Midweek report

COVID-19

Midweek report

David Ermer–Congress, COVID-19, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • FedWeek reports,
    • “OPM has sought to allay privacy concerns about its plan to access detailed medical information on FEHB/PSHB enrollees, with one of the organizations that raised such concerns—the National Active and Retired Federal Employees Association—cautiously optimistic that OPM is addressing them.
    • “In a Federal Register notice posted in December, but which only drew attention months later in April, OPM proposed to gain access to carriers’ records including office visits, treatment, prescriptions and other medical information, without a requirement that they withhold personally identifying information.” * * *
    • “He said that OPM’s inspector general’s office—which has access to such information for its audits of health plans and carriers—“will provide an encrypted copy of that data to OPM – but only after stripping out names, social security numbers, phone numbers, addresses (except for ZIP codes), and other personally identifiable data. The only member-level PII fields that will remain in the data that OPM receives will be our member’s ZIP codes, year of birth, and their member ID.”
    • “He said that OPM further will replace the member ID with random numbers and characters and that the data “will remain in a secure, separate environment, encrypted at rest and protected with our IT security best practices.”
  • FEHBlog note: At least for HIPAA privacy rule purposes, an anonymous identifier cannot be based on an actual ID number as OPM plans. Moreover, to avoid re-identification, OPM should arrange for a third party to create the anonymous identifier properly and then arrange for the OIG to insert the anonymous identifier into the claims records before they are sent to OPM.
  • Per a Senate news release,
    • “Today the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted to favorably report several bills making health care more affordable and accessible to American families. During the markup, U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the HELP Committee, led Republicans in rejecting Ranking Member Bernie Sanders’ (I-VT) attempt to sabotage the bipartisan bills with toxic poison pill amendments.
    • “I understand why Americans are frustrated with Congress. If we want Congress to work, we have to make it work,” said Dr. Cassidy. “I want part of my legacy [to be] he tried to preserve the institution. But that is a responsibility of us all.”
    • “I appreciate my colleagues’ efforts and will continue to work with Republicans and Democrats to enact a pro-patient, pro-family agenda,” continued Dr. Cassidy.
    • “The Charlotte Woodward Organ Transplant Discrimination Prevention Act, Healthy Start Reauthorization Act, Stem Cell Therapeutic and Research Reauthorization Act, EARLY Act Reauthorization, Accelerating Access to Critical Therapies for ALS Act, and the Biosimilar Red Tape Elimination Act passed unanimously as amended in an en bloc vote. The Medication Affordability and Patent Integrity Act also passed in a 16-6 vote.”
  • The American Hospital Association News relates,
    • The Department of Health and Human Services June 17 announced it will provide more than $700 million in funding for initiatives on mental illness, addiction and homelessness. Funding opportunities include $96 million for the Safety Through Recovery, Engagement, and Evidence-based Treatment and Support Program, or STREETS; $223.1 million for comprehensive community-based behavioral healthcare programs; $238.6 million for the 988 Suicide and Crisis Lifeline; $80 million for substance use prevention, treatment and recovery initiatives; and more than $70 million for mental health services and support programs. 
  • Beckers Hospital Review tells us,
    • “The Trump administration has begun enforcing federal information-blocking regulations against healthcare organizations that fail to provide patients with access to and exchange of their electronic health information, Politico reported June 17.
    • “Thomas Keane, assistant secretary for technology policy at HHS, told the publication that the agency has stepped up enforcement of data-sharing requirements as part of broader efforts to improve healthcare accessibility and affordability.
    • “Congress directed HHS to address information blocking through the 21st Century Cures Act, which was enacted in 2016. Rules implementing the law were finalized in 2020, and penalties were established in 2024.” * * *
    • “We have started issuing notices of nonconformity to information blockers,” Mr. Keane said. “We’ve had people come back to us and tell us: ‘Yes, we were information blocking.’” Mr. Keane said healthcare organizations may have financial or competitive incentives not to share patient information, but federal law requires health information to be shared for the benefit of patients.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. Approved in time for the 2026–2027 flu season, this approval reflects the Trump Administration’s commitment to increasing the availability of generic drugs.
    • “Today’s approval marks a meaningful milestone for the treatment of influenza,” said Iilun Murphy, M.D., Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the U.S. each year.”
    • “Generic baloxavir marboxil tablets may be used for:
      • ‘Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours, and who are otherwise healthy or at high risk of developing influenza-related complications; and
      • “Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.”
  • MedPage Today adds,
    • “The FDA approved oral tebipenem pivoxil (Utebzi) as the first oral carbapenem antibiotic to treat complicated urinary tract infections (UTIs), the agency announced on Wednesday.
    • “Tebipenem pivoxil is indicated for complicated UTIs, including pyelonephritis, caused by the susceptible microorganisms Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis, in adults who have limited or no alternative oral treatment options.” * * *
    • “Tebipenem pivoxil should be available to U.S. patients by the end of 2026, GSK said.”
  • BioPharma Dive tells us,
    • “UniQure, the Netherlands-based biotechnology company, intends to formally ask the Food and Drug Administration to approve its for Huntington’s disease gene therapy now that the two parties are more aligned on the closely watched treatment.
    • “UniQure said Wednesday that, during a recent meeting, FDA staff agreed three years of data gathered from a key trial of the therapy would be enough to support an approval application. As such, the company expects to file one sometime between July and the end of September. The FDA has requested another trial be conducted to confirm the treatment’s effects and, according to the UniQure, the agency wants to make sure both sides see eye to eye on this study’s design before a marketing application gets submitted.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration June 16 announced that a nationwide shortage of stereotactic breast biopsy needles is expected to last through the end of March 2027. The FDA said the shortage is due to a manufacturing disruption and that clinical management adjustments may be required for patients needing a breast biopsy. Healthcare providers are recommended to conserve their use of stereotactic breast biopsy needles. The agency said that Hologic issued a customer letter Jan. 2 that said all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed due to a risk of metal and plastic particles being dislodged from the device during use.” 

From the judicial front,

  • Healthcare Dive reports,
    • “OhioHealth has reached a proposed settlement with state and federal regulators over allegations that the Columbus, Ohio-based system strong-armed insurers into anticompetitive contracts.
    • “The deal announced Tuesday voids problematic OhioHealth contracts and prevents the system from seeking such terms in the future, according to the Department of Justice.
    • “OhioHealth, which has maintained its contracting practices are legal, did not have to admit wrongdoing as part of the settlement. The system also will not pay any penalties or fines.”
  • Fierce Healthcare tells us,
    • “The Pharmaceutical Care Management Association has joined some of the nation’s largest pharmacy benefit managers in challenging Tennessee’s new law governing the industry.
    • “The Volunteer State’s new policy would prevent PBMs from also owning or being affiliated with pharmacies operating in the state. State lawmakers argue that the law would bring greater transparency and fairness to the market, particularly to support independent pharmacies.
    • “CVS Health, parent company of “Big Three” PBM Caremark, was the first to sue over the law in late May, with Express Scripts following suit late last week.”
  • The Wall Street Journal relates,
    • Luigi Mangione will mount a psychiatric defense at his New York state trial for the killing of UnitedHealthcare Chief Executive Brian Thompson, a judge said Wednesday.
    • During a hearing in state court in Manhattan, Judge Gregory Carro said the lawyers discussed the defense strategy at a sealed proceeding earlier this month. The judge said defense lawyers intend to argue that Mangione killed the insurance executive due to an extreme emotional disturbance at the time. * * *
    • The state trial of Mangione, 28 years old, is scheduled to begin on Sept. 8. A psychiatric defense would significantly alter the nature of the trial because his lawyers would acknowledge he killed Thompson, but argue he did it because he was emotionally disturbed. If a jury agrees with that argument, his murder charge would be downgraded to manslaughter, resulting in a shorter potential prison term.
    • Mangione faces headwinds at trial, including a journal found in his backpack that prosecutors will likely use to argue that he planned the murder for months. “Extreme emotional disturbance is about a loss of self-control for which there was a reasonable explanation or excuse,” said Gary Galperin, a former prosecutor in Manhattan who now teaches at Cardozo School of Law. “The classic case is, you come home and find your spouse in bed with someone else.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “During the most recent respiratory virus season, the risk of hospitalization was higher for influenza than for COVID-19, per a US Department of Veterans Affairs (VA) study of nearly 13,000 patients.
    • “The authors, from the VA Saint Louis Health Care System, noted that while COVID-19 was tied to a substantially greater risk of hospitalization than flu early in the pandemic, data showed an increase in flu cases and hospitalizations in 2025-26 compared with previous seasons.
    • “The findings were published last week in The Lancet Infectious Diseases.
    • “However, population-level metrics reflect both infection frequency and disease severity and cannot alone determine the relative clinical severity of one pathogen versus another,” they wrote. “A head-to-head comparison of hospitalisation risk among infected individuals—which isolates disease severity from differences in infection frequency—has not been undertaken for the 2025–26 influenza season.”
  • Health Day relates,
    • “Folks are told that once you start taking Ozempic or Zepbound, you’ll need to stay on them to maintain the drugs’ benefits.
    • “But patients prescribed such GLP-1 drugs are more likely to stop them and then restart use later than was previously assumed, according to research presented Sunday at the Endocrine Society’s annual meeting in Chicago.
    • “We found that about 4 in 10 patients stopped their GLP-1 medication within the first year, and nearly 6 in 10 had stopped by the end of two years,” based on insurance records from more than 60,000 Americans with type 2 diabetes, said study investigator Sainikhil Sontha. He’s a research associate at Boston University School of Public Health.
    • “However, not everyone who stopped taking their GLP-1 remained off it.
    • “More than half of those who stopped restarted therapy within a year (42%), and nearly two-thirds did so within two years (58%),” Sontha said in a university news release. “This suggests that for many patients, these medications aren’t being abandoned permanently; use is more start-and-stop than most people assumed.”
  • and
    • Solid organ transplant survival is improving, but organ shortages persist, according to a study published in the July issue of the Journal of the American College of Surgeons.
  • and
    • “At-home blood pressure monitoring can lower risk of heart attack and stroke
    • “People participating in a remote monitoring program had a 34% lower risk of heart attack, stroke and heart disease
    • “Their readings were forwarded to a doctor, who kept tabs on their blood pressure.”
  • The Washington Post lets us know,
    • “As a doctor, I tell people to do these 4 things to reduce age-related muscle loss
    • “Resistance training, protein and recovery remain the most powerful tools for preserving strength and independence later in life.”
  • The latest NIH Research Matters covers the following topics:
    • Immune system may attack nervous system in some Long COVID patients
      • “Researchers linked antibodies that attack the body’s nervous system to some neurological symptoms of Long COVID.
      • “The results may point to possible treatments for some people with Long COVID.”
    • Depression screening using video games
      • “A study suggests that the unconscious way the brain assesses rewarding experiences is miscalibrated in patients with depression. 
      • “Game-like tasks to measure this mechanism could help doctors screen patients more quickly for depression.”
    • AI tool could speed antibiotic development
      • “Researchers developed and tested a system to improve the antibacterial effects of existing compounds.
      • “This system could help quickly create new antibiotics to overcome antibiotic resistance.”

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

  • The Wall Street Journal delves into state of the U.S. healthcare business.
  • Beckers Hospital Review ranks 40 health systems based on their first quarter 2026 operating margins, and tells us,
    • “Nashville, Tenn.-based Ascension Saint Thomas has broken ground on a $148.5 million hospital and healthcare campus in Clarksville, Tenn., expanding its presence in one of the state’s fastest-growing regions. 
    • “The 96-acre campus will include a full-service hospital that will open with 44 inpatient beds and expand to 132 beds as demand grows. The hospital will be St. Louis-based Ascension’s 19th in Tennessee, according to the health system’s website. 
    • “The hospital will offer emergency care, inpatient surgery, cardiology, neurosciences, women’s health, neonatal intensive care, oncology and orthopedic services. The broader campus will also feature physician offices, an inpatient rehabilitation hospital, outpatient surgery, advanced imaging and specialty ambulatory care services.”
  • BioPharma Dive informs us,
    • “Jazz Pharmaceuticals is enlisting the help of AbCellera in a bid to develop next-generation T-cell-engaging medicines to treat solid tumors.
    • “As part of a deal announced Wednesday, Jazz will pay AbCellera $56 million up front in exchange for discovery work and early-stage preclinical research on two programs. AbCellera also committed to start a third discovery program within 12 months, which will trigger another $28 million payment, and may undertake two additional projects if both companies agree.
    • “If Jazz exercises options for development, AbCellera could earn as much as $792 million more per program in fees and payments for reaching certain development, regulatory and commercial milestones. AbCellera would also be eligible for royalties, should any approved medications come out of the collaboration.”
  • Fierce Healthcare points out,
    • “Fitness wearable company Whoop announced Wednesday a partnership with health platform HealthEx that allows users to connect their medical records directly within the Whoop app, combining medical history with biometric data.
    • “The companies say the partnership “responds to a growing need” for “more connected health experiences” for users. The new integration allows various factors—such as chronic conditions, recent procedures and more—to be considered alongside tracking metrics, like performance and sleep. 
    • “Whoop has always focused on turning data into meaningful insights,” said Alex Vannoni, Whoop’s head of healthcare product, in a statement. “This partnership extends that approach by bringing medical history into the Whoop experience, giving members a more complete view of their health and enabling even more personalized, relevant coaching, grounded in who they are, not just what happened on a given day.”
    • “The integration is enabled by the Whoop AI and My Memory features. The artificial intelligence-driven My Memory feature, announced last month, allows users to provide context to manage personalized coaching.”
  • Beckers Payer Issues notes,
    • “Payers often work with employers, but they have to keep their own staff happy, too. 
    • “Amid a climate of payers across the country cutting jobs, Centene recently confirmed it is offering buyouts to most employees as its ACA business contracts. Against that backdrop, employee morale and retention have become pressing priorities for health plan leaders.
    • “Becker’s spoke with Sidecar Health’s chief people officer, Alex Coonce, and Elevance Health’s chief human resources officer and executive vice president, Ryan Craig, to learn about the biggest concerns for today’s health plan employees — and how each company is tackling them.”

Monday Report

David Ermer–ACA, CMS, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NIH, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“In her 1789 book The Female Reader, writer and philosopher Mary Wollstonecraft wrote: “Simplicity and sincerity generally go hand in hand, as both proceed from a love of truth.” (Source: https://tinyurl.com/4fzesrp4)

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. launched GetActive.gov, a new national resource to help Americans improve their health through movement, fitness, outdoor recreation, and active living, during a series of “Take Back Your Health” tour stops across Colorado.
    • “Secretary Kennedy joined Secretary of the Interior Doug Burgum in Grand Junction to announce the initiative and highlight the Trump Administration’s efforts to expand access to public lands and outdoor recreation opportunities. He then visited Fort Carson to see firsthand how the Army is improving nutrition for servicemembers through its campus-style dining modernization program. The Secretary also toured InnovAge in Thornton, where he met with caregivers and seniors participating in the Program of All-Inclusive Care for the Elderly (PACE).
    • “The key to reversing America’s chronic disease epidemic is empowering people to take back their health,” Secretary Kennedy said. “We are helping people Get Active, Eat Real Food, and Live Real Life. From our public lands to our military bases to our senior care centers, these Colorado visits show how we are putting Make America Healthy Again into action.”
  • The American Hospital Association News reports,
    • “The Medicaid and CHIP Payment and Access Commission June 15 released its June 2026 report to Congress. Among the topics discussed, chapter two focuses on automation in Medicaid prior authorization and makes recommendations to improve oversight and increase disclosure and transparency of managed care plans’ use of automation in PA. The third chapter includes recommendations to improve managed care plan accountability. Chapter seven examines Medicaid provider enrollment and managed care credentialing processes and highlights challenges that have effects on provider participation and state administrative burden.”
  • and
    • “The Centers for Medicare & Medicaid Services and the Department of Health and Human Services issued a request for information June 12 seeking input on CMS’ review of the Affordable Care Act’s Essential Health Benefits framework and the requirement that the scope of EHBs is equal to the scope of benefits provided under a standard employer plan. Specifically, CMS is seeking comments on current interpretations of EHBs, state approaches to selecting and updating EHB-benchmark plans, methodologies to determine the scope of benefits included as EHBs, and how those approaches relate to access and market stability under the ACA. The agencies said the information will impact CMS’ evaluation on whether revisions or additions to current EHB regulations would be appropriate. Comments are due by July 15.”
  • BioPharma Dive relates,
    • “New under-the-skin injections of the cancer immunotherapies Keytruda and Opdivo would be subject to Medicare price negotiations at the same time as their intravenous counterparts under a proposed federal rule published Friday.
    • “The Centers for Medicare and Medicaid Services said the rule would close a “loophole” that allows drugmakers to extend the patent-protected life of blockbuster drugs, commonly called “evergreening.” However, Medicare could exempt the newer formulation from its price ceiling should biosimilars of the IV version enter the market and compete on price.
    • “The rule could most immediately affect Keytruda maker Merck & Co. and Opdivo developer Bristol Myers Squibb, along with Halozyme, which developed the delivery technology that helped Opdivo and Johnson & Johnson’s Darzalex transition from IV to subcutaneous shots. Halozyme, however, said it forecasts “zero to minimal impact to its royalty revenues through at least 2035.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration said Monday that it will allow Colorado to import certain prescription drugs from Canada in an effort to bring prices down for residents, making it the second U.S. state to be granted such authorization. 
    • “For more than a quarter of a century, Americans have sought drugs from Canada for relief from the ever-rising costs of medicines, sometimes taking widely publicized bus trips across the border. It wasn’t until 2020, though, that the first Trump administration officially endorsed the practice, when it published a regulationallowing states and Indian tribes to propose import plans. The Biden administration affirmed this rule with an executive order in 2021. And Florida became the first state to earn FDA approval in 2024. 
    • “But state importation programs have proved extremely difficult to carry out, even with bipartisan support. Florida has yet to actually import any drugs from Canada, in part due to pushback from the Canadian pharmaceutical industry and fears the program will affect Canada’s drug supply. In May, the FDA extended its approval by six months to give the state more time to get its program up and running.”
  • Fierce Pharma relates,
    • “Despite prior concerns from the FDA, a regimen involving AstraZeneca’s AKT inhibitor Truqap (capivasertib) has passed muster in a specific population of prostate cancer patients. 
    • “Late last week, the U.S. regulator signed off on Truqap plus Johnson & Johnson’s Zytiga (abiraterone) and prednisone to treat adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer—the indication previously known as metastatic hormone-sensitive prostate cancer—that is determined to be PTEN-deficient.
  • and
    • Merck & Co.’s first-in-class HIF-2 alpha inhibitor Welireg is touching down in the clear cell renal cell carcinoma (ccRCC) treatment space, notching a Keytruda combination nod that stands to pad the landing for the company’s post-Keytruda outlook. 
    • The June 12 FDA approval is the first for a PD-1 and HIF-2a inhibitor combo, stipulating the regimen’s use as an adjuvant treatment for adults with ccRCC who are at intermediate-high or high risk of recurrence following kidney removal surgery. Welireg can be used in the disease setting with standard Keytruda or subcutaneous Keytruda Qlex. 
    • With that, Welireg can reach earlier-stage ccRCC for the first time following its 2023 clearance in advanced RCC, marking an “important step in addressing the needs of patients with earlier-stage renal cell carcinoma,” kidney cancer advocacy group KidneyCan’s CEO and co-founder Bryan Lewis noted in a Merck press release. 
  • Cardiovascular Busines tells us,
    • “Penumbra, a California-based medtech company known for its vascular technologies, has received U.S. Food and Drug Administration (FDA) clearance for a new computer-assisted vacuum thrombectomy (CAVT) device designed to treat acute ischemic stroke.
    • “According to Penumbra, Thunderbolt represents the first CAVT device approved in the United States for the treatment of stroke. It is powered by Penumbra’s Engine technology and uses modulated aspiration to “detect, fatigue and completely ingest” blood clots at the site of occlusion. Thunderbolt will be sent to customers prepackaged with one of the company’s catheters.”
  • MedPage Today tells us,
    • “The FDA cleared medical-grade Australian sheep blowfly (Lucilia cuprina) larvae in what maker Cuprina Holdingsopens in a new tab or window believes marks the first debridement product to use this particular species.
    • “Dubbed Medifly Maggots, the product is indicated for removing dead or infected tissue from non-healing necrotic skin and soft tissue wounds — such as pressure or neuropathic foot ulcers — and non-healing traumatic or post-surgical wounds.
    • “A healthcare worker is required to oversee the application of the prescription maggot product, which was cleared based on demonstration of equivalence to the previously cleared medical-grade green bottle blowfly larvae — Lucilia sericata (Medical Maggots).”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has struck down key provisions in a CMS rule overhauling the Affordable Care Act, in a setback for the Trump administration’s push to combat fraud that critics argue is a smokescreen for weakening the exchanges set up by the Obama-era law.
    • “On Friday, Judge Brendan Hurson of the Maryland District Court vacated eight of the rule’s most consequential provisions, including the creation of a $5 premium penalty for individuals who automatically reenroll in coverage and a policy disqualifying people who fail to reconcile tax credits with their income from receiving subsidies.
    • “The decision is not a surprise after Hurson stayed most of the provisions last year. Still, officially tossing them out is a victory for proponents of expanded ACA coverage — though a short-term one, given many of the changes were codified in the GOP’s “Big Beautiful Bill” passed last summer.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “A pregnant woman in rural Arizona with syphillis could have been treated fairly easily with an injection of penicillin. But the drug, Bicillin L-A, is manufactured only by Pfizer, and has been in short supply for a year now — which meant the drug arrived too late to prevent probable congenital syphilis in her newborn.
    • “The syphilis epidemic is worsening, congenital syphilis cases are up roughly 800% since 2012 — and this Bicillin shortage is expected to continue through 2027. Public health officials say Pfizer’s emergency allocation system is confusing and may disadvantage health departments serving low-income patients.
    • “A box of 10 syringes can cost around $8,000, and the drug is manufactured at only one Pfizer plant in Michigan to supply the whole country.
    • “Most shortages are of not-very-profitable drugs,” said Erin Fox, associate chief pharmacy officer at University of Utah Health.”
  • The American Medical Association lets us know what doctors want patientsto know about allergic rhinitis
    • “Allergic rhinitis, or hay fever, is more than just the sniffles. Understanding triggers and when to talk to a physician are key to managing allergic rhinitis.”
  • Per an National Institutes of Health news release,
    • “A clinical trial supported by the National Institutes of Health (NIH) found that adults with prediabetes assigned to a lifestyle intervention had a significantly lower risk of developing multiple chronic health conditions (known as multimorbidity) over time than those assigned to a placebo. This study, which followed participants for over two decades, also found that participants assigned to receive metformin did not experience a statistically significant reduction in multimorbidity risk. The findings, published in JAMA, highlight the lasting benefits of lifestyle programs that may lower risk of the development of chronic conditions.
    • “Multimorbidity is a common issue, and few interventions have been found to prevent or delay developing multiple chronic conditions,” said Marcel Salive, M.D., first author of the study, from NIH’s National Institute on Aging (NIA). “Our work showing that healthy lifestyle intervention can significantly lower the burden of multimorbidity is a step forward in addressing this growing problem.”
  • MedPage Today relates,
    • “COVID-19 vaccines were associated with a lower risk of major adverse cardiovascular events in “a cohort study of veterans.
    • “The 2024-2025 vaccines also demonstrated effectiveness against COVID-associated emergent care, hospitalization, and critical illness among adults.
    • “Among older adults who received a 2025-2026 vaccine, overall COVID vaccine effectiveness against symptomatic disease was 59%.
  • Healio tells us,
    • “Less than a quarter of patients with stroke and fewer than one in seven with traumatic brain injury were discharged to inpatient rehabilitation.
    • “Clinicians should plan for rehabilitation early and make it an intentional part of care.”
  • and
    • “The American College of Physicians (ACP) has published living clinical guidance to help physicians select medications for patients with overweight or obesity.
    • “Unhealthy weight remains a significant public health issue globally, with 68.5% of American adults and 59% of adults worldwide having overweight or obesity, according to Amir Qaseem, MD, PhD, MHA, MGIN, MRCP, FACP, ACP chief science officer and senior vice president of clinical policy at the Centers for Evidence Reviews, and colleagues.
    • “They wrote in Annals of Internal Medicine that first-line treatments for obesity and overweight include physical activity and nutrition, but the new guidance “addresses additional management using pharmacologic treatments when lifestyle modifications alone do not result in optimal weight loss or weight maintenance for a person.”
  • Pharmacy Times informs us,
    • “Pooling ATTAIN-1/2 female participants, menopausal stage–stratified outcomes at 72 weeks included weight, waist circumference, waist-to-height ratio, and categorical weight-loss thresholds using an efficacy estimand. 
    • “Orforglipron [Lilly’s oral GLP-1 drug] achieved statistically significant placebo-adjusted reductions across premenopause, perimenopause, and postmenopause, reaching approximately 14% body-weight loss and up to 11 cm waist reduction (P<.001). 
    • “Clinically meaningful responder rates favored orforglipron, with up to 83% achieving ≥5% weight loss vs 23% on placebo, and higher rates across ≥10%, ≥15%, and ≥20% thresholds. 
    • “More participants shifted to lower waist-to-height ratio categories on active therapy, supporting potential visceral adiposity and cardiometabolic risk mitigation in menopause-associated fat redistribution. 
    • “Unrestricted oral administration (no food/water requirements) may reduce adherence barriers in midlife women with polypharmacy, strengthening pharmacist-led counseling and referral pathways in obesity care.”
  • BioPharma Dive points out,
    • “An experimental drug that Eli Lilly recently picked up through a potentially multibillion-dollar acquisition appears to have passed its first major test, scoring positive results in a small study of patients with hard-to-treat blood cancer.
    • “Originally developed by Ajax Therapeutics, the drug inhibits an enzyme that spurs blood cell production. Several medicines that block this “JAK2” enzyme, including Incyte’s Jakafi, are already on the market, where they’re mostly used in rare, chronic blood cancers like myelofibrosis. While these medicines can be quite effective at treating symptoms, many patients either don’t respond or stop taking them because their disease progresses or they can’t tolerate the side effects, which range from nausea and fatigue to anemia and increased stroke risk.
    • “Lilly’s pill is designed to work in a slightly different way than its approved counterparts, binding to JAK2 in the “inactive” state. Researchers hypothesize this change should make for a superior therapy that also overcomes drug resistance challenges.
    • That idea now has more support thanks to data presented over the weekend at a major medical meeting in Europe.”

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

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. will launch a new line of commercial health plans called Edge across all five of its Blue Cross Blue Shield states beginning in 2027.
    • “The plans, powered by a proprietary plan design called Easify, have no deductibles and no coinsurance for in-network care, leaving members with fixed copays, according to a June 11 news release. 
    • “HCSC said the PPO plans aim to let employees in Illinois, Texas, Oklahoma, Montana and New Mexico anticipate out-of-pocket costs more easily and help employers better manage total medical spend. HCSC also said the new product will steer members toward “high-value” care using behavioral incentives.” 
  • Beckers Hospital Review relates
    • “Middle-age adults who use GLP-1 medications for obesity could save an average of $192,735 in lifetime medical costs, according to a study published in June by the National Bureau of Economic Research. 
    • “Researchers from Los Angeles-based University of Southern California simulated health and economic outcomes for U.S. adults ages 25 and older, comparing lifetime trajectories for people who used GLP-1s for obesity with those who did not. Obesity was defined as a body mass index higher than 30.”
  • and
    • “Virtual nursing for hospital discharge was associated with sharply lower 30-day emergency department readmissions across nine hospitals in a major Southeastern U.S. health system, according to a study published in npj Digital Medicine.
    • “Researchers at the University of North Carolina at Chapel Hill compared 4,662 discharges handled by remotely located virtual nurses with 4,662 traditional in-person discharges, matched on patient and hospital characteristics. Patients discharged through virtual nursing returned to the ED within 30 days at a rate of 3.7%, versus 13.3% for in-person discharge — a 72% relative reduction, or a risk ratio of 0.28. That works out to roughly 1 readmission in 27 virtual-nursing patients, compared with 1 in 8 receiving standard discharge.
    • “The effect held in both settings, with the gap widest in rural hospitals: 3.1% versus 17.9% rural, and 4.1% versus 10.7% urban.
    • “Virtual nurses delivered structured, uninterrupted discharge education — medication reconciliation, teach-back, and care-plan review — from an off-site center operating 7 a.m. to 7 p.m., seven days a week. The health system rolled out the model across the nine hospitals between 2022 and 2024.”
  • MedTech Dive informs us,
    • “Medtronic said Friday it has completed the $550 million takeover of neurovascular technology company Scientia Vascular.
    • “The deal, which Medtronic disclosed in March, covers guidewire technologies for stroke that are designed to equip physicians to access hard-to-reach parts of the brain.
    • “Buying Scientia will enable “every neurovascular procedure to start with Medtronic,” CEO Geoff Martha said on an earnings call with investors this month.”
  • Medical News Today points out,
    • Three AI-based mammography systems were able to identify subtle signs of future breast cancer years before diagnosis, with elevated cancer prediction scores seen in those who later developed the disease. 
    • In the study, approximately 20% of breast cancer cases showed AI-detectable mammographic changes as early as 6 years before diagnosis. 
    • At 90% specificity, the AI systems flagged potential future cancers in up to 19.7% of women 6 years before diagnosis, 25.2% 4 years before diagnosis, and 39.3% 2 years before diagnosis. 
    • The findings suggest AI could support earlier breast cancer detection and help enable more personalized screening strategies by identifying females who may benefit from closer monitoring or earlier intervention.
  • FYI, The Blue Cross Blue Shield Association has a job opening on its Legal Team supporting FEP.

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.”

Thursday update

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

  • Smart Brief reports,
    • “AHIP26: How data sharing, simplicity can improve care
    • “Panelists at the conference discuss the challenges that data fragmentation and siloing, as well as an unwieldy system, present — and offer solutions.”

From Washington, DC,

  • Govexec reports,
    • “A bipartisan trio of House lawmakers on Thursday reintroduced legislation aimed at expanding federal workers’ access to paid leave to handle illnesses and other circumstances not included in the 2019 law granting feds paid parental leave.
    • “The Comprehensive Paid Leave for Federal Employees Act, introduced by Reps. Don Beyer, D-Va., Brian Fitzpatrick, R-Pa., and Chrissy Houlahan, D-Pa., would grant federal employees up to 12 weeks of paid family leave each year to attend to a serious health condition or to care for a spouse, child or parent. The measure would also cover absences needed to help a family member who is the survivor of domestic violence, sexual assault or stalking, as well as to attend to a family member’s deployment into active duty military service.
    • “When Congress passed the 2020 National Defense Authorization Act, the House’s version included a provision providing 12 weeks of paid parental and family leave to feds. But during negotiations with the Senate, the measure was stripped down to remove the family leave portions, and feds became eligible for paid parental leave in October 2020.”
  • The Wall Street Journal reports,
    • “If you’re a senior, the Medicare plan you choose may have a major impact on whether you can get nursing-home care when you need it—and a new federal investigation shows the largest insurers had some of the highest denial rates.
    • “Medicare insurers had widely varying rejection rates for patients seeking nursing-home stays, as well as for long-term care hospitals and inpatient rehabilitation facilities, according to two new reports from the Office of Inspector General for the Department of Health and Human Services. * * *
    • “Appealing does appear to pay off: Of the 18% of patients who did appeal, nearly all of them were able to overturn the initial denial of skilled nursing care.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services June 11 released guidance detailing plans to implement new guidelines and standards for determining budget neutrality for Medicaid section 1115 demonstrations, which give states flexibility to design and test experimental approaches to Medicaid, including modifying eligibility, benefits, delivery systems and coverage, in ways not otherwise permitted under standard Medicaid authority. The guidance is intended to support implementation of a statutory requirement under the July 2025 reconciliation bill that the CMS Chief Actuary certifies that a demonstration is projected to be budget neutral, meaning it would not increase federal Medicaid spending relative to what expenditures would have been absent the demonstration. CMS said it plans to issue a rule with its proposed changes to budget neutrality.”
  • and
    • “The Centers for Medicare & Medicaid Services June 10 announced the establishment of a new Office of Health Technology and Products. CMS said the OHTP would modernize CMS healthcare technology and digital products, and transform platforms and services to support Medicare, Medicaid, the Children’s Health Insurance Program and other CMS-administered programs. The office will work closely with the CMS Chief Information Officer and be subject to CIO-led IT governance, cybersecurity, enterprise architecture, and capital planning and investment control responsibilities, among other areas. The OHTP will include new divisions, such as an Open Source Program group to develop policies and guidance around open-source frameworks, a Division of Data and Interoperability Platforms, and a Division of Policy responsible for the development of interoperability policies, regulations and sub-regulatory guidance. Additionally, the OHTP includes a Division of Core Products, responsible for the management and modernization of Medicare claims systems and provider-facing components such as the National Provider Directory. The OHTP and organizational changes became effective June 9.”
  • KFF explains how “Medicare Advantage Rebates Disadvantage Medicare’s Stand-Alone Drug Plan Market.
    • “Medicare Advantage Rebates Undermine Competition with Stand-Alone Drug Plans by Lowering Medicare Advantage Drug Plan Premiums.”
  • Beckers Hospital Review points out that “The 340B rebate fight escalates: 14 key developments.”
    • “From the first lawsuit to Lilly’s ultimatum: 18 months that reshaped the 340B program.”
  • Tammy Flanagan, writing in Govexec, discusses “Why Social Security’s funding gap matters to federal retirement.”
    • “Most federal employees under FERS rely on Social Security as part of retirement. The latest trustees report suggests the choices to preserve full benefits are getting tougher.”
  • Per a National Institutes of Health News release,
    • “National Institutes of Health (NIH) Director Jay Bhattacharya, M.D., today announced the selection of Raymond H. Jacobson, Ph.D., as the director of NIH’s Center for Scientific Review (CSR), which ensures expert and fair review of the tens of thousands of grant applications received by the agency each year. Dr. Jacobson will begin his role on June 14, 2026.
    • “Dr. Jacobson will continue strengthening NIH’s centralized peer review system so that we can continue backing the most scientifically meritorious research ideas in support of NIH’s mission,” said Dr. Bhattacharya. “His leadership will help ensure the first level of NIH review remains rigorous, fair, and transparent for all applicants.”
    • “Prior to his selection, Dr. Jacobson served as CSR’s acting director following the retirement of Dr. Bruce Reed. Dr. Jacobson helped guide NIH’s centralization of peer review, and as Acting Deputy Director of the NIH Office of Extramural Research in 2025, he advanced efforts to reduce administrative burden and address challenges faced by applicants. Additionally, he was the director of the CSR Division of Receipt and Referral beginning in December 2024, where he led efforts to simplify application receipt and referral policies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “When millions of soccer fans descend on North America [beginning today] for the 2026 FIFA World Cup, they will bring more than team jerseys and national pride.
    • They will also bring the microbes that travel with people.
    • Public health officials have spent years preparing for the tournament, which is expected to draw visitors from more than 100 countries to the United States, Canada and Mexico. Although diseases such as Ebola and hantavirus have been in the headlines, public health experts say the diseases most likely to show up in clinics, emergency departments or urgent care centers are likely to be less exotic.
    • “Instead, their top concerns include measles, dengue, respiratory viruses and sexually transmitted infections that are already circulating. These diseases are likely to spread more easily as fans crowd into airports, hotels, stadiums and festivals.
    • “Measles is what I’m most worried about,” said Krutika Kuppalli, an infectious diseases physician and associate professor at UT Southwestern Medical Center in Dallas.
    • “Texas will host 16 World Cup matches in 2026 — more than any other state — with nine matches in the Dallas-Arlington area and seven in Houston. Dallas will host more matches than any other World Cup venue, including a semifinal. The first U.S. match is Friday, in Los Angeles, when the U.S. faces off against Paraguay.”
  • and
    • “Neuroscientist Miia Kivipelto’s life’s work has been about preventing dementia. Now, at 52, she has begun thinking more about her own vulnerability.
    • “Midlife is the time,” said Kivipelto, a neuroscientist who recently joined the Yale School of Nursing as the inaugural director of its Center for Aging Well in New Haven, Connecticut. “It’s the last best chance to lower risk.”
    • “The idea that dementia prevention may hinge on what people do in their mid-30s to their 60s is rapidly reshaping the field. Scientists increasingly believe the disease is driven not only by changes in the aging brain, but also by years of metabolic stress, inflammation and vascular damage accumulating across the body. Many researchers now think the biological process that leads to dementia begins 15 to 20 years before the first memory problems emerge. By the time symptoms become noticeable, the disease likely will already be well established.
    • “Neuroscientists now see midlife as a critical window when the brain becomes especially vulnerable to aging — but also more responsive to intervention. 
    • “The implications are profound: The ordinary habits of middle age may matter far more than scientists once realized, and cognitive decline may not be inevitable.”
  • Per a National Institutes of Health news release,
    • “A research consortium funded by the National Institutes of Health (NIH) has established a new framework to identify and catalog senescent cells – cells that stop dividing but remain active in the body. Because senescent cells accumulate with age and are thought to contribute to many age-related conditions, researchers are working to better understand the roles they play in health and disease. In a compendium of papers published in the June 11 issue of Cell, the consortium presents the first comprehensive atlas of senescent cells across the human body, a foundational step toward developing new therapies for age-related diseases.
    • ‘In healthy tissues, senescent cells support wound healing and serve as a defense mechanism by preventing the growth of tumors. They are normally cleared by the immune system, but as immune function declines with age, senescent cells accumulate in the body instead of being eliminated. Over time, these cells then release harmful signals that contribute to chronic disease and other age-related conditions. While removing these cells has been shown to diminish the impact of aging, their rarity and diversity have made them difficult to study.
    • “To address this challenge, the NIH Common Fund launched the Cellular Senescence Network (SenNet) program in 2021 to identify and characterize senescent cells across the human body.
    • “Through the new papers, researchers in the consortium are introducing the concept of “senotypes,” a new classification system that groups senescent cells based on where they are found in the body and the conditions surrounding them.
    • “By mapping where different senotypes are found and what makes them unique, we aim to build a more complete picture of senescent cells across the body,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives (DPCPSI), who leads the NIH Common Fund. “This knowledge could help researchers move toward more targeted therapies that focus on harmful cells while preserving beneficial ones.”
  • MedPage Today tells us,
    • “Research has suggested that consumption of sugar-sweetened beverages is linked to increased risks of certain cancers.
    • “A pooled analysis of 11 studies showed that sugar-sweetened beverage intake was not associated with overall liver cancer risk but was tied to increased risks of hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
    • ‘Of note, there was no association between consumption of artificially sweetened beverages and liver cancer overall, or by subtype.
  • Health Day informs us,
    • “Sleep apnea might affect women worse than men.
    • “Women had similar outward symptoms of sleep apnea.
    • “However, they reported higher levels of side effects.”
  • STAT News lets us know,
    • “A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, including higher response rates in patients treated at an earlier stage of their disease.
    • “The updated early-stage study results reported Thursday for the Enliven drug, ELVN-001, compare favorably to a current blockbuster medicine sold by Novartis and an upstart experimental drug recently bought by Merck.” * * *
    • “Enliven has met with the Food and Drug Administration and received clearance to start a Phase 3 study later this year that will enroll patients with CML previously treated with one or more drugs. The study will compare ELVN-001 against a physician’s choice of currently approved CML drugs, excluding Scemblix.
    • “The company believes the addressable commercial market for ELVN-001 as a “second-line plus” treatment option for CML is worth $5 billion.”
  • Biopharma Dive adds,
    • “Takeda’s experimental autoimmune drug zasocitinib bested Bristol Myers Squibb’s marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday.  
    • “Takeda didn’t provide detailed data but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. It’s the second time Takeda’s drug has beaten an approved therapy, following positive results in a trial testing it against Amgen’s Otezla. 
    • “Zasocitinib is a newer kind of “TYK2 inhibitor,” a class of oral autoimmune medicines that have attracted significant industry investment in recent years. It’s become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.”
  • and
    • “An RNA drug Novartis acquired as part of its $12 billion bet on Avidity Biosciences succeeded in a trial of patients with a rare neuromuscular disease, Novartis said Thursday.
    • “Called delpacibart braxlosiran, the experimental drug met its primary biomarker endpoint in a Phase 1/2 study evaluating the treatment in a muscle-wasting disease known as facioscapulohumeral muscular dystrophy, or FSHD. The drug, a so-called “antisense oligonucleotide conjugate” or AOC, is designed to restore muscle function and help slow progression of the disease.
    • “Del-brax targets a gene called DUX4, which is expressed incorrectly in patients with FSHD.”

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

  • Modern Healthcare reports,
    • “Group healthcare costs are expected to rise 9% in 2027 as Americans use more services. 
    • “The growing use of expensive drugs, the proliferation of mental health issues and reimbursement pressures will drive healthcare cost inflation, according to a Thursday report from consultancy PwC.”
    • “Researchers spoke with actuaries at 27 health insurers that cover 103 million employer-sponsored members and 8 million Affordable Care Act enrollees to forecast healthcare inflation. 
    • “PwC projected an 8.5% increase for the individual market. In addition to the 2027 projections, the consultancy retroactively adjusted last year’s group cost growth estimate to 9% from 8.5% and the individual market projection to 8.5% from 7.5%.”
  • and
    • “U.S. companies plan to charge more for employee health plans next year, as soaring drug prices drive up insurance costs.
    • “Two-thirds of large companies expect to raise monthly premiums for employee health coverage through paycheck deductions in 2027, according to a survey of businesses with at least 500 employees by benefits consultancy Mercer. And about half (48%) of employers say they will make other changes, such as raising deductibles and copays, that will increase how much workers pay out of pocket for care.”
    • “It isn’t just employees who will be paying more. Health insurers are raising costs for employers, too, with the cost of group plans set to increase by more than 6% for the fourth year in a row, said Beth Umland, Mercer’s director of research. Annual increases previously hovered around 3% for more than a decade.
    • “Although employers initially tried to absorb those higher costs, they are beginning to pass them onto workers, Umland said. This year, employers expect to pay more than $18,500 per employee for health care benefits, a 6.7% increase from 2025 and the biggest jump in 15 years.”
  • MedCity News adds
    • “If you want to know where healthcare finance is headed, ask the people who lend hospitals money. 
    • “During a Tuesday panel at the HFMA Annual Conference in National Harbor, Maryland, two veteran healthcare credit analysts said they think the window for deliberate strategic action is closing faster than most health system leaders realize.
    • “We love incremental change in healthcare — it’s not going to work anymore,” said Kevin Holloran, senior director of nonprofit healthcare group at Fitch Ratings. “We’ve got to have some really bold thoughts and really bold moves if we’re going to be ready for 2030 and then beyond.”
    • “His urgency stems from a stark demographic reality. In 2030, the last of the Baby Boomer generation will officially reach age 65 and become Medicare-eligible. This is the same year that the most significant cuts from the federal budget reconciliation legislation will begin to bite.” * * *
    • “2030 scares me to death,” Holloran declared. “Right when you get fewer people in the workforce, you’re going to see your payer mix decline. You’re going to go from commercial to Medicare — and you’re not going to have enough people, as they’ve left the workforce.”
  • Healthcare Dive relates,
    • “Health plans are projecting commercial healthcare costs will rise 9% next year, driven in part by increased adoption of artificial intelligence billing tools by providers, according to a report released Thursday by professional services firm PwC.
    • “Nearly 70% of surveyed plans ranked providers’ use of AI documentation and coding products as a top three inflator next year, while about 20% called AI the number one inflationary trend. 
    • “Still, AI isn’t a major driver of growing healthcare costs compared with labor and supply cost inflation or increased healthcare utilization, said Glenn Hunzinger, U.S. health industries leader at PwC. “The ability to use technology and AI to more appropriately code or code things that they were never able to, that’s the trend we’re seeing,” he said. “It does have an impact on that 9%, albeit it’s not the biggest piece.”
  • Fierce Healthcare adds,
    • “Since launching eight years ago with an ambient medical transcription tool, Abridge has set is sights more broadly on building out a full-scale AI clinical assistant. The company is steadily developing tech and features to assist with billing, prior authorization and clinical decision making.
    • “Today, the company announced a major platform expansion to integrate payer and life sciences workflows. Described as an “AI-native clinician intelligence platform,” Abridge says it now connects care delivery, payment and evidence-based treatment.
    • “Abridge CEO and co-founder Shiv Rao, M.D., announced Thursday at an event in New York City that pharma giant Eli Lilly and Company made a strategic investment in the company to “support evidence-based care and research.” The financial details of the investment were not disclosed.”
  • Coviti points out,
    • “Improper use of modifier codes in radiology can lead to excessive billing, often misrepresenting radiology services and diminishing trust between providers and health plans. As new requirements and measures emerge, special investigative units (SIUs) should remain vigilant with claims analyses and proper documentation to reduce overpayments.
    • “This month’s edition of FWA Insights dives into outlier billing for modifier codes and excessive services in radiology, revealing the ramifications of medical coding discrepancies and providing practical steps to prevent fraud, waste, and abuse (FWA).”
  • Per an Institute of Clincal and Economic Research (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its revised Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “Covid-19 infections continue to occur year-round, sometimes leading to serious illness or death,” said ICER’s Chief Medical Officer, David Rind, MD, MSc. “For any preventive care, the goal is always to understand whether the potential benefits outweigh the potential harms. ICER evaluated the evidence for Covid-19 vaccines in 12 US sub-populations. Current evidence suggests that the greatest net benefit of Covid-19 vaccination is in pregnant women; infants aged 6 months to one year; and adults over the age of 65, with the net benefit increasing further with increasing age. Declining rates of serious Covid-19 year over year necessarily create some uncertainties. We hope this report will be a useful resource to policymakers and public health officials as they consider vaccination recommendations for Covid-19 for the 2026-2027 season.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on June 25, 2026. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.“
  • Fierce Healthcare tells us,
    • “Humana announced this week that it intends to divest its minority stake in Gentiva, the largest provider of end-of-life care in the country.
    • “The company said Wednesday that it has entered into a definitive agreement to sell off “all or substantially all” of its stake in Gentiva to a “consortium of investors.” The agreement puts the value of Humana’s stake in Gentiva at about $900 million, according to an announcement.
    • “Other financial terms related to the deal were not disclosed, and it’s expected to close in the third quarter of 2026, pending regulatory approval. Details on which investors are involved were also not made public.
    • “Humana said in the announcement that it plans to use the funds from the sale for “general corporate purposes,” and said it does not expect that the deal will have a material impact on its earnings for the year.”
  • BioPharma Dive informs us,
    • “Parabilis Medicines, a high-profile startup making medicines for “undruggable” targets, raised $670 million in an initial public offering on Wednesday, a record haul for a venture-backed biotechnology company.
    • “Parabilis boosted the size of its offering and ultimately sold 33.5 million shares at $20 apiece, eclipsing the amounts secured by Moderna in 2018 and Kailera Therapeutics earlier this year. It added another $75 million through a discounted private stock sale to new research partner Regeneron Pharmaceuticals.
    • ‘The IPO extends a streak this year for large new biotech stock offerings. So far in 2026 a dozen drugmakers have gone public and raised a median of about $300 million each, more than doubling the median total biotech startups secured in IPOs last year, according to BioPharma Dive data.” 
  • Per MedTech Dive,
    • “Danaher has completed its $9.9 billion takeover of Masimo, establishing itself as a competitor to Medtronic in the pulse oximetry market. 
    • “The completion of the purchase, which Danaher reported Wednesday, positions the company to start integrating Masimo in pursuit of more than $125 million of annual cost synergies and more than $50 million of annual sales synergies by the fifth full year after the deal closure.
    • “Masimo will slot into a diagnostics portfolio that features Radiometer, a Danaher business that specializes in blood gas analysis and other testing in acute care settings.”
  • and
    • “Insulet is developing an automated insulin delivery system that will be “completely different” than its competitors, Chief Medical Officer Trang Ly said in an interview after the American Diabetes Association’s Scientific Sessions. 
    • “The system, which Insulet calls “fully closed loop,” is for people with Type 2 diabetes and does not require carb-counting or insulin bolusing ahead of meals. Physicians also don’t need to program the starting settings, and dose titration is automated. 
    • “With our system there’s no bolusing at all. There’s actually no bolus button. … It’s completely different to what Medtronic and Tandem and everyone else is working on,” Ly said. “There are no settings for anyone to enter.” 
    • “Insulet shared results of its Evolution 3 study of the planned system at the conference on Saturday. The study built on previous results the company shared at another diabetes conference in March.”

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.”

Tuesday Report

David Ermer–CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, OPM, U.S. Healthcare–

Simplicity is a virtue

“Edsger Dijkstra put it best: “Simplicity is a great virtue, but it requires hard work to achieve it and education to appreciate it. And to make matters worse, complexity sells better.” This bias for complexity leads us to give undue credit to convoluted systems and ideas over simple, elegant solutions.”

From Washington DC,

  • CMS reminds us that “June 1 marked the start of Medicare Fraud Prevention Week. While this week shines a spotlight on fraud prevention, protecting Medicare is a year-round mission.” 
  • In that regard, the Wall Street Journal points out that “The Autism-Therapy Business Is Booming—and So Is the Billing Abuse. Insurers warn of fraud and exorbitant charges from providers, including one that stuck a parent with a surprise $911,400 bill.”
  • AHIP posted a news release about how healthplans are combatting fraud, waste, and abuse in Medicaid. In fact, health plans are combatting fraud, waste, and abuse whereever they offer coverage.
  • Last Wednesday, the OPM Inspector General posted his semi-annual report to Congress for the period ended March 31, 2026.
  • OPM posted a news release today on its Family Member Eligibility Documentation rule, which OPM described as “a major step in the administration’s broader effort to eliminate fraud, waste, and abuse across government programs.” As the FEHBlog noted yesterday, this final rule was published in the Federal Register today.
  • The American Hospital Association News reports,
    • “The AHA June 2 released a new report, “Making Health Care More Affordable: A Blueprint to Lower Costs, Improve Access and Enhance Quality.” 
    • “The report contains actionable and achievable strategies and solutions that are focused on improving the health of individuals and communities; transforming care delivery; reducing administrative waste in the system; lowering drug and device costs; and innovating to improve care outcomes. 
    • “The report, as well as an infographic that highlights several action items from the report, was produced with input gathered throughout the year from AHA members across the country.”
  • Healthcare Dive relates,
    • “Eli Lilly is giving hospitals and medical groups in the 340B drug discount program less than a week to comply with the drugmaker’s data sharing requirements or be cut off from valuable savings on Lilly’s medications.
    • “In January, Lilly said it would begin requiring providers to submit claims data for all of its drugs dispensed in 340B. The company hasn’t been enforcing the policy. But now, providers that don’t comply with Lilly’s ultimatum by this coming Monday will lose access to 340B discounts on the drugmaker’s medications, Lilly warned this week.
    • “Lilly argued it needs to collect more data from providers to ensure they aren’t double-dipping discounts in 340B with savings in other programs like Medicaid. However, hospitals argue the move is illegal and, if not stopped by regulators, will empower other pharmaceutical companies to take similar actions.”
  • Adam Fein, writing in his Drug Channels blog, offers his take on the curent state of the 340B drug discount program.

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and regulatory knowledge.
    • “When finalized, the guidance will outline how sponsors can use publicly available information and established platform knowledge, including chemistry, manufacturing and controls (CMC) data, nonclinical study results and clinical information, to streamline regulatory submissions for human gene therapy products that use genome editing in human somatic cells.”
  • Reuters reports,
    • “Drug developer Cingulate (CING.O) said on ​Tuesday the U.S. Food and Drug Administration declined to approve its ‌treatment for attention deficit hyperactivity disorder, citing manufacturing-related concerns.
    • “In its complete response letter, the FDA did not flag any concerns about the drug’s safety or effectiveness, Cingulate said.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Ascension’s $3.9 billion plan to acquire ambulatory surgery management services company AmSurg has received a green light from the Federal Trade Commission, so long as the nonprofit health system divests a handful of facilities in markets the regulator said would otherwise be left with reduced competition. 
    • “The proposed consent order between the FTC and Ascension was announced Tuesday and centers on seven AmSurg ambulatory surgery centers (ASCs) in Panama City, Florida; Tulsa, Oklahoma; Waco, Texas; Wichita, Kansas; and Nashville, where two sites are located. 
    • “The handoffs must be completed by the time of the acquisition’s close, per the proposed consent order. Six of the facilities are earmarked to join SC Affiliates, another national ASC operator, with the seventh center in Panama City going to Florida Gastroenterology Center, a physician group and current minority owner.” 

From the public health and medical / Rx research front,

  • Health Day reports,
    • “The number of people suffering with long COVID could be double current estimates, a new study suggests.
    • “An AI tool found that about 16% of nearly 460,000 patients with COVID-19 had developed long COVID, researchers reported May 27 in JAMA Network Open.
    • “Applied across the United States, those rates translate to more than 18 million Americans with long COVID, which is twice as high as current estimates, researchers said.
    • “Over 10 million people with long COVID would go entirely undetected by the diagnostic code that health systems and policymakers rely on to track the disease burden,” said senior researcher Hossein Estiri, an associate professor in the Mass General Brigham Department of Medicine in Boston.
    • “And it’s likely the picture is even worse than these estimates, researchers said.
    • “The figures we uncovered are almost certainly an undercount,” Estiri said in a news release.”
  • and
    • “Folks who regularly exercise can lower their risk of heart attack and heart failure linked to a genetic heart condition, a new study says.
    • “People with higher levels of moderate to vigorous physical activity had lower rates of heart health problems caused by genetically driven cardiomyopathy, researchers reported recently in the American Journal of Preventive Cardiology.
    • “Cardiomyopathy is a group of diseases that weaken the heart muscle, causing it to inefficiently pump blood to the rest of the body, researchers said in background notes.
    • “Our findings suggest that, even among people who carry genetic variants for cardiomyopathy but have no signs of disease, staying physically active may be associated with lower rates of future cardiovascular events,” said senior researcher Dr. Pankaj Arora, director of the University of Alabama at Birmingham’s (UAB) Cardiogenomics Clinic Program.
    • “Genetic risk may not be deterministic, and exercise is a modifiable factor that people can act on to help protect their heart,” he said in a news release.”
  • MedPage Today adds,
    • “Losing visceral fat by diet and exercise — regardless of pounds shed or later regained — was tied to long-term improvements in cardiometabolic health, follow-up data from two randomized trials showed. (Circulation)”
  • Gatroenterology Advisor notes,
    • “Higher levels of objectively measured physical activity are associated with significantly lower odds of irritable bowel syndrome (IBS), while greater sedentary behavior is associated with increased IBS prevalence, according to study findings published in the American Journal of Gastroenterology.”
  • The National Institutes of Health’s Research Matters post covers the following topics in today’s release:
    • “Tuberculosis test may improve diagnosis 
      • “Researchers found that a new portable diagnostic test for tuberculosis produced rapid and accurate results.
      • “The new test could offer a low-cost way to more quickly diagnose and treat people across the world.”
    • “Blood test predicts tumor response to treatment”
      • “Researchers identified distinct cellular neighborhoods common to different tumors, some of which correlate with treatment response.
      • “A blood test to analyze these neighborhoods could lead to more effective personalized cancer therapies and improve treatment monitoring and outcomes.”
    • “Short RNAs may prevent neuron death linked to ALS, dementia
      • “In cell and animal models, short RNA molecules stopped or reversed abnormal clumping of the TDP-43 protein, which is linked to brain cell death.
      • “The results suggest RNA-based therapies could one day be used to treat diseases marked by abnormal TDP-43, including ALS and Alzheimer’s disease.”
  • NBC News relates,
    • “Nearly 1 in 5 adolescents and young adults are turning to AI chatbots for advice when they’re sad, angry, nervous or stressed, according to a new study.
    • The findings, from the research institute RAND, represent an increase from early 2025, when the nonprofit conducted a similar survey. At the time, around 13% of respondents said they used chatbots for such advice, but the share rose to 19% in the group’s latest survey in November, the results of which were published Monday in the journal JAMA Pediatrics. 
    • “It’s a sad number, because you’d hope that young people would have the sorts of supportive relationships that they would feel comfortable and empowered reaching out to those around them,” said Ryan McBain, a senior policy researcher at RAND and the lead author of the study.”
  • Fierce Pharma informs us,
    • “A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug’s ability to normalize a key marker of disease progression for those with the rare liver disorder primary biliary cholangitis (PBC). 
    • “In the IDEAL trial, which compared Livdelzi to placebo, Gilead’s pill allowed significantly more patients to gain control of their alkaline phosphatase (ALP) levels, which are a key signal of disease progression. The trial’s primary endpoint hinged on the number of patients who achieved ALP levels in the normal range with at least a 15% decrease from baseline, the company said Tuesday. 
    • “The trial included 96 participants ages 18 to 75 who had inadequately controlled PBC. Patients in this group are associated with increased risk of progression to liver transplant or death compared with patients at normalized ALP levels, Gilead explained.”

Wrapping up the American Society of Clinical Oncologists annual meeting,

  • STAT News reports,
    • “The ASCO meeting is about data — lots and lots of data. But above all it is about, or should be about, patients.
    • To that, ASCO’s outgoing president, Eric Small, used his opening address at the meeting to speak about his partner, University of California, San Francisco, oncologist Amy Lin, who passed away in December. She had metastatic clear cell ovarian cancer, a rare disease with few treatment options. Small also brought a different kind of specialist to ASCO’s mainstage: David Kessler, an expert on grief and loss, who gave a talk about compassionate end-of-life care.
    • “I remember the exact moment when I said, ‘You know, someone should do something about this.’ And it dawned on me that I could. I was fortunate enough to have this platform, and could use it to at least raise it as an issue. I don’t know what the solution is, but I do know that if more of us are aware of it, and can talk about it, my hope is that it would have an impact in a room full of oncologists.”
    • :The experience, Small told STAT, made him realize that while he always tells families how profoundly sorry he is for their loss, he was “really just sending them off on a grief journey that is really complicated and really hard.”
    • “And he wanted to do something about it.
    • “Read a Q&A with Small here.”
  • NBC News relates,
    • “An experimental vaccine from Moderna and Merck shows promise in keeping deadly skin cancer from returning for years, according to new clinical trial results. 
    • “The research, presented Monday at the American Society of Clinical Oncology’s annual meeting, found that a personalized mRNA vaccine halved the risk of melanoma returning after five years. The results were also published in the Journal of Clinical Oncology.
    • “Melanoma is the deadliest form of skin cancer, and in about half of patients, the disease will come back within the first five years of treatment.
    • “The treatments we have are not perfect. People relapse,” said Dr. Janice Mehnert, the director of the melanoma and cutaneous medical oncology program at NYU Langone Health in New York and the senior trial investigator.”
  • BioPharma Dive tells us,
    • “Two drug regimens involving an experimental medicine from Celcuity halved the risk of death or disease progression in a late-stage trial in certain people with a type of advanced breast cancer. But the results still fell short of Wall Street expectations, sending the company’s shares plummeting by more than 20%.
    • “Celcuity disclosed last month that its therapy, gedatolisib, succeeded in the latest part of a Phase 3 study evaluating the treatment in breast cancer patients with or without mutations to a gene called PIK3CA. Fresh data presented Tuesday at the American Society of Clinical Oncology’s annual meeting revealed the extent to which patients with those mutations benefited from treatment with Celcuity’s therapy.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “NYU Langone Health is constructing a multibillion-dollar academic medical center and hospital on Long Island. 
    • “The new hospital in Melville will include 500 private inpatient rooms, 70 emergency department bays and the latest diagnostic imaging capabilities, the healthcare system said in a statement on Tuesday. The campus will also have space for scientific research and comprehensive outpatient care.” * * *
    • “While the project is still subject to state and local approvals, it’s estimated to create as many as 8,000 union construction jobs with an additional 2,500 jobs across the region. 
    • “The facility will be the first hospital built on Long Island since 1980, where some communities face long travel times for specialized care. A spokesperson for NYU said the system doesn’t have a final cost estimate for the project but it spent $135.5 million to purchase the land.” 
  • Healthcare Dive relates,
    • “Community Health Systems closed the sale of four hospitals in Arkansas to Missouri-based Freeman Health System for $110 million, the for-profit health system said Monday. 
    • ‘The deal, first announced in March, marks Freeman’s expansion into Arkansas. The purchase includes hospitals in Bentonville, Springdale, Johnson and Siloam Springs, as well as associated outpatient locations, physician practices and around 2,200 employees, Freeman said Monday.”
  • Meanwhile, Beckers Hospital Review points out
    • “Seven hundred and twenty rural hospitals across the U.S. — representing about one-third of all rural facilities nationwide — are at risk of closing due to severe financial problems, according to the Center for Healthcare Quality and Payment Reform’s most recent analysis. 
    • “The data, current as of May 2026, includes 294 hospitals that are at immediate risk of closure over the next two to three years due to the severity of their financial situation, according to the report. Facilities with the greatest risk of closure have more debt than assets or lack enough financial reserves to offset losses on patient services for more than a few years. 
    • “Rural hospitals are at risk of closing in almost every state, according to the report. In the majority of states, more than 25% of rural hospitals are at risk. In 10 states, 50% or more are at risk. 
    • “The number of hospitals at risk of closure represents a slight decrease from CHQPR’s January analysis, which found 734 hospitals were at risk of closure, including 309 that were at immediate risk. Since that report, three hospitals have closed and eight have converted to rural emergency hospitals. CHQPR does not assess converted rural emergency hospitals for closure risk until cost report data is available under their new designation.”  
  • Kaufman Hall tells us,
    • “Use of health-related apps and devices has increased since 2021, even as consumers become more selective about the technologies they adopt, according to a report published this month. While nearly half of consumers track biometrics, sleep, or activity levels, usage patterns vary by age, and interest in many digital health services has declined post-pandemic. This signals shifting consumer expectations and preferences for digital health technology users increasingly want tools that help them track progress conveniently and accurately while fostering motivation, accountability, and a sense of control over their health, according to the report. Integrating patient-generated data from apps and devices into digitally connected care experiences may help health systems strengthen engagement beyond the hospital walls.”
  • Fierce Healthcare adds,
    • “Wearable ownership has risen 33% in the U.S. since 2015, a new analysis from Rock Health found.
    • “Forty-six percent of respondents in the 2025 Consumer Adoption of Digital Health Survey reported owning a wearable specifically, and 57% of respondents report owning at least one wearable or other connected device. However, the report notes first-time wearable user growth has slowed.
    • “Smart watches remained the most popular device among the survey’s 8,000 respondents, with 43% reporting owning a device. Other popular devices are smart scales (13%), connected blood pressure cuffs (13%), continuous glucose monitors (9%) and smart rings (8%).
    • “The next chapter of wearable adoption will come down to whether wearables remain primarily tools for individualized self-optimization—an “N of 1” model—or evolve into infrastructure that improves population health,” the report authors wrote.” 

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.”  

Tuesday Report

David Ermer–CMS, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–

Simplicity is a Virtue.

From Washington, DC,

  • USAFacts.org tells us,
    • “Defense Department data shows that 63,670 active-duty military members have passed away since 1980. Eighty-four percent of these deaths were due to accidents, illness, and suicide or self-inflicted wounds. Two-hundred and sixty military members have died from the beginning of 2026 to May 13. Thirteen of these deaths resulted from Operation Epic Fury.
    • “Detailed record-keeping about the ways in which active-duty military members die began in 1980. Historical records from The Department of Veterans Affairs (VA) show that approximately 1.2 million service members died between 1775 and 1991.” * * *
    • “The US global war on terrorism began after Al Qaeda operatives carried out the September 11th attacks. The US invaded both Afghanistan and Iraq in the resulting conflict to remove the regimes of the Taliban and Saddam Hussein from power.
    • “From the onset of military operations in October 2001 to May 2026, the United States has lost 7,073 military personnel in Afghanistan and Iraq. Another 53,560 members have been wounded.” * * *
    • “The US began Operation Epic Fury on February 28, 2026 to dismantle Iran’s security infrastructure. As of May 13, thirteen US service members have died in the operation and 404 have been wounded in action.”
  • May they all rest in peace.
  • Modern Healthcare reports,
    • “U.S. Centers for Medicare and Medicaid Services Administrator Mehmet Oz is reorganizing leadership roles at the agency, a spokesperson told Bloomberg.
    • “Rebekah Armstrong, who currently leads the agency’s office of legislation, will be the new chief of staff, spokesperson Christopher Krepich said. Before joining the administration, Armstrong worked on Capitol Hill, for health insurance lobby group AHIP, and the first Trump administration.
    • “Stephanie Carlton, who had led the agency as deputy administrator and chief of staff, will now be focused on her deputy administrator role, according to Krepich. Her portfolio will include work on clinical artificial intelligence and modernizing Medicaid quality measures, he said.”
  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM) today issued, for public comment, a template non-disclosure agreement (NDA) for federal employees with access to sensitive government information including personally identifiable information, operational plans, personnel records, and other protected materials.
    • “The template NDA comes amid a series of recent unauthorized disclosures involving sensitive government information, including leaks related to planned immigration enforcement operations, disclosures of confidential operational details prior to a US action overseas, and the release of personal information belonging to approximately 4,500 ICE employees, including frontline enforcement personnel.
    • “The template NDA would allow agencies to use standardized confidentiality agreements for covered employees and contractors whose duties involve routine access to sensitive systems or protected information. If finalized, it would become an official government form that agencies could use as a standard part of the employee onboarding process.
    • “In much of the private sector, employees handling sensitive business or customer information are routinely required to sign confidentiality agreements, and the federal government should not be held to a lower standard,” OPM Director Scott Kupor said. “Americans should be able to trust that their personal data and sensitive government information are being handled responsibly. This proposal reinforces accountability across the federal workforce while helping agencies better protect against unauthorized disclosures.” * * *
    • “Read the proposed NDA, and accompanying Federal Register notice, here.” The public comment deadline will occur in late June 2026.
  • The American Hospital Association informs us,
    • “The AHA commented May 26 to the Federal Trade Commission and the Department of Justice on potential changes to the Hart-Scott-Rodino Antitrust Improvements Act’s premerger notification form. The AHA urged the agencies to exclude hospital mergers from any revisions to the form, reiterating its previous position, and said that changes would impose burdens that outweigh any expected benefits. The AHA highlighted how mergers can be important in helping hospitals and health systems overcome financial challenges, and that there has been no indication that hospital mergers have historically evaded FTC review. Additionally, the AHA said that new questions on the form do not weigh in on issues that typically arise in hospital mergers or use language that fits within the context of hospitals.” 

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA’s vaccine advisors will meet Thursdayopens in a new tab or window to vote on whether an XFG monovalent vaccine should be preferred for COVID-19 shots for the 2026-2027 season.
    • “The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will also discuss what circumstances would warrant a non-JN.1 lineage variant — such as BA.3.2, also called “Cicada” — for next season’s vaccines.
    • “In an FDA briefing documentopens in a new tab or window, the agency noted that in the U.S., descendants of the JN.1 variant of Omicron remain prominent and have diversified into multiple lineages, including XFG, NB.1.8.1, and LF.7.”
  • Fierce Pharma relates,
    • “More than three years after Gilead Sciences’ hepatitis D drug bulevirtide was rebuffed by the FDA due to manufacturing and delivery concerns, the treatment has since redeemed itself by scoring a green light in the U.S.
    • “Just before the Memorial Day weekend, the FDA signed off on Gilead’s Hepcludex as the first treatment for chronic hepatitis D virus infection in the United States, granting the entry inhibitor an accelerated approval in adults without cirrhosis or with compensated cirrhosis—a complication of long-term liver inflammation that leads to progressive scarring of the organ.
    • “The FDA cleared the therapy based on data from Gilead’s late-stage MYR301 study, in which Hepcludex helped patients achieve statistically significant improvements in a combined virologic and biochemical response at 48 weeks versus a control group that received delayed treatment, the company explained in a release.” 
  • STAT News adds,
    • “People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top food official in 2025. 
    • “They knew Kyle Diamantas worked at Jones Day representing food, beverage, and tobacco-industry clients. They saw the picture of him and Donald Trump Jr. holding giant, dead wild turkeys after a hunt. He had no experience in public health, in medicine or science, or in government.
    • The credentials didn’t scream qualified. And Diamantas was stepping into a center rocked by DOGE layoffs and a defiant resignation by former leader Jim Jones. 
    • “But more than a year later, leaders in the food industry, public health groups, and FDA career staffers have found that Diamantas exceeded expectations. As Diamantas takes the reins at the FDA, STAT spoke with more than 10 of these stakeholders, as well as former FDA commissioners and Diamantas’ former colleagues. They all described him as thoughtful and serious, someone who does his homework before meetings and listens to the experts in the room. 
    • “Crucially, Diamantas has earned the trust of key career staff. That simple quality was a rarity among top leaders working at former commissioner Marty Makary’s FDA.”

From the public health and medical / Rx research front,

  • Cigna Healthcare, writing in Linked In, points out everyday mental health signs that we overlook and their impact.
    • “Missed early signs show up later with consequences: “Normal stress” that’s dismissed tends to surface downstream in productivity, quality, mistakes, and relationship friction.
    • “Early detection is pattern-based, not crisis-based: Small changes that persist for days often precede visible performance issues and escalation.
    • “Benefits can operationalize early support at scale: Integrated benefits can spot non-obvious patterns and route people to the right support earlier, helping reduce escalation and making costs more predictable.”
  • The American Medical Association lets us know “what doctors want patients to know about pancreatic cancer.”
    • “Pancreatic cancer is a challenging form of cancer. It is notoriously difficult to detect early and often requires treatment across physician specialties.”
  • MedCity News reports,
    • “While conversations around GLP-1s typically center on adults, a new report sheds light on prescribing trends among adolescents and offers recommendations for how employers can manage coverage and care.
    • “The Nomi Health report, shared with MedCity News exclusively, analyzed four years of GLP-1 prescription claims data for adolescents ages 12 to 17 enrolled in a national population of self-insured employer health plans from 2022 through 2025. 
    • “It found that during this time period, GLP-1 adoption among adolescents rose more than 60% and total spend increased 111% from $857,000 to $1.8 million. In addition, scripts per member rose 30%, and cost per member increased 32%.” * * *
    • “Nomi Health provided several recommendations for how employers can act based on these findings:
      • “Analyze adolescent GLP-1 claims across at least four years to gain a better understanding of prescribing and cost trends.
      • “Check that the correct support is in place, such as behavioral counseling and lifestyle support alongside medications.
      • “Plan ahead for the gap. Rising obesity prevalence, coupled with low treatment rates, could drive significant future costs, making it important to model the impact before it becomes a surprise in the budget.”
  • Cardiovascular Business adds,
    • “New research presented at Heart Rhythm 2026 suggests taking GLP-1 receptor agonists (GLP-1-RAs) may reduce the risk of atrial fibrillation (AFib) and improve survival through mechanisms that extend beyond weight loss alone.
    • “Kenneth Bilchick, MD, MS, director of electrophysiology research and a professor of cardiovascular medicine at the University of Virginia, presented those findings at the conference. He then spoke to Cardiovascular Business for a video interview. 
    • “Bilchick said GLP-1 drugs have an anti-inflammatory effect, which may what led to the lower AFib rates in GLP-1 patients.
  • Health Day relates,
    • “Quitting smoking might protect your future brain health, a new study says.
    • “People who quit smoking had a lower risk of developing dementia, especially if they didn’t gain excess weight afterward, researchers reported May 20 in the journal Neurology.
    • “People often worry about what happens after they quit smoking — including weight gain and associated metabolic changes,” said lead researcher Hui Chen, dean of psychological and behavioral sciences at Zhejiang University School of Medicine in Hangzhou, China.
    • “What we found is that quitting is still associated with better brain outcomes but maintaining your weight may help preserve those benefits,” Chen said in a news release.”
  • Genetic Engineering and Biotechnology News notes,
    • “Researchers at Cincinnati Children’s Hospital Medical Center and Nantes Université in France have designed 3D-printed scaffolding trays that will reportedly allow scientists to produce larger versions of functional human gut organoids twice as fast as previous methods—and these organoids grow their own nerve cells.
    • “This improved technology could help accelerate production of human mini-organ tissues that are large enough to be useful in patching damage or restoring diminished functions of a person’s small intestine, stomach, or colon. Such tissues also would be valuable for future disease studies and to more accurately evaluate organ damage risks linked to oral medications, according to the investigators.”
    • Details of the study “Large-scale and innervated functional human gut tissues for transplantation via transient spheroid confinement” appear in Nature Biomedical Engineering.

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

  • The Wall Street Journal reports,
    • “Eli Lilly LLY agreed to acquire three vaccine developers in deals valued at up to nearly $4 billion combined, the company said Tuesday.
    • “The deals mark a new push by the weight-loss drug market leader into infectious-disease prevention.
    • “The details
      • “Indianapolis-based Lilly has agreed to acquire Curevo, LimmaTech Biologics and Vaccine Company, confirming an earlier report in The Wall Street Journal. 
      • “Curevo is developing a shingles vaccine that Lilly believes could be as effective as the current standard but with reduced side effects, said Daniel Skovronsky, Lilly’s chief scientific and product officer. Lilly could pay up to $1.5 billion in cash for Curevo, including an undisclosed upfront payment and a potential subsequent payment if a certain milestone is met. 
      • “LimmaTech is developing vaccines against bacterial pathogens including Staphylococcus aureus. Lilly agreed to pay up to $780 million in cash for LimmaTech, including an undisclosed upfront payment and additional payments for certain clinical and regulatory milestones.
      • “Vaccine Company is developing a vaccine against Epstein-Barr virus. Lilly agreed to pay up to $1.55 billion in cash, including an undisclosed upfront payment and potential clinical and commercial milestone payments.”
  • Fierce Healthcare relates,
    • “Trinity Health is outperforming some of its large Catholic peers, reporting $200 million of operating income (1% operating margin) over the nine-month period ended March 31, 2026, according to a recent filing. 
    • “The tally reflects a 5.4% year-over-year rise in both operating revenue and operating expenses ($20 billion and $19.8 billion, respectively), and is a narrow, $2.1 million improvement over the prior year’s nine-month operating income.” * * *
    • “Trinity’s steady operating gain places the nonprofit ahead of the country’s other 11-figure faith-based systems with offset fiscal years: CommonSpirit Health and Ascension. The former recently disclosed a $743 million adjusted operating loss (-2.4% operating margin) across three quarters, a decline that excludes the substantial on-paper costs of an early contract termination. Ascension’s operations, while broadly on the upswing, also posted a nine-month loss of $203 million (-1.1% operating margin).” 
       
  • Healthcare Dive tells us,
    • “PacificSource Health Plans, a nonprofit health plan offering coverage in four states in the Pacific Northwest, is exiting the Affordable Care Act market next year and ending all operations in Montana.
    • “PacificSource is the latest insurer to flee the exchanges as rising costs and policy turbulence make it more difficult for smaller payers to remain operational.
    • “As a not-for-profit organization, PacificSource is making difficult decisions to ensure we can continue fulfilling our mission and serving members for the long term amid growing pressures across the healthcare industry,” a spokesperson told Healthcare Dive.”
  • Modern Healthcare informs us,
    • “WakeMed Health & Hospitals rejected an unsolicited proposal from UNC Health to combine.
    • “The proposal followed Atrium Health’s May 1 announcement it plans to merge with WakeMed.
    • “A UNC Health spokesperson said the Chapel Hill, North Carolina-based system submitted a proposal to WakeMed for a “broader partnership” May 5.
    • “WakeMed, which is based in Raleigh, North Carolina, reviewed the proposal but felt the partnership with Atrium was the best path forward, a WakeMed spokesperson said. 
    • “Combined, WakeMed and UNC Health would control 80% of the healthcare market in Wake County. We have heard from numerous stakeholders, including the state treasurer, that maintaining robust competition is important for our rapidly growing region,” the WakeMed spokesperson said.” 
  • Per an Institute for Clinical and Economic Review news release,
  • Fierce Healthcare points out,
    • “Health tech companies Wheel and b.well Connected Health are partnering to offer turnkey infrastructure for next-generation AI-first virtual care.
    • “AI-first healthcare experiences and consumer-centered care models are driving innovation in healthcare. Consumer health data is widespread and embedded in daily life, with information available from apps, wearables, devices and medical records. At the same time, retailers and pharmacies are becoming care access points, while life sciences companies are going direct-to-consumers. And the Centers for Medicare and Medicaid Services (CMS) is pushing forward initiatives to open up patients’ access to health data.
    • “Wheel’s partnership with b.well gives AI-native companies, retailers, life sciences companies, payers, health systems and consumer health brands a faster, more complete way to compete in the consumer-driven healthcare race, according to the two companies.”
  • Per MedTech Dive,
    • “Olympus said Tuesday it has agreed to buy Israel-based BioProtect for $270 million to expand its product portfolio in oncology and urology. 
    • “BioProtect makes a balloon spacer system that separates the prostate from other structures during cancer radiation treatment.
    • “The transaction is expected to increase patient access to BioProtect’s technology through Olympus’ global reach and relationships with healthcare providers.”

Friday report

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

From Washington, DC

  • Roll Call informs us,
    • “Republican leaders in Congress scored some victories this week in nominations and appropriations but struck out on easily advancing their partisan “reconciliation 2.0” proposal to fund immigration enforcement.
    • “The bill faces a hurdle in the form of the Senate Parliamentarian, who on Thursday evening advised that several provisions violate the Senate’s restrictive Byrd rule — and more could be coming. 
    • “This throws an obstacle in the way of the GOP’s efforts to provide some $72 billion in funding for immigration enforcement by President Donald Trump’s June 1 deadline, as Republicans will have to rewrite parts of the package to pass it with the filibuster-proof budget reconciliation process, requiring a simple-majority vote to pass, instead of the 60-vote threshold required for regular legislation.
    • “Republicans are expected to try to rewrite the legislation to remedy the violations or, if that’s not possible, remove the offending provisions ahead of a Homeland Security Committee markup of the title next week. 
    • “Senate Parliamentarian Elizabeth MacDonough was expected to hold a second “Byrd bath” Friday to hear arguments from Democratic and Republican Senate staff about the Judiciary Committee’s portion of the bill, including Secret Service money for security upgrades tied to Trump’s White House ballroom project.” 
  • Mercer Consulting reports,
    • “With the midterm congressional elections approaching and healthcare affordability top of mind for voters, lawmakers are actively considering new healthcare transparency reforms, including requirements for providers to show plainly what patients will have to pay and new billing standards for hospitals.
    • “Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy, R-LA, highlighted such price transparency legislation — Patients Deserve Price Tags Act (S 2355/HR 5582) — during a field hearing in Louisiana during last week’s congressional recess. Cassidy’s interest could signal that the legislation, which has may cosponsors from both parties, could soon see action at the Committee. 
    • “The bill would codify and expand current hospital price transparency rules that were established in the first Trump administration by extending requirements to clinical diagnostic laboratories, imaging centers, and ambulatory surgical centers. It would also make the prices that hospitals post clearer by requiring actual dollar-and-cents amounts, not estimates, as well as sharply increase financial penalties for hospitals and insurers that fail to disclose their negotiated rates. In addition, group health plans and insurers would have to give patients upfront, personalized cost estimates through an online self-service tool, as well as paper or phone options, before care is provided. The bill also ensures group health plans have access to claims data and prohibits third-party administrators from restricting that access.
    • “While several plan sponsor trade groups publicly support the legislation, they are working with lawmakers to make certain provisions more workable and better aligned with the PBM-focused transparency rules enacted in the Consolidated Appropriations Act, 2026 and proposed by the Department of Labor.”
  • AHIP lets us know “What They Are Saying: Broad Range of Experts Agree on a Root Cause of Healthcare Cost Crisis.”
    • “The evidence continues to underscore that making healthcare more affordable requires policymakers to address the root causes of high costs head-on through common-sense solutions like cracking down on anti-competitive hospital mergers and implementing site-neutral payment reforms.
    • “To learn more about how rising hospital costs are driving premiums higher and what policymakers can do to address it, visit AHIP.org/CostConnection.”
  • Fierce Healthcare relates,
    • “A bipartisan group of lawmakers in both chambers of Congress has reintroduced a bill aimed at barring companies from owning both a pharmacy benefit manager and retail pharmacies.
    • “The bill, called the Patients Before Monopolies (PBM) Act, would force conglomerates that include a PBM to divest pharmacies that they own. The legislation has existed in some form since 2024, and since its first introduction, Arkansas has implemented a similar legislation at the state level.
    • “Last month, Tennessee legislators also passed a bill that would prevent PBMs from owning pharmacies, which the governor is expected to sign into law.”
  • Mercer adds,
    • “Several developments in 2026 signal that the Trump administration is committed to improving behavioral health benefits for group health plan participants and beneficiaries — but the administration intends to put its own stamp on enforcement of the Mental Health Parity and Addiction Equity Act and propose new rules interpreting the landmark law.”
  • Per an HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $255 million to Vibrant Emotional Health (Vibrant) to administer the 988 Suicide & Crisis Lifeline. The 988 Lifeline is a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded network administrator. The 988 Lifeline has received more than 25 million contacts via call, text, chat, and ASL videophone since its launch.”
  • Modern Healthcare notes,
    • “The Centers for Medicare and Medicaid Service solicited the healthcare industry on ways it can identify and prevent fraud.
    • “The anti-fraud push drew cautious support, with providers and insurers seeking clear guardrails.
    • “Providers and insurers urged CMS to target high-risk services and avoid sweeping actions that would hamper care.” * * *
    • “New policies should focus on high-risk activities and not burden the ”vast majority of healthcare providers that are honorable in pursuing a mission to provide high-quality healthcare,” wrote the American Health Care Association/National Center for Assisted Living, which represents long-term care providers.
    • “The agency should also be careful not to add administrative burden since hospitals “already operate under extensive oversight requirements,” the American Hospital Association wrote.”
  • Beckers Payer Issues explains the federal crackdown on healthcare fraud, waste and abuse.
  • Newfront brings us up to date on the 2026 PCORI fee, which applies to FEHB and PSHB plan carriers.
    • “IRS Notice 2025-61 adjusts the Patient-Centered Outcomes Research Institute (PCORI) fee to $3.84 per covered individual for health plan years ending on or after October 1, 2025 and before October 1, 2026, including 2025 calendar plan years. This represents a 37-cent increase from last year’s $3.47 PCORI fee.
    • “Action Item: The annual PCORI fee must be reported and paid to the IRS by July 31, 2026, via the second quarter Form 720 (Rev. June 2026).”
  • HR Dive points out,
    • “The U.S. Equal Employment Opportunity Commission plans to end employee demographic data reporting, according to a proposal sent to the White House on Thursday.
    • “The agency wants to get rid of EEO-1, EEO-2, EEO-3, EEO-4 and EEO-5 reporting requirements. EEOC also wants to axe reporting requirements related to Title VII of the Civil Rights Act, the Americans with Disabilities Act, the Genetic Information Nondiscrimination Act and the Pregnant Workers Fairness Act.
    • “EEO-1 reporting has been a cornerstone of HR duties, required by firms with 100 or more employees and federal contractors with 50 or more employees that meet certain requirements. EEOC and analysts have used it to assess demographic data nationally, and — while the process is sometimes viewed as burdensome — employers have reportedly used the collected data for self-assessments regarding nondiscrimination and diversity.”
  • The Census Bureau notes,
    • “Since 2020, city centers of many major U.S. metro areas have had sluggish population gains, with some places even declining. But where growth did occur, it was mostly on the outer edges of these metro areas — with some exceptions.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With the ink barely dry on outgoing commissioner Marty Makary’s resignation, another top regulator may be heading for the exit at the FDA. 
    • “Tracy Beth Høeg, M.D., Ph.D.—who was named acting director of the agency’s Center for Drug Evaluation and Research (CDER) following the departure of veteran oncologist Richard Pazdur, M.D., last December—is now expected to depart in Makary’s footsteps, Reuters reported Friday, citing three sources familiar with internal plans at the regulator.” * * *
    • “Reuters clarified in its report that the CDER chief’s departure is likely, but that the decision has not yet been finalized.” 
  • and
    • “With the help of DNA testing company Natera and its personalized molecular residual disease (MRD) blood test Signatera, Roche’s PD-L1 inhibitor Tecentriq has chalked up its eleventh U.S. indication in the form of a new bladder cancer approval.
    • “Tecentriq and subcutaneous Tecentriq Hybreza can now be used as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) following a cystectomy, as identified by Signatera.” 
       
  • Biopharma Dive relates,
    • “The Food and Drug Administration has placed a clinical hold on Aardvark Therapeutics’ drug for Prader-Willi Syndrome, escalating a trial stoppage that began when signs of potential heart problems were detected in a study of healthy volunteers. 
    • “Aardvark said Thursday it will “unblind,” or reveal which enrollees in a late-stage trial received ARD-101, in order to help investigators and regulators determine whether the drug is safe and effective enough to continue testing in humans.
    • “The company has dosed 68 people in the placebo-controlled Phase 3 trial and another 19 in an open-label extension study, both which were intended to measure whether ARD-101 can address the “hyperphagia,” or insatiable hunger, distinctive to Prader-Willi. The cardiovascular concerns emerged from a safety trial in healthy people who’d received much higher doses than what was administered in the other studies.” 
  • Cardiovascular Business tells us,
    • “Stryker Sustainability Solutions, an Arizona-based division of Stryker focused on reprocessing single-use medical devices, has recalled certain lots of several reprocessed electrophysiology (EP) catheters. The recall, which covers more than 8,000 devices overall, was initiated after the company identified incomplete seals due to a process control issue.
    • “According to the U.S. Food and Drug Administration (FDA), this is a Class II recall. This means the agency believes the devices “may cause temporary or medically reversible adverse health consequences.”
  • The Wall Street Journal points out,
    • “Twenty people in Japan who took Amgen’s rare-disease drug Tavneos have died, and at least 22 developed a potentially fatal liver injury, according to Kissei Pharmaceutical, which sells the medicine in the country.
    • “Kissei told doctors Friday to stop prescribing the drug to new patients.
    • “The Japanese drugmaker said the 20 deaths occurred in people who had suffered a serious liver “impairment” and attributed 13 of the deaths to a condition, called vanishing bile duct syndrome, marked by the destruction of the ducts that carry bile out of the liver.
    • “Kissei said causal links to Tavneos hadn’t been confirmed in all 20 deaths.” * * *
    • “The medicine went on sale in Japan in 2022, according to Kissei. Also that year, Amgen bought the drug’s developer, ChemoCentryx, for $3.7 billion.
    • “In January, the FDA asked Amgen to voluntarily pull the drug from the U.S. market, but Thousand Oaks, Calif.-based Amgen refused.
    • “Then in March, the FDA said it had identified 76 global cases of serious liver injury linked to Tavneos, including eight deaths. Most were reported in Japan. Of the 76 global cases the FDA identified, seven involved the syndrome, and three of those patients died.
    • “In late April, the FDA moved to formally begin withdrawal proceedings.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 15, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue into May for some regions.
    • “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 51 new measles cases in a nationwide outbreak that has now reached 1,893 infections. All but nine cases are locally acquired, with the rest related to international travel.
    • “The agency reported two new outbreaks, for a total of 27. Last year the nation saw 48 outbreaks and 2,288 cases for the entire year. The United States could top that total in the coming months.
    • “Of this year’s cases, 21% involve children younger than 5 years, and 76% involve kids and young adults up to 19 years. Among all 2026 patients, 92% have been unvaccinated or have an unknown vaccine status. Six percent of patients this year have been hospitalized, compared with 11% last year.”
  • The American Hospital Association News relates,
    • “A Centers for Disease Control and Prevention report released May 14 found that U.S.-reported dengue cases in 2024 increased 359% above the annual average from 2010-2023. Dengue is a mosquito-borne viral disease that can cause mild to severe illness and death. There were 3,798 cases reported to the CDC in 2024, compared to the average of 828 from 2010-2023. The report found that 97.2% of cases in 2024 were travel-associated and that 2.8% were acquired locally. Individuals age 50-59 accounted for 21.8% of cases, and 57.5% of cases occurred in Hispanic or Latino individuals. In addition, 36.1% of patients were hospitalized and a total of six patients died. Most travel-linked cases were acquired in the Caribbean (34.1%), North America (24.3%) and Central America (15.6%).” 
  • Health Day informs us,
    • People who have survived a heart attack appear to have a higher risk of brain decline into dementia, a new study says.
    • On average, heart attack survivors have a yearly 5% increased risk of developing cognitive impairment, researchers reported today in the journal Stroke.
    • “Having had a heart attack in the past may speed up the decline in memory and thinking over time,” said lead researcher Dr. Mohamed Ridha, an assistant professor of neurology at Ohio State University in Columbus.
    • “Given the rising burden of dementia and cognitive decline among Americans, it is important to understand how cardiovascular disease affects their brain health,” Ridha said in a news release. “This knowledge can help heart attack survivors take steps to improve their brain health as they age.”
  • and
    • “Offering sigmoidoscopy screening reduces colorectal cancer (CRC) incidence in men and women — with a greater reduction among men — and reduces CRC mortality in men, according to a study published online May 12 in the Annals of Internal Medicine.
    • “Edoardo Botteri, Ph.D., from the Norwegian Institute of Public Health in Oslo, and colleagues report on the benefits of sigmoidoscopy after 23 years in a randomized controlled trial involving persons aged 50 to 64 years. A total of 100,210 persons were randomly assigned to screening with once-only sigmoidoscopy with or without one fecal immunochemical test or to no screening. The intention-to-screen analyses included 98,654 persons: 20,552 in the screening group and 78,102 in the no-screening group.
    • “The researchers found that the 23-year cumulative risk for CRC was 4.3 and 6.0 percent in the screening and no-screening groups, respectively, among men. The corresponding risks were 4.2 and 4.7 percent among women. In men, the 23-year cumulative risk for CRC death was 1.4 and 2.2 percent in the screening and no-screening groups, respectively, while in women, the corresponding risks were 1.3 and 1.4 percent. The strongest effect was seen for rectosigmoid cancer. Screening benefits were not changed with the addition of fecal blood testing.”
  • Healio adds,
    • “The survival benefit conferred by lung cancer screening in real-world settings may be smaller than observed in the pivotal trial on which national screening guidelines are based, study results suggest.
    • “Veterans receiving primary care in the VA health system exhibited a threefold higher risk for all-cause mortality than participants in the randomized National Lung Screening Trial (NLST) who had similar age and tobacco history.
    • “This is one of the first times we have been able to directly compare people who were enrolled in the trial with people in a real-world cohort who are eligible for screening,” Alison S. Rustagi, MD, PhD, assistant professor in University of California San Francisco’s department of medicine, told Healio. “It is not often that we see hazard ratios on the order of 3 in observational analyses. This shows a profound difference between these two populations.”
  • Per Medscape.
    • “Orforglipron, an oral GLP-1 receptor agonist, helps maintain weight loss after injectable therapies like tirzepatide and semaglutide, offering a practical continuation option for patients. Cardiometabolic benefits are largely preserved despite some weight regain.”
  • Per an National Institutes of Health news release,
    • “A group of pediatric eye disease researchers supported by the National Institutes of Health (NIH) has launched an open-access tool designed to help manage pediatric cases of amblyopia, a condition in which the brain fails to properly develop normal vision in one or both eyes early in life. It is the leading cause of preventable single-eye (monocular) vision loss, affecting three of every 100 children in the nation. The tool is aimed at expanding access to evidence-based amblyopia clinical-decision-making expertise amidst a shortage of pediatric eye care specialists in the United States.
    • “This online tool quickly distills the relevant literature into individualized treatment advice for busy clinicians anywhere with internet access. Those without internet access can utilize the article figures as clinical reference sheets,” said article lead author, Allison Summers, O.D., associate professor, Oregon Health & Science University, Portland.” * * *
    • “Known as the Amblyopia Navigator Decision-Support Instrument (ANDI), the tool is designed to guide any eye doctor through the diagnosis of amblyopia. Once amblyopia is diagnosed, ANDI helps to guide the eye care clinician without specialty training in pediatric eye care through management options. The tool helps the eye doctor determine the best glasses prescription for the patient based on a few clinical findings. The tool also helps the doctor determine how long to monitor whether glasses alone are improving vision, which can work for up to a third of children without any further treatment.
    • “If glasses are not enough, ANDI walks the eye doctor through next steps: patching the stronger eye for a couple of hours a day, using atropine eye drops to temporarily blur the stronger eye, or considering newer digital treatments delivered through specially designed games or videos. If a child stops making progress, the tool advises whether to increase the intensity of treatment, switch approaches, reassess the glasses prescription, or refer to a specialist. It provides steps for follow-up visits and what signs of recurrence to watch for after treatment ends. The tool can be used at an initial visit, or any follow-up visit in their amblyopia care journey.
    • “ANDI was developed by PEDIG, an NIH-funded research network with over 400 investigators, and it draws on evidence from 147 published studies. To access ANDI, go to https://public.jaeb.org/pedig.”

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

  • Mercer consulting offers “bold strategies” for payers to better control high cost members.
    • “While stop-loss coverage can help mitigate risk, many employers are finding it’s no longer enough. Unsurprisingly, “more focused management of high-cost claimants” is the top priority of large US health plan sponsors in their strategic planning for the next few years. In this post, we’ll discuss four areas where focused efforts can help employers rein in costs.”
      • Understand your data: Analyzing claims to gain clarity. 
      • Strategic oversight of medical specialty pharmacy and gene/cell therapies. 
      • Take a peekaboo view into neonatal intensive care unit management. 
      • Outlier inpatient stays.
  • Fierce Healthcare reports,
    • “CVS’ Omnicare unit has secured court approval to sell its business to virtual care company GenieRx Holdings, the healthcare giant announced Thursday.
    • “GenieRx, which offers an array of virtual health and medication services, is a joint partnership between Milrose Capital, a private equity firm, and Integro Asset Management, a healthcare-focused investment firm. Per court documents, the deal includes $250 million in cash as well as certain other liabilities, such as payroll expenses.
    • “In the announcement, CVS said that in combining with GenieRx, Omnicare will “have the opportunity to strengthen its service.” It will also continue to support it current clients in the lead up to closure, which is expected later this year, pending needed regulatory approvals.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.
    • Patients discontinue therapy early
    • Care models incompatible with sustained support
    • Costs and side effects deter patients.
  • Fierce Pharma tells us,
    • Total prescriptions for Eli Lilly’s Foundayo reached 10,248 for the week that ended May 8, up from 7,335 the prior week, according to IQVIA data cited by Citi. While still on the rise, Foundayo’s growth pace continued to lag behind that of Novo Nordisk’s Wegovy pill during the same stage of their launch. 
    • Wegovy’s total scripts rose by 1.3% week over week to nearly 446,000, as its share in the obesity GLP-1 market climbed 0.1 percentage point to 40.5%, according to Citi.
    • However, Wegovy’s growth apparently didn’t come from its oral formulation. Wegovy pill scripts landed at about 137,000 for the week, down from roughly 143,000 the prior week, marking the first time that the pill’s scripts have fallen since the oral launch in early January.
    • Scripts from the Wegovy pill made up 31% of total Wegovy scripts for the period, down 2 percentage points from the previous week. Still, Citi analysts argued that this roughly one-third of share “suggests preferences for oral formulations.”
    • Even as Wegovy gained ground, Lilly’s Zepbound remained the obesity market leader, with 59.5% share, as its nearly 656,000 scripts marked 0.8% growth week over week. 
  • Beckers Payer Issues offers payer perspectives on artificial intelligence tools.
    • “Using AI solutions to augment the work done by humans is an attractive solution for many payers.
    • “Getting started with these technologies, however, can feel daunting.
    • “To learn more about what it takes for payers to successfully incorporate AI and support more members, Becker’s Healthcare recently spoke with Chris Caramanico, CEO of Elligint Health, Amy Qureshi, RN, executive vice president of product strategy at Elligint Health, and Steven Tolle, chairman of the board at Elligint Health. Mr Tolle has significant experience developing and implementing AI from his time at IBM, Merge and IgniteData and addition serves as Chief of AI Strategy at Elligint Health.”
  • Fierce Healthcare adds,
    • Nearly 80% of payers now prefer implementing vendor-built artificial intelligence tools rather than developing internal capabilities, a new survey from Innovaccer found.
    • The survey draws insights from 63 health insurer organization leaders, including regional health plans to national carriers, the healthcare technology and AI company said in a press release. Respondents were polled in mid-December 2025 to mid-January, and include senior and C-suite executives.
    • Innovaccer CEO and co-founder Abhinav Shashank told Fierce Healthcare that the shift to outsourced solutions reflects the focus of how to “truly operationalize AI.” 
    • “What we are seeing is an emergence of how do you have platforms that companies can effectively offer that allow for more agentic orchestration,” Shashank said. “Because the reality of it is the technology is going to be a massive addition to how payers operate.” 
  • NBC News relates,
    • “Over the past two years, medical providers across America have quietly embraced a new AI tool called OpenEvidence to help them make clinical decisions, brush up on medical knowledge and even prepare for their licensing exams. The service, a sort of chatbot for doctors, was used by about 65% of U.S. doctors across almost 27 million clinical encounters in April alone, the company told NBC News.
    • “Everyone is using it,” said Dr. Anupam Jena, an internal medicine physician at Massachusetts General Hospital in Boston and a professor of healthcare policy at Harvard. “Its growth really has been exponential.”
    • “NBC News spoke with over two dozen doctors, hospital administrators, medical students and healthcare researchers from Hawaii to Maine to explore the rise of OpenEvidence. Each individual said they either used it regularly themselves or knew someone who did.
    • “Almost two-thirds of physicians — or roughly 650,000 doctors — in the U.S. actively use OpenEvidence, while another 1.2 million use it internationally, OpenEvidence representatives said. With its quick and tailored replies, OpenEvidence has become an AI-era equivalent of consulting a colleague for their expert opinion, though the software can also write patient discharge notes and provide custom study tools for doctors’ medical exams.”