Friday update

CDC

Friday update

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Govexec reports,
    • “As the Trump administration prioritizes combating fraud in federal programs, the House this week passed almost a dozen bills, several of which are bipartisan, intended to strengthen agencies’ ability to detect and stop fraudulent payments. 
    • “The Fraud Prevention and Accountability Act (H.R. 8312) would establish an inspector general office within the Treasury Department dedicated solely to countering grift in programs that provide funding to non-federal entities.” * * *
    • “The House passed the measure in a 240-181 vote with the support of 28 Democrats.” * * * 
    • “Lawmakers also passed, without any recorded opposition, bills that would increase, from $10,000 to $20,000, the minimum monetary reward for federal employees whose disclosure of fraud, waste or mismanagement leads to cost savings (H.R. 428) and require certain government workers to receive training on preventing fraudulent and improper payments (H.R. 8428).” 
  • Per Centers for Medicare and Medicaid Services news releases,
    • “A new proposal from the Centers for Medicare & Medicaid Services (CMS) would establish a permanent framework for the Medicare Drug Price Negotiation Program (“Negotiation Program”), creating a more transparent and sustainable process for lowering drug costs for millions of Medicare beneficiaries. The proposed rule would also create greater long-term certainty for drug manufacturers that participate in negotiations. It includes policies for negotiating and renegotiating high-cost, single-source drugs beginning with initial price applicability year 2029, while continuing to support innovation and strengthen the program.
    • “This proposed rule lowers drug prices for seniors and ensures continued savings,” said CMS Administrator Dr. Mehmet Oz. “We are moving from annual updates to a permanent, predictable framework. This approach puts patients first, strengthens Medicare, and protects the innovation pipeline that delivers future cures.” * * *
    • “To view the proposed rule on the Federal Register, visit: https://www.federalregister.gov/public-inspection/current. 
    • “To view a fact sheet on the proposed rule, visit: https://www.cms.gov/files/document/mdpnp-nprm-fact-sheet.pdf. 
    • “To view Initial Price Applicability Year 2029 Key Milestones and Timeline, visit: https://www.cms.gov/files/document/mdpnp-nprm-milestones.pdf“
  • and
    • “The Centers for Medicare & Medicaid Services (CMS) is taking steps to improve healthcare quality and patient safety through enhanced oversight of Accrediting Organizations (AO). Today’s final rule, Strengthening Oversight of AO and Preventing AO Conflicts of Interest, ensures that the organizations responsible for the oversight of more than 9,000 healthcare providers and suppliers use Medicare standards, and creates greater consistency  between State Survey Agencies (SAs) and AOs in their respective survey processes. These changes will reduce provider burden, strengthen survey policies, and increase transparency.
    • “The work accrediting organizations do is vital, but it also raises an age-old question: who watches the watchmen? The answer is, we do,” said CMS Administrator Dr. Mehmet Oz. “With this new rule, CMS is advancing its commitment to upholding rigorous standards for accrediting organizations and ensuring the health and safety of American patients.”
    • “To view the final rule on the Federal Register, visit: https://www.federalregister.gov/  
    • “To view the Fact Sheet, visit: https://www.cms.gov/newsroom/fact-sheets/strengthening-cms-oversight-accrediting-organizations“
  • NCQA, writing in LinkedIn, tells us,
    • “Healthcare organizations across the country are committed to improving health equity—but many struggle with a fundamental question: how do you measure progress in a meaningful, actionable way?
    • “A new resource, Cracking the Code: A Health Equity Analytics Implementation Playbook for Healthcare Organizations, helps answer that question. The playbook offers a structured, practical approach for using advanced analytics to identify disparities, measure improvement and guide action.” * * *
    • This playbook is part of a broader effort to close gaps in care through measurement and incentives. Join us for a webinar, Beyond Measurement: Turning Health Equity Insights Into Action, hosted by The Commonwealth Fund and the California Health Care Foundation on June 30 at 3:30 pm (ET), to learn more about this work and other health equity accountability initiatives.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Penumbra said Thursday it received Food and Drug Administration clearance for its Thunderbolt computer assisted vacuum thrombectomy device to perform clot removal in stroke patients.
    • “The device is a first-of-its-kind treatment for acute ischemic stroke, introducing modulated aspiration technology to enable faster and more complete clot removal in neurovascular thrombectomy, Penumbra said.
    • “FDA authorization of the device is a positive for Boston Scientific, which agreed to acquire Penumbra for about $14.5 billion in January to expand in the mechanical thrombectomy and neurovascular markets.”
  • Per FDA news releases
    • The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024.
    • “Children deserve access to the best tools available to manage their health,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “Today’s clearance reflects the FDA’s commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.”
  • and, for pet lovers in Texas and other States bordering on Mexico,
    • “The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old. This is the first generic animal drug authorized for use against NWS. * * *
    • “NWS flies lay eggs in open wounds or mucous membranes of mammals and the larvae hatch within hours and burrow into the animal’s flesh. Nitenpyram works quickly, killing most NWS larvae within hours of the first dose. Pet owners should administer a second dose six hours after the first. Because the effects are short-acting, Nitenpyram Tablets do not prevent NWS myiasis or protect against reinfestation.
    • “Following treatment with Nitenpyram Tablets, a veterinary professional may need to physically remove any remaining live or dead larvae. This task is best performed by someone with training in veterinary medicine to minimize the risk of infection or further tissue damage. Pet owners should consult a veterinarian about appropriate wound care and how to minimize the risk of reinfestation.
    • “Nitenpyram Tablets are available over the counter and come in two tablet sizes: 11.4 and 57 mg. Dosage is based on a dog’s or cat’s weight. Do not administer to pets less than two pounds.”

From the judicial front,

  • Benefits Pro informs us,
    • “Aetna has accused a surgeon, his wife and affiliated clinics of pumping up bills by having patients start at in-network hospitals, then sending the patients to out-of-network affiliates for many services from February 2022 through April 2026.
    • “Once the patients were at the out-of-network affiliates, the affiliates billed Aetna at high out-of-network rates, according to a complaint Aetna filed June 5 in the U.S. District Court for the District of New Jersey.
    • “The affiliates made the high rates stick by using the No Surprises Act independent dispute resolution system to approve the claims, Aetna told the court.”
  • Beckers Payer Issues summarizes “what to know about MultiPlan’s litigation saga.”
  • Healthcare Dive reports,
    • “UnitedHealth has reached a tentative settlement with the Federal Trade Commission in the agency’s lawsuit against the nation’s three largest pharmacy benefit managers for allegedly inflating the cost of insulin. 
    • “The FTC is pausing the case against UnitedHealth’s PBM Optum Rx and its group purchasing organization Emisar. The agency will consider a proposed consent agreement that would “resolve the claims against the Optum Respondents in their entirety” if approved by FTC leadership, according to an order released Friday. 
    • “The potential deal comes nearly three months after CVS Health reached a proposed settlement with the agency. Cigna’s Express Scripts settled its case with the FTC early this year.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of June 12, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is low in most areas of the country. Emergency department visits and hospitalizations for RSV are highest among infants and children younger than 4 years old.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Human metapneumovirus (HMPV) and rhinovirus/enterovirus (RV/EV), which often cause cold-like respiratory illness, are also elevated nationally but declining. Whooping cough is still circulating.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 43 newly confirmed infections, US measles cases reached 2,073 today, the Centers for Disease Control and Prevention (CDC) said in an update, as Virginia has become the nation’s newest hot spot.
    • “All but 10 of the US infections this year are locally acquired, with the rest related to travel outside the country. The total for all of last year was 2,288 confirmed cases.
    • “The agency reported no new measles outbreaks, so that total stands at 30. The nation saw 48 outbreaks for the entire year in 2025.’ * * *
    • “The largest rise in cases has been in Virginia, with 110 listed on the CDC measles map, 20 more than last week. The Virginia Department of Health (VDH) yesterday confirmed 111 cases, 34 of which are new. Officials say 88 of the infections are linked to an outbreak in the state. Seven cases are linked to international travel, with the rest locally acquired.
    • “According to a VDH news release today, at least 88 of Virginia’s cases, or 79%, are in Buckingham County, and all have occurred in the past month.”
  • Cardiovascular Business informs us,
    • “Small changes in the heart over time may signal an increased risk of certain cancers, according to a new analysis published in the Journal of the American Heart Association.[1]
    • “The study’s authors reviewed data from the Multi-Ethnic Study of Atherosclerosis (MESA), focusing on more than 4,500 patients between the ages of 45 and 84 with available cardiac MRI results. Patients were followed for an average of 18 years.
    • “Overall, researchers found that certain cardiac MRI measurements already tracked to monitor cardiovascular health are also associated with cancer risk. For example, patients with increased heart muscle mass were more likely to go on to develop breast cancer. In addition, reduced left atrial function was linked to a greater risk of going on to develop colorectal cancer.
    • “This study suggests that structural and functional changes in the heart may occur alongside – or even before – biological processes linked to cancer development,” lead author Xinjiang Cai, MD, PhD, a UCLA Health cardiologist and member of the UCLA Health Jonsson Comprehensive Cancer Center, said in a statement. “It adds to mounting evidence that these two diseases share underlying biological pathways and are intertwined.”
    • Click here for the full study.
  • Per Health Day,
    • “Getting enough vitamin C may be linked to better brain health as we age.
    • “Researchers in Japan studied more than 2,000 adults over the age of 64, comparing vitamin C levels in their blood plasma to MRI scans of their brains.
    • “They found that participants with lower vitamin C levels tended to have lower gray matter volume. They also had weaker connectivity within the brain’s default mode network — a collection of regions involved in functions such as attention and autobiographical memory.
    • “After accounting for factors that can influence brain health, including age, physical activity and education level, those links remained.
    • “This finding generates the exciting hypothesis that a diet rich in vitamin C might play a supportive role in maintaining brain health and mitigating age-related cognitive decline in older adults,” said study coauthor Tomohiro Shintaku of the Graduate School of Medicine at Hirosaki University in Japan.”
  • and
    • “Melanoma disproportionately affects seniors and men, according to a research letter published in the June issue of the Journal of Geriatric Oncology.
    • “Megha Srivastav, from Florida Atlantic University in Boca Raton, and colleagues analyzed skin cancer incidence (2018 to 2021) and underlying causes of mortality due to skin cancer (2018 to 2023) among adults aged 65 years and older in Florida, using deidentified death certificate data from the U.S. Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research database.” * * *
    • “Taken together, our findings suggest that skin cancer in Florida is driven not only by ultraviolet exposure, but also by behavioral patterns, biological factors, and persistent gaps in prevention and early detection — particularly among older men,” senior author Lea Sacca, Ph.D., also from Florida Atlantic University, said in a statement.”
  • Genetic Engineering and BioTechnology News notes,
    • “Although gene therapy has shown promise for the treatment of Duchenne muscular dystrophy (DMD), the limitations of viral vectors have proven challenging to clinical advancement. Now, a new treatment platform delivered skeletal-muscle-targeted full-length DMD mRNA systemically in a murine model of DMD, successfully restoring the production of dystrophin, and dramatically improve muscle strength, endurance, and function in vivo.
    • “The approach uses allogenically engineered targeting extracellular vesicles (DMD t-EVs)— which offer distinct benefits over current viral-based gene therapies, including reduced side effects and the ability to transfer the entire DMD gene. The researchers engineered the EVs with special tags that directly target skeletal muscles after being injected into the bloodstream. The work also demonstrated the safety and biocompatibility of DMD t-EVs in non-human primates, supporting their translational potential.
    • “Our new platform overcomes the limitations of current viral-based gene therapies, allowing for the delivery of full-length mRNA, restoring wild-type translation of dystrophin and significantly improving muscle function,” said Betty Kim, MD, PhD, in the department of neurosurgery at UT MD Anderson. “We are highly encouraged by these results, which provide a blueprint for mRNA-loaded EVs as a next-generation therapeutic strategy.”
    • “The study, published today in Nature Biomedical Engineering, is entitled, “Skeletal-muscle-targeted non-viral delivery of full-length DMD mRNA for Duchenne muscular dystrophy.”
  • Per BioPharma Dive,
    • “Johnson & Johnson said its autoimmune drug Imaavy, touted as a top seller for the company, succeeded in a Phase 2/3 trial against a rare disease linked to anemia. The pharmaceutical giant said Thursday its drug, which is already used to treat myasthenia gravis, produced durable hemoglobin levels in people with warm autoimmune hemolytic anemia when compared to placebo after 24 weeks. The study enrolled 115 adults who received either Imaavy at two different doses or placebos. The data will be presented at the annual European Hematology Association meeting and support a drug label expansion to treat people with this disease, which has no approved treatment options, J&J said.”

From the U.S. healthcare business front,

  • Kaufman Hall tells us,
    • “Use of urgent care centers and retail health clinics varies by age, according to a report from the National Center for Health Statistics. Patients age 65 or older tended to use retail health clinics more than urgent care centers. The opposite was true for pediatric populations who visited urgent care centers almost three times as much as retail health clinics. Where patients live played only a moderate role in their preference, suggesting the importance of both options across urban and rural settings.”
  • Fierce Pharma lets us know,
    • “The share of Novo Nordisk’s Wegovy pill among total Wegovy scripts appears to have reached a plateau, hovering around one-third over the past few weeks. The latest number for the week ended on June 5 was 33%, compared with 30%, 32% and 31% in the prior weeks, according to Citi. 
    • “Meanwhile, the obesity market share split between Wegovy and Eli Lilly’s Zepbound has been relatively stable at around 40% to 42%, as the Indianapolis pharma’s oral Foundayo makes up only a small portion of the market even though its own scripts continue to build.
    • “Wegovy’s total scripts were up 9.8% on a weekly basis, reaching nearly 484,500. Within this haul, Wegovy pill contributed roughly 159,000, the oral version’s highest since its launch. The drug’s previous highest was 146,000 before dipping to 134,000 in our last update.
    • “Zepbound’s scripts also grew week over week by 9.3%, nearing 667,400 for the week. During the same period, IQVIA tracked slightly shy of 20,000 scripts from Foundayo in its ninth week on the market, compared with nearly 17,000 the prior week.”  
  • Fierce Healthcare reports,
    • “A group of partners has launched a turn-key program to help pharmacies embrace remote patient monitoring (RPM) and get reimbursed.
    • “The partnership is between telehealth infrastructure provider OpenLoop, RPM platform Tenovi and RxHealing, which provides operational support to pharmacies doing RPM. The program’s goal is to empower pharmacies, particularly independent ones in rural areas, to oversee and support chronic care patients between scheduled office visits. 
    • “There is no cost to pharmacies to stand up the program, executives said. The program will initially bill Medicare Part B, with commercial expansion planned.
    • “It’s a pretty seamless, out-of-the-box thing,” Jon Lensing, co-founder and CEO of OpenLoop, told Fierce Healthcare. “The work that [pharmacies are] getting reimbursed for now, they have historically done anyway, so for them there’s really no extra workload or lift.”

Tuesday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Wall Street Journal reports,
    • The House [of Representatives] passed a Republican-led $70 billion immigration-enforcement bill Tuesday, ending a monthslong stalemate over the slice of federal spending, and funding the contentious operations through the rest of President Trump’s second term.
    • The bill, which passed 214-212, comes after the Senate narrowly cleared funding for the agencies last week, using a special budget process that allowed Republicans to bypass the 60-vote threshold for most bills. Congress had approved funding for most of the Department of Homeland Security earlier this year, but Democratic opposition had held up money for Immigration and Customs Enforcement and Border Patrol. Trump is expected to sign the measure into law.
  • Healthcare Dive relates,
    • “A key House panel voted unanimously Tuesday to end a pilot program testing prior authorizations in fee-for-service Medicare.
    • “The House Appropriations Committee approved legislative language that would bar the Centers for Medicare and Medicaid Services from spending money to implement the Wasteful and Inappropriate Service Reduction Model, or WISeR, which the agency launched in six states this January. This provision was amended to a bill to fund the Health and Human Services Department in fiscal 2027, which the panel is still considering.”
    • Providers have blasted WISeR, a six-year demonstration that is partly reliant on artificial intelligence and is being managed by technology companies. 
    • The HHS appropriations bill must clear more hurdles, including advancing out of committee, passing the House and being reconciled with the Senate’s pending version of the spending package, before the WISeR provisions would become law.
  • Govexec tells us,
    • “Rep. Raja Krishnamoorthi, D-Ill., on Tuesday said the Trump administration’s recently unveiled plan to make federal employees sign a non-disclosure agreement “threatens” the federal workforce’s constitutional rights and creates a chilling effect on would-be whistleblowers and demanded information into how it was developed.
    • “Last month, the Office of Personnel Management formally proposed requiring all federal employees to sign NDAs barring them from divulging “confidential” information in most cases, prompting swift outcry from civil service groups and employment lawyers. A draft copy of the document bars signatories from disclosing information related to internal agency operations, personnel and procurement matters and “any sensitive, pre-decisional or deliberative material.”
    • “In a letter to OPM Director Scott Kupor, the Illinois Democrat criticized the proposal as “over-broad” and likely to make it more difficult for whistleblowers to divulge allegations of waste, fraud and abuse.” * * *
    • “The Democrat demanded information on OPM’s legal analysis of whether the proposed NDA comports with the First Amendment and the Whistleblower Protection Act, a definition of “confidential” for the purposes of the document, as well as any potential consequences federal employees who refuse to sign the agreement would face, and whether it would apply equally to both career employees and political appointees.”
  • Federal News Network discusses “OPM[‘s] details [about] changes for federal employees in Schedule Policy/Career.”
    • “As agencies gear up for implementation, OPM detailed what Schedule Policy/Career will mean for recruitment, adverse actions and other personnel policies.” * * *
    • “Implementation instructions for agencies on Schedule Policy/Career are now available in guidance that the Office of Personnel Management published Monday.” 
  • The Government Accountability Office issued a report titled “Federal Workforce: Executive Actions Reshaped Probationary Employment Rules and Reduced Staff Levels at Selected Agencies.”
    • “Since January 2025, in response to presidential directives and accompanying Office of Personnel Management (OPM) guidance, many federal agencies have taken steps to reduce their probationary and trial employee staffing levels. These are employees who have not yet completed the service requirements necessary to finalize their appointments, either after being newly hired or after being appointed as a supervisor or manager. Probationary periods are generally 1 or 2 years during which probationary and trial employees have limited job protections.” * * *
    • “GAO’s analysis of OPM’s Federal Workforce Data (FWD) found that, in 2025, probationary employees separated from 11 selected agencies at a slightly higher rate (19 percent) compared to all employees who separated from these agencies (15 percent). Over two-thirds of these separating probationary employees did so voluntarily as did all employees who separated from these agencies.
    • “Across most selected agencies in 2025, a greater proportion of probationary employees separated compared to all employees who separated. At the Department of Energy, for instance, about 34 percent of probationary employees separated, compared with 19 percent of all employees. The Department of Defense recorded the largest number of probationary separations—about 20,000 employees—but separation rates for probationary employees and the overall Defense workforce were nearly identical, at about 14 percent.”
  • The Wall Street Journal lets us know,
    • “Social Security is expected to deplete the fund that helps pay out retirement benefits by late 2032, the program’s trustees said Tuesday.
    • “That is earlier than their projection last year of 2033, partly because the fund expects to collect less revenue after President Trump’s new tax law. Passed last summer, the law gave senior citizens an extra deduction that reduced taxes on benefits for many Social Security recipients. 
    • “Revenues are also shrinking because declining fertility rates and immigration are reducing tax revenue by cutting the number of workers paying into the system, according to the trustees.
    • “The trustees reduced their long-term expectations for fertility rates on Tuesday, indicating they will remain lower for longer than previously projected.” * * *
    • “Unless Congress shores up the retirement program, the depletion of reserves would trigger a 22% reduction in benefits in late 2032. Because incoming payroll tax revenue doesn’t fully cover promised benefits, the program is forced to make up the difference by pulling money from its two Social Security trust funds—one for disability benefits and the other for the larger program for retirees.
    • Congress could temporarily use money from the disability trust fund to prop up the retirement fund. But that is a short-term solution because on a combined basis, the two funds are projected to become insolvent in the third quarter of 2034, according to the trustees.” * * *
    • “To shore up the system, lawmakers could borrow more, raise taxes, reduce benefits or reach an agreement that combines those measures.”
  • Fierce Healthcare points out,
    • “More than 500 hospitals falling short on price transparency requirements have received warnings from the federal government since April, with more “likely” to receive similar notices soon, the AP reported Tuesday morning. 
    • “The outlet’s report cited an unnamed “senior administration official” who shared a list of 519 nationwide hospitals that recently received either a warning notice or a Corrective Action Plan (CAP) request. 
    • “The former is an initial 90-day warning from the Centers for Medicare and Medicaid Services with instructions to correct any deficiencies, while the latter is a subsequent 45-day deadline for a hospital to submit a more concrete plan to address its compliance deficiencies. 
    • “For hospitals that do not come into compliance following these, CMS issues a civil monetary penalty that scales with bed count. These can run as high as $5,500 per day, or over $2 million per year. Twenty-eight hospitals have been issued civil monetary penalty notices to date, according to CMS.
    • “Among the list of warned hospitals obtained by the AP, Texas led other states with 42 notified facilities, followed by 38 in California, 34 in Indiana and 27 in Louisiana.” 
  • The American Hospital Association News notes,
    • “The Department of Health and Human Services June 8 released a request for information on research, policy and strategies to improve addiction and mental illness prevention, treatment and recovery. HHS said it it seeks to identify successful initiatives, recommend novel policy ideas and address research gaps. Comments are due to HHS by July 5.”

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency’s efforts to advance sunscreen innovation. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
    • ““As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy, Jr. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
    • “FDA finalized this action within seven months of issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.
    • “Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for an updated version of its Nellcor pulse oximetry system.
    • “The 510(k) clearance, which Medtronic disclosed Monday, covers a device with a new processor designed to support more consistent and reliable results across diverse skin tones. 
    • “Concerns about the accuracy of pulse oximeters in people with darker skin pigmentation led the FDA to publish draft guidance on the devices last year.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “[M]illions of Americans [suffer] with cardiovascular-kidney-metabolic syndrome, a disorder defined in 2023 by the American Heart Association. It describes a cluster of conditions—heart disease, diabetes, kidney disease—that have common risk factors and fuel one another. Long treated as isolated or individual diseases, the conditions are interrelated, usually tied to excess abdominal fat, and a major driver of heart disease, according to the AHA.
    • “On Tuesday, the AHA and three other medical societies published the first guidelines to help clinicians prevent and manage CKM, as it is called, urging them to focus on their patients’ overall metabolic health. The goal is to prevent or slow the progression of conditions that may ultimately lead to heart attacks and strokes, which are becoming more common in younger adults.
    • “The new guidelines call for doctors—from primary care to cardiology—to screen patients for metabolic risk factors and kidney function routinely. Risk from excess fat should be measured both by body-mass index (BMI) and waist circumference, according to the new guidelines, which were developed by the AHA and the American College of Cardiology with the American Diabetes Association and American Society of Nephrology.
    • “In the 1970s, smoking, high blood pressure and cholesterol were the classic risk factors for heart disease, said Dr. Chiadi Ndumele, chair of the committee that wrote the new guideline and a preventive cardiologist at Johns Hopkins University School of Medicine. Today, excess abdominal fat is a major risk factor because it can trigger chronic inflammation that damages arteries, cardiac tissue and kidneys, he said.”
  • The New York Times relates,
    • “A government alcohol study published on Tuesday concluded that the health risks of alcohol start at a single drink a day. The report was caught up in controversy after drawing the ire of the alcohol industry.
    • “At one drink a day, the researchers found, there was an increased risk of premature death from an illness or injury directly attributable to alcohol, though it was small — one in 1,000 people. But the risk of premature death jumped to one in 25 for those who had two drinks a day, a level long considered safe for men, according to the study, which was published in the Journal of Studies on Alcohol and Drugs.
    • “The Alcohol Intake and Health Study was one of two reports commissioned during the Biden administration to inform an update to the U.S. dietary guidelines.
    • “The second report, from a panel appointed by the National Academies of Sciences, Engineering and Medicine, or NASEM, came to very different conclusions. It suggested that moderate drinking (up to two drinks a day for men and one for women) was healthier than not drinking at all, although it noted that moderate drinking was also linked to a higher breast cancer risk. Some of the panelists behind that report had financial ties to the alcohol industry.”
    • * * * “One reason the studies reached such different conclusions is that while the new study examined deaths from causes directly attributable to alcohol, the NASEM report commissioned by Congress looked at overall death rates of moderate drinkers, including deaths not causally related to alcohol.
    • “Critics of the NASEM report say that people who drink in moderation often have other healthy lifestyle habits that contribute to their longevity. The moderate drinking group also included many people who consumed less than two drinks a day. Both of these factors could make the health effects of moderate drinking look less significant than they might be.
    • “Dr. Ned Calonge, an epidemiologist at the University of Colorado Anschutz Medical Campus who led the NASEM study, said he stood by its conclusions.
    • “Alcohol research is complex and I am not surprised by different methods producing different results,” Dr. Calonge said, adding that modeling studies like the Alcohol Intake and Health Study, which use data to estimate the lifetime risk of diseases and deaths caused by alcohol, also come with potential biases.
    • “At the same time, he added “I don’t believe anyone should start drinking for health reasons.”
  • and
    • “The U.S. Department of Agriculture announced three new cases of New World screwworm, including the first cases in dogs and goats, on Monday, bringing the nation’s total case count to five. It also pledged to ramp up and expedite mitigation efforts for screwworm, a parasitic fly that the nation declared eradicated in the 1960s.
    • “At a news briefing on Monday, federal and Texas state officials said that they were using technology driven by artificial intelligence to monitor screwworm populations, training ranchers to recognize infections in their livestock and expanding the number of facilities that produce and disperse sterile flies, which are the primary tool for managing screwworm.
    • “Officials are also considering whether to grant an emergency authorization of a new, genetically engineered strain of flies that could make sterile fly production faster and more efficient.
    • “We prevented and eradicated this pest before,” Gov. Greg Abbott, Republican of Texas, said during the briefing. “We can do it again.” * * *
    • “The New World screwworm is a blowfly that feeds on living flesh. Adult females lay their eggs in open wounds or orifices of warm-blooded animals. When the eggs hatch, the larvae burrow into the wound, consuming the animal’s tissue. Untreated, screwworm infections can kill animals within a week.
    • “In humans, screwworm infections are rare. Last year, American health officials confirmed a travel-related case in a Maryland resident who had recently traveled to El Salvador, but no domestically acquired human cases have been reported yet.”
  • Health Day adds,
    •  There’s a biological reason why booze makes a person crave bar snacks like chips, nuts, fries and pizza, a new study argues.
    • Alcohol appears to trigger a hormone associated with cravings for savory flavors, researchers reported recently in the journal Obesity Reviews.
    • This hormone, FGF21, is linked to protein appetite and, when activated, can shift cravings toward salty, umami-flavored foods, researchers found.
    • “Many people will recognize the experience of having a few drinks and suddenly craving something salty, like chips, French fries, pizza or other savory foods,” said lead researcher Amanda Grech, a research associate at the University of Sydney’s Charles Perkins Center.
    • “Now we have a better understanding of the hormonal dynamic at play, which may be driving overconsumption of ultra-processed foods,” Grech said in a news release.
  • Cigna Healthcare, writing in LinkedIn, discusses “Men’s Mental Health Awareness Month [meaning this month]: Making Room for What Men Carry—At Work and Beyond.”
    • “Men’s Mental Health Awareness Month is an invitation to redefine strength as something sustainable: self-awareness, early help-seeking, and staying connected under pressure. In any workplace, the most meaningful shift isn’t a grand statement—it’s a steady message, reinforced over time, that dignity comes first and support is not something you have to earn. When men are met with respect, privacy, and real permission to be human, it becomes easier to speak earlier, connect more honestly, and get care before strain becomes a crisis.”
  • MedPage Today tells us,
    • “While the American Academy of Pediatrics now recommends introducing certain allergenic foods by ages 4-6 months for all children, guidelines from the 1990s and 2000s had recommended delaying introduction until 1-3 years.
    • “As the proportion of infants introduced to egg by 6 months of age increased from 2007-2011 to 2018-2019, egg allergy prevalence adjusted for changes in known allergy risk factors fell from 9.2% to 7.6%.
    • “Infants with early-onset eczema saw the biggest impact, with egg allergy prevalence decreasing from 34.6% to 21.9%.”
  • and
    • “Respiratory tract infections (RTIs) continue to be a substantial cause of mortality in children under 5 and contribute to morbidity, hospitalizations, and healthcare costs.
    • “Nearly one in four of the current study’s hospitalized pediatric patients with acute RTIs developed severe disease.
    • “Increased risk was highest in kids with two or more underlying conditions or who were transferred from a referring hospital.”
  • The National Institutes of Health’s Reseach in Context considers “Understanding the exposome.”
    • “Tracking how the environment affects health
    • “The world around us influences our health in countless ways. This special Research in Context feature explores how scientists are using new technologies and approaches to measure the exposome—the total set of environmental exposures people encounter throughout life and their biological response to them.
  • Genetic Engineering and Biotechnology News points out,
    • “When Jingkun Zeng, PhD, joined the lab of Nobel laureate, Jennifer Doudna, PhD, as a postdoctoral researcher in 2024, he was not interested in applying CRISPR for gene editing. 
    • “The molecular scissors had demonstrated extraordinary clinical promise in correcting single-point mutations, most strikingly in Baby KJ’s case, where a rare metabolic disorder once presented a 50% mortality rate in infancy. 
    • “Yet, Zeng had his ambitious sights on stopping cancer progression, where the biology “became messy.” Cancer can be driven by hundreds of thousands of mutations, making it nearly impossible to correct each mutation one-by-one to restore healthy function. 
    • “Zeng, who completed his PhD training in cancer evolution at The Francis Crick Institute, aimed to develop new CRISPR-based technology that could therapeutically access the undruggable tumor suppressor protein, p53. Mutations in this “guardian of the genome” are found in nearly half of all cancers, and up to 70–90% of cases of the most deadly tumors, including ovarian, pancreatic, and non-small cell lung cancer. 
    • “In a new study published in Nature titled, “Targeting Cancer-Specific Mutations with RNA-Triggered Chromatin Shredding,” Zeng and colleagues from Innovative Genomics Institute (IGI), University of California (UC) Berkeley, UC San Francisco (UCSF), and Gladstone Institutes, have now engineered a CRISPR system to selectively trigger cancer cell death by chromatin shredding.  
    • “The approach recognizes cancer cells using the RNA-guided nuclease, CRISPR-Cas12a2, to recognizemutant p53 mRNA transcripts. Therapeutic effectiveness was demonstrated in mouse models of lung and liver tumors.” 
  • Per Fierce Pharma,
    • “A combination of Merck’s islatravir and Gilead’s lenacapavir has succeeded in two phase 3 trials and is in line to become the first long-acting oral HIV treatment that can be taken weekly.
    • “Both trials of the combination regimen—which includes a 2 mg dose of islatravir and a 300 mg dose of lenacapavir—included people with HIV who are virologically suppressed and both achieved their primary efficacy endpoint. 
    • “In the Islend-1 study, the combo showed its non-inferiority in those who had switched off Gilead’s once-daily pill Biktarvy. In Islend-2, the combo measured up in those who had switched off standard-of-care antiretroviral regimens. No new safety concerns were identified in either study.”
  • and
    • “Following another phase 3 failure for Gilead Sciences’ Trodelvy, the race to bring a TROP2 antibody-drug conjugate (ADC) to patients with first-line non-small cell lung cancer (NSCLC) has narrowed. 
    • “Monday, Merck & Co. and Gilead announced that they are pulling the plug on the phase 3 Evoke-03 trial, also known as Keynote-D46, following the recommendation of an external data monitoring committee. 
    • “The study was evaluating Trodelvy, combined with Keytruda, as a first-line treatment in patients with PD-L1-high NSCLC versus Keytruda alone.” * * *
    • “Without a win in first-line NSCLC, Trodelvy’s commercial future will mainly depend on its triple-negative breast cancer uses, which won’t be able to justify the $21 billion price tag that Gilead paid for the med’s developer, Immunomedics. Gilead already took major write-offs tied to Trodelvy’s second-line NSCLC failure and a market withdrawal in bladder cancer in 2024.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Health insurance executives convene this week in Las Vegas at a time when the industry is facing significant pressure on cost, access and policy changes.
    • “AHIP’s annual conference kicks off Tuesday morning, with two days of sessions and discussions that center on the major challenges facing insurers today, from new technologies to consumer engagement to rising medical costs.
    • “Fierce Healthcare will be on-site this week to provide key insights from the show floor, but before the conference opens, [the article offers] a look at some of the biggest themes to watch on the agenda.”
  • Beckers Hospital Review relates,
    • “Springfield, Mass.-based Baystate Health is planning to acquire a financially challenged hospital in the city from Hartford, Conn.-based Trinity Health of New England for $293 million through a member substitution valued at $293 million. 
    • “Baystate signed a definitive agreement in April to acquire Mercy Medical Center, a 182-bed acute care hospital, as well as Mercy’s joint ventures and affiliated medical groups from Trinity Health of New England, which is part of Livonia, Mich.-based Trinity Health. 
    • “As part of the regulatory approval process, Baystate is required to get a determination of need from the Massachusetts Department of Public Health. According to a filing with the department, MMC has experienced “significant and continued operating losses in recent years.”
  • and
    • “The American Medical Association’s House of Delegates voted to formally oppose use of the term “provider” when referring to physicians, adopting the new policy at its Annual Meeting in Chicago this week.
    • “The vote builds on existing AMA policy that already calls on healthcare entities to specify the type of clinician — using their recognized title and credentials — when using the term “provider” in contracts, advertising and other communications. It also directed AMA to prohibit use of the term in its own publications.
    • “The new policy goes further, directing the AMA to actively oppose the term when it encompasses physicians and to implement the existing policy’s external advocacy provisions, which had not yet been fully advanced.
    • “The AMA argues that the term “provider” undermines patient education, transparency and physician professionalism, and poses risks to patient safety by obscuring the distinctions among clinician types and their training, according to a June 9 news release.”
  • Radiology Business adds,
    • “The radiologist shortage is real, but it may be smaller and more local than previous reports might indicate, according to new research. 
    • “About 47% of “open” radiologist jobs are reposts of the same role. However, the “real shortage” appears to be “concentrated and stubborn,” according to an analysis shared by RadBoard, an artificial intelligence-powered platform for researching jobs in the specialty. 
    • ‘Approximately 1,470 of active radiologist openings have been sitting unfilled for over two months or more. 
    • “Most aren’t underpaid—they’re geographically inconvenient,” writes report author Kirill Lopatin, founder and CEO of xAID, which offers AI solutions to radiology groups.” 
  • The Wall Street Journal tells us,
    • GSK GSK [symbol]  agreed to buy U.S. cancer-drug developer Nuvalent NUVL for $10.6 billion, the British pharmaceutical company’s latest move to bolster its oncology business.
    • The acquisition is set to give GSK two drug candidates for lung cancer that are currently under review by the U.S. Food and Drug Administration as well as a third, earlier-stage medicine, the London-based company said Tuesday.
    • The deal comes as GSK works to rebuild its position in the market for cancer treatments, one of the most lucrative areas of the pharmaceuticals industry. GSK exited oncology in 2015 as part of a broader asset-swap deal with Switzerland’s Novartis. The company has since returned to the market with the acquisitions of Tesaro, Sierra Oncology and IDRx as well as licensing deals.
    • “Our strategy has been a brick-by-brick building approach,” GSK Chief Executive Luke Miels said, adding that the company would continue to look for further opportunities.
  • STAT News informs us,
    • “The number of prescription drug shortages in the U.S. fell by 23% last year, marking the second consecutive year of declines and the lowest level since 2017, according to a new analysis that otherwise found troubling signs about medicines that are in short supply.
    • “For instance, the average drug shortage lasted 5.3 years, exceeding the 4.3 years seen in 2024 and greatly outpacing the average two-year shortage experienced in 2019. Moreover, nearly two-thirds of out-of-stock medicines were in short supply for more than three years, and 39% were unavailable for more than five years.
    • “Meanwhile, the 75 drugs that were in short supply last year spanned 130 therapeutic categories, indicating that shortages affected a wide range of diseases and patient populations, according to the analysis by U.S. Pharmacopeia, an independent organization that develops standards for medicines.”
    • “At first glance, the numbers do appear conflicting and suggest some progress, but the overall trends are troubling, said Matthew Christian, director of supply chain insights at the organization. “The problems we have are systemic. They are not resolved and they are not new. They’re old and not going away.”
  • A commentator in Healthcare IT Today explains “The Emerging Role of AI Platforms in Healthcare Delivery: What Healthcare Leaders Need to Know.”
    • “With the launch of ChatGPT Health and Claude for Healthcare, AI has moved from the margins of healthcare IT to its center. It will define how patients engage with care and how clinicians deliver it.
    • “Participation is inevitable. Leadership is not. Organizations that act now will shape the future of care. Those that wait will inherit it.”
  • Fierce Healthcare adds,
    • “More than one-third of clinicians say artificial intelligence use is allowing them to see more patients, with a median of five additional patients per week, a new report from Philips found.
    • “The Future Health Index 2026 (PDF) drew insights from more than 2,000 healthcare professionals and more than 20,000 patients across 10 countries. 
    • “Nearly three-quarters (74%) of clinicians say their use of AI-enabled tools provided by their organization has increased over the past year. Among surveyed clinicians, 52% are using AI to transcribe clinical notes and close to half (46%) are using generative AI as a professional “buddy” to discuss work-related ideas. AI use is also growing for clinical decision support as 45% use AI tools to suggest diagnoses based on patient symptoms and 44% use AI-enabled tools to flag potential dangerous drug combinations.”
  • Per MedTech Dive,
    • “Research shared by Dexcom at the American Diabetes Association’s Scientific Sessions last weekend showed that people who have Type 2 diabetes but don’t take insulin could still benefit from wearing a glucose sensor.
    • “Dexcom telegraphed the study results ahead of the conference in a May earnings call, with CEO Jake Leach saying he expected the results could support a Medicare coverage decision “between now and the end of this year.”
    • “Thomas Martens, a medical director at the International Diabetes Center in Minneapolis and co-author of the study, said the research was intended to answer the question of whether continuous glucose monitors, or CGMs, can improve diabetes management for people who don’t take insulin. The study was funded by Dexcom.” * * *
    • “People who used the CGM had an average hemoglobin A1C reduction of 1.6% from the baseline level of 8.8%. The result was a 0.9% greater A1C reduction than the control group, which Martens said was “striking.” 
    • “People who used the CGM also had better time in range, a measure of how much time during the day a person stays within a target blood glucose range. The Dexcom G7 users had a 62% time in range compared with 41% in the control group.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, Telehealth, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Appropriations Committee June 4 released the fiscal year 2027 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies. The bill provides a total discretionary allocation of $189.3 billion. HHS is provided with $110.8 billion, which is $4 billion, or 4%, below the FY 2026 enacted level. The bill provides support for rural health, primary care, workforce, behavioral health and other programs. The appropriations subcommittee approved the bill today on a party-line basis, and additional details are expected to be released before a full committee markup currently scheduled for June 9.” 
  • Beckers Payers Issues relates
    • “CMS has logged nearly 40,000 complaints alleging potential violations of federal health insurance law since the agency began tracking them in 2022, with the vast majority of closed complaints related to the No Surprises Act, according to an enforcement report covering data through December 2025.
    • “The report tracked complaints under Title XXVII of the Public Health Service Act, which includes the NSA, Mental Health Parity and Addiction Equity Act, and ACA compliance. 
    • “The agency closed 15,145 complaints in total, which were defined broadly to include stakeholder feedback, congressional and state referrals, No Surprises Help Desk submissions, and news articles. Of those, 2,086 were closed with a violation found and 7,838 with no violation found; the remainder were duplicates or withdrawals. Complaints referred to other agencies were not included in the data.”
  • FedSmith tells us,
    • “The average federal employee salary has reached a record high, exceeding $112,000 for the first time according to data from the Office of Personnel Management. For critics, that figure may confirm a long-held belief that government employees are overpaid. For supporters of federal employees, it reflects the reality of an aging, highly educated workforce that performs increasingly complex work.” * * *
    • “The average federal employee salary has reached a record high, exceeding $112,000 for the first time according to data from the Office of Personnel Management. For critics, that figure may confirm a long-held belief that government employees are overpaid. For supporters of federal employees, it reflects the reality of an aging, highly educated workforce that performs increasingly complex work.”
  • KFF informs us
    • Three new KFF analyses examine the latest data about Medicare Advantage, including trends in enrollment, premiums, out-of-pocket limits, supplemental benefits and prior authorization.
    • The first analysis, focusing on enrollment trends, finds that 55% of eligible Medicare beneficiaries are enrolled in Medicare Advantage in 2026, though the pace of enrollment growth continued to slow. Nearly one quarter (23%) of Medicare Advantage enrollees are in special needs plans (SNPs), which limit enrollment to beneficiaries with specialized health needs or who are eligible for both Medicare and Medicaid. Most (85%) of the net increase in Medicare Advantage enrollment between 2025 and 2026 across all plan types was among SNPs. Medicare Advantage enrollment remains highly concentrated, with UnitedHealth Group leading the market, and, together with Humana, accounting for nearly half (46%) of all Medicare Advantage enrollees nationwide, the same as last year.
    • A companion analysis finds that three quarters (75%) of enrollees in individual Medicare Advantage plans with prescription drug coverage pay no premium other than the Medicare Part B premium, a selling point for enrollees. Nearly a third of enrollees (31%) are in plans that also reduce the Part B premium. Nearly all Medicare Advantage enrollees (99%) are in plans that require prior authorization for some services. Most Medicare Advantage enrollees are in plans that offer supplemental benefits not covered by traditional Medicare, such as vision, hearing and dental. Access to those three benefits remained stable, though there were decreases in the share of enrollees in plans providing other benefits, such as over-the-counter benefits, meals, and transportation.
    • Also recently available is a KFF analysis with a more detailed examination of out-of-pocket limits in Medicare Advantage plans in 2026, including variation by plan type, the distribution of enrollees facing different out-of-pocket limits, and trends over time.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration launched a safety study of the abortion pill mifepristone, potentially leading to restrictions on its distribution.
    • “The FDA study, using existing drug-safety systems, is expected to take six months and aims to withstand legal criticism.
    • “Antiabortion advocates target mifepristone’s mail and telehealth distribution rules; 65% of U.S. abortions use the pill.”
  • Fierce Pharma relates,
    • “Three times as many deaths in the study arm versus the control arm in a trial of ADC Therapeutics’ Zynlonta have raised questions about the antibody-drug conjugate (ADC), which has been on the market since the FDA granted it accelerated approval in 2021.
    • “In the phase 3 LOTIS-5 trial, which included 440 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), there were 27 deaths (13.2%) in the study arm compared to nine (4.6%) in the control group. Zynlonta was paired with Roche’s monoclonal antibody Rituxan, while those in the control arm received Rituxan plus the chemotherapies gemcitabine and oxaliplatin.
    • “Most of the deaths in the treatment arm were among patients age 75 and older and were due to infections, ADC execs said on a conference call on Wednesday. The company added that the higher rate could also be chalked up to extended monitoring of patients in the treatment arm as opposed to those in the control arm.”
  • Healio tells us,
    • “The FDA has approved a label expansion for the interleukin-23 inhibitor guselkumab to include the inhibition of structural joint damage progression in adults with psoriatic arthritis.
    • “The label update follows data from the APEX trial, in which guselkumab (Tremfya, Janssen) yielded significantly lower rates of radiographic progression compared with placebo at 24 weeks. The analysis, which was published by Philip J. Mease, MD, of Swedish Medical Center and the University of Washington, and colleagues in the Annals of the Rheumatic Diseases in December, included more than 1,000 biologic-naïve adults with active PsA.”

From the judicial front,

  • Per a Justice Department news release,
    • “The Justice Department’s National Fraud Enforcement Division today [June 4] announced that its Health Care Fraud Unit, one of the most active white-collar litigating components across the Department, secured federal jury trial convictions in six trials in just under three weeks. The convictions in six trials between May 13 and June 1 spanned federal courtrooms across the United States, including in Fort Lauderdale, Los Angeles, Detroit, New York and Nashville.
    • “Six trial convictions in under three weeks ties the Health Care Fraud Unit record for number of trials to result in a conviction in a single month period. The cases behind these recent convictions, however, represent a greater level of sophistication and complexity: more than $1.1 billion in fraud losses across six distinct schemes, including a digital health platform that industrialized Medicare fraud at national scale, a proactive data-driven prosecution of a physician who out-billed every other Medicare provider in the country for Botox, and prosecutions requiring simultaneous command of health care data analytics, financial forensics, sophisticated digital evidence, and expert testimony. These results reflect not merely the volume of trials but the caliber of the Fraud Division’s trial practice that carried each one of them to conviction. The Health Care Fraud Unit has completed nine trials to date in 2026 (all of which have resulted in convictions) and 17 trials in 2025, maintaining an extraordinary pace of white-collar trial activity.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “As of June 5, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is low in most areas of the country. Emergency department visits and hospitalizations for RSV are highest among infants and children younger than 4 years old.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.” * * *
    • “Parainfluenza virus (PIV) is elevated nationally. Human metapneumovirus (HMPV) and Rhinovirus/enterovirus (RV/EV) activities are elevated nationally but are beginning to decrease. CDC data show these trends are expected for this time of year. HMPV, PIV, and RV/EV are like other viruses that cause respiratory infections, including cough, fever, nasal congestion, and shortness of breath. Severe infection due to HMPV, PIV or RV/EV may progress to bronchitis or pneumonia. There are no vaccines available for these illnesses. Prevention measures include hand washing, cleaning surfaces, and staying home when sick.”
  • The Hill reports,
    • “The number of U.S. measles cases in 2026 has now exceeded 2,000, quickly approaching the full annual total of last year.
    • “As of June 4, the Centers for Disease Control and Prevention (CDC) has confirmed 2,030 cases so far this year, with 93 percent — or 1,890 cases — associated with outbreaks. Throughout all of 2025, the CDC confirmed 2,288 measles cases. Thirty new measles outbreaks have been confirmed this year.”
  • STAT News relates,
    • “Americans who have high-risk exposures to Ebola in the current outbreak in Central Africa will have access to an antibody treatment that has shown great promise in animal testing but hasn’t yet undergone a clinical trial to show whether it is efficacious in people, the Department of Health and Human Services confirmed Thursday.
    • “The antibody treatment, known as MBP-134, is made by San Diego-based Mapp Biopharmaceuticals, with funding from the Biomedical Advanced Research and Development Authority, an agency within HHS that helps develop medical countermeasures for rare and emerging diseases, and biological threats.
    • “It is not clear how many doses of MBP-134 exist at present. STAT asked the company and was told Mapp Bio could not reveal the number because BARDA owned the doses.
    • “An American doctor who contracted Ebola in the outbreak zone was flown last month to Germany for care; his wife, also a doctor, and their four children were also taken to Germany for quarantine. The ill physician, Peter Stafford, remains in care but is reportedly recovering. Another doctor from the same Christian missionary group who had what was considered a high-risk exposure is in quarantine in the Czech Republic; he remains healthy. There are currently no other known exposures among Americans.
    • “An expert panel advising the World Health Organization on possible therapeutics that could be tested or used in this outbreak — occurring in the northeastern part of the Democratic Republic of the Congo and neighboring Uganda — deemed MBP-134 one of the products to be prioritized for testing.”
  • Health Day tells us,
    • “The age-adjusted Parkinson disease death rate among adults aged 65 years and older declined from 2021 to 2024, according to a June 4 data brief published by the National Center for Health Statistics.
    • “Ellen A. Kramarow, Ph.D., from the National Center for Health Statistics in Hyattsville, Maryland, and colleagues used data from the National Vital Statistics System to examine trends in Parkinson disease mortality among adults aged 65 years and older in the United States.
    • “The researchers found that for adults aged 65 years and older, the age-adjusted Parkinson disease death rate was 72.0 deaths per 100,000 standard population in 2024. From 2014 through 2021, there was an increase in Parkinson disease death rates, from 57.2 to 76.3, followed by a decline, with the rate lower in 2024 than in 2021. Higher Parkinson disease death rates were seen for men than women in each age group (65 to 74, 75 to 84, and 85 years and older) in 2024. Compared with other race and Hispanic origin groups, White non-Hispanic adults had the highest death rates from Parkinson disease. There was variation seen in Parkinson disease death rates by state of residence, ranging from 47.7 to 102.1 in New York and Utah, respectively.”
  • and
    • “Rurality is associated with worse epilepsy outcomes, although the associations are attenuated among privately insured patients, according to a study published online June 3 in Neurology.
    • “Edward R. Bader, M.B., Ch.B., from the Albert Einstein College of Medicine in Bronx, New York, and colleagues conducted a retrospective cohort study using the National Inpatient Sample for 2016 to 2021 to examine the association between rurality and epilepsy outcomes.” * * *
    • “The reduction in disparities among people with private insurance suggests that there may be other factors, not just where someone lives, that could be contributing to these differences,” Bader said in a statement. “Our study highlights the need for additional research and public health efforts aimed at improving access to epilepsy care for people living in rural areas, which might include the expansion of telehealth services.”
  • MedPage Today informs us,
    • “A study of women undergoing breast imaging showed a significantly lower incidence of breast cancer in those who had a history of treatment with GLP-1 agonists.
    • “Involving more than 30,000 women, the study showed an overall breast cancer rate of 1.97%, including 1.62% in patients who received GLP-1 agonists for overweight or obesity and 2.31% in those who did not. The difference represented a 30% lower risk of breast cancer in the GLP-1 group.
    • “The findings, combined with multiple other studies, have provided impetus for a prospective clinical trial of GLP-1 drugs to prevent breast cancer, reported Elizabeth S. McDonald, MD, PhD, of Penn Medicine and Abramson Cancer Center in Philadelphia, at the American Society of Clinical Oncology (ASCO) meeting.
    • “Observational data cannot establish a causal relationship,” said McDonald. “We are seeing signals at this meeting in multiple cancers — colon, lung, liver, leukemia, endometrial, multiple myeloma — for decreased progression to metastatic disease, decreased recurrence, decreased incidence, and increased survival. The time is now to invest in a clinical trial to see if these drugs are causal for cancer prevention.”
  • Medscape points out,
    • “Patients discontinuing GLP-1 treatments often regain weight rapidly, but emerging strategies like endoscopic procedures and new oral medications show promise in maintaining weight loss. These alternatives may offer cost-effective, long-term solutions.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “The injectable form of the polio vaccine has proven effective at preventing illness but it does not block the transmission of the virus as well as the oral version of the vaccine. That is because the virus is usually transmitted through contaminated food or water and is first exposed to the GI tract, where the oral vaccine induces a mucosal immune response. To date, several countries no longer use the oral vaccine because there is a small risk of infection. It is also possible for people who receive the injected polio vaccine to spread the virus even though they are asymptomatic. 
    • “Now according to data from an Massachusetts Institute of Technology-led study, it may be possible to modify the injectable vaccine so that it can also promote a mucosal immune response. This way, the vaccine could support polio eradication efforts without the risks of the oral polio vaccine. Details are published in a new Science Advances paper titled “Am80-Lipid nanoparticles serve as an enteric mucosal adjuvant 3 following parenteral immunization with inactivated polio vaccine.”
  • Cardiovascular Business notes,
    • “Engineers with the Massachusetts Institute of Technology (MIT) have developed a noninvasive pacemaker that uses ultrasound to stimulate the heart. The group shared its early experience with the device in Nature Biomedical Engineering, highlighting its compact, wearable design.
    • “Pacemakers are one of the most important and widely used human implants, and they have saved millions of lives,” Gengxi Lu, the study’s co-corresponding author, said in a statement. “But they are invasive, and they make direct contact with the beating heart. The dream for many years has been noninvasive heart stimulation with ultrasound.”
    • “The team’s device is a small sticker worn on the chest. Tiny transducers on the sticker use ultrasound pulses to stimulate the heart in a way that opens certain ion channels in cardiac cells. Lab experiments have been a success, with the device maintaining healthy contractions in human cardiac cells.
    • “For an ultrasound pacemaker to become a reality, researchers believe they would likely begin the process by giving patient’s a one-time injection that boosts the sensitivity of cardiac cells. Once this injection was done, the patient could then theoretically attach the stamp-sized sticker and start experiencing the benefits of the small device right away.
    • “While it’s still early, the group at MIT is optimistic about this new-look pacemaker’s potential. In fact, they hope to combine this latest approach with previous research into sticker-based medical imaging to deliver a single ultrasound sticker that can simultaneously monitor and regulate a patient’s heart.”
  • Per BioPharma Dive,
    • “A clinical trial testing a migraine prevention therapy from Denmark-based Lundbeck has produced data that some on Wall Street see as mixed but still good enough to forge ahead with further development.
    • “The therapy, called bocunebart, is designed to inhibit a nervous system protein known as PACAP. This protein regulates stress and, when triggered, causes pain-sensing nerves to fire and blood vessels in the head to drastically widen. Lundbeck’s study has been evaluating bocunebart — as a direct infusion to the veins or as an under-the-skin shot — in hundreds of patients who continued experiencing migraines even after trying up to four other treatments.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Hospitals and health systems are losing money on virtual care across every major payer category even as adoption climbs, according Strata’s latest Performance Trends report.
    • “The national analysis found telehealth encounters rose 79% between January 2019 and January 2026, marking the shift from a pandemic stopgap to a permanent fixture of care delivery. Despite that growth, average total cost margins for telehealth stayed negative in 2025 across commercial, Medicare, Medicaid and self-pay patients. Remote patient monitoring has soared 4,000% over the same time period.
    • “Healthcare organizations are increasingly turning to technology and new care delivery models to address workforce shortages and improve patient access,” said Steve Wasson, Strata’s chief data and intelligence officer. “The challenge is that many of these investments, particularly in virtual care, are occurring at a time when margins remain extremely narrow.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare has acquired 17 urgent care clinics from Urgent Care Group in North and South Carolina. 
    • “The clinics include locations in Charleston, Columbia, Myrtle Beach and Spartanburg in South Carolina, and Wilmington in North Carolina, according to a June 2 news release. 
    • “The South Carolina clinics are now operating under the first HCA CareNow brand name, becoming the first such clinics in the state, The North Carolina clinics are continuing to operate under the Medac name used by Urgent Care Group.” 
  • Kaufman Hall opines,
    • “Healthcare leaders must confront whether scorecards are improving patient safety or reshaping priorities in ways that may not benefit patients.”
    • Quick take
      • The debate is no longer about whether hospitals should be measured; it’s about whether the industry is measuring what truly matters.
      • Rankings shape reputation, revenue, and strategic priorities, not just public transparency.
      • Health systems are confronting a growing tension between improving patient care and improving publicly visible scores.
      • The number of public rankings is continuously growing.
      • Leaders are questioning whether current scorecards drive meaningful safety improvements or create administrative distraction.
      • The outcome of this debate could redefine how healthcare approaches transparency, accountability, and patient trust in the years ahead.
  • Health Exec relates,
    • “In a new state-by-state analysis of patient spending on healthcare, Utah, Virginia and California are at one end of the “spend the most” vs. “spend the least” rankings. Alaska, Oregon and Maine land at the other. Can you guess which trio’s residents spend the most and which the least?
    • “Time’s up. Alaska takes the undesirable No. 1 pole position: It’s the most expensive state for people who have to pay out of pocket. On average they shell out 10.1% of the median monthly household income to pay for essential medical services and prescriptions. 
    • “Spending the least are residents of Utah, where wallets only take a hit of 5.11%.
    • “The calculations are from WalletHub, which released a report on the topic May 28.” * * *
    • For WalletHub’s full report, click here.
  • Fierce Healthcare informs us,
    • “Community health system WellSpan Health inked a seven-year strategic alliance with Philips to drive advanced imaging technology across its network and co-develop new AI and tech tools.
    • “Philips’ technology will support WellSpan’s full network of 12 hospitals, diagnostic imaging centers and ambulatory surgery centers across Central Pennsylvania and Northern Maryland. A long-term commercial agreement establishes Philips as WellSpan’s preferred vendor across patient monitoring, enterprise informatics and all applicable imaging modalities, including CT, MR, digital X-ray, ultrasound and image-guided therapy.
    • “The commercial agreement includes a structured approach to technology lifecycle management: WellSpan and Philips will align equipment, services, training and upgrade planning under a single, coordinated framework, according to the organizations.
    • “The alliance marks Philips’s first research and innovation collaboration with a U.S. community health system. The health tech giant and WellSpan plan to co-develop net-new products and features that advance care delivery, drawing on Philips’ R&D pipeline, with WellSpan serving as both a proving ground and a co-creator.”
  • Per Fierce Pharma,
    • “With a new patent settlement, Axsome Therapeutics can lower its sword against prospective generics makers taking aim at its narcolepsy med Sunosi.
    • “The central nervous system-focused drugmaker closed the books on years of Sunosi intellectual property litigation by striking a settlement with “the only remaining first-to-file generic applicant with pending product litigation related to Axsome’s product Sunosi,” the drugmaker announced in a June 3 press release.
    • “Through the settlements, five companies will be cleared to market their generic versions of Sunosi starting on September 1, 2040, if Axsome nabs a pediatric exclusivity period for the drug. If not, the knockoffs can launch on March 1, 2040, the company explained. With that, “no other patent litigation relating to Sunosi remains pending.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports on this week’s anticipated activities on Capitol Hill.
    • “After a weeklong recess, Senate Republicans return Monday with their focus set on ways to move their budget reconciliation package, which hit several hurdles before the Memorial Day break. 
    • “The House, which has been on standby while Senate leadership works out how much of the White House wishlist they can salvage, is returning later this week, with its first vote scheduled for Wednesday.”
  • The Wall Street Journal adds,
    • “The Trump administration signaled a retreat Monday on its nearly $1.8 billion “anti-weaponization” fund, which met powerful pushback from members of Congress and threatened to derail the president’s efforts to pass immigration-enforcement funding.”
  • Yesterday, the FEHBlog described OPM’s family member documentation guidance as an interim final rule because OPM had not issued a proposed rule. However, it turns out that OPM decided that public comment was unnecessary so it declared the guidance to be a final rule. The final rule will be published in the Federal Register tomorrow which means that the final rule’s effective date is July 2, 2026.
  • Federal News Network also relates,
    • “Agencies will soon be able to pay as much as $400,000 a year to certain employees with skillsets in the national security sector. President Donald Trump told the Office of Personnel Management on Friday to establish new regulations to pay experts in specific fields related to supply chain resilience, secure access to critical minerals and advanced technologies and advance priority investment programs essential to national defense and economic security. The memo said this increase in the top line pay for these positions is necessary to advance the rapid recruitment of the exceptionally skilled investment, engineering, financial and legal professionals needed to expand the nation’s capacity.”
  • Govexec notes,
    • “For the second straight month, each portfolio offered by the federal government’s 401(k)-style retirement savings program finished May in the black.”
  • The final rule making changes to the No Surprises Act’s independent dispute resolution process is scheduled to be published in the Federal Register on June 4, 2026.
  • Radiology Business tells us,
    • “Radiologists, anesthesiologists and emergency medicine physicians are jointly praising recently announced changes to the No Surprises Act while also pushing for further reform. 
    • “Medical societies representing all three specialties shared their official response to the independent dispute resolution, or IDR, final rule on Friday. Released by the Centers or Medicare & Medicaid Services May 28, the rule finalizes many updates to the NSA first proposed back in 2023.
    • “The American College of Radiology, American Society of Anesthesiologists and the American College of Emergency Physicians commended the rule, calling it a “thoughtful and collaborative approach.” They see the changes as an “important step forward,” one that will hopefully create a “more functional, transparent dispute resolution system.” 
  • These comments confirm the FEHBlog’s opinion that a follow up rule or perhaps a statutory change is needed to level the IDR process playing field which currently favors this healthcare providers.
  • The American Hospital Association News informs us,
    • “President Trump signed an executive order May 29 that directs the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices to review a scientific assessment by the Department of Health and Human Services on childhood vaccine recommendations from other developed nations. The order recommends the CDC and ACIP take any appropriate steps to update the U.S. childhood and adolescent vaccine schedule to align it with those from other nations. The administration also recommended that all immunizations on the schedule should continue to be covered without cost sharing by private insurers and covered by Medicaid, the Children’s Health Insurance Program and the Vaccines for Children Program.”
  • and
    • “The Centers for Medicare & Medicaid Services June 1 issued an interim final rule with comment period implementing the statutory requirement that certain adult Medicaid enrollees meet community engagement (work) requirements. Under the rule, certain adults must complete 80 hours per month of “qualifying activities,” such as employment, education, community service or participation in a work program, or meet equivalent income thresholds.
    • “CMS said that states must generally implement the requirement no later than Jan. 1, 2027. The rule maintains exemptions for certain populations, including individuals who are pregnant or postpartum, disabled or medically frail, or caregivers, and allows states to offer exemptions for short-term hardships. See the CMS fact sheet for more details.
    • “Provisions in the rule are effective on July 31, 2026, and comments must be submitted by that date.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA approved the oral antiviral agent ensitrelvir (Xocova) to help prevent COVID-19 in people ages 12 years or older who were exposed to the SARS-CoV-2 virus, drugmaker Shionogi announcedopens in a new tab or window.
    • “Ensitrelvir is a SARS-CoV-2 main protease inhibitor also approved in Japan as COVID-19 postexposure prophylaxis (PEP) and as a treatment for mild to moderate COVID. The drug is not approved to treat COVID-19 in the U.S.
    • “The FDA’s decision was based on the phase III SCORPIO-PEP trial, which showed the risk of getting sick from a household contact with COVID-19 dropped by more than half among those who took ensitrelvir compared with placebo.”
  • Contemporary OB/GYN relates,
    • “Wockhardt has announced that the FDA has approved cefepime and zidebactam (ZAYNICH; Wockhardt), a novel intravenous antibiotic designed to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. The approval offers a new therapeutic option for patients facing aggressive, drug-resistant infections. Prior to this approval, the drug received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
    • “In the United States, cUTIs are responsible for over 600,000 hospitalizations annually. A growing proportion of these infections are driven by antimicrobial-resistant bacteria, which represent a leading cause of bacteremia and carry significant morbidity and mortality risks. These multidrug-resistant infections place a heavy burden on the healthcare system, as affected patients typically require more intensive, prolonged care and experience higher rates of life-threatening complications.
    • “The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of ZAYNICH is a monumental step forward in validating a new option for these underserved populations,” said Dr. Dennis Deruelle, Chief Medical Officer at Wockhardt.”

From the judicial front,

  • CMS posted a notice of a court decision that will appear in tomorrow’s Federal Register,
    • SUMMARY: This is to inform the public that, on October 22, 2025, the United States District Court for the Southern District of Mississippi issued an order in Tennessee v. Kennedy, No. 1:24-cv-161-LG-BWR (S.D. Miss. Oct. 22, 2025), vacating portions of the final rule titled “Nondiscrimination in Health Programs and Activities,” published May 6, 2024 (89 FR 37522).
    • Specifically, the court vacated certain provisions of the regulation to the extent they expand Title IX’s definition of sex discrimination to include gender-identity discrimination. Pursuant to the court’s order, the vacated provisions are legally void. The other provisions of the Section 1557 Rule remain in force.
    • DATES: The Tennessee court issued its vacatur order on October 22, 2025. As long as the specified provisions of the 2024 Section 1557 Rule remain vacated, OCR and CMS cannot and will not enforce the vacated provisions.

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “An outbreak of a rare strain of Ebola in the Democratic Republic of Congo is already the third largest in history, just weeks after it likely began.
    • “It is spreading rapidly in one of the most volatile and vulnerable regions of the world, worrying U.S. and international health officials.” * * *
    • “What are the chances that Ebola will spread to the U. S.?
    • “The risk is low, according to the Centers for Disease Control and Prevention. U.S. officials have prohibited foreigners who have been to Congo, Uganda or South Sudan in the last three weeks from entering the country. U.S. citizens who have been to those countries are being directed to four U.S. airports and screened there, the CDC said. Those airports are: Washington-Dulles International, Hartsfield-Jackson Atlanta International, George Bush Intercontinental and John F. Kennedy International.
    • “The U.S. has a network of specialized treatment centers around the country to care for patients with dangerous pathogens like Ebola and hantavirus, at hospitals such as the University of Nebraska Medical Center and Emory University Hospital. However, U.S. authorities evacuated an American medical missionary who contracted Ebola in Congo to a hospital in Germany with similar capabilities, and aim to build an Ebola quarantine and treatment facility in Kenya. A Kenyan high court put the U.S. plan on hold.”
  • The American Medical Association lets us know what doctors wish their patient knew about lupus.
    • “Lupus is a complex autoimmune disease with varied symptoms. Early diagnosis and ongoing care can help patients manage flares and protect long-term health.”
  • MedPage Today relates,
    • “The cigarette smoking rate among U.S. adults dropped to another all-time low last year, with one in 11 adults saying they were current smokers, according to new government survey data.
    • “Cigarette smoking is a risk factor for lung cancer, heart disease, and stroke, and it’s long been considered the leading cause of preventable deathopens in a new tab or window.
    • “The preliminary findingsopens in a new tab or window from the CDC were based on survey responses from more than 24,200 adults. In the survey, CDC officials defined current cigarette smoking as smoking at least 100 cigarettes in a lifetime and now smoking every day or some days.” * * *
    • “In 2024, the percentage of current adult smokers fell below 10% for the first time. Last year, it was 9%, according to the new survey.
    • “The use of electronic cigarettes has been inching up among adults, but has held about steady in 2025, at about 7%.”
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) today announced that its Investigational New Drug (IND) application for mitragynine, the primary psychoactive compound found in Mitragyna speciosa (kratom), has taken effect with the U.S. Food and Drug Administration (FDA). The IND paves the way for an NIH-led phase I clinical trial to evaluate mitragynine as a potential treatment for opioid use disorder.
    • “Researchers at NIH and the University of Florida developed the purified formulation of mitragynine to be used in the trial, as well as the preclinical work that led to the submission of the IND application.
    • “This IND is a major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder, which has contributed to historically high overdose mortality rates,” said Nora Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA).”
  • The American Journal of Managed Care tells us,
    • “People living with alopecia areata (AA) may not face a heightened risk of skin cancer despite reduced scalp hair coverage, according to a new systematic review and meta-analysis that found a significantly lower incidence of melanoma among this patient population.
    • “The analysis, published in Frontiers in Oncology, evaluated data from more than 860,000 patients across 8 retrospective studies conducted in the US, Sweden, Denmark, Taiwan, and the Republic of Korea. Researchers reported that AA was associated with a statistically significant reduction in melanoma incidence, whereas rates of basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and overall skin cancer also trended lower but did not consistently reach statistical significance.
    • “The findings arrive as clinicians increasingly prescribe Janus kinase (JAK) inhibitors for moderate to severe AA, raising questions about long-term malignancy risks and the need for baseline disease-specific cancer data.”
  • Fierce Pharma informs us,
    • “AstraZeneca is polishing the case for its Imfinzi (durvalumab) and Imjudo (tremelimumab) combo in liver cancer with a new phase 3 readout from its Emerald trial program assessing the immunotherapy duo in a locoregional setting. 
    • “The phase 3 Emerald-3 study, presented June 1 at the Annual Society of Clinical Oncology (ASCO) 2026 annual meeting in Chicago, positions AZ’s Imfinzi/Imjudo regimen as a “compelling therapeutic option” for patients with unresectable embolization-eligible hepatocellular carcinoma (HCC), ASCO expert Vishwanath Sathyanarayanan, M.D., commented in an ASCO press release.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The public and private sector are committed to value-based care as a solution to high healthcare spending.
    • “Decades of value-based care interventions have not reversed perpetually rising health expenditures.
    • “UnitedHealth Group, CVS Health and other companies have made value-based care central to their business plans.
    • “The fragmented healthcare system remains an obstacle to cost containment.”
  • Beckers Hospital Review relates,
    • “Orlando (Fla.) Health recorded an operating income of $47.4 million (1.9% operating margin) in the second quarter of 2026, down from $94.7 million (3.9% margin) during the same period last year, according to its May 26 financial report.”  
  • KFF Health News, writing in Fierce Healthcare, tells us,
    • “Most patients who have taken a GLP-1 received their prescription through a primary care doctor or a specialist, KFF polling data shows. But as the uptake of telehealth has grown substantially since the start of the covid pandemic, * * * millions of Americans who have used online companies to meet a variety of their medical needs.
    • “Many of the companies have started offering GLP-1 medications for weight loss as demand for these drugs has exploded. But certain medication errors tied to GLP-1s have exploded too, according to a KFF Health News review of Food and Drug Administration data, and physicians and telemedicine researchers worry that adverse experiences tied t”o telehealth companies are becoming more common.
    • Bad outcomes aren’t unique to telehealth providers or to the compounded weight loss drugs many of them offer. In fact, product liability lawsuits alleging patient injuries have been filed overwhelmingly against pharmaceutical giants Eli Lilly and Novo Nordisk, which manufacture name-brand weight loss drugs, court data shows. The drugmakers have defended their products.
    • “However, some critics are also concerned that getting a weight loss prescription online is usually much easier than getting one through an in-person appointment. Not only do many telehealth companies write quick prescriptions for GLP-1s, but they often sell the medications, too, allowing patients to bypass in-person pharmacy visits. This one-stop shopping isn’t necessarily a good thing, according to critics who say some telehealth providers are writing prescriptions for people who should not be taking GLP-1s and then providing little or no follow-up care.
    • “It gives a black eye to telemedicine,” said Elizabeth Krupinski, an experimental psychologist at Emory University who has conducted research on the effectiveness of telehealth.”
  • Fierce Healthcare informs us,
    • “Weight loss company Noom is offering an at-home biomarker testing kit for its U.S. members, expanding its platform into diagnostics and metabolic health monitoring.
    • “It marks an expansion of the company’s proactive health program, which rolled out in December, offering microdose GLP-1 medications combined with at-home biomarker testing and insights.
    • “The at-home blood collection and lab testing service enables members to establish baseline labs and track improvements in markers such as, HbA1C, ApoB, triglycerides and hs-CRP over time, according to the company. Testing gives users with insights into biological outcomes, such as blood sugar regulation, lipid profiles and inflammation markers. By using the kit, members can skip a lab visit and receive results within about a week, paired directly with access to medication and behavior change programs, according to executives.
    • “Noom says it now provides a platform where members can test, act and track A1C improvement in a single, integrated experience.
    • “The biomarker test kits cost $125.”
  • Fierce Pharma points out,
    • “In its seventh week on the market, which ended May 22, Eli Lilly’s obesity pill Foundayo continued to track below the pace of Novo Nordisk’s rival Wegovy pill at the same point in its launch.
    • “At the same time, analysts at Jefferies and Citi again flagged caveats that could be skewing the numbers, with the Jefferies team espousing confidence that Lilly’s oral GLP-1 can still meet consensus sales projections for both the second quarter and 2026 as a whole. 
    • “Breaking down the numbers, the Jefferies team put seventh-week total Foundayo prescriptions lower versus the previous week at roughly 11,700, with the clarification that the data’s source, IQVIA, had to use a “best-estimate” tally for the latest week’s prescription trends. 
    • “That trend remains “numerically lower” than the course charted by Novo’s Wegovy pill, which racked up an impressive 67,000 prescriptions in its seventh week, although Foundayo’s performance still tracks ahead of Novo’s injectable Wegovy and Lilly’s first obesity incretin med Zepbound at the same point in their respective rollouts, the analyst team said.” 

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, HSA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • Benefits Link calls to our attention:
    • “Text of IRS Rev. Proc. 2026-24: 2027 Inflation Adjusted Amounts for Health Savings Accounts (HSAs) and Maximum Amount for Excepted Benefit Health Reimbursement Arrangements (HRAs) (PDF)
    • “For calendar year 2027, the annual limitation on deductions under section 223(b)(2)(A) for an individual with self-only coverage under a high deductible health plan [which thereby entitles the enrollee to contribute to a health savings account] is $4,500. For calendar year 2027, the annual limitation on deductions under Section 223(b)(2)(B)for an individual with family coverage under a high deductible health plan is $9,000.
    • “For calendar year 2027, a DPCSA [Direct Primary Care Service Arrangement] is not treated as a health plan with respect to an otherwise eligible individual if the aggregate monthly fees for all DPCSAs with respect to the individual do not exceed $150 or, if the individual is covered by a DPCSA that covers more than one individual, $300.
    • “For calendar year 2027, a ‘high deductible health plan’ is defined under section 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,750 for self-only coverage or $3,500 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,700 for self-only coverage or $17,400 for family coverage.
    • “For plan years beginning in 2027, the maximum amount that may be made newly available for the plan year for an excepted benefit HRA under Section 54.9831-1(c)(3)(viii) is $2,250.” 
  • Healthcare Dive shares industry reactions to yesterday’s final rule on the No Surprises Act Independent Dispute Resolution process.
    • “No Surprises has largely been successful in that goal, preventing millions of Americans from being hit with unexpected out-of-network charges. But the law came with an unintended consequence, creating a multi-billion dollar industry enabling doctors to get paid significantly more than they normally would for providing care.
    • “This rule is a missed opportunity to restore the balance that Congress intended — a balance that has been badly warped by activist courts and predatory provider interests,” James Gelfand, the CEO of the ERISA Industry Committee, which lobbies on benefits issues for large employers, said in a statement.
    • “Payers and providers have been at odds over independent dispute resolution, or IDR. Each side has long complained that the process unfairly benefits the other.
    • “But over the past few years, data has emerged suggesting that doctors and medical groups are raking in the dough from IDR — filing snowballing disputes, winning an exceptional share of awards and garnering massive payouts.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today announced a series of major initiatives to strengthen the nation’s response to Lyme disease and other tick-borne illnesses. HHS actions include a multi-million-dollar pilot program focused on tick control, up to $2.5 million in innovation challenges, funding for NIH researchers to combat Alpha-gal syndrome, and a public-private collaboration to help patients connect with experienced providers.
    • “Secretary Kennedy delivered these announcements during a press conference in New Hampshire — one of the states hardest hit by Lyme disease — after convening a roundtable with state lawmakers and Lyme disease advocates as part of his “Take Back Your Health” tour.”
  • The American Hospital Association reports,
    • The Centers for Medicare & Medicaid Services May 28 issued a final rule making changes to the Increasing Organ Transplant Access Model beginning July 1. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1, 2025. CMS finalized its proposal to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. The agency also finalized its proposal to include Medicare Advantage beneficiaries in the calculation of upside and downside risk payments. Although CMS considered lowering the maximum upside risk payment to $10,000 per transplant, it will remain $15,000 due to comments in opposition submitted by the AHA and other stakeholders. In addition, CMS adopted requirements for notifying patients of changes in waitlist status; however, in response to many concerns raised by the AHA and other commenters, it did not finalize its proposals regarding notifications of declined organ offers. Finally, in a modification of its original proposal, CMS adopted an updated risk adjustment methodology for performance on the model’s one quality measure that is consistent with the widely used Scientific Registry of Transplant Recipients framework.
  • Fierce Healthcare relates,
    • “Elevance Health has earned a reprieve from potential federal sanctions on its Medicare Advantage plans.
    • “The Centers for Medicare & Medicaid Services sent a letter (PDF) to the company Friday, saying that it has completed key steps to remedy the agency’s concerns. CMS was set to suspend enrollment in Elevance’s MA plans on March 31 if the insurer did not comply.” * * *
    • In Friday’s letter, CMS said the Elevance has completed initial data submissions through the designated channels, and sent a wire transfer for overpayments based on “all auditable estimates” in the case. How much money that amounts to was not disclosed.
    • But despite the good news, the company is not out of the water yet. CMS said it must complete further steps by June 30 to avoid sanctions, as well as tie up any loose ends from previous steps in the process by July 31.
    • Sanctions would be implemented on July 1 if new steps are not met, or on Aug. 1 if these incomplete processes are not resolved, CMS said.

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • The U.S. Food and Drug Administration (FDA) is once again warning the public about a safety concern with Johnson & Johnson MedTech’s line of Impella heart pumps. 
    • This latest alert was put in place after the company learned that certain Impella CP sets with SmartAssist “do not meet design specifications” and could experience a low purge pressure event. 
    • “Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support,” according to the FDA’s advisory. “Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion, and risk of death if not promptly corrected.”
    • One patient died as a result of this issue.
  • Fierce Pharma relates,
    • “With a pediatric approval in hand for Afrezza, MannKind believes that it finally has the boost it needs to make an impact in the market after struggling for more than a decade with the inhaled insulin powder.
    • “On Friday, the FDA signed off on an expansion for Afrezza to treat adolescents and children ages 6 and older with Type 1 or Type 2 diabetes. The drug must be used alongside basal insulin in patients with Type 1 disease, according to a May 29 press release. 
    • “The nod comes 12 years after the U.S. regulator cleared Afrezza as a fast-acting, before-meal option for adults with diabetes.”
  • and
    • “Johnson & Johnson has bolstered the psoriatic arthritis (PsA) nod for its IL-23 inhibitor Tremfya in the U.S., picking up an FDA expansion that covers the med’s ability to thwart the progression of structural joint damage in adults with active disease. 
    • “Patients with active PsA can start to suffer joint damage as early as 6 months after the onset of their condition, reinforcing the need for a treatment like Tremfya that can provide daily symptom relief and protection from structural joint damage over the long term, Philip Mease, M.D., of the Swedish Medical Center and University of Washington School of Medicine in Seattle, said in a J&J press release.” 
  • The Wall Street Journal tells us,
    • “Replimune Group REPL said Friday it has reached an agreement with the Food and Drug Administration on a path to resubmit its application for its experimental treatment for advanced melanoma.
    • “It wasn’t immediately clear whether Replimune would submit new clinical data or additional analyses of existing trial results to help secure approval.
    • “The company plans to resubmit the application in the coming days, the company said.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 29, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 31 new measles cases in a nationwide outbreak that has now reached 1,983 infections, as experts describe sometimes-serious symptoms that can warrant hospital stays, including brain inflammation and pneumonia. 
    • “All but nine of the US infections are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.” * * *
    • “According to the CDC measles map, South Carolina has recorded the most cases so far this year, at 669, but its outbreak is now over. Utah is next, with 484 cases—although the Utah health department lists 476,just two more than last week. The state recorded eight new cases the previous week and 10 the week before, for a three-week total of 20.
    • “Texas has 182 cases, and Florida 139, four of them new, according to the CDC map.
    • “Fortunately, the outbreak in our region does appear to be slowing,” said Andrew Pavia, MD, chief of pediatric infectious diseases at the University of Utah. He was part of a media briefing this week sponsored by the Infectious Diseases Society of America (IDSA).”
  • The Wall Street Journal relates,
    • “Trump administration officials are asking states to ensure 24/7 monitoring for [over a dozen] Americans exposed to hantavirus to allow home isolation.
    • “Federal officials require states to issue quarantine orders if people fail to comply, with health officials checking symptoms twice daily.
    • “The World Health Organization recommended a 42-day quarantine for high-risk exposure to the Andes strain of hantavirus.”
  • MedPage Today tells us,
    • “Alzheimer’s pathology appeared as early as midlife and correlated with poorer cognitive performance in a cohort study.
    • “Blood biomarkers identified Alzheimer’s pathology in 6% of middle-age adults.
    • “Baseline pathology predicted steeper 5-year declines in verbal memory and processing speed.”
  • and
    • “Strong preclinical evidence suggested PCSK9 inhibitors may overcome immunotherapy resistance by preventing tumor cells from evading the immune system.
    • “In patients with lung cancer, melanoma, or kidney cancer, use of PCSK9 inhibitors, in addition to immunotherapy, was associated with better survival in this matched-cohort study.
    • “The survival benefit was independent of cardiovascular outcomes, suggesting an alternative biological pathway.”
  • and
    • “Enhanced, abbreviated MRI (AMRI) outperformed ultrasonography (US) as a screen for early liver cancer in high-risk patients with cirrhosis, according to a single-center, randomized clinical trial.
    • “Overall, AMRI yielded significantly more early-to-advanced stage cancer among 759 patients: the per-patient detection rate in Barcelona-Clinic Liver Cancer (BCLC) stage 0, A, B, or C hepatocellular carcinoma (HCC) was significantly greater in those randomized to screening with hepatobiliary-phase image AMRI (HBP-AMRI) using gadoxetic acid than in those screened with US, at 8.5% versus 3.1% (P=0.002).”
  • tctMd informs us
    • “The likelihood that patients with hypertension will stop taking their prescribed blood pressure-lowering medications varies by drug regimen, a meta-analysis of short-term clinical trials suggests.
    • “Combination therapies—particularly angiotensin II receptor blockers (ARBs) paired with calcium channel blockers (CCBs)—generally were better tolerated than monotherapies, researchers reported today in JAMA, and some meds even had discontinuation rates lower than seen with placebo.
    • ‘High blood pressure is notoriously undertreated, something that’s often attributed to the  perceived tolerability, or lack thereof, of antihypertensive drugs. 
    • “Fear of adverse events remains a major reason for undertreatment of high blood pressure, the leading modifiable risk factor for death and cardiovascular disease worldwide. For years, we have assumed that more blood pressure-lowering treatment equates to worse tolerability, and hence most patients are started and remain on single drug monotherapy,” Nelson Wang, MD, PhD (University of New South Wales, Sydney, Australia), told TCTMD in an email.”
  • The Journal of American Managed Care informs us that “Endometriosis Surgery Becomes More Complex With Older Age Despite Plateauing Severity, Study Finds.”

From the American Society of Clinical Oncology conference front,

  • BioPharma Dive reports,
    • “A regimen combining Bristol Myers Squibb’s experimental mutliple myeloma drug mezigdomide with standard therapies delayed disease progression or death about 10 months longer than typical care alone, according to Phase 3 data unveiled Friday at the American Society of Clinical Oncology meeting.
    • “Trial enrollees who got mezigdomide along with Amgen’s Kyprolis and a steroid were 52% less likely to have progressed or died during the trial period compared with people receiving only those two other therapies. Study recruits in the “SUCCESSOR-2” trial had already seen their disease advance after at least one treatment line. Many had previously received two or more therapies.
    • “Mezigdomide is one of two protein-degrading drugs Bristol Myers has already submitted to U.S. regulators and hopes to position as successors to its popular multiple myeloma therapies Revlimid and Pomalyst. The treatment lanscape has become more competitive, though, with the emergence in recent years of cell therapies and bispecific antibodies that are becoming part of early-stage treatment.”
  • and
    • “Merck & Co. has said many new products will be needed to absorb the coming financial impact when its blockbuster cancer medicine Keytruda loses patent protection. One, discovered by China-based Kelun-Biotech and licensed to Merck a few years ago, has now come to the forefront.
    • “Dubbed sacituzumab tirumotecan, or sac-TMT, the therapy is part of a class of “antibody-drug conjugates” drugmakers see as potentially supplanting traditional chemotherapy in many cancers. Merck has been so encouraged by the clinical results it’s seen so far that it’s put the drug into a sprawling Phase 3 program consisting of 17 studies in a range of tumor types.
    • “Sac-TMT “could be one of our cornerstone ADCs, and that’s why you see our conviction in all of these trials,” said Shweta Jain, who oversees Merck’s oncology assets, in an interview with BioPharma Dive.”
  • STAT News adds,
    • “Investors have never really been excited about Pfizer’s Lorbrena, a targeted drug that is the successor to the company’s earlier targeted drug, Xalkori, to treat non-small cell lung cancer that is caused by any of a number of genetic alterations to the gene including ALK and ROS1. For patients, it has been a breakthrough.”
    • “Lorbrena was approved as second- or third-line treatment in 2018, and then as first-line treatment in 2021. Its main benefit over Xalkori is that Lorbrena can penetrate the brain. Non-small cell lung cancer often metastasizes there, but the large size of the earlier molecule meant that patients would have their disease controlled throughout their body, except inside their heads.
    • “Two years ago at ASCO, Pfizer presented data showing that five years out, Lorbrena reduced disease progression by 81% in patients with altered versions of the ALK gene. Today, researchers presented data that are even more remarkable. At seven years, patients had a 55% likelihood of being alive without disease progression, compared to 3% for those who were taking Xalkori. In an interview, Jeff Legos, Pfizer’s chief oncology officer, said that this appeared to be the longest progression-free survival ever reported in metastatic or advanced non-small cell lung cancer.
    • ‘ALK+ non-small cell lung cancer accounts for less than 5% of cases of disease. But in those patients, about a third will develop brain metastases within two years. Lorbrena reduced those metastases by 91% compared to Xalkori.” 

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “UnitedHealth UNH Group plans to stop requiring doctors to get approvals for an array of pediatric procedures, tests and services, further cutting back on a process that has long been detested by physicians and patients.
    • “UnitedHealth, parent of the biggest U.S. health insurer, on Friday said that the changes will eliminate roughly two-thirds of prior-authorization requirements for members under the age of 18 by the end of the year.
    • “UnitedHealthcare said it will stop requiring signoffs for many diagnostic services, routine surgical procedures and specialty care services across pediatric subspecialties such as cardiology, neurology, pulmonology and orthopedics.
    • “The insurer will additionally introduce authorization waivers for certain procedures performed at pediatric hospitals.
    • “UnitedHealthcare said it is conducting a rigorous and data-driven review of all pediatric prior authorization requirements in order to determine which services can be safely removed.”
  • Beckers Payer Issues informs us,
    • “The forces reshaping health plans over the next several years are converging fast. Across the industry, executives and clinical leaders point to three trends that will define which organizations will thrive: the rapid maturation of AI from pilot projects into core operational workflows, the intensifying pressure to make healthcare genuinely affordable, and the rising tide of consumer expectations for transparency, simplicity and personalized care. 
    • “Becker’s asked 16 health plan executives which trend they think will most influence health plans over the next few years.”
    • You can read the exec’s thoughts in the article.
  • Beckers Hospital Review ranks 66 health systems by long term debt.
    • “Long-term debt continues to weigh on health system balance sheets, even as many reported improved operating margins in 2025. Some systems have been actively deleveraging through hospital divestitures, debt refinancings and operational improvements, while others have taken “on new debt to fund capital projects, acquisitions and EHR investments.
    • Highly leveraged systems are looking to sell hospitals, facilities or business lines to reduce leverage and secure long-term sustainability, while systems with stronger balance sheets are using the dislocation to pursue growth through M&A.”
  • Healthcare Dive points out,
    • “The Coalition for Health AI released a series of governance resources this week that aim to help health systems safely roll out artificial intelligence tools. 
    • “The playbooks, developed through community workshops and work groups that included more than 150 clinicians and health AI leaders, provide examples and guidance on implenting AI, including resources on setting up AI policies, managing third party developers and assessing risks. 
    • “The goal is to provide a standardized, but flexible framework that health systems can use to deploy AI tools, regardless of their size or available resources, CHAI said.”

Thursday report

David Ermer–CDC, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Mental health care, No Surprises Act, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The departments of Health and Human Services, Labor and the Treasury [and the Office of Personnel Management] issued a final rule May 28 intended to improve the functioning of the No Surprises Act (NSA) independent dispute resolution process. The rule streamlines communication between payers, providers and certified IDR entities and clarifies timelines and processes. It improves the functionality of the IDR process by finalizing various changes, including allowing up to 50 items and services to be batched in the same payment dispute. The final rule also increases access to the IDR process by reducing the administrative fees associated with it. The AHA supported many of these changes in comments on the proposed rule.”
  • The rule decreases the federal government fee for handling an NSA arbitration from $115 per party to $15 per party. The FEHBlog expects the arbitrators’ fees to increase accordingly over time. No good deed, etc.
  • The FEHBlog also expected the final rule to include an administrative remedy that would allow providers and payers to enforce or challenge arbitration awards.
  • The FEHBlog agrees with AHIP’s comments on the final rule.
    • “While the focus on addressing flawed incentives in the IDR process is a significant first step, more action is needed to protect Americans from unconscionable price gouging by some PE-backed providers and IDR middlemen.” – Chris Bond, AHIP spokesman”
  • Tammy Flanagan, writing in Govexec, discusses “[w]hat retiring feds should do before asking for help.
    • “Clear timelines, complete records and focused questions can make retirement problems easier to resolve, especially as agencies face mounting workloads.”
  • Federal News Network tells us,
    • “The Postal Service is putting immediate restrictions on nonessential spending to avoid running out of cash sooner than expected.
    • “Postmaster General David Steiner wrote in a memo Tuesday that the restrictions will impact hiring, travel and training as well as other areas of spending. Departments within USPS may be asked to provide a summary of “cost-containment actions taken and expected savings.”
    • “Steiner told members of the House Oversight Committee in March that USPS will run out of cash in early 2027, as long as it continues to pay its bills on time. But USPS is relying on some emergency measures to conserve cash.
    • “As you are aware, we are currently experiencing a temporary cash-flow shortage that requires us to take decisive steps to manage our available resources responsibly,” Steiner wrote in the memo. “To protect core operations and ensure that we can continue meeting all essential obligations, we are implementing immediate restrictions on non-essential spending across all departments.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA’s vaccine advisors voted 8 to 0, with one abstention, in favor of a monovalent XFG vaccine for COVID-19 shots for the 2026-2027 season.
    • “The Vaccines and Related Biological Products Advisory Committee (VRBPAC) also discussed the need to target the long-simmering BA.3.2 variant, also known as “cicada,” though most expressed confidence that targeting XFG was the right way to go.
    • “The XFG variant is the most common variant in the U.S. right now, and looking at the other JN.1 variants that may be coming up, I still think that the BA.3.2 variant is not as common. I think we have to keep surveillance very vigilant though,” said Anna Durbin, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, adding that the “immunogenicity of the vaccines looks good, so I was very comfortable voting yes.”
  • Fierce Pharma relates,
    • “AstraZeneca has fired another volley in its bladder cancer competition with Merck’s Keytruda, with the FDA on Thursday clearing its PD-L1 inhibitor Imfinzi as part of the first immunotherapy combo regimen in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who haven’t previously received standard of care Bacillus Calmette-Guérin (BCG) treatment. 
    • “The green light clears Imfinzi in the indication alongside BCG induction and maintenance therapy, AZ said in a May 28 release. 
    • “This marks the second recent bladder cancer nod for Imfinzi, which was approved in March of last year in muscle invasive bladder cancer (MIBC), in that instance in combination with the chemotherapies gemcitabine and cisplatin ahead of bladder-removing surgery and then on its own following the procedure.”
  • and
    • “As AbbVie continues to capitalize on its ImmunoGen deal, the growth of commercial antibody-drug conjugate (ADC) Elahere, another of the acquired company’s clinical assets has crossed the FDA finish line. 
    • “The FDA on Wednesday announced the approval of AbbVie’s CD123-direct ADC pivekimab sunirine-pvzy, which will hit the market under the Decnupaz moniker, as a treatment for adults with the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN). 
    • “The condition is a rare and aggressive cancer of the bone marrow and blood that can also affect organs like the lymph nodes, spleen and skin. Most patients with BPDCN present with purple-colored skin lesions and the malignancy is often diagnosed in more men than women, with most patients aged 60 years and older.” 
  • Health Exec tells us,
    • “The U.S. Food and Drug Administration (FDA) said it’s aware of an issue with IV tubes, where black matter has been found within the walls of the plastic walls, signaling a contamination issue.
    • “ICU Medical said samples containing the particulates are being returned for analysis to help identify the problem. Until then, the devices are being removed from use and distribution.
    • “Typically sterile, these tubes are used to connect medication and fluid bags to patients, as administered through an IV line.
    • “ICU Medical and the FDA said in an announcement this could be a potentially high-risk issue, though there was no mention of patient injuries. The FDA described the notice as an early alert regarding a potential safety issue.”

From the judicial front,

  • Modern Healthcare reports,
    • “Clover Health won a lawsuit [in the U.S. District Court for the Southern District of Georgia] challenging its 2026 Medicare Advantage star ratings.
    • “A federal court ruled that 20 quality measures the Centers for Medicare and Medicaid Services used are improper.
    • “The decision could have industrywide implications because CMS rated all Medicare Advantage insurers on those metrics. 
    • “CMS filed a motion to reconsider the ruling.

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention today released a report highlighting data on patients hospitalized during a 2025 measles outbreak centered in West Texas. There were 762 confirmed cases during the outbreak, which lasted from late January through mid-August 2025. The report found that of the 60 hospitalized patients, nearly 91% were children and adolescents under age 18 and nearly 56% were age 4 or younger. Additionally, 4 out of 5 hospitalized adults age 18-44 were pregnant women in their third trimester. Available medical records of 54 patients were reviewed. All 54 were found to be unvaccinated or had an unknown vaccination status.”
  • Healio relates,
    • “Measures of ideal heart health including healthy levels of physical activity, BMI, BP and sleep were associated with lower risk for severe COVID-19 among people with no history of heart disease during the pandemic, researchers reported.
    • “For every 1 standard deviation increase in total American Heart Association’s Life’s Essential 8 score, individuals without prior CVD experienced an approximately 20% reduced risk for severe COVID-19 infection, according to data published in the Journal of the American Heart Association.”
  • Health Day adds,
    • “Being incredibly fit shouldn’t increase a young adult’s risk of dangerous irregular heart rhythm, a new study says.
    • “Young male athletes and fitness buffs aren’t more likely to develop atrial fibrillation, despite earlier studies that showed an apparent link, researchers reported May 21 in the journal Circulation.
    • “Our study shows that there are good reasons to nuance and tone down the message, which has been widespread at times, that high levels of fitness or participating in races would pose a big risk to a person’s cardiovascular health,” said lead investigator Marcel Ballin, an associated researcher at Uppsala University in Sweden.
    • “The risk of atrial fibrillation is certainly not zero, but that said, the benefits are significantly greater,” he said in a news release.”
  • and
    • “Adopting low-insulinemic and planetary health diets during menopause is associated with optimized weight management, according to a study published online May 20 in JAMA Network Open.
    • “Tong Xia, M.D., Ph.D., from Brigham and Women’s Hospital in Boston, and colleagues compared dietary patterns and their associations with weight gain and obesity risk in the years surrounding menopause. The analysis included 38,283 women participating in the Nurses’ Health Study II, with 12-year observations surrounding menopause.
    • “The researchers found that after adjusting for age, race and ethnicity, marital status, income, postmenopausal hormone therapy use, parity, smoking, alcohol, energy intake, physical activity, and baseline body mass index, the reverse empirical dietary index for hyperinsulinemia (EDIH; quintile 5 versus 1) was associated with the largest reduction in weight gain (mean, −0.28 kg/year). The lowest risk for incident obesity was seen with the Planetary Health Diet Index (PHDI; hazard ratio, 0.46) and reverse EDIH (hazard ratio, 0.51). The largest positive correlations in the EDIH were seen with red or processed meats, sodium, and French fries, while for the PHDI, the largest positive correlations were seen with nuts, unsaturated fats, whole-grain carbohydrates, and vegetable protein.” 
  • The Washington Post informs us,
    • Ozempic was supposed to be a gut story. Then Allison Shapiro looked at the brain scans.
    • An assistant professor at the University of Colorado Anschutz, she was part of a team studying 13 teens and young women with a hormonal disorder affecting the ovaries who were put on GLP-1 drugs. As part of testing to catalogue the effect of the medication on their bodies, Shapiro took snapshots of their brains before and after.
    • She was astonished to find extensive changes.
    • Within only a few months, the brain connections in the salience network, which helps target attention, had multiplied.
    • “We didn’t expect to see this effect, and we really don’t know what it means,” Shapiro said.”

  • BioPharma Dive tells us,
    • “An RNA-based shot developed by GSK and Ionis Pharmaceuticals helped wipe out hepatitis B in about a fifth of the patients who received it in a pair of clinical trials, according to study results published Thursday in the New England Journal of Medicine.
    • “Called bepirovirsen, the shot could represent an important advance for people with chronic hepatitis B infections, less than 1% of whom can achieve such a “functional cure” with the help of oral antivirals. None of the participants who received a placebo hit that mark in the two trials presented Thursday.
    • ‘The Food and Drug Administration is already reviewing an approval application for bepirovirsen, and has granted the drug “fast track” and “breakthrough therapy” designations that could speed up its evaluation. An approval decision is expected no later than Oct. 26.”
  • Genetic Engineering and BioTechnology News points out,
    • “Biohub, the non-profit research organization co-founded by Priscilla Chan, MD, and Mark Zuckerberg, has now unveiled the latest update to the ESM protein language model family, with expanded capabilities in binder design and protein function mapping for therapeutic discovery. The release comes just seven months after Biohub recruited the team behind EvolutionaryScale. 
    • “The system includes ESMC (Evolutionary Scale Modeling Cambrian), a language model trained on approximately 2.8 billion sequences drawn from a breadth of life, including organisms adapted to extreme environments, and more than 20,000 types of proteins found in the human body. Evolutionary information encoded in ESMC is translated into atomic-resolution protein structures and interactions using the design engine and prediction model, ESMFold2. 
    • “Alex Rives, PhD, head of science at Biohub and former chief scientist at EvolutionaryScale, presented the work at this week’s “AI in Biology” symposium at Cold Spring Harbor Laboratory.  
    • “These models aim to transform the earliest stages of drug discovery by making biology more programmable. While traditional discovery workflows rely on slow and resource intensive experimental screens to identify promising drug candidates, rational protein design guided by in silico predictions has the potential to dramatically accelerate development timelines. 
    • “We’re at an exciting point in protein biology where accurate digital representations allow asking experimental questions at a scale that wouldn’t be possible in the laboratory,” Rives told GEN Edge.”  

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Highmark Health recovered in the first quarter after reporting losses last year, the health system and insurer announced Thursday.
    • “The Pittsburgh-based nonprofit company reported a 1,308% jump in first-quarter net income to $183 million and a 1,340% improvement in operating income to $216 million. Revenues grew 3.8% to $8.3 billion. Highmark Health lost $175 million in 2025.
    • “Highmark Health Plans’ strategic adjustments in Medicare and Medicaid drove the rebound, Highmark Health Chief Financial Officer and Treasurer Carl Daley said.” 
  • Fierce Pharma relates
    • “The top pharmacy benefit manager (PBM) in the U.S., CVS Caremark, will restore coverage to obesity products from Eli Lilly, allowing a significant number of patients to gain access to the drugs through their existing insurance.
    • “CVS will begin covering Lilly’s GLP-1 pill Foundayo on Monday of next week, June 1, while coverage of Lilly’s injected treatment Zepbound begins on October 1. CVS Caremark, which is the pharmacy chain’s drug benefits unit, is the largest PBM in the country.”
  • and 
    • “CVS Health is growing its partnership with Salesforce, leveraging its agentic AI-driven Agentforce Health to boost personalization in its call centers.
    • “The companies announced on Thursday morning that the platform will connect data across CVS, including Aetna and Caremark, to make it easier for call center teams to address a member’s unique needs in a single interaction when possible.
    • “The Agentforce tool will surface critical insights to call center teams in advance, preparing them more effectively for conversations. The goal, the partners said, is to improve the experience for both the member and the workers through a more streamlined interaction.”
  • OptumRx, writing in Linked In, discusses the four drug classes that drive spending.
    • Inflamatory conditions drugs,
    • Oncology drugs,
    • Diabetes drugs, and
    • Obestty Drugs.
  • Beckers Payer Issues points out,
    • “CVS Health’s insurance branch will roll out “Aetna Mental Health On Demand” in 2027, the company said in a May 28 news release.
    • “Aetna members who are at least 13 years old will be able to access licensed clinicians via chat, phone or video. These professionals are trained on a “single-session intervention model” to drive immediate impact, such as through crisis management. Clinicians can provide a personalized plan, advocate for members, connect them with more resources and help with follow-ups and further care coordination.
    • “The platform also contains integrated AI tools for note-taking and administrative tasks. Clinicians participated in hundreds of chats and were able to respond to members within 13 seconds, the news release said about an initial rollout.” 
  • Healthcare Dive tells us,
    • “Teladoc Health said Thursday it is partnering with Walmart to add its virtual care services to the retail giant’s digital healthcare platform.
    • “With the partnership, Teladoc’s virtual care offerings — including urgent care, dermatology and nutrition support — are now available through Walmart’s Better Care Services platform, which connects customers to third-party digital health providers. 
    • “The deal should put Teladoc’s services in front of more potential patients, Kelly Bliss, president of the company’s U.S. group health business, told Healthcare Dive. “We have the largest nationwide network of virtual care providers in the country, and so we want to activate that network and our clinical services wherever people are making health decisions,” she said.”
  •  and
    • “Amazon’s healthcare leader is stepping down from this summer, and the co-founder of telehealth company Amwell will replace him, the retail and technology giant said Wednesday. 
    • “Neil Lindsay, who became senior vice president of Amazon Health Services in 2021, is leaving to pursue personal projects, he said in a message to Amazon employees.
    • “Dr. Roy Schoenberg, the former co-CEO of Amwell who helped found the telehealth provider two decades ago, will start as new head of Amazon’s health business on July 1. Lindsay will stay on as an advisor to Schoenberg through the end of the year.”
  • Per MedTech Dive.
    • “Ōura plans to roll out a swath of health and wellness features in June, following the launch of its latest smart ring.
    • “Among the new additions will be a tool to track nighttime blood pressure patterns and the ability to view nighttime breathing data over a 30-day period. Ōura announced the features, along with its Ōura Ring 5, on Thursday.
    • “Jason Russell, vice president of consumer software product at Ōura, told MedTech Dive that the blood pressure feature is intended to show trends in overnight changes and the relationship to daily habits, such as sleep, stress and exercise. 
    • “Ōura plans to offer blood pressure signals as a wellness feature, meaning it would not be regulated as a medical device, but there are some limitations on what it can tell users.”  

Midweek Update

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Patient safety, U.S. Healthcare–

Simplicity is a Virtue.

From Washington, DC,

  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM) today proposed a rule to eliminate the federal government’s time-in-grade requirement, an outdated rule that forces many General Schedule federal employees to wait 52 weeks before becoming eligible for promotion.
    • “The proposed rule would shift federal advancement away from time served and toward merit, performance, skills, and demonstrated readiness for higher-level work. Employees would still be required to meet OPM qualification standards and any additional job-related agency requirements.
    • “Federal employees should be rewarded for what they can do, not how long they have waited,” OPM Director Scott Kupor said. “This proposed rule strengthens merit, gives managers more flexibility to recognize high performers, and helps agencies move talented people into mission-critical roles faster.” * * *
    • “Read the proposed rule here“
  • The OPM Director, writing his Secrets of OPM blog in Linked In, discusses the proposed rule that would require federal employees to sign a non-disclosure agreement.
    • “Every well-functioning organization, whether it’s a startup, Fortune 500 company, nonprofit, law firm, university, or government agency, depends on the ability to have candid internal discussions about strategy, policy, personnel, operations, and decision-making.
    • “There’s a reason this principle is embedded throughout federal law. Under the Freedom of Information Act (FOIA), pre-decisional deliberations are generally protected from disclosure because organizations work better when people can debate ideas openly and honestly before a final decision is made. If every brainstorming session, disagreement, or draft proposal is instantly leaked into public view, people stop speaking candidly. Collaboration suffers. Decision-making suffers. Organizations become slower, more political, and less effective.
    • “Put differently: you cannot run a functional organization if employees believe internal deliberations will immediately be broadcast outside the organization.
    • “And contrary to some headlines, this proposal does not eliminate whistleblower protections. If someone witnesses illegal conduct, fraud, abuse, or misconduct, longstanding whistleblower laws remain fully intact. Protected disclosures are protected disclosures.”
  • The public comment deadline for this proposed rule is June 26, 2026.
  • Per a Justice Department news release,
    • “Today, the Civil Division announced reforms to accelerate the review of False Claims Act whistleblower complaints alleging fraud against federally funded, state-administered benefits programs. These reforms will empower the Department to move quickly on meritorious qui tam cases, maximize finite enforcement resources, and focus on dismantling sophisticated fraud schemes that exploit taxpayer-funded programs.” * * *
    • “The Civil Division will now prioritize qui tam complaints alleging fraud against public benefits programs by performing its initial review within 60 to 120 days. At the conclusion of that review, the Department will decide whether to:
      • “Permit the relator to proceed with the action and to assume primary responsibility for litigating it, subject to the government’s ongoing supervision and ultimate control of the matter;
      • “Conclude the allegations warrant further government investigation; or,
      • “Determine the qui tam should be dismissed under 31 U.S.C. §3730(c)(2)(A) because the allegations lack adequate specificity or are legally deficient.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Outlook Therapeutics has notched a win in its uphill battle to commercialize an ophthalmic version of Roche’s Avastin (bevacizumab) in the U.S., with the FDA now agreeing that the drug has demonstrated its effectiveness as a treatment for wet age-related macular degeneration. 
    • “The FDA’s change of heart comes after it granted an appeal of Outlook’s formal dispute resolution (FDR) request, which the company initiated last month following its third rejection of Lytenava (ONS-5010).
    • “As a result of the proceedings, the FDA’s Office of New Drugs (OND) concluded that clinical trial results, coupled with natural history and other mechanistic and pharmacodynamic data, were enough to establish “substantial evidence of effectiveness” for the drug, Outlook explained in a Tuesday release.” * * *
    • “The decision stipulates that Outlook can resubmit its biologics license application for Lynteva, which will be given an FDA decision date that should fall within 60 days of receipt of resubmission.
    • “Outlook expects to file the resubmission next month, it said.” 
  • Fierce BioTech relates,
    • “The FDA has delayed a decision on the approval of AstraZeneca’s camizestrant, deferring its ruling to review analyses filed after an advisory committee voted against the breast cancer prospect.
    • “AstraZeneca filed for FDA approval of the oral SERD based on a phase 3 switching study. Patients in the Serena-6 trial received an aromatase inhibitor and a CDK4/6 inhibitor. After detecting an ESR1 mutation, investigators swapped the aromatase inhibitor for camizestrant. AstraZeneca linked switching to its oral SERD to a 56% jump in progression-free survival.
    • “However, the FDA raised questions about the study design, and its advisory committee voted six to three that AstraZeneca failed to show camizestrant provides a clinically meaningful benefit. The vote was a blow to AstraZeneca’s hopes of winning approval, although the FDA can go against advisory committees.
    • “After the setback, AstraZeneca provided additional analyses requested by the FDA. The analyses include data on circulating tumor DNA clearance linked to longer-term efficacy outcomes, which AstraZeneca will share next week at the American Society of Clinical Oncology annual meeting. The FDA has pushed back its ruling on whether to approve camizestrant while it reviews the analyses.” 
  • MedTech Dive tells us,
    • “Insulet is recalling 7 million insulin patch pumps due to a manufacturing issue where devices may have a small tear in the tubing just above the skin.
    • “The problem can cause insulin to leak outside of the body, with the potential for people to not receive enough medication. For people with diabetes, this can lead to serious complications associated with high blood sugar, such as diabetic ketoacidosis, a medical emergency caused by a severe lack of insulin.
    • “Insulet said in a Tuesday notice that it has received 24 reports of serious adverse events, including hospitalization and diabetic ketoacidosis. The company has not reported any deaths related to the recall.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The American Cancer Society released updated colorectal cancer screening guidelines May 27 that include the addition of a blood-based screening test to be taken in a doctor’s office. The blood test, which detects tumor DNA in the blood, is only recommended for individuals who decline or do not complete preferred screening tests. The organization said a colonoscopy remains the primary recommendation for screening. The blood test has been found to be less effective in detecting advanced precancerous lesions and stage I cancers, according to the ACS. In addition, the organization announced guidelines for using stool-based tests by Cologuard and ColoSense. The ACS reaffirmed that individuals at average risk for colorectal cancer begin screening at age 45.”
  • MedPage Today relates,
    • “In advanced heart failure, cardiac remuscularization with BioVAT was associated with an increase in the target heart wall thickness, left ventricular ejection fraction, and quality of life in a small early-stage study.
    • “BioVAT consists of thin patches of engineered cardiac muscle that can be surgically attached to the outside of the ventricle where cardiomyocytes have been lost.
    • “Questions of efficacy and potential electrical dysfunction require longer-term follow-up and further clinical investigation.”
  • Health Day tells us,
    • “The college years are prime time for the emergence of mental illnesses involving psychosis, according to a new study.
    • “However, almost 60% of college students who seek mental health care after a psychotic episode do not get the recommended treatment, researchers recently reported in the journal Social Psychiatry and Psychiatric Epidemiology.
    • “Going without even one of the recommended three components of treatment — counseling, therapy and medication — could have consequences, researchers warned.
    • “Early intervention and access to services such as therapy and medication in this population are important because it improves outcomes related to overall quality of life, school involvement, employment, symptom severity and relapse rate,” lead author Clara Godoy-Henderson said in a news release. She’s a graduate student in health services and policy research at the Boston University School of Public Health.
    • “It’s estimated that about 3% of Americans are affected by psychosis, a condition in which individuals lose touch with reality and may experience delusions or hallucinations, researchers said in background notes.”
  • BioPharma Dive informs us,
    • “Kailera said Wednesday its triple-acting obesity shot spurred double-digit weight loss in a short Phase 1 dosing trial conducted in China by partner Hengrui Pharmaceuticals, with investigators reporting that enrollees lost up to 16% of their body weight over 12 weeks.
    • “The data compare favorably to early-stage data reported by Zepbound maker Eli Lilly with its so-called “triple-G” agonist drug, which hadn’t reached 10% at the 12-week time point, wrote T.D. Cowen analyst Yaron Werber. Kailera is readying its own Phase 1 trial outside China, which will have data in 2027, while Hengrui is advancing the drug into Phase 2 in China.
    • “Data from the triple-G drug, called KAI-4729, follows positive mid-stage data for Kailera and Hengrui’s dual-acting Zepbound competitor, which has already entered a Phase 3 study. The rapid advancement of Kailera’s pipeline licensed from Hengrui has driven investor enthusiasm for the company and allowed it to enter the publicly traded markets with one of biotech’s largest-ever initial public offerings.”
  • and
    • “Apogee Therapeutics is set to begin Phase 3 studies of an eczema treatment designed to compete with the mega-blockbuster medicine Dupixent after another round of successful Phase 2 testing.
    • “The late-stage research will kick off in the second half of this year, Apogee said Wednesday. It will include three placebo-controlled trials with about 400 patients each, with one study evaluating the medicine in combination with topical corticosteroids. Patients will be followed for a year after an initial 16-week induction period.
    • “Apogee released the plans as it shared the latest positive Phase 2 results and announced as much as $1.3 billion in financing from a collaboration with Blackstone Life Sciences. Apogee says it now won’t need any future equity financing.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “On a sunny Wednesday morning last month, dozens of preschoolers filed into a Compleat Kidz autism clinic in Concord, N.C. One wore light-up sneakers. Another had a Spider-Man lunchbox. They settled into tiny green cubicles, each accompanied by a staff member, and started their work.
    • “A decade ago, this Charlotte suburb had no clinics providing therapy to children with autism. Now it has 12. Inside this one, children buzzed with activity as they worked long sessions with therapists. One 6-year-old girl, exhausted after hours of therapy, fell fast asleep in her therapist’s lap.
    • “Soon, a supervisor, Stephen Schroeder, intervened.
    • “How long?” Mr. Schroeder asked Courtney Evans, the therapist.
    • “I set the timer for 7. We’re almost done,” Ms. Evans said. A couple of minutes later, she nudged the child awake. The girl cried.
    • “At Compleat Kid, a fast-growing chain of autism clinics based in North Carolina, the policy is firm: Naps cannot be longer than seven minutes before children are awakened to resume therapy. The company says this is necessary to prevent fraud since clinics can be paid only when children are awake and getting services. But it also allows the clinic to bill insurers or Medicaid for more hours.
    • “Across the United States, where treatment for autistic children was once fairly rare, thousands of clinics have sprung up, turning a once obscure therapy into a multibillion-dollar industry. The growth has been fueled by rising autism diagnoses, state insurance mandates and a federal requirement that Medicaid cover the therapy. Private equity investors have rushed into the business, buying up chains and opening new clinics.”
  • Beckers Payer Issues relates,
    • “Member satisfaction with commercial health plans has held nearly flat for a third consecutive year, even as rising premiums and deductibles continue to strain the member-plan relationship, according to J.D. Power’s 2026 U.S. Commercial Member Health Plan Study.
    • “J.D. Power published its annual ranking of the top commercial health plan in each region on May 27. Now in its 20th year, the study measures satisfaction among members of 148 health plans in 22 regions based on eight dimensions including trust, digital channels, claims resolution and cost. This year’s results are based on responses from 37,768 commercial members surveyed from September 2025 through March 2026.
    • “The study rates health plans on a 1,000-point scale. The average satisfaction score for commercial plans in 2026 is 562, down one point from 2025 and three points from 2024. 
    • “More than half of surveyed members saw their monthly premium rise this year, a shift the study linked to a 116-point drop in satisfaction. Another 34% faced higher annual deductibles, contributing to an 111-point decline. Claims resolution emerged as one of the clearest opportunities for plans to differentiate. Members who rated their claims experience as excellent scored 734 on satisfaction, compared to 404 among those who described it as good, just okay, or poor.”
  • and
    • “Health plans that aren’t built around provider networks will be allowed on the ACA individual marketplace beginning in 2028, marking a structural change to a system that has operated exclusively on network-based models since the ACA launched more than a decade ago.
    • “For Sidecar Health, an insurer that sells employer-sponsored plans without provider networks, the change opens a market it has long wanted to enter. The company administers benefits for hundreds of employer clients, ranging from companies with 51 to 60,000 covered lives across 25 industries in 48 states.
    • “The individual population and individual people and families — they’re a critical piece of our mission,” Sidecar CEO Patrick Quigley told Becker’s. “Today we only serve employers. What this does is open the door for us to serve even more people, and an audience that is frankly often left behind.”
    • “Sidecar’s model sets fixed benefit amounts based on average local prices rather than contracting with providers. Its members pay at the point of care using a company-issued Visa card and keep half the savings when a provider charges less than the benefit amount. The company says that in 2025, fewer than 1% of claims were clinically denied.”
  • Fierce Healthcare tells us,
    • “GoodRx announced Wednesday the launch of GoodRx Companion, a subscription program that offers access to virtual healthcare services and prescription medications at discounted prices.
    • “Through the $14.99 monthly GoodRx Companion subscription, users can access free and low-cost generic medications, online care visits and additional healthcare services. The company says the new subscription advances its strategy by adding broader offerings alongside its weight loss, erectile dysfunction and hair loss programs.
    • “More than 200 generic medications are free through the telehealth platform, with “hundreds more” for less than $10 across pharmacies nationwide, according to the company. Telehealth visits are $19 through GoodRx Companion to address common health conditions, such as influenza, urinary tract infections (UTIs) and more.”
  • and
    • “Humana’s CenterWell Pharmacy has invested $83 million in its latest distribution center, opening in Florida.
    • “The company announced Wednesday that the new facility will build out the company’s prescription delivery infrastructure in the state, offering an easier and more coordinated experience for members and CenterWell patients.
    • “In addition to home delivery options for Humana members, the 162,000-square-foot facility in Orlando will also offer payer-agnostic services such as direct-to-consumer and direct-to-employer partnerships, which are growing in popularity as prescription costs rise.
    • “The facility can process up to 64,000 prescriptions each day, and will employ 165 people, Humana said.”
  • Healio informs us,
    • The number of U.S. dialysis facilities closing has risen since 2018, particularly smaller, rural and Midwest facilities, according to study data published in American Journal of Kidney Diseases. * * *
    • “The annual opening-to-closure ratios decreased from 8.9 in 2018 to 0.8 in 2024.
    • “More research is needed to determine whether closures impact patient outcomes.”
  • Per a KFF news release,
    • “Drew Altman, Founding President and CEO of KFF, Announces Retirement Plans; Board Appoints Larry Levitt and Mollyann Brodie as Next Leadership Team.”
  • Best wishes in retirement, Mr. Altman.

Friday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Patient safety, U.S. Healthcare, Uncategorized–

Simplificity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The House Appropriations Committee advanced a draft fiscal 2027 Legislative Branch spending bill on Wednesday that would slash the budget for the Government Accountability Office by nearly one-quarter and give a boost to Capitol Police.
    • “The party-line vote of 34-28 came after a contentious markup stretching late into the evening, as Democrats argued the GAO cut would undermine its mission.”
  • The Hill informs us,
    • “Federal Reserve Chair Kevin Warsh was sworn in Friday beside President Trump, kicking off his term as the new head of the central bank at a critical time for the U.S. economy.” * * *
    • “Warsh, 56, returns to the Fed board after serving as a member from 2006 to 2011. He was nominated to the Fed by former President George W. Bush, whom he served as a White House economic adviser before becoming the youngest Fed board member in history.
    • A graduate of Stanford University and Harvard Law School, Warsh also worked at Morgan Stanley and served in various academic and advisory roles outside of his government service. 
    • Warsh was most recently a fellow at Stanford’s Hoover Institution, an influential conservative think tank known for its close ties to prominent Republican policymakers.
  • Healthcare Dive relates,
    • “The HHS is continuing its crackdown on healthcare fraud, launching a program that will use artificial intelligence to examine audits from states and other federal grant recipients — and potentially affect Medicaid funds.
    • “The Office of the Assistant Secretary for Financial Resources will look across all states to analyze at least five years of audits that grantees file annually with the federal government, the department said Thursday. 
    • “The agency says past audits include internal control issues and “chronic” noncompliance. If recipients aren’t able to fix those problems, the HHS could temporarily withhold payments, hold back future funds, or suspend or terminate awards.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with updated use instructions. The FDA said that Abiomed identified an issue where if a patient is treated with a left ventricular Impella device and experiences an extended period longer than 80 minutes with no residual pulsatility, the Abiomed Automated Impella Controller may be forced to restart due to an internal software error.” 
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis (scarring), liver cancer, liver failure, and even death.
    • “Today’s approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available,” said Wendy Carter, D.O., Acting Director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research. “For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications.”

From the judicial front,

  • Bloomberg Law reports,
    • “The importance of the $885 million antitrust verdict this week against Takeda Pharmaceuticals Co. Ltd. had less to do with the nine-figure damages than ending private plaintiffs’ losing streak challenging deals delaying cheaper generics.
    • “The Boston federal jury’s finding that Takeda improperly paid a competitor to delay it from bringing a generic version of its Amitiza constipation medication to market marked the first time a private plaintiff won at trial in a reverse-payment case.
    • “Most challenges to deals between branded drug companies and generic makers either settle or are dismissed before reaching trial, with the more nuanced agreements sometimes making it to a jury. Three have been tried before a jury since the US Supreme Court put drugmakers on notice that the dealings could run afoul of antitrust laws. Until Monday, juries had rejected plaintiffs’ claims each time. 
    • “I expect the case to send ripples through legal departments — if not boardrooms — across the country,” said Robin Feldman, a law professor at the University of California in San Francisco who studies pharmaceutical regulation and intellectual property. She called the verdict a “groundbreaking decision.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country. Because of the later start, some areas of the country may continue to see higher levels of RSV through May. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is low in most areas of the country. Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “As the nation moves closer to topping last year’s measles total in just the first half of 2026, the Centers for Disease Control and Prevention (CDC) today confirmed 59 new cases in a nationwide outbreak that has now reached 1,952 infections. 
    • “All but nine cases are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.”
  • and
    • “Although an Ebola outbreak is growing rapidly in central Africa, experts say it doesn’t pose a public health threat to the United States.
    • “The outbreak, centered in the Democratic Republic of the Congo (DRC), has grown to nearly 750 suspected cases and more than 170 deaths, the World Health Organization (WHO) announced today. Although the risk from Ebola in the DRC is high, the risk of global spread is low, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said. 
    • “Many US infectious diseases experts agree.
    • “This is a horrible situation in affected areas of Africa,” said Michael T. Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, which publishes CIDRAP News. “But for the world, it is not.”
    • “That’s because Ebola, which spreads through contact with bodily fluids, is far more difficult to spread than the airborne respiratory viruses that Americans have confronted in recent years, such as influenza, COVID-19, measles, and even the Andes strain of the hantavirus, which recently caused an outbreak on a cruise ship.”
  • BioPharma Dive points out,
    • “ASCO26: 5 data snapshots ahead of the year’s biggest cancer drug meeting.
    • “Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting gave a peek at anticipated datasets from Merck, BioNTech, Eli Lilly and Moderna.”
  • Per a National Institutes of Health news release,
    • “A team of researchers at the National Institutes of Health (NIH) have unveiled new details about the events GLP-1 receptor agonists trigger within neurons, which have been largely unexplored until now. A study in mice identified key intracellular signaling processes that are tied to the weight-loss effects of the GLP-1 drug semaglutide. The findings improve our understanding of how increasingly prevalent GLP-1s may influence human behavior and identify new opportunities to potentially enhance treatment.
    • “The weight-loss benefits of GLP-1s are well documented and scientists generally know the brain regions associated with these effects. However, several questions remain, such as why responses to medication differ between patients and why the effects for most eventually plateau.
    • “We know much less about the nuts and bolts of what goes on within the neurons that these medications target. By digging into these mechanisms, we’re beginning to answer some of these questions,” said co-corresponding author Andrew Lutas, Ph.D., an investigator at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).”
  • CNN reports,
    • “Pregnant women are routinely advised to take prenatal vitamins for their health and their baby’s development. Now, a new study published Monday in JAMA Network Open concluded that children whose mothers received higher-dose vitamin D supplements during pregnancy performed better on certain memory tests at age 10.”
  • MedPage Today relates,
    • “Preserved global brain structure appeared to buffer cognitive decline in people with Alzheimer’s pathology.
    • “Younger-appearing brains had weaker links between pathology and poorer outcomes in multiple cognitive domains.
    • “Other measures of brain reserve or cognitive reserve showed no clear protective cognitive effect.”
  • Health Day tells us,
    • “Middle-aged people who have migraine with an aura could be more at risk for stroke.
    • “Those who had migraine with aura had a 73% increased risk of stroke
    • “Middle-aged men who suffered any kind of migraine had a more than 3.5-fold increased risk of stroke.”
  • and
    • “Use of calcium, vitamin D, or combined supplementation has little to no effect on the prevention of fractures and falls in adults, according to a review published online May 20 in The BMJ.
    • “Olivier Massé, Pharm.D., from CIUSSS du Nord-de-l’Île-de Montréal, and colleagues conducted a systematic review and meta-analysis to examine the effect of calcium, vitamin D, or combined supplementation on fractures and falls in adults. A total of 69 trials, with 153,902 participants, were included in the review.
    • “Most trial participants were community dwelling (87 percent) and not at high fracture or fall risk (73 percent). The researchers found that little to no effect was found from use of calcium supplements (risk ratio, 0.91), vitamin D supplements (risk ratio, 1.00), or combined supplementation (risk ratio, 0.91) for the primary outcome of any fracture. There was little to no effect on other fracture and fall outcomes seen for calcium, vitamin D, or combined supplementation, based mainly on moderate-to-high certainty of evidence. After extensive exploration of heterogeneity across multiple subgroup analyses, the findings remained robust.”
  • BioPharma Dive informs us,
    • “The outlook for an experimental Parkinson’s disease drug dimmed on Thursday with the announcement that it had failed a key clinical trial.
    • “Developed through a partnership Denali Therapeutics and Biogen, the drug is designed to inhibit an enzyme tied to one of the most common genetic drivers of Parkinson’s: a gene called LRRK2. When this gene mutates, it causes the waste disposal systems in cells to malfunction, leading to the buildup of toxic proteins that damage and destroy neurons.
    • “In 2022, Biogen and Denali kicked off what would ultimately become a nearly 650-person trial that pitted their drug against a placebo. The companies are now saying this mid-stage study showed the drug — codenamed BIIB122 — was not significantly better at slowing the disease progression, as measured by a well-known scale clinicians use to assess how Parkinson’s is affecting a patient’s movement and daily life.”

From the U.S. healthcare business and artificial intelligence front,

  • Per an EBRI news release,
    • “The Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey found that the majority of insured individuals still receive health insurance through their employer.
    • “Employment-based health coverage remained the dominant source of health insurance for privately insured adults, with six in 10 receiving coverage through their own job.” * * *
    • “Coverage patterns have been largely stable, with about one-third enrolled in individual-only coverage and most others covering a spouse or partner.”
  • Fierce Pharma relates,
    • “With both Novo Nordisk’s and Eli Lilly’s oral GLP-1s establishing their footing in the U.S. obesity market, the companies’ respective Wegovy pill and orforglipron tablet Foundayo are making their mark on prescription trends for a class previously confined primarily to injectables.
    • “Looking at the past four weeks, total U.S. GLP-1 prescriptions were up 3.6%, compared to 1.8% at the same time last year, analysts at Citi wrote in a Friday note to clients, citing script tracking data from IQVIA. The Citi team attributed that momentum to the ability of Novo’s and Lilly’s new oral launches to “broaden and reshape the market” for obesity incretin drugs.”
  • MedCity News considers whether “Mark Cuban’s Cost Plus Wellness Appeal to Employers?”
    • Employer advocates said Cost Plus Wellness could help spur more direct contracting and transparency in healthcare, though they questioned whether the model can scale and adequately measure provider quality and outcomes.
  • Beckers Hospital Review reports,
    • “Philadelphia-based Penn Medicine reported an operating income of $238.5 million (2.4% margin) for the nine months ended March 31, up 46.3% from $163 million (1.9% margin) in the same period last year, according to financial documents filed May 20.
    • “The results follow the April 1, 2025, acquisition of Doylestown (Pa.) Health. Doylestown Hospital, a 245-bed teaching hospital, became Penn Medicine’s seventh hospital and is now known as Penn Medicine Doylestown Health.”
  • STAT News tells us,
    • “Retro Biosciences, the longevity startup backed by OpenAI CEO Sam Altman, has raised more money at a $1.8 billion valuation, it announced Friday. 
    • “Retro has a big mission: Add 10 healthy years to the human lifespan. It is seeking to do that by using a variety of technologies, including in vivo gene therapies, cell replacement therapies, and other approaches to spur younger, healthier cells into aging tissues.
    • “The company is currently running its first clinical trial — testing a pill designed to enhance the body’s ability to better clear out protein aggregates in patients with Alzheimer’s disease. Retro CEO Joe Betts-LaCroix told the audience at STAT’s Breakthrough Summit West on Tuesday that the trial is going “super good” and that researchers haven’t seen any dose-limiting toxicities. He said he anticipates releasing some data from the trial around August.”  
  • Fierce Healthcare informs us,
    • “Innovaccer acquired CaduceusHealth to combine its AI platform with the company’s revenue cycle management services and staff to serve ambulatory care providers.
    • ‘Innovaccer, founded in 2014, built software solutions to unify enterprise data and applies AI to automate manual tasks and streamline workflows for payers and providers. Last year, it rolled out Flow Auth, an AI-powered prior authorization solution that is part of Flow by Innovaccer, an AI-powered revenue cycle suite designed to modernize financial operations for health systems. Other capabilities include Flow Capture, an autonomous medical coding solution and Flow Collect, an AI-powered denial management and revenue recovery tool.
    • “Innovaccer claims that it now serves over 200 health systems and payers, 95% of community pharmacies and 80 million patient lives across the United States. Flow is built on Gravity, Innovaccer’s healthcare AI infrastructure platform.”
  • and
    • “Eugene, Ore.-based Ksana Health is undertaking a multi-institutional research effort aimed at creating a new class of artificial intelligence to advance mental health and substance use disorder treatment and prevention.
    • “The software company was awarded a $17.9 million contract by the U.S. Department of Health and Human Services (HHS) to create a Large Health Behavior Model (LHBM). Its goal is to train AI models on smartphones and other wearables data, including sleep, mobility and language use linked to large scale electronic health records (EHRs).
    • “This initiative augments Ksana’s current efforts to shift behavioral healthcare from episodic, subjective assessment toward continuous, data-driven health promotion, reducing healthcare spending, improving quality of life, and reaching populations that currently lack access to effective behavioral health support,” said Tony Scripa, Ksana Health COO and project co-investigator, in a statement.”
  • and
    • “More than seven in 10 Medicare members report feeling confusion or uncertainty when navigating online health information, a new whitepaper from CVS Health found. 
    • “The research (PDF) drew insights from Medicare-eligible consumers through surveys, interviews and ethnographic studies. 
    • “Seventy-one percent of respondents report an eagerness to use more digital health care tools and 86% report an eagerness to use them. However, 58% of respondents report that low digital health literacy is negatively impacting their ability to manage their health. 
    • “We’re caring for the fastest-growing and most clinically complex population in the country, and what we found in the research challenges a common assumption—older adults actually are more open to engaging with technology than many think,” said Dr. Benjamin Kornitzer, M.D., Aetna senior vice president and CMO, in a statement. “It creates a real opportunity to meet them where they are and provide day-to-day support, whether it’s managing medications, following up after a visit, or staying on track with chronic conditions. Technology and engagement can help them live healthier, more independent lives.”
    • “As a result, CVS said it is applying insights from the research across its digital offerings, including clearer navigation, stronger accessibility features and added privacy and security transparency.” 

Thursday report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

A commenter, Patrick Morselli, accurately observed in response to the OPM Director’s blog post that “Simplicity has a high cost in most organizations. Feels like the hardest work is undoing complexity other smart people left behind.”

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Republicans broke with President Trump over his administration’s plan to create a $1.8 billion settlement fund to pay people who claim political persecution, with widespread opposition forcing party leaders Thursday to abandon votes on immigration-enforcement funding and send lawmakers home early for their Memorial Day break.
    • “The “anti-weaponization” fund is a Trump priority, after he alleged for years that his supporters, including those prosecuted over the Jan. 6, 2021, attack at the Capitol, had been targeted unfairly by the Biden administration. But its creation has run into blowback in the Senate, and the immigration-enforcement bill gave senators leverage to dig in their heels.
    • “I don’t like the fund at all,” said Sen. John Curtis (R., Utah), who added he didn’t think any guardrails could fix it. Sen. Thom Tillis (R., N.C.), a frequent target of Trump criticism who is retiring, called it a “payout pot for punks.”
    • “With no resolution in sight, Senate Majority Leader John Thune (R., S.D.) sent senators home for their weeklong Memorial Day recess, putting the Republican-led Congress on course to miss Trump’s deadline to have the Immigration and Customs Enforcement and Border Patrol measure on his desk by June 1.”
  • Healthcare Dive relates,
    • “Lawmakers are mulling reform of how Medicare pays physicians, concerned that insufficient reimbursement in the federal insurance program is incentivizing consolidation and increasing healthcare costs.
    • “Physician pay has declined over the past two decades when accounting for inflation, spurring independent providers to be acquired by hospital systems rather than go it alone, provider witnesses told representatives during a House Energy and Commerce subcommittee hearing Wednesday. And representatives agreed that’s a concern.
    • “Making sure that independent physician practices stay open […] is one of the most critical ways we can ensure competition and drive down costs,” said Rep. Kim Schrier, D-Wash.”
  • The American Hospital Association adds,
    • “Rep. Randy Feenstra, R-Iowa, introduced the Rural Maternity Options for Medical Support Act on May 19. The bill would guarantee that beds used solely for labor and delivery are not counted toward the 25-bed limit for critical access hospitals. The bill is co-sponsored by Reps. Darin LaHood, R-Ill., Jill Tokuda, D-Hawaii, and Kim Schrier, D-Wash. 
    • “New and expecting moms deserve access to high-quality labor and delivery services,” said Lisa Kidder Hrobsky, AHA senior vice president for advocacy and political affairs. “The Rural Maternity Options for Medical Support Act of 2026 strengthens access to maternal health services for mothers in rural areas by ensuring that higher volume critical access hospitals have labor and delivery beds available, even if their other patient beds are full. The AHA appreciates Rep. Feenstra’s leadership to support critical access hospitals and families across the nation.” 
  • and
    • “The House Education and Workforce Committee May 21 unanimously passed the Transparency in Billing Act (H.R. 8684). The bill would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and it would impose civil monetary penalties on hospitals that violate the requirement. 
    • The AHA has previously opposed this policy, saying that hospitals are already transparent about the location of care delivery on their bills and that it would create a significant administrative burden to providers and the health care industry at large.” 
  • Fierce Healthcare tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. removed two key leaders of the U.S. Preventive Services Task Force (USPSTF), a key advisory panel that offers guidance on preventive services, according to media reports.
    • ‘Vice chairs John Wong, M.D. and Esa Davis, M.D. were dismissed from the task force in letters sent to them by Kennedy on May 11, The New York Times reported on Wednesday, citing copies of the letters obtained by reporters. STAT, CNN, Politico and The Hill also reported the terminations, citing the letters.” * * *
    • “The terminations leave the panel with just eight sitting members. Five other members saw their terms expire at the start of this year, and Kennedy did not replace them, and the previous chair, Michael Silverstein, departed on his own, STAT reported.”
  • Federal Network News informs us,
    • “Shane Stevens, the top official for the Office of Personnel Management’s healthcare and insurance arm, is stepping down from his role, Federal News Network has learned.
    • “Stevens, a political appointee, has been serving as associate director of healthcare and insurance at OPM since last summer. He announced in an email Thursday afternoon that he is voluntarily resigning, effective immediately.”
  • Best wishes, Mr. Stevens. Thanks for your service.
  • Tammy Flanagan, writing in Govexec, lets us know “what federal employees get wrong about divorce and retirement.”
    • “Errors involving survivor benefits, health coverage and court orders can create financial problems years after a marriage ends.”
  • FedWeek explains “Insuring Children at College and Federal Benefits Considerations (with a Checklist).”

From the Food and Drug Administration front,

  • Radiology Business reports,
    • “Medtronic is recalling more than 18,000 surgical devices due to a risk of contamination. The recall includes certain lots of the company’s Gundry and DLP retrograde cannulae, which are cardiopulmonary bypass vascular catheters used to perform open heart surgeries.
    • “This recall was put in place due to the potential of a sterile barrier breach. Only certain lots of these devices are included in the recall.
    • ‘The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall. This means the agency believes these devices could cause “temporary or medically reversible adverse health consequences.”
  • STAT News relates,
    • “Wearable maker Whoop has not resolved a dispute with the Food and Drug Administration over a blood pressure feature the company launched last year, according to a top health executive at the company. 
    • “FDA warned Whoop last July over the feature that gives users a daily estimate of their systolic and diastolic blood pressure, saying that it’s a medical device that requires agency review. Whoop argues that the feature is exempt from FDA review because it is intended for wellness purposes.” * * *
    • “The dispute between FDA and Whoop turned up the heat in a simmering debate about how the agency ought to oversee low-risk products. Proponents of deregulation argue that the time and expense required for FDA authorization impede innovation and that FDA review is unnecessary to ensure the safety of many products that potentially benefit consumers.”

From the judicial front,

  • Federal News Network reports,
    • “Some federal employees may now have an easier time qualifying for disability retirement benefits, following a recent precedential decision from the U.S. Court of Appeals for the Federal Circuit.”
    • “In April, the court ruled that federal employees’ disability retirement applications cannot be denied solely based on a lack of “objective” medical evidence. The ruling applies in cases where federal employees have already been removed from their jobs due to a “medical inability to perform.”
    • “Objective documentation, like lab tests or prescription lists, can support an argument but cannot be the sole basis for denying claims, the court said. “Subjective” medical evidence, like a diagnosis based on self-described symptoms, must also be considered. If employees’ disability retirement claims rely on subjective evidence, they won’t automatically be denied benefits.
    • “The decision last month overturned a 2024 ruling from the Merit Systems Protection Board, which had upheld the Office of Personnel Management’s denial of a disability retirement application from a former OPM employee in 2016.”
  • The New York Times relates,
    • “The Justice Department announced charges on Thursday against 15 people for attempting to defraud Minnesota Medicaid and other social service programs in the state of more than $90 million. 
    • “Top officials, including Robert F. Kennedy Jr., the health and human services secretary, and Mehmet Oz, head of the Centers for Medicare and Medicaid Services, appeared in Minneapolis to announce the charges. “The fraud here in Minnesota is shocking,” said Colin McDonald, an assistant attorney general overseeing the administration’s crackdown on fraud.
    • “Among the defendants are an owner and an employee of autism clinics, who are charged with submitting $46.6 million in fraudulent claims to Medicaid, the public health plan that covers low-income people. Additional defendants were charged with filing bogus claims to Medicaid for other services, including those that assist disabled people with obtaining housing and living independently.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The world’s most popular weight-loss and diabetes drugs are linked to a powerful new possible benefit: better outcomes for cancer patients. 
    • “A suite of four new studies suggest that people taking so-called GLP-1 drugs like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro saw reductions in tumor progression, lower overall chance of death and less risk of developing breast cancer.
    • “It’s really provocative that they showed, in several cancers, that people who took these drugs seem to have a lower risk of their cancer returning,” said Dr. Jennifer Ligibel, a breast oncologist at the Dana-Farber Cancer Institute who wasn’t involved in any of the studies.
    • “One study from researchers at the Cleveland Clinic Cancer Institute tracked more than 10,000 patients with early-stage cancers who started GLP-1 drugs after diagnosis and compared their disease progression to those on a different diabetes medication. Those on GLP-1s were less likely to see their cancer spread.
    • “In lung cancer patients, the rate of progression to advanced disease was cut roughly in half—10% in GLP-1 users versus 22% in the comparison group. Breast cancer patients showed a similar pattern, with progression rates of 10% versus 20%. Colorectal and liver cancers also showed statistically significant reductions.”
  • and
    • “An investigational drug developed by Eli Lilly LLY  delivered clinically meaningful weight loss in a trial, the company said as it looks to expand its obesity treatment portfolio amid soaring demand.
    • “Lilly said Thursday that retatrutide, designed to be taken once a week, met the primary endpoint in a phase 3 clinical trial, as well as key secondary endpoints.
    • “According to Ania Jastreboff, a Yale School of Medicine professor and lead investigator for the trial, every dose of retatrutide assessed resulted in clinically meaningful weight reduction for nearly all participants. On average, those with severe obesity on the highest dose lost 30% of their body weight over two years, Jastreboff added.
    • “The trial evaluated the therapy’s efficacy and safety on adults who are overweight and had other medical conditions such as type 2 diabetes, chronic pain and cardiovascular issues.
    • “More results will be shared later this year, Lilly added.”
  • Healio adds,
    • “Studies show that GLP-1 receptor agonists have significant potential for treating glaucoma, diabetic retinopathy and other eye diseases, but important nuances remain to be investigated, according to a review published in BMC Ophthalmology.
    • “Although GLP-1 RAs have revolutionized metabolic disease management, their potential therapeutic role in ocular diseases — particularly those driven by shared metabolic and inflammatory pathways — remains underexplored,” Yu Luo, of Beijing University of Chinese Medicine, and colleagues wrote. “Their multifaceted neuroprotective properties and anti-inflammatory mechanisms present a distinctive therapeutic opportunity for ophthalmic pathologies, potentially offering direct ocular benefits beyond systemic metabolic control.”
  • and
    • “Adults with obesity achieved greater long-term weight loss if they partook in a nutrition plan designed for rapid weight loss compared with one designed for gradual weight loss, according to trial data.
    • “Line Kristin Johnson, RD, PhD, senior researcher at Vestfold Hospital Trust in Norway, said there has been debate among researchers regarding whether rapid weight loss leads to worse long-term outcomes for people with obesity. In findings from a randomized pragmatic trial presented at the European Congress on Obesity, Johnson and colleagues found implementing a calorie-restricted eating pattern for rapid weight loss can induce a larger decrease in body weight at 1 year than a gradual weight-loss eating pattern.”
  • Endocrinology Advisor points out,
    • “Life-course body size progression, particularly transitioning from a thinner childhood body size to adult obesity, significantly increases risks for stroke, coronary artery disease, and heart failure.”
  • Healio also notes,
    • “Only a third of cancer survivors receive advice on weight control and improving their diet from health care professionals, and less than half are informed about the benefits of physical activity.
    • “Individuals who do receive advice on losing weight, salt and fat intake, and exercise are three to eight times more likely to engage in healthy behaviors than those who did not.
    • “We need more effort to deliver lifestyle behaviors to patients,” Chao Cao, PhD, MPH, instructor in the department of medical oncology at Dana-Farber Cancer Institute, told Healio.”
  • Fierce Pharma tells us,
    • “Phase 3 data for Merck & Co. and Kelun-Biotech’s antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) suggest the race is heating up to establish a new standard of care in first-line non-small cell lung cancer.
    • “According to an abstract released ahead of the ASCO 2026 annual meeting, combining the TROP2-directed ADC with Keytruda slashed the risk of disease progression or death by a major 65% compared with Keytruda alone in treatment-naïve, PD-L1-positive NSCLC. The p-value is below 0.0001, suggesting high statistical significance.
    • “Key overall survival results, which will underpin regulatory considerations in first-line NSCLC, were not mature at the Sept. 29, 2025, data cutoff, but a strong trend with a preliminary 45% improvement in favor of the combo arm was observed.” 
  • Per MedPage Today,
    • “Undetected attention deficit-hyperactivity disorder (ADHD) was not uncommon among adults hospitalized after traffic accidents, according to a cross-sectional study from the Dominican Republic.
    • ‘Among 95 adults admitted for traffic-related injuries without a prior diagnosis, more than a third (34.7%) screened positive on the Adult ADHD Self-Report Scale, reported Amanda Abreu, MD, of the Universidad Iberoamericana in Santo Domingo, Dominican Republic.
    • “High-risk driving behaviors — including violations, mistakes, and slips — were more common among adults who screened positive (66.6% vs 30.6%, P=0.0016), she reported at the American Psychiatric Association annual meeting.
    • “We’re not saying that ADHD alone caused the accidents, nor are they unsafe drivers, but these findings suggest that this is a really vulnerable population we should look into, and we should help protect,” Abreu said.”
  • and
    • “Low-risk pancreatic cystic lesions were found to be associated with a long-term risk of pancreatic cancer in a retrospective cohort study.
    • “The incidence rate of pancreatic cancer among patients with pancreatic cystic lesions was higher than that of the general population (1.89 vs 0.14 per 1,000 person-years).
    • ‘Over a quarter of patients were diagnosed with pancreatic cancer more than 5 years after detection of lesions, suggesting longer-term follow-up is needed to avoid missed diagnoses.”
  • Per the Wall Street Journal,
    • “New French research links natural food color additives to increased risks of Type 2 diabetes and cancer, similar to synthetic dyes.
    • “Beta-carotene, curcumin and anthocyanins used as color additives were linked to a higher risk of Type 2 diabetes. Beta-carotene used as a food coloring was also linked to breast cancer.
    • “The findings challenge the Trump administration’s push for natural dyes and food companies’ shift away from artificial colors.”
  • Per BioPharma Dive,
    • “BioMarin is looking to expand the use of its top-selling medicine, Voxzogo, with positive study results released Wednesday.
    • I’n 2021, Voxzogo became the first drug approved to improve growth in children with achondroplasia, the most common form of dwarfism. The new results pertain to a related condition called hypochondroplasia that generally presents in less severe ways and might not be noticed until later in a child’s life.
    • ‘In the Phase 3 trial, researchers found participants given Voxzogo were growing faster than those who received a placebo. After a year, the Voxzogo patients also had significant increases in standing height and arm span, a key finding that could help children function better in daily tasks and retain more independence.”

From the U.S. healthcare business and artificial intelligence front,

  • Managed Healthcare Executive reports,
    • ‘For the average person, healthcare costs rose 7.9% in 2026 to $8,460, which is the highest annual increase in more than a decade, according to the 2026 Milliman Medical Index
      (MMI). For a hypothetical family of four, healthcare costs reached $37,824, Milliman found. The Milliman Medical Index measures healthcare costs covered by a typical employer-sponsored health insurance plan.”
    • “The increase reflects structural forces that are not going away, Milliman Principal and Consulting Actuary Deana Bell said in a news release. “Outpatient costs have quadrupled for the MMI’s family of four since the MMI was first published in 2005, with much of the trend exacerbated by delivery system consolidation, specialty drug growth, and site-of-care shifts.”
  • Beckers Hospital Review relates,
    • “The National Council of State Boards of Nursing found the District of Columbia has the most licensed nurses per capita, while Utah is the state with the fewest for the second year in a row.
    • “The organization created a course of nursing licensure statistics in the U.S. and its territories. The data was compiled using the NCSBN’s database and Nursys, an electronic information system where regulatory bodies enter licensure data. All of the council’s 58 members shared licensure data, which amounted to 6,903,665 registered and practical nurses — up from 6,870,362 last year.
    • ‘According to the data, Wyoming and Vermont had the fewest licensed nurses in their states overall, at 9,620 and 13,528, respectively. Meanwhile, California and New York had the most licensed nurses at 708,141 and 610,207, respectively.” 
  • Healthcare Dive tells us,
    • “Nonprofit health system Providence is throwing in the towel on the majority of its health insurance businesses, citing the difficulty of running a regional health plan amid regulatory pressures and rising costs.
    • “Starting next year, Providence, which covers about 440,000 people in a handful of western states, will no longer offer Medicaid, Affordable Care Act or employer-sponsored plans, the Renton, Washington-based system announced on Wednesday.
    • ‘The decision comes as Providence attempts to shore up its financial footing and refocus on delivering care. Still, the company plans to maintain its Medicare Advantage operations through a partnership with a national carrier, according to the release.”
  • Modern Healthcare tells us,
    • “Sutter Health and Allina Health have moved a step closer to joining forces.
    • “Sacramento, California-based Sutter and Minneapolis-based Allina said Thursday they signed a definitive agreement to form a $26 billion combined system with 39 hospitals. The agreement follows a letter of intent announced in March. The proposal is on track to close by the end of the year pending customary regulatory approval, the organizations said in a news release.” 
  • BioPharma Dive informs us,
    • “Eli Lilly has snagged Engage Biologics, a biotechnology company that aims to deliver genetic medicines without viral payloads, in a deal worth up to $202 million.
    • “Lilly said Wednesday it has acquired the preclinical biotech in an all-cash deal, including an undisclosed upfront payment, with the possibility of future payouts based on research, development and commercialization milestones. The acquisition gives Lilly non-viral DNA delivery technology, dubbed the “Tethosome” platform.
    • “We believe that the combination of Engage’s platform with Lilly’s significant capabilities will meaningfully accelerate development of new genetic therapies,” Will Olsen, co-founder and CEO of Engage, said in a statement.”
  • Fierce Healthcare lets us know,
    • “Electronic medical record (EMR) company Canvas Medical launched Canvas Studio Thursday, a no-code interface that allows clinicians and other healthcare professionals to build custom EMR workflows.
    • “Canvas Medical CEO Adam Farren told Fierce Healthcare the company was “serving a market” for software developers to customize workflows for end users within its ONC-certified EHR platform. 
    • “What Studio does is replace the developer with an AI agent, so that the end user, the clinician or administrative staff user, can directly customize and extend Canvas themselves using the agent,” Farren said.”
  • and
    • “Employers are set to significantly increase their use of AI in health benefits, a new survey shows, even as they continue to face barriers to rolling out the tech.
    • “WTW polled 312 employers with about 4.6 million workers for the 2026 AI Use in Health and Benefits Survey, and found that 72% of those surveyed plan to embed AI into their benefits programs in the next two years. By comparison, only 20% said they are currently doing so.
    • “The employers cited several key areas where they see AI likely supporting benefits at work, such as improved communication, cited by 68%, and data insights and analytics, noted by 59%. In addition, 57% of those surveyed said AI would likely support greater personalization.
    • “Jeff Chandler, North America commercialization leader for Health & Benefits at WTW, said in a press release that these top priorities are all “areas where AI can materially improve how benefits teams make decisions and support employees.”

Midweek update

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

Simplicity is a virtue.

Medium adds, “Simplicity, though not traditionally viewed as a virtue, is the greatest virtue of all because it makes practicing every other virtue that much easier.”

From Washington, DC,

  • Healthcare Dive reports,
    • “Senate Democrats are trying to roll back a pilot program that adds artificial intelligence-backed prior authorization for some services in Medicare. 
    • “Sens. Ron Wyden, D-Ore., Maria Cantwell, D-Wash., Richard Blumenthal, D-Conn., and Kirsten Gillibrand, D-N.Y., introduced a resolution Wednesday that would invoke the Congressional Review Act — a legislative tool lawmakers can use to overturn agency actions — to end the WISeR model, which went into effect in six states this year. 
    • “Democrats have railed against the pilot for months, arguing the model delays or denies Medicare beneficiaries’ care. “Americans are sick and tired of abusive prior authorization tactics putting needed health care out of reach,” Wyden said in a statement. “The last thing seniors need is even more AI denying the care they need.”
  • The American Hospital Association relates,
    • “The AHA May 20 provided comments to the House Energy and Commerce Subcommittee on Health for a hearing on the physician fee schedule, the Medicare Access and CHIP Reauthorization Act and potential payment reform. The AHA highlighted responses to previous congressional requests for information on reform to MACRA and physician payments. They include asking Congress to provide conversion factor updates for the physician fee schedule that reflect changes in input costs and inflation, and to improve cost measures used in the Merit-based Incentive Payment System. The AHA also outlined policy considerations for alternative payment model design, advanced APM participation incentives and accountable care organizations.” 
  • STAT News tells us,
    • “Health secretary Robert F. Kennedy Jr. has elevated a senior health official to serve as an interim surgeon general until that position is filled by a Senate-confirmed nominee. 
    • “Stephanie Haridopolos, a family medicine physician who is currently a senior adviser and chief of staff for the Office of the U.S. Surgeon General, is now the office’s director of health communications, Kennedy told staff in an email sent late Tuesday. According to that email, Assistant Secretary for Health Brian Christine used his “delegation of authority powers” to allow Haridopolos to carry out the duties of surgeon general. 
    • “She will “promote [U.S. Surgeon General] public health actions, advisories, and guidance until our next Surgeon General is sworn into office,” Kennedy said.”
  • An HHS news release adds,
    • “The U.S. Department of Health and Human Services (HHS) Office of the Surgeon General today released the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents, which raises national awareness about the growing risks associated with excessive and harmful screen use among young people.
    • “Children and adolescents now spend as much or more time on screens as they do sleeping or in school. National estimates show that adolescents average seven to nine hours a day on entertainment screens, and most report using their devices right before bed. What they encounter online and the excessive, and sometimes compulsive, use of screens is increasingly linked to real-world harm.” * * *
    • The Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents is available at https://www.surgeongeneral.gov. Additional resources for families, schools, and communities are available here.
  • Govexec informs us,
    • “Federal employee morale dropped last year, as President Donald Trump downsized and otherwise overhauled the civil service, according to a new data analysis from Gallup. 
    • “[A]fter the reforms took effect, federal workers experienced declines in employee engagement and job satisfaction, alongside increases in burnout and job-search activity,” the researchers wrote. “These shifts were larger than those observed among comparable state and local government workers — and private sector counterparts — during the same period.”
    • “The analytics firm noted, however, that the data shows there was a “rebound” in some areas by the end of 2025.” 
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) proposed today a sweeping crackdown on state Medicaid payment practices that have driven payment rates well above Medicare levels, leading to excessive federal costs. The Medicaid Managed Care State Directed Payments (SDP) and Medicaid Fee-for-Service (FFS) Targeted Practitioner Payments Proposed Rule would set clear caps and better align Medicaid payments with Medicare standards. If finalized, the proposed rule would generate an estimated $775 billion in total savings over 10 years, including $510 billion in federal savings. Our goal: to refocus Medicaid dollars on individuals and families instead of inefficient payment schemes.
    • “The proposed rule would:
      • “Cap SDP provider payment rates at 100% of Medicare payment rates for expansion states and 110% of Medicare payment rates for non-expansion states (or 100% of the Medicaid state plan rate if a comparable Medicare rate is not available), consistent with section 71116 of the WFTC legislation and historical Medicaid FFS payment levels,
      • “Apply similar limits to certain targeted Medicaid fee-for-service payments, and
      • ‘Establish consistent national standards to improve transparency and accountability.
    • “CMS is seeking public comment on the proposed rule, including feedback on implementation. “To view the proposed rule on the Federal Register, visit: https://www.federalregister.gov/d/2026-10292. 
    • “To view the fact sheet, visit: https://www.cms.gov/newsroom/fact-sheets/medicaid-managed-care-state-directed-payments-medicaid-fee-service-targeted-medicaid-practitioner“

From the Food and Drug Administration front,

  • BioSpace reports,
    • “No child deaths were directly linked to COVID-19 vaccines, according to the FDA’s long-awaited analysis of adverse events.
    • “Late last year, former CBER director Vinay Prasad claimed in a leaked internal memo that “at least 10 children have died after and because of receiving COVID-19 vaccination.” The FDA, after much blowback from the industry and independent experts, promised to disclose its analysis by the end of 2025, but the agency largely kept its specific findings under wraps.
    • “Those findings were made publicly available last week as part of a letter from Sen. Ron Johnson (R-WI) to health secretary Robert F. Kennedy, Jr., seeking for greater transparency around the safety of COVID-19 vaccines.”
  • Fierce Pharma relates,
    • “Patrick Soon-Shiong’s ImmunityBio has convinced the FDA to weigh its case for a potential expansion of its bladder cancer med Anktiva, citing “overlapping features” in the indication it’s targeting with the interleukin-15 agonist’s existing approval. 
    • “The FDA has now accepted ImmunityBio’s application for Anktiva plus the Bacillus Calmette-Guérin (BCG) vaccine in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA has set a target decision date of Jan. 6, 2027, ImmunityBio said in a May 19 release.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention yesterday issued an advisory on the Ebola disease outbreak in the Democratic Republic of the Congo and Uganda. The agency said the risk of spread to the U.S. is currently considered low. The notice includes recommendations for clinicians and guidance for U.S. travelers visiting DRC or Uganda. The World Health Organization declared a public health emergency of international concern May 17 due to the outbreak.” 
  • The Washington Post relates,
    • “Teens averaged over 50 minutes of smartphone use between the hours of 10 p.m. and 6 a.m. on school nights, researchers found, and nearly half of the teens used their phones between midnight and 4 a.m. The majority of that phone use was spent on social media apps like YouTube, Instagram or TikTok, the study found. Others were looking at streaming apps or playing games like Roblox or Clash Royale.
    • “The study, published Monday in the journal JAMA Pediatrics, followed the screen use of 657 adolescents, a cohort with an average age of 15. All are participants in the national Adolescent Brain Cognitive Development Study, which includes a racially and economically diverse sample of children and is the largest long-term study of brain development and child health in the United States. 
    • “Researchers drew data from an app installed on the teens’ phones that passively tracked their screen use patterns, said Jason Nagata, the lead author and an associate professor of pediatrics at the University of California at San Francisco. This is significant because “a lot of prior studies have relied on self-reporting of screen use,” he said, which isn’t as thorough or accurate.” * * *
    • “And the full impact on sleep likely goes beyond the minutes spent staring at a glowing screen, Nagata adds. Social media use in particular “is very emotionally activating,” he says. “There’s a lot of stimulation, and that can make it harder for teens in particular to wind down, even after you’ve turned the phone off.”
  • Genetic Engineering and BioTechnology News tells us,
    • “Researchers headed by a team at Icahn School of Medicine at Mount Sinai have discovered that many gut bacteria use a flexible survival strategy—known as epigenetic “bet-hedging”—to withstand disruptions such as antibiotics and diet changes.
    • “Studying infant and gut microbiomes, the investigators showed that microbes can switch between functional states, rather than relying solely on genetic mutations, to try to survive shifting conditions. While bet-hedging has been observed in disease-causing bacteria, this is the first study to show that it is widespread among the beneficial microbes that make up the healthy human gut.
    • “The findings shed light on a previously hidden layer of microbiome biology and may help explain why probiotics and fecal microbiota transplantation (FMT) produce inconsistent benefits across individuals.
    • “Gang Fang, PhD, professor of genetics and genomic sciences and director of the Center for Genomic AI and Microbiome Medicine at the Icahn School of Medicine at Mount Sinai, is senior and corresponding author of the team’s published paper in Cell Host & Microbe, titled “Epigenetic phase variation in the gut microbiome enhances bacterial adaptation
  • STAT News adds,
    • “While Tippi MacKenzie was a postdoctoral fellow in the early 2000s, she and her lab mates experimented with using the then-new technology of gene replacement therapy to try to treat inherited disorders in mice before they were born. Over and over it worked. They cured mice with hemophilia and mice with tyrosinemia. And the whole time, people kept telling her that gene therapy in human fetuses was just around the corner, just five years away. 
    • “It’s now been 25 years, and such a reality has yet to materialize. But after promising discussions with the Food and Drug Administration, MacKenzie is now closer than anyone’s ever been.
    • “Her team has submitted an investigational new drug (IND) application to the agency seeking approval for a small trial that aims to treat five fetal patients with a rare lysosomal storage disorder. The agency told them they could bypass animal testing, because the safety profile of the vector they plan to use already has been so well characterized by other academics and companies developing gene therapies for kids and adults.
    • “Thinking back on it, of course, you can’t really do in utero gene therapy until the field of adult and pediatric gene therapy has been well established,” MacKenzie said Tuesday at STAT’s Breakthrough Summit West. “So we basically had to wait for everything to catch up.”
  • Per a National Institute of Standards and Technology news release,
    • “My Research Is Working Toward a Pain-Free Mammogram Alternative.”\
      • “A woman in the U.S. has a one in eight chance of developing breast cancer. That’s a scary number, but the good news is that more women are being diagnosed early and surviving than ever before. 
      • “We have a long way to go before low-field MRI becomes a common alternative to mammograms. But my fellow researchers and I will continue to work to make this happen, because all patients deserve a highly accurate and pain-free approach to screening for breast cancer.” 
  • Medscape informs us,
    • “Digital tools can enhance GLP-1 therapy for obesity and diabetes by bridging gaps in patient education and follow-up. However, clinicians must focus on meaningful outcomes and personalized guidance to ensure effective use and adherence.”
  • MedPage Today points out,
    • “Antibiotics are sometimes prescribed for lower back pain when more conventional therapies don’t work, based on some studies showing bacteria in affected spinal discs.
    • “In this randomized trial, no benefit from amoxicillin-clavulanate could be discerned for patients with refractory low back pain and herniated discs at 1 year.
    • “The authors recommended that antibiotics no longer be prescribed for this indication.”
  • Per Healio,
    • “Data collected from a number of clinical trials found that despite recent “buzz,” there is no significant link between GLP-1 receptor agonists and the progression of diabetic retinopathy, according to a speaker.
    • “These medications have been labeled not to be good for patients who have preexisting diabetic retinopathy, but I don’t think that is fair,” Majda Hadziahmetovic, MD, associate professor of ophthalmology at Duke University, said during a virtual presentation at Real World Ophthalmology.“Those conclusions actually came from two main clinical trials, and both of those clinical trials were cardiovascular outcome trials. Diabetic retinopathy and retinal health were just the side effects that they were not looking at very carefully.”
  • and
    • “Self-collection may be as effective as clinician-collected HPV tests and improve screening rates.
    • “But its implementation requires OB/GYNs to first transition [from pap smears] to primary high-risk HPV screening.”
  • Infectious Disease Advisor adds,
    • “Screening recommendations for HCV [hepatitis C] have expanded in recent years to include universal screening among adults, with an emphasis on reflexive testing strategies in which a positive HCV antibody (Ab) result automatically triggers confirmatory RNA testing. This approach is intended to reduce delays in diagnosis and improve identification of patients eligible for treatment. To evaluate how these recommendations have influenced testing practices, researchers conducted a retrospective analysis of HCV testing patterns from 2018 to 2024 within a large US commercial laboratory network.” * * *
    • “Increased adoption of reflexive HCV testing, alongside laboratory stewardship initiatives and updated screening recommendations, has contributed to more complete and timely diagnostic evaluation of HCV infection.”
  • Per MedTech Dive,
    • “Medtronic on Wednesday said two analyses of its Symplicity Spyral renal denervation system, presented as abstracts at the EuroPCR meeting in Paris, showed the procedure significantly reduced blood pressure in patients over three years.
    • “Outcomes after renal denervation for 787 patients who had prior cardiovascular events were evaluated in one study, while the second followed 903 people with severe hypertension.
    • “The analyses, from the global SYMPLICITY registry, add to a growing body of evidence supporting renal denervation, Medtronic said.”

From the U.S. healthcare business and artificial intelligence front,

  • 401k Specialist reports,
    • “While some workers believe they’ll be employed past retirement age, the truth is that some may be forced into an early retirement.  
    • “Findings from the 2026 Annual Retirement Study from the Allianz Center for the Future of Retirement show that over half of Americans (53%) currently have a target age they plan to retire at.
    • “However, the reality is that many depart the workforce earlier than initially expected. While the findings report that 53% of Americans retired on their own schedule, 42% had to retire earlier than planned. In fact, only 5% of retirees surveyed reported leaving their role later than anticipated.
    • “The findings emulate recent research from the Society of Actuaries, which showed that 59% of its respondents retired earlier, and only 6% left the workforce later than planned.
    • “When asked why they exited the workforce earlier, Allianz found that most reasons were beyond the retiree’s control. Common causes included health issues that prevented job performance (30%) and unexpected job loss (21%), while others realized they were financially ready earlier than expected (21%).
    • “Finances, as expected, play a major role when deciding when to retire. Retirees must consider day-to-day costs and inflation numbers, along with necessary expenses like medical expenditures as they age.
  • Fierce Healthcare relates,
    • “Patient collections are playing a bigger and bigger role in health systems’ total revenues, bringing a new focus on the difficulties organizations face in securing timely, or any, payments for their services, a new survey report warns. 
    • ‘The poll of 205 healthcare revenue heads, conducted by healthcare fintech vendor PayZen and the Healthcare Financial Management Association, found that 22% of respondents named patient balances as their top priority, roughly double the 11% rate reported a year prior. Patient balances were a “nearly universal” presence among the respondents’ concerns, also up from the 73% rate of a year prior. 
    • “Commercial revenue remained the respondents’ overall top priority, though the portion who indicated so dipped from last year’s 75% to 62%. Government program revenue also inched upward from 13% to 16%, naming it their top revenue concern.” 
  • and
    • “Maven, a virtual provider for women’s and family health, has launched its direct-to-consumer products featuring a virtual care clinic, a GLP-1 offering and a hormone therapy offering.
    • “They are available through cash-pay for now. The goal is to close gaps between prescriptions and follow-ups that GLP-1s and hormone therapies require. 
    • “In terms of pricing, the GLP-1s start at $150 a month. For the hormone product, there is a $150 1-time fee, which includes two virtual visits, in addition to medication costs. Specialty care visits in the virtual clinic are currently pay-per-visit, though insurance coverage for those is the eventual goal.”
  • BioPharma Dive tells us,
    • “Privately held Mentari Therapeutics plans to hit the public markets through a reverse merger with InMed Pharmaceuticals, creating a combined company focused on antibody drugs that can prevent migraines.
    • “The deal, announced Tuesday, has already received approval from the boards of both parties and is expected to close in the back half of this year. Terms hold that InMed shareholders would own roughly 1.5% of the combined company, which is slated to have a pro forma equity value of about $421 million. Baked into that value is a concurrent private placement that will result in gross proceeds of approximately $290 million.”
  • MedTech Dive informs us,
    • “Medtronic said Wednesday it has agreed to buy SPR Therapeutics, a company making a device that uses peripheral nerve stimulation to treat chronic pain.
    • “Under the terms of the deal, Medtronic would pay $650 million in cash to buy all outstanding equity in SPR Therapeutics. The purchase would add to Medtronic’s neuromodulation business, allowing the company to provide more pain relief options earlier in people’s care.
    • “The deal is Medtronic’s third major acquisition announced so far this year. In March, Medtronic agreed to buy neurovascular technology company Scientia Vascular for $550 million, and in February, the company announced plans to buy CathWorks, which makes tools to help detect coronary artery disease, for up to $585 million. Medtronic closed the CathWorks acquisition in April.”
  • Per Healthcare Dive,
    • Aetna’s chief digital and technology officer on how the insurer is using AI for patient engagement
    • Nathan Frank discusses how the insurer is using AI to engage members, how the company thinks about risks, and the importance of monitoring the tools and soliciting feedback.
  • Per Fierce BioTech,
    • “The big new thing in medtech for 2026 is AI-powered apps and chatbots designed to help patients navigate their laboratory test results. Now, testing giant Labcorp is getting in on the act. 
    • “The company is launching “MyLabcorp,” a mobile app that brings together lab results with AI-enabled features and clinical guideline-based content.
    • “The idea is that this can be viewed on a user’s phone via the app, giving users “additional context about their health and support more informed conversations with healthcare providers,” according to a May 20 statement.” 
  • Per Fierce Healthcare,
    • “Doximity plans to accelerate its spending on artificial intelligence this year as it aims to become a leading AI platform for doctors.
    • “The health tech company plans to up its R&D and compute spend along with more investments in brand marketing and its AI-enabled peer review capabilities, executives said during the company’s recent earnings call for its fiscal 2026 fourth quarter and full year results. The company’s 2027 fiscal year began April 1.
    • “The company plans to scale its clinical AI suite, including its ambient notetaking tool Scribe and clinical AI assistant and medical search engine Ask (formerly DoxGPT).”