Monday report

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 TexasSouth 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.” 

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