post-appointment conduct.”
    • “A federal employee’s appointment occurs at the conclusion of their one-year probationary period, when their full civil service protections kick in. Prior to that point, the Office of Personnel Management has authority to determine whether a federal job applicant or new hire is “suitable” for federal employment, which generally refers to questions of their “character or conduct.”
    • “But once an employee’s probationary period has ended, the authority to discipline or remove an employee rests solely with agency that employs them. Indeed, even if an employee threatens national security, only his or her employing agency may take action to suspend or remove them.
    • “Trump’s memo expands who may remove employees for “conduct and character” reasons to include OPM and tasks the HR agency with writing the regulations governing the agency’s ostensibly new power. Agencies may make referrals to OPM for approval, or the OPM director may reach down and order individual agencies to discipline or fire workers.”
  • Fierce Healthcare informs us,
    • “Former Republican House Representative Michael Burgess, M.D., is a top choice for the White House’s second try at a Centers for Disease Control and Prevention (CDC) director nomination, according to a Reuters report citing three anonymous sources.
    • “One of the sources described Burgess to Reuters as the likely nominee but said that the decision is not yet final. The administration has not yet commented on its next choice for the role.
    • “Burgess, 74, practiced as an obstetrics and gynecology doctor before stepping into Capitol Hill in 2003. He chose not to seek reelection this past year.”
  • Healthcare Finance offers more details on the terrorist threat against hospitals.
    • On March 18, user @AXactual made a post on X with details related to the active planning of a coordinated, multi-city terrorist attack on United States health sector organizations, according to the joint threat bulletin.
    • The terrorist attack on hospitals would reportedly be by ISIS-K, a division of the jihadist group Islamic State, according to The HIPAA Journal. The post was added to the X account of American Kinetix, which claims to be a Christian company in the United States that consists of JSOC (Joint Special OperationsCommand), the CIA and combat veterans, The HIPAA Journal said.
    • American Kinetix said it had received reports of possible pre-attack surveillance at hospitals.” * * *
    • “The primary targets would be mid-tier cities with low-security facilities, the joint threat bulletin said. With the information claiming multiple simultaneous targets, attackers would likely select health sector facilities with visibly weak security and conduct prior planning coordination.” 
  • The American Hospital Association (AHA) News lets us know,
    • “The Drug Enforcement Administration and Department of Health and Human Services yesterday announced that the effective date for the final rule regarding telemedicine prescribing of buprenorphine will be further delayed from March 21 to Dec. 31. The original effective date was Feb. 18 before the first delay to March 21. As outlined in the Jan. 20 White House memorandum announcing the regulatory freeze, the agencies decided to delay the implementation of rules to review any questions of fact, law and policy.
    • “The waiver provisions outlined in the third extension of telemedicine flexibilities for prescribing controlled substances will remain in effect to waive in-person visit requirements through Dec. 31.
    • “Once implemented, the final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation.”
  • STAT News points out,
    • “The Food and Drug Administration cleared Alnylam Pharmaceuticals’ treatment for a progressive heart condition Thursday, setting it up to compete with therapies from BridgeBio and Pfizer.
    • “Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular-related death and hospitalizations. This indication was widely expected among investors and is similar to the indications given for competing therapies.
    • “The treatment, which will be sold under the brand name Amvuttra, was additionally approved to reduce urgent heart failure visits.”
  • BioPharma Dive adds,
    • “Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available for the condition, company executives said Thursday.
    • “The price of the drug, Amvuttra, was revealed on a Thursday evening conference call discussing the Food and Drug Administration’s decision to clear the treatment in people with transthyretin amyloidosis, or ATTR, cardiomyopathy. Alnylam already markets the medicine for people with a form of the condition that affects the nerves but has long looked to an approval in cardiomyopathy as the kind of revenue driver that can help it turn a consistent profit.
    • Alnylam will begin selling Amvuttra as two other treatments, Pfizer’s tafamidis and BridgeBio Pharma’s Attruby, are already accessible. Both tafamidis and Attruby are taken orally, while Amvuttra is injected. Although none of the drugs have been tested directly against another and cross-trial comparisons come with caveats, Amvuttra’s benefits also don’t appear to be clearly superior to its rivals.

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 five 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 five 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 CIDRAP reports,
    • “The Texas Department of State Health Services (TDSHS) today reported 30 more cases in a measles outbreak in the western part of the state near the New Mexico border, as the New Mexico Department of health added 4 new cases to its total, pushing the outbreak total to 351.
    • “Meanwhile, as global cases surge, a handful of states reported new cases in people who had connections to international travel. In a weekly update today, the Centers for Disease Control and Prevention (CDC) said it has received reports of 378 cases this year, well past the 285 cases reported for all of 2024. 
    • “The cases are from 18 jurisdictions, and 90% are linked to three outbreaks. The CDC’s update includes the first cases of the year from Kansas, Ohio, and Michigan. Kansas last week reported its first measles infection since 2018, and media reports say at least six cases have been reported in the southwest part of the state in Grant and Stevens counties.”
  • The AP relates,
    • “A common blood test may miss ovarian cancer in some Black and Native American patients, delaying their treatment, a new study finds. It’s the latest example of medical tests that contribute to health care disparities.
    • “Researchers have been working to uncover these kinds of biases in medicine. Recently, the Trump administration’s crackdown on diversity, equity and inclusion has jeopardized such research as universities react to political pressure and federal agencies comb through grants looking for projects that violate the president’s orders.
    • “Native American women have the highest rate of ovarian cancer. Black women with ovarian cancer have lower rates of survival compared to white women. Finding ovarian cancer early can lead to better chances of survival.
    • ‘The new study, supported by grants from the National Cancer Institute and published Thursday in JAMA Network Open, looked at a test called CA-125. The test measures a tumor marker in the blood, and doctors use it to determine if a woman with a suspicious lump should be referred to a cancer specialist.” 
  • Per a National Cancer Institute news release,
    • “When people who smoke are screened for lung cancer, studies have suggested that the screening visit can be an opportune time for health care providers to offer them ways to stop smoking.
    • “Results from a large clinical trial now show that a comprehensive program that integrates intensive counseling and cessation medications may be a particularly effective way of accomplishing that goal.
    • “The study included more than 600 adults who were current smokers. By the end of the 3-month treatment period, nearly 40% of those randomly assigned to participate in an intensive cessation program had quit smoking and had not started up again. In contrast, about 25% of those referred to a tobacco use quitline hit that same benchmark.
    • “The results were published March 1 in JAMA Internal Medicine. 
    • “According to the study’s lead investigator, Paul Cinciripini, Ph.D., of the University of Texas MD Anderson Cancer Center, the findings confirm that when people who smoke are being screened for lung cancer, it “presents a critical opportunity” to support them in quitting. The type of support, however, appears to be particularly important, Dr. Cinciripini said.
    • “Another important takeaway is “the importance of having [dedicated cessation specialists] be a part of [cessation] treatment,” said Carolyn Reyes-Guzman, Ph.D., of NCI’s Tobacco Control Research Branch, which funded the study.” 
  • Per Healio,
    • “Risk for moderate to severe depressive symptoms during pregnancy varied widely across 20 different racial and ethnic groups, suggesting women from different cultural backgrounds view and report depression symptoms differently, data show.
    • “Our study found differences among racial and ethnic subgroups in several aspects of prenatal depression, including the likelihood of receiving a diagnosis and reporting symptoms when screened in prenatal care,” Kendria Kelly-Taylor, PhD, a research fellow with Kaiser Permanente Northern California Division of Research, told Healio. “We found most of the [racial] groups were less likely to have a diagnosis of prenatal care and more likely to report moderate-to-severe depressive symptoms when screened. Previous research provides some possible reasons for these findings, which include differences in how patients in various racial and ethnic subgroups experience symptoms, view their symptoms, and their comfort in discussing them with a clinician or having a diagnosis in their medical record.”
  • HealthDay reports,
    • “The total injury death rate in the United States increased from 2013 through 2021, then declined through 2023, according to a March data brief published by the National Center for Health Statistics.
    • “Sally C. Curtin, from the National Center for Health Statistics in Hyattsville, Maryland, presents trends in injury death rates overall and by three leading intents (unintentional, suicide, and homicide) for 2003 to 2023.
    • “Curtin found that the total age-adjusted injury death rate increased 21 percent from 2013 to 2019 (58.8 to 71.2 per 100,000 standard U.S. population) after a period of stability from 2003 to 2013; there was an additional 25 percent increase through 2021 (89.0), followed by a 4 percent decline through 2023 (85.3). From 2003 to 2019, there was a threefold increase in unintentional drug overdose death rates, followed by a 58 percent increase through 2022 and a 4 percent decline through 2023. From 2006 to 2018, there was an increase in firearm-involved suicide death rates, followed by a decline in 2019 and an increase through 2021; rates remained stable through 2023. The firearm-involved homicide death rate declined from 2003 to 2014, then increased through 2021, and declined through 2023.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Johnson & Johnson JNJ said it is increasing U.S investments to more than $55 billion over the next four years, boosting spending on manufacturing, R&D and technology in a move it says will create jobs and help speed up drug discovery and development.
    • “The healthcare conglomerate said Friday that the investment represents a 25% increase from the previous four-year period.
    • “Part of that will go toward four new manufacturing facilities in the U.S., and the expansion of existing sites, J&J said, adding that it is kick-starting the investment by breaking ground on a North Carolina biologics manufacturing facility on Friday.”
  • Beckers Hospital Review notes,
    • “East Ohio Regional Hospital, a 140-bed healthcare facility in Martins Ferry, has closed, local media outlets reported. 
    • “Signs posted at EORH entrances March 20 said “Hospital closed! Please go to the nearest hospital Trinity, Reynolds or Wheeling!” according to the outlets, including The Intelligencer and NBC and Fox affiliate WTOV.
    • “The closing is the latest chapter for the struggling hospital and comes as workers reported having not received their most recent paychecks. Employees were not paid as scheduled March 7 and said they remained unpaid as of March 20, according to The Intelligencer.”
  • Per Beckers Payer Issues,
    • The healthcare industry needs to have more conversations about patient experience, AI and preventive care, according to payer executives. 
    • Becker’s connected with 25 leaders to learn more about what they say is underdiscussed in healthcare. 
    • The leaders’ observations can be found in the article.

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.”

Thursday Report

David Ermer–CDC, Congress, FDA, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Democrats took the threat of a government shutdown off the table, following a grueling intraparty fight in which lawmakers struggled with how best to resist President Trump’s fast-paced efforts to slim down federal agencies.
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) said he would vote to advance a Republican measure, set for Friday morning, to fund the government through September. Earlier, in a closed-door lunch, he also said that enough Democrats would join him to help the Republicans clear the chamber’s critical 60-vote hurdle, people familiar with the matter said.
    • “I will vote to keep the government open and not shut it down,” Schumer said on the Senate floor, characterizing Democrats’ alternatives as a Hobson’s choice with no good option. He said that in a shutdown, Trump could decide “to cherry pick which parts of the government to reopen in a protracted shutdown.”
  • The American Hospital Association News tells us,
    • “The White House March 13 withdrew the nomination of former Republican congressman Dave Weldon for director of the Centers for Disease Control and Prevention.
    • “Meanwhile, the Senate Committee on Health, Education, Labor and Pensions advanced the nominations of Jay Bhattacharya for director of the National Institutes of Health and Marty Makary for commissioner of the Food and Drug Administration. Both nominees will next be considered by a full Senate vote.”
  • Federal News Network informs us,
    • “The Postal Service is letting a team from the Department of Government Efficiency take a closer look at its reform plans.
    • “Postmaster General Louis DeJoy, in a letter sent to congressional leaders Thursday, said he signed an agreement last night with DOGE representatives and the General Services Administration to “assist us in identifying and achieving further efficiencies.”
    • “DeJoy told lawmakers that USPS is heading in the right direction under his 10-year Deliverying for America reform plan and that DOGE’s work is “aligned with our efforts.”
    • “While we have accomplished a great deal, there is much more to be done. We are happy to have others to assist us in our worthwhile cause,” DeJoy wrote.”

From the judicial front,

  • The Wall Street Journal relates,
    • “A federal judge has ordered six federal agencies to reinstate thousands of probationary employees who were fired last month, dealing a blow to the Trump administration’s efforts to rapidly scale back the size of the federal workforce.
    • “The Trump administration has encountered a number of legal challenges in its push to slash the government’s size and spending, including a lawsuit from a coalition of 20 states over plans to eliminate nearly half of the staff of the Education Department.
    • “The Education Department, with around 4,500 employees as of last year, is the smallest cabinet-level agency. Polls show most Americans oppose eliminating the department.”
  • FEHBlog note — The Justice Department has noticed an appeal of the reinstatement order to the U.S. Court of Appeals for the Ninth Circuit.
  • Bloomberg Law adds,
    • “A US judge in Maryland directed 18 agencies to temporarily rehire thousands of terminated employees, dealing another judicial defeat to Trump administration efforts to shrink the federal sector.
    • “The government gave no advance notice before firing newer workers, known as probationary employees, and conducted no individual assessments to justify their discharge based on performance, Judge James Bredar of the US District Court for the District of Maryland said Thursday in granting a temporary restraining order. 
    • “Bredar, an Obama appointee, found the terminations were unlawful workforce reductions that negatively impacted 19 states and the District of Columbia, which sued to challenge the firings.
    • “The ruling will apply for 14 days to workers at agencies including the Labor, Health and Human Services, Education, and Energy departments; the Environmental Protection Agency; the Consumer Financial Protection Bureau; and the US Agency for International Development. 
    • “It comes after a separate federal judge in California ordered six federal agencies to rehire probationary employees they fired since Feb. 13. Both decisions add to mounting setbacks for President Donald Trump and billionaire Elon Musk, who have attempted to cull the federal workforce in the name of efficiency.”

From the public health and medical research front,

  • Cardiovascular Business points out,
    • “U.S. patients are significantly less likely to die from heart failure-related cardiac arrest now than they were 25 years ago, according to new data published in the American Journal of Cardiology. However, the authors noted, certain disparities still exist, suggesting cardiologists and other healthcare providers have much more work to do. 
    • “Heart failure currently affects over 64 million adults worldwide, with about 6 million impacted in the United States, a number expected to rise to 8 million by 2030, wrote corresponding author Sivaram Neppala, MD, an assistant professor with the cardiology division at The University of Texas Health Sciences Center, and colleagues. “Patients diagnosed with heart failure face a significantly higher risk of cardiac arrest, contributing to 30-50% of mortality cases within this population. Those with systolic dysfunction are six to nine times more likely to experience sudden cardiac death. Cardiac arrest and heart failure can lead to irregular heart rhythms and myocardial fibrosis, increasing the risk of ventricular arrhythmias and highlighting the need for urgent care.”
    • “Neppala et al. explored U.S. Centers for Disease Control and Prevention data from 1999 to 2023, tracking changes in the overall age-adjusted mortality rate (AAMR) for cardiac arrest in patients with heart failure. All patients included in their analysis were 25 years old or older.
    • “Overall, the researchers found that the AAMR for heart failure-related cardiac arrest dropped from 25.3 per 100,000 adults in 1999 to 20.6 in 2023. The reduction was the most pronounced from 1999 to 2011, with an annual percentage change of -2.95%, but then remained largely unchanged from 2011 to 2018. The overall AAMR then increased from 2018 to 2021—a time when the COVID-19 pandemic was at its most severe—before dropping yet again from 2021 to 2023. 
    • “The subsequent decline from 2021 to 2023 (APC: -4.05%) indicates recovery and improved access to healthcare, highlighting the pandemic’s effects on cardiovascular outcomes and the necessity for resilient healthcare systems,” the authors wrote.”
  • STAT News discusses the importance of improving the availability of HIV self-testing.
    • “In May 2024, the Massachusetts Department of Public Health released a troubling report on a cluster of HIV infections, with more than 200 new cases since 2018 attributable to injection drug use in the Boston region. These findings have national implications: Similar HIV outbreaks have been described nationwide during the overdose crisis, including in West Virginia, Indiana, and Ohio. The increase in HIV cases amid the U.S. drug overdose crisis underscores the urgent need for a comprehensive response tailored to the unique challenges faced by people who use drugs. The importance of such efforts cannot be understated. In fact, in Massachusetts, 14% of new HIV diagnoses every year are attributed to injection drug use — nearly twice the national average.
    • “One potential solution is HIV self-testing, which would allow for rapid identification and treatment. Identifying HIV cases is the first step in addressing clusters, and quickly learning one’s status allows people to rapidly seek both treatment and prevention. Unlike traditional laboratory-based testing, which may take several days for results delivery, HIV self-testing relies on saliva and provides results in 20 minutes. The test is easily performed outside of a clinical setting by swabbing gums and collecting a sample of saliva. HIV self-testing has been available since 2012 and is recommended by the Centers for Disease Control and Prevention for accurate HIV diagnosis. It’s even part of the Department of Health and Human Services’ plan for Ending the HIV Epidemic (EHE) by 2030.
    • “But HIV self-testing remains underutilized among not only the general public, but especially people who use drugs. As the nation emerges from the Covid-19 pandemic, during which self-testing for infectious diseases became commonplace, increasing HIV self-testing among people who use drugs may limit the spread of a virus that, while manageable with medication, can lead to significant health risks if left untreated.”
  • MedPage Today lets us know,
    • “Better midlife diet was tied to better brain connectivity and white matter integrity later in life.
    • “Lower waist-to-hip ratio was associated with better memory and executive function at 70.
    • “Diet improvements over time were linked with better white matter integrity in several brain regions.”
  • The National Cancer Institute aggregated its latest research news while the National Institute of Diabetes and Digestive and Kidney Diseases reflects on its 75th anniversary.
  • Per Beckers Hospital Review,
    • “A recently approved drug for acute ischemic stroke works as well as the treatment used in most U.S. hospitals and may offer advantages for some patients, according to a study led by a researcher from Dallas-based UT Southwestern Medical Center. 
    • “The study, published March 12 in JAMA Network Open, compared the newly approved tenecteplase in a single quick injection to alteplase, the stroke treatment that has been used for decades and requires an hourlong infusion. “

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna is revamping its C-suite and consolidating oversight of its two main businesses — insurance and health services operations — under one executive, the company announced Thursday.
    • “Brian Evanko, currently chief financial officer and the head of Cigna’s health insurance division Cigna Healthcare, will serve as Cigna’s chief operating officer, managing both Cigna Healthcare and health services division Evernorth. Ann Dennison, who was deputy CFO under Evanko, will step up as enterprise CFO. The changes are effective at the end of this month.
    • “Meanwhile, Eric Palmer, the current CEO of Evernorth, is departing the company at the end of April, an apparent victim of the restructuring. A spokesperson for Cigna did not respond to a request for comment on the reason behind Palmer’s departure.”
  • Modern Healthcare notes,
    • “Highmark Health’s insurance business challenges weighed on the organization’s overall financial performance in 2024, the company reported Thursday.
    • “The nonprofit Blue Cross Blue Shield licensee saw its net income plummet 90.6% to $50 million while revenue rose nearly 9% to $29.4 billion. The company also reported operating losses of $209 million, compared with an operating gain of $338 million in 2023.
    • “Our entire industry faces strong financial headwinds. That underscores the need for a more economically sustainable approach that delivers better health experiences and outcomes,” Highmark Health President and CEO David Holmberg said on a telephone briefing announcing the financial results.”
  • Per BioPharma Dive,
    • “Mallinckrodt and Endo Pharmaceuticals, which have struggled through bankruptcies related to opioid litigation, said Thursday that they will merge in a cash and stock transaction that will leave a combined company valued at $6.7 billion.
    • “Shareholders of Mallinckrodt will end up with 50.1% of the combined company and current Mallinckrodt CEO Siggi Olafsson will take the top job at the new entity as well. Per deal terms, Endo shareholders will receive Mallinckrodt stock and a share of $80 million in cash.
    • “After the merger, a business made up of Endo’s sterile injectables and both companies’ generic pharmaceuticals will be separated out. The companies haven’t yet decided what that separation will look like, Olafsson told analysts and investors on a conference call. The board will “make the best decision going forward” after the combination of the businesses, he said.”
  • Per MedTech Dive,
    • “Vivani Medical said Wednesday it plans to spin off its neurostimulation business to form an independent, publicly traded company. 
    • “Formerly Second Sight Medical Products, the independent company will trade as Cortigent and advance brain implants to help people recover body functions such as vision and movement.
    • “Vivani, which is focused on GLP-1 implants, acquired the neurostimulation technology through a merger in 2022 and first filed paperwork to list Cortigent as an independent company in 2023.”

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, CMS, Congress, HSA, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC

  • On Saturday, the House Appropriations Committee unveiled “The Full-Year Continuing Appropriations and Extensions Act, 2025.”
  • The Wall Street Journal adds,
    • “House lawmakers are expected to vote on the proposal, termed a continuing resolution or CR, as soon as Tuesday, with a majority needed to pass it. But even if House Republicans manage to stay united and pass the proposal over Democratic opposition, it will need at least 60 votes in the Senate, which has only 53 Republican lawmakers. 
    • “Funding for federal agencies runs out on Friday night. With no new legislation, many federal employees would be furloughed, while others would continue to report to work with no pay.” 
  • The Senate will be voting to confirm the President’s nominee for Secretary of Labor Lori Chavez-DeRemer Monday afternoon.
  • Committee meetings of note:
    • Committee: House Oversight and Government Reform
      Subcommittee: House Oversight and Government Reform Subcommittee on Government Operations
      Subject: “Shifting Gears: Moving from Recovery to Prevention of Improper Payments and Fraud”
      Date: 03/11/2025 (10:00 AM Local Time)(Add to My Calendar)
      Location: 2247 Rayburn House Office Building, Washington, D.C.
    • Committee: Senate Health, Education, Labor, and Pensions. Subject: Business meeting to consider the nominations of Jayanta Bhattacharya, of California, to be Director of the National Institutes of Health, and Martin Makary, of Virginia, to be Commissioner of Food and Drugs, both of the Department of Health and Human Services, and other pending calendar business
      Related Items: PN12-2, PN12-28
      Date: 03/13/2025 (9:30 AM Local Time)   (Add to My Calendar)
      Location: 562 Dirksen Senate Office Building, Washington, D.C.
    • Committee Senate Finance Committee Subject: Hearing to consider the nomination of Dr. Mehmet Oz to be CMS Administrator
      Witness: Dr. Mehmet Oz 
      Date: Friday, March 14, 2025, 10:00 AM Local Time)
      Location: 215 Dirksen Senate Office Building, Washington, DC
  • The AP explains “How a health savings account fits into your retirement strategy.”

From the public health front,

  • The Wall Street Journal explores how “One Couple in Their 90s Confronts a Stark Reality: Aging at Different Speeds; Lifelong partners grapple with how and whether to stay together when one can’t care for the other.”
  • The New York Times points out six sources of protein that are not meat and answers questions about fentanyl.
  • Beckers Hospital Review notes,
    • Researchers from the University of Texas Health Science Center at San Antonio have developed a drug that more than doubled median survival time and progression-free time for patients with glioblastoma during a clinical trial.
    • Patients who received the drug Rhenium Obisbemeda, or 186RNL, also experienced no dose-limiting toxic effects, according to a March 7 news release from UT Health San Antonio.
    • Glioblastoma is the most common form of brain tumor, with more than 90% of patients experiencing recurrence. If standard treatment fails, the median survival time is about eight months, the release said. \
    • “Glioblastoma has needed durable treatments that can directly target the tumor while sparing healthy tissue,” Andrew Brenner, MD, PhD, professor and chair of neuro-oncology research with Mays Cancer Center at UT Health San Antonio, said in the release. “This trial provides hope, with a second phase under way and planned for completion by the end of this year.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Higher volumes, more favorable reimbursement rates and more efficient labor spending helped Providence cut its 2024 operating losses nearly in half.
    • “On Thursday the nonprofit system reported a $644 million operating loss (-2.1% operating loss) across 2024, a stark improvement over the $1.17 billion operating loss (-4.1% operating margin) of the year prior. The 2024 tally includes $183 million in reconstruction costs “related to asset rationalization, employee reductions and other items,” according to its filing.
    • “Operating revenues across the system grew 7% year over year to $30.7 billion (5% when excluding a $426 million net gain in the first quarter), with management noting in its filing that the growth was spread across all of its operating categories.”
  • and
    • “Earlier this week, Eli Lilly partnered up with telehealth providers LifeMD and Teladoc Health to offer its lower cost, single-vial Zepbound (tirzepatide) to patients in the virtual care companies’ full-service weight loss management programs.
    • “The companies are directly contracting with Eli Lilly’s self-pay pharmacy, GiftHealth. The move could be a boon for telehealth weight loss programs, which have proved lucrative for virtual primary care companies. Many of the chronic condition management programs, including for weight loss, also offer remote monitoring, access to dietitians and health coaches, as well as the ability to be prescribed medication for weight loss, including older medications.
    • “The announcement follows Eli Lilly’s partnership with telehealth platform Ro three months ago. The pharmaceutical company launched its own direct-to-consumer telehealth offering for weight loss in January 2024. Now, it seems to be creating a marketplace of access.”
  • Beckers Payer Issues ranks Medicare insurers by the quality of their mobile applications.

Friday Report

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

From Washington, DC

  • Govexec tells us,
    • “Lawmakers are pursuing two different paths to keep the government funded past March 14, though the Republican majority in both chambers is hoping to pass a measure to keep agencies funded at their current levels through September. 
    • “The year-long continuing resolution would allow for only a small number of changes to existing spending levels, which are currently at the same total that agencies received in fiscal 2024. Democratic appropriators are hoping to instead buy more time with a short-term stopgap bill that would allow negotiators to come to a bipartisan agreement on full-year fiscal 2025 funding measures.
    • “House Speaker Mike Johnson, R-La., has said he will release the text of a continuing resolution to cover the remainder of fiscal 2025 in the coming days and put it to a vote on the House floor early next week. Johnson will face a narrow margin to pass the measure, particularly as the most conservative members of his caucus rarely vote for CRs of any duration. House Democrats have indicated they will not support the measure. 
    • “President Trump is pushing for the year-long stopgap option and the White House has lobbied Republicans to support that bill. 
    • “Despite Johnson’s plans, top appropriators from both parties in the House and Senate have continued to meet and are closing in on a deal to set the top-line funding levels for regular appropriations bills, according to a source familiar with the talks. They are hoping to finalize that agreement in the coming days to demonstrate that a full-year CR is not the only viable option to avert a shutdown.”
  • Medical Economics lets us know,
    • “The Medicare Payment Advisory Commission (MedPAC) is inching closer to a recommendation on revising how doctors get paid through the Medicare Physician Fee Schedule.
    • “On March 6, MedPAC opened its latest two-day meeting with almost 90 minutes of discussion of the best ways to balance beneficiary access and costs, physician pay, taxpayer resources, and overall costs to the U.S. Department of Health and Human Services (HHS).
    • “While the members had suggestions about the nuances of physician pay and the language to describe it, there was general agreement on two draft recommendations to Congress:
      • Congress should replace the current law updates to the physician fee schedule with an annual update based on a portion of the growth in the Medicare Economic Index (MEI). An example could be: MEI minus 1 percentage point.
      • Congress should direct the HHS secretary to improve the accuracy of relative payment rates for clinician services by updated costs data regularly, and ensuring the methodology used to determine payment rates for different services reflects the settings in which clinicians practice medicine.
    • “Depending on commissioner feedback, MedPAC could vote on the recommendations in April to be included in its June 2025 report to Congress.”
  • Per MedTech Dive,
    • “The Federal Trade Commission has challenged a private equity firm’s attempt to buy Surmodics for approximately $627 million, the regulator said Thursday.
    • “Surmodics provides outsourced hydrophilic coatings for devices. GTCR, the private equity group that is attempting to buy Surmodics, owns a majority stake in another coating company, Biocoat.
    • “The FTC said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate significant head-to-head competition between Biocoat and Surmodics.”

From the judicial front,

  • The Hill informs us,
    • “A federal judge has effectively ended the ability of compounding pharmacies to make their own copies of Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro. 
    • “In a sealed decision filed late Wednesday, Judge Mark Pittman of the Northern District of Texas declined to issue an injunction to stop the Food and Drug Administration (FDA) from declaring there was no longer a shortage of the medicines’ active ingredient, tirzepatide.” * * *
    • “Eli Lilly in a statement said the decision “marks the end of the road for mass compounding of risky, unapproved knockoffs that threaten the health and safety of Americans.” 
    • “Any company that continues mass compounding tirzepatide “is breaking the law, and we will work with regulators and law enforcement to stop it,” a company spokesperson said.  
    • “A similar OFA lawsuit against the FDA for removing from the shortage list semaglutide, the active ingredient in Ozempic, is pending.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for three 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 are moderate, 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 three 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 Washington Post reports,
    • “An unvaccinated New Mexico adult who tested positive for measles has died, the second death in a growing outbreak centered along the Texas-New Mexico border, officials said Thursday.
    • “The individual did not seek medical care before death, New Mexico health department officials said. The official cause of death is under investigation by New Mexico’s Office of the Medical Investigator. However, the state health department scientific laboratory has confirmed the presence of the measles virus in the person, the state health department said.
    • “The person was a resident of Lea County, where at least 10 cases of measles have been reported. Lea County is just over the border from Gaines County, Texas, where the outbreak is centered.
    • “Six of the Lea County cases are among adults, and four are in children. Seven of the 10 were unvaccinated, and three have unknown vaccination histories.”
  • The American Hospital Association News relates,
    • “Cigarette smoking by adults has dropped to its lowest level in 60 years, the Centers for Disease Control and Prevention reported today. Despite that, tobacco is the leading cause of preventable death in the U.S., the agency said. 
    • “From 2017-2023, an approximate 6.8 million decrease in adults who exclusively smoke cigarettes was offset by a 7.2 million increase in adults who exclusively smoke e-cigarettes. Cigarette smoking overall by U.S. adults decreased from 42.4% in 1965 to 11.6% in 2022.”
  • Per Aunt Minnie,
    • “Breast and colorectal cancer screening in 2023 rebounded from declines during the COVID-19 pandemic and surpassed pre-pandemic screening estimates, according to findings published March 5 in JAMA.
    • “Yet researchers led by Jessica Star from the American Cancer Society in Atlanta, GA, also found that cervical cancer screening numbers are still below pre-pandemic estimates, and that improvements in cancer screening rates were mostly seen in individuals with higher socioeconomic status.
    • “Improving patient communication around cancer screening and providing patient navigators to assist with the structural and cost barriers to screening are two ways health systems can help with successful screening rebounds,” Star told AuntMinnie.com.”
  • Medscape assesses Alzheimer’s Disease diagnosis and care.
  • The National Cancer Institute lets us know,
    • “How doctors treat a form of liver cancer called intermediate-stage hepatocellular carcinoma (HCC) is likely to change, based on updated findings from two large clinical trials. Both trials tested a procedure called TACE in combination with immunotherapy drugs and treatments called angiogenesis inhibitors. TACE, or transarterial chemoembolization, involves using a catheter to deliver chemotherapy directly to the liver.”
  • Per Healio,
    • “After rising over a 35-year period, thyroid cancer incidence in the U.S. plateaued from 2010 to 2019, according to findings published in The Lancet Diabetes & Endocrinology.
    • “In a retrospective analysis of data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) and National Center for Health Statistics databases, researchers found no changes in metastasis or mortality rates for adults diagnosed with thyroid cancer from 1975 to 2019, despite a rising incidence rate during that time. These findings reveal thyroid cancer may have been over-diagnosed in more recent years, according to Zachary Zumsteg, MD, associate professor of radiation oncology and biomedical sciences, and radiation oncology director of the head and neck oncology disease research group at Cedars-Sinai. However, Zumsteg noted the plateau of thyroid cancer incidence in the past 10 years of the study may be indicative of a change in diagnostic practices.”
  • Per BioPharma Dive,
    • Johnson & Johnson is terminating some research for an experimental drug that the company previously predicted could be a multibillion-dollar product.
    • In a statement released Thursday afternoon, J&J said it will stop developing the drug, called aticaprant, as an add-on therapy for patients with major depressive disorder. Over the past few years, a series of large, late-stage clinical trials tested aticaprant in adults who have hard-to-treat MDD and moderate-to-severe cases of a defining symptom of the disorder, anhedonia, which presents as a loss of interest or an inability to experience joy.
    • “While the drug continues to look safe and well-tolerated, the program has shown “insufficient efficacy in the target patient population,” according to J&J. Aticaprant may still have potential, however, so the company plans to “explore future development opportunities” in other “areas of high unmet need.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Not much has gone right for Walgreens Boots Alliance in the past decade. 
    • “Customers bought more and more household items online at sites such as Amazon.com, instead of Walgreens’s more than 8,000 stores across the U.S. The pharmacy chain inked deals with other drug suppliers and doctors’ offices, but stood pat while rivals, including CVS and Express Scripts, merged with big health insurers, gaining control of the medical-reimbursement purse strings that were squeezing pharmacies.
    • “Walgreens cash flow sagged, its debt piled up and shares sank. And on Thursday, Walgreens was sold to private-equity firm Sycamore for $10 billion, down a staggering 91% from its $106 billion peak in 2015.
    • “The storied pharmacy chain—which became a ubiquitous seller of everything from diabetes injections to nail files as retailers consolidated across the U.S.—fell after it neglected to keep up with customer preference to buy online and failed to navigate the fierce competition and intense cost pressures of healthcare.
    • “It could shrink more after its sale. Sycamore, a New York-based firm that specializes in retail and consumer investments and, more recently, is better known for smaller deals, is expected to sell off pieces of the business or work with partners to turn it around, The Wall Street Journal reported.
    • “Globally, the transaction ranks as one of the largest leveraged buyouts in the past decade.”
  • The Journal also tells us about “The Walgreens Billionaire Watching His Empire Come Apart
  • From Monaco, Stefano Pessina built a retailer valued at about $100 billion. It agreed to be taken private this week for roughly $10 billion.”
  • BioPharma Dive points out,
    • “Optum Rx, a pharmacy benefit manager owned by one of the country’s largest insurance companies, UnitedHealth Group, has added a new, much-anticipated pain drug to some of its commercial formularies.
    • “Sold as Journavx, the drug received U.S. approval in late January as a treatment for the short-lived “acute” pain typically felt after an operation or accident. Journavx works differently than other available medications, and its developer, the biotechnology juggernaut Vertex Pharmaceuticals, has positioned it as an important, non-opioid option for pain management.”
  • Beckers Hospital Review lists 18 health systems with strong finances.

Wednesday Report

David Ermer–Congress, COVID-19 vaccine, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The New York Times lets us know,
    • “Dr. Jay Bhattacharya, Donald J. Trump’s nominee to lead the National Institutes of Health, told senators at his confirmation hearing on Wednesday that studies had not shown a link between vaccines and autism, even as he urged more research on the question.” * * *
    • “Dr. Bhattacharya [,a Stanford University health economist,] burst into the news at the height of the pandemic in October 2020, when he co-wrote an anti-lockdown treatise, the Great Barrington Declaration, that argued for “focused protection” — a strategy that would focus on protecting the elderly and vulnerable while letting the virus spread among younger, healthier people.
    • ‘The nation’s medical leadership, including Dr. Francis S. Collins and Dr. Anthony S. Fauci, then director of the National Institute of Allergy and Infectious Diseases, denounced the plan. Referring to Dr. Bhattacharya and his co-authors as “fringe epidemiologists,” Dr. Collins wrote in an email that “there needs to be a quick and devastating takedown of its premises.”
    • ‘Dr. Collins, who later stepped down as the N.I.H. director to pursue his laboratory research, retired last week in anticipation of Dr. Bhattacharya’s arrival. At Wednesday’s hearing, Senator Pete Ricketts, Republican of Nebraska, introduced Dr. Bhattacharya by praising him for having “great intellectual honesty and courage” to offer an alternative approach to handling the pandemic.”
  • The Wall Street Journal reports
    • “Rep. Sylvester Turner, a Texas Democrat who was just sworn into the House in January, died on Tuesday night.” * * *
    • “Turner’s sudden death will also have an immediate consequence in the political body in which he had served: House Republicans now have slightly more cushion as Democrats await a special election to fill the seat. With his death, the majority now stands at 218-214.
    • “The House GOP majority math is so slim that the confirmation of Rep. Elise Stefanik (R., N.Y.) to serve as U.S. Ambassador to the United Nations has been held up as Republicans wait to fill the seats of former Reps. Matt Gaetz (R., Fla.) and Mike Waltz (R., Fla.). The special elections for both Florida seats are set to take place on April 1. Stefanik has continued to serve in the House for now.” * * *
    • “It wasn’t immediately clear when Texas Gov. Greg Abbott will call a special election for Turner’s seat.” 
  • MedTech Dive informs us,
    • “Philips stopped selling an implant used to repair damaged arteries after reports of 20 injuries and some devices needing to be removed.
    • “The Food and Drug Administration said in a Monday recall notice that all customers should stop using Philips’ Tack Endovascular System immediately. The agency classified the recall as Class I, the highest risk category.
    • “Philips is not aware of serious harm or death accompanying the use of the device, a company spokesperson wrote in an email. The FDA said no deaths were reported.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Justice Department under President Donald Trump is defending the federal government’s position in several Medicare Advantage lawsuits challenging policies that originated during President Joe Biden’s term.
    • “Given Trump’s overall repudiation of the Biden years and Republicans’ generally favorable disposition toward Medicare Advantage and preference for light regulation, Wall Street expected the new administration to take it easier on health insurance companies. So far, in court at least, that’s not what’s happening.
    • “Since Trump returned to the White House in January, the Justice Department has filed briefs supporting the Biden administration’s defenses against companies such as Humana and eHealth in Medicare Advantage cases regarding the Star Ratings quality assessment program, marketing rules and the risk-adjustment system.”
  • and
    • “A health system at the center of a legal dispute over emergency abortions notified a federal court Tuesday that the Justice Department is dropping its challenge to Idaho’s anti-abortion laws.
    • “President Joe Biden’s administration contended that hospitals in states with restrictive abortion laws nevertheless are required to provide the procedure in emergencies to preserve the life and health of pregnant patients under the Emergency Medical Treatment and Active Labor Act of 1986, known as EMTALA. President Donald Trump, who opposes abortion rights, was expected to change course and now has, according to Boise, Idaho-based St. Luke’s Health System.
    • “St. Luke’s submitted a brief to the U.S. District Court for the District of Idaho on Tuesday saying its attorneys received an email on Monday from an unnamed federal official informing them that the Justice Department intends to withdraw its case against the Idaho laws.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “Over half of adults and a third of kids and teens around the world will have overweight or obesity by 2050, according to two reports using data on 204 countries and territories.
    • “If observed trends over the past 30 years continue, the total number of adultsopens in a new tab or window ages 25 and older living with overweight (body mass index [BMI] 25 to <30) or obesity (BMI ≥30) will reach 3.8 billion by 2050 — more than half of the likely global adult population at that time.
    • “Meanwhile, 356 million young people ages 5 to 14 years and 390 million young people ages 15 to 24 years are projected to have overweight or obesity by 2050, reported the Global Burden of Disease (GBD) Study 2021 Adult and Adolescent BMI Collaborators in The Lancet.
    • “This polycrisis will cause more avertable adverse health outcomes in the coming decades than any other modifiable risk at an individual level,” the researchers wrote. “Urgent, bold, and comprehensive initiatives are imperative to enable multisectoral collaboration and propel structural reforms to address drivers of overweight and obesity at individual and population levels. Although new-generation antiobesity medications appear promising, tactful, whole-system, public health strategies will continue to be crucial to achieving widespread and sustainable impact.”
  • Per an NIH press release,
    • A research team funded by the National Institutes of Health (NIH) has developed a medication that shows promise in treating acute and chronic pain. The drug, known as VIP36, targets the body’s cannabinoid receptor type 1 (CB1). It was found to be effective in three different animal models for pain and does not appear to cause the harmful side effects that have frustrated other efforts to target CB1. These results enhance understanding of how to design safer and more effective drugs targeting cannabinoid receptors and are an important step towards developing novel, non-addictive treatments for pain.
  • Cardiovascular Business reports,
    • Transcatheter aortic valve replacement (TAVR) is associated with better in-hospital outcomes than surgical aortic valve replacement (SAVR), according to a new analysis published in The Annals of Thoracic Surgery.[1] However, researchers noted, SAVR was linked to superior long-term outcomes, including a lower stroke risk, for both low- and intermediate-risk patients.
    • The newly published study included data from nearly 160,000 patients 65 to 85 years old who underwent aortic valve replacement from 2018 to 2022. All data came from the U.S. Centers for Medicare and Medicaid Services database. While 124,897 patients underwent TAVR, another 34,215 underwent first-time SAVR. The median follow-up period was 2.7 years.
    • Using Society of Thoracic Surgeons mortality risk scores as their primary guide, researchers determined if each study participant was a low-, intermediate- or high-risk patient. The low-risk group was represented by more than 36,000 TAVR patients and more than 1,400 SAVR patients. The intermediate-risk group, meanwhile, was represented by more than 44,000 TAVR patients and more than 9,000 SAVR patients. The high-risk group was represented by 44,000 TAVR patients and nearly 10,000 SAVR patients. 
    • In all three risk groups, TAVR patients were older and more likely to present with a history of heart failure or coronary artery disease than SAVR patients
  • MedPage Today relates,
    • Patients using GLP-1 drugs had no difference in the odds of postoperative aspiration pneumonia versus non-users.
    • There was also no significant difference in the odds of acute respiratory failure.
    • Findings support guidance recommending that a GLP-1 agent hiatus is not necessary before surgery.
  • Per Healio,
    • “Children were around half as likely to develop one or more long COVID symptoms if they were vaccinated.
    • “Vaccinated children were 75% less likely to experience long COVID symptoms that affected daily function.”
  • Per Health Day,
    • “Physical activity can improve the mental well-being of women living with chronic pelvic pain disorders like endometriosis and uterine fibroids, a new study says.
    • “Activities like brisk walking or aerobic exercise caused measurable improvements in women with pelvic pain, researchers reported in the Journal of Pain Research.
    • “Chronic pelvic pain disorders are incredibly complex and burdensome for those affected, yet we still have very few effective treatment strategies,” said senior researcher Ipek Ensari, an assistant professor of artificial intelligence and human health at the Icahn School of Medicine at Mount Sinai in New York City.
    • “Our research suggests that physical activity could be an important tool for improving mental health in these patients, offering them a proactive way to enhance their well-being,” Ensari added in a news release.” * * *
    • “We were particularly intrigued to find that the positive effects of exercise seem to lag by a few days, meaning the mental health benefits may build up gradually,” Ensari said. “This insight is vital for both patients and health care providers, as it underscores the importance of consistency in physical activity.”
    • “As women’s mental health improved, they also experienced improvements in physical function and reductions in pain, results show.”

From the U.S. healthcare business front,

  • Fierce Healthcare brings us the latest on the HIMMS conference ongoing in Las Vegas.
  • Beckers Hospital Review notes,
    • “Rochester, Minn.-based Mayo Clinic reported an operating income of $1.3 billion (6.5% operating margin) in 2024, up from an operating income of $1.1 billion (6% margin) in 2023, according to its March 5 financial report.
    • “The health system recorded revenue of $19.8 billion in the 12 months ended Dec. 31, up from $17.9 billion in the same period last year. Mayo Clinic reported medical service revenue of $16.6 billion in 2024, up from $15 billion in 2023. 
    • “Operating expenses totaled $18.5 billion in 2024, up from $16.9 billion in 2023. Salaries and benefits totaled $10.5 billion, up from $9.7 billion in 2023. Supply and service expenses totaled $6.7 billion, up from $6 billion in the prior year. 
    • “Mayo Clinic’s success in 2024 reflects the innovative spirit of our exceptional staff and their dedication to meeting our patients’ changing needs,” Mayo Clinic President and CEO Gianrico Farrugia, MD, said. 
  • STAT News reports
    • “Novo Nordisk will start selling its obesity drug Wegovy directly to patients at a reduced price, following a similar move from Eli Lilly as the two drugmakers compete for market share and try to draw patients away from compounding pharmacies that have been making cheaper copies of weight loss drugs.
    • “Wegovy normally carries a list price of about $1,350 a month, but Novo will sell the treatment through its new direct-to-consumer offering called NovoCare Pharmacy at $499 a month for all doses to cash-paying patients, meaning patients who are paying on their own without insurance.
    • “Orders will be fulfilled by CenterWell Pharmacy, a subsidiary of Humana that offers home delivery services.”
  • Per Healthcare Dive,
    • Bankrupt Prospect Medical Holdings may need to find another buyer for its Connecticut hospital portfolio, after Yale New Haven Health, which originally signed an agreement to acquire the three facilities in 2022, called the deal “impossible” in a statement to Healthcare Dive.
    • A spokesperson for Yale New Haven said the deal was unworkable due to Prospect’s failure to pay vendors on time, disinvestment in the facilities and record of mismanagement. 
    • Connecticut Gov. Ned Lamont said in a press conference on Monday that Prospect has found possible buyers located in Connecticut and out of state that could be named in the coming weeks, according to a report from the Register Citizen.
  • Per BioPharma Dive,
    • “Jazz Pharmaceuticals is expanding its foothold in cancer drug research, announcing Wednesday it will pay $935 million to buy Chimerix and an experimental medicine under Food and Drug Administration review for treatment of a form of the brain cancer glioma.
    • “Per deal terms, Chimerix investors will receive $8.55 a share, a 72% premium on Tuesday’s closing price. Jazz expects the deal to close in the second quarter of 2025. The deal is all in cash, which Jazz will draw from holdings and investments that amounted to $3 billion at the end of 2024.
    • “If approved, Chimerix’s drug would join five other marketed cancer medicines in Jazz’s portfolio, potentially helping the Dublin-based company diversify revenue away from its biggest seller, the sleep drug Xywav.
    • “Called ONC201 or dordaviprone, the drug has been submitted for accelerated FDA approval in people who have gliomas with a mutation called H3 27M. A small 2014 study suggests that such mutations are common in people under the age of 50 who are diagnosed with glioma.”