Midweek report

CMS

Midweek report

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

Simplicity is a virtue.

From Washington, DC

  • Per Centers for Medicare and Medicaid Services fact sheets
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update Medicare payment policies and rates for Inpatient Psychiatric Facilities (IPFs) under the IPF Prospective Payment System (PPS) (CMS-1847-F) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with its statutory authority to update Medicare payment policies for IPFs annually. 
    • “This fact sheet discusses the provisions of the final rule, including annual updates to the prospective payment rates, the outlier threshold, the wage index, and associated impact analysis. In addition, the rule finalizes a policy effective for FY 2028 (October 1, 2027) to limit outlier payments at the facility level to no more than 20% of an IPF’s total IPF PPS payments in a year, for IPFs with at least 50 stays per year. For the IPF Quality Reporting Program, CMS is removing two measures from the program, as well as implementing a standardized IPF patient assessment instrument.
    • “For FY 2027, CMS is updating the IPF PPS payment rates by 2.3%, based on the 2021-based IPF market basket increase of 3.2% less a 0.9 percentage point productivity adjustment. Additionally, CMS is updating the outlier threshold so that estimated outlier payments remain at 2% of total IPF PPS payments. Total estimated payments to IPFs would increase by 2.3%, or $60 million, in FY 2027, relative to IPF payments in FY 2026.”
  • and 
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule for updates to Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with the legal requirements to update Medicare payment policies for SNFs annually. This fact sheet discusses the final rule’s provisions.
    • “For FY 2027, CMS finalized updating SNF PPS rates by 2.4% based on the final SNF market basket of 3.3%, reduced by a 0.9% productivity adjustment, for an estimated increase of $882.74 million in aggregate payments to SNFs.”
  • Beckers Hospital Review points out twelve things to know about these rules.
  • The American Hospital Association News relates,
    • “The Health and Human Services Secretary today announced that dozens of insurers, medical societies, healthcare providers and behavioral health experts have pledged to strengthen the nation’s behavioral health system by advancing best practices aimed at improving mental health and addiction treatment. The pledge commits participants to promoting timely access, improving quality measurement and accountability, supporting patient-centered recovery services and expanding whole-person treatment that addresses behavioral and physical health needs. HHS said the initiative aligns with the administration’s broader efforts to address addiction and mental illness and improve long-term patient outcomes.” 
  • Federal News Network clears up common misconceptions about federal retirement benefits.
    • “Misconception: Federal Employee Health Benefits (FEHB) go away at retirement, or become more expensive.
    • “Fact: Under certain eligibility requirements, federal employees can continue their FEHB coverage into retirement. These requirements include enrollment in FEHB for at least five consecutive years leading up to, and having coverage on, the retirement date. It is important to note that qualified spouses, dependent children, and children with disabilities can be covered without meeting this five-year rule. Employees become classified as annuitants upon retiring, at which point the government will continue to cover about 72% of the FEHB premium.
    • In addition, retirees can also enroll in Medicare parts A and B, offering nearly comprehensive coverage, with Medicare as the primary payer and FEHB as secondary. To reduce costs, some retirees opt for a basic FEHB plan.”
    • “Misconception: Spouses will automatically continue to be covered by FEHB into retirement
    • “Fact: This is the biggest caveat about survivor’s benefits: If survivors were on the federal retiree’s health insurance plan, that health insurance will cease if there is no survivor’s benefit. Any amount of survivor’s benefit will continue the health insurance plan, so prospective retirees and their spouses should speak with a federal retirement consultant, and consider the holistic picture of their assets, the spouse’s income, their needs and budget, life insurance, and whether they have any additional financial obligations, like debt or a child in college.”
    • “Misconception: Survivor’s benefits are automatic and free
    • “Fact: Federal employees will need to make some decisions about survivor’s benefits on their retirement application. The pension is the main place where retirees need to consider their options along with their potential beneficiaries — these will primarily be spouses, except in a few special circumstances. Each of these options comes with a cost, in the form of a monthly percentage deducted from the overall pension. The options and percentages vary between the Federal Employees Retirement System and the Civil Service Retirement System.”
  • Beckers Hospital Review tells us,
    • “Federal policy changes could reshape pharmacy reimbursement, drug pricing and hospital operations in 2027, according to a new Vizient outlook. The report, published July 27, highlights four pharmacy developments health systems should monitor as they plan for the year ahead.
    • “The four policy developments:
      • “340B outpatient drug reimbursement: CMS has proposed reducing reimbursement for 340B-acquired drugs from average sales price plus 6% to ASP-33.4%. 
      • “340B remedy offset: CMS has proposed increasing the offset from -0.5% to -3%, a change the agency estimates would reduce payments by $2.3 billion in 2027.
      • “Section 232 tariffs: New pharmaceutical tariffs and ongoing investigations into medical devices could affect supply chains and costs.
      • “Medicare Drug Price Negotiation Program: CMS has issued draft guidance for implementing negotiated prices in 2028, including drugs covered under Medicare Parts B and D.

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
    • “Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”
    • “Ezplaz is a freeze-dried (lyophilized) plasma product derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B blood types, chosen to mitigate risk of giving to patients in emergencies before their blood type is determined.”
  • Contemporary OB/GYN relates,
    • “On July 29, 2026, the FDA approved norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo; Viatris Inc.) as a once-weekly combined hormonal contraceptive (CHC) patch with a low dose of estrogen for women of childbearing potential with a body mass index (BMI) below 30 kg/m², the company announced in a news release.1
    • “The approval was granted under the FDA’s 505(b)(2) regulatory pathway and was supported by results from the phase 3 Luminous Study (NCT05139121).2 Norelgestromin and ethinyl estradiol delivers norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day over each 7-day wear interval. The patch, which is reversible and non-invasive, is applied once weekly for 3 consecutive weeks, followed by 1 patch-free week.” * * *
    • “Viatris expects norelgestromin and ethinyl estradiol to be commercially available later in 2026.”
  • and
    • “Natural Cycles has received its sixth FDA clearance, this time for an updated version of the algorithm underlying its FDA-cleared birth control app. The company described the update as combining statistical modeling with machine learning trained on real-world fertility data to generate more individualized fertility predictions for users, according to a news release published July 27, 2026.”
  • Cancer Network tells us,
    • “The FDA has granted fast track designation to ISM6331, an AI-designed pan-TEAD inhibitor, for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed on or after prior anti–PD-1 antibody therapy, with or without anti–CTLA-4 antibody therapy, and platinum-based chemotherapy, according to a news release from the developer, Insilico Medicine.”
  • Cardiovascular Business points out,
    • “The U.S. Food and Drug Administration (FDA) has granted de novo market clearance for the first and only biomarker technology to directly see and quantity coronary inflammation from routine coronary CT angiography (CCTA). 
    • “The CaRi-Heart technology from Caristo Diagnostics has been heralded by numerous cardiac CT experts as a potential paradigm shift in cardiology. It is the first technology that can visualize and clearly quantify coronary inflammation using fat attenuation index (FAI) scores. This helps care teams estimate the residual risk of heart attacks in patients who otherwise appear to be managed well on optimal medical therapy.
    • “We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” Ron Blankstein, MD, director of cardiac CT at Brigham and Women’s and a former Society of Cardiovascular Computed Tomography (SCCT) president, said in a statement. “And now for the first time, clinicians can specifically measure coronary inflammation, obtaining a more complete picture of cardiovascular risk compared to standard CCTA, or calcium scoring alone. It is exciting to see Caristo’s long-awaited, pioneering solution available in the U.S.”
  • STAT News informs us.
    • “A group of outside experts convened Wednesday by the Food and Drug Administration concluded clinical data for a treatment for Duchenne muscular dystrophy from Capricor Therapeutics did not provide “substantial evidence” of efficacy.  
    • “The vote was 9-3, sending to the FDA a recommendation that the Capricor treatment, called deramiocel, should not be approved. 
    • “The FDA is not required to adhere to the expert panel’s stance, but it typically does. The agency review is still underway with a decision expected by Aug. 22. 
    • “The negative vote came at the end of an all-day meeting during which disputed results from a Phase 3 clinical trial were discussed and debated. Capricor’s presentation highlighted an analysis showing deramiocel preserved upper-arm function and staved off the heart failure most patients with Duchenne eventually experience.
    • “The FDA countered with a critique of the data that reached opposite conclusions — deramiocel was unable to separate from placebo at all. The agency also spent a good deal of time during Wednesday’s meeting calling out Capricor, saying it made major changes to the study’s statistical analysis plan that degraded the robustness of the data and made even seemingly positive outcomes hard to interpret.” 
  • Beckers Hospital Review notes,
    • “The FDA has published 17 revised draft product-specific guidances for peptide products, updating its recommendations for the development and assessment of certain generic peptide drugs.” * * *
    • “The FDA said the updates provide recommendations in five areas: submission of recombinantly, synthetically or semi-synthetically produced peptides as abbreviated new drug applications, innate immune response testing, impurity thresholds, higher order structure assessment and biological activity assessment.
    • “The FDA also said it is withdrawing its May 2021 guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, because it no longer reflects the agency’s current scientific thinking. The Center for Drug Evaluation and Research plans to revise that guidance this year.”

From the public health and medical / Rx research front

  • The Washington Post reports,
    • “About 12,000 pounds of smoked bacon imported from Canada were recalled because of lack of proper reinspection before entering the country, the Agriculture Department’s Food Safety and Inspection Service said.
    • “The bacon from Maple Leaf Foods was shipped to grocery distributors and retailers in Idaho, Oregon and Washington state. FSIS inspects imported products for packaging, documentation, condition and contamination.” * * *
    • “There are currently no confirmed cases of illness or injuries due to the products, FSIS said.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention yesterday reported 18,207 confirmed or suspected cases of cyclosporiasis across the U.S. from the current outbreak. The agency said it is investigating multiple case clusters, including an outbreak impacting nine states that is linked to iceberg lettuce. A July 17 Food and Drug Administration notice said that Taylor Farms recalled iceberg lettuce sourced from central Mexico that was distributed to 27 states, due to the potential of being contaminated with cyclospora.” 
  • The New York Times lets us know about “Nine Things Experts Wish You’d Do in Midlife to Increase Longevity.”
    • “How you treat your body and brain in your midlife years, loosely defined as 40 to 60, can hugely influence how you age in the decades to come.
    • “The seeds for many age-related diseases, including cardiovascular disease, diabetes, cancer and dementia, are sown in middle age, so it’s important to start thinking about prevention early. And it takes a lifetime of healthy habits, not just a few weeks, to move the needle on your longevity.
    • “Midlife is the ideal time to make changes, not only to benefit you in the present, but also in the future,” said Margie Lachman, a psychology professor at Brandeis University and the author of “Primetime: A New Vision for Midlife.”
    • “After all, she added, “What happens in midlife doesn’t stay in midlife.”
    • “We spoke with experts about some small habits that can make a big difference.”
  • Health Day tells us,
    • “Childhood obesity can be effectively treated through a family-based program provided through their local pediatrician, a new clinical trial says.
    • “About 42% of kids in the program lost enough weight to improve their heart health and lower their diabetes risk within a year and a half, researchers reported July 27 in JAMA Pediatrics.
    • “The program teaches families how to establish healthy eating and exercise habits, including positive reinforcement and supportive routines, researchers said.
    • “Our results show that an established, effective obesity treatment for children and adolescents can be successfully delivered in their pediatrician’s office,” lead researcher Amanda Staiano said in a news release. She is director of the Pediatric Obesity and Health Behavior Laboratory at Pennington Biomedical Research Center at Louisiana State University.”
  • Drug Topics informs us,
    • “Alcohol use, binge drinking, and heavy drinking have all increased significantly among pregnant women in the US from 2011 to 2024, according to a JAMA study. Likewise, with no end in sight for the trends in their findings, study authors consider them “concerning,” highlighting the need to address the growing trends among expecting mothers and their alcohol consumption.
    • “It is well established that alcohol is a teratogen, and numerous existing guidelines advise women to abstain from alcohol during pregnancy and while breastfeeding,” wrote the authors of a study in Drug and Alcohol Review. “However, many women consume alcohol in pregnancy even after learning they are pregnant. Worldwide, approximately 10% of women in the general population consume alcohol in pregnancy, although the European region has the highest rate of consumption (25%).
    • “The JAMA analysis revealed that from 2011 to 2024, the relative increase in current alcohol use among pregnant individuals reached 59%, and binge drinking rose by 77% and heavy drinking surged by a startling 166%. These absolute increases, 5.4%, 2%, and 1.2%, respectively, represent a significant shift in behavior that researchers indicate has no clear sign of reversal.”
  • Genetic Engineering and BioTechnology New lets us know,
    • “Engineers and neuroscientists at the University of California (UC) San Diego have developed a soft, wearable fingertip patch that continuously tracks a Parkinson’s disease (PD) patient’s levodopa medication levels by measuring chemicals in their sweat, with no batteries required. Tests in healthy volunteers and in Parkinson’s disease patients showed that measurements generated using the device were comparable to those obtained by standard laboratory blood tests.
    • “The wearable device offers a way to continuously track real-time concentrations of levodopa in the body and could enable doctors to precisely customize daily medication schedules for patients at home.
    • “The research was led by Tamoghna Saha, PhD, a postdoctoral researcher in the lab of Joseph Wang, DSc, professor in the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at the UC San Diego Jacobs School of Engineering. Saha is co-first author of the team’s published paper in PNAS titled “A wearable patch for continuous levodopa monitoring in sweat: Towards exertion and power-free pharmacodynamic assessment in Parkinson’s disease.” In their paper the authors wrote in summary, “Overall, our easy-to-use, energy-efficient wearable supports real-time, stimulation-free monitoring, potentially enabling at-home dosage adjustments and paving the way for future autonomous closed-loop L-dopa therapeutic system development.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On August 5, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.”
  • Per STAT News,
    • “For decades, efforts to develop non-opioid pain drugs were marked by failure. But what was once a graveyard of drug discovery is quickly turning into a race for a multibillion-dollar market, with Latigo Biotherapeutics publishing positive data on Wednesday for a therapy meant to rival a Vertex medicine already on the market.
    • “The startup’s Phase 2 trial enrolled 343 patients who’d gotten tummy tuck surgery; they were randomized to receive a high or low dose of Latigo’s experimental pill, a placebo, or a combination of acetaminophen and the opioid hydrocodone. Those given either dose of Latigo’s oral drug, LTG-001, showed statistically significant pain relief compared to placebo after 48 hours. And while participants in all groups had the option to use the opioid oxycodone if they needed additional pain management, those on a high dose of Latigo’s therapy were significantly less likely to do so than participants on placebo.” * * *
    • “The biotech plans to start a Phase 3 study later this year of patients who’ve had bunion removal surgery, with results expected in the second half of 2027.”

From the U.S. healthcare business and articifical intelligence fronts,

  • Beckers Payer Issues reports,
    • “Humana reported a $694 million profit for the second quarter, up more than 27% year over year, according to its July 29 earnings report.
    • “Revenue reached $40.8 billion, a 26% increase from the same period in 2025, driven by Medicare membership growth, higher per-member Medicare Advantage and standalone prescription drug plan premiums from increases in benchmark funding and the Part D direct subsidy, and a payer-agnostic CenterWell client base. Star ratings headwinds persisted.
    • “Total Medicare membership reached 11.1 million, up from 8.2 million in the comparable quarter. Total medical membership was 17.9 million, an increase from 14.8 million.
    • “The company’s benefit ratio was 91.1%, up from 89.7% in the second quarter of 2025, spurred by the star ratings revenue issue, new individual MA members with higher benefit ratios and an expectation of lower favorable prior period development. However, MA recontracting, pricing and clinical excellence efforts offset that growth.”
  • Beckers Hospital Review notes,
    • “Jaewon Ryu, MD, the founding CEO of Risant Health, will step down, and Dale Maxwell has been named interim CEO.
    • “According to a July 29 news release, Dr. Ryu made the decision to leave the role to focus on his family. Mr. Maxwell, former president and CEO of Albuquerque, N.M.-based Presbyterian Healthcare Services, will serve as interim CEO while the Risant Health board conducts a national search for a permanent successor.
    • “Washington, D.C.-based Risant Health is a nonprofit created by Oakland, Calif.-based Kaiser Permanente to expand value-based care by partnering with community health systems. As the organization’s inaugural CEO, Dr. Ryu built its leadership team and operating model and oversaw the additions of Danville, Pa.-based Geisinger, which operates 10 hospital campuses, and Greensboro, N.C.-based Cone Health, which has five hospitals and more than 150 locations.
    • “Jaewon has been instrumental in turning the vision for Risant Health into reality,” Greg Adams, chair and CEO of Kaiser Permanente and chair of the Risant Health board, said in the release. Mr. Adams said Dr. Ryu built an exceptional leadership team and positioned the organization to expand value-based care.”
  • Fierce Healthcare relates,
    • “AI doctor startup Doctronic aims to broaden its reach beyond adult primary care by acquiring text-based pediatric care platform Summer Health.
    • “The companies did not disclose the financial terms of the deal.
    • “Fast-growing Doctronic is an AI-native primary care provider that has supported 30 million health encounters in just two years. It offers a proprietary AI doctor and nationwide network of licensed clinicians delivering personalized medical guidance and video visits for $39, according to the company.
    • “The startup offers a free personal AI doctor via chatbot to help navigate symptoms and answer medical questions and can connect users with a licensed physician through a virtual visit. Doctronic, available in all 50 states, is being tested by the state of Utah to refill prescriptions as part of a pilot program.”
  • and
    • “Hospitals should plan for their supply chain expenses to climb in 2027, with the prices for indirect spending categories like IT, construction and even food projected to grow at an even faster rate than those for drugs, Vizient warned in its most recent forecast report. 
    • “Vizient’s latest twice-yearly report mapped out overall supply chain price inflation of 3.39% for 2027, an increase of 0.61 percentage points compared to the forecast it released in February for the 12-month period beginning in H2 2026. 
    • “The primary culprits, Vizient research and intelligence director Jeff King told Fierce Healthcare, are AI demand and elevated costs of logistics and energy that are being felt across the world.”
  • and
    • “Alongside an update to its 2026 ratings, national nonprofit Leapfrog Group announced Monday the launch of an expanded ambulatory service center (ASC) reporting program. The expanded Leapfrog ASC Public Reporting Program, first unveiled in April, reports safety and quality information for facilities nationwide. More than 3,900 ASCs are now included in the 2026 ratings, along with more than 2,400 hospitals—which the nonprofit says is the highest level of participation in its 26-year history.”
  • Fierce Pharma points out,
    • “With increased sales of its newer drugs compensating for declining revenues from its multiple sclerosis (MS) portfolio, Biogen is once again positioned for a “growth story,” CEO Chris Viehbacher said Wednesday during the company’s second-quarter earnings call.
    • “To that end, Biogen reported revenue of $2.74 billion for the period, marking its highest quarterly haul since Q3 of 2021. With the result, the company flipped its 2026 revenue guidance from an expected mid-single digit decline in 2026 to a mid-single digit increase.  
    • “This quarter is a reflection of the significant progress Biogen has made repositioning the company for long-term growth,” Viehbacher added.
  • Beckers Hospital Review tells us what 17 pharmacy leaders think about “the biggest shifts they’re seeing in patient expectations.”
  • MedCity News informs us,
    • “For many people, managing a disease means chronic therapy. Scribe Therapeutics has a different vision: genetic medicines that offer durable effects for the masses. With its lead program on a path to report its first human data next year, Scribe has joined the public markets, raising $128.7 million. 
    • “While current genetic medicines are largely limited to rare disorders, we are engineering our technologies for use in common diseases affecting millions,” Scribe said in its IPO filing. “By targeting prevalent diseases with significant unmet need and high clinical burden, we aim to usher in a new era of broadly scalable, transformative, and preventative genetic medicines.”
    • * * * “Alameda, California-based Scribe has selected cardiometabolic disorders as its first focus. Lead therapeutic candidate STX-1150 is intended to lower the “bad” form of cholesterol, which is a risk factor for atherosclerotic cardiovascular disease (ASCVD). This therapy is designed to lower LDL-cholesterol by repressing expression of PCSK9, a protein that in high amounts, reduces the ability of the liver to clear cholesterol from the blood. Injectable PCSK9 inhibitors are already available from Amgen, Regeneron Pharmaceuticals, and Novartis. Last week, Merck received FDA approval for Lipfendra, an oral PCSK9 inhibitor. While dosing frequency for these therapies varies, all of them are taken chronically.”
  • STAT News reports,
    • “Hundreds of thousands of U.S. doctors use clinical large language models, pitched by companies like OpenEvidence, Doximity, and UpToDate as an antidote to the dangers of hallucination-prone generalist models from Big Tech. Yet few studies have pitted them against each other — and this summer brought a high-profile head-to-head. 
    • “Researchers from NYU Langone Health had tested general and clinical models, including OpenEvidence and UpToDate Expert AI, on three sets of clinical questions. The findings, published in Nature Medicine in June: The clinical AI performed worse than the general models. 
    • “The results rang out like a gunshot. “I’ve never seen a single paper trigger the kind of reactions this one has in the health AI community,” wrote Kaiser Permanente’s vice president of AI and emerging technologies on LinkedIn. The paper’s findings, like all science, are subject to interpretation and debate — but many online reactions treated them more like a clear victory for general frontier models.” * * *
    • “Scientists acknowledge that no one test will ever tell the whole story about clinical AI performance. And day-to-day, the choice of when and how to use large language models in care — by individual doctors, and increasingly health system leaders — is shaped by more than research.
    • “I don’t see the benchmarks really playing a role among doctors,” said OpenEvidence’s Nadler. “Academics like talking about them.” 
    • “The more important question, companies, doctors, and researchers agree, is how these tools impact patients. 
    • “Anytime a new technology is introduced into medicine, its impact on those outcomes depends on how it’s used by physicians. Are they using the tool safely and correctly, on the right patients, in the right situations?
    • “In the case of AI, that often comes down to trust. An accurate model inspires confidence, but it can still occasionally be wrong — potentially leading a physician astray, if they rely on it outright. Conversely, a good model can leave gains on the table if a physician doesn’t trust its output.” 


Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Centers for Medicare and Medicaid Service news release,
    • “On July 28, 2026, the Centers for Medicare & Medicaid Services (CMS) released preliminary technical Medicare Part D bid information for contract year (CY) 2027 to help Part D plan sponsors finalize their Part D and Medicare Advantage (MA) offerings and prepare for Medicare Open Enrollment. 
    • “Additionally, CMS is announcing the conclusion of the Part D Premium Stabilization Demonstration, a voluntary demonstration for standalone prescription drug plans implemented in CY 2025 to address volatility and variation in standalone premiums following benefit changes mandated by the Inflation Reduction Act (IRA). For CY 2027, CMS bid analysis indicates that Part D plan sponsors had sufficient experience under the redesigned Part D benefit to support their assumptions in developing the prescription drug plan bids. Therefore, CMS will discontinue the demonstration at the end of CY 2026 to return the program to operating under traditional market conditions in CY 2027. 
    • “As in past years, CMS will release the 2027 MA and Part D landscape in mid-to-late September, once all offerings are finalized. In addition, CMS will release final average MA and Part D premiums, along with other key information, in September with the MA and Part D landscape.” 
  • The Wall Street Journal adds,
    • “The average premium for a Part D plan was around $36 a month this year, according to KFF, a health-policy nonprofit. 
    • “The administration official said around 25% of Medicare Part D plan enrollees would see premiums for their plans stay flat or go down next year. Around 30% will have an increase of less than $10 to their monthly bill. 
    • “For the remaining 45%, he said, the increases are largely in the $11 to $20 range a month. 
    • “Seniors should be able to find lower premiums if they switch plans, he said, adding affordable options are still available.
    • “Medicare drug coverage premiums are rising because the plans have been hit by growing expenses for GLP-1 medications and other specialty drugs. Changes implemented under 2022’s Inflation Reduction Act also have pushed up premiums. The law reduced many Medicare enrollees’ out-of-pocket expenses but required insurers to shoulder more of the costs. 
    • “Those pressures are expected to continue in 2027, said Juliette Cubanski, a vice president at KFF.” 
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services July 27 released its Contract Year 2025 Part C and Part D Program Audit and Enforcement Report, outlining key compliance issues identified through Medicare Advantage and Part D audits and enforcement activities. CMS emphasized recurring problems involving prior authorization and appeals processing, beneficiary access to medications and services, care coordination, enrollment and eligibility errors, and oversight of delegated entities. The report also highlights enforcement actions totaling approximately $1.54 million in civil money penalties, most of which stemmed from beneficiary cost-sharing and payment integrity failures. CMS signaled increased scrutiny of plans’ compliance with new prior authorization requirements, including the requirement beginning this year to process expedited requests within 72 hours and standard requests within seven calendar days.” 
  • A CMS news release adds,
    • “The Centers for Medicare & Medicaid Services (CMS) announced that enforcement efforts from its Medicaid Fraud War Room (MFWR) stopped more than $203 million in potentially improper Medicaid payments in just under 90 days, highlighting significant progress in protecting taxpayer dollars and strengthening Medicaid program integrity. Since its launch on April 23, the MFWR has coordinated actions against 50 unique, high-risk Medicaid providers identified through advanced data analytics and representing more than $203 million in Medicaid payments subject to federal exclusions and state enforcement efforts.
    • “Every dollar lost to Medicaid fraud is a dollar taken away from vulnerable Americans who rely on it,” said CMS Administrator Dr. Mehmet Oz. “In just under 90 days, the Medicaid Fraud War Room has proved that these losses aren’t inevitable and has shown Americans what we can accomplish with robust federal-state partnerships, advanced data analytics, and a real sense of urgency. We’ve made significant progress toward crushing waste, fraud, and abuse, but we’re not done yet. If you steal from Medicaid, we will track you down, cut you off, and work to ensure that every taxpayer dollar we spend funds quality care for eligible beneficiaries.”
  • The American Hospital Association News further tells us,
    • “An AHA blog published July 28 highlights new electronic prior authorization requirements that begin Jan. 1, 2027, as a result of the Centers for Medicare & Medicaid Services’ 2024 Interoperability and Prior Authorization final rule. The blog explains why transitioning to the new process will be a significant operational change that will include coordination with health plans, electronic health record vendors and other technology partners. READ MORE“
  • Per a CMS notice to be published tomorrow in the Federal Register,
    • In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Office of Personnel Management, “ Verification of Eligibility for Minimum Essential Coverage Under the
    • Patient Protection and Affordable Care Act through an Office of Personnel Management Health Benefit Plan”. The matching program provides CMS and State Administering Entities with the Office of Personnel Management (OPM) data to use in determining individuals’ eligibility to enroll in a qualified health plan through an exchange established under the ACA; for insurance affordability programs, certifications of exemption, and to make eligibility redeterminations and renewals, including appeal determinations.

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Even as the number of cyclospora cases in the United States hit record levels, top health regulators insisted that consumers could still trust what they were eating.
    • “The U.S. food supply is safe,” Donald Prater, the acting deputy commissioner for food at the U.S. Food and Drug Administration, told attendees Monday at the annual meeting of the International Association for Food Protection.
    • “However, there’s a couple of challenges,” he said, referring to the cyclosporiasis outbreaks that have sickened more than 11,000 people across the country. “It will take a little time. But we do believe we’re taking action and we’re protecting public health.”
  • The Hill adds,
    • “A poll released Sunday shows that 40 percent of U.S. adults are buying or eating less produce after the cyclospora outbreak. 
    • “Comparatively, according to survey results from CBS/YouGov, 4 percent of people said they are eating more produce. 
    • “Among respondents, 56 percent said there has been no change in their diet.” 
  • Fierce Pharma relates,
    • “The FDA has signed off on MannKind’s Furoscix ReadyFlow (furosemide) autoinjector for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD).
    • “Furoscix ReadyFlow becomes the first at-home treatment option to reduce the fluid buildup from HF or CKD. The drug-device combo has been designed to help patients address edema earlier, before symptoms worsen and lead to potential emergency department visits or hospitalization. It has been shown to work as effectively as an intravenous diuretic, which is usually administered in a clinic or hospital.
    • “Furoscix ReadyFlow is taken under the skin in less than 10 seconds, significantly reducing the administration time from five hours with MannKind’s currently available on-body infusor. The company expects to make Furoscix available in the U.S. by the end of August.”
  • The ASCO Post informs us,
    • “The FDA’s Oncology Center of Excellence announced three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs.  
    • “Fewer than 5% of patients with cancer currently receiving treatment are enrolled in clinical trials—even though more than 70% say they are willing to participate. The guidance documents address one reason for low participation: stringent and complex clinical trial eligibility criteria. 
    • “Unnecessarily restrictive eligibility criteria may slow subject accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug,” the three guidances say in their preambles.”  
  • The American Hospital Association News points out,
    • “Baxter is voluntarily recalling a specific lot of intravenous solution due to a report of particulate matter in the solution identified as cardboard, according to a Food and Drug Administration notice. The company is recalling lot LD175708 of its Cefazolin in Dextrose Injection with an expiration date of Feb. 14, 2027. Baxter said use of the product can potentially cause pulmonary embolism, among other harmful impacts. The company said that customers should immediately discontinue use of the solution and return all affected products. Baxter has not received any reports of adverse events related to the issue.” 
  • Cardiovascular Business adds,
    • “Medtronic is recalling specific lots of six different medical devices used as arterial cannulae during cardiopulmonary bypass procedures. This includes multiple models of the company’s 22FR EOPA 3D Arterial Cannulae and its 22FR EOPA Elongated One-Piece Arterial Cannulae.  
    • “Medtronic initiated the new recall after receiving more than 30 reports of small pinhole leaks in the wire-wound body of the devices. These leaks can be difficult to identify during routine inspection; they are primarily visible when the cannula is in a flexed position. 
    • “Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia and organ dysfunction,” according to an alert shared with customers.” 

No Surprises Act News,

  • Elevance Health, writing in STAT News, reports
    • The [Elevance Health] analysis [of No Surprises Act arbitrations] examined more than 7,300 disputed claim lines involving spine surgery, plastic surgery, colonoscopies, hysteroscopies, and other planned procedures resolved between 2024 and early 2026. Across the procedures studied, providers prevailed in nearly 90% of disputes, and the average award approached $40,000 per disputed claim line.
    • The arbitration awards were also found to be drastically higher than commonly used payment benchmarks. Across the planned procedures analyzed, the median award was more than 50 times the qualifying payment amount, which is the benchmark based on an insurer’s median in-network contracted rate. Worse still, the median arbitration award was 29 times higher than median in-network commercial claims, and 67 times higher than Medicare rates for the same procedures in the same locations. Awards for assistant surgeons were even more extreme, with the median award more than 145 times the qualifying payment amount.
    • Researchers also found that awards for these planned procedures increased over time. Between 2024 and 2025, arbitration awards for the procedures analyzed rose by 43%.
    • Although these disputes represented a relatively small share of overall IDR volume, they accounted for a disproportionate share of arbitration costs because of the size of the awards. Planned surgical procedures and associated neuromonitoring represented roughly 16% of disputes but approximately 60% of No Surprises Act arbitration costs.” * * *
    • “The findings do not describe all No Surprises Act disputes. They focus on a defined subset of planned procedures and associated services. But they point to a broader implementation question: whether some categories of scheduled services are entering IDR in ways that could increase costs.
    • “The study identifies several policy considerations for policymakers to evaluate, including strengthening eligibility standards for planned procedures entering IDR, increasing transparency around arbitration decisions, reinforcing the use of market-based payment benchmarks, and providing additional guidance for arbitrators evaluating payment disputes.”
  • FEHBlog observation: Amen to that. Those changes would lower healthcare costs.

From the public health and medical / Rx research front

  • The New York Times reports,
    • “Kira Wynn will do almost anything to avoid ovarian cancer, which killed her mother.”
    • * * * “So Ms. Wynn, 37, had a consultation with Dr. Rebecca Stone, a gynecological oncologist at Johns Hopkins Medicine. What she heard was not what she expected.
    • “Ovarian cancer,” Dr. Stone told her, is a misnomer. Nearly all ovarian cancers — and nearly all fatal ovarian cancers — are actually cancers of the fallopian tubes. The 20 percent or so that start in the ovaries are different, Dr. Stone said, and usually can be cured.
    • “Women who have their tubes — the gummy worm-shaped ducts that carry eggs from the ovaries to the uterus — removed reduce their chances of getting ovarian cancer by nearly 80 percent. It’s a five-minute operation that can be done as part of nearly any abdominal surgery, including a hysterectomy, tubal ligation, gallbladder surgery and hernia repair.
    • “Yet no doctor, Ms. Wynn said, had ever mentioned fallopian tube removal to her.
    • “That’s not surprising, Dr. Stone said, because most doctors (and the public) do not know about this new approach, even though professional groups like the American Cancer Society, the American College of Surgeons and the European Society of Gynaecological Oncology have recently issued statements encouraging doctors to offer tube removal at the time of other abdominal surgeries.”
  • The American Hospital Association relates,
    • “The American Red Cross July 27 declared a national blood supply crisis, as the organization said that blood donations have fallen to a four-year summer low. The organization said that it has less than a one-day national supply of type O positive blood and is limiting distribution of type O blood to hospitals. This year is the second time in its history that the Red Cross declared a national blood crisis, the first since January 2022.” 
  • The Washington Post adds,
    • “The American Red Cross has less than a one-day national supply of O-positive blood, the most commonly transfused blood type, and has begun limiting distributions of the blood to hospitals, it said.
    • “The only previous national blood crisis declared by the group came in 2022 as a surge of covid-19 cases lowered blood donor turnout.
    • “The American Red Cross urged all eligible donors to make appointments to give blood.”
  • Health Day tells us,
    • “Middle-aged folks have a higher risk of muscle loss if their weight “yo-yos” due to inconsistent dieting, a new study says.
    • “People who repeatedly dropped and regained weight wound up losing nearly four times as much thigh muscle during a four-year period compared to others whose weight remained relatively steady, researchers recently reported in the journal Radiology.
    • “When people’s weight cycled, they lost tremendous amounts of muscle along with the fat, and they didn’t gain the muscle back,” said lead researcher Dr. Thomas Link, a professor of radiology at the University of California-San Francisco.
    • “This tells us that understanding how to protect muscle while people are losing weight is important for overall health,” he said in a news release.”
  • The Washington Post adds,
    • “Savings to the overall health care economy from GLP-1 drugs have yet to be proven, but researchers have found evidence that health benefits could spill into the labor market.
    • “A study of workers in Denmark showed a 17.3 percent decline in long-term sick leave among those who were treated with Ozempic, the diabetes drug, according to results published this month in a National Bureau of Economic Research working paper. The researchers were from the University of Copenhagen, the University of Chicago, Duke University and the Rockwool Foundation — an independent organization that conducts research on social and economic issues.
    • “Before treatment, the study noted, an average of 5.5 percent of the workers accessed long-term sick leave (defined as longer than 30 days). That dropped nearly a full percentage point after treatment with the drug, the research found. About 84 percent of the patients in the study, which was conducted through analysis of health records and has not been peer-reviewed, had diabetes.”
  • MedPage Today points out,
    • “Nongated chest CT scans are usually performed for reasons other than to assess cardiovascular risk.
    • “Incidental coronary artery calcium (CAC) scores extracted from nongated chest CT scans accurately predicted cardiovascular risks in a community-based cohort.
    • “Patients with moderate or severe nongated CAC had significantly higher risks of cardiovascular disease and coronary heart disease versus those with zero CAC.”
  • STAT News notes,
    • “An interim look at an Alzheimer’s disease clinical trial evaluating an amyloid-targeting treatment from ProMIS Neurosciences showed low rates of brain bleeding and no incidences of brain swelling — results reported Tuesday that suggest the drug could be safer than approved treatments. 
    • “In a blinded analysis that pooled safety data from patients receiving the ProMIS drug and a placebo, the total rate of ARIA was 4.4%, with all cases mild and asymptomatic, the company said.” * * *
    • “ProMIS expects all the participants in the Phase 1 study to complete twelve months of treatment late this year, allowing the company to unblind the data and report full results, including measures of cognition and function, early in 2027.” 
  • Genetic Engineering and Biotechnology News adds,
    • “Neurodegenerative diseases are typically defined by the presence of characteristic clinical phenotypes. However, it is increasingly recognized that early intervention could give people the best chance for meaningful positive effects. As a result, early detection and prevention are becoming major priorities.
    • “Months to several years before amyotrophic lateral sclerosis (ALS) symptoms arise, levels of certain blood proteins may dramatically shift. By anticipating the arrival of symptoms, investigators could intervene with preventative therapies before the irreversible motor neuron damage that is characteristic of ALS sets in.
    • “In this study, researchers analyzed data from the long-running, National Institutes of Health (NIH)-funded Pre-symptomatic Familial ALS (Pre-fALS) study, to identify a lineup of key proteins that may predict the emergence of clinically manifest ALS.
    • “This work is published in Nature Medicine in the paper, “Longitudinal plasma proteomics predict phenoconversion to clinically manifest ALS.”
  • Per an Institute for Clinical and Economic Research news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “ICER examined the impact of Covid-19 vaccines and found that pregnant women, infants, and adults aged 65+ benefit most from vaccination. ICER’s report on this therapy was the subject of the June 2026 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. The New England CEPAC was aligned with ICER’s report findings.
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
    • “The current confusion in the US around vaccine policy is challenging for both health care professionals and the American public,” said ICER’s President and CEO Sarah K. Emond, MPP. “Policymakers, especially public health leaders, need reliable and unbiased assessments of how well therapies work for patients. For 20 years, ICER has delivered that through our evidence-based analyses and public meetings. This public meeting highlighted what we know about the current evidence on Covid-19 vaccines, and where there are opportunities to gain an even better understanding of how these vaccinations impact different subpopulations. Ultimately, ICER’s transparent and public process sheds light on the broader context that policymakers should consider when making recommendations about Covid-19 vaccines.”

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

  • MedCity News reports,
    • “It’s often said that the healthcare system is broken, from the outdated use of fax machines to perverse incentives.
    • “But who broke the healthcare system? At MedCity News’ Bullseye event in Chicago, Editor-in-Chief Arundhati Parmar posed this question to two health insurance CEOs.
    • “The response? “We did,” replied Sachin Jain, CEO of SCAN Health Plan, referring to all of those who work inside of healthcare. He added that healthcare stakeholders have normalized the abnormal.” * * *
    • “The CEO of Ascendiun, Paul Markovich, echoed this. Ascendiun is a nonprofit and parent company of Blue Shield of California, Blue Shield Promise Health Plan, Altais and Stellarus.
    • “It’s our own damn fault collectively, and I think that’s why we’re trying to focus a lot of our energy on the system. … One of the reasons I work at a health plan and a nonprofit health plan is because I think what the health plans can do is create a better system,” he said. “We tend to control the rules of how people get paid, what are the administrative burdens? Are we using a fax machine, or are we figuring out another way to connect digitally? We have the biggest influence, I think, in trying to shift the system to getting much better results from people day to day than what we’re seeing now.”
  • Healthcare Dive relates,
    • “Centene handily beat Wall Street’s expectations in the second quarter, as higher revenue from premiums and rate hikes for the managed care company’s plans shielded its bottom line from elevated medical costs.
    • “Centene posted $53.6 billion in revenue, up 10% year over year, and $1.1 billion in profit in the quarter. That’s compared to a loss of $253 million the same time last year when Centene was caught off guard by higher spending — the insurer’s first quarterly loss in more than two years.
    • “Centene raised its 2026 financial outlook on Tuesday following the outperformance, which TD Cowen analyst Ryan Langston called “huge.”
    • “Any way you slice it, this was a fantastic quarter,” CFO Drew Asher said during a morning call with investors.”
    • “It’s the second beat-and-raise this year for the St. Louis-based insurer, following a buoyant first quarter when Centene bumped its 2026 guidance on the back of better controlled medical costs.” 
  • BioPharma Dive tells us,
    • “GSK is turning to a multibillion-dollar cost-cutting program to help the company grow profits while absorbing the impact of a sizable patent cliff.
    • “In its latest quarterly earnings report on Tuesday, the British pharmaceutical company revealed a three-year restructuring plandesigned to save a total of about £1.9 billion, or $2.5 billion, per year. GSK didn’t disclose specific details about the plan, but said that it should “simplify the organization” and help “reallocate capital and resources” towards specialty medicines.
  • MedTech Dive adds,
    • “Boston Scientific announced a global restructuring that will involve changes to its supply chain and organizational structure.
    • “The heart device company said in a Monday securities filing that it expects “some headcount reductions,” though it will still post new jobs in areas of growth. Boston Scientific did not say how many positions it expects to cut. The company did not respond to MedTech Dive’s request for comment by publishing time.
    • “In total, the company expects about $700 million to $800 million in pre-tax charges, according to the filing. The restructuring, approved by the company’s board, is expected to start this year and be complete by the end of 2029.”
  • Beckers Payer Issues informs us,
    • “Deferred elective surgery was a through-line of second-quarter earnings calls at four of the country’s largest for-profit hospital operators. But their executives do not agree on what is driving the slowdown, or whether it represents lost demand at all.
    • “Nashville, Tenn.-based HCA Healthcare, Franklin, Tenn.-based Community Health Systems and Dallas-based Tenet Healthcare all reported softness in elective volumes, particularly in high-acuity areas such as orthopedic and cardiac care that generate some of hospitals’ strongest margins. 
    • “King of Prussia, Pa.-based Universal Health Services reported milder surgical softness alongside a broader volume rebound and pinned the weakness on a different cause.
    • “The distinction matters because the competing explanations point to very different futures. If patients are postponing care they cannot afford, the volume loss reflects a demand problem that additional capital and capacity will not solve. If cases are shifting to lower-cost settings, the revenue has not disappeared; it has just moved somewhere else.”
  • Beckers Hospital Review points out,
    • “New Hampshire is the best state for healthcare while Alaska is the worst, according to an analysis published July 27 by WalletHub.
    • “The personal finance company compared the states and the District of Columbia across three dimensions: cost, access and outcomes. Analysts then evaluated the dimensions across 44 metrics, including average monthly insurance premiums, hospital beds per capita, emergency room wait times, infant mortality rates and the share of patients readmitted to hospitals. Each metric was graded on a 100-point scale, with 100 representing the best healthcare at the most reasonable cost. WalletHub then calculated each state’s weighted average across all metrics to produce an overall score and used the resulting scores to rank the states. 
    • “Iowa ranked first for cost, North Dakota ranked first for access and New Hampshire ranked first for outcomes.”
  • Beckers Clinical Leadership notes,
    • “Of the 679 U.S. hospitals designated as “Magnet” hospitals for nursing excellence, about 5% have earned the recognition more than six times. 
    • “The American Nurses Credentialing Center awards Magnet recognition to hospitals based on their quality of patient care and nursing excellence. As of July 28, 36 hospitals have received six or more Magnet designations — representing just 0.6% of the nation’s 6,100 hospitals. 
    • “Since Dec. 31, 2025, four hospitals have earned their sixth Magnet designation: Englewood (N.J.) Hospital, Hospital for Special Surgery in New York City, Penn Medicine Lancaster (Pa.) General Hospital and Houston Methodist Hospital.
    • [The article lists} the 36 hospitals that have received this honor six or more times.
  • Per Fierce Healthcare,
    • “LifeBridge Health’s Sinai Hospital of Baltimore is putting an artificial intelligence-powered diagnostic for sepsis into clinical use, bringing a research-backed tool to the patients’ bedside.
    • “Chicago-based Prenosis, a biology-based technology company, developed Sepsis ImmunoScore, an AI-powered tool that can spot the early signs of sepsis. The tool analyzes 22 parameters to identify patterns in a patient’s biological immune response, enabling clinicians to detect sepsis or its progression within 24 hours.
    • “Sepsis ImmunoScore received the U.S. Food and Drug Administration’s first authorization for software to diagnose sepsis in 2024. Prenosis’ solution was approved through the FDA’s De Novo pathway.”
  • and
    • “Virtual care and health navigation company Included Health inked a deal to acquire Firefly Health to scale health plan alternatives for employers.
    • “In January, Included Health launched an alternative health plan design for employers, broadening its existing all-in-one virtual care platform. Firefly Health, founded in 2017, is a primary care and health plan provider serving more than 20,000 individuals nationally. 
    • “The deal is expected to close in the third quarter of 2026. The companies did not disclose financial details of the acquisition.”

Monday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “As the Senate speeds toward its upcoming August recess, President Donald Trump is turning up the pressure on Senate Majority Leader John Thune to keep his chamber in session and in Washington instead. 
    • “So far, that’s unlikely.  “You could stay here till Christmas” and the situation wouldn’t change, Thune said. “If I thought there was a path to getting a result, I’m all for it.” 
    • “The president posted to Truth Social on Monday morning that “Thune should not allow the United States Senate to ‘leave town’ until it passes” the SAVE America Act, a GOP-crafted package that would require proof of citizenship to register to vote and photo ID at the polls.
    • “The sweeping bill does not have the 60 votes needed to advance through the Senate — a message the South Dakota Republican leader has reiterated both publicly and privately to the other end of Pennsylvania Avenue.” 
  • Per a U.S. Senate Committee news release,
    • “On Thursday, July 30, the Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on bills to increase Americans’ educational opportunities and give them more tools to secure a strong retirement. The Committee will also vote the nominations for Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services, the Director of the Centers for Disease Control and Prevention, and the Secretary of the U.S. Department of Labor.”
  • Govexec relates,
    • “While lawmakers are debating what an appropriate regulatory framework for artificial intelligence should be, experts who spoke at a panel on Monday noted that federal employees have been using the technology for years to develop all sorts of regulations. 
    • “Cary Coglianese, a regulation professor at the University of Pennsylvania, said that agencies, for example, have been using AI to analyze thousands of public comments that some proposed rules receive. 
    • “Back in the day, contractors would literally photocopy comments, clip them out and sort them in different categories — and do what essentially natural language processing tools can do now so quickly and rather effectively,” he said. 
    • “But as the technology advances, speakers on the panel — which was sponsored by the Coalition for Sensible Safeguards, a left-leaning group of more than 220 regulatory-focused organizations — argued that AI could take over more steps in the rulemaking process, potentially supercharging the Trump administration’s efforts to slash regulations and downsize the federal government.”
  •  FEHBlog observation: The government can use AI for many more tasks, and you don’t have to be left leaning to be concerned about this development.
  • Fierce Healthcare tells us,
    • “A tiny federal agency tasked with protecting the public from injuries caused by lawn mowers and coffeemakers is demanding that some of the nation’s biggest health systems turn over detailed, personally identifiable medical records of all patients who seek help at their emergency rooms.
    • “The Consumer Product Safety Commission, responsible for tracking and issuing recalls of dangerous products sold in the U.S., began discreetly pressuring hospital executives this year to share personally identifiable health data with a private contractor. But hospital lawyers and other industry experts have questioned the agency’s authority to collect, its ability to safeguard such a swath of sensitive information, and whether it has followed the legal process to overhaul its surveillance system.
    • “After KFF Health News asked the CPSC about the new system, the agency announced the program on July 21. Left unmentioned, however, is the alarm it has raised among hospital executives, as well as the nature and extent of the agency’s data demands.”
  • and
    • “A new analysis finds that Medicare Advantage enrollees spend less on average than those in the traditional program, but report similar satisfaction levels.
    • “ATI Advisory conducted the study on behalf of the Better Medicare Alliance, analyzing data from the Medicare Current Beneficiary Survey and Cost Supplement files from 2021 to 2023. The analysis found that MA enrollees spent $2,824, or 36%, less out-of-pocket on average in 2023 compared to those in fee-for-service Medicare.
    • “And the difference in spending has risen over time, with savings 16% higher in 2023 than in 2022, according to the report.
    • “Twelve percent of MA beneficiaries said they faced a significant cost burden, or spent more than 20% of their income on healthcare, compared to 24% of people enrolled in traditional Medicare.”
  • Beckers Payer Issues adds,
    • Medicare Advantage will account for 57% of overall Medicare enrollment by 2036, up from 51% this year, according to a July report from the Congressional Budget Office.
  • and
    • “Four more Medicare Advantage prescription drug plans have received five-star ratings thanks to CMS’ recalculation.” * * *
    • In a July 21 letter to MA organizations, CMS said ratings stayed the same for 61%, increased for 9% and declined for 30% of contracts. The agency did not change ratings for plans that had worse performance in the latest review. The threshold for MA plans earning additional payments is four out of five stars. Top plans get their own perks, though, such as special enrollment period privileges and further rebate benefits.
    • CMS clarified to Becker’s that it only updated overall ratings, not the separate Parts C and D summary ratings, on the plan finder.
    • Here are the four contracts joining the five-star club:
      • Renown Health
        • Hometown Health Plan (Senior Care Plus) — Contract H2960
      • Rifkin Managed Care Holding
        • Provider Partners Health Plan of Texas — Contract H4054
        • Provider Partners Health Plan of Pennsylvania — Contract H4093
      • Longevity Health Founders

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • Nearly 100 people in 17 states have been sickened in a salmonella outbreak tied to recalled eggs, federal health officials said Friday.
    • The 98 people had illnesses that started between Nov. 21 and June 30, according to the FDA. No deaths have been reported, but 26 people have been hospitalized.
    • Investigators have determined that shell eggs recalled by Midwest Poultry Services are a likely source of the germ, but the Indiana-based company doesn’t account for all the illnesses.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved Freenome’s blood-based screening test for colorectal cancer, called SimpleScreen CRC. Abbott will exclusively market the test in the U.S., starting this fall, the companies said Monday.
    • “Abbott already sells the Cologuard stool test for colorectal cancer screening, following its $21 billion acquisition of Exact Sciences earlier this year. Through its collaboration with Freenome, Abbott now adds a blood test to its colorectal cancer screening portfolio.
    • “SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening, which gained FDA approval in 2024. TD Cowen analysts said that with a very large population of patients who are unscreened, “We see room for multiple players.”
  • Fierce Pharma relates,
    • “The FDA has approved Otsuka Pharmaceutical’s once-daily extended-release capsule Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
    • “Approval of the first-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) gives the Japanese drugmaker its “next major CNS launch” and positions the therapy to become a potential blockbuster in a large, under-penetrated market, according to Jefferies analysts in a July 26 note.
    • “Before Simtriyo can launch in the U.S. market, it must clear controlled-substance review by the Drug Enforcement Administration (DEA), a standard, up-to-three-month procedure for all central nervous system stimulants.”
  • Contemporary OB/GYN informs us,
    • “Roche received FDA 510(k) clearance for its cobas BV/CV (Bacterial vaginosis/Candida vaginitis) assay, a molecular diagnostic test that returns results for both conditions from a single vaginal swab. The assay is intended for professional laboratory use, based on a clinician’s order, the company noted in a July 24, 2026, news release.
    • “The test uses real-time polymerase chain reaction technology to identify the specific bacteria and yeast species that are responsible for BV and CV in symptomatic patients. Roche stated that the assay is designed to support faster, more accurate diagnosis than syndromic evaluation alone, with the goal of improving both patient outcomes and laboratory efficiency.
    • “BV and CV are among the most common causes of vaginal symptoms in the United States, and both conditions can present with overlapping symptoms that complicate clinical diagnosis based on history and examination alone.”
  • NBC News San Diego CA points out,
    • “The Food and Drug Administration has recalled a commonly prescribed thyroid medication.
    • “The recall involves levothyroxine sodium tablets that are used to treat hypothyroidism and decrease the size of enlarged thyroid glands, according to Mayo Clinic.
    • “The FDA said they had been functioning as “subpotent drugs,” meaning they had less of an active ingredient and were ultimately less effective.
    • “Major Pharmaceuticals packaged and distributed the recalled tablets, while Cardinal Health also distributed some of the recalled products.
    • “Twelve different dosages and cartons from the two companies were listed in the FDA’s recall notice. You can read the full list here.”

From the judicial front,

  • Bloomberg Law reports,
    • “Novo Nordisk A/S is asking a federal judge to halt Eli Lilly & Co.’s advertisements for its GLP-1 drugs, escalating a legal fight against the company’s campaign for weight loss treatments.
    • “The company said Friday [July 24] it filed a motion for preliminary injunction seeking to block Lilly’s advertisements of its obesity drugs, days after filing a lawsuit accusing the company of deceptive promotions. 
    • “Misleading advertisements that selectively compare lower doses of Novo Nordisk’s medicines against higher doses of Lilly’s medicines, based on outdated studies, leave patients with the mistaken impression that Lilly’s drugs are vastly superior, and that is simply not true,” John F. Kuckelman, senior vice president and group general counsel of Novo, said in a statement.”
  • and
    • “Johnson & Johnson on Monday said it agreed to a $5.5 billion commitment to resolve litigation related to claims that its talc products caused ovarian cancer. 
    • “The drugmaker said the proposed resolution represents “an efficient conclusion” to the lawsuits. The agreement requires the participation of lead plaintiff firms in ovarian talc litigation pending in state and federal court that represent at least 95% of claims, according to J&J. 
    • “While we are confident the company would have ultimately prevailed with further litigation, as it has in the vast majority of cases tried to date, this resolution allows the Company to put this matter behind it and remain focused on its mission to develop medicines and devices that save lives,” J&J Vice President of Litigation Erik Haas said in the statement on the company’s website.” 
  • Beckers Payer Issues identifies five health system vs. payer lawsuits to watch.

From the public health and medical / Rx research front,

  • Health Day reports,
    • “More than one-third of women and one-quarter of men engage in intentional outdoor tanning, with variance observed by age, race, physical activity level, and alcohol use, according to a study published online July 22 in JAMA Dermatology.
    • “Dawn M. Holman, M.P.H., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues examined the prevalence of intentional outdoor tanning among U.S. adults. The analysis included 31,615 adults participating in the 2024 National Health Interview Survey.” * * *
    • “These findings support the need to address intentional outdoor tanning in the context of skin cancer prevention,” the authors write. “The variation in demographic and behavioral factors points to venues for future research and interventions.”
  • The American Medical Association lets us know “what doctors want patients to know about summer skin safety” and “what doctors want patients to know about cardiac stress tests.“
  • The American Hospital Associagtion News relates,
    • “The Substance Abuse and Mental Health Services Administration July 27 released results from its latest national survey on drug use and mental health. The survey found that fewer adolescents 12-17 and adults 18-25 used alcohol, tobacco, marijuana and other drugs between 2021 and 2025. In addition, 27.6% of adolescents received mental health treatment in the past year, while 21.6% of adults 18 or older received treatment. The survey highlighted additional findings on suicide, substance use treatment and recovery.”
  • and
    • “The Association for the Advancement of Blood and Biotherapies Interorganizational Task Force on Domestic Disasters and Acts of Terrorism announced July 24 that the U.S. blood supply is at significant risk for shortages due to weeks of decline in blood donations. The task force said the reduced supply is more pronounced in certain areas of the country, and in some areas blood collectors are already reporting an impact on the availability of blood for some patients. The organization is urging eligible donors to make and keep an appointment to donate blood as soon as possible. An AHA Member Advisory will be issued on the matter, which will include a call to action and resources for conserving blood supplies.” 
  • MedPage tells us,
    • “Despite the availability of multivalent pneumococcal vaccines, infants remain susceptible to invasive pneumococcal diseases.
    • “In this French study, infants immunized against RSV with nirsevimab were about 35% less likely to be hospitalized for invasive pneumococcal disease through 9 months.
    • “The rise in pneumococcal disease cases in kids involving serotypes not covered by vaccines highlights the need for complementary prevention strategies, the researchers said.”
  • and
    • “Diabetes and weight loss are associated with an increased risk of fragility fractures, which can be associated with substantial morbidity and mortality.
    • “In this retrospective study of adults with type 2 diabetes, those starting a GLP-1 drug had a 21% lower risk of fragility fractures over 3 years compared with initiators of a DPP-4 inhibitor.
    • “The lower fracture risk associated with GLP-1 drugs was independent of changes in body mass index.”
  • Health Day adds,
    • “Worried that your Ozempic is becoming less effective over time?
    • “Don’t worry — you’re still eating less, even if you are feeling a bit hungrier, a new study says.
    • “People on semaglutide for weight loss continue to eat less even after they’ve taken the drug for more than a year, researchers report in the August issue of The American Journal of Clinical Nutrition.
    • “While some of the drug’s early reduction of hunger and food-related thoughts wanes over time, people continue to eat substantially fewer calories compared to others provided a placebo, researchers found.”
  • MedScape notes,
    • “A compression device worn around the abdomen during colonoscopy reduced cecal intubation time by more than 1.5 minutes and significantly lowered post-procedural pain, the need for manual abdominal pressure, and patient position changes. Greatest improvements were seen in patients who were lean or had obesity.”
  • Per a National Institutes of Health news release,
    • “Months to several years before amyotrophic lateral sclerosis (ALS) symptoms arise, levels of certain blood proteins may dramatically shift. Researchers analyzed data from the long-running, National Institutes of Health (NIH)-funded Pre-symptomatic Familial ALS (Pre-fALS) study, to identify a lineup of key proteins that may predict the emergence of clinically manifest ALS. By anticipating the arrival of symptoms, investigators could intervene with preventative therapies before the irreversible motor neuron damage that is characteristic of ALS sets in.
    • “If someone carrying an ALS-associated genetic variant had asked me in the past when they would become symptomatic, I would have struggled to provide a reasonable estimate,” said senior author Michael Benatar, M.D., Ph.D., a professor of neurology and public health sciences at the University of Miami. “These biomarkers give us a far better idea of the timing, allowing us to estimate the time to symptom onset with an average error of about 18 months. That’s something we can work with.”

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

  • Beckers Payer Issue tells us eight things to know about healthcare spending trends. 
  • Modern Healthcare reports,
    • “Cone Health CEO Dr. Paul Krakovitz said the system is focusing on value-based care coordination.
    • “Cone’s parent system, Risant Health [,a subsidiary of Kaiser Permanente], provides a national network with added scale and expertise to operate in a highly competitive healthcare market.
    • “Krokovitz said the system is expanding to take advantage of North Carolina’s booming population growth.” * * *
    • “We’re coming up on our second anniversary soon. The tools that Risant is bringing us in terms of value-based care and giving us national scale have been impressive. They’ve been very open-minded. Most importantly, they’ve stuck to the value of the deal, which has been making sure Cone Health remains a community-based health system.”
  • Beckers Hospital Review relates,
    • “King of Prussia, Pa.-based Universal Health Services recorded an operating income of $516.7 million (11.1% operating margin) during the second quarter of 2026, compared to an operating income of $500.3 million (11.7% margin) during the same period last year, according to its July 27 financial report.” * * *
    • “UHS operates 30 inpatient acute care hospitals, 346 inpatient behavioral health facilities, about 170 outpatient and other facilities, a health plan and a physician network in 40 states, Washington, D.C., Puerto Rico and the United Kingdom.”
  • Leapfrog posted its 2026 hospital safety ratings.
  • The Wall Street Journal informs us,
    • “Argenx agreed to buy Forte Biosciences for $2.2 billion to strengthen its immunology pipeline.
    • “The purchase price of $77 a share in cash represents a 41% premium to Forte’s closing price on Friday.
    • “The deal adds Forte’s experimental drug FB102, which Argenx said has potential to address multiple autoimmune diseases.”
  • and
    • “AstraZeneca reported higher second-quarter sales driven by cancer medicines and said it remains on track to hit its 2030 revenue target.
    • “AstraZeneca’s second-quarter revenue rose to $15.38 billion from $14.46 billion, driven by a 15% increase in oncology product sales.
    • “Chief Executive Pascal Soriot sought to reassure investors after a recent trial failure raised doubts about the company’s 2030 revenue goal.”
  • MedCity News discusses “What Happens When Patients Trust AI Over Their Doctor?”
    • As patients increasingly bring AI chatbot advice into exam rooms, where does liability land when that advice goes wrong? Health law attorney Meghan O’Connor said the answer still isn’t clear, but silence is the riskiest response for providers.

Weekend Update

David Ermer–CMS, Congress, Medical / Rx research, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Punchbowl News lets us know,
    • “The Senate is the only game in town on Capitol Hill for the next two weeks, with the House gone already.
    • “The late Sen. Lindsey Graham’s (R-S.C.) memorial service is Tuesday afternoon at National Cathedral. President Donald Trump, Israeli Prime Minister Benjamin Netanyahu and Ukrainian President Volodymyr Zelensky are all expected to attend. There’s also a Capitol Rotunda ceremony on Tuesday morning.
    • “The Senate has a full plate during its two-week sprint to August recess. Senate Majority Leader John Thune is under pressure from competing factions of his conference — and the White House — over the SAVE America Act, reconciliation 3.0, the midterms and much more.”
  • Bloomberg Law reports,
    • “Mehmet Oz [,an MD who administers the Centers for Medicare and Medicaid Services within the Department of Health and Human Services] has been loyal to Health and Human Services Secretary Robert F. Kennedy Jr. while cultivating a close relationship with President Donald Trump and a reputation as a serious operator in the administration.
    • Oz has been playing a significant role in the administration, with access to the president and involvement in various policy discussions, leading to speculation that he could be the heir apparent to lead the health department if Kennedy departs.
    • Despite potential challenges and criticisms, Oz has earned respect from some outside the administration, including major healthcare companies and industry groups, and has been working to implement the administration’s health policies and reduce healthcare costs.

From the public health and medical/Rx research front.

  • The Wall Street Journal relates,
    • “The eyes are a window to the soul, but the mouth may reveal just as much about a person’s health—and the diseases that shape how we age.
    • “To better understand those connections, scientists are studying how issues that start in the mouth may contribute to chronic inflammation elsewhere in the body. In particular, they’re examining how bacteria from diseased gums, and the immune response they trigger, may contribute to conditions including heart disease, diabetes, cognitive decline, arthritis, respiratory disease and chronic liver disease.
    • “The emerging science poses a challenge for healthcare, given the traditional divide between medicine and dentistry—fields that have long been divided by separate training, records and insurance systems. “Dentists haven’t traditionally been trained to think about whole-body health in relation to the mouth, and doctors haven’t been trained to see dental health as a first step to overall well-being,” says Dr. Jessica Lederhausen, a dentist and author of “Oral,” a book exploring the role of lifestyle on oral health.
    • “But that is changing. Dental schools, which have taught how diseases like diabetes affect the mouth, are also placing greater emphasis on how oral disease can affect the rest of the body. Medical-education leaders have called on medical schools to better integrate oral health into physician training.“
  • Newsweek relates,
    • “Air quality alerts spanned large swaths of the western United States on Sunday as wildfire smoke and high ozone levels triggered unhealthy breathing conditions across Oregon, Idaho, Washington, Montana, Colorado, and California.
    • “Data from AirNow, the Environmental Protection Agency’s (EPA) monitoring platform, showed widespread “unhealthy” air or worse, driven primarily by smoke from ongoing fires in Canada and the Pacific Northwest. Officials urged residents in affected zones to remain indoors, limit strenuous outdoor activities, and take precautions if they suffer from asthma, heart disease, or other respiratory ailments.”
    • The primary health threat stems from fine particulate matter, known as PM2.5, which is small enough to penetrate deep into human lung tissue.
  • Columbia University tells us,
    • “If you’re among the hundreds of millions of people now using an AI chatbot on a regular basis, chances are you’ve tried asking it for personal advice. So you know the peculiar comfort that comes from instantly receiving thorough, information-packed takes on your most private concerns, delivered in a warm, affirming tone. “That’s an excellent question and you’re smart to ask it!” a typical chatbot response might begin, whether you’re considering cosmetic surgery or leaving your spouse. “Now let’s think this through, step by step.”
    • “Today, roughly one in three US adults and nearly 20 percent of adolescents are turning to chatbots for personal guidance, seeking insights on everything from relationship problems and workplace conflicts to deeper concerns about anxiety and depression. No one knows yet exactly how this is affecting people, because the phenomenon is so new. But many experts are alarmed. 
    • “People should not be relying on chatbots for emotional support or therapy, that’s for sure,” says Ragy Girgis ’14PH, a Columbia psychiatrist and outspoken advocate for research on the issue. “The technology cannot be trusted to be accurate or helpful in that way.”
  • Oschner Health informs us,
    • “Ultra-processed foods have been a hot topic in wellness conversations, and for good reason. Research continues to link diets high in these foods with anxiety and inflammation, obesity, Type 2 diabetes, heart disease, certain cancers and more.
    • “But this isn’t a story about fear. The goal is not perfection. It’s about awareness — understanding why some foods are so easy to overeat and how small shifts can help protect our long-term health.” * * *
    • Food scientists use the term “bliss point” to describe the “sweet spot” combination of carbohydrate, salt, fat and texture that lights up our brain’s pleasure centers. That combination can make food especially rewarding to eat —and incredibly difficult to stop eating.
    • “For a recent episode of my FUELED Wellness + Nutrition podcast, I [Molly Kimball RD] interviewed Erica LaFata, PhD, a clinical psychologist and researcher whose work focuses on the addictive and reinforcing properties of ultra-processed foods.
    • “This isn’t just about willpower; people aren’t suddenly becoming worse at regulating their eating behavior,” noted LaFata. The food environment itself has changed, making highly rewarding, ultra-processed foods easier to access and consume than ever before.” * * *
    • “This isn’t about obsessing over every ingredient label. It’s about recognizing how these foods are designed and marketed to us so we can make more intentional choices.
    • “LaFata believes that awareness itself can be empowering. It helps us recognize that the issue isn’t simply willpower, but the food environment surrounding us every day.
    • “Small shifts toward whole and minimally processed foods can support overall health. Making intentional choices–even when foods are designed to keep us coming back for more–is a step in the right direction.”

From the U.S. healthcare business front,

  • The New York Times explains “What Geriatric Emergency Departments Do Differently.”
    • “These specialized units can help keep older patients out of the hospital, lower their health care costs and more.” * * *
    • “Since 2017, the American College of Emergency Physicians has accredited 624 such geriatric emergency departments across the United States, including 73 in Veterans Affairs medical centers. “A fairly exponential rate of growth,” said Dr. Kevin Biese, the emergency doctor who directs the Geriatric Emergency Department Collaborative.
    • “Few of these units are restricted to older patients. Instead, like the E.R. in La Jolla [CA], they serve all ages but incorporate senior-friendly practices and protocols in an environment aimed at staving off disorientation, falls and other elder hazards. They’re classified from Level 1, for those fulfilling the highest number of criteria, to Level 3.
    • “Adults 75 and older visit the emergency room at a higher rate than any other age group except infants: 76 visits per 100 people in 2022. Yet standard emergency care “wasn’t correctly designed for the needs of older adults,” Dr. Biese said.”
  • NavigateWell recommends
    • Questions [for employers to ask before your next [health benefits] renewal
      • Before your next renewal, work with your broker to answer these questions and identify where your greatest opportunity for activation exists.
      • Where are employees delaying preventive care or failing to act on identified risks?
      • Are our benefits connected through one experience or expected to work independently?
      • Are we measuring health improvement or simply participation?
      • Which partners are willing to share accountability for outcomes?
      • Healthcare costs will continue to rise. But employers still have an opportunity to influence what happens before tomorrow’s claims are created. The future of employer healthcare strategy requires both.
  • The Wall Street Journal relates,
    • Regeneron REGN Pharmaceuticals co-founder and chief scientific officer George Yancopoulos is more comfortable in a leather jacket than a suit—so much so, his own team had to talk him into wearing one to the White House.
    • “He conceded, but not without adding a colorful tie, hand-painted by Nobel laureate Wally Gilbert. Yancopoulos isn’t one to blend in.
    • “The meeting with President Trump in April was organized in part to tout Regeneron’s latest invention: a gene therapy that restores hearing to children born with a rare genetic deafness, affecting fewer than 50 newborns a year in the U.S. Regeneron—at Yancopoulos’s urging—decided to give it away, free.
    • “We did it to make a statement,” said Yancopoulos, 66. “We want to remind people that when people are sick, you pray for a miracle. And where do they come from? They come from our industry.”
    • “Nearly four decades since he co-founded the biotech Regeneron, Yancopoulos has more than 1,000 patents worldwide, including 77 granted in the U.S., and has authored more than 500 scientific papers. He has turned Regeneron into one of the world’s most valuable drug companies, with a market cap of roughly $70 billion, by repeatedly pioneering technologies that opened up entirely new classes of blockbuster drugs.”

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • Bloomberg Law reports,
    • “The health insurance industry is adding to scrutiny of the American Medical Association’s control of billing codes, voicing resistance to the group’s planned overhaul of how doctors bill health plans for maternity care.
    • “Insurers say they didn’t have enough time to prepare for the change, while AMA claims the industry didn’t raise concerns during the development process. The dispute is gaining attention from policymakers amid a broader political rift between the AMA and Republicans over the country’s healthcare billing system.
    • “The AMA develops and trademarks the Current Procedural Terminology, or CPT, codes that doctors use to bill insurers for medical services. The codes are baked into government programs like Medicare, and critics—as well as Medicare’s payment advisory panel—have long questioned the conflict of interest in letting AMA help determine doctors’ payments.” * * *
    • “Overall, the new protocol eliminates 17 codes in favor of 12 new codes and six revised codes. AMA developed the codes over the course of three years with its CPT panel, which includes seats for representatives nominated by health insurance trade group AHIP and the Blue Cross Blue Shield Association. The codes were released in April, before the typical September release, to give everyone more time to prepare.
    • “But insurers say it’s not enough, pointing to the fact that babies due to be born in 2027 are already on the way. And while insurance representatives serve on the panel, participants are legally blocked from sharing information about the meetings, according to AHIP.” * * *
    • “The Centers for Medicare & Medicaid Services last week proposed extending the current coding system for an additional year alongside the new codes, saying it’s concerned the change will be disruptive.”
  • Beckers Payer Issues relates,
    • “Committees in the House and Senate each advanced healthcare price transparency legislation this week, both aiming to expand disclosure requirements for hospitals, insurers and other healthcare providers.  
    • “Both measures would expand the existing hospital and payer price transparency rules, bring ASCs and labs under similar mandates for the first time and add new reporting requirements for insurers, pharmacy benefit managers and health plan administrators, though they differ on penalty structures, effective dates and scope.” * * *
      • Patients Deserve Price Tags Act
        • “The Senate Committee on Health, Education, Labor and Pensions advanced legislation July 22 that would implement new price transparency requirements for hospitals, insurers, laboratories, imaging providers and ASCs, while also expanding group health plans’ access to claims and reimbursement data held by insurers and PBMs.
        • “The committee passed the Patients Deserve Price Tags Act by a vote of 21-1, one of several healthcare bills advanced together in the same en bloc vote. The bill now heads to the full Senate.
      • The Lower Costs, More Transparency Act
        • The House Energy and Commerce Committee advanced a broad healthcare price and cost transparency package July 21 in a 45-0 vote that would also expand price transparency rules for hospitals, insurers, ASCs and the administrators of employer-sponsored health plans if signed into law.
        • The bill was also referred to the House Ways and Means and Education and Workforce committees.
  • The Hill adds,
    • “Bipartisan legislation to cap the cost of insulin at $35 for people with private health insurance advanced through a key Senate committee Wednesday, but its future remains uncertain. 
    • “The measure cleared the Senate Health, Education, Labor and Pensions [HELP”] Committee by a bipartisan 17-5 vote, with six Republicans joining every Democrat on the panel.” 
  • STAT New notes,
    • “People with diabetes who use a popular long-acting insulin pen made by Sanofi have had to become pharmacy scouts in recent weeks as they encounter supply issues.
    • “The Lantus Solostar pen containing 3 milliliters of insulin glargine has been running low for several weeks because of increased demand “driven by broader market dynamics,” a Sanofi spokesperson told STAT. The issue is not technically considered a shortage by the Food and Drug Administration, but patients are nonetheless having trouble finding the medication.”* * *
    • “Pharmacists can try to switch patients over to Semglee or Rezvoglar, the FDA-approved biosimilars, if their insurance allows that. Or they could ask prescribers to go for Lilly’s Basaglar, which comes in pen form.”
  • Thompson Reuters tells us about
    • Rev. Proc. 2026-26 (July 21, 2026). Available at https://www.irs.gov/pub/irs-drop/rp-26-26.pdf
      • “The IRS has announced 2027 indexing adjustments for important percentages under the Affordable Care Act (ACA). The indexing adjustments are based on projections of premium growth and income growth. For 2025 and several years prior, the premium growth rate was based on per enrollee spending for employer-sponsored insurance as published in the National Health Expenditure Account. However, HHS revised the measure to also capture increases in individual market premiums, starting with the 2026 benefit year. The IRS is applying this updated premium growth measure for 2027 as well.
      • “The required contribution percentage is used to determine whether employer-sponsored health coverage is “affordable” for purposes of employer shared responsibility under Code § 4980H. It is adjusted from a 9.5% baseline to 10.22% for plan years beginning in 2027. (This is an increase from 9.96% for 2026.) The percentages used to determine the amount of household income that individuals who are eligible for premium tax credits must contribute toward the cost of Exchange coverage vary across household income bands. The 2027 percentages range from 2.15% to 10.22%.”
  • STAT News informs us,
    • “The Senate’s [HELP] panel delayed until next week a vote on Erica Schwartz to run the Centers for Disease Control and Prevention, after postponing a separate vote on Sean Kaufman for a key public health preparedness role.”
  • and
    • “Nearly 18 months after taking office, President Trump has nominated a leader for the federal agency that oversees mental health and addiction policy. 
    • “If confirmed by the Senate, Timothy Westlake, a Wisconsin-based physician with decades of experience in both clinical and policy roles, would serve as assistant secretary of mental health and substance use. The position would also make him head of the Substance Abuse and Mental Health Services Administration, which has operated without a long-term leader since Trump was inaugurated in January 2025.” 
  • Tammy Flanagan, writing in Govexec, discusses “Why your retirement experience may depend more on the agency than the benefit.”
    • “Federal retirees interact with OPM, the Thrift Savings Plan and Social Security at different stages of retirement. Their latest performance data reveals starkly different customer service experiences and highlights where delays remain most likely.”
  • OPM Director Scott Kupor added (Substack link) a post to this Secrets of OPM blog. This one concerns the vital importance of investment income to benefit programs.
    • “The federal government manages a number of trust funds, but the two largest are the Social Security Trust Fund (about $2.7 trillion today) and the Civil Service Retirement and Disability Funds (CSRDF) (about $1.1 trillion today), the latter of which we at the Office of Personnel Management (OPM) have the privilege of overseeing.”
    • “It’s unlikely we are going to get Congress to eliminate the Treasury-only investment restrictions on the Social Security Trust Fund or the CSRDF. One can dream, but we all know that hope is not a strategy. However, all hope is not lost – and we at OPM have partnered with the Treasury Department to change what we can to the benefit of the American taxpayer.
    • “Enter “duration.”
    • “A very quick lesson on the economics of treasuries (and bonds more generally). Treasuries have varying expiration dates (or “duration,” as the finance nerds prefer). For example, you can buy Treasury bills (less than 1-year in duration), Treasury notes (with 2, 3, 5, and 7-year durations) and Treasury bonds (with 20 and 30-year durations). It’s not always the case, but in general the longer the duration, the higher the interest rate the government will pay you on the bond. Today, a 30-year duration bond pays about 5% in annual interest, whereas the 10-year pays 4.5% and a 1-year pays 4%.
    • “Historically, the CSRDF has had an average duration across its entire Treasury portfolio of about 7.5 years. That means, that we had lots of different maturities, ranging from less than 1-year to up to 15-years, but the average was right in the middle. As a result, we have achieved the roughly 3-4% annualized returns that I mentioned above on the overall fund balance.”* * *
    • “Partnering with Treasury, we concluded that a longer average duration was appropriate for the CSRDF from a risk and pension liability perspective and would yield a better economic return to the fund. As a result, OPM has increased our duration from 7.5 years to 15 years by adding longer-date treasuries (e.g., 20- and 30-year bonds) to the portfolio.
    • “Who cares? Well, this enabled us to increase the expected investment return of the portfolio to approximately 4.4%.”

From the Food and Drug Administration front,

  • A Dallas Texas NBC TV station reports,
    • “The FDA announced that nearly 20 million eggs (more than 1.5 million cartons) are being recalled due to the risk of Salmonella.
    • “Midwest Poultry Services voluntarily issued the recall of white shell eggs and brown cage-free shell eggs that were sold at Kroger and Brookshire Grocery stores in Texas, as well as smaller retail outlets.
    • “The eggs are also sold in Louisiana, Oklahoma, Arkansas, New Mexico, and Mississippi.
    • “The eggs were produced and distributed in Texas between June 6 and July 3; the latest sell-by or best-by date is Aug. 17.
    • “The recalled eggs will have an identifying code number printed on the left or right sides of the carton in date-coding ink only. Only codes P-1950 or 0840962 with a Julian Date between 157 and 184 printed on the side of the carton are recalled.”
  • Fierce Pharma relates,
    • “An FDA advisory committee has recommended that two peptide drugs that were previously restricted because of potential safety concerns be restored to the 503A Bulk Drug Substances list, which would remove the restrictions on how they are produced by compounders.
    • “Eight of the 15 members of the Pharmacy Compounding Advisory Committee (PCAC) voted to add both drugs back to the list, with six members voting ‘no’ and one abstaining. 
    • “BPC-157 and KPV are the first two of seven drugs that are being reviewed Thursday and Friday by the PCAC. In 2023, 12 peptides were reclassified, which restricted their use. In addition to safety concerns, the FDA cited a lack of evidence supporting their efficacy.”
    • “BPC-157, which is not approved by the FDA, is a synthetic anti-inflammatory peptide used to treat ulcerative colitis. BPC-157 and KPV, also an anti-inflammatory,  have also gained popularity in wellness and fitness influencer circles for supposed soft-tissue healing and bone repair capabilities. 
    • “The FDA is not required to follow the recommendations of the PCAC. The agency will make the final decision on whether the peptides can be manufactured by compounders.”  
  • The Wall Street Journal informs us,
    • “The U.S. Food and Drug and Administration said Wednesday it is investigating an additional cyclospora outbreak that the agency said has sickened at least 72 people.
    • It is the latest of four continuing cyclospora outbreaks being investigated by the FDA. The largest involves at least 1,644 cases, which have been linked to shredded iceberg lettuce supplied by Taylor Farms and served at Taco Bellin five states. 
    • “The companies have said that the shredded lettuce, sourced from central Mexico, has been removed from the U.S. market. Taylor Farms said last week that it voluntarily recalled iceberg lettuce grown and processed in Mexico, including products sold in grocery stores and restaurants across 27 states in the U.S.
    • “The FDA hasn’t yet identified a source for any of the other cyclospora outbreaks.”
    • “The FDA also said it was investigating at least 106 reported cases of salmonella and eight cases of listeria. The sources of those illnesses have yet to be identified.”

No Surprises Act News

  • Modern Healthcare reports,
    • “The Centers for Medicare and Medicaid Services and its contractors can’t keep up with the ceaseless onslaught of No Surprises Act out-of-network billing cases, federal data show.
    • “Providers and health insurance plans initiated 1.43 million Independent Dispute Resolution arbitrations this year through May, 46% more than during the comparable period in 2025. The system resolved 1.36 million cases over those five months.” * * *
    • “There’s no real end in sight,” said Lawson Mansell, a senior health policy analyst at the Niskanen Center, a centrist think tank.
    • “There have been 6.3 million cases since Independent Dispute Resolution began in 2022, and arbitrators have resolved 5.9 million. Providers file the lion’s share of cases.” * * *
    • “The new gateway may reduce the backlog, Mansell said. But because providers can win large payments, they have an incentive to continue filing many cases, he said.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Health and Human Services Department will fight to restore policies it says are vital to protecting the health insurance exchanges against fraud.
    • “HHS filed an appeal with the U.S. Court of Appeals for the 4th Circuit on Tuesday to reverse a decision the U.S. District Court for the District of Maryland handed down last month that invalidated portions of a program integrity final rule the Centers for Medicare and Medicaid Services issued last year.
    • “Democratic elected officials representing Baltimore, Chicago and Columbus, Ohio, are the lead plaintiffs in the case alongside the left-leaning advocacy groups Doctors For America and the Main Street Alliance. The plaintiffs contend CMS didn’t follow proper regulatory procedure when it issued the regulation.” * * *
    • “Last week, the same district court temporarily blocked sections of a separate health insurance exchange rule in a case brought by some of the same plaintiffs.”
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services yesterday released implementation guidance following a district court ruling July 16 that enjoined eight provisions from its 2027 notice of benefit and payment parameters final rule, which were set to become effective July 20. The rule issues standards for qualified health plans offered through the health insurance marketplaces. “Accordingly, for plan year 2026, Exchanges must immediately begin to update their systems to stop removing or denying advance payments of the premium tax credit for any new applicants or existing enrollees due to having failed to file and reconcile prior years’ premium tax credits,” CMS wrote. “Exchanges must continue in this manner for plan year 2027.” The agency said that the Department of Health and Human Services reimplemented the automatic 60-day time extension to resolve inconsistencies in household income data.”

From the public health and medical / Rx research front,

  • Fox News reports,
    • “As New York City continues to investigate an outbreak of Legionnaires’ disease that has claimed multiple lives and sickened dozens of people, doctors say there are ways people can reduce the risk of exposure.
    • “As of July 21, there have been five deaths and 82 diagnoses linked to the Upper East Side outbreak, according to the New York City Department of Health and Mental Hygiene. Eight patients remain hospitalized.
    • “Health officials said no new cases had been reported in the previous six days, suggesting the source of exposure has likely been eliminated, although the investigation remains ongoing.
    • “Legionnaires’ disease is a serious type of pneumonia that is typically spread by tiny water droplets containing Legionella bacteria, according to the Centers for Disease Control and Prevention.”
  • The Wall Street Journal informs us,
    • “Many people are reconsidering their Caesar salad lunches and berry breakfasts as cases of cyclosporiasis, the explosive-diarrhea illness, continue to rise in the U.S.
    • “The good news is, they don’t have to. The Centers for Disease Control and Prevention hasn’t recommended that people cut fresh produce out of their diets, only that they avoid recalled iceberg lettuce from Taylor Farms.
    • “We asked food-safety experts what we know—and don’t—about how to safely eat produce right now.” * * *
    • The only food recalled in connection with the current cyclosporiasis outbreak is iceberg lettuce from Taylor Farms de Mexico, sourced from central Mexico. The CDC lists all of the affected products here. Of course, this list could grow so consumers should keep an eye on the latest news.
    • “The vast majority of fresh fruits and vegetables are safe to eat, food-safety experts say. All fresh produce carries some inherent risk, separate from the cyclosporiasis outbreak, but experts say the health benefits of eating these foods generally outweigh those. 
    • “It’s a special time of year,” said Kali Kniel, a professor of microbial food safety at the University of Delaware. “Go to the farmers market, buy local if you can, where you know a farmer in your area has grown that directly.”
    • “Commercial processing can magnify certain food-safety risks, including chopping and shredding in large facilities where a single contaminated leaf can mix with other produce. For salad lovers, experts recommend buying whole heads of lettuce and removing and discarding the outer couple of layers of leaves.
    • “Mixed-lettuce bags might make life easier, but they are particularly risky since the lettuce is pulled from different sources, said Marion Nestle, a professor emerita of nutrition, food studies and public health at New York University.” * * *
    • “Cooking produce to 158 degrees Fahrenheit is the surest way to eliminate risk of contamination, experts say. 
    • “Peeling, too, or removing outer layers of produce, is another effective safeguard. Cyclospora parasites often become entrapped in produce through contaminated water used to grow or wash it, so areas that come into contact with water are more likely to be affected. 
    • “Freezing might reduce some risk by eventually killing eggs of the parasite, but doesn’t guarantee safety.”
  • and
    • “Congratulations if you’re among the country’s nearly 56 million ex-smokers. Many health benefits are coming your way—some of them within just a few minutes.
    • “Over the long term, though, the health picture gets a lot more complex. Some problems caused by smoking take decades to clear up, and certain lung damage can’t be fixed. Plus, a higher risk for lung cancer never completely fades.
    • “Even so, there are plenty of steps ex-smokers can take to boost the benefits from quitting, from changing their diet to beefing up their exercise regimen. Even if restoring pristine lung condition isn’t an option, doctors say quitting still matters—both for health and quality of life.
    • “Quitting is absolutely one of the most powerful things that someone can do for their health at any stage, at any time,” says Eric Singhi, a thoracic medical oncologist with the MD Anderson Cancer Center in Houston.”
  • Cardiovascular Business tells us,
    • “Approximately 20 million routine chest CT scans are performed for non-cardiac reasons in the U.S. each year. They represent a large untapped opportunity to detect coronary artery disease.
    • “That’s according to a presentation at SCCT2026, the Society of Cardiovascular Computed Tomography (SCCT) annual meeting, by Suhny Abbara, MD, MSCCT, senior associate consultant and professor of radiology at Mayo Clinic in Jacksonville, Florida, editor-in-chief of Radiology, the flagship journal of the Radiological Society of North America (RSNA), and a former SCCT president. He urged health systems to capitalize on the incidental findings already visible on millions of imaging exams.
    • “As a cardiac CT person, I think I can make less of a difference population-wise with coronary CT,” Abbara said. “Those are patients that are already on our radar. There is a huge number of patients, 20 to 40 times more, where we can detect coronary atherosclerosis serendipitously in a CT done for other reasons.”
  • Health Day relates,
    • “Obesity treatment for young people in the U.S. is rapidly changing.
    • “Adolescents and young adults are increasingly using GLP-1 weight-loss medications, while rates of bariatric surgery are declining, according to a study published July 20 in JAMA Pediatrics.
    • “This research is the first national-scale Epic Cosmos analysis, to our knowledge, to characterize real-world use of combined GLP-1 receptor agonist therapy and metabolic and bariatric surgery among adolescents and young adults with obesity,” said lead author Sarah Messiah, associate dean for research at UT Southwestern’s Peter O’Donnell Jr. School of Public Health.
    • “Researchers analyzed records from more than 204,000 patients between 13 and 25 years of age who were treated for obesity between May 2022 and January 2026.
    • “They found exclusive GLP-1 use increased from 88.2% in 2022 to 96.1% by early 2026. During the same period, bariatric surgery rates fell from 11.6% to 3.7%.”
  • BioPharma Dive adds,
    • “Eli Lilly on Thursday bolstered the case for its new experimental obesity medicine, announcing the success of two more Phase 3 trials and plans to seek approval of the drug next year. 
    • “The Triumph-2 and Triumph-3 studies build on research released in May that found the drug, retatrutide, could help people lose 30% of their body weight after 104 weeks, reaching a level associated with bariatric surgery. The two new trials included overweight or obese patients who also had either type 2 diabetes or cardiovascular disease.
    • “The overall weight loss in the two studies was less than in the Triumph-1 study released in May, showing an average of 21% body weight loss after 80 weeks in the diabetes group and 23% loss in the cardiovascular disease cohort at the highest doses. Still, those results met expectations for patients with underlying conditions who often lose less weight, RBC Capital Markets analyst Trung Huynh wrote in a note to clients.”
  • The American Hospital Association lets us know “what doctors want patients to know about heart failure.
    • “Heart failure can affect energy, breathing and daily life, but early diagnosis, treatment and follow-up can help people manage symptoms.”
  • Fierce Pharma reports,
    • Johnson & Johnson has unveiled massive phase 3 survival data for its dual bispecific combination in earlier-line multiple myeloma, delivering another catalyst that could add a new twist in the commercial trajectories of off-the-shelf T-cell engagers versus personalized CAR-T therapies.
    • The combination of J&J’s Tecvayli and Talvey slashed the risk of disease progression or death by 89% compared to standard-of-care cocktails in second- to fifth-line multiple myeloma patients, according to results from the phase 3 MonumenTAL-6 trial. 
    • In another remarkable showing, the two T-cell engagers targeting BCMA and GPRC5D delivered a 62% reduction in the risk of death, J&J announced Thursday.

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

  • Beckers Hospital Review reports,
    • “Dallas-based Tenet Healthcare recorded an $826 million net income in the second quarter of 2026, up from $288 million during the same period, according to its July 23 financial report. 
    • “The publicly traded for-profit system reported operating income of $1.5 billion (26.7% operating margin) during the three months ended June 30, up from $823 million (15.6% margin) during the same period last year. 
    • “Total operating revenue was $5.6 billion in the second quarter of 2026, a 6.8% increase year over year. Tenet received $413 million in revenue in Q2 from the early conclusion of Conifer’s revenue-cycle services contract with Chicago-based CommonSpirit Health, bringing full control of the company back under Tenet. 
    • “Tenet’s salaries, wages and benefits totaled $2.23 billion in Q2 2026, a 3.3% increase year over year. Supply expenses totaled $984 million, a 5.6% increase. Other operating expenses totaled $1.2 billion, a 4.9% increase. 
  • and
    • “Most patients decide on a hospital before settling on a physician — or land on both in the same step — when they first encounter a new health concern, according to survey results U.S. News & World Report published July 20.
    • “U.S. News worked with PureSpectrum to poll 500 Americans nationwide who had personally arranged care for themselves or a family member within the past two years.
    • “Fifty-three percent of respondents said the hospital came first in their decision, or that hospital and physician were chosen together. The other 47% picked their physician before the hospital entered the picture.
    • “When a preferred physician cannot practice at a patient’s hospital of choice, 80% follow that physician to a different facility rather than give up the relationship. Only 20% take the opposite route, opting for a different physician to stay at the hospital they want.
    • “Patients trust referrals from physicians the most when it comes to sources of information about hospitals, averaging at 4.0 on a five-point scale of trustworthiness. Next was data directories, such as online directories or hospital websites, at 3.5 to 3.7, followed by AI chatbots, social media and podcasts, at 2.7 to 2.8.
    • “Age shifts that picture: patients between 26 and 40 place nearly as much trust in podcasts, AI chatbots and social platforms as they do in referrals or hospital websites — a gap that is far wider among older patients. That same younger group also leans on consumer reviews: 81% said sites like Google and Yelp shape what they decide.”
  • Beckers Physician Leadership points out five things to know about “the forces reshaping physician compensation in 2026.”
  • Fierce Healthcare tells us,
    • “Teladoc Health unveiled a new virtual care model for employers and health plans designed to offer a more coordinated, personalized approach for members, while tying payment to clinical and financial outcomes.
    • “The model, called Teladoc One, was built to replace fragmented, condition-specific healthcare programs with an integrated offering that dynamically supports a person’s entire health needs rather than only addressing one disease at a time, company executives said. As part of the model, Teladoc Health care teams deliver and coordinate care across virtual settings and in partnership with a member’s local providers. 
    • “Teladoc One, fundamentally, is a new care model that’s changing the way that we deliver care,” Kelly Bliss, president of U.S. Group Health at Teladoc Health, told Fierce Healthcare in an interview.”
  • and
    • “Cigna Healthcare is taking steps to significantly expand its personalized care management programs, leaning on AI to identify risks sooner and simplify the patient journey.
    • “Through the initiative, Cigna’s care teams use predictive analytics to identify individuals who may benefit from supports or intervention earlier, which can avert more negative outcomes or disease progression down the road.
    • “The insurer also deploys its more than 1,250 clinicians, including nurse managers and behavioral health professionals, to guide the care journey. They are empowered to coordinate care between providers and point members to supports available through their health plan that may be beneficial.”
  • and
    • “Erlanger Health System plans to join Prisma Health, creating a 27-hospital system in exchange for a $2 billion strategic capital commitment toward care in the Chattanooga, Tennessee area.
    • “The nonprofit health systems announced their signed non-binding letter of intent Wednesday morning but did not provide a tentative timeline for the deal. A final agreement will require approvals from Erlanger’s board of directors, who already have backed the deal, as well as Erlanger’s independent oversight monitor board, the local county commission and other state and federal regulators. 
    • “The pair said their proposed partnership will boost access to specialty care, better fund long-term capital projects, secure “mission critical programs” such as southeast Tennessee’s only Level 1 trauma center and other safety-net operations, and generally help the organization grow amid a toughening operating environment.” 
  • Beckers Health IT lets us know,
    • “OpenAI has expanded Health, a ChatGPT feature that lets users securely connect personal health data, to all eligible users in the U.S.
    • “The rollout covers logged-in users age 18 and older on web and iOS across the Free, Go, Plus and Pro plans, according to a July 23 OpenAI news release.
    • “Health lets users connect Apple Health data and supported medical records from U.S. hospital systems, One Medical or Function Health. With permission, ChatGPT can then use that information across any conversation, not just within a dedicated Health tab, to compare lab results, summarize changes since a last appointment, or factor in a recent injury or dietary restriction.
    • “OpenAI said the wider release builds on a limited early test in which more than 70% of health-related conversations happened outside the dedicated Health space, prompting the company to fold that context into everyday chats. Connected medical records and Apple Health data, along with conversations that use them, are not used to train OpenAI’s foundation models or target ads, the company said. Users can disconnect data sources at any time, and connected data is deleted from OpenAI’s systems within 30 days.
    • “The feature runs on GPT-5.5 Instant for free users and GPT-5.6 Sol for paid users, both developed with input from physicians and evaluated on OpenAI’s HealthBench Professional benchmark.” 
  • The Wall Street Journal adds,
    • “One of the looming worries about artificial intelligence is that it will automate away jobs. A report from researchers at Google released Thursday says that, so far, the technology is mainly being used as an aid to workers.
    • “It is a finding that, if it holds true as AI continues to develop, could point to a future where the demand for highly skilled workers is accentuated rather than diminished. 
    • “Just because you’re using AI doesn’t mean it’s going to automate your job,” said Google economist Scott Strand, one of the researchers.” * * *
    • “The research says that while workers in higher-paid occupations tend to use AI more, its use isn’t limited to jobs typically held by college-educated workers. People in manual and technical trades, such as electricians and auto mechanics, are using AI significantly as a hands-on collaborator, and are uploading images and videos to solve problems far more frequently than their white-collar counterparts. 
    • “The research also finds that people are turning to AI to help speed up drudge work at home, such as dealing with government paperwork, building household budgets or helping with home repairs. The gains people are getting from AI use at home are unlikely to show up in standard economic statistics.”

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.”

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.”