Weekend Update

Simplicity is a virtue.

From Washington, DC,

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

From the public health and medical / Rx research front,

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

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

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

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