Pre-holiday weekend report

Mental health care

Pre-holiday weekend report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

Note — The FEHBlog will be writing his weekly cybersecurity report tomorrow and will resume regular FEHBlog posts on Sunday July 5. Happy Independence Day! We are so blessed to be Americans.

From Washington, DC,

  • Roll Call reports,
    • “As America gets ready to celebrate its 250th birthday, Congress is taking a road trip back to the place where it all began — Independence Hall in Philadelphia. 
    • “Led by Pennsylvania Democratic Rep. Brendan F. Boyle, members will gather for a ceremonial event Thursday in his hometown, an effort Boyle said was two years in the making. 
    • “This is going to be truly one of the highlights of my tenure in Congress, to be sitting there where our Founding Fathers sat exactly 250 years prior, to the exact day,” Boyle said, adding he hoped it could be a rare “unifying moment.” 
    • “While July 4 gets most of the fanfare, Boyle said its lesser-known neighbor, July 2, deserves more attention as the day the Second Continental Congress voted to declare independence from Great Britain in 1776. 
    • “It was always the date that John Adams thought would be celebrated as America’s birthday. Unfortunately, this was another instance in which Adams lost to [Thomas] Jefferson — because Americans came to, of course, celebrate two days later the Fourth of July, which is the date Congress adopted the Declaration of Independence,” he said.” 
  • OPM Director Scott Kupor added a third post (OPM.gov link) to his Secrets of OPM blog this week. In this post, Director Kupor commemorates the new paperless federal retirement system by spurning the altar of Michael Scott, the fictious paper czar of Scranton, PA.
  • Healthcare Dive reports,
    • “The CMS proposed a rule on Thursday that would slash Medicare payment rates for a program [known as 340B] that hospitals use to buy discounted drugs and implement site-neutral payments for some imaging services next year.
    • Reforming the 340B drug discount program and better equalizing payments between sites of care have been priorities in the second Trump administration. Thursday’s proposed rule builds upon those agendas, including by expanding the services subject to site-neutral payments and more aggressively tamping down on discounts given to hospitals in the 340B drug program, which regulators previously tried to overhaul before dialing down their efforts in the face of opposition from the industry.
    • Medicare officials said the proposed rule would control costs and ensure Medicare money is directed toward “clinically appropriate” care. * * *
    • “The 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center rule proposes to increase pay for outpatient care by 2.4%, slightly less generous than the 2.6% rate update finalized last year.
    • “The rule would request information from stakeholders about how hospitals post publicly available price data, an ongoing priority for the Trump administration. Additionally, if finalized, the rule would allow certain accrediting organizations to assess hospitals on their compliance with laws regarding emergency care.”
  • The American Hospital Association News tells us,
    • “The House Education and Workforce Subcommittee on Health, Employment, Labor and Pensions July 1 examined whether direct health care contracts between employers and providers could help address rising health care costs. During the hearing, lawmakers from both parties expressed interest in arrangements that bypass traditional insurers, with supporters citing lower costs, reduced administrative burdens and improved access to care. Witnesses highlighted advantages such as simplified billing, price transparency and direct primary care services, while lawmakers also discussed the need for greater insurer transparency and access to health plan data. The committee did not signal specific legislative proposals following the hearing.”
  • and
    • “The Trusted Exchange Framework and Common Agreement Recognized Coordinating Entity published updated standard operating procedures for the individual access services exchange protocol and new FAQs. The revised SOP removed references to “TEFCA IAS Consent” workflows and associated patient matching methodologies, retaining the ability for providers to verify requests for access and use of data. Updates were made based on recommendations that the AHA and other stakeholders provided to SOP proposals. The SOP will be effective Aug. 3, 2026.”

No Surprises Act news

  • Federal Hearings and Appeals Services, which is certified IDR entity, tells us about
    • “The Cooling Off Period: What Providers and Health Plans Need to Know
      • “What is actually changing with the cooling off period under the final rule for the federal IDR program? To help clarify both the ongoing rules, the coming changes, and their timing, FHAS is offering two new tools to support parties.
        • “First, a new guide to the cooling off period explains which claims are subject to the cooling off period, how long it lasts, what will change under the final rule, and when those changes are coming.
        • “Second, FHAS has launched a new Cooling-Off Calculator which parties can use today to determine cooling off period dates and new dispute initiation timeframes. FHAS can help your team understand, anticipate, and implement changes directed by the final rule.”

From the judicial front,

  • Healthcare Dive reports,
    • “Elevance is suing the CMS after the agency recalculated the Medicare Advantage star ratings of a competitor in a more favorable way than it did for other plans.
    • “After losing a lawsuit earlier this year, the CMS reran 2026 quality scores for Clover Health, dropping 20 measures that a judge ruled could not be factored in. Regulators then recalculated stars for other MA insurers last month, but cut out extra measures, too — measures that Elevance performed well on, the insurer argued in its complaint filed Wednesday in Georgia district court.
    • “Elevance says it lost out on $115 million in bonus payments as a result. The company is asking the court to force CMS to redo its own ratings using the same methodology as for Clover.”
  • STAT News relates,
    • “In a victory for the pharmaceutical industry, a federal judge blocked a Colorado state panel from placing a cap on the price of a blockbuster drug sold by Amgen after deciding the company is “likely to be significantly harmed.”
    • “The ruling pauses a controversial, first-in-the-nation move by the Colorado Prescription Drug Affordability Board, which was created four years ago in response to the rising cost of prescription medicines and is permitted to set upper payment limits on what most state residents will pay for selected drugs.” * * *
    • “Last October, the board then voted to limit what health plans in the state will pay for the drug. The board capped Enbrel prices at $600 for a ​50-milligram weekly dose, or $30,350 a year per person, effective on January 1, 2027. That compared with roughly $53,000 that the average plan in the state paid in 2023, according to a state claims database.
    • “The drugmaker then quickly filed a second lawsuit, reiterating its earlier arguments. Meanwhile, the company had until July 5 to decide whether to continue selling the treatment, which has a list price exceeding $100,000 a year and generated $2.23 billion in sales last year, in Colorado.
    • “But Judge Daniel Domenico of the U.S. District Court in Denver agreed with the company. In his ruling, which was issued on Wednesday, he noted that the state has a ​legitimate interest in helping patients afford Enbrel, but “capping the price of a patented drug” is not an ​option.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The U.S. overall death rate in 2025 fell to its lowest point on record, even as influenza and pneumonia are now among the nation’s top 10 causes of death for the first time in years, according to new data from the Centers for Disease Control and Prevention.
    • “The death rate fell 4.6% last year, to 689.2 deaths per 100,000 people, down from 722.1 in 2024, according to the CDC’s National Center for Health Statistics. The death rate declined across every age group and nearly every demographic group tracked in the provisional report.
    • “The main driver of the record low was a continued drop in drug overdose deaths, said Farida Ahmad, a health scientist at the CDC and one of the report’s co-authors. Another factor, she added, was that Covid-19 no longer contributed to as many deaths.
    • “Against that backdrop, influenza and pneumonia stood out—moving from 11th to eighth place in all age groups—with 56,511 deaths in 2025 compared with 48,139 in 2024. It is the first time the influenza category has cracked the top 10 since 2020.”
  • AAMC relates,
    • “Patients arrive in the emergency department (ED) doubled over in pain and retching uncontrollably, a brew of symptoms physicians have nicknamed “scromiting” — a combination of screaming and vomiting. The problem: an underrecognized consequence of cannabis use called cannabinoid hyperemesis syndrome (CHS), and emergency medicine physicians say few conditions leave patients more obviously miserable.
    • “My heart breaks for them,” says Kathleen Clem, MD, an emergency medicine physician at Dartmouth Health in Lebanon, New Hampshire, and interim associate dean for faculty affairs at the Geisel School of Medicine at Dartmouth. “They come in because they absolutely cannot keep anything down. They’re dehydrated and their belly is sore from vomiting so much. Sometimes they vomit so much, they’ll break little blood vessels in their esophagus, and little bits of blood come up with that.”
    • “The leading cause of marijuana-related ED visits, CHS is associated with the chronic and long-term use of marijuana products, and it is becoming more prevalent, likely due to the increased legalization of marijuana. Some 24 states have legalized recreational marijuana use since 2012, and 40 states allow its use as a medicinal treatment. An additional eight states allow “limited-access” medical cannabis, which refers to low-THC (tetrahydrocannabinol) products and CBD (cannabinoid) oil.
    • “In the United States, cannabis use has nearly doubled in the past decade, with 22.3% of individuals 12 years and older — 64.2 million people — reporting its use in the past year, up from 12.6% in 2013, according to data from the Substance Abuse and Mental Health Services Administration. And research shows a 15-fold increase in the number of people reporting daily or near daily cannabis use from 1992 to 2022.”
  • The Today Show adds,
    • “Cyclosporiasis, a nasty parasitic infection that causes “explosive” watery diarrhea, has sickened dozens of people in Michigan and other parts of the United States.
    • “Cases of the gastrointestinal illness, caused by a parasite that spreads through contaminated food, have been on the rise in multiple states since May, according to the U.S. Centers for Disease Control and Prevention. At least 20 people have been hospitalized nationwide so far. 
    • “The CDC is working to identify potential sources of the parasitic infection, which is commonly linked to fresh produce.” * * *
    • “The U.S. typically sees several hundred cases of cyclosporiasis annually. In recent years, the number of infections reported in the U.S. has increased significantly.” * * *
    • “The best way to prevent infection is to avoid consuming food or water that may be contaminated with feces, the CDC says. Following proper hand hygiene and safe food handling practices can also lower your risk of foodborne illness.”
  • The New York Times points out,
    • Habitual users of fentanyl have developed such a strong tolerance to the drug that standard doses of medications to manage withdrawal and initiate recovery are no longer working for many patients, a team of researchers in Los Angeles has found.
    • Their study, published in the journal Drug and Alcohol Dependence, presents a picture of the dangerous volatility of the city’s street supply and the capacity of users to tolerate ever greater amounts of pure fentanyl, which is at least 50 times more potent than heroin.
    • “In a summary of the findings, Morgan Godvin, one of the lead authors of the study and a health services researcher at the University of California, Los Angeles, said that a seasoned user’s daily street dose of fentanyl was roughly equivalent to 1,250 hospital doses of 100 micrograms of fentanyl given during and after surgery.
    • “In any other context, that would be unsurvivable,” she wrote. “Among people who use fentanyl every day, it is routine.”
    • “The study reinforces the belief among many addiction experts that, for high-tolerance patients, the standard treatment regimens for opioid addiction have become outdated. Doses of medications such as buprenorphine and methadone, opioids that help satisfy cravings without inducing a high, were calculated to treat addictions to heroin and prescription painkillers. The results of the new research, experts said, support a growing call by clinicians for treatment guidelines to be revised to keep pace with the convulsive drug market.”
  • MedPage Today tells us,
    • “A global study showed that body mass index-associated gaps in blood pressure and cholesterol have diminished from 1990 to 2024.
    • “With more medications being used, older people with obesity were metabolically similar to, and in some countries even lower risk than, people with a normal BMI.
    • “Young adults with obesity remain metabolically higher risk, however, and should be a focus of prevention and treatment, some say.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For nearly half a century, scientists have known that malaria parasites force their way into human red blood cells (RBCs) through a ring-shaped structure called the moving junction (MJ). What no one could work out was what it actually does. The structure assembles, does its job, and dissipates in the space of 60 seconds—gone before anyone can get a close look.
    • “A team at Columbia University has now finally caught the moving junction in the act. By freezing parasites at the onset of invasion and lifting the intact complex straight out of the cell, the researchers obtained the first high-resolution view of its three-dimensional structure. What they saw overturned a decades-old assumption about how the parasite gets in. Rather than a passive doorway, the moving junction turns out to be a molecular machine that actively remodels the host cell’s membrane to help the parasite force its way inside.
    • “The findings detail how the team obtained the structure and then used it as a blueprint to design a mini-protein, from scratch, that blocks invasion—a proof of concept for a new kind of antimalarial drug.”
  • The Washington Post lets us know,
    • “When it comes to dementia risk, certain factors, such as genetics, are out of your control. However, plenty of research suggests lifestyle behaviors— things you can change — may help improve your chances of staying sharp as you age. In a new study, people with an elevated risk of dementia were less likely to develop the condition if they followed a healthy dietary pattern, particularly a less inflammatory one.”
  • Per BioPharma Dive,
    • “Roche’s experimental medicine divarasib helped patients with a certain type of lung cancer live longer than two approved treatments in a new study.
    • “The Phase 3 trial compared divarasib with Amgen’s Lumakra and Bristol Myers Squibb’s Krazati in patients with KRAS G12C non-small cell lung cancer who had already received previous treatment. Researchers found significant improvements in both overall survival and progression-free survival for the group taking divarasib, Roche said Thursday.
    • “Roche did not release detailed data, saying the results would be presented at an upcoming medical meeting. There were no new safety findings of concern and most treatment-related side effects were “manageable and reversible,” the company said.”

From the U.S. healthcare business front,

  • Healthexec reports,
    • With Election Day only four months away, healthcare is again emerging as a major source of idealistic campaign promises. Many of these are driven by widespread public angst. What sorts of changes can U.S. healthcare stakeholders realistically expect once the results are in? 
    • “Professional prognosticators at the global accounting and consulting firm PricewaterhouseCoopers, aka PwC, have considered the policy possibilities and are sharing their thinking in writing. * * * PwC offers forward-looking insights and advice for organizations across healthcare’s four major subsectors. 
      • “PROVIDERS: Policy drivers are reshaping delivery and access. 
        Healthcare providers will do well to “examine their care delivery footprints, leverage automation and technology to reimagine the workforce and operations in order to mitigate economic strain,” PwC comments. 
        ‘This should include identifying opportunities to diversify revenue sources, partnerships or M&A with other stakeholders, and prioritizing investment in new technology to reduce impacts of the increase in uncompensated care and workforce constraints.’
      • “PAYERS: Policy drivers are reshaping cost structures. 
        “Healthcare payers will likely need to strengthen care management capabilities as they expand their holistic support to members, the analysts forecast. 
        ‘This will include, in the future, leveraging sophisticated data models and interactive real-time communications to understand and influence member behavior patterns, accelerate paths to appropriate cost-effective care, and drive financial savings for members and plans.’
      • “PHARMA: Policy drivers are reshaping pipeline decisions, regulatory strategy and market access. 
        “In the future, pharmaceutical manufacturers, propelled by accelerating science and shifting patient expectations, “should expand from drug manufacturers to ‘lifespan partners,’ requiring more agile operating models and greater collaboration across technology, and ecosystem players,” the authors write.  
        ‘In the interim, pharmaceutical manufacturers can embrace innovative approaches to access, affordability and evidence generation to meet the needs of today’s consumer and keep pace with pipeline and pricing pressures.’
      • “MEDTECH: Policy drivers are reducing federal oversight of AI-powered and wellness devices. 
        “Going forward, the subsector is expected to become a broader ecosystem player, building interoperable, intelligent systems that connect care across hospitals and the home, PwC remarks. 
        ‘MedTech should strengthen capabilities for post market surveillance as FDA shifts oversight focus from a premarket review paradigm to an emphasis on performance and safety once on the market, particularly for low risk, consumer devices.’
  • Cardiovascular News relates,
    • “The American College of Cardiology (ACC) reached a major milestone this summer; its highest honor, the HeartCARE Center National Distinction of Excellence, has officially been awarded to 100 U.S. hospitals [all of which are listed in the article]. 
    • “The ACC established the HeartCARE Center designation in 2018 to celebrate hospitals and health systems that “demonstrate ongoing excellence through comprehensive accreditation, data-driven performance measurement and continuous quality improvement initiatives.” Recipients must be “forward-thinking organizations” that participate in ACC Accreditation Services programs, NCDR registries and other quality improvement campaigns focused on cardiovascular health.
    • “Reaching 100 hospitals recognized as ACC HeartCARE Centers marks an important milestone in our ongoing effort to elevate the standard of cardiovascular care,” Steven B. Deitelzweig, MD, chair of the ACC Accreditation Oversight Committee, said in a statement. “Each of these institutions has demonstrated a deep commitment to evidence-based care, continuous quality improvement and measurable outcomes—ensuring that patients receive the highest level of cardiovascular care, no matter where they live.”
  • Beckers Hospital News tells us,
    • “The Kroger Co. will acquire supermarket chain Giant Eagle, Inc. for $1.65 billion, expanding its pharmacy footprint across northern Ohio, western Pennsylvania, West Virginia, Maryland and Indiana.
    • “Giant Eagle operates 11 standalone pharmacies, according to a July 1 news release. Kroger said the acquisition will strengthen its presence in adjacent markets and build on Giant Eagle’s pharmacy business, loyalty program and private label portfolio. 
    • “The deal adds to Kroger’s pharmacy footprint at a time when retail pharmacy access is contracting elsewhere in the industry, with Walgreens restructuring into five standalone companies following multibillion-dollar operating losses and Rite Aid’s footprint largely gone — a gap health systems have increasingly stepped in to fill by opening their own pharmacies.” 
  • MedTech Dive informs us,
    • “Guardant Health said Wednesday its Shield test for colorectal cancer is now covered by UnitedHealth, the first major private U.S. health insurer to reimburse for the screening.
    • “The decision by UnitedHealth, the largest private U.S. health insurer, expands access to the screening to about 100 million Americans, the company said.
    • “Canaccord Genuity analyst Kyle Mikson, in a note to clients, called the coverage decision a “watershed moment” for liquid biopsy-based cancer screening and for the category of blood-based cancer testing.”

Tuesday Report

David Ermer–Agentic & Generative AI, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
  • Simplicity is a virtue.

From Washington, DC,

  • Today’s Federal Register included an OPM system of records notice greenlighting
    • “OPM/Central-15, Health Benefits Claims and Cost Records.’’ The system of records contains health benefits service use and cost [a/k/a claims] data about enrollees and their family members, who are or have been covered under the FEHB [or PSHB] Program.”
  • The OPM Director explained in a recent “Secrets of OPM” blog post
    • “OPM will scramble, or pseudonymize, the member ID information using a state-of-the-art cryptographic hashing process, replacing the Member ID with a random set of numbers and characters that is divorced from the real identity of the plan participant. That scrambled dataset will be then used by OPM’s analysts to uncover anomalies that are the classic indicators of fraud, while the stripped, encrypted data from the OIG will remain in a secure, separate environment, encrypted at rest and protected with our IT security best practices. Importantly, the data set that OPM analysts will use cannot be mapped back to any plan participant.”
  • The Federal Register notice (91 Fed. Reg. at 37,441) contradicts the Director as follows:
    • “Pseudonymization is employed as a privacy-enhancing safeguard; however, records remain subject to the Privacy Act because OPM retains the ability to re-identify records for authorized operational purposes. OPM will apply pseudonymization wherever practicable, and routine disclosures ordinarily will be made using pseudonymized records unless identifiable information is reasonably necessary to accomplish an authorized purpose.“
  • What’s more, Federal Register notice states (id. at 37,439),
    • “This modified system is effective upon publication in the Federal Register, with the exception of the routine uses, which become effective July 23, 2026.”
  • The Federal Register notice is open for public comment until July 23, 2026.
  • The American Hospital Association News reports,
    • “A bipartisan group of senators June 18 urged the Centers for Medicare & Medicaid Services to improve implementation of the Rural Health Transformation Program. In a letter, led by Sens. Michael Bennet, D-Colo., co-chair of the Senate Rural Health Caucus, and Susan Collins, R-Maine, lawmakers expressed concerns that the current structure and guidance for implementing the RHTP could “unintentionally disadvantage” many rural hospitals the program was intended for. 
    • “CMS’s recent clarification that states may use provider payment funding for workforce recruitment and retention, infrastructure investments, technical assistance, systems development for alternative payment model participation, and support for non-clinical roles is a step in the right direction,” the senators wrote. “These flexibilities recognize many of the practical challenges rural providers face and are important steps toward helping hospitals and clinics remain viable. We believe that implementation can be improved further by lifting the cap on infrastructure and capital improvements for rural facilities, as many need significant improvement and equipment upgrades. We also believe that clarifying the permissibility of direct payments to providers is crucial.” 
  • Beckers Payer Issues relates,
    • “The White House Council of Economic Advisers addressed the possibility of banning antisteering practices, which prohibit insurers from guiding patients to lower-cost providers, in payer-provider contracting. Its conclusion: Prices and premiums could drop.
    • “Along with broader antisteering issues, the memo tackles all-or-nothing contracting, which demands insurers accept all of a system’s hospitals and affiliated physicians — or none at all.
    • “These contracting strategies have been in the spotlight. On June 16, Columbus-based OhioHealth reached an agreement with the Justice Department and the state’s attorney general to end a civil lawsuit that alleged the system used anticompetitive contract provisions to raise costs for patients and employers. Under the agreement, the system did not admit any wrongdoing nor face penalties. In March, the Justice Department filed a similar lawsuit targeting New York City-based NewYork-Presbyterian.”

From the Food and Drug Administration front,

  • STAT News tells us,
    • “For many years, generic drugs have accounted for roughly 90% of the prescriptions doled out to Americans thanks to their lower cost. Yet reliable supplies have been an issue due to inconsistent quality — more than 60% of the generic shortages have been attributed to quality concerns, according to the Food and Drug Administration. Numerous manufacturers, many based in India, have been cited for violating manufacturing protocols that led to product recalls and, sometimes, bans on sending drugs to the U.S.
    • “But Kevin Schulman, a professor and deputy director of the Clinical Excellence Research Center at the Stanford University School of Medicine, believes a solution is within reach. Schulman — who has also worked with an independent lab called Valisure that found impurities in some widely used medicines — argues the FDA should encourage testing by independent, accredited laboratories.” * * *
    • “The cost of testing is cheap. You run sample testing on, say, 10 out of 600,000 bottles and it’s maybe $6 bucks each. … It’s ridiculous that we’re not doing it already.”
  • Oncology News Central reports,
    • “The U.S. Food and Drug Administration (FDA) has fully approved afamitresgene autoleucel (afami-cel; Tecelra) and expanded its indication to include patients aged 12 years and older with unresectable or metastatic synovial sarcoma whose disease has progressed after chemotherapy. Eligible patients must be positive for HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 and have tumors that express the MAGE-A4 antigen.
    • “US WorldMeds, the maker of afami-cel, announced the approval of the MAGE-A4-directed genetically modified autologous T-cell immunotherapy in a June 22 news release. The company noted that the conversion and expansion of the drug’s accelerated approval in 2024 also marks the first engineered T-cell therapy approved for children as young as age 12 years with a solid tumor.”
  • Beckers Hospital Review relates,
    • “Inventia Healthcare Limited is recalling 11,460 bottles of Chlorthalidone Tablets USP, 25 mg, a blood pressure medication distributed nationwide after the product failed dissolution specifications.
    • “The recall was initiated June 5 and was classified as a Class II recall by the FDA on June 22, according to a June 22 enforcement report. The recall affects 100-tablet and 1,000-tablet bottles from two lots with expiration dates of April 2027.
    • “Chlorthalidone is a diuretic used to treat high blood pressure and can also reduce swelling related to heart, kidney, or liver disease. Failed dissolution specifications mean the tablets may not dissolve properly in the body, potentially affecting how the drug’s active ingredients are absorbed.
    • “Inventia Healthcare Limited manufactured the product. Rising Pharma Holdings distributed it in the U.S.”

From the judicial front,

  • The Wall Street Journal reports,
    • “The Justice Department on Tuesday unveiled charges against around 450 defendants for alleged healthcare fraud totaling over $6.5 billion as part of the Trump administration’s stepped-up antifraud efforts.
    • “The announcement includes charges against 90 medical professionals and targets a range of alleged healthcare fraud schemes, such as wound care and opioid distribution. It also includes what officials said is a record number of Medicaid fraud defendants, with nearly 300 people accused of submitting over $500 million in false Medicaid claims.
    • “Federal officials said the operation spanned 57 federal court districts and 41 states and territories, involving 46 state Medicaid Fraud Control Units in what they described as the department’s largest coordinated antifraud effort to date. They added that authorities seized more than $127 million in cash, luxury vehicles, jewelry and other assets. * * *
    • “As part of Tuesday’s announcement, the Justice Department also unveiled a series of new data-sharing agreements across the federal government that officials said will significantly expand their access to fraud-related data. 
    • “Among them are memorandums of understanding with the Federal Trade Commission, giving prosecutors access to consumer-complaint data relevant to telemarketing and telemedicine scams. Officials announced an agreement with the Department of Homeland Security, providing travel information that can help identify providers billing for services while they are physically outside their clinics.
    • “The Justice Department also announced an agreement with the Centers for Medicare and Medicaid Services that gives prosecutors access to CMS’s fraud-detection system, which uses machine learning to identify suspicious billing by healthcare providers. Officials said the tool is already helping investigators spot potential fraud faster and send cases to specialized teams that analyze emerging fraud trends.”
  • Bloomberg Law relates,
    • “Enanta Pharmaceuticals Inc. failed to convince the Federal Circuit to revive a patent it claims Pfizer Inc. infringed with its blockbuster Covid-19 antiviral drug Paxlovid.
    • “Enanta’s US Patent No. 11,358,953 was properly canceled and Enanta’s related infringement suit was properly nixed ahead of a trial, the US Court of Appeals for the Federal Circuit said.”
    • Here is a link to the Court’s opinion. 

From the public health and medical / Rx research front

  • Health Day reports,
    • “Middle-aged women have the highest levels of problematic alcohol use, a new national survey shows, yet they may be the least aware that drinking can increase breast cancer risk.
    • “Researchers questioned 2,200 women, 18 and older, about their drinking habits and mental health, as well as their knowledge and beliefs about alcohol and breast cancer.
    • “The results revealed a striking paradox: Middle-aged women reported the highest levels of problematic drinking while also showing the lowest awareness of its link to breast cancer.
    • “Research consistently shows that breast cancer risk increases as alcohol consumption increases, meaning there does not appear to be a completely ‘safe’ level of alcohol use when it comes to cancer risk,” said Dipali Rinker, research assistant professor at the University of Houston.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A new study suggests that the 2025-26 COVID-19 vaccine helps protect against serious illness by reducing the risk of hospitalization and emergency department/urgent care (ED/UC) visits, adding protection for a population with significant existing immunity from previous infections and vaccinations. 
    • “The study, published today in JAMA Network Open, found that adults who received the updated vaccine were about 50% less likely to require ED/UC treatment for COVID and 55% less likely to be hospitalized than those who did not receive the vaccine.”
  • MedPage Today relates,
    • “Guidelines recommend antibiotics, intranasal corticosteroid sprays, and saline rinses for individual episodes of acute rhinosinusitis, with endoscopic sinus surgery as a possible treatment if the condition recurs multiple times a year.
    • “Endoscopic sinus surgery improved quality of life related to recurrent acute rhinosinusitis compared with conservative medical therapy alone in a small randomized trial.
    • “The trial was limited by premature termination, resulting in imprecise effect sizes.”
  • The New York Times tells us,
    • “Psychiatry has a long history of treating mental illness with drugs that were developed for entirely different purposes.
    • “Take depression medications: The first antidepressant was initially designed for tuberculosis. One of the newest treatments, ketamine, started as an anesthetic. Now, scientists are investigating whether anti-inflammatory drugs might benefit some patients. A medication for rheumatoid arthritis was the focus of a small studypublished last month, building on decades of research examining a connection between inflammation and depression.
    • “Roughly 25 percent of people with depression have elevated levels of inflammatory proteins in their blood, and the inflammation seems to develop before the depression does. In studies where people were given a substance to stimulate inflammation, participants experienced feelings of depression and anxiety shortly after.
    • “People with high inflammation are less likely to benefit from traditional antidepressants. “I don’t think that this is likely important for everyone with depression,” said Dr. David Goldsmith, an associate professor of psychiatry and behavioral sciences at the Emory University School of Medicine. But inflammation “may help explain why a lot of individuals don’t respond to first-line treatments for depression, like S.S.R.I.s,” he said.”

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

  • Modern Healthcare reports,
    • “Digital health company Cadence has raised $100 million in a Series C round to scale its artificial intelligence-enhanced remote monitoring platform for patients with chronic illnesses.
    • “The company also announced Tuesday it is partnering with Durham, North Carolina-based Duke Health — which participated in the funding round — and Arlington-headquartered Texas Health Resources to monitor patients at home. 
    • “The funding announcement comes amid scaled-up interest in remote patient monitoring — and increasing scrutiny of the care-delivery model by insurers and regulators. 
    • “Cadence partners with health systems to remotely monitor the vitals of patients with hypertension, diabetes, heart disease and other chronic conditions. Its nurses have access to electronic health records and can adjust patient medications if necessary.”
  • Fierce Healthcare relates,
    • “With employers seeking new solutions to address rising healthcare costs, Health Care Service Corporation is rolling out its Edge health plans, a new alternative option aimed at simplifying the member experience.
    • “Edge is supported by a proprietary plan design called Easify, with the goal of making the coverage easier for members to understand and use. Members pay a simple copay, and will not have a deductible or coinsurance for care that’s in-network. The plans also includes a broad, PPO network.
    • “The goal, the insurer said in an announcement, is to help connect members with high-quality and cost-effective care. Members are provided digital tools and personalized supports that are designed to explain options clearly and help them find appropriate care.
    • “In addition, Edge plans offer incentives to members who select high-quality providers, according to the announcement.”
  • and
    • “Elevance Health is making strides toward a simpler and more streamlined clinical review process through its Health OS platform.
    • “Health OS is a secure data platform the insurer built to unify data from key sources, such as electronic health records, labs and health information exchanges, to support faster clinical decisions without the need for greater administrative effort from providers.
    • “It also connects with other data systems, such as Epic’s Payer Platform, to collate necessary data. Elevance was the first to lean on Epic’s tool to address inpatient concurrent care reviews, which occur when a patient is admitted for one condition, such as treatment for pneumonia, and then develop a concurrent issue, such as sepsis.
    • “These types of reviews have traditionally required manual documentation, which can lead to delays, incomplete information or additional administrative effort.”
  • Healthcare Dive tells us,
    • “New Jersey nonprofit health systems Hackensack Meridian Health and Hunterdon Health are considering a merger, as regional hospitals continue to explore partnerships to keep up with larger, better-resourced competitors.
    • “HMH and Hunterdon have signed a letter of intent to merge after the boards of both systems voted to move forward, according to a press release on Monday. 
    • “Still, the letter of intent is nonbinding and doesn’t represent a final deal. No immediate changes are planned at HMH or Hunterdon as the pair work toward a definitive agreement, the press release said.”
  • Beckers Hospital Review informs us,
    • “The Lown Institute published its 2026 Lown Hospitals Index “Honor Roll” June 23, spotlighting the top hospitals for social responsibility in every state.
    • “To compile the list, the nonpartisan healthcare think tank assessed 2,718 acute care hospitals, 900 critical access hospitals and 331 health systems nationwide across more than 50 metrics related to health equity, value of care and patient outcomes. Lown used publicly available data from CMS and the IRS, among other sources, for its analysis. Learn more about the methodology here. 
    • “Overall, 123 acute care hospitals, 37 critical access hospitals and 11 health systems earned a spot on the Lown Index Honor Roll.” 
  • Drug Channels offers it “annual look at pharmacist salaries and employment.”
    • “As we predicted, the situation was grim for retail pharmacists. Employment in retail outpatient pharmacies fell by 8,200 positions in 2025, following a drop of 11,700 positions over 2023 and 2024 combined. 
    • “Meanwhile, pharmacist employment at hospitals grew by 3,000 positions, after hospitals added more than 11,000 pharmacist jobs in 2023 and 2024. Nearly half of all pharmacists now work outside a traditional retail setting. 
    • “Overall pharmacist salaries averaged $140,920, but varied widely across practice settings. Salary growth in many settings, however, did not keep pace with overall inflation.” 
  • STAT News points out,
    • “Doctors using OpenEvidence will soon be able to upload an image of an electrocardiogram to get an algorithmic prediction of whether a patient has structural heart disease. 
    • “Called EchoNext, the artificial intelligence model was developed by researchers at New York-Presbyterian Hospital and Columbia University and is being commercialized by a spinout called Pathway Labs. The company this month received a sweeping Food and Drug Administration clearance for the technology that can sniff out six forms of structural heart disease — including conditions where blood doesn’t flow properly through the organ owing to blocked or leaky valves and where the chambers of the heart don’t pump blood as well as they should — from EKG. 
    • “In addition to marketing it to hospitals, Pathway will take the novel step of licensing the technology to OpenEvidence, a medical evidence search engine that’s used by hundreds of thousands of clinicians.
    • “We don’t want FDA-approved AI tools siloed in the ivory tower of academic medical centers, which historically have been the only places with the infrastructure to put them in front of physicians and patients,” Travis Zack, the chief medical officer of OpenEvidence, told STAT by email. “Instead, we envision a different model: The minute these AI biomarkers are approved, every doctor in the country has access to them through a trusted information platform.”

Tuesday Report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Patient safety, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

Fron Washington, DC,

  • Beckers Hospital Review reports,
    • “Senate Finance Committee minority staff has released a request for information outlining three policy options aimed at lowering prescription drug prices, reducing patient out-of-pocket costs and supporting biopharmaceutical innovation. 
    • “The proposal, released June 16, builds on a February plan led by Sen. Ron Wyden, D-Ore., and several Senate Democrats and is the latest in a string of Democratic actions targeting drug pricing under the Trump administration. Most recently, Mr. Wyden and 18 fellow Senate Democrats introduced the Drug Deal Disclosure Act in April, which would require HHS to release contracts and communications tied to the administration’s drug pricing agreements with major pharmaceutical companies and direct the Congressional Budget Office and Government Accountability Office to analyze their impact on Medicare, Medicaid and patient costs.” * * *
    • “Stakeholders have until Aug. 17 to submit comments.”
  • Avalere Health adds,
    • The US Pharmacopeia Convention (USP) is a nonprofit organization that disseminates public compendial quality standards for medicines and maintains two drug classification systems: the Medicare Model Guidelines (MMG) for Part D plans and the Drug Classification (DC) for non-Part D plans.
    • “Statute required Part D plan formularies to include at least two drugs per class. The Centers for Medicare and Medicaid Services (CMS) determines the categories and classes of clinical concern—commonly known as the six protected classes¹—and requires Part D plans to cover “all or substantially all drugs” within each class in their formularies.
    • Under a cooperative agreement with CMS, USP updates these drug categories and classes “every three years in the MMG. These updates, made in consultation with manufacturers and other stakeholders, adjust for the market entrance of new Part D eligible drugs and for drugs with newly approved indications.
    • “On June 1, USP released the draft MMG version 10.0 (v.10.0) for public comment. The finalized v.10.0 is expected in September.”
  • MedTech Dive informs us,
    • “The Centers for Medicare and Medicaid Services on Monday proposed an updated national coverage determination for transcatheter aortic valve replacement that could expand the treatment to more patients, benefiting Edwards Lifesciences.
    • “The proposed NCD adds Medicare coverage for beneficiaries with asymptomatic severe aortic valve stenosis who are enrolled in a CMS-approved study.
    • “We are encouraged the draft coverage policy has the potential to improve timely access to lifesaving TAVR therapy for Medicare beneficiaries,” an Edwards spokesperson wrote in an email.”
  • Moreover, the Centers for Medicare and Medicaid Services issued a
    • “request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers (“PBMs”) and their affiliates to inform implementation of recent legislation. It specifically focuses on gathering information to inform two specific legislative requirements that are effective beginning calendar year 2028: restrictions on the remuneration that PBMs and their affiliates may receive for services in connection with the utilization of covered Part D drugs; and data reporting requirements.”
    • The public comment period will expire on July 20, 2026.
  • Fierce Healthcare tells us,
    • “Beneficiaries face a series of complex decisions in enrolling in Medicare coverage, and a key federal panel outlines some of the pain points.
    • “The Medicare Payment Advisory Commission (MedPAC) released its June report to Congress on Monday, where it notes that when an individual becomes Medicare eligible, they have to immediately make a series of decisions about coverage that may be confusing.
    • “Eligible individuals are also tasked with similar decision points at other times in the year, which adds to the complexity, per MedPAC.” * * *
    • “The advisory group’s report undercuts a key argument often cited by providers seeking additional support from policymakers: that the increased penetration of Medicare Advantage plans, particularly in rural markets, is dangerously dragging providers’ financial stability.”
    • * * * “MedPAC’s report also included familiar recommendations for Congress regarding Medicare payment system incentives.
    • “For instance, “to bring [fee-for-service] Medicare’s overall payment levels closer in line with provider costs,” the group reiterated its support for “slightly” higher hospital outpatient and inpatient payments and physician payments compared to current law. MedPAC also recommends Medicare adopt site-neutral payment rates “for certain services that can be safely provided in more than one ambulatory setting,” and called for various new data sources and formulas to more accurately set relative payments.” 
  • The Congressional Budget Office made a “Call for New Research on the No Surprises Act.”
    • “CBO will continue to monitor evidence about outcomes of the No Surprises Act as it prepares cost estimates and projections for Congress. The agency could benefit from additional research that relies on more-recent data to understand trends related to network participation, prices, and ownership structure. The claims data used in existing studies end in 2023, when patterns from arbitration were only beginning to develop.
    • “Additionally, determining whether trends in prices are causally related to the No Surprises Act is difficult because prices for some specialties affected by the law may have been trending downward before it was enacted and because the rollout of the law coincided with a period of historic inflation. Quasi-experimental evidence could isolate the effects of the law from other trends in prices. Evidence that helps determine whether changes in prices or network participation vary with the degree to which the IDR system is used in a particular market might also help identify changes attributable to the law instead of other factors.
    • “CBO would welcome additional quantitative or qualitative research on the arbitrators’ decision-making process and any incentives they face. Because of the lawsuits challenging the use of the QPA as a guideline, the alternative benchmarks that are being used to determine outcomes from arbitration are unclear.
    • “And finally, CBO would welcome research about how health care markets continue to evolve in the wake of the law. Early evidence suggests that large organizations dominate arbitration activity, potentially disadvantaging smaller providers and encouraging consolidation (Adler, Fiedler, and Agarwal 2026; Hoadley and Watts 2025). Continued analysis of market structure and competition will be critical for understanding the law’s long-term effects.”
  • The American Hospital Association relates,
    • “The Administration for Strategic Preparedness and Response June 16 announced the launch of the Digital Stockpile and Manufacturing Response Network Challenge, a three-phase competition to improve the rapid domestic production of key medical supplies for emergencies. ASPR will award up to $2.04 million to participants from industry, academia, nonprofit organizations and the government for concepts for the network. The agency said it will host a series of virtual information sessions on the challenge beginning in July.” 
  • and
    • “The Health Resources and Services Administration announced June 16 that it will award a total of $2.8 million in grants through its Delta Rural Integrated Health Network Program. The program supports the development of integrated health networks among rural hospitals, primary care clinics, behavioral health providers and other essential services. HRSA will issue eight awards of $350,000 per year for two years. Applications are due by July 17. A recording of a technical assistance webinar on the program is also available.” 

From the Food and Drug Administration front,

  • Bloomberg reports,
    • “Nara Organics recalled all of its whole milk infant formula after three babies were hospitalized with confirmed or suspected botulism, the second total recall of a baby formula brand after it was linked to the deadly illness. 
    • “The US Centers for Disease Control and Prevention warned parents not to use Nara’s formula, which is sold on the company’s website and at Target, on Saturday after three babies confirmed to have consumed it contracted botulism. They are from California, Pennsylvania and Washington, the CDC said. No deaths have been reported.”
  • Cardiovascular Business points out,
    • “Medline, the Illinois-based medical supplier that went public in December 2025, has recalled nearly 50,000 procedure kits used in the cardiac cath lab and other parts of the hospital. 
    • “The recall was put in place due to a risk of issues with the Mastisol Liquid Adhesive included in these procedure kits. Developed by Ferndale Laboratories, Mastisol is commonly used to secure dressings, tapes and medical devices for long periods of time.
    • “Medline has identified a risk of the adhesive’s packaging cracking, which renders it “unusable for application.”
    • “No kits need to be returned. However, a warning label should be added that tells clinicians to use an alternative adhesive.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online. This action aligns with President Trump’s Great American Recovery Initiative, a federal effort to address the U.S.’ addiction and substance use disorder crisis and coordinate the government’s approach to prevention, treatment, and long-term recovery.” * * *
    • “The number of overdose deaths has dramatically decreased since the first FDA approval of an OTC naloxone nasal spray in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl. In the 12-month period ending in August 2023, 111,451 overdose deaths were reported; in the 12-month period ending in December 2025, 68,632 overdose deaths were reported.” * * *
    • “The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, Inc.”
  • BioPharma Dive relates,
    • “Food and Drug Administration scientists evaluating a potentially new messenger RNA flu vaccine from Moderna have expressed skepticism about the evidence supporting its benefits, according to documents filed days before a crucial advisory committee meeting. 
    • “On Thursday, the FDA will convene a panel of experts to discuss use of the shot, dubbed mFlusiva and in development for seasonal influenza. Panelists are set to vote on whether the benefits of vaccination outweigh the risks in people either between the ages of 50 and 64, or those who are 65 and older. Moderna hopes the discussion will set the stage for approval of a vaccine U.S. regulators controversially refused to review earlier this year before abruptly changing course.” 
  • Genetic Engineering and Biotechnology News adds
    • “Flu shots reduce hospitalizations and deaths for the roughly one billion people worldwide that get the flu each year. But they are less effective when the vaccine strains don’t closely match the viruses circulating in the community. Today’s vaccines are made months in advance of the flu season due to a long manufacturing process. When projections are off, strain mismatch can reduce the efficacy of the flu vaccines from about 60% (in a good year) down to 19%. A broader immune response could translate to a more effective vaccine even when the virus is changing faster than vaccine makers can update their shots.
    • “Now, an investigational mRNA influenza vaccine, developed by Moderna, helps the immune system recognize a wider range of influenza viruses than today’s standard flu shot, offering stronger and potentially longer-lasting protection. The vaccine is currently under review by the U.S. Food and Drug Administration and, if approved, would be the first mRNA vaccine against influenza.
    • The findings are published in Nature Immunology in the paper, “mRNA-based influenza vaccine expands the breadth of the B cell response in humans.”

From the judicial front,

  • HR Dive reports,
    • “A federal judge agreed to dismiss an LGBTQ+ advocacy organization’s lawsuit claiming that the U.S. Equal Employment Opportunity Commission “abdicated” its duty to enforce federal workplace protections for transgender workers because the plaintiffs lacked standing, according to a decision issued Friday.
    • “FreeState Justice filed the lawsuit last July, alleging that EEOC unlawfully denied transgender workers access to its charge-investigation process and other enforcement protections as part of a “Trans Exclusion Policy.” But courts lack authority to review such discretionary agency decisions, Judge George Russell III held, quoting the November 2025 decision of a separate court in a lawsuit challenging alleged nonenforcement by EEOC.
    • “Russell dismissed the case without prejudice, writing that the EEOC’s decision to alter investigations of gender identity discrimination claims was “deeply troubling” but nonetheless unreviewable. FreeState did not immediately respond to a request for comment.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Cybele Maylone, 46, has been hearing about hormone therapy nonstop. Whether it is her friends going through menopause or posts from influencers on her social media feed, the subject has seemed unavoidable: who was on it, which doctor finally took their symptoms seriously and, most importantly, how good it felt to be on the medication. The hot flashes waning. Brain fog lifting. Sleep returning.
    • “To Ms. Maylone, it sounds like a miracle drug. But for her and millions of other women, it is not an option.
    • “She was diagnosed in 2023 with a type of breast cancer fed by estrogen, and now takes a drug that suppresses the hormone to reduce her risk of recurrence. While breast cancer is the most widely recognized reason women may not be able take hormone therapy, which delivers estrogen or progesterone through pills and patches, the list also includes endometrial cancer, certain cardiovascular issues, severe liver disease and blood clotting disorders.
    • “Ms. Maylone and other women said they feel deeply frustrated that they can’t take a drug that so many women around them seem to have benefited from.” * * *
    • “Ms. Maylone said that when she tried to raise the subject with her providers, she hit a wall. “Through no fault of their own, they’re like, ‘We’re trying to have you not have cancer,’” she said. “It just feels like you hit a dead end.”
    • “There is a “humongous provider knowledge gap” when it comes to menopause care, said Dr. Rajita Patil, director of the Comprehensive Menopause Program at UCLA. While demand has exploded, many clinicians are still not up to speed on the full range of treatments, including nonhormonal options, she said.”
  • The American Hospital Association News relates,
    • “A report issued by the Centers for Disease Control and Prevention June 11 found that 15.2% of pregnant women in the U.S. reported current alcohol consumption. The report, which examined 2021-2024 data from the Behavioral Risk Factor Surveillance System, also found that 4.9% of pregnant women reported binge drinking, and 2.2% reported heavy drinking during the past 30 days.” 
  • On the bright side, STAT News tells us,
    • “Infant mortality in the U.S. dropped to a new all-time low in 2025, according to preliminary government data.
    • There were slightly fewer than 5.4 infant deaths per 1,000 live births in 2025, according to the Centers for Disease Control and Prevention.
    • “While that appears to be a small decline from about 5.5 in 2024 and 5.6 in the two years preceding, researchers say it is statistically meaningful and translates to hundreds of fewer infant deaths per year.
    • “It’s difficult to pinpoint what’s driving the recent developments, but “this is an encouraging data point, and we hope that this trend will continue,” said Dr. Michael Warren, chief medical and health officer for the March of Dimes.”
  • The Wall Street Journal informs us,
    • “For years, doctors relied only on written memory tests, invasive spinal taps and expensive imaging to diagnose Alzheimer’s disease. Now, two Food and Drug Administration-cleared blood tests are simplifying the diagnosis.
    • “The tests, from manufacturers Fujirebio Diagnostics and Roche Holding, were cleared last year and look for different versions of tau, a protein that forms into tangles in the brain and can lead to memory loss. Fujirebio’s test also measures a protein called beta-amyloid, which can form sticky plaques that are a hallmark of Alzheimer’s disease and the target of recently approved drugs for the condition. 
    • “These tests, which use different methods and report results in different ways, can help evaluate patients with early signs of cognitive decline, neurologists say, but they aren’t designed to predict Alzheimer’s risk in healthy people. Even if they could, there are no approved treatments to prevent the onset of the disease yet.”
  • Per BioPharma Dive,
    • “Edgewise Therapeutics said its experimental heart disease drug hit the goals of a Phase 2 clinical trial, reducing signs of disease and biological markers in two types of cardiomyopathy and supporting advancement of the medicine into pivotal studies.
    • “The Colorado-based biotechnology company is testing its pill, called EDG-7500, in both the obstructive and non-obstructive forms of cardiomyopathy, seeking to improve blood flow and relieve heart failure symptoms in people whose hearts have thickened and weakened as their disease progressed.
    • “The trial data come two weeks after Edgewise wagered the company’s future on cardiovascular disease by selling off its experimental muscular dystrophy pipeline. In cardiomyopathy, Edgewise will have hefty competition, however, as it would face Bristol Myers Squibb’s Camzyos and Cytokinetics’ Myqorzo in the obstructive form of the disease.”
  • and
    • “Shares of Neumora Therapeutics lost half their value after one of the company’s drugs failed a pair of Phase 3 trials in major depressive disorder. Neumora’s drug navacaprant is part of a class of medicines that target kappa opioid receptors and have been hailed as potential blockbusters. But two prospects — navacaprant and J&J’s aticaprant— have now missed key goals in depression studies, and Neumora said Monday that it plans to end development of its drug altogether. The latest findings are “disappointing but not unexpected,” wrote William Blair analyst Myles Minter in a Monday note to investors. Minter referred to the setback as a “clearing event” that shifts focus to a pipeline that now includes drugs for obesity, schizophrenia and Alzheimer’s disease agitation. Neumora has lost most of its value since going public in 2023.” 

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

  • Beckers Payer Issues reports,
    • “When Katerina Guerraz, Aetna’s COO, stepped into her role in mid-2024, the company was having, by her own admission, a really tough year. Rather than look for incremental fixes, she and her team decided to set a new direction entirely — one focused on fundamentally redesigning how Aetna operates, not just for the company, but for the providers and members it serves.
    • “We completely need a different north star — figure out how do we work differently with providers, how do we really design around the member experience, and then where can, how fast can we accelerate and apply technology for automation, and just have more smart workflows and streamline the work, not just for our constituents, but also for our colleagues,” Ms. Guerraz told Becker’s. “That’s the big difference — how you apply this, so it actually makes the healthcare system better, simpler, and you take a lot of the friction out.”
    • “The result is a sweeping operational push tackling claims processing, workforce training, provider relationships and member navigation — all connected by a single goal: taking friction out of the healthcare system.
    • “The push for real-time claims.”
  • and
    • “ICHRA, reference-based pricing, narrow networks, direct contracting, cash pay — it seems you can’t escape these terms today in the employer health benefits market. Each is traceable back to the same gradual shift happening among the leverage structures that have defined the payer-provider relationship for decades.
    • “Much of that shift is because of a departure from fully insured coverage, in which an employer pays an insurer to take on risk, to self-funded plans, where the employer pays claims directly and hires an insurer to handle the back-end administrative functions. From 2015 to 2025, self-funding among large employers stayed flat at roughly 80%, while the real movement came from small firms, according to KFF. Among small employers, fully self-funded enrollment rose from 17% to 27% over the decade and level-funded coverage (a self-funded variant paired with stop-loss coverage) surged from 7% in 2019 to 37% in 2025.
    • “As employers have taken on more risk and gained more visibility into what their plans actually pay (or at least try to), more scrutiny is arising around the value of insurers’ provider networks and their ability to actually negotiate lower prices.
    • “I don’t think provider networks are disappearing. I think they’re being questioned in ways they weren’t five years ago,” Stacy Mays, a former senior health insurance executive, told Becker’s. Since her time at organizations such as UnitedHealth and Capital Blue Cross, Ms. Mays has gone on to start her own consulting firm, Copeland Road Health Ventures.
    • “Before federal price transparency rules took effect, she said, most employers had little visibility into the rates their plans actually paid and were told that discounts were broadly similar across carriers. The data has since shown otherwise, revealing wide variation across networks and, in some cases, cash prices below contracted rates. If a network’s main value was negotiating better prices, she said, employers and providers are now positioned to see when that may not be the case.
    • “If you look at networks from the employer perspective, you have to ask whether employers are really getting value from a network or whether the network is simply the accepted way that healthcare is organized,” Ms. Mays said.”
  • Beckers Hospital Review lets us know the “days of cash on hand figures for 50 health systems as of March 31, according to their most recent financial reports.”
  • Fierce Healthcare relates,
    • “Telehealth utilization increased 10.1% across the U.S. from the fourth quarter of 2025 to the first three months of 2026, a new report from Fair Health found.
    • “Telehealth utilization, measured as a percentage of medical claim lines, increased from 5.01% of medical claim lines in the fourth quarter of 2025 to 5.51% in Q1 2026. The relative increase was 12% in the Midwest, 11.8% in the Northeast, 9% in the South and 8.1% in the West, Fair Health data indicated.
    • “The percentage of patients with a telehealth claim also increased nationally and in all four regions from the fourth quarter of 2025 to the first quarter of 2026. Nationally, that percentage increased from 17.3% in the fourth quarter to 18.4% in the first quarter, a 6.3% rise. The largest relative increase was in the Northeast, at 7.3%.
    • “The data is part of Fair Health’s newly launched Quarterly Telehealth Regional Tracker, building on data from the non-profit’s National Private Insurance Claims database. The database is built on commercial medical and dental claims from more than 75 contributors nationwide, the company says.”
  • BioPharma Dive tells us,
    • “Continuing a string of acquisitions this year, Eli Lilly said Tuesday it will buy non-opioid pain drug developer 4E Therapeutics.
    • “The deal hands Lilly a pipeline full of experimental pain treatments that 4E says are designed to be non-addictive. The biotechnology company specializes in MNK inhibitors, which go after a variant of enzymes involved in a signaling pathway that translates information outside of the cell to its interior. Its lead asset, “4ET1103,” is in development for nerve damage-related pain and has completed an early trial in humans demonstrating safety.
    • “Other drugs in 4E’s portfolio include experimental treatments for migraines and acute pain. The Austin, Texas-based startup raised just under $10 million across private funding and grants from the National Institutes of Health to advance its drug.
    • “The companies did not disclose the financial terms of the deal.”
  • MedCity News informs us,
    • “AI is rapidly gaining traction in the health insurance industry. But according to one health insurance executive, AI shouldn’t be used for the “sake of AI,” but to empower what the health insurer is trying to accomplish.
    • “During an interview at AHIP 2026 last week, Elevance Health Chief Digital Information Officer Ratnakar Lavu shared the company’s three key priorities for AI:
      • Simplifying and personalizing the member experience
      • Simplifying the provider experience, and
      • Making sure employees have the right information at the right time.
  • STAT News points out,
    • “A biotech is doing something that doesn’t happen enough: Talking about its failure.
    • “Verge Labs, formerly known as Verge Genomics, recently announced that its Phase 1b trial for an ALS drug failed. Now it’s trying to explain why, actually, this was a good thing. The company tells Brittany Trang it used the learnings to develop an artificial intelligence neurology model that predicts which patients are more likely to respond to treatment. The tech could help the company recruit candidates for clinical trials in the future. The new model reflects Verge’s “frontier AI lab” pivot  announced at the end of May.
    • “Read more here.”
  • and
    • “For decades, brain-computer interface research has been confined to small, tightly-controlled experiments in the lab. That era may be coming to a close.
    • “Casey Harrell, a man with ALS whose speech is very difficult to understand,  used a BCI system to communicate at home for more than 3,800 hours over the course of nearly two years. He operated it independently at an average speed of 56 words per minute, according to a study published Monday in Nature Medicine.
    • “Harrell is part of the BrainGate clinical trials, which includes researchers from several institutions and which STAT has written about in the past. His BCI system was developed by University of California, Davis researchers.
    • “Harrell’s not the first person to have a long-term brain implant, and other studies have demonstrated communication rates that more accurately reflect speaking. But experts suggest this study reflects where the field should go, if it wants to ensure the technology will be embraced by both users and regulators.”

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.”

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.”

Tuesday Report

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

Simplicity is a virtue

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

From Washington DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

Wrapping up the American Society of Clinical Oncologists annual meeting,

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

From the U.S. healthcare business front,

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

Friday Report

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

Simplicity is a virtue

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the American Society of Clinical Oncology conference front,

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

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

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

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

From the U.S. healthcare business front,

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

Midweek Update

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

Simplicity is a Virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

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

Simplicity is a Virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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