Midweek report

NIH

Midweek report

David Ermer–CDC, Congress, FDA, NIH, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Beckers Hospital Review reports,
    • “In July, committees in the House and Senate advanced price transparency legislation that aims to expand disclosure requirements for hospitals, insurers and other healthcare providers.
    • “The Senate Committee on Health, Education, Labor and Pensions advanced the Patients Deserve Price Tags Act, which would implement new price transparency requirements for hospitals, insurers, laboratories, imaging providers and ASCs, while also expanding group health plans’ access to claims and reimbursement data held by insurers and PBMs.
    • “Starting in 2027, the bill would require hospitals to extend consumer-friendly price disclosures to every shoppable service they offer, eliminating the current cap that lets hospitals limit that disclosure to 300 services. A hospital CEO, CFO or similarly senior official would have to personally attest that pricing data is accurate — an attestation the bill treats as material to federal payment, which could raise False Claims Act exposure for errors. The bill would also eliminate online price-estimator tools as a standalone compliance option, add escalating daily penalties tied to bed count, and extend similar disclosure requirements to labs, imaging providers and hospital-affiliated ASCs by mid-2027. Providers would also be barred from pursuing collections when charges exceed a prior good-faith estimate, absent documented exceptions.
    • “The American Hospital Association opposed the bill, citing added administrative burden and objecting specifically to the removal of price-estimator tools as a compliance method and to a new ownership-disclosure requirement.
    • “Meanwhile, the House Energy and Commerce Committee advanced its own package, the Lower Costs, More Transparency Act. Starting in 2028, the bill would codify existing hospital shoppable-service and cash-price posting rules into law, require hospitals to publish facility identifiers and any ownership stake of 5% or more, and extend transparency mandates to freestanding ASCs, labs and imaging centers for the first time. It would also require insurers and group plans to publicly report prior authorization data — including denial rates, appeal-overturn rates and average decision times — and to disclose how premium dollars are split between claims, taxes and fees, and retained earnings, including at the Medicare Advantage plan level.
    • “The AHA said it supports giving patients clearer price information but warned that writing current requirements into law could limit CMS’ flexibility to refine them going forward.”
  • Beckers Payer Issues relates,
    • “Enacting site-neutral payments under Medicare for imaging services would generate an estimated $9.7 billion in combined savings over 10 years, according to a new analysis commissioned by the Blue Cross Blue Shield Association.
    • “The report, prepared by external consulting groups and published Aug. 24, quantifies both the Medicare impact and the spillover effects on commercial insurance markets. In July, CMS proposedin its 2027 hospital outpatient prospective payment system rule to extend site-neutral payment policies to imaging services without contrast (X-rays and MRIs for example) to off-campus hospital outpatient departments. Under the proposal, payments would be reduced from the full OPPS rate to the physician fee schedule equivalent rate, or an estimated 60% reduction.
    • “If finalized, the BCBSA analysis estimates $7.2 billion in total Medicare savings from 2027 to 2036, with $5.3 billion going to the federal government and $1.9 billion in reduced beneficiary out-of-pocket costs. CMS itself estimated $260 million in combined savings in 2027 alone, split between $190 million in government savings and $70 million in beneficiary savings.
    • “In the commercial market, the analysis estimates $2.5 billion in total commercial savings over the 10-year period, broken down as $1.6 billion in employer premium contributions, $530 million in enrollee premium contributions and $300 million in member out-of-pocket savings.”
  • Fierce Pharma informs us,
    • “RNA-based vaccines and therapeutics may have faced a bumpy road in the U.S. recently, but a major new federal investment proves the government is still betting big on its future.
    • “The Advanced Research Projects Agency for Health (ARPA-H) has narrowed down to five teams—a mix of biotechs and academic institutions—that will now receive up to $125 million in aggregate to help automate the production process for potential on-demand, personalized RNA-based medicines. 
    • “The new project falls under ARPA-H’s Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, which it says aims to build out automated production and real-time quality control through a distributed network. The idea, according to the agency, is to enable manufacturing of treatments near the patients they serve, rather than keeping genetic medicines sequestered around “major biomanufacturing hubs.
    • “Manufacturing expenses and the logistical headaches associated with the actual administration of genetic medicines—such as gene therapies—have proven to be a limiting factor for the field’s uptake in the real world.”  

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

  • Govexec reports,
    • “The Office of Personnel Management’s healthcare and insurance division, following recent staffing reductions, is getting new leadership ahead of its busy Open Season. 
    • “Matthew Kiley, a former Department of Health and Human Services official under the first Trump administration, will serve as the associate director of OPM’s healthcare and insurance division, starting Sept. 8, according to an internal memo obtained by Government Executive.
    • “A copy of Kiley’s resume shared with OPM employees and partially viewed by GovExec shows Kiley is the founder and former president of the Weyhill Group, a boutique management consulting firm in the greater Philadelphia area that serves clients in financial services, insurance and healthcare. 
    • “According to Kiley’s LinkedIn page, he also led the Office of Health Policy within HHS’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) between November 2019 and and January 2021.”
  •  Good luck, Mr. Kiley.
  • Federal News Network tells us,
    • “Agencies have a few months left to survey their employees before the required end-of-year deadline — and for most, it will be their first time distributing the Federal Employee Viewpoint Survey on their own.
    • “The change comes in the wake of the Office of Personnel Management’s proposal to decentralize the governmentwide employee engagement survey, which OPM has run for more than 20 years. Starting this year, however, OPM intends to leave the survey creation and distribution to individual agencies.
    • “Agencies have flexibility in determining the approach, timing and methodology that best meets their needs, provided their survey addresses all required elements,” OPM wrote in a July guidance document.
    • “For some federal workforce experts, moving FEVS to an agency-specific survey has been a welcome change. The opportunity for agencies to now add in questions tailored specifically to their own workforces is “exactly how it should be,” said Sydney Heimbrock, public sector chief industry advisor at Qualtrics.”

From the Food and Drug Administration front,

  • Pharmaceutical Technology reports,
    • “The US Food and Drug Administration (FDA) has continued its clampdown on the illegal trade of black-market peptides by issuing a string of warnings to online sellers, as non-approved drugs within this class generate a significant interest amongst the public on social media. 
    • “The five warning letters, which were issued to US-headquartered Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations LLC dba Tex Peptides, all detail violations in FDA regulations related to the sale of new peptide-based drugs, which remain unapproved and unregulated.  
    • “The FDA’s issues primarily centre around each company’s attempts to sell illicit weight loss products, with all five websites flagged in this crackdown advertising their own versions of Eli Lilly’s obesity candidate, retatrutide – a drug that is yet to secure approval within any global market. This comes a little after Lilly itself sounded the alarm on the drug’s burgeoning black market, which has begun to take off as some patients look to secure cheaper alternatives to branded weight loss medications.” 
  • BioPharma Dive relates,
    • “After a year of ups and downs, UniQure on Wednesday said it’s submitted applications for what could become the first medication approved to treat the underlying cause of Huntington’s disease.
    • “The Dutch company is asking the Food and Drug Administration to give its AMT-130 gene therapy a priority review, which could result in a decision in about eight months. UniQure said it’s also completed a submission with U.K. regulators.
    • “UniQure based its applications on previously announced three-year data that showed AMT-130 could significantly slow signs of disease progression. It’s asking the FDA for an “accelerated approval,” which means it would have to later supply research confirming the product’s clinical benefits.”

From the fraud, waste and abuse front,

  • Bloomberg Tax reports,
    • “The next phase of federal fraud enforcement is going to be data-driven. After using data mining and matching to uncover pandemic-relief fraud, the Justice Department and other agencies are expanding those tools to healthcare, foreign bribery, securities, consumer fraud, and public safety cases.
    • “This shift is significant and changes how investigations begin. The DOJ recently announced it is building the most sophisticated, innovative, and data-driven white-collar law enforcement component in the world, uniquely positioned to fight fraud at every level. This will include a cross-disciplinary team of experts in data science, and cutting-edge technology and resources.
    • “Rather than waiting for tips, audits, or referrals, the government will be using analytics, AI, cloud computing, and shared agency data to spot outliers and build cases earlier. For companies and individuals operating in data-rich regulatory environments, fraud risk may surface long before a subpoena arrives.”
  • The HHS Office of Inspector General tells us,
    • “CMS oversight of Medicare Part D sponsors did not prevent payments to pharmacies for some OTC drugs sold under obsolete Rx-only labeling.
    • “Part D sponsors made payments for five drugs associated with obsolete Rx-only labeling more than 1 year after the brand-name drugs were switched to OTC use. For calendar years (CYs) 2021 through 2023, Part D sponsors made $587.7 million in ineligible payments associated with the five drugs.
    • “The ineligible payments occurred because CMS: (1) updated its Part D Formulary Reference File using obsolete FDA data on Rx-only drugs and (2) did not set a timeframe for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling.
    • “Before we issued our draft report, FDA issued a policy in December 2025 requiring generic drug manufacturers to update their labeling “at the earliest time possible and within 6 months” after FDA approves an associated brand-name drug’s switch from Rx-only to OTC use.
    • “We recommend that CMS issue guidance on timeframes for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling after an Rx-to-OTC switch. This step could have helped to prevent $587.7 million in ineligible payments for CYs 2021 through 2023.
    • “CMS concurred with our recommendation.”

No Surprises Act News

  • Beckers Hospital Review reports,
    • “The House Ways and Means Committee is working on an overhaul of the No Surprises Act and a markup could happen in September, Punchbowl News reported Aug. 19. 
    • “Congress passed legislation creating the No Surprises Act in 2020, but critics say the law’s independent dispute resolution process has produced inflated reimbursement awards, raising concerns about rising healthcare costs. 
    • “The emerging proposal would combine Rep. Greg Murphy’s bill penalizing insurers that miss payment deadlines with new provisions aimed at curbing ineligible provider claims, according to the report. For revenue cycle teams, that’s a potential two-way street: faster insurer payment on IDR-eligible claims, but stricter eligibility standards before a claim can enter the process in the first place.
    • “The Senate HELP Committee is also planning a roundtable on the No Surprises Act this fall, according to the report.” 
  • Beckers ACS Review informs us,
    • “New federal data shows the independent dispute resolution process created under the No Surprises Act is being used more than ever. Total federal IDR disputes rose from 653,445 in Q3 of 2025 to 719,118 in Q4 of 2025 — a roughly 10% jump. 
    • “One state is driving an outsize share. According to CMS’ IDR Supplemental Tables for Q3 and Q4 2025, Texas generated more arbitration disputes than the next nine states combined.”
  • Modern Healthcare shares information about the federal IDR dispute arbitrators.
    • “Arbitrators rule for providers at varying rates. Some back providers as much as 98% of the time, while others approach an even split in the fourth quarter of 2025, according to Georgetown University research published in the journal Health Affairs Forefront last month.
    • “Island Peer Review Organization, Provider Resources, EdiPhy Advisors, MCMC Services and Maximus Federal Services side with providers more than 90% of the time, while Medical Evaluators of Texas and ProPeer Resources pick providers’ bids less than 60% of the time, according to an analysis of Centers for Medicare and Medicaid Services data from the second half of 2025 by Elevance Health Vice President of Health Economics Ariel Bayewitz. * * *
    • “The sway arbitrators hold underscores their significance and why the industry needs greater transparency, said Erin Duffy, managing director of the University of Southern California Schaeffer Institute for Public Policy and Government Service. “There’s so much opacity right now,” she said.” * * *
    • “Each time an arbitrator determines a dispute is eligible and then makes a ruling, it collects a fee. If providers and insurers cannot mutually agree on an arbitrator, one is randomly assigned. 
    • “Fee amounts are decided at an arbitrator’s discretion. Island Peer Review Organization, EdiPhy Advisors and Livanta charge the most, according to a Modern Healthcare analysis of CMS data.
    • “Since the federal system has seen millions of more disputes than expected, arbitrators have received exponentially larger payouts than anticipated.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “Professional organizations representing pediatricians, family physicians, obstetricians, and other medical professionals jointly released guidelines Wednesday for who should get vaccines aimed at staving off influenza, Covid-19, and respiratory syncytial virus, or RSV, this coming winter.
    • “The combined effort, undertaken in conjunction with the University of Minnesota’s Vaccine Integrity Project, has two goals: to help medical professionals guide their patients, and to help individuals plan to get the vaccinations that should help them either evade these ailments, or minimize their risks of severe illness if they do become infected.” * * *
    • “A spokesperson for the CDC confirmed Wednesday that this respiratory season, flu and Covid vaccines, as well as monoclonal antibodies given to babies to protect them against RSV, will continue to be provided under the federal government’s Vaccines for Children program, which supplies free vaccines for roughly half of the nation’s children.” * * *
    • “Papers outlining the rationale for the various vaccination recommendations were published Wednesday in the Journal of the American Medical Association, JAMA, and an interactive tool to help doctors and the public review the science behind the decisions will be posted on the Vaccine Integrity Project’s website.”
       
  • Beckers Clinical Leadership adds,
    • “The American Academy of Pediatrics reaffirmed its recommendation that young and high-risk children receive COVID-19 vaccines and expanded the list of high-risk children it advises to receive respiratory syncytial virus immunization for a second season.
    • “The recommendations, published Sept. 2, come amid upheaval among federal health officials. About three weeks ago, President Donald Trump directed HHS to assess a reduced immunization schedule for children.
    • “COVID-19 vaccines and the respiratory syncytial virus (RSV) products are expected to remain covered under private insurance and the Vaccines for Children program.”
  • and
    • “More parents are declining hepatitis B vaccination and vitamin K prophylaxis for infants, and female infants are less likely than males to receive either, according to a research letter published Aug. 31 in JAMA. 
    • “Researchers at Children’s Hospital of Philadelphia and University of Pennsylvania, also in Philadelphia, set out to determine whether a infant’s sex was associated with a parent’s acceptance of vitamin K prophylaxis and hepatitis B vaccines. 
    • “The retrospective study analyzed live births from January 2018 to December 2025 at three University of Pennsylvania hospitals. Across 93,163 infants, 777 — or 8.3 infants per 1,000 births — did not receive vitamin K prophylaxis. For all infants, the rate of vitamin K prophylaxis declines doubled between 2018 and 2025. 
    • “A larger number, 9,400, did not receive the hepatitis B vaccine, according to the study. The rate equals 100.9 infants per 1,000 births. Parental declines increased between 2018 and 2025. 
    • “Compared to infant males, infant females were less likely to receive either the vitamin K or hepatitis B vaccine, the researchers found.”
  • Yesterday, the CDC offered recommendations for seasonal flu vaccinations.
    • Because of legal uncertainties and inquiries, the CDC states the recommendations for seasonal influenza vaccination from the July 2025 immunization schedule remain in effect for the 2026-2027 influenza season.
  • Health Day tells us,
    • “Low T” is a trendy health topic, with aging men sold testosterone as a veritable Fountain of Youth.
    • “But too much testosterone can also pose a risk to heart health, a new evidence review says.
    • “Men with low testosterone or high testosterone levels both have a higher risk of atrial fibrillation, a heart health disorder that increases risk of stroke, researchers report in the Journal of the Endocrine Society.
    • “Both too little and too much testosterone appear to raise the risk of atrial fibrillation, through separate biological mechanisms, which means the dose and the target level matter,” said senior researcher Dr. Rajat Barua in a news release. He is a cardiologist at the Kansas City Veterans Affairs Medical Center in Kansas City, Missouri.”
  • and
    • “There’s been a shocking increase in the number of kids who’ve accidentally eaten recreational drugs left around by adults, a new study says.
    • “The rate of accidental ingestions of recreational drugs among children younger than age 6 increased by more than 3,300% between 2000 and 2024, researchers report in the journal BMC Public Health. 
    • “Weed accounted for 85% of these reported ingestions, with edibles representing about half of all ingestions, researchers found.
    • “The recreational drug ingestion rate among children younger than 6 years reported to United States poison centers increased substantially over the study period, with increases especially pronounced for edible marijuana and psilocybin products,” said senior researcher Dr. Gary Smith in a news release. He is director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.”
  • and
    • “Lower predicted prevalences of birth defects are seen in association with periconception parental vitamin B12 and postconception maternal red blood cell (RBC) folate, according to a study published online Sept. 1 in the Annals of Internal Medicine.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded study has shown that the GLP-1 drug semaglutide extended lifespan in older, healthy mice by tempering the detrimental effects of aging. Researchers at the University of California, Berkeley directly compared the effects of the treatment to those of reduced food intake. They found that the drug mimicked the anti-aging benefits of calorie restriction, conferring even greater benefits in some areas.
    • “While GLP-1s have been found to delay the onset of many age-related diseases in animals, this new study in healthy older mice offers evidence that these drugs may slow physiological aging itself, a notion that could potentially tie the widespread benefits of GLP-1s to a common source.
    • “Most chronic diseases are deeply rooted in the aging process. If GLP-1 agonists do indeed slow it down, then a wide range of clinical benefits is exactly what you’d expect to see,” said Rafael de Cabo, Ph.D., a senior investigator at the NIH’s National Institute on Aging (NIA), and author of a commentary on the new study.”
  • Beckers Hospital Review points out,
    • “More than a dozen experimental obesity drugs are working their way through clinical trials, and the last year has reshuffled the leaderboard: some candidates have advanced into pivotal phase 3 studies, others have won approval overseas and at least one program has been abandoned. 
    • “[The article includes] a status check on 13 of the most closely watched drugs.
  • MedPage Today notes,
    • “In a cohort study of men with nonmetastatic prostate cancer, the highest level of post-diagnosis saturated fat consumption was associated with greater all-cause mortality compared with the lowest level.
    • “This increased risk of all-cause mortality was likely due to deaths from cardiovascular disease.
    • “There was no association between consumption of dietary fats and prostate cancer mortality.”
  • Per STAT News
    • “The biotech company Ultragenyx said Wednesday that its experimental therapy for Angelman syndrome, a rare disease that causes severe intellectual disabilities and developmental delays, showed no benefit compared to a sham treatment in a large Phase 3 trial. 
    • “The drug, GTX-102, had shown powerful results in early trials, raising the hopes of families affected by the devastating condition. Many advocates for patients with other neurological conditions also hoped it could be the first of many medicines that improve cognition, communication, and other aspects of the lives of patients with intellectual disabilities.
    • “The news is a significant blow for Ultragenyx’s business as well. Although the company has multiple approved medicines, they are for mostly ultra-rare diseases, and investors had been banking on the Angelman drug as the company’s path to profitability.”

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

  • The New York Times reports,
    • Large and small employers are bracing for what looks to be the sharpest increase in health care costs in more than two decades. The cost per worker is projected to go up an average of 11 percent next year, or somewhat lower if workers’ insurance benefits are reduced, according to a U.S. survey released Wednesday.
    • “The employers’ final costs, after they make changes to health plans, are still expected to increase about 8 percent next year, the steepest since 2003, according to Marsh, the benefits consultant formerly known as Mercer.
    • “More than a third of the 1,800 employers surveyed said they anticipated that costs would rise at least 10 percent after making cuts.” * * *
    • “The Marsh survey is the latest report by an employer group or benefit consultant predicting a sharp rise in health care costs next year. Many Americans, even those with insurance, are already struggling to afford care, according to various surveys, and health care has become a top issue for voters.
    • “This seems to be a new normal,” said Ellen Kelsay, the chief executive of Business Group on Health, which represents large employers that offer health benefits.”
  • Beckers Hospital Review adds,
    • “Hospitals are seeing more self-pay patients as coverage losses mount across both the ACA and Medicaid markets.
    • “In a study published Aug. 31, Epic Research found self-pay visits are increasing across hospital settings as Medicaid enrollment has fallen across the country following the expiration of continuous enrollment protections in place during the pandemic. 
    • “Epic’s research looked at more than 550 million U.S. healthcare encounters between the first quarter of 2022 and the second quarter of 2026 and found that self-pay visits are increasing the most in emergency departments, climbing from 5.5% to 7.6% during the period. Across the same timeframe, self-pay inpatient admissions rose from 1.9% to 2.6%, births from 0.8% to 1.3% and primary care from 1.8% to 1.9%.”
  • and
    • “New Hyde Park, N.Y.-based Northwell Health recorded operating income of $76.1 million (1.4% margin) in the second quarter of 2026, down from $100.3 million (2% margin) in the same quarter last year, according to its Aug. 31 financial report.” 
  • Healthcare Dive relates,
    • “Johns Hopkins Health Plans is elevating its finance leader to interim CEO while the Baltimore-area managed care company looks for a permanent successor for its previous chief executive, who left to join a rival insurer last month.
    • “Placing Daniel Chojnowski in the interim position will provide stability as JHHP recruits for its next CEO, the insurer said in a Tuesday post on LinkedIn. James Holland, JHHP’s former chief executive, served in the role for seven years before leaving to lead Humana’s Medicaid division in August.
    • “Chojnowski “embodies the modern CFO, which has evolved from the number-crunching budget guard to a strategic partner, helping to steer organizational decisions,” JHHP said.”
  • Tech Target tells us,
    • “Since 1936, Nemours Children’s Health has provided pediatric healthcare, research and education to children and families. Today, Nemours has more than 70 specialty, primary and urgent care facilities in Delaware, Florida, Pennsylvania and New Jersey. It is reimagining how to deliver pediatric healthcare for better health outcomes, with the belief that nearly 80% of what affects a child’s health occurs in their home, school and community.
    • “As hospitals and healthcare organizations across the U.S. face rising costs, staffing pressures and demand for capacity, hospital-at-home programs are evolving into enterprise-scale distributed care models. That shift requires healthcare providers to coordinate remote monitoring, clinical workflows, escalation processes, scheduling and patient engagement across integrated technology platforms. Nemours Children’s approached Advanced Care at Home (ACaH) not as a standalone telehealth initiative, but as a coordinated care delivery model integrated into enterprise workflows, operational oversight and its existing Epic electronic health record (EHR) infrastructure.
    • “For Nemours, hospital-at-home became less of a telehealth service and more of a distributed operating model requiring centralized workflow coordination, operational accountability and enterprise-wide visibility.
    • “Through its ACaH program, Nemours Children’s extends certain pediatric care, monitoring and recovery services into patients’ homes through remote monitoring, virtual visits, care coordination and integrated clinical workflows.”
  • Fierce Healthcare informs us,
    • “Thyme Care landed a series E financing round of more than $125 million backed by strategic payers and providers as it aims to expand beyond cancer care navigation.
    • “The fresh financing will fuel the company’s continued growth and establish a new parent organization, Thyme Companies, that aims to build a broader portfolio of businesses to address broader cancer care challenges.
    • “JPMorgan’s Morgan Health led the series E round, with participation from strategic investors including Humana and CVS Health Ventures, valuing the oncology-focused company at more than $2 billion. Institutional investors AlleyCorp, HealthQuest Capital, Foresite Capital, Concord Health Partners, Frist Cressey Ventures, Town Hall Ventures and a16z Bio + Health also backed the round.”
  • Per MedTech Dive,
    • “Medtronic said it will invest about $700 million in a partnership with Cornerstone Robotics that includes rights to distribute the Hong Kong-based company’s soft tissue surgical robot in China, Singapore and Europe.
    • “Cornerstone developed its Sentire robotic system in-house and won Europe’s CE mark in May for its use in general surgery and gynecologic, thoracic and urologic procedures. The robot is also approved in China and Singapore.
    • “Distributing Cornerstone’s Sentire robot alongside Medtronic’s Hugo system will expand access to robotic surgery and give surgeons and health systems more choice, Medtronic said. “It’s a global play for us. It’s one of a number of investments we’re making in soft tissue,” Medtronic CEO Geoff Martha told investors on the company’s earnings call Tuesday.”
  • and
    • “Stryker said Monday it has agreed to acquire ZuriMED, a company making a device to treat rotator cuff tears. The companies did not share the terms of the deal.
    • “Zurich, Switzerland-based ZuriMED makes a system for rotator cuff augmentation, a procedure where a patch is applied to a torn rotator cuff to support healing and prevent the tissue from re-tearing. 
    • “Stryker expects the acquisition to strengthen its rotator cuff portfolio and support shoulder specialists in sports medicine and arthroplasty.”

Tuesday report

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

Simplicity is a virtue

From Washington, DC

  • Beckers Hospital Review reports,
    • “CMS awarded Alaska $160 million through the Rural Health Transformation Program, funding 142 projects to expand access to rural healthcare statewide.
    • “The funding package includes $6.5 million to bring the first robotic-assisted minimally invasive surgery program to Southern Southeast Alaska, $5 million to build a tribally led residential treatment and recovery campus in Southeast Alaska, and more than $3.1 million to deploy AI-powered medical imaging across 21 acute care hospitals for faster stroke detection.
    • “Alaska will also use $250,000 to develop a drone-based pharmaceutical delivery system for villages spread across 94,000 square miles, where medication deliveries can take five to 14 days during winter months. Nearly $4.6 million will strengthen the Alaska Family Medicine Residency Program, and $4.75 million will expand health information exchange connectivity for rural providers.”
  • Beckers Payer Issues relates,
    • “Nine months after President Donald Trump announced a deal offering states discounted pricing on GLP-1 drugs for Medicaid patients, most states are declining to participate, according to an Aug. 22 Politico report.
    • “Only Indiana has publicly signed on, while 29 state Medicaid programs have said they will not participate and 14 more did not respond to requests for comment, according to the report. CMS also declined to provide a list of participating states.” * * *
    • “Medicaid spending on GLP-1s grew from $1 billion in 2019 to almost $9 billion in 2024, and nearly 40% of patients with obesity could qualify for coverage if states opted in, according to the report. States that do not cover the drugs can still direct Medicaid enrollees to purchase them out of pocket through TrumpRx. The platform lists injectable Wegovy and Ozempic at average prices of about $350 a month, down from more than $1,000, though some pricing comparisons have found many listed drugs are available for less through existing Medicare Part D or Medicaid discounts. Even at the discounted rates, the drugs may remain unaffordable for many low-income patients.”
  • Beckers ASC Review tells us,
    • “The Federal Trade Commission has finalized a consent order requiring Ascension Health Alliance to divest seven Amsurg ASCs across five markets as a condition of its $3.9 billion acquisition of Amsurg, which closed in early June, according to an Aug. 25 news release from the FTC.
    • “The seven centers span Nashville, Panama City, Fla., Tulsa, Okla., Waco, Texas and Wichita, Kan. Six will be divested to Optum’s SC Affiliates, while the Panama City center will go to Florida Gastroenterology Center. The FTC alleged the acquisition would limit competition for outpatient surgical services performed by gastroenterologists, ophthalmologists and orthopedists in those markets, potentially leading to higher prices and lower quality of care. 
    • “The final order also requires Ascension to provide prior notice to the FTC before acquiring any additional ASCs in the metro areas around the divested centers. The Commission voted 2-0 to approve the final order.
    • “The deal, which expanded Ascension’s ASC footprint from 58 to more than 300 centers across 34 states, gives the St. Louis-based health system one of the largest ASC networks in the country.” 
  • SHRM informs us,
    • “The U.S. Department of Labor (DOL) has finalized three rules dismantling or scaling back longstanding affirmative action requirements for federal contractors, completing a major piece of the White House’s effort to reshape federal equal employment opportunity enforcement.
    • “Published in the Federal Register Aug. 21, the rules address three pillars of the regulatory framework administered by DOL’s Office of Federal Contract Compliance Programs (OFCCP): Executive Order 11246, Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA).” * * *
    • “For contractors, the result is a substantially different compliance landscape — one with fewer federally mandated affirmative action metrics and data-collection requirements. However, there remain continuing obligations to prevent unlawful discrimination and, in the disability and protected-veteran contexts, enduring statutory affirmative action duties.”

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

  • OPM published in today’s Federal Register the following final rule corrections:
    • Improving Performance, Accountability and Responsiveness in the Civil Service, and Recruitment and Relocation Incentive Waivers; Correcting Amendments FR Document:2026-17334 Citation: 91 FR 54796 PDF Pages 54796-54797 (2 pages) Permalink
    • Reduction in Force Appeals; Correction FR Document:2026-17338 Citation:91 FR 54796 PDF Page 54796 (1 page) Permalink
    • Reduction in Force; Correction FR Document:2026-17335 Citation:91 FR 54794 PDF Pages 54794-54796 (3 pages) Permalink
    • Streamlining Probationary and Trial Period Appeals; Correction and Technical Amendment FR Document:2026-17336 Citation: 91 FR 54793 PDF Pages 54793-54794 (2 pages) Permalink
    • Suitability Action Appeals; Correction. FR Document:2026-17337 Citation:91 FR 54798 PDF Page 54798 (1 page) Permalink
  • OPM Director Scott Kupor added another post to this Secrets of OPM blog (Substack link).
    • “This week, the Partnership for Public Service published an analysis claiming that agencies paid employees to leave through the Deferred Resignation Program (DRP) and then quietly hired their replacements. This is a claim that has surfaced frequently in the media in the past year: that the DRP reductions were not real because of backfills.
    • “The Partnership’s own analysis, however, confirms that these claims have no merit.
    • “According to OPM’s workforce data, 139,928 employees participated in the DRP. The Partnership identifies 20,557 subsequent hires that it considers “backfills.” Even accepting that figure at face value – the Partnership is using broad job classifications that can often encompass hundreds of actual jobs as a very imperfect proxy that likely significantly overstates actual backfills – it amounts to 14.7 percent of DRP participants.
    • Thus, more than 85 percent of employees who took the program are not matched to any subsequent hire. That’s pretty good for a program that was rolled out government-wide. Simply put, 85% of the reductions were real and lasting.”

From the Food and Drug Administration front,

  • Reuters reports.
    • “The U.S. Department of Health and Human Services is planning to appoint two new deputy commissioners at the Food and Drug ​Administration, CNBC reported, citing sources familiar with the ‌matter.
    • “One role would focus on technology, including healthcare and AI, while the other would oversee drugs, according to two people familiar with the plans.”
  • Per Fierce Pharma,
    • “Jazz Pharmaceuticals’ bispecific antibody Ziihera has gained FDA approval for first-line HER2-positive stomach cancer, unlocking another market as the company builds toward a $2 billion-plus peak sales target. 
    • “The latest green light allows Ziihera to be used in addition to chemotherapy, with or without BeOne Medicines’ Tevimbra, in previously untreated, HER2-positive advanced gastroesophageal adenocarcinoma (GEA). 
    • ‘The approval permits Jazz to challenge more than a decade of practice, in which trastuzumab (Herceptin) has been the standard HER2 agent used alongside platinum-based chemotherapy—with or without a PD-1 inhibitor—as first-line therapy for these stomach cancer patients.” 
  • The Hill tells us.
    • “Vitruvias Therapeutics is voluntarily recalling one lot of thyroid tablets because they could potentially be “superpotent,” federal regulators announced this week.
    • “The high potency 30mg tablets could cause hyperthyroidism, or an overactive thyroid, according to the Food and Drug Administration. The affected lot (504950) was distributed nationwide to Vitruvias Therapeutics’ direct accounts from Jan. 31 to Sept. 30, 2025.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) together in a single device.
    • “Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”
    • “According to the Centers for Disease Control and Prevention, an estimated 40.1 million Americans are living with diabetes, a condition that requires careful monitoring of blood sugar levels. For the estimated 2.1 million Americans with type 1 diabetes, blood sugar is only part of the picture. When the body produces too much ketone, which is made by the body when it is using fat instead of glucose for energy, it can lead to diabetic ketoacidosis, or DKA — a serious complication that can develop quickly and become life-threatening if left untreated.”
  • Beckers Hospital Review points out,
    • “The FDA cleared Amygdala Neurosciences’ Investigational New Drug application for ANS-858, allowing the company to move the drug into clinical development.
    • “ANS-858 is a selective, reversible, orally bioavailable inhibitor of aldehyde dehydrogenase 2 (ALDH2), according to an Aug. 18 news release from the company. It plans to begin a phase 1 clinical trial, which is designed to support later evaluation of ANS-858 across multiple indications in phase 2 clinical trials.
    • “Amygdala Neurosciences is initially advancing ANS-858 as a potential treatment for alcohol use disorder and other substance use disorders. It is also evaluating the drug in compulsive eating disorders associated with binge eating and obesity.”
  •  Cardiovascular Business informs us,
    • “Young M. Lee, MD, a cerebrovascular surgeon with University Medical Center New Orleans, was the first U.S. physician to perform a stroke thrombectomy with Thunderbolt, a computer-assisted vacuum thrombectomy (CAVT) system from Penumbra that gained U.S. Food and Drug Administration (FDA) clearance back in June. 
    • “Lee performed the procedure on a young male patient who presented with a right middle cerebral artery (MCA) syndrome and a right M1 occlusion. He spoke to Cardiovascular Business about the experience, noting that this first patient was an especially challenging case due to preexisting intracranial atherosclerotic disease.
    • “I was able to observe the Thunderbolt essentially detect the clot and completely aspirate the clot starting from its proximal end in the mid-M1 segment all the way up to the point of the MCA bifurcation,” he explained. “With the fluoroscopy running, I could see the aspiration catheter advance towards the MCA bifurcation as the pump responded to what was happening, which is not something you see with a traditional non-modulated aspiration technique.”

From the judicial front,

  • Federal News Network reports,
    • “The Trump administration is facing a new lawsuit from federal unions after it issued a pair of recent final rules overhauling federal employee suitability standards and performance evaluations.
    • “Filed on Monday in the U.S. District Court for the Northern District of California, the unions’ lawsuit contends that the Office of Personnel Management exceeded statutory authority and violated the intent of the Civil Service Reform Act when it issued regulations to change suitability and fitness regulations and reshape the performance management system for the federal workforce.
    • “Taken together, the changes will make it easier for OPM and agencies to fire federal employees, while limiting opportunity for employees to challenge their removals or other adverse actions, the unions argued. Their lawsuit is the latest of several legal challenges unions are taking against the Trump administration’s efforts to revise federal workforce policies and regulations.
    • “The American Federation of Government Employees is leading the lawsuit, with other plaintiffs including the National Federation of Federal Employees (NFFE), the International Federation of Professional and Technical Engineers (IFPTE) and the American Federation of State, County and Municipal Employees (AFSCME).”
  • Per a Justice Department news release,
    • “The Department of Justice today announced the emergency scheduling of three highly potent opioid compounds that pose an imminent hazard to public safety: mitragynine pseudoindoxyl, commonly known as MGPI, and two synthetic compounds known as MGM-15 and MGM-16.
    • “The Justice Department is acting before these dangerous compounds become a broader threat,” said Attorney General Todd Blanche. “These are potent opioids being manufactured and sold in consumer products, often under labels that obscure their true risks. This action will protect our nation’s children and communities from the dangers of drug addiction and abuse.”
    • “The Drug Enforcement Administration is temporarily placing the three 7-hydroxymitragynine-related substances in schedule I of the Controlled Substances Act. Preclinical evidence indicates that all three are potent mu-opioid receptor agonists and may present risks associated with other mu-opioid agonists, including dependence and respiratory depression. MGPI and MGM-15 are manufactured and marketed in products sold for their opioid effects. MGM-16 has not been confirmed in the consumer market but is a highly potent compound that could emerge as a substitute for related substances.”
  • The New York Times adds,
    • “Since the early 2000s, the number of fatal overdoses in the United States has soared. And the rate in Baltimore — 110 deaths per 100,000 residents, according to a recent analysis by the San Francisco Chronicle — is the highest among cities with a populations of a half-million or more.
    • “The initial cause was prescription opioids, then heroin, and then, starting a decade ago, a new generation of synthetic opioids, mainly fentanyl. Now, new combinations of ultrapotent lab-made drugs reach the street almost daily, making the narcotics supply — in Baltimore and beyond — more dangerous, polluted and unpredictable than it has ever been.” * * *
    • “Because lab-made drugs are so easily mixed and altered, their effect is uncertain; few buyers know what they’re actually getting, and the possibilities are expanding dangerously. Last summer, several mass overdoses in Baltimore resulted when fentanyl was mixed with N-methylclonazepam, a powerful sedative. Across the country, 22 percent of drug samples contained five or more compounds, an increase from 8.8 percent in 2022, according to testing done by the National Institutes for Science and Technology.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Two unvaccinated people in Pennsylvania have died after contracting measles, the state health department said, the U.S.’s first measles-associated deaths reported this year.
    • “Both of the people lived in Lancaster County, a populous area in the southeast part of the state known for its large Amish community, the health department said Tuesday. The deaths mark Pennsylvania’s first measles-related fatalities in 35 years and are part of a larger outbreak in the state. 
    • “Pennsylvania has confirmed more than 390 cases of measles across 28 counties so far this year, all in people who weren’t fully vaccinated. Nearly half have come from Lancaster County. About a third of the Pennsylvanians affected are under 18 years old.
    • “I want to be clear: This illness and death from measles is completely preventable,” said Pennsylvania Gov. Josh Shapiro. “We already have the tools to protect ourselves and our families from this disease, which is one of the most contagious diseases on the face of the earth.”
  • The National Institutes of Health’s Research Matters covers the following topics in its latest issue.
    • “Dementia-free years may decrease with smoking, hypertension, and diabetes.
      • “Researchers found that smoking, high blood pressure, and diabetes in midlife lower the number of years a person is likely to live without dementia.
      • “The findings could help guide behavior and lifestyle changes to prevent dementia.
    • “Coating stops tooth decay in children.”
      • “A clinical trial found that a topical treatment called silver diamine fluoride stops cavities in young children from getting worse.
      • “The simple treatment could prevent surgery and other serious consequences for children with severe tooth decay.”
    • “DNA organization changes in Alzheimer’s disease, aging.”
      • “New research showed the 3D organization of DNA in cells changes in Alzheimer’s disease and aging.
      • “The results suggest the changes may contribute to altered gene activity observed in Alzheimer’s and aging.”
  • Health Day relates,
    • “A combo of hormone therapy and targeted drugs appears to help patients with metastatic breast cancer
    • “About 97% of patients benefited during the first six months
    • “The treatment, mainly using pills and under-the-skin injections, could eventually offer some patients an easier first-line option.”
  • and
    • “Hoping for a quick response from your doctor to a message sent through your patient portal?
    • “Then keep it cordial and positive, a new study suggests.
    • “Doctors were more likely to respond to messages that addressed them by name and had a positive tone, researchers reported Aug. 24 in JAMA Network Open.”
  • Beckers Hospital Review lets us know,
    • “Pediatric medications have more active FDA-listed shortages than any other therapeutic category, according to the FDA’s drug shortage database.
    • “Here are the categories with the most active shortage listings, ranked by number of active shortages as of Aug. 25:
      • 1. Pediatric: 18
      • 2. Anesthesia: 10 (tie)
      • 2. Cardiovascular: 10 (tie)
      • 3. Analgesia/addiction: 9 (tie)
      • 3. Gastroenterology: 9 (tie)
      • 4. Endocrinology/metabolism: 8 (tie)
      • 4. Neurology: 8 (tie)
      • 5. Anti-infective: 7 (tie)
      • 5. Oncology: 7 (tie)
      • 5. Psychiatry: 7 (tie)

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

  • Beckers Payer Issues reports,
    • “Most large health insurers posted stronger-than-expected earnings in the second quarter, but much of the improvement might not be durable, according to a Moody’s Ratings analysis published Aug. 24.
    • “Average EBITDA margins across the seven largest publicly traded insurers rose to 4.7% in Q2, up from 3.9% in the same period a year earlier. UnitedHealth Group posted the largest swing, expanding to 6.2% from 3.7%, while Centene jumped to 3.7% from 0.6% on the back of marketplace margin recovery and outperformance in its Medicare Advantage and prescription drug plan businesses. Five of the six insurers that reported results raised or affirmed full-year guidance.
    • “The rating agency cited high-cost specialty drugs, sustained behavioral health demand and aggressive provider billing and coding as ongoing pressures. The report also described a “clear industry pivot toward margin stabilization rather than top-line growth,” calling the shift broadly credit positive.”
  • Beckers ASC Review adds,
    • “For nearly as long as health insurers have used prior authorization to control costs, physicians and hospitals have argued it does more harm than good. 
    • “The pushback against prior authorization has reached new heights in recent months as healthcare leadership, legislators and physician advocacy organizations have proposed major reforms or outright bans of the practice.” 
  • Healthcare Dive relates,
    • “Name: Dr. Patrick Fox
    • “Previous title: President, Wellpoint New Jersey
    • “New title: President, Carelon Behavioral Health
    • “Fox is assuming the top role at Elevance’s behavioral health division effective immediately, the Indianapolis-based insurer announced Monday.”
  • Beckers Hospital Review tells us,
    • “New York City-based NewYork-Presbyterian reported operating income of $124.2 million (4% operating margin) during the second quarter of 2026, up from $101.7 million (3.6% margin) during the same period last year, according to its Aug. 24 disclosure report.”
  • and
    • “Orlando (Fla.) Health recorded operating income of $81.5 million (3.0% operating margin) in the third quarter of fiscal 2026, up from $56.3 million (2.2% margin) during the same period last year, according to its Aug. 25 finance report.”
  • and
    • “As health systems continue to grapple with financial pressures from rising labor and supply costs and reimbursement challenges, days cash on hand remains an important measure of financial stability. 
    • “[The article shares} days cash on hand figures for 25 health systems as of June 30, according to their most recent financial reports”
  • Fierce Healthcare tells us,
    • “The Oregon Health Authority (OHA) approved a deal on Monday that would merge the nonprofits MultiCare Health System and Samaritan Health Services.
    • “State regulators said the OHA’s Health Care Market Oversight (HCMO) program reviewed how the proposed merger would affect Samaritan’s facilities and its impact on Oregon citizens’ access to affordable and equitable healthcare. 
    • “HCMO approved the deal provided it meets established conditions (PDF), including requiring MultiCare to follow its financial commitment of investing $700 million towards Samaritan and posting a public-facing version of the commitment on Samaritan’s website. Other conditions involve reinvestment of Samaritan’s operating margins into local communities and a requirement to maintain existing services.”
  • and
    • “Artificial intelligence-driven specialty care navigation platform Switchboard Health announced Tuesday the acquisition of virtual orthopedics and musculoskeletal (MSK) management provider Livara Health.
    • “Switchboard Health will embed Livara’s MSK program in its automation platform for referral management and care navigation, through the acquisition, to enable providers and health plans to enroll patients.
    • “Financial details of the transaction were not disclosed.”
  • Beckers Physician Leadership informs us,
    • More than half of active U.S. physicians worked for hospital systems as of 2024, up from 20% in 2010, and hospital systems have acquired more than 20,000 physician practices since 2015, according to a recent study published in JAMA Network Open.
    • Becker’s ASC Review tracked more than 50 physician practice deals in 2026 — with consolidation taking over some areas of medicine more than others. 
    • [The article provides] a breakdown by across five specialties.

Notable Death

  • The Wall Street Journal reports,
    • “One night in 1973, Dolly Parton had a song on her mind. She was thinking about a bank teller who had been flirting with her spouse.
    • “She got this terrible crush on my husband,” Parton told NPR in 2008. “And he just loved going to the bank because she paid him so much attention.”
    • “Needing a name for this tall, redheaded temptress, she thought of another flame-haired girl, an 8-year-old who approached her for an autograph after a taping of “The Porter Wagoner Show,” the TV series on which she was featured. That child’s name was Jolene.
    • “Parton died Tuesday at age 80 in Nashville, Tenn., according to her family. The cause of death wasn’t released. In May, Parton canceled a Las Vegas residency because of health issues.”
  • Beckers Hospital Review adds,
    • “Beyond her music and film career, Ms. Parton spent decades directing philanthropic dollars toward hospitals and medical research, much of it concentrated in her native East Tennessee and at Nashville-based Vanderbilt Health. [The article shares] seven ways her giving left an imprint on healthcare.

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Electronic health records, FDA, Federal employment benefits, HSA, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Beckers Hospital Review reports,
    • “The U.S. national debt surpassed $40 trillion for the first time Aug. 19, adding another layer of financial uncertainty for hospitals already navigating elevated borrowing costs and significant federal reimbursement pressures, according to The New York Times. 
    • “The news comes as the federal government is on track to borrow more than $2 trillion this year, with rising interest expenses consuming an increasingly large share of federal spending, according to the report. 
    • “The knock-on effects extend far beyond the federal government’s balance sheet. Higher Treasury yields can increase hospitals’ cost of capital, while the deteriorating fiscal outlook could intensify scrutiny of Medicare, Medicaid and other federal healthcare programs already targeted by the Trump administration for spending reductions.”
  • STAT News relates,
    • “Erica Schwartz, the new director of the Centers for Disease Control and Prevention, told agency staff on Wednesday that she was prepared to disagree with administration leaders and sought to empower others to do the same, according to a recording of the meeting obtained by STAT.
    • “During her first all-hands address on Wednesday, Schwartz identified three priorities: preserving trust through radical transparency and scientific rigor; strengthening the CDC’s ability to respond to disease threats; and building up the agency’s relationship with state and local partners.”
    • “She said she was ready to stand up to health secretary Robert F. Kennedy Jr. if needed to accomplish those goals.
    • :Schwartz said she wasn’t blind to what her predecessor, Susan Monarez, went through — being fired because she wouldn’t agree to follow Kennedy’s orders on vaccine policy — and said she was clear with Kennedy she would act and share information as a physician.
    • “I feel very comfortable and very confident, already having like three or four meetings with them since I started this position, of speaking truth to power,” she said. “I do not feel at all challenged with speaking, you know, what the science tells me and what you all are telling me to represent for the CDC.”
  • Per a CMS news release,
    • “The Trump Administration announced a $90 million investment is being delivered to South Dakota through the federal Rural Health Transformation Program (RHTP) to accelerate digital health modernization, strengthen cybersecurity, and enhance interoperability across rural and underserved communities. This investment will strengthen South Dakota’s health workforce, improve infrastructure, advance technology, and support innovative approaches tailored to the unique healthcare needs across the state.
    • “President Trump understands that every American deserves high-quality healthcare, no matter where they live,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are putting resources directly into rural communities to strengthen the health workforce, modernize infrastructure, expand access, and bring care closer to home. We are giving states the flexibility to build solutions around the people they serve, while demanding accountability for results. That is how we strengthen rural health, improve the lives of patients and families, and Make America Healthy Again.”
  • Beckers Payer Issues tells us,
    • “The average end-of-year balances for health savings accounts reached $5,532 in 2024, up from $4,747 the year prior.
    • “However, that balance fell far below out-of-pocket maximums. In 2025, out-of-pocket maximums for HSA-eligible health plans were $8,300 for individual coverage and $16,600 for families.
    • “The Employee Benefit Research Institute released an issue brief Aug. 13 detailing HSA trends from 2011 through 2024. The institute formed its HSA database more than a decade ago. As of the end of 2024, the database had 15.2 million accounts with total assets of $53.7 billion.
    • “The report outlined the “triple tax advantage” of HSAs: tax-free contributions, tax-free growth and tax-free qualified withdrawals.”
  • Fierce Healthcare points out,
    • “While many individuals believe they have a firm grasp on their Medicare benefits, the reality is far different, according to a new survey.
    • “Insurance agency eHealth conducted a survey of 1,000 Americans and found that 89% of beneficiaries feel “confident” that they understand their Medicare benefits and coverage options. However, just 13% could identify each of the main facets of Medicare, such as the traditional program, Medicare Advantage, Part D and Medicare supplement plans.
    • “In addition, most (88%) said they did not know there is no annual cap on out-of-pocket spending in traditional Medicare, while 82% of those nearing Medicare eligibility said they were not aware that there is a 20% coinsurance for medical services.
    • “Close to half (42%) of beneficiaries were unaware or underestimated that 20% coinsurance, according to the report.”
  • Beckers Behavioral Health informs us,
    • “The percentage of U.S. adults who report doing any kind of gambling during the past year fell to 45%, down from 64% a decade ago, according to an Aug. 17 report from Gallup. 
    • “The findings are based on telephone interviews conducted by ReconMR June 1 to July 19, 2026, with a random sample of 2,201 adults, aged 18 and older, living in all 50 U.S. states and the District of Columbia. Gallup also conducted a web survey from June 1-15, 2026, with a stratified random sample of 2,043 adults, aged 18 and older, who are members of the Gallup Panel.’ 

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

  • FedWeek lets us know,
    • “The [Federal Employee Benefits] open season this year will run November 9-December 14. Available plans and their premiums for the upcoming year typically are announced a month or so in advance, with fuller details released just ahead of the enrollment period.”
  • OPM Director Scott Kupor made his latest post to his Secrets of OPM blog available on LinkedIn today. The post concerns a recent OPM employee survey.

From the Food and Drug Administration front,

  • CBS News reports,
    • “The Food and Drug Administration upgraded a recall of frozen blueberries and mixed berries sold at Publix grocery stores across the U.S. to the highest health risk level on Tuesday, according to an enforcement report.” 
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) to reduce daily cornstarch intake as an adjunct to nutritional management in adults and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa), a rare, inherited genetic disorder caused by a deficiency of the enzyme glucose-6-phosphatase, which prevents the body from properly breaking down stored glycogen into glucose. Genglycos is the first approved treatment for this condition.
    • “The accelerated approval pathway allows the FDA to approve certain drugs or biologics intended to treat a serious or life-threatening disease or condition if the agency determines the treatment has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
    • “Patients with GSDIa face possible life-threatening complications and have limited treatment options that include primarily life-long, strict dietary management,” said Karim Mikhail, B. Pharm., M.S., acting director of the Center for Biologics Evaluation and Research (CBER). “Today’s approval is a great milestone in using a gene therapy to treat this disease and improve the quality of life for people with this condition.”
  • and
    • “The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the current phlebotomist shortage in the U.S.
    • “This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.”
  • Fierce Pharma tells us,
    • “After more than 10 years in development, Regeneron secured a landmark approval for its monoclonal antibody garetosmab, now commercially known as Pasatru. The drug has become the second cleared by the FDA to treat fibrodysplasia ossificans progressiva (FOP) and the first to reduce clinician-assessed flare-ups in adults with the disease.
    • “Pasatru, given intravenously every four weeks, is designed to block what is believed to be the key protein behind the FOP disease process—activin A—which was pinpointed by Regeneron scientists as a possible target for treating FOP more than a decade ago. 
    • “The approval follows a victory last year in a phase 3 study, which randomized 63 adults with FOP to receive one of two doses of the anti-activin A antibody or placebo every four weeks for 56 weeks. In the trial, both high- and low-dose Pasatru reduced new bone lesions in FOP patients by 90% over 56 weeks. And high dose Pasatru reduced bouts of painful localized inflammation by 89% compared to placebo, too.
    • “By the end of the trial, an independent data monitoring committee recommended all patients on placebo be switched to Pasatru as soon as possible.” 

No Surprises Act News,

  • Modern Healthcare reports,
    • “Providers are triumphing against insurers in bitter out-of-network billing battles at a record pace and by an unprecedented margin.
    • “President Donald Trump enacted the No Surprises Act in 2020. The law succeeded in protecting patients from many surprise medical bills. But its baseball-style arbitration system was quickly overwhelmed.
    • “Independent Dispute Resolution filings represent a tiny percentage of commercial health insurance claims, but cases have increased each year since the process debuted in 2022. Disputes rose almost 75% to more than 2.5 million from 2024 to 2025, according to an analysis of Centers for Medicare and Medicaid Services data the Niskanen Center published in July. CMS originally projected there would be about 17,000 cases a year.
    • “Providers won 83.6% disputes in the fourth quarter of 2025, a share that’s been consistent since 2023, according to the Niskanen Center, a centrist think tank.
    • “Provider groups maintain these wins are warranted and arbitrators have agreed. Publicly held insurers including UnitedHealth Group subsidiary UnitedHealthcare, CVS Health subsidiary Aetna and Elevance Health contend out-of-network providers are abusing the system. Last month, CMS acknowledged arbitration is not working as intended and suggested it would take action.
    • “When we look at other models of arbitration, the win rates tend to be 50-50, and it tends to be a pretty rare option of last resort,” said Christopher Whaley, a health economist at Brown University. ”Obviously, that’s not happening in the No Surprises Act arena.”
  • FEHBlog observation: The NSA IDR rules stack the deck in favor of the providers who have inside information on the provider’s credentials and the patient’s acuity.

From the judicial front,

  • Fierce Pharma reports,
    • “In their attempts to challenge the Medicare drug price negotiation program, introduced by former President Joe Biden under the Inflation Reduction Act (IRA), biopharma companies have been largely shut out in federal courts.
    • “On Tuesday, however, Teva Pharmaceuticals gained a partial win as the U.S. Court of Appeals for Washington, D.C. sent (PDF) a previous ruling back to the District Court for further review. It concerns Teva’s challenge to the requirement by the Centers for Medicare & Medicaid Services (CMS) that a generic drug be genuinely marketed before its brand-name reference product is excluded from negotiation.
    • “The appeals court did not decide on the legality of the CMS’s “bona fide marketing” standard. It only determined that it should be considered by the lower court. 
    • “The district court never addressed whether CMS’s standard comports with the IRA, and we leave that question for it to consider in the first instance,” Circuit Judge J. Michelle Childs wrote.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Packaged-food makers are testing new strategies to appeal to consumers using GLP-1 weight-loss drugs, which suppress hunger and alter taste.
    • “JPMorgan estimates that GLP-1 treatments could drain $30 billion to $55 billion in annual revenue from the food and beverage industry by 2030.
    • “Companies like Conagra and General Mills are developing protein-rich products aimed at GLP-1 users.”
  • Health Day adds,
    • “Are you worried that extra pounds might be harming your health?
    • “Check the notches on your belt, a new study suggests.
    • “Waist size might be one of the simplest and most effective measures to detect health risks associated with obesity, researchers reported recently in JAMA Network Open.
    • “Pay attention to the need to loosen your belt or get bigger pants,” lead researcher Dr. Aayush Visaria said in a news release. He is a faculty member at Rutgers Health-RWJBarnabas Health Center for Climate, Health, and Healthcare in New Jersey. 
    • “Although clothing size isn’t the same as a proper waist circumference measurement, it can be an early sign of unhealthy amounts of body fat,” Visaria said. “Measuring your waist, along with your weight, can help identify health risks earlier and provide an opportunity to reduce your risk of diabetes, heart disease, stroke and some cancers.”
  • Cardiovascular Business relates,
    • “Rates of heart failure (HF) in the United States are stable or even beginning to decline. When it comes to HF with preserved ejection fraction (HFpEF), however, the numbers are on the rise. 
    • “This prompted the American College of Cardiology (ACC) to create an expert consensus decision pathway document focused on the efficient management of HFpEF patients.[1]
    • “The new document represents an update of the ACC’s 2023 recommendations, exploring new data to provide an abbreviated, practical guidance for patient management. The format was revised to associate treatment algorithms and tables to match the evolving clinical evidence.
    • “Despite advances in HF therapy, it remains a major consumer of healthcare resources and death worldwide. HFpEF accounts for more than 50% of new cases of HF each year and has outcomes comparable to heart failure with reduced ejection fraction (HFrEF). However, the consensus authors said HFpEF is often underdiagnosed and results in substantial resource utilization.”
  • and
    • “The use of artificial intelligence (AI) to identify incidental cardiac findings is a growing area of research, and now the identification of aortic stenosis (AS) is being tested on noncardiac chest CT scans. Cedars-Sinai Medical Center researchers are conducting a real-world study of an opportunistic algorithm that looks at all chest scans for the hallmark signs of AS.
    • “Some imaging experts have said this specific use of AI could serve as an early screening system to catch patients with heart disease years before they would become symptomatic, adding diagnostic value beyond why these scans were originally ordered. AS is one of the most common and serious heart valve disease problems, but most patients are unaware they have it at first and go undiagnosed until they become symptomatic. The American Heart Association (AHA), for example, believes there is still a sizable population of patients who remain undiagnosed or untreated.” 
  • Medscape offers physicians “Five Steps to Earlier Heart Failure Detection.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded scientific team has shown that under the right circumstances, 3D cell culture models of human brain tissue, known as organoids, can express features of later stage brain development. This breakthrough could turn previously unattainable, long-term, benchtop studies of neurodevelopmental disorders into a reality.
    • “The unprecedented longevity and lifelike qualities of these tissue models could afford us the opportunity to dig deeper into how conditions such as autism emerge and unfold later in life,” said Andrea Beckel-Mitchener, Ph.D., acting director of NIH’s National Institute of Mental Health (NIMH).”
  • Genetic Engineering and BioTechnology News adds,
    • “The Human Cell Atlas (HCA) was co-founded in 2016 by Aviv Regev, PhD, currently the head, executive vice president of research and early development at Genentech and Sarah Teichmann, FMedSci FRS, professor at the University of Cambridge and vice president translational research at GSK.
    • “This year, the group celebrated its 10-year anniversary, at the annual meeting in June, held in Boston. The first day was focused on the successes of the past decade. The second day looked ahead to the future, and the impact the HCA will make on research and drug discovery. GEN spoke with Holger Heyn, PhD, ICREA professor at the Centro Nacional de Análisis Genómico (CNAG) and co-founder of Omniscope about the meeting and what the next 10 years may bring. Heyn has been with the HCA since (almost) the beginning and currently serves as the co-chair of the Standards and Technologies working group, co-chair of the Industry Partnership Program, an organizing committee member, and a member of the task force to design HCA 2.0.”
    • The interview can be found in the article.
  • In the big research news of the day, the New York Times informs us,
    • “An experimental mRNA vaccine allowed people with high-risk melanoma to live longer, cancer-free, the pharmaceutical companies Moderna and Merck announced Wednesday.
    • “For decades, cancer vaccines have been one of the most tantalizing ideas in cancer treatment — offering the hope of harnessing a person’s own immune system to attack tumors.
    • “It’s a big deal,” said Dr. Elias Sayour, a pediatric oncologist at the University of Florida, who was not involved in the trial. The results, he said, “could help usher a whole new wave of new therapeutic treatments for cancer.” * * *
    • “The study is the most advanced of a number of trials testing the approach against a variety of cancers, including lung, bladder, kidney and pancreatic cancer. While small trials have shown the promise of the approach, the Moderna and Merck trial was seen as a bellwether in demonstrating the technology — and a first step toward transforming cancer care with treatments that are individualized to a person’s tumor and that may ultimately be able to stay ahead of it as it changes.”
  • The Wall Street Journal adds,
    • “Novo Nordisk is studying smaller doses of its Wegovy weight-loss pill to find the lowest dose that still allows patients to lose weight.
    • “The study began last week, has enrolled 450 overweight people and will test two low doses of the pill compared to a placebo.
    • “Novo Nordisk recently disclosed that uptake of the pill has been particularly strong for its lowest doses across self-paying patients.”

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

  • The Association of Healthcare Journalist reports,
    • “Investing more in primary care is linked to lower health care costs, according to a new report.
    • Journalists can cover this story nationally and locally, especially in rural areas where access to primary care can be more challenging, according to the report, “Investing in Primary Care: The Missing Strategy in America’s Fight Against Chronic Disease,” from the Milbank Memorial Fund.
    • “The report matters to reporters because it shows that adults and children with primary care physicians (PCPs) or a regular source of primary care have lower health care costs than those without.
    • “The report comes as Congress and President Trump are implementing changes under the 2025 budget reconciliation bill, cutting billions of dollars in federal Medicaid spending. Such a big decrease means low-income families could lose their Medicaid coverage, and not all physicians will treat the uninsured, the Milbank report notes. 
    • “The Milbank report is also timely because federal efforts since 2021 to increase the number of primary care doctors “have fallen short”, as Dennis Thompson reported for HealthDay. Primary care positions increased by just 2% under laws Congress passed in 2021 and 2023 to increase U.S. medical residencies, while residency positions in interventional radiology and psychiatry increased the most, rising by 16% and 13% respectively, he wrote, citing research JAMA published in June.” 
  • Beckers ASC Review adds,
    • “Physicians who once worked in a physician-owned practice before their current job are significantly more likely than their peers to be heading for the exit, according to the 2026 PAI Employed Physician Survey.
    • “Among physicians with prior experience in a physician-owned setting, 35% cite a lack of clinical autonomy as a reason they’re considering a new job, compared with 21% of physicians who’ve never practiced outside a corporate structure. They’re also more likely to say they plan to leave clinical practice entirely before retiring — 20% versus 12%.
    • “That group also reports operating under tighter terms: 63% are bound by a non-compete agreement, versus 48% of physicians without prior independent-practice experience, and 53% have patient-volume targets built into their compensation, versus 41%.”
  • Beckers Hospital Review relates,
    • “Altamonte Springs, Fla.-based AdventHealth recorded operating income of $916.2 million (13.4% operating margin) during the second quarter of 2026, up from $657.4 million (11.7% margin) during the same period last year.”
  • Beckers Health IT tells us,
    • “A year ago, health system CIOs walking the halls of Epic’s Users Group Meeting were still convincing themselves — and their boards — that generative AI in the EHR was more than a demo. This year, that debate is over. The new one is about speed.
    • “What strikes me overall is just the pace is blistering,” Tom Bentley, BSN, RN, chief information and digital technology officer of Columbus-based Ohio State University Wexner Medical Center, told Becker’s at the EHR giant’s sprawling headquarters in Verona, Wis. “Epic is cranking out new functionality, and I’m thinking what every CIO is thinking about: How do we increase our pace of adoption?”
    • “Epic used its Aug. 18 keynote to detail the scope of that push, including its Agent Factory platform that will soon allow health systems to build their own AI agents, the advancement of Cosmos-powered prediction tools called Curiosity, and the debut of an AI-assisted outpatient visit called Ergo.”
  • Beckers Payer Issues adds,
    • ‘The health systems and health plans that have pushed AI furthest into their operations are among the least equipped to prove what it is returning, according to a survey of 64 U.S. healthcare CFOs and finance leaders published Aug. 12 by Deloitte.
    • ‘Only 18% of organizations Deloitte classified as “AI scalers” said they have mature financial attribution capabilities, meaning they consistently measure AI’s effect on revenue growth or cost savings with defined baselines and clear ownership of key performance indicators. Among “AI starters,” 31% reported that level of maturity.’

Tuesday report

David Ermer–CDC, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Washington Post reports about the President’s August 10, 2026, executive order on child vaccinations.
    • “Insurers probably would still cover childhood vaccines even if Trump administration officials change the schedule. 
    • “If this EO were to withstand legal scrutiny, it appears insurers should still cover recommended vaccines for free,” Jennifer Kates, a senior vice president at KFF, a health policy research and news organization, wrote in an email. She added that spacing the shots over multiple visits is already an option for parents. 
    • “Major insurers have also previously indicated they would continue to cover vaccines even in the face of potential changes. White House officials told reporters on Monday that they believed health insurers would continue to cover vaccines currently on the childhood immunization schedule regardless of whether recommendations change.”
  • STAT News relates,
    • “As of July 1, eligible Medicare beneficiaries may obtain these medications for a sharply discounted out-of-pocket cost of $50 per month. That is the headline many patients will hear and remember.
    • “What follows, however, is far more complicated. Eligibility depends on a detailed checklist of body mass index thresholds, specific combinations of chronic conditions, and prior treatment histories. Many patients will not absorb these details, and many clinics will need time and effort to interpret them.” * * *
    • “As a result, the administrative workload associated with GLP‑1 prescribing often rivals the clinical work itself, stretching already limited primary care resources and diverting attention from other critical aspects of chronic disease management.
    • “Each step introduces friction — points where patients may be delayed, confused, or lost in the process entirely. Programs that are difficult to navigate tend to benefit those with time, health literacy, and persistent advocacy while leaving behind those who are already at risk of poorer outcomes. A benefit that exists on paper is altogether different from access in practice.
    • “For clinicians, the burden is also real. Primary care is already stretched thin, managing rising patient complexity alongside mounting administrative demands. Many practices will absorb this new Bridge workload, driven, as always, by a commitment to their patients. But that commitment is not an unlimited resource. Each additional administrative layer adds to the strain on a specialty already facing workforce shortages, burnout, and declining morale.
    • “Faced with these demands, some private practices may decide that participation in the Bridge program is simply not sustainable.” 
  • MedTech Dive tells us,
    • “Orthopedics firms are shrugging off worries that a new, mandatory Medicare joint replacement model could drive down implant payments.
    • “The Centers for Medicare and Medicaid Services finalized the Comprehensive Care for Joint Replacement Expanded Model, called CJR-X, as part of its hospital inpatient payments rule at the end of July. CJR-X would go into effect in 2028, making hospitals responsible for more spending on joint replacement surgery and associated costs, including the hospital stay and follow-up care provided in the first 90 days of recovery. Hospitals may be eligible for an additional payment from Medicare, or may be required to repay a portion of a patient’s care, depending on quality and spending. Regulators expect the model to save the government $725 million over five years.”

From the Food and Drug Administration front,

  • Reuters reports,
    • “The U.S. Food and Drug Administration on Tuesday finalized guidance for preparation and ‌packaging of fresh-cut produce, recommending measures such as sanitation control, supplier verification and refrigeration to reduce the risk of foodborne illnesses.
    • “The guidance for ready-to-eat produce comes as ongoing outbreaks of cyclosporiasis and salmonella due to contaminated lettuce and jalapenos ​have sickened thousands of people in the United States.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has finalized a new recall related to an issue with certain Johnson & Johnson MedTech introducer sheaths. 
    • “These devices are used to introduce Impella heart pumps to the bodies of patients. Johnson & Johnson MedTech and Oscor, the company’s manufacturing partner, received multiple reports of the sheaths leaking in ways that could result in access-site bleeding. 
    • “If leakage does occur, it would come from the device’s sidearm or under the sheath cap. This issue has only been seen with specific lots of 14 and 23 French introducer kits compatible with the Impella RP Flex with SmartAssist, Impella RP Set with SmartAssist, Impella 5.5 Set with SmartAssist, and Impella CP Set.”
  • and
    • “Bracco Imaging has secured U.S. Food and Drug Administration (FDA) clearance for VueJect, a new ultrasound contrast delivery system built specifically for cardiovascular imaging procedures. This represents the latest addition to Bracco’s contrast-enhanced ultrasound (CEUS) portfolio. 
    • “According to Bracco, VueJect was designed to improve workflow efficiency, provide consistency from one operator to the next and enable the continuous administration of ultrasound contrast agents such as Bracco’s Lumason.” 

From the judicial front,

  • The International Foundation of Employee Benefit Plans notes,
    • “The Federal Trade Commission’s settlements with Caremark Rx and Express Scripts could reshape how pharmacy benefit managers present pricing options to plan sponsors. While the PBMs denied allegations that they inflated insulin costs, the settlement orders require new standard offerings designed to increase transparency, limit member out-of-pocket costs and give plan sponsors clearer alternatives to rebate-driven pricing.
    • “A previous blog covered the FTC orders requiring Caremark Rx and Express Scripts to stop favoring high-list-price versions of drugs over identical low-list-price versions on their standard formularies. This post looks at the settlement terms most relevant to plan sponsors and members.”

From the public health and medical / Rx research front

  • The Washington Post reports,
    • “About 30,000 pounds of Argentine beef has been recalled by the U.S. Agriculture Department because it wasn’t inspected before entering the country. 
    • “The different cuts of raw beef from the company Corte Argentino USA were shipped to retailers and grocery distributors in Florida and Texas. The meat was produced from May 15 to May 20 and had freeze-by dates of Sept. 15-20. 
    • “The recalled meat included cuts of top sirloin and eye round.
    • “The Agriculture Department’s Food and Safety Inspection Service checks imported products for packaging, documentation, condition and contamination. The agency said no confirmed cases of illness have been linked to the products. 
    • “Consumers are advised not to eat the meat, and either discard it or return it for a refund.”
  • MedPage Today relates,
    • “The CDC on Tuesday warned doctors about the risk for severe arboviral neuroinvasive diseaseopens in a new tab or window in patients on B cell-depleting or modulating agents, calling out anti-CD20 monoclonal antibodies in particular.
    • “Published case reports indicate an overall mortality of about 40% for patients on anti-CD20 antibodies with arboviral neuroinvasive disease, and neurologic sequelae were common in survivors. The most common virus involved in the reports was West Nile, but severe cases also involved eastern equine encephalitis, Powassano, La Crosse, and others.
    • “In recent years, a novel clinical presentation of chronic, neurodegenerative encephalitis developing over months to years has been described in at least five patients receiving rituximab who were infected with an orthobunyavirus, including Jamestown Canyon virus, Cache Valley virus, or Potosi virus,” the CDC said in a Health Alert Network advisory.”
  • and
    • “Guidelines recommend individualizing HbA1c goals to health status in older adults with type 2 diabetes.
    • “A review of electronic health records found that most older adults with type 2 diabetes outside target HbA1c goals didn’t receive medication adjustments in the right direction.
    • “Only 17% of below-goal patients had their regimen deintensified, while 33% of above-goal patients had their treatment intensified.”
  • Beckers Hospital Review tells us,
    • “Researchers at Baltimore-based University of Maryland School of Medicine found approximately 5% of adults hospitalized with firearm injuries develop a bacterial infection, with most infections occurring during hospitalization.
    • “The study, published Aug. 3 in JAMA Network Open, used the Premier Healthcare Database to analyze 24,024 adults hospitalized with firearm injuries at 323 hospitals between January 2019 and May 2021. Bacterial infection was defined by positive culture results from any source and antibiotics initiated within 2 days of those results that were continued for at least four days or until discharge.”
  • Healio adds,
    • “Percentages of adolescents who engaged in suicidal thoughts and behavior fell from 2021 to 2025, according to the 2025 National Survey on Drug Use and Health.
    • “These are encouraging trends,” Brandon Johnson, MHS, MCHES, chief, suicide prevention branch, Substance Abuse and Mental Health.”
  • Cardiovascular Business informs us,
    • “Abdominal fat is a more accurate predictor of heart disease than body mass index (BMI) alone, according to new findings published in JACC.[1]
    • “BMI remains the most common way that clinicians determine if an individual is overweight or obese. The team behind this new analysis hoped to learn if taking waist circumference (WC) and waist-to-hip ratio (WHR) into account could lead to better assessments of a person’s risk of developing cardiovascular disease (CVD). 
    • “The study included data from more than 260,000 adults over the age of 20 years old. The median follow-up period was 20 years. 
    • “Among patients with a normal weight as determined bv BMI, 5% had a high WC and 18% had a higher WHR. Among overweight patients, 39% had a high WC and 40% had a high WHR. Finally, among obese patients, 9% had a low WC and 45% had a low WHR.”
  • The New York Times points out “The Best Healthy Eating Advice of 2026 (So Far).”
    • “Frozen yogurt is not exactly a health food.”
    • “Your diet influences your cancer risk.”
    • “Be wary of ‘low-carb’ diets.”
    • “The science of intermittent fasting isn’t as sound as you may think.”
    • “Oats are powerhouses of nutrition.”
    • “There is such a thing as too much protein.”
    • “You should probably try to get more fiber.”
    • “The dangers of alcohol start at one drink per day.”
    • “Don’t pass on peas.”
    • “Sipping warm water before breakfast has benefits, but is not a cure-all.”
  • The latest NIH Research Matters post covers the following topics,
    • Childhood screen detects mental health risks
      • Screening for home and family stresses may help identify children at risk for depression and sleep disorders that traditional adversity screening misses.
      • This type of screening could be used to identify and intervene with children at risk of mental health conditions.
    • Immune cells cross blood-brain barrier during human aging
      • “Researchers found that some of the brain’s immune cells are replaced by immune cells from bone marrow as people age.
      • “The findings suggest that scientists might one day be able to use immune cells born outside the brain to deliver therapies for brain disorders.”
    • Improving Parkinson’s disease treatment
      • “Researchers identified a drug candidate that enhanced effectiveness and reduced side effects of the standard Parkinson’s disease treatment in animal models.
      • “If the drug candidate proves effective in people, it could be an effective way to improve treatment for Parkinson’s disease.”
  • Health Day points out,
    • “Heart health appears to affect brain health among people with a genetic risk for Alzheimer’s disease, a new study says. 
    • “People whose hearts are pumping blood less effectively tend to have brains that are shrinking faster, researchers recently reported in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.
    • “This is true among people who carry APOE-ε4, a genetic variant that is known to increase risk of Alzheimer’s, researchers said.
    • “Our findings suggest that even subtle reductions in cardiac function may have important implications for brain health, particularly among individuals at increased genetic risk for Alzheimer’s disease,” lead researcher Dr. Elizabeth Moore said in a news release. She’s a clinical fellow in neurology at Mass General Brigham in Boston.”
  • and
    • “If you have atrial fibrillation, or A-fib, getting moving may make a real difference.
    • “A-fib is an irregular heartbeat that raises the risk of stroke — and it affects an estimated 10.5 million adults in the U.S. Yet research shows that people with A-fib tend to be less active than the general population.
    • “A new study of more than 87,000 adults found that even a little physical activity was tied to better odds of avoiding stroke and death — and the benefits held up whether or not participants had A-fib.”
  • The New York Times lets us know,
    • “A.I. Is Finding Sperm Where Doctors Couldn’t
    • “New technology may make it easier for men with extremely low sperm counts to have biological children.”

From the U.S. healthcare business front

  • Beckers Hospital Review reports,
    • “Kaiser Permanente has committed up to $32 million to support the expansion of the Hope Emergency Center at Martin Luther King Jr. Community Hospital in Los Angeles.
    • “The commitment includes a $25 million charitable grant, the largest gift in the hospital’s history, along with the purchase and loan of a $7 million modular building to keep emergency care running during construction, according to an Aug. 11 news release. The funding will also support long-term improvements to emergency services in South Los Angeles.”
  • and
    • “Nonprofit systems expand into Pennsylvania as for-profits exit.” * * *
    • “The expansion of large nonprofit systems into Pennsylvania might suggest the state has become more attractive, but worsening conditions are leaving smaller hospitals with fewer options.
    • “I’d actually say it’s less attractive to expand [into Pennsylvania] than in the past,” Ben Gerber, CEO of Peak Health and senior vice president and chief strategy officer of WVU Medicine, told Becker’s. “But the hospitals there are running out of options, and they can’t survive on their own. They need partners with broader scale and capability.
    • “It’s not that it’s become more attractive for us; it’s that it’s become impossible for smaller health systems to continue standing, and someone’s got to step in.” 
  • Beckers Behavioral Health relates,
    • “Smithfield, N.C.-based Johnston Health has the lowest median emergency department visit time for psychiatric and mental health patients.
    • “Becker’s has compiled lists of hospitals and health systems with the shortest and longest emergency department visit times for psychiatric and mental health patients using CMS’ Timely and Effective Care-Hospital data. 
    • “The CDC tracks the median length of stay for ED patients as part of its “timely and effective care” measure set. The data was released May 13 and covers ED visits recorded from July 2024 through June 2025. Measures in this dataset apply to all adults and children treated in hospitals paid under either the inpatient or outpatient prospective payment systems. Learn more about the measures here.
    • “Most hospitals on the list of the shortest visit times are small community or critical access hospitals that may see lower annual ED volumes and patient acuities than facilities operating level 1 or 2 trauma centers. CMS does not include hospitals’ total ED volumes or case mix index in its dataset. To effectively assess ED performance, experts recommend benchmarking against a cohort of similar facilities.
    • [The article identifies] 20 hospitals and health systems with the shortest and longest median ED visit times before leaving the visit, along with the sample size.
  • Fierce Healthcare lets us know,
    • “Health insurers are under significant financial pressure, and the gap between the organizations that are adapting and those that are not is growing, according to a new report.
    • “HealthScape Advisors, an organization under Chartis, released its annual look at health plans’ financial performance and found that the number of plans posting an operating loss has increased over the past several years. In 2023, 54% of health plans reported an operating loss, and that grew to 70% in 2024.
    • “The number of insurers with an operating loss then rose a second time to 73% in 2025, according to the report.
    • “Operating losses are concentrated among regional plans and Blues plans, with 72% of regional insurers and 83% of Blues reporting one in 2025.”
  • MedTech Dive tells us,
    • “Teledyne Technologies said Monday it has agreed to buy Varex Imaging for about $1.1 billion. 
    • “Varex designs, manufactures and sells X-ray imaging components and other products for use in medical and industrial applications. 
    • “Teledyne provides digital imaging technologies for industrial, government and medical use but has minimal overlap between its portfolio and Varex’s products.”
  • Drug Channels blog informs us,
    • “The United States has almost 8,000 fewer retail pharmacies than it did in 2018, and more than 2,000 closed in 2025 alone. Rite Aid has liquidated. Walgreens is working through a multi-year plan to shutter hundreds of stores. CVS has trimmed hundreds more.
    • “Yet total U.S. prescription dispensing revenues for all dispensing formats reached a record $751 billion in 2025, up 10% from 2024.
    • “Record closures and record revenue in the same year may seem contradictory, but national totals obscure very different effects on the community. The impact of the retail pharmacy shakeout on patient access has become geographically K-shaped: dense markets can absorb pharmacy closures with little loss of patient access, while rural communities can lose their only nearby pharmacy.
    • “The economic pressures on pharmacies are similar across the country. The access consequences of a closure are not. [In the article,] we examine what is driving the shakeout and why geography determines which communities can absorb them.

Monday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

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.”

Tuesday report

David Ermer–Agentic & Generative AI, Congress, FDA, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “House Republican leaders are giving up on trying to put the pieces back together for a rule needed to take up a raft of pre-recess legislative priorities after a group of GOP rebels blocked the procedural measure earlier, largely over lack of movement on voter ID requirements.
    • “The decision to send members home early for the July Fourth recess after Tuesday afternoon votes came after Speaker Mike Johnson, R-La., huddled in his office with Rules Chairwoman Virginia Foxx, R-N.C., and others on how to reconstruct a path forward.” 
  • Modern Healthcare relates,
    • “A bipartisan House bill would require extensive reporting on private equity firms’ healthcare holdings and ownership structures.
    • “The draft measure could reveal tactics such as sale-leaseback arrangements like those that contributed to Steward Health Care’s bankruptcy.
    • “Some Democrats want to go further than transparency and say enforcement needs to be tougher.”
  • Beckers Hospital Review tells us,
    • “A growing number of states are moving to cap what hospitals can charge commercial payers and employers, turning hospital pricing into one of the most active battlegrounds in state health policy.
    • “Several states enacted hospital price caps in 2025, and the 2026 legislative sessions have brought a fresh wave of proposals tied to Medicare rates, according to The Commonwealth Fund. ” * * *
    • “For now, the cap fight is a state story. The federal government’s lever on hospital prices has been transparency and site-neutral payments, not price ceilings.
    • “CMS finalized price transparency rules requiring hospitals to post median and percentile allowed amounts in their machine-readable files, with enforcement beginning April 1, 2026. In June, the White House warned more than 500 hospitals to post pricing information or face fines. CMS also expanded site-neutral payment policies in its 2026 outpatient rule, aligning some hospital outpatient rates with lower-cost settings. Meanwhile, renewed scrutiny of the 340B drug discount program has systems bracing for further cuts.
    • “What began as isolated state efforts has evolved into a broader movement to rein in hospital prices. Whether these policies ultimately lower costs without undermining hospital finances will likely shape the next chapter of healthcare affordability debates.”
  • ZeroHedge shares different perspectives on the Affordable Care Act plan’s enrollment loss.
    • Obamacare enrollment declined by nearly 3 million in 2026, sparking renewed debate about the affordability of healthcare in America.
    • “National politicians and policy experts disagreed on the reasons for the dip in enrollment, with some saying that it was driven by rising premiums. 
    • “Others said the decline was evidence that program integrity measures taken by the Trump administration were successful in rooting out fraud and waste.” 
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services June 30 announced it will terminate emergency use authorization declarations for certain drugs and medical devices used to treat COVID-19, saying circumstances justifying the authorizations no longer exist. The declaration for drugs and biological products will end June 29, 2027, while the declaration for medical devices will end Dec. 26, 2026. The EUA declarations were issued in 2020 to accelerate access to medical products during the COVID-19 pandemic.” 
  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM), in partnership with the US Department of War (DOW), today announced the launch of War Force, a DOW-specific recruiting initiative under OPM’s Tech Force program designed to attract exceptional software engineers to support the nation’s most critical national security missions.
    • “Through War Force, OPM will recruit top engineering talent from across the country and connect qualified candidates with high-impact technical roles at the Department of War. The initiative builds on the success of Tech Force by tailoring recruitment to the Department’s unique operational and mission requirements.
    • “America’s national security depends on attracting the best technical talent to some of government’s most important missions,” OPM Director Scott Kupor said. “War Force builds on the momentum of Tech Force by connecting outstanding engineers with opportunities to solve complex challenges alongside the War Department. We’re making it easier for top talent to serve their country through meaningful technical work.” * * *
    • “Applicants must be US citizens and eligible to obtain and maintain a Secret/Top Secret clearance. Applications close July 10, 2026. View the job announcement and apply here.”

No Surprises Act news

  • Beckers ASC News reports,
    • “Some surgical assistants are using arbitration provisions in federal billing law to collect far more than the surgeons they assist, according to The New York Times.
    • “Surgical assistants are typically paid a standard fee equal to about 16% of a surgeon’s reimbursement. But some are now collecting far more than the surgeons they assist by capitalizing on a law meant to protect patients from surprise billing, according to a New York Times report.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration is losing another top drug reviewer in Vijay Kumar, who intends to step down as acting director of the office of gene and cell therapy reviews in the Center for Biologics Evaluation and Research, a spokesperson said Tuesday.
    • “Acting CBER Director Karim Mikhail will serve as the acting director of the Office of Therapeutic Products “to ensure absolute regulatory continuity” while the FDA seeks candidates for the role within and outside the agency, the spokesperson said. Kumar will remain with the FDA, having been elevated to the acting director role from his position as lead physician.
    • “Kumar’s decision comes amid personnel turbulence at the FDA, following the resignation of former Commissioner Marty Makary and CBER Director Vinay Prasad, along with the firing of Tracy Beth Høeg as director of the Center for Drug Evaluation and Research. Multiple top-level positions at the agency are staffed by officials in time-limited acting roles, without a clear indication when they will be filled permanently.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). It represents a novel approach to allogeneic hematopoietic stem cell transplantation in some adult patients with high-risk blood cancers. It addresses an important unmet need in transplantation, where curing the cancer is often only part of the challenge; avoiding chronic GVHD is equally important for long-term outcomes.
    • “Tregzi uses stem cells and immune cells collected from blood of a closely matched donor to help the body fight cancer while reducing the risk of a serious complication called chronic GVHD — a condition that can occur when transplanted donor blood cells attack the patient’s body. Patients receive this treatment after undergoing chemotherapy to prepare their bodies for a bone marrow or stem cell transplant.
    • “For patients with blood cancers who need stem cell transplantation, chronic graft-versus-host disease has long been one of the most feared and difficult-to-prevent complications,” said Karim Mikhail, B.Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “Today’s approval offers a genuine new approach that can help reconstitute the immune system while substantially reducing that risk and reflects the promise of what cellular therapy can deliver for patients.”  
  • The Wall Street Journal relates,
    • “U.S. officials are allowing Zyn to market itself as being less harmful than traditional cigarettes, making the product the first nicotine pouch on the market to be granted such a distinction.
    • “The Food and Drug Administration announced that 20 different Zyn nicotine pouches—including flavors ranging from cool mint to cinnamon—can carry language stating that using the pouches instead of smoking cigarettes puts users at a lower risk of mouth cancer, stroke, heart disease, lung cancer, emphysema and chronic bronchitis.
    • “Zyn nicotine pouches, a product of Swedish Match USA which is owned by Philip Morris International PM -1.07%decrease; down pointing triangle, contain no tobacco and are the most popular brand in the U.S. They were granted permission to stay on the market in early 2025, the first pouch to receive the authorization.
    • “Nicotine pouches look similar to small tea bags and are filled with nicotine, salt and can contain other materials like flavorings and wood pulp.” 
  • Beckers Hospital Review tells us,
    • “The New England Journal of Medicine has retracted the clinical trial publication behind Amgen’s rare disease drug Tavneos after two of the study’s authors requested the retraction over undisclosed changes to how patient outcomes were assessed. 
    • “In a June 29 retraction statement, NEJM said the primary endpoint assessments for nine patients were readjudicated after the trial’s database was locked and unblinded, without the two authors’ knowledge, calling the omission “inconsistent with proper research conduct.”
    • “The retraction is the latest setback in a months-long dispute between Amgen and the FDA over Tavneos, a treatment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis that Amgen acquired through its $3.7 billion purchase of ChemoCentryx in 2022. The FDA first asked Amgen to voluntarily withdraw the drug from the market in January, citing concerns over how ChemoCentryx had re-adjudicated efficacy data for nine of the 331 patients in the pivotal trial. Amgen declined the request on Feb. 3, saying it was not aware of issues with the underlying patient data and that its own review of clinical findings and real-world evidence continued to support the drug’s effectiveness.”
  • Per Cardiovascular Business,
    • “Stryker is recalling its InZone Detachment System due to a potential battery issue. The recall includes a total of nearly 45,000 devices. 
    • “The InZone Detachment System helps interventional radiologists and neurosurgeons perform neurovascular embolization procedures to treat intracranial aneurysms, and neurovascular abnormalities such as arteriovenous malformations and fistulae. The device is also indicated for arterial and venous embolizations in the peripheral vasculature.
    • “The device, compatible with a variety of detachable coils, was designed to detect potentially challenging conditions and adjust as necessary. It includes a detachment button, a series of LED indicators and a cable connection port.”
  • and
    • “Artivion, an Atlanta-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for its AMDS Hybrid Prosthesis.
    • “The AMDS was designed to help clinicians treat DeBakey Type 1 dissections complicated by malperfusion. It works as a complement to hemiarch replacement, preserving the native arch and making reinterventions possible if needed. According to Artivion, it is the first surgical device of its kind.
    • “In December 2024, the AMDS received the FDA’s Humanitarian Device Exemption (HDE). This allowed select patients to undergo treatment with the device, but a separate institutional review board (IRB) approval was still required in each instance. Thanks to this full approval, the AMDS is now covered across the board for the treatment of all DeBakey Type 1 dissections with clinical or radiographic malperfusion.”

From the public health and medical / Rx research,

  • The New York Times reports,
    • “Two of the hottest trends in health — longevity medicine and weight loss drugs — are colliding.
    • “A theory that GLP-1 medications like Ozempic or Zepbound might help people live longer has been bandied about by biohackers and aging researchers for several years. Online pharmacies already market compounded versions of the drugs to purportedly extend health span. But so far, academic research into the hypothesis has been scant.”
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) has issued the most expansive data release in the history of its All of Us Research Program, making available data from more than 747,000 participants and establishing All of Us as the world’s largest integrated genomic and electronic health record (EHR) database. The latest data release includes more than 535,000 whole genome sequences linked to nearly 482,000 electronic health records, a combination of genomic depth and clinical breadth unmatched by any research program in the world.
    • “There’s a paradox at the heart of precision medicine,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “To tailor treatments to individuals, you actually need very large populations to uncover the patterns that connect genetics, lifestyle, and the environment to health outcomes. That is exactly what All of Us provides: research at unprecedented scale.”
    • The new data issuance represents growth of more than 114,000 participants since the previous data version, bringing the program’s total enrolled-participant count to over 883,000. The dataset now encompasses more than 1.3 billion genetic variants, 553,000 genotyping arrays, 96,000 structural variant records, and 600,000 physical measurements, alongside 747,000 survey responses capturing social circumstances, behaviors, and environments. EHR data grew by 22% in this release, driven by expanded data sources including participant-mediated EHR submissions and health information exchange data.
    • “All of Us reflects the trust of people across the country who chose to contribute to research to benefit everyone,” said All of Us Research Program CEO Josh Denny, M.D. “This release puts a richer dataset into the hands of scientists working on real clinical problems. This is how we advance the health of all Americans.”
  • Health Day relates,
    • “Many young adults may be missing important preventive healthcare screenings, according to a national survey.
    • “The poll of more than 1,000 U.S. adults, commissioned by Ohio State University in Columbus, found only 71% of people ages 18 to 29 have a regular doctor, compared with 97% of adults 65 and older.
    • “Even among young adults who do have a doctor, fewer than half — just 47% — had a checkup in the past year.
    • “The authors say skipping routine visits can mean missing recommended screenings, vaccines and early warning signs of conditions like high blood pressure, high cholesterol and diabetes.
    • Dr. Zachary Bittinger, a family medicine physician at Ohio State University Wexner Medical Center, said having a primary doctor is especially important when you are young.
    • “We look ahead five years, 10 years and 20 years, because that’s ideally how long you see your primary doctor,” he said. “That kind of relationship means that for each stage of life, from college to raising children to retirement, you get the kind of advice that keeps you safe.”
  • MedPage Today informs us,
    • “A large population-based cohort study in Hong Kong demonstrated that acetaminophen (Tylenol) use during pregnancy was unlikely to increase the risk of autism spectrum disorder or attention deficit-hyperactivity disorder (ADHD) in exposed children.
    • “In sibling-matched analyses, prenatal acetaminophen exposure was not associated with autism (adjusted HR 1.00, 95% CI 0.91-1.11) or ADHD (adjusted HR 1.01, 95% CI 0.93-1.08), reported Eric Yuk Fai Wan, PhD, of the University of Hong Kong, and co-authors.
    • “Findings were consistent regardless of when exposure happened, the cumulative acetaminophen dose, or how often the drug was used, the researchers wrote in JAMA Internal Medicine.
  • MedCity News discusses “The Terminology Gap Undermining Cervical Cancer Screening Guidelines.”
    • “While the Pap identifies the cell changes, the HPV test determines the root cause before those changes even happen. Both tests have saved lives. But they are not interchangeable, and treating them as such puts the patient at risk.” 
  • Genetic Engineering and BioTechnology News points out,
    • “Neurodegenerative diseases affect tens of millions of people worldwide. A new study published in Cell Death Discovery titled, “Sustained dysregulation of iron and glutathione homeostasis induces chronoferroptosis, a persistent ferroptotic adaptation in neuronal cells,” points to iron accumulation as a key target in the effort to predict, prevent, and treat neurodegenerative diseases. 
    • “Resilience has become a huge topic of discussion when it comes to Alzheimer’s disease and other neurodegenerative disorders, trying to make the brain more resilient in the face of stressors that contribute to neurodegeneration,” said Pam Maher, PhD, co-corresponding author and a research professor at the Salk Institute. “Our study reveals that cells lose resilience when iron hits a certain level, making neurons more susceptible to stressors that damage or even kill them.”
    • “Found in dark leafy greens, starchy cereals, lean meats, seafood, and other common foods, iron helps red blood cells develop, carries oxygen, makes hormones, and engages in key functions across the immune system and energy production. 
    • “It’s one of the most important minerals in the body,” says co-corresponding author Nawab John Dar, PhD, a postdoctoral researcher in Maher’s lab. “So, it isn’t the iron itself that is a problem with age. It is this accumulation of iron over time that is the problem.” 
  • BioPharma Dive notes “10 clinical trials to watch in the second half of 2026.”
    • “The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.”

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

  • Beckers Payer Issues reports,
    • “Some CEOs may come and go. But David Cordani, the outgoing CEO of The Cigna Group, has been with the company for around 35 years, becoming president in 2008 and CEO in 2009.
    • “Mr. Cordani departs his role July 1 but will remain as executive chair of the board. Prior to his Cigna head executive position, Mr. Cordani assumed leadership roles in finance, marketing and operations across the company. Later, he played a broader role in the health insurance landscape, as well, serving as AHIP chair in 2019. 
    • “During his time as Cigna’s CEO, Mr. Cordani gave the company a major makeover, betting big beyond insurance. Those bets appear to have paid off: In 2025, the company brought in about $275 billion in revenue, up from roughly $18 billion when Mr. Cordani began his tenure, according to Cigna. The company now employs more than 70,000 and serves about 185 million customer and patient relationships across its business lines.
    • “Since becoming CEO, one of Mr. Cordani’s boldest moves was the $67 billion acquisition of pharmacy benefit manager Express Scripts in 2018. The deal survived Justice Department scrutiny and ultimately paved the way for Cigna to unify health services under the Evernorth Health Services brand in 2020. In 2025, Evernorth brought in nearly $235 billion in revenue, with more than $132 billion from pharmacy benefit services and $102 billion from specialty and care services.”
  • The American Hospital Association News relates,
    • “The AHA June 30 announced the appointment of Steve Walsh as its next president and chief executive officer. Walsh, who has served as president and CEO of the Massachusetts Health & Hospital Association since 2017, will assume leadership of the nation’s largest hospital and healthcare system membership organization this fall.  
    • “Following a thoughtful national search, the Board unanimously selected Steve Walsh to serve as the next President and Chief Executive Officer of the American Hospital Association,” said Marc L. Boom, M.D., chair of the AHA Board of Trustees and president and CEO of Houston Methodist. “Steve is a proven healthcare leader, innovator and accomplished advocate for healthcare improvement, who understands both the challenges facing hospitals and the opportunities ahead. Throughout his career, he has demonstrated an ability to bring people together, build consensus and advance meaningful solutions on behalf of patients, caregivers and communities.” 
    • Boom also thanked and praised outgoing AHA President and CEO Rick Pollack, noting the “Board’s decision reflects our confidence that Steve is uniquely prepared to build upon the strong foundation established by Rick Pollack while helping the Association strengthen its role as a trusted voice, convener and advocate for health care providers across America.” 
  • Modern Healthcare tells us,
    • “Empath units are gaining national attention for improving care for people in crisis while reducing the strain on ERs ill-equipped to treat them.
    • “M Health Fairview Southdale Hospital loses $500,000 annually on its Empath psychiatric unit due to insufficient government reimbursements.
    • “Hospitals are pressing for higher payments for such visits, which are less intensive than inpatient admission but more involved than outpatient therapy.”
  • MedTech Dive informs us
    • “Zimmer Biomet has agreed to pay up to $140 million to acquire Pacira BioSciences’ iovera pain relief device, the companies announced Tuesday.
    • “Zimmer has agreed to pay $70 million upfront and up to $70 million more in revenue-based milestones through 2031. Zimmer will acquire the rights to develop, manufacture and sell iovera as part of the agreement. 
    • “BTIG analyst Ryan Zimmerman wrote in a research note Tuesday that the acquisition complements Zimmer’s existing product portfolio. Iovera has room to expand into new markets and is supported by legislation that went into effect last year to expand access to non-opioid pain treatments.”
  • Per STAT News,
    • “Anthropic, the artificial intelligence firm, on Tuesday announced the availability of Claude Science, an application that optimizes the company’s large language model for use in scientific laboratories and, especially, within the research operations of pharmaceutical companies.
    • “At a launch event here, Anthropic CEO Dario Amodei said that until now, humans have wrestled with the complexity of biology only with their minds. While biology is not as simple or clean as code, he still thinks it can be just as powerful in this domain.
    • “It’s going to be a general purpose technology that helps us to make sense of that complexity, in its full complexity, better.” But, he admitted, “We don’t know for sure if that’s going to work out. But I think we’re seeing signs that we’re seeing the beginnings of it.”
    • “The product is a beachhead in Anthropic’s larger battle for the future of biology. The firm has ambitions so big they would seem caricature-like were it not for its financial means. A month ago Anthropic said it had reached annualized sales of $42 billion — about as much as the drug giant GSK — and that it is valued, based on a $65 billion funding round, at $965 billion, far more than any health care company except Eli Lilly.”

Midweek report

David Ermer–Congress, COVID-19, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • FedWeek reports,
    • “OPM has sought to allay privacy concerns about its plan to access detailed medical information on FEHB/PSHB enrollees, with one of the organizations that raised such concerns—the National Active and Retired Federal Employees Association—cautiously optimistic that OPM is addressing them.
    • “In a Federal Register notice posted in December, but which only drew attention months later in April, OPM proposed to gain access to carriers’ records including office visits, treatment, prescriptions and other medical information, without a requirement that they withhold personally identifying information.” * * *
    • “He said that OPM’s inspector general’s office—which has access to such information for its audits of health plans and carriers—“will provide an encrypted copy of that data to OPM – but only after stripping out names, social security numbers, phone numbers, addresses (except for ZIP codes), and other personally identifiable data. The only member-level PII fields that will remain in the data that OPM receives will be our member’s ZIP codes, year of birth, and their member ID.”
    • “He said that OPM further will replace the member ID with random numbers and characters and that the data “will remain in a secure, separate environment, encrypted at rest and protected with our IT security best practices.”
  • FEHBlog note: At least for HIPAA privacy rule purposes, an anonymous identifier cannot be based on an actual ID number as OPM plans. Moreover, to avoid re-identification, OPM should arrange for a third party to create the anonymous identifier properly and then arrange for the OIG to insert the anonymous identifier into the claims records before they are sent to OPM.
  • Per a Senate news release,
    • “Today the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted to favorably report several bills making health care more affordable and accessible to American families. During the markup, U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the HELP Committee, led Republicans in rejecting Ranking Member Bernie Sanders’ (I-VT) attempt to sabotage the bipartisan bills with toxic poison pill amendments.
    • “I understand why Americans are frustrated with Congress. If we want Congress to work, we have to make it work,” said Dr. Cassidy. “I want part of my legacy [to be] he tried to preserve the institution. But that is a responsibility of us all.”
    • “I appreciate my colleagues’ efforts and will continue to work with Republicans and Democrats to enact a pro-patient, pro-family agenda,” continued Dr. Cassidy.
    • “The Charlotte Woodward Organ Transplant Discrimination Prevention Act, Healthy Start Reauthorization Act, Stem Cell Therapeutic and Research Reauthorization Act, EARLY Act Reauthorization, Accelerating Access to Critical Therapies for ALS Act, and the Biosimilar Red Tape Elimination Act passed unanimously as amended in an en bloc vote. The Medication Affordability and Patent Integrity Act also passed in a 16-6 vote.”
  • The American Hospital Association News relates,
    • The Department of Health and Human Services June 17 announced it will provide more than $700 million in funding for initiatives on mental illness, addiction and homelessness. Funding opportunities include $96 million for the Safety Through Recovery, Engagement, and Evidence-based Treatment and Support Program, or STREETS; $223.1 million for comprehensive community-based behavioral healthcare programs; $238.6 million for the 988 Suicide and Crisis Lifeline; $80 million for substance use prevention, treatment and recovery initiatives; and more than $70 million for mental health services and support programs. 
  • Beckers Hospital Review tells us,
    • “The Trump administration has begun enforcing federal information-blocking regulations against healthcare organizations that fail to provide patients with access to and exchange of their electronic health information, Politico reported June 17.
    • “Thomas Keane, assistant secretary for technology policy at HHS, told the publication that the agency has stepped up enforcement of data-sharing requirements as part of broader efforts to improve healthcare accessibility and affordability.
    • “Congress directed HHS to address information blocking through the 21st Century Cures Act, which was enacted in 2016. Rules implementing the law were finalized in 2020, and penalties were established in 2024.” * * *
    • “We have started issuing notices of nonconformity to information blockers,” Mr. Keane said. “We’ve had people come back to us and tell us: ‘Yes, we were information blocking.’” Mr. Keane said healthcare organizations may have financial or competitive incentives not to share patient information, but federal law requires health information to be shared for the benefit of patients.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. Approved in time for the 2026–2027 flu season, this approval reflects the Trump Administration’s commitment to increasing the availability of generic drugs.
    • “Today’s approval marks a meaningful milestone for the treatment of influenza,” said Iilun Murphy, M.D., Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the U.S. each year.”
    • “Generic baloxavir marboxil tablets may be used for:
      • ‘Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours, and who are otherwise healthy or at high risk of developing influenza-related complications; and
      • “Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.”
  • MedPage Today adds,
    • “The FDA approved oral tebipenem pivoxil (Utebzi) as the first oral carbapenem antibiotic to treat complicated urinary tract infections (UTIs), the agency announced on Wednesday.
    • “Tebipenem pivoxil is indicated for complicated UTIs, including pyelonephritis, caused by the susceptible microorganisms Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis, in adults who have limited or no alternative oral treatment options.” * * *
    • “Tebipenem pivoxil should be available to U.S. patients by the end of 2026, GSK said.”
  • BioPharma Dive tells us,
    • “UniQure, the Netherlands-based biotechnology company, intends to formally ask the Food and Drug Administration to approve its for Huntington’s disease gene therapy now that the two parties are more aligned on the closely watched treatment.
    • “UniQure said Wednesday that, during a recent meeting, FDA staff agreed three years of data gathered from a key trial of the therapy would be enough to support an approval application. As such, the company expects to file one sometime between July and the end of September. The FDA has requested another trial be conducted to confirm the treatment’s effects and, according to the UniQure, the agency wants to make sure both sides see eye to eye on this study’s design before a marketing application gets submitted.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration June 16 announced that a nationwide shortage of stereotactic breast biopsy needles is expected to last through the end of March 2027. The FDA said the shortage is due to a manufacturing disruption and that clinical management adjustments may be required for patients needing a breast biopsy. Healthcare providers are recommended to conserve their use of stereotactic breast biopsy needles. The agency said that Hologic issued a customer letter Jan. 2 that said all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed due to a risk of metal and plastic particles being dislodged from the device during use.” 

From the judicial front,

  • Healthcare Dive reports,
    • “OhioHealth has reached a proposed settlement with state and federal regulators over allegations that the Columbus, Ohio-based system strong-armed insurers into anticompetitive contracts.
    • “The deal announced Tuesday voids problematic OhioHealth contracts and prevents the system from seeking such terms in the future, according to the Department of Justice.
    • “OhioHealth, which has maintained its contracting practices are legal, did not have to admit wrongdoing as part of the settlement. The system also will not pay any penalties or fines.”
  • Fierce Healthcare tells us,
    • “The Pharmaceutical Care Management Association has joined some of the nation’s largest pharmacy benefit managers in challenging Tennessee’s new law governing the industry.
    • “The Volunteer State’s new policy would prevent PBMs from also owning or being affiliated with pharmacies operating in the state. State lawmakers argue that the law would bring greater transparency and fairness to the market, particularly to support independent pharmacies.
    • “CVS Health, parent company of “Big Three” PBM Caremark, was the first to sue over the law in late May, with Express Scripts following suit late last week.”
  • The Wall Street Journal relates,
    • Luigi Mangione will mount a psychiatric defense at his New York state trial for the killing of UnitedHealthcare Chief Executive Brian Thompson, a judge said Wednesday.
    • During a hearing in state court in Manhattan, Judge Gregory Carro said the lawyers discussed the defense strategy at a sealed proceeding earlier this month. The judge said defense lawyers intend to argue that Mangione killed the insurance executive due to an extreme emotional disturbance at the time. * * *
    • The state trial of Mangione, 28 years old, is scheduled to begin on Sept. 8. A psychiatric defense would significantly alter the nature of the trial because his lawyers would acknowledge he killed Thompson, but argue he did it because he was emotionally disturbed. If a jury agrees with that argument, his murder charge would be downgraded to manslaughter, resulting in a shorter potential prison term.
    • Mangione faces headwinds at trial, including a journal found in his backpack that prosecutors will likely use to argue that he planned the murder for months. “Extreme emotional disturbance is about a loss of self-control for which there was a reasonable explanation or excuse,” said Gary Galperin, a former prosecutor in Manhattan who now teaches at Cardozo School of Law. “The classic case is, you come home and find your spouse in bed with someone else.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “During the most recent respiratory virus season, the risk of hospitalization was higher for influenza than for COVID-19, per a US Department of Veterans Affairs (VA) study of nearly 13,000 patients.
    • “The authors, from the VA Saint Louis Health Care System, noted that while COVID-19 was tied to a substantially greater risk of hospitalization than flu early in the pandemic, data showed an increase in flu cases and hospitalizations in 2025-26 compared with previous seasons.
    • “The findings were published last week in The Lancet Infectious Diseases.
    • “However, population-level metrics reflect both infection frequency and disease severity and cannot alone determine the relative clinical severity of one pathogen versus another,” they wrote. “A head-to-head comparison of hospitalisation risk among infected individuals—which isolates disease severity from differences in infection frequency—has not been undertaken for the 2025–26 influenza season.”
  • Health Day relates,
    • “Folks are told that once you start taking Ozempic or Zepbound, you’ll need to stay on them to maintain the drugs’ benefits.
    • “But patients prescribed such GLP-1 drugs are more likely to stop them and then restart use later than was previously assumed, according to research presented Sunday at the Endocrine Society’s annual meeting in Chicago.
    • “We found that about 4 in 10 patients stopped their GLP-1 medication within the first year, and nearly 6 in 10 had stopped by the end of two years,” based on insurance records from more than 60,000 Americans with type 2 diabetes, said study investigator Sainikhil Sontha. He’s a research associate at Boston University School of Public Health.
    • “However, not everyone who stopped taking their GLP-1 remained off it.
    • “More than half of those who stopped restarted therapy within a year (42%), and nearly two-thirds did so within two years (58%),” Sontha said in a university news release. “This suggests that for many patients, these medications aren’t being abandoned permanently; use is more start-and-stop than most people assumed.”
  • and
    • Solid organ transplant survival is improving, but organ shortages persist, according to a study published in the July issue of the Journal of the American College of Surgeons.
  • and
    • “At-home blood pressure monitoring can lower risk of heart attack and stroke
    • “People participating in a remote monitoring program had a 34% lower risk of heart attack, stroke and heart disease
    • “Their readings were forwarded to a doctor, who kept tabs on their blood pressure.”
  • The Washington Post lets us know,
    • “As a doctor, I tell people to do these 4 things to reduce age-related muscle loss
    • “Resistance training, protein and recovery remain the most powerful tools for preserving strength and independence later in life.”
  • The latest NIH Research Matters covers the following topics:
    • Immune system may attack nervous system in some Long COVID patients
      • “Researchers linked antibodies that attack the body’s nervous system to some neurological symptoms of Long COVID.
      • “The results may point to possible treatments for some people with Long COVID.”
    • Depression screening using video games
      • “A study suggests that the unconscious way the brain assesses rewarding experiences is miscalibrated in patients with depression. 
      • “Game-like tasks to measure this mechanism could help doctors screen patients more quickly for depression.”
    • AI tool could speed antibiotic development
      • “Researchers developed and tested a system to improve the antibacterial effects of existing compounds.
      • “This system could help quickly create new antibiotics to overcome antibiotic resistance.”

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

  • The Wall Street Journal delves into state of the U.S. healthcare business.
  • Beckers Hospital Review ranks 40 health systems based on their first quarter 2026 operating margins, and tells us,
    • “Nashville, Tenn.-based Ascension Saint Thomas has broken ground on a $148.5 million hospital and healthcare campus in Clarksville, Tenn., expanding its presence in one of the state’s fastest-growing regions. 
    • “The 96-acre campus will include a full-service hospital that will open with 44 inpatient beds and expand to 132 beds as demand grows. The hospital will be St. Louis-based Ascension’s 19th in Tennessee, according to the health system’s website. 
    • “The hospital will offer emergency care, inpatient surgery, cardiology, neurosciences, women’s health, neonatal intensive care, oncology and orthopedic services. The broader campus will also feature physician offices, an inpatient rehabilitation hospital, outpatient surgery, advanced imaging and specialty ambulatory care services.”
  • BioPharma Dive informs us,
    • “Jazz Pharmaceuticals is enlisting the help of AbCellera in a bid to develop next-generation T-cell-engaging medicines to treat solid tumors.
    • “As part of a deal announced Wednesday, Jazz will pay AbCellera $56 million up front in exchange for discovery work and early-stage preclinical research on two programs. AbCellera also committed to start a third discovery program within 12 months, which will trigger another $28 million payment, and may undertake two additional projects if both companies agree.
    • “If Jazz exercises options for development, AbCellera could earn as much as $792 million more per program in fees and payments for reaching certain development, regulatory and commercial milestones. AbCellera would also be eligible for royalties, should any approved medications come out of the collaboration.”
  • Fierce Healthcare points out,
    • “Fitness wearable company Whoop announced Wednesday a partnership with health platform HealthEx that allows users to connect their medical records directly within the Whoop app, combining medical history with biometric data.
    • “The companies say the partnership “responds to a growing need” for “more connected health experiences” for users. The new integration allows various factors—such as chronic conditions, recent procedures and more—to be considered alongside tracking metrics, like performance and sleep. 
    • “Whoop has always focused on turning data into meaningful insights,” said Alex Vannoni, Whoop’s head of healthcare product, in a statement. “This partnership extends that approach by bringing medical history into the Whoop experience, giving members a more complete view of their health and enabling even more personalized, relevant coaching, grounded in who they are, not just what happened on a given day.”
    • “The integration is enabled by the Whoop AI and My Memory features. The artificial intelligence-driven My Memory feature, announced last month, allows users to provide context to manage personalized coaching.”
  • Beckers Payer Issues notes,
    • “Payers often work with employers, but they have to keep their own staff happy, too. 
    • “Amid a climate of payers across the country cutting jobs, Centene recently confirmed it is offering buyouts to most employees as its ACA business contracts. Against that backdrop, employee morale and retention have become pressing priorities for health plan leaders.
    • “Becker’s spoke with Sidecar Health’s chief people officer, Alex Coonce, and Elevance Health’s chief human resources officer and executive vice president, Ryan Craig, to learn about the biggest concerns for today’s health plan employees — and how each company is tackling them.”

Monday Report

David Ermer–ACA, CMS, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NIH, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“In her 1789 book The Female Reader, writer and philosopher Mary Wollstonecraft wrote: “Simplicity and sincerity generally go hand in hand, as both proceed from a love of truth.” (Source: https://tinyurl.com/4fzesrp4)

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. launched GetActive.gov, a new national resource to help Americans improve their health through movement, fitness, outdoor recreation, and active living, during a series of “Take Back Your Health” tour stops across Colorado.
    • “Secretary Kennedy joined Secretary of the Interior Doug Burgum in Grand Junction to announce the initiative and highlight the Trump Administration’s efforts to expand access to public lands and outdoor recreation opportunities. He then visited Fort Carson to see firsthand how the Army is improving nutrition for servicemembers through its campus-style dining modernization program. The Secretary also toured InnovAge in Thornton, where he met with caregivers and seniors participating in the Program of All-Inclusive Care for the Elderly (PACE).
    • “The key to reversing America’s chronic disease epidemic is empowering people to take back their health,” Secretary Kennedy said. “We are helping people Get Active, Eat Real Food, and Live Real Life. From our public lands to our military bases to our senior care centers, these Colorado visits show how we are putting Make America Healthy Again into action.”
  • The American Hospital Association News reports,
    • “The Medicaid and CHIP Payment and Access Commission June 15 released its June 2026 report to Congress. Among the topics discussed, chapter two focuses on automation in Medicaid prior authorization and makes recommendations to improve oversight and increase disclosure and transparency of managed care plans’ use of automation in PA. The third chapter includes recommendations to improve managed care plan accountability. Chapter seven examines Medicaid provider enrollment and managed care credentialing processes and highlights challenges that have effects on provider participation and state administrative burden.”
  • and
    • “The Centers for Medicare & Medicaid Services and the Department of Health and Human Services issued a request for information June 12 seeking input on CMS’ review of the Affordable Care Act’s Essential Health Benefits framework and the requirement that the scope of EHBs is equal to the scope of benefits provided under a standard employer plan. Specifically, CMS is seeking comments on current interpretations of EHBs, state approaches to selecting and updating EHB-benchmark plans, methodologies to determine the scope of benefits included as EHBs, and how those approaches relate to access and market stability under the ACA. The agencies said the information will impact CMS’ evaluation on whether revisions or additions to current EHB regulations would be appropriate. Comments are due by July 15.”
  • BioPharma Dive relates,
    • “New under-the-skin injections of the cancer immunotherapies Keytruda and Opdivo would be subject to Medicare price negotiations at the same time as their intravenous counterparts under a proposed federal rule published Friday.
    • “The Centers for Medicare and Medicaid Services said the rule would close a “loophole” that allows drugmakers to extend the patent-protected life of blockbuster drugs, commonly called “evergreening.” However, Medicare could exempt the newer formulation from its price ceiling should biosimilars of the IV version enter the market and compete on price.
    • “The rule could most immediately affect Keytruda maker Merck & Co. and Opdivo developer Bristol Myers Squibb, along with Halozyme, which developed the delivery technology that helped Opdivo and Johnson & Johnson’s Darzalex transition from IV to subcutaneous shots. Halozyme, however, said it forecasts “zero to minimal impact to its royalty revenues through at least 2035.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration said Monday that it will allow Colorado to import certain prescription drugs from Canada in an effort to bring prices down for residents, making it the second U.S. state to be granted such authorization. 
    • “For more than a quarter of a century, Americans have sought drugs from Canada for relief from the ever-rising costs of medicines, sometimes taking widely publicized bus trips across the border. It wasn’t until 2020, though, that the first Trump administration officially endorsed the practice, when it published a regulationallowing states and Indian tribes to propose import plans. The Biden administration affirmed this rule with an executive order in 2021. And Florida became the first state to earn FDA approval in 2024. 
    • “But state importation programs have proved extremely difficult to carry out, even with bipartisan support. Florida has yet to actually import any drugs from Canada, in part due to pushback from the Canadian pharmaceutical industry and fears the program will affect Canada’s drug supply. In May, the FDA extended its approval by six months to give the state more time to get its program up and running.”
  • Fierce Pharma relates,
    • “Despite prior concerns from the FDA, a regimen involving AstraZeneca’s AKT inhibitor Truqap (capivasertib) has passed muster in a specific population of prostate cancer patients. 
    • “Late last week, the U.S. regulator signed off on Truqap plus Johnson & Johnson’s Zytiga (abiraterone) and prednisone to treat adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer—the indication previously known as metastatic hormone-sensitive prostate cancer—that is determined to be PTEN-deficient.
  • and
    • Merck & Co.’s first-in-class HIF-2 alpha inhibitor Welireg is touching down in the clear cell renal cell carcinoma (ccRCC) treatment space, notching a Keytruda combination nod that stands to pad the landing for the company’s post-Keytruda outlook. 
    • The June 12 FDA approval is the first for a PD-1 and HIF-2a inhibitor combo, stipulating the regimen’s use as an adjuvant treatment for adults with ccRCC who are at intermediate-high or high risk of recurrence following kidney removal surgery. Welireg can be used in the disease setting with standard Keytruda or subcutaneous Keytruda Qlex. 
    • With that, Welireg can reach earlier-stage ccRCC for the first time following its 2023 clearance in advanced RCC, marking an “important step in addressing the needs of patients with earlier-stage renal cell carcinoma,” kidney cancer advocacy group KidneyCan’s CEO and co-founder Bryan Lewis noted in a Merck press release. 
  • Cardiovascular Busines tells us,
    • “Penumbra, a California-based medtech company known for its vascular technologies, has received U.S. Food and Drug Administration (FDA) clearance for a new computer-assisted vacuum thrombectomy (CAVT) device designed to treat acute ischemic stroke.
    • “According to Penumbra, Thunderbolt represents the first CAVT device approved in the United States for the treatment of stroke. It is powered by Penumbra’s Engine technology and uses modulated aspiration to “detect, fatigue and completely ingest” blood clots at the site of occlusion. Thunderbolt will be sent to customers prepackaged with one of the company’s catheters.”
  • MedPage Today tells us,
    • “The FDA cleared medical-grade Australian sheep blowfly (Lucilia cuprina) larvae in what maker Cuprina Holdingsopens in a new tab or window believes marks the first debridement product to use this particular species.
    • “Dubbed Medifly Maggots, the product is indicated for removing dead or infected tissue from non-healing necrotic skin and soft tissue wounds — such as pressure or neuropathic foot ulcers — and non-healing traumatic or post-surgical wounds.
    • “A healthcare worker is required to oversee the application of the prescription maggot product, which was cleared based on demonstration of equivalence to the previously cleared medical-grade green bottle blowfly larvae — Lucilia sericata (Medical Maggots).”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has struck down key provisions in a CMS rule overhauling the Affordable Care Act, in a setback for the Trump administration’s push to combat fraud that critics argue is a smokescreen for weakening the exchanges set up by the Obama-era law.
    • “On Friday, Judge Brendan Hurson of the Maryland District Court vacated eight of the rule’s most consequential provisions, including the creation of a $5 premium penalty for individuals who automatically reenroll in coverage and a policy disqualifying people who fail to reconcile tax credits with their income from receiving subsidies.
    • “The decision is not a surprise after Hurson stayed most of the provisions last year. Still, officially tossing them out is a victory for proponents of expanded ACA coverage — though a short-term one, given many of the changes were codified in the GOP’s “Big Beautiful Bill” passed last summer.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “A pregnant woman in rural Arizona with syphillis could have been treated fairly easily with an injection of penicillin. But the drug, Bicillin L-A, is manufactured only by Pfizer, and has been in short supply for a year now — which meant the drug arrived too late to prevent probable congenital syphilis in her newborn.
    • “The syphilis epidemic is worsening, congenital syphilis cases are up roughly 800% since 2012 — and this Bicillin shortage is expected to continue through 2027. Public health officials say Pfizer’s emergency allocation system is confusing and may disadvantage health departments serving low-income patients.
    • “A box of 10 syringes can cost around $8,000, and the drug is manufactured at only one Pfizer plant in Michigan to supply the whole country.
    • “Most shortages are of not-very-profitable drugs,” said Erin Fox, associate chief pharmacy officer at University of Utah Health.”
  • The American Medical Association lets us know what doctors want patientsto know about allergic rhinitis
    • “Allergic rhinitis, or hay fever, is more than just the sniffles. Understanding triggers and when to talk to a physician are key to managing allergic rhinitis.”
  • Per an National Institutes of Health news release,
    • “A clinical trial supported by the National Institutes of Health (NIH) found that adults with prediabetes assigned to a lifestyle intervention had a significantly lower risk of developing multiple chronic health conditions (known as multimorbidity) over time than those assigned to a placebo. This study, which followed participants for over two decades, also found that participants assigned to receive metformin did not experience a statistically significant reduction in multimorbidity risk. The findings, published in JAMA, highlight the lasting benefits of lifestyle programs that may lower risk of the development of chronic conditions.
    • “Multimorbidity is a common issue, and few interventions have been found to prevent or delay developing multiple chronic conditions,” said Marcel Salive, M.D., first author of the study, from NIH’s National Institute on Aging (NIA). “Our work showing that healthy lifestyle intervention can significantly lower the burden of multimorbidity is a step forward in addressing this growing problem.”
  • MedPage Today relates,
    • “COVID-19 vaccines were associated with a lower risk of major adverse cardiovascular events in “a cohort study of veterans.
    • “The 2024-2025 vaccines also demonstrated effectiveness against COVID-associated emergent care, hospitalization, and critical illness among adults.
    • “Among older adults who received a 2025-2026 vaccine, overall COVID vaccine effectiveness against symptomatic disease was 59%.
  • Healio tells us,
    • “Less than a quarter of patients with stroke and fewer than one in seven with traumatic brain injury were discharged to inpatient rehabilitation.
    • “Clinicians should plan for rehabilitation early and make it an intentional part of care.”
  • and
    • “The American College of Physicians (ACP) has published living clinical guidance to help physicians select medications for patients with overweight or obesity.
    • “Unhealthy weight remains a significant public health issue globally, with 68.5% of American adults and 59% of adults worldwide having overweight or obesity, according to Amir Qaseem, MD, PhD, MHA, MGIN, MRCP, FACP, ACP chief science officer and senior vice president of clinical policy at the Centers for Evidence Reviews, and colleagues.
    • “They wrote in Annals of Internal Medicine that first-line treatments for obesity and overweight include physical activity and nutrition, but the new guidance “addresses additional management using pharmacologic treatments when lifestyle modifications alone do not result in optimal weight loss or weight maintenance for a person.”
  • Pharmacy Times informs us,
    • “Pooling ATTAIN-1/2 female participants, menopausal stage–stratified outcomes at 72 weeks included weight, waist circumference, waist-to-height ratio, and categorical weight-loss thresholds using an efficacy estimand. 
    • “Orforglipron [Lilly’s oral GLP-1 drug] achieved statistically significant placebo-adjusted reductions across premenopause, perimenopause, and postmenopause, reaching approximately 14% body-weight loss and up to 11 cm waist reduction (P<.001). 
    • “Clinically meaningful responder rates favored orforglipron, with up to 83% achieving ≥5% weight loss vs 23% on placebo, and higher rates across ≥10%, ≥15%, and ≥20% thresholds. 
    • “More participants shifted to lower waist-to-height ratio categories on active therapy, supporting potential visceral adiposity and cardiometabolic risk mitigation in menopause-associated fat redistribution. 
    • “Unrestricted oral administration (no food/water requirements) may reduce adherence barriers in midlife women with polypharmacy, strengthening pharmacist-led counseling and referral pathways in obesity care.”
  • BioPharma Dive points out,
    • “An experimental drug that Eli Lilly recently picked up through a potentially multibillion-dollar acquisition appears to have passed its first major test, scoring positive results in a small study of patients with hard-to-treat blood cancer.
    • “Originally developed by Ajax Therapeutics, the drug inhibits an enzyme that spurs blood cell production. Several medicines that block this “JAK2” enzyme, including Incyte’s Jakafi, are already on the market, where they’re mostly used in rare, chronic blood cancers like myelofibrosis. While these medicines can be quite effective at treating symptoms, many patients either don’t respond or stop taking them because their disease progresses or they can’t tolerate the side effects, which range from nausea and fatigue to anemia and increased stroke risk.
    • “Lilly’s pill is designed to work in a slightly different way than its approved counterparts, binding to JAK2 in the “inactive” state. Researchers hypothesize this change should make for a superior therapy that also overcomes drug resistance challenges.
    • That idea now has more support thanks to data presented over the weekend at a major medical meeting in Europe.”

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

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. will launch a new line of commercial health plans called Edge across all five of its Blue Cross Blue Shield states beginning in 2027.
    • “The plans, powered by a proprietary plan design called Easify, have no deductibles and no coinsurance for in-network care, leaving members with fixed copays, according to a June 11 news release. 
    • “HCSC said the PPO plans aim to let employees in Illinois, Texas, Oklahoma, Montana and New Mexico anticipate out-of-pocket costs more easily and help employers better manage total medical spend. HCSC also said the new product will steer members toward “high-value” care using behavioral incentives.” 
  • Beckers Hospital Review relates
    • “Middle-age adults who use GLP-1 medications for obesity could save an average of $192,735 in lifetime medical costs, according to a study published in June by the National Bureau of Economic Research. 
    • “Researchers from Los Angeles-based University of Southern California simulated health and economic outcomes for U.S. adults ages 25 and older, comparing lifetime trajectories for people who used GLP-1s for obesity with those who did not. Obesity was defined as a body mass index higher than 30.”
  • and
    • “Virtual nursing for hospital discharge was associated with sharply lower 30-day emergency department readmissions across nine hospitals in a major Southeastern U.S. health system, according to a study published in npj Digital Medicine.
    • “Researchers at the University of North Carolina at Chapel Hill compared 4,662 discharges handled by remotely located virtual nurses with 4,662 traditional in-person discharges, matched on patient and hospital characteristics. Patients discharged through virtual nursing returned to the ED within 30 days at a rate of 3.7%, versus 13.3% for in-person discharge — a 72% relative reduction, or a risk ratio of 0.28. That works out to roughly 1 readmission in 27 virtual-nursing patients, compared with 1 in 8 receiving standard discharge.
    • “The effect held in both settings, with the gap widest in rural hospitals: 3.1% versus 17.9% rural, and 4.1% versus 10.7% urban.
    • “Virtual nurses delivered structured, uninterrupted discharge education — medication reconciliation, teach-back, and care-plan review — from an off-site center operating 7 a.m. to 7 p.m., seven days a week. The health system rolled out the model across the nine hospitals between 2022 and 2024.”
  • MedTech Dive informs us,
    • “Medtronic said Friday it has completed the $550 million takeover of neurovascular technology company Scientia Vascular.
    • “The deal, which Medtronic disclosed in March, covers guidewire technologies for stroke that are designed to equip physicians to access hard-to-reach parts of the brain.
    • “Buying Scientia will enable “every neurovascular procedure to start with Medtronic,” CEO Geoff Martha said on an earnings call with investors this month.”
  • Medical News Today points out,
    • Three AI-based mammography systems were able to identify subtle signs of future breast cancer years before diagnosis, with elevated cancer prediction scores seen in those who later developed the disease. 
    • In the study, approximately 20% of breast cancer cases showed AI-detectable mammographic changes as early as 6 years before diagnosis. 
    • At 90% specificity, the AI systems flagged potential future cancers in up to 19.7% of women 6 years before diagnosis, 25.2% 4 years before diagnosis, and 39.3% 2 years before diagnosis. 
    • The findings suggest AI could support earlier breast cancer detection and help enable more personalized screening strategies by identifying females who may benefit from closer monitoring or earlier intervention.
  • FYI, The Blue Cross Blue Shield Association has a job opening on its Legal Team supporting FEP.

Thursday update

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

  • Smart Brief reports,
    • “AHIP26: How data sharing, simplicity can improve care
    • “Panelists at the conference discuss the challenges that data fragmentation and siloing, as well as an unwieldy system, present — and offer solutions.”

From Washington, DC,

  • Govexec reports,
    • “A bipartisan trio of House lawmakers on Thursday reintroduced legislation aimed at expanding federal workers’ access to paid leave to handle illnesses and other circumstances not included in the 2019 law granting feds paid parental leave.
    • “The Comprehensive Paid Leave for Federal Employees Act, introduced by Reps. Don Beyer, D-Va., Brian Fitzpatrick, R-Pa., and Chrissy Houlahan, D-Pa., would grant federal employees up to 12 weeks of paid family leave each year to attend to a serious health condition or to care for a spouse, child or parent. The measure would also cover absences needed to help a family member who is the survivor of domestic violence, sexual assault or stalking, as well as to attend to a family member’s deployment into active duty military service.
    • “When Congress passed the 2020 National Defense Authorization Act, the House’s version included a provision providing 12 weeks of paid parental and family leave to feds. But during negotiations with the Senate, the measure was stripped down to remove the family leave portions, and feds became eligible for paid parental leave in October 2020.”
  • The Wall Street Journal reports,
    • “If you’re a senior, the Medicare plan you choose may have a major impact on whether you can get nursing-home care when you need it—and a new federal investigation shows the largest insurers had some of the highest denial rates.
    • “Medicare insurers had widely varying rejection rates for patients seeking nursing-home stays, as well as for long-term care hospitals and inpatient rehabilitation facilities, according to two new reports from the Office of Inspector General for the Department of Health and Human Services. * * *
    • “Appealing does appear to pay off: Of the 18% of patients who did appeal, nearly all of them were able to overturn the initial denial of skilled nursing care.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services June 11 released guidance detailing plans to implement new guidelines and standards for determining budget neutrality for Medicaid section 1115 demonstrations, which give states flexibility to design and test experimental approaches to Medicaid, including modifying eligibility, benefits, delivery systems and coverage, in ways not otherwise permitted under standard Medicaid authority. The guidance is intended to support implementation of a statutory requirement under the July 2025 reconciliation bill that the CMS Chief Actuary certifies that a demonstration is projected to be budget neutral, meaning it would not increase federal Medicaid spending relative to what expenditures would have been absent the demonstration. CMS said it plans to issue a rule with its proposed changes to budget neutrality.”
  • and
    • “The Centers for Medicare & Medicaid Services June 10 announced the establishment of a new Office of Health Technology and Products. CMS said the OHTP would modernize CMS healthcare technology and digital products, and transform platforms and services to support Medicare, Medicaid, the Children’s Health Insurance Program and other CMS-administered programs. The office will work closely with the CMS Chief Information Officer and be subject to CIO-led IT governance, cybersecurity, enterprise architecture, and capital planning and investment control responsibilities, among other areas. The OHTP will include new divisions, such as an Open Source Program group to develop policies and guidance around open-source frameworks, a Division of Data and Interoperability Platforms, and a Division of Policy responsible for the development of interoperability policies, regulations and sub-regulatory guidance. Additionally, the OHTP includes a Division of Core Products, responsible for the management and modernization of Medicare claims systems and provider-facing components such as the National Provider Directory. The OHTP and organizational changes became effective June 9.”
  • KFF explains how “Medicare Advantage Rebates Disadvantage Medicare’s Stand-Alone Drug Plan Market.
    • “Medicare Advantage Rebates Undermine Competition with Stand-Alone Drug Plans by Lowering Medicare Advantage Drug Plan Premiums.”
  • Beckers Hospital Review points out that “The 340B rebate fight escalates: 14 key developments.”
    • “From the first lawsuit to Lilly’s ultimatum: 18 months that reshaped the 340B program.”
  • Tammy Flanagan, writing in Govexec, discusses “Why Social Security’s funding gap matters to federal retirement.”
    • “Most federal employees under FERS rely on Social Security as part of retirement. The latest trustees report suggests the choices to preserve full benefits are getting tougher.”
  • Per a National Institutes of Health News release,
    • “National Institutes of Health (NIH) Director Jay Bhattacharya, M.D., today announced the selection of Raymond H. Jacobson, Ph.D., as the director of NIH’s Center for Scientific Review (CSR), which ensures expert and fair review of the tens of thousands of grant applications received by the agency each year. Dr. Jacobson will begin his role on June 14, 2026.
    • “Dr. Jacobson will continue strengthening NIH’s centralized peer review system so that we can continue backing the most scientifically meritorious research ideas in support of NIH’s mission,” said Dr. Bhattacharya. “His leadership will help ensure the first level of NIH review remains rigorous, fair, and transparent for all applicants.”
    • “Prior to his selection, Dr. Jacobson served as CSR’s acting director following the retirement of Dr. Bruce Reed. Dr. Jacobson helped guide NIH’s centralization of peer review, and as Acting Deputy Director of the NIH Office of Extramural Research in 2025, he advanced efforts to reduce administrative burden and address challenges faced by applicants. Additionally, he was the director of the CSR Division of Receipt and Referral beginning in December 2024, where he led efforts to simplify application receipt and referral policies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “When millions of soccer fans descend on North America [beginning today] for the 2026 FIFA World Cup, they will bring more than team jerseys and national pride.
    • They will also bring the microbes that travel with people.
    • Public health officials have spent years preparing for the tournament, which is expected to draw visitors from more than 100 countries to the United States, Canada and Mexico. Although diseases such as Ebola and hantavirus have been in the headlines, public health experts say the diseases most likely to show up in clinics, emergency departments or urgent care centers are likely to be less exotic.
    • “Instead, their top concerns include measles, dengue, respiratory viruses and sexually transmitted infections that are already circulating. These diseases are likely to spread more easily as fans crowd into airports, hotels, stadiums and festivals.
    • “Measles is what I’m most worried about,” said Krutika Kuppalli, an infectious diseases physician and associate professor at UT Southwestern Medical Center in Dallas.
    • “Texas will host 16 World Cup matches in 2026 — more than any other state — with nine matches in the Dallas-Arlington area and seven in Houston. Dallas will host more matches than any other World Cup venue, including a semifinal. The first U.S. match is Friday, in Los Angeles, when the U.S. faces off against Paraguay.”
  • and
    • “Neuroscientist Miia Kivipelto’s life’s work has been about preventing dementia. Now, at 52, she has begun thinking more about her own vulnerability.
    • “Midlife is the time,” said Kivipelto, a neuroscientist who recently joined the Yale School of Nursing as the inaugural director of its Center for Aging Well in New Haven, Connecticut. “It’s the last best chance to lower risk.”
    • “The idea that dementia prevention may hinge on what people do in their mid-30s to their 60s is rapidly reshaping the field. Scientists increasingly believe the disease is driven not only by changes in the aging brain, but also by years of metabolic stress, inflammation and vascular damage accumulating across the body. Many researchers now think the biological process that leads to dementia begins 15 to 20 years before the first memory problems emerge. By the time symptoms become noticeable, the disease likely will already be well established.
    • “Neuroscientists now see midlife as a critical window when the brain becomes especially vulnerable to aging — but also more responsive to intervention. 
    • “The implications are profound: The ordinary habits of middle age may matter far more than scientists once realized, and cognitive decline may not be inevitable.”
  • Per a National Institutes of Health news release,
    • “A research consortium funded by the National Institutes of Health (NIH) has established a new framework to identify and catalog senescent cells – cells that stop dividing but remain active in the body. Because senescent cells accumulate with age and are thought to contribute to many age-related conditions, researchers are working to better understand the roles they play in health and disease. In a compendium of papers published in the June 11 issue of Cell, the consortium presents the first comprehensive atlas of senescent cells across the human body, a foundational step toward developing new therapies for age-related diseases.
    • ‘In healthy tissues, senescent cells support wound healing and serve as a defense mechanism by preventing the growth of tumors. They are normally cleared by the immune system, but as immune function declines with age, senescent cells accumulate in the body instead of being eliminated. Over time, these cells then release harmful signals that contribute to chronic disease and other age-related conditions. While removing these cells has been shown to diminish the impact of aging, their rarity and diversity have made them difficult to study.
    • “To address this challenge, the NIH Common Fund launched the Cellular Senescence Network (SenNet) program in 2021 to identify and characterize senescent cells across the human body.
    • “Through the new papers, researchers in the consortium are introducing the concept of “senotypes,” a new classification system that groups senescent cells based on where they are found in the body and the conditions surrounding them.
    • “By mapping where different senotypes are found and what makes them unique, we aim to build a more complete picture of senescent cells across the body,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives (DPCPSI), who leads the NIH Common Fund. “This knowledge could help researchers move toward more targeted therapies that focus on harmful cells while preserving beneficial ones.”
  • MedPage Today tells us,
    • “Research has suggested that consumption of sugar-sweetened beverages is linked to increased risks of certain cancers.
    • “A pooled analysis of 11 studies showed that sugar-sweetened beverage intake was not associated with overall liver cancer risk but was tied to increased risks of hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
    • ‘Of note, there was no association between consumption of artificially sweetened beverages and liver cancer overall, or by subtype.
  • Health Day informs us,
    • “Sleep apnea might affect women worse than men.
    • “Women had similar outward symptoms of sleep apnea.
    • “However, they reported higher levels of side effects.”
  • STAT News lets us know,
    • “A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, including higher response rates in patients treated at an earlier stage of their disease.
    • “The updated early-stage study results reported Thursday for the Enliven drug, ELVN-001, compare favorably to a current blockbuster medicine sold by Novartis and an upstart experimental drug recently bought by Merck.” * * *
    • “Enliven has met with the Food and Drug Administration and received clearance to start a Phase 3 study later this year that will enroll patients with CML previously treated with one or more drugs. The study will compare ELVN-001 against a physician’s choice of currently approved CML drugs, excluding Scemblix.
    • “The company believes the addressable commercial market for ELVN-001 as a “second-line plus” treatment option for CML is worth $5 billion.”
  • Biopharma Dive adds,
    • “Takeda’s experimental autoimmune drug zasocitinib bested Bristol Myers Squibb’s marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday.  
    • “Takeda didn’t provide detailed data but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. It’s the second time Takeda’s drug has beaten an approved therapy, following positive results in a trial testing it against Amgen’s Otezla. 
    • “Zasocitinib is a newer kind of “TYK2 inhibitor,” a class of oral autoimmune medicines that have attracted significant industry investment in recent years. It’s become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.”
  • and
    • “An RNA drug Novartis acquired as part of its $12 billion bet on Avidity Biosciences succeeded in a trial of patients with a rare neuromuscular disease, Novartis said Thursday.
    • “Called delpacibart braxlosiran, the experimental drug met its primary biomarker endpoint in a Phase 1/2 study evaluating the treatment in a muscle-wasting disease known as facioscapulohumeral muscular dystrophy, or FSHD. The drug, a so-called “antisense oligonucleotide conjugate” or AOC, is designed to restore muscle function and help slow progression of the disease.
    • “Del-brax targets a gene called DUX4, which is expressed incorrectly in patients with FSHD.”

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

  • Modern Healthcare reports,
    • “Group healthcare costs are expected to rise 9% in 2027 as Americans use more services. 
    • “The growing use of expensive drugs, the proliferation of mental health issues and reimbursement pressures will drive healthcare cost inflation, according to a Thursday report from consultancy PwC.”
    • “Researchers spoke with actuaries at 27 health insurers that cover 103 million employer-sponsored members and 8 million Affordable Care Act enrollees to forecast healthcare inflation. 
    • “PwC projected an 8.5% increase for the individual market. In addition to the 2027 projections, the consultancy retroactively adjusted last year’s group cost growth estimate to 9% from 8.5% and the individual market projection to 8.5% from 7.5%.”
  • and
    • “U.S. companies plan to charge more for employee health plans next year, as soaring drug prices drive up insurance costs.
    • “Two-thirds of large companies expect to raise monthly premiums for employee health coverage through paycheck deductions in 2027, according to a survey of businesses with at least 500 employees by benefits consultancy Mercer. And about half (48%) of employers say they will make other changes, such as raising deductibles and copays, that will increase how much workers pay out of pocket for care.”
    • “It isn’t just employees who will be paying more. Health insurers are raising costs for employers, too, with the cost of group plans set to increase by more than 6% for the fourth year in a row, said Beth Umland, Mercer’s director of research. Annual increases previously hovered around 3% for more than a decade.
    • “Although employers initially tried to absorb those higher costs, they are beginning to pass them onto workers, Umland said. This year, employers expect to pay more than $18,500 per employee for health care benefits, a 6.7% increase from 2025 and the biggest jump in 15 years.”
  • MedCity News adds
    • “If you want to know where healthcare finance is headed, ask the people who lend hospitals money. 
    • “During a Tuesday panel at the HFMA Annual Conference in National Harbor, Maryland, two veteran healthcare credit analysts said they think the window for deliberate strategic action is closing faster than most health system leaders realize.
    • “We love incremental change in healthcare — it’s not going to work anymore,” said Kevin Holloran, senior director of nonprofit healthcare group at Fitch Ratings. “We’ve got to have some really bold thoughts and really bold moves if we’re going to be ready for 2030 and then beyond.”
    • “His urgency stems from a stark demographic reality. In 2030, the last of the Baby Boomer generation will officially reach age 65 and become Medicare-eligible. This is the same year that the most significant cuts from the federal budget reconciliation legislation will begin to bite.” * * *
    • “2030 scares me to death,” Holloran declared. “Right when you get fewer people in the workforce, you’re going to see your payer mix decline. You’re going to go from commercial to Medicare — and you’re not going to have enough people, as they’ve left the workforce.”
  • Healthcare Dive relates,
    • “Health plans are projecting commercial healthcare costs will rise 9% next year, driven in part by increased adoption of artificial intelligence billing tools by providers, according to a report released Thursday by professional services firm PwC.
    • “Nearly 70% of surveyed plans ranked providers’ use of AI documentation and coding products as a top three inflator next year, while about 20% called AI the number one inflationary trend. 
    • “Still, AI isn’t a major driver of growing healthcare costs compared with labor and supply cost inflation or increased healthcare utilization, said Glenn Hunzinger, U.S. health industries leader at PwC. “The ability to use technology and AI to more appropriately code or code things that they were never able to, that’s the trend we’re seeing,” he said. “It does have an impact on that 9%, albeit it’s not the biggest piece.”
  • Fierce Healthcare adds,
    • “Since launching eight years ago with an ambient medical transcription tool, Abridge has set is sights more broadly on building out a full-scale AI clinical assistant. The company is steadily developing tech and features to assist with billing, prior authorization and clinical decision making.
    • “Today, the company announced a major platform expansion to integrate payer and life sciences workflows. Described as an “AI-native clinician intelligence platform,” Abridge says it now connects care delivery, payment and evidence-based treatment.
    • “Abridge CEO and co-founder Shiv Rao, M.D., announced Thursday at an event in New York City that pharma giant Eli Lilly and Company made a strategic investment in the company to “support evidence-based care and research.” The financial details of the investment were not disclosed.”
  • Coviti points out,
    • “Improper use of modifier codes in radiology can lead to excessive billing, often misrepresenting radiology services and diminishing trust between providers and health plans. As new requirements and measures emerge, special investigative units (SIUs) should remain vigilant with claims analyses and proper documentation to reduce overpayments.
    • “This month’s edition of FWA Insights dives into outlier billing for modifier codes and excessive services in radiology, revealing the ramifications of medical coding discrepancies and providing practical steps to prevent fraud, waste, and abuse (FWA).”
  • Per an Institute of Clincal and Economic Research (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its revised Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “Covid-19 infections continue to occur year-round, sometimes leading to serious illness or death,” said ICER’s Chief Medical Officer, David Rind, MD, MSc. “For any preventive care, the goal is always to understand whether the potential benefits outweigh the potential harms. ICER evaluated the evidence for Covid-19 vaccines in 12 US sub-populations. Current evidence suggests that the greatest net benefit of Covid-19 vaccination is in pregnant women; infants aged 6 months to one year; and adults over the age of 65, with the net benefit increasing further with increasing age. Declining rates of serious Covid-19 year over year necessarily create some uncertainties. We hope this report will be a useful resource to policymakers and public health officials as they consider vaccination recommendations for Covid-19 for the 2026-2027 season.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on June 25, 2026. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.“
  • Fierce Healthcare tells us,
    • “Humana announced this week that it intends to divest its minority stake in Gentiva, the largest provider of end-of-life care in the country.
    • “The company said Wednesday that it has entered into a definitive agreement to sell off “all or substantially all” of its stake in Gentiva to a “consortium of investors.” The agreement puts the value of Humana’s stake in Gentiva at about $900 million, according to an announcement.
    • “Other financial terms related to the deal were not disclosed, and it’s expected to close in the third quarter of 2026, pending regulatory approval. Details on which investors are involved were also not made public.
    • “Humana said in the announcement that it plans to use the funds from the sale for “general corporate purposes,” and said it does not expect that the deal will have a material impact on its earnings for the year.”
  • BioPharma Dive informs us,
    • “Parabilis Medicines, a high-profile startup making medicines for “undruggable” targets, raised $670 million in an initial public offering on Wednesday, a record haul for a venture-backed biotechnology company.
    • “Parabilis boosted the size of its offering and ultimately sold 33.5 million shares at $20 apiece, eclipsing the amounts secured by Moderna in 2018 and Kailera Therapeutics earlier this year. It added another $75 million through a discounted private stock sale to new research partner Regeneron Pharmaceuticals.
    • ‘The IPO extends a streak this year for large new biotech stock offerings. So far in 2026 a dozen drugmakers have gone public and raised a median of about $300 million each, more than doubling the median total biotech startups secured in IPOs last year, according to BioPharma Dive data.” 
  • Per MedTech Dive,
    • “Danaher has completed its $9.9 billion takeover of Masimo, establishing itself as a competitor to Medtronic in the pulse oximetry market. 
    • “The completion of the purchase, which Danaher reported Wednesday, positions the company to start integrating Masimo in pursuit of more than $125 million of annual cost synergies and more than $50 million of annual sales synergies by the fifth full year after the deal closure.
    • “Masimo will slot into a diagnostics portfolio that features Radiometer, a Danaher business that specializes in blood gas analysis and other testing in acute care settings.”
  • and
    • “Insulet is developing an automated insulin delivery system that will be “completely different” than its competitors, Chief Medical Officer Trang Ly said in an interview after the American Diabetes Association’s Scientific Sessions. 
    • “The system, which Insulet calls “fully closed loop,” is for people with Type 2 diabetes and does not require carb-counting or insulin bolusing ahead of meals. Physicians also don’t need to program the starting settings, and dose titration is automated. 
    • “With our system there’s no bolusing at all. There’s actually no bolus button. … It’s completely different to what Medtronic and Tandem and everyone else is working on,” Ly said. “There are no settings for anyone to enter.” 
    • “Insulet shared results of its Evolution 3 study of the planned system at the conference on Saturday. The study built on previous results the company shared at another diabetes conference in March.”