Thursday Report

FDA

Thursday Report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Rx coverage, SCOTUS, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “The chair of the Senate health committee introduced a bill to restrict a federal drug discount program known as 340B that has been lucrative for nonprofit hospitals.
    • “The bill by Sen. Bill Cassidy (R-La.) comes as hospitals face attacks on their bottom lines, especially in Medicaid. The tax bill that Republicans passed last summer significantly decreased the federal government’s share of Medicaid costs and is expected to reduce the number of people on Medicaid. Hospitals also face the prospect of legislation that would lower hospital payments to levels charged by doctor offices, an idea known as site-neutral payments.” * * *
    • “Cassidy’s bill would implement many pharmaceutical-industry backed restrictions on the program. It would allow drugmakers to give hospitals retroactive rebates, instead of the upfront discounts that hospitals prefer. Hospitals could insist on receiving upfront discounts, but only if they pass them on to patients. They’d also need to establish a sliding-fee scale for prescription drugs, effectively sharing some of the discounts with low-income and uninsured patients.” * * *
    • “Similarly, the bill would place restrictions on the contract pharmacies that hospitals use to administer the discounts. Hospitals would be limited to five contract pharmacies, which would be required to be located in a 340B entity’s service area. The bill also would define conditions for contract pharmacies to participate in the 340B program.” * * *
    • “There are also transparency measures in the bill. Hospitals would have to annually report profits from the drug discount program, the number and types of patients who received 340B drugs, and details of charity care they offer.”
  • The Whistleblower Network News relates,
    • “Sen. Chuck Grassley (R-Iowa) is calling on the Office of Personnel Management (OPM) to revise a proposed government-wide nondisclosure agreement, warning that the draft form could discourage federal employees from reporting waste, fraud, and abuse.
    • “On May 27, OPM, the federal government’s chief human resources agency and personnel policy manager, published a notice seeking public comment on a proposed nondisclosure agreement for use by federal agencies with new and existing employees. According to OPM, the proposed form is intended to standardize confidentiality obligations across the federal government and protect non-public, confidential and proprietary information obtained through official duties.
    • “Grassley, who chairs the Senate Judiciary Committee and co-founded the Senate Whistleblower Protection Caucus, warned that the draft does not go far enough to ensure federal employees understand that the agreement cannot override their whistleblower rights. In a letter to OPM Director Scott Kupor, Grassley urged the agency to update the draft NDA to include the full anti-gag provision required by federal law. Grassley also framed the issue as one implicating federal employees’ constitutional rights.”
  • The Wall Street Journal tells us “What to Know About the Government’s $6.5 Billion Healthcare Fraud Crackdown.”
    • “An $865,000 Bulgari necklace, $600,000 spent on vehicles and more are detailed in documents.”
  • The American Hospital Association News tells us,
    • “The House Energy and Commerce Subcommittee on Health June 25 held a markup session on bills regarding healthcare price transparency, illicit drugs and prior authorization. Bills considered by the subcommittee included the Lower Costs, More Transparency Act (H.R. 9393), legislation that would codify existing price transparency regulations for hospitals and health plans; the Prices on the Wall Act (H.R. 9390), a bill that would require hospitals to post pricing physically on their walls; and the Improving Seniors’ Timely Access to Care Act (H.R. 3514), an AHA-supported measure that would reduce variation in prior authorization methods used for Medicare Advantage plans. 
    • “The AHA provided comments to the subcommittee June 10 for a hearing discussing some of the proposals from today’s markup. All of the bills considered June 25 were advanced to the full committee for consideration.”
  • Bloomberg Law informs us,
    • “Out-of-network doctors are winning drastically higher arbitration payouts for planned procedures under a law protecting patients from unexpected emergency bills, according to data from insurer Elevance Health Inc.
    • “Over the last two years, median arbitration awards won by out-of-network doctors for the most common billing codes for planned procedures are 53 times the in-network rate, the insurer said in a paper shared with Bloomberg Law. Elevance said doctors are exploiting a loophole under the No Surprises Act meant to exclude procedures where patients knowingly consent to paying for out-of-network care.” * * *
    • “The No Surprises Act is largely intended to protect patients when they need emergency care at out-of-network hospitals. But it also allows doctors to file arbitration disputes for in-network procedures where the secondary physician, such as an anesthesiologist, is out-of-network. Doctors are prohibited from balance-billing in those situations unless the patient signs a specific waiver acknowledging the additional costs.
    • “Planned procedures made up around 60% of Elevance’s “independent dispute resolution” awards, and the amounts dwarfed those won for emergency care. Overall, arbitration awards for provider groups filing the most disputes are three to nine times higher than in-network benchmarks. Elevance’s data, by contrast, show that doctors performing planned procedures were winning awards 53 times the in-network benchmark rate.”
  • The FEHBlog who represents a payer (not Elevance) in these No Surprises Act cases seconds Elevance’s contention. What’s more an out-of-network primary surgeon can use the No Suprises Act process as long as the surgery occurs in an in-network facility.
  • Per an AHIP news release,
    • “Recent polls show that rising healthcare costs are a top concern for Americans across the political spectrum and voters strongly support common-sense policy solutions to address the root causes driving the healthcare affordability crisis.
    • “New polling data from the Century Foundation underscores the breadth of bipartisan support for policy solutions: 
      • “Two-thirds of voters said that the federal government should make “stop[ping] hospitals from charging excessive prices” their top priority – more than any other policy proposal.
      • “Support for reining in hospitals’ ever-higher prices is decisive across partisan and demographic lines, including 71% of Democrats, 66% of Republicans and 75% of rural voters.
      • “Six in 10 voters said reining in surprise medical billing by providers should be a top priority – the second-highest priority of all proposals tested.
    • “Voters’ bipartisan concerns are well-grounded in the data. Healthcare costs are rising faster than inflation, driven by unchecked growth in the price of hospital care, physician services and prescription drugs. Americans’ premiums and out-of-pocket costs directly reflect these rising costs.”
  • Tammy Flanagan, writing in Govexec, points out, at the conclusion of a longer article
    • “Even as Medicare and FEHB premiums continue to rise, many retirees still find the combination worthwhile when plans include cost-sharing waivers, rebates or Medicare Advantage structures that shift more costs away from point-of-care spending. Higher-income retirees subject to IRMAA face a sharper calculation: higher fixed premiums today versus potential exposure to higher out-of-pocket costs later. For many, the decision is less about optimization than risk tolerance over time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Doctors treating cancer patients nationwide are facing a shortage of essential generic chemotherapy drugs, a situation that many fear could lead to widespread rationing.
    • “The shortages stem from manufacturing problems, shipping delays and decisions by some companies to stop producing the medications, according to the Food and Drug Administration.
    • “The decades-old medicines are challenging to make in sterile plants and command a very low price in the United States. But they are considered among the most effective treatments for some cancers without more targeted options, including some breast, lung, and head and neck cancers. * * *
    • “From a systemwide policy change, not a single thing has changed,” said Laura Bray, the executive director of Angels for Change, a nonprofit that works to alleviate drug shortages. “It’s time for Washington to get involved and help the citizens of the United States ensure that we have lifesaving medicine.”
  • Fierce Pharma relates,
    • “After 35 years of research and development in pharmaceutical products, Ionis began marketing its drugs for the first time in 2024.
    • “While the company’s maiden voyage into commercialization has progressed “remarkably smoothly,” according to CEO Brett Monia, Ph.D., those efforts will now ratchet up to a new level with the FDA approval of Tryngolza to treat severe hypertriglyceridemia (sHTG).
    • “With the nod, Ionis advances from selling two rare disease drugs to marketing a product that could be used by millions of potential patients.
    • There is no other drug on the market designed specifically to treat sHTG or to combat its accompanying bouts with pancreatitis, which can land patients in the hospital for extended stays and be life-threatening.” * * *
    • “In anticipation of the approval, Ionis’ launch team has been in place since February, promoting Tryngolza to endocrinologists, cardiologists and lipid specialists for FCS while also educating them on sHTG.   
    • “The physicians are just chomping at the bit, waiting to prescribe Tryngolza for their sHTG patients since they manage so many of them,” Monia said.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “The [U.S.] Supreme Court on Thursday ruled for Bayer in its fight against claims that it failed to warn consumers that Roundup causes cancer, boosting the company’s efforts to resolve costly litigation over its popular weedkiller. 
    • “In a 7-2 decision, the court said the pharmaceutical and agriculture company can’t be held liable under state law for failing to warn about the alleged risk when a federal regulator—the Environmental Protection Agency—didn’t require the product to carry a warning label.” * * *
    • “In a statement, a Bayer spokesperson said Thursday’s decision was “good for science, farmers, and industries that depend on regulatory clarity for innovation. It should help significantly contain the Roundup litigation after nearly a decade of legal battles.”
    • “It is a significant victory for Bayer Chief Executive Bill Anderson, who took over the German conglomerate in 2023 with a mandate to help steer it through the litigation. Securing a win at the Supreme Court, along with its proposed settlement, are crucial parts of the company’s strategy to finally move past the long-running Roundup litigation woes.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Here’s another reason to cover up in the thick of tick season this summer: There is a bite that can leave you allergic to burgers, bacon and steak.
    • “That’s right—Lyme disease isn’t the only health threat ticks can pose. More people are learning about alpha-gal syndrome, a potentially life-changing allergy linked to the lone-star tick.
    • “The condition triggers a red-meat allergy. In some cases, it also causes an allergy to dairy and other products or medication derived from mammals (think gelatin).
    • “And lone-star ticks are on the move, thanks to climate change and burgeoning white-tailed deer populations. They are moving beyond their traditional base in the Southeast and south-central U.S., pushing farther north and west. 
    • “The ticks are especially common in coastal areas, such as Martha’s Vineyard off the coast of Massachusetts and Suffolk County in New York. And no, despite their name, the ticks didn’t originate in Texas. They are called that because of a single white dot on their backs that looks like a single star.” * * *
    • “An added problem: Some doctors believe cases are still being missed. After all, until recently many healthcare providers knew little about the condition caused by lone-star tick bites.
    • “A 2023 CDC report found that 42% of healthcare providers had limited knowledge of alpha-gal syndrome and 35% weren’t confident in their ability to diagnose it. 
    • “Patients say misdiagnosis of the syndrome is common and diagnoses can be delayed. That’s because allergic reactions often take place three to six hours after eating the culprit. Among common misdiagnoses: irritable bowel syndrome.”
  • Contemporary Pediatrics tells us,
    • “Researchers found evidence that childhood influences may contribute to 85 adult health diagnoses, including tobacco use disorder, heart disease, digestive disorders, and urinary conditions.
    • “Later age at menarche may serve as a marker of childhood environmental or acquired factors that affect long-term health outcomes.
    • “Findings support the need for greater research into childhood determinants of adult disease and potential prevention strategies across the lifespan.”
  • MedPage Today informs us,
    • “Most in-vitro fertilization (IVF) add-on treatments have little to no evidence of benefit.
    • “Many patients rely on social media and IVF clinic websites for information about them, which may be overhyped.
    • “Better information for patients, and trials of benefits and harms of add-ons are needed.”
    • * * * For example, “[f]our add-ons seemed to have no effect on live birth rates:
      • “EmbryoGlue: OR 1.12, 95% CI 0.91-1.37, P=0.29; seven RCTs; low-certainty evidence
      • “Preimplantation genetic testing for aneuploidy: OR 1.16, 95% CI 0.91-1.47, P=0.23; five trials; moderate certainty
      • “Endometrial receptivity testing: three trials; meta-analysis not undertaken; moderate certainty
      • “Corticosteroids: OR 0.95, 95% CI 0.70-1.27, P=0.71; two trials; moderate certainty.”
  • and
    • “Use and misuse of GLP-1 receptor agonists were common in people with eating disorders, interim results of an ongoing cross-sectional study suggested.
    • “Among over 400 people with eating disorders, 32.1% said they have used GLP-1 drugs, and 22% reported current use, wrote Nicholas C. Peiper, PhD, MPH, of the University of Louisville in Kentucky, and co-authors in a research letter in JAMA Psychiatry.opens in a new tab or window
    • “Notably, 10.1% said they have misused the medications, and 9.9% reported using noncommercial compounded products.”
  • Healio notes,
    • “Omega-3 fatty acids may not deliver benefits for cognitive function on their own, according to a study published in eBioMedicine.
    • “The results show the need for a multimodal approach to preventing dementia in older adults, one that simultaneously addresses physical inactivity, vascular health and other risk factors, Hussein Yassine, MD, director of the USC Center for Personalized Brain Health, and colleagues wrote.”
  • Cardiovascular Business lets us know,
    • “Oral nicorandil can reduce the risk of contrast-associated acute kidney injury (CA-AKI) when patients with renal dysfunction undergo percutaneous coronary intervention (PCI), according to new research published in Circulation: Cardiovascular Interventions.[1] The greatest impact was seen in patients receiving three high doses of the medication per day.
    • “Nicorandil is currently indicated for the treatment of angina. Because it is associated with improved hemodynamics in addition to anti-oxidant and anti-apoptotic benefits, the team behind this study hoped to learn more about its potential effect on high-risk PCI patients who present with renal dysfunction.
    • “Researchers focused on more than 600 patients with renal dysfunction who underwent PCI from 2022 to 2025. While approximately one-third of those patients received 5 mg of nicorandil three times per day, another one-third received 10 mg of nicorandil three times per day. The remaining patients received no nicorandil and served as the study’s control group.
    • “Overall, the rates of CA-AKI within 72 hours were 8.7% for the high-dose group, 10.9% for the conventional dose group and 19.8% for the control group. High-dose nicorandil was linked to a 61% relative risk reduction without significantly increasing the risk of adverse events.”
  • Per BioPharma Dive,
    • “Biotechnology startup RQ Bio has snagged a nine-figure funding round to support development of a drug it believes to be capable of providing broad, long-lasting protection against seasonal influenza.
    • “The London-based biotech said Wednesday it raised 85.5 million pounds, or $115 million, to advance a program known as RQB01. Currently in preclinical testing, the therapy has an undisclosed “differentiated dual mechanism” targeting parts of the virus that remain unchanged even after mutations. RQ Bio claims this approach could help ward off flu-related illness from a variety of different strains, with a single dose providing protective effects that persist for a full season.
    • “The financing round was led by Frazier Life Sciences, included participation from founding investor LifeArc Ventures, and involved other well-known firms such as Forbion and EQT Life Sciences.”

From the U.S. healthcare business front,

  • HealthLeaders reports,
    • “PwC projects a 9.0% commercial medical cost trend for group plans in 2027, driven by structural inflators like AI-enabled documentation tools, rising specialty pharmacy costs, and IDR payments. 
    • “As payers aggressively deploy AI-driven pre-payment reviews to combat rising costs, providers are automating their defenses, creating an expensive administrative arms race that fails to lower systemic costs for the consumer.
    • “To navigate this financial squeeze without alienating their communities, health systems must shift away from back-end collections and prioritize transparent, empathetic pre-service financial clearance.”
  • Beckers Payer Issues relates,
    • “Optum is speaking with multiple large New York health systems to sell some specialties in the state, the company confirmed to Becker’s June 24.
    • “The UnitedHealth Group subsidiary is considering the sale of certain specialties, including orthopedics, general surgery and urology. The specialties are affiliated with Optum Medical Care and Crystal Run Healthcare, which Optum purchased in 2023.
    • “We are in discussions with several large health systems across New York regarding the transition of certain specialty services with the goal to keep that care local,” Jon Nasser, MD, CEO of Optum New York and New Jersey, said in a statement shared with Becker’s. 
    • ‘Optum has already signed or is negotiating letters of intent with the interested health systems. The company aims to reach agreements and close sales by the end of 2026.”
  • and
    • “Walgreens will begin supporting eligible Medicare beneficiaries through the new Medicare GLP-1 Bridge program at about 8,000 pharmacies when the initiative launches July 1.
    • “More than 56 million patients in the Medicare network may be eligible for the program, according to a June 25 news release. Walgreens pharmacists will help patients navigate eligibility requirements, answer questions about participating medications and provide ongoing support during treatment. Free delivery will be available in most states for select oral GLP-1 tablets, as well.
    • “Walgreens joins CVS Health, Walmart and Sam’s Club in supporting the Medicare GLP-1 Bridge program. CVS said it will offer expanded pharmacist support, a $49 MinuteClinic virtual weight management visit and a $50 monthly copay option for eligible Medicare beneficiaries. Walmart and Sam’s Club said they will provide pharmacist consultations and educational resources through nearly 5,000 pharmacy locations.”
  • Beckers Hospital Review tells us,
    • “Orlando Health Watson Clinic Lakeland (Fla.) Highlands Hospital is scheduled to open July 8 after more than six years of construction and planning.
    • “The more than $500 million facility is the first hospital opening in Lakeland in over a century, and Orlando Health’s 50th facility in Florida, including clinics, freestanding emergency departments, hospitals, and institutes, according to a June 25 news release shared with Becker’s. 
    • “Orlando Health Watson Clinic Lakeland Highlands Hospital has hired 1,500 employees, and is offering full scholarship programs to full- and part-time staff. The 558,233-square-foot facility has seven floors, 206 patient beds, 49 emergency room beds and sits on nearly 80 acres.
    • “The hospital has eight labor and delivery beds, 28 postpartum rooms and two cesarean section operating rooms. In the next few months, it will open a neonatal intensive care unit that comprises 12 beds for babies who need specialized postbirth care.”
  • Radiology Business adds,
    • “The University of Pittsburgh Medical Center recently held a ribbon cutting for an $8 million new interventional radiology suite. 
    • “UPMC Williamsport, a 224-bed acute care hospital, said the relocated IR facility seeks to bring minimally invasive care closer to home for patients in north central Pennsylvania. The upgraded suite now includes two state-of-the-art labs, equipped with next-generation imaging systems. 
    • “UPMC said the scanners will allow radiologists to visualize blood vessels and internal structures in real time. There, they’ll deliver procedures including stent placements and balloon angioplasties with “greater accuracy and control.” 
    • “This investment reflects UPMC’s ongoing commitment to expanding access to advanced, high-quality care across north central Pennsylvania,” Luke Klingler, director of the health system’s Heart and Vascular Institute, said in an announcement June 17. “The new interventional radiology suite strengthens our ability to meet the evolving needs of our communities by enhancing clinical capabilities, supporting multidisciplinary collaboration, and ensuring patients can receive leading-edge, minimally invasive care close to home.”
  • MedCity News informs us,
    • “Michigan-based insurer Priority Health has teamed up with Garner Health, a digital platform that steers patients to high-performing doctors to lower costs, the companies announced on Wednesday.
    • “Priority Health serves 1.4 million members in Michigan, Indiana, Ohio and Wisconsin. The new partnership will support both self-funded and fully funded employer groups, and will become available starting August 1.
    • ‘The partnership seeks to make it easier for Priority Health’s members to find high-quality physicians in their area. Garner Health has a dataset of over 60 billion medical records that helps identify the best quality doctors. When members choose high-performing providers through Garner’s dataset, their employer then covers most or all of their out-of-pocket costs. This incentivizes employees to choose better doctors and lowers costs for employers by avoiding unnecessary procedures.”
  • Per Fierce Healthcare,
    • “Virtual care platform First Stop Health unveiled an expansion of its Healthy Weight Program amid increasing GLP-1 demand and subsequent healthcare plan costs.
    • “The program integrates weight management, including GLP-1 prescriptions when appropriate, directly into its primary care model. New to the program is a cash-pay access option for employers who do not currently cover GLP-1 prescriptions and a managed coverage program for those who do offer coverage. 
    • “The goal isn’t simply weight loss — it’s improving metabolic health and reducing long-term health risk,” said Cole Barfield, M.D., First Stop Health chief medical officer, in an emailed statement to Fierce Healthcare. 
    • “Barfield said the virtual care platform aids “employers on either side of the coverage decision” by “combining clinically appropriate prescribing with primary care, dietitians, health coaches, and diabetes educators who support sustainable behavior change.” 
    • “Medication can be transformative, but it works best when it’s part of a real care relationship focused on the whole person,” Barfield said.”

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Healthcare Dive reports,
    • “U.S. healthcare spending spiked 7.3% last year to reach $5.7 trillion, driven by soaring spending on hospital services and pricey prescription drugs like GLP-1s, according to new government data.
    • “The sharp spending growth isn’t primarily caused by increasing prices. Cost growth has been moderate. Instead, Americans are consuming more healthcare after a lag during the coronavirus pandemic, CMS actuaries said. It’s the same trend they called out in the national health expenditures report for 2024.
    • “But the high rate of growth last year was still surprising, according to Jacqueline Fiore, an economist with the CMS’ Office of the Actuary.
    • “Spending growth continuted to grow more rapidly for 2025 than we had expected,” Fiore said on a call with press Wednesday to discuss the projections, which the CMS released in the journal Health Affairs.
    • “The forces accelerating spending, however, are no surprise. Retail prescription drug spending is forecast to grow at the fastest clip over the next decade, but especially in 2025 and 2026 due to more Americans utilizing expensive drugs for conditions like cancer — and rabid demand for GLP-1s.”
  • Modern Healthcare adds,
    • “National health expenditures will rise to nearly $9 trillion and comprise 20.6% of gross domestic product by 2034, according to a federal report released Wednesday. * * *
    • “Health expenditures are forecast to rise an average 5.4% per year through 2034, when they will reach $8.97 trillion, the study found. Healthcare spending will continue to outpace the economy, which the actuaries anticipate will grow an average 4.1% annually over that time. * * *
    • “Hospital spending is projected to have risen 8.2% to $1.8 trillion in 2025, below the 8.9% rate in 2024. Spending on physician and clinical services is projected to have increased 6.2% to $1.2 trillion, down from an 8.1% growth rate in the prior year.”
  • NPR relates,
    • “Helped by pausing payments to worker retirement funds, the U.S. Postal Service is no longer on track to run out of money and stop deliveries next year, Postmaster General David Steiner confirmed to Congress on Wednesday.
    • “But with people and businesses still sending a lot less mail compared to decades ago, the self-funded federal agency remains close to a financial cliff as it struggles to continue delivering mail six days a week to just about every address in the country.
    • “A cash crisis at USPS may now come sometime between 2031 and 2034, according to the agency’s latest projections.
    • “What we are doing right now is we’re basically borrowing money from our retirement plans to fund current operations,” Steiner told lawmakers at a hearing before the Senate Homeland Security and Governmental Affairs Committee. “I’m not particularly comfortable with that. I promise you our employees are not particularly comfortable with that. You all shouldn’t be comfortable with that. None of us should be comfortable with that. To me, that’s why we have to have this discussion of how we fix this broken business model.”
  • Beckers Hospital Review tells us,
    • “A bipartisan group of senators led by Senator Brian Schatz, a Democrat from Hawaii, introduced the Ensuring Access to General Surgery Act of 2026, legislation that would create the first formal federal shortage designation for general surgeons and direct the Health Resources and Services Administration to map gaps in surgical care access nationwide.
    • “According to a June 23 news release by The American College of Surgeons, who also backed the bill, the proposal would require HRSA to study and define general surgery workforce shortage areas and collect data on the adequacy of surgical services across the country. It would also authorize the HHS secretary to establish a formal general surgery shortage area designation — a tool that currently exists for primary care and other specialties but has never been applied to general surgery.”
  • Per an HHS news release dated June 23,
    • “The U.S. Department of Health and Human Services (HHS) today announced the successful conclusion of the federal public health response to the Hantavirus exposure event associated with the M/V Hondius cruise ship. The final 42-day monitoring period ended on June 21 at 2 p.m. EDT. No individuals in the United States remain under public health monitoring for Hantavirus exposure.
    • “Under the leadership of Secretary Robert F. Kennedy, Jr., HHS worked closely with federal, state, and local public health partners to identify potentially exposed individuals, conduct monitoring, provide clinical guidance, and ensure readiness across the United States healthcare system. As a result of these efforts, no sustained transmission of Hantavirus occurred in the United States, and all monitoring activities related to the event have been completed.
    • “Proponents argue the absence of that designation has left policymakers without a standardized mechanism to identify underserved communities, recruit surgeons to those areas, or direct federal resources toward access gaps. The legislation is the Senate companion to House bill HR 7198, introduced earlier this year.”
  • Per a CMS fact sheet,
    • “On June 24, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies under the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2027. This rule also proposes updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2027 and proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2027, CMS is proposing to increase the ESRD PPS base rate to $299.55, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 1.1%. This amount includes a proposed $15.96 increase to account for the incorporation of phosphate binders into the ESRD PPS base rate. The CY 2027 ESRD PPS proposed rule also proposes changes to the low-volume payment adjustment, changes to the payment adjustments for pediatric patients, an increase to the home and self-dialysis training add-on amount and technical modifications to the transitional drug add-on payment adjustment (TDAPA), and a post-TDAPA add-on payment adjustment.” * * *
    • The proposed rule can be downloaded from the Federal Register at: https://www.federalregister.gov/d/2026-12925.
  • Fierce Healthcare unpacks for us “CMS’ decision to recalculate 2026 MA star ratings after Clover Health ruling.”
  • Healthcare Dive notes,
    • “The Rural Health Transformation Program is beginning to reshape how hospitals in rural America deliver care. But with nearly a trillion dollars in Medicaid cuts looming and pressure to show results or risk losing funding, many states are pursuing the safest path available: paying hospitals to downsize.” * * *
    • “Framing the program as incentivizing hospitals to shrink is misleading, said Robert Parris, a managing director who leads government-focused healthcare advisory work at consulting firm Huron. What’s actually happening, he said, is that communities are getting more of what they need and less of what they don’t.
    • “It’s more about reallocation as opposed to taking away,” Parris said.
    • “The program is also shifting how leaders think — from what services a facility can provide within its own walls to what care the surrounding population actually has access to, said Paul Johnson, a managing director who works directly with rural hospital clients at Huron.
    • “Many hospitals had these changes on their wish lists for years, but they couldn’t justify the investment because they were focused on surviving the next budget cycle.
    • “It’s almost like a license for them to pivot into things that they know they’ve had to do,” Johnson said.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The game is on for TROP2 antibody-drug conjugates in first-line triple-negative breast cancer.
    • “Less than a month after an approval for Daiichi Sankyo and AstraZeneca’s Datroway for front-line TNBC patients who are not candidates for PD-1/L1 inhibitors, the FDA has handed Gilead Sciences’ Trodelvy a rivaling approval that allows the drug to be used regardless of patients’ PD-L1 status.
    • “The new FDA approval for Trodelvy in first-line TNBC now allows the first-in-class TROP2 ADC to be used either alone for patients who aren’t eligible for PD-1/L1 inhibitors or in combination with Merck & Co.’s Keytruda for those with PD-L1-positive tumors, defined as a combined positive score of at least 10.”
  • and
    • “It’s been seven years since Pfizer scored an expansion for its breast cancer blockbuster Ibrance, and during that time, the drug has started to lag sales of two others in its class—Eli Lilly’s Verzenio and Novartis’ Kisqali.
    • “But on Wednesday, the FDA gave the CDK4/6 inhibitor a shot in the arm, signing off on Ibrance as a maintenance option for patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer after induction treatment.
    • “CDK4/6 inhibitors such as Ibrance are well-established treatments for HR-positive, HER2-negative breast cancer, but the HR+/HER2+ indication represents a new frontier. 
    • “With today’s FDA approval, Ibrance becomes the first and only CDK4/6 inhibitor indicated for patients with HR+ metastatic breast cancer regardless of HER2 status, extending its impact to patients who continue to face challenges with treatment resistance,” Aamir Malik, Pfizer’s U.S. commercial chief, said in a Jun. 24 statement.” 
  • Cardiovascular Business relates,
    • “GuideAI Health, a Boston-based medtech company founded by radiologists, has secured U.S. Food and Drug Administration (FDA) clearance for artificial intelligence (AI)-powered software that flags early warning signs of peripheral artery disease (PAD).
    • “VascularAssist Occlusion Triage (VAOT) alerts clinicians when it detects a suspected vascular occlusion, ensuring the patient receives a prioritized review. The newly approved software has been linked to high patient-level sensitivities for both 2D and 3D analyses of medical imaging exams of the lower extremities.
    • “Receiving FDA 510(k) clearance for VAOT is a defining milestone for GuideAI and for the patients we ultimately aim to serve,” Raj Shah, MD, MBA, CEO of GuideAI Health, said in a prepared statement. “Peripheral vascular disease is too often missed or detected late, with devastating consequences. VAOT brings AI-powered triage directly into the radiology workflow, helping clinicians identify vascular disease sooner so patients can be directed to the right care faster. This clearance marks the first step in our broader vision to set a new standard in AI-driven vascular care.”
  • and
    • “Pathway Labs, a New York-based artificial intelligence (AI) company founded by a cardiologist, has received U.S. Food and Drug Administration (FDA) clearance for its EchoNext screening tool that detects signs of structural heart disease in electrocardiograms (ECGs).
    • “We have colonoscopies, we have mammograms, but we have not had equivalents for most forms of heart disease,” Pierre Elias, MD, Pathway Labs founder and CEO, medical director for artificial intelligence at NewYork-Presbyterian and assistant professor of medicine and biomedical informatics at Columbia University Vagelos College of Physicians and Surgeons, said in a statement. “Through EchoNext, we are able to diagnose critical, high-risk conditions that the human eye can’t, and potentially deliver lifesaving treatment earlier.”
    • EchoNext was cleared to identify a total of six different types of heart disease, flagging ECG results when a follow-up echocardiogram is recommended. The advanced algorithm was trained on more than 700,000 ECG-echo pairs. Recent studies have found that it can identify structural heart disease with a greater accuracy than trained cardiologists.
    • “Pathway Labs celebrated these clearances by officially launching EchoNext. The company has also partnered OpenEvidence to help expand access to the algorithm throughout the United States.” 
  • MedTech Dive tells us,
    • “The Food and Drug Administration has dropped a warning letter against wearable device firm Whoop following changes the company made to its blood pressure feature.
    • “In a closeout letter posted Tuesday, the FDA said it does not intend to enforce device requirements on the modified version of Whoop’s feature, consistent with guidance the agency issued earlier this year that would exempt more wearable features from oversight.
    • “Whoop CEO Will Ahmed said in a Wednesday LinkedIn post that the regulatory update was a “major development” and praised the updated wellness guidance.”
  • Healio informs us,
    • “The FDA announced approval of generic Priftin tablets to treat two types of tuberculosis caused by Mycobacterium tuberculosis, marking the first generic of this drug, according to an agency notice.
    • “The FDA outlined that the generic of Priftin (rifapentine) is for patients aged 12 years and older with active pulmonary TB and for patients aged 2 years and older with latent tuberculosis infection at high risk for progression to TB disease.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Cancer death rates in the U.S. have dropped dramatically in the past 35 years, falling by 35%, according to a report from the American Association for Cancer Research published Wednesday. The decline, which translates to nearly 5 million fewer cancer deaths since 1991, has been driven in large part by increased screening and advances in cancer treatments.
    • But the progress has not been seen equally across the country. 
    • “African American communities and American Indian and Alaska Native populations have the highest overall cancer death rates of any U.S. racial or ethnic group, and this means higher incidence and mortality for multiple cancers,” said the chair of the report, Mariana Stern, a professor of clinical population and public health sciences and urology at the Keck School of Medicine of the University of Southern California.
    • “Black people in the U.S. have long had higher cancer death rates than white people, though the gap has narrowed in recent years. Still, Black people are about twice as likely to die from multiple myeloma and cancers of the stomach, prostate and gallbladder as white people. For breast cancer, mortality rates are 35% higher among Black women than among white women. 
    • “Colorectal cancer — which is rising in people under 50 — also has higher mortality rates among Black and American Indian/Alaska Native populations, compared with white people.” 
    • “Increased screening has contributed to 79% of the colorectal cancer deaths averted, according to the AACR report. During a colonoscopy, doctors remove precancerous polyps before they have the chance to turn into cancer. People at average risk are advised to begin screening at age 45.
    • “But screening rates are lower among non-white populations, the report found.”
  • Following up on the Fierce Pharma articles above, the Wall Street Journal reports,
    • “Drug companies have found promising new options for one of the most aggressive and hardest-to-treat forms of breast cancer after decades with few breakthroughs.
    • “Gilead Sciences won Food and Drug Administration approval Wednesday to sell its drug Trodelvy as a first treatment for newly diagnosed patients with the advanced form of a type of breast cancer known as “triple negative” because it has characteristics that render common treatments ineffective. 
    • “It is the second such approval in about a month: AstraZeneca and Daiichi Sankyo’s rival drug, Datroway, was approved for a similar group of patients in May.
    • “Both of the drugs are antibody-drug conjugates—a type of targeted therapy that uses an antibody to identify a protein found on most triple-negative tumor cells and then delivers a concentrated dose of chemotherapy directly into the cancer. 
    • “The aim is to spare more healthy tissue than standard chemotherapy, which attacks growing cells throughout the body. These drugs both reduced the risk of progression of the disease by around 40% when compared with chemo.
    • “The progress is a lot more palpable right now and bringing us a greater deal of hope and excitement,” said Dr. Carmen Calfa, a breast medical oncologist at the Sylvester Comprehensive Cancer Center in Miami who wasn’t involved in either study.”
  • STAT News adds,
    • “It is one of the oldest mysteries in medicine: Why do fundamentally healthy people drop dead? Sudden cardiac arrest kills upward of 350,000 people a year in the U.S., a fate that is particularly tragic because it’s preventable with an implantable defibrillator.
    • “The challenge is figuring out who needs one.
    • “A study published in Nature on Wednesday uses artificial intelligence to identify those people, and pinpoints a possible reason why they so often evade detection. It reports that a culprit once considered relatively benign — cardiac fibrosis, or scar tissue scattered throughout the heart — is commonly present in people with the highest risk of sudden death.
    • “In a nice normal heart, everything happens at the same time, things are synchronized,” said Ziad Obermeyer, a University of California, Berkeley, scientist and lead author of the paper. “When you have fibrosis, you have these little dead areas that cause a breakdown of order.”
    • “The resulting disorganization, and its deadly implications, can be detected by AI on widely available electrocardiogram, or EKG, tracings, opening up the possibility that the technology could help direct lifesaving treatment to exactly the people who need it, the study found. Currently, about two-thirds of the defibrillators implanted in patients based on medical guidelines never deliver a lifesaving shock, a gap that exposes patients to risks of complications and imposes significant costs on the health care system.”
  • Fierce Pharma informs us,
    • A Nature Medicine paper landed on Feb. 2 like a stone in a pond, sending out ripples that quickly turned into tidal waves across biomedical circles. By midday, renowned physician-scientist Eric Topol, M.D., had signaled its importance to his more than 700K followers on X, then hailing it as “probably the best proof of the importance of timing of therapy that we’ve seen in medicine to date.” By the time the Super Bowl kicked off on Feb. 8, the study’s 3 p.m. threshold has become a punchline, as longtime biotech investor and TV host Brad Loncar jested that the Patriots’ sluggish offense was “like immunotherapy administered after 3:00 PM.”
    • “However, by Feb. 19, the journal would put up an editor’s note, alerting readers to several concerns around the article, titled “Time-of-day immunotherapy in non-small cell lung cancer: a randomized phase 3 trial.” Topol apparently deleted his comment at some point as well.  
    • “At the time, concerns raised against the article ran the gamut from major revisions to trial design and inconsistent trial protocol, to unusual efficacy and safety data patterns.
    • “Now, after a four-month investigation, Nature has decided to pull the study.”
  • Side note – Beckers Clinical Leadership identifies “The top 25 U.S. healthcare institutions for research in 2025 were, according to Nature.” “Boston-based Massachusetts General Hospital was the highest-performing U.S. healthcare institution on Nature‘s 2026 Research Leaders ranking.” 
  • The National Institute of Standards and Technology lets us know about its test of seven “At-Home Gut Microbiome Test Kits.”
  • Health Day points out,
    • “That juice box you hand your child as a daily treat could be setting them up for poor heart health later on, a new study says.
    • “Drinking fruit juice or sugary sodas throughout childhood may be linked to an increased risk of high blood pressure in adulthood, researchers reported June 22 in the journal Circulation.
    • “Kids who drank 12 ounces or more of fruit juice every day had a 35% higher risk of developing high blood pressure in adulthood, researchers found.
    • “Likewise, those who drank 24 ounces or more of sugary sodas or sports drinks had a 52% higher risk.
    • “The study also found that substituting either with a piece of whole fruit lowered a child’s future risk of high blood pressure.”

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

  • Beckers Payers Issues reports that “A year after promising ‘change and reform,’ UnitedHealth opens its doors.”
    • “It’s not every day the country’s largest healthcare company provides on-the-record access to its senior leadership team, no topics barred. But that is exactly what UnitedHealth Group has done, inviting reporters and social media influencers to its corporate headquarters in June for a daylong showcase of where the company is heading.
    • “Staged across sleek suburban-Minneapolis campuses, the day felt closer to a Silicon Valley product keynote than an insurer’s media event, complete with live software demos, an AI assistant making medical appointments, and a walk through of the company’s intelligence center it uses to triage member and patient issues across the country. 
    • “Across nearly every session, UnitedHealth presented itself as a technology and data company, one that can build tools for its tens of millions of members, patients and customers – and also sell solutions to the rest of the industry. Coming about two years after the Change Healthcare cyberattack laid bare how much of the nation’s claims plumbing already runs through Optum, the ambition is notable.” 
  • Beckers Hospital Review relates,
    • “New York City-based Memorial Sloan Kettering Cancer Center has broken ground on a $2.3 billion inpatient facility, the Kenneth C. Griffin Pavilion.
    • “The new facility will be connected to the cancer center’s main hospital by a dedicated patient bridge, according to a Memorial Sloan Kettering news release shared with Becker’s.
    • “Memorial Sloan Kettering expects to start serving patients at the new facility in 2030.”
  • and
    • “Houston Methodist has received a $110 million gift, its largest single commitment in the system’s more than 100-year history.” * * *
    • “The funding will establish a new innovation fund supporting research and care within the Houston Methodist Academic Institute and Neurological Institute, as well as an excellence fund for women’s health initiatives in the department of obstetrics and gynecology.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare has agreed to sell 31 home health and hospice agencies across eight states to Deaconess Associations Incorporated, a Cincinnati-based company that manages a diversified portfolio of $1 billion in healthcare services, programs, investments and community grant initiatives.
    • “Upon closing, the agencies will become part of Central Pyramid, one of Deaconess Associations Incorporated’s four owned subsidiaries and a home health and hospice operator with nearly four decades of experience. The agreement expands Central Pyramid’s geographic footprint and positions it to serve patients across more communities.
    • “Deaconess framed the deal as part of a strategy to invest in organizations that strengthen its existing operations and expand access to care as services move beyond traditional clinical settings.”
  • Fierce Healthcare points out,
    • “The past several years have seen strong growth in life insurance, in part thanks to the COVID-19 pandemic, with half of Americans owning a policy today. 
    • “While life insurance has traditionally been seen as a death benefit—something that offers families financial assurance after a loved one has passed—part of the industry is expanding into wellness benefits for the living. 
    • “This reflects burgeoning demand: a third of consumers are interested in free mental health and wellness services to go along with their life insurance, trade group LIMRA finds. Nearly a quarter are also interested in gym memberships, health coaching and diet planning. 
    • “John Hancock has been leading the way for over a decade. In 2015, it launched its Vitality program with the idea of encouraging healthy living. Discounts on fresh produce, wearables and various health memberships are just one part of the array of offerings.
    • ‘John Hancock CEO Brooks Tingle is honest about the business incentive. Life insurers make money by investing their customers’ premiums. That means the longer they live, the more money the company stands to make.” 
  • The American Hospital Association News notes,
    • “Results from a KFF poll published June 17 found that 31% of adults use social media at least monthly to seek health information and advice, similar to 29% who said they use artificial intelligence for the same purposes. Most adults said they either “never” or “occasionally” use AI (71%) or social media (69%) to find health information. Among adults who use social media for health information, 36% said learning from people with the same health condition or who share similar experiences was a “major reason.” A smaller share (17%) said that not having a regular healthcare provider or not being able to afford the cost of seeing a provider was a “major reason” for turning to social media.”

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.”

Monday report

David Ermer–Agentic & Generative AI, CDC, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The solstice this weekend marked the start of astronomical summer — and in Washington, D.C., that means the legislative clock is ticking.
    • “Lawmakers are eager to head home and campaign on a housing bill that’s nearing passage, but progress on several other issues has stalled, and it’s unclear whether a visit from President Donald Trump will break the logjam or cause further obstruction.”
  • Congress.gov finally has updated this week’s Committee hearings list. No hearings were held today. Of note,
    • Senate Committee on Homeland Security and Governmental Affairs
    • Wednesday, June 24, 2026
    • 9:30 AM (EDT) – Senate | 342 Dirksen Senate Office Building, Washington, D.C.
    • Open Hearing: Hearings to examine reforming the U.S. Postal Service’s business model.
    • Meeting Details
  • Federal News Network tells us,
    • “The Federal Regulatory Council is giving the federal community one more chance to speak up before the first set of major revisions to acquisition regulations becomes final.
    • “In Tuesday’s Federal Register, the FAR Council will release the first tranche of proposed rules for 17 sections of the FAR.
    • “Industry and government have largely seen these changes in the deviations, but there are additional differences or changes from what we have in deviations,” said an OMB official, who requested anonymity in order to discuss the proposed rules. “The general premise for each of the rules should already be familiar to most people. This is now to tell us where we missed something or how to refine a particular area.”
  • Kevin Moss, writing in Federal News Network, points out,
    • “Benjamin Franklin famously wrote, “In this world nothing can be said to be certain, except death and taxes.” If Flexible Spending Accounts had existed in his time, he might have added one more certainty: If you use an FSA, you’ll save money on your healthcare expenses.
    • “Yet despite rising healthcare costs and tighter budgets, most federal employees are leaving this guaranteed savings opportunity on the table. In fact, only one in five participate in the FSA program, meaning most employees are paying more than they need to.
    • “The good news? FSAs aren’t complicated, and you don’t have to be a benefits expert to take advantage of them.
    • “In this article, we’ll break down how they work, share a simple strategy to help you use one successfully (even if it’s your first time), and show why this is one of the easiest ways federal employees can immediately reduce their out-of-pocket healthcare costs.”
  • The FEHBlog heartily agrees with Mr. Moss.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a coordinated department-wide effort [PDF, 2.10 MB]* to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.
    • “For decades, randomized clinical trials have served as the gold standard for evaluating the safety and effectiveness of new medical treatments. Yet in recent years, a growing share of early-stage clinical research has moved overseas, threatening America’s position as the global leader in biomedical innovation. Under President Trump’s leadership, HHS is taking decisive action to reverse that trend and make the United States the preferred destination for clinical research and medical discovery.”
  • Beckers Payer Issues relates,
    • “Earlier in June, the HHS Office of Inspector General published two reports shedding light on post-acute care denials and overturned appeals from Medicare Advantage organizations. AHIP is pushing back.
    • “The reports ignore serious, well-documented concerns about wide variations in the cost and quality of post-acute care and skilled nursing facilities. More than 35 million Americans actively choose MA because it provides them with better, more affordable care — including helping seniors transition to high-quality, clinically appropriate care settings to support their rehab and recovery,” an AHIP spokesperson said in a June 11 statement.
    • “AHIP cited previous OIG research from 2018 that raised concerns about spending and quality with post-acute care. Based on a sample, OIG estimated Medicare paid inpatient rehabilitation facilities across the country $5.7 billion for unnecessary or unreasonable beneficiary care. The news release also featured Stanford (Calif.) University research from 2022 on risks of skilled nursing facility overuse based on Medicare’s reimbursement approach.
    • “AHIP also pointed to a lack of context in the OIG reports. Administrative issues — including out-of-network providers, services excluded from coverage and missing documentation — could all contribute to denials, not just denials that did not meet medical necessity standards. AHIP said reports also excluded common rationales for overturned denials, such as providers’ offices adding information that was initially missing from a claim.
    • “When combined with timely clinical information from our provider partners, prior authorization supports safe, effective and affordable care,” a CVS spokesperson previously told Becker’s. “We review requests promptly, offer a clear appeals process and are leading the way for continuous patient-centered improvements.”
    • “AHIP commissioned insights from analytics firm Inovalon, finding that, compared to fee for service, MA patients had 30% fewer inpatient days and 71% fewer preventable hospitalizations.”

From the Food and Drug Administration front,

  • The American Hospital Association reports,
    • “The Food and Drug Administration June 22 announced multiple actions to help accelerate early- and late-stage drug development. The actions are part of a larger Department of Health and Human Services initiative announced June 22 on clinical research efforts, called Operation TrailBlazer. The FDA’s efforts include a request for information on a new drug pilot program that would shorten the period from drug identification to first-in-human studies and protect clinical trial participants. The program would create a network of qualified research institutions, including academic medical centers, healthcare networks, contract research organizations, regulatory advisors and other research organizations, to partner with sponsors and develop and review protocols for first-in-human clinical trials intended for new drug submissions to the FDA.” 
  • The Wall Street Journal relates,
    • “The Food and Drug Administration has agreed to reverse its rejection of Regenxbio’s RGNX experimental gene therapy for a rare and fatal brain disease, the company said, the latest about-face by the agency under new leadership.
    • “The FDA didn’t respond to requests for comment.” * * *
    • “Regenxbio’s Navsunli therapy targets Hunter syndrome, a rare genetic disease that causes irreversible brain damage and cell death, usually leading to death in a patient’s midteens. 
    • “The disease affects about 2,000 people worldwide—nearly all boys—and about 50 people are diagnosed a year in the U.S.
    • “Navsunli promises to replace a defective gene, allowing boys who take the drug to start producing a protein that prevents the buildup of harmful substances in the brain and tissues.”
  • MedTech Dive tells us,
    • “Johnson & Johnson’s Abiomed alerted physicians to a risk associated with eight instances of major bleeding in patients treated with its Impella heart pumps.
    • “The Food and Drug Administration, which posted an early alert notice about the issue Thursday, said Abiomed and its manufacturing partner, Oscor, wrote to users about the catheter introducer issue this month.
    • “Hospitals can continue to use existing inventory. However, physicians should consider a device exchange or using the repositioning sheath to minimize blood loss if they see a potential leak.”
  • and
    • “Zoll received a warning letter from the Food and Drug Administration citing quality concerns and problems with how the firm handles complaints. 
    • “The warning letter focused on MRI compatibility problems with some of Zoll’s portable ventilators. It also cited concerns with automated external defibrillators and electrodes used with the company’s defibrillators.
    • “Zoll, a subsidiary of Asahi Kasei that makes ventilators, defibrillators and other medical devices, received the warning letter on April 30, and the FDA posted the letter on Tuesday. The warning followed an inspection of Zoll’s facility in Chelmsford, Massachusetts, where the company is headquartered, between February and April 2025. 
    • “The FDA uses warning letters to flag significant violations after an inspection.”

From the public health and medical / Rx research front,

  • The AP reports,
    • “Utah has spent the past year fighting measles outbreaks — a grim milestone that could affect whether the United States can keep its measles-free designation. 
    • “More than 680 people have gotten sick since the state’s first outbreak began on June 20, 2025.
    • “Unlike measles outbreaks in Texas, South Carolina and Arizona, the spread in Utah has been tough to contain to one region — infecting undervaccinated communities in nearly every county. 
    • “Measles popped up in healthcare settings, big-box stores and restaurants, and youth sporting events. In February, an exposure at a state high school wrestling championship sparked at least 46 cases among attendees.” * * *
    • “More than 16% of the region’s kindergarteners were missing their measles vaccines in the last school year, according to state data. Statewide, 12.8% were missing their vaccine, putting the state far short of the 95% vaccination rate needed to prevent measles outbreaks.”
  • The American Medical Association lets us know what doctors want their patient to know about rib injuries.
    • “Rib injuries can range from bruises and stress injuries to fractures with overlapping symptoms.”
  • The Wall Street Journal tells us,
    • “Elementary school-age children are receiving GLP-1 weight-loss drugs such as Wegovy, despite that the medications aren’t being approved for obesity in this age group.
    • “Doctors prescribing GLP-1s to young children cite the severity of childhood obesity and its complications, seeing significant BMI decreases in some patients.
    • “Some doctors express concern about potential long-term effects on bone growth and brain development, while a guideline recommends medication only for children 12 and older.”
  • MedPage Today informs us,
    • “Adults ages 80 and older with unusually fast gait had about half the cognitive impairment risk as others, data from several studies suggested.
    • “Earlier research showed that super movers — people 80 and older who walk as fast as people 30 years younger — had a lower burden of disease, a healthier lifestyle, and a younger biological age.
    • “Findings suggested that mobility may reflect broad resilience across brain, cardiovascular, and muscle systems.”
  • and
    • “Previous research showed that combining the multicomponent blood-based biomarker Stockholm3 test with an MRI-targeted biopsy approach decreased overdetection of prostate cancers, while still detecting clinically significant cancers.
    • “In this analysis, the Stockholm3 test identified more clinically significant prostate cancers, while missing fewer cases, compared with standard PSA screening.
    • “These results support the use of the Stockholm3 test in the context of a risk-adapted screening approach, researchers said.”
  • and
    • “A major health system tested one multilevel approach to antithrombotic stewardship in the face of antiplatelet overprescribing among [direct oral anticoagulants] DOAC users.
    • “Antiplatelet use dropped following an initial educational outreach and a subsequent clinical pharmacist-facing electronic flag within a DOAC population management tool.
    • “The greatest benefit was observed in patients with stable [cornary artery disease] CAD, a group appropriate for antiplatelet deimplementation.”
  • STAT News notes,
    • “Pfizer said Monday that an experimental drug it hoped could replace a widely used chemotherapy in one of the most common forms of lung cancer fell short in a clinical trial.
    • “Expectations had been high that the drug, sigvotatug vedotin, could replace docetaxel, a chemotherapy initially approved in 1996. Last year Pfizer’s CEO, Albert Bourla, said on an earnings call the drug “could be a driver of growth later this decade.” In a note to investors in May, Leerink analyst David Risinger called the upcoming data readout a “major oncology catalyst” and said he had spoken to a doctor who was “optimistic” about its potential.” * * *
    • “The drug is an antibody-drug conjugate targeting integrin beta-6, a protein that is involved in tissue repair and is undetectable in normal cells but upregulated in cancer cells and is expressed in 90% of non-small cell lung cancer tumors. Pfizer was studying it compared to docetaxel in patients with locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer.
    • “But the drug did not result in a statistically significant improvement in overall survival over docetaxel. This was the study’s main goal, which means researchers will likely view other potentially encouraging conclusions from the clinical trial as requiring further proof.”

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

  • The Wall Street Journal reports,
    • “AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion to bolster its core immunology franchise.
    • “The deal includes Apogee’s experimental drug zumilokibart, a potential rival to Dupixent for moderate to severe atopic dermatitis.
    • “The acquisition, expected to close in the third quarter, will cut adjusted per-share earnings by 46 cents in 2027.”
  • STAT News adds,
    • “Pharma goes on a spending spree, snapping up biotechs in a hurry.
      • “M&A activity [like the AbbVie deal] has soared in the first half of the year.” * * *
      • “The amount of money put toward M&A in the first three months of 2026 was the highest seen since 2020, according to a report from PwC. 
      • “The flurry of M&A is also a welcome reprieve for biotech startup executives, who have struggled to finance their drug trials or early lab research, as well as venture capitalists searching for investment returns. It’s provided a lifeline to some biotech startups struggling to stay afloat.” 
  • Modern Healthcare relates,
    • “As the federal government expands access to weight-loss drugs for Medicare patients, Walmart and its Sam’s Club subsidiary are ramping up support services for beneficiaries who may be seeking the medications. 
    • “The Medicare GLP-1 Bridge program, which the Centers for Medicare and Medicaid Services is launching July 1, will allow eligible Part D beneficiaries access to certain GLP-1 drugs often used for weight management. 
    • “The retailers noted in a Monday news release Medicare patients may face hurdles understanding eligibility requirements, prescription coverage processes, provider documentation needs and pharmacy fulfillment options.
    • “The initiative, also launching July 1, will offer educational materials, consultations with pharmacists, assistance navigating government and healthcare resources, increased in-store support, digital health tools and connection to additional health services like vision care. 
    • “The retailer said in the release it is not responsible for eligibility determinations, coverage decisions and treatment recommendations.”
  • Beckers Hospital Review adds,
    • “CVS Health is expanding support services for patients using GLP-1 medications, including a new $50 monthly copay option for eligible Medicare beneficiaries and a $49 virtual weight management visit through MinuteClinic.
    • “CVS Pharmacy will begin participating in the CMS’ Medicare GLP-1 Bridge program July 1, according to a June 22 company news release. Established under agreements the Trump administration negotiated with Eli Lilly and Novo Nordisk in November, the program will set a $245 monthly Medicare price for Ozempic, Wegovy, Mounjaro and Zepbound, with patients paying $50 per month out of pocket. 
    • “The company also launched a new MinuteClinic virtual care offering available in 47 states and Washington, D.C. The service connects eligible adults ages 18-64 with licensed clinicians who can evaluate patients for weight loss treatment and, when clinically appropriate, prescribe FDA-approved GLP-1 medications. Visits cost $49 and do not require a recurring membership fee.
    • “CVS said the initiative also includes expanded pharmacist support and over-the-counter products designed to help patients manage common GLP-1 side effects and remain on therapy. The company plans to offer dedicated product displays in select stores focused on nausea, gastrointestinal discomfort, hydration and nutrition support.”
  • HR Dive notes,
    • “SHRM members are shaking up their prescription drug benefits strategies thanks to cost increases that are driven in part by a massive uptake of weight loss medications, analysts for the HR organization said during its 2026 annual conference on Tuesday.
    • “Specifically, GLP-1 drugs have become a “massive line item” for employers, said Kathryn Mayer, senior specialist, content at SHRM. The organization’s 2026 Employee Benefits Survey found that while close to half of the roughly 5,500 employer respondents covered GLP-1s for Type 2 diabetes management, only 15% did so for weight management.
    • “We’re finding that employers are struggling to fund GLPs,” said Calven Engstrom, a SHRM senior researcher. But given strong evidence of the drugs’ effectiveness and high demand from employees — a 2025 KFF poll found that 1 in 8 U.S. adults said they were currently taking a GLP-1 drug— organizations have to weigh competing interests.
    • “Many of these organizations are trying to balance employee health outcomes with the long-term affordability and sustainability of their typical health plan,” Engstrom said, adding that utilization rates for GLP-1s are probably among the most closely monitored by employers at the moment.”
  • Per a Fair Health news release,
    • “The national median total cost for a C-section for commercially insured patients staying in network is $19,911, and for vaginal delivery it is $15,728, according to FAIR Health’s Cost of Giving Birth Tracker. These figures reflect the national median allowed (in-network) amount for the procedures. 
    • ‘The Cost of Giving Birth Tracker is a free, interactive tool, updated today, that tracks the cost of giving birth state by state. Available on FAIR Health’s website fairhealth.org, the Cost of Giving Birth Tracker consists of heat maps that show state-specific and national median charge and allowed amounts for vaginal deliveries and C-sections. The tool draws on the national, independent nonprofit FAIR Health’s database of commercial healthcare claim records—the nation’s largest such repository, which is growing at a rate of more than four billion claim records a year.
    • “The Cost of Giving Birth Tracker includes inpatient and outpatient facility and professional costs. Services include the delivery itself (e.g., pharmacy, nursery, labor and delivery room, medical and surgical supplies, room and board for the mother), anesthesia, fetal nonstress tests, ultrasounds, laboratory work and a breast pump. The data come from the September 2025 release of the vaginal delivery and C-section FH® Total Treatment Cost benchmarks.”
  • Modern Healthcare informs us,
    • “Health systems are investing in remote patient monitoring despite reimbursement rates that often don’t cover technology and staffing costs.
    • “Providers are banking on remote monitoring programs’ long-term, less easily quantified benefits.
    • “Stanford Health Care, UMass Memorial Health, OSF HealthCare and others are using technology to keep an eye on patients outside hospital walls.”
  • Fierce Healthcare notes,
    • “Online portal messages sent to providers more than doubled between 2020 and 2025 as patients now have much more direct access to physicians. But there hasn’t been a corresponding drop-off in clinic visits as digital medicine is adding to clinicians’ workload rather than replacing in-person care, a new study finds.
    • “At least 12% of Americans now communicate with their healthcare providers about appointments, test results and ongoing treatments via secure online patient portals and health apps, according to a study led by researchers at NYU Langone Health and published today in the Journal of the American Medical Association (JAMA) online.
    • “Online portal messages jumped 153% from 2020 to 2025, from an average pace of 2.2 per year in early 2020 to 5.4 per year in late 2025. But these digital messages are not replacing in-office visits, which have returned to an average of between two and three per year per patient. In-person office visits saw a modest 17% increase, going from 2.37 to 2.77 per patient per year, during the study period.
    • “By contrast, total telephone calls decreased by 6% over the same period.”
  • and
    • “Nine months after announcing its seed funding round, Prosper AI banked $30 million to scale its agentic AI platform to power administrative tasks from patient scheduling to insurance verification and patient billing.
    • “While many voice AI companies focus on specific tasks, like patient scheduling or billing, Prosper AI was designed to manage the broader patient journey, according to executives. The platform answers patient calls, schedules appointments directly in the electronic health record, verifies insurance benefits, automates patient billing and contacts insurers on the phone when additional information is needed. 
    • “Prosper AI’s ambition is to build an AI workforce for healthcare operations teams, Xavier de Gracia, the startup’s co-founder and co-CEO, told Fierce Healthcare. Prosper AI first shared the funding news with Fierce Healthcare.
    • “We believe that three to five years from now, larger patient groups and health systems are going to have a layer of workforce that’s going to be AI, not only humans, and it’s going to complement the work that humans are doing, and we believe that EHRs are going to partner and are already partnering to build a layer on top of the electronic health record. Our vision is to be completely agentic.” 

Thursday report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

In recognition of Juneteenth, a Friday report will not be posted tomorrow. The FEHBlog will return on Saturday with the latest Cybersecurity Saturday post.

From Washington, DC.

  • Healthcare Dive reports,
    • The CMS is recalculating 2026 Medicare Advantage stars for insurers after the agency lost a court case over its methodology.
    • Only plans that see their stars increase will have their ratings updated and be able to resubmit bids for next year, regulators said in a memo to plans Wednesday. It could be a major boon for insurers, given the stars are linked to lucrative bonuses and competitive advantages in the privatized Medicare program.
    • Still, the recalculation basically results in no change in average star ratings for other insurers besides Clover Health, which brought the lawsuit against the CMS, according to TD Cowen analysts. Some insurers may choose to sue over the approach.
  • STAT News relates,
    • “Making good on its threat, Eli Lilly has begun eliminating mandated price breaks to a few dozen hospitals that participate in a federal drug discount program after failing to receive comprehensive claims data.
    • “The move comes after the company warned earlier this month it would take such a step as part of a policy announced in January in order to reduce what it calls duplicate discounts paid to the hospitals. Trade groups representing hospitals, however, argue the move is unlawful and want Congress to intervene.
    • “At the time, Lilly maintained that more than 2,300 hospitals had complied with its demand, but some larger hospitals systems around the U.S. refused to do so, despite recent follow-up letters regarding the policy, which went into effect Feb. 1. Up to 1,000 had so far not complied, and Lilly indicated it was pressing about 50 larger hospitals to provide data.
    • “A Lilly spokesperson declined to say how many hospitals are now being denied the mandated discounts but sent us a statement saying, “Lilly is collecting claims data to stop the rampant fraud, waste, and abuse in the 340B program that is harming employers, state and federal governments, and patients.”
  • The American Hospital Association News tells us,
    • “The Health Resources and Services Administration Maternal and Child Health Bureau has announced grant opportunities available supporting maternal and child health initiatives. The Maternal Produce Prescription Program, or MP3, will provide grants for the development and implementation of community-based produce prescription programs and related nutrition education for maternal populations at risk of poor health outcomes due to nutrition insecurity and other health-related factors. Grants are also available for the Regional Pediatric Prevention Network, which will provide funding to hospitals working on advancing pediatric emergency and disaster preparedness locally, regionally and nationally, including for children with special healthcare needs and behavioral health concerns, children living in poverty, and children in rural, remote and tribal areas. The network will include at least 10 children’s hospitals, or their university pediatric partners, as well as community partners. The application deadline is July 17 for the MP3 and RPPN programs. 
    • “Funding is also available for the Maternal Health Emergency Management Training program, which seeks to increase capacity and improve the quality of care provided by clinicians and first responders who encounter pregnant and postpartum women in nondelivery and/or low-resource clinical settings. The deadline to apply for the MHEMT program is July 20.” 
  • Federal News Network inteviews Tammy Flanagan about the Federal Employees Group Life Insurance Program.
  • JAMA discusses original research concerning the Inflation Reduction Act.
    • “Question  How did prescription drug use change after the Inflation Reduction Act implemented annual out-of-pocket spending caps in Medicare starting in 2024?
    • “Findings  In this cohort study using a difference-in-differences framework of 3053 medications covering 92.9% of gross Medicare Part D spending in 2023, prescriptions for medications paid by Medicare increased after the out-of-pocket cap was implemented in 2024 compared with those paid by commercial insurance; this change was most pronounced among the highest-cost medications, with a 22.7% increase in 2024-2025.
    • “Meaning  Results of this study suggest that implementing annual out-of-pocket caps in Medicare was associated with higher use of medications and that the policy improved Medicare-insured patients’ access to costly medications.”
  • Fierce Pharma notes,
    • “Before Indian drugmaker Aurobindo can complete its acquisition of Pennsylvania generics specialist Lannet, it will have to divest four drugs from the proposed $250 million buyout to resolve anticompetitive concerns, the Federal Trade Commission said.
    • “Aurobindo’s acquisition of Lannett would combine two of a limited number of competitors in the markets for four different generic pharmaceutical products that provide critical relief for patients,” the FTC wrote of its proposed consent order (PDF).
    • “The U.S. regulator has specified that Aurobindo must sell the products to New Jersey generics maker Quagen Pharmaceuticals.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “A Food and Drug Administration advisory committee voted that the benefits of a seasonal flu vaccine from Moderna MRNA outweigh its risks, part of the agency’s review of a potential new treatment.
    • “Moderna said Thursday the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the benefits of the vaccine, mRNA-1010, exceed the risks for the prevention of flu in adults 50 through 64 years old, and in adults 65 years of age and older.
    • “The FDA plans to consider the committee’s recommendations as part of its ongoing review of Moderna’s biologics license application for mRNA-1010, the company said. Advisory committee recommendations are nonbinding, and the FDA is responsible for making final approval.”
  • Fierce Pharma relates,
    • “With FDA acceptance of its application, Roche has moved a step closer to gaining a thumbs up for its potential combination treatment of Polivy and subcutaneous Lunsumiofor adults with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy.
    • “The U.S. regulator says it’s aiming to decide whether to approve the application by Feb. 9, 2027.
    • “The application is backed by results from a phase 3 study, which showed that after a median follow-up of 23 months, the Lunsumio and Polivy combination demonstrated a 59% reduction in risk of disease progression or death compared to Rituxan plus the chemotherapies gemcitabine and oxaliplatin.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), announced today that it is requesting updates to the prescribing information for testosterone replacement therapy products following a comprehensive review of new clinical data and existing scientific evidence.
    • “The proposed changes would:
      • “Remove the limitation of use stating that the safety and effectiveness of testosterone replacement therapy in men with age-related hypogonadism have not been established.
      • “Update information related to prostate cancer risk.
      • “Revise warnings regarding benign prostatic hyperplasia, also known as enlarged prostate.
    • “During Men’s Health Month, we are putting science back at the center of men’s healthcare,” said HHS Secretary Robert F. Kennedy, Jr. “By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men.”
  • Cardiovascular Business informs us,
    • “More than 11,000 bottles of a popular blood pressure medication have been recalled due to a failed test. The voluntary recall was initiated on June 5, according to key details provided by the U.S. Food and Drug Administration (FDA).
    • “This recall includes 11,460 bottles of Chlorthalidone Tablets manufactured by India-based Inventia Healthcare Limitedand distributed by New Jersey-based Rising Pharma Holdings. Chlorthalidone is a diuretic or “water pill” used to treat hypertension and reduce excess fluid caused by heart, kidney or liver disease. 
    • “These drugs have been recalled due to “failed dissolution specifications.” This means tablets tested by a regulatory body did not break down correctly, creating a risk of the drug being less effective than intended.
    • “The recalled bottles include either 100 or 1,000 of these tablets. They all have an expiration date of April 2027.
    • “Click here for additional details about this recall from the FDA. The incident has not yet been classified as a Class I or II recall.”

From the judicial front,

  • Healthcare Dive reports,
    • “Pharmacy benefit managers want to make sure that an Illinois law creating drug pricing transparency and reforming health benefits administration doesn’t apply to them.
    • “On Tuesday, powerful PBM lobby the Pharmaceutical Care Management Association filed a complaint in federal court against the Illinois Department of Insurance, arguing that the Prescription Drug Affordability Act signed into law last summer clashes with federal oversight of employee benefit plans and that PBMs should be carved out from its provisions.”
  • Beckers Hospital Review relates,
    • “A federal judge has denied The Leapfrog Group’s attempt to reverse a ruling that found its hospital safety grades violated Florida consumer protection law, and separately put a $10.5 million fee dispute on hold, pending appeal.
    • “On June 17, U.S. District Judge Donald Middlebrooks rejected Leapfrog’s motion to reconsider his March 6 ruling, which found the organization violated Florida’s Deceptive and Unfair Trade Practices Act by penalizing hospitals that declined to participate in its voluntary survey with artificially low safety grades.”
  • The Wall Street Journal informs us,
    • “Luigi Mangione’s defense team said Thursday they no longer intended to present a psychiatric defense at his coming New York state-court murder trial, abruptly reversing course after a judge made public the unusual strategy a day earlier.
    • ‘In a single-sentence letter to the presiding judge, the lawyers wrote that, at this time, they were withdrawing a defense in which Mangione would have argued he killed UnitedHealthcare Chief Executive Brian Thompson due to an emotional disturbance.
    • “Mangione’s defense team and a spokesman for the Manhattan district attorney’s office declined to comment.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “While infant formula in the U.S. has a good overall safety record, the stakes are incredibly high if something goes wrong. Food safety experts who spoke with STAT say they want regulators and the industry to take even stronger measures to prevent disease outbreaks that put babies’ lives at risk. And they want consumers to be wary of marketing from newer, high-end formula companies like ByHeart and Nara that position their products as safer than other options.
    • “I think a lot of parents can be confused and think that if they spend more money on a formula, it’s safer,” said Steven Abrams, a professor of pediatrics at Dell Medical School at the University of Texas at Austin. In fact, formulas are remarkably similar to one another because they’re required to use a blend of 30 ingredients necessary to give babies the nutrition they need. All formulas are also subject to annual FDA inspections and requirements to test for the pathogens salmonella and Cronobacter.
    • “Of designations like organic, GMO-free, or added probiotics and prebiotics, Abrams said, there’s no evidence that such features “have the slightest health effect on babies.”
    • “Nara and ByHeart were both manufacturers “claiming to produce a healthier type of infant formula because they were using whole milk,” said Frank Yiannas, a former deputy commissioner for food policy and response at the FDA. The fact that both brands have been linked with infant botulism, he said, suggests that “reformulating powdered infant formula should be done with extreme due diligence and caution.”
  • and
    • “If you’re an older adult, getting vaccinated against shingles could lower your risk of developing dementia.
    • “A new study found that elderly nursing home residents who received at least one dose of the shingles vaccine known as Shingrix, the only shot of its kind available in the United States, were 24 percent less likely to develop dementia over a four-year period compared to those who were not vaccinated, according to results published this week in the peer-reviewed journal Annals of Internal Medicine.
    • The research adds to the growing body of evidence showing a connection between the viral infection and cognitive decline.
    • “The fact that this is a super high-risk population for dementia and we’re still seeing a potential benefit is really remarkable and important evidence for this population,” said Kaleen Hayes, the study’s lead author and an assistant professor at Brown University who studies the use of medications for chronic conditions in older adults.”
  • and
    • “Fentanyl is by far the biggest opioid killer in the U.S. With more than a quarter of a million deaths since 2021 and about 200 fatalities a day, fentanyl is one of the country’s most urgent public health crises. But drug experts warn that nitazenes can be even more potent and are being mixed with fentanyl and other substances, creating increasingly lethal combinations.
    • “We’re always concerned about fentanyl being mixed in with other drugs — cocaine, meth, heroin,” said Frank Tarentino, associate chief of operations for the DEA’s northeast region. “You add nitazenes to that and it makes it exponentially more dangerous and frightening for drug law enforcement, parents, caregivers, educators, and the young.”
    • “Data obtained from the DEA’s National Forensic Laboratory Information System (NFLIS) show reports of confirmed seizures from nitazenes rising sharply — from 43 positive tests in 2019 to almost 2,000 in 2024 (the most recent year for which data are available). By March this year, more than 8,000 nitazene reports had been recorded since 2019. But experts said that not all laboratories can test for nitazenes — which come in many forms including powders, pills, and sprays — and many don’t feed into the NFLIS system, meaning these numbers are almost certainly an underestimate.” * * *
    • “Nitazenes are predominantly sold online, both on the clear web and dark web, and are often laced into other substances to increase their potency. Experts say this puts unsuspecting users seeking more common drugs, such as oxycodone, fentanyl, or stimulants like cocaine, at risk of fatal overdoses.”
  • The Washington Post tells us “7 unexpected takeaways from the newest research on cannabis and brain effects.”
    • “Whether it’s used in adolescence, midlife or older age may make a big difference.”
  • The American Medical Association lets us know “What doctors want patients to know about summer skin safety.”
    • “Too much sun exposure can have damaging effects on skin, but following proper precautions can help. Follow these summer sun safety tips.”
  • Health Day points out,
    • “Pregnant women are exposed to dozens of common chemicals linked to early delivery and low birth weight, according to a new study.
    • “Researchers tested urine samples from more than 5,000 women who gave birth between 2000 and 2021, and compared the findings with pregnancy outcomes.
    • “They screened for 113 chemicals commonly found in food, water, air pollution, personal care products, fragrances and other household items.
    • “On average, the tests detected 45 chemicals in each sample, with as many as 64 found in some participants.
    • “Among them were phthalates used to make plastics more flexible, as well as some newer plasticizers.
    • “Some of these compounds were consistently associated with earlier delivery and lower birth weight, according to the results.” * * *
    • “The researchers are calling on governments and companies to do more to reduce harmful chemicals in everyday products and ensure new ones are safe.”
  • MedPage Today informs us,
    • “In a cohort study, U.S. women logging at least 2 hours a week of resistance training had a 20% lower risk of incident major cardiovascular disease (CVD) over nearly 15 years.
    • “The benefit of resistance training persisted even if women also engaged in aerobic activity and limited sedentary time.
    • “A lower risk of major CVD could also be observed in those who reached ≥1 hour of weekly resistance training and were consistent about it over the years.”

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

  • The American Hospital Association News reports,
    • “Hospital and health system leaders gathered June 17 and 18 in Washington, D.C., for U.S. News & World Report’s Healthcare of Tomorrow Conference, focusing on the future of healthcare delivery. AHA Chair-elect Bill Gassen, president and CEO of Sanford Health in Sioux Falls, S.D., participated in a panel titled “Reimagining Healthcare: The Hospital and Health System of Tomorrow.” The session included discussion on challenges and opportunities shaping the future of hospitals and health systems, and involved topics such as artificial intelligence and digital transformation, care delivery models, community partnerships and sustainable financial performance.  
    • “When I think about the future of health care, I believe success will be defined by how well organizations can connect care across settings, specialties and communities to better serve patients,” said Gassen. “The organizations that will be best positioned for the future are those that can combine deep local relationships and community trust with the capabilities needed to deliver increasingly complex care, invest in innovation, develop the workforce and keep care accessible and affordable over the long term.” Former AHA Board Member Warner Thomas, president and CEO of Sutter Health, and Redonda Miller, M.D., president and CEO of The Johns Hopkins Hospital, also participated on the panel.” 
  • Kaufmann Hall relates,
    • The latest issue [April 2026] of the National Hospital Flash Report covers these and other key performance metrics.
    • Key Takeaways:
      • Hospital performance remains under pressure in 2026. Mixed performance on key volume indicators, staffing challenges, and expense growth continue to pressure hospital operations, reinforcing the need for focused prioritization and strategic planning.
      • Expense growth continues to outpace inflation. Drug and labor expense remains a key contributor to expense growth, driven by both cost and utilization as the population ages, underscoring the importance of strategic spend management across the board.
      • Payer mix continues to erode. Year-over-year climbs in bad debt and charity care reflect broader shifts in payer mix, shifts in coverage, and growth in uninsured populations, requiring hospitals to proactively adapt and manage long-term revenue risks.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Hospital Review ranks 81 health systems by annual revenue and identifies four hospital closures that have happened in 2026.
  • Bloomberg tells us,
    • “Johnson & Johnson has no plans to enter the booming obesity market, opting instead to focus on diseases such as cancer, Chief Executive Officer Joaquin Duato said in an interview for an upcoming episode of The David Rubenstein Show: Peer to Peer Conversations.
    • “The comments set J&J apart from many of its rivals trying to develop or acquire obesity medicines following blockbuster weight-loss drugs from Eli Lilly & Co. and Novo Nordisk A/S.“
  • Fierce Pharma informs us,
    • “What’s been Novo Nordisk’s secret weapon to turn the tables on Eli Lilly and win the current market battle over their oral GLP-1 obesity drugs? Name recognition.
    • “That’s according to Jim Hickey, an analyst with Spherix Global Insights, who has studied the competition by surveying 50 primary care physicians (PCPs) and 50 endocrinologists in the United States, as well as writing monthly reports on the uptake of the drugs, both of which debuted on the market earlier this year. 
    • “It’s interesting to see how strongly Novo Nordisk has come out of the gate,” Hickey said in an interview with Fierce. “It’s a very strong launch from what we can see. That lines up with the data Novo Nordisk has shared. I think a big difference between the two really comes down to familiarity. We see the familiarity ratings for the Wegovy pill as being much stronger than what we can see for Foundayo.”
  • Fierce Healthcare points out,
    • “Lantern and Marathon Health are joining forces to launch an integrated model that brings together primary and specialty care, a key concern for employers as costs rise.
    • “The partnership combines Marathon’s advanced primary care model with Lantern’s specialty care platform, simplifying the patient care journey, better managing costs and reducing unnecessary procedures. Marathon clients that do not currently work with Lantern can purchase its services through Marathon, making the process easier for employers, too.
    • “The two initially collaborated on a pilot program with early adopters, focused on orthopedic care, and found between a 37% and 100% increase in referrals to Lantern. Referrals from Marathon led to a 47% increase in either completed or averted surgical procedures, the companies said.”
  • Per BioPharma Dive,
    • “Biogen plans to buy startup RayThera to gain access to a portfolio of immunology drug candidates, including one slated to enter the clinic in the third quarter. 
    • “Founded in 2023, RayThera says its mission is to develop safer, more effective therapies for immunological diseases. But the company has said little publicly about what it’s doing. RayThera’s website doesn’t detail what it’s been working on, instead touting the company’s “nimble and adaptable approach” and containing a pipeline page with three prospects listed only as “anti-inflammatory.”
    • “The deal with Biogen is also rather opaque, per a statement released Wednesday. RayThera investors will get an undisclosed upfront payment and could reap as much as $1 billion if unspecified clinical and regulatory goals are met.”
  • and
    • “An emerging area of drug development got more crowded Wednesday, with the debut of a biotechnology startup trying to create new migraine prevention therapies.
    • “Vedana Therapeutics formed in response to an earlier class of migraine-thwarting medicines that first hit the market toward the end of the last decade. These medicines inhibit specific proteins, “CGRPs,” that play a key role in migraines by transmitting pain signals, widening blood vessels and triggering inflammation in the tissues around the brain. While effective for many, a large portion of patients — more than half, by some estimates — don’t respond to, or stop taking, CGRP-blocking therapies.”
  • McKinsey & Co. discusses “The health system CEO imperative: Turning AI’s promise into performance.”
  • The Wall Street Journal reports,
    • “The clash over AI doctors has begun, and its front line is in Utah.
    • “It started with technology from the startup Doctronic. The state launched a project in January that will allow the service to renew prescriptions for patients. The hope is it will improve medication access.
    • “Any Utah adult can log in to get a refill on cholesterol medications or antidepressants, among other prescriptions. When fully implemented, the project will break new ground by letting an artificial-intelligence product, acting on its own, perform this job typically done by physicians.
    • “Doctors aren’t happy about it.
    • “People can have life and death reactions to medications,” said Dr. Alan Smith, a family physician who chairs the Utah medical board but said he wasn’t speaking for the group. “And then I worry about liability. Who is actually liable for problems that may occur because of a refill of a medication?”
    • “Most of the state’s medical licensing board, including Smith, signed a letter calling for the project to be suspended on safety grounds. They said Doctronic’s tool hasn’t been vetted enough, and prescribing can create risks because drugs cause side effects or might not be appropriate to continue. The Utah Medical Association said it agreed with the letter.
    • “State officials overseeing the pilot program said that the medical board has no authority over the project but that they will consult with it.
    • “The debate over AI doctors extends far beyond Utah’s borders.” 

Midweek report

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

Simplicity is a virtue.

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

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.”

Monday Report

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

Simplicity is a virtue.

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend Update

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

Simplicity is a virtue.

From Washington, DC,

  • The Hill reports,
    • “The Supreme Court is in its final sprint.
    • “President Trump’s agenda is on the line as the justices dash to hand down their remaining decisions by their self-imposed deadline of the end of June. 
    • “With 20 argued cases left, the court’s pace is exactly on par with this time last term. 
    • “But among those remaining cases are potentially seismic decisions on birthright citizenship, presidential firing power, transgender athletes, mail ballots and more. 
    • “The next opinions are expected Thursday.”
  • FedScoop reports,
    • “The Trump administration is already trying to bring talent from industry into the government via its U.S. Tech Force program, but the next step could be putting federal workers on exchanges to companies, according to remarks from an Office of Personnel Management official Thursday.
    • “During a panel at a federal technology-focused conference, Kevin Hennecken, senior advisor to the director at OPM and leader of the Trump administration’s Tech Force hiring effort, mentioned the agency’s interest in such a program as a way of helping train federal workers. 
    • “Something OPM has been focused on is “creating more pathways for people to sort of experiment going to the private sector for periods of time and coming back,” Hennecken said. “I think that can also be quite helpful, just to expose them to some different ways of getting things done.”
  • Per a June 11, 2026, HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced $40 million in funding opportunities for eight grant programs that will advance President Trump’s Great American Recovery Initiative by preventing addiction, strengthening the behavioral health workforce, and supporting efforts to address mental illness and prevent suicide.”

From the Food and Drug Administration front,

  • Fox Business reports,
    • “The Food and Drug Administration (FDA) has classified a recall of more than 900 cases of Alfredo sauce at its highest risk level after a supplier recalled a dry milk powder ingredient used in the product due to potential salmonella contamination.
    • The FDA designated the recall as a Class I event, its most serious classification, meaning there is a reasonable probability that use of or exposure to the product could cause serious adverse health consequences or death.
    • The recall affects 913 cases of Alfredo sauce packaged in 3-pound, 7-ounce sealed poly bags and 12 bags per case, according to an FDA enforcement report.
  • STAT News relates,
    • “The Food and Drug Administration on Friday approved teplizumab, a type 1 diabetes drug developed by Sanofi, for children aged 8 and older with stage 3 diabetes. 
    • “The drug was selected to go through a speedy review program launched last year by former FDA Commissioner Marty Makary, but the agency missed its goal date of April 21 to deliver a decision.” * * *
    • “Teplizumab, or Tzield, is a monoclonal antibody that aims to delay the progression of type 1 diabetes. The FDA first approved the drug to delay the onset of stage 3 diabetes in adults, and in children ages 8 and older with stage 2 disease. In April, the FDA expanded that approval to allow children as young as 1 year old to take the medication.
    • “The FDA cleared the drug under the accelerated approval pathway based on the surrogate endpoint of higher C-peptide levels. Sanofi will have to verify and describe clinical benefits for type 1 diabetes patients in follow-up studies.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “On the heels of a legal challenge from CVS, Express Scripts has also sued to challenge Tennessee’s new pharmacy benefit management law.
    • “Under the law, PBMs would be barred from also owning pharmacies in the state. In its complaint, Express Scripts says that policy would not just impact retail pharmacies but would force its parent company, Evernorth, to shutter an Accredo specialty pharmacy center based in Memphis.
    • “Closing that facility, the company said, could cost thousands of jobs. And broadly speaking, the law could lead to pharmacy deserts in rural areas, where more than a third of its residents currently live.
    • “It could also limit access to home delivery services, the PBM said. Express Scripts Pharmacy shipped more than 2 million prescriptions to people in the Volunteer State last year alone.
    • “Other services that could be impacted by the law include fertility pharmacies, through which Express Scripts affiliates supported thousands of Tennesseans, the company said.
    • “Express Scripts argues that “shortsighted law” is unconstitutional and cannot be enforced, according to an announcement.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A relentless measles outbreak in Utah has been spreading for nearly a year, putting the U.S. on a path to losing the measles-elimination status it earned more than two decades ago. 
    • “Fueling the nearly 12-month outbreak: more parents opting not to vaccinate their children for school; infections hitting communities statewide; and lenient public-health policies on quarantining exposed students.
    • “Utah’s streak of 679 cases is the latest and longest-lasting of a series of measles outbreaks in the U.S. since early last year. The Centers for Disease Control and Prevention is in the process of assessing whether any outbreaks lasted more than 12 months, which is a determinant of whether the U.S. would lose its status as a country that eliminated measles as of 2000.
    • “State health officials suspect there has been continuous spread since at least August. Utah’s outbreak has proved trickier to stop than other recent streaks of measles cases.” 
  • Medscape tells us,
    • “In adults with obesity and without diabetes, using GLP-1s vs other antiobesity medications was significantly associated with a decreased risk for osteoporosis, major osteoporotic fractures, degenerative disk disorders, and osteoarthritis.” * * *
    • “GLP-1s are uniquely positioned to achieve sustained weight loss without compromising — and possibly enhancing — bone integrity. They may be particularly suitable for individuals with preexisting risk factors for osteoporosis or degenerative joint disease, in whom other obesity agents may exacerbate skeletal fragility. Incorporating bone health assessment into obesity management may aid in optimizing therapeutic selection and improving comprehensive patient care,” the authors wrote.”
  • Healio informs us,
    • “At 2 years, crinecerfont demonstrated favorable effects on weight, body composition and insulin resistance in adults with classic congenital adrenal hyperplasia, researchers reported at ENDO 2026.
    • “In addition, crinecerfont (Crenessity, Neurocrine Biosciences) was associated with stable or improved bone age progression in children and adolescents with classic congenital adrenal hyperplasia (CAH), according to results from another ENDO 2026 presentation.”
  • and
    • “In patients with obesity, exercise as assessed by wearable-measured activity declined after they initiated GLP-1 receptor agonist therapy, according to findings presented at ENDO 2026.
    • “GLP-1 receptor agonists are now used by millions of adults for weight loss, and we know from prior work that exercise is critical for preserving lean muscle and sustaining long-term weight reduction,” Sajana Maharjan, MD, from the department of internal medicine at HSHS St. John’s Hospital in Springfield, Illinois, told Healio. “What was missing was an objective answer to a basic question: Do patients actually become more active as they lose weight on these drugs? Most prior studies relied on self-reported activity. The NIH All of Us Research Program, which links electronic health records with Fitbit data, gave us a chance to answer that question with wearable-measured activity in the same patients before and after starting therapy.” * * *
    • “Exercise needs to be actively prescribed alongside GLP-1 therapy, not assumed to follow from weight loss,” Maharjan told Healio. “Practically, that means structured exercise counseling at the time of initiation, a strong emphasis on resistance training to protect lean muscle, and physical therapy or pain management referrals for patients with joint or muscle pain. Our findings also suggest that men may need more targeted support, since they showed the steepest declines. Wearables themselves can play a useful role in tracking progress and keeping activity goals in front of patients over time. GLP-1 medications reduce not only fat but also lean muscle mass, which makes maintaining physical activity even more important during treatment. Patients who lose weight without staying active risk losing strength and function alongside the fat loss they came in for.”
  • and
    • “In patients being treated for hypertension, those taking a GLP-1 receptor agonist had higher rates of hypotensive events compared with those not taking one, researchers reported at ENDO 2026.
    • “I began to notice multiple patients in clinic who were started on GLP-1s (by me and others) who were complaining of lightheadedness, dizziness and fainting. They had low blood pressure on my examination,” Micah J. Eimer, MD, associate chief medical officer in the division of cardiology at Northwestern Medicine, told Healio. “Hypotension is the most dreaded potential side effect of treating hypertension and actually far more dangerous. The results were confirmatory to our clinical suspicion.” * * *
    • “Eimer told Healio that “blood pressure needs to be monitored in patients who are taking GLP-1s at the initiation of therapy and during dose escalation. Patients should also be warned about signs of low blood pressure so that they can report them. I am particularly worried about the risk to patients who obtain GLP-1s without direct and ongoing clinical supervision.”
  • The Wall Street Journal point out,
    • “New research indicates the brain can truly multitask by rewiring its circuitry with practice.
    • “A study in the Journal of Cognitive Neuroscience showed participants’ brains could automate tasks by offloading them from the prefrontal cortex to the temporal cortex.
    • “Automation requires extensive repetition, making effortful tasks easier and less attentionally demanding, study co-authors said.”
  • Per Fierce Pharma,
    • “In a plenary session at the 2026 European Hematology Association (EHA) annual meeting in Stockholm, Johnson & Johnson brought to the world stage a reminder of its status as a leading developer of multiple myeloma treatments. 
    • “The company spotlighted results from its MonumenTAL-3 phase 3 study, which added its GPRC5D bispecific antibody, Talvey, to the mainstay melanoma drug Darzalex Faspro in patients with relapsed or refractory multiple myeloma who had tried at least one prior line of therapy. When used with or without Bristol Myers Squibb’s Pomalyst (pomalidomide), the regimen cut the risk of disease progression or death by up to 72% and proved a clinically meaningful reduction of up to 53% in the risk of death compared with standard Darzalex Faspro, Pomalyst and dexamethasone (DPd), J&J said in a June 13 press release. 
    • “The trial showed a progression-free survival rate of up to 81.3% for the Talvey combos after 24 months compared with the standard-of-care regimen’s 51.2%, and an overall survival rate of up to 89.2% compared with 79.1% for DPd.”

From the U.S. healthcare business,

  • The Wall Street Journal reports on the future of healthcare technology.
    • “New scientific advances are poised to shift healthcare toward earlier disease prediction and prevention within the next five to 10 years.
    • “Blood tests, AI tools, and GLP-1 drugs are emerging for early detection and prevention of Alzheimer’s and heart disease.
    • “New therapies aim to regenerate damaged joints for arthritis and detect breast cancer recurrence earlier using circulating tumor DNA.”
  • MedCity News relates,
    • “Ascendiun CEO Paul Markovich recently launched a national policy reform movement called Worthy. During an interview at AHIP 2026, he shared four key policy efforts that Worthy is promoting.
      • “1. Digital health records: Markovich is proposing getting every American a comprehensive, real-time digital health record that can personalize their care. He said this would save over $300 billion in administrative costs throughout the system. Much of the healthcare system is currently run on outdated technology and fax machines.
      • “2. Change the way healthcare is paid for: The healthcare industry needs to transition to paying for outcomes versus the fee-for-service model.
      • “3. Make prescription drugs affordable: The price of pharmaceutical drugs has been growing at levels that aren’t sustainable for the public, Markovich said. He called for efforts to ensure intermediaries aren’t rewarded for selling a higher volume of more expensive drugs.
      • “4. Put the healthcare system on a budget: Markovich is calling for putting healthcare organizations on a budget and implementing financial consequences for missing budget targets. He argued that hospitals, in particular, are paid more to do more, incentivizing them to conduct more tests, scans, keep people overnight, etc. This eventually leads to more inflation. Instead, Markovich proposes reimbursing hospitals a fixed amount on a monthly basis and adjusting it for the risk of the population and the size of the population.”
  • and
    • “Rocket Pharmaceuticals sold its rare disease pediatric priority review voucher for $180 million, cash that the company will use to support a pipeline now led by a gene therapy in development for a rare, inherited disease with no FDA-approved therapies.
    • “Rocket announced the voucher sale on Friday. The Cranbury, New Jersey-based gene therapy developer did not disclose who purchased the voucher, saying only in a regulatory filing that the buyer was “a large pharmaceutical company.”
    • “The FDA awarded the voucher in March alongside the accelerated approval of Rocket’s Kresladi, the first gene therapy for leukocyte-adhesion deficiency type 1 (LAD-1), an inherited immunodeficiency that can become fatal to babies. Such vouchers may be applied to another eligible rare disease therapy, cutting the standard 10-month review down to six months. But vouchers are transferable and many recipients choose to sell them.”
  • A commentator observes in MedCity News,
    • “In the Age of AI, Interoperability Isn’t Enough: Why Healthcare Needs Shared Understanding, Not Just Shared Data.”
    • ‘The industry needs a framework that can translate clinical nuance into a consistent, trusted representation across systems and use cases.” * * *
    • “Today, we rely on localized definitions of quality and accuracy shaped by providers’ current manual coding guidelines, individual workflows, and historical practices. The result is predictable: subjectivity. Agreement on accuracy across coders hovers around 50%, even among experienced and fully certified coders. In that environment, interoperability alone cannot deliver alignment.
    • “What is needed is a layer above interoperability, an objective framework for context and quality that establishes shared understanding. This framework does not eliminate variation; it normalizes it, creating a consistent and trusted output across clinical, operational, and financial use cases.
    • “Also, the framework must be uniformly administered. Acting as a compliance engine, this layer ensures that codes are not only technically correct but appropriate across use cases, clinical, financial, and analytical. When that standard is met, codes become more than billing artifacts; they become a reliable representation of patient history and a consistent entry point into the broader clinical record, regardless of where the data originated. Over time, this reduces friction across the system, including audits, denials that are ultimately reversed, and the burden of prior authorization.”

Friday update

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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