Tuesday Report

SCOTUS

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, NIH, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • The International Foundation of Employee Benefit Plans let us know,
    • Over a dozen bills that would amend the Internal Revenue Code of 1986 to expand health savings accounts (HSAs) have been introduced in Congress this year, according to the International Foundation’s [article]. If enacted, the bills aim to change the disadvantages of HSAs and/or high-deductible health plans (HDHPs) that make them inaccessible or undesirable to some people. If enacted, some bills would allow more people to own HSAs, contribute more annually, and use HSA dollars for more items and services. Other bills would change HDHPs to allow more than preventive services, such as chronic disease treatments, to be covered before the deductible.
  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, May 6, 2025, at 10:00 AM to consider James O’Neill to be Deputy Secretary of the Department of Health and Human Services (HHS) and Gary Andres to be an Assistant Secretary of HHS.”  
  • Beckers Payer Issues offers five notes on the Trump Administration’s approach to Medicare Advantage so far.
  • Modern Healthcare adds,
    • “Leaders at the Centers for Medicare and Medicaid Services are exploring proposals to limit health insurers’ use of tactics that can delay medical care, people familiar with the discussions said. 
    • “The aim of the proposals would be to cut the number of medical procedures subject to “prior authorization,” meaning ones in which doctors have to fill out additional paperwork for ultimate approval. CMS is exploring making policies more uniform across different health insurance plans. 
    • “Another goal is automating coverage determinations so patients can get decisions faster, said the people, who weren’t authorized to speak publicly on the matter. The discussions are in preliminary stages, and the agency’s direction could change.”
  • Modern Healthcare also shares some health insurer associations’ deregulatory ideas offered to the Trump Administration.
    • “The Coalition Against Surprise Medical Billing, which includes the health insurance trade group AHIP and the Blue Cross Blue Shield Association, wants CMS to make the No Surprises Act out-of-network billing dispute resolution process more favorable to their members, it wrote the White House, HHS, the Treasury Department and the Labor Department last Tuesday.
    • “The Alliance of Community Health Plans, which represents insurers affiliated with nonprofit health systems, wants CMS to nix a variety of quality and performance reporting requirements, including for defunct programs such as the Medicare Advantage Value-Based Insurance Design model, which CMS shut down last year.
    • “The association also wants CMS to ease rules regarding beneficiary communications, such as requiring them to opt into digital communications. These mandates are the “epitome of administrative burdens,” Alliance of Community Health Plans President and CEO Ceci Connelly wrote to CMS April 9.”
  • MedPage Today’s editor in chief interviews the new FDA Commissioner Marty Makary, MD, here.

From the judicial front,

  • STAT News reports,
    • “The Supreme Court on Tuesday rejected hospitals’ argument that the federal government doesn’t pay them enough for treating low-income patients [by a 7-2 majority].
    • “The seven-justice majority instead sided with the Department of Health and Human Services’ interpretation of the law concerning disproportionate share hospital, or DSH, payments, which compensate hospitals for treating low-income patients. More than 200 hospitals brought the case, Advocate Christ Medical Center v. Kennedy, arguing the federal agency’s misreading of the law causes it to underpay them by well over $1 billion each year.” 

From the public health and medical research front,

  • The National Institutes of Health (NIH) announced,
    • adopting a new initiative to expand innovative, human-based science while reducing animal use in research. Developing and using cutting-edge alternative nonanimal research models aligns with the U.S. Food and Drug Administration’s (FDA) recent initiative to reduce testing in animals. While traditional animal models continue to be vital to advancing scientific knowledge, using new and emerging technologies can offer unique strengths that, when utilized correctly or in combination, can expand the toolbox for researchers to answer previously difficult or unanswerable biomedical research questions.
    • “For decades, our biomedical research system has relied heavily on animal models. With this initiative, NIH is ushering in a new era of innovation,” said NIH Director Dr. Jay Bhattacharya. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted—from clinical development to real-world application. This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.”
  • The current issue of NIH Research Matters covers the following topics: “Restoring speech after paralysis | CT scans and cancer risks | Visual information processing in the brain.”
  • Health Day tells us,
    • “A Kaiser Permanente colon cancer screening initiative put a huge dent in cancer cases and deaths over two decades, a new study says.
    • “The systematic outreach program doubled colon cancer screening rates, researchers are scheduled to report at the upcoming Digestive Disease Week meeting in San Diego.
    • “As a result, cancer cases were cut by a third and colon cancer deaths by half, researchers report.
    • “In addition, racial disparities in colon cancer outcomes nearly vanished as a result of the initiative, researchers said.
    • “By offering an effective screening approach equally to everyone, we were able to eliminate much of the disparity,” said lead investigator Dr. Douglas Corley, chief research officer with the Kaiser Permanente Division of Research in Northern California.
    • “Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients,” he said in a news release. “Now, those differences are nearly gone.”
  • MedPage Today informs us,
    • “The addition of the pregnancy checkbox on death certificates in 2003 was responsible for most of the spike in maternal deaths since 2000.
    • “However, in 2021, adjusted maternal death rates peaked at 18.86 per 100,000 live births, in line with the COVID pandemic.
    • “Of note, both infant and fetal death rates per 1,000 live births declined across the study period.” * * *
    • “Our work is the first to quantitatively separate out the effect of change in data collection from actual trends in maternal mortality,” co-author Robin Park, MSc, also of the University of Oxford, told MedPage Today. “Adjusting for the change in data collection, we find that the rate of maternal mortality has been relatively constant since 2000.”
    • “Park noted that while the checkbox doesn’t change the definition of maternal death, “anecdotal evidence suggests that it makes coders more likely to add a maternal or pregnancy-related cause of death,” and thus it’s been difficult for researchers to “parse out the true trends from changes in data collection.”
  • Per MedTech Dive,
    • “Since its U.S. debut more than a year ago, pulsed field ablation continues to gain converts at a fast pace, with devices from Boston Scientific and Medtronic leading the way.
    • “The procedure is becoming physicians’ preferred ablation method for treating atrial fibrillation, an irregular rhythm that can lead to complications such as blood clots, stroke and heart failure. PFA delivers electrical pulses to targeted areas of the heart causing abnormal rhythms, offering a potentially safer approach than older treatments that use heat or extreme cold to ablate the tissue.
    • “In connection with the Heart Rhythm Society’s 2025 meeting in San Diego, which wrapped this weekend, Boston Scientific, Medtronic, Abbott and Johnson & Johnson all unveiled data supporting their devices.
    • “Truist analysts, in a note to clients Sunday, said physicians they spoke with at the event reported that the more efficient PFA procedures were allowing their institutions to perform at least 20% to 30% more cases.”

From the U.S. healthcare business front,

  • 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 tirzepatide (Zepbound®, Eli Lilly & Co.) and semaglutide (Wegovy®, Novo Nordisk) for the treatment of obesity. ICER will also assess how these treatments affect additional obesity-related outcomes.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 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 Wall Street Journal reports,
    • “AstraZeneca’s core EPS rose to $2.49, revenue increased 10% to $13.59B, but shares fell over 4% amid legal challenges in China.
    • “The company reaffirmed its 2025 targets after oncology revenue grew 13% to $5.64B, driven by Tagrisso and Imfinzi.
    • “China revenue rose 3%, but the company faces potential fines in the country over alleged illegal drug imports.”
  • and
    • “Hims & Hers partners with Novo Nordisk to offer Wegovy for weight loss, with subscriptions starting at $599 a month.
    • “The collaboration includes clinical support and nutrition guidance via Hims & Hers’ platform and NovoCare Pharmacy.
    • “Novo and Lilly are partnering with telehealth providers amid competition in the weight-loss drug market.”
  • and
    • “Merck is investing $1 billion in a Delaware plant to expand its U.S. manufacturing, amid potential tariff concerns.
    • “The plant will produce biologic drugs and a new, easier-to-use version of Keytruda, the company’s blockbuster cancer drug.
    • “The facility is Merck’s first in-house U.S. site for Keytruda, ensuring domestic supply and creating at least 500 on-site jobs.”
  • Per Healthcare Dive,
    • “Universal Health Services reported earnings for the first quarter on Monday evening that came in below Wall Street’s expectations for revenue. The for-profit’s behavioral health business also underperformed compared to its acute care service line.
    • “Behavioral health adjusted admissions declined by 1.6% compared to the prior year, while acute care admissions grew by 2.4%. Executives blamed the leap year in 2024 and atypical winter weather in some markets for depressed patient days, noting adolescent behavioral care utilization rates were particularly impacted by weather-related school closures. 
    • “CEO Marc Miller told investors during a Tuesday morning earnings call that UHS could get its behavioral health unit back on track to grow patient day revenue by 2.5% to 3% by the end of the year. However, the executive declined to specify when investors could expect to see improvement and dodged questions about whether volumes are expected to improve in the second quarter or the back half of the year.”
  • Per Fierce Healthcare,
    • “Though it opted to stick with annual guidance numbers given in February, Tenet Healthcare’s “outstanding” first-quarter performance has the company pushing ahead on growth initiatives in the face of financial headwinds and policy uncertainties.
    • “Tuesday morning, the hospital and ambulatory surgical center operator shared a $406 million net income attributable to the company ($4.27 per diluted share) for the first three months of the year. Net operating revenues decreased year over year from $5.4 billion to $5.2 billion, largely reflecting hospital divestitures during the prior year.
    • “Its adjusted EBITDA of $1.16 billion was up 14% over the same period a year prior and “well above the high end of our guidance range,” Chief Financial Officer Sun Park said Tuesday.
    • “Tenet CEO Saum Sutaria, M.D., told analysts that the earnings growth stems from divesting low-margin facilities and recent years’ focus on operating discipline. It’s set the stage for Tenet to continue focusing on labor structure and supply standardization, to increase its operating leverage and to build out its portfolio of well-performing assets.”
  • and
    • “Telehealth company LifeMD bought assets from Optimal Human Health MD to accelerate its push into the women’s health market.
    • “The acquisition establishes a scalable clinical and operational foundation for a comprehensive virtual health program, set to launch this summer, focused on hormone health, bone density, metabolism and long-term wellness. LifeMD’s virtual women’s health platform will target areas such as menopause and osteoporosis.
    • “The company did not disclose financial details of the acquisition.”
  • Modern Healthcare reports,
    • “Dr. Shawn Griffin, president and CEO of URAC, has had a front row seat to AI’s evolution in healthcare and he’s worried there are not enough guardrails.
    • “There is an urgent need for standards to be developed and quickly, given the change in presidential administrations, said Griffin, who six years ago became the first physician to lead the nonprofit accreditation organization for hospitals, health plans, telehealth providers, pharmacies and other healthcare players.”
    • “Looking at the way that AI was coming into healthcare, we recognized that there was a need for some sort of verifiable standards to be implemented to protect patients and to look out for their best interests in this area that’s moving so fast,” Griffin said. “It’s been on our radar screen for a few years.”
    • In the fall, URAC plans to launch a healthcare AI accreditation program, making it one of several organizations initiating these specific types of accreditation programs.

Friday Report

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Patient safety, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Today, the Supreme Court held a conference of its justices at which the Court decided next steps with the Kennedy v. Braidwood Management case heard last Monday.
  • Bloomberg Law reports that following the conference,
    • “The Supreme Court ordered more briefing after arguments in a dispute over Obamacare’s preventative services mandate, which requires insurers to cover certain treatments like cancer screenings free of charge.
    • “In an order on Friday, the justices asked the parties to address whether the health secretary has the power to appoint the members of the US Preventive Services Task Force, which recommends services that should be covered under the Affordable Care Act. 
    • “The court wants to know “whether Congress has ‘by Law’ vested” the secretary with this authority.” * * *
    • “Additional briefs are due May 5. It’s rare but not unheard of for the court to request more briefing after a case has been argued.
    • “This occasionally occurs on issues that come up during argument if they weren’t initially briefed by the parties.”
    • FEHBlog note — That’s exactly what happened in the Braidwood Management case.
  • STAT News tells us,
    • “The federal health department is not creating a new registry of Americans with autism, a Department of Health and Human Services official said in a written statement Thursday. Instead, the official said, HHS will launch a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments.
    • “The announcement arrives two days after National Institutes of Health Director Jay Bhattacharya announced the intent to create such a registry at an all staff meeting, kicking off a firestorm of panic and confusion among autism self-advocates and the broader research community. Much of the fear centered around Bhattacharya’s remarks that the government would pull health data from private sources, such as electronic health records maintained by health care providers, pharmacy data, insurance claims and even wearables like smart watches and fitness trackers.”
  • Science Soft Healthcare predicts that “”By the end of 2026, 25–30% of all medical visits in the United States will be conducted via telemedicine. Although the adoption rate of telemedicine has been low in 2024, it will grow considerably with regulatory support from the US Congress.”
    • “In 2023, telemedicine usage in mental health was over three times higher than in other medical specialties, according to Epic Research. We believe that the resilient demand for telemedicine in mental health indicates that the technology is here to stay.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride Injection 500mg/100mL Infusion bags due to the products potentially containing inert polypropylene fibers. As of April 18, Amneal Pharmaceuticals said it received no reports of adverse events or injuries related to the recall. The recalled IV bags were distributed nationwide to wholesalers and distributors from April 23-Nov. 8, 2024.”

In other judicial news,

  • STAT News reports,
    • “Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy.
    • “A federal judge on Thursday ruled against a compounding trade group’s request for a preliminary injunction that would have prevented the Food and Drug Administration from taking action against its members for making copies of semaglutide.
    • “Compounding pharmacies are legally allowed to make versions of branded treatments if the drugs are deemed to be in shortage by the FDA. For the two years when Ozempic and Wegovy were recently in shortage, compounders rushed to make copies to meet the enormous demand for weight loss treatments. But when semaglutide was ultimately taken off the FDA’s shortage list in February, the compounding trade group, called the Outsourcing Facilities Association, quickly sued the agency, arguing that there were still in actuality shortages of the branded treatments.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today:
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • “RSV
      • “RSV activity continues to decline in most areas of the country.
    • “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.
    • “Other Respiratory Illnesses
      • “Mycoplasma pneumoniae
        • Respiratory infections caused by the bacteria Mycoplasma pneumoniae have increased in some areas of the United States over the last few weeks as indicated by emergency department visits and test positivity. M. pneumoniae infections are generally mild but can sometimes be severe, causing what’s known as “walking pneumonia.” Most people will recover without medicine, but some need antibiotics to get better. Learn more: About Mycoplasma pneumoniae Infection | M. pneumoniae | CDC.
      • “Pertussis
        • “Reported cases of whooping cough (pertussis) continue to be elevated nationwide but preliminary case reports have been trending downward for the past several months. Whooping cough is very contagious and can spread easily from person to person. Babies younger than 1 year old are at highest risk of severe disease and complications. The best way to prevent complications from whooping cough is to get vaccinated. Learn more: About Whooping Cough | Whooping Cough | CDC.“
  • The University of Minnesota’s CIDRAP adds,
    • “Flu activity continues to ebb nationwide, with rates of influenza-like illness (ILI) dropping further last week, but flu-related deaths in children climbed to 204, up 6 from the previous week, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.”
  • The AHA News lets us know,
    • “There have been 884 confirmed cases of measles nationwide so far this year, with cases reported by 29 states, according to the latest data from the Centers for Disease Control and Prevention. There have been 11 outbreaks, and 93% of confirmed cases (820 of 884) are outbreak-associated. The vaccination status of 97% of all cases is classified as “unvaccinated or unknown.”
    • “The CDC April 24 released a report that said increasing national and local measles, mumps and rubella vaccination coverage is essential to preventing measles cases and outbreaks. The report also said that cases this year are the second highest in 25 years. A JAMA study also released April 24 found that measles could become endemic again within another 25 years if current childhood vaccination rates remain the same.”
  • The University of Minnesota’s CIDRAP drills down on these measles statistics.
  • Eating Well reports,
    • “A recall on a popular brand of apple juice sold in 28 states was just announced, according to the Food and Drug Administration. This is due to a potential contamination with patulin, a mycotoxin that can cause internal organ damage when consumed in excess. Approximately 173,616 bottles are affected by this recall.
    • “The product impacted is Martinelli Apple Juice sold in its signature clear, round glass bottles with a white metal screw top lid. The recalled 10-ounce apple juice bottles were sold in 4-packs, contain a UPC of “0 41244 04102 2” and have a best-by date of December 5, 2026. They were sold at retail locations in the following states: Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin.
    • “This recall was just classified as a Class II recall, meaning that drinking this apple juice can  “cause temporary or medically reversible adverse health consequences,” per the FDA.
  • Healio points out,
    • An estimated 24,499 people visited the ED for adverse events related to semaglutide in the 2 years after its approval for weight loss, according to a study published in Annals of Internal Medicine.
    • The most common symptoms included nausea, vomiting and diarrhea, which had been previously documented in clinical trials. However, researchers also discovered that 16% of ED visits involved hypoglycemia.
    • “What I see in clinical practice is that some patients end up in the ED due to these severe symptoms from semaglutide, and it is not recognized in the ED,” Pieter Cohen, MD, associate professor of medicine at Harvard Medical School and internist at Cambridge Health Alliance, told Healio. “It is really important to make sure we are asking our patients about the use of semaglutide when they have these symptoms, particularly since use is so prevalent these days.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Centene beat Wall Street expectations for earnings and revenue in the first quarter thanks to significant membership increases, especially in Affordable Care Act and Medicare prescription drug plans, according to results released Friday.
    • “Citing the strong enrollment, the St. Louis-based payer raised its revenue guidance and reiterated its earnings guidance for 2025.
    • “However, Centene signaled medical costs may also be increasing, raising the outlook for its full-year medical loss ratio — a marker of spending on patient care. Centene’s stock fell 7% in Friday morning trade following the results.”
  • Per BioPharma Dive,
    • “Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations.  
    • “Gilead’s oncology portfolio generated $758 million in sales over the first three months of the year, down about 4% compared to the same period in 2024. Slower-than-expected sales of Gilead’s breast cancer drug Trodelvy were the main culprit, though the company also blamed lower demand for a decline in cancer cell therapy revenue.
    • “Gilead’s HIV drug business, though, helped offset those losses, garnering $4.6 billion and climbing 6% year over year. The company expects further growth in the future, as by June 19 the Food and Drug Administration could significantly expand use of lenacapavir, a twice-yearly injectable medicine proven in testing to prevent HIV infections.
  • Beckers Payer Issues provides 101 things to know about Blue Cross Blue Shield.
  • Beckers Hospital Review offers a list of the 25 most expensive hospital drugs.
  • Fierce Healthcare tells us,
    • “HCA Healthcare reaffirmed its 2025 guidance following an opening quarter of solid care demand and better-than-expected earnings.
    • “The country’s largest for-profit health system announced Friday morning $1.61 billion of net income attributable to the company ($6.45 per diluted share) and revenues of $18.32 billion for the first quarter. Both are improvements over the prior year’s $1.59 billion ($5.93 per diluted share) and $17.34 billion.
    • “Adjusted EBITDA for the quarter was $3.73 billion, also up from $3.35 billion in the first quarter of 2024.”
  • Per Fierce Pharma,
    • “With the potential for pharmaceutical import tariffs spurring a rush of life sciences investments in the U.S., AbbVie is joining the trend with plans to spend billions in the country over the next decade.
    • “AbbVie aims to invest $10 billion in the U.S. through 2035 to support its current growth plans and expand into new areas like obesity, the Chicago drugmaker’s CEO, Rob Michael, said on a call with analysts Friday.
    • “AbbVie’s executives did not go into the fine details of the domestic investment plan on the call, though the company’s CFO Scott Reents noted that a portion of the sum will be earmarked to build four new U.S. production facilities devoted to active pharmaceutical ingredients (API), drug product, peptides and devices.”
  • and
    • “After unveiling a new drug substance facility in North Carolina in December, Amgen is doubling down on expanding its U.S. production presence with plans for a major upgrade at its plant in central Ohio.
    • “The new project represents the latest in a string of pharma investments in the U.S. as the Trump administration threatens to clamp down on the industry with sector-specific import tariffs.
    • “Amgen is plugging $900 million into an expansion of its biomanufacturing facility in New Albany, Ohio, the company said Friday. The project is expected to bring the total number of Amgen jobs in the state to 750 and increase the company’s overall investment in Ohio to more than $1.4 billion.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, NIH, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a report detailing findings from an investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Cassidy requested information from hospitals, Federally Qualified Health Centers, contract pharmacies and drug manufacturers.  
    • “Cassidy said the “investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” and the report outlines potential reforms needed to improve the program to better serve patients.   
    • “In a statement shared with media, AHA President and CEO Rick Pollack said, “The AHA appreciates Senator Cassidy’s leadership on 340B issues. As his report correctly observes, the 340B program was created to help hospitals reach more eligible patients and provide more comprehensive services. Even this investigation — which the report recognizes was ‘limited in scope’ given the variety of 340B hospitals across the country — demonstrates that hospitals use 340B savings to provide financial assistance to low-income patients and to maintain programs that enhance patient services and access to care. In short, 340B is vital in advancing health in communities across the country.”  
  • The President signed an executive order strengthening probationary periods in the federal civil service. Here’s a link to a fact sheet.
  • Govexec tells us, “Ex-feds launch websites to help unemployed civil servants find new jobs. Many federal employees are looking for positions outside of government following reductions in force and the Trump administration’s push for workers to take separation incentives.”
  • Per a Drug Enforcement Administration news release,
    • DEA’s National Prescription Drug Take Back Day is your chance to rid your medicine cabinet of unneeded and unwanted medications. Start your spring cleaning this year on April 26 by visiting a collection site near you.
    • Mark your calendar for this upcoming event! Participating drop-off sites will be open from 10 a.m. to 2 p.m. (local time) on Saturday, April 26. Collection sites are located around the country and will be collecting:
      • Tablets
      • Capsules
      • Patches
      • Other solid forms of prescription drugs.
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan for evaluating a measure regarding “Vision in Children Ages 6 Months to 5 Years: Screening.” The public comment deadline is May 21, 2025.
  • Per the AHA News,
    • “The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.”

From the judicial front,

  • Professor Katie Keith wrote an article in Health Affairs Forefront about the Kennedy v. Braidwood Management oral argument presented to the Supreme Court last Monday.
  • Fierce Pharma informs us,
    • “Halozyme is not holding back against Merck & Co. in the companies’ injectable Keytruda patent dispute, having now escalated a verbal warning into a lawsuit.
    • “In a lawsuit filed Thursday in a New Jersey federal court, Halozyme alleges that a proposed subcutaneous formulation of Merck’s popular cancer drug Keytruda infringes 15 of its patents.
    • “Those intellectual properties belong to a Halozyme patent family called Mdase, which covers a large group of modified human hyaluronidases. A hyaluronidase protein may allow for under-the-skin administration of otherwise intravenously infused drugs.
    • “Halozyme is seeking an injunction to block Merck’s planned commercialization of subcutaneous (SC) Keytruda, which is under FDA review with a decision expected by Sept. 23. The San Diego drug delivery expert is also asking for monetary relief and “an enhancement of damages,” because the alleged infringement is said to be willful, according to its complaint.
    • “Even though SC Keytruda has not reached the market, Merck opened itself to patent litigation after publicly laying out its intention to launch the product this year pending FDA approval.”

In State government news,

  • Mercer offers a roundup of selected state healthcare developments in the first quarter of 2025.

From the public health and medical research front,

  • CNN reports,
    • “The United States has seen progress in reducing certain cancer risks, as overall smoking rates remain on a decline. But for other risk factors, such as those tied to cervical cancer, there is room for improvement, according to a new American Cancer Society report.
    • “The prevalence of people smoking fell from about 14% in 2019 to 11% in 2023, according to the report published Wednesday in the journal Cancer Epidemiology, Biomarkers & Prevention. Cigarette smoking is known to significantly increase the risk of developing cancer. It’s estimated to cause about 1 out of every 3 cancer deaths in the US. * * *
    • “The prevalence of people being up-to-date on recommended cervical cancer screenings has dropped from 74.8% in 2019 to 73.4% in 2021 among ages 21 to 65, the report found, leaving more women at risk of not detecting disease early. The reported noted that the decrease is alarming as HPV vaccination rates have remained “statistically unchanged” in recent years. In 2023, 61.4% of adolescents ages 13 to 17 were up-to-date for the HPV vaccination series, similar to 61.7% in 2021 and up from 54.2% in 2019.
    • “HPV or human papillomavirus is a group of more than 150 viruses that can cause certain types of cancer. Spread primarily through sexual contact, most cases of HPV clear on their own within two years, but when the infection does not go away, health problems like cancer may occur – which is why preventing these infections with vaccination has been key.”
  • The National Cancer Institute announced,
    • “Researchers have discovered what appears to be a critical biological driver of the most common form of ovarian cancer. The discovery, they believe, could spearhead the development of approaches for finding ovarian cancer at its earliest stages or preventing the disease from taking hold in the first place.
    • “Multiple studies have shown that high-grade serous ovarian cancer arises from precancerous growths called serous tubal intraepithelial carcinoma (STIC) lesions in the fallopian tubes. These lesions can eventually travel into the ovaries and transform into full-blown tumors.
    • “In this new study, Lan Coffman, M.D., Ph.D., of the University of Pittsburgh School of Medicine, and her colleagues showed that STIC lesions appear to arise and turn into tumors in the ovaries with the assistance of a type of stem cell that they called high-risk mesenchymal stem cells (MSCs).
    • “These high-risk MSCs—which have specific characteristics that appear to help their cancer-fueling capabilities—were abundant in the tissue, or stroma, immediately underneath STIC lesionsExit Disclaimer in fallopian tube tissue samples from women without cancer. They were also sometimes present in normal tissue. 
    • “When the researchers implanted high-risk MSCs along with healthy fallopian tube cells into mice, some developed ovarian cancer, including, in some cases, metastatic cancer, the researchers reported March 14 in Cancer Discovery.
    • “It’s not yet clear if high-risk MSCs are the primary instigator that causes healthy fallopian cells to transform into high-grade serous ovarian cancer, Dr. Coffman said, but the group’s findings support the idea that these cells are intimately involved. 
    • “What we believe we’re seeing is that [high-risk MSCs] are a supportive ‘soil’ for cancer initiation,” she said.”
  • Beckers Hospital Review adds,
    • “Some early-onset colorectal cancers may be caused by exposure to a bacterial toxin within the first 10 years of life, according to a study published April 23 in Nature.
    • “An international research team, led by Ludmil Alexandrov, PhD, from the University of California San Diego, analyzed 981 colorectal cancer genomes from patients across 11 countries for the study.” 
  • STAT News points out “Studies zoom in on clues to why Lyme disease persists and which antibiotic to prescribe. Cellular debris lingering in the liver and and a penicillin relative are identified.”
  • The AHA News tells us,
    • “A study published April 8 by the Public Library of Science’s Journal of Global Public Health found that driving while infected with COVID-19 raises the risk of an accident by 25%. The study analyzed public health and transportation data from seven states from 2020-2023. The results showed a significant association between acute COVID-19 infections and an increase in vehicle crashes.”
  • The Wall Street Journal reports,
    • A new study by French researchers found that some combinations of food additives were associated with a higher risk of Type 2 diabetes.
    • Researchers found that combinations of emulsifiers, colors and sweeteners increased the diabetes risk beyond what could be explained by individual substances alone.
    • Food-industry representatives defended combinations of what they said were safe ingredients, which they said are important for food safety and quality.
  • WTW notes, “Therapeutic alliance, the bond between client and therapist, is a game-changer in mental health programs. Employers must focus on measuring to predict better results and reduce dropout rates.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck’s first-quarter net income increased, driven by Keytruda sales, reaching $5.08 billion, or $2.01 a share, up from $4.76 billion year-over-year.
    • Despite sales of Keytruda rising 4% to $7.2 billion, Merck cut its 2025 adjusted earnings projection, citing tariffs and a license agreement.
    • Sales of HPV vaccine Gardasil fell 41% due to lower Chinese demand, while animal-health product sales rose 5% to $1.6 billion.
  • and
    • “Roche’s Q1 sales beat estimates due to demand for drugs like Ocrevus and Hemlibra.
    • “Roche is boosting its U.S. manufacturing to avoid potential tariffs, investing $50 billion over five years.
    • “Roche maintains its full-year guidance, anticipating mid-single-digit sales growth.”
  • Healthcare Dive adds,
    • “Molina beat analyst expectations for earnings and revenue in the first quarter, with a topline of $11.1 billion, up 12% year over year, and net income of $298 million, down 1% year over year, according to results released Wednesday.
    • “The California-based insurer said its medical costs increased moderately in the quarter, mostly due to utilization of long-term supports and services, expensive drugs and behavioral health, along with more spending on seasonal illnesses like the flu. However, costs were generally in line with what Molina had predicted, a bright spot after UnitedHealth, the largest private insurer in the U.S., reported an unexpected spike in spending earlier this month.
    • “Molina’s results can be viewed as “good enough,” TD Cowen analyst Ryan Langston wrote in a note on the insurer’s first quarter performance.”
  • Per BioPharma Dive,
    • Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and regulatory uncertainty.
    • Sales climbed 9.7% to 9.9 billion euros, or $11.3 billion, in the period, beating the consensus analyst estimate of 9.6 billion euros. Earnings for the core business rose almost 16% to 1.79 euros a share, topping the consensus expectation of 1.70 euros a share.
    • The French drugmaker benefited from the launch of new drugs and the continuing growth of Dupixent, a blockbuster medicine used to treat conditions including asthma, eczema and chronic obstructive pulmonary disease. The drug’s sales jumped 20% to 3.5 billion euros in the quarter, Sanofi said Thursday.
  • Per MedTech Dive,
    • Medtronic is seeking Food and Drug Administration clearance for an interoperable version of its latest insulin pump, an important step in the manufacturer’s collaboration with diabetes technology rival Abbott. 
    • Medtronic said on Thursday that it made two 510(k) submissions to the FDA: one for its MiniMed 780G insulin pump as an alternate controller enabled device, and another for its SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller.
    • The clearances would allow Medtronic’s technology to be part of an automated insulin delivery system, which can adjust insulin dosing to patients based on real-time readings from glucose monitors, using components made by other companies.
  • and
    • Edwards Lifesciences maintained full-year financial forecasts on Wednesday, projecting sales of its heart valves would offset hits from tariff and acquisition costs.
    • First-quarter sales of transcatheter aortic valve replacements, Edwards’ largest business, were better than the company expected, executives said on an earnings call.
    • Edwards’ TAVR sales were stifled last year by capacity constraints as heart teams performed more mitral and tricuspid valve procedures with the company’s newest devices. Hospitals are now addressing capacity issues by expanding capabilities for handling increased volumes, said Larry Wood, group president of TAVR and surgical structural heart. 
  • Modern Healthcare reports,
    • “Health systems have been shouldering the cost of mobile integrated healthcare programs for at-risk patients, but some insurers may be ready to start picking up the tab as providers prove they can save money.
    • “UMass Memorial Health, Geisinger, Prisma Health and others that operate these at-home care programs say the service saves millions of dollars by preventing emergency room visits and rehospitalizations of chronically ill patients. Government and private insurers have been covering little to none of the cost, but that could be changing as systems get information to prove the programs are effective.”
  • Mobihealth News informs us,
    • San Francisco-based Hinge Health, a digital musculoskeletal care platform, announced it is partnering with Cigna Healthcare to offer the health insurance company’s self-insured clients access to Hinge’s digital musculoskeletal (MSK) care platform. 
    • Hinge offers individuals with MSK conditions access to a multidisciplinary care team, including health coaches, orthopedic surgeons and physical therapists, as well as to digital tools like surgery decision support.
    • The company also provides a pelvic health program tailored for women and Enso, its FDA-cleared wearable that delivers electrical pulses to help alleviate everyday pain.
    • Cigna’s members who choose to enroll will have access to Hinge Health through Cigna’s condition-specific care program Pathwell Bone & Joint Solution.
    • Hinge touts that it is now an MSK provider for the five largest national health plans in the U.S. by self-insured lives. 
  • Per Fierce Healthcare,
    • “Health insurers can’t lose sight of improvements to the consumer experience as they find ways to reduce and manage rising costs, according to a new report from Forrester.
    • “The analysts offered one broad takeaway for payers: “Cut costs, not corners.” They noted that the industry is at a key crossroads where it’s critical to improve consumer experience and boost trust and consider those challenges as they build strategies around cost.
    • “Health insurers must improve CX, build consumer trust, and find innovative ways to create more sustainable cost structures and better economics for customers,” they wrote. “But the thirst for cost efficiency can’t cloud insurers’ strategic visions to create better health outcomes.”
  • Per Fierce Pharma,
    • “With the threat of Trump administration’s tariffs swirling and biopharma companies bracing for impact, many are announcing their intention to strengthen their presence in the U.S.
    • “The latest to hop on the invest-in-USA bandwagon is Thermo Fisher Scientific. The Massachusetts-based producer of medical instruments, diagnostics and pharmaceuticals will spend an additional $2 billion in the U.S. over the next four years “strengthening American innovation, manufacturing and economic competitiveness,” the company said in a release.
    • “Three-quarters of the pledge will bolster Thermo Fisher’s manufacturing operations, while the remaining $500 million will expand its R&D efforts.”

Monday Report

David Ermer–ACA, CDC, FDA, Medical / Rx research, Obesity, Patient safety, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Associated Press, Roll Call, Fierce Healthcare, and the FEHBlog agree based on today’s oral argument that the U.S. Supreme Court will not affirm the U.S. Court of Appeals for the Fifth Circuit’s holding that the members of the U.S. Preventive Services Task Force are principal officers of the United States who must be nominated by the President and confirmed by the Senate. The Supreme Court will issue its decision in June or early July.
  • STAT News reports,
    • “Hospitals, health insurers, and insurance agents are asking President Trump to pump the brakes on a regulation that would lead to potentially millions of people losing their health insurance.
    • “That’s not to say the health care industry disagrees with all of Trump’s proposals, which would make it more difficult for people to get health coverage through the Affordable Care Act’s marketplaces. But at a minimum, lobbyists are urging the White House not to enforce any new rules until 2027 at the earliest, according to a review of public letters that were due this month.” * * *
    • “One particular proposal puts insurers and providers at odds. In 2021, the Biden administration created monthly “special enrollment periods” that allow anyone who makes between 138% and 150% of the poverty line to enroll in an ACA plan. Usually, outside of losing a job or other special circumstances, people can only sign up for an ACA policy during the annual open enrollment window. The idea is to discourage people from getting insurance only when they get sick or injured.
    • The Trump administration wants to eliminate those monthly special enrollment periods immediately. Big insurers such as Centene and UnitedHealthcare, health insurance lobbying groups like America’s Health Insurance Plans and the Blue Cross Blue Shield Association, and broker groups like the National Association of Benefits and Insurance Professionals support that move. They contend some people, and brokers, are taking advantage of the continuous enrollment opportunities.
    • “Excessive [special enrollment periods] are administratively burdensome and create challenges for health plans to distribute enrollee risk,” Ceci Connolly, the CEO of the Alliance of Community Health Plans, told federal officials.” 
    • “Hospitals pushed back on the idea that people are abusing the process. They also have a lot to lose from Trump’s proposals. ACA plans pay more than Medicare and Medicaid plans, and if millions of people switch to Medicaid or become uninsured, hospitals risk losing tens of billions of dollars in revenue.”
  • Bloomberg Law tells us,
    • “With mass reductions in force across the federal government on the horizon, the AFL-CIO, federal workers’ unions, and advocacy groups have mobilized a network of more than 1,000 volunteer attorneys to provide legal services to laid off federal employees.
    • “Leaders behind the new Federal Workers Legal Defense Network launched last week say they saw a need for more federal-sector labor law resources based on the sheer number of federal workers being let go and the Trump administration’s response to lawsuits seeking to restore these jobs. More than 100,000 federal workers have left or been fired from the federal government so far.”
  • Per a Justice Department news release,
    • “The Justice Department, together with the Drug Enforcement Administration (DEA) and Department of Health and Human Services Office of Inspector General (HHS-OIG), today announced a $300 million settlement with Walgreens Boots Alliance, Walgreen Co., and various subsidiaries (collectively, Walgreens) to resolve allegations that the national chain pharmacy illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA) and then sought payment for many of those invalid prescriptions by Medicare and other federal health care programs in violation of the False Claims Act (FCA). The settlement amount is based on Walgreens’s ability to pay. Walgreens will owe the United States an additional $50 million if the company is sold, merged, or transferred prior to fiscal year 2032.” * * *
    • “In addition to the monetary payments announced today, Walgreens has entered into agreements with DEA and HHS-OIG to address its future obligations in dispensing controlled substances. Walgreens and DEA entered into a memorandum of agreement that requires the company to implement and maintain certain compliance measures for the next seven years.” * * *
    • “The civil settlement resolves four cases brought under the qui tam, or whistleblower provisions of the FCA by former Walgreens employees. The FCA authorizes whistleblowers to sue on behalf of the United States and receive a share of any recovery. It also permits the United States to intervene and take over such lawsuits, as it did here. The relators will receive a 17.25% share of the government’s FCA recovery in this matter.”
  • Fierce Healthcare adds,
    • ‘In a statement, Walgreens’ spokesperson Fraser Engerman said, “We strongly disagree with the government’s legal theory and admit no liability. Our pharmacists are dedicated healthcare professionals who care deeply about patient safety and continue to play a critical role in providing education and resources to help combat opioid misuse and abuse across our country.
    • “This resolution allows us to close all opioid related litigation with federal, state, and local governments and provides us with favorable terms from a cashflow perspective while we focus on our turnaround strategy that will benefit our team members, patients, customers, and shareholders,” Engerman said.”
  • The American Hospital Association (AHA) News relates,
    • “The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi. 
    • “BD identified an increase in material fatigue leaks associated with certain PowerPICC Intravascular Catheters. The FDA sent a letter to affected consumers recommending unused catheters be removed from where they are used or sold, and in-use catheters have updated instructions.
    • “Conavi reported an incident where the sheath of its Novasight Hybrid catheter detached during use. Conavi sent all affected providers a recall notice recommending they return the product to the company.”
  • MedTech Dive informs us,
    • “Medtronic has received Food and Drug Administration approval for a version of its latest glucose sensor that can pair with the company’s insulin pumps.
    • “The device, called Simplera Sync, can be used with Medtronic’s MiniMed 780G insulin pumps as part of an automated insulin delivery system, the company said Friday.
    • “Medtronic is planning a limited launch of the sensor starting this fall. CEO Geoff Martha told investors in February that the company expects Simplera Sync, and a new glucose monitor being developed with Abbott, to grow the company’s U.S. diabetes business.”
  • and
    • “Precision Neuroscience received 510(k) clearance for an electrode array that can be implanted for up to 30 days to map brain activity, the company announced Thursday. 
    • “The clearance is a milestone for the New York-based startup, which plans to use the electrode array as part of a brain-computer interface that is currently in development.
    • “Precision Neuroscience said the decision was the first time a company developing a next-generation wireless BCI has received FDA clearance, as it competes with rivals including Elon Musk’s Neuralink and Synchron, whose backers include Jeff Bezos and Bill Gates.”

From the public health and medical research front,

  • The AHA News lets us know,
    • “Overall cancer death rates declined steadily among both men and women from 2018 through 2022, according to the National Institutes of Health’s latest annual report. Cancer death rates decreased an average of 1.7% per year for men and 1.3% per year for women. Progress in reducing cancer deaths overall is mostly due to declines in both incidence and death rates for lung cancer and other smoking-related cancers, but cancers associated with obesity have been increasing, researchers noted.”
  • STAT News points out,
    • “High blood pressure earned its reputation as the silent killer by causing heart attacks, heart failure, and strokes.
    • “It’s also been a suspect in dementia. Some studies have hinted at a correlation between lower blood pressure and fewer dementia cases, but they were too small and too short to lend statistical significance to the link. It’s also been noted that people with untreated high blood pressure carry a 42% higher risk of developing dementia. 
    • “Now a new study published Monday in Nature Medicine reports that intensive blood pressure control lowered the risk of dementia by 15% and cognitive impairment by 16%. The large, cluster-randomized trial in rural China once again illuminated the role of “village doctors,” the local term for community health workers, who outdid usual care.
    • “This is an incredibly important study,” Dan Jones, a past president of the American Heart Association, told STAT. He was not involved in the new research. “Here’s something tangible that now we can tell our patients. This is so important for motivating people to control their blood pressure and treating it intensively as well.”  
  • BioPharma Dive notes,
    • “A two-drug regimen involving AstraZeneca and Daiichi Sankyo’s Enhertu topped standard therapy in a large study in HER2-positive breast cancer, the companies said Monday.
    • “In a Phase 3 trial, a combination of Enhertu and the targeted therapy pertuzumab held tumors in check longer than THP, a regimen of chemotherapy and precision medicines that’s commonly used as an initial treatment for metastatic breast tumors expressing the HER2 protein. The companies didn’t provide specifics, but said the regimen displayed a “highly statistically significant and clinically meaningful effect” on so-called progression-free survival in the study, with benefits across all patient subgroups.
    • “Additionally, while it is too early to tell whether Enhertu and pertuzumab are extending lives, “an early trend” favors their impact on survival, the companies said. Investigators and patients also remain blinded to a different arm of the trial comparing Enhertu alone to THP. That part of the study will continue to a final analysis.
    • “Safety was consistent with what’s been observed in use of each individual therapy, the companies said. AstraZeneca and Daiichi will present the findings at a future medical meeting and share the results with regulators.”
  • Fierce Pharma adds,
    • “In the first phase 3 trial to show the superiority of a TROP2-targeted antibody-drug conjugate and an immunotherapy agent in first-line triple-negative breast cancer (TNBC), Gilead Sciences’ Trodelvy has notched a much-needed win.
    • “Trodelvy’s combination with Merck & Co.’s Keytruda was better than Keytruda and chemotherapy at prolonging the time before cancer returns or death in patients with previously untreated metastatic TNBC whose tumors express PD-L1, Gilead announced Monday.
    • ‘The readout came from the phase 3 Ascent-04, or Keynote-D19, trial, which sets PD-L1 positivity cutoff at a combined positive score of at least 10, the same population that got Keytruda-chemo its FDA nod in this setting in 2020.”
  • Per Infectious Disease Advisor,
    • “Neurologic manifestations of syphilis increased across demographic groups and among those with HIV infection from 2019 to 2022, suggesting the need to evaluate all patients with syphilis for evidence of neurologic signs and symptoms.”
  • The American Medical Association lets us know “what doctors wish patients knew about becoming a living kidney donor.”
  • Consumer Reports, writing in the Washington Post, shares “tools and tips to help make life easier when your eyes don’t work as well anymore.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Prospect Medical Holdings-owned Crozer Health plans to start closing facilities following a lengthy, but unsuccessful, battle to secure a buyer.
    • “Prospect Medical filed a motion Monday asking the U.S. Bankruptcy Court for the Northern District of Texas for an emergency hearing to approve an expedited closure for Upland, Pennsylvania-based Crozer’s hospitals and outpatient facilities.
    • “Crozer plans Wednesday to start diverting emergency cases to other facilities and to stop elective inpatient admissions, in addition to trauma, surgical, OB-GYN, burn, behavioral health, oncology and outpatient services. Next Monday, Crozer plans to close all ambulatory services, according to court documents.
  • Beckers Hospital Review adds,
    • “Mid Coast Medical Center Trinity (Texas) will close April 25, after months of attempting to secure facility long-term sustainability and financial stability. 
    • “El Campo, Texas-based Mid Coast Health System, which manages and operates the facility, pointed to “significant financial challenges experienced by hundreds of rural hospitals” that have been made worse by “delays in establishing Medicare and Medicaid billing with commercial health insurance” for the closure, according to an April 18 news release on the hospital’s Facebook page. 
    • “The health system also pointed to increased accounts payable for supplies and services, lower-than-expected revenue from collections owed on patient copays and insufficient local tax revenue for operational shortfalls.” 
  • The Washington Post reports,
    • “Americans spent an estimated $71.7 billion on GLP-1 drugs including Ozempic and Wegovy in 2023, a 500 percent increase from their spending on such drugs five years earlier, according to a research letter published in JAMA Network Open.”
  • Per BioPharma Dive,
    • Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss drug in obesity earlier this year, a spokesperson confirmed to BioPharma Dive. 
    • Novo first reported in 2023 that the drug, an oral form of semaglutide, succeeded in a Phase 3 trial, helping people on the highest dose lose about 15% of their body weight after 64 weeks. However, the Danish drugmaker didn’t seek approval immediately afterwards, instead focusing attention on other medicines that might improve upon the injectable drug it sells as Wegovy for obesity and Ozempic for diabetes. 
    • The approval filing comes as a race with rival Eli Lilly to develop a weight loss pill has intensified. Lilly last week said its oral GLP-1 pill succeeded in a large trial in diabetes. That drug, orforglipron, could be submitted to regulators if an ongoing study in obesity also meets its objectives. 
  • ABC News explains how pharmacies are speeding up home delivery of prescription drugs.
  • Per Modern Healthcare,
    • “Labcorp has completed its acquisition of North Mississippi Health Services’ ambulatory outreach laboratory business. 
    • “Tupelo-based North Mississippi will still operate its hospital and clinic labs, according to a Monday news release. Under the purchase agreement, Labcorp plans to open three patient service centers by mid-year in Tupelo, West Point and Amory, Mississippi. It also will become a referral laboratory for the health system’s hospitals and clinics. Financial terms were not disclosed.” 
  • Per Beckers Hospital Review,
    • Inadequate coordination of patient discharges was named among the top 10 threats to patient safety in 2025, according to a recent report from ECRI and the Institute for Safe Medication Practices. Gaps in communication, follow-up and medication management continue to put patients at risk after they leave the hospital.
    • To strengthen discharge processes and ensure safer transitions of care, hospitals are deploying more proactive, interdisciplinary approaches — from virtual medication reconciliation to integrated navigation platforms and social determinants of health screening.
    • Becker’s recently asked three hospital and health system leaders to share one key strategy their organization is implementing to improve discharge coordination and reduce safety risks.
    • Their responses are featured [in the article.]
  • and
    • “The American College of Obstetricians and Gynecologists is recommending “a paradigm shift” to prenatal care, opting for a more personalized and tailored approach to improve access and outcomes.” 
    • The article shares five things to know about this change.
  • Healthcare Dive reminds us,
    • “The healthcare industry is awash in consumer financing options, for everything from plastic surgery to teeth whitening to a Botox top-up and your dog’s mangled paw. 
    • “Dermatologists, vets and dentists – the domain of many elective procedures — are primary customers of medical financing. 
    • “Less common is low-cost financing for insured people facing an unexpected medical emergency or a $1,000 insurance deductible.
    • “As the U.S. health system has pushed more treatment costs onto patients through higher-cost deductible plans – and overall healthcare inflation – more people have fallen into arrears on medical bills, said Brandon Pace, chief legal officer at PayZen, a San Francisco startup that’s seeking to expand the buy now, pay later installment model into the medical field.”

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, SCOTUS–

From Washington, DC,

  • Congress remains on a District/State work break this week.
  • Tomorrow at 10 am ET. the U.S. Supreme Court will hear oral arguments in the Kennedy v. Braidwood Management, No. 24-316, case. Amy Howe provides background on the case here. The case considers the constitutional authority of the U.S. Preventive Services Task Force to make recommendations for no-cost coverage of preventive services under the Affordable Care Act.
  • MedPage Today points out,
    • “The need to revamp the Organ Procurement and Transplantation Network (OPTN) is dire. Nearly 25% of livers and 33% of kidneys collected for donation go unused. The average transplant wait time is 3-5 years, but it can stretch even longer in some parts of the country. Much of the network’s donation and recipient data collection is performed manually, prolonging pre-transplant procedures. All of this is unwelcome news for more than 100,000 people currently on the organ transplant waitlist. And many are running out of time.
    • “Despite these challenges, the U.S. organ transplant system still saves over 48,000 lives a year. And policymakers have been pushing to increase this numbers. The Health Resources and Services Administration (HRSA), the entity housed within HHS that oversees the transplant network, is tasked with modernizing the system and saving more lives. HRSA is working hard to close the gap between recipient identification, donor matching, and subsequent transplant surgeries.
    • “HRSA must continue to push modernization efforts aggressively, using operational and technology improvements and stakeholder collaboration to save more lives and increase public trust in the transplant system. Reform efforts should focus on three key areas: streamlining of responsibilities, technological upgrades, and transparency.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Consuming more than eight alcoholic drinks a week is associated with brain injuries linked to Alzheimer’s disease and cognitive decline, a recent study in the journal Neurology suggests.
    • “The analysis looked for links between heavy drinking and brain health. Researchers used autopsy data from the Biobank for Aging Studies at the University of São Paulo Medical School in Brazil collected between 2004 and 2024. The team analyzed data from 1,781 people ages 50 or older at death. The average age at death was 74.9. * * *
    • The analysis showed that heavy drinkers and former heavy drinkers, respectively, had 41 percent and 31 percent higher odds of neurofibrillary tangles — clumps of the protein tau that accumulate inside brain neurons and have been associated with Alzheimer’s disease.
    • “Moderate, heavy and former heavy drinkers also had a higher risk of hyaline arteriolosclerosis, which thickens the walls of small blood vessels in the brain, impeding blood flow and causing brain damage over time. Though 40 percent of those who never drank had vascular brain lesions, they were more common in moderate (44.6 percent), heavy (44.1 percent) and former heavy drinkers (50.2 percent), the study found.”
  • Per Medscape,
    • “An investigational drug, currently known as AZD0780, lowers low-density-lipoprotein cholesterol (LDL-C) to target levels in most patients whose cholesterol is still over target despite statin therapy, results from the phase 2b PURSUIT trial show.
    • “AZD0780 inhibits PCSK9, a protein that regulates cholesterol metabolism. Inhibition of this protein has proven useful in lowering LDL-C. Current drugs in this class include two monoclonal antibodies, alirocumab and evolocumab, and a small interfering RNA, inclisiran. However, unlike current PCSK9 inhibitors, which must be injected, AZD0780 is an oral therapy.
    • “We’ve had PCSK9 inhibitors on the market in the United States for 10 years,” said investigator Michael Koren, MD, a cardiologist and CEO of the ENCORE Research Group in Jacksonville, Florida. However, “people are still not getting to goal,” he explained during his presentation of the results at the American College of Cardiology Scientific Session 2025 in Chicago, which were published simultaneously in the Journal of the American College of Cardiology.”
  • The Wall Street Journal informs us about “How Your Midlife Eating Habits Can Help You Live Longer and Healthier.”
    • “If you reach 70 years old healthy and disease-free, you might have your diet to thank, new research suggests.
    • “The study, which analyzed the health data of more than 100,000 people over the course of 30 years, is the first of its kind to examine how dietary patterns affect not only lifespan but also how well people age. The upshot: A diet emphasizing vegetables, fruits, healthy fats and some animal products such as fish and dairy over the long term was the most likely to make a difference in aging in good health.
    • “Sticking to a balanced diet with a moderate amount of healthy animal protein, in fact, outperformed following a more plant-based diet, in terms of healthy aging. The researchers also found that eating more ultra processed foods was linked to worse physical and cognitive health in older age.
    • “The study, published in Nature Medicine and led by researchers at Harvard University, the University of Copenhagen and the University of Montreal, adds to the growing body of research on human health spans—the number of years we live in good health—and the factors that can extend those years.” 

From the U.S. healthcare business front,

  • Tech Target identifies “13 AI healthcare companies to watch in 2025. These AI healthcare companies are using generative AI to enhance efficiency, improve patient care and innovate diagnostics. We also explore types of AI in the healthcare space.”
  • Per a press release,
    • “At HIMSS25, Performant Healthcare, Inc. (Nasdaq: PHLT), a leader in technology-enabled payment integrity, eligibility and related analytics services, conducted a targeted survey of nearly 150 healthcare technology leaders to better understand the key drivers behind healthcare technology decision-making. The findings point to a healthcare landscape increasingly shaped by innovation, efficiency and the imperative to deliver better outcomes for patients.
    • “This press release features multimedia. View the full release here
  • Per a press release,
    • U.S. Business Action to End HIV has been named one of Modern Healthcare’s 2025 Innovator Awards recipients.
    • Modern Healthcare’s Innovators program recognizes leaders and organizations driving innovation that improves care and achieves measurable results.
    • U.S. Business Action to End HIV is reimagining the role of businesses in ending HIV. The Coalition empowers companies to reduce stigma, increase access to care, support community organizations, and advocate for policy change.
  • Fierce Healthcare tells us,
    • “Despite growing awareness around fertility challenges, 77% of women have hidden or downplayed their fertility treatment at work. 
    • “So finds the latest survey from Maven Clinic, a virtual women’s and family health provider. The survey reached more than 1,000 U.S. women who have gone through the fertility journey. The fertility journey comes with many challenges, from financial to emotional. These are often hidden from public view, Maven executives argue.
    • “Financial cost remains one of the biggest barriers to fertility care, with 75% of people experiencing financial strain when navigating fertility. Nearly half of survey respondents felt unprepared for the cost, particularly around medications or hormonal treatments, genetic testing and diagnostic testing.
    • “Most respondents (83%) had to cut back on expenses, and more than half had to use their savings meant for other life goals to afford fertility care. A third of the people said they took on debt, while 59% took on extra work.
    • “At the same time, people going through the fertility journey must deal with the emotional toll it can take. Most (91%) said fertility challenges impact their mental health, the survey found. And 78% reported limiting social interactions, like weddings and family gatherings, due to the emotional stress.” 

Friday Report

David Ermer–AHRQ, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC.

  • Medical Economics reports,
    • Health care is in crisis, but tying physician reimbursement to inflation is one way to stabilize the American health care system, according to the American Medical Association (AMA).
    • On April 10, the Medicare Payment Advisory Commission voted unanimously to recommend Congress replace current law updates to the physician fee schedule with an annual change based on the Medicare Economic Index, such as MEI minus 1%.
    • That is “a timely recommendation as lawmakers wrestle with how to handle yet another cut in physician pay,” according to AMA. Association President Bruce A. Scott, MD, issued a statement of support similar to previous ones because the issue has been under discussion for months. In fact, Scott noted MedPAC has suggested the same to Congress at least three consecutive years.
      The current baseline increase to physician reimbursement is 0.25%, or 0.75% for doctors participating in an alternative payment model. MedPAC said Congress should consider setting reimbursement at the rate of the Medicare Economic Index minus 1%, every year for the foreseeable future.
  • Fierce Healthcare lets us know,
    • “A new assessment of 18 Center for Medicare and Medicaid Innovation models reaffirms recent criticism of the agency’s aggregate cost savings—or more accurately, losses—while highlighting several individual payment models that appear effective in cutting down federal spending and improving care quality.
    • “The white paper published Wednesday by healthcare consulting and advisory firm Avalere Health looked at newer quality metrics for outcomes than prior CMMI model analyses and also dug into whether the agency had been transparent and provided opportunities for feedback when designing the models.
    • “The findings come in the wake of a damning late 2023 Congressional Budget Office assessment of the agency’s work, which found CMMI increased indirect spending by $5.4 billion between 2011 and 2020 (0.1% of net Medicare spending during that time) and spurred sharp scrutiny from cost-conscious lawmakers.”
  • and
    • “Disability protections against gender dysphoria implemented via rulemaking during the Biden administration will not be supported going forward, the Department of Health and Human Services (HHS) announced April 10.
    • “In a two-page clarification, HHS Secretary Robert F. Kennedy Jr. signed off on a rule update that declares language characterizing gender dysphoria as a disability to not be enforceable because its inclusion was in the preamble—not the regulatory text—to a final rule from May 2024.
    • “The Department is nonetheless concerned there has been significant confusion about the preamble language referencing gender dysphoria in the [final rule],” the update (PDF) in the Federal Register reads. “It is well-established that where, as here, the language included in the regulatory text itself is clear, statements made in the preamble to a final rule published in the Federal Register, lack the force and effect of law and are not enforceable.”
  • Federal News Network tells us, “OPM lacks funds to relocate ‘significant’ number of remote employees in return-to-office plans. OPM is joining many agencies in giving employees another chance to take a “deferred resignation” offer before it proceeds with nonvoluntary layoffs.”
  • Tammy Flanagan, writing in Govexec, informs us about “What to know about early retirement offers to federal employees.

From the Food and Drug Administration front,

  • Fierce Pharma relates
    • “Bristol Myers Squibb has received the FDA’s green light to introduce another immunotherapy-based treatment in first-line liver cancer.
    • “The company’s combination of Opdivo and Yervoy is now approved for patients with newly diagnosed unresectable or metastatic hepatocellular carcinoma, the FDA said Friday.
    • “The immunotherapy regimen combines two well-established agents and may offer the potential for a longer life compared with traditional targeted therapy, Wendy Short Bartie, Bristol Myers’ senior VP of U.S. oncology commercialization, said in an interview with Fierce Pharma.
    • “The first-line approval also converted a previous accelerated approval for Opdivo-Yervoy as a second-line liver cancer treatment. Further, it puts BMS toe to toe with two other immuno-oncology regimens—Roche’s Tecentriq and Avastin, and AstraZeneca’s Imfinzi and Imjudo.”
  • Per MedTech Dive,
    • “Intuitive said Thursday the Food and Drug Administration has cleared a stapler for use with its single-port robotic surgery system.
    • “The device, which Intuitive said is the first stapler designed for single-port robotic surgery, shares features found in the company’s multi-port products to reduce the risk of tissue damage.
    • “CFO Jamie Samath said in January that the stapler nod would trigger the start of “broad commercial efforts” for the single-port system in two indications recently authorized by the FDA.”
  • and
    • “Dexcom received Food and Drug Administration clearance for a 15-day version of its G7 glucose sensor, the company announced Thursday.
    • “Dexcom claims its continuous glucose monitor is the most accurate and has the longest wear time. The company also expects the shift from a 10-day to a 15-day sensor to improve its margins, executives said in a February earnings call.
    • “The announcement alleviated investor concerns that a recent FDA warning letter might delay the decision. Dexcom expects a full launch in the second half of 2025, giving the company time to integrate the updated device with insulin pumps.”

From the judicial front,

  • The Congressional Research Service offers a legal sidebar about the impending April 21 oral argument in the Kennedy v Braidwood Management case which concerns the Affordable Care Act’s preventive care services coverage mandate.
  • Bloomberg Law reports,
    • “A Maine woman can’t proceed with a suit claiming that her health insurance plan’s coverage exclusion for weight loss drugs unlawfully discriminates against obese people, a federal court said.
    • “Rebecca Holland didn’t allege any facts showing that Elevance Health Inc. ever regarded her or other obese plan members as disabled, the US District Court for the District of Maine said Wednesday. Her “bare conclusory allegations to the contrary” didn’t support a ruling that the exclusion was discriminatory, Chief Judge Lance E. Walker said.
    • “Medicare and private insurers generally cover the cost of drugs like Ozempic when used to treat Type 2 diabetes but have been reluctant to pay for it when used for weight loss purposes. Several state and federal plaintiffs are trying to change that by claiming that obesity qualifies as a disability, and the exclusions violate discrimination laws.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity is declining nationally. Wastewater levels are at low levels, emergency department visits are at very 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
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The American Hospital News points out,
    • “There have been 712 confirmed cases of measles reported by 25 states so far this year, according to the latest figures released April 11 by the Centers for Disease Control and Prevention. The agency said 93% of those cases (660 of 712) are outbreak-associated and 11% of cases have been hospitalized. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • ProPublic adds,
    • “In the past six months, two babies in Louisiana have died of pertussis, the disease commonly known as whooping cough.
    • “Washington state recently announced its first confirmed death from pertussis in more than a decade.
    • “Idaho and South Dakota each reported a death this year, and Oregon last year reported two as well as its highest number of cases since 1950.
    • “While much of the country is focused on the spiraling measles outbreak concentrated in the small, dusty towns of West Texas, cases of pertussis have skyrocketed by more than 1,500% nationwide since hitting a recent low in 2021 amid the COVID-19 pandemic. Deaths tied to the disease are also up, hitting 10 last year, compared with about two to four in previous years. Cases are on track to exceed that total this year.”
  • The New York Times reports,
    • “Surgeons removed a genetically engineered pig’s kidney from an Alabama woman after she experienced acute organ rejection, NYU Langone Health officials said on Friday.
    • “Towana Looney, 53, lived with the kidney for 130 days, which is longer than anyone else has tolerated an organ from a genetically modified animal. She has resumed dialysis, hospital officials said.
    • “Dr. Robert Montgomery, Ms. Looney’s surgeon and the director of the NYU Langone Transplant Institute, said that the so-called explant was not a setback for the field of xenotransplantation — the effort to use organs from animals to replace those that have failed in humans.
    • “This is the longest one of these organs has lasted,” he said in an interview, adding that Ms. Looney had other medical conditions that might have complicated her prognosis.
    • “All this takes time,” he said. “This game is going to be won by incremental improvements, singles and doubles, not trying to swing for the fences and get a home run.”
  • Health Day notes,
    • “About one in 10 U.S. adults with substance use disorder (SUD) report past-year hospitalizations, according to a research letter published online April 1 in the Annals of Internal Medicine.
    • “Eden Y. Bernstein, M.D., M.P.H., from the University of Colorado School of Medicine in Aurora, and colleagues described the prevalence of hospitalizations among U.S. adults with SUD. Adults were classified into non-mutually exclusive groups by presence of any SUD, individual SUD, and two or more SUDs. The proportion and number of U.S. adults who reported hospitalizations was estimated for each group.
    • “The researchers identified 60 million U.S. adults with SUD, of whom 5.8 million (9.7 percent) reported past-year hospitalizations. The proportion of hospitalized adults ranged from 7.3 to 23.6 percent among those with alcohol use disorder (AUD) and opioid use disorder (OUD), respectively. Among adults with SUD, those with versus without past-year hospitalizations were more likely to be older and more likely to have two or more medical comorbid conditions. Hospitalized adults with AUD, cannabis use disorder, and tobacco use disorder were also more likely to have serious mental illness. Across all groups apart from AUD, hospitalized adults were less likely to be uninsured. Hospitalized adults with OUD were less likely to be non-Hispanic Black.”
  • Per a National Cancer Institute news release,
    • “Why do some cancers come back many years after treatments had eliminated all signs of the disease? The answer may involve rogue cancer cells that spread to other parts of the body early in the disease and then enter a sleeping, or dormant, state, according to a growing body of research. 
    • “These dormant cancer cells can survive in the body undetected for months, years, or even decades, the research suggests. At some point, however, the cells may awaken and begin the process of forming metastatic tumors.  
    • “What causes disseminated cancer cells to enter, and then to leave, a dormant state is not known. 
    • “But recent studies of tumor dormancy have yielded clues that scientists believe could one day help them find ways to prevent metastases, which account for most cancer deaths.”
  • Genetic Engineering and Biotechnology News adds,
    • “Cancer vaccines have been a tantalizing idea for decades, but the vast complexity of the human immune system has posed significant challenges. Now, technological advances like rapid DNA sequencing, lymph node targeting, and AI-informed antigen selection are enabling the creation of precision vaccines that target cancers effectively while minimizing harmful side effects.”
  • AHRQ’s Effective Health Care Program shares a paper about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • The University of Minnesota’s CIDRAP relates,
    • “A new smartphone-sized device can deliver tuberculosis (TB) test results at the point of care in less than an hour, an innovation that could improve diagnosis of the deadly disease in settings in which access to healthcare facilities and lab equipment is limited, its Tulane University developers reported yesterday in Science Translational Medicine.
    • “Over 90% of new TB cases occur in low- and middle-income countries.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review calls attention to the fact that CMS has approved seven new health systems to offer hospital at home programs.
  • Beckers Payer Issues informs us,
    • “CVS Health has named Benjamin Kornitzer, MD, as Aetna’s chief medical officer. 
    • “Most recently, Dr. Kornitzer was chief medical officer at agilon health, a primary care physician services company primarily serving Medicare Advantage patients.
    • “He also previously served as CMO of Mount Sinai Health System in New York.”
  • Fierce Healthcare reports,
    • “A better consumer experience has implications for clinical improvements, according to a new report from CVS Health.
    • “The healthcare giant is putting a focus on innovation in this area, and to identify opportunities conducted an analysis that compared Net Promoter System (NPS) scores with clinical outcomes. It found that, for example, patients who were highly satisfied with the experience at their pharmacies were more likely to be adherent to their medications.
    • “The white paper notes that nonadherence to prescribed medications drives 16% of U.S. health spending each year, or about $500 billion.” 
  • Modern Healthcare tells us,
    • “Eli Lilly is partnering with digital health companies to boost sales of its weight loss medications.
    • “The drugmaker added hybrid weight loss startup Knownwell to its third-party marketplace of telehealth offerings earlier this month. Eli Lilly has also signed deals with Ro, Form Health and 9am Health.” 
  • BioPharma Dive recently updated its prescription drug patent tracker.
  • Bloomberg Law adds,
    • “Novo Nordisk A/S and Eli Lilly & Co. are using dense clusters of patents to extend monopolies on blockbuster diabetes and weight-loss drugs including Ozempic, Wegovy, and Mounjaro, fueling high prices and health inequities, according to an advocacy group report.
    • “The pharmaceutical companies’ adoption of a “financialized business model” prioritizes profits and shareholder returns through an aggressive strategy for securing additional patents for minor changes to extend their drugs’ market exclusivity well beyond the expiration of its original patents, according to a report released Thursday by the Initiative for Medicines, Access and Knowledge on “the heavy price” of those glucagon-like peptide 1 therapies.” * * *
    • In a statement Friday, Lilly said the “report is grossly inaccurate and includes patents that have nothing to do with tirzepatide.”
    • “To date, Lilly has only listed three patents in the Orange Book for” its two tirzepatide products, it added.
    • “Our business model is built on the fact that patents are limited in scope and duration, and when they expire, we welcome generic and biosimilar manufacturers to develop lower-cost alternatives,” the statement continued. “Lilly is already focused on developing the next innovation for patients that will eventually become generic.”
    • “The Orange Book is a US Food and Drug Administration registry listing patents that cover approved drugs that allows branded-drug makers to trigger a 30-month delay of FDA approval by filing a suit alleging infringement of a listed patent.
    • “Novo in a Friday statement said it has no more than four patents listed in the Orange Book for Ozempic , no more than eight for Wegovy, and 11 for Rybelsus.
    • “While the US healthcare system is complex and there are many factors that play a role in determining what people will pay for medicines,” Novo said, “the net price of Ozempic has declined by 40% since launch in the US and Wegovy is following a similar trajectory.”

Midweek Report

David Ermer–CDC, Congress, Medical / Rx research, Mental health care, Obesity, Rx coverage, SCOTUS, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC

  • The Wall Street Journal reports
    • “President Trump told Republicans wavering on the party’s fiscal framework to “close your eyes and get there.” GOP opponents of the plan say they are heading into the budget showdown with eyes wide open, and some appear willing to block the president’s push, setting up a too-close-to-call vote late Wednesday.
    • “Trump and House GOP leaders have routinely melted internal party opposition this year with promises and appeals to Republican unity. This time, they face dug-in critics of the budget passed by the Senate on Saturday.
    • “Republican leaders are optimistic they can get the measure through the House, and Speaker Mike Johnson (R., La.) told reporters that he thought it would pass. The House advanced the measure past a procedural hurdle in a 216-215 tally, setting up the final debate and vote. That procedural vote contained an unrelated provision that will make it harder this year for the House to reverse Trump’s tariffs.”
  • Politico adds,
    • “House Republican leaders canceled a vote on the Senate’s budget resolution Wednesday night, as Speaker Mike Johnson came to terms with what had been clear for many hours: Too many Republicans would vote in opposition and the measure was bound to fail.” * * *
    • “Lawmakers are slated to head back to their districts Thursday for a two-week recess, meaning that the president could have to wait to see any forward motion on his “big, beautiful bill” if a compromise can’t be reached soon.
    • “Johnson said Wednesday night that House leadership will now explore either amending the Senate-adopted budget or going straight to conference with the Senate and working out differences there.
    • “We’re going to make that decision,” he told reporters just after the resolution was pulled.”
  • The American Hospital Association News tells us,
    • “President Trump announced on April 9 (https://tinyurl.com/2t463edy) that reciprocal tariffs that went into effect after midnight for certain nations will be paused for 90 days, while tariffs for China would be increased to 125%. A 10% universal tariff on imported goods from all countries that began April 5 remains in effect.”
  • and
    • “The Office of Management and Budget April 9 released a notice seeking public input on rules to potentially be rescinded, requesting detailed reasons for their rescission. Comments must be received by OMB no later than 30 days after publication of the notice in the Federal Register. The notice will be published April 11. Comments can be submitted at www.regulations.gov.”

From the judicial front,

  • Federal News Network lets us know,
    • “For the second time in as many days, a higher court has paused a judicial ruling that ordered the reinstatement of federal employees who were fired en masse, leaving thousands of probationary workers vulnerable once again to potential termination.
    • “In a 2-1 ruling Wednesday, a three-judge panel of the Fourth U.S. Circuit Court of Appeals temporarily set aside a Maryland judge’s injunction that had ordered agencies to reinstate employees in 19 states and the District of Columbia. The majority found the government was likely to succeed in proving that the Maryland district court had no jurisdiction over the states’ claims that federal agencies had engaged in an illegal Reduction in Force (RIF).
    • “The panel’s ruling comes one day after the Supreme Court issued a separate stay that had a similar effect on a California court’s ruling that had also ordered the reinstatement of some agencies’ fired probationary workers. In that case, the high court, in an unsigned order Tuesday, also put the preliminary injunction on hold while claims of illegal firing work their way through the appeals process.” * * *
    • “And in California, the judge is considering whether to issue another preliminary injunction that could withstand the ruling the Supreme Court issued Tuesday. In that order, the justices found that the outside organizations harmed by the mass firings didn’t have standing to sue, but explicitly left open the possibility that other plaintiffs, including federal unions, could win an injunction of their own.
    • “In a San Francisco courtroom Wednesday, Judge William Alsup heard arguments over whether unions had standing to sue and win another injunction. However, he postponed issuing a ruling until attorneys in the case provide more information, including data about how many employees were affected by the mass terminations, their relationships with the union plaintiffs, and possible evidence that would show that agencies’ firing decisions were made at the behest of the Office of Personnel Management.”
  • Bloomberg Law points out,
    • “US Chief Justice John Roberts let President Donald Trump temporarily oust top officials at two independent agencies while the Supreme Court decides how to handle a new showdown over presidential power.
    • “Roberts’ order Wednesday puts on hold a federal appeals court decision that had let National Labor Relations Board member Gwynne Wilcox and Merit Systems Protection Board member Cathy Harris go back to work. Roberts said his order will last until either he or the full court issues a longer-term decision.
    • “The case is testing a 1935 Supreme Court ruling that let Congress shield high-ranking officials from being fired, paving the way for the independent agencies that now proliferate across the US government. The legal wrangling ultimately could affect whether Trump has the power to fire Federal Reserve Chair Jerome Powell.”
  • Beckers Payer Issues notes, “A New York federal [district] judge dismissed an antitrust lawsuit against UnitedHealthcare and MultiPlan that alleged the companies conspired to reduce reimbursement rates for an anesthesia services provider.”

From the public health and medical research front,

  • AP reports,
    • “A day care facility in a Texas county that’s part of the measles outbreak has multiple cases, including children too young to be fully vaccinated, public health officials say.
    • “West Texas is in the middle of a still-growing measles outbreak with 505 cases reported on Tuesday. The state expanded the number of counties in the outbreak area this week to 10. The highly contagious virus began to spread in late January and health officials say it has spread to New Mexico, Oklahoma, Kansas and Mexico. 
    • “Three people who were unvaccinated have died from measles-related illnesses this year, including two elementary school-aged children in Texas. The second child died Thursday at a Lubbock hospital, and Health Secretary Robert F. Kennedy Jr. attended the funeral in Seminole, the epicenter of the outbreak. 
    • “As of Friday, there were seven cases at a day care where one young child who was infectious gave it to two other children before it spread to other classrooms, Lubbock Public Health director Katherine Wells said.”
  • Per Newsweek,
    • “Cabot Creamery is recalling 1,700 pounds of butter after testing found elevated levels of coliform bacteria in the product, a marker of potential fecal contamination.
    • “The voluntary recall, initiated by Agri-Mark Inc, Cabot Creamery’s parent company, affects the brand’s 8-ounce Extra Creamy Premium Sea Salted Butter and was distributed in seven states.”
  • The New York Times reports,
    • “During a recent five-year period, a substantial portion of maternal deaths in America — almost one-third — took place more than six weeks after childbirth, at a time when most new mothers think they are in the clear, researchers reported on Wednesday.
    • “The study, published in JAMA Network Open, is one of the first to track maternal health complications during pregnancy and in the year after delivery.
    • “Pregnancy-related death rates in the United States rose almost 28 percent from 2018 to 2022, the researchers found, surging at the height of the Covid-19 pandemic in 2021 before subsiding somewhat.
    • “Our study illustrates why we can’t take our eyes off maternal health,” said Dr. Rose L. Molina, an associate professor of obstetrics, gynecology and reproductive biology at Harvard Medical School and one of the study’s authors.
    • “Women need “access to high-quality care from the moment of conception to a full year after birth,” she added. While there has been a growing emphasis on care in the year after childbirth, “we’re not there yet.”
  • The National Cancer Institute’s Cancer Information Highlights discusses “Targeting a Gene Fusion | Fat Cells to Starve Tumors | TIL Shrinks Solid Cancers.”
  • Per an NIH news release,
    • “In a massive scientific effort funded by the National Institutes of Health (NIH), hundreds of researchers have helped to map the connections between hundreds of thousands of neurons in the mouse brain and then overlayed their firing patterns in response to visual stimuli. This breakthrough is a critical piece of foundational science to build toward understanding how our brains process visual information to reconstruct the images we see every day.
    • “Information processing in the human brain occurs via electrical firing of 86 billion neurons that make trillions of connections with each other. The secrets of how our brain enable us to think, feel, and act lie hidden in the complexity of its wiring diagram and the barrage of electrical signals that move across it in millisecond time frames. While the current findings focus on a tiny fraction of the brain, they reveal the complex connections between the cells and show how those connections are wired to produce functional responses. This information, which was previously beyond our reach, could help us understand how the brain functions normally and offer a guide to what goes wrong as the result of various disorders or injuries.”  
  • Per UPI,
    • “Emergency room visits attributed to popular weight loss drugs such as Ozempic and Wegovy remain quite rare overall, but do show an unexpected link to hypoglycemia, according to a study released Monday.
    • “Semaglutide brand names include Ozempic, Rybelus, and Wegovy, all made by Novo Nordisk, and Mounjaro from Eli Lilly.
    • “The study, led by the Centers for Disease Control and Prevention and Cambridge Health Alliance, was published in the Annals of Internal Medicine. It provides reassuring evidence that serious adverse events associated with the burgeoning use of the drugs are uncommon.
    • “That’s impressive given the overwhelming popularity of semaglutides, which are among a class of “wonder drugs” known as GLP-1 agonists.”
  • STAT New informs us,
    • Since 2021, when the information blocking rules kicked in, health systems and patients have been reckoning with the impact of electronic medical records that allow instant access to test results — good, bad, and in between — sometimes before a doctor has ever seen them. Patients overwhelmingly prefer having their health information as soon as possible, even before it’s interpreted. But there’s a tradeoff between medical transparency and the worry that can be caused when a result is unclear, or even inaccurate.
    • A new study published in JAMA Network Open on Tuesday aims to understand how health systems might find the right balance. “We were curious if refresh, refresh, refresh behavior could be measured,” said senior author Trent Rosenbloom, who directs the patient portal at Vanderbilt University Medical Center. Over two years, researchers and physicians at Vanderbilt tracked how 290,000 patients at the medical center viewed their test results online. In 2022 and 2023, more than 100,000 patients — 37% of the total — refreshed the portal as they waited for results to appear. Some patients clicked to check their results as many as 16 times.  * * *
    • “Across health systems, information officers are working on other ways to ensure automatic test results are more of a benefit than a burden. At Stanford Medicine, said chief medical information officer Christopher Sharp, every primary care practice now uses large language models to generate interpretations of test results, which a doctor can sign off on to send to a patient. The system is also being piloted in specialties with more high-sensitivity results, and Stanford hopes to have it implemented across the entire organization by September.”

From the U.S. healthcare business front,

  • Beckers Payer Issue lets us know,
    • “Blue Cross and Blue Shield of North Carolina reported a net income of $69 million in 2024, Business North Carolina reported April 7. 
    • “The company recorded $11.9 billion of revenue in 2024, compared to $12.2 billion in 2023.
    • “Claims and medical expenses increased 7.2% to $10.4 billion in 2024, and the company’s reserves are equal to 3.3 months of claims and administrative expenses.”
  • Per Beckers Hospital Review,
    • “Despite economic volatility, Fitch still expects healthcare providers to experience a “modest margin expansion” this year due to easing inflationary pressures and reimbursement increases, according to an April 9 report.
    • “The firm anticipates healthcare providers will see Medicare and commercial rate bumps 3% to 4% this year as rates increase and the volume of high acuity cases grows with the aging population.
    • “The workforce challenges plaguing healthcare providers over the last several years are lessening as well, according to the report.
    • “Chronic personnel shortages will continue to ease, suppressing wage inflation and reducing reliance on costlier external agency labour,” the report notes. “Wages are unlikely to exert pressure on provider margins in 2025, with revenue growth likely to match or exceed wage growth.”
    • “The healthcare providers in a more stable financial situation will be in the best position to grow over the next few years. Struggling hospitals will continue to have challenges, and some may seek merger or acquisition partners to stay operational.”
  • Per Modern Healthcare,
    • “A court ruling striking down a federal nursing home staffing mandate brought a sigh of relief from nursing home operators even as the industry still faces financial uncertainty.
    • “An end to the mandate could bring stability to nursing home budgets and valuations. However, some nursing homes still face challenges, such as tougher state staffing minimums, as well as the threat of potential Medicaid rate cuts.
    • “A federal judge in Texas on Monday tossed the controversial nursing home mandate the Biden administration rolled out last year that required nursing homes to have a registered nurse onsite 24 hours a day, seven days a week. The court also blocked a requirement that nursing homes provide at least 3.48 hours of care per resident, per day.
    • “The Health and Human Services Department said in an email it does not comment on legal matters when asked about a possible appeal. However, many in the industry had been expecting the Trump administration to roll back the regulation.”
  • and
    • “Nonprofit health insurance company CareSource has invested more than $400 million to buy struggling nonprofit insurer Commonwealth Care Alliance. 
    • “The deal adds nearly 50,000 Dual Special Needs Plan members who are eligible for both Medicaid and Medicare to CareSource’s book of business, the companies said in a news release Wednesday. CareSource also acquired Commonwealth Care Alliance’s two primary care clinics and its home care practice through the transaction. CareSource counts 2 million Medicaid, Medicare and exchange plan enrollees across seven states.
    • “CareSource CEO Erhardt Preitauer will take over as head of Commonwealth Care Alliance, replacing current CEO Chris Palmeri, who will depart the company. Palmeri currently serves on the board of directors of the insurance lobbying group AHIP. At the start of the year, he stepped down from his role as board chair of the Association of Community Affiliated Plans, a nonprofit Medicaid insurer trade group.
    • “The deal had not been previously announced.” 

Tuesday Report

David Ermer–AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare–

From Washington, DC

  • NBC News reports,
    • “Speaker Mike Johnson, R-La., is facing a growing rebellion from conservative hard-liners in the House as Republicans seek to take up a budget blueprint that was recently adopted by the Senate to pass President Donald Trump’s agenda.
    • “House GOP leaders are eyeing a vote this week on the measure, which would unlock the path for committees to craft a massive bill to cut taxes, boost immigration enforcement and defense spending and lift the debt limit without Democratic votes.
    • “But a slew of House conservatives have blasted the Senate’s version for requiring just $4 billion in spending cuts. The House’s version, by contrast, called for $1.5 trillion to $2 trillion in spending cuts while largely steering clear of specifics.”
  • CBS News informs us,
    • “The Centers for Disease Control and Prevention has begun redeploying staff to respond to the deadly outbreak of measles in Texas, a spokesperson said Monday, a week after steep layoffs at the agency impacted its response to the spread of the virus. 
    • “A team of three deployed yesterday to meet with county and state officials to assess the immediate needs to respond to this outbreak. The team is meeting with officials again today,” CDC spokesperson Jason McDonald said in an email. 
    • “Health and Human Services Secretary Robert F. Kennedy Jr. first said Sunday that the CDC would be redeploying to Texas at its governor’s request, after another unvaccinated child died in the measles outbreak. An 8-year-old girl was the second fatality there this year.
    • “Once the assessment is complete, more CDC staff will be sent to Texas per Sec. Kennedy’s order and the governor’s request. The first teams deployed to Texas arrived on March and returned to CDC on April 1,” McDonald said.”
  • Per MedPage Today,
    • The U.S. Preventive Services Task Force (USPSTF) still recommends primary care behavioral counseling for breastfeeding, mostly in line with its 2016 guidelines.
    • In the updated recommendation statement published in JAMA, USPSTF wrote that “providing interventions or referrals, during pregnancy and after birth, to support breastfeeding” received a B grade, indicating moderate certainty these interventions will have moderate net benefit.

From the judicial front,

  • The Wall Street Journal tells us,
    • “The Supreme Court lifted a lower-court order that directed the Trump administration to reinstate about 16,000 federal employees it fired, handing the White House the third victory in a row as it seeks the justices’ emergency action to stop district judges from slowing its policies. 
    • “The justices on Tuesday said that environmental groups and other nonprofit organizations who say they were harmed by the reduction in public services caused by the layoffs didn’t have legal standing to bring suit. 
    • “The brief order was unsigned, as is typical when the court acts on emergency requests. Two liberal justices, Sonia Sotomayor and Ketanji Brown Jackson, said they voted to deny the Trump administration’s request.” * * *
    • “The Supreme Court on Tuesday agreed with the Trump administration that the nonprofits lacked legal standing to bring the case. The court added, though, that the order didn’t address other plaintiffs in the suit, including several labor unions and the state of Washington. Alsup’s injunction wasn’t based on their claims, although those parties may face other questions regarding their standing to bring suit.
    • “Tuesday’s order doesn’t resolve broader legal disputes over the administration’s mass layoffs of federal employees.”
  • Bloomberg Law relates,
    • “A string of lawsuits targeting the use of artificial intelligence and algorithms in claims denials is raising risks for private health insurers and employers, even as the litigation encounters early obstacles.
    • “A California federal judge’s recent decision to partially allow a case to proceed over Cigna Corp.’s alleged use of algorithms to improperly deny benefits signals that automation tools come with legal hazards.” * * *
    • “To the extent that these tools are being used to block or deny coverage across the board for medically necessary services and to a large number of beneficiaries—if that is the case and that’s how these have been used, that could expose insurers to significant risk,” said David Greenberg, partner at ArentFox Schiff LLP.
    • “Courts have allowed several lawsuits to proceed, but plaintiffs still face significant challenges in making their cases. In some instances, the insurance companies denied that the plaintiffs’ medical claims were even handled by an algorithm. Proving otherwise can be difficult.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • The Centers for Disease Control and Prevention April 8 sent an alert to health care providers on measles prevention and treatment. The agency said that risk remains low for most individuals across the U.S. and that the measles, mumps and rubella vaccine is the best way to protect against the disease. 
  • and
    • “The incidence of invasive group A strep infections increased from 3.6 to 8.2 cases per 100,000 people from 2013 to 2022, according to a study authored by the Centers for Disease Control and Prevention published April 7 by JAMA. The authors concluded that accelerated efforts to prevent and control these infections are needed, especially among groups at highest risk of infection, which includes individuals 65 years or older, American Indian or Alaska Native persons, residents of long-term care facilities, people experiencing homelessness, and people who inject drugs.” 
  • Per Medscape,
    • “Around 38 million people in the United States — or slightly over 11% of the population — have diabetes, according to the National Diabetes Statistics Report. Experts only expect that number to increase, and research suggests that the burden will be especially significant in low to low-middle socioeconomic areas.
    • “Consider the Mississippi Delta, a swath of fertile land in the floodplain of the Mississippi River. It has a rich and diverse cultural heritage, with a minority-majority population, along with significant economic challenges and a persistently high poverty rate. The region also has one of the highest diabetes rates in the country, which has put the healthcare community on alert.
    • “We are more intensely screening almost everybody,” said Brent Smith, MD, a family physician in Greenville, Mississippi, and a member of the board of directors of the American Academy of Family Physicians.”
  • AP reports,
    • “Health care systems can reduce suicides through patient screening, safety planning and mental health counseling, a new study suggests, an important finding as the U.S. confronts it 11th leading cause of death.
    • “The “Zero Suicide Model” was developed in 2001 at Detroit-based Henry Ford Health, where the focus on people considering suicide included collaborating with patients to reduce their access to lethal means such as firearms and then following up with treatment.
    • “The approach made a difference, and for all of 2009, the health system saw no suicides among patients. The researchers then studied what happened when a different health system, Kaiser Permanente, adopted the program in four locations from 2012 through 2019.
    • “Suicides and suicide attempts fell in three of the locations, while the fourth maintained a low rate of suicides and attempts. Suicide attempts were tracked in electronic health records and insurance claims data. Suicides were measured using government death records.”‘
  • The Washington Post notes,
    • “Those who exercised the most had a 26 percent lower cancer risk than those who exercised the least in an analysis of biomedical data, according to research published in the British Journal of Sports Medicine.
    • “The article drew upon data from UK Biobank, a longitudinal study that enrolled 500,000 adults in Britain between 2006 and 2010. After enrolling, more than 106,000 adults were invited to participate in the sub-study on physical activity. The final sample, stratified into five groups, or quintiles, of physical activity levels, included about 85,000 participants with a median age of 63 years.” * * *
    • “The research identified an inverse relationship between overall daily physical activity and cancer risk, indicating that even modest increases in activity levels were sufficient to significantly reduce the risk of the 13 cancers. Individuals in the second-highest quintile of physical activity had a 16 percent lower risk compared with those in the lowest quintile. Higher levels of activity had a more protective effect.”
  • Per MedTech Dive,
    • “Johnson & Johnson said Monday it has enrolled the first patient in a pivotal study of a device for clearing “difficult-to-cross” coronary arteries.
    • “Like other products made by J&J’s Shockwave Medical, the Javelin intravascular lithotripsy catheter uses sound pressure waves to break up calcium deposits that are blocking blood flow. 
    • “The device is differentiated from other Shockwave products, and rival catheters from Abbott and Boston Scientific, because it emits waves from its tip. Other devices send waves from a balloon catheter that must cross the blocked part of the artery to be effective.” * * *

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “Hospital average operating margins dropped from 3.4% in January to 2.5% in February, but are still above 2024 averages, according to Kaufman Hall’s “National Hospital Flash Report.”
    • “Kaufman Hall, a Vizient company, gathered financial performance data from 1,300 hospitals. The average operating margin dropped 11% month over month but grew 5% year over year. The average operating EBITDA margin decreased 7% month over month but grew 1% year over year.
    • “Net operating revenue per calendar day increased 8% year over year, driven by an 11% jump in inpatient revenue. Outpatient revenue grew just 8% compared to February 2024.
    • “Expenses were also on the rise, with total expenses also up 8% year over year driven by a 10% growth in supply expenses per calendar day. Drug expenses and non-labor expenses both jumped 9% while labor expenses grew 6% year over year. Purchased services expenses also increased 13% from February 2024.
    • “Patient volume held steady, as discharges per calendar day were up 6% year over year in February. Observation days dropped 9% and the average length of stay was flat compared to the same period last year. Emergency department visits increased 4%.”
  • Modern Healthcare adds,
    • “Health systems announced five hospital merger and acquisition proposals in the first three months of the year, the lowest quarterly amount in more than a decade.
    • “Providers were reluctant to wade into hospital transactions amid the uncertainty surrounding tariffs, federal funding concerns, state and federal regulatory changes and economic volatility, according to a new report from consultancy Kaufman Hall. Four of the five proposed hospital deals involved financially distressed facilities, the report found.”
  • Specifically, Fierce Healthcare reports,
    • “Northwell Health and Nuvance Health’s 28-hospital merger has cleared its final regulatory hurdle and is expected to close within the next 30 days.
    • “Tuesday, Connecticut’s Office of Health Strategy announced it had reached an agreement with the two health systems after just over two months of negotiations over their Certificate of Need application. The pair’s merger, announced 14 months ago, had received a similar all-clear from New York’s Public Health and Health Planning Council last September as well as sign-offs from each state’s attorneys general during the summer.
    • “Alongside price constraints tied in part to state and regional cost growth benchmark, Northwell—the acquirer—will invest at least $1 billion into Nuvance’s Connecticut and New York hospitals and refrain from any real estate sale leasebacks over a five-year period.”
  • Fierce Healthcare also lets us know,
    • “Rural hospital leaders are questioning whether they can continue to afford to do business with Medicare Advantage (MA) companies, and some say the only way to maintain services and protect patients is to end their contracts with the private insurers.
    • “MA plans pay hospitals lower rates than traditional Medicare, said Jason Merkley, CEO of the Brookings Health System in South Dakota. Merkley worried the losses would spark staff layoffs and cuts to patient services. So, last year, Brookings Health dropped all four contracts it had with major MA companies.
    • “I’ve had lots of discussions with CEOs and executive teams across the country in regard to that,” said Merkley, whose health system operates a hospital and clinics in the small city of Brookings and surrounding rural areas.
    • “Merkley and other rural hospital operators in recent years have enumerated a long list of concerns about the publicly funded, privately run health plans. In addition to the reimbursement issue, their complaints include payment delays and a resistance to authorizing patient care.
    • “But rural hospitals abandoning their MA contracts can leave local patients without nearby in-network providers or force them to scramble to switch coverage.”
  • Per Healthcare Dive,
    • “CVS Health named a new CFO Tuesday as the healthcare giant continues to shake up its leadership team. 
    • “Brian Newman, most recently CFO of shipping and logistics firm UPS, will start at CVS on April 21. Tom Cowhey, who took on the permanent CFO position at CVS early last year, will become a strategic advisor to CEO David Joyner, effective May 12. 
    • “In addition to the leadership change, CVS said it expects financial results for 2025 to meet or exceed its previously issued guidance. In February, the company reported expected adjusted earnings for the year between $5.75 and $6 a share.” 
  • Per Beckers Hospital Review,
    • “Walgreens Boots Alliance reported a $5.6 billion operating loss in its fiscal second quarter, an improvement from the $13.2 billion loss in the same period last year as the troubled retailer continues to prepare for a private equity buyout. 
    • “Operating losses included a $3 billion impairment charge tied to its Village MD business, according to an April 8 company news release. 
    • “Despite ongoing challenges, Walgreens reported better than expected results in sales, with sales rising 4% to $38.59 billion. In addition, pharmacy sales rose 12% while retail sales fell by 3%. 
    • “The company announced last month that it would be acquired by Sycamore Partners in a deal valued at $10 billion. Walgreens also recently suspended its quarterly dividend part of a broader cost cutting effort.”
  • Per Fierce Pharma,
    • “While much of the recent GLP-1 saga has been written in the U.S., Novo Nordisk continues to expand its semaglutide empire across the globe and make inroads into large markets like Brazil.
    • “Now, in a bid to boost its production capacity in Latin America’s most populous country, Novo is plugging 6.4 billion Brazilian reais (roughly $1.09 billion) into an expansion of its manufacturing plant in the Brazilian city of Montes Claros.
    • “The investment, which marks one of the largest ever for pharmaceuticals in Brazil, will “significantly” bolster the facility’s capacity to crank out a variety of injectables, including GLP-1 medicines like Ozempic and Wegovy, Novo said in a Portuguese-language press release.”

From the artificial intelligence front,

  • Cardiovascular Business reports,
    • “Powerful Medical, a New York-based artificial intelligence (AI) company, has received the FDA’s breakthrough device designation for its AI model designed to detect signs of an ST-elevation myocardial infarction (STEMI) in electrocardiography results.
    • “The company’s PMcardio STEMI AI ECG model, nicknamed “Queen of Hearts,” identifies STEMI and STEMI-equivalent patterns in a patient’s ECG. It was trained by Stephen W. Smith, MD, an emergency physician at Hennepin County Medical Center and founder of Dr. Smith’s ECG Blog.
    • “For the last 20 years, life-saving treatment exists for heart attack patients, yet far too many still don’t receive the urgent care they need due to delays in diagnosis and inefficient triage,” said Robert Herman, MD, PhD, chief medical officer of Powerful Medical, said in a statement. “By equipping physicians and allied providers with an AI-powered tool for accurate and immediate STEMI detection, available around the clock, we can bridge this gap, ensure timely treatment, and improve patient outcomes, often preventing avoidable deaths.”
  • and
    • “Artificial intelligence (AI)-assisted mammography may be able to predict a woman’s risk of developing cardiovascular disease, according to new data being presented at ACC.25, the American College of Cardiology’s annual conference.
    • “Breast artery calcifications are already visible when radiologists review mammograms, but nothing typically happens with those findings. Researchers aimed to see if AI could do some of the heavy lifting and help translate those findings into an easy-to-understand cardiovascular risk score.
    • “The group trained an advanced AI model to segment calcified vessels in mammography images and produce a risk score that calculates the patient’s risk of developing heart disease. To help make the new-look algorithm as accurate as possible, they developed it using mammography images and electronic health record data from more than 56,000 patients. The patients were all treated from 2013 to 2020 within the Emory Healthcare health system, and at least five years of follow-up data were available for each of them.
    • “Advances in deep learning and AI have made it much more feasible to extract and use more information from images to inform opportunistic screening,” lead author Theo Dapamede, MD, PhD, a postdoctoral fellow at Emory University in Atlanta, said in a statement.”
  • Per Beckers Clinical Leadership,
    • “An AI tool that analyzes nurses’ notes for subtle clinical changes helped reduce patient risk of death by 35.6%, length of stay by 11.2% and sepsis risk by 7.5%, according to research published April 2 in Nature. 
    • “In a yearlong, multisite study, researchers assessed the tool across 74 clinical units in two health systems. Among 60,893 hospital encounters, about half involved the early warning system and the other half did not. 
    • “The system, dubbed COmmnuticating Narrative Concerns Entered by RNs (CONCERN), is a machine learning algorithm that uses real-time nursing surveillance notes and data patterns to detect all-cause deterioration risks. 
    • ‘Other EWSs often “rely on late and noisy physiologic indicators of deterioration” such as lab results and vital signs, according to the researchers. In contrast, this tool leverages nurses’ “subtle, yet observable, clinical changes that may not be captured in physiological data or well displayed in EHRs,” including small changes in mental status from baseline or slower recovery of arterial blood pressure after turning a patient.” 

Monday Report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • The Wall Street Journal reports,
    • “House Republicans’ moves to advance President Trump’s “one big, beautiful bill” this week have been cast into doubt by defections from GOP lawmakers worried that spending cuts are being pushed aside in a rush to enact tax reductions.
    • “Republican leaders want to vote on a fiscal framework that would unlock a fast track to legislation carrying many Trump priorities, including tax cuts and new spending on border security and the military. Trump and House Speaker Mike Johnson (R., La.) are hoping to show progress on extending expiring tax cuts to counteract the market chaos sparked in recent sessions by Trump’s tariff rollout.” 
  • and
    • The Trump administration will substantially increase payment rates for Medicare insurers next year, generating more than $25 billion in additional revenue for the industry and doubling the boost proposed in January.
    • The rate increase of 5.06%, compared with 2.23% in the earlier proposal from the Biden administration, overshoots even optimistic expectations from many Wall Street analysts, and will likely lead to a rally in the shares of big Medicare insurers such as UnitedHealth Group, Humana and CVS Health, parent of Aetna.
    • The Centers for Medicare and Medicaid Services announced the increase for 2026 payment rates on Monday. Investors are expected to view the bump as a sign of the Trump administration’s support for Medicare Advantage, the program under which private insurers administer the benefits of the federal program for older and disabled Americans. 
      The Medicare agency said the increase in the planned payment rate reflected rising medical costs, and that more recent data had led to the steeper final rise compared with the January proposal. 
  • Here are links to the CMS Medicare Advantage and Medicare D 2026 rate announcement, the related CMS fact sheet, and a CMS fact sheet about final 2026 Part D program redesign instructions:
    • “In CY 2026, the structure of the Part D benefit will be updated to reflect provisions of the IRA that become effective on January 1, 2026. The CY 2026 updates include the following:
    • “The CY 2026 annual out-of-pocket (OOP) threshold of $2,100, which is the original 2025 out-of-pocket cap of $2,000, adjusted based on the annual percentage increase in average expenditures for covered Part D drugs in the U.S. for Part D eligible individuals in the previous year (API).
    • “Changes to the liability of enrollees, sponsors, manufacturers, and CMS in the new standard Part D benefit design, specifically to account for the start of negotiated prices taking effect with respect to selected drugs for initial price applicability year 2026 under the Negotiation Program; and
    • “The establishment of the selected drug subsidy program.” * * *
    • “With the enhancements to the Part D benefit under the IRA, the current simplified determination methodology no longer reflects actuarial equivalence with defined standard Part D coverage. Accordingly, CMS has developed a revised simplified determination methodology that better reflects actuarial equivalence with the richer Part D defined standard benefit under the IRA. For CY 2026 only, non-RDS group health plans are permitted to use either the existing simplified determination methodology or the revised simplified determination methodology to determine whether their prescription drug coverage is creditable. Under the revised simplified determination methodology, the group health plan coverage must be designed to pay at least 72% of participants’ prescription drug expenses, versus 60% under the existing methodology.” 
  • In another surprising Medicare development, STAT News informs us,
    • “Medicare’s financial future unexpectedly got a lot rosier, at least according to some federal budget wonks. 
    • “The Congressional Budget Office recently published its long-term predictions of the federal budget and buried a big surprise for people who follow the Medicare program. The government’s primary piggy bank that pays for Medicare [Part A hospital and other facility] benefits won’t be depleted until 2052 — 17 years later than what CBO analysts predicted last year. 
    • “Quite a few responded they don’t believe it,” he said. “But they [CBO] do have their justification there. And of course this is a long-term projection, and a lot can change.”
  • The New York Times reports,
    • “Health Secretary Robert F. Kennedy Jr. kicked off a tour through southwestern states on Monday by calling on states to ban fluoride in drinking water supplies, a move that would reverse what some medical experts consider one of the most important public health practices in the country’s history.
    • “The announcement came at a news conference in Utah, the first state to enact such a ban into law. The state’s new law is set to take effect in early May, despite concerns from public health experts who consider fluoridation of water core to preventing tooth decay.
    • “It makes no sense to have it in our water supply,” Mr. Kennedy said, echoing a position he took during the 2024 presidential campaign. “I’m very, very proud of this state for being the first state to ban it, and I hope many more will come.”
    • “The Centers for Disease Control and Prevention, which Mr. Kennedy oversees as health secretary, has listed fluoridation as one of the 10 great public health achievements of the 20th century. After the news conference, Stefanie Spear, Mr. Kennedy’s principal deputy chief of staff, said Mr. Kennedy would direct the C.D.C.’s community preventative services task force to study fluoride and make a new recommendation.”
  • Per FedSmith,
    • “Retirement planning is a complex process for federal employees, requiring careful attention to eligibility rules and regulations. Among the many requirements that determine post-retirement benefits, the 5-year rule plays a crucial role in three key programs: Federal Employees Health Benefits (FEHB), Federal Employees’ Group Life Insurance (FEGLI), and Roth Thrift Savings Plan (Roth TSP). Understanding these rules can ensure a smooth transition into retirement while maintaining access to critical benefits.”
    • The article provides an understanding of these important rules.

From the judicial front,

  • Govexec relates,
    • “There’s a quorum again on the board that hears appeals of firings and suspensions of federal employees after a majority of judges on the U.S. Court of Appeals for the D.C. Circuit vacated an earlier decision that temporarily enabled President Donald Trump to remove a Democratic appointee to the Merit Systems Protection Board. 
    • “Trump in February attempted to fire Cathy Harris, a Biden appointee, from the MSPB. A district judge blocked the removal, but that order was paused on March 28 in a 2-1 decision by a three-judge panel of the D.C. Circuit while it heard the Trump administration’s appeal. 
    • “On Monday, however, a majority of D.C. circuit court judges overruled that decision through en banc reconsideration, which is a rare process that can be utilized if a litigant feels a circuit panel didn’t adhere to Supreme Court precedent. Such reconsideration involves all circuit judges who are in regular active service rather than the usual three-judge panel. 
    • “The circuit court judges were split 7-4 in granting the motion for en banc reconsideration. 
    • “At issue in this case is Humphrey’s Executor, a 1935 Supreme Court decision that found the president doesn’t have unfettered authority to remove officials on multimember, quasi-judicial bodies.” * * *
    • “Monday’s decision, as well as the overturned March 28 order, also apply to Gwynne Wilcox, a Biden appointee to the National Labor Relations Board who Trump similarly fired but who was later reinstated by a district court. 
    • “In a brief, lawyers for the Trump administration said they would seek emergency relief from the Supreme Court if Wilcox and Harris were allowed to return to their positions.”  
  • Bloomberg Law reports,
    • “A federal judge in Texas on Monday vacated a Biden administration rule that would have required about 75% of US nursing homes to add direct-care workers or face administrative penalties and fines.
    • “In his order granting a motion for summary judgment for the plaintiffs, the American Health Care Association, Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, said the nation’s nursing homes suffer from “failures,” including “inadequate staffing levels, poor infection control, failures in oversight and regulation, and deficiencies that result in actual patient harm.” All of which “deserve an effectual response,” he wrote.
    • “But any regulatory response must be consistent with Congress’s legislation governing nursing homes. The Final Rule’s challenged provisions are not,” Kacsmaryk declared of the varied requirements of the mandate, which included that facilities have a registered nurse on site around the clock. “Though the Final Rule attempts to remedy chronic nursing home deficiencies, it does so deficiently.” 
    • “Although “rooted in laudable goals, the Final Rule still must be consistent with Congress’s statutes,” Kacsmaryk added. “To allow otherwise permits agencies to amend statutes though they lack legislative power. Separation of powers demands more than praiseworthy intent.”

From the public health and medical research front,

  • The American Hospital Association News clarifies,
    • “A second Texas child died from measles April 3 amid an ongoing outbreak in the state, the Texas Department of State Health Services announced April 6. The child was not vaccinated and had no reported underlying conditions, the agency said. The latest death follows a child that died Feb. 26. An unvaccinated adult in New Mexico that died in March also tested positive for measles after their death, but measles was not confirmed as the official cause of death.”
  • The American Medical Association News lets us know what doctors wish their patients knew about improving their mental health.
  • Per MedPage Today,
    • “Biomarker and cognitive data supported treatment with the anti-amyloid agent lecanemab (Leqembi) for up to 36 months in early Alzheimer’s disease, initial findings from the CLARITY AD open-label extension study suggested.
    • “Continuous treatment led to greater changes in plasma amyloid-beta 42/40 levels, reported Christopher van Dyck, MD, of Yale University in New Haven, Connecticut, in a poster presented at the American Academy of Neurologyopens (AAN) annual meeting.” * * *
    • “Serious adverse events occurred in 20.5% of the total sample of 1,616 people in the core CLARITY AD trial and the open-label extension study who received lecanemab. Amyloid-related imaging abnormalities with edema (ARIA-E) occurred in 14.7%, ARIA with hemosiderin deposits (ARIA-H) occurred in 23.8%, and intracerebral hemorrhage (ICH) occurred in 0.7%. Three deaths concurrent with ARIA or ICH occurred.
    • “These findings provide the first evidence for a continued benefit of lecanemab and disease modification over the long term, out to 36 months,” van Dyck told MedPage Today.
    • “They also suggest that individuals with lower pathology — no or low tau, or low amyloid — experience a particularly robust stabilization of symptoms,” he continued. “These results collectively underscore the importance of early initiation and continued long-term treatment.”
  • and
    • “In a study of people without a history of cancer, comorbidities in midlife were associated with an overall risk of cancer.
    • “There was a stronger association between comorbidities and risk of multiple individual cancer types.
    • “The findings support the incorporation of formal comorbidity screening and/or risk assessment as a routine aspect of cancer screening visits.”
  • AHA News tells us,
    • “The National Institutes of Health April 7 released a study that found twins — smaller at birth on average than singletons — develop slower in early pregnancy than what was previously known. The ultrasound study found that twins have less fat tissue and muscle mass than singletons beginning at 15 weeks. Scientists believe the smaller size could be a way of adapting to accommodate more resources for two fetuses later in pregnancy. The NIH said confirmation of the findings in additional research could help guide physicians in monitoring and managing twin pregnancies.”
  • Per BioPharma Dive,
    • “Rhythm Pharmaceuticals on Monday said its drug for rare obesity conditions met the main goal of a Phase 3 clinical trial, helping people with weight gain triggered by brain injury lose about one-sixth of their body weight over one year of treatment.
    • The company plans to ask U.S. and European regulators to expand approval of the drug, called setmelanotide. The once-daily shot is marketed as Imcivree after being authorized in the U.S. in 2020 to treat people with genetically driven forms of obesity.
    • Imcivree earned $130 million in 2024 sales across its currently approved uses. Stifel analyst Paul Matteis wrote in a note to clients that the new indication is “a blockbuster opportunity with the potential for a fast ramp” in sales, adding that the weight loss data look “very strong.”

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Emergency department use has nearly recovered to prepandemic levels, but rising acuity, insufficient capacity and a laundry list of financial roadblocks are straining their viability and threatening patients’ access to care, according to a new report from RAND’s healthcare research arm.
    • “The nonprofit, nonpartisan organization’s nearly 200-page report (PDF)—sponsored by the Emergency Medicine Policy Institute (EMPI)—paints a distressing picture of the current state of EDs, which are among the few settings where patients receive 24/7 unscheduled acute care regardless of payment thanks to the federal Emergency Medical Treatment and Labor Act (EMTALA).
    • “EDs, the report notes, have lately faced more complex and sicker patients. Steady increases in demand and limited capacity have led to an increase in ED crowding (referred to as boarding), longer waits and potentially violence toward healthcare workers, which compromise care quality and emergency care worker attrition due to burnout. At the same time, EDs are providing more uncompensated care and expanding the scope of their work into specialties like geriatric care and care coordination.”
  • Per BioPharma Dive,
    • “Labcorp is now offering a blood-based biomarker test in the U.S. to support the diagnosis of Alzheimer’s disease.
    • “The immunoassay measures the ratio of ptau-217 and beta amyloid 42, two distinct biomarkers of Alzheimer’s, according to the Wednesday announcement. The Global CEO Initiative on Alzheimer’s Disease has called ptau-217 one the most promising blood-based biomarkers for amyloid status.
    • “Manufacturers of Alzheimer’s drugs have identified blood tests as a way to reduce the reliance on imaging and cerebrospinal fluid assays and to accelerate diagnosis and treatment.”
  • and
    • “GSK is betting potentially billions of dollars that a smaller drug company’s technology can help create new treatments for brain-corroding diseases.
    • “Through a licensing deal announced Sunday, GSK has gained access to drug delivery technology from South Korea’s ABL Bio. This “Grabody-B” platform is designed to shuttle medicines across arguably the trickiest obstacle in neuroscience — the blood-brain barrier or “BBB” — by using a protein that normally shepherds an important growth hormone across the divide.
    • “The platform had already caught the attention of another pharmaceutical giant, Sanofi, which in 2022 entered a collaboration with ABL to develop new therapies for diseases like Parkinson’s.”
  • KFF Health News tells us,
    • “Underscoring the massive scale of America’s medical debt problem, a New York-based nonprofit has struck a deal to pay off old medical bills for an estimated 20 million people.
    • “Undue Medical Debt, which buys patient debt, is retiring $30 billion worth of unpaid bills in a single transaction with Pendrick Capital Partners, a Virginia-based debt trading company. The average patient debt being retired is $1,100, according to the nonprofit, with some reaching the hundreds of thousands of dollars.
    • “The deal will prevent the debt being sold and protect millions of people from being targeted by collectors. But even proponents of retiring patient debt acknowledge that these deals cannot solve a crisis that now touches around 100 million people in the U.S.
    • “We don’t think that the way we finance health care is sustainable,” Undue Medical Debt chief executive Allison Sesso said in an interview with KFF Health News. “Medical debt has unreasonable expectations,” she said. “The people who owe the debts can’t pay.”
    • “In the past year alone, Americans borrowed an estimated $74 billion to pay for health care, a nationwide West Health-Gallup survey found. And even those who benefit from Undue’s debt relief may have other medical debt that won’t be relieved.
    • “This large purchase also highlights the challenges that debt collectors, hospitals, and other health care providers face as patients rack up big bills that aren’t covered by their health insurance.”

From the artificial intelligence front,

  • Modern Healthcare interviewed Pat Geraghty, Guidewell’s CEO, who discusses the use of AI in prior authorization approvals
    • “How do you educate consumers about the value of prior authorization? 
    • “There’s been a lot of noise around this topic recently. 
    • “We don’t want to come out and say, “let me just explain prior auth to you.” What we’re trying to do is say, “We know we can be better. We can use technology to help us be better. We can make the process quicker and smoother, and we’re going to do that and we’re committing to that.”
    • “We also want to be clear about the rest of the issues around prior auth. There is some clarification and explaining that is appropriate, but it’s not the lead thing. The lead thing is making sure we’re taking the hassle out of the process.
    • “How are you using technology to improve the process? 
    • “We use AI to say yes, not deny, and that allows us to get a very quick answer to the provider. We had 2.4 million authorizations last year that were done in just seconds. About 80% of our prior authorizations are on an automated basis.
    • “But the more complex the issue is, the more it really does involve the oversight of a clinician who understands the area that is being reviewed. You wouldn’t want to give up those kinds of dialogues. Oftentimes the discussions may end up with a modified treatment plan that’s best for all involved. It also is one of the ways we have a check on fraud, waste and abuse.
    • “The thing we find that drives the highest volume for denials is when a service is not covered by the health plan.”
  • The Washington Post reports, “AI is coming to skin cancer detection. Technology is already assisting with diagnoses, but experts predict better tools for non-experts will become available in the not-too-distant future.”

Happy National Employee Benefits Day!

David Ermer–ACA, CDC, Congress, FDA, NIH, Rx coverage, SCOTUS, U.S. Healthcare–

“National Employee Benefits Day is celebrated each year in April. The day recognizes trustees, administrators, benefits practitioners and professional advisors for their dedication to providing quality benefits and the important role they play in their colleagues’ well-being.”

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Republicans rallied behind a fiscal framework that allows more than $5 trillion in tax cuts over a decade, taking a crucial step toward turning President Trump’s agenda—tax cuts, border security and national defense—into law. 
    • “But the GOP budget resolution released Wednesday won’t be the final word along the complicated path to a major tax and spending bill. The plan employs a controversial accounting maneuver, postpones decisions about spending cuts and conflicts with a competing House plan. 
    • “The Senate is likely to vote on its budget later this week, but key House members are already objecting, warning that the Senate’s approach doesn’t guarantee the deep spending cuts they see as necessary.”
  • Modern Healthcare adds,
    • “The Senate Budget Committee unveiled a budget resolution Wednesday that could pave the way to less draconian cuts in health programs than House lawmakers previously proposed.
    • “The Senate proposal includes the House’s earlier recommendations that could lead to billions in health program cuts — but it also includes instructions for the Senate to go a different route while renewing tax cuts passed during President Donald Trump’s first term. The upper chamber’s resolution would delay sorting out differences with the House.
    • “The Senate’s budget resolution and negotiations with the lower chamber could provide for greater flexibility around healthcare cuts, which moderate Republicans in the House said they would not support if they were too steep. It also means the healthcare sector will have to wait to see what healthcare cuts — or spending — could be on tap until the Senate has done its work.”
  • Per a news release, “Today, Health, Employment, Labor, and Pensions Subcommittee of the House Education and Labor Committee held a hearing titled “A Healthy Workforce: Expanding Access and Affordability in Employer-Sponsored Health Care.”
  • Modern Healthcare points out,
    • “The Health and Human Services Department is restructuring agencies that enforce regulation, handle claims disputes, and investigate potential civil rights violations as part of a department-wide reorganization.
    • “A new assistant secretary for enforcement will oversee three parts of HHS — the Departmental Appeals Board, the Office of Medicare Hearings and Appeals and the Office of Civil Rights — as part of a sweeping overhaul announced last week. The new role raises questions about how HHS plans to handle billions of dollars in claims disputes and appeals resolutions, as well as how the offices will operate within the new structure. Healthcare attorneys are also watching for how HHS handles the operational elements of the reorganization, including staffing decisions and the chain of command at the affected offices.”
  • Fierce Healthcare lets us know,
    • “President Donald Trump made good on his threat of announcing new and steeper tariffs during a Wednesday afternoon White House event, setting the stage for higher prices and supply chain uncertainty for numerous industries including healthcare.
    • “The tariffs, set to go into effect at midnight, are the largest trade policy shift for the U.S. in decades and an end to the so-called free-trade era. They include a minimum 10% tariff that affects “all countries,” according to the White House. 
    • “Additionally, a slew of higher, individualized reciprocal tariffs will go into effect for dozens of countries with which the U.S. has a large trade deficit, the White House said. These are broadly designed to be around half of those imposed by most trade partners, including longtime allies.
    • “A 39% European Union tariff rate, for instance, will be matched by a 20% rate, the president explained. A 67% tariff imposed by China will see a reciprocal 34% tariff from the U.S.
    • “Pharmaceuticals are among a select list of goods that will not be subject to the higher reciprocal tariffs, according to a fact sheet released shortly after the signing ceremony and affirmed in the signed executive order. 
    • “The president also signed an order to close the “de minimis loophole,” a trade policy signed into law by Congress that allows shipments valued at less than $800 to be duty-free, for Chinese imports.”
  • Healthcare Dive points out,
    • “Enrollment in the Affordable Care Act marketplaces reached a new high in 2025, boosted by growth in states won by President Donald Trump in last year’s election, according to a research brief by KFF. 
    • “Sign-ups in the insurance marketplaces have more than doubled over the past five years, increasing from 11.4 million in 2020 to 24.3 million in 2025, the health policy research firm said Wednesday. 
    • “Much of the growth is linked to more generous federal financial assistance for the health plans first made available in 2021, according to KFF. But those enhanced premium subsidies are set to expire at the end of the year absent congressional action.”
  • The Wall Street Journal relates,
    • “Federal drug regulators have missed the deadline for making a key decision regarding a Covid-19 vaccine from Novavax, days after the Food and Drug Administration’s vaccine chief was pushed out.
    • “The agency was set to give full approval to Novavax’s shot, but senior leaders at the agency are now sitting on the decision and have said the Novavax application needed more data and was unlikely to be approved soon, people familiar with the matter said. 
    • ‘The FDA has allowed emergency use of Novavax’s Covid-19 vaccine. It set an April 1 deadline for a decision on whether to grant a normal, full approval, the people said.
    • “The decision would have cleared the vaccine’s continuing use though the pandemic emergency has passed. The FDA gave full approval to Covid-19 shots from Pfizer and its partner BioNTech and from Moderna in 2021 and 2022, respectively.
    • “Novavax said it is “continuing to communicate with the FDA and dialogue to ensure they have all the information required to complete our” application. 
    • “A Health and Human Services Department spokesman declined to comment. The FDA didn’t immediately respond to requests for comment.”

From the judicial front,

  • Bloomberg Law reports,
    • “Portions of a Tennessee law aimed at increasing pharmacy access are preempted by the federal employee benefits statute and can’t be enforced against certain self-funded employer health plans, a federal judge ruled.
    • “The law’s “any-willing-provider” requirement—which limits a plan’s ability to exclude pharmacies from its network—has an “impermissible connection” with benefit plans governed by the Employee Retirement Income Security Act, Judge Charles E. Atchley Jr. said Monday for the US District Court for the Eastern District of Tennessee. That’s because it dictates the scope of provider networks eliminates plans’ “discretion to shape benefits as they see fit,” he said.
    • “ERISA also preempts the Tennessee law’s prohibition on using financial incentives to promote or discourage use of a particular pharmacy, Atchley said, explaining that the law prevents ERISA-governed plans from “designing and providing benefits in a way that the plan determines best serves participants.”
    • “The decision is a victory for commercial bakery McKee Foods Corp., which initially filed suit to counter a campaign by defendant Thrifty Med Plus Pharmacy to be reinstated in the pharmacy network for McKee’s employee health plan.” * * *
    • “The case is McKee Foods Corp. v. BFP Inc., E.D. Tenn., No. 1:21-cv-00279, 3/31/25.”
  • The Wall Street Journal reports,
    • “The Federal Trade Commission’s [internal] lawsuit against three large pharmacy-benefit managers over insulin prices is on hold after President Trump fired two of the agency’s commissioners. 
    • “The FTC this week halted a lawsuit against the country’s largest drug middlemen, which negotiate drug prices for employers and insurers. The FTC said it needs to pause the litigation because its two remaining commissioners, both Republicans, are recused from the case, leaving none to oversee it.
    • “The antitrust enforcer in September 2024 sued Cigna’s Express Scripts, UnitedHealth Group’s Optum Rx and CVS Health’s CVS Caremark, accusing the firms of inflating the price of insulin. The lawsuit said firms profited by pocketing the discounts they had negotiated for the higher-priced insulin products they steered their customers to buy.
    • The FTC said in a court filing that the companies had agreed to put the case on hold for at least 105 days.”

From the public health and medical research front,

  • The AHA News informs us,
    • “A National Institutes of Health study published today found that blood pressure patterns observed during the first half of pregnancy can determine a woman’s risk of developing hypertension up to 14 years after giving birth. The study found that women showing certain blood pressure patterns during the first 20 weeks of pregnancy were more likely to develop hypertension years later. Researchers identified six risk groups of blood pressure trajectory that ranged from ultra-low to elevated-stable patterns. Women with elevated-stable patterns were at the highest risk.” 
  • Per Beckers Hospital Review,
    • “Lung cancer screening more than tripled after the U.S. Preventive Services Task Force expanded screening eligibility in 2021, according to a March 20 research letter published in JAMA Oncology.” * * *
    • “Read the full analysis here.” 
  • Nevertheless, MedPage Today cautions,
    • “Among eligible populations, screening for breast and colorectal cancers was nearly four times more common than for lung cancer.
    • “Among those who never had lung cancer screening, roughly 60% had undergone screening for breast and colorectal cancers.
    • “The findings suggest individuals eligible for low-dose CT screening may be receptive to efforts aimed at increasing uptake.”
  • Per Medscape,
    • “Two recent studies have added to the growing body of research suggesting consuming more dairy reduces a person’s risk of getting colorectal cancer.
    • “A prospective cohort study in Nature Communications published in January looked at the incidence of colorectal cancer (CRC) in more than 540,000 UK women over 16 years and found a 14% reduced risk for the cancer for every 200 g of dairy milk consumed per day. It also found an 8% reduced risk per 50 g of yogurt per day.
    • “The other study, from GutMicrobes, also published in January, looked specifically at yogurt intake with a focus on Bifidobacterium, a bacteria commonly found in yogurt. The researchers found that people who had at least two servings per week of yogurt had a 20% lower risk for Bifidobacterium-positive tumors than those who had less than one serving per month of yogurt, “suggesting the antitumor effect of yogurt intake on the specific tumor subgroup.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Jobs in the health insurance industry fell last year, something that hasn’t happened since 2009 and bucked an uptick in overall employment.
    • “It is a turning point for the industry, after years of profit growth and strategic expansions into pharmacy and provider businesses that increased headcount. Some of the largest publicly traded insurers reported steep workforce declines, according to a Modern Healthcare analysis of regulatory filings.
    • “Elevance Health, Humana, UnitedHealth Group and Centene cut their workforces, with the biggest reductions coming from the latter two companies. CVS Health and Molina Healthcare kept their workforce steady. Cigna grew its headcount nearly 1.4%.
    • “Across the seven companies, employment dipped 4.6% in 2024. Moreover, when not accounting for UnitedHealth Group, which reported a major reduction overseas, staffing among the other six still slipped 1.4%. National employment across all industries grew 1.2% last year, according to the Bureau of Labor Statistics.
    • “It was such a growth story for many years, and that’s tapered a little bit,” said Judy Busby, senior vice president and managing director of insurance staffing company The Jacobson Group.”
  • Per Beckers Hospital Review,
    • “Nonradiologists interpreted 43.6% of office-based imaging studies in 2022, according to a study published April 2 in the American Journal of Roentgenology. 
    • “Researchers from the Harvey L. Neiman Health Policy Institute analyzed more than 1.6 million Medicare physician office-based imaging claims ordered by nonradiologists. They found that just 36.4% of the studies were interpreted by a radiologist.” * * *
    • “For imaging type, nonradiologists interpreted 52% of ultrasound images, 5.3% of CT scans and 6.1% of MRIs. Smaller practices — those with one to nine providers — had a higher rate of self-interpretation than practices with 500 or more physicians.”Our results raise potential implications for quality of patient care,” Vijay Rao, MD, senior vice president of enterprise radiology at Philadelphia-based Jefferson Health and one of the study’s authors, said in a news release. “The large differences between radiologists and nonradiologists in interpretation training could lead to differences in diagnostic accuracy.”
  • Per MedTech Dive,
    • “Artis BioSolutions emerged from stealth Wednesday, announcing that it has acquired Landmark Bio, an alliance of academic institutions, hospitals and biotech companies founded in 2021 to help turn research ideas into broadly available genetic medicines.
    • “Landmark will continue to operate as a distinct entity, based in Watertown, Massachusetts. The acquisition by Artis BioSolutions will allow Landmark to scale up operations and “bring breakthrough therapies to more patients” Landmark CEO Ran Zheng said in a statement.
    • “Artis BioSolutions, backed by the venture capital firm Oak HC/FT, is now well positioned as a contract development and manufacturing organization for advanced therapies, the company said Wednesday. Artis BioSolutions said it can help customers speed up timelines, lower manufacturing costs and improve both product quality and supply chain management.”
  • The Wall Street Journal reports,
    • “Hims & Hers’s addition of obesity drug Zepbound won’t do much to bolster its weight-loss business, analysts say.
    • “Hims & Hers has been selling a compound GLP-1 for around $165 a month but will now offer the brand-name Zepbound for around $1,900 a month. Investors worry patients won’t make that price leap and that Hims, which has built its business on affordable healthcare, will struggle to meet its revenue goal.
    • “It’s probably unlikely that a compounded GLP-1 customer at Hims that’s paying $165 per month is going to transition to paying $1,900 per month for the fully branded,” Needham analyst Ryan MacDonald said. “There’s a question about how achievable the weight-loss revenue guidance is for 2025.”