Tuesday Report

Rx coverage

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, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare relates,
    • “A coalition of healthcare trade associations and companies representing 550 providers and accountable care organizations is pleading with Congress to restore incentive bonuses for Medicare alternative payment models.
    • “The American Medical Association, Boston-based Mass General Brigham and others wrote congressional leaders Thursday expressing concern that failure to renew bonus payments will worsen providers’ financial instability, particularly in underserved regions.
    • “While we have seen steady growth for advanced [alternative payment models] in recent years, 2025 is a pivotal year for Medicare’s value transformation,” the letter says. “The expiration of Medicare’s advanced [alternative payment model] incentive payments and sharp increase in qualifying thresholds is creating significant challenges for physician practices and hospitals as they plan for the years ahead.”
  • BioPharma Dive reports,
    • “The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines against influenza strains seen as potential pandemic risks, leaving the future of the underlying research uncertain.
    • “Moderna revealed in a statement Wednesday that the HHS had terminated the contract, which could have handed the company more than $700 million in total funding. Moderna also reported that an experimental H5 avian influenza vaccine it’s developed showed promising results in an early-stage clinical trial. But without the government’s help, it will now be forced to “explore alternatives for late-stage development and manufacturing.”
    • “While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis,” said CEO Stéphane Bancel, in a statement. “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”
  • Govexec tells us,
    • “Federal job applicants will soon be quizzed on their favorite Trump administration policy as part of the hiring process, according to the Office of Personnel Management’s new “merit hiring plan.”
    • “How would you help advance the president’s executive orders and policy priorities in this role?” asks one of four essay questions that job seekers must answer if they are seeking any federal position GS-5 or above. “Identify one or two relevant executive orders or policy initiatives that are significant to you, and explain how you would help implement them if hired.”
    • “The federal government’s dedicated HR agency published the plan via a joint memo from Vince Haley, director of President Trump’s Domestic Policy Council and acting OPM Director Charles Ezell. The document is a hodgepodge of bipartisan reforms developed under both Trump and former President Biden to accelerate and improve the hiring process, alongside plans to eradicate longstanding efforts to make the federal workforce more reflective of the American populace.”
  • Tammy Flanagan, writing in Govexec, discusses what the latest FERS changes found in the budget reconciliation bill mean for federal and postal employee retirement benefits.
  • The Congressional Budget Office announced its 2025 panel of health advisors.
  • STAT News informs us,
    • “The White House will fix errors in a much-anticipated federal government report spearheaded by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., which decried America’s food supply, pesticides and prescription drugs.
    • “Kennedy’s wide-ranging “Make America Healthy Again” report, released last week, cited hundreds of studies, but a closer look by the news organization NOTUS found that some of those studies did not actually exist.
    • “Asked about the report’s problems, White House press secretary Karoline Leavitt said the report will be updated.
    • “I understand there was some formatting issues with the MAHA report that are being addressed, and the report will be updated,” Leavitt told reporters during her briefing. “But it does not negate the substance of the report, which, as you know, is one of the most transformative health reports that has ever been released by the federal government.”
  • The International Foundation of Employee Benefits Plans discusses what the President’s April 15 executive order on PBM transparency means for employers and other purchasers of PBM services.
  • Per Fierce Pharma,
    • “Six years after being spun out from Novartis and becoming a public company, eye care specialist Alcon has gained its first FDA approval for a prescription drug, scoring a nod for dry eye disease (DED) treatment Tryptyr (acoltremon ophthalmic solution).
    • “Tryptyr, which is administered as a single drop twice daily, is a first-in-class TRPM8 receptor agonist intended to activate tear production. 
    • “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of (DED),” Marjan Farid, M.D., professor of ophthalmology at the University of California, Irvine, said in a release.
    • “There are roughly 38 million in the U.S. who have DED. Fewer than 10% of those who have been diagnosed are being treated with a prescription product, according to Alcon.”

From the judicial front,

  • Chain Drug Review reports,
    • “Express Scripts, a Cigna-owned pharmacy benefit manager, and CVS Health have filed separate lawsuits against the state of Arkansas, seeking to halt the implementation of a new law that would bar PBMs from owning, managing, or controlling pharmacies within the state. 
    • “In a statement, CVS Health said the “unconstitutional law puts local politics ahead of patients, restricting their access to life-saving medications and undermining fair competition.“
    • “The lawsuits, filed Thursday in the U.S. District Court for the Eastern District of Arkansas, argue that the law, scheduled to take effect in 2026, is unconstitutional under multiple provisions, according to Modern Healthcare. Both companies claim the legislation would lead to significant disruptions in pharmacy access, workforce displacement, and increased medication costs.”
    • FEHBlog note — Good luck, CVS and ESI.
  • The Groom Law Group, which represents ERIC in its federal court lawsuit challenging the problematic to say the least 2024 mental health parity amendments, brings us up to date on the litigation, which so far has been successful.

From the public health and medical research front,

  • The Wall Street Journal lets us know,
    • “Adults diagnosed with autism spectrum disorder experience a range of benefits, including improved self-understanding, reduced self-blame and enhanced communication with others.
    • “The diagnosis can lead to positive changes in relationships, as individuals can now better explain their needs and behaviors to loved ones.
    • “Adults with autism may make adjustments to their routines and social interactions to accommodate their sensory sensitivities and communication challenges.”
  • Cardiovascular Business points out,
    • “Smoking marijuana and eating THC-based gummies have a negative impact on a person’s vascular health, according to new research published in JAMA Cardiology. In fact, the impact appears to be comparable to the damage seen in some tobacco users.
    • “There is a popular belief that marijuana smoke is harmless,” wrote first author Leila Mohammadi, MD, PhD, a vascular specialist with the University of California San Francisco, and colleagues. “However, marijuana smoke contains many of the thousands of chemicals contained in tobacco smoke, along with fine particles that contribute to cardiovascular morbidity and mortality. As cannabis legalization increases, it is crucial to understand the public health and clinical implications of marijuana use.” * * *
    • “Click here to review the full analysis.”
  • Per MedPage Today,
    • “Use of the investigational non-opioid analgesic resiniferatoxin appeared to improve pain control in patients with advanced cancer who had intractable pain, though all patients experienced adverse events (AEs), according to an interim analysis of a first-in-human phase I trial.
    • “Among 19 patients with refractory cancer pain localized to the abdomen and/or lower extremities, a total of 213 treatment-emergent AEs were reported with a single intrathecal injection of resiniferatoxin, including 37 serious AEs in 14 patients, and at least one AE in all patients, reported Andrew J. Mannes, MD, of the NIH, and colleagues.” * * *
    • “In an accompanying editorial, Krishna B. Shah, MD, and Bilal Dar, MD, both of the Baylor College of Medicine in Houston, noted that the improvements in efficacy “exceeded thresholds typically considered clinically meaningful,” and that the drug has the potential to provide “durable, opioid-sparing analgesia while preserving functional and cognitive abilities.”
    • “These interim results “represent an important step toward expanding the therapeutic interventional opioid-sparing options for patients with refractory cancer pain,” they wrote.”
  • Medscape notes,
    • “Extreme fatigue, bone loss, and abdominal pain are real-world adverse events noted with the use of glucagon-like peptide 1 receptor agonists (GLP-1s) that may not have been apparent from the clinical trials.
    • “In a wide-ranging “meet the professor” lecture at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025, obesity expert W. Timothy Garvey, MD, the Charles E. Butterworth, Jr. professor and university professor at the University of Alabama (UAB) and director of the UAB Diabetes Research Center at Birmingham, Alabama, said these phenomena all point to the importance of close clinical management of people taking GLP-1s and to the dangers of online prescribing of these medications.
    • “You can’t engage in complications-centric obesity care unless you evaluate the patient for complications, which doesn’t happen with online availability of prescriptions,” said Garvey.”
  • Per BioPharma Dive,
    • “Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing Phase 3 trial had signs of liver stress.
    • “Lab tests showed the patient had grade 4 liver transaminase elevations that “appear to be resolving” without hospitalization or medical treatment and have since fallen to less dangerous levels, Intellia said in a filing with the Securities and Exchange Commission late Wednesday. “We continue to monitor these events as the Magnitude study progresses,” the company said.
    • “The Magnitude trial is testing Intellia’s experimental therapy in a type of deadly heart condition known as transthyretin amyloidosis with cardiomyopathy, or ATTR-CM. Intellia has already recruited 365 patients and plans to enroll a total of 765 by early 2027. Though the study is blinded, it’s likely that the patient with the potentially serious liver signals received treatment with Intellia’s therapy, analysts said.”

From the U.S. healthcare business front,

  • Fierce Healthcare tells us,
    • “Healthcare C-suite leaders are trying to keep pace with rapid changes in U.S. economic and regulatory policies in the first four months of the second Trump administration.
    • “Among 700 business executives across six industries, nearly half (48%) of business executives rank economic policy among the top three factors driving strategic change over the next one to two years, according to a new PwC May pulse survey. 
    • “For healthcare executives, persistent policy and market volatility is a bigger concern, with six out of 10 (61%) rethinking short-term business strategies due to economic policies.
    • “Leaders at healthcare organizations also cited a number of other factors affecting short-term strategic changes — AI and data regulations (56%), U.S. trade policy (44%) and U.S. federal government spending and budget policy (37%). Healthcare C-suite leaders seem less concerned about corporate tax policy, cited by 34% as a factor driving short-term strategic changes, as well as the U.S. antitrust and competition environment (24%), climate policy (22%) and U.S. immigration policy (22%).
    • “About half (48%) of the business executives surveyed expect the current uncertainty to last less than a year, but many anticipate it could extend through the next presidential election.” 
  • Modern Healthcare reports,
    • “Private practice is slowly fading as a way to do business, going the way of landline phones, bank deposit slips and fax machines.
    • “An analysis by the American Medical Association found the percentage of physicians in a practice wholly owned by physicians last year to be at the lowest level since the survey began in 2012. The AMA examined data from its biennial Physician Practice Benchmark Survey, most recently conducted in 2024.
    • “The percentage of physicians working in private practice has dropped below 45%.
    • “Of the remaining physicians surveyed, the highest percentage are employed by hospitals.
    • “Along with that shift, only 35% of physicians described their employment status as owners in 2024.”
  • The Wall Street Journal explains how Novo Nordisk lost its mojo in the GLP-1 drugs market.
    • “Novo Nordisk, once Europe’s most valuable company, is losing its grip on the anti-obesity market due to production issues and slow marketing.
    • “Eli Lilly’s weight-loss drug Zepbound has surpassed Novo Nordisk’s Wegovy in weekly U.S. prescriptions, and Lilly has a more promising pipeline.
    • “Novo Nordisk’s CEO was ousted, shares have tumbled, and the company faces challenges in R&D and direct-to-consumer marketing.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • ICER publishes Evidence Report on Treatment for Secondary Progressive Multiple Sclerosis
    • There are significant uncertainties regarding long term efficacy of tolebrutinib;
    • ICER estimates that treatment would achieve common thresholds of cost-effectiveness if priced between $3,250 and $5,900 per year.
  • Health Affairs concludes in a recent article,
    • “Because many value-based care programs in the US are fragmented, heterogeneous and complex, none are driving large-scale, systemic change. Clinical care redesign driven by value-based healthcare programs has been halting and has achieved far less than promised.
    • “A rising mood of despair over the ability to achieve a sustainable, high-value healthcare system is causing some to support interventions such as price controls and heavier regulation to drive down spending. However, a key missing ingredient in value-based reforms has been sufficiently nuanced information about the clinical context in which patients are treated. A primary challenge in finally achieving high value healthcare in the US is discovering how to harness the comprehensive and nuanced data generated in the provision of care, which is available in each patient’s EHR, to support systemic care redesign to achieve better outcomes at lower cost. Adding that key ingredient could be transformative.
    • “The system currently used to extract data from EHRs in the US, ICD-10-CM, does not adequately capture clinical detail and nuance. Gaps, limitations, and errors in describing healthcare today lead directly to our inability to accurately measure both the outcomes resulting from the care provided and the cost of that care. The WHO created and released ICD-11 to address these issues, and with an appropriate comprehensive extension such as ICD-11-CCL the ability to measure and attain value in healthcare would be achievable. However, even if the US loses access to ICD-11, there is another viable option. SNOMED CT is a comprehensive clinical terminology, optimized for the capture of clinical nuance, that uses architecture designed for computerized data analytics. It is already used to capture and store clinical content in EHRs and could be leveraged through the creation of a comprehensive code set to also extract and transmit data with all clinical nuance preserved. Such a system would overcome most, if not all, of the current limitations in ICD-10-CM and could empower existing value-based programs to improve the cost-effectiveness of healthcare.”
  • Per Fierce Healthcare,
    • “Retail giant Walmart is rolling out a new platform for insurers and benefit managers that’s designed to make it easier to encourage healthy eating.
    • “The tool, called Everyday Health Signals, is powered by artificial intelligence, analyzing a consumers’ retail history on Walmart.com to surface personalized feedback such as shopping lists and nutrition analyses. Given that the retailer sees 145 million customers each week in stores and online, it has a bevy of data to pull from, according to an announcement.
    • “Eligible customers can opt in to allowing Everyday Health Signals to dig into their shopping history, Walmart said.
    • “The program is initially launching in partnership with NationsBenefits, connecting its members to data they can use to meet key health goals. Walmart intends to expand to other insurers and benefits organizations in the future.”
  • and
    • “Humana is the latest major insurer to partner with digital sleep clinic Dreem Health to improve members’ sleep care.
    • “California-based Dreem Health was acquired by sleep diagnostics company Sunrise in December. The company already has partnerships with the country’s largest payers including Aetna, Blue Cross Blue Shield, Cigna, HealthNet, UnitedHealthcare and Medicare.
    • “Sunrise was built on the back of research conducted by Jean-Benoit Martinot, M.D., the father of Sunrise CEO and founder Laurent Martinot. The company developed a small device that patients are able to use to diagnose sleep disorders from anywhere—without the inconvenience of spending the night hooked up to wires in a lab—while still providing a near-similar level of information.
    • “Our dream today is to become the largest sleep clinic in the country,” said Laurent Martinot in an interview with Fierce Healthcare. “We already have the largest virtual care sleep clinic. We would like to become the No. 1 one place you go if you feel you are not sleeping well and you need some care.”
    • “The Sunrise device is a diagnostic tool that is able to measure jaw movements, muscle contractions and snoring noises (through a built-in mic) from the comfort of a patient’s own bed. It’s disposable and is able to record data for up to three nights. A report is generated after just one night of sleep, allowing a care team to engage and start next steps immediately.”
  • Modern Healthcare reports,
    • “Highmark Health is off to a challenging start to the year as its insurance business dinged the company’s bottom line during the first quarter.
    • “On Thursday, the privately held for-profit Blue Cross and Blue Shield licensee reported net income of $13 million, a steep decline from $194 million the prior year, as revenue rose 11% to $8 billion
    • “As we’ve seen with the nationals on the health plan side, elevated trends are here to stay,” said Carl Daley, chief financial officer and treasurer of Highmark Health.”
  • Per BioPharma Dive,
    • “Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s assets and intellectual property rights.
    • “ITeos has for years struggled to develop a cancer treatment that sufficiently impressed investors and its pharmaceutical partners. Two weeks ago, it said it was shelving its most advanced drug prospect, a TIGIT-targeting treatment developed with GSK.
    • “The immuno-oncology developer is the latest biotechnology company considering merger prospects or liquidatation of its assets this year. Others such as Cargo Therapeutics and Third Harmonic Bio have made their own plans to dissolve.”

Tuesday Report

David Ermer–CDC, CMS, Congress, COVID-19, Electronic health records, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • Federal News Network interviews Bloomberg Government deputy news director Loren Duggan about what’s next for the Big Beautiful Bill Act.
  • Per a Senate press release,
    • Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) joined Sens. John Cornyn (R-Texas) and Amy Klobuchar (D-Minn.) to introduce the Don’t Sell My DNA Act to safeguard consumers’ sensitive genetic data during corporate bankruptcy proceedings.
    • The Don’t Sell My DNA Act strengthens consumer privacy protections by:
      • Modernizing the Bankruptcy Code to include genetic information in the definition of “personally identifiable information”;
      • Requiring written notice and affirmative consumer consent prior to the use, sale or lease of genetic information during bankruptcy proceedings; and
      • Requiring the trustee or debtor in possession of genetic information to permanently delete any data not subject to a sale or lease.
    • “Consumers should feel confident that any personal information shared with a public company isn’t up for grabs when that company files for bankruptcy,” Grassley said. “This bill would fill gaps in current law to help safeguard consumers’ genetic information and ensure Americans’ DNA isn’t treated like any other financial asset.”
  • The American Hospital Association lets us know,
    • Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention would no longer recommend the COVID-19 vaccine for healthy children and pregnant women. 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) Innovation Center announced Monday it is extending three tracks within the Kidney Care Choices (KCC) Model through 2027.
    • “Starting in performance year 2026, the model’s financial methodology and participation options will be modified to “improve model sustainability,” the agency said. However, one KCC Model track will be shuttered a year early at the end of December.
    • “The KCC Model has 93 participants, and implementation first began in January 2022. The most recent participants were announced Jan. 15.”
  • The Equal Employment Opportunity Commission announced last week
    • The EEOC collects workforce data from employers with more than 100 employees (lower thresholds apply to federal contractors). Employers meeting the reporting thresholds have a legal obligation to provide the data; it is not voluntary.  * * *
    • The 2024 EEO-1 Component 1 data collection opened on Tuesday, May 20, 2025. The deadline to file the 2024 EEO-1 Component 1 report is Tuesday, June 24, 2025.
    • “As part of EEOC Acting Chair Lucas’ efforts to identify continued cost savings for the American public, there will be a shorter collection period during which filers may submit their 2024 reports. The collection period will not extend beyond the Tuesday, June 24, 2025 “Published Due Date” deadline. Additionally, beginning with the 2024 EEO-1 Component 1 data collection, all communications sent to filers will be electronic.” * * *
    • “Filers should visit the dedicated EEO-1 Component 1 website at www.eeocdata.org/eeo1
      to access the EEO-1 Component 1 Online Filing System (OFS), to find supplementary resource materials such as the 2024 EEO-1 Component 1 Instruction Booklet and 2024 EEO-1 Component 1 Data File Upload Specifications, and to get the latest updates. Filers needing additional assistance can access the Filer Support Team Message Center upon logging into the OFS.”

In Food and Drug Administration News,

  • The American Hospital Association News tells us,
    • “The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious injury or death. BD said it became aware of some users encountering challenges removing the plastic plugs from the rubber lumen to inflate the balloons. BD and their subsidiary C.R. Bard Urology and Critical Care sent all affected customers a letter with updated use instructions. There have been two serious injuries, and one death associated with the issue.”
  • Per Fierce Pharma,
    • Despite facing ongoing legal pressure from its rival United Therapeutics, Liquidia has successfully landed a pair of long-awaited FDA approvals for its dry powder formulation of treprostinil.
    • The FDA has cleared treprostinil—also known by the trade name Yutrepia—to improve exercise ability in adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • and
    • The FDA has also approved Sanofi’s meningococcal vaccine MenQuadfi for use in infants as young as 6 weeks, multiple news outlets reported Tuesday. The shot was already cleared to protect against four prolific strains of meningococcal bacteria in individuals as young as 2 years and older.
    • The FDA based its decision on data from three phase 3 trials that found MenQuadfi worked as well as GSK’s rival meningococcal vaccine Menveo when given with other routine vaccines in children between the ages of 6 weeks to 19 months, Reuters pointed out. Sanofi’s trials enrolled more than 6,000 participants.
  • BioPharma Dive reports,
    • “A patient who received an experimental gene therapy developed by Rocket Pharmaceuticals has died following treatment, the company disclosed Tuesday.
    • “According to Rocket, the patient experienced what’s known as capillary leak syndrome, where plasma and proteins seep from blood vessels into surrounding tissue, and later died from an acute systemic infection.
    • “The Food and Drug Administration ordered the study’s halt Friday, while Rocket works with clinical trial monitors and other experts to investigate the cause. The company said it is focusing on a “novel immune suppression agent” it recently added to a pre-treatment preparatory regimen.”

From the judicial front,

  • The American Medical Association informs us,
    • “In a win for the nation’s youth—and all Americans’ health—the U.S. Supreme Court has ruled (PDF) that the Food and Drug Administration (FDA) did not act in an arbitrary and capricious manner when it told applicants that they could not put certain flavored e-cigarette liquids on the shelf.
    • “The unanimous decision overturned a 5th U.S. Circuit Court of Appeals ruling. Had that appellate-court ruling been allowed to stand, companies could have marketed products that clearly were designed to appeal to children, with names such as “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Pink Lemonade,” “Iced Pineapple Express” and “Killer Kustard Blueberry.”
    • “Justice Samuel A. Alito Jr., who wrote the opinion for the court, said the FDA did not act arbitrarily and capriciously when it denied the companies’ applications for premarket approval of the tobacco products. The companies challenged the agency’s decision arguing that, among other things, that the FDA didn’t give them fair notice about the evidentiary and comparative requirements used during the application stage and that the agency had changed its position on scientific evidence. 
    • “The high court remanded the case to the 5th Circuit to review other legal arguments, so this is not the end of the litigation, but it is a favorable step forward. The 5th Circuit’s decision was an outlier among the federal circuits that have considered similar cases.”
  • Per Govexec,
    • “At least one agency’s staff impacted by the mass dismissals of probationary workers can pursue their reinstatements as a class, the panel that hears federal employees’ challenges to firings has for the first time ruled, creating a new path for sweeping reversals of those terminations. 
    • “Hundreds of recently hired and subsequently fired employees at the Homeland Security Department will be part of a class action alleging their dismissals were unlawful after a Merit Systems Protection Board administrative judge granted the request. The DHS ruling was the first to come down after a consortium of lawyers filed similar challenges on behalf of fired probationary employees at 20 federal agencies. 
    • “I find that a class appeal is the fairest and most efficient way to adjudicate the appeal and that the putative class counsel and named appellants will adequately represent the interests of the parties,” said Sara Snyder, the chief administrative judge for MSPB’s western regional office.” 

From the public health and medical research front,

  • CBS News reports,
    • Cases of the new COVID-19 variant NB.1.8.1, linked to a large surge in China, have been detected in multiple locations across the United States, according to the Centers for Disease Control and Prevention. The earliest cases in the U.S. date back to late March and early April, and were detected through a screening program at airports for arriving international travelers.
    • “CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners,” a CDC spokesperson said in a statement last week.
    • The spokesperson said that, so far, too few U.S. sequences have been reported of NB.1.8.1 to be included in the agency’s variant estimates dashboard.
    • But hospitalizations abroad have raised questions about the new variant, its symptoms and more.
    • Answers to those questions may be found in the CBS News article.
  • ABC News adds,
    • “More than five years after the first cases of COVID-19 were detected in the United States, hundreds of people are still dying every week.
    • “Last month, an average of about 350 people died each week from COVID, according to data from the Centers for Disease Control and Prevention (CDC).” * * *
    • “The experts said there are a few reasons why people might still be dying from the virus, including low vaccination uptake, waning immunity and not enough people accessing treatments.” * * *
    • “CDC data shows that those aged 75 and older currently have the highest rate of COVID-19 deaths at 4.66 per 100,000.”
  • The American Medical Association let us know what doctors wish their patients knew about lung cancer screening.
  • The Washington Post relates,
    • “Engagement with digital technology was associated with a 58 percent reduced risk of cognitive impairment in people middle-aged and older, according to a study in the journal Nature Human Behavior.
    • “Researchers conducted a systematic review of 57 studies to see whether exposure to technology has helped or harmed cognition among the first generation of adults with prolonged exposure to digital devices such as smartphones, tablets and computers. The studies involved more than 411,000 adults with an average age of 69.
    • “The analysis revealed that technology could play a role in preserving brain function, not worsening it, said co-authors Jared Benge, a clinical neuropsychologist at the University of Texas at Austin’s Dell Medical School, and Michael Scullin, an associate professor of psychology and neuroscience at Baylor University.”
  • Per Medscape,
    • “Herpes simplex virus 1 (HSV-1) infection is associated with an increased risk of developing Alzheimer’s disease (AD), but treating the viral infection may offer protection, a new study found.
    • “In a matched case-control study of nearly 700,000 older adults, HSV-1 was more common in those with AD, and antiviral therapy for HSV-1 was associated with a lower risk of developing AD.
    • “However, the authors and outside experts cautioned that no firm conclusions can be drawn from this observational study and called for more research.
    • “The study was published online on May 20 in BMJ Open. It was funded by Gilead Sciences, which is actively involved in the research and development of treatments for HSV.”
  • The Wall Street Journal points out,
    • Good posture improves circulation, respiration, digestion and bladder function. It also enhances cognitive ability and mood.
    • To improve posture, become aware of your body position, stand against a wall to align yourself, and perform dynamic stretching exercises.
    • Upright posture is associated with confidence, self-esteem, and reduced anxiety. Physical therapists can help develop personalized plans to improve posture.

From the U.S. healthcare business front,

  • Fair Health released today a claims-based analysis of GLP-1 drugs and obesity. Beckers Hospital Review summarizes this analysis here.
  • The Wall Street Journal considers the price outlook for GLP-1 drugs used to treat obesity.
  • Fierce Pharma tells us,
    • “After a fourth quarter in which revenue boomed throughout the biopharma industry, there were reversals for several drugmakers in the first three months of 2025. 
    • “The companies that took the biggest hits were in the United States, where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services.
    • “Among the top 25 revenue companies in the industry in Q1, there were seven that saw year-over-year sales declines, all from the U.S. Viatris took the biggest hit at 11%, followed by Pfizer (-8%), Organon (-7%), Bristol Myers Squibb (-6%), Regeneron (-4%), Merck (-2%) and Gilead (-0.3%).”
  • Per BioPharma Dive,
    • “Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have already caught the attention of other large pharmaceutical firms.
    • “Per an announcement Tuesday, Lilly plans to acquire SiteOne Therapeutics in an all-cash deal. The companies aren’t disclosing how much money is being exchanged upfront or when they expect the transaction to close. But, if SiteOne’s research programs hit certain regulatory and commercial goals, the amount paid to its shareholders could reach that 10-figure mark.”
  • and
    • “Biogen is partnering with RNA drug developer City Therapeutics to develop a better way of reaching an unspecified target that “mediates key central nervous system diseases.” Biogen will pay City, a startup that launched publicly late last year, $16 million in upfront fees and invest another $30 million in convertible notes that could later become a minority stake. “With this effort, we are further expanding the modalities in our R&D toolbox to potentially reach our targets of interest more precisely by adding an RNAi-based approach,” Biogen research head Jane Grogan said in a statement.”
  • Per an Institute for Clinical and Economic Review news release,
    • “ICER today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of apitegromab(Scholar Rock Holdings), nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
  • Beckers Health IT discusses why Texas Health is taking a loss on its hospital at home program and summarizes Medscape’s list of telehealth friendly states which Utah leads.
  • Beckers Clinical Leadership identifies the 24 U.S. hospitals that have received the American Nurses Credentialling Center’s Magnet with Distinction award. “The Magnet with Distinction program was created as a special designation to celebrate hospitals and healthcare organizations that exceed scoring thresholds required to earn Magnet recognition.”
  • The Wall Street Journal reports,
    • “AI-powered ambient-listening technology is expanding in healthcare, documenting doctor-patient encounters.
    • “AI scribes save doctors time on documentation, reducing burnout and improving focus on patients, according to pilot programs.
    • “Concerns exist around patient privacy, data security and costs, but patient feedback has been largely positive.”
  • Fierce Healthcare offers insights into how Anthem Blue Cross is growing its behavioral health network in California.
    • “The insurer’s network is built on partnerships with multiple organizations, with recent additions including Headway, Rula and Octave. Through its relationship with these firms, the insurer is seeking to make it simpler for members to find providers that meet their unique needs.
    • “Through Headway, the insurer connects employers and plan members with personalized services. Rula, meanwhile, makes it easier for members to schedule an appointment with one of the more than 10,000 providers in its network.
    • “Octave, similarly, is built to make it simple for members to find a provider across multiple specialties, backgrounds and evidence-based approaches, according to the announcement.”
  • NIST explains for those interested how an MRI machine works.

Memorial Day Weekend Update

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–

Happy Memorial Day!

From Washington, DC

  • Congress is on a District / State work break this week.
  • Federal News Network points out five workforce bills for federal employees to watch this summer.
  • Federal News Network also looks back at the history of the Federal Employees Dental and Vision Insurnace Program which was launch in late 2006.

From the public health and medical research front,

  • The Washington Post sheds light on an e Coli outbreak “which a Feb. 11 internal Food and Drug Administration memo linked to a single lettuce processor and ranch as the source of the contamination. In what many experts said was a break with common practice, officials never issued public communications after the investigation or identified the grower who produced the lettuce.”
  • The Post also lets us know,
    • The National Cancer Institute says 85 percent of children diagnosed with cancer are alive at least five years later and that there were nearly 496,000 pediatric cancer survivors in the United States in 2020. While the good news is encouraging, long-term survivor care brings its own challenges — something pediatric oncologists are working to improve.
    • “Kids with cancer are beating a disease we never beat 30, 40 years ago,” says Greg Armstrong, who chairs the department of epidemiology and cancer control at St. Jude’s Children’s Research Hospital and is also the principal investigator of its Childhood Cancer Survivor Study. “There’s an entire population of kids who didn’t exist before. Now we need to figure out how to best support them.”
  • Consumer Reports, writing in the Washington Post, explains how to cope with heartburn.
  • The New York Times considers whether or not there is a “least bad” alcohol for human consumption. “We all know about the health risks of drinking. But if you’re going to partake, it’s natural to want to minimize the damage.”
  • The Wall Street Journal considers
    • “A lack of fiber causes changes in the microbiome that can trigger immune dysfunction and chronic inflammation.
    • “Low fiber intake may contribute to rising cancer rates among young people, especially with the popularity of ultra-processed foods.
    • “Increase fiber intake through diverse fruits, vegetables and whole grains, rather than relying on supplements.”
  • Medscape discusses the overlooked link between Vitamin D and GI health.
  • RAND delves into suicide among veterans.
  • In GLP-1 drug news, the Wall Street Journal notes
    • GLP-1 drugs like Ozempic show promise beyond diabetes/weight loss, potentially treating heart, kidney, liver issues, sleep apnea, and Alzheimer’s.
    • Millions more could benefit from GLP-1s, but doctors caution against use in people who don’t medically fit the bill because it could cause malnourishment.
    • The use of GLP-1 drugs will grow, but high costs, tolerability, and manufacturing capacity could limit uptake despite new versions being developed.
  • and
    • Some consumers are microdosing GLP-1 drugs like Ozempic to save money, lessen side effects, or for perceived health benefits.
    • Doctors note some patients are ‘super responders’ and can maintain weight loss at low doses, but most will need to escalate their dose.
    • A survey found 36% of GLP-1 users microdose, often learning about it from TikTok, despite safety concerns from doctors and manufacturers.

From the U.S. healthcare business front,

  • Blue Cross Blue Shield of Michigan’s CEO Tricia Smith, writing in Crain’s Detroit Business, explains how her company is tackling the healthcare affordability issue.
  • Per Beckers Payer Issues,
    • Blue Cross Blue Shield of Minnesota will offer access to specialty behavioral care through partnerships with Equip and Pelago. 
    • Equip provides fully virtual care for eating disorders, according to a May 22 news release. 
    • Pelago offers virtual treatment for opioid and alcohol dependency. It provides three levels of care based on acuity. Both Equip and Pelago will be available to BCBS Minnesota members with commercial or individual coverage. 
  • Beckers Hospital Review offers ten things to know about HCA and Tenet Health, two large U.S. healthcare systems.
  • Fierce Healthcare explains how rural hospitals are powering innovation in healthcare.
    • “One of the best examples of rural innovation scaling to broader impact is Project ECHO, launched in my native New Mexico to address the hepatitis C crisis in underserved areas. Faced with long waitlists and limited specialist access, Sanjeev Arora, M.D., developed a model that used simple videoconferencing technology to mentor rural clinicians in treating complex conditions. 
    • “Instead of centralizing care, it democratized it—turning primary care providers into specialists through case-based learning and ongoing support. What started as a rural solution became a global model, now used in over 40 countries to manage everything from cancer to addiction to COVID-19. Project ECHO redefined how knowledge moves through healthcare. And it all began by listening deeply to the needs of rural providers and designing something that worked in their reality first.”

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Federal News Network tells us,
    • “The Office of Personnel Management is taking a second bite at the apple to modernize its human resources platform.
    • “OPM released a new request for proposals on Thursday through the General Services Administration schedules program for a secure, cloud-based software-as-a-service (SaaS) human capital management (HCM) platform.
    • “The objective of this acquisition is to deploy an integrated, enterprise-wide core HR platform—powered by a secure, FedRAMP-authorized SaaS solution—that consolidates key human capital functions, including personnel management, time and attendance, leave, benefits administration, learning and performance management and workforce analytics,” the RFP states. “The platform must enable seamless interoperability with critical external systems (e.g., USA Staffing, GSA Payroll, eOPF, eHRI, LMS, and benefits systems) and eliminate the data and process gaps currently affecting onboarding, pay accuracy, personnel action sequencing, leave eligibility and audit reporting.”
    • “The solicitation says the platform will be used for OPM’s workforce of 2,000 to 3,000 people.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare & Medicaid Services (CMS) revealed several updates to the ACO REACH program in 2026, though the model’s long-term future remains unclear.
    • “The CMS said it is making changes to the model based on preliminary data on 2023 performance (PDF), which found that standard accountable care organizations saved $197.5 million in aggregate that year. New entrant ACOs, meanwhile, generated $36.8 million in aggregate savings, reducing gross spending at higher rates that standard organizations.
    • “In addition, high-needs ACOs reduced spending by $2.3 million in the aggregate, according to the preliminary report. The CMS is set to release full data on ACO REACH later this year.
    • “The proposed changes come in a confusing environment for ACOs, which have pushed the agency to outline plans for the ACO REACH program, currently set to expire in 2026.”
  • The American Hospital Association News let us know,
    • “AHA May 23 submitted recommendations to the Department of Justice and Federal Trade Commission in response to the agencies’ requests for information on unnecessary or burdensome anticompetitive regulations. “[T]he U.S. health care system imposes a bewildering array of regulations on hospitals and health systems, adding significant administrative costs, disincentivizing pro-competitive arrangements, and promoting vertical consolidation of large commercial insurers to the detriment of patients and providers across the country,” AHA Deputy General Counsel Julie Rapoport Schenker wrote in the letters to the agencies. The AHA’s recommendations included addressing regulations that foster anticompetitive conduct by insurers and limit the ability of hospitals and health systems to thrive in a competitive free market, among others.” 

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP points out,
    • “Excess deaths in the United States kept rising even after the peak of the COVID-19 pandemic, with more than 1.5 million in 2022 and 2023 that would have been prevented had US death rates matched those of peer countries, estimates a Boston University (BU)-led study today in JAMA Health Forum.
    • “The data show a continuation of a decades-old trend toward increasing US excess deaths, mainly among working-age adults, largely driven by drug overdoses, gun violence, auto accidents, and preventable cardiometabolic causes, the researchers say.
    • “The US has been in a protracted health crisis for decades, with health outcomes far worse than other high-income countries,” says lead and corresponding author Jacob Bor, ScD, said in a BU news release. “This longer-run tragedy continued to unfold in the shadows of the COVID-19 pandemic.”
  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The New York Times reports,
    • “Cancer screening poses a quandary for women with dense breast tissue. They’re at elevated risk for breast cancer, but mammograms often miss tumors buried in dense breasts — and insurers often resist paying for additional scans that may help find the masses.
    • “Now a large study comparing various types of scans has found that mammography enhanced with iodine-based dye can detect three times as many invasive cancers in dense breast tissue as ultrasound.
    • “And so-called contrast-enhanced mammography can find tumors that are much smaller than those found by regular mammography. M.R.I.s are better at detecting more tumors than standard mammograms, the study found but are considerably more expensive.
    • “The scans were given to women with dense breast tissue who had already undergone mammograms that hadn’t turned up any abnormalities.”
    • “Contrast-enhanced mammography needs to become standard of care for women with dense breasts,” if they are at high risk of developing breast cancer, said Dr. Fiona J. Gilbert, a professor of radiology at the University of Cambridge’s School of Clinical Medicine. She is lead author of the study, which was published Wednesday in The Lancet.”
  • NCQA offers via LinkedIn a White Paper, Webinar and a New HEDIS Measure for Asthma Awareness Month, which is May.
    • “The HEDIS MY 2026 measure set will include a new measure focused on asthma, Follow-Up After Acute Care Visits for Asthma (AAF-E). Patients with uncontrolled asthma are more likely to seek care for acute exacerbations, rather than focusing on preventive care. The new measure focuses on the patient-clinician relationship as encouraging treatment adherence and efficacy. Guiding patients toward non-acute care—and clinicians with whom they have a trusted relationship—may help improve asthma outcomes.”
  • The Wall Street Journal delves into “new tests [that] promise to reveal the secrets in your blood. A wave of diagnostic tests—some here, some coming—can identify cancer and Alzheimer’s at earlier stages and predict flare-ups of other conditions.”
  • Per HCPLive,
    • “Semaglutide demonstrated notable protective effects on osteoporosis and gout in people with obesity and type 2 diabetes (T2D) in a new cohort study.
    • “The impact of newer anti-obesity medications on skeletal health remains incompletely understood, particularly in populations with varying metabolic profiles,” lead investigator Jo-Ching Chen, Chung Shan Medical University Hospital, Taichung, Taiwan, and colleagues wrote.
    • “Chen and colleagues conducted a 5-year cohort study examining skeletal health outcomes in people with obesity and T2D receiving semaglutide vs conventional glucose-lowering medications (sitagliptin, empagliflozin, glipizide), and obese individuals without T2D receiving semaglutide vs traditional anti-obesity medications (Contrave, phentermine, Qsymia).”
  • Per Fierce Pharma,
    • “After meeting the mark alongside Keytruda in PD-L1-positive breast cancer earlier this year, Gilead Sciences’ antibody-drug conjugate Trodelvy has impressed in a solo showing in a similar indication.
    • “In the late-stage Ascent-03 trial, Trodelvy bested standard-of-care chemotherapy at extending the time before disease worsening or death in certain patients with previously untreated metastatic triple-negative breast cancer (TNBC).
    • “The study specifically assessed the TROP2-targeted ADC in patients who aren’t candidates for PD-1 or PD-L1 inhibitors, either because their tumors don’t express the PD-L1 protein or because the patients are ineligible.
    • “The “highly statistically significant and clinically meaningful” improvement on the progression-free survival metric allowed the study to meet its primary endpoint, Gilead said. The company will discuss the Ascent-03 results with regulators and plans to present detailed results from the trial at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “The nation’s leading nonprofit healthcare providers struggled financially during the quarter ended March 31.
    • “Most of the major systems, including Kaiser Permanente, Mass General Brigham, Cleveland Clinic, Mayo Clinic, Ascension and Providence, recorded operating margins that were flat or lower than this time last year, despite growing patient volumes.
    • “The results come as analysts have been sounding the alarm with escalating urgency about how headwinds, including market volatility and policy changes in Washington, could harm provider finances.” 
  • Beckers Health IT explains “two ways Amazon is changing healthcare, per CEO Andy Jassy.”
  • Per Health Leaders,
    • “A recent Experian Health survey shows steady improvement in access to care but suggests a disconnect between patients and providers on digital tools.
    • “Providers continue to face challenges with capacity constraints and staffing shortages.
    • “Patients call for better pricing estimates and self-scheduling tools.”
  • Healthcare Innovation lets us know,
    • Aligning itself with new strategies coming out of the Center for Medicare and Medicaid Innovation, the Health Care Payment Learning & Action Network (HCPLAN) announced it will launch four new initiatives focused on healthcare choice and competition, patient empowerment, preventative care, and technology-enabled healthcare, while discontinuing its alternative payment model measurement effort, which had been funded by CMMI.
    • The HCPLAN is a group of public and private healthcare leaders that was formed to provide thought leadership, strategic direction, and ongoing support to accelerate the adoption of alternative payment models (APMs) and accountable care.
    • Since its launch in 2015, the HCPLAN APM Measurement Effort has monitored the shift of U.S. healthcare from fee-for-service to APMs. The 2024 APM Measurement Effort results demonstrated the continued growth in APM adoption and initiatives to enhance patient access, affordability, and quality of care. As part of its efforts to advance the availability and reduce the cost of key data needed to improve care, the HCPLAN will explore alternative pathways for the continuation of this effort.
  • MedTech Dive explores “Why Medtronic plans to spin out its diabetes business. While some analysts questioned why Medtronic would leave a fast-growing market, others backed the company’s plan to focus on segments with higher margins.”
  • Per Fierce Healthcare,
    • “Pharmacy benefit manager WellDyne is partnering with Waltz Health to bring greater transparency to its specialty pharmacy clients.
    • “WellDyne is teaming up with Waltz as well as Mark Cuban Cost Plus Drugs as part of its broader member routing strategy, which surfaces real-time alerts and smart prompts that can help its members find the most affordable medication option for them.
    • “The PBM’s tech stack also uses automated algorithms to adjudicate claims in the background and let members know when they may be able to achieve savings. The technology optimizes claims across different touch points including retail, home delivery, discount cards and other avenues.
    • “Rich Wipperfurth, chief commercial officer for WellDyne, said traditional models are also built on simplicity but in a way that steers the member toward preferred distribution channels, pharmacies and other sources.
    • “WellDyne wants to inject more choice back into the equation, Wipperfurth said.”

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.”

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Joshua Hoehne on Unsplash

From Washington, DC,

  • Govexec tells us,
    • Rep. Gerry Connolly, D-Va., died Wednesday morning after a battle with esophageal cancer. He was 75 years old.
    • Connolly is leaving behind a legacy as a legislator who fought for the federal workforce, government contractors and the economic development of his home region of Northern Virginia.
    • In April, Connolly announced he would not seek re-election in 2026 and would step down from his post as the ranking member of the House Oversight Committee. He first announced his diagnosis in November, shortly after easily winning a ninth term to the House.
  • RIP, Congressman.
  • The Wall Street Journal reports,
    • “House Republicans made a series of last-minute changes to their sprawling tax-and-spending bill, searching for a path that could unite the party’s warring wings headed into a nail-biter floor vote expected early Thursday.
    • “New language to assuage conservatives would accelerate new Medicaid work requirements to December 2026 from 2029 and end certain tax credits for wind energy and solar energy by 2028 instead of a slower phaseout through 2031. The updates would also formally lock in a $40,000 cap on the state and local tax deduction starting this year, up from a $30,000 cap in the prior plan; that change was designed to satisfy Republicans from high-tax states such as New York and New Jersey. 
    • “Lawmakers from states such as Florida and Texas that haven’t expanded Medicaid under Obamacare would get a favorable change to a funding formula, and border states would get $12 billion for security costs incurred during the Biden administration. An indoor-tanning excise tax that was eliminated in the original bill text would be maintained and a nuclear-energy tax break would be expanded. Federal land swaps in Nevada and Utah would be eliminated. Gun-rights supporters won changes to the tax treatment of suppressors. 
    • “The revised legislation advanced in an initial vote in the early hours of Thursday morning, with all Republicans except one in favor, and all Democrats opposed.” * * *
    • “I believe we are going to land this airplane,” Johnson said during a hectic day of legislating that saw the House Rules Committee start a hearing at 1 a.m. and continue past sunset. He is trying to finish the bill in the House before Memorial Day; it would then go to the Senate, and Republicans are aiming to get it to Trump’s desk by July 4.” 
  • Per the New York Times,
    • “The House early Thursday narrowly passed a wide-ranging bill to deliver President Trump’s domestic agenda, after Speaker Mike Johnson put down several mini-rebellions in Republican ranks to muscle the legislation to its first major victory over unified Democratic opposition.
    • “The early morning vote was 215 to 214, mostly along party lines.”
  • Fierce Healthcare adds,
    • “We have a tiny sliver that really matters to employers and working families,” said James Gelfand, president and CEO of The ERISA Industry Committee, a group representing large employers. “But I can say those provisions are monumental to us.”
    • “There’s a laundry list of items Gelfand and others are happy the bill, in its current form, includes.
    • “Employer-offered worksite clinics with free or discounted primary care services would now be available to employees on high-deductible health plans (HDHPs), even if they already have an HSA.” * * *
    • “Other changes allow HSA funds to be spent on gym memberships, increases the HSA contribution limit for some individuals, classifies bronze and catastrophic plans as a HDHP that can pair with an HSA and permits one spouse to contribute to an HSA even if the other spouse has a flexible spending account.” * * *
    • “The bill [further codifies a rule from 2019 creating the [ICHRA] program and lets employees use pretax dollars through a cafeteria plan to pay for on-exchange marketplace premiums, explains the KFF.
  • and
    • “A bipartisan bill aiming to reform prior authorization has been reintroduced in the Senate.
    • “The Improving Seniors’ Timely Access to Care Act seeks to streamline the prior auth process in Medicare Advantage (MA), which would ease administrative burdens on providers and reduce delays in accessing care for patients.
    • “The bill is co-sponsored by Sens. Roger Marshall, R-Kan., and Mark Warner, D-Va., and is supported by dozens of senators on both sides of the aisle. A version of the legislation in the House is also backed by a bipartisan group.”
  • Per an CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) announced a significant expansion of its auditing efforts for Medicare Advantage (MA) plans. Beginning immediately, CMS will audit all eligible MA contracts for each payment year in all newly initiated audits and invest additional resources to expedite the completion of audits for payment years 2018 through 2024.”
  • The American Hospital Association News informs us,
    • “The Administration for Strategic Preparedness and Response today released a bulletin on workplace violence in health care that includes recommendations for strengthening security protocols, enhancing emergency preparedness, supporting workforce mental health and promoting information sharing.”

From the Food and Drug Administration front,

  • BioPharma Dive points out,
    • “After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older.
    • “The biotechnology company said it plans to resubmit its candidate later this year after it gathers data from an ongoing Phase 3 trial of a standalone seasonal influenza vaccine it’s developing. Earlier this month, Moderna had told investors the FDA would require efficacy data from this trial before considering approval of the combo vaccine.
    • “Moderna’s confirmation comes one day after the FDA announced new rules for COVID vaccine approvals, for which it will now require placebo-controlled studies for any clearance in healthy adults under 65 years old.”
  • and
    • “Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe blood cancer.
    • “Members of the Oncologic Drugs Advisory Committee voted 6-2 that the benefits of Darzalex’s use in high-risk smoldering multiple myeloma outweighed its risks. However, panelists wrestled with some controversial aspects of the Phase 3 trial J&J is using to ask for an expanded approval. Namely, FDA staff had flagged the trial’s inclusion of patients that could be classified as having a lower risk of progression, as well as an unclear survival benefit following disease progression.
    • “The FDA isn’t required to follow the advice of its outside expert panels but usually does.”
  • MedTech Dive adds,
    • “Teal Health published data Monday from a trial of its cervical cancer screening sample self-collection device in JAMA Network Open.
    • “The paper describes a trial of 599 people who both self-collected samples and underwent standard clinician collection. Self-collection correctly identified 95.2% of the positive samples.
    • “Teal won Food and Drug Administration approval for the self-collection device in early May, setting the company up to start shipping the product to customers in June.”
  • The New York Times provides helpful background information about the Alzheimer’s Disease blood test that the FDA approved for marketing last week.
    • “The test, manufactured by Fujirebio Diagnostics, is intended to be used only by specialists in Alzheimer’s, the F.D.A. said. Its mouthful of a name — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — describes what the test measures: levels of two proteins, amyloid and tau, that are hallmarks of Alzheimer’s disease.
    • “In people who develop Alzheimer’s, amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is much more closely correlated with cognitive decline.” * * *
    • “The F.D.A., and Alzheimer’s experts, emphasized that the blood test should be given only to people who are already experiencing cognitive decline and are ages 55 and older. Moreover, it should not be used on its own to diagnose or to rule out Alzheimer’s.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Biden’s cancer diagnosis has sparked a debate over prostate-cancer screening guidelines.
    • “Increased diagnoses of later-stage cancers are suspected to be linked to changing screening guidance.
    • “Some prostate-cancer specialists said that there has also been a shift in how they manage lower-risk prostate cancer.”
  • Per STAT News,
    • “In what researchers hope could be a case of 1 + 1 = 3, new research suggests that combining a model to predict 10-year cardiovascular risk with an imaging test of coronary arteries could be better than either method alone at identifying people in danger of their first heart attack.
    • “The model is PREVENT, which computes a risk score based on measures familiar from the primary care office: blood pressure, cholesterol levels, kidney function, age, and BMI, as well as questions about type 2 diabetes, smoking, and social determinants of health. The imaging test is a CT scan that detects calcium buildup in arteries leading to the heart. High amounts of calcium, alone and inside fatty plaques, can lead to blockages and heart attacks.” * * *
    • “It’s not always clear who should be screened for coronary calcium; thus, we decided to see if the PREVENT score could be used in this novel manner,” Morgan Grams of New York University’s Grossman School of Medicine told STAT. She is an author of the study published Wednesday in the Journal of the American Heart Association. “Once we determined that it could, we assessed whether the coronary calcium score could add information to PREVENT in the prediction of incident cardiovascular disease. It did.”
       
  • Per a National Institute of Health news release,
    • Research teams funded by the National Institutes of Health (NIH) have created a versatile set of gene delivery systems that can reach different neural cell types in the human brain and spinal cord with exceptional accuracy. These delivery systems are a significant step toward future precise gene therapy to the brain that could safely control errant brain activity with high precision. In contrast, current therapies for brain disorders mostly treat only symptoms.
    • The new delivery systems carry genetic material into the brain and spinal cord for targeted use by specific cell types. This platform has the potential to transform how scientists can study neural circuits. It provides researchers with gene delivery systems for various species used in research, without the need for genetically modified, or transgenic, animals. Examples include illuminating fine structures of brain cells with fluorescent proteins and activating or silencing circuits that control behavior and cognition.
    • “Imagine this new platform as a delivery truck dropping off specialized genetic packages in specific cell neighborhoods in the brain and spinal cord,” said John Ngai, Director of the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. “With these delivery systems, we can now access and manipulate specific cells in the brain and spinal cord – access that was not possible before at this scale.”
  • Healio notes,
    • “Increased dietary fiber was associated with reduced likelihood of stroke, especially small-vessel stroke, in addition to reduced all-cause mortality and improved poststroke survival, researchers reported.
    • “Data on the link between daily dietary fiber intake and odds of stroke and adverse stroke outcomes were published in Stroke.”

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “Sanofi will acquire Vigil Neuroscience for $470M, potentially reaching $600M with milestone payments.
    • “The deal centers on neurology, adding VG-3927, an Alzheimer’s treatment, to Sanofi’s pipeline.
    • “Vigil’s VGL101 molecule will return to Amgen before the Sanofi acquisition closes in Q3.”
  • Fierce Healthcare reports,
    • “Digital physical therapy company Hinge Health priced its IPO at $32 per share on Wednesday, at the top of the company’s expected price range.
    • “The company said it raised $437 million by selling 13,666,000 million shares of its Class A common stock, according to a press release issued Wednesday. Hinge Health said it sold 8.5 million shares and 5.1 million shares are being sold by existing shareholders.
    • “Hinge Health will begin trading tomorrow morning on the New York Stock Exchange under the ticker symbol “HNGE.” The offering is expected to close May 23.”
  • Fierce Pharma relates,
    • “Cigna’s Evernorth is rolling out a new pharmacy benefit management program that caps members’ monthly cost for key GLP-1 drugs.
    • “Evernorth said in an announcement that through its Express Scripts arm it negotiated directly with the manufacturers for Wegovy and Zepbound—Novo Nordisk and Eli Lilly, respectively—to cap patients’ monthly costs at $200. The company said this could save as much as $3,600 per year compared to savings patients receive through direct-to-consumer discount programs.
    • “Evernorth added that the costs will contribute toward a patient’s deductible as well.
  • CNBC adds, “Evernorth’s new weight loss pricing program will begin in the second half of the year, as employers begin to make decisions about coverage for next year’s plans.”
  • Per STAT News,
    • “Five years after launching, a unique nonprofit drug company has published data showing that consumers and health plans saved considerable money on a generic cancer medicine thanks to its “transparent” pricing model. And it maintains that the findings validate plans to distribute and — eventually — manufacture still more copycat medicines for the U.S. market.
    • “The company — CivicaScript — was created as a vehicle to combat stubbornly high drug prices even after dominant brand-name medicines lost patent protection and generic competitors entered the market. Backed mostly by 18 Blue Cross Blue Shield plans, the nonprofit made its first drug available — a generic version of the Zytiga prostate cancer treatment — in August 2022.
    • “The initial wholesale price was $160, plus an $11 dispensing fee paid to pharmacies, but uptake was slow until it was accepted by pharmacy benefit managers and other health plans. But eventually, the gambit worked: Between September 2023 and December 2023, patients saved 64% and payers saved 92% by purchasing the generic distributed by CivicaScript, according to a new analysis.”
  • Beckers Payer Issues offers the view of eleven payer “leaders to learn what’s overhyped in healthcare.” 

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Following up on yesterday’s post about the House budget reconciliation bill, Govexec informs us,
    • “According to the latest draft of the bill, published early Monday morning, Republicans have ditched the plan to effectively un-grandfather employees hired prior to 2014 into paying more of their paychecks toward their retirement benefits.
    • “On the FERS supplement, which can amount to one-third of a federal retiree’s income until they turn 62, lawmakers expanded an exemption for federal workers who are required to retire early, such as air traffic controllers and federal law enforcement personnel, to cover all such employees, regardless of whether they actually are forced out because they hit the mandatory retirement age. The implementation date, previously set on the date of the bill’s enactment, has been shifted to Jan. 1, 2028, and language now exists clarifying that federal employees may maintain eligibility for the supplement provided they are “entitled” to it prior to 2028.
    • “The latest draft also delays the change in federal retirees’ annuity calculations from the high-3 to high-5 average salary model by one year, to Jan. 1, 2028.”
  • KFF posted a summary of Medicaid provisions in the House budget reconciliation bill.
  • Roll Call reports,
    • “President Donald Trump urged the House GOP to stop negotiating and pass his “big, beautiful” filibuster-proof reconciliation bill Tuesday, with sharp words for blue-state Republicans pushing for more tax relief and conservatives seeking additional spending cuts.
    • “In an appearance during the weekly GOP conference meeting, Trump told conservatives to lay off Medicaid, scolded blue-state Republicans for rejecting a $30,000 cap on state and local tax deductions and urged the party to increase the country’s borrowing limit through the rest of his term, members leaving the meeting said. * * *
    • “Trump’s visit did little to move the needle in support of the bill, leaving leadership where they started the week: trying to strike a balance between steeper cuts needed to satisfy conservatives without alienating centrists, and finding space for more SALT relief.
    • “Republicans can afford to lose no more than three GOP votes and pass the partisan legislation.
    • “After the meeting, Speaker Mike Johnson said he was ready to convene the holdouts in smaller groups to try to reach a deal.”
  • Per a Congressional press release,
    • “Congressman Gerald E. Connolly (D-VA) and Congressman James Comer (R-KY), the Ranking Member and Chairman of the House Committee on Oversight and Government Reform respectively, introduced the Esophageal Cancer Awareness Act, bipartisan legislation to commission a Government Accountability Office (GAO) study on gaps in screening and prevention of esophageal cancer. 
    • “Esophageal Cancer is quickly on the rise, touching the lives of tens of thousands of Americans – including mine,” said Ranking Member Connolly. “It is vital that we all do our part to raise awareness and push for more research and more effective prevention efforts. I am immensely grateful to my colleague, Chairman Comer, for joining me in introducing this important legislation today. Together, we will fight to end esophageal cancer, bringing hope to thousands of American families.” * * *
    • “Text of the legislation is available here.”
  • The American Hospital Association News tells us,
    • Secretary of Health and Human Services Robert F. Kennedy Jr. May 20 appeared before the Senate Appropriations Committee for a hearing to testify on the discretionary budget proposal for fiscal year 2026.
      • Roll Call offers more details on the hearing.
  • and
    • “The Department of Health and Human Services May 20 announced it has identified specific pricing targets for pharmaceutical manufacturers to meet to satisfy requirements of the Trump administration’s executive order allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in an Organization for Economic Co-operation and Development country with a gross domestic product per capita that is at least 60% of the U.S. GDP per capita.”
      • Beckers Hospital Review calls attention to six things to know about this announcement.

From the Foord and Drug Administration front,

  • The Wall Street Journal points out,
    • “The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.
    • “Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects that it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.”
  • MedPage Today notes,
    • The FDA warned that some people develop severe itching, or pruritus, after stopping long-term use of the antihistamines cetirizine (Zyrtec) or levocetirizine (Xyzal).
    • Prescribing information for the oral allergy drugs — which are taken daily and sold both in prescription and over-the-counter (OTC) forms — will be updated to warn about the post-discontinuation risk. The itching typically occurs within a few days of stopping the products.
    • “Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach,” the FDA said in its safety communication.”
  • Fierce Pharma adds,
    • “Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts in an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What’s more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.
    • “A panel of experts on the FDA’s Oncologic Drugs Advisory Committee voted 8 to 1 Tuesday that results from Roche’s phase 3 Starglo trial are not applicable to a U.S. patient population. The trial evaluated the combination of Columvi and the chemotherapy regimen GemOx in second- or later-line transplant-ineligible DLBCL. 
    • “A patient representative cast the only yes vote.”
  • MedTech Dive announced the creation of an online database that tracks FDA approval of medical devices that incorporate artificial intelligence.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Covid-19 virus in the U.S. has largely faded from view. But it hasn’t faded away. 
    • “National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. 
    • “Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 
    • “It is at our lowest levels it has been since the beginning of the pandemic,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Our challenge is we don’t know what that means for tomorrow.” 
  • Per MedPage Today,
    • “The use of antibiotics in patients hospitalized with non-severe COVID-19 was not associated with better outcomes, a large retrospective cohort study found.
    • “Among more than half a million U.S. patients with COVID, those given antibiotics on their first day of hospitalization had a slightly higher rate of deterioration or death compared with those who didn’t receive antibiotics (20.8% vs 18.4%), reported researchers led by Michael Pulia, MD, PhD, of the University of Wisconsin-Madison.
    • “The difference didn’t meet criteria for being of clinical significance. However, a propensity-matched analysis did show a significantly higher odds of poor clinical outcomes for those who received antibiotics (OR 1.03, 95% CI 1.01-1.05, P=0.003), according to findings published in JAMA Network Open.
    • “Hopefully, studies like this raise the bar for antibiotic initiation in patients with confirmed COVID-19, even if they are sick enough to require hospital admission,” Pulia told MedPage Today.
    • “Pulia noted that there’s often a lot of uncertainty as to whether a patient hospitalized with COVID also has a bacterial infection, so physicians may prescribe antibiotics to be safe. “Hopefully, studies like this will reduce this uncertainty and improve judicious antibiotic use, thus helping in the fight against antibiotic resistance,” he said.”
  • The New York Times discusses “A New System Aims to Save Injured Brains and Lives. Nearly 100 neurology experts collaborated on the creation of a new method of evaluating patients with traumatic brain injuries.”
  • The latest National Institutes of Health’s (NIH) Research Matters covers “Cancer trends in younger people | Measuring biological age | Brain rewiring in motor learning.”
  • Per a NIH news release,
    • For the first time, researchers at the National Institutes of Health (NIH) identified patterns of metabolites in blood and urine that can be used as an objective measure of an individual’s consumption of energy from ultra-processed foods. Metabolites are left after the body converts food into energy, a process known as metabolism. Scientists used these data to develop a score based on multiple metabolites, known as a poly-metabolite score, that has the potential to reduce the reliance on, or complement the use of, self-reported dietary data in large population studies. The findings appeared May 20, 2025, in PLOS Medicine.   
    • “Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said lead investigator Erikka Loftfield, Ph.D., M.P.H., of NIH’s National Cancer Institute.”
  • MedPage points out,
    • “Dementia incidence fell among Medicare beneficiaries from 2015 to 2021, but prevalence rose.
    • “Incidence was higher for Black beneficiaries than any other racial or ethnic group.
    • “Those living in socioeconomically deprived neighborhoods had the highest incidence and prevalence.”
  • FYI, “Prevalence differs from incidence in that prevalence includes all cases, both new and preexisting, in the population at the specified time, whereas incidence is limited to new cases only.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
  • STAT News lets us know,
    • “Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps.
    • “Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved, but policymakers and insurers have been hesitant to open the path to reimbursement too quickly.” * * *
    • “In a new report, the Peterson Health Technology Institute (PHTI) finds that Rejoyn, an app for depression from Otsuka Precision Health, and DaylightRx, an app for anxiety from Big Health, warrant further adoption because their clinical trials show strong evidence of benefits. Both apps are intended to be used alongside ongoing mental health treatment, and in most cases, the institute found the apps will save money.” * * *
    • “Elsewhere, advocates from the American Telemedicine Association’s advocacy arm, ATA Action, are preparing to brief lawmakers about data showing that Germany’s broad expansion of coverage for digital apps resulted in 234 million euros in spending from 2020 to 2024. The report, produced by Germany’s National Association of Statutory Health Insurance Funds, also found 861,000 total app activations. That’s a cost of about 271 euros per use.”
  • Fierce Healthcare adds,
    • “Employers are continuing to invest in their well-being programs, but they will be raising the bar for what’s expected from their vendors.
    • “The Business Group on Health released a survey looking at employer strategies around well-being initiatives, polling 131 firms that employ 11.2 million people collectively. The employers represent multiple sizes and geographies, with 60% being multinational.
    • “The survey found that 93% of employers intend to either maintain or expand their well-being programs for 2025. Most (73%) said they will keep their existing offerings, while 20% said they will grow.
    • “In tandem, 94% of those surveyed said they will be increasing the expectations they have for well-being program vendors to show improvements to outcomes. Jim Winkler, chief strategy officer for the Business Group, said during a media briefing that this isn’t a new trend but that employers are simply turning up the heat on these vendors.”
  • Per Institutes for Clinical and Economic Review news releases,
    • The Institute for Clinical and Economic Review (ICER) posted a Protocol today [May 19] outlining how it will conduct a new annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.”
  • and
    • The Institute for Clinical and Economic Review (ICER) announced today [May 20] that it will assess the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences) for smoking cessation [which is the first new smoking cessation drug for many years].
    • The assessment will be publicly discussed during a meeting of the Midwest CEPAC in January 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment. 
  • Reuters reports,
    • “Online weight-loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s (NOVOb.CO) Wegovy as the U.S. drugs regulator clamps down on mass production of copies of the in-demand medicine.
    • “Noom will offer its version of compounded semaglutide – the active ingredient in Wegovy and diabetes drug Ozempic – as part of a program personalized for patients, which it says will comply with changing U.S. Food and Drug Administration regulations.”
  • Beckers Payer Issues informs us,
    • “CVS Health has named Creagh Milford, DO, as president of Oak Street Health.
    • “Dr. Milford has been with CVS since 2021, most recently serving as president of retail health. 
    • “I’m excited to start a new chapter at CVS Health as President of Oak Street Health, where I have the honor of developing and executing business strategy to further grow the organization,” he wrote on Linkedin on May 19. “As a practicing physician, I am passionate about providing consumer-centric primary care to patients — and Oak Street Health shares that passion, resulting in better experiences and outcomes for the older adults we serve.”

Monday Report

David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports,
    • “House Budget Committee Republicans advanced a sweeping reconciliation bill Sunday night, but for the GOP, the internal debate is far from over. * * *
    • “Rep. Chip Roy, R-Texas, one of four conservative Budget Committee members who agreed to vote “present” Sunday to allow the House to move forward with the bill designed to implement Trump’s policy agenda, said in a statement, “the bill does not yet meet the moment.”
    • “The Rules Committee is scheduled to convene at 1 a.m. Wednesday to set the ground rules for floor debate on the measure after releasing an updated committee print version of the legislative text overnight.
    • “Among the newest changes is the removal of a provision opposed by Rep. Michael R. Turner, R-Ohio, that would force federal agency employees, lawmakers and congressional staff to contribute more of their salaries to their pension plans. The effective dates of two other pension-related provisions would be delayed to 2028.”
    • “Roy said provisions related to curbing spending enacted under President Joe Biden, especially for environmental and energy programs, needed to see further cuts. He also criticized the bill’s Medicaid language.
    • “Roy said in a statement that the bill “fails to end the Medicaid money laundering scam and perverse funding structure that provides seven times more federal dollars for each dollar of state spending for the able-bodied relative to the vulnerable. This all ultimately increases the likelihood of continuing deficits and non-Obamacare-expansion states like Texas expanding in the future,” Roy said in a statement.”
  • STAT News adds,
    • “Although moderate and conservative Republicans disagree over some Medicaid policies that have been considered, both groups support imposing work requirements on adults without kids or disabilities. For that reason, the bill leaned hard on that policy by applying work requirements on beneficiaries up to the age of 64, instead of 55. Those people would keep Medicaid if, twice a year, they document that they’re working at least 80 hours a month. They could also maintain coverage if they perform community service or are enrolled in educational programs.
    • “Those work requirements would take effect in 2029, and conservatives are demanding they start next year.” 
  • Here is a link to a House Budget Committee document that identifies the changes that the Committee approved last night.

From the public health and medical research front,

  • Blue Cross FEP offers a healthcare checklist for women of all ages on LinkedIn.
  • The American Medical Association tells us “what doctors wish patients knew about getting a cesarean section.”
  • The New York Times reports
    • “Men are taller than women, by an average of about five inches. But why? It’s not a genetic inevitability — there are many species in the tree of life where females outclass males.
    • “A new study, published on Monday in the Proceedings of the National Academy of Sciences that involved genetic data from a million people, has found a partial explanation.
    • “It involves a gene called SHOX, which is known to be associated with height. SHOX is present on both the X chromosome — females have two X chromosomes — and the Y chromosome; males have one X and one Y.”
  • Per Medscape,
    • “An oral obesity treatment (SYNT-101) that mimics the metabolic effects of gastric bypass established preliminary safety, tolerability, and efficacy in a first-in-human study.”
  • and
    • “An online obesity clinic named Embla was associated with weight loss like that seen in randomized controlled trials (RCTs) of semaglutide, but with less than half of the semaglutide dose, according to new real-world data.
    • “Average weight loss reached 16.7% after 64 weeks’ use of the digital health platform, which combines tailored semaglutide dosing with intensive behavioral therapy delivered via an app. In clinical trials of semaglutide, the dose was 2.4 mg/wk, but patients in the present study used an average of 1 mg/wk. Similar mean weight loss was observed across baseline body mass index (BMI) classes and with all medication doses.
    • “This [study] showed us that combining an intensive behavioral intervention within an e-health weight management clinic can reproduce some of the results we see in confirmatory trials but in the context of a real-world cohort and with far less medication used,” said lead researcher Henrik Gudbergsen, MD, chief medical officer at Embla and general practitioner.
    • “The intensive behavioral therapy is key, and it goes a long way when you want to lose weight,” Gudbergsen added. He presented the findings at European Congress on Obesity (ECO) 2025. Publication of the study in The Lancet Digital Health is pending, but a preprint version is available.”
  • MedPage Today informs us, “Health officials are making a renewed call for vigilance against bird flu, but some experts are puzzling over why reports of new human cases have stopped.” * * *
    • During a call with U.S. doctors this month one CDC official noted that there is a seasonality to bird flu: Cases peak in the fall and early winter, possibly due to the migration patterns of wild birds that are primary spreaders of the virus.
    • That could mean the U.S. is experiencing a natural — maybe temporary — decline in cases.” * * *
    • “The CDC characterizes the risk to the general public as low, although it is higher for people who work with cattle and poultry or who are in contact with wild birds.
    • “Earlier this month, an agency assessment said there is a “moderate risk” that currently circulating strains of bird flu could cause a future pandemic, but the CDC stressed that other emerging forms of bird flu have been similarly labeled in the past.
    • “Still, research is continuing.”
  • Advice from GoodRx
    • Over the last few years, many artificial tear products have been recalled over safety concerns. These recalls have included products from Global Pharma Healthcare, Kilitch Healthcare India, and Brassica Pharma. Most recently, eye drops made by BRS Analytical Service, LLC have been recalled.
    • Recalled artificial tear eye drops, gels, and ointments had previously been sold in retail stores, such as CVS and Walmart, and online. Before using or buying artificial tears, check the most recent recall list to see if your product is affected.
    • Contact your healthcare team right away if you’ve used artificial tears and notice vision changes or eye infection symptoms.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Regeneron Pharmaceuticals, a biotechnology company with a long history of large-scale genetics research, plans to buy DNA testing firm 23andMe out of bankruptcy, announcing Monday it was named the successful bidder in a court-run auction.
    • “Regeneron’s offer, which is still subject to court and regulatory approvals, is a bet it can do what 23andMe couldn’t and mine the troves of genetics data the testing firm collects to discover new drug targets. Regeneron plans to continue 23andMe’s consumer genome services without interruption — a task made easier by its decade of experience sequencing the DNA of millions of people through its genetics center. * * *
    • “Under the proposed deal, Regeneron will pay $256 million to acquire “substantially all” of 23andMe’s assets, including its personal genome service, health and research service and biobank. It will also offer jobs to all of the employees at those business units.
    • “The purchase would not include the telehealth business Lemonaid Health, which 23andMe will wind down.
    • “Regeneron expects the deal will close in the third quarter, assuming it obtains all the necessary approvals. An ombudsman appointed by the bankruptcy court will review the transaction to assess how it might affect the privacy of individuals who previously used 23andMe to sequence their genome. A report from that review is due to the court by June 10, and a hearing is set for June 17.”
  • Fierce Pharma informs us,
    • “With $27 billion earmarked to expand its U.S. production footprint starting this year, Eli Lilly is busy scouting out potential sites for new drug ingredients plants.
    • “Eli Lilly is jockeying for a tax break in Texas as it weighs whether to build a $5.9 billion active pharmaceutical ingredient (API) manufacturing facility in Houston, according to a recent filing (PDF) with the state.
    • “Should the proposal move forward, Lilly plans to purchase roughly 236 acres at Houston’s Generation Park from the commercial development’s owner, McCord Development. The final project would comprise multiple buildings and outdoor facilities, plus infrastructure buildout and equipment installation, according to the filing.
    • “Assuming Lilly settles in Houston, the drugmaker expects the new plant will employ 604 full-time staffers upon ramp-up completion. The company would look to hire operations technicians and production specialists, as well as a mix of roles across maintenance, quality control, engineering, administration and management functions.”
  • Per Fierce Healthcare,
    • “Vertical consolidation in healthcare has been a hot-button topic of late as regulators eye strategies to bring down healthcare costs.
    • “But do these massive “payvider” firms do more harm than good? The jury is still out, according to a panel of experts hosted by the Brookings Institution. The panelists highlighted both the risks of vertical integration between payers and providers as well as the potential positives of these relationships.”
  • and
    • “A new study suggests “upcoding” practices are growing across outpatient service lines.
    • “The report, compiled by researchers at Trilliant Health, found that the share of visits that were coded at higher intensities grew in emergency care, urgent care and physician office visits between 2018 and 2023. For example, the number of emergency department visits coded as 99284, or level four of five total, grew from 32.5% to 39.6% in the study window.
    • “Providers use standard CPT codes for outpatient visits, ranging from level one to level five, to indicate the intensity of services offered and the amount of time clinicians spent with a patient.
    • “The study similarly found an increase in urgent care visits coded at level four, with the share growing from 34% to 40.6% between 2018 and 2023. For physician office visits, the share of those coded at level four increased from 38.5% to 45%.
    • “In tandem, the study found a decline in the number of patient visits coded at lower intensity. For urgent care, the share of visits coded at level one decreased from 9.5% to 2.9% by 2023.”
  • Beckers Hospital Review lets us know,
    • “U.S. hospitals and health systems in many regions are seeing a sharp rise in uncompensated care, with new data showing big increases in bad debt and charity care deductions during the first quarter of 2025.
    • “Disruptions in health insurance coverage can drive increases in bad debt and charity care deductions for U.S. hospitals and health systems. According to the latest data from Q1 2025, health systems across the country already experienced significant increases in bad debt and charity deductions in recent years,” noted Strata in its “Healthcare Performance Trends: Q1 2025” report.”