Tuesday report

NIH

Tuesday report

David Ermer–ACA, AHRQ, CMS, Congress, FDA, Medical / Rx research, NIH, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump is urging Republicans to get their “one big, beautiful bill” to his desk by July 4. That’s just a week from Friday, and lawmakers still face a series of hurdles and headaches on issues ranging from artificial intelligence to deficit spending to rural hospitals.
    • “Senate GOP leaders are revising their version in advance of potential votes later this week, searching for a mix that can garner a majority in the chamber, which is divided 53-47. Anything that gets through the Senate must pass the House, which is divided 220-212 in Republicans’ favor; any subsequent House changes would require another Senate vote. Lawmakers are scheduled to leave Washington for a recess next week but signaled they were prepared to stay to finish the bill.”
  • The American Hospital Association News tells us,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. today appeared before the House Energy and Commerce Subcommittee on Health for a hearing to testify on the HHS fiscal year 2026 budget proposal, which requests $94.7 billion.”  
  • Modern Healthcare informs us,
    • Prescription drug middlemen should end the complicated system of drug rebates before the government steps in to change it, Medicare and Medicaid chief Mehmet Oz said Tuesday.
    • The remarks signal the Trump administration may revive attempts to eliminate the payments drugmakers send to pharmacy benefit managers after prescriptions are filled. In his first term in 2019, President Donald Trump considered regulations that would have eliminated that system, but officials abandoned them before they went into effect.
    • “There’s a possibility that we have a window now where the three big PBMs might actually consider doing away with the rebate-slash-kickback system,” Oz told a meeting hosted by Transparency-Rx, a coalition of smaller PBMs committed to more open pricing. The three largest companies in the industry, CVS Health Corp., UnitedHealth Group and Cigna Group, handle about 80% of US prescriptions.” * * *
    • “Oz met with large insurers about separate issues on Monday. The insurers voluntarily committed to reduce the use of preapprovals for medical care, and Oz said that there could be an opportunity for insurers to take similar voluntary action to change how they pay for medicines.”
  • Healthcare Dive also discusses the CMS Administrator’s presentation at this meeting with a focus on drug price transparency.
  • Federal News Network lets us know,
    • “Rep. Robert Garcia was elected the top Democrat on the powerful House Oversight Committee on Tuesday, charting a new direction for the party’s opposition to congressional Republicans and President Donald Trump’s administration.
    • “Garcia, of California, won the job overwhelmingly in a closed-door vote of the House Democratic caucus. He beat out Rep. Stephen Lynch of Massachusetts, 150-63.”
  • Fierce Healthcare summarizes the public comments submitted in response to the May 13, 2025, CMS and National Coordinator of Health IT RFI “on how to ease data exchange among the healthcare ecosystem for patients, providers, payers, vendors and value-based care organizations.”
  • Fierce Healthcare also points out,
    • “While major provider organizations welcomed insurers’ pledge earlier this week to reform prior authorization, these groups withheld praise without yet seeing the efforts bear fruit.
    • “Bobby Mukkamala, M.D., president of the American Medical Association, said in a statement that patients and physicians both will need to see the promises made yield significant results to ease the headaches around prior auth.
    • “Mukkamala said that many of the elements of Monday’s pledge echo a 2018 consensus statement from major payer and provider organizations, such as reducing the number of required prior authorizations, preserving the continuity of care for the patient and expanding automation.
    • “He said the AMA will “closely monitor” the rollout of the prior authorization changes and continue to work with regulators and legislators on this issue.”
  • The U.S. Preventive Services Task Force today gave a Grade B to “screening women of reproductive age, including those who are pregnant and postpartum for intimate partner violence.” The USPSTF also “concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for caregiver abuse and neglect in older or vulnerable adults [Grade I]. Both grades are consistent with the conclusions that the USPSTF reached in 2018 following a similar analysis.
  • MedPage Today adds,
    • “Expanding eligibility criteria for lung cancer screening to include 20-year smoking history without requiring a certain number of pack-years yielded a relative 28% increase in the number recommended for screening.
    • “The number of lung cancers identified would have increased by a relative 17%.
    • “The increase in detection was particularly seen among women and Black persons, groups with under-detection by current criteria.”
  • Per PR Newswire,
    • “More than 1.3 million women in the U.S. enter menopause every year. Menopause affects every woman—but not every woman gets the care, clarity, and support she deserves. A new national program, “Menopause for All,” intends to change that and will launch in Baltimore, MD and Washington, D.C., on June 28th and 29th, respectively.
    • “The National Menopause Foundation, a leading patient advocacy organization dedicated to empowering women with the knowledge and resources they need to navigate menopause through igniting community and harnessing science, has teamed up with Perry, a pioneering digital health platform transforming perimenopause care through expert-led community support, evidence-based education, and training of health care professionals. Together, they believe menopause care should be local, personal, and accessible.
    • From trusted medical professionals and wellness experts to culturally sensitive support groups, the Menopause for All program will help women and their families connect with resources in their own local communities—because navigating menopause shouldn’t be done alone or in the dark.
    • Menopause for All events are free and open to the public, but space is limited. On Saturday, June 28, 2025, the event will be held at Enoch Pratt Free Library, 400 Cathedral Street in Baltimore, MD from 1:30-4:30 p.m. On Sunday, June 29, 2025, the event will be held at the Hill Center at the Old Navy Hospital, 921 Pennsylvania Avenue, SE Washington, D.C., from 2:30-5:30 p.m.
    • “Our expert-led sessions will provide women with practical, scientifically-backed guidance and real solutions ensuring every woman has the care and support she deserves,” added Claire Gill, founder and President of NMF. “We’re grateful to our presenting sponsor [and FEHB, PSHB and FEDVIP carrier] Government Employees Health Association (G.E.H.A) and supporting sponsor Clearblue for their commitment to advancing women’s midlife health.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The FDA has blessed AstraZeneca and Daiichi Sankyo’s Datroway to treat patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). The accelerated nod—which could hinge upon verification of clinical benefit in a confirmatory trial—applies to patients who have received prior EFGR-related treatment and platinum-based chemotherapy.
    • “The label expansion comes five months after Datroway secured its first FDA nod, for patients with previously treated metastatic, HR-positive, HER2-negative breast cancer. With the nod, Datroway becomes the first TROP2-directed therapy in the U.S. for NSCLC.
    • “Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available,” Jacob Sands, M.D., of the Dana-Farber Cancer Institute and an investigator in two trials that paved the way for the latest approval, said in a June 23 press release.”
  • STAT News relates,
    • “A sutureless device for peripheral nerve repair could be available on the market in the coming months.
    • “The Food and Drug Administration has authorized a polymer-based device developed by medical technology company Tissium. The authorization, announced Tuesday, will give physicians a new method for treating peripheral nerve injuries.
    • “This approval is really a game-changer for patients with peripheral nerve injuries,” said Jeffrey Karp, a Tissium co-founder who developed the device’s technology. “For the first time, surgeons now have a sutureless, bio-inspired option that can really simplify the procedure while improving outcomes.”
  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) has announced an expansion of an earlier Medtronic recall, now issuing a new Class 1 recall for Medline Industries’ procedure kits that contain Medtronic aortic root cannulas. The recalls indicate that there may be excess material in the male luer, which could potentially lead to serious adverse events, including procedure delays, neurological deficits, strokes, or even death.”
  • Per Health Exec,
    • “In what is being referred to as a recall, the U.S. Food and Drug Administration (FDA) released a notice on behalf of GE HealthCare for a line of its Carestations due to a risk the ventilation systems may not work properly. Despite the serious risk of death or injury caused by inadequate respiration, the problem has been isolated and can be fixed with updated use instructions. 
    • “Although no devices have been removed from care settings, this recall has been designated a Class I by the FDA, reserved for the most serious issues. Luckily, no injuries or deaths have been reported. 
    • “The systems are typically used to aid with anesthesia in patients of all ages. They can be found in many hospitals and surgery centers across the country.” 

From the public health and medical research front,

  • MedPage Today tells us,
    • “Over the last two decades, U.S. neonatal mortality has generally declined, though not all leading causes of death followed this trend.
    • “There were 283,696 neonatal deaths from perinatal complications, with the top leading causes being disorders related to short gestation and low birth weight; maternal complications of pregnancy; and complications of placenta, cord, and membranes.
    • “Mortality due to slow fetal growth and fetal malnutrition increased annually, and mortality from maternal complications and bacterial sepsis of the newborn remained stable.”
  • Per Endocrinology Advisor,
    • “Individuals with celiac disease or thyroid disease have a significantly increased risk of developing type 1 diabetes (T1D), according to study findings published in Diabetes, Obesity and Metabolism.”
  • Per Pulmonology Advisor,
    • “Obstructive sleep apnea (OSA) is highly prevalent in those age 50 years and older, but manifests differently by race/ethnicity and sex, with the most rapid-eye-movement (REM) sleep respiratory events in Black women and the highest oxygen saturation (SpO2) levels in Mexican American women. These were among study findings published in the Annals of the American Thoracic Society.”
  • BioPharma Dive lets us know,
    • “A targeted lung cancer drug from Nuvalent led to tumor responses in about half of people who previously received at least one therapy like it, and 44% of those who had received at least two similar medicines, according to results from a clinical trial the company shared Tuesday.
    • “The study of Nuvalent’s drug, zidesamtinib, involves people whose metastatic non-small lung cancer has alterations in the gene ROS1. In addition to past treatment with so-called tyrosine kinase inhibitors, some participants had also received chemotherapy beforehand. Nuvalent will use the data to support a U.S. approval application for these “pre-treated” patients, which it expects to complete in the third quarter.
    • ‘Nuvalent is also studying zidesamtinib in ROS1-positive lung cancer patients who haven’t yet been treated and is discussing with the Food and Drug Administration the possibility of a “line-agnostic expansion” for the drug. A similar medicine from Nuvation Bio was approved this month for patients regardless of whether they’d previously been given a tyrosine kinase inhibitor.”
  • Per Healio,
    • “COPD mortality rates varied across North Carolina, often correlating with access to care and other risk factors, according to a pair of posters presented at the American Thoracic Society International Conference.
    • “What we’re looking at is your risk of COPD mortality based on your ZIP code,” Alexa M. Zajecka, MD, a first-year pulmonary critical care fellow at East Carolina University Medical Center, told Healio.”
    • “The researchers noted that although COPD is a leading cause of mortality and that North Carolina has one of the highest COPD-related death rates in the United States, there has been little research into its spatial clustering at the local level.” 
  • Gen Edge reports,
    • Amyotrophic lateral sclerosis (ALS) remains one of the most devastating and biologically elusive neurodegenerative diseases. Despite decades of research, its underlying mechanisms are still not fully understood. The condition presents a complex and highly variable interplay of genetic mutations, environmental factors, and cellular dysfunctions that differ widely across patients. This heterogeneity has slowed the development of effective diagnostics and therapeutics, leaving researchers to chase a moving target across a fragmented molecular landscape.
    • Yet much of ALS research still relies on static models—snapshots of a disease in motion. The condition unfolds dynamically, impacting multiple neural and non-neural cell types in real time. Capturing that progression requires lifelike systems that can replicate ALS as it unfolds in the human body. Without that, critical windows for intervention may remain hidden in plain sight.
    • “In a new study published in Cell Stem Cell titled, “An organ-chip model of sporadic ALS using iPSC-derived spinal cord motor neurons and an integrated blood-brain-like barrier,” researchers at Cedars-Sinai have developed a dynamic ALS model using patient-derived stem cells. This system may help uncover both the causes of ALS and new therapeutic targets.”
  • Per an NIH Intramural Research Program release,
    • It seems like every news report touting the health benefits of a daily glass of wine is soon followed by another that claims consuming any amount of alcohol harms health. While the jury is still out on this issue for younger individuals, a recent IRP study suggests that alcohol consumption may accelerate the typical age-related erosion of the cardiovascular system

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “It is becoming more difficult for insured and uninsured Americans to access affordable healthcare services, according to a new report from S&P Global Ratings.
    • “The United States spends more on healthcare services than any other country by any metric, according to the report. As of 2023, an individual could expect average out-of-pocket annual healthcare costs to run them an average of $6,159 annually and ancillary costs to account for approximately 6% of their average annual income before taxes.
    • “Efforts to rein in healthcare spending thus far have been mixed, and recent cost pressures could cause costs to climb further still, according to the report. Should headwinds continue, providers may be forced to make tough choices about what services they offer and where.”
  • and
    • “Ascension CEO Joseph Impicciche will retire at the end of the year, the nonprofit health system announced Tuesday.
    • “The health system’s board of directors has appointed President Eduardo Conrado to succeed Impicciche, effective Jan. 1, 2026.
    • “Ascension said it has been preparing for Impicciche’s departure for some time, adding the executive will be “actively engaged” in Conrado’s transition.”
  • Per BioPharma Dive,
    • “Perceptive Xontogeny Venture Funds and venBio Partners are contributing up to $40 million to a spinout of genetic medicine maker Lexeo Therapeutics to that will aim to advance drugs for heart conditions.
    • “The new biotech will focus on RNA-based medicines for genetically mediated cardiac conditions using a non-viral delivery method, according to a Tuesday announcement from Lexeo.
    • “Under the agreement, Lexeo will hold double-digit percentage equity in the new company, and could receive future milestone payments, royalties and opt-in rights to its programs.”
  • MedCity News informs us,
    • “Cohere Health, a clinical intelligence company, launched a new solution called Review Assist, which speeds up medical necessity reviews for health plans, the company announced on Monday.
    • “Boston-based Cohere Health provides AI-powered prior authorization solutions to help improve the relationship between payers and providers. The new tool is meant to help health plan clinical staff with prior authorization reviews, which are often extremely burdensome, according to the company. The typical process requires reviewers to analyze hundreds of pages of clinical records in order to determine if a patient procedure is medically necessary.
    • “Review Assist operates within existing utilization management workflows. It uses Cohere’s AI and large language models to analyze unstructured and structured clinical data and provide actionable insights for reviewers, as well as links to its source for this information. In addition, it has an AI chatbot that can answer questions for the reviewer and find additional insights.”
  • and describes Cigna Healthcare’s six new digital tools to improve the customer experience.
  • Per Beckers Health IT,
    • “Amazon One Medical and Edison, N.J.-based Hackensack Meridian Health continue to open clinics across New Jersey to expand access to primary care.
    • “The two organizations joined forces in 2023 to co-open the offices and make Hackensack a specialty care referral partner of Amazon One Medical.
    • “We hope to have 20 or maybe even more of these types of centers,” Hackensack CEO Robert Garrett said at a ribbon-cutting of the latest clinic June 17 covered by NJBiz. “It’s so well-needed. We’re going to be looking at different locations throughout the state of New Jersey in terms of where we think there’s a need for greater access to care.”
  • Modern Healthcare reports,
    • Current Health cofounder Chris McGhee has reacquired the at-home care company from Best Buy Co.
    • Financial details of the transaction were not disclosed.
    • “McGhee is returning as Current’s CEO. Former Chief Technology Officer Stewart Whiting and other former team members are also returning, according to a Tuesday announcement on the company’s website.”

Tuesday report

David Ermer–Congress, FDA, Medical / Rx research, Medicare, NIH, U.S. Healthcare–

From Washington, DC,

  • KFF compares the healthcare provisions in the House of Representatives big, beautiful bill against the developing Senate version. Of note the Senate version does not include the House bill’s provisions expanding the utility of health savings accounts.
  • STAT News adds,
    • “The Medicare pay bump for doctors that was part of the House version of Republicans’ tax bill was dropped in the Senate’s version, released Monday evening. 
    • “The provision, which would boost doctors’ payment for treating Medicare patients by tying it to inflation, has long been a top priority for physician groups.” 
  • Federal News Network tells us,
    • “The Trump administration is attempting to address what it says are inflated numbers of high-performing federal employees, while also telling agencies to swiftly discipline or remove any feds deemed poor performers.
    • “In a memo published Tuesday, the Office of Personnel Management told agencies to begin adopting a new performance management system designed by the Trump administration. The new system attempts to more strictly delineate between different levels of employee performance and encourage agencies to rate fewer employees as high performers.
    • “For many decades now, performance management across the federal workforce has fallen short of what the American people should expect,” OPM Acting Director Charles Ezell wrote in Tuesday’s memo to agencies. “Too often, this has resulted in a lack of accountability and inflated performance ratings.”
  • Radiology Business reports,
    • “Radiology Partners has “significantly outmatched other provider groups” via the No Surprises Act, scoring wins at more than 600% of the initial “qualifying payment amount” offer, according to new research. 
    • “The Centers for Medicare & Medicaid Services recently released NSA data from the first half of 2024. As Radiology Business reported previously, industry giant Rad Partners was the No. 1 initiator of these disputes tied to out-of-network healthcare services, with 136,784 between January and July. Georgetown University researchers recently took a closer look at the data, publishing their findings June 11 in Health Affairs. 
    • “They highlighted RP’s significant payment wins via the “independent dispute resolution” (IDR) process in 2024. In Q1, the practice earned a median prevailing offer at 631% of the qualifying payment amount—essentially, the median contracted rate for a service in the same geographic region. These wins continued in Q2, with a median at 610% of QPA.  
    • “These high numbers highlight the disconnect between the two sides as they debate what constitutes a reasonable payment for [out-of-network] services,” Jack Hoadley, PhD, research professor emeritus with Georgetown’s Center on Health Insurance Reforms, and co-authors explained. “Providers believe the high volume of IDR disputes reflects inadequate payment by plans, exacerbated by possible manipulation of the [qualifying payment amount]. Plans respond that their QPAs are accurate and that providers should be willing to accept payments that align closely with in-network rates.”P

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Embracing artificial intelligence. Taking on companies that make ultra-processed foods. And offering a fast-track to approve drugs the Trump administration views as a priority.
    • “Welcome to the new Food and Drug Administration as envisioned by Dr. Marty Makary, who is leading the agency under Health Secretary Robert F. Kennedy Jr. Both men have said they want to overhaul the agency, citing what they see as the FDA’s reputation for coziness with pharmaceutical companies.
    • “Makary’s goal is “to deliver more transparency, unleash innovation, eliminate conflicts and lower drug pricing,” said Calley Means, a White House adviser and ally of Makary’s.
    • “The changes are coming so swiftly, and often without input from career scientists, that Makary faces declining staff morale threatening to stymie his efforts. He must also contend with the administration’s staff cuts at the FDA, which have been partly undone but shrank the workforce nonetheless. And critics say Makary is playing fast and loose with the FDA’s commitment to world-class science.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
    • “The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.
    • “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary M.D., M.P.H. “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”  
  • Per Modern Healthcare,
    • “Taiwanese surgical robotics company Brain Navi Biotechnology said Tuesday the Food and Drug Administration approved its NaoTrac neurosurgical robot.
    • “It’s designed to assist with brain tumor biopsies, deep brain stimulation and other complex brain surgeries.”
  • Per Cardiovascular Business,
    • “Inquis Medical, a California-based medtech company focused on peripheral vascular treatments, has received U.S. Food and Drug Administration (FDA) clearance for its Aventus Thrombectomy System to be used to treat pulmonary embolism (PE).
    • “The Aventus Thrombectomy System, a next-generation mechanical thrombectomy device, was previously cleared to target blood clots in a patient’s peripheral arteries. This new expanded clearance paves the way for PE patients to be treated using the same technology.”
  • Per MedTech Dive,
    • “Zyno Medical has recalled infusion pumps that shipped with software that had not undergone verification and validation testing, the Food and Drug Administration said Monday.
    • “The company released the Z-800 pumps with incorrect software versions. The software created a risk of incorrect air-in-line detection and audio alarms that could cause serious harm.
    • “Zyno has not reported any serious injuries or deaths. The recall, which the FDA assigned to Class I, started eight months after Zyno removed Z-800 pumps from use over another software issue.”

From the State law front,

  • Healthcare Dive reports,
    • “Iowa passed a law last week that places limits on pharmacy benefit managers, joining a growing number of states cracking down on the drug middlemen in an effort to constrain rising prescription drug costs and protect rural pharmacies. 
    • “The legislation includes numerous provisions aimed at tamping down on PBMs’ “outsized control” over the pharmaceutical supply chain, Gov. Kim Reynolds said in a statement. That includes preventing PBMs from steering patients to particular pharmacies, equalizing reimbursement between pharmacies and reforming how PBMs are paid.
    • “However, some experts have raised concerns that the law could lead to higher costs for health plans and patients.”

From the judicial front,

  • Bloomberg Law reports,
    • “The FDA lawfully determined that Novo Nordisk A/S’s Ozempic drug shortage ended and that drug compounders can’t keep making copies of the weight loss medicine, a federal judge ruled. 
    • “Judge Mark T. Pittman for the US District Court for the Northern District of Texas agreed with the Food and Drug Administration that it lawfully removed semaglutide from the drug shortage list last year, granting on June 13 the agency’s motion for summary judgment against compounders. 
    • “The opinion is currently sealed but will eventually be redacted, according to the court’s docket.”
    • The case number is 4:25-cv-00174.

From the public health and medical research front,

  • Cardiovascular Business reports,
    • “Mayo Clinic in Rochester, Minnesota, is the No. 1 heart hospital in the United States, according to a data-based ranking published by Newsweek. Cleveland Clinic and its Miller Family Heart, Vascular & Thoracic Institute came in at No. 2, followed by Massachusetts General Hospital/the Corrigan Minehan Heart Center at No. 3, NYU Langone Hospitals – Tisch Hospital at No. 4 and Stanford Health Care/Stanford Hospital at No. 5.
    • “The ranking is part of a new America’s Best Hospitals for Specialize Care 2025 report.
    • “Newsweek and Statista partnered on the list, naming their Top 200 Hospitals for Cardiac Care. While 45% of each facility’s overall score was determined by a variety of hospital quality metrics, another 35% was determined by survey responses from U.S. healthcare professionals collected in early 2025. In addition, 15% of the overall scores was determined by patient satisfaction surveys, and the final 5% was based on Statista’s PROMs Implementation Survey.“
  • Per Health Day,
    •  “Rheumatoid arthritis (RA) has steadily increased around the world during the past three decades, a new AI-powered study reports.
    • “The autoimmune disease affected 17.9 million people worldwide in 2021, a 13% increase from 1990, researchers reported today in the Annals of the Rheumatic Diseases.
    • “Results indicate that the global burden of RA has been vastly underestimated, researchers concluded.
    • “Further, the research team projects that rheumatoid arthritis will continue to increase unless steps are taken to prevent it or treat existing cases.”
  • and
    • “A new breakthrough can help people with schizophrenia keep up with their psychiatric meds, researchers said.
    • “A pill taken just once a week, gradually releasing medicine from within the stomach, can greatly simplify the drug schedule faced by schizophrenia patients, researchers reported June 10 in the journal The Lancet.
    • “The newly developed pill maintains consistent levels of the psychiatric drug risperidone in patient’s bodies, and controlled their symptoms just as well as daily doses, results showed.
    • “We’ve converted something that has to be taken once a day to once a week, orally, using a technology that can be adapted for a variety of medications,” researcher Giovanni Traverso, an associate professor of mechanical engineering at MIT, said in a news release.”
  • Per Beckers Hospital Review,
    • “A study found that a once-daily pill called obicetrapib significantly lowered LDL cholesterol in patients at high risk for heart disease. 
    • ‘The clinical trial, published May 7 in The New England Journal of Medicine, enrolled 2,500 participants with either a history of atherosclerotic cardiovascular disease or familial hypercholesterolemia, all of which were already taking the maximum tolerated doses of other cholesterol-lowering drugs. 
    • “After 84 days, those taking NewAmsterdam Pharma’s obicetrapib saw their LDL levels drop nearly 30% while the placebo group experienced a slight increase. The cholesterol-lowering effect was consistent across the treatment group and the rate of side effects was similar among the two groups.”
  • MedPage Today discusses “What the MAHA Report Gets Right, and Wrong, on Nutrition. Time will tell the impact of ensuing policies on health.”
  • and lets us know
    • “A rheumatology trainee who went on TikTok to find information on her own condition may have uncovered a novel and possibly tectonic approach to treating fibromyalgia, her presentation here suggested.
    • “That experience led to an analysis of the massive TriNetX medical records database, which indicated that fibromyalgia patients who used glucagon-like peptide-1 (GLP-1) receptor agonist drugs were less likely to use opioids and to report pain, fatigue, and malaise compared with propensity-matched non-users, according to Nouran Eshak, MBChB, of the Mayo Clinic in Scottsdale, Arizona.
    • “The findings were strong enough, Eshak told attendees at the European Alliance of Associations for Rheumatology annual meeting, that clinicians should “consider using GLP-1 agonists in fibromyalgia patients when comorbidities such as obesity, diabetes, or sleep apnea are present.” Those are approved indications for such agents, and therefore patients would face fewer barriers to access.
    • “Still, these findings are no substitute for prospective data, such as from randomized trials, Eshak stressed.”
  • The NIH’s Reseach Matters covers the following topics this week — “Y chromosome loss and cancer | Cysteine and weight loss | Treating malaria in mosquitoes.”
  • Per Medscape,
    • “When canagliflozin (Invokana) was approved in 2013, the SGLT2 inhibitor was touted as a first in a new medication class that was, at the time, the only oral, once-daily medication to reduce blood glucose as well as body weight and systolic blood pressure.
    • “Since then, additional SGLT2 inhibitors have been approved (dapagliflozin, empagliflozin, bexagliflozin, and ertugliflozin), and the indications for prescribing the medications have expanded.
    • “The medications have gone from targeting glucose-lowering to also providing cardiac protection, including for diabetes-free patients with heart failure.
    • “Next, experts said, discussions will focus on other decisions, such as when and whether to prescribe the SGLT2 inhibitors with GLP-1 receptor agonists for the best outcomes.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies to treat cardiovascular disease. 
    • “The deal announced Tuesday offers Verve stockholders $10.50 a share, plus a contingent value right worth another $3 a share. The non-tradeable CVR would pay out if the company’s experimental VERVE-102 treatment advances enough to dose a patient in a Phase 3 trial within 10 years of the transaction’s closing.
    • “Verve CEO Sekar Kathiresan and other top stockholders have already agreed to tender shares that represent about 17.8% of Verve’s outstanding stock and the gene editing company’s board recommends that all investors agree to the tender offer, Lilly said. A second-step merger will follow if needed. The companies expect to complete the transaction in the third quarter.”
  • The Wall Street Journal reports,
    • “Dozens of companies have pledged to build more manufacturing in the U.S. since President Trump took office. Generic drugmakers aren’t among them. 
    • “And they have no plans to change that anytime soon.
    • “Makers of generics—cheaper copies that make up 90% of Americans’ prescription medications—say further domestic investment is too risky in such a low-margin and unpredictable business, unless the government helps to steady the sector. 
    • “Drugmakers want more clarity from the Trump administration on the potential pharmaceutical tariffs, which some companies warn could lead them to close U.S. plants altogether. 
    • “Where’s the incentive?” said Richard Saynor, chief executive officer of Sandoz, whose U.S. slate of roughly 150 generic drugs range from blood thinners to antipsychotics. “You sell a packet of antibiotics more cheaply than a packet of M&M’s. That’s offensive, and we lose money doing that.”
  • and
    • “Fresenius Medical Care could end up benefiting from blockbuster obesity drugs, according to its chief executive, contrary to concerns that such treatments could be negative for the dialysis specialist.
    • “I believe [the effect] is neutral to positive, not negative,” Fresenius Medical Care’s Chief Executive Helen Giza said in an interview.
    • “Ozempic and others in the class of drugs known as GLP-1 have shown promise in clinical trials beyond their most common uses for diabetes and weight loss to treat heart, kidney and liver diseases, among a growing list of conditions. As signs of their potential emerged, investors raced to look for winners and losers.”
  • Per STAT News,
    • “A central theme in Humana’s plan for boosting Medicare Advantage profitability in the future is a strategy its peers have relied on for over a decade: coaxing members in for their annual wellness visits.”
  • Per Fierce Healthcare,
    • “Lark Health is rolling out a new, artificial-intelligence-enabled platform to manage the costs related to GLP-1s, and it has tapped a former insurance industry executive to lead the charge.
    • “Matthew Gibbs, who previously served as chief pharmacy officer at Blue Shield of California, will join Lark as president. In that role, he will spearhead the launch of LarkVantage, a platform designed to mitigate the challenges associated with utilization reviews for GLP-1s.”
  • Reuters informs us,
    • “Eli Lilly (LLY.N) will ship the two highest doses of its popular weight-loss drug Zepbound to cash-paying customers on its website starting early August, the U.S. drugmaker said on Monday.
    • “With the addition of the 12.5 milligrams and 15 mg doses, all approved doses of Zepbound will be available on the website in single-dose vials for $499 per month or less, regardless of insurance status, the company said.
    • “Lilly and rival Novo Nordisk (NOVOb.CO), opens new tab started offering vials at discounted prices on their respective websites to expand access and stave off competition from compounded versions or cheaper copies of their weight-loss drugs.
    • “The LillyDirect website was launched last year to help patients directly order some drugs.”

Midweek Report

David Ermer–Congress, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington, DC

  • The American Hospital Association News tells us,
    • “A Congressional Budget Office report released June 4 found that enactment of the fiscal year 2025 budget reconciliation bill, the One Big Beautiful Bill Act (H.R. 1), would lead to 10.9 million people becoming uninsured in 2034 due to significant changes to the Medicaid program and Affordable Care Act coverage. A follow-up letter from the CBO provides more detail on how these changes would impact the number of uninsured. The CBO also estimated that the bill would lower gross benchmark premiums for marketplace plans under the ACA by an average of 12.2%.”
  • Per a Senate news release,
    • On Wednesday, June 11, 2025, at 10:15 am the Senate Judiciary Committee will hold a hearing titled “23 and You, the Privacy and National Security Implications of the 23 and Me Bankruptcy.”
  • STAT News reports,
    • In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment.
    • “The dispute with Halozyme Therapeutics occurs as Merck plans to sell a new injectable version of Keytruda that the company is betting will sustain a medicine that has accounted for nearly half of its sales. Patent protection for the treatment, which is currently administered intravenously and generated $29.5 billion in revenue last year, lapses in 2028.
    • “At issue before the PTO are certain enzymes called Mdase that Halozyme developed to enable the administration of drugs by injection. Last November, Merck petitioned the PTO to reconsider seven patents that were awarded to Halozyme, arguing they were overly broad and should not have been granted. The filing came a few months after the PTO granted one patent in particular.
    • “Patent challenges are almost a daily feature of behind-the-scenes jockeying in the pharmaceutical industry, but the battle over Keytruda is more closely watched than most since the stakes are so high for Merck. In March, the company asked the Food and Drug Administration to approve the injectable version, which would cut treatment time in half, and a decision is expected in September.”
  • Per an HHS new release,
    • “The U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announces the appointment of Paula M. Stannard as Director of the Office for Civil Rights. In this role, Director Stannard is the Department’s chief officer and adviser to Secretary Robert F. Kennedy, Jr. concerning the implementation, compliance, and enforcement of Federal health information privacy, security, and breach notification rules under the Health Insurance Portability and Accountability Act (HIPAA) as well as Federal civil rights, conscience, and religious freedom laws in HHS’ jurisdiction.
    • “I’m proud to welcome Paula back to HHS,” said Secretary Robert F. Kennedy, Jr. “She’s a proven public servant who delivered results during her time at HHS under both President Trump and President George W. Bush. Paula brings deep institutional knowledge, relentless focus, and an unwavering commitment to civil rights. Under her leadership, the Office for Civil Rights will drive forward President Trump’s bold civil rights agenda with clarity, energy, and purpose.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “Moderna Inc. has agreed to do a placebo-controlled trial of its new Covid vaccine that was recently approved by US regulators, Health and Human Services Secretary Robert F. Kennedy Jr. said Tuesday.
    • “In a post on X, Kennedy said he wanted to “address those of you who have anxieties” about the Food and Drug Administration’s limited approval of Moderna’s vaccine, which was cleared for a narrower segment of the population than prior shots. 
    • “Moderna declined to comment. As a condition for approving the new shot, the FDA required a future placebo-controlled study in adults ages 50 to 64 without high-risk conditions, according to agency documents.
    • “Kennedy said that “the FDA will monitor and collect data throughout the trial for every adverse outcome” and “scrutinize every aspect of the trial.”
  • Per a press release,
    • Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced today FDA clearance of its most significant technological advancement to date. The clearance includes an entirely new portable MRI scanner powered by the proprietary Optive AI™ software. This new system delivers the highest level of image quality, functionality, and usability to date, unlocking a new brain imaging paradigm for clinicians and their patients.
  • Per FiercePharma,
    • “Bayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitor Nubeqa, scoring an FDA approval to expand its use to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
    • “The label expansion comes three years after the FDA signed off on Nubeqa in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with mCSPC. The new nod allows Nubeqa to be used along with ADT by those who can’t tolerate chemo.
    • “The FDA endorsement was based on results of a phase 3 trial, ARANOTE, which showed that Nubeqa significantly extended the time before tumor progression or death in patients with mCSPC compared with ADT alone. In the study of 669 patients who were randomized 2 to 1 to receive 600 mg of Nubeqa plus ADT or placebo plus ADT, Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46%, allowing the trial to achieve its primary endpoint.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help speed the reviews of certain gene therapy applications it brings to the regulator in the future.
    • “The so-called platform technology designation issued to Sarepta is meant to streamline the development and evaluation process for gene therapies using a specific delivery tool, a viral vector dubbed rAAVrh74. That component is part of multiple Sarepta programs, among them the already approved Duchenne muscular dystrophy gene therapy Elevidys.
    • “According to Sarepta, the designation is one of the first given to a drug program since the initiative was launched by the FDA. It enables Sarepta to use evidence previously gathered from studies involving the vector in future applications, though differences in how some of its newer gene therapies are manufactured may limit its usefulness.”
  • Per MedTech Dive,
    • “Smiths Medical has recalled infusion pumps to update the instructions to address three problems that could lead to serious injury or death. The devices are staying on the market. 
    • “The Food and Drug Administration, which published Class I notices about the recalls Tuesday, said issues with some CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps could interrupt or delay treatment. Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm.” 

From the public health and medical research front,

  • STAT News reports,
    • “KJ Muldoon, the first infant treated with a personalized gene-editing drug, has been discharged from the hospital for the first time in his life, the Children’s Hospital of Philadelphia announced Tuesday. After 307 days at CHOP, KJ was dressed in what early studies suggest are the world’s smallest and cutest graduation cap-and-gown before leaving.
    • “It’s a promising sign for KJ, his family, and the therapy researchers built in just 6 months. Born with an ultra-rare disease that prevented his liver from breaking down ammonia, he was rushed to CHOP, where specialists kept him under strict monitoring to prevent ammonia from flaring and doing long-term damage. Typically, he would receive a liver transplant. Instead, scientists across the country teamed to devise a gene-editing treatment.
    • “KJ received the first of three doses at six months old. He’s now 10 months old. The hope is that, while not cured, he has been left with a far more mild version of his disease. Meanwhile, researchers are working on ways to scale his treatment for thousands of others.”
  • and
    • “Circulating tumor DNA blood tests are rapidly gaining popularity among oncologists for their potential to detect cancer recurrence and treatment resistance earlier than traditional imaging. But despite their promise, data presented at the annual ASCO meeting this week suggest that the clinical value of ctDNA tests is still unproven.
    • “While some trials hint at benefits, others lack conclusive survival outcomes — which raises concern about whether early interventions based on ctDNA actually improve patients’ lives.
    • “We need evidence to know the true value of these tests,” University of Pennsylvania cancer researcher Angela DeMichelle told STAT’s Angus Chen. “They have incredible potential to help people, but if we don’t do the studies and don’t do them the right way, we can hurt people.”
  • The American Journal of Managed Care adds,
    • A blood-based circulating tumor DNA (ctDNA) test detected colorectal cancer (CRC) with 79.2% sensitivity and 91.5% specificity, according to a recent prospective study. These findings suggest the investigational test may be a viable noninvasive screening option, although its ability to detect advanced precancerous lesions remains limited.
    • The population-based, observational study is published in JAMA.
    • “This study was designed as a large, prospective diagnostic accuracy evaluation of a blood-based CRC screening test, with blinded comparison to colonoscopy in an average-risk screening population,” wrote the researchers of the study. “It enrolled a geographically and demographically diverse cohort across 201 sites, approximating the racial and ethnic distribution of the US.”
    • “CRC is the second leading cause of cancer-related deaths globally, with more than 1.9 million new cases and 930,000 deaths estimated in 2020 alone. Increased access to screening options—including stool-based tests, visual exams, and emerging blood-based tests—can help detect CRC at its most treatable stages and reduce both incidence and mortality.”
  • Per Reuters,
    • “American teens are increasingly turning to the weight-loss drug Wegovy as more families and their doctors gain confidence in its use for young people with obesity, new data shared with Reuters shows.
    • “The average rate of teens beginning treatment with the highly effective Novo Nordisk (NOVOb.CO), opens new tab drug grew 50% last year to 14.8 prescriptions per 100,000 adolescents, according to an analysis by health data firm Truveta.”
  • Per Healio,
    • “Enrollment in a patient-delivered intervention allowed adults with overweight or obesity to better maintain weight loss than those receiving standard of care, according to trial findings published in JAMA Internal Medicine.
    • “In the CHAMPS randomized controlled trial, adults with overweight or obesity who previously lost at least 5% of their body weight with lifestyle intervention were randomly assigned to a weight-loss maintenance intervention led by fellow patients who previously lost weight or to standard of care weight maintenance led by a physician. Adults participating in the patient-led intervention were more successful at maintaining their body weight.”
  • Medscape notes,
    • “As part of treating the overall well-being of your patients, it may be beneficial to recommend nutritional counseling. More insurance carriers are providing this service as a benefit.
    • “When patients have conditions such as type 2 diabetes, high blood pressure, heart disease or obesity, suggesting nutritional counseling could help your patients become more informed about making healthier choices. More health insurance plans cover nutritional counseling, although some may only provide coverage for specific conditions.
    • “Integrating nutritional counseling into routine clinical practice is essential and necessary to achieving optimal health outcomes,” said Scott Isaacs, MD, adjunct assistant professor of medicine, Emory University, and president of the American Association of Clinical Endocrinology, who is based in Atlanta. “By ensuring that nutritional counseling is accessible, personalized, and supported by insurance, we empower our patients to prevent disease, effectively manage chronic conditions, and improve both quality of live and longevity.”
  • The Wall Street Journal reports,
    • “New research is helping to answer an important question about ultra-processed foods: Which ones might be healthier? 
    • “One reason many ultra–processed foods often lead us to eat big meals and heavy snacks is because of their texture, which makes them go down easily and quickly, according to a new study presented this week at a conference in Orlando, Fla., of the American Society for Nutrition.
    • “But some diets filled with ultra-processed foods don’t cause us to eat as much. People in the study who had a diet of slower-to-eat ultra-processed foods such as crunchy breakfast cereal and multigrain buns consumed an average of 369 fewer calories a day than when they were eating quick-to-eat ultra-processed foods such as commercially made smoothies and soft breads.
    • “Meals that are equally satisfying were eaten in different ways purely as a function of the way they’re textured,” said Ciarán Forde, a professor at Wageningen University in the Netherlands, who led the study.”
  • Per an NIH press release,
    • Researchers at the National Institutes of Health (NIH) have identified which brain circuits are vital for visual acuity and how they are affected by damaged retinal cells. While vision restoration therapies, such as stem-cell and gene therapies, aim to replace or repair damaged cells in the eye, it is critical to understand how brain circuits involved in vision are affected by retinal cell loss. Study results suggest that targeting these circuits may be necessary to achieve optimal recovery of visual function, and have significant implications for the development of future vision restoration therapies that address visual pathways beyond the retina. The study published today in The Journal of Neuroscience.
    • “A huge amount of progress has been made in repairing the eye, however little attention has been paid to the functional consequences beyond the eye,” said the study’s lead investigator, Farran Briggs, Ph.D., senior investigator at NIH’s National Eye Institute (NEI). “Brain circuits downstream of damaged or dying retinal cells in the eye may also undergo some loss of function following changes to their retinal inputs.”

From the U.S. healthcare business front,

  • Beckers Health IT lets us know about six things concerning “CVS Health’s $20B bet on integrated, tech-enabled care,” and five details about Mark Cuban’s pharmacy network.
  • Modern Healthcare reports,
    • “Despite tight budgets and other operational challenges, health systems are increasingly investing in replacement hospitals and sustainability, while maintaining a strong focus on outpatient facilities in construction and design projects.
    • “More than 53% of the construction and design firms that responded to Modern Healthcare’s 2025 Construction and Design Survey said the industry is growing, even as it faces financial headwinds such as funding limitations, inflation and recent tariffs.”
  • Per BioPharma Dive,
    • “Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm Camurus that promises to produce longer-acting medications.
    • “Camurus’ FluidCrystal technology is designed to methodically release a therapeutic drug substance into the body over a period of days or months. After an injection, the solution interacts with bodily fluids to transform into a liquid crystalline gel. The gel holds the active ingredient and then slowly degrades, releasing medicine.
    • “The deal includes an unspecified upfront payment as part of an initial package that may be worth as much as $290 million, Camurus said Tuesday. That figure also includes payments for reaching certain development and regulatory milestones. Another $580 million could be available for meeting sales goals, along with mid-single digit royalties for successful products.”
  • BioPharma Dive summarizes its reporters’ takeaways from the ASCO conference which ended yesterday.
  • Fierce Healthcare relates,
    • “DispatchHealth and Medically Home closed their merger deal on Wednesday, combining the forces of at-home care and hospital-at-home leaders.   
    • “Operating under the DispatchHealth brand, the combined company will provide three core service lines. Its hospital-alternative care service, also called hospital at home, provides inpatient hospital-level care at home. The company also provides emergency-level care, when appropriate, to help patients avoid ED visits. 
    • “The merger was announced in mid-March. In the coming months, the company will integrate Medically Home’s technology platform and clinical command center for use nationwide, the company said.
    • “The two leadership teams have combined. Jennifer Webster will continue as the CEO of DispatchHealth. Graham Barnes, who took over as CEO of Medically Home in August 2024, is departing to pursue new opportunities. Pippa Shulman, D.O., has assumed the role of chief medical officer, according to a press release.”

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.
  • This afternoon, the House of Representatives passed by voice vote the Esophageal Cancer Awareness Act, HR 3490.
    • “This bill requires the Government Accountability Office to report to Congress on (1) the impact of esophageal cancer-related health care spending under the Federal Employees Health Benefits Program (FEHBP) for federal employees and retirees diagnosed with esophageal cancer, and (2) how often FEHBP participants with a high risk of esophageal cancer undergo screenings according to established guidelines.” 
    • The bill honors the late Rep. Gerald Connelly (D VA) who died from the disease. The bill now heads to Senate.
  • The New York Times reports,
    • “President Trump on Tuesday ratcheted up pressure on Senate Republicans to quickly embrace and pass legislation carrying his domestic agenda, intensifying a battle inside the G.O.P. about what should be in the measure and how much it should cost.”
  • Govexec adds,
    • “The Trump administration plans to send its first spending cuts request to Congress on Tuesday, asking lawmakers to swiftly eliminate $9.4 billion in funding for the Corporation for Public Broadcasting and various foreign aid programs.
    • “The request for what are called rescissions allows the White House budget office to legally freeze spending on those accounts for 45 days while the Republican-controlled Congress debates whether to approve the recommendation in full or in part, or to ignore it.
    • “The proposal calls on lawmakers to eliminate $1.1 billion from the Corporation for Public Broadcasting, which provides funding for National Public Radio and the Public Broadcasting Service. That means NPR and PBS would lose their already approved federal allocations, if the request is approved by Congress.”
  • Fierce Healthcare points out,
    • “The Centers for Medicare and Medicaid Services plans to undertake several new health tech initiatives, senior leaders announced today at a closed meeting with stakeholders. 
    • “The Department of Health and Human Services held a meeting today to discuss health tech policy and its recent request for information on health tech initiatives. CMS seems to be moving ahead with some of the initiatives it asked stakeholders to provide feedback on in its RFI — among them a national provider directory and modern identity verification for Medicare beneficiaries.
    • “This comes as the HHS’ health IT office announced a new leader this morning, Thomas Keane, M.D. Keane spoke at the meeting of stakeholders today at the Hubert H. Humphrey building in Washington, D.C.” 
  • Healthcare Dive adds,
    • Thomas Keane, a software engineer and interventional radiologist, began his role as national coordinator [for health information technology] Monday, the spokesperson said. He previously worked at the ASTP and served as a senior advisor to the deputy secretary of the HHS, according to his biography on the agency’s website. 
  • Healthcare Dive also relates,
    • “The Trump administration rescinded guidance on Tuesday directing hospitals to perform abortions during medical emergencies, even in states with restrictive abortion bans. 
    • “The Biden administration published the guidance in 2022, shortly after Roe v. Wade was overturned, asserting doctors were required to perform emergency care, even if that included abortions, under the Emergency Medical Treatment and Labor Act. * * *
    • “The CMS now says that guidance “does not reflect the policy of this Administration.” The new guidance is effective May 29, and furthers an executive order from President Donald Trump seeking to remove regulatory red tape, the CMS said.” * * *
    • “Texas and Idaho, which have some of the nation’s most restrictive abortion bans, have repeatedly argued that there is no conflict between EMTALA and their policies, because both states allow abortion when the mother’s life is at risk.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal district court judge on Tuesday denied motions to dismiss complaints in two lawsuits against data analytics firm MultiPlan — now operating as Claritev — and a number of insurers.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois denied Claritev’s motion to dismiss complaints in two lawsuits involving federal and state antitrust and consumer protection claims.” * * *
    • “Both lawsuits allege Claritev colluded with insurers to reduce pay for out-of-network providers, violating state and federal antitrust laws under the Sherman Act.
    • “We remain confident in the strength of our legal position and look forward to presenting the facts as the case moves forward,” Claritev said in a statement Tuesday. “These lawsuits will only serve to increase healthcare cost for employers and patients. We will vigorously defend ourselves through the legal process while remaining focused on delivering value to our customers and the broader healthcare ecosystem.”
  • Per Healthcare Dive,
    • “Centene is being sued for wrongful death after one of its members died after failing to get the mental healthcare he needed because of the insurer’s inadequate provider networks, according to the lawsuit filed by the member’s mother.
    • “The suit, filed late May in the Superior Court of Maricopa County in Arizona, accuses Centene’s subsidiary in the state, Health Net, of maintaining “ghost networks” — wherein insurers say providers are in network that aren’t, inflating the care options available under their plans to the detriment of actual access.
    • “As a result, Centene violated state and federal laws requiring network accuracy and adequacy, according to the suit, which also accuses the St. Louis-based payer of negligence and fraud. Centene did not respond to a request for comment.”
  • Per MedTech Dive,
    • “The Food and Drug Administration did not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over laboratory developed tests, according to two lab industry groups.
    • “The 60-day window for the FDA to appeal the ruling by the U.S. District Court for the Eastern District of Texas expired over the weekend. The Association for Molecular Pathology supported the FDA’s move not to appeal.
    • “This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs,” AMP President Jane Gibson said in an emailed statement.”

News from the American Society of Clinical Oncology’s conference

  • The New York Times reports,
    • “A group of 97 patients had longstanding multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year.
    • “They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice.
    • “They all got immunotherapy, in a study that was a last-ditch effort.
    • “A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients — a result never before seen in this disease.
    • “These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words “potential cure.”
    • “The new study, reported Tuesday at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which has an exclusive licensing agreement with Legend Biotech.”
  • Per Fierce Pharma,
    • “Though they are both multiple myeloma drugs with the same mechanism of action, Sanofi’s Sarclisa has had difficulty competing with Johnson & Johnson’s powerhouse Darzalex, largely because it reached the market five years later.
    • “But one advancement that could help Sanofi close some of the gap is its on-body delivery system for its CD38 antibody.
    • “Tuesday, at the American Society of Clinical Oncology annual meeting in Chicago, Sanofi presented data from two trials that showed Sarclisa administered subcutaneously (SC) from an investigational on-body injector (OBI) reduced treatment time and produced similar efficacy and safety compared to intravenous (IV) infusion.”
  • Per BioPharma Dive,
    • “An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company.
    • “The study, known as Oasis-4, is the fourth successful trial test of Bayer’s drug, called elinzanetant. Detailed data presented at the American Society of Clinical Oncology’s annual meeting Monday showed treatment reduced vasomotor symptoms in women receiving endocrine therapy to treat or prevent hormone receptor-positive breast cancer.”
  • and
    • “A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial.
    • “Results from this trial, named Amplitude, were released Tuesday at the American Society of Clinical Oncology’s meeting in Chicago. They could potentially expand the number of people able to receive J&J’s Akeega, a pill that combines the active ingredients from the medicines Zejula and Zytiga.”
  • The Wall Street Journal reports,
    • “Roche said Tecentriq combined with lurbinectedin shows significant survival benefits for patients with extensive-stage small cell lung cancer.
    • “The Swiss pharmaceutical company said Tuesday that late-stage trials showed the combination led to a 46% reduction in the risk of the disease progressing or death, and 27% reduction in the risk of death.
    • “The combination can be used a as a first-line maintenance treatment for people with the cancer following induction therapy with carboplatin, etoposide and Tecentriq, it said.
    • “The safety profile of the combination was consistent with the known safety profiles of Tecentriq and lurbinectedin, Roche said.”

In other medical research and public health news,

  • Cigna, writing in LinkedIn, explains why early detection is so important to fighting breast cancer.
  • The latest issue of the National Institutes of Health’s Research Matter covers “Customized gene therapy | Parents with substance use disorders | Ultra-processed food consumption.”
  • The New York Times discusses “Anorexia in Middle Age and Beyond. A growing number of older women are seeking treatment for eating disorders. Many have struggled without help for decades.”
  • MedCity News informs us,
    • “The World Health Organization estimates that about 10% of women and girls of reproductive age around the world — roughly 190 million people — suffer from chronic pain as a result of endometriosis. 
    • “Take this estimate with a grain of salt, though — it’s likely too low. The average diagnostic delay for endometriosis patients is eight years, driven in large part by the fact that the standard method used to diagnose the disease is an invasive surgical procedure.”
    • Boston-based biotech startup Heranova Lifesciences is working to address this problem by developing a non-invasive blood-based test. Just this spring, the company announced the LDT validation and U.S. launch of this product, which is called HerResolve. * * *
    • “The gold standard that doctors use to diagnose endometriosis is laparoscopy followed by histological confirmation. With this method, doctors put patients under anesthesia and perform a laparoscopy to look at the tissue and lesions growing outside the uterus — then, the doctor takes a tissue sample to confirm the diagnosis under a microscope.
    • “This method of testing is invasive — and not very quick. Heranova’s test seeks to address these issues by using machine learning to analyze a panel of biomarkers in a patient’s blood sample to determine whether or not they have endometriosis. 
    • “The test’s accuracy is on par with laparoscopy followed by histopathology, said Farideh Bischoff, Heranova’s chief medical officer.”
  • Per Health Day,
    • “Clinicians consider administration of human papillomavirus (HPV) vaccine as feasible at age 9 to 10 years, and parents appear to be receptive to discussing vaccination at this age, according to a study published online June 2 in Pediatrics.
    • “Caroline K. Tietbohl, Ph.D., from the University of Colorado and Children’s Hospital Colorado in Aurora, and colleagues conducted an explanatory sequential mixed-methods study as part of an ongoing randomized trial that compared initiation at ages 9 to 10 years (intervention) versus 11 to 12 years (control) across 17 practices in Colorado (nine intervention) and 16 practices in California (eight intervention). At one month after study initiation, practice clinicians were surveyed, and semi structured interviews were conducted at three months after study initiation.” * * *
    • “The results of our prospective trial will determine if initiating vaccination earlier increases vaccination completion rates, especially by age 13 years,” the authors write.
  • The Wall Street Journal reports,
    • People are more likely to get cancer as they age. Dr. Miriam Merad has an unconventional idea of how that might be reversed: using allergy drugs and other seemingly unlikely medications to damp a condition known as “inflammaging.”
    • The immunologist and oncologist has spent years examining malignant tumors to learn why people over age 50 account for nine in 10 cancer diagnoses in the U.S. She and her research team at the Icahn School of Medicine at Mount Sinai in New York City have homed in on an answer: the aging immune system. Their studies of individual immune cells in human lung tumors, as well as in old mice, have revealed how chronic, or pathogenic, inflammation in older people—dubbed inflammaging—interferes with the immune system and fuels cancer growth.
    • Merad and other researchers are testing whether existing anti-inflammatory medications usually used to fight rheumatoid arthritis or allergy conditions like asthma or eczema can slow cancer in older patients. They are also searching for new drugs. “Aging is something that we think we can transform,” says Merad, director of the Marc and Jennifer Lipschultz Precision Immunology Institute at Mount Sinai.”

From the U.S. healthcare business front,

  • Becker Payer Issues lets us know,
    • “Following a tumultuous period for UnitedHealth Group, new CEO and board chair Stephen Hemsley addressed investors on June 2, acknowledging the company’s recent shortcomings and detailing his plan to restore the high performance that investors and customers expect moving forward.
    • “Mr. Hemsley expressed a deep commitment to regaining trust through increased transparency, improved pricing strategies, and a renewed focus on internal operations, particularly at Optum Health and UnitedHealthcare. 
    • “We are well aware we have not fulfilled your expectations or our own,” he said. “We apologize for that performance and we are humbly determined to earn back your trust and your confidence.”
    • The article also provides eight notes on Mr. Hemsley’s talk.
  • STAT News adds,
    • UnitedHealth Group’s new CEO told investors that the company is reevaluating how it tallies Medicare Advantage patients’ diagnoses for reimbursement purposes, an issue currently under investigation by the Justice Department. 
    • Stephen Hemsley’s remarks during the company’s annual shareholder meeting on Monday signal a noteworthy shift: UnitedHealth is now publicly acknowledging potential issues with how it assesses the health of its Medicare Advantage members.” * * *
    • “Our management team has been working with urgency through a comprehensive and methodical review of our operations from end to end,” Hemsley said. “Digging into every part of the organization to evaluate how we have been performing and to improve that performance.”
  • Fierce Pharma notes,
    • “Medicare Part D beneficiaries can now tap into Amazon Pharmacy’s PillPack for pre-sorted medication packets, the retail giant announced on Tuesday.
    • “PillPack sorts a patient’s medications into personalized, tear-away packets that are labeled by date and time, which can make it easier to follow prescribed regimens. The expansion brings this service to more than 50 million Part D enrollees who take daily medications, Amazon said.
    • “Once eligible customers sign up for packets through PillPack, Amazon Pharmacy will coordinate needed refills to ensure prescriptions arrive on time.
    • “In addition to growing its reach in the Part D market, Amazon announced that it will roll out new services to support caregivers in managing medications for a family member or loved one.”
  • Modern Healthcare reports,
    • “Pyx Health, a digital mental health platform, on Tuesday announced its acquisition of FarmboxRx, a company that provides fresh produce food boxes to Medicare and Medicaid members.”
  • Beckers Hospital Review informs us that “Hospitals [are] push[ing] back on low Leapfrog grades.”
  • Per Fierce Healthcare,
    • “In January, H1 picked up provider data management software company Ribbon Health to broaden its reach into the health plan, provider system and digital health sectors.
    • “Five months later, the healthcare tech company has acquired Veda Data Solutions to build out its provider data and automation solutions for payers.
    • “Financial terms of the deal were not disclosed.
    • “Founded 10 years ago, Veda fixes bad provider data for healthcare organizations. Inaccurate and out-of-date health plan provider directories continue to be a thorny problem in healthcare and can make it difficult for patients to find a clinician when they need care.”

Friday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NCQA, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash
  • The University of Minnesota’s CIDRAP tells us,
    • “The Centers for Disease Control and Prevention (CDC) yesterday updated its childhood immunization schedule with a revised recommendation on COVID-19 vaccines for healthy children.
    • “The changes partly reflect a new position on COVID vaccine recommendations for healthy children announced earlier in the week by Department of Health and Human Services Secretary Robert F. Kennedy Jr., though they do not go as far as Kennedy had suggested.
    • “The CDC childhood immunization schedule now says that healthy children ages 6 months to 17 years, when the parent expresses a desire for their child to vaccinated, “may receive COVID-19 vaccination, informed by the clinical judgement of a healthcare provider and personal preference and circumstances.” Previously, the agency had recommended COVID-19 vaccines for healthy children ages 6 months and older, based on the recommendation of the CDC’s Advisory Committee on Immunization Practices.” * * *
    • “[A]ccording to the CDC, shared clinical decision-making recommendations on the immunization schedule are required to be covered by private insurers [with no cost sharing when provided in-network] under the Affordable Care Act.
    • “The CDC is still recommending COVID vaccination for children ages 6 months to 17 years who are moderately or severely immunocompromised.”
  • Govexec informs us,
    • “The White House on Friday told the government’s top watchdog it will only cooperate when doing so does not impede its ability to carry out President Trump’s agenda, reigniting a feud that traces back to the president’s first term in office. 
    • “The letter, from Office of Management and Budget General Counsel Mark Paoletta to the Government Accountability Office, follows the watchdog last week finding the Trump administration violated federal spending laws by withholding money appropriated by Congress. Paoletta denied that the administration has flouted the Impoundment Control Act, the law that prohibits the executive branch from withholding congressionally appropriated funds for policy reasons. 
    • “The OMB official criticized GAO for asking too many questions of the White House, including the dozens of probes the watchdog has opened into potential illegal impoundments. Paoletta noted that GAO has around 50 “open engagements” with the budget office. 
    • “Not only does GAO exceed its statutory authority when it unhelpfully injects itself into an agency’s implementation of a program, GAO also hampers the Executive Branch’s ability to carry out its statutory mandates,” Paoletta said in the letter, which was first reported by The Washington Post. He added the legislative branch agency often attempts to substitute its “policy views for those of the president.” 
  • The American Medical Association News lets us know,
    • “The Government Accountability Office May 29 released a report recommending the Centers for Medicare & Medicaid Services target behavioral health services when auditing Medicare Advantage plans’ use of prior authorization. CMS said it currently does not target behavioral health services because they make up a small percentage of MA services, the report said.     
    • “The report describes selected MA organizations’ prior authorization requirements and use of internal coverage criteria for prior authorization decisions on behavioral health services. It also examines CMS’ oversight of the use of internal coverage criteria, among other issues. GAO said that CMS “would take the recommendation under advisement in the future.” 

In Food and Drug Administration news,

  • Per Healio,
    • “The FDA approved Tryptyr to treat the signs and symptoms of dry eye disease, according to a press release from Alcon.” * * *
    • “Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” Marjan Farid, MD, professor of ophthalmology at the University of California, Irvine, said in the release. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.” * * *
    • “Alcon expects a third quarter launch for Tryptyr in the U.S.”
  • Per HCPLive,
    • “The US Food and Drug Administration (FDA) has approved hydrocortisone (KHINDIVI) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency.1
    • “Announced by Eton Pharmaceuticals on May 28, 2025, this approval marked the first FDA-approved oral solution formulation of hydrocortisone, designed to address administration and dosing accuracy in patients who may have difficulty swallowing pills or special administration needs.” * * *
    • “Adrenal insufficiency is a rare, serious condition characterized by decreased production of aldosterone and cortisol due to reduced adrenal gland function. It can present acutely in an adrenal crisis or chronically, and if not recognized, can lead to very high morbidity and mortality.2 In the release, Eton Pharmaceuticals estimated that more than 5,000 adrenal insufficiency patients are present in the US between the ages of 5 and 17.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity, emergency department visits, and laboratory percent positivity are at very low levels.
      • Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The University of Minnesota’s CIDRAP adds,
    • “The US Centers for Disease Control and Prevention (CDC) in its weekly update today reported 42 measles cases, some tied to a large outbreak centered in West Texas and others linked to instances of community transmission or travel to other states or countries, lifting the nation’s total to 1,088 infections.
    • “Two more states reported their first cases this week, Iowa and Nebraska, putting the number of affected jurisdictions at 33. The number of outbreaks remained at 14, and 90% of cases are linked to outbreaks.” * * *
    • “The Texas Department of State Health Services (TDSHS) today reported 9 more cases in the West Texas outbreak, putting the total since January at 738. Though 35 counties have reported cases linked to the outbreak, only 7 still have ongoing transmission. 
    • “Like other states, Texas also continues to record measles cases from various sources that apparently aren’t linked to the larger outbreak, and today officials reported 8 more such infections, lifting that total to 32. 
    • “A few other states have reported cases linked to West Texas activity, but no new illnesses were reported in New Mexico or Oklahoma. On May 28, Kansas reported a total of 64 cases from 11 counties, 59 of them linked to an outbreak in the southwestern part of the state.’
  • CBS News reports,
    • “Hormel Foods Corporation is recalling over 256,000 pounds of canned beef stew nationwide due to potential contamination with wood fragments, according to federal health officials.
    • “In a recall notice posted Wednesday [May 28], the U.S. Department of Agriculture’s Food Safety and Inspection Service said the 20-oz. metal cans containing “Dinty Moore Beef Stew” were shipped to retail locations nationwide.
    • “The recalled products have a “FEB 2028” best by date, lot code “T02045” and establishment number “EST 199G” printed on the can. 
    • “The problem was discovered after the establishment notified FSIS that they had received three consumer complaints reporting pieces of wood in the beef stew product,” the notice read. 
    • “So far, there have been no confirmed reports of injury.”
  • The American Medical Association lets us know “what doctors wish patients knew about improving eye health.”
  • Health Day points out,
    • “Among U.S. youth, overdose deaths attributable to synthetic opioids alone are increasingly predominant, according to a study published online May 20 in Pediatrics.
    • “Megan Miller, M.P.H., from the New York University Grossman School of Medicine in New York City, and colleagues examined trends in overdose deaths involving combinations of synthetic opioids with benzodiazepine, cocaine, heroin, prescription opioids, and other stimulants. Findings were based on U.S. youth aged 15 to 24 years from 2018 to 2022 using the National Vital Statistics System multiple cause of death datasets.
    • “The researchers found that between 2018 and 2022, overdose death counts increased from 4,652 to 6,723 (10.85 to 15.16 per 100,000), with a slight decrease between 2021 and 2022. Deaths involving synthetic opioids only showed the largest increases (1.8 to 4.8 deaths per 100,000). Regardless of race, ethnicity, or sex, fatal synthetic opioid-only overdose rates were higher than polydrug overdose rates involving synthetic opioids since 2020. In 2022, rates of synthetic-only overdose deaths were 2.49- and 2.15-times higher among male versus female youth and among those aged 20 to 24 versus 15 to 19 years, respectively.”
  • and
    • “Heart disease, strokes and diabetes contribute to many dementia cases in the United States, but the risk is not equal everywhere, a new study says.
    • “Overall, more than a third (37%) of U.S. dementia cases are linked to eight conditions: diabetes, heart failure, atrial fibrillation, coronary artery disease, heart attack, stroke, high blood pressure and high cholesterol, researchers found.
    • “The South has the strongest link between these diseases and dementia, researchers reported recently in the journal Alzheimer’s & Dementia.
    • “A substantial number of dementia cases could be eliminated by mitigating modifiable cardiometabolic risk factors, especially in U.S. counties with a high risk of dementia attributed to these risk factors,” senior researcher Dr. Brad Racette said in a news release. He’s chair of neurology at Barrow Neurological Institute in Phoenix.”
  • Per a National Institutes of Health news release,
    • “A research team funded by the National Institutes of Health (NIH) has identified a diagnostic aid that has the potential to accurately predict the recurrence of diabetic foot ulcers that appear to be fully healed. By measuring the skin’s barrier function through a process known as trans-epidermal water loss, or TEWL, scientists were able to determine which wounds were more likely to reopen. TEWL measurements are a major factor in burn care, where deep layers of the skin are often damaged. The findings suggest that full restoration of skin barrier function should be incorporated into existing wound treatment standards to ensure complete wound closure and to better identify patients at risk of wound recurrence.
    • “This study is an important initial step to give clinicians treating diabetic foot ulcers a reliable diagnostic aid for the first time to assess an individual’s risk of ulcer recurrence,” said Teresa Jones, M.D. program director for the Division of Diabetes, Endocrinology, & Metabolic Diseases at NIH’s National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK). “Foot ulcers are such a confounding issue with diabetes and being able to determine which wounds are at highest risk for recurrence could save many lives and limbs.”  
  • NCQA, writing in LinkedIn, tells us,
    • The use of peer support is a growing trend for populations affected by mental health and substance use disorders. Peers—both paid and volunteer—have many of the same lived experiences as the people they serve, and can help them navigate the health care system, access treatment and overcome barriers to recovery.
    • Peers are another avenue of support in the behavioral care system—their shared experience related to mental health, addiction and recovery helps them build trust relationships. Many studies show the benefits of peer support: decreased days in inpatient care, increased engagement in outpatient treatment, reduced readmission rates and lower relapse rates.
    • “There’s a stigma associated with receiving mental health and substance use treatment,” says Chrissy Craig, MSPH, NCQA’s Senior Health Care Analyst. “Because of their lived experience, peers can connect with people who may not be ready to engage in traditional treatment approaches. They can build trust and encourage individuals to get the help they need.”
    • Recognizing the importance of peer support, NCQA has added it as an option for follow-up care in four HEDIS® measures:
      • Follow-Up After Emergency Department Visit for Substance Use (FUA).
      • Follow-Up After Hospitalization for Mental Illness (FUH).
      • Follow-Up After Emergency Department Visit for Mental Illness (FUM).
      • Follow-Up After High-Intensity Care for Substance Use Disorder (FUI) (MY 2026).
  • Per Health Leaders Media,
    • “An AI tool that can detect inflammation in the coronary artery could help clinicians diagnose heart disease much earlier, even decades before the patient shows any outward signs of distress.
    • “CaRi-Heart Technology, developed by Connecticut-based Caristo Diagnostics, was recently given its own Category III CPT code by the American Medical Association’s CPT Editorial Panel, an important step in the path to adoption after FDA approval and, just as important, payer reimbursement. The technology has also shown promising results in trials conducted in 2024 at five National Health Service hospitals in the UK, where reports indicate more than half of patients analyzed by the AI tool had their treatments changed.
    • “To clinicians, the tool could be a critical step forward in the diagnosis and treatment of heart disease, the leading cause of death in the country.”
  • The Wall Street Journal reports,
    • “Sanofi and Regeneron’s respiratory drug, itepekimab, showed mixed results in late-stage trials for COPD.
    • “One trial saw a statistically significant 27% reduction, while the other missed its primary goal with only a 2% reduction.
    • “Sanofi shares fell 7% and Regeneron shares dropped 12% after the results; future steps will be discussed with regulators.”
  • Per BioPharma Dive,
    • “A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to approval in the U.S.
    • “When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to chemotherapy alone in patients whose non-small cell lung cancer has a mutation in a gene called EGFR. However, a 21% reduction in death risk, specifically, didn’t meet the threshold for statistical significance, Summit said in a statement Friday.
    • “Summit intends to seek Food and Drug Administration approval based on the study results. Yet in its statement, the company indicated the timing of a filing is uncertain given the agency has made clear that a survival benefit is “necessary” to support a submission.”

Fromm the U.S. healthcare business front,

  • The actuarial consulting firm, Milliman, announced on May 27,
    • the release of the 2025 Milliman Medical Index (MMI), which measures healthcare costs for Americans covered by a typical employer-sponsored health insurance plan. Healthcare costs for the average person increased 6.7% in 2025, with pharmacy costs increasing by 9.7% and outpatient facility care costs rising 8.5%. Healthcare costs for a hypothetical family of four rose to $35,119.
    • “Pharmaceutical costs have been a leading driver of healthcare spending in recent years,” says Milliman Principal and Consulting Actuary Dave Liner. “This year, outpatient facility services and pharmacy costs together accounted for nearly 70% of the total cost increase. Much of the outpatient growth is linked to high-cost drugs administered in outpatient settings.”
    • In recognition of the MMI’s 20th anniversary, this edition includes a look back at how healthcare costs have evolved in the last 20 years. “Since we began publishing the MMI 20 years ago, healthcare costs for American families have nearly tripled,” says Milliman Principal and Consulting Actuary Deana Bell. “Annual growth has averaged 6.1%, far outpacing any other household expense. No other cost category has risen as steeply or as consistently over the past two decades. Outpatient facility care saw the largest increase of any category, rising 286% since 2005, reflecting the growing complexity of procedures now handled outside of inpatient settings.”
    • Read this year’s MMI.
  • An essayist writing in the Wall Street Journal, opines “America’s hospital-bed shortage is about to become a crisis. As new construction declines and occupancy rates soar, experts warn that hospitals may soon cease to function properly because of overcrowding.”
  • Modern Healthcare reports,
    • “Health systems, accountable care organizations and others are bringing extra staff and tracking technology into post-acute care to reduce hospital readmissions.
    • “Health systems, such as OSF Healthcare, and accountable care organizations, such as Provider Partners Connect Care are using remote patient monitoring equipment, electronic medical records software and additional staff to ensure patients don’t have a set-back that will send them back to the hospital. Readmissions add costs that ripple through the healthcare system and the Centers for Medicare and Medicaid Services penalizes hospitals and nursing homes for higher-than-predicted readmissions within 30 days of a hospital discharge.”
  • and
    • “UnityPoint Health, based in West Des Moines, Iowa, and MercyOne Siouxland Medical Center in Sioux City, Iowa, have signed a letter of intent for UnityPoint to acquire the medical center. The proposed agreement includes the hospital, its associated facilities, physician practices and home care services. The acquisition is expected to be finalized this summer, pending customary closing conditions.”
  • and
    • MDaudit, a cloud-based continuous risk monitoring platform that helps healthcare organizations reduce billing vulnerabilities and increase revenue, has entered into a definitive merger agreement to acquire Streamline Health Solutions, a provider of tools that help healthcare providers improve financial performance. The all-cash transaction is valued at approximately $37.4 million, including debt. The deal is expected to close in the third quarter.
  • Per Fierce Healthcare,
    • Women’s healthcare company Wisp has launched a diagnostics arm to offer low-cost testing at home for sexual and reproductive health, the company announced May 28. 
    • Wisp is an online platform that prescribes medication for a range of women’s health needs such as oral contraception, yeast infections, fertility, emergency contraception and some medication abortion. Women can pick up their prescriptions at the pharmacy on the same day as their request, following approval by a provider. Wisp also ships medications in discreet packaging. 
    • Wisp will now offer at-home tests for common sexually transmitted infections and free telehealth consultations for positive results, according to a release by the company. Patients will send completed urine tests or swabs to a partnered CLIA/CAP accredited laboratory and receive results in three to five business days. 
    • “The new model expands on Wisp’s direct-to-consumer telehealth platform and eliminates the need for patients to visit an in-person clinic to complete diagnostic testing. Patients can collect samples at home with tests sent in discreet packaging to maintain privacy in their healthcare and receive services entirely from home.”
  • and
    • “Talkspace inked a partnership with Amazon Pharmacy to streamline psychiatric medication fulfillment and home delivery for its members.
    • “It marks the first time a virtual behavioral health solution has integrated with Amazon Pharmacy, the companies said.
    • “Psychiatric patients of Talkspace can now have their medications fulfilled through Amazon Pharmacy and delivered to their homes for seamless medication management. Talkspace and Amazon Pharmacy tout the partnership will improve medication adherence for Talkspace members.” 
  • Per Healthcare Dive,
    • Best Buy reported $109 million in charges primarily linked to restructuring at the electronics retailer’s health unit in its first quarter, the company said in earnings released Thursday. 
    • The company began restructuring its health business after it recorded a non-cash goodwill impairment charge of $475 million in its fourth quarter ended Feb. 1, linked to a downward revision in the long-term financial projections for its health segment. 
    • The retailer partners with healthcare organizations to provide in-home health services, but the business has taken “longer to develop than we initially thought,” as providers grapple with financial challenges and the future of the federal government’s hospital at home waiver seems uncertain, Best Buy CEO Corie Barry said during a call with investors Thursday.

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • President Trump’s “big, beautiful bill” squeezed through the House after a late scramble to get rival factions on board. Next it goes to the Senate, where GOP lawmakers are already making demands and party leaders will once again need to bridge sharp disagreements.
    • The more than 1,000-page bill passed the House early Thursday morning after Speaker Mike Johnson (R., La.) found a recipe that satisfied just enough lawmakers, who approved the measure by just one vote after an all-night session. Now Senate Republican leader John Thune (R., S.D.) needs to line up enough support within his own narrow majority—without making changes that fracture the fragile House agreement and derail the party’s hopes to finish the bill by its July 4 target.
  • Federal News Network explains,
    • “Four of the six provisions on federal benefits cuts that originated from Republicans on the House Oversight and Government Reform Committee remain in the House-passed version of the bill, which now heads to the Senate for consideration. But notably, the proposed change to a “high-5” annuity calculation is no longer on the table. The provision was struck from the reconciliation legislation prior to the House’s passage of the bill.
    • “Oversight committee Democrats, as well as Rep. Mike Turner (R-Ohio), led efforts to remove the “high-5” proposal from the reconciliation bill. Rep. Stephen Lynch (D-Mass.) proposed an amendment to strike the “high-5” provision, which was ultimately adopted.
  • Tammy Flanagan, writing in Govexec, answers frequently asked questions about federal retirement.
  • The American Hospital Association (AHA) News tells us,
    • “Food and Drug Administration Commissioner Marty Makary testified May 22 before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on the discretionary budget proposal for fiscal year 2026. The proposal includes $93.8 billion for the Department of Health and Human Services, which oversees the FDA. The allocation is a 26.2% reduction from the FY 2025 enacted level.”  
  • The House of Representatives and the Senate left Washington DC today for a weeklong District/State work break following Memorial Day next Monday. The Senate Majority Leader announced his plans to file additional cloture motions for Presidential nominees when the Senate returns to Capitol Hill on June 2. That list does not include the President nominee for OPM Director Scott Kupor.
  • The AHA News informs us,
    • “The White House May 22 released its Make America Healthy Again report that focuses on childhood chronic disease. The report highlights findings from the MAHA Commission related to poor diet, exposure to environmental chemicals, lack of physical activity, stress and overmedicalization. The report lists a series of recommendations and next steps for research, including studies on nutrition, lifestyle interventions and precision toxicology. In parallel, the commission will develop a strategy to be released in August.”
  • The Washington Post assesses the report here.
  • The AHA News adds,
    • “The Departments of Labor, Health and Human Services, and the Treasury May 22 released several new guidance documents and requests for information on price transparency, following the February executive orderon the same subject. As part of this package, CMS released new guidance on calculating the estimated allowed amount values in the hospital machine-readable files. Whenever possible, hospitals should use the average dollar amount received over the last 12-month period (or less, if the payment methodology was only used for part of the year), which should be derived from the electronic remittance data. If there is no historic data, hospitals should use the expected payment amount, encoded as a dollar figure. This replaces previous guidance which allowed hospitals to use a code of nine number nines to signify that there was not sufficient historic data for that item or service over the last year. CMS also released an RFI on hospital price transparency accuracy and completeness. Comments are due July 21. The AHA plans to submit comments.  
    • “The departments also released a FAQ document, announcing that a new standard format for the insurer machine-readable files will be released Oct. 1, 2025. The new format aims to reduce the file size of the insurer files by decreasing duplicative data. In addition, the departments issued an RFI on improving prescription drug price transparency as part of the Transparency in Coverage, or insurer transparency rule.”

From the Food and Drug Administration front,

  • Per BioPharma Dive,
    • “Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons, maintaining guidance they gave last year.
    • The advisory committee convened Thursday for the first time under the Trump administration, meeting two days after FDA leadership unveiled new guidelines for COVID vaccine approvals. All nine members of the panel voted in favor of targeting shots to the JN.1 family of variants.
    • The FDA doesn’t have to follow the panel’s advice but usually does.”
  • STAT News adds,
    • “In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA vaccines to widen the age range of boys and young men that their labels say are at risk for a rare side effect causing heart inflammation.
    • “The letters, first reported by CBS News, asked Moderna and partners Pfizer and BioNTech to make updates to safety information based on new studies of myocarditis or pericarditis or both after vaccination. Both reactions are rare and known to occur most often in young men within a week after the second shot in the two-dose Covid-19 vaccine regimen, according to the Centers for Disease Control and Prevention. Most cases were mild, causing no more than brief chest pain.”
  • Per MedTech Dive,
    • “Stryker has received 510(k) clearance for a minimally invasive back pain treatment, positioning it to challenge Boston Scientific for the market. 
    • “The Food and Drug Administration clearance, which Stryker disclosed Monday, covers the use of the OptaBlate basivertebral nerve ablation system to provide relief for low back pain.
    • “Stryker is entering a growing market. Boston Scientific’s rival device, which it acquired for $850 million upfront in 2023, “grew strong double digits” in the first quarter, CEO Mike Mahoney told investors in an April earnings call.”
  • Per Fierce Pharma,
    • “While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for chronic obstructive pulmonary disease (COPD), the British drugmaker is confident its IL-5 antibody still has a major role to play in tackling the traditionally tough-to-treat respiratory condition.
    • “Now, following an unexpected delay earlier this month, the company has a fresh FDA green light to put its thesis to the test.
    • “The FDA on Thursday approved Nucala as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.” 
  • and
    • “In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to expand Talzenna into a broader prostate cancer population has failed to impress.
    • “Late Wednesday, eight outside experts on the FDA’s Oncologic Drugs Advisory Committee delivered a unanimous 8-to-0 ‘No’ vote on the question of whether Pfizer’s PARP inhibitor Talzenna has a favorable benefit-risk profile in metastatic castration-resistant prostate cancer (mCRPC) patients without homologous recombination repair (HRR) gene mutations.
    • “Patients without HRR mutations make up the majority of the mCRPC patient population at about 70%, according to briefing docs released ahead of the meeting.”

From the judicial front,

  • Healthcare Dive tells us,
    • “A bankruptcy judge on Wednesday approved Rite Aid’s pharmacy asset sales to a variety of buyers, including some of the bankrupt drugstore chain’s rivals.
    • “Financial details were not disclosed, and sale documents redacted purchase prices for Rite Aid’s assets, which went to retail pharmacy chains like CVS and Walgreens, along with grocers Albertsons, Kroger and Giant Eagle and other buyers.” * * *
    • “The liquidation is a growth opportunity for CVS, already the nation’s largest drugstore chain with more than 9,000 pharmacies. The Woonsocket, Rhode Island-based company purchased prescription files from 625 Rite Aid stores in 15 states and fully acquired 64 brick-and-mortar Rite Aid locations in Idaho, Oregon and Washington.”
  • The Associated Press reports,
    • “The Supreme Court’s conservative majority on Thursday declined to reinstate independent agency board members fired by President Donald Trump, endorsing a robust view of presidential power.” * * *
    • “The court’s action essentially extended an order Chief Justice John Roberts issued in April that had the effect of removing two board members who Trump fired from agencies that deal with labor issues, including one with a key role for federal workers as Trump aims to drastically downsize the workforce.
    • “Neither agency has enough appointed members to take final actions on issues before them, as Trump has not sought to appoint replacements.”
    • “The decision Thursday keeps on hold an appellate ruling that had temporarily reinstated Gwynne Wilcox to the National Labor Relations Board and Cathy Harris to the Merit Systems Protection Board.”
  • Bloomberg Law points out,
    • “A federal district court judge in California said she will likely extend a freeze on President Donald Trump’s plan to lay off thousands of federal workers, dealing another blow to his unprecedented overhaul of the federal workforce. 
    • “Judge Susan Illston of the US District Court for the Northern District of California at a Thursday hearing said she is inclined to grant a preliminary injunction halting the layoffs while the case proceeds, temporarily protecting the jobs of thousands of federal workers.” 

From the public health and medical research front,

  • NBC News reports,
    • “New data from Truveta, a health care and analytics company, shows that the percentage of 6-month-old babies in Texas getting their measles vaccination in April increased by more than 30 times the prior year’s average.
    • “That means parents aren’t just getting the vaccine early, they’re getting it as early as they can,” Nina Masters, a senior scientist at Truveta and part of the research team, said in an interview with NBC News.
    • “Typically, the MMR is given in two doses, around a child’s first birthday, and again around the time a child enters kindergarten, at age 4 or 5. One dose is 93% effective at preventing measles, according to the Centers for Disease Control and Prevention. A second dose increases protection to 97%.”
  • Per Fierce Pharma,
    • “Roche, hoping to carve out a standard-of-care spot for its PI3K inhibitor Itovebi, now has another leg to stand on with new evidence that shows the drug can extend the lives of certain patients with breast cancer.
    • “Adding Itovebi to Ibrance and Faslodex slashed the risk of death by 33% in patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer that has grown during or after hormone therapy treatment. The data, to be presented at the American Society of Clinical Oncology’s (ASCO’s) annual meeting, come from Roche’s pivotal phase 3 INAVO120 trial. 
    • “In the 325-patient study, Roche’s Itovebi triplet combination kept patients alive for a median of 34 months compared to 27 months for those who took a placebo along with Ibrance and Faslodex.”
  • and
    • “Roche’s plan to bolster Tecentriq’s position in small cell lung cancer with Jazz Pharmaceuticals’ Zepzelca has paid off. But the pair’s success leaves room for improvement for future contenders.
    • “Adding Zepzelca on top of Tecentriq as maintenance treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) significantly reduced patients’ risk of death by 27% compared with Tecentriq alone, according to data from the phase 3 IMforte trial.
    • “Patients who received the combo lived a median 13.2 months, versus 10.6 for those who got Tecentriq alone. The results will be presented at the 2025 American Society of Clinical Oncology annual meeting.”
  • STAT News relates,
    • “Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis of a mid-stage clinical trial. 
    • “The survival data are only a snapshot. Merus, a Dutch biotech, will need to complete a larger, randomized study to prove more definitively that its drug can extend the lives of patients with head and neck cancer beyond the ability of current treatments. But for now, the preliminary survival results are encouraging and matched the expectations of investors.
    • “Merus released the new petosemtamab data ahead of a presentation next week at the annual meeting of the American Society of Clinical Oncology.”
  • Per BioPharma Dive, “AI tool could help doctors ID breast cancers vulnerable to Enhertu. Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New research shows AI can improve diagnosis.”
  • Per a National Institutes of Health news release,
    • “National Institutes of Health (NIH) scientists have developed a new surgical technique for implanting multiple tissue grafts in the eye’s retina. The findings in animals may help advance treatment options for dry age-related macular degeneration (AMD), which is a leading cause of vision loss among older Americans. A report about the technique published today in JCI Insight.
    • “In diseases such as AMD, the light-sensitive retina tissue at the back of the eye degenerates. Scientists are testing therapies for restoring damaged retinas with grafts of tissue grown in the lab from patient-derived stem cells. Until now, surgeons have only been able to place one graft in the retina, limiting the area that can be treated in patients, and as well as the ability to conduct side-by-side comparisons in animal models. Such comparisons are crucial for confirming that the tissue grafts are integrating with the retina and the underlying blood supply from a network of tiny blood vessels known as the choriocapillaris.
    • “For the technique, investigators designed a new surgical clamp that maintains eye pressure during the insertion of two tissue patches in immediate succession while minimizing damage to the surrounding tissue.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies initially declined to pay more than one dollar for every $10 providers submitted in claims last year, an increase from 2023.
    • “Payers in 2024 initially denied 11.8% of dollars associated with hospital-based claims, according to a report from consultant Kodiak Solutions. That compares with 11.53% of dollars denied in 2023.
    • “The company examined data from its revenue cycle analytics platform used by more than 2,100 hospitals and 300,000 physicians. It categorized any initial bill that commercial, Medicaid and Medicare insurers initially rejected, or requested more information for, as a denial.
    • “Insurers often overturned their initial denials and ended up paying nearly 97% of dollars requested, according to the report.”
  • Reuters informs us,
    • “Median annual list price for new drugs over $370,000 in 2024
    • “72% of new drugs in 2024 for orphan diseases
    • “Drugmakers emphasize value, offer savings programs amid rising list prices.”
  • The International Foundation for Employee Benefit Plans shares its survey of GLP-1 drug coverage and expenses among employer sponsored plans.
  • Fierce Pharma notes,
    • “It’s plainly apparent that Novo Nordisk has had May 22 circled its calendar since February, when the FDA began the countdown for compounders to stop selling their versions of semaglutide.
    • “Now that the day has come, the Danish drugmaker is capitalizing on the chance to steer more patients toward its branded offerings.
    • “Self-paying patients new to Wegovy can access a one-month supply of the obesity blockbuster for $199 through June 30, Novo announced on Thursday. After that, the drug will go for its standing price of $499 a month for cash-paying customers, which was discounted in March from a previous price tag of $650 per month.”
  • Fierce Healthcare relates,
    • “Shares of Hinge Health jumped 22% above the initial public offering price in the company’s New York Stock Exchange debut on Thursday, bringing its market capitalization to more than $3 billion.
    • “The physical therapy company’s stock opened at $39.25 on Thursday and closed at $37.56, up 17% from its $32 per share IPO price. Hinge Health’s IPO has been closely watched given the recent stagnation in the exit markets and signals a potential upswing in the public investor market.”
  • Becker Hospital Review announced,
    • “Northern Light Inland Hospital and its associated clinical services in Waterville, Maine, will officially close May 27, marking the end of operations for the facility that has been gradually winding down since the closure was announced earlier this year.
    • “The hospital’s emergency department will stop accepting new patients at 12 p.m. on May 27. All remaining clinical services will cease at 5 p.m. the same day, the health system said in a May 22 news release.”

Wednesday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC,

  • NBC News reports
    • “Two Key House committees advanced their portions of a sweeping package for President Donald Trump’s agenda on party-line votes Wednesday following marathon meetings. 
    • “The tax-writing Ways and Means Committee advanced its bill, which would permanently extend Trump’s 2017 cuts, Wednesday morning after a session that clocked in at more than 17 hours.
    • “Later Wednesday, the Energy and Commerce Committee passed its legislation, which includes steep Medicaid cuts, after meeting for more than 26 hours.”
    • “The House Agriculture Committee was still debating its part of the broader package which includes a $290 billion cut to Supplemental Nutrition Assistance Program (SNAP), late Wednesday afternoon. The panel began its markup around 7:30 p.m. Tuesday before breaking around midnight and reconvening Wednesday morning. 
    • “The Ways and Means and Energy and Commerce committees did not make substantive changes to the original plans offered by their chairs.” 
  • Following the creation of committee recommendations, the House Budget Committee will take responsibility for the budget reconciliation bill. Per a Budget Committee news release today,
    • “On Friday, May 16th, 2025, at 9:00 AM in 210 Cannon House Office Building, the House Committee on the Budget will hold a markup to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2025, H. Con. Res. 14. 
    • “Committee hearings and markups are available LIVE from our website or YouTube.”
  • The American Hospital Association News tells us,
    • “Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 14 testified on President Trump’s discretionary budget proposal for fiscal year 2026 in hearings before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies and the Senate Committee on Health, Education, Labor and Pensions. The proposal includes $93.8 billion for HHS, which is a 26.2% reduction from the FY 2025 enacted level.”
  • The Wall Street Journal offers its insights on these hearings here.
  • Federal News Network lets us know that OPM is proceeding with its retirement application processing improvements, notwithstanding the cancellation of the Workday contract.
  • Govexec takes on “Age gap retirement planning for federal employees: Avoiding the ‘Widow’s Penalty,’ Medicare planning and more. How to think about the best ways to utilize your retirement and health care benefits when you may be older, or younger, than your spouse.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is taking bold steps to modernize the nation’s digital health ecosystem with a focus on empowering Medicare beneficiaries through greater access to innovative health technologies. The agency, in partnership with the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), is seeking public input on how best to advance a seamless, secure, and patient-centered digital health infrastructure. The goal is to unlock the power of modern technology to help seniors and their families take control of their health and well-being, manage chronic conditions, and access care more efficiently.” * * *
    • “The request for information (RFI) invites input from patients, caregivers, providers, payers, technology developers, and other stakeholders on how CMS and ASTP/ONC can: 
      • “Drive the development and adoption of digital health management and care navigation applications; 
      • “Strengthen interoperability and secure access to health data through open, standards-based technologies; 
      • “Identify barriers preventing the seamless exchange of health information across systems; and
      • Reduce administrative burden while accelerating progress toward value-based, patient-centered care.”
    • “The public comment period will be open through June 16. The RFI is available at https://public-inspection.federalregister.gov/2025-08701.pdf, and the public should submit all comments through the provided weblink.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The number of people who died of drug overdoses in the U.S. dropped dramatically in 2024, a promising sign amid a national fentanyl crisis that has fueled a surge in drug-related deaths in recent years.  
    • “Drug-overdose deaths dropped by 27% to around 80,000 deaths in 2024 from about 110,000 in 2023, according to preliminary data released by the Centers for Disease Control and Prevention on Wednesday. The deaths reported last year fell closer to levels not seen since before the Covid-19 pandemic, which exacerbated the country’s drug-overdose crisis and led to a surge in deaths.
    • “Yearly declines in new overdose deaths are rare and tend to be small, making 2024’s drop unprecedented in its scope. This is also only the fourth year in more than three decades in which the U.S. reported fewer drug fatalities, but also the second in a row after a modest reduction in 2023.” * * *
    • “Despite the drop in drug-overdose related deaths in 2024, the yearly tally is still much higher than those recorded less than a decade ago and before the opioid crisis took off in the 1990s. The U.S. recorded well over 100,000 deaths a year from 2021 to 2023, according to federal data.”
  • Reuters informs us,
    • “The Texas health department reported 717 cases of measles in the state on Tuesday, an increase of eight since its last update on Friday, as the U.S. battles one of the worst outbreaks of the childhood disease in the country.
    • “Cases in Gaines County, the epicenter of the outbreak, rose to 405 from 403 since the last update, according to the Texas Department of State Health Services.
    • “Texas had reported seven additional cases in the last update on Friday, which was the lowest increase since the outbreak began in February.
    • “New Mexico’s health department reported 71 cases, unchanged from its last update. Most of the state’s cases are from Lea County, adjacent to Gaines County in Texas.”
  • Per Becker’s Hospital Review,
    • “Seventy-six percent of oncologists reported seeing an increasing number of patients presenting with advanced-stage cancer. Of those, 75% attributed the increase to screening barriers, according to a survey published May 13 by the Harris Poll on behalf of Quest Diagnostics. 
    • “The Harris Poll surveyed 174 medical oncologists and 76 surgical oncologists on their experiences with advanced-stage cancer diagnoses and recurrence between Aug. 6 and Sept. 4.” * * *
    • “Read the full survey results here.” 
  • The National Cancer Institute (NCI) posted its latest edition of Cancer Currents, which is a research blog.
  • Per HCPLive,
    • “Findings from a recent study suggest iron deficiency anemia (IDA)independently and significantly increases the odds of ischemic stroke in young adults.
    • “IDA is the most common form of anemia globally. It results from iron deficiency, when there are insufficient iron stores to support the production of red blood cells. IDA disproportionately affects women due to regular iron losses through menstruation and increased iron demands during pregnancy. Maternal anemia can lead to the child exhibiting intellectual disability, autism spectrum disorder, and attention-deficit/hyperactivity disorder.
    • “Additionally, it is currently estimated that 10-15% of all strokes occur in adults aged 18-50, a group that also exhibits an increased prevalence of IDA. However, little data has been collected regarding the association between IDA and stroke in young adults.
    • “Although multiple studies have explored the association of IDA and thrombotic events in children, our study was the first to explore its role in ischemic stroke in a young adult population, that is, most susceptible to IDA,” wrote Jahnavi Gollamudi, MD, University of Cincinnati, and colleagues.
    • “Investigators classified patients into 2 groups: those with a first-time ischemic stroke diagnosis were defined as Group A, and those without a history of ischemic stroke were defined as Group B.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a series of changes in the architecture and cell composition of connective tissues of the breast, known as stromal tissue, that is associated with an increased risk of developing aggressive breast cancer among women with benign breast disease, and poorer rates of survival among women with invasive breast cancer. This process, which they call stromal disruption, could potentially be used as a biomarker to identify women with benign breast disease who are at high risk of developing aggressive breast cancers, as well as those with breast cancer who may be at increased risk of recurrence or death.
    • “Such insights could help inform the development of cancer prevention and treatment strategies that target the stromal microenvironment. In addition, stromal disruption is inexpensive to assess and could be widely adopted, particularly in low-resource settings where molecular analysis is impractical or very expensive.”
  • Per Fierce Pharma,
    • “After flexing its antibody-drug conjugate bona fides at last year’s American Society of Clinical Oncology (ASCO) conference, AbbVie is advancing its solid tumor ambitions with a new FDA green light.
    • “The FDA on Wednesday granted an accelerated approval to AbbVie’s c-Met-directed ADC Emrelis, also known as telisotuzumab vedotin, as a new treatment option for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) who’ve previously received systemic therapy. The drug is cleared in patients whose tumors exhibit high overexpression of the c-Met protein.
    • “The c-Met protein is overexpressed in around 25% of patients with advanced epidermal growth factor receptor wild-type, non-squamous NSCLC, and roughly half of those patients have high c-Met overexpression, AbbVie explained in a press release.”
  • Per BioPharma Dive,
    • “A two-drug regimen involving an experimental cancer immunotherapy from iTeos Therapeutics and GSK didn’t significantly delay tumor progression in a Phase 2 trial, leading the companies to end development and terminate the collaboration they formed around the drug four years ago.
    • “When added to GSK’s drug Jemperli, the immunotherapy, known as belrestotug and aimed at a cellular target called TIGIT, didn’t meet preset criteria for progression-free survival compared to Jemperli alone in people with non-small cell lung cancer. The study showed a “trend below the meaningful threshold” for drug responses in study arms including people with head and neck cancer, the companies said Tuesday.
    • “Based on the results, iTeos and GSK are stopping all ongoing trials of belrestotug, including an ongoing Phase 3 study in lung cancer. iTeos is “taking immediate steps to preserve capital” as well as starting a strategic review.”

From the U.S. healthcare business front,

  • We start with global news from the Wall Street Journal,
    • “GSK will acquire a liver-disease treatment from Boston Pharmaceuticals for up to $2 billion as it seeks to boost its pipeline of new drugs.
    • “The British pharma giant said Wednesday that it will pay the U.S. biotech company $1.2 billion upfront, with a further $800 million in potential success-based milestone payments.
    • “The drug is currently in late-stage trials, with a potential market launch in 2029. It aims to treat a form of liver disease characterized by inflammation and damage caused by a build-up of fat. GSK said the drug is also being explored for use in alcohol-related liver disease, and that mid-stage data has shown potential to reverse liver fibrosis and halt disease progression.
    • “Unlike current daily tablet treatments, efimosfermin is designed to be administered as a monthly shot. GSK plans to develop it both as a monotherapy–which uses one type of treatment–and in combination with its own experimental liver-disease therapies.”
  • and
    • “Danish pharmaceutical company Novo Nordisk has signed a collaboration deal with U.S. biotech Septerna that will see the two companies develop pills to treat obesity, type 2 diabetes and other cardiometabolic diseases.
    • “Under the terms of the agreement, Septerna is eligible to receive around $2.2 billion from Novo Nordisk, including over $200 million in upfront and near-term milestone payments.
    • “The U.S. company will also receive research, development and commercial milestone payments, on top of tiered royalties on global net sales of marketed products. Novo Nordisk will cover all research-and-development costs.”
  • STAT News lets us know,
    • “The mood at the annual meeting of the American Society of Cell and Gene Therapy isn’t amazing. The biotech market has been bad for years. The FDA and NIH are shrouded in uncertainty. But many researchers tried to project confidence. Over the last four years, 16 gene and cell therapies have been approved, as one presenter noted Tuesday. Also, there was a purple-clad Mardi Gras-style stilt walker directing attendees into the main hall — so there’s that.”
  • Beckers Hospital Review points out that “A total of 66 hospitals [named in the article] received both Healthgrades’ Outstanding Patient Experience and Patient Safety Excellence awards.”
  • Per Beckers Payer Issues,
    • “Contract disputes between insurers and health systems are down in 2025 compared to the second half of 2024.
    • “According to data from FTI Consulting, there were 133 total disputes in 2024, compared to 86 in 2023 and 51 in 2022. In the first quarter of 2025, 26 total disputes have been recorded, compared to 50 in Q4 2024 and 37 in Q3 2024. Network breaks between Medicare Advantage plans and health systems tripled from 2022 to 2024.
    • “FTI has tracked media reports regarding negotiations over reimbursement rates between provider organizations and insurance companies during each quarter since early 2022.”
  • HR Dive notes,
    • “While 86% of employers think their benefits are modern, only 59% of workers agree,  according to the results of Prudential’s 2025 Benefits and Beyond study, released Monday. 
    • “Workers say their top challenges are saving for retirement (45%), cost of everyday goods (44%), cost of housing (29%) and making it paycheck to paycheck (26%); and 1 in 10 workers identified being able to survive paycheck to paycheck as their No. 1 worry, the study found. 
    • “The study’s findings are clear: When it comes to workplace benefits, there is a disconnect on what companies offer and what employees actually need — now and in the future,” the press release said.”

Tuesday Report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Last week, the President issued another Executive Order on deregulation. The EO begins
    • “Deregulation is a critical priority for my Administration.  We will foster prosperity by freeing Americans from the heavy burden of Federal regulations accumulated over decades.”
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services May 13 announced a 60-day public comment period opened for stakeholders regarding its request for information to remove outdated or unnecessary regulations. The request stems from an executive order issued in January requiring HHS to implement a “10-to-1” rule, eliminating at least 10 existing regulations for every new regulation introduced. Comments on the RFI can be submitted at regulations.gov/deregulation.”
  • When will OPM make a similar deregulation announcement?
  • The Congressional Research Service released a report on the House Oversight and Government Reform Committee’s budget reconciliation measures. The Congressional Budget Office posted its own report on those recommendations.
    • “In CBO’s estimation, the reconciliation recommendations of the House Committee on Oversight and Government Reform would, on net, decrease deficits by $51.0 billion over the 2025‑2034 period. The estimated budgetary effects of the legislation are shown in Table 1. The costs of the legislation mainly fall within budget functions 550 (health), 600 (income security), 800 (general government), and 950 (undistributed offsetting receipts).”
  • Modern Healthcare reports,
    • “Doctors that treat Medicare beneficiaries would receive a pay boost under the sweeping tax-and-spending cuts legislation House Republicans unveiled Monday.
    • “Medicare reimbursements to physicians declined 2.9% this year, provoking outcries from medical societies that complain doctor pay has failed to keep up with cost increases. The GOP measure would raise rates next year and remake the Medicare Physician Fee Schedule to link future updates to the Medicare Economic Index, which generally rises faster than overall inflation.
    • “In 2026, the legislation would hike Medicare physician payments by an estimated 2.25%. That projection is based on how the bill would modify the “conversion factor” that determines Medicare fees for physician services. Next year, that formula would be boosted by 75% of growth in the Medicare Economic Index. In later years, it would fall to 10% of medical inflation.
    • “The physician pay increase comes with a downside for some providers, however. While the measure would raise rates, it would curtail financial incentives under alternative payment models.”
  • Bloomberg Law reports,
    • “House Republicans revived a set of policies that would change how prescription drug middlemen do business, as President Donald Trump again denounced the industry, sending shares of some of the companies down Monday.
    • “The budget proposal from the House Committee on Energy and Commerce includes a set of reforms that Congress considered last year but ultimately didn’t pass. It would remove one method that the companies, which negotiate with drugmakers and pharmacies on behalf of employers, health insurers and government programs, use to boost profits.
    • “The revival of the modest reforms in the House budget plan adds to pressure on the companies, which are already facing intense scrutiny in Washington. Trump complained about the companies known as pharmacy benefit managers during a press conference Monday touting his executive order intended to help lower the prices Americans pay for drugs.”
  • The Senate Judiciary Committee held a hearing today on the allegedly adverse impact of prescription benefit manager practices on rural pharmacies.
  • Beckers Hospital Review looks into a Republican budget reconciliation proposal in Congress to “place a 10-year moratorium on state and local governments regulating AI. The provision would prevent any laws targeting AI models, systems or automated decision tools during that time.”
  • The AHA News informs us,
    • “The Centers for Medicare & Medicaid Services May 13 launched a new strategy focused on three pillars: promoting evidence-based prevention, empowering people to achieve their health goals, and driving choice and competition. To support the new strategic plan, CMS Administrator Mehmet Oz, M.D., and Innovation Center Director Abe Sutton hosted a public webinar highlighting the Innovation Center’s commitment to take learnings from historical investments in value-based care to the “Make America Healthy Again” initiative. They also highlighted the need for models to demonstrate cost savings and improved outcomes in accordance with statutory requirements. The agency posted FAQs regarding the new strategic direction on a new homepage.”
  • and
    • “The Centers for Medicare & Medicaid Services May 12 issued a proposed regulation that would change how states may structure provider taxes for purposes of generating revenue for their Medicaid programs. CMS states that these changes are intended to prevent states from adopting provider taxes that are not “generally redistributive” and therefore may be in violation of the statute. While CMS notes that they have particular concerns about certain Medicaid managed care organization taxes, these policies, if adopted, would apply to all provider taxes. The public has 60 days to comment.”
  • Beckers Hospital Review offers eight things to know about this proposed regulation.
  • The U.S. Preventive Services Task Force confirmed today the continuing validity of its Grade A recommendation of “early, universal screening for syphilis infection during pregnancy [for asymptomatic women]; if an individual is not screened early in pregnancy, the USPSTF recommends screening at the first available opportunity.” * * * “To achieve the benefit of screening, it is important that screening occur as early in pregnancy as possible and that everyone with abnormal syphilis test results receive timely, evidence-based evaluation and treatment.”

From the judicial front,

  • STAT News reports,
    • “The now 13-year-long legal saga over who invented CRISPR took yet another unexpected turn on Monday, in a ruling that could not only change U.S. ownership of patent rights to the groundbreaking gene-editing technology but more broadly redefine how the law determines when an invention has been made. 
    • “The U.S. Court of Appeals for the Federal Circuit sided with the University of California and the University of Vienna in their bid to revive a fight over foundational CRISPR-Cas9 patents that the schools say should go to their Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier. In 2022, the U.S. Patent and Trademark Office determined that a group of scientists led by Feng Zhang of the Broad Institute of Harvard and the Massachusetts Institute of Technology had conceived of uses of the technology in humans before Doudna and Charpentier.” 

From the public health and medical research front,

  • From HHS news releases,
    • “The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA. Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood. Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.
    • “The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” said FDA Commissioner Marty Makary, M.D., M.P.H. “I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced the next steps in Operation Stork Speed–a groundbreaking initiative to ensure the safety, reliability, and nutritional adequacy of infant formula for American families. The FDA issued a Request for Information (RFI) to begin the nutrient review process required by law for infant formula. Currently, infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998.
    • “Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center,” said HHS Secretary Robert F. Kennedy, Jr. “Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen. You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.”
    • “Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international. The agency also welcomes data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.
    • “Commenters will have 120 days to submit responses. Further information on how to submit a comment can be found here.”
  • This week’s issue of NIH Research Matters covers the following topics — “Measuring tinnitus | Fat metabolism & pancreatic cancer | Senescent cell subtypes.”
  • The Washington Post reports,
    • “More U.S. high-schoolers used nicotine pouches — smokeless nicotine powder products — last year than the year before, according to new research published in JAMA Network Open.
    • “The researchers, who used data from a nationally representative survey of 10,146 youths in 2023 and 2024, said 5.4 percent of 10th- and 12th-graders reported having used nicotine pouches, up from 3 percent the year before. The 10th- and 12th-graders’ use of pouches in the 12 months and 30 days before the surveys also increased year to year. Males were also more likely to use pouches than females.
    • “Looking at race and ethnicity data, use was highest among White, non-Hispanic 10th- and 12th-grade teens — 9 percent had used a nicotine pouch at some point. Teens in rural areas were also more likely to use the products than urban or suburban youths: In 2024, 11.2 percent of rural youths vs. 5.9 percent of suburban and 3 percent of urban youths said they’d used a pouch.”
  • Per Healio,
    • “Social determinants of health at the community level, such as median income and walkability, have a larger influence on hip replacement outcomes than an individual patient’s race, according to data.
    • “The study was inspired by “persistent disparities observed in total hip arthroplasty outcomes, often attributed to individual factors such as race,” study author Bella Mehta, MD, MBBS, MS, a rheumatologist at Hospital for Special Surgery, told Healio.”
  • Per MedPage Today,
    • “Treating early Alzheimer’s disease patients with lecanemab (Leqembi) was feasible and most patients tolerated the drug well, a retrospective study at one specialty memory clinic showed.
    • “Infusion-related reactions occurred in 37% of 234 Alzheimer’s patients treated with lecanemab and typically were mild, according to Suzanne Schindler, MD, PhD, of Washington University School of Medicine in St. Louis, and co-authors.
    • “Amyloid-related imaging abnormalities (ARIA) emerged in 42 of 194 people (22%) who received at least four lecanemab infusions and had at least one MRI, the researchers reported in JAMA Neurology.
    • “Overall, 29 people (15%) had ARIA with brain edema or effusion (ARIA-E) — with or without ARIA with brain hemorrhage or hemosiderin deposition (ARIA-H), including microhemorrhages and superficial siderosis — and 13 people had isolated ARIA-H (6.7%).
    • “Most ARIA cases were asymptomatic (74%) and radiographically mild (62%). Eleven patients (5.7%) developed symptomatic ARIA; two (1.0%) were patients with clinically severe ARIA symptoms. No patients developed a macrohemorrhage or died.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Andrew Witty is stepping down as chief executive officer of UnitedHealth, citing personal reasons, the healthcare giant announced Tuesday.
    • “Witty, who has run UnitedHealth since 2021, is departing following a sharp downturn in the company’s financial performance from higher medical spending and unfavorable policy changes. He will be replaced effective immediately by Stephen Hemsley, the chairman of UnitedHealth’s board and its CEO from 2006 to 2017.
    • “UnitedHealth also suspended its 2025 guidance on Tuesday, pointing to the ongoing increase in medical care activity.”
  • The Wall Street Journal adds,
    • “In a call with analysts Tuesday, the company said it was seeing medical costs continue to accelerate beyond the trends it flagged last month and signs that the issue was spreading beyond enrollees in its Medicare plans. 
    • “To all stakeholders, including employees and shareholders, I’m deeply disappointed in and apologize for the performance setbacks we have encountered from both external and internal challenges,” Hemsley said. “This company has both the opportunities and capabilities to deliver exceptional services and outcomes for customers, consumers and care providers, and to continue to reliably generate the earnings growth that align with our 13% to 16% long term growth range.”
    • “The company said it expects to return to growth in 2026.”
  • Beckers Payer Issues offers us five things to know about Mr. Hemsley.
  • Beckers Payer Issues also discusses recent developments in the GLP-1 drug market.

Thursday Report

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, SDOH, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Senate Press Gallery indicates that the Majority Leader John Thune (R SD) plans to file cloture motions on six Presidential nominees (not including Scott Kupor) on Monday. Nevertheless, this action gives the FEHBlog hope that Scott Kupor’s nomination to be OPM Director will be brought to Senate floor this month.
  • The American Hospital Association News tells us,
    • “Reps. Jennifer McClellan, D-Va., and Don Bacon, R-Neb., and Sens. Jeff Merkley, D-Ore., and Cindy Hyde-Smith, R-Miss., today reintroduced AHA-supported legislation addressing mental health and substance use disorder facility shortages. The Mental Health Infrastructure Improvement Act (H.R. 3266) would establish a new federal loan and loan guarantee program within the Department of Health and Human Services to build or renovate mental health or substance use disorder treatment facilities. At least a quarter of the funding would be reserved for pediatric- and adolescent-serving facilities. The bill would also prioritize facilities located in high-need, underserved or rural areas, and those capable of providing integrated care for patients with complex needs.”
       
  • Federal News Network informs us,
    • “The Office of Personnel Management is hoping the sole-source, one-year contract it just awarded to Workday, a cloud-based HR services company, will help the agency manage what’s turned into a massive influx of HR work.” * * *
    • “The contract with Workday will cover services for HR and personnel processing, payroll and benefits systems, time and attendance tracking, talent acquisition and performance management, all while ensuring compliance with federal requirements, according to the contract award notice.” * * *
    • “The Workday contract, worth $342,200, will last for one year, at the end of which OPM said it plans to conduct an open competition for the next iteration of the HR IT contract.”
  • Per an FDA news release,
    • “In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.
    • “I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said Dr. Makary.
    • “The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
    • “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).”
  • Tammy Flanagan, writing in Govexec, lets us know how Social Security benefits fit into the federal retirement picture.

From the public health and medical research front,

  • Medpage Today points out,
    • “Detections of H5N1 avian influenza have slowed in both animals and humans, but continued surveillance is warranted, CDC researchers said.
    • “In dairy cattle, cases surged over the fall and early winter but eased in January, while cases in poultry flocks fell after February, and came down last month in backyard flocks, according to data on CDC’s website that was shared during a clinician outreach and communication activity (COCA) call on Tuesday.
    • “Most of our human cases are known to be associated with animal exposures, so fewer infections in the animals leads to fewer infections in people,” Alicia Budd, MPH, team lead of the national surveillance and outbreak response team at the National Center for Immunization and Respiratory Diseases (NCIRD), said during the call.
    • “It’s certainly great to see these declines in both animal and human cases, but it’s also critical that we maintain targeted monitoring and our general surveillance, so that if this situation changes, we’d be able to identify that quickly,” Budd added.”
  • and
    • “The nation’s infant mortality rate dropped last year after 2 years of hovering at a late-pandemic plateau.
    • “Some experts think one reason for the drop could be a vaccination campaign against respiratory syncytial virus (RSV)opens in a new tab or window, which is a common cause of cold-like symptoms that can be dangerous for infants.
    • “The infant mortality national rate dropped to about 5.5 infant deaths per 1,000 live births in 2024, according to provisional data from the CDC posted Thursday. That’s down from about 5.6 per 1,000 live births, where it had been the previous 2 years.
    • “CDC officials believe the findings will not change much when the final numbers come out later this year.”
  • Per Healio,
    • “Tobacco-related ischemic heart disease mortality has increased in the U.S. since 1999.
    • “The aging of the population and the introduction of novel nicotine products may be among the drivers.”
  • and
    • “A risk prediction model assesses seven variables to determine the best intervention for lowering type 2 diabetes risk.
    • “Intensive lifestyle intervention was the optimal treatment strategy for most adults.”
  • Per Cardiovascular Business,
    • “Cardiovascular risk factors such as obesity and high blood pressure are much more prevalent in some parts of the United States than others—and some of those gaps are only widening as time goes on. 
    • “That was the biggest takeaway from a new analysis published in The American Journal of Cardiology. The study’s authors reviewed answers to the Behavioral Risk Factor Surveillance System (BRFSS) survey from 2011 to 2021 to track changes in various health inequities over time.
    • “Delays in preventive care and screening as well as economic loss, disruptions in insurance coverage and worsening social determinants of health (food insecurity, housing instability) have fallen more heavily on low-income, minority and rural communities since the pandemic,” wrote first author Rachel K. Gardner, MD, a researcher with Beth Israel Deaconess Medical Center and Brigham and Women’s Hospital, and colleagues. “In addition, the spillover effects of the pandemic have disproportionately impacted some U.S. states more than others. Together, these changes could have profound implications for cardiovascular health across the country. However, little is known about how inequities in the burden of cardiometabolic and lifestyle risk factors across U.S. states have changed, especially since the pandemic. Understanding these epidemiological changes in place-based inequities is critically important and could inform targeted public health and policy interventions at the state- and national-level to advance cardiovascular health.”
    • “The BRFSS survey is the world’s largest continuous health survey of its kind, collecting data from more than 400,000 adult participants each year. Gardner et al. based their comparison on data from 506,467 adults who participated in the survey in 2011 as well as 438,693 who participated in 2021.” * * *
    • Click here for the full study.
  • Beckers Hospital Review reports,
    • “Moderna’s new combination vaccine for seasonal influenza and COVID-19 has outperformed current standard vaccines in a large phase 3 clinical trial, showing stronger immune responses to both viruses in adults 50 years or older. 
    • “The findings, published May 7 in JAMA Network, come from a randomized study of more than 8,000 participants conducted across 146 U.S. sites. Participants either received the investigational combo vaccine mRNA-1083 or the standard influenza and COVID-19 vaccines recommended for their age group. 
    • “Among adults ages 50 to 64, mRNA-1083 generated a stronger immune response against all four influenza strains. In adults 65 and older, it outperformed the high-dose flu vaccine in three of the four strains. In both age groups, the vaccine also produced higher immune responses to SARS-CoV-2 compared to standard COVID-19 vaccine.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have completed a comprehensive analysis of cancer statistics for different age groups in the United States and found that from 2010 through 2019, the incidence of 14 cancer types increased among people under age 50. Of these cancer types, nine—including several common cancers, such as breast cancer and colorectal cancer—also increased in some groups of people aged 50 and older. However, the incidence of 19 other cancer types—including lung cancer and prostate cancer—decreased among people under age 50, so the total rate of all cancers diagnosed in both younger and older age groups did not increase, nor did the rate of cancer death.
    • “This study provides a starting point for understanding which cancers are increasing among individuals under age 50,” said lead investigator Meredith Shiels, Ph.D., of NIH’s National Cancer Institute. “The causes of these increases are likely to be cancer specific, including cancer risk factors becoming more common at younger ages, changes in cancer screening or detection, and updates to clinical diagnosis or coding of cancers.”
    • “The study appeared May 8, 2025, in Cancer Discovery“.
  • The National Cancer Institute adds,
    • “Scientists have developed a method of rapidly measuring the levels of certain genetic mutations in brain tissue samples collected from patients during surgery. 
    • “In a new study, researchers showed that the droplet digital polymerase chain reaction (ddPCR) method they developed could produce results in 15 minutes—the first time ddPCR has generated results so quickly. 
    • “Their tool accurately measured the levels of tumor cells in dozens of brain tissue samples, they reported. And it detected minute numbers of cancer cells, as few as five cells per square millimeter, according to findings published February 25 in Med.
    • “The researchers developed the tool, which they call Ultra-Rapid ddPCR, to provide surgeons with information that could potentially help guide their decision-making during surgery.
    • “This new technology could be an additional source of information for a surgeon who is deciding whether to keep removing tissue during an operation,” said study co-leader Daniel Orringer, M.D., a neurosurgeon at NYU Grossman School of Medicine. “If the test detects tumor cells at a surgical margin, then surgeons could decide to keep cutting.”

In Food and Drug Administration News,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
    • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
    • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
  • Per Medical Economics,
    • “BrightHeart, a Paris-based artificial intelligence company for obstetrics and pediatric cardiology, announced it has received FDA 510(k) clearance for an updated version of its BrightHeart platform. The new approval allows clinicians to access the company’s AI-driven analysis in real time using a cart-side tablet during fetal ultrasound exams.
    • “The technology aims to address a persistent clinical challenge: detecting congenital heart defects (CHDs) in utero. CHDs are the most common type of birth defect, but up to 70% go undiagnosed during standard prenatal ultrasounds, according to the company.
    • “BrightHeart’s AI platform flags potential structural abnormalities in the fetal heart, helping to alert clinicians to possible CHDs during routine exams. The company says the real-time tablet integration streamlines workflows and improves the accuracy of screenings.
    • “Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy,” said Cécile Dupont, CEO of BrightHeart and partner at Sofinnova Partners. “We were thrilled to achieve clearance through our first Special 510(k) submission within just a few months.”

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “Nonphysician providers now make up more than two out of every five health care professionals in the United States, as hospitals and medical groups increasingly rely on advanced practice providers to meet growing patient demand and improve efficiency, according to a new report from Kaufman Hall.
    • “The Physician Flash Report, released by the health care consulting firm and its parent company Vizient, found that 40.6% of the nation’s provider workforce is composed of APPs such as nurse practitioners and physician assistants. The report points to continued growth in this segment and predicts that APPs and physicians may soon comprise equal halves of the clinician workforce.
    • “Advanced practice providers like physician assistants and nurse practitioners play a vital and increasingly visible role in health care,” said Matthew Bates, managing director and Physician Enterprise Service Line leader with Kaufman Hall. “When deployed correctly, advanced practice providers let physicians practice at the top of their license. They give doctors more time to focus on diagnosis and treatment, which can make physician practices more efficient and address other challenges, including physician burnout.”
  • Reuters tells us,
    • “Another Big Pharma is opening up its wallet to pour billions into its U.S. operations amid political pressure from the Trump administration.
    • “This time it’s Gilead coming to the table with a fresh $11 billion in hand to spend across its manufacturing and research centers in the U.S.
    • “Gilead broke down the new spending routes in a Wednesday release. The majority, $5 billion, will be funneled into technology, operations, and R&D site activities, while $4 billion will go into capital projects, including labs and equipment. The final $2 billion will be “invested in digital and advanced engineering initiatives,” the pharma said.”
  • The White House summarized all of these drug manufacturing investments here.
  • Fierce Healthcare relates,
    • “Ayble Health, a virtual GI clinic, has teamed up with Priority Health, a nonprofit health plan in Michigan, to offer commercial members access to the digestive health solution. 
    • “Ayble relies on a multidisciplinary care team, AI-powered nutrition and psychology programs and wellness tools to manage symptoms. Starting June 1, Ayble will be available as a standard benefit for Priority members who have a MyPriority HMO or employer health plan. More than 500,000 adult members will have access. 
    • “When it comes to sourcing solutions like Ayble Health, Priority Health looks for approaches that can improve care quality, engage patients effectively and provide cost-efficient services,” Alicia Coronas, vice president of employer solutions product and marketing at Priority, told Fierce Healthcare. “We evaluate solutions to find the best-in-class partner that is aligned to our vision and mission.”

Tuesday Report

David Ermer–CDC, FDA, Government Contracting, NIH, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Yesterday, according to the American Hospital Association News, the President signed an
    • “executive order, “Improving the Safety and Security of Biological Research,” orders the Director of the Office of Science and Technology Policy to immediately establish guidance for the heads of relevant agencies to end federal funding of gain-of-function research and other life-sciences research conducted by certain foreign entities. The order also directs OSTP to replace the “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” within 120 days and replace the “Framework for Nucleic Acid Synthesis Screening” within 90 days. The OSTP is also directed to establish a reporting mechanism for gain-of-function research.”
  • Science interviewed Dr. “Jay” Bhattacharya, the Director of the National Institutes for Health.
  • The Washington Post reports,
    • “Vinay Prasad, a critic of the Food and Drug Administration, has been tapped as the agency’s top regulator of vaccines, gene therapies and the blood supply.
    • “Prasad, a University of California at San Francisco professor and epidemiologist, will replace Peter Marks, whom the Trump administration forced out in late March. Prasad, who is also a hematologist and oncologist, is the latest vocal critic of pandemic-era policies to join the administration.
    • “He brings a great set of skills, energy, and competence to the FDA,” Marty Makary, the FDA commissioner, wrote Tuesday in an email to staff obtained by The Washington Post.”
  • and
    • “President Donald Trump and the U.S. Postal Service’s governing board are expected to name FedEx board member and former Waste Management CEO David Steiner as the nation’s next postmaster general, according to two people familiar with the decision, helping solidify the White House’s control over the historically independent mail service.
    • “Steiner replaces Louis DeJoy, whom Trump forced out of the role in March amid the mail chief’s clashes with billionaire Elon Musk’s U.S. DOGE Service and congressional dissatisfaction with the agency’s performance and finances, The Washington Post has reported. The people familiar with the decision spoke on the condition of anonymity to describe private conversations and meetings.
  • Govexec lets us know,
    • “The Trump administration is moving quick on its promise to conduct a massive overhaul of the Federal Acquisition Regulation, a project being called Revolutionary FAR Overhaul.
    • “FAR is the subject of one of two executive orders President Trump signed in mid-April to reform how the federal government buys goods and services.
    • “In documents released Friday, the administration is proposing the elimination of significant portions of the FAR. What would remain are only those provisions required by law or are “essential to sound procurement.” * * *
    • “The government is also asking for “informal” feedback on Part 34 ahead of the formal rulemaking process. Follow this link to share your thoughts.”
  • Per Federal News Network,
    • “Just over 7,800 federal employees retired last month, the lowest amount so far in 2025. The Office of Personnel Management said more than 33,500 federal employees retired in the first quarter of 2025 compared to 29,700 during the first three months of 2024. OPM’s retirement backlog dropped to 16,700, almost 4,000 less than March. On average, OPM is processing retirement claims in 54 days, but those applications that took less than 60 days for the agency to get OPM the paperwork were processed in 33 days on average.”
  • The Government Accountability Office released a WatchBlog post titled “Nonprofit Drug Companies Aim to Curb High Prices and Shortages.”
    • “The rising cost of prescription drugs continues to make headlines. This increase has significant implications for people who rely on medications and for taxpayer-funded health care programs. For example, Medicare spending on prescription drugs nearly doubled between 2014 and 2022.
    • “At the same time, the country has faced several drug shortages of medications ranging from antibiotics to chemotherapy drugs.
    • “Nonprofit drug companies could play a role in helping to address rising prices and drug shortages. Today’s WatchBlog post looks at our new report on nonprofit drug companies.”

From the public health and medical research front,

  • Your Local Epidemiologist, a Substack to which the FEHBlog subscribes, tells us,
    • “As of Sunday, the U.S. had 967 confirmed cases. We are getting closer and closer to reaching the record high (1,200) since we eliminated measles in 2000. 
    • “Of that, 817 cases are from the Southwest outbreak. The good news is that it may be slowing down in West Texas. We know this from three soft data points:
      • “This is the first week with no hospitalized children in West Texas for measles.
      • “A downward trend in reported weekly cases * * *. Ultimately, we want a bell-shaped curve, which may be starting to take shape.
      • “Fewer new cases are reported anecdotally by clinicians on the ground.”
    • “Transmission continues, just at a slower pace. While any case could still spark a new outbreak in communities with low vaccination rates (for example, all eyes are on El Paso right now), big thanks to the public health workers working to contain.”
  • MedPage Today informs us,
    • “During the first respiratory syncytial virus (RSV) season in which a maternal vaccine and a monoclonal antibody for infants were available, most infants were immunized via either intervention, according to an analysis of Vaccine Safety Datalink data.
    • “Overall, 72% of 36,949 infants were immunized in the 2023-2024 RSV season with either the bivalent RSV prefusion F protein vaccine (Abrysvo) or nirsevimab (Beyfortus), Stephanie Irving, MHS, of the Kaiser Permanente Center for Health Research in Portland, Oregon, and colleagues reported in Pediatrics.
    • “This really is a success story,” Irving told MedPage Today, “but it is important to also point out that more than a quarter of infants were not immunized against RSV.”
    • “The researchers also noted that there were disparities in access by race and ethnicity, with lowest uptake among Black (60.5%) and Middle Eastern/North African (60.2%) mothers. Rates were highest among Asian mothers (83.7%).”
  • CNN reports,
    • “Using marijuana during pregnancy is linked to poor fetal development, low infant birth weight, dangerously early deliveries and even death, according to a new meta-analysis of research.
    • “The most striking finding is the increased risk of perinatal mortality — death either during the pregnancy or shortly after the pregnancy,” said obstetrician and lead study author Dr. Jamie Lo, an associate professor of obstetrics, gynecology and urology in the School of Medicine at Oregon Health & Science University in Portland.
    • “Prior work we’ve done shows prenatal cannabis use impacts fetal lung function and development, reducing the baby’s lung volume,” Lo said. “We’ve also found that there is significantly decreased blood flow and oxygen availability in the placenta. These are the likely underlying mechanisms driving some of our findings.”
    • “The placenta is a critical link between the mother and the developing fetus, delivering oxygen, nutrients and hormones necessary for growth. When that link is damaged, both the mother and the fetus are at risk.”
  • The AP reports,
    • “A new salmonella outbreak linked to backyard poultry has sickened at least seven people in six states, health officials said Monday.
    • “Two cases were identified in Missouri, and one each in Florida, Illinois, South Dakota, Utah and Wisconsin, the Centers for Disease Control and Prevention said.
    • “People got sick in February and March of this year, the CDC said. They all had the same strain of salmonella — a version that has been traced to hatcheries in the past. The investigation is continuing, health officials said.
    • “Salmonella bacteria cause about 1.35 million infections in the United States every year, and recent outbreaks have been tied to sources such as cucumbers, eggs, unpasteurized milk, fresh basil, geckos and pet bearded dragons.
    • “But one concern is that chickens and other backyard poultry can carry salmonella bacteria even if they look healthy and clean. A backyard poultry-associated outbreak that ended last year was tied to 470 cases spread across 48 states, including one death.”
  • Beckers Hospital Review offers a list of “455 hospitals in the U.S. have a Clostridioides difficile infection rate of zero, as based on the healthcare-associated infections dataset from CMS.”
  • NIH Research Matters covers the following topics this week “Youth vaping drug | How nerves sense heat & pain | Non-hallucinogenic LSD analogue.”
  • Per Beckers Clinical Leadership,
    • “In a first-of-its-kind procedure, clinicians at the University of Maryland Medical Center in Baltimore removed a rare spinal tumor through a patient’s eye socket. 
    • “The patient, Karla Flores of Rosedale, Md., had two slow-growing developmental bone tumors in her spine and wrapped around her brain stem, according to the University of Maryland Medical System. The tumors, called chordomas, are rare and diagnosed only about 300 times annually in the U.S., the system said in a May 5 news release. 
    • “In two procedures, surgeons removed the tumor around the brain stem with a traditional craniotomy — through the skull — and with an endoscope through her nose. A team of neurosurgeons, radiation oncologists, and skull base and facial plastic surgeons contributed to Ms. Flores’ care.”
  • Health Day relates,
    • “An experimental drug might help people with uncontrolled high blood pressure, according to early clinical trial results.
    • “People taking lorundrostat experienced twice the decline in their systolic blood pressure than people taking a placebo, researchers reported recently in the New England Journal of Medicine. Systolic, the top number of a blood pressure reading, refers to the pressure within blood vessels during a heartbeat.
    • “While blood pressure readings remained elevated at the end of this Phase II trial in some participants treated with lorundrostat, we find these results promising because almost all participants involved in the study were not able to sufficiently lower their blood pressure with medication before,” principal investigator Dr. Michael Wilkinson, an associate professor with the University of California-San Diego School of Medicine, said in a news release.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us that “Each of the six major national insurers turned a profit in the first quarter of 2025, though financial pressures related to government programs—particularly Medicare Advantage (MA)—once again reared their ugly heads.”
  • Reuters relates,
    • “Bristol Myers Squibb (BMY.N), said on Monday it will invest $40 billion in the U.S. over the next five years, as it seeks to expand its research and manufacturing presence in the country amid U.S. President Donald Trump’s tariff threats.
    • “The announcement of new investment was first made by CEO Christopher Boerner in an opinion piece published in Stat News on Monday and was later confirmed to Reuters by a company spokesperson.”
  • STAT News adds,
    • “Vertex Pharmaceuticals on Monday reported disappointing first-quarter earnings impacted by weaker-than-expected sales of its drugs for cystic fibrosis, and little or no contributions from a gene therapy for sickle cell disease and a recently launched pain medicine. 
    • “A “tolerability issue” caused a temporary pause to an early stage study involving a closely watched, inhaled, mRNA-based therapy for cystic fibrosis, the company said.” 
  • Per Healthcare Dive,
    • “Rite Aid filed for bankruptcy on Monday, with plans to sell itself, and has already had “meaningful interest” from potential national and regional strategic buyers. Stores will remain open and operating, but plans are to liquidate all locations unless a buyer comes forward, according to court documents. 
    • ‘The drugstore retailer has secured commitments from some existing lenders to access $1.94 billion in new financing. That plus cash from operations is expected to be sufficient funding during the sale and court-supervised Chapter 11 process. 
    • “A sale is imminent, with an auction set for May 14 for the pharmacy assets and June 20 for other assets, per court documents. The company just exited a previous bankruptcy in September, after filing less than two years ago, emerging as a private business with about $2 billion less debt plus some $2.5 billion in exit financing.”
  • Per Healio,
    • “The FDA has approved a dihydroergotamine-based nasal powder for the acute treatment of migraine with or without aura in adults, according to the manufacturer. 
    • “In a press release, Satsuma Pharmaceuticals Inc. said that Atzumi, formerly known as STS101, is a proprietary product that combines an advanced nasal powder formulation of dihydroergotamine (DHE) and a novel nasal delivery device.
    • “Oral DHE has poor absorption, so other formulations are important for delivering the medication,” Abby Metzler, MD, associate professor of neurology at the University of Minnesota, told Healio. “This new nasal powder formulation adds another option that may help by providing a non-invasive option that is less likely to drip down the back of the throat into the stomach, increasing absorption of the medication.”
  • Outside of the U.S. STAT News lets us know,
    • “For more than three decades, a charity here has funded research aimed at developing medicines for genetic diseases. Recently, though, it added an unusual new role — as a gene therapy company of sorts. 
    • “The charity, the Telethon Foundation, took ownership from a small biotech of a drug that has been approved in Europe to treat an ultra-rare immune disorder called ADA-SCID. In taking such a step — something no nonprofit had done anywhere — it hoped to both rescue the gene therapy from disuse, and to come up with a new model for delivering these one-time, cutting-edge medicines in a financially sustainable way. 
    • “The fact that a charity — and not a biopharma company — now has the rights to the medicine is a reflection of the bleak situation the gene therapy field has found itself in, and how other groups, from nonprofits to academic researchers, are trying to mend the failures of the drug development system.”