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.”