Thursday report

Federal employment benefits

Thursday report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Service news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced $102 million in New Access Points awards to significantly expand the reach of the Health Center Program. The awards represent the first major expansion of the Health Center Program since the first Trump Administration in 2019, supporting 158 new and existing health centers to establish 415 new sites and expand access to comprehensive primary care for nearly 1 million people nationwide.
    • “Strong primary care prevents disease and gives Americans greater control over their health,” said HHS Secretary Robert F. Kennedy, Jr. “This $102 million investment will bring high-quality care to nearly one million more Americans, expand prevention and nutrition services, and help communities tackle chronic disease at its roots. We are giving more Americans the tools to live healthier lives and Make America Healthy Again.”
    • “Learn more about the Health Center Program and find a health center near you.
    • “Visit the New Access Points webpage for more details on the program and a list of 2026 award recipients.”
  • Per a Government Accountability Office news release about a new report,
    • “National Crisis and Support Hotlines: Contact Volume Increased and Operations Remained Relatively Consistent in 2025
    • “GAO-26-109046. Published: Aug 13, 2026
    • “The federal government operates the following hotlines:
      • “Health and Human Services’ 988 Suicide & Crisis Lifeline provides 24/7 support to people in distress
      • “HHS’s National Maternal Mental Health Hotline provides emotional support to pregnant and postpartum women
      • “Veterans Affairs’ Veterans Crisis Line provides support to veterans, service members, and their families
    • In February 2025, the President issued an executive order aimed at reducing the size of the federal workforce. While HHS and VA reduced their staff, the hotlines’ operations and services remained mostly consistent, with an increase in chats, texts, and calls.
  • FEHBlog observation: While aware of the 988 line, he wants to call attention to the other two lines.

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

  • Federal News Network reports about, “FEHB and Medicare: Understanding how they work together in retirement.”
  • Fedweek explains “How FEDVIP Differs from FEHB in Retirement.”
  • Tammy Flanagan, writing in Govexec, advises “Before you take money out of your TSP, weigh these trade-offs.”
    • “A withdrawal can affect everything from your tax bill and Medicare premiums to how long your savings last and what your heirs receive.”
  • Federal News Network tells us,
    • “Following a year of sweeping staffing reductions, the Trump administration is laying the groundwork for agencies to ramp up recruitment efforts. The Office of Personnel Management has directed agencies to begin assembling “annual staffing plans” for fiscal 2027.”
  • Chief Data Officer Magazine informs us,
    • “The U.S. Office of Personnel Management (OPM) has directed federal agencies to make technology recruitment a key component of their fiscal year 2027 workforce plans. Guidance issued by OPM directs agencies to include dedicated hiring strategies for roles in artificial intelligence (AI), cybersecurity, software engineering, data science, digital services, and other technology fields in staffing plans due by Sept. 30.
    • “Agencies are also expected to assess how the adoption of modern technologies will affect workforce needs and align hiring accordingly.”
  • Federal News Network adds,
    • “The Merit Systems Protection Board is officially transitioning away some of its authority over adverse action appeal decisions. A new final rule from MSPB removes all references to the board’s prior jurisdiction over appeals due to firings or demotions during a reduction in force, probationary period or for a suitability-related reason. The adjustments at MSPB come after the Office of Personnel Management finalized rules to take over decisions in those three categories of workplace disputes. The change takes full effect in early September.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports.
    • “Novartis is recalling a single lot of valsartan, a blood pressure drug the company sells under the brand name Diovan, due to failed dissolution specifications. This means it is not dissolving correctly, which can impact the drug’s effectiveness. 
    • “The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, meaning exposure to the drug may lead to “temporary or medically reversible adverse health consequences.” 
    • “Diovan is an angiotensin II receptor blocker used to treat hypertension and heart failure. It may also be prescribed to patients after a heart attack. This specific lot, AV5913C, includes packages of 90 160-mg tablets that expire in June 2027. The drugs were manufactured by Pantheon Manufacturing Services in Greenville, North Carolina, and distributed by Novartis Pharmaceutical Corp. in Hanover, New Jersey.”
  • Yahoo News relates,
    • “There’s an ongoing recall on a specific type of bladder medication distributed and prescribed nationwide, according to the U.S. Food and Drug Administration (FDA). This is due to an impurity issue.
    • “The medication being recalled is 25-milligram, 30-count bottles of mirabegron extended-release tablets manufactured by Zydus Lifesciences. The recalled bottles contain a lot code of “E408618,” an NDC of “70710-1159-3” and the expiration date “11/30/2026.” * * *
    • “Check your medication, and if you have the recalled product on hand, contact your pharmacy for a refund or replacement. Seek medical attention if you are experiencing any health concerns after consuming the affected pills.”
  • Reuters tells us,
    • “The U.S. FDA on Thursday approved Bristol Myers Squibb’s (BMY.N) oral combination treatment for patients ​with a rare form of blood cancer whose illness had relapsed or ‌not responded to other treatments, the health regulator said.
    • “The drug, iberdomide, with brand name Zenbexus, is given in combination with J&J’s (JNJ.N), opens new tab Darzalex and dexamethasone, a prescription medication used to reduce inflammation.” * * *
    • “The list price of Zenbexus is $29,500 ‌for ⁠a 28-day cycle, Bristol said. The company expects product availability within the coming weeks.”
  • The American Hospital Association News adds,
    • “The AHA Aug. 13 responded to a Food and Drug Administration request for input on the risks and benefits to health and safety associated with non-device software. Among its recommendations, the AHA supported the benefits of clinical decision support software and requested the FDA to permanently adopt flexibilities for CDS that generate only one clinical recommendation. The AHA also requested that the FDA clarify its general wellness guidance by providing additional resources on labeling and clarifying or removing references to allow non-device general wellness applications to make recommendations on escalation to a healthcare provider. Finally, the AHA encouraged the FDA to continue to update guidance, education and other materials to account for novel artificial intelligence applications, including generative AI. Input will support an agency report, as required under Section 3060 of the 21st Century Cures Act.”

No Surprises Act News

  • Following up on yesterday’s discussion of the U.S. Court of Appeals for the Fifth Circuit’s opinion about the calculation of qualifying payment amounts (“QPA”), the American Hospital Association tells us,
    • “A statement posted Aug. 13 on the Centers for Medicare & Medicaid Services website said that the agencies are reviewing the court’s opinion and judgement and anticipates issuing guidance shortly.” 
  • FEHBlog Observation: The Fifth Circuit is a victory for the majority of health care providers who accept the QPAs. No one can object to that outcome.
  • Beckers Hospital Review recounts “the never-ending No Surprises saga.”
    • “When President Trump signed the No Surprises Act into law in 2020, the straightforward premise was that patients should not be blindsided by massive emergency care bills from out-of-network physicians they never chose. On that front, the law has largely worked. 
    • “But the system Congress built to resolve payment disputes between insurers and providers has led to an increasingly expensive and bitter standoff that insurers say is driving up premiums, while physicians report waiting months to get paid. And employers, particularly the self-funded plans that cover the majority of commercially insured workers, say they’re the ones now stuck with a big chunk of the bill. In recent months, the courts, Congress and federal regulators have all been moving in different directions on exactly what to do about it.”

From the judicial front,

  • Beckers Hospital Review reports,
    • “The federal government has referred dozens of hospitals, pharmacy benefit managers and pharmacies to investigators over potentially fraudulent billing related to pediatric gender-affirming care.
    • “Vice President JD Vance referred hospitals and clinics identified in a new HHS report to the Justice Department, while HHS Secretary Robert F. Kennedy Jr. referred flagged organizations to HHS’ Office of Inspector General over “potentially anomalous billing patterns” identified through an analysis of insurance claims, according to an Aug. 13 news release.” * * *
    • “In the report, HHS shared its analysis of claims data spanning 2015 to 2025, identifying $47.6 million in claims for puberty-blocking drugs prescribed to patients 9 to 17 years old with endocrine disorder diagnoses, excluding precocious puberty. The patients also did not have a gender-related diagnosis documented. Of those claims, $42.6 million stemmed from an unspecified endocrine disorder diagnosis, the report said.” * * *
    • “The referrals mark the latest escalation in a federal crackdown on pediatric gender-affirming care that began shortly after President Donald Trump returned to office in January 2025. Some pediatric hospitals, most recently Hartford-based Connecticut Children’s Medical Center, have struck deals with the Justice Department and stopped providing gender-affirming care services.”
       
  • The Wall Street Journal relates,
    • “Luigi Mangione is expected to plead guilty Friday in a Manhattan federal court, where he is facing stalking charges in connection with the killing of UnitedHealthcare CEO Brian Thompson outside a Midtown hotel in 2024, people familiar with the matter said.
    • “The expected plea potentially resolves the federal case just a month before Mangione is scheduled to go to trial in New York state court on murder and other charges. But the people familiar with the matter cautioned that Mangione still could change his mind. And his defense team has abruptly shifted strategies previously.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Arthritis in its many manifestations is among the most common chronic conditions, affecting some 53 million adult Americans, and its associated pain often impairs the ability to perform daily activities including work.
    • “The Healthy People 2030 initiative set a goal of reducing the prevalence of joint pain in the U.S. to about 52%.
    • “In this analysis of National Health Interview Survey data from 2023, moderate to severe joint pain was reported by 58% of those with arthritis, with no change from 2019 (57%) after adjusting for age distribution.”
  • and
    • “Estrogen-only menopausal hormone therapy was linked with reduced Alzheimer’s pathology in an autopsy study.
    • “Estrogen treatment was also tied to lower odds of dementia diagnosis.
    • “More than 20 years after the landmark Women’s Health Initiative trial, hormone replacement therapy remains controversial.”
  • Beckers Behavioral Health relates,
    • “A nationwide, evidence-based tobacco treatment program for cancer patients and survivors in the U.S. would save $12.32 billion in healthcare costs over 10 years, according to a study published July 14 in JCO Oncology Practice.
    • “Led by researchers from Houston-based University of Texas MD Anderson Cancer Center, the study projected 10-year survival trends and healthcare cost savings associated with a nationwide smoking cessation program targeted to 18 million U.S. cancer survivors.” * * *
    • “Read the full study here.” 
  • Healio adds,
    • “Exercise capacity, oxygen uptake and ventilation at peak exercise were significantly reduced in e-cigarette and conventional cigarette users vs. never smokers.
    • “Vascular function also followed this pattern.”
  • BioPharma Dive lets us know,
    • “Taiho Oncology and partner Cullinan Therapeutics said a targeted medicine they’re developing has succeeded in a Phase 3 trial in frontline lung cancer, with investigators halting the study at an early data check because of clearly positive results.
    • “Taiho and Cullinan have been testing that therapy, zipalertinib, alongside chemotherapy in the first-line setting in people whose lung tumors have a so-called exon 20 insertion in a gene called EGFR. They didn’t release detailed data, but on Wednesday said that the combination “demonstrated a statistically significant and clinically meaningful improvement” in progression-free survival, meeting a pre-planned threshold for unblinding the trial.
    • “The Food and Drug Administration is already reviewing zipalertinib as a second-line treatment and is expected to make a decision by Feb. 27. If approved, the drug will add to an already competitive market battle. Johnson & Johnson’s Rybrevant and AstraZeneca and Dizal’s Zegfrovy are both available, and another biotechnology company, ArriVent BioPharma, is expecting Phase 3 data later this year.”
  • and
    • “Boulevard Bio, a new startup co-founded by pioneering autoimmune disease researcher Georg Schett, officially launched Wednesday with $65 million in its coffers and three experimental drugs.
    • “One of those medicines is already in early testing. Called BLVD-101, that drug is a so-called bispecific antibody aimed at a pair of targets known to drive the progressive kidney condition IgA nephropathy.
    • “IgAN has become a popular target for drugmakers of late. In the last year, U.S. regulators have approved two drugs, Vera Therapeutics’ Trutakna and Otsuka Pharmaceutical’s Voyxact. A third from Vertex Pharmaceuticals could follow.”
  • Fierce Pharma notes,
    • “Roughly a year and a half after the approval of Vykat XR, a group of clinicians with deep ties to the Prader-Willi syndrome (PWS) community is flagging potential safety concerns about the rare disease med, acquired in Neurocrine’s $2.9 billion buyout of Soleno Therapeutics last spring.
    • “The package insert for Vykat XR (diazoxide choline)—a potassium channel activator that became the first drug approved to treat the sensation of insatiable hunger, or hyperphagia, in PWS in March 2025—already cites the risk of fluid overload, based on an increased incidence of edema seen during clinical trials. 
    • “Since becoming more widely available, additional reports of edema and related complications in patients taking Vykat XR have been posted to the FDA’s Adverse Event Monitoring System (AEMS), including seven reports of death and more than 100 other reports of serious adverse events, mostly tied to edema, respiratory and cardiac complications.
    • “The adverse event trend, which doesn’t establish that Vykat XR caused the events, was flagged in a statement (PDF) from PWS patient organizations the Foundation for Prader-Willi Research, the International Prader-Willi Syndrome Organization and Prader-Willi Syndrome USA. The issue was first reported by Stat News earlier on Wednesday.” 

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

  • The American Hospital Association News reports,
    • “A blog by Robyn Tessin, AHA director of policy, discusses the ways value-based care can meet patients’ needs, resulting in improved affordability and access to timely, coordinated care. “The promise of value-based care is a healthcare system that feels less like a collection of separate transactions and more like a connected journey centered on each patient,” Tessin writes. “No single payment model can solve every affordability challenge. But providers, policymakers, payers and patients can build on what is working — strengthening existing models such as [accountable care organizations], scaling innovations in care coordination and ensuring that the models’ financial incentives are meaningful for patients.” READ MORE 
  • Beckers Payer Issues adds,
    • “Mishawaka, Ind.-based Franciscan Alliance has partnered with Millennium Physician Group to expand value-based care and primary care access across Indiana.
    • “Fort Myers, Fla.-based Millennium is part of a national value-based care platform partially owned by Elevance Health.
    • “The partnership will combine Franciscan’s physician network with Millennium’s practice management, analytics and value-based care capabilities. Franciscan physicians will remain part of the health system’s physician network while gaining access to additional operational support, technology, care coordination resources and analytics.
    • “As Franciscan Alliance celebrates 150 years of serving Indiana, this partnership represents the next chapter in that mission,” Franciscan Alliance President and CEO Kevin Leahy said in an Aug. 12 news release. “By combining our trusted community presence with Millennium’s proven expertise in value-based care, we are strengthening our ability to expand access, enhance quality and deliver more affordable healthcare for generations to come.
    • “The organizations said the partnership is designed to reduce administrative burdens for physicians, improve clinical performance and strengthen chronic disease management and care coordination.”
  • Reuters relates,
    • “Novo Nordisk (NOVOb.CO) CEO Mike Doustdar said investors are underestimating the demand for differentiation among obesity drugs, ‌and that new treatment options like pills will keep it from becoming a winner-take-all battle with rival Eli Lilly.
    • “Novo was first to bring a highly effective GLP-1 weight-loss injection, Wegovy, to the U.S. market, but is under pressure to regain ground lost to Lilly’s (LLY.N) Zepbound in a business that ​analysts expect will be worth more than $100 billion a year by 2030.
    • “Doustdar, who took the helm at the Danish ​drugmaker a year ago, said that patients are just beginning to understand which GLP-1 drug is ⁠best suited to them, and he expects more segmentation as new medicines are approved. More than 100 million U.S. adults ​are classified as obese.
    • “Right now the investor community has thought this is supposed to be a zero-sum game between two players – ​there’s a loser and a winner,” Doustdar said in an interview with Reuters on Wednesday.
    • “As you foresee the future of GLP-1s and obesity and weight-loss drugs, it will not be Coke versus Pepsi. It will be Coke and Pepsi and Fanta and Dr Pepper and Red Bull. People are ​thirsty, and they can make their choices,” he said.”
  • Beckers ASC Review tells us,
    • “For much of the past decade, the story of physicians’ practice has moved decidedly away from independence. 
    • “Hospital and corporate employment of physicians climbed from 62% to 78% between 2019 and 2023, and private practice fell from 60% of physicians in 2012 to just 42% in 2024, according to data from the Government Accountability Office.
    • “But 2026 is producing early signs that the pendulum may be swinging back, not toward the traditional solo practitioner model, but toward a new one built around management services organizations, physician practice networks and other arrangements designed to help physicians reclaim ownership and autonomy without giving up the scale and capital that made employment attractive in the first place.”
  • Healthcare Dive informs us,
    • “Nonprofit hospitals and health systems rated by credit ratings agency Fitch raised their operating margins and extended their financial recovery last year, according to a Fitch Ratings report based on audited fiscal 2025 data.
    • “The median operating margin among 222 nonprofit providers rose to 1.5%, compared to 1.1% in 2024, according to the report, and gains were increasingly concentrated among more financially stable providers. 
    • “Still, Fitch warned that 2025 could prove to be an “operational peak” before Medicaid funding reductions and other policy changes begin to pressure hospital revenue more significantly in 2027. Financially unstable and Medicaid-dependent providers have less financial cushion to absorb the coming strain, according to the credit ratings agency.”
  • Fierce Healthcare points out,
    • “Aetna is seeing its value-based care efforts pay off in both preventive care metrics and cost savings, according to a new analysis from the company.
    • “The insurer compared (PDF) outcomes across 20 different measures for individuals in its Medicare Advantage plans between value-based models and fee-for-service, and found that the value-based arrangements supported better results across 17 of the included measures.
    • “For example, value-based care models far outpaced fee-for-service in managing blood sugar and high blood pressure. Under value-based care, 43% more members controlled their HbA1C and 34% had controlled blood pressure, according to the analysis.
    • “In addition, 20% more patients were screened for colorectal cancer under value-based care and there were 7% fewer hospitalizations. These providers also generated $315 million in savings during plan year 2023, 2.6% higher than fee-for-service providers.”
  • and
    • “Cedar, a patient financial platform for healthcare providers, launched an agentic artificial intelligence platform Thursday aimed at patient medical billing.
    • “Kora Platform is a suite of purpose-built AI agents that integrates with healthcare organizations’ existing electronic health records (EHRs), telephony and call center systems. Some of the capabilities included within the suite include autonomous inbound voice, autonomous outbound voice, two-way text and advanced reporting.
    • “We really want Kora Platform to be this agentic advocate that’s sitting in the pocket of every patient,” Cedar Chief Strategy Officer Dugan Winkie told Fierce Healthcare.”
  • The American Medical Association lets us know about “four AI prompts to help prepare for your doctor’s appointment.”
    • “Here are some top expert tips on how to use AI chatbots in a way that makes the most of your time in the exam room with your physician.”

Midweek update

David Ermer–Agentic & Generative AI, AHRQ, CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a $4 million initiative to expand access to rapid, point-of-care syphilis testing, with a focus on reaching women in emergency departments and other nontraditional healthcare settings.
    • “Congenital syphilis is preventable, yet too many mothers and babies are still suffering its devastating consequences,” said HHS Secretary Robert F. Kennedy Jr. “HHS is putting rapid tests where women receive care so we can detect infections earlier, treat them faster, and protect more babies.”
  • Beckers Behavioral Health adds,
    • “HHS Secretary Robert F. Kennedy Jr., White House Office of National Drug Control Policy Director Sara Carter, and Housing and Urban Development Secretary Scott Turner released a toolkit Aug. 12 focused on addressing homelessness and addiction through treatment.
    • “The “Best Practices Toolkit: Addressing Homelessness and Addiction Through Treatment First” outlines strategies for communities to “help Americans transition from homelessness and addiction to recovery and self-sufficiency,” according to an Aug. 12 news release from HHS.
    • “The toolkit centers on a “Treatment First” model, which prioritizes coordinated and accountability-driven engagement in evidence-based treatment and recovery support services. It supports drug treatment and recovery efforts through the Great American Recovery Initiative.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services today released an advisory for certain clinicians who are qualifying alternative payment model participants and eligible to receive APM incentive payments, notifying them that their current billing information must be updated to receive funds for the 2026 payment year. CMS said that it was unable to identify a taxpayer identification number associated with some participants after processing 2026 APM incentive payments and therefore was unable to disburse payments. The agency said that all information must be received by Oct. 13. Following that date, CMS said any claim to an APM incentive payment for the 2026 payment period based on an eligible clinician’s qualifying APM participant status for the 2024 performance period will be forfeited.” 
  • Beckers Hospital Review adds,
    • “Participation in mandatory value-based payment programs from CMS is associated with significantly higher annual administrative costs for hospitals, according to a study published Aug. 7 in JAMA Health Forum.
    • “Researchers at the Brown University School of Public Health in Providence, R.I., examined 2006 to 2020 Medicare cost report data for 4,332 hospitals, including 2,820 that participated in the Hospital Value-Based Purchasing program, Hospital Readmissions Reduction Program and Hospital-Acquired Condition Reduction Program. They also assessed costs associated with participation in the Comprehensive Care for Joint Replacement model. * * *
    • “Participation in the first three programs was tied to annual administrative cost increases ranging from $650,000 per hospital compared with long-term acute care hospitals to $1.23 million compared with general acute care hospitals in Maryland. Participation in the CJR model was linked to a $1.4 million annual increase in administrative costs per hospital.
    • “Aggregated nationally, the programs accounted for more than $3 billion in additional annual administrative spending.”
  • Beckers Clinical Leadership tells us,
    • “HHS is creating a new pathway to evaluate which conditions should be added to the national newborn screening panel as part of a broader effort to modernize a review process that officials say has lagged behind advances in genetic medicine.
    • “The Health Resources and Services Administration on Aug. 11 launched a framework to streamline evidence reviews for the Recommended Uniform Screening Panel, the federal guideline nearly all state newborn screening programs follow. 
    • :A Federal Register notice published Aug. 12 laid out the mechanism: a National Newborn Screening Stakeholder Workgroup funded through a $700,000 award to the Silver Spring, Md.-based Association of Public Health Laboratories.”

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

  • My Federal Retirement reports,
    • “Based on CPI-W data through July 2026, the trend toward an estimated 2027 COLA holds at 3.1% for Social Security and CSRS retirees, which would translate to a FERS COLA of approximately 2.1% once the FERS reduction formula is applied — unchanged from last month’s estimate. The official 2027 COLA won’t be announced by the Social Security Administration until mid-October 2026. This page is updated monthly as new CPI-W data is released.”

From the Food and Drug Adminstration front,

  • The Hill reports,
    • The Food and Drug Administration (FDA) is assuring Americans that they should feel confident eating fresh produce again, seeking to ease concerns over the nation’s food supply after a cyclospora outbreak linked to iceberg lettuce spread across more than a dozen states.
    • “We have the safest food supply in the world,” acting FDA Commissioner Kyle Diamantas said in a Tuesday interview with CNBC. “Americans should feel confident in eating fresh produce including leafy greens at this point.
    • “Diamantas added that his agency “remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market” since California-based vegetable producer Taylor Farms voluntarily recalled products linked to the outbreak on July 17.” * * *
    • “The FDA and CDC are still investigating the outbreak, and officials have warned that the number of confirmed illnesses could continue to climb long after the recall because it can take as long as six weeks to determine whether an illness is connected to the outbreak.”
  • Medscape relates,
    • “Following unprecedented results from the RASolute 302 trial, cancer centers across the US are making daraxonrasib available to patients ahead of FDA approval.
    • “The RAS inhibitor has been in the news since it was shown to nearly double median overall survival vs standard chemotherapy — from 6.7 to 13.2 months — among patients with previously treated metastatic pancreatic cancer.
    • “The survival gain, in a notoriously difficult-to-treat disease, earned a standing ovation when the data were presented at this year’s American Society of Clinical Oncology annual meeting. And on July 22, daraxonrasib’s maker Revolution Medicines, announced that the FDA had accepted its approval application.”
  • Beckers Hospital Review tells us,
    • “San Francisco-based Hims & Hers plans to start selling compounded peptides by the end of 2026, with six more to follow pending final FDA rulemaking, executives said Aug. 10.
    • “The direct-to-consumer telehealth company laid out a phased rollout on its second-quarter earnings call. Executives said they expect to offer a first group of already-permitted peptides — including sermorelin, glutathione and a product it markets as MEDplus — by year’s end, then expand to six wellness peptides an FDA advisory committee recommended in July.
    • “We are currently developing a best-in-class peptide experience including U.S.-manufactured products, clinical-led guidance and ongoing blood testing,” co-founder and CEO Andrew Dudum said. He said the company is “waiting on full and final rulemaking from the FDA” before launching the recommended peptides.”

From the judicial front,

  • Bloomberg Law reports,
    • “The full Fifth Circuit partly struck down a series of federal rules on surprise medical bills, concerning the qualifying payment amount, or median in-network rate. 
    • “The court overturned a provision allowing insurers to include “ghost rates” in the QPA, and rejected a provision excluding bonuses and case-specific rates from the QPA. 
    • “The court sided with the agencies on a provision excluding one-time, case-specific agreements from the QPA calculation, saying the word rate “connotes a per-unit price for multiple units.”
  • Beckers Hospital Review adds,
    • “The court said the agencies can use their enforcement discretion to let insurers keep using existing QPAs while new calculations are completed, preserving balance billing protections for patients in the interim.”
  • The Wall Street Journal relates,
    • “Eli Lilly filed six lawsuits against U.S. entities it alleges are selling a version of its investigational weight-loss drug on the black market.
    • “The lawsuits claim the entities sell retatrutide, a GLP-1 drug that is still in trials and not yet approved by the FDA.
    • “Eli Lilly is calling on social media platforms and payment processors to help stop the black market sales of the drug.”

From the NCQA front,

  • The Cotiviti Blog tells us,
    • “Many health plans wrapped up Measurement Year (MY) 2025 with a smoother HEDIS® season than ever before. The organizations that performed best weren’t necessarily those with the largest teams or budgets—they were the ones with integrated data, aligned workflows, and the ability to identify and act on quality opportunities earlier.
    • For many health plans, MY 2025 brought an unexpected outcome: fewer fire drills. The most successful organizations relied on repeatable steps focused on:
      • Integrated clinical and quality data
      • Aligned teams around clear priorities
      • Chart review productivity reporting
      • Population-level measures dashboards
    • Established repeatable workflows that reduced operational friction throughout the season
    • High-achieving plans started by identifying the right opportunities by using HEDIS logic and integrated data sources to pinpoint the gaps that matter most. Effective approaches centered on opportunities where both impact and intervention are possible, targeting outreach at the provider, care manager, or member level depending on where change can occur most effectively.
    • Next, operationalizing those insights was key during MY 2025. Analytics may reveal performance gaps, but improvement happens when those findings are embedded directly into workflows. Plans that consistently outperform their peers translate data into outreach campaigns, care management activities, and provider engagement efforts with clearly defined accountability.
    • Standardization is equally important. Quality initiatives only create value when the work performed is accurately reflected in reporting. Aligning documentation and coding practices with NCQA-approved value sets helps ensure that quality improvements appear in measure results.
    • Finally, leading health plans embrace continuous measurement. They evaluate intervention effectiveness, monitor gap closure rates, assess outcomes, and create feedback loops that help refine future strategies. Over time, this transforms quality programs from a series of one-off campaigns into a scalable operating model built around continuous improvement.

From the public health and medical / Rx research front,

  • MedPage Today tells us,
    • “Wait times are increasing between cancer diagnosis and the start of first-course therapy for six cancer types, according to a retrospective cohort study.
    • “Predictors of longer wait times included Medicaid insurance, lowest-quartile income, Black race, increased travel distance, and treatment at academic institutions, among other factors.
    • “These results should be considered in the context of previous research linking treatment delays with worse survival outcomes, researchers said.”
  • Beckers Hospital Review notes,
    • “Ascension Saint Thomas in Nashville has rescheduled some elective surgeries and said it could be forced to cancel or delay additional cases because of shortages of blood products.
    • “Platelets are a particular concern at Saint Thomas, according to an Aug. 6 news release from the hospital, which is part of the St. Louis-based Ascension health system. Chief Clinical Officer Brian Wilcox, MD, told NBC News affiliate WNKY that the shortage is affecting hospitals nationwide as donations of blood products have fallen to a four-year summer low even as demand for transfusions holds steady.
    • :The disruption comes as the American Red Cross declared its second national blood crisis in history July 27, with type O blood critically scarce and distributions to hospitals now limited. The shortage began building in May, when a gap widened between the amount of blood hospitals need and the amount being donated. The Red Cross is currently sending hospitals roughly 3,500 more units of blood per week than expected.
    • “An Illinois Red Cross spokesperson told NBC News affiliate WGEM that without a constant blood supply, hospitals could be forced into situations where doctors have to choose who gets blood and who doesn’t, adding that elective surgeries that need transfusions may have to be postponed.”
  • Cardiovascular Business adds,
    • “Clinicians should pay close attention to any incidental lung findings identified when transcatheter aortic valve replacement (TAVR) patients undergo preprocedural CT scans. That is according to new findings published in Heart Lung, a journal from the American Association of Heart Failure Nurses.[1]
    • “Over the past decade, TAVR has transformed the therapeutic landscape of symptomatic severe aortic stenosis (AS),” wrote first author Mustafa Mousa Basha, MD, a researcher with University Hospital Bonn in Germany, and colleagues. “Pulmonary diseases are frequently co-existent in AS patients, often ranging from mild restriction to a mixed restrictive and obstructive pattern, and represent an important risk factor for postoperative complications following TAVR.”
  • STAT News relates,
    • “Not long after guidelines shifted to considering statin therapy as early as age 30, new research from France suggests there may be no harm in stopping the cholesterol-lowering drugs at age 75 in people with no history of cardiovascular disease. The lessons, however, may not translate elsewhere. 
    • “The “non-inferiority” study, published Tuesday in the Lancet Healthy Longevity, does not advise doctors to tear up statin prescriptions for older people. Nor does it conclude that going off statin therapy is better than staying on. It does say patients should talk to their doctors to see if they’d be no worse off for dropping the daily pills.
    • “Invoking patient choice, the authors highlight the lack of scientific literature on older people, noting what research does exist has found the link between cholesterol and cardiovascular events weakens with age. They believe their own study needs to be repeated for a longer period of time and extended to populations at higher cardiovascular risk or otherwise not as healthy as their participants.
    • “For the majority of American patients over the age of 75, this trial will not change anything,” Romit Bhattacharya, a general and preventive cardiologist from the Mass General Brigham Heart and Vascular Institute, told STAT in an interview. He was not involved in the research. “It does give us a little bit of permission and greater flexibility and choice for our individuals who maybe have a short time horizon to live and who are already quite healthy and engaged in care.”
  • The New York Times reports,
    • “President Trump issued an executive order this week calling for immunizations for measles, mumps and rubella, a mainstay of vaccination programs worldwide, to be offered as three individual jabs given at separate times, instead of in one combination shot.
    • “In an Oval Office signing ceremony, the president made a frightening and unsubstantiated claim about the combination shot. “Together, there could be a possibility they’re quite lethal.” 
    • “Researchers have not linked the combination M.M.R. shot to a risk of death, and there is no evidence that it is dangerous or that splitting it into its three components is any safer or more effective, vaccine experts said. Combination shots for the diseases have been used in the United States since 1971, and were introduced only after careful comparison against individual shots. They have been given to hundreds of millions of children.
    • “What’s more, separate vaccines for measles, mumps or rubella have not been available in the United States for many years. Vaccine manufacturers said it would take a minimum of five to 10 years for them to be tested and made available.”
  • Health Day informs us,
    • “Restarting obesity medications, including glucagon-like peptide-1 (GLP-1) receptor agonists, soon after sleeve gastrectomy (SG) surgery is associated with greater one-year weight loss than surgery alone in adolescents, according to a research letter published online July 22 in JAMA Surgery.”
  • and
    • “The 4C meningococcal B (MenB) vaccine confers modest protection against gonorrhea among adolescents, according to a study published online Aug. 4 in Open Forum Infectious Diseases.”
  • Genetic Engineering and Biotechnology News points out,
    • :A multi-disciplinary, multi-institutional group of researchers said they relied on their expertise in genetics, mechanics, chemistry, and biology to create a chip the size of a postage stamp to model a particular class of heart conditions.
    • “The team, led by Guang Li, PhD, an associate professor in the University of Pittsburgh School of Medicine’s department of cell biology, has grown heart valves on organoids. The study “Human iPSC-derived heart valve-like assembloids model valve development and disease pathology” appears in Cell Stem Cell and is an important step toward better understanding and treating a number of serious heart disorders, according to the scientists.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.” * * *
    • The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on September 9, 2026.

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

  • The Austin American-Statesman reports,
    • “On Wednesday, the University of Texas System Board of Regents’ Facilities Planning and Construction Committee will adopt a timeline and budget for phase one of the much-awaited artificial intelligence-native hospital, UT Dell Medical Center. 
    • “Construction on the $5 billion hospital is expected to begin this fall, and initial site preparation could begin within a month after board approval of this first phase, which does not include the actual building but includes design and site preparation as well as equipment that takes time to arrive such as MRIs. The committee’s agenda includes information such as a timeline and the cost of the project, which has not yet been disclosed publicly. 
    • “The hospital will include both specialty care and an MD Anderson Cancer Center Central Texas location. UT announced the project in 2023 as a $2.5 billion investment to expand access to high-quality healthcare for Central Texas and bring thousands of jobs to Austin, but when a new site chosen and the hospitals were combined into one, the price tag went up to an estimated $5 billion.” 
  • Modern Healthcare relates,
    • “Intermountain Health and AdventHealth have signed a definitive agreement to merge services at multiple hospitals, clinics and medical practices through a joint venture in the Denver area. 
    • “The deal is slated to close in early 2027, pending regulatory approval, according to a Wednesday notice from AdventHealth. The organizations signed the definitive agreement last week.
    • “Financial terms were not disclosed.”
  • KFF Health News explains how “Hospital Prepayment Requirements Add New Wrinkles to Patients’ Financial Responsibility.”
  • Beckers Health IT tells us,
    • “Bethlehem, Pa.-based St. Luke’s University Health Network and UnitedHealthcare have automated claim status updates for 88% of the claims exchanged between the two organizations, using Epic’s Payer Platform, according to Epic’s newly released 2026-2027 Almanac.
    • “The two organizations turned on Epic’s Claim Status feature to give St. Luke’s staff real-time visibility into where claims stand with UnitedHealthcare, replacing manual status checks that previously required calling the payer or logging into external portals. Brian Burd, IT director at St. Luke’s, said the health system’s main motivation was to improve revenue cycle efficiency by reducing manual claim status inquiries and speeding up follow-ups.
    • “UnitedHealthcare manages most of its claims operations outside Epic, so the insurer routes claim data through its own Epic environment first, then delivers it to St. Luke’s through the Payer Platform connection. That setup avoided the time and transaction fees of building a separate direct link between the two systems.
    • “Since the feature went live, UnitedHealthcare has seen a 25% drop in claim status calls from St. Luke’s, while St. Luke’s staff have shifted their time from chasing payer updates to higher-value revenue cycle work.”
  • Beckers ASC Review informs us,
    • “There comes a point when health system’s ASC moves stop being a side project and start requiring a more involved strategy, and, according to Atlas Healthcare Partners CEO Aric Burke it’s when revenue is above roughly $2 billion to $3 billion, and a portfolio has grown past about five centers.
    • “I think health systems over two to three billion in revenue probably need to have a real, dedicated ASC strategy,” Mr. Burke told Becker’s.”
  • and 
    • “Anesthesia has become one of the most persistent staffing headaches for ASCs and hospitals alike.
    • “It’s not just a bad labor market, but a pipeline problem stacked on top of an aging workforce, a bottlenecked training system and a reimbursement environment that’s making it harder to attract new anesthesiologists and certified registered nurse anesthetists into the specialty.”
  • and
    • “GI procedure demand keeps climbing while Medicare keeps cutting what it pays for the exact setting where those procedures are cheapest to perform.”
  • Beckers Hospital Review notes,
    • “U.S. News & World Report released its debut ratings Aug. 12 for the best GLP-1 telehealth platforms, its first evaluation of the online companies prescribing brand-name weight loss drugs.
    • “The media company rated 20 platforms offering FDA-approved, brand-name GLP-1 medications, including Wegovy, Zepbound, Ozempic and Foundayo, according to an Aug. 12 news release. Companies that offer only compounded GLP-1s were excluded, and for platforms selling both, U.S. News evaluated only the branded portion of the business.”
    • Here are the top five:
      • “Amazon One Medical: 4.8
      • “Found: 4.6
      • “Mochi Health: 4.4
      • “Ro: 4.4
      • “Noom: 4.3”
  • MedTech Dive lets us know,
    • “Abbott and Google plan to pair Abbott’s over-the-counter glucose sensor with Google’s artificial intelligence and consumer technology, the companies said Tuesday.
    • “The multiyear partnership is focused on making metabolic insights from Abbott’s device easier to use, helping people proactively manage their health. 
    • “The two companies plan to launch a large study that could inform Google’s AI health coaching and future features for Abbott’s Lingo sensor. Abbott did not disclose how many people they plan to enroll in the study.”

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “The Senate easily passed a bipartisan continuing resolution early Saturday morning, likely easing the traditional September rush to head off a partial government shutdown in October.
    • “On a lopsided vote of 90-6, the Senate passed a measure that would extend current funding through Dec. 11, giving lawmakers about 10 extra weeks to complete full-year appropriations bills for fiscal 2027.
    • “But the bill still requires a vote in the House, which won’t be back in session until the first week of September. The House had passed a more bare-bones funding extension last month without many of the “anomalies,” or deviations in current spending, requested by the Trump administration.”
  • Bloomberg Law adds,
    • The US Senate confirmed Todd Blanche as attorney general, elevating President Donald Trump’s one-time personal defense lawyer to lead the nation’s top federal law enforcement agency.
    • Republicans closed ranks and supported Blanche, 52, in a 50-49 vote even after two GOP senators joined Democrats in opposition. Republican Senator Bill Cassidy of Louisiana, one of the holdouts, came out in support of Blanche after Senators Susan Collins of Maine and Lisa Murkowski of Alaska voted against him. 
  • The House of Representative and the Senate are now on District / State work breaks until August 31 for the House and September 14 for the Senate.

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

  • Kevin Moss, in an interview with Federal News Network, explains why “Retirement [from the federal goverment or the Postal Service] doesn’t make your health benefits simpler. It makes them more complicated.

From the public health and medical / Rx research front,

  • The American Medical Association points out,
    • “The measles vaccine is given as part of the measles, mumps and rubella vaccine, so we call it MMR. It’s also given as part of MMRV, which adds in varicella for chickenpox,” Dr. Land said, noting “It’s typically given to child at age 1.”
    • “We give it at 12 months, but it can be given at 12 or 15 months—it can be given as either MMR or MMRV—and then again at 4 to 5 years old,” she said, emphasizing “the measles vaccine is probably the most successful vaccine that we have.”
    • “If you’ve had both of your vaccinations, you are 97% immune for life,” Dr. Land said. “If you have just one dose, you’re 93% and that is incredible protection.”
    • “For adults who do not have immunity or have not received vaccination, “one dose is typically enough,” Dr. Kaufman West said. “But depending on your medical history and what’s going on with you, it’s a good idea to talk to your physician and see if there would be any changes to that.”
  • CBS News reports,
    • “Federal officials on Saturday issued a public health alert for meat products containing jalapeños that may be linked to a salmonella outbreak that has sickened hundreds of people across at least 27 states. 
    • “The U.S. Department of Agriculture’s Food Safety and Inspection Service, or FSIS, said the alert applied to red meat and poultry products containing jalapeños that may be contaminated with salmonella. 
    • “The USDA said that it learned of the issue when it discovered that multiple establishments that are regulated by FSIS had received a recalled ingredient. 
    • “It released a list of 18 recalled products that are impacted by the alert. Those included the brands Taylor Farms, Ready Meals, Meal Simple, Higher Harvest and Deli Kitchen. 
    • “The agency said in a statement that it “expects additional downstream products will be identified as this ingredient recall progresses.”
  • The Washington Post relates,
    • “Cyclospora and other parasites can survive sewage treatment in small quantities, and crops are sometimes irrigated with treated water.
    • “That’s why scientific researchers and public health officials are pointing to sewage contamination in the food supply as one of the most plausible theories for the current U.S. cyclospora outbreak. The government says it is still investigating the cause.
    • “The parasite’s spread can become a self-perpetuating cycle. Cyclospora is found only in humans, where it replicates in the intestinal tract, causing severe diarrhea. The organism reproduces by releasing oocysts, which are excreted in those human feces. In the United States, feces usually end up in sewage systems.
    • “In many states, sewage water is treated — though not always in ways that remove or kill the oocysts — and then released into waterways that can be used to irrigate crops. The oocysts mature in the environment with warm temperatures in about a week. Then a human comes along and eats the irrigated food or drinks the water and gets sick, releasing more oocysts into sewage systems.”
  • The FEHBlog asked Claude AI about the last paragraph. Here is his response:
    • “[T]he Post’s “many states” is best read as a general characterization — sewage discharge into surface waters is a nationwide Clean Water Act practice — but the specific research documenting the produce-safety risk concentrates on four states: Arizona, Texas, Georgia, and Florida/California.”
  • Healio tells us,
    • “A pivotal trial is now underway for i-Lumen AMD, a bioelectric therapy being investigated for intermediate to advanced dry age-related macular degeneration, according to a press release from i-Lumen Scientific.
    • “The noninvasive, office-based therapy applies low-level microcurrent stimulation via the closed eyelid, which may improve photoreceptor cell function by repolarizing retinal pigment epithelium cells, according to the company.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “More than a million times a year, a U.S. surgeon slices open a knee, strips out worn cartilage, caps the leg bones with metal and drops in a plastic spacer to allow the new joint to glide.
    • “But while these knee-replacement procedures have become standard, the prices charged have not.
    • “At Catawba Valley Medical Center in Hickory, North Carolina, for example, the cost of the procedure under a Blue Cross Blue Shield health plan this year was about $16,000, according to data from Serif Health, a San Francisco start-up that collects recently released data from hospitals and insurers. Little more than an hour’s drive east, however, at Mission Hospital in Asheville, the cost of the procedure under the same health plan was around $40,000, or more than double, the data showed.
    • “Formed by the merger of the two largest hospitals in the region, Mission has little competition and more power to demand the higher price.
    • “The comparison between these two hospitals illuminates how large hospital systems created by a wave of U.S. mergers in recent decades can dominate the competition and push up health care costs. 
    • “While many factors affect the price of a medical procedure, hospitals with few competitors can charge more, health economists say.” * * *
    • “Over time, anyone who pays for health insurance pays a price for hospital monopolies, as insurers boost premiums as medical costs rise. The full cost for an employer to pay for an average family health insurance plan rose to more than $27,000 in 2025, up from $21,000 just six years ago, according to figures from KFF.”
  • The American Medical Association adds,
    • “A report recently released by Resolve, a contract review and negotiation firm specializing in physician employment, draws on data from the thousands of physician contracts the firm handles to outline must-know trends nationally, as well as across regions, practice settings and more.
    • “The report shows that physicians’ base salaries grew roughly 2% to 4% per year, a growth rate down from years past, in which physicians were seeing increases of 5% to 6% per year. 
    • :And importantly, more of physician compensation comes in sign-on and retention bonuses than in past years, and it is increasingly tied to variable factors such as relative value units (RVUs), along with quality and other metrics.
    • “Physician compensation did not simply grow or shrink; it became more conditional,” the report’s authors noted.” 

Thursday report

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

Simplicity is a virtue.

From of a Washington, DC

  • The New York Times reports,
    • “The White House’s push to delay a ban on intoxicating hemp products that President Trump signed into law last year has snarled an otherwise straightforward effort to pass legislation that would lock in government funding through the fall before senators leave Washington on a summer recess.
    • “In an unusual display of defiance, a group of Republicans led by Senator Ted Budd of North Carolina was vowing to kill the hemp proposal that Senate leaders had tucked into the spending bill at the request of Mr. Trump.
    • “The measure would postpone the date the ban will go into effect, from November to Dec. 11.”
  • Beckers Hospital Review relates,
    • “Sens. Maggie Hassan, D-N.H., and Roger Marshall, R-Kan., introduced the Stop Superbugs Act on Aug. 4 alongside a Joint Economic Committee-Minority report estimating antimicrobial resistance costs the U.S. healthcare system at least $5.7 billion annually.”
  • Beckers Behavior Health adds,
    • Federal lawmakers have introduced or revived several bills this year [discussed in the article] aimed at expanding access to addiction and mental health treatment, from new Medicare coverage for residential opioid treatment to permanent funding for community behavioral health clinics.
  • The current president of the Infectious Diseases Society of America, Ronald Nahass, suggests in STAT News that “The U.S. needs a 9/11 Commission-style independent body to investigate Covid response.” The FEHBlog heartily agrees.
  • Beckers Payer Issues tells us,
    • “This fall, CMS will start sharing monthly utilization reports with Part D plans on how their enrollees are using the Medicare GLP-1 Bridge program.
    • “The agency said in an Aug. 5 memo that the reports will be organized at both the contract and plan level and will include claims-level data such as the date of service, drug dispensed, quantity, days supply, prescriber, fill number and beneficiary identifier. All Part D plans will be covered, except for PACE organizations, cost plans and private fee-for-service plans.
    • “CMS uses a central processor to handle prior authorization, claims adjudication and pharmacy reimbursement, meaning Part D sponsors don’t carry risk for GLP-1 drugs furnished through the demonstration. The utilization reports would give insurers a window into how their own members are using the program despite having no direct role in administering it.”
  • The Wall Street Journal adds,
    • “Amazon AMZN .com said patients with Medicare Part D prescription plans now have access to certain GLP-1 weight-loss medications through Amazon Pharmacy.
    • “Oral and injectable versions of Novo Nordisk’s NOVO.B  Wegovy and Eli Lilly’s LLY  Zepbound KwikPen and Foundayo pills will be available and cost $50 a month with free home delivery, Amazon said. It’s offering same-day delivery in more than 3,100 U.S. locations, and no Prime membership is required, the company added.
    • “The medications are available through the Medicare GLP-1 Bridge Program, a short-term federal initiative running through Dec. 31, 2027, that allows eligible Medicare Part D members who meet specific clinical criteria to access weight management prescriptions.” * * *
    • “Amazon Pharmacy manages the entire process, including verifying eligibility, handling prior authorizations, and initiating enrollment, once a clinician submits an electronic GLP-1 prescription, the company said. Customers need to link their Medicare information and Bridge insuranceplan to their account.
    • “Once a patient’s clinician sends the prescription, we take care of the rest and deliver their medication to their door,” said Tanvi Patel, vice president and general manager of Amazon Pharmacy.”

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

  • Govexec reports,
    • “President Trump is expected sometime this month to issue a plan to freeze federal employee pay in 2027, though if last year was any indication, it may not be that straightforward.
    • “When the White House published its fiscal 2027 budget proposal in April, the document, which normally lays out the administration’s pay plan for the following year, was silent on civilian compensation. The Office of Management and Budget later confirmed that Trump was in fact proposing “no pay increase” for 2027, while military service members would see between a 5% and 7% raise, depending upon their rank.
    • “Trump now has until the end of August to formalize his alternative pay plan for next year; otherwise, much larger automatic increases in locality pay would take effect, due to a formula in the 1990 Federal Pay Comparability Act that has been criticized by presidents of both parties since its enactment.”
  • Federal News Network explains how “OPM is preparing to take over federal employee appeals” as the FEHBlog has noted.
    • “OPM outlined significant changes in the new appeal adjudication process, including the loss of federal employees’ “categorical right” to a hearing.” 
  • Fed Agent informs us,
    • “Federal employees who file claims for back pay, unpaid overtime, unused leave, and other compensation issues will soon be required to submit them through the Office of Personnel Management’s (OPM) eFile system rather than by mail or email. 
    • “The changes could be especially relevant for law enforcement officers and other federal employees who file Fair Labor Standards Act (FLSA) overtime claims.
    • “In an updated rule for Procedures on Settling Claims, OPM said switching to an eFile system “will be used for all appeals and claims to allow for faster receipt facilitating OPM’s processing and review.”
    • “The new system will apply to a wide range of submissions, including claims filed by current and former federal employees, as well as claims submitted by beneficiaries of deceased federal employees and deceased veterans.”

From the FDA front,

  • The Wall Street Journal reports,
    • “Replimune Group said Thursday that the Food and Drug Administration has approved its therapy for advanced skin cancer, ending a regulatory saga that spanned three submissions and two rejections and was a flashpoint in the tenure of the agency’s last commissioner.
    • “Replimune’s drug, marketed as Tudriqev, is a genetically modified virus that doctors inject directly into tumors, where it is designed to kill cancer cells and trigger an immune response against tumors elsewhere in the body.
    • “The drug’s arduous journey through the FDA made it a poster child for the biotech industry’s criticism of the agency under former Commissioner Marty Makary. Replimune and other industry officials said the FDA, in its rejections, had reversed positions it had established in earlier meetings with the company.”
  • Targeted Oncology relates,
    • “The FDA granted accelerated approval to RP1 (vusolimogene oderparepvec; Tudriqev), an oncolytic virus therapy, in combination with nivolumab (Opdivo), for the treatment of advanced melanoma following progression on an anti–PD-1–containing regimen.
    • “The decision follows a July 30, 2026, meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), which voted 10-3 in favor of the potential accelerated approval based on data from the phase 2 IGNYTE trial (NCT03767348). Despite the FDA raising concerns over the study design and clinical meaningfulness of the trial data, the committee supported the accelerated approval because of the unmet need in this setting, with the confirmatory IGNYTE-3 trial (NCT06264180) already underway to support regular approval.”

No Surprises Act News,

  • FHAS, a certifed independent dispute resolution entity, offers helpful guidance about implementing the NSA RARC codes in out-of-network electronic and paper claims.

From the judicial front,

  • Beckers Physician Leadership reports,
    • “A physician in Texas was sentenced to 12.5 years in prison for operating a medical clinic as an illegal pill mill. 
    • “Maryam Qayum, MD, owned, operated and was the sole prescriber at Recare Health Clinic in Houston. The clinic was operated as a cash-only pill mill, and Dr. Qayum issued prescriptions without a legitimate medical purpose, according to an Aug. 5 news release from the Justice Department. 
    • ‘Between 2022 and 2025, Dr. Qayum issued more than 3 million prescriptions for opioids including oxycodone and hydrocodone. Law enforcement shut down the clinic in 2025.”
  • Beckers Health IT relates,
    • “Health systems, insurers and AI companies are facing a wave of litigation in 2026 over how artificial intelligence is used to make or influence decisions about patient care, coverage and billing.”
    • The article discusses three such cases. 

From the public health and medical / Rx research front,

  • Health Exec identifies “Current and potential outbreaks to be aware of—and ready to talk about.”
  • Cardiology Business adds,
    • “The American College of Cardiology (ACC) has shared a new concise clinical guidance (CCG) detailing specific vaccine recommendations for adults and children with a history of cardiovascular disease (CVD).[1] The group reviewed its own evidence-based guidelines as well as updated resources developed by the American College of Physicians and U.S. Centers for Disease Control and Prevention. 
    • “Patients with heart disease face a higher risk of adverse outcomes, including hospitalization and death, following respiratory virus infection compared with the general population,” wrote first author Paul A. Heidenreich, MD, a cardiologist with Stanford University and chair of the CCG’s writing committee, and colleagues. “Additionally, the likelihood of infection after exposure may be elevated in this population.”
    • “Heidenreich et al. also emphasized that both randomized clinical trials and observational studies have consistently demonstrated the advantages of vaccination. Adverse side effects, the group added, are “exceedingly rare and are far outweighed by the demonstrated benefits.”  
  • MedPage Today notes,
    • “The U.S. Preventive Services Task Force recommends annual fecal immunochemical test screening starting at age 45 among average-risk adults to reduce the risk of death from colorectal cancer.
    • “In a retrospective population-based cohort study from Spain, fecal immunochemical test-based screening was linked to an ongoing decline in colorectal cancer mortality.
    • “Counterfactual analyses suggested a 41.7% relative reduction in mortality overall, a 46.2% relative reduction in those ages 50 to 69, and a 45.4% relative reduction in those ages 70 and older compared with projected trends without screening.”
  • The American Medical Association lets us know what doctors want their patients to know about hand, foot, and mouth disease.
  • The Washington Post reports,
    • “Hundreds of people in 27 states have been sickened in a salmonella outbreak linked to jalapeño peppers, including at Chipotle and Qdoba restaurants, the Centers for Disease Control and Prevention said.
    • “As of Tuesday, 345 cases had been reported with 36 people hospitalized, the agency said Wednesday. The cases, which date back to June 19, are expected to rise and expand to more states. 
    • “Twenty-seven “illness clusters” have been identified at Chipotle and Qdoba locations in seven states, the agency said, after health officials found that most of those who got sick reported eating in a Mexican-style restaurant. * * *
    • Neither restaurant is considered an ongoing risk, the CDC said. The distributor is recalling the affected peppers, and other businesses are being urged to check their stocks for recalled jalapeños and not sell or serve them, it said.
    • Salmonella bacteria, the most frequently reported cause of foodborne illness, can cause diarrhea, vomiting, fever and stomach pain.
  • Beckers Hospital Review relates,
    • “The CDC is tracking clinical cases of Candida auris in more than half of U.S. states this year, though the total number of infections from the deadly fungus is down from this time in 2025.
    • “The agency has recorded 3,302 clinical cases of Candida auris across 27 states through the week ending July 18, according to National Notifiable Diseases Surveillance System data. That’s down from 4,102 clinical cases reported over the same period in 2025.
    • “A separate CDC screening count, which tracks colonization detected before any illness develops, logged 3,130 cases across 23 states over the same period, essentially flat compared with 3,348 a year earlier.
    • ‘California leads all states in clinical cases with 826, followed by Texas with 391 and Ohio and Tennessee tied at 274 each. The screening count tells a different geographic story: Texas leads with 706 screening cases, followed by Michigan (503) and Illinois (366).”
  • Beckers Clinical Leadership adds,
    • “The Virginia Department of Health said Aug. 4 it has identified the state’s first locally acquired case of dengue.
    • “The patient lives in the Fairfax and Loudoun county area and had not traveled outside Virginia before falling ill.
    • “State officials traced the infection to an earlier traveler who had contracted dengue abroad. A local Aedes mosquito bit that infectious patient, then transmitted the virus to the second resident. The health department said it has found no evidence of continued local spread.
    • “The department called the overall risk of acquiring dengue in Virginia low.”
  • MedPage Today tells us,
    • “Anxiety and depression have been extensively studied in patients with inflammatory bowel disease (IBD), but research has rarely investigated the pre-diagnostic period.
    • “In a Swedish cohort study, the relative rate of any psychiatric disorder started to increase 2-3 years before IBD diagnosis, peaked soon after diagnosis, and rapidly decreased post diagnosis, but remained elevated at 10 years.
    • “This increased risk was mainly driven by major depressive disorders, anxiety disorders, and substance misuse.”
  • STAT News informs us,
    • “In the race for new ways to treat Alzheimer’s and other devastating neurologic diseases, the protein tau has become a tantalizing target for drug developers. A new study lends support to those efforts by describing a previously unknown role that tau plays in neurodegeneration — and suggesting a novel way researchers might block the protein’s activity.
    • “A team led by Stanford scientists found that tau can gum up the works of a cell’s mitochondria, its energy-producing powerhouse. The protein sends electrons flowing in the opposite direction of their usual microscopic relay race, a reversal that generates reactive oxygen species, cellular stress, and inflammation. Scientists found that blocking this phenomenon, known as reverse electron transport, reversed many of the harmful effects and improved learning and memory in flies and mice.
    • “Whether the same will hold true in people is for now unclear, though an analysis of human cells grown in the lab and patient brain tissue suggests blocking the retrograde flow of electrons could make neurons healthier. Two of the study’s authors have started a biotech startup to put this idea to the test. 
    • “The findings, published on Thursday in the journal Neuron, have implications for a range of so-called tauopathies, diseases marked by an abnormal buildup of tau, such as Alzheimer’s, Huntington’s, and frontotemporal dementia.”
  • Genetic Engineering and Biotechnology News points out,
    • Chronically infecting viruses—such as Epstein Barr, cytomegalovirus, and herpes virus—are ubiquitous in humans. Although their presence is often innocuous and asymptomatic, the viruses can reactivate during stress, and emerging evidence suggests that their reactivation may contribute to autoimmune disease and other chronic conditions. SARS-CoV-2 infection is known to reactivate some chronic viruses, yet the full extent of the effects is not well understood.
    • Now, a study including 15 biomedical research institutions across the United States, Boston Children’s Hospital researchers and their collaborators have discovered that COVID-19 reactivates certain dormant viruses in hospitalized patients. These findings expand understanding of chronically infecting viruses and could inform development of strategies to combat their reactivation.
    • “This work is published in a new study in Nature, entitled, “Virus reactivation in acute and long COVID-19.”
  • The New York Times notes,
    • “Novo Nordisk stunned the cardiology world last week when it announced that a large study it was running on an experimental drug for heart disease had failed. The drug, widely expected to be a blockbuster, was no better than a placebo.
    • “The drug, ziltivekimab, reduces inflammation, which is generally thought to be a cause of atherosclerosis. Stopping that inflammation was hoped to be a way to save lives.
    • “Now the drug’s failure is raising a troubling question. Is inflammation really a cause or is it just a marker of atherosclerosis, the way gray hair is a marker of aging?
    • “Cardiologists had mixed reactions to the news. Dr. Sanjay Kaul, a cardiologist at Cedars Sinai, quoted Thomas Huxley on X: “The great tragedy of science — the slaying of a beautiful hypothesis by an ugly fact.”

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

  • Health Exec points out,
    • “The latest lineup of America’s “best of the best” hospitals from US News & World Report is something of an embarrassment of riches for a few cities and health systems. 
    • “The list—which ranked hospitals numerically until 2023 but now presents 20 institutions alphabetically as an “honor roll”—names one health system three times.
    • “That would be Mayo Clinic, recognized for each of its operations in Rochester, Minn., Phoenix, Ariz., and Jacksonville, Fla. 
    • “Meanwhile New York City is home to three winning institutions—Mount Sinai, NewYork-Presbyterian and NYU Langone. 
    • “A few cities have two hospitals in the roll. These are Boston (Brigham and Women’s, Massachusetts General), Chicago (Northwestern, Rush) and Los Angeles (Cedars-Sinai, UCLA Ronald Reagan).
    • “The state with the most honorees is California, which has bragging rights to five—the two L.A. hospitals named above plus Stanford Health Care in Palo Alto, UC San-Diego Health in that city and UCSF Health in San Francisco.”
  • Beckers Hospital Review adds,
    • “The Emergency Nurses Association awarded a record-breaking 126 emergency departments with the 2026 Lantern Award.
    • “To receive a Lantern Award, EDs must submit a comprehensive application which measures how they excel in meeting challenges, including ED boarding, improving pediatric readiness and enhancing nurse professional development, according to a July 27 news release. ENA Lantern Award Committee reviews and scores applications based on evidence-based practices and innovation in emergency care. Learn more here. The Lantern Awards have been awarded annually since 2011.
    • “Last year, 96 hospitals received a Lantern Award.”
    • The article lists the 2026 awardees by State.
  • Beckers Hospital Review outlines the 23 hospital M&A transactions that have happened this year.
  • Beckers Payer Issues calls attention to “the thread running through payers’ and for-profit [health] systems’ Q2 earnings,” and tells us,
    • “Oscar Health’s membership as of June 30 was 2,963,002, up from 2,027,148 at the same time in 2025.
    • “The company reported net income of $361.8 million for the second quarter of 2026, up from a $228.4 million loss during the same period last year. Revenue was roughly $4.9 billion, up 70.4% year over year. Earnings from operations were $388.6 million versus a prior $230.5 million loss, driven by stronger underwriting performance, along with favorable prior period development.
    • “The insurer logged a medical loss ratio of 79.2% for the quarter, down from 91.1%. 
    • ‘The full-year 2026 outlook for earnings from operations is now $500 million to $700 million, a boost from $250 million to $450 million previously.”
  • BioPharma Dive reports,
    • “LifeMine Therapeutics, a biotechnology company led by serial entrepreneur Greg Verdine, said Thursday it raised $263 million in a pair of venture financings that will push a novel, protective treatment for organ transplants deeper into later clinical testing.
    • “To find that new drug, codenamed “LIFE-001,” LifeMine looked to a billion-year-old place: the fungal genome. It’s the same starting point that led to the first statin, penicillin, and a widely used immunosuppressant called cyclosporine. While these and many other medicines are derived from fungi, LifeMine has for years been working to make the discovery process more systematic and repeatable, amassing a database of genomic information in the hopes of uncovering promising drug prospects. 
  • MedTech Dive interviews “Medtronic’s George Murgatroyd [about] an advanced computing platform that works with the company’s Hugo robot will power AI algorithms that can assist surgeons as they operate.”

  • Beckers Physician Leadership notes,
    • “Aflac’s fourth annual Wellness Matters Survey found 76% of Gen Z and 63% of millennials now turn to artificial intelligence as their first line of primary healthcare, according to results released Aug. 4.
    • “The survey, conducted in March 2026 by Kantar Profiles among 2,000 employed U.S. adults ages 18 to 65, found AI use for healthcare drops sharply with age: 47% of all Americans surveyed use AI for health information, compared to 76% of Gen Z and 63% of millennials.
    • “The shift toward AI comes as younger workers skip in-person care. Sixty-five percent of Gen Z and 61% of millennials reported skipping routine checkups in the past year, compared to 47% of Gen X and 33% of baby boomers. Only 48% of Gen Z respondents have a primary care doctor, versus 87% of baby boomers.
    • “Emergency and urgent care use also rose among Gen Z, climbing to 62% in 2026 from 51% in 2025. Usage increased among Hispanic, Black, and Asian American respondents as well.
    • “Matthew Owenby, Aflac’s chief human resources officer and chief administrative officer, said younger Americans are substituting convenience for consistent care. “Young Americans are replacing in-person preventive care with the convenience and speed of digital health support,” Mr. Owenby said.”

Midweek report

David Ermer–AHRQ, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, Patient safety, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “A bipartisan group of senators Aug. 5 introduced the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act), a bill aimed at providing statutory clarity for the 340B Drug Pricing Program while establishing new transparency, reporting and program integrity requirements. The bill was introduced by Sens. Jerry Moran, R-Kan.; Tammy Baldwin, D-Wis.; Shelley Moore Capito, R-W.Va.; Tim Kaine, D-Va.; John Boozman, R-Ark.; and John Hickenlooper, D-Colo. 
    • “The AHA appreciates the leadership of the Senate 340B Bipartisan Working Group,” said Aimee Kuhlman, AHA group vice president of advocacy and grassroots. “We look forward to reviewing their legislation in detail, discussing it with our 340B hospitals, and working with them and other policymakers to ensure the 340B program remains strong for patients, communities, and providers across the country.”
  • and
    • “The Senate Aug. 5 voted 51-44 to confirm Erica Schwartz as the new director of the Centers for Disease Control and Prevention. Schwartz was previously deputy surgeon general during the first Trump administration.”
  • Per an Health and Human Service Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today began the decertification of Network for Hope, the federally designated organ procurement organization (OPO) serving Kentucky and parts of Indiana, Ohio, and West Virginia, after multiple federal reviews found persistent patient safety failures despite extensive oversight and despite Network for Hope having been provided repeated opportunities to correct them. Those failures put prospective organ donors and patients awaiting lifesaving transplants at risk.”
  • Roll Call relates,
    • “At King’s College Hospital in the south of London, anyone who has blood drawn in the emergency department is automatically tested for hepatitis B and C.
    • “Posters throughout the facility inform patients that the screening is routine, part of a new approach helping find and treat thousands of people who might otherwise never know they have the viruses, which can be fatal if left untreated.
    • “We pick up a lot of people who would never have actively accessed this kind of testing themselves — women in later life, people who’d never think they’re the sort of person who would have this condition,” said Dr. Oliver Mizzi, a consultant in emergency medicine at the hospital.
    • “Across England, 90 hospitals now have opt-out testing for hepatitis, leading to thousands getting treatment and putting the country on the path to meeting its goal of eliminating the hepatitis C virus as a public health threat by 2030.
    • “As Congress considers legislation to establish a national hepatitis C elimination program, experts say expanding opt-out testing in emergency departments is an indispensable way identify undiagnosed infections.”

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

  • FedSmith reports,
    • “The OPM retirement backlog kept falling in July, marking a fifth consecutive monthly decline. The backlog dropped by 9,067 cases, or 26.8%, last month to 24,784 total retirement claims, even as the average time to process a claim climbed to a record 109 days, the highest figure since OPM began publishing the data in 2018.
    • “The Office of Personnel Management (OPM) received 10,538 new retirement claims in July while processing 17,841 cases, a gap of more than 7,300 cases that continued pushing the backlog down. OPM has now cut the backlog for five straight months since it peaked at 65,237 in February.
    • “So far in 2026, the average number of retirement claims received per month (both digital and paper) is 15,336 and OPM has processed 17,594. For digital, the monthly averages have been 9,429 received and 8,726 processed.”
  • Per LinkedIn, James Muetzel has been promoted to the position of Principal Deputy Associate Director for Healthcare and Insurance at U.S. OPM.

From the Food and Drug Administration front,

  • Food and Wine reports,
    • “The FDA is investigating 10 active foodborne illness outbreaks, a higher-than-usual number that experts attribute to improved detection methods and a more interconnected food supply.
    • “Two Cyclospora outbreaks linked to iceberg lettuce account for the most reported illnesses, with cases in 41 states. Michigan reports the highest number of illnesses, hospitalizations, and deaths.
    • “The remaining FDA investigations involve Salmonella, Listeria monocytogenes, E. coli, and Clostridium botulinum. Some are linked to recalled products such as frozen blueberries, powdered infant formula, eggs, and soft cheeses, while others remain under investigation.”
  • STAT News relates,
    • “The Food and Drug Administration on Wednesday approved a novel type of treatment for narcolepsy made by Takeda, backing a drug class that scientists hope can transform the treatment of sleep disorders and potentially address a broad range of neurologic conditions. 
    • “The twice-a-day pill, which will be marketed as Orzeyful, is an orexin receptor agonist. It’s cleared to treat narcolepsy type 1, a taxing condition in which patients have a deficiency of the orexin neuron and experience bouts of sleepiness and muscle weakness during the day.
    • “The drug is likely to be very appealing to patients. Current therapies, stimulants and sodium oxybates, carry risk of misuse, and patients still feel sleepy while taking them. In two Phase 3 trials, Orzeyful helped patients stay awake during the day for much longer than what’s been seen with current treatments. Throughout the studies, participants also reported less daytime sleepiness, less frequent muscle weakness, and greater attentiveness.”
  • BioSpacc lets us know,
    • From an outright refusal to file to a backpedaled review earlier this year, Moderna has secured the FDA’s greenlight for its mRNA-based flu vaccine mFLUVISA.
    • The decision, revealed late on Wednesday, grants traditional approval for mFLUVISA to prevent seasonal influenza in patients 50 through 64 years of age, and accelerated approval for use in people 65 years and older. MFLUVISA is the first mRNA-based flu shot in the U.S., according to Moderna’s announcement.
    • The company expects to make mFLUVISA available “in the coming weeks,” in time for the 2026-2027 respiratory virus season in the U.S. Moderna didn’t disclose pricing for mFLUVISA.
  • Per a Reckitt news release,
    • “Reckitt announced today a milestone for the cold and flu category and the company: Mucinex® 12HR Cold & Fever Multi-Symptom is the first U.S. Food and Drug Administration (FDA)-approved over-the-counter (OTC) innovation in the cold and flu category in 14 years, and the first New Drug Application (NDA) under the Reckitt name to receive FDA approval.¹ Developed to align with the way consumers choose to manage cold and flu symptoms, this achievement reflects more than a decade of Reckitt’s scientific research, development, clinical evaluation and regulatory collaboration.”
  • MedTech adds,
    • “BD is recalling certain lots of intraosseous vascular access system needle sets due to a problem associated with four deaths, according to a Food and Drug Administration early alert posted Tuesday. 
    • “The needles are used to provide access to the bone marrow in emergency care situations when intravenous access is difficult. BD said in a statement last week that certain lots were manufactured with out of tolerance dimensions and may be more difficult to remove after placement. 
    • “BD reported four deaths where inability to remove the stylet occurred during resuscitation efforts for cardiac arrests. The company has received 75 complaints, including 45 serious injury reports.”

From the judicial front,

  • The New York Times reports,
    • “The Justice Department filed charges on Tuesday against Dr. Stephen Dubin, a doctor in Nevada, alleging that he orchestrated a $95 million Medicare fraud scheme that involved applying expensive and unnecessary wound coverings to elderly patients.
    • “Dr. Dubin was included in a 2025 New York Times investigation into skin substitutes, bandages manufactured out of dehydrated placentas that cost thousands of dollars per square inch but have not been found to help most wounds heal any better than regular bandages.
    • Medicare paid nearly $15 billion for skin substitutes in 2025, a spike that analysts have called one of the largest examples of waste in the federal health program’s history.
    • “After the Times investigation, the Trump administration sharply cut reimbursement rates for skin substitutes. Spending on the products has since plummeted to $100 million so far this year.”

From the public health and medical / Rx research front

  • Medscape reports,
    • “The ranks of long-term cancer survivors are growing, thanks to improved therapies, but along with that welcome trend comes a hard truth: Life-saving treatments can also have sometimes lasting adverse effects.
    • “Cardiac damage, a well-known risk of certain chemotherapies and other cancer treatments, may arise during treatment. But it can also surface years later, when it may not be recognized as a cancer therapy side effect.
    • “That’s the tsunami coming to medical systems around the world,” said Alexander Lyon, BM, BCh, PhD, a consulting cardiologist at Royal Brompton Hospital in London, England, and the co-chair of a task force that issued the first European guidelines in cardio-oncology in 2022.
    • Those guidelines, and similar ones from US groups, recommend various measures for preventing, detecting, and managing cardiac toxicity from cancer therapy. 
  • Beckers Clinical Leadership relates,
    • “About half of US hospital patients were on an antibiotic in 2023 — essentially flat from 2015 — even as nearly all hospitals now run stewardship programs, a CDC survey found.
    • “Among 151 hospitals that took part in both the 2015 and 2023 point-prevalence surveys, antibiotic use held steady: 49.2% of patients in 2015 and 49.1% in 2023. The findings were published July 31 in Open Forum Infectious Diseases.”
  • Healio adds,
    • “A Mayo Clinic study showed that more than 80% of patients who did not meet prescribing criteria for acute sinusitis were unnecessarily prescribed antibiotics, revealing a gap in adherence to treatment guidelines.
    • “The researchers found that clinicians often relied solely on a 10-day symptom duration to justify prescriptions, ignoring evidence that viral infections — which cannot be treated by antibiotics — can last that long.” * * *
    • “Guidelines from both the Infectious Diseases Society of America and American Academy of Otolaryngology “suggest a conservative approach” to treating sinusitis, the study noted. Those guidelines recommend antibiotics when symptoms have persisted for more than 10 days while also advising treatment for severe symptoms such as high fever and purulent discharge or facial pain lasting for 3 or more days.”
  • and
    • “Men prescribed testosterone without hypogonadism had 49% higher risk for CV events than men with hypogonadism.
    • “Asian men without hypogonadism had the most pronounced increased CV risk among racial-ethnic groups.”
  • Alzheimer’s’ News Today informs us,
    • “A panel of 19 blood proteins may help estimate when symptoms of amyotrophic lateral sclerosis (ALS) will emerge in people who carry disease-associated genetic variants, a new study suggests. When the model was tested using data from carriers whose symptom-onset dates were known, its estimates differed from the actual timing by an average of 1.6 years.
    • “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,” Michael Benatar, MD, PhD, senior author of the study at the University of Miami, said in a press release. “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.”
    • “The study, “Longitudinal plasma proteomics predict phenoconversion to clinically manifest ALS,” was published in Nature Medicine. The work was funded by the National Institutes of Health (NIH), the Muscular Dystrophy Association, the ALS Association, and other organizations.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health CVS  said it will revamp its weight management program through a partnership with Eli Lilly LLY  as the company lifted its full-year outlook and reported a nearly threefold increase in its second-quarter profit.
    • “The company on Wednesday said patients will be able to use the CVS Health app to view transparent pricing options for Zepbound and Foundayo, two Lilly GLP-1 treatments, by early in the fourth quarter. Those treatments also may be available for same-day pickup at CVS pharmacies, the company said.
    • “CVS Health also will offer expanded pharmacy support for GLP-1 patients and $29 MinuteClinic online visits for eligible patients to connect with clinicians about GLP-1 treatments.
    • “Weight management is a deeply personal health journey, and too many people face barriers before they start treatment,” said Sid Tenneti, interim president of CVS’ pharmacy and consumer wellness segment. “Our collaboration with Lilly is one more way we’re expanding direct to consumer access to help eligible patients find options that work best for them.”
    • “The company also lifted its full-year outlook, projecting revenue of at least $414 billion and adjusted earnings between $7.90 and $8.10 a share.” * * *
    • “In the health care benefits segment, revenue rose 3.5% to $37.54 billion, driven by an increase in the government business. Health services revenue rose 11.5% to $51.8 billion, and pharmacy and consumer wellness revenue ticked up about 0.7% to $33.82 billion.”
  • and
    • “Eli Lilly reported higher net income and revenue in the recent quarter, driven by surging demand for its GLP-1 weight-loss drugs.
    • “Sales of the weight-loss treatment Mounjaro rose 91% to $9.94 billion, while Zepbound sales increased 46% to $4.93 billion.
    • “Eli Lilly raised its full-year revenue outlook, but lowered the high end of its adjusted earnings guidance.”
  • Fierce Healthcare adds,
    • “AstraZeneca and Bristol Myers Squibb do not have any ongoing discussions about a potential deal, Reuters reported Wednesday, citing a senior source close to the matter.
    • “There is ⁠no deal between AstraZeneca and BMS. There ​never was a deal to be done, and ​there are no discussions between the companies,” the person said, as quoted by Reuters.
    • “The development comes after the Financial Times reported Sunday that AZ was in talks to combine with BMS. A merger would create a new pharmaceutical giant valued at nearly $400 billion.”
  • Modern Healthcare relates,
    • “A decades-old spin on traditional employee health benefits is making a comeback.
    • “Cigna Group subsidiary Cigna Healthcare, UnitedHealth Group subsidiary UnitedHealthcare division and a bevy of insurers and emerging companies are offering “level-funded” products to employers desperate to reduce rising healthcare costs.
    • “A level-funded plan is a hybrid of the two most common forms of employer-sponsored health insurance: self-funded plans (also called self-insured), under which the employer assumes all financial risk for medical costs and pays a third-party administrator to manage the plan; and fully insured plans, under which an employer pays premiums to an insurance company that bears the risk. Level-funded plans feature a cap on what employers pay paired with stop-loss coverage for excess costs.
    • “Level-funded plans are intended for small and midsized businesses that lack the resources to fully cover their workers’ claims in self-funded plans but are subject to significant year-to-year fluctuations in premiums based on medical expenses in fully insured arrangements. Level-funded plans can offer a balanced approach that mitigates both kinds of risk.”
  • Fierce Healthcare tells us,
    • “Hinge Health inked a deal to acquire a digital gastrointestinal care management startup as it moves to broaden its business beyond musculoskeletal and migraine care.
    • “Hinge Health plans to pick up Cylinder Health for $105 million in cash. The acquisition accelerates Hinge Health’s entry into one of healthcare’s largest underserved categories, executives said, and the company plans to launch an integrated gastrointestinal (GI) care program in 2027. The deal is expected to close in the third quarter.
    • “With its expansion into GI care, the company is “following the same playbook” as it used for MSK and migraine care, Daniel Perez, co-founder and CEO of Hinge Health, told investors during the company’s second-quarter earnings call Tuesday. The company’s vision from the outset has been “use technology to automate the delivery of care within MSK and beyond,” Perez said, noting that the company’s tech platform was designed to scale across multiple conditions.”
  • Beckers Payer Issues informs us,
    • “In 2026, Aetna offers the best digital experience among major insurers on both desktop and mobile, according to new research from Corporate Insight shared with Becker’s.
    • “Corporate Insight’s “2026 Commercial Health Plan Experience Benchmark,” published Aug. 5, evaluated 24 commercial payers across more than 240 desktop and mobile functions. The report identifies overall health plan leaders on each platform, as well as top experiences across eight key categories, including claims, coverage and health information, design and navigation, digital care tools, health and wellness resources, prescriptions and pharmacy, profile and settings, and support.
    • “The analysis also consisted of 32 subcategories and 120+ attributes covering functionality, design, navigation and usability. Websites and mobile apps received scores on a scale of 1-100. The 2025 rankings are here.”

Tuesday report

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

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the public health and medical/Rx research front,

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

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

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

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • The New York Times reports,
    • “The Senate health ​committee on Thursday advanced the nomination of Dr. Erica Schwartz, President Trump’s pick for director of the Centers for Disease Control and Prevention, for a full Senate vote.
    • “The committee’s Republican members and Senator Tim Kaine, Democrat of Virginia, all voted in favor of her candidacy, with the remaining Democrats opposed.” * * *
    • “The committee on Thursday also voted to ​advance ⁠the nomination of Sean Kaufman for assistant secretary for preparedness and response, a role that includes oversight of emergency measures during public health crises.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services [(CMS)] July 30 released the fiscal year 2027 final rule for inpatient rehabilitation facilities. The rule will increase payments by 2.3% overall, which includes a 3.2% market basket update reduced by a 0.9 percentage point productivity adjustment. In addition, CMS updated the outlier threshold, which it says will increase overall payments by 0.4% in FY 2027.
    • “CMS also finalized two changes to the IRF coverage requirements. This includes a requirement that therapies be initiated within 36 hours of admission to the IRF and an initial interdisciplinary team meeting be held within four days of admission to the IRF. CMS did not finalize a third proposal that would have required the patient’s current functional status be documented on the preadmission screening. For the IRF Quality Reporting Program, CMS finalized a shortened timeframe for submitting program data.
    • “Changes are generally effective Oct. 1, 2026.”
  • Per a CMS fact sheet,
    • “On July 30, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-1851-F) that would update Medicare hospice payments and the aggregate cap amount for fiscal year (FY) 2027 under existing statutory and regulatory requirements.” * * *
    • “For FY 2027, CMS updated the hospice payment rate by 2.3% (an estimated increase of $755 million in payments from FY 2026). This figure results from the finalized 3.2% inpatient hospital market basket percentage increase reduced, as required by law, by a finalized 0.9 percentage point productivity adjustment. The finalized FY 2027 rates for hospices that do not submit required quality data information include the finalized FY 2027 hospice payment update percentage of 2.3% minus four percentage points as required by law, which would result in a 1.7% reduction over the previous year’s payment rate. These finalized payment rates reflect the most accurate, updated data available on the cost of goods, services, and labor.
    • “Hospice payments are subject to a statutory aggregate cap limiting the overall payments made to a hospice annually. The finalized hospice cap amount for FY 2027 is $36,174.75 (FY 2026 cap amount of $35,361.44 increased by the FY 2027 hospice payment update percentage of 2.3%).” 
  • Beckers Hospital Review shares 11 things to know about these new CMS rules.
  • U.S. Office of Personnel Management, writing in Substack, added another post to this Secrets of OPM blog titled “Plans are good, Execution is better.”
    • “Last year, I wrote about how the federal government needed to adopt a more disciplined approach to workforce planning. Every successful organization develops a thoughtful plan for the talent it needs to accomplish its mission. The federal government should be no different.
    • “Today, we’re taking the next step.
    • “The guidance OPM has issued to agencies on Annual Staffing Plans is about much more than compliance with a new planning process. It is about changing how the federal government thinks about hiring. Rather than defaulting to last year’s staffing levels or treating hiring as a series of isolated decisions, agencies will build comprehensive staffing strategies that begin with a simple question: “What workforce do we need to best serve the American people?””
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued an interim final rule removing references to the Uniform Guidelines on Employee Selection Procedures (UGESP) from OPM’s federal personnel regulations, bringing the agency’s regulations into conformity with the Department of Justice Office of Legal Counsel’s June 9, 2026, legal opinion concluding the Uniform Guidelines are unlawful and unconstitutional by encouraging race-conscious decision-making via “disparate impact” liability.
    • “The rule removes UGESP regulatory provisions while preserving longstanding federal requirements that employment practices be job-related, professionally developed, based on sound job analysis, and administered without prohibited discrimination.” * * *
    • “Federal hiring should be based on merit, qualifications, and the ability to perform the job,” OPM Director Scott Kupor said. “This rule ensures OPM’s regulations reflect legal guidance while preserving the rigorous, job-related standards that help agencies recruit and hire the most qualified workforce in service to the American people.”
    • “The interim final rule is effective upon publication in the Federal Register. OPM will accept public comments for 60 days before determining whether to revise, withdraw, or finalize the rule.”
  • NextGov adds,
    • “The General Services Administration on Wednesday celebrated the graduation of 71 U.S. Digital Corps fellows, marking the largest graduating class since the program’s inception. Those graduates updated the FedRAMP website, helped streamline Agriculture Department environmental reviews and supported other technology projects during their stints in the federal government.
    • “This government has starved for talent, for people who understand how to do all the things that we want to do to deliver better,” OPM Director Scott Kupor said during graduation remarks.
    • “Some of the graduates of the two-year fellowship program are continuing civil service while others are headed to the private sector.”
  • Tammy Flanagan, writing in Govexec, explains “Why time, not timing, is the biggest retirement advantage for federal employees.”
    • “A look at decades of market shifts and TSP data shows the biggest driver of retirement wealth isn’t picking the right stock. It’s starting early, contributing consistently and letting compounding do its work.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “A Food and Drug Administration advisory panel voted 10-3 Thursday for Replimune Group’s experimental melanoma therapy, after a contentious meeting in which experts raised doubts about whether the company’s data and trial design could be trusted to show the skin-cancer drug works.
    • “Thursday’s recommendation is the latest turn in a regulatory saga that has stretched nearly two years.” * * * 
    • “Thursday’s meeting came a day after another closely watched advisory session, in which FDA advisers voted against Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy—a rejection that, like Replimune’s, followed a prior FDA denial.” 
  • MedTech Dive relates,
    • “Artificial intelligence is here to stay at the FDA, but its integration and evolution may not be a straight line now that one of its biggest proponents, former commissioner Marty Makary, has stepped down.” * * *
    • “Acting commissioner Kyle Diamantas said AI remains a top priority for the FDA. Still, recent high-level departures, including Makary, Jeremy Walsh, chief artificial intelligence officer, and Sridhar Mantha, acting chief information officer, have raised questions about the future of AI implementation.
    • “It’s unclear now what the leadership and governance structure are around FDA-wide efforts,” said Tala Fakhouri, chief artificial intelligence and regulatory strategy officer at Parexel, and a former FDA AI policy official.”

No Surprises Act news,

  • Beckers Payer Issues reports,
    • “Another health insurance CEO is taking aim at the No Surprises Act’s arbitration system.
    • “We do support the overall strategic intent of consumer protection from surprise billing. However, we’re seeing some clear abuses of the IDR vehicle in practice,” Cigna Group President and CEO Brian Evanko said on the company’s second-quarter earnings call July 30, adding that the system is seeing “unsustainable volume levels, much of which is concentrated amongst a small number of providers.” 
    • “On July 22, a Wall Street Journal analysis of CMS data put 2025 arbitration payouts at nearly $15 billion, up from $4.08 billion in 2024, with arbitration firms collecting about $1.3 billion in fees. On the earnings call, Mr. Evanko referenced last year’s payout figure but said the impact “has been manageable” within Cigna’s insurance business.”

From the judicial front,

  • Fierce Healthcare reports,
    • “A federal judge has rejected a request from 26 states for a preliminary injunction in the Trump administration’s rollout of work requirements in Medicaid.
    • “The Centers for Medicare & Medicaid Services finalized implementation guidelines for states in June, with the eligibility requirements set to take effect on Jan. 1. States have until Aug. 31 to communicate with enrollees about the impacts of the changes.
    • “In an order issued Wednesday, Massachusetts District Judge Richard Stearns wrote that the states did not prove that establishing the systems necessary to make the eligibility determinations would cause them irreparable harm, as CMS said it would reimburse them for 90% of the costs for setting up those mechanisms.
    • :However, he said that the order does not reflect the court’s opinion on the merits of the broader litigation, which challenge provisions of the rule under the Administrative Procedure Act. Making a determination on that, as it questions whether officials hewed closely to Congressional intent in regulating the rollout of the requirements, requires a more complete picture.”
  • Healthcare Dive relates,
    • “The Federal Trade Commission is suing Hims & Hers [in a California federal court], alleging the telehealth company illegally shared sensitive health information with advertisers and misled customers about its billing practices. 
    • “The agency says California-based Hims & Hers made it difficult for users to cancel subscriptions, charged patients for medications before they consulted with a provider and shared their health data with third-party advertising platforms like Meta and Snap. 
    • “Hims & Hers called the FTC’s claims “baseless,” saying in a Wednesday statement that the agency “contorts the law to try to manufacture claims.”
  • Per a Justice Department news release,
    • “Access DX Laboratory, located in Houston, Texas, its former CEO Michael Stewart, and Florida businessman Harold Shatz, have each entered into settlements and will pay a combined total of $36.4 million to the United States to resolve allegations that they violated the False Claims Act (FCA) by paying kickbacks and billing Medicare and Medicaid for medically unnecessary genetic testing.
    • “The United States alleged that, from January 2018 through January 2020, Access DX, Stewart, and Shatz paid kickbacks to marketers in return for referrals of patients for genetic testing, unbundled billing codes for genetic testing, paid telemedicine providers for false and fraudulent doctors’ orders, and submitted and caused the submission of false claims for genetic testing.” * * *
    • “Except to the extent admitted by Stewart and Shatz in their plea agreements, the claims resolved by the settlement are allegations only and there has been no determination of liability.” 

From the public health and medical/Rx research front,

  • The AP reports,
    • “A first-of-its-kind U.S. study suggests invasive mold infections may be an underappreciated — and potentially deadly — threat.
    • “The researchers detected about 450 cases in Atlanta-area hospitals over five years. About a third of the patients died in the hospital.
    • “The findings, published this week by the U.S. Centers for Disease Control and Prevention, come from an attempt to better gauge how common these kinds of illnesses are. The government does not require doctors to report the illnesses.
    • “It’s kind of the first time we’ve had an estimate like this,” said the CDC’s Dr. Jeremy Gold, the study’s senior author.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. today announced the launch of The Real Food Show, a new cooking series designed to help Americans prepare healthy, affordable meals using real, everyday ingredients.
    • “More than a cooking show, The Real Food Show is a national initiative that empowers families to make healthy eating practical, approachable, and affordable. Each episode combines simple recipes with the science behind them, translating the new Dietary Guidelines for Americans into meals that Americans can prepare in their own kitchens.”
    • “Visit The Real Food Show webpage for more details.”
  • Radiology Business tells us,
    • “Adult CT radiation doses have decreased substantially over the last decade in the U.S., according to new research published Tuesday. 
    • “About 10 years have passed since data underlying the most recent national benchmarks for radiation dosing were collected. This underscores the need for updated reference values, as these guidelines may not reflect new advances in scanner technology, reconstruction methods and protocol changes, experts write in RSNA’s Radiology. 
    • “Researchers recently aimed to address this information gap, analyzing adult CT acquisitions performed across U.S. facilities in 2025. They discovered clear progress, with CT diagnostic reference levels declining an average of nearly 22% since 2014.
    • “The magnitude and consistency of these reductions across examination categories suggest that such advances have translated into measurable, population-level dose reductions in routine clinical imaging in the United States,” Kalpana M. Kanal, PhD, with the Department of Radiology at the University of Washington, Seattle, and colleagues wrote July 28.”
  • The July 30 issue of NIH Research Matters covers the following topics:
    • Tracking diets via wastewater
      • “Measuring DNA from food in wastewater could provide snapshots of dietary patterns.
      • “Monitoring these patterns could be a powerful tool for informing nutrition policy.” 
    • Lung tumor signals may tamp down food intake
      • “Researchers found that a high-fat diet in mice amplifies nerve signals between certain lung cancers and the brain, leading to reduced appetite and weight loss.
      • “If confirmed in further studies, the results could inform strategies to improve nutrition and survival in certain patients with cancer.”
    • Bacteria share proteins to survive antibiotics
      • “Researchers found that some bacteria share proteins that help others survive antibiotics.
      • “The study suggests a novel approach that may help treat persistent bacterial infections.”
  • MedPage Today informs us,
    • “Consuming less sugar before birth and during the first 1 to 2 years of life was tied to a lower risk of dementia decades later, U.K. Biobank data showed.
    • “The study used the abrupt end of World War II rationing as a natural experiment to test whether early-life sugar exposure was associated with late-life dementia.
    • “Previous research has linked early-life sugar rationing to less risk of diabetes and hypertension in adults and better cardiovascular outcomes.”
  • Health Day adds,
    • “Want to give your tot a brain boost when it comes to learning language?
    • “Maintain eye contact as much as possible when you’re talking to them, a new study suggests.
    • “Eye contact helps a baby decide what is important, acting as a switch that triggers synchronization of their brain waves with those of the speaker, researchers reported recently in the journal Nature Communications.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “An international team of researchers has identified multiple new genetic risk factors associated with fibromyalgia, a syndrome characterized by widespread pain and tenderness, fatigue, and problems with sleep, memory and mood.
    • :The team analyzed genetic data from more than 2.5 million adults, of which 55,000 were fibromyalgia patients. They identified DNA sequence variants in 26 regions of the genome that affect the risk of developing fibromyalgia. Many of the genes implicated in these regions are involved in brain and nerve function.
    • “The results provide the strongest evidence yet that fibromyalgia is primarily a nervous system disorder rather than an autoimmune disease, as has long been debated. “This work changes how we think about fibromyalgia at a fundamental level,” said Michael Wainberg, PhD, an investigator at the Lunenfeld-Tanenbaum Research Institute, part of Sinai Health, and the University of Toronto. “For decades, patients have been dismissed or told their pain is simply psychological. Our findings confirm the condition has a clear biological basis.”
    • “Weinberg is co-senior author of the researchers’ published paper in Nature Medicine, titled “The genetic architecture of fibromyalgia across 2.5 million individuals,” in which they concluded, “This study provides robust genetic evidence defining fibromyalgia as a central nervous system disorder, thereby establishing a biological framework for its complex pathophysiology and extensive clinical comorbidities.”
  • Fierce Pharma points out,
    • “Investors anxiously waiting for Bristol Myers Squibb’s key Alzheimer’s disease psychosis readout for Cabenfy will have to wait a little longer. The company has once again delayed the expected phase 3 data from its Adept trial program, even as it delivered a group-wide quarterly beat that’s driving a significant forecast raise. 
    • “Rather than readouts in 2026, BMS now expects data from the three Adept trials to arrive beginning in early 2027 and be “spread across the year,” CEO Chris Boerner, Ph.D., said on the company’s earnings call Thursday.
    • “The delay was attributed to slower enrollment in the Adept-2 and Adept-4 studies and slower relapse event accrual in Adept-1, Boerner explained. Adept-1 could undergo an interim analysis as early as later this year, and BMS also plans to share safety and efficacy data this year from the trial’s open-label lead-in portion, he added.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna’s employer-sponsored plans reaped higher profits than expected in the second quarter after hiking premiums, spurring the company to raise its earnings outlook for 2026.
    • “Cigna results released Thursday are a relief for investors worried about broader pressures in the employer-sponsored market, which covers the majority of U.S. adults and has been a buoy for insurers slammed with higher spending in government programs in recent years.” * * *
    • “Cigna’s health services division Evernorth — which includes Express Scripts, one of the largest pharmacy benefit managers in the U.S. — brought in $1.7 billion in operating income in the quarter, down 2% year over year despite revenue growth.”
  • Modern Healthcare adds,
    • “The weight-loss drug boom is beginning to show signs of a slowdown as employers and insurers pull back on coverage, signaling the market could be entering a more restrained phase after years of breakneck expansion.
    • “In the past few months, growth in prescriptions for GLP-1 drugs for weight loss like Novo Nordisk A/S’ Wegovy and Eli Lilly & Co.’s Zepbound have moderated, according to Cigna Group Chief Executive Officer Brian Evanko. The insurer’s unit that manages drug benefits has noted coverage declines and slower utilization growth compared to prior periods, executives said during an earnings call with Wall Street analysts Thursday.”
  • Optum Rx, writing in LinkedIn, discusses “how plan sponsors can stay ahead of the latest drug cost trends.”
  • Fierce Healthcare relates,
    • “Teladoc Health trimmed its 2026 revenue outlook as its virtual behavioral health unit, BetterHelp, faces revenue pressure with consumer demand for insurance-covered services outpacing clinical capacity.
    • “Teladoc shares fell more than 27% on Thursday following the company’s release of its second-quarter financial performance report on Wednesday.
    • “The company is shifting from subscription to visit-based revenue models, while also transitioning its virtual mental health business to accept insurance, moving from a cash-pay model to an in-network, insurance-covered model. The company is making “considerable progress” in building the insurance offering, including establishing a baseline national footprint a year after launching its first state, Teladoc Health CEO Chuck Divita told analysts and investors on a call Wednesday. 
    • “We have contracted for over $150 million in-network lives and credentialed more than 8,000 mental health professionals for the network at this point,” he said.”
  • and
    • “Nearly three-quarters of patients with gambling disorder achieved clinically meaningful symptom improvement through Birches Health, a new study finds.
    • “The peer-reviewed outcomes study was recently published in the Journal of Medical Internet Research. It was a retrospective analysis of 1,305 adults treated by Birches between mid-2024 and mid-2026. 
    • “Birches, a virtual provider for digital addictions, says the study is the largest real-world dataset on virtual gambling disorder treatment in the U.S.” ‘
  • Beckers Hospital Review tells us,
    • “Forbes rated the country’s hospitals state by state for 2026, with 259 earning the top mark of five stars.
    • “The Forbes Top Hospitals by State list, published July 14, draws on the national Forbes Top Hospitals 2026 ratings, which score general acute-care hospitals on measures pulled from the CMS Provider Data Catalog across four areas: patient outcomes (weighted at 55%), hospital best practices (20%), value (15%) and patient experience (10%). Each hospital lands on a single Forbes Overall Hospital Quality Rating of one to five stars.
    • “The article includes] the top of that scale: every hospital awarded five stars for overall quality, grouped by state. The five-star tier spans 42 states, ranging from a single hospital in states such as Alabama, Delaware and Wyoming to 19 in Wisconsin. Eight states — Alaska, Connecticut, Hawaii, Mississippi, Nevada, New Hampshire, Rhode Island and Vermont — along with the District of Columbia had no hospital reach five stars.”
  • Radiolology Business informs us,
    • “A new analysis from Definitive Healthcare pinpoints [and the article lists] the 10 largest imaging center corporations in the U.S., based on location count. 
    • “RadNet tops the list with approximately 383 outposts at the time of the analysis, followed by the US Oncology Network (141), a chain of independent cancer docs backed by McKesson. Definitive Healthcare, a publicly traded commercial-intelligence firm, based the findings off data from its ImagingView product, which includes info from more than 22,000 centers. 
    • “As demand for outpatient imaging continues to rise, larger imaging companies are expanding through acquisitions, new site development, and care models focused on improving access and convenience for patients,” Definitive Healthcare said in an update posted July 23. “Several factors are contributing to this growth, including advances in imaging technology, increased demand for preventive diagnostic screenings, and an aging U.S. population.”
  • Fierce Healthcare notes,
    • “Health tech company Stellarus announced Thursday the launch of an artificial intelligence-driven copilot geared towards helping health plan customer service representatives.
    • ‘The solution—dubbed Customer Service Representative (CSR) Chat—provides representatives with real-time guidance and contextual support during live interactions, surfacing relevant information, policy and recommended responses directly in workflows. 
    • ‘Stellarus president and CEO Vanessa Colella told Fierce Healthcare in an interview that “unsustainable healthcare costs” have been dominating conversations about the American healthcare system.
    • “It’s not about talking about someday it might not be working,” Colella said. “It is not working today. One of the places that it’s not working is cost. And another place it’s not working is member experience.”
    • “The solution hopes to address both core issues through administrative burden reduction and allowing representatives and members “to have the conversation that matters,” according to Colella.”

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

No Surprises Act News

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Midweek report

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

Simplicity is a virtue

From Washington, DC

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

From the Food and Drug Administration,

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

No Surprises Act News

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Noteworthy Event

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

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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