Thursday Report

Congress

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.” 

Weekend Update

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

Simplicity is a virtue.

Happy Summer Solstice.

From Washington, DC,

  • The Coalition against Surprise Medical Billing opines,
    • “When the Congressional Budget Office (CBO) puts out a public call for new research on the cost impacts of the No Surprises Act, it’s the latest signal that the law’s arbitration process, also known as Independent Dispute Resolution (IDR), has veered far off course.
    • ‘In a new blog post, CBO asks for the latest data on inflationary awards and the excessive flood of disputes that have now become standard with IDR. The agency’s takeaway is clear: the data now point to arbitration as a growing threat to the cost savings the law was meant to deliver.
    • “CBO does not mince words about the impact:
    • “Although evidence suggests that prices for services affected by the No Surprises Act may have initially decreased, arbitration outcomes could lead to higher prices over time. If providers can systematically secure large payments through the IDR process, they have an incentive to remain out of network or demand higher in-network rates.”
    • “This is one of the many unintended consequences from IDR abuse and misuse. A handful of private equity-backed providers and IDR middlemen have turned IDR into a profit engine: from 2022 through 2025, 4.8 million disputes were filed — against the roughly 17,000 disputes a year that were originally projected. Providers prevail in roughly 88 percent of cases, and awards routinely run 3-9 times in-network rates, with some specialties receiving upwards of 17 times in-network payments.
    • “And here is the part that has raised alarms for employers and consumers footing the bill. CBO cautions that IDR’s spillover effect has broad cost implications:
    • “Although surveys of insurers suggest that less than 0.05 percent of all claims go to arbitration, those claims could have an outsized effect on bargaining and, over time, cause negotiated prices to increase. An increase in prices would increase premiums for commercial health insurance and, in turn, lead to larger federal deficits.”

From the public health and medical / Rx research front

  • The New York Times reports,
    • “Buildings May Soon Have ‘Immune Systems’ That Fight Airborne Disease.”
      • “Following the pandemic, the federal government is spending $150 million on new technology to ensure clean indoor air. Here’s what scientists are pursuing.”
  • The Wall Street Journal adds,
    • “I Don’t Expect My Grandchildren to Experience Dementia
      • “An Alzheimer’s specialist says science will continue to make great leaps in diagnosing and treating Alzheimer’s. But that’s only part of the battle.” * * *
      • “If I could boil my formula for the future of dementia care into two words, it would be this: Hope heals. Alzheimer’s disease and other forms of dementia are so frightening because they threaten to rob us of the very essence of our history and being. This fear can tilt aging into a dark space, devoid of any good future.
      • “Fortunately, we have entered a new era of disease management in which we know more and can do more, enabling us to implement brain-healthy strategies before symptoms begin and mitigating them after they start. This proactive approach will broaden and improve the span of normal and meaningful living. 
      • “At the same time, we must acknowledge that caring for someone with dementia is extremely challenging and might seem impossible to do it right. The solutions have already been discovered; now they need wider implementation. We have both the opportunity and the responsibility to do better by actively engaging with affected individuals and families in comprehensive ways that will, I am certain, not only improve care but also the very course of this disease. In doing so, we send a powerful message to ourselves and our society about every person’s inherent value. The central goal in this brave new world is to help affected individuals not just survive, but to thrive.”
  • Medscape tells us,
    • “Protein supplements = convenience foods; help meet 1.2-1.6 g/kg/d targets.
    • “Creatine monohydrate: best-studied; 3-5 g/d effective for most adults.
    • “Kidney safety concerns in healthy adults are repeatedly debunked for protein + creatine.
    • “GLP-1 users may need lower protein intake; resistance training remains primary for muscle preservation.
    • “Whey isolate or plant-based leucine-augmented blends can support muscle protein synthesis.”
  • and
    • “According to findings from a phase 2 trial published in Nature Medicine, a monoclonal antibody targeting myostatin reduced lean body mass loss by more than half during treatment with the GLP-1 or glucose-dependent insulinotropic polypeptide receptor agonist tirzepatide, while the overall weight loss remained unchanged.
    • “These findings address a growing concern surrounding obesity pharmacotherapy. Weight loss typically involves a reduction in both fat mass and lean body mass, which includes muscle, bone, connective tissue, and body water. Loss of muscle mass is considered particularly important because of its potential effects on strength, physical performance, and metabolic health.”
  • MedPage Today informs us,
    • “An increasing number of Americans are getting — and surviving — cancer. There were more than 18 million cancer survivors in the U.S. in 2025, and the National Cancer Institute estimates that number will grow to 22 million by 2035. But long after completing treatment, many survivors face lingering mental health challenges that go unaddressed.” * * *
    • Studiesopens in a new tab or window show cancer survivors experience anxiety and depression that can last years after they finish treatment.
    • The advocacy group Cancer Nation surveyed patients nationwide last year. It found that about a third of those who had finished treatment reported anxiety about their cancer potentially coming back, as well as problems with not feeling like their “old self.” Only 1 in 5 of the surveyed survivors reported seeing a mental health professional.

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

  • Modern Healthcare reports,
    • “More procedures are shifting from hospitals to ambulatory surgery centers, and the lower-reimbursement settings are driving demand for surgical robots that are more affordable and more agile. 
    • “Intuitive Surgical remains the dominant player in hospital-based, soft-tissue robotic surgery and is trying to gain a foothold in ambulatory surgery centers. Distalmotion, which announced the first U.S. sale of its Dexter Robotic Surgery System in March 2025, designed the robot with the outpatient setting in mind.” * * *
    • “In an interview, Distalmotion CEO Greg Roche said all the robots it’s sold this year in the U.S. went to ambulatory surgery centers. Dexter’s compact footprint and mobility make it well suited for this environment, he said.”
  • MedTech Dive adds,
    • “‘Putting the body back together’ with MMI’s microsurgery robot
      • “MMI built a robot to help surgeons perform microsurgical procedures with more control than is possible with the human hand alone.”
  • The Health Care Cost Institute relates,
    • “Use of medications for opioid use disorder (MOUD) grew from 2018 to 2022, but fewer than half of people with opioid use disorder and employer-sponsored insurance received MOUD.
    • “Primary care providers prescribed more than 70% of MOUD among people with employer-sponsored insurance.
    • “Fewer than half of patients with employer-sponsored insurance filled enough prescriptions to regularly take MOUD for one year.” * * *
    • “Clinical guidelines say that patients should be on MOUD for at least six months, but experts believe that a year or more of treatment is needed to achieve sustainable recovery from OUD.” * * *
    • “MOUD treatment rates and adherence may be low because of stigma associated with the disease and treatment. Public health campaigns targeted at employed adults may also increase demand for MOUD.”
  • Beckers Payer Issues tells us,
    • ‘Pharmacy benefit managers Abarca Health and LucyRx are merging, the companies said in a June 17 news release.
    • “Together, the organizations will reach 9 million members. The companies will operate as subsidiaries under Healthcare Revolution Partners. The news release said clients and members will not experience disruptions due to the merger.
    • “The transaction is expected to close in the third quarter of 2026.'”
  • Modern Healthcare informs us,
    • “At UnitedHealth Group Inc., artificial intelligence reads aloud summaries of medical charts as nurses drive to patients’ homes. It listens to millions of customer calls to find the causes of complaints. One trial even has AI agents calling doctors’ offices to schedule appointments for patients.
    • “The largest U.S. health insurer plans to invest $3 billion in AI over 2026 and 2027. UnitedHealth executives say they’re seeing a 2-to-1 return, as AI automates cumbersome manual processes and makes workers more efficient. Executives say the technology can reduce friction for patients while lowering costs.
    • “There’s a lot riding on them being right. UnitedHealth put AI at the heart of its turnaround strategy since profits collapsed last year, to drive efficiency and to address customers’ frustrations such as by speeding up care approvals. Wall Street expects it to boost earnings by cutting expenses. Insurers and medical providers together spend $80 billion a year on administrative transactions, Morgan Stanley analysts led by Erin Wright said in a June research note.”
    • “The cost savings potential is clear, particularly for manual, data-intensive processes such as prior authorization,” they said, adding that UnitedHealth will also profit from selling AI products and services to other healthcare companies.
    • “Many healthcare transactions that have long been digitized in other industries still involve phone calls, faxes and paper. An early example UnitedHealth points to is a system called Optum Real that allows medical providers to check in real time whether a service is covered. The system has processed about a billion transactions since it started last year.”

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.”

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.”

Thursday update

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

Simplicity is a virtue.

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

From Washington, DC,

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

From the public health and medical / Rx research front,

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

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

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