Friday update

Medical / Rx research

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.”

Midweek update

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “Republican James Gallagher took the oath of office Wednesday, filling the seat of the late Rep. Doug LaMalfa in California’s 1st District and giving House leaders some breathing room in what has been a tumultuous year of deaths and resignations in Congress. 
    • “A former state Assembly GOP leader, Gallagher ran with endorsements from President Donald Trump and congressional leadership, easily winning the June 2 special open primary for the remainder of LaMalfa’s term. 
    • “Gallagher gives the House GOP another vote after the April resignation of Texas Rep. Tony Gonzales. Democrats have seen several recent departures of their own, including two scandal-driven resignations and the unexpected death of Georgia Rep. David Scott. 
    • “The addition of Gallagher bumps up the GOP’s hold on the majority to six, including California Rep. Kevin Kiley, who is an independent but caucuses with Republicans.”
  • Federal News Network informs us,
    • “House appropriators are backing the Trump administration’s proposed pay raise for troops in fiscal 2027 as part of a $1.1 trillion defense spending bill released Wednesday.
    • “Military service members could see their paychecks grow by 5% to 7%, depending on their rank. Enlisted troops, particularly those at the lowest levels, would receive the largest raises.”
  • The American Hospital Association News relates,
    • :The House Appropriations Committee June 9 approved their version of the FY 2027 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies by a 34-28 vote. The bill provides a total discretionary allocation of $110.8 billion for HHS, representing roughly $4 billion, or 4%, below the FY 2026 enacted level. Within that total, the Health Resources and Services Administration was allocated $8.35 billion, marking an $873 million decrease overall. However, the agency provided $1.44 billion for workforce initiatives, a roughly $25 million increase, and $576 million for rural health, marking a $158 million increase. 
    • “The bill also maintains funding for Children’s Hospitals Graduate Medical Education ($400 million), National Institutes of Health ($48.8 billion), as well as other key initiatives within the healthcare workforce, behavioral health, and maternal and child health programs. The committee recommended $70 million, a $237 million decrease, for the Hospital Preparedness Program. The Senate Appropriations Committee will release its version of the FY 2027 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies at a later date.”
  • and
    • “The AHA provided a statement to the House Energy and Commerce Subcommittee on Health today for a hearing titled “Lowering Health Care Costs for All Americans: Examining Policies to Increase Health Care Transparency.” Lawmakers considered a range of legislative proposals, including a measure to codify existing price transparency regulations for hospitals and health plans, a bill requiring hospitals to post pricing physically on their walls, a bill requiring health insurers to share overhead costs and claim payments, a measure requiring insurers to publicly display claim denial rates and more. 
    • “The hospital field takes transparency compliance seriously, and we want to continue the work of providing patients with essential information on their care,” the AHA wrote. “We would caution, however, against codifying regulations that do not meet the goals sought by either patients or health care purchasers and instead result in ‘transparency in name only.’ Before Congress considers additional legislative solutions, it will be important to understand how existing policies are performing, as well as the tremendous financial costs of compliance, to ensure that any future policymaking retains what is working and improves upon what is not delivering true transparency.”
  • and
    • “The Hospital Insurance Trust Fund has been projected to become insolvent in 2033, according to the Medicare Board of Trustees’ annual report released June 9. The fund pays benefits under Medicare Part A, which covers inpatient hospital services, care provided by skilled nursing facilities, home health care and hospice care. The projections assume that the trust fund will receive lower levels of revenue due to recent tax law changes. “The projections in this year’s report continue to demonstrate the need for timely and effective action to address Medicare’s remaining financial challenges — including the HI trust fund’s projected depletion, this fund’s long-range financial imbalance, and the rapid growth in Medicare expenditures,” the trustees wrote.” 
  • MedCity News adds,
    • “CMS Administrator Dr. Mehmet Oz is optimistic about Washington’s ability to bend the healthcare cost curve, he said during a Tuesday address at the HFMA Annual Conference in National Harbor, Maryland.
    • “It’s not all rosy, but there’s some opportunities. As a clinician, I’ll tell you, if you have an opportunity to fix a problem, it gives you more hope than if you think the issue is terminal. We’re definitely not terminal,” he declared.
    • “During his talk, Dr. Oz outlined a few key areas that CMS is targeting to make healthcare more affordable. Below are the main pillars of the agency’s affordability agenda.”
      • Fraud, waste and abuse
      • Drug pricing reform
      • Tech modernization
      • Preventive health and nutrition
      • Deregulation
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced a new series of initiatives to combat fraud, waste, and abuse across the Federal Employees Health Benefits (FEHB) Program and Postal Service Health Benefits (PSHB) Program. OPM is undertaking this effort as part of its ongoing work with the White House Task Force to Eliminate Fraud, led by Vice President JD Vance.
    • “President Trump has made eliminating fraud, waste, and abuse across the federal government a top priority,” OPM Director Scott Kupor said. “Working alongside the White House Task Force to Eliminate Fraud, OPM is taking additional steps to safeguard the premiums paid by federal employees and taxpayers, protect beneficiaries, and ensure health insurance companies are meeting the highest standards of accountability.” * * *
    • “OPM is also building a data science and audit team that will review de-identified claims data in partnership with the OPM Office of Inspector General to proactively identify cases of fraud, waste, and over-billing. This will end the practice of relying upon retrospective reviews of data to find and address fraud and will be a proactive approach in identifying problems as they arise and implementing corrective mechanisms that save hard-earned premium dollars paid by federal employees.”
  • The FEHBlog expects that OPM will find that FEHB and PSHB carriers are doing a good job preventing fraud waste and abuse because they hold the insurance risk, not the federal government.
  • Fedscoop tells us,
    • “The Office of Personnel Management on Wednesday awarded its anticipated contract to modernize and consolidate federal human resources functions to Oracle, capping a process that’s been over a year in the making. 
    • “The nearly $400 million award puts Oracle in charge of a process to bring over 100 HR systems under one single platform that the agency is calling its Core Human Capital Management system. OPM says it believes the project will make significant reductions in the overall cost of HR platforms to taxpayers.
    • “Historically, federal agencies have relied on fragmented, aging HR systems that are costly to maintain and difficult to scale,” OPM Director Scott Kupor said in a written statement included in a press release. 
    • “He called the award “a foundational investment in the future of federal workforce management.”
  • OPM Director Scott Kupor, writing in LinkIn, adds a post about this contact award to his Secrets of OPM blog.
  • STAT News points out,
    • “The National Institutes of Health has appointed researcher John Powers III to lead its infectious disease institute on an acting basis, after weeks of being in leadership limbo following reports that the previous director, Jeffery Taubenberger, had stepped down.
    • “The appointment of Powers, previously a senior adviser at the National Institute of Allergy and Infectious Diseases and Taubenberger’s deputy, comes at a moment of heightened attention for the institute.
    • “The NIH’s second-largest agency, responsible for $6.5 billion worth of funding, has been without a permanent leader since the ousting of Jeanne Marrazzo last March. In recent weeks, a handful of other top leaders have also been reassigned to other posts, causing lawmakers to express concern about the bench of infectious disease expertise at a time of alarm over the recent hantavirus outbreak and the Ebola outbreak in Central Africa.” 

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA issued a drug safety communication approving a label change that warns about the risk of kidney stones or kidney injury with the over-the-counter (OTC) weight loss drug orlistat (Alli), the agency saidopens in a new tab or window Wednesday.
    • “The label now recommends that consumers with a history of kidney disease or kidney stones consult a healthcare provider before using the drug.
    • “The FDA advised clinicians to inform patients about reports of acute kidney injury (AKI), hyperoxaluria, calcium oxalate nephrolithiasis, or oxalate nephropathy linked to orlistat. Patients should also stop taking the drug if they develop symptoms like back or groin pain, painful urination, blood in urine, feet or leg swelling, or less frequent urination.”
  • Per a Lilly news release,
    • “Eli Lilly and Company (NYSE: LLY) announced today [June 9] that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of EBGLYSS (lebrikizumab-lbkz) for subcutaneous use in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis. EBGLYSS is already approved for a once-monthly maintenance dose, with long-term data showing durable disease control. Now, EBGLYSS gives patients with moderate-to-severe atopic dermatitis the option to manage their condition with as few as six maintenance injections per year.1
    • “Today’s approval builds on EBGLYSS’ established long-term durability, with a new option for one maintenance dose every eight weeks. For people living with moderate-to-severe atopic dermatitis, that means a treatment they only need to take as few as six times a year—without prescription topicals from the start,” said Adrienne Brown, executive vice president and president of Lilly Immunology. “EBGLYSS now gives patients the opportunity to flare less and live their lives with fewer interruptions from atopic dermatitis.”

From the judicial front,

  • Per a Justice Department news release,
    • “Ahold Delhaize USA Inc. (Ahold Delhaize), headquartered in Quincy, Massachusetts, has agreed to pay the United States and participating states a total of $40 million to resolve allegations that it violated the False Claims Act and state analogs by reporting inflated “usual and customary” prices on claims to federal healthcare programs.” * * *
    • “The United States alleged that Ahold Delhaize supermarkets with in-store retail pharmacies – including supermarket chains operating under the names Giant, Hannaford, Stop & Shop, Food Lion, and others – operated prescription savings programs pursuant to which enrolled members received discounted prices on prescription drugs. The United States contends that, in light of the features and operations of those savings programs, and the applicable Medicare Part D, Medicaid, and TRICARE program requirements (including, where applicable, contractual requirements), the discounted prices should have been reported as “usual and customary” prices on claims submitted to Medicare Part D, Medicaid, and TRICARE. Reported “usual and customary” prices serve as ceiling prices on payments to pharmacies under the applicable healthcare program payment formulas. The United States contends that Ahold Delhaize pharmacies failed to accurately report their discounted prices as their “usual and customary” prices on claims to Medicare Part D, Medicaid, and TRICARE, causing those programs to pay inflated amounts on such claims.”
  • Modern Healthcare reports,
    • “Clover Health received higher Medicare Advantage star ratings following a legal victory against the Centers for Medicare and Medicaid Services.
    • “The health insurer estimated that revised quality scores would trigger $120 million in bonus payments.
    • “CMS also instructed Clover Health to resubmit its bids for the 2027 plan year.
    • “The court ruling may affect similar cases from CareFirst BlueCross BlueShield and Humana.”

From the public health and medical / Rx research front,

  • Health Day reports,
    • “The kids are not all right, at least in the United States, according to a new report showing a nosedive in children’s well-being from 2019 to 2024.
    • “In 29 states, the overall U.S. score fell from 553 to 547 on a 1,000-point scale, a decline that surpasses pre-pandemic numbers, the report found.
    • “This score measures children’s well-being across four categories: economic well-being, education, health, and family and community, according to the Anne E. Casey Foundation’s 2026 Kids Count Data Book.
    • “Here are some notable findings:
      • “Eleven of 15 states that saw the greatest gains in children’s well-being were in the South. South Carolina had the largest spike of any state, 38 points.
      • “Five of the seven states with the largest declines in well-being were in the Northeast, led by Maine.
      • “Scores among the West were widely varied – ranging from 281 in New Mexico to 759 in Utah, which fared at the top in the region.
      • “Four Midwestern states — Nebraska, North Dakota, Iowa and Minnesota — followed behind Maine for the biggest drops in kids’ well-being.”
  • and
    • “Those who prefer to go to sleep later report poorer mental health, which is partially explained by greater reported loneliness, according to a study presented at SLEEP 2026, the annual meeting of the Associated Professional Sleep Societies, held from June 14 to 17 in Baltimore.
    • “Alec Harlow, from Brigham Young University in Provo, Utah, and colleagues examined how chronotype, nocturnal loneliness, and general loneliness relate to mental health. The analysis included 442 survey participants.” 
  • and
    • “Researchers found no clear increase in pregnancy risks found with first-trimester GLP-1 exposure
    • “The findings may reassure women with unintentional early pregnancy GLP-1 use
    • “Although the results are encouraging, the data were less precise for rare outcomes, so additional studies are needed.”
  • STAT News relates,
    • “The American College of Obstetricians and Gynecologists has released a recommended vaccine schedule for pregnant people, one that diverges from the advice currently offered by the Centers for Disease Control and Prevention.
    • “ACOG is recommending four vaccines be routinely administered during pregnancy, with several other vaccines recommended under certain circumstances. The new schedule is endorsed by 13 medical societies and health organizations.
    • “Changing national recommendations coupled with rampant vaccine misinformation are resulting in confusion for both patients and health care professionals,” ACOG President Camille Clare said in a press release. “It is incredibly important for the public to have access to reliable, evidence-based information on maternal immunizations from a trusted source. ACOG is proud to be that source.” 
    • “The current CDC vaccine schedule for pregnant people includes only two recommendations, one for a vaccine to protect against tetanus, diphtheria, and pertussis, known as Tdap, and one to generate protection against respiratory syncytial virus, or RSV, in the developing fetus.” 
  • MedPage Today notes,
    • “Despite being more commonly diagnosed in women ages 40 or younger, an estimated 10% to 15% of early triple-negative breast cancer (TNBC) cases are diagnosed in patients over 70.
    • “Current guidelines recommend the use of adjuvant chemotherapy in early-stage TNBC regardless of a patient’s age; however, recent data published in JAMA Network Open indicated that underutilization of adjuvant chemotherapy may have contributed to worse outcomes in this patient population in the past.
    • “When we use these treatments for elderly patients it is a very well-known fact that most of the time we undertreat,” said Ahmed Elkhanany, MD of Baylor College of Medicine in Houston. “This may lead to a decrease in their outcomes compared with other patients.”
  • The Wall Street Journal points out,
    • “Sanofi stopped a late-stage study of its experimental drug, riliprubart, for a rare immune disorder due to insufficient efficacy.
    • “The decision marks an early setback for Sanofi’s newly appointed Chief Executive Belen Garijo, who took office last month.
    • “Sanofi will evaluate continuing other riliprubart studies and expects no significant cost or change to its 2026 guidance.”

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

  • Fierce Healthcare reports,
    • “CAQH has rebranded as DataSpring, a name leaders say reflects the organization’s push toward a more modern and innovative future.
    • “The Council for Affordable Quality Healthcare was founded more than 25 years ago and has evolved from its initial mission to make healthcare work better for patients, now offering critical data services to both providers and payers. 
    • “The DataSpring name “reflects the organization’s central role in delivering a connected healthcare ecosystem through accurate, authorized data from providers and payers,” per an announcement. The group announced the rebrand at the AHIP 2026 conference this week, with signage across Las Vegas reflecting the new identity.”
  • and
    • “Despite steady demand for obesity medications, 49% of payers who do not currently cover GLP-1s for obesity would not do so at any price, a new report from Pharmaceutical Strategies Group (PSG) found. 
    • “The 2026 Trends in Drug Benefit Design report drew insights from a survey of 237 benefits leaders across employers, health plans and unions. 
    • “Nine in 10 respondents in the survey report being moderately or very concerned about the affordability of GLP-1 medications. Moreover, 72% report discontinuation rates are at least moderately influential in coverage decisions. 
    • When asked the top reason for excluding coverage for obesity, 45% report coverage is too expensive for all members who would be prescribed the medication. Other factors include view of the medications as lifestyle drugs (24%), ongoing cost exposure (18%) and high discontinuation rates resulting in a lack of ROI (5%). Analysts note 9% of respondents selected “other” and described different reasons for excluding coverage.
  • Healthcare Dive tells us,
  • The American Medical Association shares highlights from the Association’s House of Delegates meeting.
  • The Wall Street Journal informs us,
    • “Johnson & Johnson aims to be the No. 1 oncology company by 2030, with its CEO stating a cure for some cancers is a realistic goal.
    • “J&J agreed to acquire biotech company Firefly Bio for $1 billion in cash, adding new cancer-fighting platforms to its portfolio.
    • “Artificial intelligence is helping J&J develop medicines faster, though its impact on the company’s bottom line is yet to be seen.”
  • The Health Care Cost Institute lets us know,
    • “Total spending on a health care service is the result of the price of that service and how frequently it is used.  High spending could be the result of high prices, high utilization, or both. Within imaging, the highest priced service (MRI) was one of the less commonly used. The most frequently used imaging service (x-rays), in contrast, was the lowest price service. It could stand to reason, then, that they would be the imaging services with the most spending.   
    • “Instead, in 2022, the imaging category with the highest spending per person was CT scans ($116 in 2022). CT scans were the second highest priced service, and only the third most commonly used service.  Ultrasounds were the service with the next highest spending per person ($113). They were the second lowest priced imaging service but were the second most commonly used service. X-rays made up the third highest spending per person in 2022 ($112). X-rays were the most used imaging service and the least expensive.”
  • Per Fierce Healthcare,
    • “Almost two-thirds of Americans who have asked artificial intelligence tools for medical advice acted on the guidance without consulting a doctor, an eHealth survey of more than 1,000 people found.
    • “Half of respondents had turned to AI for medical advice. More than four-fifths of AI users said they trust the medical advice the tools provide, with 29% of Americans saying they have complete faith in the outputs. EHealth found 17% of AI users mostly distrust the medical advice the technology provides, while 1% completely distrust the outputs.
    • “While a minority of people using AI for medical advice are skeptical of the tools’ outputs, most users are confident enough in the information to use the technology to shape their care decisions. More than 70% of AI users changed their decision to seek medical care based on a tool’s medical advice. The figure includes 36% of AI users who opted against seeking medical care based on the advice.” 

Tuesday report

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

Simplicity is a virtue.

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Monday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call takes a look at what’s ahead of Congress this week,
  • and also lets us know,
    • “President Donald Trump on Monday sent to the Senate the nomination of acting Attorney General Todd Blanche to fill the role permanently, teeing up what could be a bruising confirmation process for a Trump ally who has drawn bipartisan criticism for recent Justice Department moves.”
  • Per a HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Education today hosted eight of the nation’s leading accreditors, assessors, and medical organizations to announce a historic development to increase nutrition requirements at every level of U.S. medical education, competency-evaluation, training, and residency. Additionally, 19 medical schools across the country have signed the Trump administration’s Nutrition Education Pledge, vowing to incorporate 40 hours of nutritional education or its competency equivalent into graduation requirements starting this fall.
    • “Poor diets are the primary driver of America’s chronic disease epidemic, and today’s announcement reflects the shifting landscape toward placing nutrition and prevention at the core of patient health,” said Secretary Robert F. Kennedy, Jr. “Still, more work remains, and I look forward to seeing nutrition play an increased role as the latest science, data, and best practices develop.”
    • “Last August, HHS and the Department of Education sent a letter to medical organizations encouraging them to improve their standards and place nutrition at the core of their programs.”
  • Beckers Hospital Review informs us,
    • “TrumpRx.gov is adding 160 prescription drugs to the platform, bringing its total to more than 800  according to a June 5 Truth Social post from President Donald Trump.
    • “The president said the expansion would allow TrumpRx.gov to offer discounted pricing for medications that account for roughly four out of every five prescriptions filled in the U.S. The administration also claims the platform has saved American patients more than $400 million since its February launch.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced additional leading technology companies have committed to partnering with the US Tech Force (Tech Force), the government-wide initiative to recruit top technologists to modernize the federal government and strengthen America’s technical workforce.
    • “The new industry partners include Arista Networks, Armada, Cisco, Cognition AI, Cognizant, Payward, Moveworks from ServiceNow, Scale AI, and Wiz.
    • “These companies will contribute to Tech Force by providing technical training resources, executive engagement and programming, nominating employees for temporary government service, and helping create paths for Tech Force alumni into the private sector.” * * *
    • “More information about Tech Force is available here.”
  • The American Hospital Association News reports,
    • “The Drug Enforcement Administration today released a final rule implementing provisions from the Restoring Hope for Mental Health and Well-Being Act of 2022, which passed as part of the Consolidated Appropriations Act of 2023, eliminating the need for a separate waiver for qualified practitioners to dispense certain types of controlled substances for medications for opioid use disorder treatment, or MOUD. While the original requirements were amended by the SUPPORT Act of 2018 and changes were implemented in an interim final rule in 2020, the 2022 legislation struck the amended section from regulation, thus requiring DEA to respond to public comments on the interim final rule and update regulatory language accordingly.”

From the Food and Drug Administration front,

  • Fierce Pharma informs us
    • “The FDA has expanded the label for Pfizer’s subcutaneous hemophilia drug Hympavzi, now including patients age 6 and older who have hemophilia A or B.
    • “The anti-tissue factor pathway inhibitor was initially approved in October of 2024 for those age 12 and older with hemophilia A or B who have not developed the antibodies—also known as inhibitors—produced by the immune system that block or destroy infused clotting factor medications.
    • “The new expansion covers all patients 6 and older, regardless of their inhibitor status. The new nod also opens up the treatment to those 12 and older who have developed the inhibitors.”
  • CBS News reports,
    • “Retatrutide isn’t supposed to be everywhere.
    • “Touted as the next generation in the GLP-1 craze, it’s an experimental weight-loss drug that is not authorized outside of clinical trials. The Food and Drug Administration hasn’t reviewed whether it is safe and effective, which is the legal path for prescription drugs to come to market. And yet retatrutide is for sale all over the internet, a phenomenon with no modern precedent.
    • “It isn’t just shadowy online vendors offering what they claim to be research-grade retatrutide.
    • “A CBS News investigation found dozens of clinics across the country, staffed by licensed physicians and nurse practitioners, openly advertising retatrutide. That practice defies a longstanding norm in medicine – to wait for the FDA to approve a drug before prescribing it – and is contributing to a booming commercial marketplace for a drug that is barred from sale by federal law.” * * *
    • “It’s on the states to really police this kind of conduct,” said Nathan Cortez, a professor at SMU Dedman School of Law, adding that they often lack enforcement resources. “At some point it becomes so blatant and widespread that, you’re wondering, ‘What are we doing here? Are we going to enforce the law or not?'”
  • The Wall Street Journal adds,
    • Eli Lilly LLY shares rose in early European trade after a late-stage trial showed its drug was effective in weight loss and in alleviating obesity-linked conditions.
    • “Shares jumped 4.4% premarket to $1,181, extending a record high hit at Friday’s market close. The stock is up over 30% since the Indiana-based company reported first-quarter earnings on April 30.
    • “Participants in a Phase 3 trial of retatrutide—an experimental drug targeting obesity-related hormones—showed substantial weight loss, with those taking 12 mg doses losing an average of around 70 pounds over an 80-week period, the company said.
    • ‘One-third of participants on 12 mg doses saw their weight fall into a healthy weight range, while two-thirds fell below the threshold for obesity, Eli Lilly said.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Massachusetts June 8 vacated the $100,000 fee for new H-1B visas established by a proclamation in September 2025. Judge Leo T. Sorkin declared the fees unlawful and said in his decision that it “exceeds the fee-setting authority delegated by Congress.” The AHA last year asked the administration to make healthcare personnel exempt from the fees. The federal government is likely to appeal the June 8 decision.”

Reports from the American Diabetes Association’s annual meeting,

  • Fierce Pharma adds,
    • “With an obesity green light already in hand, Eli Lilly is pushing for its newly launched Foundayo (orforglipron) to break into Type 2 diabetes, in turn rounding out its oral offering in line with Novo Nordisk’s duo of GLP-1 pills in both indications. 
    • “Now, in results from a trio of pivotal phase 3 studies presented Monday at the American Diabetes Association 2026 Scientific Sessions, Lilly is aiming its diabetes data squarely at two of the oral GLP-1’s biggest potential rivals.
    • “Sure to grab the most attention at the conference are results from Achieve-3, a head-to-head trial in which Foundayo topped Novo’s oral semaglutide on metrics of blood sugar reduction and weight loss in T2D patients.” 
  • STAT News notes,
    • “AstraZeneca’s investigational GLP-1 pill showed promise in mid-stage obesity and diabetes studies, but it may still be too early to determine how it stacks up against oral treatments already on the market.
    • “In one Phase 2 trial of people with obesity, called VISTA, those on the highest dose of the drug, called elecoglipron, lost 11.2% of their weight after 36 weeks, when looking at all patients regardless of discontinuations, according to data presented Monday at the annual meeting of the American Diabetes Association and published in the Lancet. (Eli Lilly’s pill Foundayo led to the same rate of weight loss in a Phase 3 study that lasted twice as long, but it’s hard to compare across trials in different phases.)”
    • “In a separate Phase 2 trial in people with diabetes, called SOLSTICE, patients on the highest dose saw up to a 1.74 percentage-point decrease in a measure of blood sugar called A1C after 26 weeks. The study, also published in the Lancet, enrolled people taking oral Ozempic open-label as a comparator group, and they experienced a smaller A1C decrease of 1.32 percentage points.”
  • The American Journal of Managed Care relates,
    • “A trio of studies presented at the American Diabetes Association 2026 Scientific Sessions has reframed the conversation of diet during pregnancy, pointing to diet quality, not just quantity, as a meaningful lever for managing gestational glycemia and postpartum metabolic risk. This is a conversation that has long been viewed through the narrow lens of weight gain and fetal growth.
    • “Across hundreds of pregnancies, researchers of 3 oral presentations found that higher intake of fiber, nonstarchy vegetables, and plant protein were independently associated with lower continuous glucose monitor (CGM) readings,1 while lower-carbohydrate diets in women with gestational diabetes improved glycemic control but raised micronutrient concerns.2 Perhaps most strikingly, women randomly assigned to a higher-complex carbohydrate diet during pregnancy still showed measurably lower postpartum glucose responses 2 months after delivery, suggesting that what a pregnant woman eats may matter long after the birth.3
    • “Together, these findings challenge prevailing assumptions about optimal gestational nutrition and open new questions about how prenatal dietary interventions might be designed to protect both mother and child over the long term.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Tango Therapeutics said Monday its experimental drug vopimetostat showed promise in a small trial in pancreatic cancer, with nearly all of the enrollees followed so far responding to a regimen that combined its medicine with Revolution Medicines’ closely watched treatment daraxonrasib.
    • “The data suggest vopimetostat outperformed daraxonrasib alone in a similar population of people whose disease had progressed after at least one treatment line and exceeded Wall Street expectations. The company plans to initiate a Phase 3 trial later this year testing the combination.” 
  • The American Medical Association lets us know what doctors wish their patient knew about diverticulitis.
    • “Diverticulitis can turn silent colon pouches into painful inflammation. But plenty of interventions are available, depending on severity of diverticulitis.”
  • Per a National Institutes of Health news release,
    • “By inducing specific patterns of activity in small portions of the brain in awake mice, researchers supported by the National Institutes of Health (NIH) have triggered a recalibration of neural connections that normally only occurs during sleep. This new approach offset the effects of sleep deprivation in memory tasks and revealed features of sleep that are key to its restorative effect.
    • “What we’re essentially doing is forcing sleep in a local region of the brain. While that part is solidifying memories and restoring learning capacity, other parts stay aware/vigilant and connected to environment,” said corresponding author Chiara Cirelli, M.D., Ph.D., a professor of psychiatry at the University of Wisconsin-Madison. “Dolphins do something similar, sleeping with only one brain hemisphere at a time.”
    • “Non-rapid eye movement (NREM) sleep, which makes up about 80% of sleep for adults, is when the junctions between neurons that make memories are evaluated. During this phase, the brain protects important connections for long-term storage, prunes those that are less necessary, and makes space for new ones.”
  • Genetic Engineering and Biotechnology News relates,
    • “A study tracking thousands of B cells across more than 100 germinal centers (GCs) in mice has revealed how the system consistently produces highly effective antibodies. The findings overturn longstanding ideas about how germinal centers function, revealing that they are far more selective than once thought, and challenge the idea that antibody improvement is driven mainly by rare growth “bursts” among the most successful B cells. The discovery could have implications for immune cell evolution, and ultimately guide the design of vaccines against rapidly mutating pathogens like influenza. It could also lead to new ways of studying evolution itself.
    • “The traditional, mechanistic view of germinal centers is to think of them as selection machines sorting out the best antibodies,” said research lead Gabriel D. Victora, PhD, head of the Laboratory of Lymphocyte Dynamics at The Rockefeller University. “But when you look very, very closely, you see a process that’s almost essentially random—a little bit better than a coin toss—which repeats many times until the immune system arrives at the right answer consistently. That’s much more akin to how evolution operates than the way a machine does.”
    • “Victora and colleagues reported on their findings in Cell, in a paper titled “Replaying germinal center evolution on a quantified affinity landscape.”
  • Medscape points out,
    • “Metabolic-bariatric surgery (MBS) in patients aged 65 years or older resulted in long-term meaningful weight loss and remission of obesity-related conditions, although complication rates of about 8% were noted.”
  • The Cancer Therapy Advisor notes,
    • “Hyperthyroidism may be associated with an increased risk of breast cancer, particularly premenopausal breast cancer, according to research published in Cancer Epidemiology, Biomarkers & Prevention.
    • “Findings from in vitro studies have indicated that thyroid hormones can have estrogen-like effects. That suggests that thyroid hormones may affect cellular proliferation of breast tissue and subsequently increase breast cancer risk in people with hyperthyroidism, researchers explained. In this study, the researchers assessed the effects of hyperthyroidism and hypothyroidism on incident breast cancer in women from the Sister Study.
    • “Women diagnosed with hyperthyroidism or receiving related treatment may have elevated BC [breast cancer] risk, particularly premenopausal BC,” the researchers concluded. “Although more research is needed, premenopausal women treated for hyperthyroidism may benefit from enhanced breast cancer screening.”

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

  • Fierce Healthcare reports,
    • “Medicare Advantage insurer Essence Healthcare is continuing to build out its partnership with Oura and has unveiled a new clinical program that aims to identify potential sleep apnea risk.
    • “Essence is rolling out a new clinical workflow that will arm physicians with insights into patients’ nighttime breathing habits to identify those who may be at risk for obstructive sleep apnea. The insurer offers the ring as a covered benefit through some of its plans and has been working with Oura’s team to identify more clinical applications for its data.
    • “News of the partnership expansion was shared first with Fierce Healthcare.
    • “Through the program, insights into members’ sleep, as identified by the Oura Ring, will be shared with Essence with the patients’ consent. The insurer then uses Lumeris’ Tom platform to reach out to at-risk individuals and guide them through STOP-BANG, a common evidence-based screening for sleep apnea.”
  • and
    • “Artificial intelligence is here to stay in healthcare, and the industry’s largest players, like CVS Health, are making huge commitments to the tech.
    • “But embracing AI requires a workforce that’s ready for the revolution. With that backdrop, CVS has rolled out its internal AI Learning Academy, which aims to educate its workforce on practical applications for the technology and how it can impact and improve their workflows.
    • “The program was built in collaboration between human resources and tech leaders at the company. Greg Karanastasis, senior vice president for talent and development at CVS, told Fierce Healthcare that the aim was to build something bigger than just a training program.”
  • Per an Institute for Clinical and Economic Research (ICER) news release,
  • MedCity News tells us about “The 3 Biggest Roadblocks to Egg Freezing — and How Providers Are Working to Remove Them.”
    • “Egg freezing has gained popularity as a fertility preservation tool, but experts say high costs, uncertain outcomes and timing challenges continue to deter many women from pursuing it.”
  • MedTech Dive informs us,
    • “Boston Scientific is investing approximately $138 million to build a 500,000-square-foot distribution facility in Plainfield, Indiana.
    • “Indiana Gov. Mike Braun, who announced the project last week, said Boston Scientific will break ground on the facility this year and ultimately create up to 300 jobs. 
    • “Boston Scientific is building the facility to complement its existing distribution network, which includes sites in Georgia, Massachusetts and Minnesota.”
  • BioPharma Dive notes,
    • “Incyte, a drugmaker with a heavy focus on blood diseases and cancers, plans to take control of an experimental medicine that could help control bleeding in a variety of disorders.
    • “Vega Therapeutics, a subsidiary of the “hub-and-spoke” biotech Star Therapeutics, has been developing this “VGA039” medicine primarily as a treatment for von Willebrand disease — the most common inherited bleeding disorder. Now, Incyte has agreed to buy Vega for $1.25 billion up front. Star would be eligible to receive as much as $750 million more if certain sales goals are eventually met.
    • “Patients with von Willebrand disease lack an important clotting protein, meaning that, when they suffer any kind of injury, the bleeding usually takes longer to stop. In severe cases, this bleeding can cause joint or organ damage and be life-threatening. Current preventative treatments include so-called factor replacement therapies given as intravenous infusions two to three times a week. VGA039, meanwhile, comes as a once-monthly, under-the-skin injection that patients can do themselves.”
  • The Wall Street Journal relates,
    • “Roche Holding struck a deal with Nurix Therapeutics NRIX to license an experimental blood-cancer drug for up to $2.3 billion, expanding its pipeline in oncology and potentially other therapeutic areas.
    • The Swiss drugmaker on Monday said it would make an upfront cash payment to Nurix of $700 million, with additional payments subject to the drug, bexobrutideg, reaching development, regulatory and sales targets.
    • Bexobrutideg is due to enter late-stage studies for the treatment of chronic lymphocytic leukemia this summer, Roche said.
    • “The main opportunity for us is in B-cell malignancies. There are many B-cell malignancies and the most dominant of interest for us is chronic lymphocytic leukemia,” Roche’s deputy chief medical officer, Stefan Frings, said in an interview.
    • “The company said the medicine has potential to offer higher efficacy and more favorable tolerability than established therapies for leukemia. The drug is a so-called BTK degrader designed to remove the BTK enzyme from cells, rather than blocking its effects, and overcome resistance.”
  • and
    • “Johnson & Johnson JNJ  has agreed to buy biotechnology company Firefly Bio for $1 billion in cash in a deal that bolsters the drugmaker’s oncology pipeline.
    • “J&J on Monday said Firefly is developing its proprietary Firelink degrader antibody conjugate platform, for KRAS-driven cancers, which have limited treatment options with survival measured in months.
    • “Mutations of the KRAS gene have long been considered undruggable because the gene’s structure lacks the deep binding pockets most drugs need.
    • ‘J&J said the Firelink platform is a novel approach to overcome limitations of existing treatments by delivering a highly selective protein degrader to tumor cells, while avoiding healthy cells.”
  • and
    • “Novo Nordisk NOVO.B said prescriptions for its Wegovy weight-loss pill have surpassed three million since launching in early January.
    • “The Danish drugmaker said late Sunday that the pill hit one million prescriptions 12 weeks after reaching U.S. pharmacies and online providers, with a further two million prescriptions achieved in the following 10 weeks.
    • “More than 80% of new prescriptions filled for the Wegovy pill are for patients new to the GLP-1 class of drugs, which the company says indicates that the new oral formulation is expanding the obesity treatment market, rather than replacing existing injectable therapies.”
  • Fierce Pharma adds,
    • “On a weekly basis, total GLP-1 prescriptions were trending downward over the week of June 1, falling 5.7% week-over-week, Citi analysts noted. Other than the continued rollout of Lilly and Novo’s respective weight loss pills, the analysts cited the effect of the Trump administration’s “most favored nation” pricing policies as a key future event that they think could impact total prescriptions.” 

Noteworthy Death

  • AP reports
    • “Harvard University professor Robert Coles, the psychiatrist and Pulitzer Prize-winning author who championed the cause of children grappling with poverty and segregation, has died at 97, his son said Sunday.
    • “The son, also named Robert Coles, told The Associated Press that his father died Thursday at a hospice center in Lincoln, Massachusetts.
    • “The elder Coles was famed for documenting the needs of children, particularly those caught in the crucible of social upheaval. The second and third parts of his five-volume “Children of Crisis” won him a Pulitzer Prize in 1973 for general nonfiction.
    • “In a 1965 Washington Post essay, he wrote that, expecting to find many psychiatric problems among the children of poverty, that instead “I was constantly surprised at the endurance shown by children we would all call poor or, in the current fashion, ‘culturally disadvantaged.’”
  • RIP

Weekend Update

David Ermer–Congress, Medical / Rx research, Obesity, U.S. Healthcare–

Simplicity is a virtue.

  • Per a House Energy and Commerce Committee news release,
    • “The Subcommittee on Health has scheduled a hearing on Wednesday, June 10, 2026, at 10:15 a.m. (ET) in 2123 Rayburn House Office Building. The title of the hearing is “Lowering Health Care Costs for All Americans: Examining Policies to Increase Health Care Transparency.”
  • HR Dive reports,
    • “A hospital may employ staff as overtime-exempt specialists who simultaneously take shifts performing nonexempt staff nurse work during the same workweek without altering the employees’ exemption status under the Fair Labor Standards Act, the U.S. Department of Labor said in an opinion letter issued Thursday.
    • “The document is one of a group of four letters issued last week by DOL Wage and Hour Division Administrator Andrew Rogers. Rogers said the FLSA’s executive, administrative and professional overtime exemption applies to employees whose “primary duty” involves performance of exempt work.”

From the public health and medical / Rx research front.

  • The Wall Street Journal reports,
    • “The federal government reported America’s total fertility rate dropped to 1.57, sparking alarm about a graying, shrinking population.
    • “Experts note the 1.57 total fertility rate is a snapshot, with 30% of the decline from falling teen pregnancy rates.
    • “Medical solutions like IVF and egg freezing, along with policies for workplace flexibility and childcare, are discussed to address declining fertility.”
  • and
    • “Cancer rates are rising among people under 50, an alarming trend that has led some patients to take preventive measures. While women under 45 make up a small number of overall breast cancer cases, incident rates have increased 1.1% each year for the past 10 years. 
    • “Armed with more information than ever about their genetics, women with higher risk factors are opting for surgeries that reduce their odds of developing cancer by as much as 95%. Doctors specializing in breast reconstruction say they are seeing ever-younger women opting to remove their breasts as a prophylactic measure. 
    • “At this point, seeing a patient in their early 30s is totally routine,” said Dr. Steven Sultan, a plastic and reconstructive surgeon at New York City’s Mount Sinai Hospital, referring to cancer patients. He said about 20% of his cases are prophylactic, a term that encompasses women who take action as soon as they learn about genetic risk factors and those who have undergone biopsies after suspicious scans but do not have cancer. In the past few years, he’s seen a notable change in 20-somethings coming into his office, both with cancer as well as for prophylactic surgeries.” 
  • The New York Times relates,
    • “Scientists at Columbia University have edited the DNA of early human embryos with unprecedented accuracy, an achievement that could open the way to babies engineered with particular characteristics.
    • “The prospect has fueled controversy for years. On the one hand, the technology might one day enable parents to safely repair disease-causing mutations in embryos. But it might also be used to select desired traits — a practice that some ethicists have argued is nothing short of eugenics.
    • “Dieter Egli, a geneticist at Columbia University who led the research, called for a public conversation about the pros and cons of altering embryonic DNA. “As a scientist, you can provide the data for discussion, but then essentially there you stop and let others take over,” he said.
    • “With a newer technology called base editing, Dr. Egli and his colleagues were able to meticulously replace individual genetic letters in sequences of DNA without causing the damage often observed with an earlier form of gene editing, CRISPR.
    • “Dr. Egli cautioned that the research left unanswered many questions about harmful side effects. “We’re not saying this is going to be used tomorrow in the clinics,” he said.
    • “Dr. Egli and his colleagues posted their study online. The research is under review for publication in a scientific journal.”
  • Medscape tells us,
    • “Metabolic disruptions in individuals with alcohol use disorder (AUD) and obesity may intensify alcohol cravings, suggesting a potential metabolic-addictive axis. This highlights the need for integrated treatment approaches targeting both metabolic and addiction pathways.” * * *
    • “Lead author Zachary Harvanek, MD, PhD, assistant professor of medicine at Yale School of Medicine, New Haven, Connecticut, cautioned that the findings are preliminary and require confirmation in larger studies before they can influence clinical practice. However, he said the results suggest that metabolic health may play a meaningful role in alcohol cravings and could help identify a distinct subgroup of patients with AUD at an especially high risk for relaThe findings also support growing interest in therapies that target metabolic pathways, including GLP-1s, as potential treatments for AUD in certain patients.
  • and
    • “Behavioral economics may enhance obesity management by improving adherence to lifestyle changes through financial incentives, gamification, and digital nudges. These strategies could complement pharmacologic treatments, though their long-term effectiveness remains uncertain.” * * *
    • “We all know that many patients regain weight after stopping GLP-1 medications — often a large proportion of what they lost within a year,” said Thomas Tsang, MD, chief medical officer at Omada Health. “In many cases, it’s because patients never had the opportunity to learn the behavioral skills and lifestyle tools needed to sustain those changes after the medication is stopped.”
    • “Tsang also expressed caution about programs that rely primarily on financial incentives. “If the incentive is purely financial, the concern is whether the behavior change will last after the incentive disappears,” he said. “What matters more is helping people develop durable habits and confidence that they can sustain over time.” * * *
    • Tsang also raised ethical concerns about programs that rely heavily on financial incentives, particularly if they disproportionately target economically vulnerable populations.
    • “There’s a fine line between rewarding progress and essentially paying people to lose weight,” he said. “We want patients focused on health and sustainable behavior change, not just achieving a short-term goal for a financial reward.”
    • “For now, most experts view behavioral-economics interventions as promising but still evolving tools.
    • “As the obesity treatment landscape expands — particularly with the rapid adoption of new pharmacologic therapies — understanding how behavioral design can support long-term adherence may become an increasingly important area of research.”
  • STAT New informs us,
    • “Detailed data from a mid-stage study offered further evidence that the obesity drug Pfizer acquired from the biotech Metsera could be dosed monthly. But it’s not clear how competitive the treatment would be against weekly injectables on the market and in development that may lead to greater weight loss.
    • “In the study, called VESPER-3, patients with obesity took weekly doses of the drug, called berobenatide, for 12 weeks and then transitioned to higher monthly doses out to 28 weeks. By then, patients lost up to 12.1% of their weight, when analyzing just those who stayed on treatment, as Pfizer previously reported. 
    • “New data presented at the annual meeting of the American Diabetes Association on Saturday show that when patients transitioned from weekly to monthly dosing, the rate of weight loss continued at a similar pace; they had not yet hit a plateau by 28 weeks. That’s a promising sign, but the rate of weight loss at 28 weeks was still less than what was seen at a similar time point in the pivotal trial of Eli Lilly’s Zepbound.
    • “Additionally, up to 11.3% of treated patients discontinued because of side effects, compared with none in the placebo group. When patients in the highest-dose groups transitioned from a weekly dose of 1.2 milligrams to monthly doses that were four times as large (4.8 mg), they experienced a notable increase in nausea and vomiting, the new data show.
    • “To help improve tolerability, Pfizer will titrate the monthly doses going forward rather than put patients on the 4.8-milligram dose right away, said Jim List, the company’s chief internal medicine officer.”
  • Healio points out,
    • “A triple receptor agonist provided weight loss for adults with obesity, with or without type 2 diabetes, to an extent not seen with previous pharmacotherapy options, according to data from two phase 3 trials.
    • “During a symposium at the American Diabetes Association Scientific Sessions, researchers presented data from phase 3 trials investigating retatrutide (Eli Lilly), a once-weekly injectable GLP-1/GIP/glucagon triple hormone agonist. In the TRIUMPH-1 trial, the medication led to weight loss of up to 25% at 80 weeks and up to 29.9% at 104 weeks with the highest dose, as well as other benefits. 
    • “Retatrutide … was generally well tolerated, and provided substantial reduction in weight, as well as clinically meaningful improvements in health outcomes for patients with obesity, obstructive sleep apnea and knee osteoarthritis,” Ania M. Jastreboff, MD, PhD,director of the Yale Obesity Research Center and principal investigator of the TRIUMPH-1 trial, said in a press conference.
    • “In the TRANSCEND-T2D-1 trial, which was simultaneously published in The Lancet, HbA1c declined by 1.9 percentage points at 40 weeks for adults with type 2 diabetes with the two highest doses of the drug. Additionally, mean weight loss with the highest dose of retatrutide reached 12.7% at 40 weeks.”
  • MedPage Today let us know,
    • “Two investigational drugs for lupus with encouraging primary phase II results yielded more good news from follow-on studies, reports here indicated.
    • “The Toll-like receptor (TLR) inhibitor enpatoran showed no diminution and perhaps some increase in efficacy for patients with cutaneous and systemic lupus with 48 weeks of additional treatment beyond the original 24 weeks, and no new safety concerns arose, according to Eric Morand, MBBS, PhD, of Monash University in Melbourne, Australia.
    • “The other study involved the anti-B cell agent ianalumab that is being tested in systemic lupus (and a variety of other conditions). Edward Vital, MBChB, PhD, of the University of Leeds in England, reported data collected after treatment had stopped in a phase II trial and after B-cell populations had rebounded. With a median of 44 weeks of post-treatment follow-up, not only did biomarker responses continue unabated, clinical indices also showed little loss of efficacy.” * * *
    • For both drugs, the phase II results were strong enough that their respective sponsors have initiated twinned phase III trials: ELOWEN-1and ELOWEN-2 for enpatoran, and SIRIUS-SLE-1 and SIRIUS-SLE-2 for ianalumab.

From the U.S. healthcare business report,

  • MedCity News reports about “The Smart Way to Build the Future of Fertility Benefits.
    • “The challenge isn’t just access to fertility benefits, it’s how those benefits are structured and delivered. Here are three emerging themes that can help employers better align cost, quality and experience.” * * *
    • “First, look “under the hood” when evaluating healthcare options. Don’t just look at the price tag; compare the outcomes. High-quality medical care saves money in the long run and leads to better results. Accurate diagnostics, advanced lab practices, and evidence-based protocols increase the likelihood of pregnancy and reduce the number of failed IVF cycles – saving time, money, and emotional strain for employees. 
    • “Second, prioritize collaboration, not fragmentation. Fertility care works best when clinicians, labs, and pharmacies operate in a more coordinated way. Collaboration enables faster, better-informed decisions, reduces referrals, and shortens the time to pregnancy. It also lowers costs by avoiding redundant testing and treatment. For employees, integrated care means less logistical stress and more confidence in the process. 
    • “Third, demand transparency in drug pricing. IVF medications can be one of the most opaque and wasteful parts of the process. Typically, patients receive their rebates at the end of the year, if at all, while leftover drugs go unused. More transparent approaches, including upfront drug pricing, same-day delivery, and as-needed dispensing, reduces waste and helps employees with financial planning.” 
  • The Wall Street Journal relates,
    • “Coverage for Ozempic and other drugs used for weight loss has fast become one of the most coveted workplace benefits—so much so that companies say they can no longer afford to provide it.
    • “With as many as one in eight American adults taking the pills or injectables now, big employers from Cigna to PricewaterhouseCoopers are dropping coverage of so-called GLP-1s in droves. Others, like Chevron, are making workers jump through extra hoops to get coverage—and to ensure the drugs are used effectively—such as requiring multiple weigh-ins a month, meal-tracking on apps or sessions with an online health coach. 
    • “More than a quarter of big companies say they are adding criteria this year or next, while 11% have dropped or are planning to drop coverage for weight-loss purposes altogether, according to soon-to-be released data from benefits-advisory firm Mercer.”
  • and
    • “A columnist wore an Oura Ring 5, Google Fitbit Air, Whoop MG, and Apple Watch Series 11 for three weeks to compare their performance.
    • “Sleep tracking was tested against a polysomnogram in a sleep study; the Apple Watch and Fitbit Air showed the most accurate sleep duration.
    • “Heart-rate tracking was compared against a chest strap. Oura and Whoop offer detailed data but require subscriptions.” * * *
    • “Oura requires a $6-a-month subscription. Stop paying and it locks up your biometrics, leaving you with basic three-score feedback (sleep, readiness and activity). Whoop doesn’t charge an upfront hardware cost but there’s a mandatory membership starting at $199 a year. And the accessories—bra, shorts, etc.—aren’t cheap.
    • “That still isn’t a lot to pay if you can get off the couch and build lasting change. But if you want data without a monthly fee, the pricier Apple Watch will provide it. And you can skip the Google Health $10-a-month premium plan and still use the Fitbit. 
    • “Living a healthy life is easy in theory but hard in practice. I welcome wearables steering me toward good choices, and decided the Oura Ring plus an Apple Watch is still the best combo for me. After a decade and a half of tracking my fitness, I’ve settled on using these devices to identify long-term trends and help me build better habits. Yet no matter how smart and capable they’ve become, they still can’t replace my own body’s intuition.”

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.”

Midweek Update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, No Surprises Act, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

“Simplicity is not about doing less; it’s about focusing on what matters most. The future of performance management is about creating value with clarity & ease.”

From Washington, DC,

  • BioPharma Dive reports,
    • “A bipartisan House bill proposed Tuesday would require government screening of U.S. investments in Chinese biotechnology in the wake of two pharmaceutical deals potentially worth more than $10 billion each.
    • “Reps. John Moolenaar, R-Mich., chairman of the Select Committee on China, and Debbie Dingell, D-Mich., are sponsoring the bill, dubbed the Biotech Investment National Security Act. It would amend the COINS legislation passed last year to restrict investment in certain sensitive technologies, adding biotechnology to the list.
    • “Under the new bill, licensing deals, joint ventures and equity investments in China could be subject to both Treasury and Defense Department reviews. Moolenaar and Dingell focused on licensing deals involving technology and intellectual property and excluded agricultural biotechnology, industrial fermentation and basic academic research.”
  • Federal News Network relates
    • “Close to 8,000 career federal employees will be moved into a new employment category with limited job protections, after the Trump administration took the final step to make Schedule Policy/Career a reality.
    • ‘An executive order President Donald Trump signed Wednesday afternoon formalizes the long-expected federal employment classification and eliminates civil service protections for thousands of senior-level positions across government. The move is meant to boost workforce accountability, but has also drawn sharp criticism from federal unions, employee organizations and other stakeholders.
    • “Trump administration officials said the creation of Schedule Policy/Career aims to improve employee accountability and ensure the federal workforce is carrying out the president’s policy agenda. Officials also said it’s currently too difficult to remove federal employees for poor performance.
    • “It’s also about a restoration, in our mind, of the democratic process,” Office of Personnel Management Director Scott Kupor told reporters during a press call Wednesday. “What Schedule Policy/Career does is really nothing new. This is exactly the way the system worked for a very long time … In order to affect the policy priorities of the administration, we need to have people willing to and capable of carrying out those directives.” * * *
    • “The targeted 8,000 career federal positions for the new classification is far lower than OPM’s initial estimate that Schedule Policy/Career would cover about 50,000 positions. Some earlier estimates had also suggested as many as 200,000 positions could be converted.”
  • Govexec tells us,
    • “With one protest withdrawn and a second one denied, the Office of Personnel Management is now free to move forward with its plan to award a 10-year contract to modernize the government’s human resource systems.
    • “OPM released the final solicitation in October for the Federal HR 2.0 contract to modernize systems that cover 2 million employees across the government. The agency wants a single integrated platform that will be the infrastructure for a more data-driven federal HR ecosystem, according to solicitation documents.
    • “Bidders had to submit proposals by Oct. 31 and OPM followed a two-step process for evaluation. After step one, IBM Corp. and then Economic Systems Inc. filed their protests.
    • “IBM filed its protest on Feb. 25 but withdrew without explanation on April 3. Meanwhile, Economic Systems filed a protest on March 2. On Monday, the Government Accountability Office posted on its public docket that it had denied Economic Systems protest.
    • “OPM could not make an award while the protests were active, but it could continue to evaluate proposals. Now it can pick a winner with the protests out of the way.
    • ‘While no dollar value has been disclosed, the undertaking is massive.”
  • Kevin Moss, writing in Federal News Network, encourages federal employees to take a look at joining FEHB and PSHB high deductible plans that allow them to contribute to triple tax deductible health savings accounts.

From the Food and Drug Administration front,

  • U.S. News and World Report reports,
    • “Acting U.S. FDA Commissioner Kyle Diamantas met ⁠with ⁠rare disease groups on Wednesday, according to groups ⁠attending and a government official, as the new chief seeks to repair relations with a sector disappointed ​by his predecessor.
    • “Representatives for rare disease organizations including Friends of Cancer Research and the Foundation for Angelman Syndrome Therapeutics are pushing Diamantas for greater certainty and support ‌for treatments for small patient populations, the ‌groups said.
    • “The acting chief is seeking to steady operations and mend fences following Commissioner Marty Makary’s resignation last month. Makary had clashed with the White ⁠House over issues including ⁠vaping products.
    • “Jeff Allen, CEO of Friends of Cancer Research, in a phone interview with Reuters ​following the meeting, described it as a “breath of fresh air.”
  • MedTech Dive relates,
    • “Edwards Lifesciences said it has secured FDA approval for the first surgical valve replacement designed for patients with tricuspid valve disease.
    • “The approval introduces a surgical option for a long-underserved area of structural heart care, extending Edwards’ Resilia tissue technology to the tricuspid position, a spokesperson told MedTech Dive in an email. 
    • “Called Triformis Resilia, the valve has a flattened sewing ring shape that mirrors the native tricuspid valve’s annulus anatomy.”

From the judicial front,

  • STAT News reports,
    • ‘A fourth major health insurer is suing HaloMD over its use of the No Surprises Act’s arbitration process, arguing that the middleman deceived arbitrators by sending them a “sham letter” and misleading price data. 
    • “Highmark Health, a Pennsylvania-based Blue Cross Blue Shield licensee with over 7 million members, claims in a complaint filed June 1 in U.S. District Court in Western Pennsylvania that HaloMD and one of its clients, a neuromonitoring provider called Bromedicon, submitted more than 450 ineligible disputes with the company and won more than $3.9 million. Like the three Blue Cross plans before it, Highmark wants those awards tossed and its money returned.” * * *
    • “Other insurers have so far gotten chilly receptions to their suits. Judges in California and Texas have dismissed similar lawsuits against HaloMD and its provider clients, finding their allegations — that the company deliberately submitted ineligible disputes and won huge payouts anyway — didn’t warrant the court’s review. The rulings don’t bode well for Highmark or outstanding cases in Georgia and Ohio.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Eating a diet high in ultraprocessed foods is associated with an increased risk of dementia, according to new research, adding to the growing list of health problems linked to foods such as packaged cookies, hot dogs and chips.
    • “In a study published Wednesday in the American Journal of Public Health, the group of people who reported eating the highest amount of ultraprocessed foods had a 58% higher risk of later developing dementia and a 46% increased risk of developing cognitive impairment than those who said they ate the least.” * * *
    • “Nutrition researchers generally define ultraprocessed foods as items containing ingredients that wouldn’t generally be found in a home kitchen, such as emulsifiers—used to improve the texture of food—and high-fructose corn syrup. 
    • “The new study found that diets high in minimally processed foods, such as fresh fruits, vegetables, whole grains, fish and unprocessed meats, were linked to a decreased risk of dementia and cognitive impairment. People who ate the most minimally processed foods had a 41% lower risk of dementia compared with those who ate the least.”
  • and
    • “New research suggests anesthesia may be closer to being in a coma than previously thought, not just a deep sleep.
    • “Researchers compared brain-wave data from anesthetized patients with those awake, asleep or in a coma.
    • “Understanding these brain patterns could help redesign anesthesia to resemble natural sleep, reducing postoperative issues, experts say.”
  • MedPage Today relates,
    • “Deaths of despair — fatalities from drugs, alcohol, and suicide — declined by 16% in 2024, according to a report from Trust for America’s Health.
  • and
    • “Weight loss is known to reduce the need for joint replacement surgery in overweight or obese people with knee osteoarthritis (OA), and glucagon-like peptide-1 (GLP-1) receptor agonists are an established way to lose weight.
    • “This study of health records demonstrated that use of GLP-1 drugs was associated with reduced arthroplasty rates, with longer exposure leading to correspondingly lower rates.
    • “Reasons for initiating GLP-1 drug therapy were not known, however, and weight loss was not tracked over time, so the mechanisms underlying the observed associations remain unknown.”
  • Gastroenterology Advisor tells us,
    • “A baseline colonoscopy among individuals aged 40 to 49 years is associated with a significantly reduced risk for colorectal cancer (CRC), especially for men aged 45 to 49 years, according to study results published in the American Journal of Gastroenterology.” * * *
    • “These findings provide large-scale observational evidence that the risk-reducing association of an early baseline evaluation becomes increasingly apparent over several years of follow-up,” the study authors stated.”
  • Health Day notes,
    • “Scientists may be one step closer to staging Alzheimer’s disease with a simple blood test.
    • “The test could offer a cheaper, less invasive alternative to brain scans and spinal taps now used to diagnose and determine the extent of disease.
    • “Researchers developed a model that uses just two forms of tau protein in the blood to track Alzheimer’s progression. They tried it on more than 1,000 patients, including people who were cognitively unimpaired, patients with mild cognitive impairment, patients with Alzheimer’s dementia and people with other neurodegenerative diseases.
    • “The result: Staging from the blood model closely matched the accuracy of PET brain scans.”
  • and
    • “Population-based screening for early-stage type 1 diabetes identifies most children who progress to clinical type 1 diabetes, with additional cases detected with repeat screening, according to a study published online May 21 in the Journal of the American Medical Association.”

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

  • Beckers Payer Issues reports,
    • “Cigna will stop covering GLP-1s for weight loss through its own employee health plan July 1, the company confirmed to Becker’s.
    • “We regularly review our health benefits to ensure they remain sustainable, accessible and aligned with the unique needs of our workforce. As availability has increased and new options have emerged, we’ve made the decision to end our plan’s coverage for GLP-1s for weight loss,” a company spokesperson said. “We remain committed to supporting our employees’ health through a range of weight-management programs and resources.”
    • “The change will not apply to those using GLP-1s for diabetes, the spokesperson said. It also will not apply to Cigna plans beyond its own, a spokesperson confirmed to Reuters, which first reported the development June 2. GLP-1 users for weight loss have until June 30 to obtain refills. 
    • ‘An internal document reviewed by Reuters said employees can pay for these drugs with cash directly through manufacturer websites or TrumpRx. However, that spending would not count toward deductibles. Cigna will continue to cover generic weight-loss drugs that predate GLP-1s, such as phentermine, diethylpropion, benzphetamine and phendimetrazine, according to Reuters.
    • “Cigna joins a wave of healthcare employers cutting back GLP-1 access for their workers as cost pressures mount.”
  • The Wall Street Journal provides “Five Takeaways From the WSJ’s Autism Billing-Abuse Investigation — Insurers’ fraud warnings, a nearly $1 million surprise therapy bill and the back story of a visit to the Brooklyn-based provider the Perfect Child.”
  • MedTech Dive relates,
    • “Medtronic ended its fiscal year on a high note, growing revenue by nearly double digits in its fiscal fourth quarter.
    • “The medtech company brought in $9.8 billion of revenue in the quarter, representing year-over-year growth of nearly 10%. The performance was better than expected, J.P. Morgan analyst Robbie Marcus said in a note to investors.
    • CEO Geoff Martha said Medtronic delivered its strongest annual top-line growth in 10 years.
    • “Through a dynamic macro environment, we have executed, and we’ve executed with discipline to deliver an excellent fiscal ’26 that will continue into fiscal ’27,” Martha told investors Wednesday morning.
    • “The performance was driven by solid sales for its cardiovascular unit and strong growth for businesses within the segment.”
  • The Wall Street Journal inform us,
    • “Eli Lilly LLY signed a collaboration and licensing agreement worth up to $1.9 billion with Ascidian Therapeutics to research and develop kidney-disease treatments.
    • “Ascidian, a Boston-based biotechnology company, said Wednesday it granted Eli Lilly exclusive, target-specific rights to its RNA-exon-editing technology for undisclosed kidney-disease targets.
    • “The RNA-exon editors are capable of altering parts of genetic code to repair genetic instructions that cause disease.
    • “Ascidian said it will lead discovery and certain preclinical activities, while Eli Lilly will be responsible for other preclinical work, clinical development, manufacturing and commercialization.
    • “Ascidian is eligible to receive up to $1.9 billion, including an upfront payment, development and commercial milestone payments, and tiered royalties on commercial sales worldwide, it said.”
  • Fierce Healthcare tells us,
    • “Mayo Clinic plans to develop and deploy a frontier AI model specifically designed for healthcare in collaboration with Microsoft. 
    • “The strategic collaboration combines Mayo Clinic’s global healthcare expertise, de-identified clinical health data and longitudinal insights with Microsoft’s advanced AI, cloud engineering and tech capabilities, the companies announced Tuesday.
    • “The two organizations say they are developing a frontier AI model “capable of supporting the broadest scope of clinical reasoning and healthcare use cases,” according to a press release.
    • “The frontier AI model is designed to synthesize diverse clinical data to support earlier diagnoses, more personalized treatment decisions and better patient outcomes. The AI collaboration will make Mayo Clinic’s medical expertise and integrated model of care available to more people when and where they need it, the two organizations said.”
  • Beckers Hospital Review adds,
    • “Washington, D.C.-based Children’s National Hospital has introduced a pediatric AI innovation hub to translate the technology from concept to bedside use.
    • “The partnership with Blacksburg-based Virginia Tech will bring together pediatric clinicians, biomedical researchers and AI specialists to create advancements for what has been an underserved community thus far in the technology’s evolution.
    • “Children have historically been underrepresented in AI research despite having fundamentally different physiology, disease patterns and developmental needs,” said Marius George Linguraru, director of AI research at Children’s National, in a June 2 news release. “We have an opportunity to build pediatric AI the right way from the beginning by developing and validating these technologies specifically for children and within pediatric clinical settings.”
  • Fierce Pharma points out,
    • “Pharma solutions firm Cencora and Gilead Sciences have expanded their longstanding partnership, cutting a deal in which the distribution giant will support access to Gilead’s CAR-T cancer therapies Yescarta and Tecartus.
    • “The collaboration is designed to facilitate more efficient access to the blood cancer therapies, which were developed by Gilead’s CAR-T subsidiary Kite Pharma. 
    • “Under the agreement, Cencora will leverage its substantial distribution infrastructure to bolster cell therapy availability at an “increasing number” of authorized U.S. treatment centers, including health systems and community oncology practices, according to a June 2 release.” 
  • HR Dive lets us know,
    • “Workers over age 55 make up almost a quarter of the workforce (23.2%), according to a report from MyPerfectResume. Moreover, according to researchers, the growth of the older workforce outpaces the general workforce. Likewise, the share of workers over age 65 increased by more than 40%, according to the report.”

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.” 

Monday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical/Rx research front,

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

From the U.S. healthcare business front,

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