Tuesday report

Mental health care

Tuesday report

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

From Washington, DC,

  • Punchbowl News reports,
    • “The Senate’s ability to clear its pile-up of legislation and nominations before a five-week summer recess may come down to two GOP decisions: whether to attempt to pass a budget resolution and whether to force a crypto vote that could fail.
    • “A short-term government funding bill cleared its first procedural hurdle Monday night, with 89 votes — a major boost for the bipartisan push to fast-track it. That followed 86 votes for a landmark Russia sanctions bill last week.
    • “Neither bill can pass before the scheduled August recess without consent from all 100 senators. That gives Democrats leverage, and they’re using it against two Republican priorities.”
  • Beckers Behavioral Health relates,
    • “The Centers for Medicare & Medicaid Services released a toolkit to help state Medicaid and Children’s Health Insurance Program agencies strengthen oversight of applied behavior analysis (ABA) services for children with autism, according to an Aug. 4 news release from the federal agency. 
    • :This toolkit comes as Medicaid spending on autism therapy has surged in several states in recent years. In Colorado, Medicaid spent more on autism therapy for children last year than on emergency room care for all patients, according to a recent investigation by The New York Times. The investigation also found some clinics prescribe 25 or even 40 hours of therapy each week for young children. Average daily appointments also have increased over time, according to Medicaid data analyzed by Trilliant Health.” * * *
    • “CMS said the resource is designed to help states ensure ABA services are medically necessary, individualized and evidence-based while identifying fraud, waste and abuse. The agency said it does not establish new federal requirements, reduce Early and Periodic Screening, Diagnostic, and Treatment obligations, endorse a single ABA treatment approach or limit access to medically necessary care.”
  • The ABA toolkit is available at: https://www.medicaid.gov/medicaid/downloads/autism-services-aba-toolkit.pdf 
  • Beckers Clinical Leadership notes,
    • “CMS will require hospitals to report performance on a patient malnutrition measure starting in 2028 under the Hospital Inpatient Quality Reporting Program.
    • The agency finalized the measure as part of its fiscal year 2027 Inpatient Prospective Payment System final rule released July 31.
  • Beckers Payer Issues points out,
    • “ACA insurers are pitching a median rate increase of 15% for 2027, the second year in a row of double-digit premium hikes, according to a July 8 Peterson-KFF Health System Tracker analysis that was updated Aug. 3.
    • “The tracker reviewed 276 insurers in marketplaces across the country with publicly filed rates. The tracker’s analysis considered an insurer’s premium increase as the enrollment-weighted average rate change across its offerings in a state. While rates will be finalized in late summer, these filings provide a glimpse of the year ahead.” * * *
    • “For 2026, the median nationwide proposed rate change was 18%. The median finalized rate change was 20%.”

From the U.S. Office of Personnel Management front,

  • Govexec reports,
    • “Most funds offered as part of the federal government’s 401(k)-style retirement savings program finished July in the red, continuing the downward trend that began the prior month.
    • “Only the Thrift Savings Plan’s G Fund, which is made up of government securities, grew last month, increasing by its statutorily mandated rate of 0.39%. So far this year, the G Fund has gained 2.57% in value.
    • “The common stocks of the C Fund were virtually flat in July, falling 0.07% and bringing its 2026 performance down to 10.13%. And the international (I) fund lost 1.01% last month; since January, the I Fund is up 15.35%.
    • “The small- and mid-size businesses of the S Fund finished July 4.12% in the red. So far this year, the S Fund has gained 13.52%. And the fixed income (F) Fund lost 1.29% last month, bringing its 2026 losses to 0.56%.
    • “Each of the TSP’s lifecycle (L) funds, which shift toward more conservative investments as participants approach retirement age, likewise lost ground in July.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the electronic Official Personnel Folder (eOPF) Document Request Service (DRS), a secure online portal that enables eligible former federal employees to request and receive copies of their official personnel records electronically — eliminating a manual process that previously often required paper forms, agency requests, or a request to the National Personnel Records Center.”
    • * * * “Users access the Document Request Service through Login.gov, complete a one-time identity verification, and submit a brief online request. Once processed, they receive a secure email containing a time-limited download link to a password-protected ZIP file with their complete eOPF Employment Folder.
    • “The DRS is available to separated federal employees whose records are maintained in eOPF, as well as current federal employees whose agencies do not provide government-furnished equipment to access their own personnel records. Current employees with access to the eOPF application should continue to retrieve their records directly through that system.
    • “The launch of the Document Request Service is part of OPM’s broader effort to modernize federal human resources systems, improve customer service, and reduce reliance on manual, paper-based processes across the federal government. Additional information, including a user guide, is available at Documents Request Service – eOPF Resource Center.”
  • FEHBlog Observation — OPM continually is improving IT services for which the agency deserves credit. The efforts make it more puzzling why OPM has not yet implemented the HIPAA 820 Standard Enrollment Roster Transaction in the FEHB, PSHB, and FEDVIP programs.
  • Noah Peters, an OPM Senior Adviser has added a post to the Secrets of OPM blog titled (OPM.gov link) “Restoring Merit With the Right Civil Service Exam.”

From the Food and Drug Administration front,

  • QualityAssuranceMag reports,
    • “A multistate outbreak of E. coli O145:H28 infections has been linked to organic frozen blueberries from Frutas y Hortalizas del Sur S.A., of San Carlos, Chile, sold under the GreenWise brand at Publix.
    • “The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), along with state and local partners, are investigating the outbreak, which has sickened 12 and hospitalized four in two states, Florida and Georgia.
    • “Publix recalled all lots of GreenWise Organic Frozen Whole Blueberries and Whole Mixed Berries due to potential E. coli contamination. Recalled product was shipped to Publix retail stores in eight states: Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee and Virginia.” 
  • MedTech Dive relates,
    • “Caristo Diagnostics has received de novo authorization for an AI tool that quantifies coronary inflammation from routine imaging scans, the company said last week.
    • “The Food and Drug Administration authorization covers a device, CaRi-Heart, that uses coronary computed tomography angiography to estimate a patient’s risk of cardiovascular mortality over 10 years.
    • “Research suggests the tool could help physicians stratify risk among patients who present with chest pain but are free from obstructive coronary artery disease.”
  • and
    • “DeepHealth last week received the Food and Drug Administration’s 510(k) clearance for an artificial intelligence tool that reads breast ultrasound images and generates reports.
    • “The feature can help clinicians localize suspicious soft tissue lesions; characterize details about the lesion such as its shape, orientation, and margin; and generate a report with key findings and impressions. Radiologists still have control of the final assessment. 
    • “DeepHealth’s parent company, RadNet, plans to offer the tool across its network of imaging centers by the end of the year.”
  • Targeted Oncology tells us,
    • “FDA authorized a new rituximab biosimilar based on comprehensive comparability data demonstrating high similarity to reference rituximab and no clinically meaningful clinical differences. 
    • “Market expansion of CD20 biosimilars may increase competitive pressure, shaping formulary positioning, contracting, and purchasing decisions that weigh price against continuity of supply. 
    • “Rituximab remains foundational across B-cell malignancies and autoimmune indications, reflecting its CD20-binding mechanism and B-cell depletion via multiple immune effector pathways. 
    • “Class safety considerations persist, including boxed warnings for fatal infusion reactions, severe mucocutaneous reactions, HBV reactivation, and PML, alongside risks of serious infections.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has announced that Ascend Laboratories is recalling specific lots of dabigatran etexilate, a blood thinner taken to reduce the risk of stroke or blood clots in patients with nonvalvular atrial fibrillation. This is a generic version of a popular direct oral anticoagulant (DOAC) most commonly sold by Boehringer Ingelheim under the brand name Pradaxa. 
    • “The recall was put in place due to a failed impurity/degradation test. After 12 months, the drug produced an out-of-specification (OOS) test result.“
    • “The FDA is still investigating this issue. Click here for additional details from the agency.”
  • The American Hospital Association News points out.
    • “The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products. Certain kits by Medline Industries have been recalled due to the containment of recalled Huons Bupivacaine Hydrochloride Dextrose Injections. The injections pose a risk of infection, inflammatory response and/or reduced anesthetic effectiveness. Certain convenience kits by Medical Action Industries have also been recalled due to the containment of Medline’s Namic Angiographic Star Off Handle Manifolds, which have been found to contain particulate within the fluid path of the manifolds.
    • “In addition, the FDA issued an early alert for certain Intraosseous Vascular Access System Needle Sets by Becton Dickinson due to some lots being manufactured with out-of-tolerance dimensions. BD said it has resulted in some lots being manufactured with out-of-tolerance dimensions, with some users reporting difficulty removing the obturator following placement of the needle sets.” 

From the public health and medical/Rx research front,

  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention is expanding the largest known cyclosporiasis outbreak to 15 states, adding six states where illnesses have been traced to shredded iceberg lettuce sourced from central Mexico, according to three individuals familiar with the investigation.
    • “Missouri, which is reporting 1,095 cases, is one of the states being added, according to a state health department spokesperson. The number of state cases jumped dramatically in the past week. Patients who were interviewed at length by state and local investigators said they consumed Taco Bell before getting sick, spokesperson Lisa Cox said.
    • “The other states are Arkansas, Iowa, Nebraska, New Hampshire and North Carolina, according to a fourth person familiar with the investigation.”
  • The New York Times considers,
    • “Is It OK to Eat the Same Things Every Day?
    • “Some people do it to lose weight, others to avoid the hassle of planning meals. We asked experts how “food monotony” affects your health.”
  • Beckers Hospital Review relates,
    • “In 2025, New Mexico confirmed 100 measles cases across nine of its 33 counties, and each case cost an average $53,522, according to research published Aug. 4 in Annals of Internal Medicine. 
    • “Researchers with the CDC and New Mexico Department of Health analyzed the societal economic burden of these 100 cases through public health response costs, direct medical costs and productivity losses. The public health response costs totaled about $3.2 million, including $2.1 million for vaccination-related activities. About 130 public health responders worked on contact tracing across 205 contacts, which each cost $1,817, according to the study. 
    • “The $53,522 per measles case, equal to $5.35 million in total, ranged from February through September 2025.”
  • MedPage Today tells us,
    • “A peptide vaccine targeting KRAS mutations in patients at high risk for pancreatic cancer induced durable T-cell responses.
    • “In 16 patients with evaluable pancreatic cysts, three had complete resolution of the cysts, three had partial regression, and the rest had stable cyst status.
    • “No patient developed severe vaccine-related adverse events.”
  • and
    • “In a randomized trial, a novel system for autonomous control of supplemental oxygen for inpatients who needed it improved the proportion of time spent with adequate oxygen levels.
    • “The study showed safety of the approach and lower oxygen use overall compared with usual care.
    • “The trial could not assess clinical outcome effects like reduced respiratory decompensation, shorter hospital stays, or improved survival.”
  • Health Day points out,
    • “Women who enter menopause at an earlier age have an increased risk of high blood pressure, a new study says.
    • “Researchers found that nearly 23% of women with premature menopause and 19% of women with early menopause had high blood pressure, compared to under 17% of women with normal menopause, researchers found.
    • “Overall, premature menopause brought a 12% higher risk of high blood pressure compared to women who reached menopause after age 45, researchers reported recently in the journal Menopause.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Recurrent urinary tract infections (rUTIs) are among the most common bacterial infections worldwide. The difficult-to-treat condition, which affects primarily women, is defined as two urinary tract infections (UTIs) within six months or three UTIs within the past year. They are a leading cause of outpatient antibiotic use, accounting for more than 15% of all prescriptions.
    • “While antibiotics remain the standard treatment, frequent recurrences and rising antibiotic resistance highlight the need for alternative therapeutic approaches. Now, researchers have, for the first time, administered a combined phage therapy (PT) with fecal microbiota transplantation (FMT), to decolonize urinary and intestinal reservoirs of rUTI patients.
    • “The novel treatment approach, combining PT and elective FMT, was administered to three female patients, between May and July 2023, with rUTI that did not respond to antibiotics and commonly used non-antibiotic strategies. All had microbiologically confirmed E. coli in multiple infections.
    • “All three women received PT orally and intravesically (locally applied to the bladder via catheter) for eight days outside of acute episodes. Two of these three patients were elected to receive subsequent FMT. Since the bacteria causing the recurring infections often reside in the gut as well as the urinary tract, the FMT treatment targeted the intestinal reservoirs of E. coli that survive antibiotic treatment of acute infections and can become increasingly resistant.
    • “While phage therapy acts to remove the pathogen, FMT aims to restore a healthy microbiome, combining both immediate and long-term effects,” Lena Biehl, MD, PhD, group leader at Fraunhofer ITMP, deputy lead of Cologne Microbiota Bank, University Hospital Cologne.
    • “This work is published in Nature Microbiology in the paper, “Combined Phage therapy and fecal microbiota transplantation to treat recurrent urinary tract infection: a case series.”
  • Per Fierce Pharma,
    • “In a milestone for IgA nephropathy, Otsuka’s Voyxact has shown for the first time in a phase 3 trial that a drug can stabilize patients’ kidney function decline to the normal rate seen in healthy adults. 
    • “Results from the phase 3 Visionary trial showed that Voyxact (sibeprenlimab) achieved an annualized estimated glomerular filtration rate (eGFR) slope of a 0.3 mL/min/1.73m² gain over two years, suggesting an improvement in kidney function. The rate matches the normal age-related decline of less than 1 mL/min/1.73m² per year, as laid out in the KDIGO 2025 Clinical Practice Guideline for IgAN.
    • “To be presented at the GlomCon Hawaii 2026 conference, the latest Voyxact result is better than an annualized eGFR slope of negative 4.2 mL/min/1.73m² for placebo. It’s also better than Voyxact’s own performance over 12 months, when it recorded an annualized loss of 3 mL/min/1.73m² at an interim analysis of the Visionary trial.”
  • and
    • After a yearslong struggle, Jazz Pharmaceuticals has called time on Zepzelca as a second-line treatment for small cell lung cancer.
    • In alignment with the FDA, Jazz plans to ask the agency to remove the second-line SCLC indication from Zepzelca’s label, the company said Monday alongside its second-quarter earnings report.
    • The decision comes after the confirmatory phase 3 Lagoon trial recently failed on its primary endpoint of overall survival. In the study, Zepzelca (lurbinectedin) monotherapy performed even worse than other chemotherapy regimens, while a combination of Zepzelca and irinotecan showed a numerical advantage that didn’t meet statistical significance.

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

  • Beckers Payer Issues tells us,
    • “Louisiana workers pay the largest share of their income toward their portion of health insurance premiums, while workers in Hawaii pay the smallest, according to an AHIP analysis of Commonwealth Fund data published in July.”
    • The article lists all of the States’ percentages. 
  • and
    • “UnitedHealthcare is rolling out new reimbursement limits on five categories of lab tests across its commercial, ACA, Medicare Advantage and Medicaid plans.
    • “The five policies cover allergen testing, liver fibrosis testing, in vitro chemotherapy sensitivity assays, testosterone blood tests and vitamin B12 testing. 
    • “The policies generally take effect Sept. 1 for commercial, exchange and MA plans, though several states have an effective date of Oct. 1 in the commercial and exchange markets. The Medicaid rollout is staggered by state, with effective dates ranging from August through November.
    • “Broadly, the policies set frequency caps or exclude specific test types from reimbursement.”
  • Fierce Healthcare informs us
    • “AI health tech company Daffodil Health is rolling out a new platform aimed at supporting payers in managing the No Surprises Act dispute process.
    • “The number of cases reaching the NSA’s independent dispute resolution process continues to grow. For example, when the process was established by regulators, they projected about 17,000 cases would make it to IDR each year—however, 1.2 million were filed in just the first half of 2025.
    • “Daffodil’s tool is built to support insurers and third-party administrators in handling that volume of disputes, starting with intake and through negotiation, arbitration and reporting, the company said in an announcement.”
  • Beckers ACS Review lets us know,
    • “Austin, Texas-based Ouma Health has acquired a multisite maternal-fetal medicine practice led by Tamara Takoudes, MD, expanding the telemedicine company’s footprint across Connecticut, Massachusetts, Maine and New Hampshire, according to an Aug. 4 news release.
    • “The acquisition adds established in-person clinical locations to Ouma’s national teleMFM network and strengthens the company’s relationships with hospitals, imaging centers, birth centers and community obstetric practices across New England. 
    • “Ouma, which describes itself as the nation’s largest independent maternity telemedicine company, said the deal is part of a broader effort to build clinical infrastructure for high-risk pregnancy care as MFM workforce shortages and hospital labor and delivery unit closures continue to limit access in many communities. Financial terms were not disclosed.”
  • Beckers Behavioral Health adds,
    • “San Francisco-based Amae Health, a provider of mental healthcare, is collaborating with Google Health Enterprise to bring wearable-derived data into its precision psychiatry care model.
    • “The collaboration will allow Amae Health’s care teams to incorporate data from wearable devices — including sleep patterns, physical activity, heart rate variability and changes in daily routines — alongside existing clinical information, according to an Aug. 4 news release. The company said the additional data is intended to help clinicians detect changes in patients’ conditions earlier and better identify potential relapses among people with schizophrenia, bipolar disorder and major depressive disorder.”
  • Per a Lown Institute news release,
    • “U.S. hospitals can excel at both clinical care and making critical investments in the people and communities they serve. That is the key takeaway of the 2026 Lown Hospitals Index ‘Honor Roll’, which recognizes 123 institutions that achieved top ratings on health equity, value of care, and patient outcomes.
    • “With financial pressures forcing painful choices on many hospitals, those on the Lown Honor Roll have found ways to put their patients and communities first,” said Vikas Saini, MD, president of the Lown Institute. “These hospitals are staying true to their mission when it matters most, and in healthcare, that’s everything.”
  • Per Beckers Hospital Review,
    • U.S. News & World Report released its 2026-27 Best Hospitals rankings and ratings Aug. 4, which included a list of 505 Best Regional Hospitals across 49 states and the District of Columbia.
    • The latest edition of Best Hospitals, now in its 37th year, evaluated hospitals on measures such as risk-adjusted mortality rates, preventable complications and patient experience. This year’s rankings placed significantly greater weight on risk-adjusted patient outcome measures in determining results. For the first time, Maternity Care recognition was also incorporated into Best Regional Hospitals point calculations. More information about the methodology is available here and here.
  • Healthcare Dive adds,
    • “New Jersey health system Hackensack Meridian Health has become the first organization to earn the Joint Commission’s seal of approval for the responsible use of artificial intelligence in healthcare.
    • “The Joint Commission, an independent accreditation organization, launched the certification in June with the goal of endorsing U.S. healthcare organizations able to demonstrate they have the proper governance, resources, policies and training programs for the safe and effective use of AI.
    • “HMH has been refining its AI systems for years, according to Dr. Lauren Koniaris, the organization’s chief medical informatics officer. “As we expand our clinical AI initiatives, we operate under the utmost governance to ensure patient quality and safety are always the priority,” she said”
  • Per the Wall Street Journal,
    • “Pfizer reported second-quarter revenue of $15.03 billion, up 3% and beating analyst expectations as non-Covid drug sales grew.
    • “Pfizer recorded a second-quarter loss of $248 million, driven by a $3.8 billion write-down on an experimental lung-cancer drug.
    • “Pfizer raised the low end of its full-year sales guidance to a range of $60.5 billion to $62.5 billion.”
  • and
    • “Amgen AMGN  lifted its outlook for the year after strong drug sales bolstered the company’s bottom line in the second quarter, but added that it would end development of an early-stage obesity treatment.
    • “The biotechnology company on Tuesday said it was halting the development of AMG 513, a potential obesity treatment currently in a phase 1 study. That study will be carried to completion to follow enrolled participants, Amgen said. The company didn’t provide a reason for the discontinuation.
    • “With development of AMG 513 ending, Amgen’s only candidate in the space is MariTide, which is currently in phase 3 studies for a range of indications such as obesity, Type 2 diabetes and chronic weight management.
    • “Amgen also lifted its guidance, saying it now expects full-year revenue between $38.2 billion and $39.4 billion, up from a previous view of $37.1 billion to $38.5 billion. Adjusted per-share earnings are expected between $22.30 and $23.50, up from a range of $21.70 to $23.10.”
  • and
    • “Gilead Sciences reported second-quarter revenue rose to $7.8 billion, but swung to a $10.5 billion loss due to acquired research expenses.
    • “Gilead Sciences’ revenue growth was driven by a 12% rise in HIV product sales to $5.69 billion, while sales of Covid-19 drug Veklury fell 81%.
    • “Gilead Sciences narrowed its full-year product-sales guidance to a range of $30.1 billion to $30.4 billion.”
  • and
    • “Novo Nordisk said annual sales and operating profit should fall less than previously expected following a boost in the second quarter.
    • “Novo Nordisk expects adjusted sales and operating profit to decline up to 6% at constant exchange rates this year, compared with its prior forecast of a 4% to 12% decline.
    • “Adjusted sales for Novo Nordisk grew 7% to 78.49 billion Danish kroner in the second quarter, while adjusted operating profit rose 11%.”
  • STAT News adds,
    • “BioNTech on Monday named Guido Oelkers, formerly the leader of the Swedish biopharma company Sobi, as its new CEO, as the Covid-19 vaccine developer continues its shift to oncology.
    • “Oelkers will replace Ugur Sahin as CEO. In March, BioNTech announced that Sahin and his cofounder and wife Özlem Türeci, the company’s chief medical officer, would depart the company to lead a new biotech focused on developing mRNA medicines.
    • “Oelkers, who has worked in biopharma for more than 30 years, will start by Feb. 1, 2027, the company said. He said that he would continue BioNTech’s work to be a global company with multiple approved medicines by 2030.”
  • BioPharma Dive helps us track the patent expiration dates of name brand prescription drugs.

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “Senate leadership on Sunday released the text of a bipartisan government funding stopgap measure that would block the White House’s proposal to give political appointees control over federal research grants. 
    • “The continuing resolution would fund the government until Dec. 11. It would only block the Trump administration’s new grants proposal until that time, but it will be more difficult for Republicans to allow the White House’s plan to take effect now that they’ve agreed to blocking it, even if temporarily.” 
  • Roll Call adds,
    • “Just as Senate GOP leaders plan to begin moving several big-ticket items ahead of a planned August recess, President Donald Trump will head out west for a Los Angeles-area fundraiser and an economic speech in Las Vegas.
    • “Trump is set to return to Washington, D.C., Wednesday night — when the chamber could be a few votes away from a monthlong recess in a midterm election year. And the president’s recent statements, threats and willingness to shift on policy shows he’s capable of slowing things down.” * * *
    • “[Senate Majority Leader John] Thune has teed up an ambitious week as he tries to move several big-ticket measures while also freeing vulnerable GOP senators to get back home to campaign until mid-September. He wants to pass a continuing resolution to fund the government until Dec. 11, including a number of White House-requested priorities the House did not have when it passed its own continuing resolution before leaving for the summer last month.
    • “Also on Thune’s list: a cryptocurrency bill, over 70 executive branch nominations and a Russia sanctions bill largely crafted by the late Sen. Lindsey Graham, a South Carolina Republican and close Trump ally.”
  • and
    • “The Senate is back on track to consider acting Attorney General Todd Blanche’s nomination to lead the Justice Department permanently after two key GOP holdouts said they were “pleased” with a deal they struck. 
    • “The DOJ said in a statement posted Sunday night that it has “rescinded” a $1.8 billion “anti-weaponization” fund meant to compensate people targeted by the federal government. The fund was part of a settlement brokered by Blanche that resolved President Donald Trump’s $10 billion suit against the Internal Revenue Service tied to the release of his tax returns during his first term in office.
    • “It was enough to satisfy Sens. John Cornyn, R-Texas, and Thom Tillis, R-N.C., who expressed “gratitude” in a Monday statement and wrote, “We look forward to voting to advance his nomination out of the Senate Judiciary Committee soon.”
    • “The Judiciary panel is now scheduled to vote on Blanche’s nomination Tuesday morning, after canceling a meeting last week.”
  • Govexec relates,
    • “Federal employees and contractors whose sensitive personal data was stolen in the massive Office of Personnel Management breaches disclosed a decade ago would receive identity protection for the rest of their lives under new bicameral legislation.
    • “Senate Intelligence Committee Vice Chair Mark Warner, D-Va., and Del. Eleanor Holmes Norton, D-D.C., plan to introduce the RECOVER PII Act on Monday, aiming to prevent the federal government’s identity-protection program for victims from expiring Sept. 30, according to bill text first seen by Nextgov/FCW.” * * *
    • “Congress responded to the breach in a 2017 appropriations law by requiring OPM to provide victims with at least 10 years of complimentary identity protection and no less than $5 million in identity-theft insurance. The new bill would replace that limit with coverage lasting for the remainder of each affected person’s life while retaining the insurance requirement.
    • “We have a responsibility to stand by the federal workers who were put at risk through no fault of their own,” Warner said. “This legislation will ensure those affected continue to receive the identity protection they need, while helping better safeguard personal information from future exploitation.”
    • “The bill would also allow agencies to reimburse federal employees and contractors for privacy tools and services, such as those that remove or limit their personal information online. Agencies would decide whether to offer the reimbursements, which would not be limited to OPM breach victims and would come from their salary-and-expense budgets.”
  • Per Health and Human Services news releases,
    • U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today traveled to southwest Virginia as part of his “Take Back Your Health” tour to highlight Trump Administration’s efforts to expand addiction recovery, strengthen American agricultural and food supply chains, and recognize President Trump’s historic $50 billion Rural Health Transformation Fund.
    • “On Monday, Secretary Kennedy joined Congressman John McGuire for visits to Tranquility Grove Rehabilitation Center and the Virginia Tech Controlled Environment Agriculture Innovation Center. Under President Trump’s leadership, combating addiction and mental illness remains a national priority. The Administration is also advancing innovative agricultural technologies that strengthen domestic food production, improve supply chain resilience, and help deliver healthier food to the American people.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today marked National Health Center Week by announcing that Health Resources and Services Administration (HRSA)-funded health centers served more than 32.7 million patients in 2025 — an increase of more than 350,000 patients from 2024 and the highest number of patients served in the Health Center Program’s 61-year history.”
  • Per a Centers for Medicare and Medicaid Service news release,
    • “The Centers for Medicare & Medicaid Services (CMS) recently hosted the one-year celebration of the Health Technology Ecosystem, bringing together leaders from the government, healthcare, and technology sectors to feature the significant progress made over the past year in advancing interoperability, improving health data sharing, and expanding patient access to digital health tools.
    • “The event featured remarks from U.S. Department of Health and Human Services (HHS) leadership, with speakers reflecting on Health Technology Ecosystem accomplishments during its first year, highlighted industry collaboration, and outlined priorities for the initiative’s next phase.” * * *
    • “The event concluded with a discussion of the next phase of the Health Technology Ecosystem and opportunities to expand industry participation. Leaders also introduced new areas for future collaboration, including real-time benefits, price transparency, advanced appointment scheduling, clinical trial matching, bulk HL7® Fast Healthcare Interoperability Resources (FHIR®) capabilities, and provider add-on services. CMS encouraged additional organizations to join the initiative as the Health Technology Ecosystem continues to evolve through collaboration across government and the private sector.”
    • “A recording of opening session highlights is available at: https://youtu.be/ATVSdE4cnVQ?si=03QLFmQ2tuRx7w-O
    • “The recording of the full event is available at: https://www.youtube.com/playlist?list=PLaV7m2-zFKpgncdcV8Wnzv42DQo2ZqkUD“
  • Per an NCQA blog post,
    • “The Healthcare Effectiveness Data and Information Set (HEDIS®) is continuously evolving to reflect clinical best practices and to support the needs of organizations that deliver and coordinate care.
    • “For HEDIS Measurement Year (MY) 2027, NCQA introduced several updates:
      • “Added 6 new measures.
      • “Updated 3 existing measures.
      • “Transitioned 1 measure to Electronic Clinical Data Systems (ECDS) reporting.
      • “Restructured ECDS-reported measures reorganized by clinical domain.
      • “Made minor adjustments made across multiple measures.”
    • “NCQA seeks feedback about the proposed retirement of select HEDIS measures for Measurement Year (MY) 2027. The ad hoc public comment period is open from August 3 to August 17. Read on to learn more about the measures proposed for retirement and visit our public comment webpage to submit your comments.
    • “The newest additions to HEDIS address follow-up after a positive colorectal cancer screening, prenatal syphilis screenings, person-centered outcome goals and the use of continuous glucose monitoring.”

From the U.S. Office of Personnel Management front,

  • Federal News Network reports,
    • “The Trump administration is giving agencies the green light to implement a new performance management system for federal employees — while also saying significant portions of those changes are “non-negotiable” with federal unions.
    • “In recent guidance issued to agencies, OPM detailed which aspects of the government’s new performance review system override collective bargaining obligations — and what is still subject to negotiation.
    • “Generally, the guidance narrows federal unions’ ability to bargain over performance appraisals. Any collective bargaining provisions that allow for grievances over performance ratings, or that would prevent agencies from using a forced distribution system, are now non-negotiable with unions, according to OPM’s memo.
    • “But some aspects of performance management are still negotiable, according to OPM, as long as they remain consistent with both the final rule and any applicable laws. Those include employees’ informal requests for a reconsideration of their rating; rules on awards and recognition programs; and feedback procedures between supervisors and employees.”
  • The AI Journal relates,
    • “ACI International Inc (NYSE: CACI) announced today that it will serve as one of Oracle’s technology partners for the U.S. Office of Personnel Management’s (OPM) Federal Human Resources Information Technology (HRIT) Modernization contract. Working alongside Oracle, Baker Tilly, and Deloitte on this 10-year contract worth nearly $400 million, CACI will modernize and consolidate disparate federal human resource systems into a single, secure, cloud-based platform for federal civilian employees, including HR professionals and leaders. The consolidation of federal HR systems into a single shared platform is expected to reduce taxpayer costs by more than 90 percent while improving efficiency, security, and service delivery across the government.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Novartis’ blockbuster radioligand therapy Pluvicto has cleared a key milestone on its quest to hit $5 billion in peak sales, securing a U.S. nod in an earlier form of prostate cancer that nearly doubles the number of patients that could benefit from the drug. 
    • “Late Friday, the FDA signed off on Pluvicto in tandem with an androgen receptor pathway inhibitor (ARPI) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC).”
  • Alzheimers’ News Today relates,
    • “The U.S. Food and Drug Administration (FDA) has granted fast track designation to remlifanserin, an experimental treatment that Acadia Pharmaceuticals is developing for hallucinations and delusions associated with Alzheimer’s disease psychosis.
    • “The FDA grants this designation to investigational medicines intended to treat serious conditions and fill an unmet medical need. Fast track status provides benefits such as more frequent communication with the FDA, with the goal of speeding a therapy’s development and review.
    • “FDA Fast Track designation for remlifanserin underscores the significant unmet need for new treatment options for people living with Alzheimer’s disease psychosis, a serious condition for which there are currently no FDA-approved therapies. This is an important milestone for the remlifanserin program,” Catherine Owen Adams, CEO of Acadia, said in a company press release.”
  • Parkinson’s News Today tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to sasineprocel (ANPD001), an experimental cell therapy to treat Parkinson’s disease.
    • “The designation, given to promising regenerative therapies (treatments that aim to replace or restore disease-damaged tissue) that could substantially improve care for serious diseases, provides developer Aspen Neuroscience with perks such as more intensive FDA guidance.
    • “This significant milestone highlights the transformative nature of sasineprocel as a potentially disease-modifying therapy for patients facing a serious disease with substantial unmet medical need,” Damien McDevitt, PhD, president and CEO of Aspen, said in a company press release.” 

From the judicial front,

  • Beckers Payer Issues reports,
    • “Five federal employees are suing U.S. Office of Personnel Management Director Scott Kupor over alleged sex discrimination due to the rollback of coverage for gender-affirming care.
    • “Plaintiffs, backed by the Human Rights Campaign Foundation, filed the lawsuit Aug. 3 in the U.S. District Court for the District of Columbia. The potential class action focuses on OPM’s coverage policy following a January 2025 executive order from President Donald Trump. The order said “sexes are not changeable,” and the country recognizes only male and female sexes.” * * *
    • “The lawsuit calls for two classes, one seeking injunctive relief and the other seeking damages. The complaint also requests retroactive coverage.”
  • STAT News relates,
    • “Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.
    • “Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Two people have died in connection with the cyclosporiasis outbreak that has spread across the U.S. this summer, according to public-health officials in Michigan, marking the first deaths tied to the unusually large flare up of the food-borne illness.
    • “Both of the people had “significant underlying health conditions” that may have been exacerbated by cyclosporiasis and dehydration, Michigan’s Department of Health and Human Services said. It didn’t provide any additional information about the people who died but said cyclosporiasis deaths are uncommon in the United States.” * * *
    • “The Centers for Disease Control and Prevention said it has received reports of more than 6,700 laboratory-confirmed cases of cyclosporiasis, with another 11,500 suspected. Typically, the U.S. sees about 250 reported cases by this time of year.
    • “The exact source of the parasite remains unclear. Authorities have been probing various cyclospora outbreaks as if they are distinct, but it is possible they are related and investigators so far haven’t been able to connect them. Food-safety experts say the vast majority of fresh fruits and vegetables are still safe to eat.
    • “The largest outbreak has been linked to Taylor Farms’ shredded iceberg lettuce, which was sold at retailers including Taco Bell. On July 17, Taylor Farms said it was removing all iceberg lettuce sourced from central Mexico from the U.S. market. Taco Bell finished pulling potentially affected product from its supply chain on the same day. 
    • “Yum Brands, the parent company of Taco Bell, was in communication with Michigan public-health authorities weeks before the recall, according to emails the health department shared with The Wall Street Journal on Monday. 
    • “In an email to a Yum Brands employee on July 2, a state epidemiologist said the department had “a strong signal from our epidemiologic interviews that we need to continue to work with Taco Bell.” 
  • Fox Business relates,
    • “Marijuana is officially leading the pack for the most-used daily drug among Americans.
    • “New data from the 2025 National Survey on Drug Use and Health, from the Substance Abuse and Mental Health Services Administration (SAMHSA), reveals that there are 21.4 million daily or near-daily marijuana users in the U.S.
    • “This surpasses the 19.9 million people who smoke cigarettes and the 17.2 million who consume alcohol.” * * *
    • Although marijuana is now the most commonly used substance on a daily or near-daily basis, alcohol remains the most widely used substance overall. During the previous month, about 129 million people drank alcohol while 43.8 million used marijuana.
  • Cardiovascular Business tells us,
    • “Twenty years after its launch, the Get With The Guidelines-Heart Failure (GWTG-HF) registry from the American Heart Association (AHA) has grown into one of the nation’s most influential cardiovascular databases, helping accelerate the adoption of guideline-directed medical therapy (GDMT) while generating evidence that has reshaped heart failure care.
    • “Since its inception in 2005, the registry has collected more than 1.6 million patient records from more than 800 hospitals, representing about 60% of U.S. hospitals. The database has produced more than 150 peer-reviewed publications and is increasingly being used to support implementation science, registry-based clinical trials and long-term outcomes research.
    • “What started as a quality improvement initiative has led to substantially better processes of care and, most likely, improved survival, fewer symptoms and a tremendous learning platform,” Clyde W. Yancy, MD, MSc, chief of cardiology and professor of medicine at Northwestern University, said in a video interview with Cardiovascular Business.
    • “He added that the registry was created to solve a longstanding challenge in medicine: the fact that it often takes years for clinical evidence to truly influence changes in daily practice.” 
  • Drug Topics informs us,
    • “A survey study published in JAMA Network Open found that pregnant women and parents of young children generally prefer maternal respiratory syncytial virus (RSV) vaccination over infant RSV antibody shot administration as a means of protecting infants against RSV-associated hospitalization. The 2 concurrent national cross-sectional surveys, fielded in April 2024 among 174 pregnant women and 1765 parents of children aged 0 to 5 years, found that only about half of participants reported positive intentions toward either immunization option, underscoring a persistent gap between product availability and uptake.”
  • Fierce Healthcare lets us know,
    • “A new study evaluating the impact of virtual lactation support found it boosted maternal health and breastfeeding success outcomes. 
    • “The study evaluated SimpliFed, a virtual baby-feeding platform led by UMass Chan Medical School. Participants who completed three or more telelactation visits breastfed for nearly 16 weeks longer than those who did not engage with any visits. The impact was even more drastic for moms with mental health conditions, where average feeding duration increased by 24 weeks. The study, presented as a poster, is not yet published online.
    • “The researchers recruited a group of 200 participants from prenatal through postpartum. All were offered unlimited access to the SimpliFed platform for 12 months. Utilization was evenly split: a third did not complete any visits; a third completed one to two; and a third completed three or more.
    • “Dropping breastfeeding rates over time were common, mirroring national trends. Most participants, regardless of whether they engaged with SimpliFed, breastfed at one week postpartum; three-quarters did by six months; and about half did at 12 months. However, completing three or more SimpliFed visits led to longer duration of breastfeeding compared to others in the cohort.”
  • MedPage Today adds,
    • “A study of U.S. children found no evidence linking neonatal male circumcision with autism spectrum disorder, prospective data from the ECHO cohort showed.
    • “Among nearly 2,800 boys in 14 ECHO sites, 6% of those who were circumcised had autism compared with 9% of uncircumcised males, according to Monica McGrath, ScD, MHS, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and co-authors.
    • “After adjusting for confounders, circumcision was not associated with an autism diagnosis (OR 0.83, 95% CI 0.59-1.17), McGrath and colleagues reported in JAMA Pediatrics.
    • “Stratifying data by region, preterm birth, and neonatal intensive care unit (NICU) admission yielded either an inverse or no association. Circumcision also was not associated with autism-related traits or behaviors.”
  • Beckers Hospital Review points out,
    • “Active U.S. drug shortages increased to 227 in the second quarter of 2026, marking the third consecutive quarterly increase, according to the American Society of Health-System Pharmacists. Nearly half of all new shortages this year involve medications made by a single manufacturer, a concentration that increases supply chain vulnerability, and the FDA’s database continues to reflect new discontinuations weekly.”
    • The article identifies the nine drugs most recently placed in shortage status.

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

  • The Wall Street Journal reports,
    • “AstraZeneca AZN shares fell sharply and Bristol Myers Squibb’sBMY  climbed, after media reports that the two drugmakers held merger talks.
    • “London-listed shares in AstraZeneca were down 6.4% in European morning trading. Meanwhile, Bristol’s shares were up 5.5% in U.S. premarket trading.
    • “The stock moves came after the Financial Times reported, citing unnamed sources, that AstraZeneca held discussions with Bristol about a tie-up in recent months, which could lead to a deal in the near future or fall apart.
    • “An AstraZeneca spokesman declined to comment, while Bristol didn’t respond to a request for comment.
    • “A potential deal between AstraZeneca and Bristol Myers Squibb would create a pharma giant with a combined market value of roughly $400 billion and more than $100 billion in annual sales.”
  • Beckers Hospital Review relates,
    • :Gaithersburg, Md.-based Adventist HealthCare recorded operating income of $18.2 million (3% operating margin) through the first six months of fiscal 2026, up from an operating loss of $205,000 (-0.1% margin) during the same period last year, according to its July 29 financial report.” * * *
    • “Among the system’s hospitals, Silver Spring, Md.-based White Oak Medical Center posted $11.9 million in operating income through Q2, up from a $2.8 million operating loss during the same period last year. Rockville, Md.-based Shady Grove Medical Center posted $16.5 million in operating income, up from $10.2 million. Fort Washington (Md.) Medical Center Medical Center posted a $1.2 million operating loss, widened from a $960,000 loss during the same period last year.”  
  • Beckers Behavioral Health tells us,
    • “Ochsner Behavioral Health Acadiana welcomed its first patients July 8, marking the official launch of a regional behavioral health network built jointly by Ochsner Lafayette (La.) General and Plano, Texas-based Oceans Healthcare. 
    • “The network pairs a newly built hospital in Lafayette with the former Oceans Behavioral Hospital Broussard, now renamed Ochsner Behavioral Health Acadiana-Broussard, giving the partners 100 inpatient beds across the two campuses under a single license — more than double the 38 beds they previously operated in the region.
    • “The logic behind the partnership, Oceans Healthcare COO Jeff Pritchard said, comes down to completing the continuum.
    • “Many patients come through the doors of a health system; they have ERs, they have hospitals, they have various clinics,” he said. “By forging a connection with them, we can create a path to those patients who need behavioral health support, so there’s no loss of care in the transition.”
  • Cardiovascular Business informs us,
    • “Cleerly, a Denver-based artificial intelligence (AI) company, has partnered with New York-based Allelica to launch the new Cleerly Polygenic Cardiovascular Risk Score Test. 
    • “Allelica specializes in polygenic risk scores (PRS) that predict a patient’s genetic risk of developing different diseases. Cleerly, meanwhile, its known for its AI-powered coronary CT angiography (CCTA) evaluations. Together, these two companies have collaborated on a new test designed to help physicians diagnose and manage heart patients with suspected coronary artery disease.
    • “Genetic risk and imaging answer two different questions for a physician,” James K. Min, MD, FACC, FESC, MSCCT, founder and CEO of Cleerly, said in a statement. “Inherited risk points to who is biologically predisposed to coronary disease, and our imaging analysis shows what is actually present inside the arteries. Bringing those two views together gives physicians a clearer, more individualized picture of each patient’s coronary risk.”
  • Per BioPharma Dive,
    • “Brain drug developers Supernus and Individor on Monday announced plans to merge, bringing together two companies specializing in drugs for central nervous system disorders that had combined revenues of $2 billion in 2025.
    • “Per deal terms, Supernus shareholders will receive 1.54 shares of Individor for every Supernus share they own, and Individor shareholders will receive a one-time $1 billion cash dividend before the deal’s close, financed by a $650 million loan and the combined companies’ cash on hand. After the close, the former Individor shareholders will own around 57% of the combined company and Supernus’ will own around 43%.
    • “Following the close, the company will be called Supernus, headquartered at Supernus’ Rockville, Maryland offices, and will be headed by its current CEO, Jack Khattar. Individor board member Tony Kingsley will become the combined company’s board chair. The board is expected to consist of eight members evenly split between Individor and Supernus.”
  • Per MedTech Dive,
    • “Global investment firm KKR said Monday it has agreed to buy device manufacturer Integer Holdings for about $5.7 billion.
    • “The companies expect to close the deal before the end of the year, at which point Integer would become a private company. Shares of Integer rose by nearly 20% to $121.21 Friday afternoon following a Wall Street Journal report that the two companies were nearing a deal.
    • “Integer, which bills itself as one of the largest global medical device contract development and manufacturing organizations, expects the acquisition would provide flexibility and long-term capital to invest in its capacity, technology and innovation.”

Friday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., defied expectations and kept his fractured conference together to pass several priority items before House members jetted home on Thursday to kick off a five-week recess. 
    • “But how much of that legislation their colleagues in the Senate will take up is a different question, as divisions continue to deepen.
    • “The House adopted a GOP-backed budget resolution along party lines on Wednesday, taking the first step toward passing a $95 billion reconciliation package that’s focused mostly on the Iran war. 
    • “But Senate Majority Leader John Thune, R-S.D. has remained lukewarm on such a package, especially if it includes certain aspects of the so-called SAVE America Act, which would require proof of citizenship to register to vote and photo ID at the polls. 
    • “I can’t count 50 right now on a budget resolution,” Thune told reporters on Thursday. He said the path to clearing the chamber’s so-called Byrd bath, which assesses compliance with reconciliation rules, “is still an open question.”
  • Beckers Clinical Leadership relates,
    • “HHS has rewritten the governing charters for the Advisory Commission on Childhood Vaccines and the National Vaccine Advisory Committee.
    • “The ACCV charter, filed July 21, removes the standalone designated federal officer section that appeared in the previous version, which specified that a full-time federal employee would approve meeting agendas, call meetings and maintain public-facing information on the committee’s activities.
    • “In its place, the new charter refers more broadly to “the federal official responsible for ACCV oversight” calling or approving meetings. The revised charter also adds a provision allowing that federal official, if appointed by the HRSA administrator, to serve as temporary chair if ACCV members have not selected a chair and vice chair. The ACCV advises the HHS secretary on the National Vaccine Injury Compensation Program, including changes to the Vaccine Injury Table and how the government collects and uses vaccine adverse event data.
    • “The revised NVAC charter adds duties not previously included in the panel’s purview, directing members to weigh what it terms “non-immunization strategies,” including healthy lifestyle and disease prevention initiatives, off-label use of already approved drugs and dietary supplements marketed for immune support.”
  • Govexex tells us,
    • “The National Active and Retired Federal Employees Association on Thursday said the Office of Personnel Management still has not sufficiently protected federal workers and retirees as part of a plan to collect claims-level health data in an effort to root out fraud.” * * *
    • “[I]n a letter to [OPM Director Scott] Kupor Thursday, NARFE National President William Shackelford said that while his organization appreciates the steps taken thus far to shield FEHBP and PSHBP participants’ identities, he remains troubled by OPM’s insistence that it be able to re-identify employees via their health records in the future. Under the Health Insurance Portability and Accountability Act, health care data should be not just pseudonymized, but de-identified entirely, he wrote.
    • “NARFE’s position is straightforward. OPM has moved in the right direction,” Shackelford wrote. “But we asked for de-identified data and OPM has offered pseudonymized data, and those are not the same commitment. Pseudonymization does not remove the risk that our members’ health information will be linked back to them; it makes that linkage a matter of OPM’s discretion, exercisable by whoever holds the relevant authority in any future administration.”
    • “Additionally, most of OPM’s reassurances about privacy and the data collection’s anti-fraud purpose exist solely within Kupor’s blog post, and not the proposal published in the Federal Register last month.”
  • Over 700 public comments were submitted by yesterday’s deadline. As the FEHBlog has noted, OPM is not giving FEHB and PSHB carriers and the OPM Inspector General credit for preventing most fraud, waste and abuse in these programs.
  • The American Hospital Association News informs us,
    • “The U.S. Trade Representative yesterday announced it is implementing a 10% or 12.5% tariff on 60 trading partners, which became effective today. These tariffs follow an investigation under Section 301 of the Trade Act of 1974 for lacking or failing to enforce a ban on goods produced with forced labor, according to the agency. Nations that the USTR said had made commitments to adopt and effectively enforce forced labor import prohibitions will receive a 10% tariff, while nations that the agency said had failed to adopt a forced labor import ban will receive a 12.5% tariff. The USTR notice outlines which products are excluded from the new tariffs, including products already subject to Section 232 tariffs, products qualifying under the U.S.-Mexico-Canada trade agreement and certain pharmaceuticals and pharmaceutical ingredients.”
  • and
    • “The Consumer Product Safety Commission yesterday announced it is modernizing the National Electronic Injury Surveillance System, the national database for tracking consumer product-related injuries. The CPSC said that it will replace its manual coding process, used since 1972, with an electronic data exchange through a Qualified Information Network. The new system, NEISS-Remodel, will expand the network to all 50 states, up from 36 under the previous system. NEISS-R is expected to become fully operational by the beginning of 2027.” 

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • It’s been over two months since Dr. Marty Makary stepped down from his post as FDA commissioner, and there has yet to be visible progress toward naming his permanent successor. The gap in leadership is sparking concerns among industry watchdogs that pharma could lack clear guidance on federal priorities for weeks or months to come.
    • The Trump administration has yet to name a nominee to replace acting commissioner Kyle Diamantas — and there are currently multiple hurdles in front of any confirmation process. In particular, the Senate isn’t going to be around much in the coming months. 
  • The Wall Street Journal relates,
    • “Biohackers, longevity enthusiasts and alternative medicine doctors want the peptide BPC-157. Now compounders may be one step closer to lawfully providing it. 
    • “The Food and Drug Administration’s Pharmacy Compounding Advisory Committee voted in favor of easing restrictions on six of seven peptides up for consideration, following strong warnings from the agency’s scientists. It’s now up to the FDA to decide whether to greenlight the drugs for compounding pharmacies to make—and pave the way for a peptide gold rush.
    • * * * “The committee voted against one peptide called Emideltide, evaluated for opioid withdrawal, chronic insomnia, and narcolepsy. David Pope, a pharmacist who voted affirmatively for other peptides, voted “no” on this one, citing a complex regimen and “potentially dangerous downstream consequences.”
  • USA Today tells us,
    • “Consumers will soon have a new over-the-counter pain relief option that combines Tylenol with naproxen, an anti-inflammatory medication.
    • “The Food and Drug Administration on July 24 approved the non-prescription combination of 650 mg of Tylenol (acetaminophen) and 220 mg of naproxen sodium.
    • “The non-opioid tablet can be used by adults and children aged 12 and ​older for temporary relief of headaches, back pain, muscle aches, toothache, menstrual cramps and minor pain from arthritis, the FDA said.
    • ‘Kenvue, which owns Tylenol, said the tablet combination will soon be available for purchase without a prescription at major retailers.”
  • Fierce Pharma informs us,
    • “With all eyes on Tavneos’ seemingly precarious approval status in the U.S., Amgen is advancing plans to defend the ANCA-associated vasculitis (AAV) drug it inherited in its $3.7 billion buyout of ChemoCentryx. 
    • “The California pharma on Thursday submitted data and analyses to the FDA to help secure a hearing in hopes of keeping Tavneos on the U.S. market. The package includes a third-party re-evaluation of the med’s controversial pivotal trial, real-world evidence and patient and HCP testimonials.
  • Cardiovascular Business lets us know,
    • “Penumbra is recalling specific lots of its RED 68 Perfusion Catheter due to an ongoing safety concern. 
    • “The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall. This means using the device without following the manufacturer’s recommendations could lead to “temporary or medically reversible adverse health consequences.” 
    • ‘The recall was put in place due to a risk of the catheters fracturing. Penumbra has said “manufacturing issues” are to blame, but the company is still investigating the issue to learn more.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 24, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Considering multiple data sources, COVID-19 activity is low and stable nationally but is beginning to show early signs of an increase in the West and South.
    • “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.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) is elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association News reports,
    • “There have been 2,318 confirmed measles cases in the U.S. so far this year, the most in the country since 1991, according to the latest data from the Centers for Disease Control and Prevention. There were 2,289 cases in 2025. Cases this year have been reported by 45 jurisdictions. The CDC said that 93% of cases are outbreak-associated. The vaccination status of 93% of cases is unvaccinated or unknown. The agency said that 7% of cases this year have been hospitalized, lower than last year’s figure of 11%.”
  • The Washington Post offers an opportunity to check out your county’ measles vaccination rates for kindgarteners.
    • “The share of U.S. counties where 95 percent or more of kindergartners were vaccinated against measles — the number doctors say is needed to achieve overall protection for the class, known as “herd immunity” — has dropped from 50 percent before the pandemic to 28 percent, according to The Post’s examination of the public records from 44 states and the District of Columbia.”
  • The Wall Street Journal tells us,
    • “Public-health officials are investigating four additional states as part of a multistate cyclospora outbreak linked to iceberg lettuce that they warn could be even broader.
    • Illinois, Kansas, Oklahoma and Pennsylvania are the latest states added to the investigation, the Centers for Disease Control and Prevention said Friday. The health agency said last week it was investigating the outbreak in Indiana, Kentucky, Michigan, Ohio and West Virginia. 
    • “The CDC said epidemiologic data continued to show the outbreak stemmed from the consumption of iceberg lettuce from Taylor Farms. Nearly 2,000 people who ate food from Taco Bell have been sickened in those nine states during the outbreak, the agency said. Nearly 100 people have been hospitalized. 
    • “The iceberg-lettuce outbreak might be even broader than what health authorities have found. The authorities are investigating a number of food-related outbreaks, including several involving cyclospora, a parasite that causes explosive diarrhea. For now, the authorities are probing the various cyclospora outbreaks as if they are distinct, but it is possible they are related and investigators so far haven’t been able to connect them.”
  • and
    • “Warmer winters and changes in land use are driving ticks carrying Lyme disease and alpha-gal syndrome into new areas such as Ohio and Michigan.
    • “In 2025, Lyme disease cases jumped more than 60% in Ohio and almost 80% in Michigan as blacklegged tick populations expanded.
    • “Lone-star ticks, which cause the meat allergy alpha-gal syndrome, are established in 19 counties in Ohio and five in Michigan.”
  • The New York Times points out,
    • “The same chemical process that turns a baking cake golden brown is at work aging your body’s cells. Over decades, your tissues, baking steadily at 98.6 degrees, slowly accumulate compounds called advanced glycation end products, or AGEs, as sugars interact with protein and fat in the bloodstream. The buildup of AGEs is a hallmark of the aging process, making tissues like collagen sticky and rigid and causing inflammation that can lead to heart disease, eye damage, kidney disease and diabetes.
    • “Researchers have tried unsuccessfully to develop medications that can stop AGEs from forming. But a new study, published on July 16 in the journal Nature Communications, describes a different tack: Scientists created an enzyme that cleans one of the most common AGEs from human tissue, helping to turn back the clock even after the aging compounds have settled in the body. This cleanse can help repair the tissue and has the potential to allow cells to act younger.
    • “It’s a small step in this bigger direction, because aging is very complicated,” said Aaron Cravens, a founder and the chief executive of Revel Pharmaceuticals, which developed the new enzyme, and the lead author of the study. “It’s the first time, I think, that anyone in the field has shown at the structural level that you can actually reverse some of these changes.”
  • MedPage adds,
    • “Exceptional memory at age 80 and beyond was not due simply to good genes, an analysis of prospective data suggested.
    • “The study assessed outcomes for superagers — people 80 or older with episodic memory at least as good as adults 20 or 30 years younger — and cognitively average controls.
    • “Genotype distributions and APOE status did not differ between groups, reported Ignazio Stefano Piras, PhD, of the Translational Genomics Research Institute at City of Hope in Phoenix, and co-authors.
    • “Neither APOE nor any of three polygenic risk scores predicted whether a person would be a superager, Piras and colleagues wrote in Alzheimer’s Research & Therapy. Results were similar after accounting for global non-European or African ancestry.”
  • Health Day informs us,
    • “About 50% to 88% of children with autism experience motor skill challenges
    • “Organized sports — especially martial arts and aquatic training — can improve motor skills
    • “Consistently large improvements were seen in balance, coordination, overall motor skills and object control.”
  • and
    • “Increases in a problematic social media use may contribute to worsening attention-deficit/hyperactivity disorder (ADHD) symptoms during adolescence, particularly among boys, according to a study published online July 17 in JAMA Network Open.”
  • The Wall Street Journal notes,
    • “Ipsen said its drug Bylvay missed the primary objective in a late-stage clinical trial for biliary atresia, a rare liver disease affecting babies.
    • “Bylvay missed the study’s primary objective of showing an improvement in native liver survival rates compared to a placebo, Ipsen said.
    • “Ipsen said biliary atresia, the leading cause of pediatric liver transplants, has no approved therapeutic options beyond surgery or transplant.”
  • Per BioPharma Dive,
    • “Sanofi is calling it quits on an experimental eczema drug that it had seen as a potential successor to its blockbuster medication Dupixent, according to a Friday announcement.
    • “Sanofi had said in January that it intended to seek clearance of the drug, amlitelimab, in atopic dermatitis despite mixed late-stage study results and signs of possible safety concerns. On Friday, though, the French pharmaceutical firm said that, during a pipeline review, it found that the “totality of efficacy and safety evidence generated to date” doesn’t support further development of amlitelimab in that indication.
    • “Sanofi’s decision follows a recent move by Amgen and Kyowa Kirin to shelve a similar experimental medicine. The pharma company will continue testing amlitelimab in celiac disease, though, and is slated to reveal data from a mid-stage study by the end of the year.”

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

  • Fierce Healthcare reports,
    • “HCA Healthcare on Friday affirmed its earlier warnings about Affordable Care Act (ACA) exchange subsidies fallout, telling analysts that patients who dropped off marketplace plan coverage due to increased premiums have “migrated almost one for one” to uninsurance. 
    • “The country’s largest for-profit brought in $20.23 billion in second-quarter revenue, up 8.7% year-over-year, net income of $1.69 billion, up 2.8%, and adjusted EBITDA of $4.027 billion, up 4.6%, according to financial results published Friday morning. The company also reported diluted earnings per share increasing 11.6% to $7.62 per share.
    • “In particular, a payer mix shift driven by increased uninsured volumes had an “unfavorable impact” on income of approximately $400 million before income taxes, above its estimates from earlier in the year.”
  • and
    • “Clinician-led artificial intelligence platform Anterior and health tech company Stellarus entered a strategic partnership Thursday to tackle automating prior authorizations.
    • “The partnership aims to support providers through automating tasks—such as case research and policy application—to allow teams to focus on complex determinations. The companies say providers will receive quicker, first-time approvals, ultimately giving members quicker care access. 
    • “Stellarus provides the healthcare technology platform, integration expertise and operational experience to help health plans put AI into practice, while Anterior brings leading clinical AI to automate the research, documentation and policy application that support prior authorization,” said Vanessa Colella, Stellarus president and CEO.”
  • and
    • “Addressing healthcare’s biggest challenges will require payers and providers working together.
    • “That’s why the team at Aetna has spent the past several years investing in ways to bridge those trust gaps and better unite the two sides of the industry that are often at odds. And a new survey suggests that work is paying off.
    • “Morning Consult polled 723 provider executives across multiple disciplines on Aetna’s behalf, and found an average provider trust score of 6.1 on a scale of one to 10. By comparison, a similar poll conducted in the first quarter found a 5.4 trust score.”
  • Modern Healthcare relates,
    • “Surgery Partners plans to sell its ownership interest in two Idaho hospitals to Intermountain Health.
    • ‘The proposed transaction, which values the facilities at an estimated $1.15 billion, would include Surgery Partners’ Idaho Falls Community Hospital and Mountain View Hospital, also in Idaho Falls, along with affiliated clinics.
    • “Surgery Partners is expected to receive about $795 million in the transaction, according to a Friday news release.”
       
  • MedTech Dive tells us,
    • “Edwards Lifesciences reported strong sales of its heart valves in the second quarter and outlined several upcoming catalysts expected to maintain solid growth rates, starting with an anticipated Medicare coverage expansion.
    • “Sales were better than the company expected for transcatheter aortic valve replacement devices, Edwards’ largest product line, as well as newer repair and replacement treatments for mitral and tricuspid diseases, due to increasing clinical demand, executives said on a Thursday earnings call.
    • “CEO Bernard Zovighian tied TAVR demand to growing evidence backing earlier use of the procedure to treat aortic stenosis patients and predicted the “durable” momentum would support the company’s 10% total sales growth target long term.”
  • Fierce Pharma informs us,
    • “After a post-[July 4th] holiday lull, prescriptions for GLP-1s have more than bounced back. Weekly prescriptions for Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo reached new highs during the previous week, collecting 169,800 and 26,760, respectively, according to IQVIA data cited by Citi. The two oral drugs’ previous records were about 161.5K and 24.3K, respectively. 
    • “Other GLP-1 drugs also enjoyed a boost, as total GLP-1 scripts across obesity and diabetes increased 6.6% sequentially, according to Citi.
    • “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.” 

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.”

Monday update

David Ermer–Congress, FDA, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • House Majority Leader Stephen Scalise lets us know,
    • On Tuesday, [July 21] the House will meet at 10:00 a.m. for morning hour and noon for legislative business. First votes expected: 1:30 p.m. Last votes expected: 8:30 p.m. * * *
    • Legislation Considered Pursuant to a Rule:
    • Begin Consideration of H.R. 8800 – National Defense Authorization Act for Fiscal Year 2027 (Sponsored by Rep. Rogers (AL) / Armed Services Committee)
    • H.R. 6955 – Main Street Capital Access Act (Sponsored by Rep. Hill / Financial Services Committee)
    • H.R. 9770 – Continuing Appropriations Act, 2027 (Sponsored by Rep. Cole / Appropriations Committee)
  • Beckers Hospital Review reports,
    • “TrumpRx, the federal direct-to-consumer drug discount website President Donald Trump launched Feb. 5, reaches its six-month mark Aug. 5. The site has grown from 40 branded drugs at launch to 92 in July, with more than 600 generics added in May. But that catalog still covers fewer than 12% of the more than 800 brand-name drugs made by the 17 manufacturers that signed most-favored-nation pricing deals with the administration, according to an NPR analysis of an FDA drug database published July 16.” * * *
    • “Health policy researchers told NPR that TrumpRx is most useful for uninsured and underinsured cash-paying patients, particularly those seeking fertility treatment or obesity medications that insurance frequently excludes. That is not the majority of prescription drug users. Insured patients are often better off checking their copay first, a caveat TrumpRx displays on the site.”
  • Beckers Payer Issues adds,
    • “Basing Medicaid drug prices on what other wealthy countries pay could save 47 states and the District of Columbia a combined $8.6 billion — about 35% of net spending on the drugs studied — according to research published July 15 in JAMA.
    • “The analysis, led by Thomas Hwang, MD, of Boston-based Brigham and Women’s Hospital, modeled the CMS Generating Cost Reductions for US Medicaid, or GENEROUS, model
    • “Under most-favored-nation pricing, drugmakers give participating state Medicaid programs added rebates whenever Medicaid’s net price surpasses the price paid abroad. 
    • “CMS announced the voluntary model in November 2025 and launched it in January. It will run five years, and 17 pharmaceutical companies had agreed to participate, as of May, in exchange for protection from pharmaceutical tariffs.”
  • Per a Government Accountability Office news release,
    • “The Office of Personnel Management has undergone significant workforce changes in the last 2 years.
    • “Between December 2024 and March 2026:
      • OPM’s staff decreased by 35%
      • The agency eliminated 10 offices
      • 57% of employees who left OPM had 11 or more years of service—representing a loss of institutional knowledge
    • “These changes risk worsening pre-existing skills gaps we previously recommended OPM address. In addition, the OPM Office of the Inspector General identified the agency’s workforce reduction as a top management challenge for 2026, citing immediate gaps in operational capacity.”
  • A guest author, Kevin Hennecken (LinkedIn link), added a post (OPM link) to the OPM Director’s Secrets of OPM blog. He discusses the Tech Force that OPM is developing under the Dirctor’s leadership.

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The Food and Drug Administration said Sunday that a laboratory finding showing cyclospora contamination in a sample of shredded iceberg lettuce supplied by Taylor Farms de Mexico was a false positive. 
    • “But the agency did not back away from its conclusion that the company remains linked to a multistate outbreak of cyclosporiasis through its traceback investigation. 
    • “FDA’s traceback investigation and outbreak data continue to converge on shredded iceberg lettuce from Taylor Farms locations in central Mexico,” the agency said on social media Monday afternoon. It said there was “overwhelming epidemiological data” to support the voluntary recall.” * * *
    • “Federal and state investigators continue to examine thousands cases of cyclosporiasis nationwide. Michigan on Monday reported more than6,000 cases.
    • “It may not be just Taco Bell, it may not be just Taylor Farms, it may not be just lettuce,” said Barbara Kowalcyk, director of George Washington University’s Institute for Food Safety and Nutrition Security. “Lots of products carry the risk of being contaminated with cyclospora.”
    • “Other products could still be implicated, Kowalcyk said. “Next week it could be something else. It could be blueberries or raspberries or basil… or a food vehicle that we haven’t identified as a way of transmitting this pathogen,” she said. “The bottom line is this investigation is not over. It’s not just Taco Bell. It’s probably not just iceberg lettuce.”
  • The New York Times adds,
    • “The leading suspect, it seemed, was the cilantro.
    • “Weeks before an outbreak of cyclosporiasis, now traced at least in part to iceberg lettuce, laid low thousands of Americans this summer, the New York City Health Department investigated a smaller outbreak. Testing labs and doctors notified the city that people were coming down with the intestinal illness, which is caused by a parasite and can result in explosive diarrhea and other types of gastric distress.
    • “The New York investigation back in April — one of multiple case clusters the city’s disease detectives have pursued this year — led to cilantro.
    • “But how exactly do health authorities figure out how people got sick?
    • “City officials shared details of the cilantro case with The New York Times. The city’s work is only one link in a chain that also involves state and federal disease surveillance efforts, but it helps illustrate how complicated it can be to pinpoint sources of contamination in a global food-supply system. The C.D.C. says it is continuing to investigate cyclosporiasis cases unrelated to the iceberg lettuce contamination.
    • “So far this year, 442 cases of cyclosporiasis have been diagnosed in the city — far above the average of 216 cases for an entire year during the period 2019 to 2024.”
  • MedTech Dive relates,
    • “Resmed has contacted customers about a ventilator issue linked to five serious injuries, the Food and Drug Administration said Wednesday.
    • “A subset of Astral 100 and Astral 150 ventilators can inadvertently enter a fail-safe state and stop delivering therapy, creating a risk of serious injury or death.
    • Resmed informed customers of the issue on June 25, asking them to continue using the devices with precautions. The FDA shared the message in an early alert notification last week.

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services released guidance July 17 on new remittance advice remark codes required for use following updates to the No Surprises Act independent dispute resolution process. RARCs are standardized codes that convey information about claims processing. The guidance specifies circumstances in which group health plans and health insurance issuers offering group or individual health insurance coverage must use each RARC and technical instructions to facilitate usage. CMS said that plans and issuers can continue to use claim adjustment reason codes they consider most appropriate for any claim adjustment. The RARCs specified apply for items and services furnished on or after Jan. 1, 2027.”

From the judicial front,

  • Bloomberg Law reports,
    • “Anthropic PBC and a group of authors received final approval Monday of their $1.5 billion settlement to end a copyright class action over the AI company’s downloading of millions of pirated books, $122 million of which will go to the authors’ attorneys and litigation costs.
    • “The pact is the largest copyright class action settlement in US history and one of the first deals in the dozens of similar lawsuits pending against AI giants including OpenAI Inc., Meta Platforms Inc., and Google. It provides about $3,100 per author of more than 480,000 works Anthropic downloaded from pirate libraries Library Genesis and Pirate Library Mirror.
    • “As of April, claims for 440,490 of the works have been filed.
    • “The deal “provides meaningful relief” to the authors and publishers given the potential range of relief, “especially since further litigation would likely be complex, expensive, lengthy, and risky,” said Judge Araceli Martinez-Olguin of the US District Court for the Northern District of California.
    • “Success at trial was not assured, and a loss would have left the Class with no recourse.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “More than 56% of U.S. adults between the ages of 30 to 79 years old are now eligible to start undergoing statins, according to new findings published in JAMA.
    • “Those numbers are based on the new dyslipidemia guidelines published in March by the American College of Cardiology, American Heart Association and several other leading medical societies.[2] The 2026 guidelines included several major changes, the researchers noted. The age range targeted for treatment broadened from 40–75 to 30–79, for example, and clinicians started focusing on 30-year risk instead of just 10-year risk. 
    • “What do these updates mean for patient care? According to the team’s analysis, many more patients—approximately 21.5 million—are now eligible for statins. 
    • “The shift to a longer view of cardiovascular disease risk is a sea change for doctors in counseling patients,” lead author Timothy S. Anderson, MD, a primary care physician and health quality researcher with the University of Pittsburgh School of Medicine, said in a statement. “We wanted to better understand the potential population-health effect of this shift.”
  • The American Medical Association lets us know what doctors want their patients to know about Crohn’s Disease.
    • “Crohn’s disease is a condition that can affect any part of the digestive system. While it affects people throughout their lives in different ways, more treatment options are now available. Physicians are also finding promising lifestyle adjustments to help with the disease.”
  • Health Day tells us,
    • “Higher levels of testosterone in girls during puberty are associated with mental health symptoms such as depression and anxiety.
    • “Testosterone increases were more significant than other hormonal changes, including estrogen.
    • “Hormones can impact the brain before puberty becomes physically apparent.”
  • and
    • “Heart-healthy vegetables may differ for men and women
    • “Men benefit most from legumes, while women benefit most from cruciferous vegetables, research shows
    • “Even one daily serving is linked to better health.”
  • The Wall Street Journal adds,
    • “An American Heart Association statement says drinking up to five cups of coffee a day is safe for most adults and might benefit heart health.
    • “Consuming three to five eight-ounce cups of coffee daily is linked to a lower risk of heart disease, stroke and Type 2 diabetes.
    • “The potential benefits of coffee can be diluted or eliminated by adding sugar, syrups and creamers with high saturated fat.”
  • Genetic Engineering and Biotechnology News relates,
    • “A vaccine to prevent pancreatic cancer, targeting common KRAS mutations, was found to be safe and stimulated KRAS-specific T-cell responses in 90% of study participants who were at high risk of developing pancreatic ductal adenocarcinoma (PDAC), according to Phase I clinical trial results. After a median follow-up of 16.5 months, none of the participants developed pancreatic cancer, and some of the precancerous lesions shrank or stopped growing. “The study represents the first proof of concept for the use of vaccines for interception of pancreatic cancer in human patients.
    • “The findings are published in Cancer Discovery, in the paper, “First-in-human Testing of a Mutant KRAS Vaccine for Pancreatic Cancer Interception in High-risk Cohorts.”

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

  • AHIP reports today that “Health Plans Are on Track to Streamline Prior Authorization.”
  • Beckers Payer Issues introduces the leader of the BCBS affiliate in every state and five AI execs driving health insurers’ strategies
  • Healio relates,
    • “Variation in facility fees was linked to significant differences in cost of cardiology services with major national insurers, according to a study published in JAMA Network Open.
    • “Facility fees varied by nearly $30,000 for certain cardiology procedures, with UnitedHealthcare and Blue Cross Blue Shield having the highest facility prices and Aetna consistently having the lowest, researchers reported.”
  • BioPharma Dive tells us,
    • “Nearly four times as many Americans are taking a GLP-1 weight loss drug now compared to two years ago. But about 20% still aren’t using an FDA-approved medicine, despite efforts to curb compounded copycats, according to a recent Gallup survey. The number could be even higher. Another 12% weren’t sure if they were using a brand-name medication.
  • and
    • “Tempus AI said Monday it has agreed to buy Personalis for $1.5 billion. 
    • “Fremont, California-based Personalis makes a molecular residual disease test for cancer. Tempus expects the acquisition will allow it to better support patients around cancer diagnostics, treatment selection, recurrence and monitoring. 
    • “The planned purchase follows recent interest in blood-based cancer tests across the medtech industry. Abbott in March closed its $21 billion purchase of Exact Sciences, Guardant’s colon cancer blood test received UnitedHealth coverage, and Freenome recently shared results of a pivotal study of its blood-based screening for colorectal cancer.”
  • STAT News adds,
    • “It’s officially a trend. For the third time in nine months, a pharma company has announced that it is assembling the largest AI supercomputer in the life sciences industry. This time, it is Bristol Myers Squibb.” * * *
    • “The Princeton, N.J.-based company’s move to own its AI infrastructure, announced on Monday, is the latest in a string of pharma bets on AI data centers. In October 2025, Eli Lilly announced it was building pharma’s largest AI data center with over 1,000 of what was then NVIDIA’s latest processors. In March, Roche announced it had the “greatest announced GPU footprint available to a pharmaceutical company” with 2,176 processors on its premises in the U.S. and Europe, plus more available in the cloud for a total of over 3,500 processors. Now BMS says it is increasing its AI computing capacity more than tenfold to become the “most powerful” AI buildout in pharma, though executives declined to specify a number of processors.”
  • Cardiovascular News informs us,
    • “Heartflow had a busy four days at SCCT2026, the annual meeting of the Society of Cardiovascular ComputedTomography (SCCT). The company’s advanced artificial intelligence (AI) technologies were at the heart of multiple presentations, for example, and it officially launched a new staging tool based on total plaque volume (TPV) calculations.
    • “Heartflow’s AI software turns coronary CT angiography (CCTA) images into personalized 3D models of the heart. With tools like Plaque Analysis and Roadmap Analysis, the company’s Heartflow One platform helps care teams explore, evaluate and manage a patient’s coronary health. 
    • “Heartflow technology was featured in eight different clinical studies presented at SCCT2026, providing an in-depth look at the cardiovascular health of more than 36,000 adult patients. DECIDE, for example, focused on registry data from nearly 12,000 symptomatic patients with zero coronary artery calcium (CAC) scores. These individuals would have typically been categorized as zero-risk patients, but researchers found that approximately one-half of the cohort actually did present with non-calcified plaques that were missed by the original CAC score.
    • “While coronary calcium scoring has been a helpful foundational tool, relying on calcium scoring alone leaves a diagnostic gap for clinicians, particularly regarding high-risk non-calcified plaque,” investigator Vincent L. Sorrell, MD, co-director of the Cardiovascular Research Priority Area at the Gill Heart and Vascular Institute at University of Kentucky HealthCare, said in a statement. “The DECIDE data demonstrate that Heartflow’s TPV-based staging unmasks important cardiovascular disease in over half of symptomatic patients who present with a calcium score of zero. This enhances our ability to accurately identify at-risk individuals and optimize preventive management based on a more precise understanding of their actual disease burden.”

Midweek report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

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

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

From the U.S. healthcare business front,

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

Tuesday report

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

Simplicity is a virtue

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • ‘ARPA-H, the U.S.’ “moonshot” agency for health research, announced Thursday that it will spend up to $160 million to push forward custom gene editing treatments for a spate of rare diseases. 
    • ‘The program, called THRIVE, will back seven different teams pursuing various groups of conditions affecting different organ systems. 
    • “Each team has a deadline of starting clinical trials by year three of the program, although some may start much sooner.” * * *
    • “Each of the groups will work with a partner, such as a biotech company or contract manufacturer, or multiple partners to assure they can manufacture the program to Food and Drug Administration standards.”
  • Beckers Hospital Review relates,
    • “Peptides have become one of the most closely watched regulatory questions in healthcare this summer, with a federal advisory committee vote set for July 23-24 that could reshape what’s legally available to prescribers, wellness clinics and patients nationwide.
    • “What are peptides?
      • Peptides are short chains of amino acids that often serve as signaling molecules for physiological functions in the body, including tissue repair, metabolism and inflammation. Some peptides, like insulin and semaglutide, the active ingredient in Ozempic and Wegovy, are FDA-approved drugs. Others — including BPC-157, TB-500 and a handful of others marketed for injury recovery, weight loss, sleep and anti-aging — have circulated for years through wellness clinics, medical spas and online retailers without ever being FDA-approved or added to the list of substances legally allowed in pharmacy compounding. 
      • “That distinction matters because of how compounding law works. Under Section 503A of the Food, Drug and Cosmetic Act, a licensed pharmacy can only compound a drug for an individual patient using a bulk substance if it’s FDA-approved, has a recognized USP monograph, or appears on the FDA’s 503A Bulks List. If a peptide isn’t on that list, pharmacies generally can’t legally compound it — which is exactly the question now in front of regulators. 
    • “The upcoming vote 
      • “The FDA’s Pharmacy Compounding Advisory Committee meets July 23-24 to decide whether seven peptides should be added to the 503A bulks list: BPC-157, KPV, TB-500 and MOTs-C, Emideltide (also called DSIP), Semax and Epitalon. The committee’s recommendation is non-binding, but the FDA has historically followed it.”
  • Tammy Flanagan, writing in Govexec, explains OPM’s new all-digital federal retirement benefit application process.
  • Per an HHS news release,
    • “President Donald J. Trump signed an Emergency Declaration for the Northern Mariana Islands and the Territory of Guam, and Secretary Robert F. Kennedy, Jr. has declared a public health emergency to address the consequences of Typhoon Bavi. Under these circumstances, the Secretary has also exercised the authority to waive sanctions and penalties against a covered hospital that does not comply with the following provisions of the HIPAA Privacy Rule:
      • the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
      • the requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
      • the requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
      • the patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
      • the patient’s right to request confidential communications. See 45 CFR 164.522(b).
    • “When the Secretary issues such a waiver, it only applies: (1) in the emergency area and for the emergency period identified in the public health emergency declaration; (2) to hospitals that have instituted a disaster protocol; and (3) for up to 72 hours from the time the hospital implements its disaster protocol. When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.”

From the Food and Drug Administration front,

  • USA Today reports,
    • “If headlines about heavy metals in tampons raised concerns, the Food and Drug Administration says there’s some reassuring news.
    • “A new agency study found trace amounts of metals including arsenic, cadmium and lead in tampons sold in the U.S., but concluded the levels released during use are too low to pose a health risk.
    • “The findings are the FDA’s latest response to a widely publicized 2024 study that detected metals in popular tampon brands and sparked questions about possible health effects. After analyzing 11 tampon products from six brands, FDA researchers found that while metals can be detected in the products, exposure during normal use remains far below levels considered harmful.”
  • MedTech Dive informs us,
    • “Johnson & Johnson has won Food and Drug Administration approval for a catheter that delivers radiofrequency and pulsed field energy to treat atrial fibrillation.
    • “The approval, which J&J disclosed Wednesday, covers the Dual Energy Thermocool Smarttouch SF Platform. J&J already had approval for a single, radiofrequency energy version of the device.
    • “Integrated into the company’s Carto mapping system, the dual-energy catheter is part of J&J’s push to leverage its electrophysiology strength to reverse market share losses triggered by PFA.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has issued an early alert for specific lots of BD ChloraPrep Applicators by Medline because of a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. Medline has instructed impacted customers to remove the recalled convenience kits from where they are used or sold. The company said that other components within the convenience kits may still be used.” 
  • BioPharma Dive cautions,
    • “The regulatory gears in the U.S. are increasingly creaking under the weight of new, complex drug technologies and intensifying overseas clinical trials competition from countries like China and Australia.
    • “Now, the Department of Health and Human Services is making moves to speed early drug research under a new plan dubbed Operation Trialblazer. The blueprint, which involves initiatives at multiple federal agencies, including the Food and Drug Administration and the National Institutes of Health, focuses on modernizing regulations and processes, improving patient access and participation, and enhancing the use of data and technology to streamline the regulatory process.
    • “It’s the latest in a series of actions aimed at supporting drug research. But whether the new reforms will make a meaningful impact is an open question.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “CVS Health and its embattled Omnicare unit have agreed to pay $440 million to the Department of Justice to satisfy a nearly $950 million judgment against the company as part of an ongoing fraud case.
    • “In April 2025, a federal jury ruled that Omnicare submitted more than 3.3 million fraudulent prescription claims between 2010 and 2018, earning $135.6 million in overpayments as a result. Then, in July 2025, a judge ordered Omnicare to pay $948.8 million in fees and damages as part of the case.
    • “In the new court docs, CVS said that it has agreed to make an initial $130 million payment within 14 days of the agreement’s effective date. The remaining $310 million must be paid out by March 15, 2028.
    • “The agreement with DOJ is contingent on the closure of Omnicare’s sale to GenieRx Holdings, according to the filing. As it navigated the legal fallout of the False Claims Act case, Omnicare filed for bankruptcy in September 2025, and CVS announced plans to sell to GenieRx in May of this year.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Annual cancer cases are projected to rise considerably worldwide by 2050, according to a World Health Organization report on cancer published Wednesday. With its assessment, the United Nations body tempered optimism about improvements in cancer surveillance and treatment and warned that global health care inequities are driving further cases and deaths. 
    • “Around 20.6 million people were diagnosed with cancer in 2024, according to the findings. That number could reach 35 million a year by 2050.
    • “The new cases will disproportionately appear in lower-income countries with poorer access to cancer surveillance and treatment, according to the report.” * * *
    • “In the United States, the rate of new cases has generally been stable in recent years, according to the National Institutes of Health. The WHO report predicts that cancer rates will increase in all regions across the world, though the biggest increases are projected in Africa and the Eastern Mediterranean region.”
  • Health Day adds,
    • “More men die from cancer than women, and a new study suggests one potential reason why.
    • “Men are more likely than women to be diagnosed with advanced cancer that has spread to other parts of the body, researchers report in the July issue of the journal Cancer Epidemiology, Biomarkers & Prevention.
    • “That means their cancer is being detected too late, when it’s tougher to treat and more likely to be fatal, researchers said.
    • “We know that, overall, males are more likely than females to die from many types of cancer. We also know that cancer stage at diagnosis is a key predictor of cancer survival,” lead researcher Beth Maclin, a postdoctoral fellow at the National Cancer Institute in Bethesda, Maryland, said in a news release.” * * *
    • “My overall message is that everyone should go to the doctor regularly,” Maclin said. “Don’t delay seeing a doctor if you notice something has changed in your body.”
  • The AP relates,
    • “Nearly 1,000 people in Michigan have been diagnosed with a parasitic infection that can cause weeks of watery diarrhea, making it the largest such outbreak in state history and one of the nation’s largest in years.
    • “No deaths have been reported and the source of the cyclospora infections hasn’t been identified. Meanwhile, investigations into similar illnesses have been going on in 28 other states, including in Ohio, where people just across the Michigan border are also becoming sick.
    • “Michigan officials first announced the outbreak last week, when they were aware of more than 170 cases — all in the southeastern corner of the state — since June 22. Michigan usually identifies only about 50 cases each year.
    • “On Wednesday, the state reported the number had grown to 992, including about 40 hospitalizations. Just across the state line, Lucas County, Ohio, reported 306 cases as of Wednesday. Northwest Ohio has seen more than 500 cases.
    • “Cyclospora surges can be tricky to investigate, and food poisoning sources can be hard to establish. But “there is clearly a linked outbreak happening right now,” Dr. Natasha Bagdasarian, Michigan’s chief medical executive, told The Associated Press on Wednesday.”
  • MedPage Today tells us,
    • “Chronic kidney disease prevalence held steady at around 14.8% over the last decade, despite treatment advances.
    • “This translated to an estimated 36 million affected U.S. adults, based on national health survey data.
    • “The prevalence of diabetes-related chronic kidney disease increased during the period spanning 2013-2014 to 2021-2023.” * * *
    • “This means single-organ care is no longer enough, said [Sophie] Claudel [, MD]. Based on the data, a growing proportion of the population may be at risk for progressive cardiovascular-kidney-metabolic (CKM) syndrome.
  • Healio informs us,
    • “GLP-1s may prevent adverse outcomes in patients with peripheral artery disease and diabetes, according to data published in the Journal of the American Heart Association. 
    • “Researchers reported that GLP-1 receptor agonist use among patients with PAD and diabetes was associated with lower risk for mortality, hospitalization, revascularization and amputation compared with those prescribed metformin.
    • “Obesity and PAD, including chronic limb-threatening ischemia, are linked to increased inflammation, poor blood vessel function, insulin resistance, oxidative stress and faster hardening of the arteries,” Akiva Rosenzveig, MD, cardiology fellow at Cleveland Clinic, said in a press release. “These results indicate GLP-1 [receptor agonists] can help reduce inflammation, improve blood vessel function and manage blood sugar levels.”
  • Medscape adds,
    • “The FDA approved Zepbound (tirzepatide) in December 2024 for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in patients with obesityafter research showed that the medication improved outcomes in these patients.
    • “Sleep apnea is among the most common sleep disorders. It occurs when the airways relax and block breathing during sleep. Patients may repeatedly stop breathing, leading to disrupted sleep, snoring, and excessive sleepiness during the day.
    • “Now new research has shown that certain patients seem to benefit more than others from the medication. Patients with the most severe sleep apnea along with those who are younger and have less severe obesity experienced nearly twice the reduction in symptoms compared to those who are older and have more severe obesity.”
  • Fierce Pharma points out,
    • “In a first for the neurotoxin market, Ipsen announced Thursday that its Dysport has hit the goals in two phase 3 trials for the prevention of both episodic and chronic migraines.
    • “While AbbVie’s market-leading Botox has been approved by the FDA to prevent headaches in patients with chronic migraine since 2010, Dysport is now the first botulinum toxin to also report positive phase 3 results in episodic migraine, according to Ipsen.
    • “The readouts come from studies in Ipsen’s Beond program, comprising 1,510 patients, split between C-Beond (chronic) and E-Beond (episodic). Both trials have met their primary endpoints, showing a statistically significant reduction in monthly migraine days versus placebo.
    • “Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population,” Ipsen’s global head of R&D, Christelle Huguet, Ph.D., said in a July 9 statement.
    • “Ipsen will review the full data and prepare for regulatory filings, including with the FDA, a company spokesperson told Fierce Pharma.” 
  • BioPharma Dive lets us know,
    • “A nucleic acid-based medicine from AstraZeneca and Ionis Pharmaceuticals missed its main objective in a big study of people with a deadly heart condition in a major setback with notable ramifications for multiple other drugmakers. 
    • “In a pair of statements, the companies said that when compared to a placebo in people with transthyretin-mediated amyloid cardiomyopathy, or ATTR-CM, their drug, eplontersen, didn’t significantly reduce the risk of death or recurrent cardiovascular events after 140 weeks. Eplontersen had no treatment effect among participants already receiving a commonly used “stabilizer” medication. A 29% risk reduction was observed in people who weren’t getting those drugs, AstraZeneca and Ionis said.
    • “The companies didn’t provide additional study details, only noting that the drug was “well tolerated” and showed positive signs on multiple other secondary study measures. Those specifics will be presented at a medical meeting in August. “
  • and
    • “Roche said Thursday it’s discontinuing two Ionis-partnered drugs for Huntington’s disease after clinical setbacks, with one missing its main trial goal and the other suspended because of a safety worry.
    • “A Phase 2 test of the antisense oligonucleotide tominersen “did not meet its efficacy objective” in spite of having a significant impact on biological disease signs, Roche said in a letter to patient groups. Meanwhile, enrollees in a Phase 1 trial of a drug codenamed RG6496 won’t receive a second dose because animal safety testing revealed that it “cannot be given chronically with repeated doses,” Roche said.
    • “The Swiss pharmaceutical giant had once before suspended a late-stage trial of tominersen because it didn’t appear to be helping patients. Roche forged ahead with a hypothesis that younger and less-advanced patients might benefit, but now that pathway has hit a dead end.”
  • Per Genetic Engineering and BioTechnology News,
    • “A landmark Phase I/II clinical study led by researchers at Skåne University Hospital and Lund University has shown that transplanting stem-cell-derived dopamine progenitor cells into the brain is feasible. Eight patients with Parkinson’s disease (PD) received transplants of STEM-PD, a cryopreserved, off-the-shelf dopaminergic progenitor product derived from human pluripotent stem cells. The three-year Phase I/II, open-label, multicenter, single-arm, dose-escalation study identified no serious side effects linked to the transplanted cells during the first year of follow‑up.
    • “The possibility of replacing dopamine neurons that are lost in Parkinson’s disease has been a long-standing goal in the field,” said Malin Parmar, professor of cellular neuroscience at Lund University, and lead of the STEM-PD program. “The findings represent an important milestone for regenerative medicine approaches in Parkinson’s disease and support continued clinical development of stem cell-based therapies.”
    • “Results from the study were reported by Parmar and colleagues in Nature Medicine. In their paper, titled “Human embryonic stem cell-derived dopaminergic cells for Parkinson’s disease: a Phase I/II open-label trial,” the team wrote, “In conclusion, particularly in the context of other recently published trials using human PS cell-derived dopaminergic cell therapies for PD, these findings further support the continued development of this therapeutic approach, including evaluation of the STEM-PD product in larger patient cohorts.”

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

  • Healthcare Dive reports,
    • “CVS’ insurance division Aetna has a finally gotten a handle on medical spending after a turbulent few years, according to the healthcare giant’s chief executive.
    • “We’ve got, I think, our arms around how to project and predict where healthcare costs are going, and making sure we’re pricing our products accordingly,” CVS CEO David Joyner said at an event hosted by the Economic Club in Washington, D.C., on Thursday.
    • “Joyner’s comments — which come about a month before CVS is scheduled to report second quarter results — are likely a welcome signal for investors that Aetna can continue recent progress on controlling spending.” * * *
    • “The biggest challenge for CVS isn’t managing members’ costs: It’s policy uncertainty out of Washington, Joyner said.
    • “I spend a lot of my time, both at the federal level and in the states, trying to help educate and also describe what are the real drivers of healthcare costs, and then making sure that we play an active role to help with members of Congress,” the CEO said.”
  • Fierce Healthcare relates,
    • “UnitedHealthcare is rolling out a new benefit option aimed at making it easier for employers to offer more personalized wellness programs.
    • “Called Lifestyle Spending Accounts (LSAs), the benefit allows employers to offer a stipend that members can put toward wellness solutions. The LSAs are integrated with UnitedHealth’s UHC Store, which is a digital storefront where members can purchase select health and wellness programs at a discount.
    • “The accounts exist alongside health savings accounts or flexible spending accounts, allowing individuals to purchase health and wellness generally not available under HSAs or FSAs, UnitedHealthcare said.”
  • Benefits Pro tells us,
    • “Both the levels and growth of health care spending from 2005 to 2023 were greatest among Americans with the highest incomes, according to a new report in Health Affairs.
    • “Among the lowest income quintile, spending grew more rapidly just after 2014 but declined from 2018 to 2023. By contrast, spending in the highest income quintile grew more rapidly in recent years. As a result, the difference in age and health status-adjusted spending between the highest and lowest income quintiles declined after implementation of the Affordable Care Act subsidies but increased more recently. The adjusted per capita spending difference in 2023 was more than $4,700.
    • “If spending continues its most recent trajectory, that difference will continue to grow,” the report said. “These spending patterns were driven largely by outpatient and prescription drug spending, which tend to be more discretionary than inpatient and emergency department spending. Prescription drug spending showed a particularly pronounced recent divergence for the top income quintile. Recent spending growth was most evident in the population younger than age 65, which has more variation in insurance coverage, affecting both service use and prices.”
  • Psychology Today lets us know,
    • “Mental health leave [under federal and state leave acts] has sharply increased in the U.S. since the pandemic.
    • “Women, especially caregivers, account for the majority of mental health leaves.
    • “Access to mental health leave highlights structural inequalities in the workplace.
    • “Early, ongoing treatment with an established provider can support the mental health leave process.”
  • Per Smart Brief,
    • “Healthcare AI’s next challenge isn’t adoption. It’s reliability
    • “Healthcare has reached a point where the challenge with AI is not adoption but ensuring it is accountable and dependable post-deployment, writes Sina Bari, vice president of healthcare and life sciences AI at iMerit.”
  • Per MedTech Dive,
    • “Stereotaxis said Thursday it finalized the acquisition of French surgical robotics company Robocath.
    • “Announced in April, the deal is valued at up to $45 million and brings together two robot developers focused on endovascular interventions, which are performed inside blood vessels.
    • “Combining the companies’ expertise will speed development of next-generation robotic technologies for electrophysiology, interventional cardiology and neurointerventions, the companies said.”
  • Per Fierce Pharma,
    • “Unexpectedly catapulted into global fame as a COVID-19 vaccine maker, BioNTech is on the verge of returning to its oncology roots with potentially its first commercial cancer drug. Yet, to Chief Commercial Officer Annemarie Hanekamp, the upcoming launch is less of a standalone milestone than a strategic springboard for a far more critical pipeline product. 
    • “Backed by positive phase 2 data and an ongoing confirmatory phase 3 trial, BioNTech is readying its Duality Biologics-partnered antibody-drug conjugate (ADC) trastuzumab pamirtecan (T-Pam) for submission with the FDA for previously treated HER2-expressing endometrial cancer. 
    • “If approved, the drug will compete with AstraZeneca and Daiichi Sankyo’s blockbuster HER2 ADC, Enhertu, which boasts a pan-tumor indication. Challenging the market leader, however, is not BioNTech’s end goal for T-Pam.
    • “This is not about competing head to head with Enhertu and overtaking them,” Hanekamp said in a recent interview with Fierce Pharma. “We’re very realistic, and we know in the oncology space, first-mover advantage matters. They’ve been in the market for a while, it’s an amazing drug, and we don’t claim to be all that differentiated versus Enhertu.”
    • “Instead, Hanekamp views T-Pam as a “strategic launch,” an exercise to “run water through the pipes” and test BioNTech’s commercial infrastructure in oncology.”

Tuesday report

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

Simplicity is a virtue

From Washington, DC,

  • Roll Call reports,
    • “The sweltering Fourth of July weekend is over, but for both parties in House and Senate leadership, the heat is still cranked up.
    • “Both chambers are likely to return next Monday to the same sweat-inducing tangle of legislative problems that left them stumped as they headed out of town at the end of June.
    • “Speaker Mike Johnson, R-La., is looking for a solution so “irresistible” that his fellow Republicans will have to accept it — but the numbers are working against him.
    • “For one thing, August is fast approaching, leaving just a couple weeks in Washington before lawmakers depart for an even longer summer break. And as Senate Majority Leader John Thune, R-S.D., has said all along, mathematical realities can’t be changed in the Senate, even when it comes to the White House-backed voter ID bill dubbed the SAVE America Act.”
  • Beckers Hospital Review relates,
    • “CMS is proposing to create a new payment pathway for algorithm-driven diagnostic software, including AI tools, as part of its 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgery Center proposed rule, issued July 2. 
    • “The proposal marks CMS’ first attempt to build a standardized payment structure for what it calls “Software as a Medical Service” — clinical software that uses algorithms to analyze patient data and produce a diagnosis, risk score or treatment recommendation.”
  • and
    • “The planned July meeting for the U.S. Preventive Services Task Force has been postponed until late August, an HHS spokesperson told Becker’s.” * * *
    • “The HHS spokesperson said the July meeting was postponed due to an “unprecedented” number of nominations for task force membership, to allow more time for selection and onboarding of new members.”
  • Fierce Healthcare reports,
    • “The American Medical Association (AMA) updated maternity care coding Thursday, in what it says is the “most significant” move in decades to improve care delivery and data to advance maternal health.
    • “Beginning Jan. 1, 2027 (PDF), current procedural terminology (CPT) codes will reflect modern obstetric care, enable accurate and transparent reporting across the full pregnancy spectrum and create a data foundation for improved care throughout the entire patient journey.
    • ‘The update featured the deletion of 17 codes, the creation of six codes and the revision of six codes. It also includes new subsections, revised guidelines and relocation for some existing codes.
    • “Moreover, new CPT codes (PDF) will separately identify four phases of care: antepartum, labor management, delivery and postpartum.” * * *
    • “There is no expected impact on health plan benefits or an increase in cost-sharing, according to an AMA analysis using data from more than 650 physicians and certified nursing midwives.”
  • FEHBlog observation. We shall see.
  • KFF Health News explains how surprise Medicare Part D premiums can adversely affect Medicare Part D beneficiaries.

From the Food and Drug Administration front

  • Per a July 6, 2026, FDA announcement,
    • “The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of E. coli O145:H28 infections linked to frozen GreenWise brand-organic blueberries recalled by Frutas y Hortalizas del Sur S.A, of San Carlos, Chile.”
    • “Recalled frozen GreenWise-brand organic blueberries in 10-oz packages with printed lot code of 60401 and Best by Date of February 9, 2028.” * * *
    • “Recalled product was shipped to Publix retail stores throughout 8 states including Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee, and Virginia. Blueberries may have been distributed to other retailers, and FDA will update this advisory as more information becomes available.” 
  • Cardiovascular Business reports,
    • “Medtronic is recalling certain lots of the delivery catheter system for its Harmony Transcatheter Pulmonary Valve (TPV) System due to a significant safety risk. The U.S. Food and Drug Administration (FDA) has ruled this as a Class I recall, which means using the device could cause “serious adverse health consequences or death.”
    • “Medtronic initiated the recall after identifying an issue with the delivery system that could lead to distal tip detachment during implant procedures. More than 1,800 devices are included in this Class I recall.
    • ‘The Harmony TPV system is used to treat a native or surgically repaired right ventricular outflow tract (RVOT) in patients with severe pulmonary regurgitation. It has received FDA approval in addition to CE mark approval. Click here to read about a recent analysis of the device’s safety and effectiveness.”
  • Fierce Pharma relates,
    • “When Vera Therapeutics in-licensed atacicept from Merck KGaA about six years ago, patients with IgA nephropathy (IgAN) had no FDA-approved treatment options. Today, the dual-target drug has crossed the regulatory finish line but is entering a vastly different landscape as the sixth drug approved for the rare kidney disease.
    • “Atacicept, a recombinant fusion protein to be marketed under the brand name Trutakna, is now the first drug in the U.S. that inhibits both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL), two cytokines involved in B-cell survival and the production of autoantibodies associated with IgAN.” 

From the judicial front,

  • Per a June 25, 2026, Justice Department news release,
    • “Julianna C. Lung pleaded guilty in federal court today to health care fraud, admitting she marketed and sold hearing protection devices to United States Border Patrol agents, other federal employees, and their family members, then falsely billed insurance providers for what she claimed were medically-necessary hearing aids.
    • “According to her plea agreement, Lung submitted approximately 385 fraudulent claims to health insurance plans participating in the Federal Employees Health Benefits (FEHB) program. The claims falsely represented that beneficiaries suffered from hearing loss or tinnitus that required treatment.
    • “In reality, Lung told customers the devices were intended to protect their hearing—not treat a medical condition—and assured them their insurance would cover the cost for that purpose.
    • “As a result of the scheme, FEHB plans paid approximately $2,500 per device, totaling about $962,500 in fraudulent reimbursements.”

From the public health and medical / Rx research front,

  • Dr. Drew Altman, writing in KFF Health News, tells us,
    • Many of us in health care are deeply concerned about misinformation (and declining trust), so it seems important to underscore that while the American people may not always be as science-based as we might like them to be, they may also not be as anti-science as you may think they are—only a sliver of the public are hard-core refusniks who believe the lies, myths, misinformation or misbeliefs about vaccines. Occasionally, a lie breaks through when it’s amplified by someone influential and by the media. For example, 41% of the American people believed there were death panels in the ACA, but that’s the exception, not the norm.
    • In our most recent Tracking Poll on Health Information and Trust, we tested out who believed and didn’t believe each of four vaccine-related myths: “Getting the measles vaccine is more dangerous than becoming infected with measles;” “mRNA vaccines can change your DNA;” “measles, mumps, and rubella vaccines, also known as the MMR vaccines, have been proven to cause autism in children;” and, “more people have died from the COVID-19 vaccines than have died from the COVID-19 virus.” Here’s what stood out to me from these findings:
      The share of the public who believe these four myths is very small. Between 3% and 8% of the adult population believe these different vaccine myths are “definitely true.” By any standard, that’s a small, even tiny share of the overall adult population (for context, about a quarter of adults say they are MAGA). These are likely most of the folks you see in the spikes in social media engagement we sometimes observe when influencers or leaders like Secretary Kennedy amplify vaccine or
      other myths. 
    • Looked at another way, the hard-core group is even smaller: Just 1.3% believe all four false claims about vaccines are “definitely true.” 
    • By contrast, between 31% and 44% of the public think these claims are basically nonsense, meaning the share who don’t believe these things at all outnumber those who definitely do by almost 5-to-1 or more. That’s hardly the impression you get when you read reports about social media posts and views with characterizations like “engagement spiked” or “views tripled.” It’s important to track social media engagement to know how misinformation is spreading and who is spreading it, but it doesn’t give us a real picture of reach or impact. How many people believe it? How strongly? Who are they? Where did they get their information? Who do they trust and not trust when it comes to health information? That’s why we do our information and trust surveys. 
    • As I have written before and we have widely reported, most people are floundering around in a muddled middle uncertain what to believe. Take, for example, the slam dunk falsehood that “more people have died from the COVID-19 vaccines than from COVID-19 itself.” As you can see in the chart below, 53% of the American people are not certain about the answer to that question, with 34% saying that’s “probably false” and 19% “probably true,” Estimates are that the vaccine saved 2.5 million lives, and many more years of life. 
  • The Washington Post reports,
    • “The number of people injecting themselves with or taking an oral version of the new class of weight-loss drugs continues to rise dramatically.
    • “A Gallup poll released Tuesday based on a web survey of 5,065 U.S. adults says that 15 percent of U.S. adults reported using GLP-1 medications to lose weight at some point, while 11 percent say they currently are taking them.
    • “That’s up from a Gallup poll in 2024 that found 6 percent had ever taken them, and 3 percent were currently on the therapy.
    • “At the same time, respondents’ self-reported obesity rates have dipped, and diabetes rates have flattened. “The growing popularity of GLP-1 medications continues to point to broader health benefits for American adults as obesity levels curtail and the diabetes rate levels off after years of increases,” Gallup said.”
  • Beckers Payer Issues adds,
    • “The share of employers covering GLP-1s for both diabetes and weight loss has held steady at 36% year over year, according to a survey from the International Foundation of Employee Benefit Plans.
    • “The survey was conducted June 2 to June 12. The foundation represents more than 31,000 multiemployer, corporate and public sector members representing over 25 million lives.”
  • Radiology Business tells us,
    • “Experts are calling for greater integration of breast and lung cancer screening programs to help bolster monitoring for both diseases. 
    • “Researchers with Thomas Jefferson University, Philadelphia, made the case in a new analysis published July 3 by the Journal of the American College of Radiology. They noted that, despite the proven lifesaving benefits of mammography, completion rates remain as low as 55%, with worse screening adherence among socioeconomically disadvantaged patient populations. 
    • “Women eligible for lung cancer screening represent a unique population, they note, with elevated cancer risk and “substantial healthcare needs.” Previous studies have explored lung cancer screening among women already receiving mammography, but less is known about whether those actively engaged in LCS programs are up to date on their breast exams. 
    • “This represents an important gap in the literature because dual BCS/LCS-eligible women can be more efficiently identified from an [lung cancer screening] cohort than from a [breast cancer screening] cohort,” lead author Meghan Maceyko, MD, with the Department of Surgery at Thomas Jefferson, and colleagues wrote Friday. “Additionally, LCS participants may have access to highly structured LCS navigation pathways to facilitate BCS completion.”
  • The American Journal of Managed Care informs us,
    • “Adults with diabetes treated with insulin who were prescribed continuous glucose monitoring (CGM) by their primary care clinician were associated with meaningful and durable improvements in hemoglobin A1c (HbA1C), along with fewer hospitalizations and emergency department (ED) visits, according to a cohort study published in JAMA Network Open.”
      .
  • MedPage Today points out,
    • “Influenza vaccine effectiveness against death among U.S. kids and teens averaged 80% in recent years.
    • “Vaccine effectiveness against death was 77% among kids with underlying medical conditions and 87% among those without.
    • “The findings come against a backdrop of declining influenza vaccine uptake since 2021.”
  • and
    • “Roughly 22 high school students die each week from a fentanyl overdose.
    • “In a nationally representative survey study, less than half of 8th graders surveyed attributed great risk to experimental use of fentanyl.
    • “The study’s findings are a “call to action” to better educate children and teens about the synthetic opioid’s risks, a researcher said.”
  • Per Health Day,
    • “Artificial sweeteners may affect metabolism.
    • “Artificial and low-calorie sweeteners have been linked to higher fasting insulin, higher HbA1c and reduced insulin sensitivity.
    • “Alterations to the gut microbiome may help explain the observed metabolic changes.”
  • Cardiovascular Business notes,
    • “A polypill containing three different medications is associated with significant benefits for select heart failure patients, according to new findings published in Nature Medicine.[1]
    • “For the POLY-HF randomized trial, researchers explored data from 212 heart failure patients treated at two U.S. healthcare facilities. The median age was 54 years old, and 78% of patients were men. Nearly seven in 10 patients were either uninsured, or faced other barriers that can make it harder to receive optimal medical therapy.” * * *
    • “The study’s primary outcome, change in left ventricular ejection fraction after six months, was 3.3% higher for patients taking the polypill than it was for patients taking each medication separately. In addition, patients taking the polypill had a 60% lower rate of heart failure hospitalizations or ED visits.
    • “Adherence, evaluated by studying each participant’s blood for metoprolol and spironolactone, was also higher for patients taking the polypill than it was for patients taking each medication separately.”
  • Per STAT News,
    • “Compass Pathways said its investigational psilocybin treatment had lasting benefits on patients with severe depression out to six months.
    • “The biotech previously reported that 39% of patients who took two high doses in a Phase 3 trial achieved what Compass called a “clinically meaningful reduction” on a depression rating scale after six weeks. Today, it said that on average, those participants maintained the benefit through at least six months.
    • “In the trial, participants who didn’t achieve remission in the first six weeks were eligible to then get an additional dose. Compass said this morning that 28% of participants who had achieved a clinically meaningful response but not remission at six weeks did later go into remission after the additional dose. * * *
    • “Compass’ treatment is one of three psychedelic compounds the FDA has selected to review on an accelerated basis. It’s possible the drug could be approved as soon as this year.”

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

  • STAT New reports,
    • “It has never been more difficult for employers to offer health insurance for their workers. That’s especially true for America’s small businesses, the backbones of entire communities. More and more, they’re giving up entirely.
    • “America’s employer-based health insurance system — the dominant form of coverage for people younger than 65 — is crumbling. The percentage of working-age adults who get their health coverage from a job has declined from 67% in 1998 to about 60%. It’s also more expensive than ever.”
  • FEHBlog observation — To lower premiums, uncouple the employer market from the Affordable Care Act.
  • Modern Healthcare reports,
    • “Care navigators are helping health systems reduce unnecessary admissions and save money as chronically ill older adults and uninsured patients flood emergency departments. 
    • “Care navigators are typically nurses embedded in emergency departments who connect patients to less costly outpatient services to avoid hospitalizations. Providers, including St. Louis-based BJC Health System and Chicago-based Northwestern Medicine, have been growing care navigator programs.”
  • Healthcare Dive relates,
    • “Ascension has agreed to snap up a regional health system in a deal worth almost $1 billion as the Catholic nonprofit giant continues to beef up its portfolio.
    • “On Monday, Franklin, Tenn.-based Williamson Health announced it plans to sell to Ascension through the company’s Tennessee business Ascension Saint Thomas, after Williamson’s board voted unanimously in support of the change of ownership.
    • “The proposed transaction is still subject to approval by the Williamson County Board of Commissioners and other regulators. If the deal advances, the companies expect it to be finalized in 2027 or 2028.”
  • Beckers Hospital Review tells us,
    • “Jupiter (Fla.) Medical Center, an independent, nonprofit health system, broke ground June 24 on its second hospital, the “Jupiter Medical Center Neighborhood Hospital at The Health Park at Avenir.”
    • “The 53,000-square-foot facility will comprise 29 inpatient beds, four operating rooms, 24-hour emergency services, imaging services and a diagnostic laboratory, according to a news release. 
    • “Jupiter Medical Center Neighborhood Hospital at The Health Park at Avenir will be adjacent to a 47,000-square-foot, three-story medical office building for Jupiter Medical Center physicians. The building will feature cardiology, concierge medicine, gastroenterology, general surgery, primary care, pulmonary and orthopedics.
    • ‘Both the hospital and medical office building are expected to open in early 2028.” 
  • Fierce Healthcare informs us,
    • “Handspring Health offers a virtual mental health clinic for youth and families, purpose-built around evidence-based care and ongoing training and support for clinicians.
    • “The startup, which launched four years ago, picked up $19 million in series B funding to grow its clinician workforce, expand value-based care partnerships with payers and broaden its geographic reach.”
  • Fierce Pharma lets us know how “biosimilar experts size up US hurdles, opportunities ahead.”
  • Beckers Payers Issues explains “How 4 health plans are innovating with specialty pharmacy.”
  • MedCity News offers “The AI Playbook for Health Plans: 5 Steps for Leaders Who Don’t Know Where to Start.”
    • “It starts with a simple mindset shift, realizing that a successful AI journey begins with identifying a business problem, not with technology. The plans that make real progress embrace this mindset first then follow these five steps.” 

Weekend Update

David Ermer–Congress, Mental health care, No Surprises Act, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Congress will be out of session this week following the semiquincential holiday.
  • STAT News reports,
    • “Dozens of congressional lawmakers are urging the Trump administration to force Eli Lilly to reinstate mandated price breaks to hospitals that participate in a federal drug discount program but have refused to provide the company with claims data.
    • “In a letter to Department of Health and Human Services Secretary Robert F. Kennedy Jr., the bipartisan group of lawmakers argued that Lilly is failing to comply with federal law by eliminating the price breaks. The drugmaker stopped offering discounts last month to reduce what it calls duplicate discounts paid to the hospitals.” * * *
    • “Congress did not authorize manufacturers to unilaterally impose additional reporting mandates or data-sharing requirements as a prerequisite for obtaining those discounts,” the lawmakers wrote. “Lilly’s actions effectively condition participation in the 340B program on compliance with manufacturer-imposed requirements that extend beyond the statutory framework established by Congress.”
  • On July 3, a federal holiday, the Office of Management and Budget’s Office of Information and Regulatory Affairs posted the “2026 Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions,” which was historically known as the semi-annual regulatory agenda.
  • The Office of Personnel Management’s agenda includes the following FEHB / PSHB related rules:
    • “This proposed rule [RIN: 3206-AO45, projected to be published in September 2026] would implement section 9816 of the Internal Revenue Code of 1986, section 716 of the Employee Retirement Income Security Act of 1974 (ERISA), and section 2799A1 of the Public Health Service Act (PHS), as directed by section 111 of the No Surprises Act; and may include other provisions under the Consolidated Appropriations Act, 2021. Pursuant to 5 U.S.C. 8902(p), Federal Employees Health Benefits (FEHB) carriers must comply with Advanced Explanation of Benefits requirements in the same manner as those provisions apply to a group health plan or health insurance issuer offering group or individual health insurance coverage. This rule would also clarify that FEHB carriers must comply with the applicable Medicare limits set forth at 5 U.S.C. 8904(b) notwithstanding a payment determination calling for a payment in excess of those limits.”
    • “OPM is proposing new standards [RI: 3206-AO93, projected to be published in November 2026] to improve enrollment integrity and accuracy in Federal employee benefits programs, including the Federal Employees Health Benefits (FEHB) and Federal Employee Group Life Insurance Programs. This would include amendments to 5 CFR parts 870 and 890 to establish a new eligibility determination process for children who are age 26 and over and who are incapable of self-support (ISS). In addition, OPM will (1) allow employing offices to adjust enrollment type from Self and Family or Self plus one to Self Only if there is only one person covered by the enrollment and (2) prohibit ineligible family members from receiving a 31-day extension of coverage when their coverage is terminated due to a reduction in the enrollee’s enrollment type.”
    • This proposed rule RIN: 3206-AP13; projected to be published in July 2027) would implement section 108 of the No Surprises Act.” Section 108 requires the No Surprises Act regulators to promulgate a rule describing the requirements of Public Health Service Act Section 2706, which is the Affordable Care Act’s provider non-discrimination provision.
    • The Office of Personnel Management (OPM) is amending its regulations to implement the Administrative False Claims Act of 1986, as amended by the National Defense Authorization Act for Fiscal Year 2025 [RIN: 3206-AP00; projected to be published this month]. This proposed rule would revise the administrative procedures for imposing civil penalties and assessments against persons who make, submit, or present false claims and statements to OPM.
  • OPM’s announced in LinkedIn
    • “Fraud in federal healthcare programs isn’t a rounding error — it’s likely billions of dollars a year, and it’s now a White House priority.
    • “I’m hiring the engineering leader who’ll help make that fight real from the inside. U.S. Office of Personnel Management (OPM) is looking for a Division Chief to lead our Healthcare Engineering Division — working directly with the White House Task Force to Eliminate Fraud, chaired by Vice President Vance. This role owns the technical work behind better services and lower costs and leads the AI/ML systems, infrastructure, and full SDLC for programs touching millions of federal employees, retirees, and their families.
    • “GS-15 scope: $147,945–$197,200, budget authority over major IT investments, a team of engineers and data scientists reporting to you.
    • “If you want engineering work with real consequences, apply by July 8.”
  • FEHBlog observation – Since the late 1980s, OPM’s Inspector General has been fighting fraud, waste, and abuse “from the inside” with strong, effective support from the FEHB and PSHB carriers which hold the financial risk for their plans.
  • ACDIS tells us,
    • “CMS has published the fiscal year (FY) 2027 ICD-10-CM code set, including 190 new codes, 30 deleted codes, and four revised codes. These updates will become effective on October 1, 2026.
    • “Of the 190 new codes, 33 are related to continuing pregnancy after vanishing twin syndrome (category O31.4) and 17 codes related to the toxic effect of cycloparaffins (category T52.82).”

From the public health and medical / Rx research front,

  • The Wall Street Journal explains new developments in sunscreens sold in our country.
  • Healio reports,
    • “Adults with type 2 diabetes who were provided medically tailored healthy meals and lifestyle counseling for 6 months had a lower HbA1c than those who received a monthly food subsidy, researchers reported.
    • “Food insecurity is a common barrier to eating healthy meals for people with diabetes, according to Seth A. Berkowitz, MD, MPH, associate professor of medicine at University of North Carolina School of Medicine. In an open-label, parallel-group, randomized trial presented at the American Diabetes Association Scientific Sessions, Berkowitz and colleagues compared health outcomes among two nutritional interventions: medically tailored meals that were created and delivered directly to people’s homes, and subsidies where participants received money to purchase food themselves.”
  • and
    • “A single injection of sura-vec reduced the severity of nonproliferative diabetic retinopathy for up to 2 years, according to data presented at Optometry’s Meeting.
    • “Early intervention is essential to prevent progression to blinding complications, yet the burden of frequent intravitreal injections with current anti-VEGF therapies make long-term treatment difficult for many patients,” Steve Pakola, MD, chief medical officer at Regenxbio, told Healio. “We believe sura-vec has the potential to redefine the treatment paradigm by delivering sustained anti-VEGF expression through a one-time, in-office gene therapy, reducing treatment burden while helping preserve vision long-term.”
  • Health Day informs us,
    • “More than half the calories consumed by young kids in the U.S. come from ultra-processed foods.
    • “Now, a new study warns that those foods, including sugary cereals, packaged snacks, fast food and processed meats, may be linked to measurable differences in brain structure by age 6.
    • “A team at Children’s Hospital Los Angeles followed 144 Latino and Hispanic mother-child pairs from infancy through age 6, tracking kids’ diets over time and using MRI scans to measure brain structure.” * * *
    • “Our findings suggest that what children eat early in life may shape brain development in ways we’re just beginning to understand,” said senior author Michael Goran, director of the Nutrition and Obesity Program at the hospital’s Saban Research Institute. “Even without differences in cognitive performance, we’re seeing measurable changes in brain structure.”
    • “More work is needed to understand what these structural differences may mean for long-term health.”
  • and
    • “Here’s more pressure for harried mothers — a sluggish response to baby’s coos and babbles might increase their risk of childhood psychiatric problems.
    • “Moms who respond within one second of their baby’s vocalizations appear to lower the child’s risk of mental health problems by age 7, researchers reported July 1 in the journal PLOS One.
    • “Specifically, for every 10% increase in the likelihood of a mom responding within a second, the child’s odds of a later psychiatric diagnosis decreased by 17%, researchers found.
    • “The results “suggest a robust association between slow parental responses to their infants’ signals and later problems,” senior researcher Philip Wilson, an emeritus professor at the University of Aberdeen in the U.K., said in a news release.”

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

  • HealthExec reports,
    • “More than half of all patients taking GLP-1s such as semaglutide are using them to treat a diagnosed medical condition, signaling that the demand for the popular weight loss drugs may not be purely for vanity, a new study using payer claims data reveals.
    • “In its report, healthcare market research firm Trilliant Health was able to show that, while popular GLP-1 substances such as Ozempic, Zepbound and Wegovy may have been originally approved to manage blood sugar, their medical use has expanded significantly since the latter was given FDA approval for chronic weight management in 2021, spurring the modern trend.
    • “According to the data analyzed by Trilliant, the number of patients prescribed this class of pharmaceuticals has risen nearly 636% between 2018 and 2024, when the data cuts off. Notably, the first GLP-1 approved to be prescribed for weight management was Saxenda, given the greenlight in 2014 for adults.” * * *
    • “The most common indication for why patients were prescribed GLP-1s was obstructive sleep apnea, potentially directly related to obesity, coming in at 25.5% of scripts. The second highest medical condition was major depressive disorder, coming in at 18.2%.
    • “After that, chronic kidney disease was the most common reason for prescriptions at 10.6%, followed by fatty liver disease.
    • “Trilliant noted that conditions related to overeating specifically—binge eating—were the least common reason for patients to be given the drugs, coming in at only 0.5%.
    • “The firm added that, when considering that many patients were also prescribed GLP-1s for more than one medically valid condition, demand for the drugs will only grow, and payer plans should be prepared for the continued spike.” * * *
    • “The full report is available by clicking here.”
  • Medscape adds,
    • “Substance use disorders (SUDs) may become the next therapeutic target for GLP-1 receptor agonists (GLP-1s). Although the evidence remains preliminary, growing preclinical, observational, and early clinical data suggest these drugs may reduce the cravings that drive addiction.
    • “Interest has accelerated over the past few years, fueled by reports that patients taking semaglutide or tirzepatide for diabetes or obesity drink less alcohol, smoke fewer cigarettes, or experience fewer cravings. Those observations have prompted a wave of studies exploring whether these drugs could have a role in treating alcohol, nicotine, opioid, and other SUDs.
    • “More recently, large retrospective analyses have suggested that GLP-1s may be associated with lower rates of overdose, SUD-related mortality, and new-onset SUDs.
    • “At this point, however, much of the evidence comes from animal studies, observational research, and patient reports. Definitive answers will require randomized clinical trials. More than 30 studies are now investigating GLP-1s for alcohol, nicotine, opioid, cocaine, and methamphetamine use disorders, making addiction one of the fastest-growing areas of GLP-1 research.”
  • BioPharma Dive relates,
    • Celea Therapeutics, a biotechnology startup testing a next-generation treatment for idiopathic pulmonary fibrosis, said in a Thursday announcement it has brought in $180 million to continue its work.
    • Launched in 2025, the PureTech Health spinout is working on a medicine that it says is a retooled version of pirfenidone, also known as Roche’s Esbriet, a drug that slows the progression of scarring in the lungs.
    • The venture round was backed by RA Capital Management, Leaps by Bayer and PureTech, as well as two other unnamed funds. The proceeds from this fundraising will be used to launch its drug deupirfenidone into late-stage testing in the third quarter of 2026.
  • HR Dive tells us,
    • HR is still adapting to artificial intelligence rather than taking the lead on redesigning the workflow around AI, according to a report released by the Institute for Corporate Productivity (i4cp) Tuesday [June 30].
    • After surveying more than 1,300 business and HR leaders worldwide, i4cp researchers determined that even though workplaces are moving past “isolated AI use cases,” AI implementation is still a “series of disconnected experiments,” according to a Tuesday statement.
    • AI is increasing expectations for what HR practitioners are expected to bring to the table, but “most HR functions are still experimenting at the margins rather than redesigning how work actually gets done,” Katheryn Brekken, senior research analyst at i4cp, said in a statement.