Midweek report

Agentic & Generative AI

Midweek report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Beckers Payer Issues calls attention to eight bills in Congress that payers should be following.
  • Per a Senate news release,
    • “Today the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted to favorably report multiple bills making health care more affordable and accessible to American families.” * * *
    • “The National Plan for Epilepsy Act, Expedited Access to Biosimilars Act, and Making America’s Food Safer Act passed unanimously 22-0 as amended in an en bloc vote. The Patients Deserve Price Tags Act, CLEAR LABELS Act, EMPOWER for Health Act, Title VIII Nursing Workforce Reauthorization Act of 2025, and Rural Obstetrics Readiness Act passed 21-1 as amended in an en bloc vote. The SAFE Drugs Act of 2026 passed as amended 17-5, the INSULIN Act of 2026 passed as amended 17-5, and the Childhood Diabetes Reduction Act passed as amended 12-10.”
  • Bloomberg Law reports,
    • “Legislation advanced on a bipartisan basis by the House oversight panel Wednesday aims to regulate pharmacy benefit managers contracting with health benefits for federal employees.
    • “The measure (H.R. 6610) would set standards for pharmacy reimbursement, require that drug rebates be applied to copayments and coinsurances, and prohibit PBMs from steering beneficiaries to specific pharmacies for the Federal Employees Health Benefits Program. The measure was approved 40-2.
    • “For too long, federal employees and tax payer-funded federal agencies have been held captive by a health care system manipulated at every turn by three large PBMs and their affiliate companies,” said Oversight Chair James Comer (R-Ky.).”
  • FEHBlog observation: The bill would price fix small molecule drug prescriptions. It’s not a good idea from a market place standpoint to set prices in statutes. The next step for this bill is House floor consideration, but the House will be on a District work break beginning tomorrow until August 31. So, there is time for cooler heads to prevail.
  • CBS News relates,
    • “The Trump administration is forging ahead with a controversial plan to collect the medical records of millions of federal workers and retirees, as well as their family members.
    • “The Office of Personnel Management said in a notice posted last month that it will begin routinely collecting identifiable, personal health information on more than 8 million people — despite concerns from privacy advocates and Democrats, who have demanded the agency drop the plan. The notice will go into effect July 24, allowing OPM to begin its collection at any point afterward.” * * *
    • “In its latest notice, OPM argues that the vast trove of data is necessary to ferret out fraud and overpayments in the FEHB and PSHB programs. Those programs cost roughly $80 billion a year, with about $50 billion covered by the federal government and $30 billion funded by enrollees. The Trump administration has ramped up efforts, led by Vice President JD Vance, to curtail what it says is rampant fraud and misuse of publicly funded health benefits.
    • “The effort still faces criticism that it doesn’t go far enough to protect the privacy of federal workers and their families.
    • “Clearly, this administration has not earned our trust with Americans’ sensitive data,” Sen. Mark Warner (D-Va.) said in an emailed statement to KFF Health News. “If OPM wants to work in good faith to reduce fraud, they should come to Congress, including to folks like me who are engaged on this issue and represent many federal workers and retirees and their families, and work to build consensus and trust before implementing these sweeping changes.”
  • FEHBlog observation: OPM overlooks the fact that carriers, who hold the financial risk in the FEHB and PSHB programs, already focus on preventing fraud, waste, and abuse, in cooperation with the OPM Inspector General’s office. Carriers submit annual reports on those efforts to OPM.
  • Per an OPM news release,
    • “ICYMI: OPM Director Scott Kupor Discusses Merit-Based Federal Hiring and Restoring Accountability on The Ingraham Angle.”
  • Beckers Hospital Review informs us,
    • “President Donald Trump plans to place tariffs on generic drug imports, building on the 100% tariff he imposed on patented pharmaceutical products in April. While that policy exempted generic drugs and biosimilars for the time being, the White House said it would reassess the exemption within a year. 
    • “Here are three things to know from the latest announcement, made in a July 21 Truth Social post:
      • “The tariff schedule would be rolled out over three years. Starting Aug. 1, generic drugs will continhttps://www.hhs.gov/press-room/hhs-joins-genesis-mission-ai-chronic-disease-research.htmlue entering the U.S. tariff-free for a two-year period. After that, the tariff rises to 100% for one year, then to 200% thereafter.
      • “President Trump said the schedule is meant to “reshore” generic pharmaceutical production into the U.S., calling the escalating tariffs a “penalty” for companies that do not build manufacturing plants and equipment domestically within the two-year window.
      • “President Trump said the policy on patented, branded or innovative drugs “will remain as is.” Under the April policy, those tariffs are set to take effect July 31 for large companies and Sept. 29 for smaller firms, with reduced or zero rates available to companies that reach most favored nation pricing agreements with HHS and onshoring agreements with the Commerce Department. This announcement effectively replaces the one-year review window for generics with a defined, longer timeline.”
  • The American Hospital Association News points out,
    • “The Department of Health and Human Services July 22 announced that it will participate in the Genesis Mission, an artificial intelligence initiative focusing on scientific research that originated from a November 2025 executive order. HHS will work with the Office of Science and Technology Policy to launch a series of science and technology challenges involving AI, including one focusing on identifying root causes of chronic disease and others on pediatric cancer research and drug discovery and development.
    • “In addition, OSTP July 22 released a report, “Science: A New Golden Age,” on scientific initiatives using AI. The report outlines four pillars: revitalizing America’s science and technology enterprise through recommendations such as refocusing on individual scientists and diversifying funding mechanisms; securing U.S. dominance in critical and emerging technologies through efforts such as public-private partnerships and challenges; ensuring science and technology betters the lives of all Americans through recommendations such as training and career pathways; and launching a golden age of science through efforts such as the Genesis Mission. An annex to the report, the “White House Fiscal Year 2028 Research and Development Budget Priorities Memorandum,” consists of directives for federal agencies to implement recommendations in the report.” 
  • Per Department of Health and Human Services news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced that the Centers for Medicare and Medicaid Services (CMS) sent a notification urging every State Medicaid Director to phase out the use of mercury-containing dental fillings by restricting or ending their respective state’s Medicaid coverage for dental procedure codes for “dental amalgams.” Dental amalgams are a material that combines mercury with other heavy metals to fill cavities but pose health and environmental risks.”
  • Healthcare Dive notes,
    • “The Department of Labor’s employee benefits arm proposed a rule Wednesday that would allow insurers to share mandatory group health plan disclosures with their beneficiaries electronically.
    • “Many of the communications, like summary plan descriptions, claims denials or notices that coverage can continue after a job loss, are currently sent via physical mail. But if the rule is finalized, plans will be able to post the documents online and notify a member by text or email when a disclosure is available.
    • “It’s “a big step forward in how Americans receive important information about their health benefits,” Daniel Aronowitz, who leads the DOL’s Employee Benefits Security Administration, said during a press briefing.”

From the Food and Drug Administration,

  • MedPage Today reports,
    • “The FDA approved zidesamtinib (Jideytro) for previously treated adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), drugmaker GSK announced Wednesday.
    • “Zidesamtinib is a next-generation, brain-penetrant ROS1-selective inhibitor designed to overcome ROS1 resistance mutations.
    • “Approval was based on the phase I/II ARROS-1 trial that included patients with ROS1-positive NSCLC who were previously treated with a ROS1 kinase inhibitor. In the overall population of 117 patients, the objective response rate (ORR) was 44%, with rates of duration of response at 6 and 12 months of 82% and 69%, respectively.”
  • MedTech Dive relates,
    • “Johnson & Johnson said Wednesday it received Food and Drug Administration de novo authorization for its Ottava robotic surgery system to perform multiple procedures in general surgery.
    • “The authorization brings to the U.S. market a second heavyweight challenger to Intuitive’s da Vinci robot in soft tissue procedures, following Medtronic’s FDA clearance in late 2025. A wave of smaller companies, including CMR Surgical, Distalmotion and Moon Surgical, are also launching robotic systems in the U.S., giving Intuitive its first competition in more than two decades.
    • “J&J said it will launch Ottava with select U.S. customers while working to obtain additional indications and regulatory jurisdictions over time.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The participating manufacturer intends to offer a device for use in providing care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model and intended to improve health outcomes for Americans managing certain chronic diseases.
    • “The FDA selected Dexcom, Inc., as the first participant in the TEMPO pilot. The Dexcom Glucose Health Program, which the FDA will continue to evaluate for its intended use during the pilot, is intended to address two clinical use areas in the ACCESS Model.
    • “The Dexcom Glucose Health Program is intended to enable patients aligned to the ACCESS model and their healthcare professionals or caregivers to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for informed decision-making and behavioral modifications. The program is intended as an aid in the screening for prediabetes and type 2 diabetes through integrated digital health metrics. It may also contribute to improving glycemic control and lowering HbA1c in people with prediabetes.”
  • and
    • “The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again. The FDA is issuing a final order revoking the authorized use of Orange B as a color additive in food and is proposing to revoke the authorized use of Citrus Red No. 2 as a color additive in food.”

No Surprises Act News

  • The Wall Street Journal reports,
    • “A controversial process for arbitrating medical billing disputes awarded nearly $15 billion in payouts to healthcare providers last year, according to new federal data analyzed by The Wall Street Journal, more than triple the total for 2024.
    • Doctor groups representing radiologists, anesthesiologists and emergency-room physicians have been among the winners under the setup, which was created under a 2020 law meant to protect patients from surprise medical bills. Insurers have to make the awarded payouts, and they have generally ended up on the losing end since arbitration began four years ago.
    • “For 2025, total payouts under the arbitration process reached $14.85 billion, according to a Journal analysis of new, previously unreleased data from the Centers for Medicare and Medicaid Services. The figure for 2024 was $4.08 billion, according to the analysis.
    • ““It’s shocking that it’s rising so fast,” said Jack Hoadley, a research professor emeritus at Georgetown University’s Center on Health Insurance Reforms.”
  • FEHBlog observation: It is indeed a big bowl of wrong.

From the judicial front,

  • Fierce Healthcare reports,
    • “The Trump administration will appeal a Georgia court ruling that triggered a broad recalculation of insurers’ Medicare Advantage star rating scores for 2026.
    • “In court documents filed Tuesday, federal agencies said they would appeal the ruling to the Eleventh Circuit Court of Appeals. In late May, a judge in Georgia’s Southern District Court came down in favor of Clover Health, tossing 20 measures that the Centers for Medicare & Medicaid Services used to calculate its scores.
    • “The court cut 10 of those measures, as the judge determined CMS exceeded its statutory authority in the data sources used, while the remaining 10 were rejected because the court ruled CMS did not meet its rulemaking and comment requirements to use them.”
    • “The ruling also triggered several follow-up lawsuits from other payers over the calculations, including Elevance Health, Alignment Healthcare and SCAN Health Plan.”
  • Per a Department of Justice news release,
    • “A federal jury in the Southern District of Florida convicted a Florida licensed pharmacist and pharmacy owner yesterday for her role in dispensing over 300,000 oxycodone 30mg pills to pharmacy patrons who had no medical need for the drug.
    • “According to court documents and evidence presented at trial, Olushola Yusuf, 60, of Tampa, dispensed oxycodone to nearly all her pharmacy customers. Yusuf charged customers approximately 10 times the typical cost of the drug and required payment from them in cash. In total, Yusuf dispensed at least 335,351 pills of oxycodone 30mg during the conspiracy. Oxycodone 30mg is the maximum strength available of the drug and is both sought after and potentially dangerous due to its potency. It is typically prescribed to seriously ill patients, such as those suffering from chronic cancer pain or traumatic injuries.”

From the public health and medical / Rx research front,

  • Beckers Clincal Leadership informs us,
    • “In the nation’s largest outbreak of cyclosporiasis, the CDC has reported 4,940 lab-confirmed and 341 hospitalizations across 41 states, according to a July 21 update. 
    • “Between May 1 and July 20, the federal health agency reported 4,173 domestic cases and 767 illnesses acquired outside the U.S. A majority of hospitalizations, 308, are also domestically linked.
    • “In 2025, the U.S. recorded 3,955 cyclosporiasis cases, meaning the number of illnesses over the past 11 weeks have exceeded last year’s total, according to the Washington Post. 
    • “The FDA and CDC’s traceback investigations have “converged” on now-recalled iceberg lettuce grown in Mexico by Taylor Farms, one of the largest fresh-produce suppliers for the U.S. Despite a false positive test, federal officials seem to have traced a significant portion of the outbreak to Taylor Farms. 
    • “Normally, cyclosporiasis cases annually peak between May 1 and Aug. 31. This year, a spike of illnesses had a June 26 onset date, according to the CDC. Michigan and surrounding states appear to be hardest-hit, with Michigan officials reporting 6,571 cases and 102 hospitalizations as of July 21, and Ohio logging 1,246 confirmed cases as of July 16.” 
  • The Washington Post reports,
    • “The United States has now reported the most measles cases in any year since 1991, not only surpassing all of last year’s record total, but also reaching the highest level in 35 years, with more than five months still remaining in 2026.
    • “The country reported 2,295 cases as of Tuesday, according to data from Johns Hopkins University’s U.S. measles tracker. The total surpasses last year’s 2,289 cases and is the highest annual count since the highly contagious disease was eliminated in the United States in 2000.
    • “The fact that we’ve reached this total this early in the year is really a reflection of those large outbreaks earlier in the year, particularly in South Carolina and Utah,” said William Moss, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. “It’s very frustrating. This is a reflection that we have been unable to stop measles virus transmission in this country.” * * *
    • “The latest milestone underscores how the country has entered a new phase in its battle with measles, with repeated new infections of the deadly disease igniting sustained outbreaks in multiple states rather than staying concentrated in a few undervaccinated communities.”
  • The American Medical Association lets us know “6 things patients should know about red light therapy.”
    • Does red light therapy really work for wrinkles, hair growth and to boost skin health? The latest “Health vs. Hype” episode explores the facts.
  • The Wall Street Journal points out,
    • “Architect Lloyd Alter states dangerous bathroom designs cause falls, the leading injury-related death for adults aged 65 and older.
    • “Freestanding bathtubs and shower-tubs are dangerous due to slippery surfaces, thin edges and a lack of grab bars.
    • “Toilets also present fall risks due to straining and high “comfort height” designs; grab bars and lower toilets are recommended solutions.”
  • STAT News relates,
    • “Europeans can now receive a device that can partially restore their vision loss. Americans may not have to wait long to get it, either.
    • “Science Corporation announced Wednesday that European regulators had approved the commercial sale of the startup’s retinal implant that improves eyesight for patients with age-related macular degeneration in their central vision, enough to read books and road signs more clearly. 
    • “We have a cochlear implant for vision now,” said Science founder and CEO Max Hodak.
    • “The implant, called PRIMA, also received a Humanitarian Use Device designation from the FDA in March, which puts the device on track to debut in the United States early next year if it receives agency approval. If it hits this milestone, PRIMA would be the second brain-computer interface (BCI) to enter the U.S. market.” * * *
    • “The Science device’s impact could be substantial. Geographic atrophy accounts for 20% of all legal blindness due to age-related macular degeneration and affects more than 1 million people in the U.S. PRIMA received FDA’s special designation because Science intends to initially use it for only the most severe cases of atrophy, which affects fewer than 8,000 people per year.” 
       
  • MedPage Today notes,
    • “Five adverse pregnancy outcomes were independently associated with increased peripheral artery disease (PAD) risk later on.
    • “These associations remained in co-sibling analyses, suggesting that familial factors are not to blame.
    • “Women with adverse pregnancy outcomes should have lifelong clinical follow up.”
  • Per Health Day,
    • “Cognitive function, manual dexterity, and breathing ability all play an important role in helping people with chronic obstructive pulmonary disease (COPD) use their inhalers correctly, according to a study published online May 27 in the Annals of the American Thoracic Society.”
  • Per BioPharma Dive,
    • “A genetic medicine from Arrowhead Pharmaceuticals has succeeded in two late-stage clinical trials focused on a condition that increases the risk of sudden, potentially life-threatening cases of pancreas swelling.
    • “The medicine, known as plozasiran, is a small piece of synthetic RNA designed to lower fat levels in the bloodstream. It does this by degrading the instructions cells use to create a protein that slows down triglyceride metabolism. Plozasiran is already approved, and sold under the brand name Redemplo, as a treatment for a rare disease that leads to extremely high levels of triglycerides. Arrowhead, though, is trying to expand the drug’s use.
    • “Positive results released Wednesday should help in that mission. Across the two trials, which enrolled adults with “severe hypertriglyceridemia,” an under-the-skin injection of Arrowhead’s drug once every three months respectively cut median triglyceride levels by 79% and 81% after one year. The reduction seen in placebo-treated patients, meanwhile, was around 27%.”

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

  • Beckers Payer Issues reports,
    • “Molina Healthcare reported $60 million in net income for the second quarter of 2026, a 76% year-over-year drop from $255 million.
    • “The insurer attributed the decline mainly to lower premium revenue and a higher medical loss ratio. Total revenue for the quarter was nearly $10.9 billion, down 4.8% year-over-year. 
    • “Even with the profit decline, Molina raised its full year 2026 adjusted earnings guidance to at least $5.25 per diluted share, up from at least $5, and lifted its GAAP guidance to at least $2.15 per share. The company said a $1.50 per share improvement in its Medicare business was offset by an equal decline in its ACA marketplace business, and that without the marketplace reduction, full year adjusted guidance would have risen to $6.75 per share.
    • “Molina’s MLR in Q2 was 92.2%, up from 90.4% in the second quarter of 2025. The company had approximately 4.9 million members as of June 30, down from 5.7 million a year earlier. Marketplace membership fell to 283,000, from 655,000 at the end of 2025 and 690,000 a year ago. The company tied the decrease to its pricing and product strategy, the expiration of enhanced ACA subsidies and new program integrity measures.”
  • Fierce Healthcare relates,
    • “Community Health Systems fell short of the market’s earnings and revenue expectations during its second quarter, posting a loss when excluding funds received for its recent hospital divestitures. 
    • “The for-profit reported Wednesday after market close net operating revenues of $2.83 billion. Net income attributable to stockholders was $70 million, or 50 cents per diluted share, but fell to a 19 cents per diluted share loss after excluding the facility sales and other adjusting items.
    • “The reported revenue and adjusted earnings are about $70 million and nine cents per share behind analysts’ estimates, per Seeking Alpha.
    • “The latter also outpaces the five cents per share net loss the system had logged for the same period last year, despite a same-store net operating revenue increase of 2.4% and same-store admissions and adjusted admissions gains of 1.9% and 2.9%. 
    • “The company primarily attributed the year-over-year performance decrease to “an unfavorable change in payor mix and higher medical specialist fees.” These were offset by improved volumes, higher reimbursement rates, greater net benefit from supplemental reimbursement programs and tighter contract labor and professional liability expenses, according to the release.”
  • and
    • “Visana Health, a virtual women’s health provider, has redesigned its annual visit to be more comprehensive and personalized.
    • “Visana’s Complete Women’s Health Visit combines preventive care, symptom evaluation and expertise across gynecology, primary care and endocrinology to tailor care to each patient. The telehealth visits are 45 minutes long and go beyond a pap smear and mammogram to include hormonal, metabolic, cardiovascular, reproductive, sexual and emotional wellbeing assessments. 
    • “It’s really a tailored visit to the individual and then optimized for what her risks are and what her questions are,” Barbara Levy, M.D., chief medical officer at Visana, told Fierce Healthcare.”
  • Beckers Hospital Review tells us,
    • “Seven hundred rural hospitals across the U.S., or about one-third of all rural facilities in the country, are at risk of closing due to severe financial challenges, according to a July 21 Center for Healthcare Quality and Payment Reform analysis.
    • “The analysis comprises 264 hospitals that are at immediate risk of closure, according to the report. In almost every state, rural hospitals are at risk of closure. In most states, more than 25% of rural hospitals are at risk and in 11 states, 50% or more are at risk.
    • “The latest data is a slight decrease from CHQPR’s May analysis, which found 720 hospitals were at risk of closure with 294 at immediate risk. 
    • “More than 100 rural U.S. hospitals have closed in the past decade, with 110 closing since 2015, according to the report. Fifty-three hospitals have ended inpatient services since the beginning of 2023 to qualify for federal grants only available to rural emergency hospitals.”
  • The Cotiviti consulting firm discusses fraud, waste and abuse in behavioral health care.
    • “Behavioral health continues to be shaped by expanding access, evolving care delivery models, and regulatory change. While these advancements have improved patient access to critical services, they have also introduced new complexities for payers working to maintain program integrity and reduce fraud, waste and abuse (FWA) risks.
    • “For health plans, particularly those serving Medicaid and other government-sponsored populations, identifying emerging billing patterns, strengthening review processes, and aligning internal teams around consistent standards can help reduce financial leakage while supporting appropriate care delivery.”
  • Beckers Hospital Review points out,
    • “GLP-1 medications are linked to a 17.3% drop in long-term sickness leave over four years, according to a working paper published in July by the National Bureau of Economic Research.
    • “Researchers compared 7,011 patients who started Ozempic during the drug’s first 17 months of availability to a matched group of 7,011 patients who initiated treatment four years later.”
  • and
    • “Where the GLP-1 compounding fight stands: 5 things to know.”
  • Per Fierce Healthcare.
    • “Samsung rolled out a beta version of its artificial intelligence-powered personal health assistant on Tuesday.
    • “The new AI assistant—dubbed Samsung Health Assistant—is embedded into the Samsung Health app and is currently available to eligible users across the U.S. It allows users to ask health questions and receive personalized guidance and recommendations through its “unique knowledge base.” Insights have been validated by a team of physicians and certified health coaches, executives say.
    • “Our new Health Assistant advances Samsung’s vision for Connected Care by giving users a deeper understanding of their mind and body through daily health monitoring and increasing opportunities for early detection,” said Hon Pak, M.D., senior vice president and head of the digital health team at Samsung Electronics, in a statement.”

Noteworthy Event

  • The Washington Post reports,
    • “An Australian woman gave birth to identical quadruplet girls last week, all from one fertilized egg that split into four.
    • “The chance of conceiving monozygotic quadruplets is 1 in 15 million, said Alexa Bendall, a maternal fetal specialist, in an interview released by Royal Brisbane and Women’s Hospital in Queensland. 
    • “The girls are named Emily, Harriet, Catherine and Alexa — in the doctor’s honor. 
    • Triplet and quadruplet pregnancies are high risk for complications for the mother and children throughout gestation, compared with twins, according to scientific research by Cambridge University Press.
    • “From an academic perspective, it’s really interesting,” Bendall said. “From a human perspective, to be able to be part of the family’s journey and come out with four beautiful babies and a healthy mum is very precious.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Washington Post tells us,
    • “The House passed a stopgap bill to fund the government into December in an effort to avoid another government shutdown weeks before the midterms, but the effort faces an uphill climb in the Senate.
    • “The resolution, which would fund the government through Dec. 4, passed 220-205. 
    • “House Speaker Mike Johnson (R-Louisiana) pushed the measure to preempt a showdown with Democrats in the fall over government funding as lawmakers are unlikely to meet a Sept. 30 deadline ahead of the new fiscal year.” * * *
    • “Senate Majority Leader John Thune (R-South Dakota) said he’ll bring a bipartisan agreement to fund the government to the floor before the August break. That measure would then need to be approved by the House when lawmakers return at the end of August before it goes to Trump’s desk.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) today deferred more than $1 billion in federal Medicaid payments to California and Minnesota as the states submit additional documentation supporting certain high-risk Medicaid claims. The action advances the Trump administration’s effort to combat fraud, waste, and abuse in Medicaid and safeguard federal taxpayer dollars.” * * *
    • “CMS is deferring approximately $867.5 million in federal Medicaid payments to California and $199 million to Minnesota after focused financial reviews identified claims that require additional review before federal matching funds are released. These are payment deferrals (not permanent funding cuts) and both states will have the opportunity to provide documentation showing the claims meet federal Medicaid requirements.
    • “Additionally, under Secretary Kennedy’s direction, HHS and the HHS Office of Inspector General continue to exercise exclusion authorities as a critical tool to remove bad actors from Medicare and Medicaid programs — and, in many cases, permanently bar them from returning.”
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services today released a proposed rule that would update Medicaid provider tax policies included in the July 2025 reconciliation law and change how the agency determines whether certain healthcare taxes comply with federal requirements. States commonly use provider taxes to help finance Medicaid. CMS said the proposed changes are intended to ensure those taxes are not structured in a way that effectively guarantees providers receive their tax payments back. 
    • “The proposal would replace the current 6% indirect hold harmless threshold with state- and provider class-specific thresholds based on taxes enacted and imposed as of July 4, 2025, and would implement a phased reduction in allowable thresholds for Medicaid expansion states beginning in fiscal year 2028. The rule proposes revised interpretations of “enacted” and “imposed” taxes as described in CMS’ preliminary guidance issued Nov.14, 2025. CMS also proposes to sunset the current alternative “75/75” compliance test and establish a new provider tax class, “Services of Health Insurers,” bringing existing state taxes on health insurers under CMS oversight. 
    • “Comments are due 60 days after publication in the Federal Register.” 
  • Govexec relates,
    • “The Office of Personnel Management is set to propose new rules this week implementing a 2022 law aimed at reforming retirement benefits for federal first responders who are injured during their service and forced to pursue jobs elsewhere in government.
    • “Federal workers in professions like law enforcement and firefighting participate in the federal government’s defined benefit retirement program on an accelerated basis—in exchange for paying more toward their pensions each paycheck, they become eligible for their full annuity once they have served 20 years and reached age 50. They are also subject to mandatory retirement at age 57.
    • “But if a federal first responder is injured on the job and unable to continue in their current role, they lose access to the accelerated retirement timeline, despite the increased payments they have already made along the way.
    • “A proposed rule set for publication Wednesday in the Federal Register would implement the First Responder Fair RETIRE Act, a 2022 law aimed at fixing this flaw. The legislation allows first responders forced to take a job elsewhere in the federal government to continue to pay accelerated contributions and reach retirement when they originally planned. And it grants feds the chance to be refunded the extra half-percentage point of their salary that went toward retirement if they leave federal service altogether prior to reaching retirement age.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA added eight new members to an advisory committee slated to review whether pharmacies can legally market peptides, after criticism the panel is stacked with those tied to peptide-related businesses and clinics.
    • “The panelists were added as temporary voting members to the Pharmacy Compounding Advisory Committee, which is scheduled to convene Thursday and Friday to evaluate whether seven unapproved peptides can be reclassified to allow pharmacies to legally manufacture them. The committee will consider whether to reverse a 2023 Biden-era decision that nearly 20 peptides pose safety risks and can no longer be legally compounded.
    • “The temporary members include clinical researchers, professors of medicine, and pain and substance use experts.
    • “They seem considerably more qualified and less conflicted than the others who were added recently,” Peter Lurie, a former FDA associate commissioner, now the president of the Center for Science in the Public Interest, said in an email. “The new members are mostly confined to certain peptides, not the case for the earlier nominees.”
  • MedTech Dive relates,
    • “Philips received 510(k) clearance for a new version of its pulse oximeter clip sensor that the company says is accurate across a broad range of skin tones. 
    • “The reusable clip sensor has optical refinements to improve signal quality and measurement consistency and support reliable oxygen saturation measurements across diverse patient populations and clinical conditions, the company said in the Tuesday announcement. 
    • “Medtech firms have sought to update their pulse oximetry technology after several studies raised concerns about the devices being less accurate for people with dark skin pigmentation. The Food and Drug Administration issued updated testing recommendations for pulse oximeters in a 2025 draft guidance, but has not finalized it.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Columbia July 21 upheld a lower court’s decision that Section 340B of the Public Health Service Act does not permit drug companies to impose proposed rebate models on 340B purchasers unless the Secretary of the Department of Health and Human Services approves. The court did not weigh in on the lawfulness of the department’s proposed rebate program or any other version of a rebate model that it could approve.  
    • “The manufacturers’ reading would also counterintuitively let manufacturers, rather than the Secretary, take the lead in administering the 340B Program, rendering the Secretary’s role largely reactive,” the court explained. “Put simply, the statute places the Secretary, not the manufacturers, in the driver’s seat of this important program.” 
  • FEHBlog observation: By upholding a lower court’s decision, the article is referring to an initial decision by a Magistrate Judge.
  • BioPharma Dive relates,
    • “Novo Nordisk is suing its biggest obesity drug rival, alleging on Tuesday that Eli Lilly is engaging in deceptive advertising by intentionally using outdated studies to compare the higher doses of its medicines to lower doses of Novo’s products.
    • “Filed in a New Jersey [U.S.] District Court, the lawsuit follows a cease-and-desist order in which Novo asked Lilly to take down the advertisements. Lilly hasn’t, so the Danish drugmaker is seeking a permanent injunction to get the ads pulled and for Lilly to “conduct a corrective advertising campaign.” Lilly countered in a statement that the advertising is “truthful, it is transparent, and it is grounded in the most direct scientific evidence available.”
    • “The lawsuit comes as Lilly has gotten the upper hand in a high-stakes battle for market share. Lilly’s medicine, Zepbound, recorded $4 billion in sales in the first quarter of 2026 compared with the 18.2 billion krone, or $2.7 billion, generated by Novo’s Wegovy. The turf war escalated this year with both companies launching obesity pills that could extend the reach of weight-loss medicines.”
  • Per a Department of Justice news release,
    • “A foreign national was arrested yesterday on criminal charges related to his orchestration of a scheme to defraud Medicare over half a billion dollars for unnecessary genetic testing.
    • “Khalid Satary, 54, was charged by indictment in 2019 in the Eastern District of Louisiana as part of one of the largest health care fraud schemes ever charged by the Department of Justice. According to the indictment and court documents, from 2016 to 2019, Satary owned and operated several diagnostic testing laboratories throughout the United States that billed Medicare for expensive and medically unnecessary genetic tests. Satary allegedly conspired with dozens of patient recruiters, telemarketing call centers, and telemedicine companies to utilize deceptive marketing campaigns and illegal kickbacks and bribes to generate cancer genetic test samples that reimbursed between $10,000 to $20,000 per sample. Through his laboratories, Satary billed Medicare for over $547 million. He also allegedly paid millions of dollars in illegal kickbacks and bribes to doctors and patient recruiters. In connection with the indictment, the government seized 16 bank accounts and restrained real estate from Satary.”

From the public health and medical / Rx research front,

  • Phrma reports,
    • “A new study published in The Lancet offers some of the strongest real-world evidence to date that vaccination against human papillomavirus (HPV) is saving lives.” * * *
    • “Researchers say these findings indicate that eliminating cervical cancer is now an achievable goal. But that progress depends on maintaining timely and high vaccination rates with policies that support coverage and access to vaccines.
    • “The new findings, drawing on population-level disease surveillance, show that HPV vaccination is changing what is possible in cancer prevention.
    • “Policymakers should support policies that preserve access and help ensure families can get recommended vaccines without unnecessary barriers.”
  • Medscape adds,
    • More than 80% of patients with early Alzheimer’s disease (AD) treated with lecanemab (Leqembi, Eisai/Biogen) in routine practice remained clinically stable or improved over an average of 17 months of treatment, an interim analysis of the real-world LEADER study showed.
    • The real-world safety profile of the antiamyloid therapy was consistent with the drug’s US prescribing information, with most amyloid-related imaging abnormalities (ARIA) being asymptomatic and mild.
  • The AP relates,
    • “Road deaths are declining in the U.S. and worldwide, but lower-income countries aren’t experiencing much of the improvement, according to a study published Monday.
    • “Global rates of road injuries and deaths each fell more than 30% between 1990 and 2023, according to the study published in Lancet Public Health, which noted the progress varied from country to country.
    • “Pedestrian and vehicle occupant deaths rose over that time in six countries — including the United States. However, more recent data shows road deaths fell in the U.S. in 2024 and 2025.”
  • The New York Times tells us,
    • “Diet is one of the most important factors shaping health, but it’s surprisingly difficult for researchers to figure out what people eat.
    • “Researchers’ usual tools, like food frequency questionnaires or asking people to recall what they ate the day before, are tedious and expensive, said Christopher Gardner, a nutrition scientist at Stanford. Such efforts depend on people being candid and accurate; people forget about 15 to 20 percent of what they ate after a few days.
    • “It’s one of the reasons that nutrition research is so difficult and why the best evidence comes from small metabolic chamber studies, Dr. Gardner said. In such studies, researchers essentially “incarcerate someone,” he added. “They can’t leave. You cook the food for them, you slide it under the door, you know if they didn’t finish it.”
    • ‘But a new study, published today in the Proceedings of the National Academy of Sciences, points to a treasure trove of nutrition data: sewage. Using wastewater in North Carolina, researchers searched for traces of food DNA that had survived digestion. For less than a penny a person, they identified hundreds of foods that had been consumed — like chocolate, lettuce, turkey, blueberries, black pepper — and could even infer the socioeconomic profile of a community.”
  • The Wall Street Journal informs us,
    • “When Molly Taylor started taking Mounjaro in the fall of 2024, she marveled at the speed of results. She wasn’t overweight, but she hadn’t been comfortable in her body. Now, she could eat whatever she wanted, just in smaller portions, and people were complimenting her looks. She no longer felt self-conscious. 
    • “Then her mindset began to shift. 
    • “I gradually started to worry about what I was eating, how many calories were in it, if it was going to stop me from losing more weight,” said the 23-year-old nanny, who is studying to be a nurse in London. “I think that’s when I was starting to develop anorexia.” 
    • “GLP-1s have been hailed as miracle drugs, their rise leading to critical breakthroughs in America’s fight against obesity. Roughly 13 million Americans are now on them, according to research from JPMorgan published in February. The drugs mimic naturally occurring hormones to suppress appetite and cravings and make people feel full. For those who’ve struggled with restrictive eating and anorexia, that can be a tantalizing proposition—and a dangerous one. 
    • “Anorexia kills a higher percentage of patients than any other eating disorder, and it is the second most deadly mental illness after opioid addiction, according to data compiled by the nonprofit National Association of Anorexia Nervosa and Associated Disorders.”
  • Cigna Healthcare, writing in LinkedIn, points out,
    • “Mental health challenges rarely arrive as a single, dramatic moment. More often, they accumulate quietly—sleep gets lighter, patience gets shorter, motivation slips, and everyday tasks start to take more effort than they used to. People may still be showing up and getting things done, but with less ease, less connection, and lower reserves.
    • “Telehealth and evidence-based mental health apps can make care easier to access and easier to stick with. When support fits more naturally into real life, people are more likely to seek help sooner. That often shows up at work as steadier attention, clearer communication, more consistent follow-through, and fewer days of simply pushing through.” * * *
    • “Telehealth and mental health apps won’t solve every problem, but they can make it easier to get help sooner and stay with it. For many common needs, the evidence suggests remote therapy can be as effective as in-person care, and structured digital programs can reinforce skills between sessions. In practice, that can make day-to-day life feel more manageable.”
  • MedPage Today offers us “The Roadmap to DSM-6 — A look at conflicts of interest in the formation of psychiatry’s playbook.”
  • Health Day notes,
    • “Snoring at night might not just disrupt a partner or pets; it could also impact memory function and dementia risk.
    • “A new study in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Associationexamined the link between obstructive sleep apnea (OSA), memory and dementia risk. Researchers used cognition testing on adults aged 40 to 77 to compare people with and without the sleep disorder.
    • “Those with untreated OSA had worse cognition and memory function. They also had an increased dementia risk. 
    • “If the sleep apnea was treated, however, that changed. Adults who managed their apnea had brain testing results on par with adults without it.”
  • Per Radiology Business,
    • “A significant number of incidental breast masses are overlooked on CT scans of the chest, which could potentially lead to delays in diagnosis and treatment, researchers caution. 
    • “A new Academic Radiology analysis of incidentally detected cancers suggests that up to two-thirds of visible breast masses on emergency chest CTs go unnoticed by readers. At once center, such misses resulted in significant delays in cancer diagnosis, up to 33 months in some cases.  
    • “Although emergency chest CT scans are usually completed for other clinical indications, experts involved in the study say they present an opportunity to catch cancer earlier. However, visible lesions on these scans often are overlooked. 
    • “In recent years, especially with the COVID-19 pandemic, a significant increase in CT use in emergency departments has been observed,” Olgun Sahin, MD, with the Department of Radiology, Izmir City Hospital in Turkey, and colleagues explained. “The increasing number of chest CT scans is assumed to lead to a corresponding increase in the detection of incidental breast cancers. However, despite this increased detection potential, published data on clinical practice is striking. A retrospective study by Park et al. revealed that 64.3% of incidental breast cancers were missed in initial chest CT reporting. Similarly, Abougazia et al. recently reported 67.9% of such cases.” 
  • Per Fierce Pharma,
    • “Detailed phase 3 results suggest the two-drug combination of Gilead Sciences’ lenacapavir and Merck & Co.’s islatravir has what it takes to become the first complete weekly pill for the treatment of HIV.
    • “Two Islend clinical trials confirmed that a once-weekly, single-tablet combination of islatravir and lenacapavir (ISL/LEN) matches daily treatments like Gilead’s Biktarvy at maintaining HIV viral suppression, according to data slated for presentation at the 26th International AIDS Conference in Rio de Janeiro, Brazil. 
    • “Positioned to become the first complete weekly oral HIV treatment, ISL/LEN combines a major scientific leap with the promise of meeting diverse patient needs, Jared Baeten, M.D., Ph.D., Gilead’s clinical development lead in virology, said in an interview with Fierce Pharma.”
  • Per BioPharma Dive,
    • “Agios Pharmaceuticals has decided not to further develop one of its more closely watched medicines as a treatment for sickle cell disease due to disappointing results from a mid-stage clinical trial.
    • “The drug, called tebapivat, “did not demonstrate the level of differentiation required to support continued development,” Agios said in a statement. Tebapivat has been billed as a “next-generation” version of another Agios medicine, mitapivat, which is already approved for use in two blood disorders. These drugs work by activating the “pyruvate kinase” enzyme that’s essential for the health and survival of red blood cells.”

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

  • Modern Healthcare reports,
    • “Hospital systems are improving care transitions to help offset an expected decline of post-acute providers. 
    • “Systems are preparing for fewer post-acute referral partners, which could increase their costs, reduce revenue and slow patients’ recovery after a hospital stay. Home health, skilled-nursing, rehabilitation and hospice facilities are the focus of a sweeping fraud crackdown that has stripped some post-acute providers of their Medicare eligibility. Also, in May, the Centers for Medicare and Medicaid Services announced a six-month moratorium on new Medicare enrollment of hospices and home health agencies.
    • “The increased oversight threatens to exacerbate persistent inpatient discharge delays that are limiting access to care. Hospital systems have not experienced additional care transition hurdles yet, and executives hope expanding workforce strategies and new technology will blunt any impact.”
  • Fierce Healthcare relates,
    • “Nonprofit health systems AdventHealth and Intermountain Health announced plans Tuesday to bring Denver-area hospitals and ambulatory sites under a new, to-be-formed joint venture. 
    • “The pair have signed a letter of intent and expect to have a definitive agreement in hand “in the coming weeks” as they pursue an early 2027 close. 
    • “The proposed entity would comprise eight hospitals—five from AdventHealth and three from Intermountain—as well as “dozens” of their affiliated medical practices, clinics, urgent care and emergency centers. These represent the entirety of AdventHealth’s presence in the area, and all but one of Intermountain’s local hospitals (Intermountain Health Saint Joseph Hospital, in Denver, being the exception).”
  • and 
    • “Cardinal Health is pursuing two tuck-in acquisitions to expand its home care business.
    • “The pharmaceuticals and specialty products distributor announced on Monday it had agreed to buy AdaptHealth Corp’s diabetes health business unit and medical supply provider Strive Medical in separate deals worth $360 million.
    • “The deals will accelerate Cardinal Health’s at-home solutions’ growth strategy, the company said.”
  • and
    • “Amazon Pharmacy is collaborating with digital prescription platform eNAvvi to provide clinicians with real-time medication information and delivery options through its e-prescribing workflow.
    • “The partnership allows providers to see current pricing and stock for prescriptions, including cash pricing versus estimated insurance copays, and shows how quickly medications will reach patients, the companies said. The goal of the partnership is to support medication adherence and increase access for patients, especially for those in “pharmacy deserts.”
    • “eNavvi CEO Simon Chang said in a statement the collaboration “fundamentally changes what physicians can see and do at the moment of prescribing.”” 
  • The Wall Street Journal tells us,
    • “[The Swiss drug maker] Novartis returned to sales growth in the second quarter, reporting net sales of $14.41 billion.
    • “Core operating profit for Novartis was flat at $5.94 billion, beating analyst expectations of $5.31 billion.
    • “Novartis expects core operating profit to decline by a low single-digit percentage this year as it faces the worst patent cliff in its history.”
  • Healthcare Dive informs us,
    • “As employers grapple with worker demand for GLP-1 drugs for weight loss, 1 in 5 employers recommend employees use their FSA, HSA or integrated HRA to acquire them, according to new research from the International Foundation of Employee Benefit Plans.
    • “While most employers don’t cover GLP-1s for weight loss, many try to support workers in other ways, said Carey Wooton, associate vice president of education at the International Foundation; nearly three-quarters provide disease management and case management, more than 6 in 10 offer nutritional counseling, and a similar share cover bariatric surgery.
    • “Cost remains a major impediment to coverage. GLP-1s for weight loss represented 11.4% of annual claims for corporations in 2025, up from 6.9% in 2023, the report found.”
  • Alan Fein, writing in his Drug Channels blog, discusses “2025 Gross-to-Net Realities at Eight Top Drugmakers: The Net Pricing Drug Channel Emerges.”
  • MedTech Dive lets us know,
    • “Medtronic on Tuesday said it has developed an application for its Hugo surgical robot that enables the use of artificial intelligence to support decision-making during procedures.
    • “The Touch Surgery Aide platform incorporates Nvidia’s computing infrastructure and runs Medtronic’s AI application, called Instrument Exit Point, or IEP. The application has received Food and Drug Administration clearance, Medtronic said.
    • “Medtronic will offer an early look at the new platform this week at the Society of Robotic Surgery meeting in Florida.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity, Uncategorized–

From the War with Iran front,

  • Cybersecurity Dive reports,
    • “Threat actors linked to Iran are using artificial intelligence to enhance their cyber and information warfare capabilities, putting the U.S. and its allies at higher risk of asymmetric attack, according to a report released Thursday by Recorded Future. 
    • “Iran-nexus actors have used generative AI and large language models in a range of activities, including the development of malware, conducting research on industrial control systems, exploiting software vulnerabilities and other uses. 
    • “There are no indications yet that Iran has developed fully autonomous models, but the country is clearly using AI to accelerate its existing capabilities. 
    • “AI has not transformed Iran into a fundamentally different cyber power, but it has compressed the distance between intent and action,” Alexander Leslie, senior advisor at Recorded Future, told Cybersecurity Dive.” 

From the Project Glasswing front.

  • CRN reports,
    • “Microsoft’s unprecedented July security update—which potentially includes patches for more than 600 vulnerabilities—is confirmation that ultra-powerful AI models for discovering software flaws are already starting to signal massively bigger challenges in vulnerability management, according to MSP executives.
    • “For months, the industry has been watching for indicators that vulnerability discovery capabilities from frontier AI models such as Anthropic’s Claude Mythos would lead to increased CVEs (Common Vulnerabilities and Exposures). While some hints of this had surfaced previously, the hundreds of CVEs that received software patches Tuesday as part of Microsoft’s monthly release of software bug fixes is the clearest sign of this yet, MSP executives told CRN.
    • “Estimates of the number of vulnerabilities disclosed by Microsoft during the release, colloquially known as “Patch Tuesday,” have varied but could be above 600, according to TrendAI’s Zero Day Initiative. Dustin Childs, head of threat awareness at TrendAI, counted 621 new Microsoft CVEs for the July security update.
    • “The bug apocalypse has fully descended upon us,” Childs wrote in a post.” * * *
    • “Microsoft has been among the tech industry vendors that have received access to Anthropic’s Claude Mythos model for the purposes of proactively discovering vulnerabilities in its own products, as part of the Project Glasswing initiative announced in April. Similarly, OpenAI has provided Microsoft with access to its frontier AI vulnerability-discovery models through its Trusted Access for Cyber initiative.”

From the cybersecurity and law enforcement front,

  • Cybersecurity Dive reports,
    • “The Trump administration on Tuesday [July 14] announced the launch of a program that will coordinate the security community’s use of frontier AI models to rapidly identify and fix vulnerabilities.
    • “The vulnerability management clearinghouse, which the administration is calling Gold Eagle, is a response to the skyrocketing number of vulnerabilities that AI models are finding and the strain that that surge is placing on the security community. Through the clearinghouse, the government will coordinate efforts by private companies and independent researchers to scan critical software packages for flaws, fix any flaws that surface and deploy those fixes to end users.” * * *
    • “Gold Eagle “has already begun to intake and prioritize identified cybersecurity vulnerabilities from across industries and sectors, coordinate scanning verifications, and ultimately ensure the security of our nation’s software and networks,” the White House said in a statement.
    • “The core of the Gold Eagle program is the Vulnerability Information and Coordination Environment (VINCE), which the government is operating in partnership with Carnegie Mellon University’s Software Engineering Institute. The VINCE platform will allow anyone to report vulnerabilities to the Gold Eagle program for triage and mitigation.
    • “VINCE will enable “vulnerability and patching coordination at a speed and scale never seen before,” National Cyber Director Sean Cairncross told reporters during a briefing on Tuesday.
    • “Gold Eagle will focus heavily on open-source software, whose code underpins a wide range of critical infrastructure but is often poorly scrutinized.”
  • Dark Reading adds,
    • “Katie Moussouris, founder and CEO of Luta Security as well as a pioneer in vulnerability remediation, tells Dark Reading that the cross-sector vulnerability coordination gap Gold Eagle targets “is real,” as the Known Exploited Vulnerabilities (KEV) catalog, National Vulnerability Database (NVD), and Information Sharing and Analysis Center (ISACs) do not address cross-sector prioritization. And as she has long said, vulnerability management policy problems don’t resolve on their own.
    • “The bottleneck was never knowing about more bugs. It was having the people and process to prioritize and fix them and ensure they do not recur,” she says. “Remediation prioritization according to the new BOD 26-04 will take skills and process at each affected organization, by definition, since two and possibly three out of four of the prioritization criteria are subjective and specific per organization.” * * *
    • “Moussouris cited CISA’s recent postmortem on its AWS keys being exposed in a public GitHub repository for six months as an example of something that highlights pre-existing process weaknesses at the federal level.” * * *
    • Knostic chief AI officer Sounil Yu says that if the government wants to help stakeholders via “frontier AI capabilities,” the most useful application would be something that accelerates the implementation of vulnerability fixes.
    • “Finding vulnerabilities proactively has not been the constraint. Even finding a fix or patch has not been a significant constraint. The constraint has traditionally been in implementing the fix wherever the software has been deployed,” he says. “But if you unpack it further, it’s deploying the fix and then recertifying that everything is working as expected.”
    • “Similarly, Sachin Jade, chief product officer at Cyware, tells Dark Reading that while AI tools can surface vulnerabilities faster than anyone can currently act on them, there is also a lag in determining which findings are real, prioritizing severity, and developing and deploying a fix.
    • “This program is a good start, and we as the industry have to work collectively to sharpen our approaches, increase defense velocity, empower sharing and collective defense, and become proactive in our mindsets,” Jade says.”
  • Beckers Health IT asks and answers “Healthcare Security Teams Have More Alerts Than Ever. So Why Is Risk Still Getting Through?”
    • “People remain the core of healthcare cybersecurity. When automation handles repetitive work, analysts can focus on meaningful threats, response planning and the gaps most likely to affect the organization.
    • “IBM found that organizations extensively using AI and automation in security operations identified and contained breaches 80 days faster and experienced an average of $1.9 million less in breach costs. That does not mean technology replaces experienced professionals. It shows what can happen when they receive better-organized information sooner.
    • “The most resilient healthcare organizations will be the ones that can work through data faster, identify what is relevant and act within clear safeguards before a security gap interrupts claims or patient care.”
  • Security Week relates,
    • “The Department of War has suspended CMMC Phase 2’s mandatory third-party assessment requirement, citing concerns that the assessor ecosystem couldn’t scale to meet demand and that compliance costs were pushing small and mid-sized firms out of the defense industrial base. 
    • “A newly formed CMMC Reform Task Force will spend 60 days reviewing the program, gathering industry feedback, and reporting recommendations by mid-September. 
    • Crucially, the pause only affects independent verification, with Phase 1 self-assessment obligations, SPRS score submissions, and the underlying DFARS 252.204-7012 requirement to protect controlled unclassified information (CUI) remaining fully in effect. 
    • “Industry professionals broadly agree that the suspension pauses third-party CMMC audits but not the underlying legal obligation to protect CUI, warning that self-attestation without verification raises False Claims Act exposure. However, experts are split on whether the fix should be to scope assessments down, automate them, or preserve them largely as-is.”
  • Per a July 15, 2026, Cybersecurity and Infrastructure Security Agency (CISA) news release,
    • “Today, the Cybersecurity and Infrastructure Security Agency (CISA), in partnership with the National Security Agency (NSA), Japan Computer Emergency Response Team Coordination Center (JPCERT/CC), Netherlands’ National Cyber Security Centre (NCSC-NL), and United Kingdom’s National Cyber Security Centre (NCSC-UK), published Establishing a Coordinated Vulnerability Disclosure Program to Work With Security Researchers.
    • “This guidance helps software manufacturers and online service providers collaborate effectively with security researchers who identify weaknesses in software, networks, and hardware in a structured, transparent framework. A well-defined coordinated vulnerability disclosure (CVD) program enables software manufacturers and online service providers to better assess potential risk, improve their vulnerability management processes, and make informed decisions that improve product security for their customers.
    • “Coordinated vulnerability disclosure is foundational to building a secure software ecosystem. The practices in this guide help protect customers, strengthen products and support CISA’s Secure by Design initiative, which encourages companies to be transparent and responsible in how they build and maintain their technology,” said Acting Executive Assistant Director for Cybersecurity Chris Butera. “CISA encourages suppliers to establish a coordinated vulnerability disclosure program and build constructive, collaborative relationships with security researchers to enhance product security.”  
  • Cyberscoop tells us
    • “A total of eight cyber personnel have served in a program that began in 2022 to rotate workers between federal agencies to bolster the workforce, a watchdog report said Thursday.
    • “Over the life of the Federal Rotational Cyber Workforce program that effectively went away last year, 13 agencies offered 106 positions and received 634 applications, according to the Government Accountability Office. Eight workers won approval to participate.
    • “The goal of the Office of Personnel Management-led program, established by bipartisan legislation, was that “participating employees develop knowledge and skills that they can bring back to their home agencies,” as the GAO noted.
    • “OPM evaluated possible shortcomings in implementing the program in late 2024 and developed plans for improving it, but never followed up on them, the GAO said. As of next summer the program will officially end, OPM said.”
  • and
    • “A pair of young men were sentenced to 66 months in jail for committing acyberattack on the Transport for London that brought the network’s operations to a standstill in 2024, the United Kingdom’s National Crime Agency said Thursday [July 16].
    • “Thalha Jubair and Owen Flowers were arrested at their homes in September 2025, barely a year after the attack, and pleaded guilty last month just as their trials were set to begin. Flowers was previously arrested in connection with the attack in September, but was released after questioning by officers.
    • “Jubair and Flowers were leading members and highly involved in Scattered Spider, a nebulous hacker subset of The Com, according to researchers. The 20-year-old Jubair was a prolific cybercriminal and core member of the unbound collective. 
    • “U.S. authorities last year accused Jubair of direct, prominent involvement in at least 120 cyberattacks, including extortion of 47 U.S.-based organizations and the January 2025 attack on the federal court system. 
  • Beckers Health IT identified 11 cases from a Federal crackdown on hospital hackers.
    • “Federal authorities are intensifying their pursuit of the cybercriminals behind hospital and healthcare ransomware attacks, bringing charges against ransomware developers, state-sponsored hackers and even insiders from the cybersecurity industry.
    • “The latest move came July 14, when the Justice Department indicted three Russian nationals and two “bulletproof hosting” companies tied to $62 million in U.S. victim losses. The action is part of Operation Riptide, the FBI’s ongoing campaign against cybercrime infrastructure, after Americans reported more than $20 billion in cybercrime losses last year, a 26% single-year increase.”

From the cybersecurity breaches and vulnerabilities front,

  • HIPAA Journal posted its May 2026 Healthcare Data Breach report last Tuesday.
    • “Based on the current data on the HHS’ Office for Civil Rights (OCR) breach portal, 61 healthcare data breaches affecting 500 or more individuals were reported in May 2026. May’s current total represents a 27.1% month-over-month increase in data breaches. Over the past 12 months, an average of 64 large healthcare data breaches were reported each month.”
  • MedTech Dive reports,
    • “Abbott disclosed on Thursday [July 16] that a cyberattack hit its cancer diagnostics business.
    • The medical device company said in a statement posted to its websitethat there was unauthorized access to a limited number of internal systems in its cancer diagnostics business. There was no impact on other Abbott businesses, sites or systems.
    • Abbott’s cancer diagnostics business includes Exact Sciences, which the company acquired in a $21 billion deal earlier this year. The legacy Exact Sciences systems are separate from Abbott’s, according to the statement.
  • Beckers Health IT relates,
    • “A cyberattack on New Jersey law firm Greenbaum Rowe Smith & Davis has exposed data on 12,801 patients across three health systems in the state.
    • “Greenbaum discovered unauthorized access to its systems through a compromised user account in November 2025 and traced the intrusion to Nov. 25-27, 2025, according to the firm’s notification. Affected organizations include Edison, N.J.-based Hackensack Meridian Health, Morristown, N.J.-based Atlantic Health and Trinitas Regional Medical Center in Elizabeth, N.J., part of West Orange, N.J.-based RWJBarnabas Health.
    • “An investigation completed in April found an unauthorized third party accessed patient names, addresses, medical record numbers, medical history, provider details, medical bill amounts and health insurance information. For a subset of individuals, Social Security numbers or dates of birth also were exposed, Greenbaum said.”
  • Bleeping Computer tells us,
    • “Ernst & Young is notifying customers of a data breach caused by the compromise of a third-party support ticket system used by its IT personnel.
    • “According to the company, support tickets submitted through the platform may have included documents containing client tax information.
    • “Ernst & Young (EY) is among the world’s four largest auditing and professional services providers, offering auditing, tax, consulting, and transaction advisory services to major organizations in more than 150 countries.” * * *
    • “Ernst & Young says it secured its systems and notified federal law enforcement authorities, while it has assured that the unauthorized access has been removed.
    • “The company also states that it is not aware of any misuse or further exposure of the stolen files and has no indication that particular individuals were targeted by the threat actors.”
  • CISA added ten known exploited vulnerabilities to its catalog this week.
    • July 13, 2026
      • CVE-2008-4128 Cisco IOS Cross-Site Request Forgery Vulnerability
        • Security Affairs discusses this KVE here.
    • July 14, 2026
      • CVE-2026-15409 SonicWall SMA1000 Appliances Server-Side Request Forgery Vulnerability
      • CVE-2026-15410 SonicWall SMA1000 Appliances Code Injection Vulnerability
      • CVE-2026-56155 Microsoft Active Directory Federation Services Insufficient Granularity of Access Control Vulnerability
      • CVE-2026-56164 Microsoft SharePoint Server Missing Authentication for Critical Function Vulnerability
        • The Hackers News discusses the SonicWall KVEs here
        • Cybersecurity News discusses the Microsoft Active Directory KVE here.
        • Cybersecurity News discusses the Microsoft Sharepoint Server KVE here.
    • July 15, 2026
      • CVE-2023-4346 KNX Association KNX Protocol Connection Authorization Option 1 Overly Restrictive Account Lockout Mechanism Vulnerability
      • CVE-2026-46817 Oracle E-Business Suite Improper Privilege Management Vulnerability
        • The Hacker News discusses these KVEs here.
    • July 16, 2026
      • CVE-2026-25089 Fortinet FortiSandbox OS Command Injection Vulnerability  
      • CVE-2026-39808 Fortinet FortiSandbox OS Command Injection Vulnerability  
      • CVE-2026-58644 Microsoft SharePoint Deserialization of Untrusted Data Vulnerability 
        • Bleeping Computer discusses the Fortinet KVEs here.
        • The Hackers News discusses the Microsoft Sharepoint KVE here.
  • The American Hospital Association News adds,
    • “The Cybersecurity and Infrastructure Security Agency has issued an alert warning of four Microsoft SharePoint vulnerabilities being exploited by cyber threat actors. CISA said the vulnerabilities affect all supported on-premises versions of SharePoint Server, including the Subscription Edition, 2019 and 2016. Threat actors can establish remote code execution and perform other actions to deploy malware. CISA said organizations should monitor SharePoint Servers closely for any signs of exploitation or unusual activity. An additional vulnerability was found, but it is not yet known to have been exploited. Microsoft identified it as a potential risk if it is left unpatched. CISA urged organizations to apply the latest patches and security updates from Microsoft, among other recommendations. 
    • “Nearly everyone using Microsoft products is using SharePoint, the backbone of the Office suite,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “Hospitals with their SharePoint instances housed on premises should pay particular attention to this alert. The common vulnerabilities and exposures listed in the report have patches available, and they should be deployed as soon as possible. Hospitals should also verify that the security measures mentioned are in place.” 
  • and
    • “The Cybersecurity and Infrastructure Security Agency and other U.S. and international agencies released a joint advisory July 13, warning of Russian cyber actors targeting vulnerable network devices, primarily routers, in critical infrastructure sectors globally, including healthcare. The advisory details how the threat actors primarily use scanning to identify poorly configured devices for exploitation. The actors then exfiltrate sensitive information and facilitate malicious activity. The advisory includes recommendations to help defend against potential threats.
    • “This malicious cyber activity has been attributed to the Russian Federal Security Bureau, a foreign intelligence agency of the Russian government,” said John Riggi, AHA national advisor for cybersecurity and risk. “Therefore, this represents an advanced and persistent cyber threat targeting U.S. healthcare that should be prioritized. The first step in mitigating this threat and other nation-state cyber threas is to install the latest network router encryption standard, Simple Network Management Protocol v3.”
  • Cybersecurity Dive tells us,
    • “Businesses should be on guard for a hacking campaign in which attackers spoof OAuth client IDs to collect information about targets’ user directories, the security firm Proofpoint said on Monday.
    • “The security firm said it had observed “multiple campaigns at scale abusing spoofed OAuth application identifiers, with distinct tooling, infrastructure, and execution patterns indicating independent adoption by multiple threat actors.”
    • “The report explains how organizations should monitor their networks for this reconnaissance technique.”
  • Cyberscoop points out,
    • “Cyberstalkers are increasingly exploiting a feature in Google Chrome meant for mobile phone user convenience, but can give intruders broad access to a device owner’s private information, according to researchers.
    • “Certo Software said in a blog post Tuesday that stalkers are making use of Chrome’s sync capability — meant to make it so signing into Chrome on one device makes it easier to do so on other devices, too — to spy on a phone owner’s browsing history and gain access to their stored passwords.”
  • Bleeping Computer adds,
    • “A flaw in Anthropic’s Claude for Chrome browser extension could allow a malicious extension to trigger predefined AI actions by simulating user clicks, potentially allowing it to abuse Claude’s access to connected services such as Gmail, Google Docs, Google Calendar, and Salesforce.
    • ‘The issue was discovered by Ax Sharma of Manifold Security, who says it stems from how the Claude extension determines whether a user intentionally requested one of its built-in tasks.
    • “Chrome extensions with permission to run on a website can inject JavaScript into the page, allowing them to read and modify its contents. This includes changing page elements, reading information displayed on a site, and generating click and keyboard events programmatically.
    • “According to Manifold’s report, the Claude extension listens for click events on a specific page element that launches one of its built-in AI workflows. These workflows are predefined tasks that allow Claude to perform actions in connected services such as Gmail, Google Docs, Google Calendar, and Salesforce.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Coca-Cola on Thursday said it is investigating a ransomware attack that impacted its Fairlife dairy unit and has suspended production at the company’s U.S. production facilities. 
    • “In a filing with the Securities and Exchange Commission, the company said it trying to determine the full scope of the attack and what impact it might have on its business. Coca-Cola said the attack has had no effect on the quality and safety of its Fairlife products, which include ultra-filtered, lactose-free milk as well as protein and nutritional shakes.”
  • Per a Sophos news release,
    • “This year’s data has a few eyebrow-raising departures from the patterns of past State of Ransomware reports. Exploited vulnerabilities lost their three-year grip on the top root-cause spot. Median ransom demands and payments both dropped, yet the average recovery bill still climbed. And small organizations (100-250 employees) are falling further behind their larger peers on the one metric that matters most: stopping the attack before data gets encrypted.
    • “The seventh annual Sophos State of Ransomware report is based on a vendor-agnostic survey of 2,158 IT and security leaders whose organizations were hit by ransomware in the last 12 months.
    • “Click here to access the full report now.”
  • Dark Reading adds,
    • “According to Sophos’ survey, malicious email (26%) and phishing (24%) dethroned the three-year reign of vulnerabilities (18%, down from 32%) as the top root cause of ransomware attacks. Two-thirds (67%) of victims also said the ransomware attack they suffered was their most significant identity attack over the past year.
    • “With phishing and malicious email now accounting for half of all ransomwareroot causes in this report, organizations should deploy advanced email filtering, implement DMARC/DKIM/SPF protocols, and invest in regular phishing awareness training,” Sophos said. “The shift toward email-based attacks suggests that technical vulnerability patching alone is insufficient.”
    • “The third most common root cause of ransomware attacks was also identity related, with compromised credentials used in 23% of cases. This is particularly significant because of one of the most startling findings: Multifactor authentication (MFA) was deployed for 97% of instances where compromised credentials were the root cause of ransomware attacks.” * * *
    • While staying patched remains important as always, it appears the fight against ransomware is moving from patch management to identity protection.
    • “Organizations should prioritize identity threat detection and response (ITDR), enforce multifactor authentication across all access points, and regularly audit both human and non-human identity credentials,” Sophos said. The vendor stopped short of recommending a specific type of MFA, suggesting the biggest failure wasn’t MFA itself but rather incomplete deployment or perhaps a lack of comprehensive inventorying.”
  • InfoSecurity Magazine lets us know,
    • “The number of ransomware attacks which target government departments and agencies has risen to the extent that one has its services restricted by encryption every single day.
    • “The figure comes from analysis by researchers at Comparitech, who studied ransomware incidents which targeted government entities between January and June 2026.
    • The research, published on July 16, recorded that 187 government organizations were hit with ransomware during the first six months of 2026. That represents a 13% increase on the 165 ransomware attacks recorded during the second half of 2025.
    • “The increase in recorded ransomware events is notable because the figure of 187 incidents across 182 days means that the average number of ransomware attacks against government bodies now stands at an average of one every day.
    • “Of those 187 recorded incidents, just over half (89) were publicly confirmed by the organization which was hit.”
  • Bleeping Computers warns
    • “A new ransomware actor called Spirals completed a corporate intrusion, from initial access to data theft and encryption, in less than 24 hours.
    • “The attack occurred in June and breached an IT services firm in South Asia after compromising an Internet Information Services (IIS) server exposed on the public web.” * * *
    • “Symantec’s report provides network indicators and file hashes associated with the documented Spirals attack to help organizations worldwide set up defenses against this threat group.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports
    • “Cybersecurity mergers and acquisitions reached 219 in the first half of 2026, putting the sector on track to surpass last year’s 400 deals.
    • “The rush to acquire artificial-intelligence capabilities is driving the surge in cybersecurity dealmaking.
    • “Technology and cybersecurity companies accounted for 88% of disclosed cyber acquisition spending in the first half of the year.”
  • Cybersecurity Dive relates,
    • “Enterprise security teams are incorporating AI into their programs at a faster rate than ever before, but a significant gap exists in the governance policies that are designed to support that expansion, according to a report released Monday by the SANS Institute.
    • “Four out of 10 security practitioners said there is no formal policy in their organization for AI adoption, according to the report. More than six of 10 practitioners said they have no visibility into where AI models are being used or what kind of information is being exposed. 
    • “About 75% of security practitioners have a governance role related to enterprise AI, yet more than half of respondents said there are no established frameworks for AI audits, the report showed.”
  • Dark Reading adds,
    • “Having completed its $32 billion acquisition of Wiz earlier this year, Google is fulfilling its plan to automate threat detection, investigation, and remediation with a new “agentic defense” platform built around intelligent security agents.
    • “Wiz, founded in 2020, quickly became one of the fastest-growing cloud security companies by introducing graph-based analysis to correlate cloud assets, identities, vulnerabilities, and exposures across multicloud environments. The acquisition gives Google a cloud-native security platform that supplements its existing artificial intelligence (AI), threat intelligence, and incident response features.
    • “On Monday [July 13], Google revealed it had integrated Wiz attack surface management (ASM) and Google Threat Intelligence (TI). When Wiz ingests posture and workload telemetry from Google Cloud, it enriches detections in real time with Google TI and pushes prioritized exposure data directly into SecOps playbooks and cases, enabling SOC teams to investigate and respond to cloud‑native risks without switching between tools.
    • “The integration builds on Google’s AI Threat Defense, launched in May, and other automation capabilities that combine Gemini with Wiz’s scanning, simulation, and remediation to counter AI-powered threats. It leverages the reasoning capabilities of its Gemini AI modeling platform and other frontier models alongside Wiz’s contextual risk prioritization capabilities. Google AI Threat Defense uses Gemini’s code remediation features and CodeMender, along with expertise from Mandiant.”
  • Cyberscoop notes,
    • “As AI-enabled hacking becomes a bigger threat for cybersecurity and national security, public attention has focused on mainly a few leading frontier AIcompanies developing more powerful large language models.
    • “These models, and the billions of dollars behind them matter, but they’re only part of a larger shift. Enterprises are now building their own technology platforms that take these general-purpose LLMs and turn them into bespoke cybersecurity tools.
    • “Industry professionals refer to these tools as a “harness.” They control the model’s behavior, limit its risks, and connect it to internal IT systems and networks so it can work reliably at scale.
    • “New research from Cato Networks shared exclusively with CyberScoop shows how much power can come from a harness. It paired OpenAI’s ChatGPT 5.5 and GPT 5.5-Cyber models with its own tool and tested the abilities of the agent to hack into a victim network with as little human direction as possible.” * * *
    • “Dan Rapp, chief AI and data officer at Proofpoint, said their harness, “Satori,” has become a critical tool for keeping their agentic AI on track while giving humans the ability to step in when things go awry.
    • “I think what you’re seeing in the foundation of frontier models is you have raw intelligence, raw reasoning power, but to get these systems to perform the way you want to, both context engineering – the content provided ensuring that its accurate and relevant – and the harness engineering are essential to actually get the systems to perform well,” Rapp told CyberScoop.”
  • Dark Reading explains how to “Manage Vendor Risk in a Few Practical Steps.”
    • “Risk tolerance, exposure visibility, board oversight — handling third-party risk is complicated but achievable with disciplined, precise governance.”
  • Tech Target highlights “Multifactor authentication: 5 examples and strategic use cases.”
    • “Before implementing MFA, conduct a careful study to determine which security factors offer the strongest protection. Passwords and PINs aren’t cutting it any longer.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Politico reports,
    • “House GOP leaders released text Friday for a bill to fund the vast majority of the federal government from the start of the next fiscal year on Oct. 1 until after the midterm elections — bypassing the bipartisan appropriations process and daring Democrats to pick a shutdown fight months before voters head to the polls.
    • “Speaker Mike Johnson said Thursday he plans to put the legislation on the floor next week.
    • “The measure would fund the government through Dec. 4 and, as Republican leaders promised, would not include additional policy riders or unrelated provisions.”
  • Roll Call offers a wrap up of this week’s activities on Capitol Hill.
  • STAT News relates,
    • “Pretty much everyone who cares about public health agrees that it’s a good idea to help people quit smoking, the No. 1 cause of preventable death in the U.S. Doctors may soon get some extra encouragement to lend a hand, thanks to proposed changes in Medicare’s physician fee schedules.
    • “Physicians who offer counseling on quitting cigarettes or other tobacco products during visits with patients would get a 19% increase in reimbursement, according to a few paragraphs buried in the 1,592-page document released this week. The same adjustment would also apply to assessments of, and interventions for, alcohol and substance misuse during doctors’ visits.
    • “Given the evidence supported role these services play in preventing and managing chronic disease […] we believe that valuation should more accurately reflect the clinical intensity and work associated with these time-based services,” the proposal from the Centers for Medicare and Medicaid Services explains. Comments on the proposal are due Sept. 14. 
    • “The prioritization of cessation as a service is long overdue, and we’re very excited about it,” said Anne DiGiulio, the American Lung Association’s senior director of nationwide tobacco cessation and health policy.”
  • Health Day adds,
    • “For people assigned to smoking very low nicotine-content cigarettes (VLNCs), there is minimal evidence for compensation for reduced nicotine levels, according to a review published online July 15 in JAMA Network Open.
    • “Rachel L. Denlinger-Apte, Ph.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues examined whether people who smoke may increase their smoking to compensate for the reduced nicotine levels when smoking VLNCs for prolonged periods. Data were obtained from 17 randomized controlled trials published between 2010 and 2024, representing 5,500 adolescents and adults who smoked cigarettes daily or nondaily. A subset of 2,454 participants from seven trials were included in the pooled meta-analysis.”
  • Food Dive relates,
    • “The FDA’s acting head of food on Tuesday [July 14] admitted crafting its highly anticipated definition of ultraprocessed foods is proving “quite challenging,” though he added it’s still a “priority” for the agency.
    • “Just because it’s a tough challenge, it doesn’t mean it’s something that we should shy away from,” Donald Prater, FDA’s acting deputy commissioner for food, said during a keynote at the IFT First conference in Chicago.
  • Genetic Engineering and Biotechnology News adds,
    • “Ketogenic diets, originally developed in the 1920s to treat epilepsy, have been adapted in the past few decades as a strategy to lose weight or increase lifespan. This type of diet (a high percentage of fat, low percentage of carbohydrates, and normal or reduced amounts of protein) forces the body to burn fatty acids for energy in place of carbohydrates such as glucose. Burning these lipids produces ketone bodies—primarily β-hydroxybutyrate (BHB) and acetoacetate—as byproducts of fatty acid metabolism. The impact of ketogenic diets on the gastrointestinal tract remains poorly understood.
    • “In recent years, scientists investigated whether this type of diet might affect the development of cancer. While some research has shown that the diet may protect against the development of colon cancer, a new study suggests that in the small intestine, a ketogenic diet may increase the risk of cancer—with a mechanism through fatty acid oxidation rather than ketone metabolism.”
    • “This work appears in Nature in the paper, “Ketogenic diet mediates intestinal tumorigenesis through lipids not ketones.”

From the Food and Drug Administration,

  • Fierce Pharma reports,
    • “With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, Novartis is on its way to cornering the market for the indication.
    • “On Friday its first drug to hit the market for IgAN, Fabhalta, gained a full blessing from the FDA, with the U.S. regulator converting the drug’s accelerated approval into a traditional nod. Fabhalta is now endorsed to slow kidney function decline in adult IgAN patients who are at risk for disease progression. 
    • “The original, speedy IgAN approval for the first-in-class factor B complement inhibitor came two years ago to reduce proteinuria.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has shared updated recommendations about recalled thoracic stent grafts. Customers were previously told they could still use the devices as long as they were aware of the risk and knew how to respond if an issue occurred. Now, however, the FDA is emphasizing that these devices should be returned to the manufacturer and not be used to treat any other patients.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has temporarily halted provisions of a rule from the Trump administration meant to reshape the Affordable Care Act exchanges days before they were scheduled to go into effect.
    • “On Thursday, a Maryland district court determined the coalition of cities and provider groups that filed a lawsuit challenging the rule would suffer “irreparable harm” from the policies, including the expansion of bare-bones catastrophic coverage and stricter verification of enrollees’ eligibility for subsidies.
    • “The stay is a victory for insurers, given it staves off further disruption to the already destabilized ACA marketplaces. However, the relief may be short-lived, as some of the policies codified in the GOP’s “Big Beautiful Bill” will be enacted in 2028.”

From the public health and medical / Rx research front,

  • The Centers for Medicare and Medicaid Services announced today,
    • “As of July 17, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “COVID-19 activity is very low and stable nationally but is beginning to show early signs of an increase, mainly in the South.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Rhinovirus/enterovirus (RV/EV) activity is elevated in some regions. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 29 newly confirmed cases, the the US measles total is just 29 cases short of last year’s sobering total, the Centers for Disease Control and Prevention (CDC) said in an update today.
    • “The CDC announced 2,260 confirmed cases so far in 2026, all but 15 of them locally acquired. The total for all of last year was 2,289 infections, which was the most since 1991. The country could lose its measles elimination status this fall, which it gained in 2000.
    • Of the 2,260 cases for the year, 20% of infections are in children age 5 and under, and 70% involve kids and young adults to age 19. Six percent of patients have been hospitalized, compared with 10% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status. 
    • “No measles deaths have been reported this year, compared with three in 2025.”
  • MedPage Today adds,
    • “Declining U.S. vaccination rates have led to a resurgence in large measles outbreaks.
    • “Two papers examining South Carolina and Utah’s outbreak showed that hypoxemia and pneumonia were the most common conditions leading to hospitalization for measles.
    • “In the South Carolina report, two of 13 hospitalized patients developed measles encephalitis, a life-threatening complication that can cause brain damage.”
  • The American Hospital Association points out,
    • “A Centers for Disease Control and Prevention report released July 16 found that wastewater surveillance failed to detect an internationally circulating measles genotype that accounted for about 5% to 10% of U.S. measles cases in 2025, highlighting potential challenges of using wastewater surveillance as a public health tool. The report said that of two unrelated measles cases reported to the Wisconsin Department of Health Services in February 2026, wastewater surveillance detected one case before the case was reported. The second, caused by the international B3 genotype, was undetected. Public health officials later released a modified laboratory procedure that improved the detection of the B3 genotype. The CDC said that wastewater testing should be standardized and revalidated against circulating viruses and supported by publicly available whole-genome sequencing data.”
  • The Washington Post reports,
    • “Taylor Farms announced Friday that it is “voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market,” after federal investigators identified some of the lettuce it provided to Taco Bell restaurants as linked to one of the largest U.S. outbreaks of cyclosporiasis this summer. 
    • “The company said in a statement that it made the decision based on information provided by the Food and Drug Administration, whose investigators had traced the outbreak to “a specific independent farm” representing less than 1 percent of the U.S. iceberg lettuce supply. The company added that it would remove all iceberg lettuce from the region indefinitely “out of an abundance of caution.”
    • “The company said no other Taylor Fresh Foods products across the country are impacted. It said no Taylor Farms branded salad kits contain iceberg lettuce.” * * *
    • “Other companies have begun to respond to a parasite-borne illness that has sickened thousands, and the federal health investigation has widened beyond Taco Bell restaurants. Sysco, one of the world’s largest food suppliers, on Thursday voluntarily stopped distributing certain iceberg lettuce products from Mexico after the agency said it was tracing where the contaminated lettuce may have been distributed throughout the food supply.”
  • The Wall Street Journal explains “What to Know About the Cyclosporiasis Outbreak and How to Stay Safe”
    • “More than 30 states have reported cases of the illness. Taco Bell’s lettuce is linked to cases in at least five states.” * * *
    • “Norovirus is a highly contagious virus that can cause vomiting and diarrhea, but it typically comes on within 12 to 48 hours of exposure and lasts one to three days. 
    • “Cyclospora, on the other hand, can cause weeks of relapsing diarrhea where someone gets sick, feels better, and then gets sick again, said Caitlin Rivers, director of the Center for Outbreak Response Innovation and an associate professor at the Johns Hopkins Bloomberg School of Public Health. “It lasts much longer than a stomach bug where you’re sick for a day and you bounce back.” 
    • “Another big difference: Many foodborne illnesses, like norovirus, are highly infectious and spread between humans through something as simple as touching a doorknob. 
    • “One piece of good news: Cyclosporiasis is rarely contagious between people.” 
  • The Washington Post tells us,
    • “Plumes of thick, toxic wildfire smoke from fires burning in Canada are billowing into the United States. The phenomenon, where smoke blots out the blue sky overhead, making the air appear milky-white or even orange, has become a relatively regular fixture of summers where out-of-control wildfires in the West bring noxious smoke downwind.” * * *
    • “There’s essentially a west-to-east conveyor belt that’s pumping high-altitude smoke eastward. That’s because the smoke is surfing the jet stream, a river of swiftly moving winds in the upper atmosphere. The jet stream is cresting around a ridge of high pressure parked over the central states.
    • “The smoke is also being steered by persistent troughing, or areas of low pressure, east of the Hudson Bay in northern Quebec. That counterclockwise-spinning low induces northwesterly winds, which are winds that blow from the northwest and pump the smoke in a southeast direction.
    • “That brings surface-level smoke into the Lower 48 in copious quantities. Medium-range weather models suggest a similar pattern continues into late July, meaning smoke will continue taking this trajectory.” * * *
    • “As of early Friday morning, Chicago, Detroit, D.C. and New York City were the most polluted major cities in the world — exceeding Delhi and Kolkata, India; Jakarta, Indonesia; and most major cities in China.”
  • Kaufmann Hall notes,
    • “Less than half of adults in rural communities have had a routine medical visit or cancer screening in the past year, according to a recent survey by the Prevent Cancer Foundation. The broader survey of U.S. adults found that half of all respondents expressed concerns and confusion about the cost of medical screenings. Nearly 15% of respondents also expressed concerns about the costs of follow-up appointments and lost wages. The news comes as the American Association for Cancer Research’s latestprogress report finds that declines in cancer death rates have been slower among rural residents than those living in urban areas.”
  • The Wall Street Journal journalist lets us know “I Tested My Blood for Microplastics. I Got a Number, but Few Answers.
    • “Plastics are accumulating in our bodies, but scientists aren’t sure how bad that is for our health.”
    • “Microplastics are ubiquitous. Bottled water and processed food are big culprits. So is clothing, furniture and just about everything else.
    • “It’s hard to find things that are not made of plastic,” says Phoebe Stapleton, an associate professor in the department of pharmacology and toxicology at the Ernest Mario School of Pharmacy at Rutgers University. 
    • “And they get into our bodies through both ingestion and inhalation. There hasn’t been a tissue or organ in the body where microplastics haven’t been found. Lungs, heart, kidneys, liver, brain, testicles, the fluid in our eyes, and ovaries—all have microplastics, says Stapleton.
    • “No wonder there’s more interest in testing. The blood test has been commercially available since 2023. I purchased it for $135 through Bryan Johnson’s longevity health site, Blueprint.” 
  • STAT News informs us,
    • “For the last year, a small California startup has been making extraordinary claims about the ability of its technology to potentially treat Duchenne muscular dystrophy — and maybe a slew of other genetic diseases, too.
    • “The company, Sonothera, does not yet have clinical data. But it’s presented data in animals so stunning that other experts can’t quite wrap their minds around it.” * * *
    • “The technology in question is ultrasound — yes, the same technology used for imaging pregnancies. Sonothera is using it to deliver replacement genes into the muscles of mice and monkeys.
    • “The approach marks a radical departure in the gene-therapy field, which has long relied on viruses to ferry genes into cells. Those viruses, while occasionally powerful, have severe drawbacks. They can only deliver genes of a certain size and can only be administered once, after which patients develop immunity. If the first treatment didn’t get enough of the gene to enough cells — well, you’d better have some other fix.” * * *
    • “Answers may come soon in clinical trials. Sonothera’s backers point to multiple pieces of supporting evidence, including improved muscle function in mice. And the company is still optimizing its therapy. 
    • “For humans, Sonothera’s goals are far more modest than what was achieved in some of its studies: a 15% increase in dystrophin, while creating protein in at least 20% of a patient’s muscle fibers.”
  • Per BioPharma Dive,
    • “GSK is discontinuing trials of an experimental chronic cough medicine it bought in a $2 billion deal three years ago, announcing Friday that camlipixant had failed to meet nearly all of the goals in two Phase 3 trials. The British pharmaceutical giant said the “limited efficacy demonstrated is unlikely to transform patient care.”
    • “The termination closes a blockbuster opportunity for GSK, which hoped to add camlipixant to a portfolio of respiratory drugs that includes asthma and COPD treatments like Trelegy and Anoro. The company said it is continuing Phase 2 trials in people with irritable bowel syndrome.
    • “Camlipixant’s failure follows that of two others in the “P2X3 antagonist” class that were developed by Bayer and Merck & Co, the latter of which spent more than $500 million to gain control of its drug. The setback also clears away a threat to Trevi Therapeutics, which is advancing a different type of treatment in chronic cough.”
  • and
    • “Merck & Co.’s partner Kelun-Biotech said its experimental medicine sac-TMT helped patients with a form of lung cancer stave off disease progression better than a standard regimen including chemotherapy in a new Phase 3 study.
    • “The trial, conducted in China, included patients with locally advanced or metastastic non-squamous non-small cell lung cancer whose tumor cells don’t have enough of a protein called PD-L1. When working properly, PD-L1 helps the immune system focus on killing diseased cells instead of healthy ones. But too much or too little of this protein can throw the system off kilter.
    • “Kelun previously saw success with sac-TMT in PD-L1-positive patients and is now tackling the “negative” patients who represent what it calls a “therapeutic bottleneck.” Sac-TMT is the first so-called antibody drug conjugate to succeed in a Phase 3 study of this patient population in combination with an immunotherapy like Keytruda, Kelun said Tuesday [July 14].”

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

  • Beckers Hospital Review reports,
    • “Vascular surgery is projected to have the highest shortages of physicians, the Health Resources and Services Administration’s National Center for Health Workforce Analysis found.
    • “The HRSA workforce simulation model assesses the adequacy of the nation’s projected workforce supply for 35 physician specialties from 2023 through 2038.
    • “Across all specialties, there is a projected shortage of 141,160 full-time equivalent physicians by 2038. Only five of the 35 physician specialties are expected to see a surplus of workers. The shortages in some specialties can be mitigated by increasing the use of nurse practitioners and physician assistants, according to the center.”
  • and 
    • “Novant Health is the latest health system to launch round-the-clock virtual primary care that uses AI to assess patients before connecting them with a clinician, joining at least seven other systems offering similar 24/7 care models.”
    • The article lists seven other health systems using this model.
  • and
    • The pandemic revealed a demand for telehealth, forcing the healthcare industry to rethink how and where care could be delivered. 
    • Patients and providers alike discovered that high-quality care doesn’t have to mean an in-person visit. Hospitals, health systems and healthcare companies rapidly expanded their telehealth offerings accordingly.
    • The momentum hasn’t slowed, and today’s telehealth landscape is defined by smarter platforms, broader access and solutions designed to bring expert care directly to patients regardless of geography, mobility, or circumstance. 
    • [The article lists] 272 telehealth companies to know. 
  • STAT News relates,
    • “Every day, doctors turn to specialized calculators to make decisions about their patients’ care. Kidney performance? There’s a calculator for that. Chance of a successful vaginal birth after a previous C-section? There’s a calculator for that. 
    • “Medicine has accumulated hundreds of these clinical scores and decision-making tools, and their numbers continue to grow along with the scale of clinical data. But just because a calculator exists doesn’t mean doctors should always trust its output. 
    • “In clinical practice, a lot of the tools that we use, we genuinely have no idea how limited it is in its validation,” said health systems researcher and gastroenterologist Shazia Siddique. That is why MDCalc, the company Siddique joined last year, is launching a quality-rating system to apply to the more than 800 clinical tools and calculators that doctors use through its site.”
  • Per Fierce Pharma,
    • “Following the Independence Day holiday, the overall GLP-1 market was down 5.1% week over week as measured by total prescriptions across obesity and diabetes uses, according to IQVIA data cited by Citi.
    • “In the obesity field specifically, total scripts for Eli Lilly’s Zepbound shrank by 3.1% sequentially to a little below 660K, while Novo Nordisk’s Wegovy dipped 4.4% to about 448.5K.
    • “Against this backdrop, Lilly’s oral Foundayo seemed to enjoy a small inflection point, with a total 24,303 scripts notably breaking away from its roughly 20K level in the prior five weeks.  
    • “Meanwhile, joining the bigger trend, Wegovy pill scripts dropped to 147.5K during the week, versus about 153K the prior week or 161.5K at its peak. But the contribution of the oral version to the overall Wegovy scripts remained stable at around a third, per Citi’s note.” 
  • Per BioPharma Dive,
    • “Cash-strapped biotechnology company Jasper Therapeutics has gained a financial lifeline through a merger with a privately held immune drug developer.
    • “Jasper said Thursday it has completed an all-stock acquisition of Kira Pharmaceuticals and, alongside that deal, raised $132 million in a private stock offering. The new funding will enable Jasper, which had just $14 million in cash at the end of March, to operate through the second half of 2028. The combined company will retain the Jasper stock ticker, but have a bigger pipeline that now includes two immune disease drugs Kira has been developing.” 

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, Obesity, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Budget Committee July 16 passed a budget resolution by a 20-14 vote along party lines during a markup, paving the way for a new reconciliation bill that is narrowly focused on providing additional funding for defense, farm aid and election-related provisions. The budget resolution instructs the House Committees on Administration, Agriculture, Armed Services, and Intelligence to draft legislation by Sept. 11 that provides up to $95 billion in funding. The resolution does not include a request for committees to offset the increase in spending, and no committees with a healthcare jurisdiction received instructions. The budget resolution could be considered by the full House next week. The House and Senate must pass an identical budget resolution before moving forward with a reconciliation bill.”
  • Roll Call offers more detailed on this budget resolution process here.
  • STAT News relates,
    • “A Senate vote to halt a Medicare pilot that uses artificial intelligence to approve or deny care failed along party lines on Thursday.
    • “Republicans voted to block consideration of a Democratic-led measure, which would have stopped the Trump administration from employing prior authorization in original Medicare, where the practice is rarely allowed. The vote was 46 to 50.
    • “The White House had pushed back against the Democratic bill. Medicare officials gave a handout to lawmakers’ offices on Tuesday outlining what they say are the benefits of the test, known as WISeR.”
  • Per a Senate news release,
    • “U.S. Senators Bill Cassidy, M.D. (R-LA), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, and Bernie Sanders (I-VT), Ranking Member of the HELP Committee, applaud the unanimous vote in the Senate to pass the Older Americans Act (OAA). The bill supports the health, independence and dignity of older adults across the nation.” * * *
    • “The bipartisan reauthorization of the Older American Act marks a major step forward in strengthening the nation’s commitment to older adults. The legislation expands critical nutrition, health and community-based services. It reauthorizes OAA programs through fiscal year 2030 and makes improvements to better support family caregivers and direct care workers, Tribal seniors and those with disabilities in their communities.”
  • Per a House of Representatives news release,
    • “Large hospital systems and insurance companies will be required to be more transparent about their prices and financing practices while seniors and patients living in rural and underserved communities will have more access to better health care under [a boatload of] legislation approved by the Ways and Means Committee. Among the policies advanced by the Committee are reforms that will force health insurers and providers to be more open and honest about the cost of care before a patient undergoes treatment. Insurance companies that provide Medicare Advantage plans will also be required to disclose more information about their companies’ finances – including revenues and administrative spending – provide clearer guidelines for how they utilize the prior authorization process, and update and streamline that process to ensure seniors get timely access to care.
    • “In addition to ensuring patients have the information they need to make more informed health care decisions, the Committee also approved legislation to expand and protect access to care in rural and underserved communities – including remote patient monitoring services and anesthesia services – as well as legislation to provide long-term care sooner for the sickest patients who need it. For seniors in nursing homes, legislation approved by the Committee will ensure essential caregivers, like a family member, can enter and provide care – even during a designated emergency when other visitation rights might be suspended.”
  • The Centers for Medicare and Medicaid Services discusses the steps that agency is taking to strengthen Original Medicare and further announced
    • “On July 16, 2026, the Centers for Medicare & Medicaid Services (CMS) issued program guidancethat provides interested parties with detailed processes and requirements for manufacturer effectuation of the maximum fair price (MFP) in 2028. Sections 11001 and 11002 of the Inflation Reduction Act of 2022 (IRA) (P.L. 117-169) establish the Medicare Drug Price Negotiation Program (hereinafter the “Negotiation Program”) to negotiate MFPs for certain high expenditure, single source drugs and biological products. The program’s requirements are described in sections 1191 through 1198 of the Social Security Act (hereinafter “the Act”), as added by sections 11001 and 11002 of the IRA and subsequently amended.
    • “This draft guidance sets forth policies regarding manufacturer effectuation of the MFP in 2028 for selected drugs payable under Part B and/or covered under Part D. The Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028(“final guidance for initial price applicability year 2028”) established the MFP effectuation policies for 2026, 2027, and 2028 for selected drugs covered under Part D and such policies currently remain in effect. When issued later this year, the final guidance will supersede for 2028 only the sections of the final guidance for initial price applicability year 2028 with respect to MFP effectuation for selected drugs covered under Part D that are included and updated herein.”  
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services July 16 announced nationwide implementation of a new risk-based survey review process for high-performing nursing homes. CMS pilot tested the RBS process in more than 100 facilities in 22 states beginning in 2023. The initiative includes the addition of an icon on higher performing facilities in CMS’ Care Compare tool. CMS said the approach would reduce time required and staff members needed to conduct standard recertification surveys at higher performing facilities. All nursing homes will continue being surveyed at least every 15 months. While the RBS process would be available to all qualifying nursing homes, state agencies and CMS may still opt to use the traditional long-term care survey process based on concerns regarding residents’ health and safety, such as complaint reports, CMS said.  
    • “Approximately 12% of all nursing facilities will initially qualify for the new risk-based survey. To qualify, a nursing home must meet criteria quarterly, including a five-star overall rating on the Care Compare website, accurate data submission to CMS, zero citations indicating harm or substandard care quality in the previous survey cycle, and no recent ownership changes. CMS said that survey implementation is scheduled to begin in September following state agency training. Designations for high-performing facilities in the Care Compare tool are also expected to begin in September.”
  • Per a Health and Human Services Department news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today joined U.S. Department of Agriculture (USDA) Secretary Brooke Rollins at Tampa General Hospital to celebrate the hospital’s signing of the Trump Administration’s Dietary Guidelines for Americans.” * * *
    • “Secretary Kennedy also toured Tampa General Hospital’s cafeteria, where Chef Zakarian redesigned the menu in 2025 around the principle that food is medicine.”
  • Federal News Network tells us,
    • “Dozens of House and Senate Democrats are demanding answers from the Trump administration on its implementation of Schedule Policy/Career — a move that’s already affecting thousands of career federal employees and may be poised for expansion.
    • “A letter sent to the White House on Wednesday, obtained exclusively by Federal News Network, called for details about exactly how many positions were reclassified last month, and whether the administration plans to add to the list of those stripped of their civil service protections.
    • “Lawmakers argued that the White House has not provided enough information on who has been affected and why, compounding their concerns about Schedule Policy/Career. Signed by 53 Democrats, the letter launches an inquiry into the reach and impact of the new employment classification, while warning that the policy will politicize and undermine the federal workforce.” * * *
    • “The White House is facing a July 31 deadline to respond to the congressional demands. The White House and the Office of Personnel Management did not immediately respond to Federal News Network’s requests for comment.”
  • Meanwhile, OPM Director Scott Kupor added a post to his Secrets of OPM blog about GPPA.
    • “Then-actor Ronald Reagan immortalized the phrase – “Just win one for the Gipper” – in his 1940 portrayal of George Gipp, a young Notre Dame football player who died in 1920 after a big Notre Dame win. The phrase was Gipp’s dying words to his legendary coach Knute Rockne.
    • “In the Reagan movie, Rockne recounts the story of Gipp’s heroism and selflessness to rile up his team at halftime during a tied game against Army. Notre Dame prevailed over Army and the player who scores the winning touchdown proudly proclaims: “That’s one for the Gipper.”
    • “Reagan later popularized the phrase as part of his various political campaigns, culminating with his 1988 Republican National Convention speech endorsing former Vice President George Bush: “But, George, just one personal request: Go out there and win one for the Gipper.”
    • “Ok, back to reality.
    • “This week, OPM launched a new, modernized version the Guide to Processing Personnel Actions (affectionately known as “GPPA”). And, truth be told, I’ve been waiting with bated breath to release this post – if only to bastardize Gipp’s famous words.”
  • Tammy Flanagan, writing in Govexec, explains “why Social Security’s uncertainty is becoming a federal workforce issue.”
    • A bipartisan proposal would force Congress to confront Social Security’s long-term finances, with significant implications for retirement planning under FERS.
  • The Wall Street Journal reports,
    • “The federal government is cracking down on companies that provide ketamine for consumers to take at home, as concerns grow about misuse, adverse effects and deaths.  
    • “The Drug Enforcement Administration has ongoing multiple investigations into “bad actors” prescribing the powerful mind-altering drug online, according to a person familiar with the probes.
    • ‘In late June, the Food and Drug Administration sent warning letters to 14 online marketers citing “significant violations” and ordering them to stop selling their ketamine products. 
    • “FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision,” the agency wrote in the letters to marketers whose websites include ketaminetroches.com and legitketaminesuppliers.com. “The easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events.”
  • FYI, according to the Journal of Accountancy, the Internal Revenue Service, effective July 1, 2026, released
    • “Announcement 2026-11 modified Notice 2026-10. It revised the optional standard mileage rates for computing the deductible costs of operating an automobile for business, medical, or moving expense purposes and for determining the reimbursed amount of these expenses that is deemed substantiated.
    • “The American Automobile Association reported that the average price for regular gasoline was $2.819 a gallon on Jan. 8, and $3.890 on July 15, an increase of 38%.
    • “The revised standard mileage rates, effective July 1, are: 76 cents per mile for business, an increase from 72.5 cents, and 23.5 cents per mile for medical and moving purposes, up from 20.5 cents per mile for each. The mileage rate that applies to the deduction for charitable contributions is fixed under Sec. 170(i) of the Internal Revenue Code at 14 cents per mile.
    • “All other provisions of Notice 2026-10 remain in effect.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved enlicitide, a new oral PCSK9 inhibitor from Merck, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The approval covers patients presenting with heterozygous familial hypercholesterolemia (HeFH) as well. 
    • “This is first time an oral PCSK9 inhibitor has been approved by the FDA to lower LDL-C. All PCSK9 inhibitors on the market today are injectable—an oral option that does not require needles could make a significant impact on patient care.
    • ‘Merck is selling enlicitide under the brand name Lipfendra. Patients take a 20-mg tablet of the drug once per day in addition to following a heart-healthy diet and regularly exercising. 
    • “By harnessing the innovative science of PCSK9 inhibitors and novel macrocyclic peptide technology, Lipfendra was designed to significantly lower LDL-C in the form of a convenient once-daily pill,” Dean Y. Li, MD, PhD, president of Merck Research Laboratories, said in a statement. “This is a pivotal moment as we bring the first U.S. FDA-approved oral PCSK9 inhibitor to adults with high LDL-C, offering patients an important new option. We’re proud of our work with regulators on this rigorous and efficient review process.” 
  • The Washington Post adds,
    • “These [oral PCSK9 inhibitor] drugs are an important line of defense for people whose cholesterol won’t come down enough with a statin alone. 
    • “Some patients do not respond well to a statin, which is the standard, low-cost treatment for high cholesterol. In many cases that is because of a condition called hypercholesterolemia, an inherited disorder. 
    • “Other patients may not be able to tolerate the side effects of a statin, which can cause muscle pain, weakness and headaches, as well as gastrointestinal issues.
    • “There are some patients who can’t tolerate statins, or they can’t tolerate statins at a high enough dose to achieve their LDL goals,” Michos said. “The reality is there’s a huge unmet need — lots of patients out there who are not at their goal.”
    • “And for people who don’t want to inject themselves, the new pill presents an alternative.”
  • The article delves into related topics, like potential side effects.
  • Bloomberg notes,
    • “Merck priced the drug at $10.50 a day [or approximately $3800 annually], a level that should provide broad access regardless of insurance, including the majority of Medicare patients with coinsurance requirements, spokesperson Julie Cunningham said in an email.
    • “The medicine will likely have other competition. AstraZeneca Plc is also developing a cholesterol pill, with studies showing it halved levels of so-called bad LDL cholesterol in a mid-stage trial last year.”
  • The Lupus Foundation tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to EMD Serono’s investigational drug, enpatoran, for the treatment of systemic lupus erythematosus (SLE) in those with active cutaneous skin manifestations. This designation is given only to therapies that show early promise for serious conditions and signals the FDA’s commitment to speeding up their development and review. This announcement marks a significant milestone for the lupus community, as there are currently no approved targeted therapies specifically for lupus skin manifestations.

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Investigators have linked shredded iceberg lettuce supplied to Taco Bell restaurants by Taylor Farms [based in Salinas, Calif.] as a potential source of contamination in the outbreak of a parasitic illness that has sickened thousands in United States, according to two individuals familiar with the investigation.
    • “The two spoke on the condition of anonymity to share details of the ongoing investigation.
    • “This summer’s outbreak of cyclosporiasis has been largely concentrated in southeastern Michigan, where more than 4,300 cases have been reported and at least 100 people have been hospitalized as of Thursday.”
  • FEHBlog observation: Taylor Farms sells its prepackaged salad products in Dripping Springs Texas where the FEHBlog lives so he expects that its products are widely offered. Stay clear of pre-packaged lettuce. Heads of lettuce are less expensive anyway.
  • The New York Times explains
    • “The New York Times publishes maps that track air quality and wildfire smoke nationwide. Fire.AirNow.Gov also show the air quality index in a given area, which can help you determine if you should limit the amount of time you spend outdoors [due principally to the Canadian wildfires].
    • “Air Quality Index values above 100 mean that outdoor air may be unsafe for people who are at higher risk of getting sick. (More on that below.) The Centers for Disease Control and Prevention has said that some people could experience health effects at levels between 151 and 200, and that these might be more serious for high-risk people. Levels over 200 are considered “very unhealthy” for anyone. An AQI between 301 and 500 means pollution levels are hazardous, and even more likely to cause health issues.”
  • The article offers additional information about protecting your health in smoky conditions.
  • Health Day relates,
    • “Obesity prevalence has risen substantially since 1999 and now affects more than 40 percent of U.S. adults and 20 percent of U.S. youths, according to a study published online July 6 in Circulation.
    • “Anum S. Minhas, M.D., from Johns Hopkins University in Baltimore, and colleagues used data from a median of 8,687 participants from each cycle of the National Health and Nutrition Examination Survey between 1999 and 2023.
    • “The researchers found significant increases in the prevalence of obesity (30 to 41 percent), severe obesity (5 to 10 percent), and abdominal obesity (48 to 61 percent) among adults (aged 20 years and older). These increases were seen for all adult age groups; adults 40 to 59 years old had the highest prevalence of overall obesity at the end of the study period. Women had higher end-point prevalence estimates than men for severe obesity (13 versus 7 percent) and abdominal obesity (70 versus 51 percent). Across survey cycles, non-Hispanic Black adults consistently had the highest prevalence of obesity, severe obesity, and abdominal obesity versus other race and ethnicity groups. Similar trends were seen in youths (younger than 20 years), with increases in prevalence estimates of obesity (15 to 22 percent), severe obesity (1 to 3 percent), and abdominal obesity (21 to 27 percent) during the study period.”
  • MedPage Today tells us,
    • :Epidural analgesia during labor was not linked with neonatal neurological morbidity or other adverse neonatal and pediatric outcomes.
    • “Epidurals are the most effective pain relief in labor but their impact on neonatal health remains understudied.
    • “This study was among Scottish women, who opt for epidural analgesia at far lower rates than U.S. women.”
  • Healio informs us,
    • “The weekend warrior-style exercise pattern may effectively lower risk for development of cardiometabolic disease among people with hypertension, according to a study published in the Journal of the American Heart Association.
    • “Achieving the majority of guideline-recommended physical activity over the weekend reduced risk for first cardiometabolic disease to a similar level vs. those who reach their goal throughout the week, researchers reported.”
  • and
    • “A highly sensitive blood test can detect signs of pancreatic cancer that standard methods often miss, according to results of a prospective cohort study.
    • “Digital droplet polymerase chain reaction (ddPCR) analysis performed upon diagnosis of localized disease detected KRAS-mutant circulating tumor DNA (ctDNA) nearly four times more often than more widely used next-generation sequencing, with results strongly predicting survival.
    • “Administration of ddPCR after chemotherapy or surgery also detected traces of ctDNA with the key genetic mutation at considerably higher rates, suggesting it more effectively identifies patients with residual disease who are at greater risk for recurrence.”
  • Cardiovascular Business points out,
    • “As transcatheter aortic valve replacement (TAVR) gains more and more momentum as a go-to treatment option, many patients with severe aortic stenosis are still missing out on the procedure. Can advanced artificial intelligence (AI)algorithms make a difference? 
    • “That was the question behind ALERT, a clinical trial presented at ACC.26 and simultaneously published in JACC.[1] Lead author Wayne B. Batchelor, MD, a veteran interventional cardiologist and president of Inova’s medicine service line, and colleagues aimed to learn if AI software from Chicago-based Tempus could be used to alert clinicians when suspicious findings turn up on a patient’s echocardiography results. 
    • “Batchelor is participating in an upcoming webinar to discuss ALERT at length and explore the potential impact AI-enabled clinician alerts can have on patient care.” * * *
    • “Cardiovascular Business and Medtronic are hosting the free webinar on Wednesday, July 22, at 6 p.m. ET. A live Q&A session will follow the presentation.
    • “Click here to register or view additional details.”
  • and
    • “A surgeon in Michigan has performed the world’s first single-port robotic mitral valve repair, highlighting a new minimally invasive treatment option for leaky mitral valves. 
    • “The surgery typically requires a five-port technique. This new single-port approach, however, saves patients a lot of pain and helps them recover much more quickly. Rakesh M. Suri, MD, DPhil, regional director of cardiac surgery robotics and innovation at Corewell Health William Beaumont University Hospital, performed the procedure.
    • “For two decades, we’ve worked to make heart surgery safer and less invasive,” Suri said in a statement. “With single-port robotic surgery, we can now repair the heart through one small robotic port and a tiny access incision—streamlining the procedure, reducing complexity and enhancing safety—ultimately delivering a better experience and better outcomes for patients.”
    • “The patient undergoing this historic procedure was Patrick O’Brien, a 60-year-old male and longtime Corewell Health patient.”  
  • Per BioPharma Dive,
    • “Veradermics on Wednesday delivered another research win for its experimental baldness drug, showing it can help women with mild-to-moderate pattern hair loss.
    • “The pill, known as VDPHL01, is an extended-release version of minoxidil, sold for decades under the brand name Rogaine. Veradermics theorized that prolonging exposure to the medicine would allow more consistent and intense hair growth while avoiding spikes of drug concentration that can cause side effects.
    • “The new Phase 2 study followed 28 women who took the pill either once or twice a day. Results across both groups were similar, with a mean increase of about 23 hairs per square centimeter after six months of treatment. Importantly, a majority of participants and researchers reported seeing improvement at the earliest check-in point of two months, Veradermics said.” 

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

  • The Wall Street Journal reports,
    • “UnitedHealth Group reported results well above analysts’ expectations and substantially raised its earnings projection for the year, moves likely to bolster Wall Street’s belief in the healthcare company’s financial turnaround.’ * * *
    • “The announcement comes a little more than a year after Chief Executive Officer Stephen Hemsley returned to the top job, promising major changes after a financial meltdown.
    • “For the second quarter of 2026, UnitedHealth reported net income of $5.48 billion, or $6.04 a share. That compared with net income of $3.41 billion, or $3.74 a share, a year earlier.
    • “On the back of that strength, UnitedHealth raised its guidance for full-year adjusted earnings to a range of $19.50 to $20 a share, from a prior floor of $18.25. The FactSet consensus was $18.49.
    • “It’s almost like we’re doing a reset on guidance,” said Wayne DeVeydt, UnitedHealth’s chief financial officer, in an interview. The company had been cautious about expectations after the first quarter, but now feels that the trends it saw then are durable, he said.”
  • Beckers Payer Issues adds,
    • “UnitedHealthcare is joining the choir of insurers calling for an overhaul of the No Surprises Act’s arbitration system.
    • “The IDR process is not working, certainly not as Congress intended it, and it needs to be reformed,” Dan Kueter, CEO of the insurer’s employer and individual business, said on UnitedHealth Group’s second-quarter earnings call July 16.
    • “Mr. Kueter said the independent dispute resolution process is “being exploited by select providers and select geographies,” adding about 50 basis points of incremental cost trend in 2026 and now accounting for at least 100 basis points of total commercial cost at the company.
    • “According to the insurer, upwards of 40% of claims that enter the IDR process are ineligible, and roughly 60% of arbitration cases are brought by just five entities, a concentration Mr. Kueter said marks a shift from prior years. When arbiters side with out-of-network providers, the average payout is now 11 times what Medicare would pay, with some determinations reaching 30 times Medicare rates, he said.”
  • Beckers Health IT points out,
    • “CVS Health wants to position itself as the primary data host for the Trump administration’s push on healthcare interoperability, CEO David Joyner told Politico in a July 16 interview.
    • “Mr. Joyner, who oversees a company spanning pharmacies, primary care clinics and health insurer Aetna, said fragmented data systems keep patients from making informed care decisions. He argued that opening up data access, paired with artificial intelligence, would let CVS serve as a connective layer between hospitals, pharmacies and health plans.
    • “The company’s Health100 app is central to that strategy. Mr. Joyner described it as a personal health assistant that uses AI to suggest alternatives to emergency room visits and coach patients through care decisions.
    • “Mr. Joyner’s remarks come as the Trump administration has stepped up scrutiny of health information blocking and pushed health IT developers, insurers and other industry actors toward more open data-sharing practices.
    • “Affordability is also driving the strategy. CVS Health needs to be “part of the solution as opposed to the problem,” Mr. Joyner told Politico, pointing to hospitalization utilization and drug manufacturer pricing as the largest drivers of healthcare costs ahead of the midterms.”
  • The Wall Street Journal relates,
    • “Eli Lilly LLY has struck a deal to buy mental-health-focused AtaiBeckley ATAI  for an initial $2.8 billion, continuing the drugmaker’s recent buying spree.
    • “Eli Lilly on Thursday said it would pay $6.75 a share in cash for AtaiBeckley, a 26% premium to Wednesday’s closing price of $5.36 for the New Yorkclinical-stage biopharmaceutical company.
    • “The deal also includes contingent value rights worth up to an additional $1 billion, or $2.50 a share, tied to AtaiBeckley’s pipeline of therapeutics for mental-health conditions, including psychedelic therapies such as its lead program BPL-003, which is aimed at providing relief from treatment-resistant depression, Eli Lilly said.
    • “The contingent value rights bring the total potential deal value to $3.8 billion, or $9.25 a share.”
  • Fierce Healthcare tells us,
    • “GE HealthCare and a six-hospital New York nonprofit health system have struck a 10-year, $500 million strategic partnership that will outfit the provider’s facilities with advanced imaging, AI and other technologies.
    • “The deal with Catholic Health, referred to by GE HealthCare as a Care Alliance, is among the medical technology company’s largest such partnerships to date and is expected to result in new service line expansions as well as improved care, the partners said in their Thursday morning announcement. 
    • “It’s slated to add more than 1,300 new pieces of technology across over 40 hospital and outpatient sites, about half of which will arrive within the agreement’s initial three years. The first rollouts will hit care sites “within months,” per the announcement, and include contrast-enhanced mammography, diagnostic imaging capabilities for multiple modalities and maternal-infant care monitoring tools.”
  • Beckers Hospital Review informs us,
    • “New York City-based NYU Langone Health is adding two physician practices in Palm Beach County, Fla., as the system builds a larger ambulatory care campus in West Palm Beach.
    • “NYU Langone Medical Associates—Palm Beach Gardens opened earlier this month, according to a July 15 health system news release. The practice offers internal medicine, cardiology, rheumatology, orthopedics, gynecology and gastroenterology. Three physicians are joining the location: Madina Ray, MD, relocating from NYU Langone Hospital—Brooklyn to provide rheumatologic services; Sterling McClain, DO, for gynecologic services; and Rami Elkhechen, MD, who is moving his existing South Florida sports orthopedic practice to the new site.
    • “A second location, NYU Langone Medical Associates—Boynton Beach, will open in September, offering internal medicine, urology and gynecology.
    • “With each new location, we are making it easier for patients across Palm Beach County to access the comprehensive, coordinated care they need close to home,” Oren Cahlon, MD, executive vice president, vice dean for clinical affairs and strategy, and chief clinical officer at NYU Langone, said in the release.”
  • and
    • “Drug costs are emerging as one of hospitals’ fastest-growing expense categories, outpacing labor and other nonlabor costs as organizations continue to navigate a challenging financial environment, according to Kaufman Hall’s latest “National Hospital Flash Report.”
    • “Nationally, drug expense per adjusted discharge increased 11% compared to 2023, one of the largest increases among major hospital expense categories. Drug expense per calendar day also rose 5% year over year and 25% compared to 2023, exceeding the growth rate for labor and total operating expenses.
    • “The trend is especially pronounced at the nation’s largest hospitals.”
  • and
    • “Ambulatory surgery center operator Amsurg has acquired five North Carolina-based endoscopy centers. 
    • “The newly acquired facilities are located in the eastern and central portions of the state and provide patients with a team-based approach to managing acute and  chronic gastrointestinal conditions, according to a July 14 news release. 
    • “Each of the five centers will continue providing high-quality care while benefiting from Nashville, Tenn.-based AmSurg’s operational expertise, clinical resources and growth support, according to the release.
    • “The acquisitions come just over a month after Amsurg was acquired by St. Louis-based Ascension in a deal valued at about $3.9 billion. As a condition of FTC approval, six divested Amsurg facilities are being picked up by Optum subsidiary SC Affiliates, adding to UnitedHealth’s already sizable ASC network.”
  • and
    • “Rochester, Minn.-based Mayo Clinic has deployed roughly 150 AI models across its health system, CNN reported July 16. 
    • “The tally, according to Matthew Callstrom, MD, a radiologist and medical director of the health system’s generative AI program, spans tools built with partners including Microsoft and Scale AI, drawing on Mayo Clinic’s patient records and research. 
    • “One example, a documentation tool called Record Time, was developed with Scale AI to help physicians parse patient files before visits. Alexander Ryu, MD, an internal medicine physician and vice chair of innovation for Mayo Clinic’s Department of Medicine, told the publication the tool saves him five to 30 minutes of prep time per patient by organizing records chronologically and surfacing key details.
    • “Mayo is also running a clinical trial testing whether AI can flag early-stage pancreatic cancer, a disease often not caught until it has spread.” 

Midweek report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Fedweek reports,
    • “Although it is only mid-July, time is running short for Congress to act on bills to fund federal agencies after the September 30 end of the current fiscal year, as well as on the annual must-pass defense authorization bill.
    • “While schedules are subject to change, after next week Congress is scheduled to be in session only four weeks in September until the week after the November elections. Of the dozen regular appropriations bills, the House has passed just [three] and the Senate none.
    • “Typically, in such a scenario Congress would extend current funding levels until sometime in November or even December to buy more time. However, the record-setting shutdown of last fall and the DHS-only shutdown of earlier this year have shown that both Congress and the White House are willing to allow funding to lapse in pursuit of budgetary and program goals.”
  • Healthcare Dive relates,
    • “Physicians billing Medicare would see a pay dip next year as part of a sweeping reimbursement rule that also aims to increase provider participation in accountable care organizations and overhaul quality reporting.” * * *
    • “Provider groups slammed the proposal, arguing that the payment cut would destabilize physician practices and limit investment in primary care.
    • “The updates “fall well short of what it actually costs our members to deliver care,” said Dr. Jerry Penso, president and CEO of the American Medical Group Association.”
  • Fierce Healthcare adds,
    • “New legislation introduced in the House by leaders of both parties’ doctors caucuses takes a crack at providers’ long-requested overhaul of annual physician payment adjustments.
    • “The Patients First Act (PDF of bill text) would eschew the year-to-year reimbursement formula established under 2015’s Medicare Access and CHIP Reauthorization Act (MACRA) to instead tie physician reimbursement to an inflationary measure. The formula would take the Medicare Economic Index and subtract one percentage point. The approach answers years of alarm from physicians and medical groups that the costs of running a practice have grown far faster than reimbursement.
    • “We often talk about expanding access to high-quality care, but without meaningful Medicare reimbursement reform, that mission becomes nearly impossible to achieve,” Rep. John Joyce, M.D., R-Pennsylvania, one of the bill’s cosponsors, said in a statement. “Putting patients ahead of politics, we worked together to develop this comprehensive legislation to address a system that has for far too long undermined patient access to affordable, physician driven care within their communities.” * * *
    • “Jerry Penso, M.D., president and CEO of The American Medical Group Association (AMGA), said the trade group was particularly encouraged by the inflation-tied pay updates and formal rulemaking requirement for mandatory models.  “We appreciate this physician-led policymaking process, as these members of Congress know firsthand how federal policies impact medical practices,” Penso said.”
  • Roll Call lets us know,
    • “A bipartisan pair of House members is introducing legislation aimed at treating millions of Americans of a deadly-but-curable liver disease, the culmination of a yearslong push from public health advocates.
    • “The bill, sponsored by Reps. Mariannette Miller-Meeks, R-Iowa and Diana DeGette, D-Colo., would create a national hepatitis C elimination program to expand testing and treatment especially for people least likely to access it, including those who are incarcerated, uninsured, low-income, or receiving care through the Indian Health Service.
    • “The legislation would also direct the federal government to enter into five-year subscription agreements with at least one drug manufacturer to purchase unlimited hepatitis C treatments at a fixed price. That could make a big difference in expanding access to the drug, which can cost tens of thousands of dollars per course of treatment.
    • “Hepatitis C is beatable. We have the tools to eliminate it, and this bill puts them within reach of the Americans who need them most,” Miller-Meeks said in a statement.”
  • STAT News tells us,
    • “Medicare regulators on Tuesday proposed to ban vendors from providing remote patient monitoring services on behalf of doctors, a major policy change for a rapidly growing care model that’s been the subject of increasing scrutiny.
    • “Medicare has covered remote patient monitoring since 2018, and payments ballooned to over $500 million in 2024. The proposed change follows widespread concern from the health department’s watchdog, academics, and insurers that the current remote monitoring system is paying for low-value services. If finalized, the rule would impact a large percentage of remote monitoring care as it’s delivered today.”
    • “The update comes as the Trump administration moves to rein in fraud and wasteful spending in the Medicare program. The Centers for Medicare and Medicaid Services also recently launched an alternative model to pay for digital health services. 
    • “Currently, health systems and other primary care providers are allowed to bill when they use a vendor to help patients manage conditions using data collected at home. In one common use case, a vendor’s clinical staff can keep tabs on a patient’s home blood pressure readings and provide guidance to help get a patient’s hypertension under control. If needed, the patient can be referred back to their doctor. 
    • “The proposed change, included in a draft fee schedule from CMS, would require the remote monitoring services to be performed by clinical staff employed by the health care provider billing Medicare.”  
  • Fierce Healthcare adds,
    • “The Centers for Medicare and Medicaid Services has joined lawmakers who have questioned the role of the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) in government healthcare.
    • “Tuesday’s Calendar Year 2027 Physician Fee Schedule proposed rule included, among other policy proposals, a call for public comment “on a number of areas regarding the influence of the CPT coding system and AMA process on physician payment policy as part of the Secretarial priority to Make America Healthy Again.” * * *
    • “CMS asked the public to describe any evidence of “harms or challenges associated with AMA’s monopoly over CPT-4 licenses,” and whether the development of new codes is based on identified medical necessity. The agency also asked for input on any potential alternatives to the AMA’s standards and processes, and floated the Internal Classification of Diseases, 10th Revision (ICD-10) procedure code as an option worth considering.”
  • Per the American Hospital Association News,
    • “The AHA July 15 responded to a request for information from the Centers for Medicare & Medicaid Services on the Affordable Care Act’s Essential Health Benefits framework, which creates the guardrails for defining comprehensive insurance coverage. The AHA supported updating the EHBs to reflect a changing healthcare landscape but cautioned CMS against changes to the EHBs that would dilute coverage, noting that affordability cannot be measured by premiums alone and that adequate coverage is essential for true affordability.”
  • and
    • “The Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Department of Health and Human Services July 15 released a request for information on topics regarding Clinical Laboratory Improvement Amendments of 1988 regulations. Topics include breath testing, laboratory processes and procedures, emergency preparedness, biosafety and biosecurity, cybersecurity and specialty testing areas. The agencies will accept comments through Sept. 14.”
  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the Guide to Processing Personnel Actions (GPPA) Navigator, a new digital tool that modernizes how federal Human Resources (HR) professionals access and apply personnel action guidance.
    • “The GPPA Navigator transforms decades of document-based guidance into an intuitive, searchable digital experience, giving more than 40,000 federal Human Resources specialists across government faster access to the codes, authorities, and policy guidance needed to process personnel actions accurately and consistently.
    • “The launch coincides with OPM’s comprehensive review and modernization of the Guide to Processing Personnel Actions, which streamlined content, removed outdated material, and incorporated recent policy updates to better serve today’s federal workforce.”

From the Food and Drug Administration front,

  • Fierce BioTech reports,
    • “After pausing a controversial policy to publicly release drug rejection letters in April, the FDA today confirmed that the pause has been lifted and that more documents will be coming down the line.
    • “A spokesperson for the Department of Health and Human Services told Fierce last week that the policy to release complete response letters (CRLs) in real-time had been temporarily suspendedin April, the first time the pause was confirmed. Mere days later, the agency dropped a new batch of 14 CRLs, raising questions about the policy’s status.
    • “FDA will continue to proactively publish appropriately redacted CRLs, building on the batch released on July 10,” the spokesperson told Fierce today.”
  • Reuters relates,
    • “The U.S. FDA has approved Celcuity’s (CELC.O) drug for an advanced form ​of breast cancer, the regulator said on Tuesday, making it the ‌company’s first product to gain market entry.
    • “The Food and Drug Administration’s approval was based on ​late-stage data showing the drug, gedatolisib, branded as Revtorpyk, when combined with ​Pfizer’s (PFE.N) Ibrance and fulvestrant, reduced the risk of disease progression or ⁠death by 76% compared with fulvestrant alone.”

From the U.S. public health and medical / Rx research front,

  • STAT News reports,
    • “Sen. Lindsey Graham’s death Saturday at age 71 following an aortic dissection has focused attention on the life-threatening condition. Details about his diagnosis and treatment are not available while a final death certificate is pending, but experts agree on both how serious it is and how suddenly it erupts after a long prelude.” * * *
    • “Echocardiograms and CT scans offer a picture of blood vessel health, with guidelines based on vessel width dictating when surveillance should begin. Surgery can correct the problem, but it’s a major, high-risk operation to replace the weakened aorta with a graft. Another option is a minimally invasive repair that threads a stent into the artery to close the torn vessel lining. 
    • The challenge is determining who might benefit.
    • That’s where AI might help, Cardiologist Eric Topol, who is also director of the Scripps Research Translational Institute, said, something scientists are exploring. 
    • “We are terribly weak at predicting who is going to progress from a widened aorta into a dissection, unfortunately. Where AI could make a huge contribution is to help pinpoint the people at risk because we waste a lot of imaging, putting people through all these MRIs and CTs and echoes on a frequent basis and only a very small proportion of those actually go ahead and have a dissection,” he told STAT. “Our ability to discriminate is very weak. And we need help.” 
  • Cardiovascular Business adds,
    • High cholesterol and other modifiable risk factors are responsible for a vast majority of deaths from ischemic heart disease (IHD) in the United States, according to a new analysis published in JAMA Cardiology. There has been progress in recent decades, researchers noted, but there is still a lot of work to do. 
    • “U.S. IHD mortality declined between 1980 and 2010 due to improved prevention and treatment,” wrote first author Catherine P. Benziger, MD, a cardiologist with Essentia Health, and colleagues. “Since 2010, this trend has slowed or reversed in most states due to plateaus in risk factor improvements, shifting risk factor exposures and fewer treatment advances.”
    • To learn more about the current state of this trend, Benziger et al. reviewed data from the Global Burden of Disease Study 2023. Overall, the group found that there were 473,000 IHD-related deaths in the United States in 2023. This is a significant improvement in many ways; IHD mortality was down 58.7% from 1990 to 2023 and down 19% from 2010 to 2023. However, the team’s research also identified a number of statistics that show just how much more work there is still to do when it comes to combatting these modifiable risks.
    • “One key takeaway from this analysis is the fact that modifiable risks were responsible for 88.7% of deaths from IHD. The encouraging news is that 127,000 fewer IHD deaths were linked to modifiable risk factors in 2023 than in 1990—and that comes at a time where the U.S. population has increased and grown older. Tobacco use, lead exposure and air pollution were all associated with a significantly lower number of IHD deaths in 2023, highlighting progress the country has made over the years. 
    • “The less encouraging news is the fact that some metabolic risks are on the rise, including high body mass index (BMI) and high fasting plasma glucose.”
    • “Current guidelines recommend screening at age 35 years and sooner if overweight or obesity is present, yet less than half of eligible U.S. adults report glucose testing, potentially due to issues including healthcare access, clinician guideline familiarity or patient care-seeking practices,” the authors wrote. “Glycemic and blood pressure control among U.S. patients with diabetes declined from the late 2000s onwards after a decade of progress in the late 1990s to early 2000s.”
       
  • The New York Times notes,
    • According to a New York Times analysis of provisional mortality data from the Centers for Disease Control and Prevention, the [illegal] drug death rate in Arizona last year overtook West Virginia’s for the first time since the proliferation of prescription painkillers in the late 1990s. Arizona and New Mexico now have the highest rate of drug deaths in the contiguous United States.
    • The rising drug deaths in the Southwest are in sharp contrast to the large-scale decline that has returned the U.S. drug death rate to its pre-Covid level. The reasons for this decline are still a matter of debate. 
  • CNN relates
    • “A yearly physical is the standard preventive measure for adults, but many Gen Z patients are forgoing regular doctor appointments.
    • “More than 1 in 4 young adults don’t have a primary care provider, according to a recent national survey by the Ohio State University Wexner Medical Center.
    • “For Gen Zers who do have a physician, most skip scheduled checkups or don’t schedule them: Only 47% of 18- to 29-year-olds said they have had an annual wellness visit in the past year, according to the survey findings, released June 29.” * * *
    • “An annual visit isn’t just about today’s health — it helps identify future risks, keeps preventive care on schedule and gives you a trusted clinician who knows your medical history and can help navigate health concerns, be they physical health or mental health concerns, as they arise,” said CNN wellness contributor Dr. Leana Wen, an emergency physician and clinical associate professor at George Washington University, in an email to CNN. Wen was not involved in the study.”
  • MedPage Today tells us,
    • “CDC survey data showed a 27% decline in healthcare-associated infections in U.S. hospitals from 2015 to 2023.
    • “The drop was driven primarily by declines in C. difficile infections, central catheter-associated bloodstream infections, and catheter-associated urinary tract infections.
    • “Meanwhile, the researchers said there was still room for improvement regarding surgical-site infections and infections not associated with devices or procedures.”
  • and
    • “Very high levels of plasma phosphorylated tau 217 (p-tau217), a marker of amyloid burden in the brain, predicted future risk of cognitive impairment among older adults who were initially unimpaired, a multicohort study suggested.
    • “Using different plasma assays and definitions of cognitive impairment across six cohorts, a “consistent pattern” emerged: those with very high p-tau217 had an estimated 38% risk of cognitive impairment over 5 years and an estimated 78% risk over 10 years, reported Rachel Buckley, PhD, of Mass General Brigham in Boston, at the Alzheimer’s Association International Conferenceopens in a new tab or window. The findings were published simultaneously in JAMAopens in a new tab or window.
    • “P-tau217 provided predictive information beyond amyloid PET, suggesting it may capture aspects of Alzheimer’s disease biology not explained by amyloid plaques alone, Buckley said.”
  • Reuters points out,
    • “Potential signs of frailty in older adults taking Eli Lilly’s GLP-1 obesity drug Zepbound may signal relatively high risks for adverse outcomes, according to a large study that underscores concerns about how best to monitor seniors as U.S. Medicare expands access to GLP-1 therapies.
    • “In general, frailty-associated conditions ‌such as malnutrition, dehydration and loss of muscle mass and strength developed only rarely and the results should not discourage appropriate use of Zepbound, known chemically as tirzepatide, ‌or Novo Nordisk’s GLP-1 drug Wegovy, also known as semaglutide, in older adults, the study’s researchers said. Instead, they encouraged closer follow-up of older patients taking the medicines.”
  • KFF Health News informs us,
    • “Thousands of Americans who undergo a common knee surgery might be making their problems worse rather than better.
    • “Researchers who followed patients for 10 years after they received either the actual procedure, arthroscopic knee surgery to trim degenerative cartilage tears, or merely “sham surgery” — a skin incision — for knee pain, found that the surgery provided little or no benefit and was, in fact, associated with accelerated osteoarthritis and higher rates of reoperation. That generally meant a total knee replacement.
    • “I don’t know how I would defend this procedure at all,” said one of the study’s authors, Teppo Järvinen, an orthopedist and the head of the Finnish Centre for Evidence-Based Orthopaedics. “What has been shown dramatically is that patients who have this procedure have more pain — they do worse. All the scores pointed in the same direction.”
    • “Järvinen said the Finnish study, published in April in the New England Journal of Medicine, was the first to show the surgery left many patients worse off. Though the study was small, the results were compelling, he said, because his team picked the patients “most likely to benefit.”
    • “The study does not apply to cartilage tears incurred from an acute pain-causing injury. It included subjects middle-aged or older who were experiencing knee pain and whose MRIs showed cartilage tears.”
  • Health Day adds,
    • “About 5 million Americans are thought to be using an opioid painkiller to ease their chronic pain. 
    • “A new study suggests that the safest route to reducing use of the powerful drugs is best left up to the patient.
    • “For patients, I think the data are reassuring that if opioids are tapered the right way, meaning a patient-centered approach, people can significantly reduce their opioid doses without having increased pain long term,” said study lead author Beth Darnall. She’s a professor of anesthesiology, perioperative and pain medicine at Stanford University in California.
    • “The study was published recently in the Annals of Internal Medicine and involved more than 500 adult patients.” * * *  
    • “The findings are in line with current U.S. Centers for Disease Control and Prevention (CDC) guidelines, which support a patient-driven approach to tapering off opioids for chronic pain.”
    • “The study does not apply to people who have developed an addiction to the powerful painkillers.”
  • Radiology Business lets us know,
    • “New PET imaging findings could help explain why some patients continue to experience lingering side effects from long COVID. 
    • “The analysis, which is published in eBioMedicine, indicates that individuals who have been diagnosed with the disease display significantly decreased dopamine neuron integrity on brain scans. Experts believe this could have something to do with why many continue to struggle with fatigue and lack of focus and motivation. 
    • “Our findings provide compelling evidence that long COVID involves the loss of dopamine-releasing neurons,” said study author Jeffrey Meyer, MD, PhD, senior scientist at the Brain Health Imaging Center in Toronto. “This kind of injury is well known to produce symptoms like lack of motivation and motor slowing, and may contribute to memory difficulties in other neurological conditions. Our results suggest a similar process is occurring in long COVID.” 
  • Genetic Engineering and Biotechnology News notes,
    • “An international team of scientists report that they have successfully mapped the cells and genes that regulate bone formation and loss and discovered the critical role that blood vessel cells play in bone health. By combining genomic sequencing with data from half a million individuals, the research team identified hundreds of previously unknown genes that govern bone health and revealed cells surrounding blood vessels as one of the drivers of bone repair.
    • “The study “Multiscale analysis and functional validation of the cellular and genetic determinants of skeletal disease” is published in Nature Genetics. The team says its findings fundamentally enhance our understanding of skeletal disease. It is hoped the discovery will enable the development of new therapies to rebuild lost bone, offering hope to almost half of all individuals over 50 living with rare and common skeletal conditions such as osteoporosis, osteoarthritis and osteogenesis imperfecta, as well as those with rare bone disorders and cancers that spread to bone.
    • “Most people don’t realize that bones are constantly changing; the human body replaces its skeleton every 10 years or so,” said Peter Croucher, PhD, professor at the Garvan Institute of Medical Research in Australia. “This is a hugely important process, but until now we’ve had a limited understanding of the cells and mechanisms that control this turnover of bone. “Most of the drugs now available focus only on halting bone disease, rather than rebuilding lost bone, which is really important for reversing damage.”
  • Per STAT News,
    • “In a new study published in Science Translational Medicine on Wednesday, researchers say they have uncovered how Epstein-Barr virus launches immune responses that lead to the inflammation and nervous system damage seen in people with multiple sclerosis. 
    • “It’s very nice now to be able to understand more about the underlying mechanisms of how EBV likely causes MS,” said lead author Kjetil Bjornevik, an assistant professor of epidemiology and nutrition at the Harvard T.H. Chan School of Public Health. The findings, researchers hope, could help with the development of EBV vaccines or antiviral medications that could prevent or manage MS symptoms without the major side effects of commonly used immunosuppressants. 
  • Per Fierce Pharma,
    • “Merck & Co.’s almighty Keytruda has become the first PD-1 inhibitor to show a benefit as a single agent for the front-line treatment of a subtype of endometrial cancer.
    • “Keytruda significantly improved progression-free survival over platinum-based chemotherapy in patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. The patients had either received no systemic chemotherapy or experienced recurrence more than six months after completing prior adjuvant therapy.
    • “On its other dual primary endpoint, the Keynote-C93 trial also recorded an immature trend toward improvement in overall survival at the interim analysis. The trial is ongoing, with plans to evaluate the endpoint in the future. 
    • “The positive readout sets Keytruda up to be a new chemo-free option in first-line dMMR endometrial cancer, Brian Slomovitz, M.D., from Mount Sinai Medical Center and the study’s principal investigator, noted in a July 15 release. Merck now plans to share the results with regulatory authorities.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance Health is shrinking its Medicaid business, worried about future profits in the beleaguered safety-net insurance program.
    • “The insurer is leaving Washington, D.C.’s Medicaid market this summer, and plans to exit additional Medicaid markets over the next 18 months, executives said during a call to discuss Elevance’s second quarter financial results Wednesday morning.
    • “It’s the latest example of insurers exiting underperforming markets to try to recoup margins after a difficult few years.” * * *
    • “Elevance largely delivered in the second quarter, outperforming Wall Street’s revenue and earnings expectations and boosting its 2026 earnings guidance on the strength of the results.
    • “Elevance brought in $1.5 billion in net income in the quarter, down more than 16% year over year, on operating revenue of $49.8 billion, up 1% year over year. Revenue rose thanks to Elevance hiking premiums in its health insurance plans and higher sales from Carelon.”
  • The Wall Street Journal relates,
    • “Johnson & Johnson raised its 2026 sales forecast to a range of $100.8 billion to $101.4 billion, up from its prior projection.
    • “The company increased its full-year adjusted earnings guidance to between $11.60 and $11.75 a share.
    • “Second-quarter sales rose 6.6% to $25.31 billion, driven by growth in both the pharmaceutical and medical device businesses.”
  • and
    • “Boehringer Ingelheim reported first-half net sales of 15.8 billion euros, up 16% when adjusted for currency changes.
    • “Sales of the company’s top-selling diabetes drug, Jardiance, rose to 5.7 billion euros from 4.3 billion euros in the year-earlier period.
    • “Boehringer Ingelheim is gearing up to file for U.S. approval of survodutide, its new obesity medicine.”
  • and
    • “Eli Lilly is losing to rival Novo Nordisk in the weight-loss pill market, capturing only about 11% of prescription volume for new pills.
    • “Doctors say patients prefer Novo Nordisk’s Wegovy pill over Lilly’s Foundayo because study data shows it leads to greater average weight loss.
    • “Lilly’s launch was also slowed by the time it took to secure reimbursement coverage from major pharmacy-benefit managers.”
  • Beckers Hospital Review tells us,
    • “Registered nurses in California earn the highest median pay in the country, while nurses in Alabama earn the least, according to data released May 15 by the Bureau of Labor Statistics.
    • [Included in the article] are the median hourly and annual wages for registered nurses in all 50 states and Washington, D.C., based on May 2025 data from the BLS Occupational Employment and Wage Statistics program, listed in descending order by annual wage. Nationally, registered nurses earned an annual median wage of $97,550, according to the BLS.
  • MedTech Dive offers an interview with “Jorge Garces, who joined Abbott to oversee scientific strategy for cancer diagnostics after it acquired Exact Sciences, discusses the future of the field, about Abbott’s cancer diagnostics vision: ‘There’s always a hunger to make these tests better.”
  • Fierce Healthcare informs us,
    • “Judi Health is continuing on its rebranding journey and announced on Wednesday that its pharmacy benefit management arm will now operate as Judi Rx.
    • “Previously known as Capital Rx, Judi’s PBM has operated on a transparent model for nearly a decade. Demand for new and alternative options in this market has grown as healthcare costs escalate, and Judi’s combined PBM and pharmacy benefit administrator clientele has grown to include more than 50 million lives across Medicare, Medicaid and commercial.
    • “In a June study backed by Judi, Employee Benefit News found that most organizations switching to a transparent PBM jumped ship from one of the legacy “Big Three” companies that have historically dominated this space.
    • “Alongside the Capital Rx rebrand, Judi announced that it will launch Judi Care, which represents its medical, dental and vision solutions, along with Judi Cloud, which allows for the licensure of its proprietary technology.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Roll Call reports,
    • “Sen. Darline Graham took the oath of office Tuesday to fill the vacancy left by the unexpected death of her older brother, four-term Republican Sen. Lindsey Graham. The late Graham died Saturday night at age of 71 of an aortic dissection, according to preliminary findings by the D.C. medical examiner.”
  • and
    • “Speaker Mike Johnson narrowly freed the floor from another standstill Tuesday — but it’s not clear how long the good feeling will last.
    • “The House adopted a rule for floor debate in a 215-211 vote after GOP leaders won over key holdouts by promising a markup of border security legislation before the August recess and taking steps to graft a voter ID bill onto a spending measure.
    • “With such a slim majority, leadership can only afford to lose a few Republican votes for party-line measures.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is proposing transformational reforms to Medicare’s physician payment and value-based care programs that would expand accountable care, modernize physician payment, reduce administrative burden, and help shift the healthcare system’s focus from treating illness to preventing it.
    • “The proposals would make Medicare accountable care organizations (ACOs) easier to join and more rewarding to participate in, transition clinicians away from traditional Merit-based Incentive Payment System (MIPS) reporting toward more meaningful value-based care pathways, and update physician payment policies to better reflect modern clinical practice. Together, these reforms would strengthen primary care, improve patient outcomes, and support Medicare’s long-term sustainability.
    • “We’re proposing some of the most significant Medicare reforms in recent years to strengthen primary care, expand accountable care, and modernize physician payment,” said CMS Administrator Dr. Mehmet Oz. “These changes would make it easier for clinicians to focus on prevention, improve coordination for patients, and ensure Medicare rewards better outcomes rather than more services.” * * *
    • “To view the CY 2027 Physician Fee Schedule proposed rule, please visit: https://www.federalregister.gov/public-inspection/current
    • “To view the related Quality Payment Program fact sheet, please visit: https://d2g5m5leph8kam.cloudfront.net/s3fs/s3fs-public/2026-06/2027-qpp-proposed-rule-factsheet.pdf
    • “For a fact sheet on the CY 2027 Physician Fee Schedule proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-medicare-physician-fee-schedule-proposed-rule
    • “For a fact sheet on the proposed Medicare Shared Savings Program changes in the CY 2027 PFS proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-medicare-physician-fee-schedule-proposed-rule-cms-1848-p-medicare-shared“
  • Radiology Business adds,
    • “Physicians with greater clinical knowledge are less likely to order low-value imaging and other unnecessary healthcare services, according to new research published Monday. 
    • “These wasteful tests and treatments—such as imaging for an uncomplicated headache, which provides no benefit to the patient—continue plague the U.S. healthcare system. Each year, the country spends an estimated $100 billion on low-value services, experts write in JAMA Internal Medicine. 
    • “Researchers recently aimed to better understand how higher physician knowledge might help to curb healthcare waste.  They utilized the American Board of Internal Medicine’s Longitudinal Knowledge Assessment to measure clinician know-how, matching it against IM’s ordering of 25 different low-value services including medical imaging. 
    • “Lead author Jonathan L. Vandergrift, MS, and colleagues found a clear connection, with high-knowledge docs less likely to order unnecessary scans.”
    • “These findings suggest an important question for further study: If those who scored lower in the first year increase their knowledge, and therefore their score, over time, will they then order fewer low-value services?” Vandergrift, a senior health services researcher at the ABIM, said in a news announcement July 13. “We hope to learn more about whether the healthcare system may cut unnecessary costs through education and assessments that steer clinicians toward higher-value care that provides the most benefit to patients.”
       
  • The American Hospital Association relates,
    • “The Health Resources and Services Administration announced that 340B covered entities purchased $100 billion in outpatient drugs under the federal 340B Drug Pricing Program in calendar year 2025. This represents an approximate 22% increase from CY 2024, which had sales of about $81.4 billion. HRSA partly attributed the growth to increased shifts from inpatient to outpatient care, a rise in innovative therapies and increases in drug pricing. Of the $100 billion in CY 2025 sales, 340B hospitals accounted for nearly 87%, or about $87 billion.”
  • Per a Government Accountability Office news release,
    • “In recent years, Medicare’s spending on hospice has nearly doubled. We looked at this spending and found that the way Medicare pays for hospice care could be costing taxpayers billions more than it should. 
    • “Today’s WatchBlog post looks at our new report about inefficiencies in Medicare’s payments.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA has approved Sanofi’s subcutaneous Sarclisa Escena in combination with standard-of-care regimens for patients with multiple myeloma across all existing indications of the intravenous formulation, making it the first anticancer treatment administered through an on-body injector.
    • “Sarclisa Escena is administered through Sanofi’s on-body injector and is the first multiple myeloma treatment in the U.S. available through both an on-body injector and manual subcutaneous administration, according to a July 10 news release.”
  • Cure relates,
    • “The Food and Drug Administration (FDA) on July 14, 2026, granted traditional approval to Retevmo (selpercatinib) for adults and children 2 years of age and older with locally advanced or metastatic solid tumors that carry a RET gene fusion, as identified by an FDA-approved test.
    • “To be eligible, patients must have seen their cancer progress on or after prior systemic treatment, or have no satisfactory alternative treatment options available.
    • “The approval marks an upgrade from the accelerated approval Retevmo previously received for this indication — first for adult patients in 2022 and later extended to pediatric patients ages 2 and older in 2024. Traditional approval is granted when a drug’s clinical benefit has been confirmed through additional clinical evidence.”
  • MedTech Dive reports,
    • “Medtronic is removing from the market certain lots of a catheter used to place pulmonary valves, the Food and Drug Administration said in a Monday recall notice.
    • “The affected devices have an increased risk that the distal tip may detach from the delivery catheter system, requiring another procedure to remove the tip. As of May 14, Medtronic had not reported any serious injuries or deaths associated with the issue, according to the FDA notice.
    • “A Medtronic spokesperson said in an emailed statement to MedTech Dive that the problem is limited to certain delivery systems and does not involve the valve itself. Medtronic has resolved the underlying manufacturing problem, so future shipments will not be affected by the recall, the spokesperson wrote.”

From the judicial front,

  • Healthcare Dive reports,
    • “CVS Health’s Caremark has reached a settlement with the Federal Trade Commission requiring notable changes to the pharmacy benefit manager’s business practices, including that Caremark prefer the lowest-cost drugs on its standard formularies and pass through savings negotiated with drugmakers to clients.
    • “The settlement announced by the FTC on Tuesday puts to bed regulators’ allegations that Caremark preferred more expensive versions of insulin in order to increase its rebates, driving up prices for the lifesaving diabetes drug. The FTC lodged the suit against Caremark, along with fellow PBM giants Express Scripts and Optum Rx, in 2024.
    • “Express Scripts settled with the FTC in February while Optum Rx is still finalizing an agreement with the antitrust agency.”
    • “The terms of CVS’ settlement are very similar to those secured with Express Scripts. The deal prevents the drug middleman from discriminating against cheaper drugs in its standard formularies for commercial clients, and requires it to provide a standard offering to plan sponsors that doesn’t include rebates.
    • “It requires Caremark to include any purchases a patient makes through TrumpRx, President Donald Trump’s online drug marketplace, towards the deductible in certain health plans, once regulatory changes make that possible. The settlement also includes a number of transparency provisions.
    • However, the CVS deal includes a new wrinkle meant to assuage concerns that the healthcare behemoth leverages its market power to prevent independent pharmacies from working with rival pharmacy hubs, third-party companies that provide a range of digital pharmacy services.
    • “The settlement prevents CVS from foreclosing hub service providers [FEHBlog provided link], and will create a monitor to ensure its compliance, according to the FTC.”
  • Modern Healthcare reports,
    • “The U.S. Justice Department (DOJ) sent civil investigative demands to lawyers in private litigation against Claritev [formerly known as Multiplan], escalating its antitrust probe.
    • A federal judge in June 2025 rejected Claritev’s bid to dismiss the private suits, keeping the cases alive.
    • The DOJ also has a separate ongoing antitrust investigation into one of Claritev’s major insurer clients.
  • Reuters relates,
    • “A coalition of public health organizations, pediatricians and parents sued the U.S. Food and Drug Administration on Tuesday, challenging a ​new policy that allow some manufacturers to sell vapes and ‌nicotine without the legally required license.
    • “The lawsuit, filed in U.S. District Court in Maryland, targets FDA guidance issued in May. The guidance states the agency would ​not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch ​products if the companies have marketing applications under review.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Michigan state health officials are narrowing in on lettuce as a possible culprit in the rapidly expanding explosive-diarrhea outbreak, though federal authorities say they are still working to confirm a specific food source as the cause.
    • “Donald Prater, the Food and Drug Administration’s acting deputy commissioner for food, said lettuce is one of multiple produce items under investigation as officials race to identify the outbreak’s origins.
    • “Top health officials in Michigan said bagged, prewashed salad kits could be a particular risk, based on the state’s review of cases.
    • “The early signals are telling us that lettuce does seem to be implicated,” said Dr. Natasha Bagdasarian, the state’s chief medical executive.
    • “Michigan is the hardest hit by the cyclospora parasite, with more than 3,300 cases as of Tuesday, more than double the number on Friday.”
  • The American Hospital Association News adds,
    • “The Centers for Disease Control and Prevention July 14 released an advisory on the growing cyclosporiasis cases across the U.S. The advisory said that the agency received reports of 1,645 confirmed domestic cases across 34 states and is aware of more than 5,100 cases that require further analysis for confirmation. The CDC said that of 1,645 case-patients with available information, 9% (141) were hospitalized and no patients have died. The advisory includes recommendations for clinicians on how to diagnose and treat patients with cyclosporiasis, and for facilities on how to disinfect healthcare settings. The CDC is working with the Food and Drug Administration and state and local health departments to identify the cause of the illness. The CDC said that because cyclosporiasis is often underdiagnosed and underreported, the actual total of illnesses is likely higher than what has been reported.”
  • Healio relates,
    • “Alcohol consumption and smoking were identified as the two strongest common risk factors for breast cancer and atrial fibrillation globally, according to data published in the Journal of the American Heart Association.
    • “Reducing alcohol intake and smoking behaviors to the level at which risk is smallest, nearly one-third of breast cancer cases and 12% of AF cases could be prevented, the researchers wrote.
    • “One of the most surprising aspects of our findings was how common both breast cancer and atrial fibrillation/flutter diagnoses were among women ages 55 and older in high-income regions, which highlights the influence of lifestyle,” Shu Wang, MD, PhD, director of the Breast Disease Center at Peking University People’s Hospital in Beijing, said in a press release. “This is the first study combining global data with machine learning to show the relationship between the conditions, their location across the world and the shared risk factors of these two conditions.”
  • STAT News adds,
    • “STAT’s interviews with more than 100 experts — including current and former government officials, doctors, public health advocates, substance use researchers, people in recovery, and addiction treatment leaders — identified a dozen ways the U.S. could chip away at its alcohol epidemic.” Here are the first six:
      • Screen early and often
      • “Add ‘nudges’ to health system
        • “Health systems can do their part to boost screening and treatment by adding alcohol questionnaires, including the well-validated and quick AUDIT-C test, to clinician workflows.”
      • “Get creative with funding
        • “STAT’s reporting finds that fixing the country’s alcohol epidemic will require smarter investments and clear guidance from federal health officials.”
      • “Get the word out
        • “HHS could also reinvest in public messaging about the health risks of alcohol, such as the defunct “Drink Less, Be Your Best” campaign.” 
      • “Overhaul payment 
        • “In the clinic, payment continues to be a barrier to detection and treatment of alcohol-related problems. While health care reforms in the past two decades have boosted reimbursement for mental health treatment, including substance use disorder work, physicians say parity is still not enforced well enough.”
      • “Dive into data
        • “Even without spending more on alcohol interventions, the country could use information it already has, plus a bit of cleverness, to tackle the issue.” 
  • The National Institutes of Health’s Research Matters covers the following topics in its latest post:
    • “Brain-computer device helps man speak
      • “A man unable to talk due to paralysis successfully used a brain-computer interface system at his home to speak.
      • “This technology could become a practical communication tool for people who can’t talk because of problems with their muscles.”
    • “Sleep and exercise may reduce mutation-driven inflammation 
      • “Lifestyle factors may reduce inflammation caused by some mutations in blood stem cells, according to an analysis of human and mouse data.
      • “The results suggest improving sleep and exercise may curb the health consequences of this inflammation.”
    • “Fructose and glucose trigger different brain responses
      • “Scientists found the sugars glucose and fructose affect hunger-controlling brain cells and food preferences in mice differently.
      • “The study suggests that similar nutrients can signal to the brain through distinct pathways and have different effects on appetite.”
  • MedCity News explains
    • “How AI Can Support Better Mental Health Outcomes — With Humans at the Center.
      • “Mental health care does not need to become less human to become more effective. The most effective (and responsible) path forward is one built on partnership.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Researchers at University College London (UCL) Great Ormond Street Hospital for Children (GOSH) have built a new lab model of infant lungs to show why respiratory syncytial virus (RSV) makes infants so much sicker than adults, and to allow them to test new treatments. The miniature model of a baby’s airways was created using pediatric airway cells, blood vessel cells, and neutrophils (a type of white blood cell that acts as the immune system’s primary response to infection).
    • “Studies using the new model suggest that future therapies for RSV should target both the virus and its immune response to ensure babies get the best possible outcomes. Research lead Claire Smith, PhD, at UCL Great Ormond Street Institute of Child Health, said, “This model allows us to watch early immune responses unfold and study them in a human setting that reflects the infant airway. That’s something animal models often struggle to capture, especially when it comes to age-specific effects.
    • “Senior and corresponding author Smith and colleagues reported on their findings in Nature Communications in a paper titled “Neutrophil myeloperoxidase as a functional biomarker for RSV severity: implications for in vitro therapeutic screening.” In their report they concluded, “These findings identify neutrophil–epithelial interactions as a useful target for intervention and support the use of physiologically relevant human models to accelerate the development of therapies that limit immunopathology while preserving antiviral defense.”
  • BioPharma Dive informs us
    • “Detailed findings from a closely watched clinical trial hint that a new kind of drug may offer similar benefits as approved medicines in early Alzheimer’s disease, a result that could boost the outlook for a long-studied but unproven area of scientific research.
    • “The mid-stage “Celia” trial explored whether a Biogen drug codenamed BIIB080 would be any better than a placebo at slowing the mental or functional decline of Alzheimer’s patients showing early signs of cognitive impairment. Unlike in-use therapies such as Eli Lilly’s Kisunla and Biogen and Eisai’s Leqembi, which target harmful “amyloid” proteins, BIIB080 works by gumming up the genetic instructions cells use to create another Alzheimer’s-linked protein called tau.”
  • Fierce Pharma adds,
    • “Huyabio has scored a win in the largest oncology study it has undertaken in its 22 years, as its oral histone deacetylase (HDAC) inhibitor HBI-8000 has succeeded in combination with Bristol Myers Squibb’s Opdivo in a phase 3 trial of patients with advanced skin cancer.
    • “The study, which included 404 melanoma patients across 15 countries, achieved its primary endpoint, as the combo produced a clinically meaningful improvement in progression-free survival. 
    • “Those who received HBI-8000 plus Opdivo remained alive and without their disease worsening for a median of 11.7 months, compared to a median of 7.4 months for those who were given Opdivo plus placebo. The 58% improvement was deemed statistically significant.”  

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

  • The Wall Street Journal reports,
    • “HCA Healthcare lowered its 2026 financial guidance following payer mix shifts due to health insurance exchanges.
    • “The company said the payer mix shift was driven by an increase in uninsured patients who had lost coverage on health insurance exchanges.
    • “HCA estimated that the payer mix shift had an unfavorable impact on income before income taxes of about $400 million during the second quarter.” * * *
    • “The company said it anticipates adjusted Ebitda for the second quarter of roughly $4.03 billion, and revenue for the three months of about $20.23 billion. That compared with $3.85 billion and $18.61 billion a year earlier, and is below the $4.47 billion and $19.47 billion in revenue that analysts polled by FactSet had penciled in.” * * *
    • “The company said it did see positive factors during the quarter, including growth in admissions, equivalent admissions and emergency room visits, increased benefit from Medicaid Supplemental Payment Programs and improved expense trends.”
  • Beckers Hospital Review relates,
    • “Madison, Wis.-based UW Health has reached an agreement with Marshfield Medical Center-Beaver Dam (Wis.) to bring the medical center into the health system.
    • “The hospital is part of Marshfield (Wis.) Clinic Health System, which merged with Sioux Falls, S.D.-based Sanford Health in January 2025 to create a 56-hospital, nonprofit integrated system that operates as Sanford Health. 
    • “Marshfield Medical Center-Beaver Dam is an integrated medical campus that comprises a hospital, skilled nursing facility and independent senior living apartments. The hospital also runs two assisted living facilities and primary care clinics, according to a July 13 UW Health news release shared with Becker’s.” 
  • and
    • “Little Rock, Ark.-based Baptist Health acquired Magnolia (Ark.) Regional Medical Center on July 12. 
    • “With the close of the acquisition, the 25-bed facility has been rebranded as Baptist Health Medical Center-Magnolia. 
    • “Magnolia became Baptist Health’s 14th hospital and the second acquired in less than one month. On June 14, Baptist completed its acquisition of South Arkansas Regional Hospital, a 151-bed hospital based in El Dorado. 
    • “Baptist Health signed a definitive agreement to acquire the Magnolia hospital in April.” 
  • Fierce Healthcare tells us,
    • “The American Medical Association (AMA) announced Tuesday a new interoperability initiative aimed at supporting electronic prior authorizations by better connecting clinical terminology to its Current Procedural Terminology (CPT) administrative coding.
    • “The professional association said Tuesday it will be developing and deploying SNOMED CT— a structured set of descriptive terms that serve as a shared medical vocabulary for computer systems—to CPT terminology mappings. Doing so will ultimately create a foundation for “scalable automation” to streamline workflows, improve data exchange and foster more efficient and quicker prior authorization outcomes, AMA said.
    • “Moreover, it aligns with the upcoming Jan. 1, 2027 Centers for Medicare & Medicaid Services (CMS) FHIR-based prior authorization compliance deadline.”
  • Fierce Pharma informs us,
    • “Nearly a decade after spinning out its Chinese research hub to form Dizal Pharmaceutical, AstraZeneca is paying up to $1.5 billion to buy a piece of the pipeline, securing exclusive global rights for the biotech’s oral EGFR lung cancer drug Zegfrovy (sunvozertinib).
    • “The total deal value is split between $600 million in upfront payment, up to $400 million in development milestones and another $500 million tied to certain sales milestones, according to a disclosure (Chinese, PDF) to the Shanghai Stock Exchange. Dizal is also entitled to tiered, up to low-double-digit royalties based on Zegfrovy’s global sales.
    • “The deal comes about a month after Dizal detailed positive phase 3 data for Zegfrovy in first-line non-small cell lung cancer with EGFR exon 20 insertion mutations at the 2026 American Society of Clinical Oncology annual meeting.
    • “In the global Wu-Kong28 trial, Zegfrovy significantly reduced the risk of disease progression or death by 35% compared with platinum-based chemotherapy.” 
  • and
    • “Insulet’s wearable insulin patch Omnipod may be able to seamlessly control insulin delivery for patients with diabetes, but it can’t fill all mental health-related treatment gaps on its own. To broaden its network of personalized care offerings, the company is teaming up with mental health platform Calm to roll out a host of holistic “Mind in Range” resources. 
    • “Insulet and Calm’s free-to-access mindfulness tools, launched Tuesday, July 14, are specifically tailored to the diabetes community and include short meditations, a breathing exercise and a new Calm Sleep Story narrated by fashion model Lila Moss, a diabetes patient and advocate. The collaboration marks Calm’s first integrated content partnership with a medtech company and aims to “normalize conversations” around mental health care in diabetes management, while also making mindfulness “simple and accessible,” Insulet explained in a release.” 
  • Beckers Hospital Review points out,
    • “Amazon Pharmacy is collaborating with eNavvi, a digital prescribing platform, to integrate real-time medication pricing, availability and home delivery options into clinicians’ e-prescribing workflow. 
    • “The integration gives clinicians visibility into medication costs by comparing cash prices with estimated insurance copays while automatically applying eligible manufacturer discounts, according to a July 14 news release. It also provides real-time inventory information and delivery estimates, allowing providers to make prescribing decisions based on medication availability and delivery timelines.
    • “The move builds on Amazon Pharmacy’s ongoing delivery expansion, which is on track to reach 4,500 U.S. cities and towns by the end of 2026. The company has also leaned into GLP-1 access, expanding Zepbound KwikPen availability through same-day delivery earlier this year. 
  • Beckers Health IT lets us know,
    • “OpenEvidence outperformed Claude Opus 4.8, Gemini 3.1 Pro and GPT-5.5 on real-world clinical questions in a new physician-graded study, contradicting a June Nature Medicine paper that foundgeneral-purpose AI models beat specialized clinical tools.
    • “The study, posted June 27 as a preprint on arXiv, has not yet been peer-reviewed. It had 149 practicing physicians across 36 states rate AI answers to 620 real point-of-care questions drawn from OpenEvidence’s platform, plus 187 questions from the HealthBench benchmark, judging responses on accuracy, clinical utility, source quality, verifiability and completeness.
    • “OpenEvidence posted positive win margins on all five dimensions, with differences ranging from 25 to 39 percentage points over the three general-purpose models. Claude Opus 4.8 and Gemini 3.1 Pro scored near parity with each other, while GPT-5.5 recorded the lowest win rates on every axis.”
    • “The results stood in contrast to a Nature Medicine study published June 12, which found GPT-5.2, Gemini 3.1 Pro and Claude Opus 4.6 outperformed OpenEvidence and Wolters Kluwer’s UpToDate Expert AI. OpenEvidence has since asked Nature Medicine to retract that study, alleging flawed methods; the journal has pointed the company to its formal rebuttal process instead. * * *
    • “The competing results leave hospital and health system leaders with conflicting independent evidence on how general-purpose AI models compare with specialized clinical decision support tools as adoption of both accelerates.”

Monday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, No Surprises Act, Obesity, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Wall Street Journal reports,
    • “South Carolina Gov. Henry McMaster named Darline Graham Nordone, the sister of the late Sen. Lindsey Graham of South Carolina, to serve as an interim replacement in the Senate in the aftermath of the longtime lawmaker’s death. 
    • “President Trump had told McMaster, a Republican, that an appointment of Graham Nordone “would be a fabulous tribute to Lindsey, who loved her dearly!” Graham Nordone will serve out the remainder of her late brother’s term, which ends in early January.
    • “McMaster said Graham “took care of his little sister in years long departed. It’s my honor to ask his little sister, Darline Graham, to finish his work for him now.”
    • “Graham Nordone said, “Lindsey has always been there for me, and now I will be there for him.”
  • Fierce Healthcare relates,
    • “Insurers expect to issue $759.2 million in medical loss ratio rebates this year, according to a new analysis.
    • “The report is based on data reported by payers to states and compiled by analytics firm Mark Farrah Associates. An analysis of the data from KFF projects that total rebates paid out since their 2012 launch will rise to $15.1 billion after 2026 payments are made later this year.” * * *
    • “The estimated 2026 rebate tally is the lowest since 2018, when insurers paid $706.7 million in rebates, according to the KFF report. Rebate payments peaked in 2020 at $2.5 billion.” * * *
    • “The average simple loss ratio—which does not account for taxes or quality improvements like the MLR used to calculate rebates—was 93% in 2025, meaning plans spent 93% of their premium income on claims on average.” 
  • Healthcare Dive tells us,
    • “The oversight office of the HHS said it generated about $5.6 billion in monetary impact from fighting fraud, waste and abuse in federal health programs between October and March.
    • “The HHS Office of Inspector General also said it kicked over 1,200 people and entities off federal programs and pursued enforcement actions against people accused of running sham hospices and requesting improper Medicaid payments for autism behavioral therapy services, among others.
    • “The updates, part of a report compiled every six months for Congress, outlined the Trump administration’s healthcare enforcement priorities, adding that the HHS would focus on rooting out fraud in Medicaid and Medicare Advantage.”
  • Gilsbar, an insurance brokerage, offers information about recent revisions to the IRS Form 720 which is used to pay the annual PCORI fee.

From the Food and Drug Administration front,

  • Psychdelic Alpha reports,
    • “This morning, FDA issued its final guidance on psychedelic clinical investigations and announced a September public hearing “on the potential future therapeutic use of psychedelic drugs” and an associated request for comments. (We provided a detailed breakdown of the final guidance, as well as coverage of the planned hearing, in our Pα+ article: FDA Issues Final Psychedelics Guidance, Schedules September Hearing on the Future of Psychedelic Therapies.)
    • “Then, this afternoon, HHS and VA announced that they have entered into a five-year Memorandum of Understanding (MOU) “to strengthen collaboration on the research, clinical development, and responsible deployment to veterans suffering from serious mental health conditions of potential future rapid-acting psychedelic drug products if approved by the Food & Drug Administration.”
  • The Pharmacy Times relates,
    • “The FDA approved a new starting dosage regimen for the subcutaneous formulation of lecanemab-irmb (Leqembi; Eisai, Biogen), marking the first time patients can begin treatment with home administration either by themselves or by their caregiver,
    • “Lecanemab is an amyloid beta-directed antibody that targets and removes beta-amyloid from the brain. There is no evidence that lecanemab restores or reverses lost memories or cognitive function, but it is proven to reduce both cognitive and functional decline in patients, according to the Alzheimer’s Association.” 
  • Fierce Pharma tells us,
    • “In what GSK says represents a potential way to transform treatment for patients with certain types of rectal cancer, the company’s Jemperli has met the main goal of a phase 2 trial, teeing up an application with the FDA.
    • “Interim results from the phase 2 AZUR-1 study showed a “meaningful and sustained” clinical complete response rate for Jemperli at 12 months in stage 2/3 mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, GSK said Monday.
    • ‘Without going into specifics, GSK said its PD-1 inhibitor showed a “substantial improvement” compared to historical experience with existing treatment options. The company now plans to share the data with global health authorities, including with the FDA under an accelerated approval pathway.”  

No Surprises Act news

  • Benefits Pro reports,
    • “Federal regulators today [July 10] said they are setting up a renewal process for the organizations that help health care providers and health care payers resolve No Surprises Act billing disputes.
    • One part of the new recertification process for the No Surprises Act “independent dispute resolution entities” could involve assessments of IDR entities’ fairness.
    • “Something officials may consider when looking at an recertification application is the ability of the IDR entity to “provide rationales for payment determinations meeting regulatory requirements,” according to a new set of answers to frequently asked questions about the IDR entity recertification process.
    • “Application reviewers will also look at an entity’s ability to handle a high volume of dispute assignments quickly and the entity’s ability to handle cases “accurately in accordance with statutory and regulatory timelines,” officials say.” * * *
    • “Regulators will post a list of the entities seeking recertification each week.”
  • Fierce Healthcare relates,
    • “A payer-backed group has launched a campaign challenging a bill that would build on the No Surprises Act.
    • “The Coalition Against Surprise Medical Billing (CASMB) announced on Monday that its “six-figure” campaign urges lawmakers to reject the No Surprises Act Enforcement Act, or H.R. 4710. This legislation, they argue, would “reward the actors misusing the [independent dispute resolution] process.” * * *
    • “The ad says that the No Surprises Act was passed “with good intentions,” but that Congress should focus future efforts on closing loopholes that allow for IDR abuse.”

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal appeals court revived more than 500 lawsuits that allege Tylenol and generic acetaminophen can cause attention-deficit hyperactivity disorder or autism if taken during pregnancy.
    • “The Second U.S. Circuit Court of Appeals in Manhattan ruled that a trial judge had erred by excluding expert medical witnesses, offered by the plaintiffs, who were expected to testify that there was a link between Tylenol use during pregnancy and neurodevelopmental disorders such as autism and ADHD. The 3-0 decision sends the case back to the lower court for further proceedings.”
  • Healthcare Dive relates,
    • “More insurers are filing lawsuits in an attempt to hike their Medicare Advantage quality scores after a court decision earlier this year exposed federal regulators to a new line of legal attacks.
    • “SCAN Health Plan and Alignment Healthcare both sued the CMS in D.C. district court last week, arguing regulators robbed them of higher star ratings in the privatized Medicare program.” * * *
    • “The lawsuits from SCAN and Alignment — which are both represented by the law firm Latham & Watkins — allude to larger calls for reform and cite MedPAC’s censure of the star ratings system.
    • “The Star Ratings program went off the rails years ago,” reads SCAN’s complaint. “The system is undeniably broken.”
  • Beckers Payer Issues tells us,
    • “A federal judge has dismissed with prejudice a lawsuit from Blue Cross Blue Shield of Georgia that accused medical billing company HaloMD and two physician groups of conspiring to defraud the insurer through the No Surprises Act’s arbitration process.
    • “The insurer, part of Elevance Health, alleged in May 2025 that HaloMD, Sound Physicians Emergency Medicine of Georgia and Hospitalist Medicine Physicians of Georgia submitted false attestations of dispute eligibility, flooded the independent dispute resolution system with large volumes of ineligible disputes using AI to overwhelm program safeguards, and submitted inflated payment offers, including some that exceeded the providers’ own billed charges.
    • “In his July 10 decision, Judge Thomas Thrash Jr. wrote that the court lacked jurisdiction over most of the counts and ruled that the racketeering, state-law, ERISA and deceptive trade practice claims were “collateral attacks” on the arbitration determinations. 
    • “It is highly improbable to infer from these facts that there is a vast conspiracy of providers and IDREs that have conspired to defraud the Plaintiff of millions of dollars in thousands of NSA IDR proceedings over many years,” Judge Thrash wrote. “It is highly plausible to infer that the Plaintiff engages in a consistent practice of submitting lowball offers to out-of-network providers in an effort to maximize its profits.”

From the public health and medical / Rx research front,

  • Healio reports,
    • “There are now cyclosporiasis cases in more than half of U.S. states. 
    • “The outbreak will eventually “burn” itself out even if a source is not found, an expert said.” * * *
    • “For insight into the current surge, Healio checked in with David O. Freedman, MD, FIDSA, professor emeritus of infectious diseases at the University of Alabama at Birmingham.
      • “Healio: Are all the cyclosporiasis warnings warranted or is this outbreak overhyped? 
      • “Freedman: On a national basis, for healthy people, the odds of any illness are still relatively low. Hospitalization, if ill, is extremely rare in normal hosts and care is noninvasive, involving mostly intravenous fluids and initiation of the antibiotic course. No deaths have occurred to date.
      • “The word outbreak refers to rates of illness above a normal year. On a national basis the annual average number of cases is about 3,000, which we have not reached yet, although official reports take several weeks to catch up with individual cases submitted. This is partly due to diminished CDC capacity at the national level. A small number of individual states, notably Michigan, are now reporting case numbers at the outbreak level.
      • “Healio: Can you explain why it is so important to find a source for the outbreak?
      • “Freedman: It is likely that only a portion of the total cases are the result of a single source contamination event at a farm, processing plant or distribution center. The rest of the cases will be due to the dozens of small contamination events that occur each summer in the U.S.
      • “Finding one or a few major contamination events will greatly diminish subsequent case numbers. However, it is important to remember that the incubation period from ingestion to illness is 1 to 2 weeks, so even after identification of a source, the process of withdrawing the product from the supply chain, educating the public to avoid products already in homes and waiting for incubating cases to manifest will take several weeks.
      • “Healio: Do you feel the outbreak will only continue to spread until a source for it is identified? 
      • “Freedman: Not necessarily. Outbreaks like this tend to burn themselves out as shown by the baseline seasonality that runs from May to August. Contaminated products that entered the processing chain early in the season may have been grown under different circumstances than products entering later in the season.”
  • Bloomberg Law reports
    • “New York City officials identified dozens of buildings with Legionnaires’ bacteria in Manhattan’s Upper East Side, closing in on the source of an outbreak that has infected at least 46 people and hospitalized 22.
    • “The New York City Health Department tested the cooling towers of 183 buildings in neighborhoods encompassed by three zip codes — 10028, 10128 and 10075 — that are among the city’s wealthiest and most densely populated. Of the 31 with signs of bacterial contamination, 19 already have been cleaned, officials said on a call with reporters Friday. The remainder are set to be cleaned by Saturday [July 11].
    • “Officials sought to reassure those who live in or have visited the area in recent weeks, pointing out that they would have already been exposed to the bacteria and noting that most people don’t fall ill from it.
    • “It’s safe for folks to drink water, to bathe to shower to cook and to use their air conditioner,” NYC Health Commissioner Alister Martin said.”
  • Health Day tells us,
    • “U.S. Sen. Lindsey Graham, 71, died Saturday of an aortic dissection, a sudden tear in the body’s main artery
    • “The condition is often fatal; about half of patients reach the hospital, and roughly half of those survive
    • “High blood pressure is the leading risk factor, and sudden severe chest or back pain is the key warning sign.”
  • and
    • “Weight-loss meds are transforming obesity treatment.
    • “But when it comes to heart health, exercise may still be the game changer.
    • “The study shows that while medication supports weight maintenance, it is exercise — with or without medication — that improves vascular health,” said researcher Signe Torekov, a professor of biomedical sciences at the University of Copenhagen in Denmark.”
  • MedPage Today adds,
    • “A network meta-analysis backed weight-loss benefits with several GLP-1 receptor agonists, with less certainty for newer-generation agents.
    • “Two GLP-1 drugs were also associated with reduced heart failure risk, while subcutaneous semaglutide stood alone in being tied to a reduced risk of all-cause mortality and myocardial infarction.
    • “The evidence was less certain for a reduction in kidney failure or an improvement in quality of life beyond a subjective threshold.”
  • STAT News informs us,
    • “Health secretary Robert F. Kennedy Jr. is pressing forward with his effort to help Americans stop taking psychiatric drugs, a medical practice known as deprescribing.
    • “Earlier this month, dozens of mental health professionals met with federal health officials to map out forthcoming clinical guidance they hope will help providers instruct patients on how to come off of antidepressant medications. While the Department of Health and Human Services has discussed plans to hold such a meeting, the outlines of the discussion haven’t been reported.
    • “During those talks, they reviewed guidance from European nations and worked on recommendations for nonmedication-based options for patients to address their mental health, such as therapy. A senior HHS official said they discussed gaps in the research around deprescribing SSRIs, including the side effects a person may experience, which vary depending on the drug and how long the person was on it, and how to recognize the difference between those side effects and a return of a patient’s depressive symptoms.”
  • MedPage adds,
    • “Modifiable dementia risk factors varied widely from country to country and a one-size-fits-all approach to dementia prevention will not work everywhere, data from 14 countries and regions showed.
    • “Both differences and similarities emerged in a global analysis of risks for 214,000 older adults, reported Emma Nichols, PhD, of the University of Southern California in Los Angeles, at the Alzheimer’s Association International Conference.
    • “Low education was a prevalent dementia risk factor for 85.6% of people in China compared with 12.0% of Americans, Nichols said. Obesity was a risk factor for 44.9% of older adults in the U.S., but only 13.3% of people in India.
    • “Despite differences in prevalence, similar factors — like cardiovascular risks (high cholesterol, hypertension, and diabetes) or risky behaviors (smoking and drinking) — tended to cluster together. Poor hearing, poor vision, and low education also co-occurred frequently.
    • “Risk factors often overlapped, with more than 50% of individuals having at least two risk factors, Nichols pointed out. In 11 countries and regions, the prevalence of at least four risk factors exceeded 20%.
    • “The findings were published in Lancet Healthy Longevity.
  • The CDC posted updated Core Elements of Outpatient Antibiotic Stewardship.
    • “Outpatient antibiotic stewardship programs promote appropriate antibiotic use to improve patient care and help combat antimicrobial resistance.
    • “The Core Elements of Outpatient Antibiotic Stewardship Programs provides a framework to improve antibiotic use and guide stewardship efforts for health systems, outpatient facilities, and prescribing clinicians.
    • “The guidance includes an assessment tool for evaluating stewardship efforts, a resource for measuring antibiotic use, and fact sheets that tailor stewardship strategies to specific outpatient settings.”
  • Per Health Day,
    • “Half as many young adults are misusing Adderall, Ritalin and other ADHD medications these days to help them remain alert at study or work, a new evidence review says.
    • “Misuse of ADHD stimulant meds among adults under 30 fell from 7.5% in 2016 to 3.7% in 2023, researchers report in the Journal of Clinical Psychopharmacology.
    • “We found a rapid drop in misuse of these medications, largely driven by a decline in Adderall misuse among young adults,” lead researcher Margaret Maglione said in a news release. She’s a project leader with the Southern California Evidence Review Center at the Keck School of Medicine of USC.”
  • Per MedTech Dive,
    • “Freenome said its updated blood-based colorectal cancer screening test met its primary and secondary endpoints in a pivotal validation study. Called SimpleScreen CRC, the new test showed improvement over an earlier version, particularly in detecting precancerous lesions. 
    • “Abbott, which inked a collaboration agreement with Freenome last August to bring SimpleScreen CRC to market, will commercialize the test when it gains Food and Drug Administration approval, Freenome said Thursday.
    • “The latest study results set up Abbott to be the dominant player in colorectal cancer screening, Evercore ISI analysts said in a note to clients.”

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

  • Healthcare Dive reports,
    • “Hospital dealmaking remained hot during the second quarter of 2026, extending a merger and acquisition rebound that has lately seen more mid-to-large independent systems in pursuit of financial security and growth, according to a new report. 
    • “Healthcare advisory firm Kaufman Hall, in its latest quarterly M&A report, tallied 18 new hospital transaction announcements from April through June. That’s well ahead of the eight logged during the same window last year, and comfortably above the average posted by the sector across the 2020s. 
    • “Total transacted revenue was $7.7 billion for the most recent quarter, which the firm noted was a major rebound from the $1.4 billion a year prior but falls well short of most prior years.” * * *
    • “Joining the M&A report was new hospital operating data from May suggesting a slight downturn in margins both month-to-month and compared to last year.
    • “Among the 1,300 hospitals Kaufman Hall taps for its monthly sector benchmarks, the firm reported a calendar year-to-date operating margin index of 2.9%, and a single-month operating margin index of 2.7% (both including health system allocations for the cost of shared services).
    • “The former of those reflects a 6% pullback from April’s data, and a 4% dip from May a year prior. The latter, year-to-date margin is a 5% decline from the preceding year as of the same point.” 
  • The American Hospital Association relates,
    • AHA Chair Marc Boom, M.D., presented three AHA awards during the 2026 Leadership Summit, recognizing hospitals and health systems for innovation, advancing health and excellence. See the news releases for more details on the winners and honorees.  
      • The 2026 Foster G. McGaw Prize for Excellence in Community Service, recognizing healthcare organizations for commitment to community service through programs that make communities healthier and more vital, was presented to Sky Lakes Medical Center in Klamath Falls, Ore.  
      • The 2026 Quest for Quality Prize, honoring hospitals and health systems that exemplify excellence in delivering high-quality, safe and patient-centered care, was presented to the Ralph H. Johnson VA Health System in Charlotte, N.C. 
      • The 2026 Circle of Life Award, recognizing outstanding programs in palliative and end-of-life care, was presented to Erie County Medical Center of Buffalo, N.Y., and the Geriatrics and Extended Care Hospice and Palliative Medicine Team of Orlando VA Health Care System in Orlando, Fla. 
  • Beckers Payer Issues tells us,
    • “Rejections of initial brand-name prescription attempts increased from 24.3% in 2018 to 40.7% in 2024, according to a July 9 JAMA study.
    • “Researchers from Baltimore-based Johns Hopkins Bloomberg School of Public Health and the American Enterprise Institute led the study. Looking across various types of coverage, they reviewed 1.17 million people’s pharmacy claims data for more than 2 million prescription attempts for brand-name drugs that lack generic alternatives. 
    • Here are six other things to know from the study:
      • 1. Overall, between 2018 and 2024, 32% of initial fill attempts were rejected.
      • 2. Of that share, the rejected molecule was ultimately filled within 90 days in 38.6% of cases, and a different drug in the same therapeutic class was filled for 13%. However, 48.4% had no medication filled in the same therapeutic class within that window.
      • 3. For those who ultimately received the same molecule or a therapeutic substitute, treatment was delayed an average of 12.2 days after that initial rejection.
      • 4. While 68% of the requests were paid after the initial fill attempt, 14.8% were rejected due to a formulary exclusion and 17.2% due to required prior authorization or step therapy.
      • 5. Rejections were steepest among exchange and Medicaid managed care plans, at 48.7% and 49.8%, respectively.
      • 6. Rejection rates were lower among Medicare plans.
  • Beckers Health IT informs us
    • “Technology services company UST is integrating Anthropic’s Claude into CarePath, a platform providers and payers use to run claims processing, care management and member services.
    • “Claude connects CarePath directly to underlying claims and care systems, turning fragmented health data into recommended next steps for care teams, per a July 9 Anthropic news release. Every action Claude recommends routes to a person for approval before it reaches a member, and the integration operates within the data controls healthcare requires.” * * *
    • “The company [UST] is betting that pairing Claude’s reasoning capabilities with human-approval workflows can move AI-led decisions out of pilot programs and into the production systems regulated industries depend on.”
  • Fierce Healthcare points out,
    • “Venture capital funding for digital health startups is on an upswing, fueled by an AI-powered rebound following a post-pandemic reset in 2023.
    • “Digital health companies raised $7.4 billion in the first half of 2026, up $1 billion compared to the first half of 2026 ($6.4 billion raised), according to Rock Health’s analysis of digital health deals in the first half of 2026. There were 244 deals in H1 2026. Investors poured $3.2 billion into the sector in Q2, just shy of Q1’s $4.2 billion.
    • “Building on trends from last year and into Q1 this year, capital is concentrating among a small number of megadeals as venture capital investors place their bets on innovative digital health companies, Rock Health researchers Ashwini Nagappan, Jason Lei and Maddie Knowles wrote.”

Weekend update

David Ermer–Agentic & Generative AI, Congress, Medicare, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“National Simplicity Day on July 12 honors transcendentalist Henry David Thoreau, a man who advocated a life of simplicity. A man of many talents and skills, Thoreau was a supporter of living the simple life and encouraging others to do the same.”

Clarity Benefit Solutions offers the following pledge; “I pledge to make a conscious effort to simplify the administration, service, and user experience for benefits this year because I believe in the value and power of simplicity in a complicated world. Let’s let simplicity be our new normal.”

OPM should make good on this pledge by adopting the June 2026 recommendations that the AFHO trade association offered.

From Washington, DC,

  • Roll Call discusses this week’s anticipated events on Capitol Hill.
  • 24 Wall St reminds FEHB annuitants,
    • Skipping [Medicare] Part D for two years locks in a permanent 24% monthly surcharge worth roughly $113 annually on top of any plan premium.
    • The surcharge grows every year because it tracks the national base premium, which jumped 6% in 2026 alone, compounding lifetime costs into the thousands.
    • A 63-day gap without creditable coverage triggers the penalty even with no medications, making enrollment in the cheapest Part D plan the only sure defense.

From the U.S. public health and medical / Rx research front.

  • The Cleveland Clinic Newsletter tells us,
    • “As thousands of the world’s leading Alzheimer’s researchers, clinicians, and policymakers convene this week in London for the Alzheimer’s Association International Conference 2026, we have an opportunity to change the course of history for women’s health by focusing on women’s brains.
    • “For too long, women’s health has been compartmentalized into reproductive health, breast cancer, heart health and bone health. Missing from the conversation has been a focus on the organ that regulates every part of a woman’s body: the brain. That must end. Women’s health is brain health, and brain health is the core of women’s health.
    • “Women make up nearly two-thirds of those diagnosed with Alzheimer’s. Women are also far more likely to provide the unpaid care that keeps families and care systems from collapse. Yet women’s brains remain largely under-studied, under-discussed, and underprioritized in research, risk reduction and care.”
    • “The world can no longer afford to ignore [these issues].”
  • Onco Daily relates.
    • ‘Breast cancer incidence is increasing rapidly among Asian American, Native Hawaiian, and Pacific Islander women in the United States, with especially concerning trends in early-onset disease, distant-stage diagnosis, and aggressive molecular subtypes.
    • “A new population-based study published in JAMA Network Open examined invasive breast cancer incidence trends from 2000 to 2022 across disaggregated Asian American, Native Hawaiian, and Pacific Islander ethnic groups.
    • “The study included 148,608 Asian American, Native Hawaiian, and Pacific Islander females diagnosed with invasive breast cancer using National Cancer Institute SEER Program data from 14 US states.
    • “The findings challenge the older assumption that breast cancer incidence is uniformly lower among Asian American populations. They also show why grouping Asian American, Native Hawaiian, and Pacific Islander communities into one category can hide important differences in risk, stage, and subtype.”
  • The American Heart Association informs us,
    • “Gum disease bacteria may spur calcium buildup in the heart’s aortic valve, leading to a common and serious heart valve disease, according to preliminary, independent research presented at the American Heart Association’s Basic Cardiovascular Sciences Scientific Sessions 2026. The meeting, in Boston, July 13-16, 2026, is one of the largest meetings globally dedicated to fundamental and translational research in cardiovascular science.
    • “According to the American Heart Association, calcific aortic valve stenosis (CAVS) occurs when the aortic valve thickens and calcifies, restricting blood flow from the heart to the rest of the body. In early stages, there may be no symptoms; however, as the condition progresses, it can cause fatigue, chest pain, shortness of breath, fainting, heart failure and sometimes premature death. Standard treatment for severe CAVS is valve replacement surgery.
    • “This study identifies a potential biological pathway linking chronic oral gum disease and infection to calcific aortic valve stenosis.” * * *
    • “The American Heart Association’s Healthy Smiles, Healthy Hearts™ initiative provides dental care teams with professional education highlighting the connection between oral health and heart health, a standard blood pressure screening and referral guide for patients in dental settings, and educational materials for patients to help improve both their oral and heart health.
    • “The study has limitations because its findings have not been confirmed in people. The researchers have started a clinical study to further evaluate the link between gum disease and CAVS.”
  • U.S. Medicine points out,
    • “A top priority for researchers who study aging is how to identify and treat frailty, even though there are no established therapeutic interventions for the condition.
    • “That’s why a new study of U.S. veterans is considered so important. It found that initiation of statins was associated with a significantly lower risk of incident frailty or death among the older participants, including those who were pre-frail at baseline.
    • “There are currently no approved medications specifically to prevent frailty,” explained lead author Saadia Qazi, DO, MPH, MSc, a cardiologist at the VA Boston Healthcare System and in the Division of Aging in Mass General Brigham’s Department of Medicine. “Our findings suggest that statins may offer an important opportunity to reduce the risk of frailty and help people preserve their health and independence as they age.”

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

  • Out of the Beltway informs us, “The Economist surveys recent research and concludes, “An ageing society might not cost too much.”
    • “Spending on health care depends on how much it costs to provide and how much treatment is needed. Generally, the former has increased over time. Economists attribute this to Baumol’s cost disease, diagnosed by William Baumol, an American economist. Technologically intensive sectors (think of manufacturing or software development) get more productive. Labour-intensive service sectors do not. A doctor’s consultation takes roughly as long as it did a century ago. Yet physicians’ pay must match increases in faster-growing skilled industries, or all the doctors will go to work in tech. (Baumol pointed out that a string quartet still took 45 minutes to perform a Schubert work,but was paid vastly more than when the composer was alive.) […]
    • “Two new papers from the National Bureau of Economic Research, a repository of economic thought, suggest that the vision of health care gobbling up tax revenues may not come to pass. In the first, David Cutler and Lev Klarnet, both of Harvard University, observe that in 2024 America spent $1trn less on health care than official forecasts from 2010. The second is by Liran Einav, of Stanford University, and Amy Finkelstein, of the Massachusetts Institute of Technology (MIT). Using a survey of users of Medicare, America’s system of health insurance for the old, they find that, whereas expected lifetime spending on Social Security (ie, pensions) rose by 14% between 1993 and 2017, the expected cost of Medicare increased by only 6%. That is partly because elderly Americans have been collecting their pensions for longer but spending less time seriously ill.
    • “The papers point to improvements on both sides of the equation. Start with the cost of providing health care in hospitals. Messrs Cutler and Klarnet point out that, between 2000 and 2010, it consistently rose by around 2.3 percentage points above inflation—but that later something changed. Between 2011 and 2024 hospital costs rose by only 0.5 percentage points more than overall prices. Technology has played a role. Technological improvements in health care come in two types: some are adopted because economies get richer and can afford to treat new things; others make it cheaper to provide the same outcomes. For much of the past century, the first type dominated the second. Now, it seems the second type has taken over. Baumol’s cost disease turned out to be curable.”
  • McKinsey and Co. considers that “The consumer is changing fast. Four trends—the tech-driven path to purchase, the health revolution, the experience economy, and the resourceful consumer—will redefine the sector. Will brands keep up?”
  • MedCity News notes that “Healthcare and AI are in Need of Relationship Counseling.”
    • “Performing well in controlled settings is only part of the picture, the harder question is whether AI is being integrated into clinical workflows in ways that keep responsibility, authority, and accountability properly aligned.”
  • The Wall Street Journal reports.
    • “Eating-disorder therapists say patients are increasingly using chatbots for diet and exercise advice, sometimes challenging professional guidance.
    • “Therapists warn that chatbot advice delivered without clinical context can be dangerous and delay vital treatment for eating disorders.
    • “AI companies say they are working to improve how their models recognize and respond to signs of disordered eating.’

Notable Death

  • The Frederick (MD) News Post reports,
    • “Martha Lillard had just turned 5 when she was diagnosed with polio and depended on an iron lung to live. She died June 26 in Oklahoma, the last U.S. polio patient who used the machine, her sister said. She was 78.
    • “They told her she wasn’t supposed to live past 20 years old,” Lillard’s younger sister, Cindy McVey, told The Associated Press on Friday. “She had the enthusiasm and the drive to continue living and make the best of her life.” * * *
    • “McVey described her sister as artistic and creative. She wrote poems and composed songs. She wrote her own obituary, which is now posted online by a funeral home. She described being a Humane Society volunteer. “She was an avid Beagle lover and assisted in animal rescue as a cross poster on Facebook,” Lillard wrote.”
  • RIP


Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the renewed war with Iran front,

  • Dark Reading offers an opinion piece explaining that “Iran’s Cyber Crosshairs Focus Beyond Critical Infrastructure.”
    • “Obscurity isn’t a defense. If your company has any Internet-facing vulnerability, you’re at risk from multiple threats.” * * *
    • “The groups behind recent attacks, including Handala, Ababil of Minab, and others operating within Iran’s cyber-influence ecosystem, cloak themselves in the mask of cyber activism, or “hacktivism.” They are largely opportunistic. They aren’t specifically hunting targets; they are on “Shodan Safaris” hunting easily exploited vulnerabilities or insecure systems. A law firm or logistics hub with an exposed programmable logic controller or an unpatched VPN is an easy, appealing target.
    • “Many companies don’t realize how much of their infrastructure is externally accessible, or how little it takes to exploit what’s exposed. Handala, which the US Justice Department has attributed to Iran’s Ministry of Intelligence and Security, remotely wiped over 200,000 hosts in an attack on Stryker, a medical device manufacturer, in March. The incident disrupted manufacturing and impacted their first-quarter earnings. More recently, Ababil of Minab compromised Vyncs, a GPS tracking platform used across the logistics sector, taking systems offline and defacing its website. In the Stryker incident, the attack was likely made possible through credentials stolen via commodity malware and provided for sale via illicit channels — emphasizing the opportunistic nature of these events.”
  • Security Week adds,
    • “An Iran-linked advanced persistent threat (APT) actor has been using a modular command-and-control (C&C) framework in recent attacks targeting organizations in Israel, Check Point reports.
    • “Tracked as Cavern Manticore, the APT focuses on government entities and IT providers, and appears linked to Iran’s MOIS (Ministry of Intelligence and Security), with possible ties to the OilRig subgroup Lyceum (also known as Hexane and SiameseKitten).
    • ‘Cavern Manticore’s C&C framework includes an adaptable toolset built using .NET, with various compilation formats used across components, used as an anti-analysis layer.”

From the Project Glasswing front,

  • Crypto Briefing reports,
    • “The U.S. government has begun utilizing AI technology developed by Anthropic to identify vulnerabilities in its software systems. This initiative, part of Project Glasswing, leverages Anthropic’s Mythos model to detect bugs within hours, a significant improvement over traditional methods. Despite previous concerns over security risks associated with the Mythos model, its deployment underscores the government’s commitment to strengthening cybersecurity measures. The move is seen as a strategic effort to protect critical infrastructure and enhance national security.”
  • Bleeping Computer adds,
    • Microsoft says Windows users should expect to see an increase in security updates as the company increasingly relies on artificial intelligence to discover vulnerabilities in its codebase.
    • In a blog post published today, Microsoft said advances in AI have significantly accelerated vulnerability discovery, allowing engineers to identify more security issues before they can be exploited in zero-day attacks.
    • “The pace of vulnerability discovery is changing with advances in AI making it possible to find more issues, faster, across more code, with new mechanisms that can accelerate both discovery and analysis,”  Microsoft said. * * *
    • “This announcement comes two days [July 8] after Reuters reported that the U.S. Cybersecurity and Infrastructure Security Agency (CISA) has begun using Anthropic’s Fable AI model to scan government software for vulnerabilities that cybercriminals or foreign intelligence services could exploit.
    • “According to the report, the AI-assisted code audits have already uncovered numerous vulnerabilities, though officials did not disclose how many or provide details on their severity.”
  • SC Media lets us know “what our industry learned the past 90 days since the Mythos announcement.”
    • “For years, security leaders have discussed the possibility that AI would eventually accelerate offensive cyber operations. Mythos transformed that discussion from a future-looking hypothesis into an immediate operational concern.
    • “Over the past three months, the industry has begun adjusting to a new reality. We no longer view AI simply as a productivity tool that helps developers write code or assists analysts with investigations. It’s emerged as a force multiplier for vulnerability discovery, capable of identifying weaknesses at a pace that challenges traditional security workflows. As the time between vulnerability discovery and exploitation shrinks, organizations are now forced to rethink long-standing assumptions about patch management, vulnerability prioritization, and cyber defense.
    • “This shift extends well beyond one AI model or one vendor. Whether organizations use commercial frontier models, open-weight alternatives, or internally developed AI systems, the underlying trend remains the same: AI has dramatically compressed the window defenders have to identify, validate, and remediate software flaws before attackers can weaponize them. In many ways, the security industry has entered an era in which the speed of decision-making may become just as important as the quality of detection.”

From the cybersecurity policy and law enforcement front,

  • On July 3, the Office of Management and Budget’s Office for Information and Regulatory Affairs posted the federal government’s 2026 unified regulatory agenda.
    • Fierce Healthcare tells us,
      • “Federal regulators have delayed a major overhaul of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, pushing back final action on the rule by a year.
      • “The Department of Health and Human Services (HHS) had proposed a May 2026 release for a final rule that makes significant changes to the HIPAA Security Rule and marks the first major update to the 23-year-old rule in more than 10 years.
      • “The U.S. Office of Management and Budget (OMB) website was updated and indicates that the final rule was pushed back to July 2027.”
    • Federal News Network lets us know,
      • “[The unified agenda] shows that the Cybersecurity and Infrastructure Security Agency expects to issue a final rule for the Cyber Incident Reporting for Critical Infrastructure Act in September 2026. Earlier this summer, CISA held a series of townhalls to get some final feedback on the regulations.” * * *
      • “Meanwhile, the Unified Agenda also shows that a federal contracting rule that standardizes cybersecurity requirements for unclassified IT systems will also be finalized in September 2026.
      • “The rule “will ensure federal information systems are better positioned to protect from cybersecurity threats by standardizing common cybersecurity contractual requirements across agencies for unclassified federal information systems,” according to the regulatory preview.
      • “And another federal contracting rule on “cyber threat and incident reporting and information sharing” is also projected to be finalized in September, the Unified Agenda shows.
      • “Both the CUI rule and the incident reporting rule have been long anticipated, with proposed rules dating back to 2023. They each represent landmark rules for the government contracting community, which is also grappling with the roll out of the Defense Department’s Cybersecurity Maturity Model Certification (CMMC) requirements.
      • “The CMMC regulations went into effect late last year, but DoD has been slowly ramping up the requirements for third-party audits. This November, however, the requirement for a third-party CMMC assessment is expected to become standard in all applicable contracts.
      • “DoD also expects to shortly issue more details on how the cybersecurity standards that underpin CMMC will be updated.
      • “The Unified Agenda shows that this month, DoD will adopt an interim final rule for the CMMC program that details the deadline for shifting to the National Institute of Standards and Technology Special Publication 800-171 Revision 3. Currently, CMMC assessments are tied to Revision 2 of the NIST standards.”
  • Fedscoop informs us,
    • “Greg Barbaccia is stepping down as federal CIO and leaving government at the end of August, he said in an email to the CIO Council Tuesday [June 7, 026].
    • “I’m writing to share that I’ve made the difficult decision to leave government, and my time as Federal CIO is coming to an end,” Barbaccia wrote to CIOs on the council in his email, obtained by FedScoop. 
    • “Barbaccia, who joined the Trump administration as its top IT official in January 2025, said his last day in the role will be Aug. 31.
    • “Barbaccia’s departure comes just months after he brought on former Department of Education CIO Thomas Flagg to be his deputy. Flagg would be the default acting official with Barbaccia’s departure, a government chief information officer told FedScoop on the condition of anonymity to be more candid.”
  • Cyberscoop observes,
    • “The AI-focused executive order President Donald Trump signed last monthgave the Treasury Department, the National Security Agency, and the Cybersecurity and Infrastructure Security Agency (CISA) 30 days to establish a new “AI cybersecurity clearinghouse.” The deadline passed last week.
    • “The clearinghouse is meant to coordinate the scanning, discovery, and validation of software vulnerabilities in critical infrastructure, and then prioritize how those vulnerabilities get patched and distributed.
    • “It’s the right problem to solve. The question now is whether what is created will actually solve it.”
  • and
    • “A major credential leak spurred the Cybersecurity and Infrastructure Security Agency to strengthen protections for its sensitive materials, improve how researchers can report agency vulnerabilities and develop plans for similar incidents, the agency said in a forensic report released Thursday.
    • The blog post outlines CISA’s response to the leak that the researcher who discovered it in May called one of the worst he had ever seen, which also drew congressional scrutiny.”
  • Cyberscoop adds,
    • “”A former ransomware negotiator for DigitalMint was sentenced to 70 months in jail for deceiving his employer’s clients and conspiring with ransomware affiliates to extort a combined $75.3 million from five U.S. companies he was entrusted to aid during their moments of extreme crisis, the Justice Department said Thursday. 
    • Angelo John Martino III shared confidential information he gained from his work as a ransomware negotiator, including victim organizations’ negotiating positions and insurance policy limits, to extract the maximum payment for himself and other BlackCat affiliates he colluded with in backchannels.”
  • and
    • “An Armenian national who was extradited from Ukraine to the United States last year pleaded guilty to participating in a series of attacks in 2019 and 2020 involving Ryuk ransomware, the Justice Department said Thursday.
    • “Karen Serobovich Vardanyan pleaded guilty to computer fraud and conspiracy to commit fraud and extortion. He agreed to pay nearly $1.2 million million in restitution and faces up to 15 years in jail.
    • “The 34-year-old admitted to participating in cybercrime from November 2019 to April 2020 when he and his co-conspirators deployed Ryuk ransomware against three U.S.-based organizations while living in Ukraine and Russia.”

From the cybersecurity breaches and vulnerabilities front,

  • Dark Reading reports,
    • “In February, a ransomware attack against the University of Mississippi Medical Center disrupted operations for more than two weeks. In March, a cyberattack on German medical-billing provider Unimed, which services 95% of the nation’s university hospitals and more than half of large clinics, resulted in the theft of sensitive health data for tens of thousands of patients.
    • “In the first half of 2026, cyberattacks on the healthcare sector jumped 14%, slightly more than the overall increase of 11% across all industries, according to data from technology research firm Comparitech. While healthcare providers — such as hospitals and doctors’ offices — saw a moderate rise in attacks, healthcare businesses suffered a significant increase of 35% compared with the second half of 2025 and 110% compared with the same six months from the previous year.
    • “Much of the shift in focus is likely because attackers have recognized that compromising a single provider can provide access to multiple hospitals, says Rebecca Moody, head of data research at Comparitech.”
  • Cybersecurity Dive relates,
    • “A threat actor claims to have stolen a vast trove of sensitive data from the consulting giant Accenture in a recent cyberattack.
    • “The compromised data includes source code, Microsoft Azure personal access tokens, RSA encryption keys and SSH keys, a hacker calling themselves “888” said in a dark-web post shared by Bleeping Computer.
    • “The actor says they hacked roughly 35GB of data from Accenture during the intrusion, which occurred in early July.
    • “Accenture downplayed the incident in a statement to Cybersecurity Dive.
    • “We are aware of this isolated matter and we have remediated its source,” spokesperson Peter Soh said. “There is no impact to Accenture operations and service delivery.”
    • “The stolen data could put Accenture and its clients at significant risk of further attacks. “Source code can help attackers understand internal application logic, identify weak implementation patterns, and search for hardcoded secrets or exploitable paths in custom systems,” the threat intelligence firm SOCRadar said in an analysis of the incident. Meanwhile, the exposed access keys could let hackers roam freely through code repositories and cloud storage services.”
  • and
    • “AssuranceAmerica, a closely held provider of auto and renters insurance, was the target of a cyberattack earlier this year that impacted more than 6.9 million customers, according to state regulatory filings. 
    • “The Atlanta-based firm said the incident was detected on March 17, stemming from an attack that targeted one of its employees a day earlier, according to a filing with the California Attorney General’s office. 
    • “An investigation found an unauthorized party gained access to the company’s IT department and copied a number of data files. The company said it notified law enforcement about the attack. 
    • “According to a filing with the Maine Attorney General’s office, the breach involved more than 6.9 million people. This included nearly 880 people within the state of Maine. The Maine AG discontinued posting new notices on its public site in June after its breach reporting system was the target of an attack.”
  • and
    • “An initial access broker weaponized a critical vulnerability known as CitrixBleed 2 in a series of attacks during the first half of 2026 across multiple organizations, according to a report released Thursday [July 9] by the security company Huntress. 
    • “After exploiting the vulnerability, the hackers escalated privileges, created rogue local administrator accounts and established persistence with legitimate remote access tools, including ScreenConnect and Zoho Assist. 
    • “About a half-dozen cases between January and June followed a consistent playbook. In the most advanced case, the attackers deployed DragonForce ransomware, Huntress researchers said.”
  • Healthcare Dive adds,
    • “AdaptHealth disclosed last week that a recent cyberattack resulted in patient data being stolen.
    • “A threat actor gained unauthorized access to company systems through a social engineering attack and exfiltrated data, including certain personally identifiable information, protected health information of patients and stored password files associated with insurance billing, according to a July 2 filing with the Securities and Exchange Commission.
    • “Based on information obtained to date, AdaptHealth believes that the threat actor gained unauthorized access to certain cloud-based business applications, including internal patient management systems and document storage platforms. The company also confirmed that certain external electronic health record system portals were accessed.”
  • CISA added six known exploited vulnerabilities to its catalog this week.
    • July 7, 2026 (two releases; “Per BOD 26-04, federal agencies are required to patch all four security weaknesses by July 10.”)
      • CVE-2026-48282 Adobe ColdFusion Path Traversal Vulnerability
      • CVE-2026-48908 JoomShaper SP Page Builder Unrestricted Upload of File with Dangerous Type Vulnerability
      • CVE-2026-55255 Langflow Authorization Bypass Through User-Controlled Key Vulnerability  
      • CVE-2026-56290 Joomlack Page Builder Improper Access Control Vulnerability
        • Security Week discusses these KVEs here.
    • July 10, 2026
      • CVE-2026-48939 iCagenda Unrestricted Upload of File with Dangerous Type Vulnerability
      • CVE-2026-56291 Balbooa Forms Unrestricted Upload of File with Dangerous Type Vulnerability
        • Mallory discusses these KVEs here.
  • Dark Reading adds,
    • “Microsoft has tackled yet another zero-day vulnerability published by a disgruntled security researcher with a vendetta against the software giant.
    • “On Wednesday, Microsoft issued an out-of-band patch for RoguePlanet, an elevation-of-privilege vulnerability in Windows Defender, tracked as CVE-2026-50656. The high-severity flaw, which received a 7.8 CVSS score from Microsoft, could allow an attacker to escalate privileges on a Windows device from a basic user to the highest SYSTEM-level access, which would give them complete control over the device.” * * *
      “Despite a public exploit being available for RoguePlanet, it’s unclear if the vulnerability has been exploited in the wild. Microsoft’s updated advisory states the flaw has not been exploited, and CISA has not added CVE-2026-50656 to its Known Exploited Vulnerabilities (KEV) catalog. Qualys, meanwhile, published a threat report on June 18 stating that RoguePlanet has been “exploited in attacks,” though no details were provided.”
  • Security Week relates,
    • “Organizations across multiple sectors have been targeted in a vishing campaign aimed at harvesting Microsoft 365 credentials, Okta warns.
    • “The campaign started in April and has involved voice calls directing the victims to fake Microsoft Entra ID login pages under the pretense that they need to register a new passkey.
    • “Tracked as O-UNC-066 and also known as CL-CRI-1147 and Pink, the hacking group has been targeting automotive, aviation, construction, food and beverage, healthcare, and technology organizations, mainly for data extortion.
    • “As part of the observed attacks, the threat actor has been registering domains incorporating the word ‘passkey’, and has been directing victims to pages that closely mirror the Microsoft passkey enrollment process.
    • “It appears engineered to convince a targeted user they are in the process of enrolling a passkey with Microsoft, while the threat actor simultaneously registers their own passkey in the targeted user’s Microsoft account,” Okta says.”
  • and
    • “A critical prompt injection vulnerability in GitHub Agentic Workflows could allow unauthenticated attackers to leak private repository data, Noma Labs warns.
    • “GitHub Agentic Workflows allows users to write workflows in natural language using markdown files that an AI agent will use as GitHub Actions, thus automating the interaction with code repositories.
    • “Because of the security defect, named GitLost, unauthenticated attackers can hide indirect prompts in crafted GitHub Issues posted on the public repositories of an organization that also maintains private repositories, and the AI agent will follow the instructions.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Ransomware activity grew slightly between the first and second quarters of 2026 but significantly year over year, and there were more hacker groups active during April, May and June than in any previous quarter, researchers said on Thursday [July 9].
    • “Cybercrime actors claimed breaches of 2,279 victims in Q2 2026, a 7% increase over Q1 2026 but a 43% year-over-year increase compared with Q2 2025, GuidePoint Security said in a quarterly report.
    • “The Qilin ransomware gang led the quarter, accounting for 13% of attacks, but the relatively new group The Gentlemen has grown quickly and now accounts for almost as much activity, GuidePoint said.” * * *
    • “Qilin, The Gentlemen, Akira and DragonForce compromise what GuidePoint calls the “four-headed monster” of high-volume ransomware groups. The lack of a “singular monolithic figure” could make the ransomware community more resilient to law-enforcement takedowns, the security firm said, because there are now “multiple franchises poised to absorb displaced affiliates if another were to disappear overnight.”
  • Tech Crunch relates,
    • “Last week, researchers at cloud security firm Sysdig said they’d documented the first known case of “agentic ransomware.” It was an extortion operation, dubbed JadePuffer, in which an AI agent — not a human — handled the technical execution of a real-world cyberattack from start to finish. The agent broke into a vulnerable server, stole credentials, moved through the target’s network, encrypted files, and even wrote its own ransom note, adapting to obstacles along the way like a human hacker would. Coverage of the operation described it as run “without any human oversight,” with “no human at the keyboard.”
    • “That’s not quite the full picture. In an interview on Monday with CyberScoop, Sysdig’s Michael Clark, the company’s senior director of threat research, clarified that a human was still very much involved — just not in the technical execution. “A human still set up and pointed the operation and provisioned the infrastructure behind it, the command-and-control server, the staging server used for the stolen data and chose a victim,” Clark said. The credentials used to break into the victim’s database, he added, weren’t harvested by the AI agent itself; someone obtained them separately, through a prior compromise, and handed them to the operation.
    • “None of this contradicts Sysdig’s original claim, and the technical details of the attack remain notable on their own — wild, even. The agent got in through a known bug in Langflow, a popular open source tool for building LLM apps, then moved on to a production MySQL server and exploited another known flaw to gain admin access. It encrypted over 1,300 configuration records and not only left behind a ransom note that it wrote itself but it left a Bitcoin address where the ransom could be sent. Sysdig hasn’t disclosed who was targeted.”
  • Dark Reading tells us,
    • “A newly rebranded ransomware outfit is sneaking malware into American organizations using a malicious yet Microsoft-approved driver.
    • “Researchers at Symantec recently observed a cyberattack from a group known as “Hyadina.” Hyadina is a 4-year-old ransomware-as-a-service (RaaS) operation with a new locker, “GodDamn,” an iteration on its previous lockers, “Beast” and “Monster.” It typically attacks American organizations, and it also has a distinct distaste for former Soviet countries. Its targets have spanned sectors that include healthcare, manufacturing, education, and wherever else it finds opportunity.
    • In a recent case against an unidentified organization, Hyadina used a smorgasbord of dual-use hacking tools, including legitimate remote monitoring and management (RMM) software, and more than a dozen penetration testing programs. The real kicker, though, was a malicious program with kernel access on Windows, capable of killing any and all processes, including security software.

From the cybersecurity business and defenses front,

  • Cybersecurity Dive reports,
    • “U.S. companies are merging cyber risk issues into their overall enterprise risk strategy, at a time when AI adoption and business resilience are leading to significant shifts in business priorities, according to a report released Tuesday [July 7] by Information Services Group, a technology research and advisory firm.
    • “Cybersecurity is increasingly seen as a business-critical concern, as companies accelerate their adoption of agentic AI and transform much of their technology and data infrastructure to hybrid or multicloud environments. 
    • “Enterprise leaders are closely integrating cyber spending decisions with overall IT strategy. In addition, C-suite and board members are taking greater accountability for business continuity, financial exposure and regulatory compliance.”
  • Info-Security Magazine relates,
    • “Chris Betz has officially taken the helm as the new CISO of Google Cloud. Transitioning from his previous role as Google’s VP of infrastructure security, Betz is stepping up to lead the company’s security posture at a critical turning point in the industry.
    • “In his very first interview since assuming the CISO title [which is found in the article], he shared his vision on the role generative AI will play in defending global enterprises.
    • “Coinciding with his transition, Betz published a key blog post on the Google Cloud blog titled Cloud CISO Perspectives: The 4 lessons that guided AI threat defense. In the article, he lays out Google’s playbook for using AI to defend against AI, advocating for a multi-model approach, robust security harnesses and the irreplaceable value of human expertise in modern cyber defense.”
  • Tech Target offers “a roadmap to zero trust maturity.”
    • “Transforming an organization to take on a zero-trust posture is no small affair. A phased, thoughtful approach can bolster security while supporting business outcomes.”
    • “Zero trust is not a product, control or single technology deployment; it’s a strategic architecture and operating model designed to reduce risk and improve the security posture of organizations that have traditional, perimeter-based security models. Perimeter-based models — which assume clearly defined “inside” and “outside” boundaries — fail to address modern threats because they were designed for a world that no longer exists.
    • “Zero trust relies on three foundational principles:
      • “Explicit verification. Every access request is authenticated and authorized using components such as user identity, device health, location and behavior.
      • “Least-privilege access enforcement. Users and devices receive only the minimum access required, and only for as long as needed.
      • “Assume breach. Security operates under the assumption that attackers are already present, with controls designed to limit access and damage.”
  • and sugggests an approach for “evaluating secure enterprise browsers vs. security plugins
    • “Malicious actors have long targeted and exploited browser vulnerabilities. The widespread adoption of AI increases the risk, forcing CISOs to reevaluate browser security options.” * * *
    • “In this moment of renewed attention to browser security and the risks of it failing, CISOs face two options for improving browser security: deploying secure enterprise browsers and deploying browser security plugins.”
  • Here is a link to Dark Reading’s CISO Corner.