Weekend update

CDC

Weekend update

David Ermer–CDC, Congress, Electronic health records, Medical / Rx research, Medicare, SCOTUS, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington DC,

  • The House of Representatives remains in session through July 1 for floor voting and Committee business. The Senate left Capitol Hill last Thursday and will not return until July 13.
  • MedCity News reports,
    • “A group of Democratic senators introduced a new bill on Thursday that would create a $5,000 cap on out-of-pocket costs for traditional Medicare beneficiaries.
    • “The Medicare Cost Cap Act was introduced by Senator Lisa Blunt Rochester (D-Delaware), Senate Finance Committee Ranking Member Ron Wyden (D-Oregon) and Senate Democratic Leader Chuck Schumer (D-New York).
    • “The bill seeks to “level the playing field” between traditional Medicare and Medicare Advantage, which has annual out-of-pocket spending caps (as do employer-sponsored insurance and coverage bought on the marketplace).” 
  • Healio notes,
    • “It has been nearly a year since the U.S. Preventive Services Task Force released new recommendations, and experts remain concerned about its future.
    • “HHS removed the chair and vice chair of USPSTF last month, which came after three task force meetings were canceled under HHS Secretary Robert F. Kennedy Jr.’s tenure.

From the judicial front,

  • Healthcare Finance reports,
    • “CareFirst of Maryland has filed a federal racketeering lawsuit against two former Maryland insurance brokers, alleging they used fake residences, false identities and an international referral network to enroll out-of-state and overseas clients in CareFirst health plans reserved for Maryland residents.
    • “The complaint, filed June 15 in the U.S. District Court for the District of Maryland, names Avraham Rappaport, a former licensed insurance broker based in Olney, Maryland, and his brother Eliezer Rappaport, a financial advisor and former licensed broker. It also names John Does 1-20 as alleged co-conspirators.
    • “CareFirst described itself in the filing as the victim of a “health insurance fraud conspiracy of breathtaking scale and audacity.” The insurer alleges the brothers coordinated an “international insurance-fraud machine” that allowed people who did not live in Maryland to obtain coverage through CareFirst policies intended for state residents.”

From the public health and medical / Rx research front,

  • NPR lets us know “8 things to know about the gut microbiome and keeping yours healthy.”
  • Health Day reports,
    • “A next-generation blood test could improve early detection of the most dangerous forms of prostate cancer.
    • “The major challenge in prostate cancer screening is not just to find more cancer cases, but to identify the cancers that are truly dangerous,” said first author Thorgerdur Palsdottir, a researcher at the Karolinska Institute in Stockholm. 
    • “Our results show that Stockholm3 identifies significantly more aggressive cancer cases than PSA [prostate-specific antigen], without increasing the number of unnecessary follow-ups,” she added in a news release.” * * *
    • “Unlike the standard PSA test, which measures a single blood protein, the Stockholm3 test combines multiple protein and genetic markers with factors like age and family history to better assess the risk of aggressive prostate cancer.
    • “The study — published June 23 in the Annals of Internal Medicine — showed that Stockholm3 detected 90% of prostate cancers, compared with 74% for PSA, without subjecting more men to unnecessary testing.”
  • Medscape relates,
    • GLP-1 receptor agonists (GLP-1 RAs) are associated with reduced incidence of breast cancer among women with overweight or obesity, according to two observational studies.
    • One found that GLP-1 RA users had a roughly 30% lower incidence of breast cancer than was seen in matched nonusers. The smaller of the two, which followed more than 80,000 women at high risk for breast cancer, found a more modest 16% reduction.
    • Using GLP-1 drugs to prevent cancer is “an exciting new frontier that will likely revolutionize the field of oncology, but like any new exciting therapy we need [randomized] clinical trials to understand how to optimally” use them, said Neil M. Iyengar, MD, a breast medical oncologist who was not involved in either study.
  • Cardiovascular Business tells us,
    • “Transcatheter aortic valve replacement (TAVR) is associated with certain early benefits for women not seen with surgical aortic valve replacement (SAVR), according to a new meta-analysis published in JACC: Advances.[1] These benefits were primarily seen in intermediate- and high-risk patients—and they weren’t seen at all when treating men.
    • “As TAVR expands to younger and lower-risk populations, clarifying sex-specific and time-dependent outcomes is critical for individualized valve selection,” wrote first author Hendrianus Hendrianus, MD, a researcher with Chung-Ang University in South Korea, and colleagues.
    • “The group explored data from nine different randomized controlled trials (RCTs) comparing TAVR and SAVR. Studies were required to include sex-stratified outcomes to be counted as part of this meta-analysis. The nine RCTs included more than 9,500 patients with severe aortic stenosis who were randomized to undergo TAVR or SAVR. Approximately 44% of all patients were women. The primary outcomes for these trials were slightly different from one another, but they all included all-cause mortality as a key component.
    • “After one year, TAVR was linked to a 33% relative reduction in the risk of the trial-defined endpoint for women. This was largely driven by improvements for intermediate- and high-risk patients. This trend was not seen in men.” 

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

  • BioPharma Dive reports,
    • “A surge in licensing deals involving drugs from Chinese pharmaceutical firms has triggered alarms in U.S. biotech circles, setting off arguments over what it means for national security and market competition.
    • “Nearly 100 agreements between Chinese and U.S. biotechnology firms have been publicly announced since the start of 2025, according to BioPharma Dive data. Lawmakers on Capitol Hill have signaled intentions to try and disincentivize those investments. Among recent efforts are a push to add the biotechnology sector to the list of industries where investments in China will be scrutinized by U.S. regulators.
    • “The issue featured prominently [last] week at the annual meeting of the Biotechnology Innovation Organization, the industry’s top lobbying group. Multiple panels were geared towards the way licensing deals are affecting the business development landscape and early venture investment. And during a brief meeting with reporters, BIO CEO John Crowley acknowledged the tough spot the U.S. biotech ecosystem is in as well as the pros and cons of Congressional intervention.
    • “Protecting U.S. biotech is a “national security imperative,” and “we need to maintain our lead here,” he said.”  
  • Fierce Healthcare offers a ranked list of the most expensive EHR projects underway in 2026, and relates,
    • “Innovaccer and Amazon Web Services (AWS) signed a multi-year strategic collaboration agreement to help health systems and payers deploy agentic AI solutions at scale. 
    • ‘The collaboration aims to bridge the gap between working AI pilots and deployments that meet security, compliance and scale requirements. Under the agreement, Innovaccer will scale agentic AI workloads using AWS services while expanding its go-to-market through the AWS marketplace.
    • “Innovaccer CEO and co-founder Abhinav Shashank said in a statement AI in healthcare, “has a production problem, not an innovation problem.”
    • “The organizations we work with are not short on ambition,” Shashank said. “What they need is the infrastructure to run AI agents reliably, securely, and at the scale their operations demand. AWS gives us exactly that, and what we bring is a decade of healthcare-native context that makes those agents actually work in the environments health systems and payers operate in every day. This agreement is about closing the gap between what AI can do for healthcare and what healthcare is currently getting from it.”
    • The collaboration also includes co-investment in customer success programs, the companies say.”
  • Health Day tells us,
    • “People are becoming more comfortable communicating with their doctor through clinics’ patient portals.
    • “Folks use the portals to ask their doc questions and even to review the results of recent medical tests.
    • “But there are some matters that still require a face-to-face interaction between doctor and patient, a new study says.
    • “In all, 3 of 4 patients want to hear about a cancer diagnosis directly from their doctor, rather than through a portal message or report, researchers reported June 24 in JAMA Network Open.
    • “While most patients in the general population appreciate rapid electronic access to test results, the situation for patients with cancer is much more nuanced,” lead researcher Dr. Sheena Bhalla said in a news release. She’s a medical oncologist at the Harold C. Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center in Dallas.”
  • Per Medical Economics,
    • “People enjoy healthier lives when their physicians work with community partnerships, sharing the goal of improving social and behavioral factors that treat or worsen chronic disease.
    • “Using Community Partnerships to Inform the Prevention Strategy of the Center for Medicare and Medicaid Innovation” is a new consensus study report published this spring by the National Academies of Sciences, Engineering, and Medicine. Its Standing Committee on Primary Care drafted it as a detailed road map for building effective partnerships between physicians’ practices, health care organizations, and community organizations. The committee examined what makes these partnerships work, where they fail, and what the federal government should do to fund and sustain them at scale. Drawing on real-world models from Massachusetts to Alaska, it delivers three concrete recommendations for the Centers for Medicare & Medicaid Services.
    • “This slideshow summarizes the report’s key findings. All data points come from the report, which is available free online.”

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.”

Monday report

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

Simplicity is a virtue.

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Thursday report

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

Simplicity is a virtue.

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

From Washington, DC.

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

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.”

Tuesday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Wall Street Journal reports,
    • The House [of Representatives] passed a Republican-led $70 billion immigration-enforcement bill Tuesday, ending a monthslong stalemate over the slice of federal spending, and funding the contentious operations through the rest of President Trump’s second term.
    • The bill, which passed 214-212, comes after the Senate narrowly cleared funding for the agencies last week, using a special budget process that allowed Republicans to bypass the 60-vote threshold for most bills. Congress had approved funding for most of the Department of Homeland Security earlier this year, but Democratic opposition had held up money for Immigration and Customs Enforcement and Border Patrol. Trump is expected to sign the measure into law.
  • Healthcare Dive relates,
    • “A key House panel voted unanimously Tuesday to end a pilot program testing prior authorizations in fee-for-service Medicare.
    • “The House Appropriations Committee approved legislative language that would bar the Centers for Medicare and Medicaid Services from spending money to implement the Wasteful and Inappropriate Service Reduction Model, or WISeR, which the agency launched in six states this January. This provision was amended to a bill to fund the Health and Human Services Department in fiscal 2027, which the panel is still considering.”
    • Providers have blasted WISeR, a six-year demonstration that is partly reliant on artificial intelligence and is being managed by technology companies. 
    • The HHS appropriations bill must clear more hurdles, including advancing out of committee, passing the House and being reconciled with the Senate’s pending version of the spending package, before the WISeR provisions would become law.
  • Govexec tells us,
    • “Rep. Raja Krishnamoorthi, D-Ill., on Tuesday said the Trump administration’s recently unveiled plan to make federal employees sign a non-disclosure agreement “threatens” the federal workforce’s constitutional rights and creates a chilling effect on would-be whistleblowers and demanded information into how it was developed.
    • “Last month, the Office of Personnel Management formally proposed requiring all federal employees to sign NDAs barring them from divulging “confidential” information in most cases, prompting swift outcry from civil service groups and employment lawyers. A draft copy of the document bars signatories from disclosing information related to internal agency operations, personnel and procurement matters and “any sensitive, pre-decisional or deliberative material.”
    • “In a letter to OPM Director Scott Kupor, the Illinois Democrat criticized the proposal as “over-broad” and likely to make it more difficult for whistleblowers to divulge allegations of waste, fraud and abuse.” * * *
    • “The Democrat demanded information on OPM’s legal analysis of whether the proposed NDA comports with the First Amendment and the Whistleblower Protection Act, a definition of “confidential” for the purposes of the document, as well as any potential consequences federal employees who refuse to sign the agreement would face, and whether it would apply equally to both career employees and political appointees.”
  • Federal News Network discusses “OPM[‘s] details [about] changes for federal employees in Schedule Policy/Career.”
    • “As agencies gear up for implementation, OPM detailed what Schedule Policy/Career will mean for recruitment, adverse actions and other personnel policies.” * * *
    • “Implementation instructions for agencies on Schedule Policy/Career are now available in guidance that the Office of Personnel Management published Monday.” 
  • The Government Accountability Office issued a report titled “Federal Workforce: Executive Actions Reshaped Probationary Employment Rules and Reduced Staff Levels at Selected Agencies.”
    • “Since January 2025, in response to presidential directives and accompanying Office of Personnel Management (OPM) guidance, many federal agencies have taken steps to reduce their probationary and trial employee staffing levels. These are employees who have not yet completed the service requirements necessary to finalize their appointments, either after being newly hired or after being appointed as a supervisor or manager. Probationary periods are generally 1 or 2 years during which probationary and trial employees have limited job protections.” * * *
    • “GAO’s analysis of OPM’s Federal Workforce Data (FWD) found that, in 2025, probationary employees separated from 11 selected agencies at a slightly higher rate (19 percent) compared to all employees who separated from these agencies (15 percent). Over two-thirds of these separating probationary employees did so voluntarily as did all employees who separated from these agencies.
    • “Across most selected agencies in 2025, a greater proportion of probationary employees separated compared to all employees who separated. At the Department of Energy, for instance, about 34 percent of probationary employees separated, compared with 19 percent of all employees. The Department of Defense recorded the largest number of probationary separations—about 20,000 employees—but separation rates for probationary employees and the overall Defense workforce were nearly identical, at about 14 percent.”
  • The Wall Street Journal lets us know,
    • “Social Security is expected to deplete the fund that helps pay out retirement benefits by late 2032, the program’s trustees said Tuesday.
    • “That is earlier than their projection last year of 2033, partly because the fund expects to collect less revenue after President Trump’s new tax law. Passed last summer, the law gave senior citizens an extra deduction that reduced taxes on benefits for many Social Security recipients. 
    • “Revenues are also shrinking because declining fertility rates and immigration are reducing tax revenue by cutting the number of workers paying into the system, according to the trustees.
    • “The trustees reduced their long-term expectations for fertility rates on Tuesday, indicating they will remain lower for longer than previously projected.” * * *
    • “Unless Congress shores up the retirement program, the depletion of reserves would trigger a 22% reduction in benefits in late 2032. Because incoming payroll tax revenue doesn’t fully cover promised benefits, the program is forced to make up the difference by pulling money from its two Social Security trust funds—one for disability benefits and the other for the larger program for retirees.
    • Congress could temporarily use money from the disability trust fund to prop up the retirement fund. But that is a short-term solution because on a combined basis, the two funds are projected to become insolvent in the third quarter of 2034, according to the trustees.” * * *
    • “To shore up the system, lawmakers could borrow more, raise taxes, reduce benefits or reach an agreement that combines those measures.”
  • Fierce Healthcare points out,
    • “More than 500 hospitals falling short on price transparency requirements have received warnings from the federal government since April, with more “likely” to receive similar notices soon, the AP reported Tuesday morning. 
    • “The outlet’s report cited an unnamed “senior administration official” who shared a list of 519 nationwide hospitals that recently received either a warning notice or a Corrective Action Plan (CAP) request. 
    • “The former is an initial 90-day warning from the Centers for Medicare and Medicaid Services with instructions to correct any deficiencies, while the latter is a subsequent 45-day deadline for a hospital to submit a more concrete plan to address its compliance deficiencies. 
    • “For hospitals that do not come into compliance following these, CMS issues a civil monetary penalty that scales with bed count. These can run as high as $5,500 per day, or over $2 million per year. Twenty-eight hospitals have been issued civil monetary penalty notices to date, according to CMS.
    • “Among the list of warned hospitals obtained by the AP, Texas led other states with 42 notified facilities, followed by 38 in California, 34 in Indiana and 27 in Louisiana.” 
  • The American Hospital Association News notes,
    • “The Department of Health and Human Services June 8 released a request for information on research, policy and strategies to improve addiction and mental illness prevention, treatment and recovery. HHS said it it seeks to identify successful initiatives, recommend novel policy ideas and address research gaps. Comments are due to HHS by July 5.”

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency’s efforts to advance sunscreen innovation. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
    • ““As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy, Jr. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
    • “FDA finalized this action within seven months of issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.
    • “Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for an updated version of its Nellcor pulse oximetry system.
    • “The 510(k) clearance, which Medtronic disclosed Monday, covers a device with a new processor designed to support more consistent and reliable results across diverse skin tones. 
    • “Concerns about the accuracy of pulse oximeters in people with darker skin pigmentation led the FDA to publish draft guidance on the devices last year.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “[M]illions of Americans [suffer] with cardiovascular-kidney-metabolic syndrome, a disorder defined in 2023 by the American Heart Association. It describes a cluster of conditions—heart disease, diabetes, kidney disease—that have common risk factors and fuel one another. Long treated as isolated or individual diseases, the conditions are interrelated, usually tied to excess abdominal fat, and a major driver of heart disease, according to the AHA.
    • “On Tuesday, the AHA and three other medical societies published the first guidelines to help clinicians prevent and manage CKM, as it is called, urging them to focus on their patients’ overall metabolic health. The goal is to prevent or slow the progression of conditions that may ultimately lead to heart attacks and strokes, which are becoming more common in younger adults.
    • “The new guidelines call for doctors—from primary care to cardiology—to screen patients for metabolic risk factors and kidney function routinely. Risk from excess fat should be measured both by body-mass index (BMI) and waist circumference, according to the new guidelines, which were developed by the AHA and the American College of Cardiology with the American Diabetes Association and American Society of Nephrology.
    • “In the 1970s, smoking, high blood pressure and cholesterol were the classic risk factors for heart disease, said Dr. Chiadi Ndumele, chair of the committee that wrote the new guideline and a preventive cardiologist at Johns Hopkins University School of Medicine. Today, excess abdominal fat is a major risk factor because it can trigger chronic inflammation that damages arteries, cardiac tissue and kidneys, he said.”
  • The New York Times relates,
    • “A government alcohol study published on Tuesday concluded that the health risks of alcohol start at a single drink a day. The report was caught up in controversy after drawing the ire of the alcohol industry.
    • “At one drink a day, the researchers found, there was an increased risk of premature death from an illness or injury directly attributable to alcohol, though it was small — one in 1,000 people. But the risk of premature death jumped to one in 25 for those who had two drinks a day, a level long considered safe for men, according to the study, which was published in the Journal of Studies on Alcohol and Drugs.
    • “The Alcohol Intake and Health Study was one of two reports commissioned during the Biden administration to inform an update to the U.S. dietary guidelines.
    • “The second report, from a panel appointed by the National Academies of Sciences, Engineering and Medicine, or NASEM, came to very different conclusions. It suggested that moderate drinking (up to two drinks a day for men and one for women) was healthier than not drinking at all, although it noted that moderate drinking was also linked to a higher breast cancer risk. Some of the panelists behind that report had financial ties to the alcohol industry.”
    • * * * “One reason the studies reached such different conclusions is that while the new study examined deaths from causes directly attributable to alcohol, the NASEM report commissioned by Congress looked at overall death rates of moderate drinkers, including deaths not causally related to alcohol.
    • “Critics of the NASEM report say that people who drink in moderation often have other healthy lifestyle habits that contribute to their longevity. The moderate drinking group also included many people who consumed less than two drinks a day. Both of these factors could make the health effects of moderate drinking look less significant than they might be.
    • “Dr. Ned Calonge, an epidemiologist at the University of Colorado Anschutz Medical Campus who led the NASEM study, said he stood by its conclusions.
    • “Alcohol research is complex and I am not surprised by different methods producing different results,” Dr. Calonge said, adding that modeling studies like the Alcohol Intake and Health Study, which use data to estimate the lifetime risk of diseases and deaths caused by alcohol, also come with potential biases.
    • “At the same time, he added “I don’t believe anyone should start drinking for health reasons.”
  • and
    • “The U.S. Department of Agriculture announced three new cases of New World screwworm, including the first cases in dogs and goats, on Monday, bringing the nation’s total case count to five. It also pledged to ramp up and expedite mitigation efforts for screwworm, a parasitic fly that the nation declared eradicated in the 1960s.
    • “At a news briefing on Monday, federal and Texas state officials said that they were using technology driven by artificial intelligence to monitor screwworm populations, training ranchers to recognize infections in their livestock and expanding the number of facilities that produce and disperse sterile flies, which are the primary tool for managing screwworm.
    • “Officials are also considering whether to grant an emergency authorization of a new, genetically engineered strain of flies that could make sterile fly production faster and more efficient.
    • “We prevented and eradicated this pest before,” Gov. Greg Abbott, Republican of Texas, said during the briefing. “We can do it again.” * * *
    • “The New World screwworm is a blowfly that feeds on living flesh. Adult females lay their eggs in open wounds or orifices of warm-blooded animals. When the eggs hatch, the larvae burrow into the wound, consuming the animal’s tissue. Untreated, screwworm infections can kill animals within a week.
    • “In humans, screwworm infections are rare. Last year, American health officials confirmed a travel-related case in a Maryland resident who had recently traveled to El Salvador, but no domestically acquired human cases have been reported yet.”
  • Health Day adds,
    •  There’s a biological reason why booze makes a person crave bar snacks like chips, nuts, fries and pizza, a new study argues.
    • Alcohol appears to trigger a hormone associated with cravings for savory flavors, researchers reported recently in the journal Obesity Reviews.
    • This hormone, FGF21, is linked to protein appetite and, when activated, can shift cravings toward salty, umami-flavored foods, researchers found.
    • “Many people will recognize the experience of having a few drinks and suddenly craving something salty, like chips, French fries, pizza or other savory foods,” said lead researcher Amanda Grech, a research associate at the University of Sydney’s Charles Perkins Center.
    • “Now we have a better understanding of the hormonal dynamic at play, which may be driving overconsumption of ultra-processed foods,” Grech said in a news release.
  • Cigna Healthcare, writing in LinkedIn, discusses “Men’s Mental Health Awareness Month [meaning this month]: Making Room for What Men Carry—At Work and Beyond.”
    • “Men’s Mental Health Awareness Month is an invitation to redefine strength as something sustainable: self-awareness, early help-seeking, and staying connected under pressure. In any workplace, the most meaningful shift isn’t a grand statement—it’s a steady message, reinforced over time, that dignity comes first and support is not something you have to earn. When men are met with respect, privacy, and real permission to be human, it becomes easier to speak earlier, connect more honestly, and get care before strain becomes a crisis.”
  • MedPage Today tells us,
    • “While the American Academy of Pediatrics now recommends introducing certain allergenic foods by ages 4-6 months for all children, guidelines from the 1990s and 2000s had recommended delaying introduction until 1-3 years.
    • “As the proportion of infants introduced to egg by 6 months of age increased from 2007-2011 to 2018-2019, egg allergy prevalence adjusted for changes in known allergy risk factors fell from 9.2% to 7.6%.
    • “Infants with early-onset eczema saw the biggest impact, with egg allergy prevalence decreasing from 34.6% to 21.9%.”
  • and
    • “Respiratory tract infections (RTIs) continue to be a substantial cause of mortality in children under 5 and contribute to morbidity, hospitalizations, and healthcare costs.
    • “Nearly one in four of the current study’s hospitalized pediatric patients with acute RTIs developed severe disease.
    • “Increased risk was highest in kids with two or more underlying conditions or who were transferred from a referring hospital.”
  • The National Institutes of Health’s Reseach in Context considers “Understanding the exposome.”
    • “Tracking how the environment affects health
    • “The world around us influences our health in countless ways. This special Research in Context feature explores how scientists are using new technologies and approaches to measure the exposome—the total set of environmental exposures people encounter throughout life and their biological response to them.
  • Genetic Engineering and Biotechnology News points out,
    • “When Jingkun Zeng, PhD, joined the lab of Nobel laureate, Jennifer Doudna, PhD, as a postdoctoral researcher in 2024, he was not interested in applying CRISPR for gene editing. 
    • “The molecular scissors had demonstrated extraordinary clinical promise in correcting single-point mutations, most strikingly in Baby KJ’s case, where a rare metabolic disorder once presented a 50% mortality rate in infancy. 
    • “Yet, Zeng had his ambitious sights on stopping cancer progression, where the biology “became messy.” Cancer can be driven by hundreds of thousands of mutations, making it nearly impossible to correct each mutation one-by-one to restore healthy function. 
    • “Zeng, who completed his PhD training in cancer evolution at The Francis Crick Institute, aimed to develop new CRISPR-based technology that could therapeutically access the undruggable tumor suppressor protein, p53. Mutations in this “guardian of the genome” are found in nearly half of all cancers, and up to 70–90% of cases of the most deadly tumors, including ovarian, pancreatic, and non-small cell lung cancer. 
    • “In a new study published in Nature titled, “Targeting Cancer-Specific Mutations with RNA-Triggered Chromatin Shredding,” Zeng and colleagues from Innovative Genomics Institute (IGI), University of California (UC) Berkeley, UC San Francisco (UCSF), and Gladstone Institutes, have now engineered a CRISPR system to selectively trigger cancer cell death by chromatin shredding.  
    • “The approach recognizes cancer cells using the RNA-guided nuclease, CRISPR-Cas12a2, to recognizemutant p53 mRNA transcripts. Therapeutic effectiveness was demonstrated in mouse models of lung and liver tumors.” 
  • Per Fierce Pharma,
    • “A combination of Merck’s islatravir and Gilead’s lenacapavir has succeeded in two phase 3 trials and is in line to become the first long-acting oral HIV treatment that can be taken weekly.
    • “Both trials of the combination regimen—which includes a 2 mg dose of islatravir and a 300 mg dose of lenacapavir—included people with HIV who are virologically suppressed and both achieved their primary efficacy endpoint. 
    • “In the Islend-1 study, the combo showed its non-inferiority in those who had switched off Gilead’s once-daily pill Biktarvy. In Islend-2, the combo measured up in those who had switched off standard-of-care antiretroviral regimens. No new safety concerns were identified in either study.”
  • and
    • “Following another phase 3 failure for Gilead Sciences’ Trodelvy, the race to bring a TROP2 antibody-drug conjugate (ADC) to patients with first-line non-small cell lung cancer (NSCLC) has narrowed. 
    • “Monday, Merck & Co. and Gilead announced that they are pulling the plug on the phase 3 Evoke-03 trial, also known as Keynote-D46, following the recommendation of an external data monitoring committee. 
    • “The study was evaluating Trodelvy, combined with Keytruda, as a first-line treatment in patients with PD-L1-high NSCLC versus Keytruda alone.” * * *
    • “Without a win in first-line NSCLC, Trodelvy’s commercial future will mainly depend on its triple-negative breast cancer uses, which won’t be able to justify the $21 billion price tag that Gilead paid for the med’s developer, Immunomedics. Gilead already took major write-offs tied to Trodelvy’s second-line NSCLC failure and a market withdrawal in bladder cancer in 2024.”

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

  • Fierce Healthcare reports,
    • “Health insurance executives convene this week in Las Vegas at a time when the industry is facing significant pressure on cost, access and policy changes.
    • “AHIP’s annual conference kicks off Tuesday morning, with two days of sessions and discussions that center on the major challenges facing insurers today, from new technologies to consumer engagement to rising medical costs.
    • “Fierce Healthcare will be on-site this week to provide key insights from the show floor, but before the conference opens, [the article offers] a look at some of the biggest themes to watch on the agenda.”
  • Beckers Hospital Review relates,
    • “Springfield, Mass.-based Baystate Health is planning to acquire a financially challenged hospital in the city from Hartford, Conn.-based Trinity Health of New England for $293 million through a member substitution valued at $293 million. 
    • “Baystate signed a definitive agreement in April to acquire Mercy Medical Center, a 182-bed acute care hospital, as well as Mercy’s joint ventures and affiliated medical groups from Trinity Health of New England, which is part of Livonia, Mich.-based Trinity Health. 
    • “As part of the regulatory approval process, Baystate is required to get a determination of need from the Massachusetts Department of Public Health. According to a filing with the department, MMC has experienced “significant and continued operating losses in recent years.”
  • and
    • “The American Medical Association’s House of Delegates voted to formally oppose use of the term “provider” when referring to physicians, adopting the new policy at its Annual Meeting in Chicago this week.
    • “The vote builds on existing AMA policy that already calls on healthcare entities to specify the type of clinician — using their recognized title and credentials — when using the term “provider” in contracts, advertising and other communications. It also directed AMA to prohibit use of the term in its own publications.
    • “The new policy goes further, directing the AMA to actively oppose the term when it encompasses physicians and to implement the existing policy’s external advocacy provisions, which had not yet been fully advanced.
    • “The AMA argues that the term “provider” undermines patient education, transparency and physician professionalism, and poses risks to patient safety by obscuring the distinctions among clinician types and their training, according to a June 9 news release.”
  • Radiology Business adds,
    • “The radiologist shortage is real, but it may be smaller and more local than previous reports might indicate, according to new research. 
    • “About 47% of “open” radiologist jobs are reposts of the same role. However, the “real shortage” appears to be “concentrated and stubborn,” according to an analysis shared by RadBoard, an artificial intelligence-powered platform for researching jobs in the specialty. 
    • ‘Approximately 1,470 of active radiologist openings have been sitting unfilled for over two months or more. 
    • “Most aren’t underpaid—they’re geographically inconvenient,” writes report author Kirill Lopatin, founder and CEO of xAID, which offers AI solutions to radiology groups.” 
  • The Wall Street Journal tells us,
    • GSK GSK [symbol]  agreed to buy U.S. cancer-drug developer Nuvalent NUVL for $10.6 billion, the British pharmaceutical company’s latest move to bolster its oncology business.
    • The acquisition is set to give GSK two drug candidates for lung cancer that are currently under review by the U.S. Food and Drug Administration as well as a third, earlier-stage medicine, the London-based company said Tuesday.
    • The deal comes as GSK works to rebuild its position in the market for cancer treatments, one of the most lucrative areas of the pharmaceuticals industry. GSK exited oncology in 2015 as part of a broader asset-swap deal with Switzerland’s Novartis. The company has since returned to the market with the acquisitions of Tesaro, Sierra Oncology and IDRx as well as licensing deals.
    • “Our strategy has been a brick-by-brick building approach,” GSK Chief Executive Luke Miels said, adding that the company would continue to look for further opportunities.
  • STAT News informs us,
    • “The number of prescription drug shortages in the U.S. fell by 23% last year, marking the second consecutive year of declines and the lowest level since 2017, according to a new analysis that otherwise found troubling signs about medicines that are in short supply.
    • “For instance, the average drug shortage lasted 5.3 years, exceeding the 4.3 years seen in 2024 and greatly outpacing the average two-year shortage experienced in 2019. Moreover, nearly two-thirds of out-of-stock medicines were in short supply for more than three years, and 39% were unavailable for more than five years.
    • “Meanwhile, the 75 drugs that were in short supply last year spanned 130 therapeutic categories, indicating that shortages affected a wide range of diseases and patient populations, according to the analysis by U.S. Pharmacopeia, an independent organization that develops standards for medicines.”
    • “At first glance, the numbers do appear conflicting and suggest some progress, but the overall trends are troubling, said Matthew Christian, director of supply chain insights at the organization. “The problems we have are systemic. They are not resolved and they are not new. They’re old and not going away.”
  • A commentator in Healthcare IT Today explains “The Emerging Role of AI Platforms in Healthcare Delivery: What Healthcare Leaders Need to Know.”
    • “With the launch of ChatGPT Health and Claude for Healthcare, AI has moved from the margins of healthcare IT to its center. It will define how patients engage with care and how clinicians deliver it.
    • “Participation is inevitable. Leadership is not. Organizations that act now will shape the future of care. Those that wait will inherit it.”
  • Fierce Healthcare adds,
    • “More than one-third of clinicians say artificial intelligence use is allowing them to see more patients, with a median of five additional patients per week, a new report from Philips found.
    • “The Future Health Index 2026 (PDF) drew insights from more than 2,000 healthcare professionals and more than 20,000 patients across 10 countries. 
    • “Nearly three-quarters (74%) of clinicians say their use of AI-enabled tools provided by their organization has increased over the past year. Among surveyed clinicians, 52% are using AI to transcribe clinical notes and close to half (46%) are using generative AI as a professional “buddy” to discuss work-related ideas. AI use is also growing for clinical decision support as 45% use AI tools to suggest diagnoses based on patient symptoms and 44% use AI-enabled tools to flag potential dangerous drug combinations.”
  • Per MedTech Dive,
    • “Research shared by Dexcom at the American Diabetes Association’s Scientific Sessions last weekend showed that people who have Type 2 diabetes but don’t take insulin could still benefit from wearing a glucose sensor.
    • “Dexcom telegraphed the study results ahead of the conference in a May earnings call, with CEO Jake Leach saying he expected the results could support a Medicare coverage decision “between now and the end of this year.”
    • “Thomas Martens, a medical director at the International Diabetes Center in Minneapolis and co-author of the study, said the research was intended to answer the question of whether continuous glucose monitors, or CGMs, can improve diabetes management for people who don’t take insulin. The study was funded by Dexcom.” * * *
    • “People who used the CGM had an average hemoglobin A1C reduction of 1.6% from the baseline level of 8.8%. The result was a 0.9% greater A1C reduction than the control group, which Martens said was “striking.” 
    • “People who used the CGM also had better time in range, a measure of how much time during the day a person stays within a target blood glucose range. The Dexcom G7 users had a 62% time in range compared with 41% in the control group.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, Telehealth, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Appropriations Committee June 4 released the fiscal year 2027 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies. The bill provides a total discretionary allocation of $189.3 billion. HHS is provided with $110.8 billion, which is $4 billion, or 4%, below the FY 2026 enacted level. The bill provides support for rural health, primary care, workforce, behavioral health and other programs. The appropriations subcommittee approved the bill today on a party-line basis, and additional details are expected to be released before a full committee markup currently scheduled for June 9.” 
  • Beckers Payers Issues relates
    • “CMS has logged nearly 40,000 complaints alleging potential violations of federal health insurance law since the agency began tracking them in 2022, with the vast majority of closed complaints related to the No Surprises Act, according to an enforcement report covering data through December 2025.
    • “The report tracked complaints under Title XXVII of the Public Health Service Act, which includes the NSA, Mental Health Parity and Addiction Equity Act, and ACA compliance. 
    • “The agency closed 15,145 complaints in total, which were defined broadly to include stakeholder feedback, congressional and state referrals, No Surprises Help Desk submissions, and news articles. Of those, 2,086 were closed with a violation found and 7,838 with no violation found; the remainder were duplicates or withdrawals. Complaints referred to other agencies were not included in the data.”
  • FedSmith tells us,
    • “The average federal employee salary has reached a record high, exceeding $112,000 for the first time according to data from the Office of Personnel Management. For critics, that figure may confirm a long-held belief that government employees are overpaid. For supporters of federal employees, it reflects the reality of an aging, highly educated workforce that performs increasingly complex work.” * * *
    • “The average federal employee salary has reached a record high, exceeding $112,000 for the first time according to data from the Office of Personnel Management. For critics, that figure may confirm a long-held belief that government employees are overpaid. For supporters of federal employees, it reflects the reality of an aging, highly educated workforce that performs increasingly complex work.”
  • KFF informs us
    • Three new KFF analyses examine the latest data about Medicare Advantage, including trends in enrollment, premiums, out-of-pocket limits, supplemental benefits and prior authorization.
    • The first analysis, focusing on enrollment trends, finds that 55% of eligible Medicare beneficiaries are enrolled in Medicare Advantage in 2026, though the pace of enrollment growth continued to slow. Nearly one quarter (23%) of Medicare Advantage enrollees are in special needs plans (SNPs), which limit enrollment to beneficiaries with specialized health needs or who are eligible for both Medicare and Medicaid. Most (85%) of the net increase in Medicare Advantage enrollment between 2025 and 2026 across all plan types was among SNPs. Medicare Advantage enrollment remains highly concentrated, with UnitedHealth Group leading the market, and, together with Humana, accounting for nearly half (46%) of all Medicare Advantage enrollees nationwide, the same as last year.
    • A companion analysis finds that three quarters (75%) of enrollees in individual Medicare Advantage plans with prescription drug coverage pay no premium other than the Medicare Part B premium, a selling point for enrollees. Nearly a third of enrollees (31%) are in plans that also reduce the Part B premium. Nearly all Medicare Advantage enrollees (99%) are in plans that require prior authorization for some services. Most Medicare Advantage enrollees are in plans that offer supplemental benefits not covered by traditional Medicare, such as vision, hearing and dental. Access to those three benefits remained stable, though there were decreases in the share of enrollees in plans providing other benefits, such as over-the-counter benefits, meals, and transportation.
    • Also recently available is a KFF analysis with a more detailed examination of out-of-pocket limits in Medicare Advantage plans in 2026, including variation by plan type, the distribution of enrollees facing different out-of-pocket limits, and trends over time.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration launched a safety study of the abortion pill mifepristone, potentially leading to restrictions on its distribution.
    • “The FDA study, using existing drug-safety systems, is expected to take six months and aims to withstand legal criticism.
    • “Antiabortion advocates target mifepristone’s mail and telehealth distribution rules; 65% of U.S. abortions use the pill.”
  • Fierce Pharma relates,
    • “Three times as many deaths in the study arm versus the control arm in a trial of ADC Therapeutics’ Zynlonta have raised questions about the antibody-drug conjugate (ADC), which has been on the market since the FDA granted it accelerated approval in 2021.
    • “In the phase 3 LOTIS-5 trial, which included 440 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), there were 27 deaths (13.2%) in the study arm compared to nine (4.6%) in the control group. Zynlonta was paired with Roche’s monoclonal antibody Rituxan, while those in the control arm received Rituxan plus the chemotherapies gemcitabine and oxaliplatin.
    • “Most of the deaths in the treatment arm were among patients age 75 and older and were due to infections, ADC execs said on a conference call on Wednesday. The company added that the higher rate could also be chalked up to extended monitoring of patients in the treatment arm as opposed to those in the control arm.”
  • Healio tells us,
    • “The FDA has approved a label expansion for the interleukin-23 inhibitor guselkumab to include the inhibition of structural joint damage progression in adults with psoriatic arthritis.
    • “The label update follows data from the APEX trial, in which guselkumab (Tremfya, Janssen) yielded significantly lower rates of radiographic progression compared with placebo at 24 weeks. The analysis, which was published by Philip J. Mease, MD, of Swedish Medical Center and the University of Washington, and colleagues in the Annals of the Rheumatic Diseases in December, included more than 1,000 biologic-naïve adults with active PsA.”

From the judicial front,

  • Per a Justice Department news release,
    • “The Justice Department’s National Fraud Enforcement Division today [June 4] announced that its Health Care Fraud Unit, one of the most active white-collar litigating components across the Department, secured federal jury trial convictions in six trials in just under three weeks. The convictions in six trials between May 13 and June 1 spanned federal courtrooms across the United States, including in Fort Lauderdale, Los Angeles, Detroit, New York and Nashville.
    • “Six trial convictions in under three weeks ties the Health Care Fraud Unit record for number of trials to result in a conviction in a single month period. The cases behind these recent convictions, however, represent a greater level of sophistication and complexity: more than $1.1 billion in fraud losses across six distinct schemes, including a digital health platform that industrialized Medicare fraud at national scale, a proactive data-driven prosecution of a physician who out-billed every other Medicare provider in the country for Botox, and prosecutions requiring simultaneous command of health care data analytics, financial forensics, sophisticated digital evidence, and expert testimony. These results reflect not merely the volume of trials but the caliber of the Fraud Division’s trial practice that carried each one of them to conviction. The Health Care Fraud Unit has completed nine trials to date in 2026 (all of which have resulted in convictions) and 17 trials in 2025, maintaining an extraordinary pace of white-collar trial activity.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “As of June 5, 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 virus (PIV) is elevated nationally. Human metapneumovirus (HMPV) and Rhinovirus/enterovirus (RV/EV) activities are elevated nationally but are beginning to decrease. CDC data show these trends are expected for this time of year. HMPV, PIV, and RV/EV are like other viruses that cause respiratory infections, including cough, fever, nasal congestion, and shortness of breath. Severe infection due to HMPV, PIV or RV/EV may progress to bronchitis or pneumonia. There are no vaccines available for these illnesses. Prevention measures include hand washing, cleaning surfaces, and staying home when sick.”
  • The Hill reports,
    • “The number of U.S. measles cases in 2026 has now exceeded 2,000, quickly approaching the full annual total of last year.
    • “As of June 4, the Centers for Disease Control and Prevention (CDC) has confirmed 2,030 cases so far this year, with 93 percent — or 1,890 cases — associated with outbreaks. Throughout all of 2025, the CDC confirmed 2,288 measles cases. Thirty new measles outbreaks have been confirmed this year.”
  • STAT News relates,
    • “Americans who have high-risk exposures to Ebola in the current outbreak in Central Africa will have access to an antibody treatment that has shown great promise in animal testing but hasn’t yet undergone a clinical trial to show whether it is efficacious in people, the Department of Health and Human Services confirmed Thursday.
    • “The antibody treatment, known as MBP-134, is made by San Diego-based Mapp Biopharmaceuticals, with funding from the Biomedical Advanced Research and Development Authority, an agency within HHS that helps develop medical countermeasures for rare and emerging diseases, and biological threats.
    • “It is not clear how many doses of MBP-134 exist at present. STAT asked the company and was told Mapp Bio could not reveal the number because BARDA owned the doses.
    • “An American doctor who contracted Ebola in the outbreak zone was flown last month to Germany for care; his wife, also a doctor, and their four children were also taken to Germany for quarantine. The ill physician, Peter Stafford, remains in care but is reportedly recovering. Another doctor from the same Christian missionary group who had what was considered a high-risk exposure is in quarantine in the Czech Republic; he remains healthy. There are currently no other known exposures among Americans.
    • “An expert panel advising the World Health Organization on possible therapeutics that could be tested or used in this outbreak — occurring in the northeastern part of the Democratic Republic of the Congo and neighboring Uganda — deemed MBP-134 one of the products to be prioritized for testing.”
  • Health Day tells us,
    • “The age-adjusted Parkinson disease death rate among adults aged 65 years and older declined from 2021 to 2024, according to a June 4 data brief published by the National Center for Health Statistics.
    • “Ellen A. Kramarow, Ph.D., from the National Center for Health Statistics in Hyattsville, Maryland, and colleagues used data from the National Vital Statistics System to examine trends in Parkinson disease mortality among adults aged 65 years and older in the United States.
    • “The researchers found that for adults aged 65 years and older, the age-adjusted Parkinson disease death rate was 72.0 deaths per 100,000 standard population in 2024. From 2014 through 2021, there was an increase in Parkinson disease death rates, from 57.2 to 76.3, followed by a decline, with the rate lower in 2024 than in 2021. Higher Parkinson disease death rates were seen for men than women in each age group (65 to 74, 75 to 84, and 85 years and older) in 2024. Compared with other race and Hispanic origin groups, White non-Hispanic adults had the highest death rates from Parkinson disease. There was variation seen in Parkinson disease death rates by state of residence, ranging from 47.7 to 102.1 in New York and Utah, respectively.”
  • and
    • “Rurality is associated with worse epilepsy outcomes, although the associations are attenuated among privately insured patients, according to a study published online June 3 in Neurology.
    • “Edward R. Bader, M.B., Ch.B., from the Albert Einstein College of Medicine in Bronx, New York, and colleagues conducted a retrospective cohort study using the National Inpatient Sample for 2016 to 2021 to examine the association between rurality and epilepsy outcomes.” * * *
    • “The reduction in disparities among people with private insurance suggests that there may be other factors, not just where someone lives, that could be contributing to these differences,” Bader said in a statement. “Our study highlights the need for additional research and public health efforts aimed at improving access to epilepsy care for people living in rural areas, which might include the expansion of telehealth services.”
  • MedPage Today informs us,
    • “A study of women undergoing breast imaging showed a significantly lower incidence of breast cancer in those who had a history of treatment with GLP-1 agonists.
    • “Involving more than 30,000 women, the study showed an overall breast cancer rate of 1.97%, including 1.62% in patients who received GLP-1 agonists for overweight or obesity and 2.31% in those who did not. The difference represented a 30% lower risk of breast cancer in the GLP-1 group.
    • “The findings, combined with multiple other studies, have provided impetus for a prospective clinical trial of GLP-1 drugs to prevent breast cancer, reported Elizabeth S. McDonald, MD, PhD, of Penn Medicine and Abramson Cancer Center in Philadelphia, at the American Society of Clinical Oncology (ASCO) meeting.
    • “Observational data cannot establish a causal relationship,” said McDonald. “We are seeing signals at this meeting in multiple cancers — colon, lung, liver, leukemia, endometrial, multiple myeloma — for decreased progression to metastatic disease, decreased recurrence, decreased incidence, and increased survival. The time is now to invest in a clinical trial to see if these drugs are causal for cancer prevention.”
  • Medscape points out,
    • “Patients discontinuing GLP-1 treatments often regain weight rapidly, but emerging strategies like endoscopic procedures and new oral medications show promise in maintaining weight loss. These alternatives may offer cost-effective, long-term solutions.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “The injectable form of the polio vaccine has proven effective at preventing illness but it does not block the transmission of the virus as well as the oral version of the vaccine. That is because the virus is usually transmitted through contaminated food or water and is first exposed to the GI tract, where the oral vaccine induces a mucosal immune response. To date, several countries no longer use the oral vaccine because there is a small risk of infection. It is also possible for people who receive the injected polio vaccine to spread the virus even though they are asymptomatic. 
    • “Now according to data from an Massachusetts Institute of Technology-led study, it may be possible to modify the injectable vaccine so that it can also promote a mucosal immune response. This way, the vaccine could support polio eradication efforts without the risks of the oral polio vaccine. Details are published in a new Science Advances paper titled “Am80-Lipid nanoparticles serve as an enteric mucosal adjuvant 3 following parenteral immunization with inactivated polio vaccine.”
  • Cardiovascular Business notes,
    • “Engineers with the Massachusetts Institute of Technology (MIT) have developed a noninvasive pacemaker that uses ultrasound to stimulate the heart. The group shared its early experience with the device in Nature Biomedical Engineering, highlighting its compact, wearable design.
    • “Pacemakers are one of the most important and widely used human implants, and they have saved millions of lives,” Gengxi Lu, the study’s co-corresponding author, said in a statement. “But they are invasive, and they make direct contact with the beating heart. The dream for many years has been noninvasive heart stimulation with ultrasound.”
    • “The team’s device is a small sticker worn on the chest. Tiny transducers on the sticker use ultrasound pulses to stimulate the heart in a way that opens certain ion channels in cardiac cells. Lab experiments have been a success, with the device maintaining healthy contractions in human cardiac cells.
    • “For an ultrasound pacemaker to become a reality, researchers believe they would likely begin the process by giving patient’s a one-time injection that boosts the sensitivity of cardiac cells. Once this injection was done, the patient could then theoretically attach the stamp-sized sticker and start experiencing the benefits of the small device right away.
    • “While it’s still early, the group at MIT is optimistic about this new-look pacemaker’s potential. In fact, they hope to combine this latest approach with previous research into sticker-based medical imaging to deliver a single ultrasound sticker that can simultaneously monitor and regulate a patient’s heart.”
  • Per BioPharma Dive,
    • “A clinical trial testing a migraine prevention therapy from Denmark-based Lundbeck has produced data that some on Wall Street see as mixed but still good enough to forge ahead with further development.
    • “The therapy, called bocunebart, is designed to inhibit a nervous system protein known as PACAP. This protein regulates stress and, when triggered, causes pain-sensing nerves to fire and blood vessels in the head to drastically widen. Lundbeck’s study has been evaluating bocunebart — as a direct infusion to the veins or as an under-the-skin shot — in hundreds of patients who continued experiencing migraines even after trying up to four other treatments.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Hospitals and health systems are losing money on virtual care across every major payer category even as adoption climbs, according Strata’s latest Performance Trends report.
    • “The national analysis found telehealth encounters rose 79% between January 2019 and January 2026, marking the shift from a pandemic stopgap to a permanent fixture of care delivery. Despite that growth, average total cost margins for telehealth stayed negative in 2025 across commercial, Medicare, Medicaid and self-pay patients. Remote patient monitoring has soared 4,000% over the same time period.
    • “Healthcare organizations are increasingly turning to technology and new care delivery models to address workforce shortages and improve patient access,” said Steve Wasson, Strata’s chief data and intelligence officer. “The challenge is that many of these investments, particularly in virtual care, are occurring at a time when margins remain extremely narrow.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare has acquired 17 urgent care clinics from Urgent Care Group in North and South Carolina. 
    • “The clinics include locations in Charleston, Columbia, Myrtle Beach and Spartanburg in South Carolina, and Wilmington in North Carolina, according to a June 2 news release. 
    • “The South Carolina clinics are now operating under the first HCA CareNow brand name, becoming the first such clinics in the state, The North Carolina clinics are continuing to operate under the Medac name used by Urgent Care Group.” 
  • Kaufman Hall opines,
    • “Healthcare leaders must confront whether scorecards are improving patient safety or reshaping priorities in ways that may not benefit patients.”
    • Quick take
      • The debate is no longer about whether hospitals should be measured; it’s about whether the industry is measuring what truly matters.
      • Rankings shape reputation, revenue, and strategic priorities, not just public transparency.
      • Health systems are confronting a growing tension between improving patient care and improving publicly visible scores.
      • The number of public rankings is continuously growing.
      • Leaders are questioning whether current scorecards drive meaningful safety improvements or create administrative distraction.
      • The outcome of this debate could redefine how healthcare approaches transparency, accountability, and patient trust in the years ahead.
  • Health Exec relates,
    • “In a new state-by-state analysis of patient spending on healthcare, Utah, Virginia and California are at one end of the “spend the most” vs. “spend the least” rankings. Alaska, Oregon and Maine land at the other. Can you guess which trio’s residents spend the most and which the least?
    • “Time’s up. Alaska takes the undesirable No. 1 pole position: It’s the most expensive state for people who have to pay out of pocket. On average they shell out 10.1% of the median monthly household income to pay for essential medical services and prescriptions. 
    • “Spending the least are residents of Utah, where wallets only take a hit of 5.11%.
    • “The calculations are from WalletHub, which released a report on the topic May 28.” * * *
    • For WalletHub’s full report, click here.
  • Fierce Healthcare informs us,
    • “Community health system WellSpan Health inked a seven-year strategic alliance with Philips to drive advanced imaging technology across its network and co-develop new AI and tech tools.
    • “Philips’ technology will support WellSpan’s full network of 12 hospitals, diagnostic imaging centers and ambulatory surgery centers across Central Pennsylvania and Northern Maryland. A long-term commercial agreement establishes Philips as WellSpan’s preferred vendor across patient monitoring, enterprise informatics and all applicable imaging modalities, including CT, MR, digital X-ray, ultrasound and image-guided therapy.
    • “The commercial agreement includes a structured approach to technology lifecycle management: WellSpan and Philips will align equipment, services, training and upgrade planning under a single, coordinated framework, according to the organizations.
    • “The alliance marks Philips’s first research and innovation collaboration with a U.S. community health system. The health tech giant and WellSpan plan to co-develop net-new products and features that advance care delivery, drawing on Philips’ R&D pipeline, with WellSpan serving as both a proving ground and a co-creator.”
  • Per Fierce Pharma,
    • “With a new patent settlement, Axsome Therapeutics can lower its sword against prospective generics makers taking aim at its narcolepsy med Sunosi.
    • “The central nervous system-focused drugmaker closed the books on years of Sunosi intellectual property litigation by striking a settlement with “the only remaining first-to-file generic applicant with pending product litigation related to Axsome’s product Sunosi,” the drugmaker announced in a June 3 press release.
    • “Through the settlements, five companies will be cleared to market their generic versions of Sunosi starting on September 1, 2040, if Axsome nabs a pediatric exclusivity period for the drug. If not, the knockoffs can launch on March 1, 2040, the company explained. With that, “no other patent litigation relating to Sunosi remains pending.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports on this week’s anticipated activities on Capitol Hill.
    • “After a weeklong recess, Senate Republicans return Monday with their focus set on ways to move their budget reconciliation package, which hit several hurdles before the Memorial Day break. 
    • “The House, which has been on standby while Senate leadership works out how much of the White House wishlist they can salvage, is returning later this week, with its first vote scheduled for Wednesday.”
  • The Wall Street Journal adds,
    • “The Trump administration signaled a retreat Monday on its nearly $1.8 billion “anti-weaponization” fund, which met powerful pushback from members of Congress and threatened to derail the president’s efforts to pass immigration-enforcement funding.”
  • Yesterday, the FEHBlog described OPM’s family member documentation guidance as an interim final rule because OPM had not issued a proposed rule. However, it turns out that OPM decided that public comment was unnecessary so it declared the guidance to be a final rule. The final rule will be published in the Federal Register tomorrow which means that the final rule’s effective date is July 2, 2026.
  • Federal News Network also relates,
    • “Agencies will soon be able to pay as much as $400,000 a year to certain employees with skillsets in the national security sector. President Donald Trump told the Office of Personnel Management on Friday to establish new regulations to pay experts in specific fields related to supply chain resilience, secure access to critical minerals and advanced technologies and advance priority investment programs essential to national defense and economic security. The memo said this increase in the top line pay for these positions is necessary to advance the rapid recruitment of the exceptionally skilled investment, engineering, financial and legal professionals needed to expand the nation’s capacity.”
  • Govexec notes,
    • “For the second straight month, each portfolio offered by the federal government’s 401(k)-style retirement savings program finished May in the black.”
  • The final rule making changes to the No Surprises Act’s independent dispute resolution process is scheduled to be published in the Federal Register on June 4, 2026.
  • Radiology Business tells us,
    • “Radiologists, anesthesiologists and emergency medicine physicians are jointly praising recently announced changes to the No Surprises Act while also pushing for further reform. 
    • “Medical societies representing all three specialties shared their official response to the independent dispute resolution, or IDR, final rule on Friday. Released by the Centers or Medicare & Medicaid Services May 28, the rule finalizes many updates to the NSA first proposed back in 2023.
    • “The American College of Radiology, American Society of Anesthesiologists and the American College of Emergency Physicians commended the rule, calling it a “thoughtful and collaborative approach.” They see the changes as an “important step forward,” one that will hopefully create a “more functional, transparent dispute resolution system.” 
  • These comments confirm the FEHBlog’s opinion that a follow up rule or perhaps a statutory change is needed to level the IDR process playing field which currently favors this healthcare providers.
  • The American Hospital Association News informs us,
    • “President Trump signed an executive order May 29 that directs the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices to review a scientific assessment by the Department of Health and Human Services on childhood vaccine recommendations from other developed nations. The order recommends the CDC and ACIP take any appropriate steps to update the U.S. childhood and adolescent vaccine schedule to align it with those from other nations. The administration also recommended that all immunizations on the schedule should continue to be covered without cost sharing by private insurers and covered by Medicaid, the Children’s Health Insurance Program and the Vaccines for Children Program.”
  • and
    • “The Centers for Medicare & Medicaid Services June 1 issued an interim final rule with comment period implementing the statutory requirement that certain adult Medicaid enrollees meet community engagement (work) requirements. Under the rule, certain adults must complete 80 hours per month of “qualifying activities,” such as employment, education, community service or participation in a work program, or meet equivalent income thresholds.
    • “CMS said that states must generally implement the requirement no later than Jan. 1, 2027. The rule maintains exemptions for certain populations, including individuals who are pregnant or postpartum, disabled or medically frail, or caregivers, and allows states to offer exemptions for short-term hardships. See the CMS fact sheet for more details.
    • “Provisions in the rule are effective on July 31, 2026, and comments must be submitted by that date.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA approved the oral antiviral agent ensitrelvir (Xocova) to help prevent COVID-19 in people ages 12 years or older who were exposed to the SARS-CoV-2 virus, drugmaker Shionogi announcedopens in a new tab or window.
    • “Ensitrelvir is a SARS-CoV-2 main protease inhibitor also approved in Japan as COVID-19 postexposure prophylaxis (PEP) and as a treatment for mild to moderate COVID. The drug is not approved to treat COVID-19 in the U.S.
    • “The FDA’s decision was based on the phase III SCORPIO-PEP trial, which showed the risk of getting sick from a household contact with COVID-19 dropped by more than half among those who took ensitrelvir compared with placebo.”
  • Contemporary OB/GYN relates,
    • “Wockhardt has announced that the FDA has approved cefepime and zidebactam (ZAYNICH; Wockhardt), a novel intravenous antibiotic designed to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. The approval offers a new therapeutic option for patients facing aggressive, drug-resistant infections. Prior to this approval, the drug received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
    • “In the United States, cUTIs are responsible for over 600,000 hospitalizations annually. A growing proportion of these infections are driven by antimicrobial-resistant bacteria, which represent a leading cause of bacteremia and carry significant morbidity and mortality risks. These multidrug-resistant infections place a heavy burden on the healthcare system, as affected patients typically require more intensive, prolonged care and experience higher rates of life-threatening complications.
    • “The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of ZAYNICH is a monumental step forward in validating a new option for these underserved populations,” said Dr. Dennis Deruelle, Chief Medical Officer at Wockhardt.”

From the judicial front,

  • CMS posted a notice of a court decision that will appear in tomorrow’s Federal Register,
    • SUMMARY: This is to inform the public that, on October 22, 2025, the United States District Court for the Southern District of Mississippi issued an order in Tennessee v. Kennedy, No. 1:24-cv-161-LG-BWR (S.D. Miss. Oct. 22, 2025), vacating portions of the final rule titled “Nondiscrimination in Health Programs and Activities,” published May 6, 2024 (89 FR 37522).
    • Specifically, the court vacated certain provisions of the regulation to the extent they expand Title IX’s definition of sex discrimination to include gender-identity discrimination. Pursuant to the court’s order, the vacated provisions are legally void. The other provisions of the Section 1557 Rule remain in force.
    • DATES: The Tennessee court issued its vacatur order on October 22, 2025. As long as the specified provisions of the 2024 Section 1557 Rule remain vacated, OCR and CMS cannot and will not enforce the vacated provisions.

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “An outbreak of a rare strain of Ebola in the Democratic Republic of Congo is already the third largest in history, just weeks after it likely began.
    • “It is spreading rapidly in one of the most volatile and vulnerable regions of the world, worrying U.S. and international health officials.” * * *
    • “What are the chances that Ebola will spread to the U. S.?
    • “The risk is low, according to the Centers for Disease Control and Prevention. U.S. officials have prohibited foreigners who have been to Congo, Uganda or South Sudan in the last three weeks from entering the country. U.S. citizens who have been to those countries are being directed to four U.S. airports and screened there, the CDC said. Those airports are: Washington-Dulles International, Hartsfield-Jackson Atlanta International, George Bush Intercontinental and John F. Kennedy International.
    • “The U.S. has a network of specialized treatment centers around the country to care for patients with dangerous pathogens like Ebola and hantavirus, at hospitals such as the University of Nebraska Medical Center and Emory University Hospital. However, U.S. authorities evacuated an American medical missionary who contracted Ebola in Congo to a hospital in Germany with similar capabilities, and aim to build an Ebola quarantine and treatment facility in Kenya. A Kenyan high court put the U.S. plan on hold.”
  • The American Medical Association lets us know what doctors wish their patient knew about lupus.
    • “Lupus is a complex autoimmune disease with varied symptoms. Early diagnosis and ongoing care can help patients manage flares and protect long-term health.”
  • MedPage Today relates,
    • “The cigarette smoking rate among U.S. adults dropped to another all-time low last year, with one in 11 adults saying they were current smokers, according to new government survey data.
    • “Cigarette smoking is a risk factor for lung cancer, heart disease, and stroke, and it’s long been considered the leading cause of preventable deathopens in a new tab or window.
    • “The preliminary findingsopens in a new tab or window from the CDC were based on survey responses from more than 24,200 adults. In the survey, CDC officials defined current cigarette smoking as smoking at least 100 cigarettes in a lifetime and now smoking every day or some days.” * * *
    • “In 2024, the percentage of current adult smokers fell below 10% for the first time. Last year, it was 9%, according to the new survey.
    • “The use of electronic cigarettes has been inching up among adults, but has held about steady in 2025, at about 7%.”
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) today announced that its Investigational New Drug (IND) application for mitragynine, the primary psychoactive compound found in Mitragyna speciosa (kratom), has taken effect with the U.S. Food and Drug Administration (FDA). The IND paves the way for an NIH-led phase I clinical trial to evaluate mitragynine as a potential treatment for opioid use disorder.
    • “Researchers at NIH and the University of Florida developed the purified formulation of mitragynine to be used in the trial, as well as the preclinical work that led to the submission of the IND application.
    • “This IND is a major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder, which has contributed to historically high overdose mortality rates,” said Nora Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA).”
  • The American Journal of Managed Care tells us,
    • “People living with alopecia areata (AA) may not face a heightened risk of skin cancer despite reduced scalp hair coverage, according to a new systematic review and meta-analysis that found a significantly lower incidence of melanoma among this patient population.
    • “The analysis, published in Frontiers in Oncology, evaluated data from more than 860,000 patients across 8 retrospective studies conducted in the US, Sweden, Denmark, Taiwan, and the Republic of Korea. Researchers reported that AA was associated with a statistically significant reduction in melanoma incidence, whereas rates of basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and overall skin cancer also trended lower but did not consistently reach statistical significance.
    • “The findings arrive as clinicians increasingly prescribe Janus kinase (JAK) inhibitors for moderate to severe AA, raising questions about long-term malignancy risks and the need for baseline disease-specific cancer data.”
  • Fierce Pharma informs us,
    • “AstraZeneca is polishing the case for its Imfinzi (durvalumab) and Imjudo (tremelimumab) combo in liver cancer with a new phase 3 readout from its Emerald trial program assessing the immunotherapy duo in a locoregional setting. 
    • “The phase 3 Emerald-3 study, presented June 1 at the Annual Society of Clinical Oncology (ASCO) 2026 annual meeting in Chicago, positions AZ’s Imfinzi/Imjudo regimen as a “compelling therapeutic option” for patients with unresectable embolization-eligible hepatocellular carcinoma (HCC), ASCO expert Vishwanath Sathyanarayanan, M.D., commented in an ASCO press release.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The public and private sector are committed to value-based care as a solution to high healthcare spending.
    • “Decades of value-based care interventions have not reversed perpetually rising health expenditures.
    • “UnitedHealth Group, CVS Health and other companies have made value-based care central to their business plans.
    • “The fragmented healthcare system remains an obstacle to cost containment.”
  • Beckers Hospital Review relates,
    • “Orlando (Fla.) Health recorded an operating income of $47.4 million (1.9% operating margin) in the second quarter of 2026, down from $94.7 million (3.9% margin) during the same period last year, according to its May 26 financial report.”  
  • KFF Health News, writing in Fierce Healthcare, tells us,
    • “Most patients who have taken a GLP-1 received their prescription through a primary care doctor or a specialist, KFF polling data shows. But as the uptake of telehealth has grown substantially since the start of the covid pandemic, * * * millions of Americans who have used online companies to meet a variety of their medical needs.
    • “Many of the companies have started offering GLP-1 medications for weight loss as demand for these drugs has exploded. But certain medication errors tied to GLP-1s have exploded too, according to a KFF Health News review of Food and Drug Administration data, and physicians and telemedicine researchers worry that adverse experiences tied t”o telehealth companies are becoming more common.
    • Bad outcomes aren’t unique to telehealth providers or to the compounded weight loss drugs many of them offer. In fact, product liability lawsuits alleging patient injuries have been filed overwhelmingly against pharmaceutical giants Eli Lilly and Novo Nordisk, which manufacture name-brand weight loss drugs, court data shows. The drugmakers have defended their products.
    • “However, some critics are also concerned that getting a weight loss prescription online is usually much easier than getting one through an in-person appointment. Not only do many telehealth companies write quick prescriptions for GLP-1s, but they often sell the medications, too, allowing patients to bypass in-person pharmacy visits. This one-stop shopping isn’t necessarily a good thing, according to critics who say some telehealth providers are writing prescriptions for people who should not be taking GLP-1s and then providing little or no follow-up care.
    • “It gives a black eye to telemedicine,” said Elizabeth Krupinski, an experimental psychologist at Emory University who has conducted research on the effectiveness of telehealth.”
  • Fierce Healthcare informs us,
    • “Weight loss company Noom is offering an at-home biomarker testing kit for its U.S. members, expanding its platform into diagnostics and metabolic health monitoring.
    • “It marks an expansion of the company’s proactive health program, which rolled out in December, offering microdose GLP-1 medications combined with at-home biomarker testing and insights.
    • “The at-home blood collection and lab testing service enables members to establish baseline labs and track improvements in markers such as, HbA1C, ApoB, triglycerides and hs-CRP over time, according to the company. Testing gives users with insights into biological outcomes, such as blood sugar regulation, lipid profiles and inflammation markers. By using the kit, members can skip a lab visit and receive results within about a week, paired directly with access to medication and behavior change programs, according to executives.
    • “Noom says it now provides a platform where members can test, act and track A1C improvement in a single, integrated experience.
    • “The biomarker test kits cost $125.”
  • Fierce Pharma points out,
    • “In its seventh week on the market, which ended May 22, Eli Lilly’s obesity pill Foundayo continued to track below the pace of Novo Nordisk’s rival Wegovy pill at the same point in its launch.
    • “At the same time, analysts at Jefferies and Citi again flagged caveats that could be skewing the numbers, with the Jefferies team espousing confidence that Lilly’s oral GLP-1 can still meet consensus sales projections for both the second quarter and 2026 as a whole. 
    • “Breaking down the numbers, the Jefferies team put seventh-week total Foundayo prescriptions lower versus the previous week at roughly 11,700, with the clarification that the data’s source, IQVIA, had to use a “best-estimate” tally for the latest week’s prescription trends. 
    • “That trend remains “numerically lower” than the course charted by Novo’s Wegovy pill, which racked up an impressive 67,000 prescriptions in its seventh week, although Foundayo’s performance still tracks ahead of Novo’s injectable Wegovy and Lilly’s first obesity incretin med Zepbound at the same point in their respective rollouts, the analyst team said.” 

Friday Report

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

Simplicity is a virtue

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the American Society of Clinical Oncology conference front,

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

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

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