Tuesday report

CMS

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, 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) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansion advances the Trump Administration’s Great American Recovery and A Home for Every Child initiatives by equipping states with evidence-based resources to help parents overcome addiction, thereby strengthening families and reducing the number of children entering foster care.
    • “HHS Secretary Robert F. Kennedy Jr., White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Initiative Kathryn Burgum, and ACF Assistant Secretary Alex J. Adams joined Governor Kim Reynolds in Des Moines to make the announcement.
    • “Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them,” said HHS Secretary Robert F. Kennedy, Jr. “Under President Trump’s Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care.”
    • “Iowa is proud to be first in the nation to adopt new peer-support interventions,” said Iowa Governor Kim Reynolds. “By responding to addiction and supporting struggling families, we’re building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone.”
  • Federal News Network relates,
    • “Kevin Rhodes, the administrator of the Office of Federal Procurement Policy, is leaving federal service.
    • “A person with knowledge of the situation confirmed that Rhodes’s last day will be Sept. 4.
    • “The Senate confirmed Rhodes in October 2025, making him the first permanent OFPP administrator since 2019. He started working at OMB as a senior advisor in February 2025.
    • It’s unclear who will be acting OFPP administrator once he leaves.”
  • Fierce Healthcare tells us,
    • “The American Medical Association (AMA) said Monday it “welcomes” updated guidance from the U.S. Centers for Medicare and Medicaid Services (CMS) that strengthens federal transparency requirements for prior authorization.
    • “The country’s largest physician organization had documented concerns and recommended specific corrective actions to the agency in May (PDF), following the group’s review of how 15 Medicare Advantage contracts were implementing transparency provisions of the CMS Interoperability and Prior Authorization final rule. 
    • “The 2024 final rule requires payers to publicly post prior authorization requirements and outcomes, with a three-day deadline for urgent requests and a seven-day deadline for standard requests.” * * *
    • “The updated metrics reporting framework (PDF) clarifies that posting required metrics only through password-protected portals or “other locations that cannot be reached through ordinary navigation from the payer’s public-facing website” does not satisfy the rule’s “publicly accessible” requirement.
    • “The agency now also specifies that plans must publicly identify all medical items and services requiring prior authorization and identify omission of entire categories of care from disclosures. Moreover, it clarifies disclosures must be understandable and turnaround-time metrics must include a unit of time.”
  • The American Hospital Association informs us,
    • “The Centers for Medicare & Medicaid Services yesterday announced the launch of QualTech, a new event created to identify innovative technology that improves health outcomes. CMS is seeking participants from U.S-based teams, academic institutions, nonprofit organizations, private sector companies, industry associations and other stakeholders to propose technology solutions in advance of the event. Applicants must align proposal submissions to one of four priority opportunity areas: using artificial intelligence to protect patients and strengthen healthcare quality; leveraging AI to increase annual wellness visits in Medicare; proposing a next-generation digital quality measure calculator; and supporting the development of a national quality hospital dashboard. CMS will select finalists to present at QualTech, which will be held at CMS headquarters, to CMS and Center for Clinical Standards and Quality leadership and other attendees. CMS said it may continue engagement with select organizations following the event, which could include future demonstrations, pilots, collaboration discussions and a potential role in the 2027 CMS Quality Conference. Applications must be uploaded to the QualTech submission link by Sept. 4, 2026.” 
  • Managed Healthcare Executive points out,
    • “CMS implemented MFPs for 10 high-volume Part D drugs in January 2026 after 2024 discount announcements, with projected net savings of ~$6 billion (≈22%) across those products. 
    • “Surveyed beneficiaries reported countervailing cost signals: 46% paid more for at least one negotiated drug, 39% saw premium increases, and coverage changes increased out-of-pocket exposure for 29%. 
    • “Access friction intensified, with 30% reporting 2026 barriers versus 25% in 2025, most commonly prior authorization and drug availability constraints. 
    • “Knowledge gaps were substantial, as ~40% were unaware of the $2,100 out-of-pocket cap or the Medicare Prescription Payment Plan, undermining uptake of IRA cost protections. 
    • “Payer responses appear consistent with broader market behavior, including expanded step therapy, higher premiums, and stronger generic/biosimilar preferencing, particularly affecting diabetes, dermatology, and rheumatology.”

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

  • Fedweek reports,
    • “OPM has told agencies that they “must verify 100 percent of Open Season elections in which a family member is added” in FEHB/PSHB enrollments for calendar year 2027, sending them a survey for them to verify their readiness to do so.
    • “Enrollment of ineligible persons has been a long-running issue, the subject of congressional oversight and reports from the OPM inspector general and the GAO—most recently, in a GAO report on high-priority recommendations to the agency. The cost of claims from ineligible persons is widely estimated at $1 billion a year, raising premium costs for both enrollees and the government.
    • “In a benefits administration letter dated July 15 but only recently posted, OPM noted scrutiny has been tightened in a series of administrative steps, including in a prior letter requiring at least 10 percent of new family member enrollments and recommending review of all. Language in a broader budget measure enacted last year “codifies and elevates this standard by requiring verification of family member eligibility when an enrollee adds a family member during Open Season,” it said.
  • and
    • “Recently finalized rules requiring that employee performance evaluations fit a mandated pattern will apply to the rating cycle closing next month, OPM has said, a process that will involve “calibration” by senior agency officials that potentially will reduce many of the ratings set by employees’ supervisors.
    • “While a recent memo on carrying out the changes does not specify an implementation schedule, in response to questions from FEDweek, OPM said that what it calls “standardized” rating “applies to both the FY26 and FY27 performance appraisal cycles.”
    • “Agencies must establish a calibration program for the FY26 performance appraisal closeout no later than September 20, 2026 (end of FY26 appraisal cycle). Additionally, agencies must design their new GS performance management systems, and have them approved by OPM, prior to October 1, 2026 (for FY27 implementation),” it said.
    • “Applying a standardized distribution of ratings, and designing and implementing a calibration program, is effective for the closeout of the FY26 cycle,” it said, adding that it “will be publishing FY2026 performance appraisal cycle close-out guidance separately. We expect that guidance to be released in the next few weeks.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “President Donald Trump has chosen White House policy aide Heidi Overton to lead the Food and Drug Administration, according to a person familiar with the matter, after a turbulent year at the agency marked by high-profile staff exits and industry complaints.
    • “Overton is a deputy assistant to the president for domestic policy at the White House working on health issues. She previously worked at the think tank America First Policy Institute. Overton is a medical doctor and has a doctorate in clinical investigation from Johns Hopkins University. She was also a White House fellow in the first Trump administration.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial intelligence-enabled medical devices. The paper includes considerations for risk assessment, premarket evaluation, post-market monitoring and other areas. The agency intends to gather early stakeholder input and advance broader discussion on policy frameworks for generative AI. The FDA said comments must be submitted by Oct. 19.”  
  • MedPage Today adds,
  • Per a corporate news release,
    • “LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA) has approved an autoinjector for LEROCHOL® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor that combines robust and sustained efficacy with once-monthly, single injection self-administration to support long-term adherence.
    • “The FDA also approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy.” * * *
    • “LEROCHOL autoinjector is expected to be available by January 2027 with a direct-to-patient cash price to match that of the already available pre-filled syringe at $199 per month.
  • BioPharma Dive explains that an “FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax.”
    • “Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.”

From the judicial front,

  • Beckers ASC Review reports,
    • “The American Association of Nurse Anesthesiology said July 21 that a U.S. Court of Appeals for the Sixth Circuit ruling wrongly declined to force HHS to enforce a provider nondiscrimination provision that protects certified registered nurse anesthetists from reduced insurance reimbursement.
    • “The Sixth Circuit based its ruling on associational standing, upholding a lower court’s finding that AANA lacked standing to bring the case. Mr. Molter said AANA is evaluating what the decision means for how trade associations pursue their members’ interests in federal court and is urging other associations to do the same.
    • “AANA President Jeff Molter, MSN,  MBA, CRNA, said the ruling does not endorse insurers’ practice of reimbursing CRNAs less than physician anesthesiologists for the same services. He called the decision procedural and said AANA maintains that such reduced reimbursement remains unlawful and discriminatory under current statute.”
  • The article points out nine other current anesthesia controversies.
  • Bloomberg Law relates,
    • “A federal judge in Massachusetts mostly upheld a 2025 Trump administration rule tightening oversight of Affordable Care Act exchange enrollment, adding to the legal saga dragging on over a 2026 version of the annual rule.
    • “Judge Nathaniel M. Gorton of the US District Court for the District of Massachusetts on Friday granted summary judgment for the administration in regard to provisions reducing the grace period for premium tax credit recipients to reconcile their income from two years to one year, shortening states’ open enrollment periods, increasing insurers’ flexibility to decrease the value of their plans, and changing the methodology for calculating cost-sharing amounts.
    • “But Gorton sided with the states in determining the administration did not follow the law in excluding certain “sex-trait modification procedures” from the ACA’s essential health benefits, noting that the government refused to issue a mandated report to Congress certifying that the provisions were aligned with a “typical employer plan.”
    • “When asked about the issue at oral argument, the government maintained its position that the Agency is not required to submit such a report, notwithstanding the Court’s clear ruling that it was required to do so,” he wrote in his opinion.” * * *
    • “Gorton’s opinion conflicts with the Maryland court, which rejected CMS’s ability to limit enrollment periods and increase flexibility for insurers to vary the value of their plans.
    • “CMS finalized several of the same provisions in its 2026 rule, prompting Democratic cities and states to sue again. The rule is now mostly frozen by the Maryland court.
    • “The case is California v. Kennedy , D. Mass., No. 1:25-cv-12019, opinion filed 8/14/26.”
  • The AP informs us,
    • “Luigi Mangione’s state murder trial in the killing of UnitedHealthcare CEO Brian Thompson, which was slated to begin Sept. 8, has been postponed indefinitely as his lawyers seek to have the case thrown out on double jeopardy grounds following his guilty plea last week to federal charges.
    • “Judge Gregory Carro issued an order Monday canceling the trial and giving the Manhattan District Attorney’s office, which is prosecuting the state case, until Oct. 9 to respond to the defense’s double jeopardy claims. A hearing will be held on Dec. 10, Carro said, about a week before Mangione is scheduled to be sentenced in the federal case.”

From the public health and medical / Rx research front,

  • The New York Times lets us know,
    • “What the Newest Research on Wildfire Smoke Tells Us
      • “Scientists have found that people are being exposed to more toxins than previously known.”
  • Cardiovascular Business adds,
    • “Long-term exposure to air pollution is associated with more advanced coronary atherosclerosis, including greater plaque burden and obstructive coronary artery disease, according to a large cardiac CT study published in Radiology.[1]
    • “Researchers led by Kate Hanneman, MD, MPH, associate professor and vice chair of research in the department of medical imaging at the University of Toronto, analyzed cardiac CT data from 11,128 adults who underwent clinical scans at three Toronto hospitals between 2012 and 2023. The study linked patients’ residential postal codes with air-quality data to estimate their average exposure to pollution during the 10 years before their CT examinations.
    • “What we found is that higher air pollution exposure, both gaseous and particulate, was associated with higher coronary calcium scores, higher plaque burden, and obstructive coronary disease in unadjusted models,” Hanneman explained a video interview with Cardiovascular Business at SCCT2026, the Society of Cardiovascular Computed Tomography (SCCT) annual meeting. “When we adjusted for age, sex, and traditional cardiovascular risk factors, we found that in women, higher air pollution was also associated with obstructive disease, even in these multi-variable models. So this really builds on the existing literature that tells us that higher air pollution is not good for us and it’s not good for our heart.”
  • Genetic Engineering and Biotechnology News reports,
    • “Mass General Brigham Cancer Institute researchers found that consuming one or more sugar-sweetened beverages every day was associated with an increased risk of developing gastric cancer, while artificially sweetened beverages were not associated with an increased risk. Results from the study were published in Gastro Hep Advances, in an article titled “Association between sugar-sweetened and artificially sweetened beverage intake and gastric cancer incidence.”
    • “Previous research has linked sugar-sweetened beverages with an increased risk of colorectal, breast, and liver cancers, but evidence on gastric cancer has been limited. The study analyzed data from 112,284 participants in the Nurses’ Health Study and Health Professionals Follow-Up Study. Both studies gathered detailed diet, lifestyle, and health information on U.S. adults over many decades. During the follow-up period, which spanned decades, 278 participants developed gastric cancer.
  • MedPage Today adds,
    • “A group of physicians and scientists are calling on the National Collegiate Athletic Association (NCAA) to make changes to its massive collaboration between Big 12 athletics and Monster Energy, citing potential health risks and teen deaths associated with energy-drink consumption.
    • “As part of the partnership announced last month, Big 12 football and basketball athletes will don Monster Energy-branded jerseys during the regular seasons, and the fields and courts where teams play will display the popular energy drink’s logo.
    • “Virginia-based ophthalmologist David Jacobs, MD, noticed the prominent branding of the energy drink when he went to visit his kid’s Big 12 school, and later became concerned about how the campaign could influence children.
    • “Jacobs is an alum of a Big 12 school, as is his friend, Idaho-based cardiologist Matthew Nelson, MD. The two began reaching out to other cardiologists and created the Protect Young Fansopens in a new tab or window public health initiative, which, as of press time, has gathered over 250 signatures on their petitionopens in a new tab or window asking the NCAA to end the Monster Energy partnership.
    • “We’re concerned about an increase in energy drink consumption among children and youth,” Jacobs told MedPage Today. He noted that with high-profile Big 12 sports in particular, impressionable kids will be looking up to and copying their sports idols.
    • “Their concerns are not abstract, according to an email to NCAA leadership from Jacobs, Nelson, and other physicians and scientists that was shared with MedPage Today.”
  • The American Hospital Association News relates,
    • “For the 2025-2026 school year, exemptions from one or more vaccines among U.S. kindergartners was at 4.2%, increasing from 3.6% for the previous school year, according to data released yesterday by the Centers for Disease Control and Prevention. Exemptions rose in 41 states and Washington, D.C. Vaccination coverage declined for all reported vaccines from the previous year. Coverage with the measles, mumps and rubella, or MMR; diphtheria, tetanus, and acellular pertussis, or DTaP; polio and varicella vaccines decreased in more than half of states. The CDC said there were approximately 280,000 kindergartners that attended school in 2025-2026 without documentation of completing the two-dose MMR vaccine.” 
  • MedPage Today adds,
    • :The hepatitis A vaccine is recommended for high-risk children and adults, while the hepatitis B vaccine is recommended for all adults under 60 years.
    • “In this study, researchers estimated that 40% of U.S. adults had immunity to hepatitis A and 27% were immune to hepatitis B virus.
    • “Levels of immunity against hepatitis A and hepatitis B viruses were “suboptimal” and persisted across high-risk groups, according to the researchers.”
  • and
    • “Despite routine rotavirus vaccination in over 140 countries, the virus still causes an estimated 25% of diarrhea deaths in children younger than 5 years.
    • “In a retrospective study of children ages 3 months to 4 years, receiving at least one dose of a rotavirus vaccine was 75.8% effective at preventing rotavirus-positive acute gastroenteritis death.
    • “Rotavirus vaccination was less effective against all-cause acute gastroenteritis mortality, at 20.8%.”
  • Beckers Clincal Leadership tells us,
    • “Blacklegged ticks carrying Lyme disease have expanded into the mountains of western North Carolina, far south of the disease’s traditional Northeast and Upper Midwest range, according to an Aug. 13 CDC report.
    • “Researchers surveilling 22 residential properties in Biltmore Forest, N.C., near Asheville, collected 373 ticks from November 2024 through August 2025, according to the CDC’s “Morbidity and Mortality Weekly Report.” Blacklegged ticks — the primary Lyme vector — made up 287, or 76.9%, of them.
    • “Nearly 40% of the adult blacklegged ticks, or 19 of 48 specimens, tested positive for Borrelia burgdorferi, the bacterium that causes Lyme disease. Three of seven nymphs also carried it.
    • “Nineteen residents across 17 households reported at least one tick-borne illness while living in the town, the CDC report said. Lyme disease was the most common, with 17 cases, followed by two cases of babesiosis and one of ehrlichiosis.
    • “The findings point to an emerging clinical blind spot. Many clinicians across the South have little experience diagnosing or managing tick-borne disease, the report’s authors said, and may not consider Lyme in patients with no travel history to endemic regions.”
  • Beckers Hospital Review informs us,
    • “Nearly every U.S. hospital screens patients for sepsis, but far fewer have dedicated personnel to ensure screening is successful, the CDC found. Moreover, separate research links a lack of specific accountability to higher mortality.
    • “In its latest annual survey of hospital sepsis programs, covering 2025, the CDC found that 93% of 5,430 hospitals have a standard process to screen for sepsis and 87% use order sets tailored to their patients. But only 36% employ a sepsis coordinator to oversee day-to-day operations, and 32% have support from staff with expertise in data, analytics and information technology.
    • “When it comes to reporting, 31% of hospitals share sepsis data with nursing, physician, unit and hospital leadership at routine intervals. At the remaining two-thirds of U.S. hospitals, that data does not reach leaders on a regular basis.
    • “Sepsis accounts for about 1.7 million adult hospitalizations per year, 350,000 of which end in death or discharge to hospice — more than a third of all hospital deaths, according to the CDC.”
  • The American Medical Association lets us know “this superbug’s toll exceeds 3,400. How to protect your loved ones.”
    • “The Candida auris fungus is spreading. Here’s what to know about the superbug, who’s most at risk, symptoms and what your next steps should be.”
  • Health Day points out,
    • “Many smokers still haven’t absorbed the fact that smoking and secondhand smoke cause heart attacks and strokes, despite decades of messaging around tobacco’s health risks, a new study says.
    • “More than 90% know that smoking causes lung cancer, but fewer know about its links to other fatal conditions, researchers report in the journal BMJ Open.
    • “Only about 80% knew smoking contributes to heart disease and heart attacks, and 70% are aware it causes strokes, researchers found.
    • “In fact, across two decades they found almost no progress in knowledge of the health risks associated with smoking.
    • “Knowledge gaps about the major health effects of smoking and secondhand smoke are deeply concerning,” said lead researcher Janet Chung-Hall, a research scientist for the International Tobacco Control Policy Evaluation Project at the University of Waterloo in Canada.”
  • and
    • “There’s been a nearly 400% increase in calls to U.S. poison centers related to liver injuries, mostly related to Tylenol and other medications, a new study says.
    • “Liver injuries caused by foreign substances skyrocketed from an estimated 11 cases per million people to nearly 53 cases per million between 2000 and 2024, researchers reported Aug. 13 in the journal Clinical Gastroenterology and Hepatology.
    • :Medications accounted for most of these liver injuries, including 85% of cases among men and 94% of cases among women, researchers found.
    • “Acetaminophen (Tylenol) was the drug most frequently implicated in liver injuries reported to poison centers, researchers said. About 33% of men and 45% of women reported injuries due solely to Tylenol.”
    • “Liver injuries reported to poison centers have increased substantially over the past 25 years, with acetaminophen emerging as a growing contributor,” researcher Dr. Christopher Holstege, director of the University of Virginia Health’s Blue Ridge Poison Center, said in a news release.”
  • Per BioPharma Dive,
    • A once high-flying Boston-area drug company mounted somewhat of a comeback Tuesday, reporting positive results from a clinical trial testing a potentially first-of-its-kind treatment for the dangerously low blood sugar levels some patients experience after bariatric surgery.
    • Amylyx Pharmaceuticals said its medicine, known as avexitide, hit the main goal of the late-stage study by spurring a 55% reduction in serious to severe hypoglycemic events compared to a placebo. Such events starve the brain of the sugar it needs for fuel, leading to confusion, dizziness, slurred speech and loss of coordination. In more dire cases, patients can faint, have seizures or become comatose.
    • “According to Amylyx, its medicine also appeared safe. Researchers classified a majority of the adverse events seen in the trial as mild or moderate, with the most common being diarrhea and bruising or redness at the injection site. Amylyx now plans to, before the end of the year, formally ask the Food and Drug Administration to approve avexitide.”

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

  • Healthcare Dive reports,
    • “CVS has added Teresa Heitsenrether, JPMorgan Chase’s chief data and analytics officer, to its board of directors as the healthcare behemoth continues to progress on its financial turnaround.
    • “Heitsenrether has spent four decades in financial services, according to Monday press release announcing her appointment. She’ll be joining CVS effective Nov. 18.
    • “CVS also said that Larry Robbins, who served on the board’s audit and public policy and external affairs committees, left earlier this month. Robbins, the CEO of Glenview Capital Management, joined the board in 2024 after the hedge fund pushed for changes at CVS.”
    • “As the leader of JPMorgan’s data and analytics, Heitsenrether sets strategy and governance standards, while driving the bank’s adoption of artificial intelligence.”
  • Beckers Payer Issues relates,
    • “UnitedHealthcare expanded its child and family behavioral coaching program, giving approximately 13 million eligible commercial members access to behavioral health support. 
    • “The 2026 expansion adds access for an additional 5 million members at no added cost for employers with fully insured plans. More than 500 employers now offer the program, according to an Aug. 18 news release from the company. 
    • “The program addresses mild to moderate anxiety, attention-deficit/hyperactivity disorder, bullying, depression and sleep difficulties, with participants being 12 years old on average. It offers up to four virtual coaching sessions per month, appointments within 48 hours, unlimited secure messaging and educational resources, and access to health and wellness coaches. Members can also be referred to licensed clinicians when higher-level care is needed.”
  • and 
    • “Blue Cross Blue Shield of Tennessee has the highest-ranked Medicare Advantage plan for member satisfaction in 2026, according to JD Power’s 12th annual Medicare Advantage study.
    • “The consumer insight firm published its annual ranking of the top MA plans in 12 markets on Aug. 18 after surveying more than 14,500 enrollees and evaluating plans on eight factors, including level of trust, ability to get health services when and how members want, helping save time or money, product and coverage offerings, ease of doing business, customer service representatives, problem resolution and digital channels.
    • “The average member satisfaction rating for MA plans this year is 611 on a 1,000-point scale, down 12 points from 2025 and down 41 points from 2024, marking a second consecutive year of decline.
    • “Satisfaction dropped across all dimensions of the member experience, with the largest two-year declines in areas tied to helping members save time and money, level of trust and whether coverage offerings met member needs. Fewer than half of plan members said they strongly agreed their plan is a trusted partner in their health and wellness. High-performing plans distinguished themselves through stronger new-member onboarding and communication, while special needs plans delivered significantly higher satisfaction and trust scores overall.”
  • Fierce Healthcare tells us,
    • “While operating margins trended upward in June, hospitals’ overall performance still lags 2025 and is seeing “intensifying” uncompensated care pressures and faster-than-inflation expense growth, according to the latest monthly benchmarks from Kaufman Hall. 
    • “The healthcare advisory firm reported a calendar year-to-date operating margin index of 2.5% and a single-month operating margin index of 4.5% (both including health system allocations for the cost of shared services). The former is a 6% lag compared to the first half of 2025, while the latter reflects a 6% bump over this May’s median operating margin.
    • “Echoing commentary from some of its preceding reports this year, Kaufman Hall’s primary red flag was a 2% month-over-month increase in daily bad debt and charity logged by hospitals, which year-to-date is 17% higher than the same cutoff in 2025. As a percentage of hospitals’ gross operating revenue, year to date, uncompensated care is 8% higher than 2025.” 
  • STAT News adds,
    • “For Bon Secours Mercy Health, Ensemble Health Partners is the gift that keeps on giving. 
    • “Seven years after the nonprofit health system sold stakes in its in-house billing and collections company to private equity investors, it still rakes in eye-popping amounts of cash from its minority position, with payments topping $1 billion so far this year.
    • “About two weeks ago, the Cincinnati-based system said it got a hefty $671 million payment from Ensemble Health Partners when the company signed a new private equity sponsor. That’s on top of a $427 million distribution Bon Secours Mercy recorded in February. Both payments were reported on the nonprofit system’s financial report for the second quarter, which ended June 30. 
    • “The $1.1 billion Bon Secours Mercy received from its 41% stake in Ensemble across the two payments far exceeds the system’s operating income in the first half of the year, which was $225 million. The health system generated $7.5 billion in revenue in the first six months of 2026, compared with $6.9 billion in the first half of 2025.” 
  • Beckers Hospital Review adds
    • “After years of high length-of-stay averages, hospitals are reporting significant length-of-stay reductions.”
      ,
  • Beckers Payer Issues notes,
    • “Montgomery, Ala.-based Jackson Hospital has filed to exit bankruptcy and signed a four-year deal with Blue Cross Blue Shield of Alabama, John Quinlivan, CEO of Jackson Hospital, said during an Aug. 17 news conference. 
    • “The BCBS agreement will become active once the exit is complete.
    • “The agreement does not give us everything we felt we needed, but combined with the continued support of Blue Cross Blue Shield of Alabama, Jackson Investment Group, the City of Montgomery, Montgomery County and the State of Alabama, it enables us to execute our strategic plan,” Mr. Quinlivan said. “We will enhance operational discipline, improve quality, expand services and add new services as we grow and innovate to better serve Montgomery and the Central Alabama region.”
  • Per Beckers Physician Leadership,
    • “Corporate entities now employ 82% of U.S. physicians, and about nine out of 10 physicians in employed settings are reporting symptoms of burnout, according to a new survey.
    • “The Physicians Advocacy Institute and Healthsperien’s Center for Health Research, Policy & Strategy surveyed more than 1,000 hospital- and corporate-employed physicians and found widespread burnout, administrative burdens and pressure to put corporate interests ahead of patient care.”
  • Per Fierce Healthcare,
    • “Four health systems are now using real-time prior authorization checks embedded in the Epic electronic health record, tackling a major pain point for providers.
    • “The electronic health record giant collaborated with insurers UnitedHealthcare, Network Health and Aetna to set up the electronic workflows to modernize the manual and time-consuming prior auth process.
    • “Epic launched real-time insurance reviews directly into EHR workflows using an industry-standard application programming interface (API) called Coverage Requirements Discovery (CRD). Epic is testing the API with 16 additional payers to support wider industry adoption, the company announced Monday as its annual Users Group Meeting kicks off in Verona, Wisconsin.”

Monday report

David Ermer–ACA, CDC, CMS, FDA, Medical / Rx research, Mental health care, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    •  “In the chapel of a homeless shelter, health secretary Robert F. Kennedy Jr. stood behind a lectern with a “Cancel Corruption” sign and lambasted local officials for mishandling the city’s homelessness and substance use crisis.
    • “Just 24 hours earlier, Kennedy was in the Oval Office, standing alongside President Trump, as the president signed an executive order calling for major changes to childhood vaccinations.
    • “The change in tone — from day to day and coast to coast — shows how Kennedy’s sprawling political messages tied to his Make America Healthy Again movement vary depending on the audience he is in front of.”
    • “In Los Angeles, Kennedy kept the message fairly local, speaking before conservative city officials and a mission group of roughly a hundred teenagers and praising the shelter he was visiting. But from Washington, Kennedy has become a spokesman of the administration’s more far-reaching policies: fewer vaccines for kids and more regulation of food additives, both announced on Monday from the nation’s capital, before he headed West.” 
  • Per an HHS news release,
    • The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced $96.7 million in grants and cooperative agreements to strengthen behavioral health services and supports across the country. The awards provide funding for a range of behavioral health services and initiatives, including services for people with serious mental illness who are homeless, suicide prevention and early intervention, substance use disorder treatment, training and technical assistance, peer support, and disaster-related emotional support.
    • “Every American deserves the opportunity to recover and live with dignity,” said HHS Secretary Robert F. Kennedy, Jr. “These investments will expand access to treatment, strengthen behavioral health services, and help more people move from crisis to recovery. That is how we restore health, rebuild lives, and strengthen our communities.”
  • Meritalk interviews the U.S. Office of Personnel Management’s Chief Information Officer Adam Starr.
    • “As CIO roles become more strategic, OPM CIO Adam Starr says agencies need to give technologists room to move faster, embed AI and security into the business, and create a culture that rewards measured risk.”
  • Federal News Network relates,
    • “The Defense Logistics Agency’s five-year IT modernization journey reached an important milestone earlier this summer.
    • “DLA moved its catalog system off a 35-year-old COBOL-based system and onto a new modern platform.
    • “Adarryl Roberts, DLA’s chief information officer, said the agency will now have a system that will allow it to process data and requests much faster.”
  • FEHBlog observation — This is another example of IT modernization that causes the FEHBlog to wonder why OPM cannot convert its outdated CLER system to the modern HIPAA 820 electronic transaction that allows carriers to reconcile premiums at the individual enrollee level.
  • Fierce Healthcare tells us,
    • “Amid instability in the Affordable Care Act marketplaces, proponents of ICHRA have suggested that these models could help support risk pools. A new survey from the HRA Council adds to the body of evidence on the matter. 
    • “The council, a nonpartisan organization that pushes for expanded coverage options, released its latest look at trends around individual coverage reimbursement arrangements, or ICHRA, and found that a growing number of larger employers are considering it as an option.
    • “The larger employee base from these firms could bring more younger, healthier individuals into the market, adding greater stability to the risk pools that would be felt on the exchanges, according to the report.”

From the Food and Drug Administration front,

  • The Hill reports,
    • “More cases have been linked to outbreaks of cyclospora that do not have an identified source, according to the Food and Drug Administration. The outbreak linked to iceberg lettuce, meanwhile, has expanded to two additional states. 
    • “There have been nearly 14,000 cases of domestically acquired cyclospora confirmed in the U.S. since May this year, the Centers for Disease Control and Prevention report. That’s well over the roughly 1,180 cases reported from May through August last year.
    • :Of this year’s cases, at least 9,480 were reported in the 17 states connected to the cyclospora outbreak traced back to iceberg lettuce, according to the FDA and the CDC. Two states, Maine and Massachusetts, were added to that tally late last week.
    • At least some of the nation’s cases are also linked to the ongoing cyclospora outbreaks that the FDA has been investigating. 
    • “There are seven active investigations into cyclospora outbreaks, the FDA’s tracking shows. Three – sickening 18, eight and two people, respectively – are listed as ended. Only the outbreak linked to iceberg lettuce has an identified source.
    • “Two outbreaks have grown, according to the FDA. One, which was first reported in early August, has grown to 11 cases. Another, from late July, has grown to 172 cases, up from 115. The FDA continues to conduct traceback in both outbreaks, as well as three other still active outbreaks.
    • “We may never know the cause of the outbreak. Because of how long it can take for people to experience symptoms, and the difficulties of sequencing cyclospora, investigations can “take a significant amount of time,” Gwen Biggerstaff, the deputy director of the CDC’s Division of Foodborne, Waterborne, and Environmental Diseases, previously explained.”
  • MedTech Dive relates,
    • “Johnson & Johnson said Monday its Monarch bronchoscopy robot for lung cancer diagnosis received Food and Drug Administration clearance for a software update that adds several new features to the platform, including artificial intelligence tools designed to make pre-procedure planning more intuitive.
    • “Other improvements broaden compatibility with commonly used imaging systems and support navigation and targeting to help physicians address anatomical changes that can occur during the procedure.
    • “The Quest 3 update is the Monarch system’s fourth major software launch in the past 18 months, according to J&J.”
  • and
    • “The Food and Drug Administration has selected Cadence, a software company that makes an artificial intelligence-assisted tool for hypertension management, as the second company for its digital health pilot. 
    • “The Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, exempts certain digital health devices from FDA premarket authorization requirements while allowing companies to collect real-world data through a related Medicare program. 
    • “Cadence, which announced the FDA’s selection last week, plans to report real-world data related to the safety, performance and patient outcomes associated with its device to help inform how clinical AI systems are built and regulated in the future.”

From the judicial front,

  • On August 3, 2026, a Title VII class action was filed in the U.S. District Court for the District of Columbia against OPM Director Scott Kupor and his agency due to OPM’s exclusion of gender affirming care in the FEHB and PSHB programs.  On August 14, the Chief Judge granted the named plaintiffs’ motion to use pseudonyms and seal certain identifying information. On August 17, the District Court’s Clerk assigned the case to U.S. District Judge Amit T. Mehta.

From the public health and medical / research front,

  • The Washington Post reports,
    • “More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
    • “Starting this week, that grueling regimen can be reduced to just one shot a week.
    • “Novo Nordisk announced Tuesday that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
    • More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
    • “Starting this week, that grueling regimen can be reduced to just one shot a week.
    • “The appeal of reducing 365 shots a year to 52 is obvious: greater convenience, less pain. Novo Nordisk says removing the daily requirement can create “a routine that feels more manageable.” 
    • “But there are other issues to keep in mind — most importantly, the risk of hypoglycemia, or low blood sugar, which Novo Nordisk said was a common adverse reaction in Awiqli clinical trials. Hypoglycemia can make people feel shaky, irritable, and, if the blood sugar gets very low, confused. It can be dangerous and can even cause death if it gets excessively low.
    • “Novo Nordisk announced Tuesday [August 11, 2026] that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
    • “Another factor is access: It is not yet clear which insurance plans will cover Awiqli and whether they will require patients to jump through hoops to qualify for coverage.”
  • MedPage Today relates,
    • “Using a panel of 11 genes linked to pediatric cancer predisposition syndromes, researchers found pathogenic or likely pathogenic variants in 7% of newborns who later developed a solid or brain tumor.
    • “Targeted sequencing of this panel would identify approximately 1/27,000 infants who will develop cancer by age 8 years in the setting of a genetic cancer predisposition syndrome.
    • “Researchers said it is feasible to conduct genomic newborn screening universally.” * * *
    • “[E]arly identification of these children could alter their survival outcomes, Diller and team noted.
    • “It’s become clear over the past few decades that at least 10% or more of kids who develop cancer have genetic predisposition to cancer, and a good chunk of those kids are diagnosed in the first few years of life,” Diller told MedPage Today. “It predisposes them to very-early-onset cancers. So the clinical problem is, can we do anything other than wait for them to develop their cancers?”
  • Health Day tells us,
    • “Ultra-processed foods might be linked to a higher risk of prostate cancer, a new study says.
    • “Men who ate the most ultra-processed foods had as much as a 34% higher risk of prostate cancer, compared to those who ate less, researchers reported recently in theAmerican Journal of Medicine.
    • “Among adult men in this nationally representative U.S. population, those who consumed higher amounts of UPFs had significantly higher risks of the subsequent development of prostate cancer,” said senior researcher Dr. Charles Hennekens, a professor of medicine and preventive medicine at Florida Atlantic University.
    • “These findings add to emerging evidence that UPFs have major adverse health effects and underscore the need for large-scale observational studies and randomized trials to adequately test the hypothesis,” Hennekens said in a news release.”
  • and
    • “A person’s sleep patterns could be an early sign of Alzheimer’s disease, a new study says.
    • “A greater number of micro-awakenings during sleep is linked to a greater genetic risk for Alzheimer’s, researchers reported recently in the journal Sleep.
    • “In fact, more frequent micro-awakenings go hand in hand with that genetic risk, long before any memory problems arise, according to a team from the University of Liege in Belgium. 
    • “Sleep could become an accessible marker for the early identification of vulnerable individuals,” senior researcher Gilles Vandewalle said in a news release.
    • “It’s well-known that people with Alzheimer’s have sleep problems, but sleep hasn’t been established as an early indicator of the disease, researchers noted.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN  said it is ending the Phase 3 trial of volrustomig plus chemotherapy for metastatic non-small-cell lung cancer.
    • “The Cambridge-based pharmaceutical company said Monday that the decision is based on the recommendation of the Independent Data Monitoring Committee after a planned review of trial data.
    • “The committee concluded that the volrustomig combination was unlikely to reach either of the primary endpoints for the drug in the eVolve-Lung02 trial.” * * *
    • “The other Phase 3 volrustomig trials will continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.
    • “Separately, AstraZeneca said Tagrisso plus Orpathys showed a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival in a Phase 3 trial in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer.” * * *
    • “The company said this was the first global Phase 3 trial to show significant progression-free and overall survival benefits in this setting.
    • “Tagrisso plus Orpathys is being jointly developed with Hutchmed, but is being solely commercialized by AstraZeneca.
    • “AstraZeneca also said a Phase 3 trial of Enhertu showed a significant and clinically meaningful improvement in progression-free survival as a treatment for unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small-cell lung cancer.”
  • BioPharma Dive points out,
    • “Shares for Argenx soared over 13% Monday morning after the company announced positive data from a Phase 3 trial for a rare autoimmune condition that could expand use of its blockbuster drug Vyvgart. 
    • “The Dutch biopharmaceutical company said Monday an under-the-skin injection version of Vyvgart, called Vyvgart Hytrulo, met its primary endpoint in a late-stage combined study of people with myositis, a rare autoimmune disease that attacks the muscles and has limited treatments. The company said that Vyvgart, when compared to placebo, showed improvements in two subsets of the disease, as measured by a scale evaluating muscle strength and physical health known as Total Improvement Score, or TIS.”
  • and
    • “EyePoint, a Boston-area biotechnology company, lost nearly a billion dollars in market value Monday after its main drug failed to hit the central goal of a key clinical trial.
    • “Titled LUGANO, the trial enrolled roughly 400 people with the less common “wet” form of age-related macular degeneration, meaning they have impaired vision because of abnormal, fluid-leaking blood vessels in their eyes. They received inside-the-eye injections of either “aflibercept,” the active ingredient in Regeneron Pharmaceuticals’ blockbuster medicine Eylea, or EyePoint’s drug, which the company has branded as Durayvu.
    • “Researchers then evaluated these participants for a little over a year, with a particular focus on any changes in average “best-corrected visual acuity” — a measure of how clearly a person, when outfitted with optimal prescription lenses, can read the kind of standard eye chart found in an optometrist office. EyePoint has now revealed that, on that measure, across the trial’s full dataset, its drug didn’t prove “non-inferior” to aflibercept.
    • “The company largely blamed the failure on an “asymmetric cohort” of nine patients in the Durayvu-treated group, who had vision loss — or a dropoff of at least 15 letters on the eye exam — that was “unrelated to wet AMD.” According to EyePoint, an after-the-fact analysis found the drug would have achieved non-inferiority had that group been excluded.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente reported nearly $1.7 billion in operating income (4.6% operating margin) during the second quarter of 2026, a more than $600 million improvement over the same period in 2025. 
    • “The country’s largest nonprofit health system, in a quarterly financial update shared Friday that precedes its more granular regulatory filing, outlined $35.6 billion in operating revenues, a 10.9% year-over-year increase, and nearly $34 billion in operating expenses, a 9.3% year-over-year increase.
    • “Kaiser noted that its structure as a membership-based, premiums-collecting integrated health system typically yields stronger operating income in the first half of the calendar year “due to health plan enrollment cycles,” moderating later on “as care utilization, labor costs, and other expenses increase while revenue stays relatively flat.”
    • “The quarter’s performance follows an opening frame in which the organization’s $711 million operating income (2.1% operating margin) reflected a pullback from early 2025’s $932 million operating gain (2.9% operating margin), due in part to a major month-long work strike. Year to date, that still places Kaiser and its subsidiaries about $400 million ahead of 2025. 
    • “In today’s complex health care environment, positive operating performance helps us make care more affordable, invest in our future, and expand access to value-based care,” Kaiser Permanente Chair and CEO Greg A. Adams said in a statement. “Together, Kaiser Permanente and Risant Health are helping more people benefit from evidence-based, coordinated care that improves quality, enhances the patient experience, and makes high-quality care more accessible and affordable. I’m grateful to our employees and physicians for bringing our mission to life every day.”
  • Beckers Payer Issues relates,
    • “Blue Cross Blue Shield of Massachusetts earned $83.4 million in after-tax second-quarter profit. 
    • “This was made up of $35.7 million in operating and other income, as well as $47.7 million in investment income. The insurer’s revenue was $2.7 billion, marking a net margin of 3%. During the same period in 2025, BCBS Massachusetts had a $129.7 million loss on revenue of $2.6 billion.
    • “Since the beginning of the year, after-tax net income has been $142.9 million with revenue at $5.4 billion, a 2.7% net margin. The results include a premium deficiency reserve.
    • “After two consecutive years of record losses, we are also laser focused on restoring our company’s financial health,” Executive Vice President and CFO Ruby Kam said in an Aug. 14 news release. “We are doing this by carefully managing our own administrative costs and making necessary adjustments to our pricing and benefits.”
  • Healthcare Dive tells us,
    • “Universal Health Services has completed its $835 million acquisition of online therapy provider Talkspace, bolstering the for-profit system’s already extensive behavioral health offerings.
    • “The deal closed Monday five months following its announcement, after the companies secured necessary regulatory approvals.
    • “With the buy, UHS will be able to provide a full range of behavioral health services, including inpatient, intensive outpatient, partial hospitalization, therapy sessions and virtual assessments.”
  • Beckers Clinical Leadership adds,
    • “Salt Lake City-based Intermountain Health is approaching behavioral health access challenges by first addressing one quality concern in particular: whether patients are actually getting better.
    • “That’s the premise behind the health system’s push to embed measurement-based care across its behavioral health service line, Tammer Attallah, executive clinical director of Intermountain’s behavioral health clinical program, told Becker’s. The nonprofit system has locations in six primary states and additional operations across the western U.S., operating 34 hospitals and more than 400 clinics.
    • “We want more patients to get better faster. That’s all,” he said. “It’s as simple as that.” 
  • Beckers Physician Leadership informs us,
    • “Three physician leaders shared what they believe healthcare organizations and the system as a whole need to stop asking of physicians, pointing to burdensome technology, systemic dysfunction and workflows that pull clinicians away from patient care. 
    • “James Augustine, MD. Medical Director for Lee County EMS (Fort Myers, Fla.): Mandated use of very unfriendly computer systems, which don’t contribute to good practice.
    • “Peter Bravos, MD. Chief Medical Officer of Sutter Health’s Surgery Center Division (Yuba City, Calif.): Asking physicians to personally absorb systemic dysfunction and calling it resilience. When the schedule is broken, the staffing is thin, and the administrative load keeps climbing, a wellness webinar isn’t a solution. It’s a way of relocating a system’s problem onto the individual and then measuring the individual for how well they cope with it. Resilience was never meant to be a substitute for fixing the conditions that exhaust people. Build systems worthy of the people working in them, and resilience takes care of itself.
    • “Walter Allen Fink, DO. Associate Vice President and Chief Medical Officer UT Health San Antonio: We need to stop putting unnecessary things between physicians and the work they were educated and trained to do.
    • “Too much physician time is spent working around inefficient processes, navigating technology, dealing with fragmented workflows, and doing tasks that do not really require a physician’s expertise.
    • “For me, this is bigger than just reducing administrative burden. We should be designing systems that allow physicians to spend more of their time caring for patients, making complex clinical decisions, talking with patients and families, and improving care.”
  • Fierce Healthcare notes,
    • “Since April, more than 300 enterprise health systems have adopted Abridge’s artificial intelligence-based decision support solution, and the company is now making the tool available to every clinician at its partner health systems.
    • “It’s part of Abridge’s strategy to broadly expand from AI documentation to functioning as an enterprise AI assistant for clinicians.
    • “Adoption of decision support has outpaced anything we’ve shipped before because it feels like a natural extension of Abridge. It understands the context of the patient in front of the clinician, it’s grounded in the evidence they already trust, and it connects to what they want to do next,” Shiv Rao, M.D., CEO and co-founder of Abridge, and a practicing cardiologist, said in a statement.

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The House of Representatives Budget Committee lets us know,
    • “A new report from the Department of Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) finds reforms to Medicaid provider taxes and state-directed payments in The One Big Beautiful Bill will lower health care prices for Americans across the board.
    • “The report projects the reforms will reduce non-Medicaid health care prices by as much as 3.5 percent, generating between $502 billion and $875 billion in savings for taxpayers, families, and businesses over the next decade, with annual savings reaching $100 to $175 billion once the reforms are fully in place.
    • “The savings extend beyond Medicaid: ASPE estimates that every $100 billion in Medicaid savings produces another $29 billion in savings for Medicare and commercial coverage plans, which lowers health care costs and the tax burden for hardworking American families.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced that health systems represented by the past, current, and incoming chair of the American Hospital Association (AHA) have joined the Make Hospital Food Healthier Pledge, strengthening a nationwide effort to improve the quality of food served in America’s hospitals and reinforce the role of nutrition in patient care. Corewell Health in Michigan, Houston Methodist in Texas, and Sanford Health in South Dakota all signed onto the pledge.
    • “Hospitals cannot promote healing while serving food that contributes to chronic disease,” said HHS Secretary Robert F. Kennedy, Jr. “By joining this pledge, these health systems are putting nutrition where it belongs — at the center of patient care. We are working with hospitals across America to serve healthier food, improve patient health, and Make America Healthy Again.”
  • Fierce Healthcare reports,
    • “The Pharmaceutical Care Management Association announced Thursday that its members had reached an agreement with the feds to offer information on cash prices available through TrumpRx.
    • “The commitment encompasses nine of the industry’s leading pharmacy benefit managers, including the “Big Three” in CVS’ Caremark, UnitedHealth Group’s Optum Rx and Cigna’s Express Scripts. Other participants that have signed on include Elevance Health’s CarelonRx, Humana, MedImpact Healthcare Systems, Navitus Health Solutions, Prime Therapeutics, VtylOne and WellDyne.
    • “Members covered by these PBMs will be able to see costs for drugs purchased through TrumpRx when using their plan’s real-time benefit or other pricing tools, PCMA said.”
  • McKnight’s Homecare relates,
    • “In a new memo outlining the National Fraud Enforcement Division’s enforcement priorities in a variety of industries, the Department of Justice called out home health and hospice fraud as an area of focus in the healthcare sector.
    • “National healthcare expenditures are expected to grow from over $3 trillion a year to over $7 trillion, and estimates are that between 3–10% of that amount is lost to fraud,” the Aug. 13 memo from Colin M. McDonald, assistant attorney general, said. “Home health aide and hospice scams directly impact vulnerable elderly Americans and erode patient care.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Aug. 14 released a request for comments through the Office of the National Coordinator for Health IT on a proposed three-year generic clearance to collect routine customer feedback on service delivery and performance related to the Trusted Exchange Framework and Common Agreement. TEFCA is a nationwide network for health information sharing established by ONC to fulfill mandates under the 21st Century Cures Act. HHS said data collection under the clearance would be used to standardize monitoring and performance reports for TEFCA participants. Comments are due 30 days following publication in the Federal Register.”

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

  • Govexec reports,
    • “Federal wildland firefighters will soon have more opportunities to receive hazard pay in connection with their work fighting and preventing wildfires, thanks to newly finalized regulations from the Office of Personnel Management.
    • “Currently, federal firefighters are eligible for hazard pay—a 25% increase over their normal salary—only when working to extinguish an unplanned wildfire. But they do not receive this increased pay when working on prescribed burns, in which officials intentionally ignite decaying forest material in the hopes of mitigating the risk of an uncontrolled wildfire breaking out in the future.
    • “In a new rule published in the Federal Register Friday, OPM finalized its April proposal to expand firefighters’ access to hazard pay to include prescribed burns, effective Sept. 13. The regulation authorizes hazardous duty pay for prescribed burns for firefighters hired under the “General Schedule pay sale, as well as environmental differential pay for those serving under the Federal Wage System.
    • “But OPM noted that the new hazard pay will not be available for every activity associated with a prescribed burn.
  • Also in today’s Federal Register, OPM issued a new direct final rule. Here is the summary and comment information:
    • SUMMARY: Pursuant to the President’s direction in Executive Order 14410, Implementing Schedule Policy/Career in the Excepted Service, the Office of Personnel Management (OPM) is issuing a direct final rule to update and amend obsolete and outdated provisions of the
    • Civil Service Rules that do not substantively affect agency operations.
    • DATES: This rule is effective October 13, 2026, unless significant adverse comments are received by September 14, 2026. If significant adverse comments are received, OPM will withdraw the relevant provisions of this direct final rule.
  • Federal News Network relates,
    • “Retirement is supposed to be the payoff for decades of saving, planning and serving the federal government. But for some federal employees, the first year of retirement can bring surprises they never saw coming, whether that be a delayed pension, a tax bill that looks very different from what they expected, anxiety about spending the money they’ve saved for decades, and decisions that can affect a spouse’s benefits for years to come.
    • “On this episode of Fed Thread [which the article summarizes], we called back our three financial professionals—James Campbell of Federal Employees Benefit Association, Katelyn Murray of RJFS and Serving Those Who Serve, and Chris Campbell of CJC Wealth Management and the DC Society for Financial Awareness—to talk through the financial and psychological traps feds may encounter before or after their last day. Because retirement isn’t just the day your paycheck stops. It’s the beginning of a completely different financial system.”

From the Food and Drug Administration front,

  • The Washington Post informs us,
    • “About 1.5 million dozen white and brown cage-free eggs recalled for potential salmonella contamination have been upgraded to the U.S. Food and Drug Administration’s highest-risk warning. 
    • “The agency reclassified the recall of Midwest Poultry Services eggs to Class I due to the reasonable possibility that exposure to the product would cause serious health issues or death, it said in a safety alert. 
    • “Salmonella is a bacteria that can cause diarrhea, vomiting, fever and stomach pain.
    • “The eggs were available to consumers in Brookshire Grocery stores in Texas, Louisiana, Oklahoma, Arkansas, New Mexico and Mississippi. Other locations include Kroger stores in Texas and Louisiana, as well as other small retail outlets, the FDA said.”
  • The UPI reports,
    • “U.S. health officials said they have begun inspections at the Mexican processing plant of the U.S. food distributor Taylor Farms as they deal with a continuing cyclosporiasis outbreak that has spread across 17 states.
    • “The Food and Drug Administration and the Centers for Disease Control and Prevention announced Thursday they have “initiated an onsite inspection and sampling” at Taylor Farms de Mexico’s facility in Guanajuato, Mexico, located about 185 miles northwest of Mexico City.”
  • The University of Minnesota’s CIDRA adds,
    • “The best-if-used-by dates of recalled iceberg lettuce associated with the massive Cyclospora outbreak have passed, according to an update from the US Food and Drug Administration (FDA) yesterday. This means that Cyclospora-tainted Taylor Farms lettuce should no longer be available at stores and restaurants.” 
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new brain imaging agent targeted toward Alzheimer’s, drugmaker Lantheus announced Friday. 
    • “Tauklarify, also known as MK-6240, is a radiodiagnostic agent indicated for PET (positron emission tomography) imaging of adults. Ideal candidates have cognitive impairment, with physicians evaluating them for abnormal buildup of tau—twisted, insoluble protein fibers in brain cells—a potential sign of the neurodegenerative disease. 
    • “Bedford, Massachusetts-based Lantheus—which recently reached a deal to be sold to rival Curius for $8 billion—said the drug’s safety was tested in two clinical trials. Across over 1,700 subjects, researchers reported strong results, with only about less than 1% of subjects experiencing adverse reactions.”

No Surprises Act News

  • The Centers for Medicare and Medicaid Service posted a notice today (Dropbox link) about implementation of changes to the Independent Dispute Resolution Gateway required by a recent final rule.
    • “Organizations and individuals thatprocess disputes, represent parties, or submit IDR web forms in the current Federal IDR process must sign up to manage disputes in the IDR Gateway. If a party uses a third-party administrator or another organization to process disputes, the party does notneed to sign up for the IDR Gateway but must ensure the third-party administrator or organization responsible for managing dispute processing activities signs up for an IDR Gateway account.
    • “Details about signing up for the IDR Gateway are coming soon. Until then, continue using the Federal IDR web.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “Luigi Mangione, whose coldblooded killing of an insurance executive on a Manhattan sidewalk rattled the nation and struck fear into Corporate America, pleaded guilty Friday to two federal stalking charges in the death of UnitedHealthcare leader Brian Thompson.
    • “On the morning of Dec. 4, 2024, I shot Mr. Thompson in Manhattan and he died,” Mangione solemnly told the judge during a court hearing.
    • “Mangione, wearing tan jail garb, told the judge that he spent years enduring severe pain, including a broken back, and witnessed others with similar experiences. He said that after learning of an investor conference, he emailed UnitedHealthcare, posing as an investor at a firm managing over $50 million in assets, to request information about it.
    • “Unlike my previous interactions with insurers, I received an immediate response within an hour,” Mangione added. He said he made part of a gun using a 3-D printer and planned the killing.
    • “U.S. District Judge Margaret Garnett said Mangione faces up to life in prison at his sentencing, which she set for December. Jamie McDonald, the U.S. attorney for the Southern District of New York, said after Friday’s hearing that his office intended to seek the maximum penalty, saying Mangione committed the crime in order to “draw public attention to his dislike of certain businesses.” 
    • “No grievance, political belief or ideological cause can ever justify murder,” McDonald said. “There can be no celebrity in assassination.”
  • FEHBlog observation: Well put observation, Mr. McDonald.
  • Healthcare Dive tells us,
    • “A patient advocacy group is going up against the most powerful doctor’s association in the U.S. in a bid to wrest away its ownership of U.S. medical codes and release them into the public domain.
    • “On Thursday, PatientRightsAdvocate.org sued the American Medical Association, challenging its copyright over the current procedural terminology, or CPT, billing code system, which shapes billions of dollars in healthcare payments every year.
    • “The goal of the lawsuit is to get the codes published online and let the public access them for free, the group, which lobbies for better price transparency in healthcare, said. Currently, the AMA charges licensing fees to retrieve and use CPT codes.”
  • FEHBlog observation — It’s no problem looking up CPT Codes on the internet.

From the public healh and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 14, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 101 newly confirmed measles cases nationwide, the US total has now reached 2,566 this year, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
    • “This is the second straight week of about 100 new cases after previous weeks’ totals of about half that. Most this week’s cases are in Pennsylvania, though Ohio also saw a substantial increase. 
    • “The CDC noted 38 outbreaks, the same as last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level several weeks ago. 
    • “All but 16 of this year’s cases have been locally acquired, with the rest tied to international travel.
    • “Of the 2026 cases, 19% involve children age 5 and under, and 67% involve kids and teens. Seven percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status.”
  • and
    • “A pair of new studies confirm that recently developed immunizations against respiratory syncytial virus (RSV) protect infants in their first year of life. 
    • “The research, including one study conducted in France and another in the United Kingdom, confirm that the immunizations are effective in the real world, not just in carefully supervised clinical trials”
  • MedPage Today relates,
    • “By this time of year, both the FDA and CDC normally have weighed in on fall respiratory virus vaccine recommendations. But given ongoing controversies over vaccination spurred by the Trump administration, a wrench has once again been thrown into the gears of that process.
    • “The FDA has done its part, making recommendations about vaccine composition for influenza vaccines in March, followed by recommendations for COVID shots in May. But the CDC’s Advisory Committee on Immunization Practices (ACIP) hasn’t done its part as it hasn’t held its March or June meetings this year.” * * *
    • But clinicians shouldn’t worry, because medical groups have stepped in to fill the gaps. The IDSA, the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians (AAFP) have issued guidance on fall respiratory virus shots and more, as the Trump administration has also tried to make significant changes to the pediatric immunization schedule.
    • At the same time, insurers have pledged to cover all recommended vaccines without cost-sharing through the end of 2027, Richard Hughes IV, MPH, legal counsel for AAP, said in an email in June.
    • “There are some shades of gray, however, as the FDA approved the first mRNA flu shot (mFlusiva) from Moderna earlier this month. While the company has said its shot — approved for adults 50 and up — should be available for the upcoming 2026-2027 season, it’s unclear whether it will be written into recommendations.”
  • and
    • “GLP-1 agonists and bariatric surgery are top obesity treatments, raising questions of their combined efficacy.
    • “A retrospective study found that patients taking GLP-1 drugs before surgery achieved similar 12-month weight loss as non-users (24% vs 25%).
    • “Treatment groups had comparable outcomes on surgical complications and diabetes control.”
  • Health Exec informs us,
    • “Right now U.S. healthcare has almost everything it needs to eliminate one awful affliction—and then to adapt the resulting victory for going after many others.  
    • “All it would take to set the precedent is responsible AI deployment, attuned government leadership, cross-sector partnerships and generational investments.  
    • “That, and an orchestrated targeting of the low-hanging fruit at hand—cervical cancer.  
    • “The cure-in-waiting for this maddeningly preventable cancer represents a “breakthrough with a failure to follow through,” physician-researchers explain in an article published Aug. 13 in JAMA.  
    • “Erstwhile Surgeon General Special Advisor Adam Beckman, MD, MBA, and co-author Dave Chokshi, MD, MSc, believe cervical cancer is a prime candidate for first dibs because of its 90%-plus early-stage survival rate on top of the near-perfect efficacy of vaccines for human papillomavirus (HPV), which causes many if not most cervical cancers. 
    • “All that’s lacking is the will to “bridge the stubborn gap between what we know and what we do in public health and healthcare,” the researchers write.”
  • Health Day points out,
    • “Taking the stairs instead of the elevator may do more for your health than you think.
    • “A large study published in the American Journal of Cardiovascular Drugs found people who regularly climbed the stairs were 39% less likely to die from cardiovascular disease. And 24% less likely to die from any cause. Their odds of heart attack, stroke and heart failure were also lower.
    • “Taking the stairs is a practical and often overlooked way to build physical activity into daily life,” said senior author Dr. Vassilios Vassiliou, a professor of cardiac medicine at Norwich Medical School at the University of East Anglia in the U.K. “We wanted to better understand how this everyday activity could have life-saving potential.”
  • and
    • “Gambling is a powerful temptation for today’s college students, and those hooked have a greater risk of deeper mental health issues, a new study says.
    • “Student gambling frequently occurs alongside depression, anxiety and substance use, researchers reported recently in the International Journal of Mental Health and Addiction.
    • “What’s interesting about this study is even though mental health concerns were very prominent, students who tended to gamble more were more likely to be experiencing greater levels of problems among a sample that was already experiencing plenty,” said lead researcher Nicholas McAfee, director of the William Magee Center for AOD and Wellness Education at the University of Mississippi.
    • “Gambling is a real concern for college students, given the proliferation of online betting and prediction markets in the United States, researchers said in background notes.”

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

  • The International Foundation of Employee Benefit Plans reports,
    • “U.S. employers project a median health care cost increase of 10% for 2027, according to Health Care Costs Pulse Survey: 2027 Cost Trend, a new survey from the International Foundation of Employee Benefit Plans. A similar International Foundation survey conducted in 2025 also projected a 10% increase for 2026.” 
  • Healthcare Dive adds,
    • “Nearly 4 in 5 U.S. adults said either high insurance premiums or out-of-pocket spending were the most important problem in the healthcare system, according to a Commonwealth Fund survey released Thursday. 
    • “Affordability concerns crossed party and coverage lines. Premiums were the top problem for 45% of Republicans, 44% of Democrats and 42% of independents, while more than 8 in 10 adults with employer, individual or marketplace coverage — as well as uninsured adults — said either premiums or out-of-pocket costs were the biggest issue.
    • “Still, according to the survey, Americans are split over who’s best to tackle the problem. Most respondents said the federal government is best suited to solve high healthcare prices, while Republicans were more likely to say insurance companies were best to address the issue.”
  • FEHBlog observation — Consumers pay insurance premiums and cost sharing but evidently fail to understand that those costs are driven by hospital, doctors and pharmacy charges.
  • In that regards, The Washington Post relates,
    • Prescription drug prices recorded the biggest year-over-year drop in more than 60 years in July, a startling reduction experts chalked up to an array of factors, including more generics and discount GLP-1 weight-loss drugs. 
    • While overall costs for medical services continued to rise, prices for medicinal drugs fell 2.7 percent over the 12 months ending in July, the largest annual drop on record, according to Bureau of Labor Statistics data released Wednesday. Prescription drugs, part of the medicinal drug category, fell by 3.1 percent, the steepest annual decline since March 1963.
  • EBRI calls to our attention,
    • “Plan sponsors that wish to introduce or continue offering health savings account (HSA)-eligible health plans as part of their workplace benefit program can benefit from a long-term view of HSA accountholder behaviors. As such, the Employee Benefit Research Institute (EBRI) has undertaken a series of longitudinal studies from its HSA Database, examining trends in account balances, individual and employer contributions, distributions, invested assets, and account-owner characteristics from 2011‒2024. Such analysis can help plan sponsors, providers, and policymakers better understand strategies that can help improve employee financial wellness.”
    • “HSAs offer a triple tax advantage to accountholders, enabling them to stretch money they save for health care expenses further than they otherwise could. The tax benefits of HSAs are maximized when accountholders contribute the statutory maximum and minimize withdrawals for current medical expenditures — if they are able — and invest their HSA balances in assets other than cash. However, the majority of accountholders appear to use their HSAs to pay for current expenses and do not take complete advantage of the tax benefits HSAs offer. Average contributions are well below the statutory maximum, most accountholders take a distribution from their HSA, and relatively few accountholders invest. We do find that as time goes on, accountholders tend to take fuller advantage of the benefits HSAs offer. And, despite out-of-pocket spending on health care rising by 5.9 percent in 2024, average balances in HSAs increased, rising from $4,747 in the prior year to $5,532. Further, the share of accountholders who invest their HSAs has crept steadily upward since EBRI began analyzing its HSA Database, reaching 18 percent in 2024.”
  • Beckers Hospital Review tells us,
    • “Providence Health Plan will completely shut down after it was unable to reach a deal with a national insurer to operate its Medicare Advantage business.
    • “We are in discussion with regulators about this development and the broader wind-down of Providence’s health plan operations,” a spokesperson for the system told Becker’s. “We will share more details with our members and the public as we are able under applicable regulations.”
    • “In May, the Renton, Wash.-based health system said it would shutter most of its insurance business beginning in 2027 after operating more than 40 years as a regional payer and serving more than 440,000 members. 
    • “At the time, President and CEO Erik Wexler said state and federal regulations and consolidation among large insurers had left Providence “in an untenable situation” and unable to continue operating the health plan.”
  • and
    • “Cleveland Clinic recorded operating income of $245.6 million (5% operating margin) during the second quarter of 2026, down from operating income of $255.3 million (5.6% margin) during the same period last year, according to its Aug. 14 financial report.”
  • and
    • “New Orleans-based Ochsner Health recorded operating income of $32.5 million (0.8% operating margin) in the first half of 2026, up from an operating loss of $42.7 million (-1.1% margin) during the same period last year, according to its Aug. 13 financial report.” 
  • Beckers Physician Leadership points out,
    • “Hollywood, Fla.-based DermCare Management and Dallas-based U.S. Dermatology Partners have partnered to form one of the largest dermatology groups in the U.S. 
    • “The combined company will expand patient access, preserve physician autonomy, support national dermatology clinical trials, improve practice management support and unify culture, according to an Aug. 13 news release from DermCare Management. 
    • “DermCare Management partners with more than 270 dermatology practices, and U.S. Dermatology Partners supports a network of more than 120 locations across nine states.” 

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.”

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • The Senate remains in session this evening while it considers Senator Susan Collins substitute amendment #6732 to H.R.6500, the Senate’s legislative vehicle for a Continuing Resolution to fund the federal goverment from October 1, 2026, through December 11, 2026.
  • Roll Call adds,
    • “Sen. Bill Cassidy of Louisiana said Friday he intended to vote to confirm Todd Blanche to be attorney general, ending a weekslong back-and-forth with the White House to win over GOP holdouts.
    • “All eyes were on Cassidy’s Friday morning floor speech after his fellow Republican Sens. Susan Collins of Maine and Lisa Murkowski of Alaska announced they would vote against Blanche, citing myriad concerns such as the Epstein files, the so-called “anti-weaponization” fund and questions of his independence.
    • “With Sen. Mitch McConnell, R-Ky., still absent after a hospitalization, Senate Republicans could afford to lose only two votes in their ranks if all Democrats vote against Blanche. Had Cassidy not supported Blanche, Majority Leader John Thune, R-S.D., would lack the votes to confirm him before the August recess. Now he can move ahead and hold a final vote on the Senate floor.”
  • and
    • “A bipartisan bill aimed at combating hepatitis C is stalled in the Senate due to a high score from the Congressional Budget Office, the bill’s lead sponsor Bill Cassidy, R-La., said on Thursday.
    • “The bill, co-sponsored by Sen Chris Van Hollen, D-Md., proposes a national strategy to reduce hepatitis C infections by providing free medications and expanding testing for high-risk and vulnerable groups.
    • “Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee, is a former liver doctor who spent much of his career treating the disease and has said getting this bill across the finish line is a priority before he leaves Congress in January. But the measure has not advanced since its introduction in June 2025, despite bipartisan interest.
    • “There was a score on it that was a disappointing score, but there’s at least some conversations taking place by some with the CBO to get that re-scored,” Cassidy said Thursday afternoon.
    • “Cassidy’s office would not provide the exact figure for the bill’s estimated cost but did say it was higher than a related CBO estimate last Congress.”
  • Govexec points out, “The Senate on Friday confirmed in a 51-47 party-line vote multiple executive branch nominees, including several involved in government oversight and federal employee matters.” 
  • Per an August 5, 2026, AHIMA news release,
    • “AHIMA, a founding member of the Patient ID Now coalition, applauds the Senate introduction of the Patient Matching and Transparency in Certified Health IT (MATCH IT) Act of 2026 by Senators Mark Warner (D-VA) and Jim Banks (R-IN), a companion bill to H.R.2002 introduced in the US House of Representatives by Representatives Mike Kelly (R-PA) and Bill Foster (D-IL).
    • “The MATCH IT Act addresses the problem of patient misidentification within the healthcare ecosystem. The bill would create an industry standard definition for how patient match rates are measured and would improve standardization of patients’ demographic elements entered into certified health IT products to ensure patients are accurately matched with the correct medical record.”
  • FEHBlog observation: Congress should pass this bill.
  • Per an August 6, 2026, White House news release,
    • President Donald J. Trump and Vice President JD Vance are waging war on the fraudsters and scammers who have looted hardworking Americans for far too long.
    • Today, that war becomes fully transparent at fraud.gov — a new website where Americans can track every action, every takedown, and every dollar recovered as part of the unrelenting effort.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Aug. 7 released a procedural notice on its new pathway to expedite access to certain Food and Drug Administration-designated Class II and Class III devices for Medicare beneficiaries. The Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, is designed to reduce delays between FDA market authorization and Medicare national coverage determinations. CMS is accepting comments on the procedural notice for 60 days following publication in the Federal Register.”
  • Beckers Hospital Review reports,
    • “The U.S. economy lost 23,000 jobs in July, but healthcare kept adding positions, according to the Aug. 7 jobs report from the U.S. Bureau of Labor Statistics.
    • “Here are [three] things to know from the July jobs report:
      • 1. Healthcare employment continued its upward trend in July, adding 22,000 jobs, though that marked a slower pace than the average monthly gain of 36,000 over the prior 12 months.
      • 2. Hospitals were essentially flat in July, dipping by about 400 jobs after adding roughly 9,500 in June. 
      • 3. Ambulatory healthcare services drove most of the sector’s gains, adding 18,100 jobs, including 4,200 in offices of physicians and 4,600 in home health care services. Nursing and residential care facilities added 4,300 jobs. 
  • Per an August 7, 2026, U.S. Postal Service news release,
    • “The U.S. Postal Service today announced its financial results for the third quarter of fiscal year 2026 (Apr. 1, 2026 – Jun. 30, 2026). Controllable loss, which excludes certain expenses that are not controllable by management, was $1.0 billion for the quarter, compared to controllable loss of $1.6 billion for the same quarter last year.
    • “Net loss for the quarter under generally accepted accounting principles (GAAP) totaled $2.5 billion, compared to $3.1 billion for the same quarter last year. This $562 million decrease is attributed to an operating revenue increase of $1.1 billion along with a decrease in workers’ compensation of $416 million. These are partially offset by increases in retirement benefits of $324 million, retiree health benefits of $195 million, and compensation and benefits of $129 million.
    • “Our results this quarter reflect some progress relative to those areas of the business where we can exercise control, namely with revenue generation, cost control and service improvement,” said Postmaster General David Steiner. “Nevertheless, the Postal Service is today continuing to face a severe liquidity crisis, and our financial losses this quarter reflect systemic challenges inherent in our Congressionally established business model and regulatory framework. We are taking responsible steps to conserve cash to extend our operating window, but we require thoughtful legislative and other actions to establish a financially sustainable Postal Service capable of serving the American public far into the future.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “A Food and Drug Administration advisory committee meeting is scheduled for September to evaluate data for Grail’s Galleri multicancer early detection blood test.
    • “Grail launched Galleri as a laboratory developed test in 2021. Designed to detect signals from multiple cancers using a single blood sample, the MCED test hit a setback in February when a clinical trial missed its primary endpoint.
    • “CEO Josh Ofman told analysts on an earnings call this week that Grail continues to expect Galleri to receive FDA approval in the first part of 2027.”
  • Targeted Oncology tells us,
    • “The FDA has granted fast track designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of advanced platinum-resistant ovarian cancer in combination with pembrolizumab (Keytruda), according to a news release from BioInvent International AB.”
  • Fierce Pharma informs us,
    • “Fresenius Kabi voluntarily recalled one lot of morphine sulfate injection due to a labeling mix-up with prefilled syringes of the opioid dilaudid that could trigger an overdose resulting in severe respiratory distress or death.
    • “The recall, issued in a letter dated Aug. 4 and posted to the FDA website, is for a single lot of morphine sulfate marketed as Simplist 2 mg/1 ml that was mislabeled and could contain a prefilled syringe of dilaudid 0.5 mg/0.5 ml.”

No Surprises Act News,

  • The American Hospital Association News reports,
    • “Guidance on the implementation timeline for the No Surprises Act independent dispute resolution operations final rule was released Aug. 7 by the Departments of Labor, Health and Human Services, and the Treasury, along with the Office of Personnel Management. The final rule, issued May 28, was designed to streamline communication between group health plans and health insurance issuers, providers and certified IDR entities, while clarifying timelines and processes. The guidance includes details on applicability dates of certain provisions associated with the final rule, including the stand-alone claim adjustment reason codes and remittance advice remark codes guidance.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 7, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association reports,
    • “A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study found that reactivation is correlated with the severity of the COVID-19 infection. The study included data from more than 1,100 hospitalized patients with COVID-19 and found reactivation of various Herpesviridae and Anelloviridae viruses. Researchers said that reactivation occurred frequently in “immunocompetent” individuals during severe illness.”
  • The University of Minnesota CIDRAP relates,
    • “Working-age adults living with long COVID feel less satisfied with life, experience less happiness, and have less hope, according to a study published this week in BMC Public Health. The paper highlights the association between having long COVID and poorer wellbeing. 
    • “The findings underscore that the burden of long COVID extends beyond clinical health outcomes to encompass how individuals evaluate and experience their lives,” wrote the authors, from Syracuse University in New York.
    • “Long COVID symptoms were significantly associated with lower levels of subjective wellbeing in a dose-dependent manner.”  
    • “The World Health Organization defines long COVID “as the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 94 new measles infections—most of them in Pennsylvania—bringing the US total for the year to 2,465, the agency said in its weekly update.
    • “The numbers likely provide additional data to move the United States toward losing its measles elimination status this year. The nation gained that distinction in 2000, but  has now logged consecutive years of more than 2,200 measles cases (2,289 for all of last year). This year’s total is the highest since 1991.”
  • The Washington Post tells us,
    • “Michigan health officials say new cases of cyclosporiasis are declining in the state hit hardest by an outbreak that has sickened more than 12,000 people and left two dead in the state since June. 
    • “The state’s health department said new case reports are slowing and diarrhea-related emergency department visits are trending downward. The drop in cases prompted officials to lift their broad recommendation to avoid bagged salad mixes. But Michigan continues to recommend avoiding recalled lettuce from Taylor Farms de Mexico sourced from central Mexico.
    • “Michigan officials said they believe most of their exposures took place in late June to early July and that most contaminated produce is probably no longer available for consumption.
    • “Cyclospora infections typically cause symptoms about seven days after exposure, although symptoms can take up to 14 days to appear. The health department said residents can now return to routine food-safety guidance for handling and consuming produce, including lettuce and salad greens.”
  • The AP informs us,
    • “In the past year, the U.S. has seen a jump in frequent marijuana users going to the hospital with a nausea and vomiting condition, according to a report released Thursday.
    • “The abruptness and sustained magnitude of the increase” is largely due to the condition getting its own diagnosis code last fall, which is providing a more accurate picture of what was an underrecognized problem, the authors of the U.S. Centers for Disease Control and Prevention report wrote.
    • “Hospital emergency room diagnoses of the condition, cannabis hyperemesis syndrome, rose 16% from last October to May of this year, federal researchers found.
    • “The syndrome — seen in people who frequently use marijuana, especially smokers — is characterized by recurring nausea, uncontrollable vomiting and excruciating abdominal pain.
    • “Past research has suggested that an estimated 2.75 million Americans suffer from it each year, and that hospital emergency room visits have been rising as daily recreational marijuana use has increased.”
  • MedPage Today points out,
    • “Maintaining three key health factors during midlife — normal blood pressure, no diabetes, and not smoking — was associated with nearly 13 additional dementia-free years, a study of 12,000 people in the U.S. showed.
    • “Individuals who met these criteria at age 55 lived an average 30.1 more years dementia-free, reported Josef Coresh, MD, PhD, of NYU Langone Health in New York City, and co-authors.
    • “Conversely, those who smoked, had hypertension, and had diabetes at age 55 had dementia-free survival of only 17.5 years, Coresh and colleagues wrote in Neurology Open Accessopens in a new tab or window.”
  • and
    • “Low-fat vegan diets can help aid in weight loss, but the mechanisms behind this have been unclear.
    • “Adults on a low-fat vegan diet reduced dietary energy density by 30% compared with controls in a secondary analysis of a randomized trial.
    • “Reductions in dietary energy density were significantly associated with greater weight loss after adjusting for overall energy intake.”
  • Medscape adds,
    • “Adding coronary artery calcium (CAC) scoring to risk estimates helped better identify adults at lower and higher risk for atherosclerotic cardiovascular disease (ASCVD) events. People with no detectable CAC had lower observed risk, while those with CAC had higher observed risk, especially when the decision about starting a statin was uncertain.”
  • Healio notes,
    • “Adults with type 2 diabetes and established CVD had lower risk for CV events with tirzepatide [a/k/a Zepbound] compared with sitagliptin [a/k/a Januvia].
    • “Tirzepatide decreased risk for infections leading to hospital admission.
  • Per Genetic Engineering and Biotechnology News,
    • “For people with severe food allergies, avoiding a trigger food like peanuts or tree nuts can mean constant vigilance. Approximately 8% of children and 10.8% of adults in the United States experience some type of food allergy. Even trace exposures can provoke reactions, and while oral immunotherapy can raise the threshold for some patients, the protection often depends on continued treatment and is associated with disease relapse in many patients. A new study suggests that another route to food tolerance may run through the gut microbiome.
    • “In a small Phase I open-label trial (NCT02960074), researchers at Boston Children’s Hospital tested whether oral encapsulated fecal microbiome transplantation (FMT) could safely increase peanut tolerance in adults with peanut allergy. The work, published in Science Translational Medicine, also used mouse models to probe how donor gut microbes might help restore oral tolerance. The study is titled, “Fecal microbiome transplant in food allergy in humans and mice identifies a role for bile acid metabolites in oral tolerance.”
  • The Wall Street Journal adds,
    • “Artificial-intelligence systems have been displaying some eye-opening new abilities in recent weeks: breaking out of their enclosures, hacking other companies, lying to people. 
    • “And now, for the first time, an AI model has created a new virus. A whole family of them, in fact. 
    • “In a study published in the journal Science, researchers at Stanford University and elsewhere said they successfully directed an AI model to create a collection of simple viruses that only infect bacteria and pose no threat to humans.
    • “In an interview, two of the authors said their research could help develop designer viruses that could be used to eliminate drug-resistant bacteria, which according to the World Health Organization kill millions of people every year.
    • “If we develop responsibly, I think it can lead to tremendous benefits in human health,” said Brian Hie, a computational biologist at Stanford and an author of the study.”

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

  • Fierce Healthcare reports, “Insurers see positive results in managing health costs in Q2.”
    • “The health insurance industry weathered a rough 2025, and the turnaround for some companies through the midpoint has surprised even Wall Street analysts.”
  • Beckers Payer Issues adds,
    • “Clover Health posted a $28 million profit for the second quarter of 2026, according to a recent earnings filing.
    • “During the same period last year, Clover logged a $10.6 million loss. The company had its first profitable quarter in 2024.
    • “Total revenue for the second quarter of 2026 was $743.2 million, up nearly 56% year over year. The company attributed the improved results to membership growth and a disciplined approach to administrative spend.
    • “On June 30, Clover had 157,309 members. The company’s benefit-expense ratio dipped to 87.6% this past quarter from 88.4% during the same time in 2025.”
  • and
    • “CVS Health’s pharmacy benefit manager, CVS Caremark, is bringing on Keith Reynolds as chief growth officer.
    • “Chief Sales Officer Jim Fowler will transition into retirement, according to an Aug. 7 LinkedIn post from Mr. Reynolds.” 
  • Beckers Hospital Review relates,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • [The article identifies] 52 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1
  • Health Exec adds,
    • “When a nursing home closes down, the local population and press often perceive the move as a simple exit from the market due to failing fiscal health. But in about half the cases, additional forces are in play—and “closures” may be, in truth, do-overs of one kind or another. 
    • “Researchers at the University of Massachusetts fill out the picture with facts in a study published July 31 by JAMA Health Forum.
    • “Joohyun Chung, PhD, RN, and colleagues suggest understanding the dynamics behind nursing-home closings is important because such events can disrupt continuity of care, place additional burdens on remaining facilities and disproportionately affect vulnerable populations.” 
  • Fierce Pharma tells us,
    • “Injected weight loss drugs remain favored over newer oral treatments by a significant margin, with Eli Lilly’s Zepbound leading the pack, according to a survey of healthcare specialists by Spherix Global Insights.
    • “In the poll, which includes input from 185 specialists in the United States, 80% were highly satisfied with Zepbound, compared with 59% for Novo Nordisk’s rival injectable, Wegovy. Though it remains early in the launches of Novo’s oral version of Wegovy and Lilly’s GLP-1 pill Foundayo, 48% and 47% of those surveyed were highly satisfied with the newer products, respectively.”
  • and 
    • “Prescriptions for Eli Lilly’s Foundayo continue to build, jumping 16% sequentially to 34,219 the previous week, according to IQVIA data cited by Citi. The oral GLP-1 med has been on a roll lately as it appears to celebrate four weeks of consecutive growth in total scripts. However, as Citi noted, there’s still a potential gap in IQVIA’s capture of telehealth data, and it’s not clear how much of the scripts growth was from IQVIA getting better at including those data, or, if the actual growth was much faster in telehealth channels.
    • “This week, Lilly’s reported Foundayo sales for the second quarter—$98 million in total, including $67 million in the U.S.—disappointed many. As CEO David Ricks noted on an earnings call, Lilly began broad direct-to-consumer marketing to raise consumer awareness after securing commercial access across the three major pharmacy benefit managers in June. Besides, The Medicare GLP-1 Bridge program went live on July 1, offering coverage for certain weight-loss medications, including Foundayo, for a $50 copayment per month. Ilya Yuffa, president of Lilly USA and global customer capabilities, said the company is “starting to see an inflection point on Foundayo now.”
    • “As for Novo Nordisk’s Wegovy pill, total scripts recorded by IQVIA have been largely flat with small upticks in the past two weeks, having reached roughly 172K in the previous week. The oral version of semaglutide now makes up 35% of total Wegovy scripts, which take up about 40.6% of the U.S. obesity market share, as Lilly’s Zepbound remains the leader.” 
  • Fierce Healthcare informs us,
    • “Despite the rapid implementation of artificial intelligence solutions across the healthcare industry, many organizations are still working on establishing necessary infrastructures and governance foundations, a new report from UPMC’s Center for Connected Medicine and KLAS Research found.
    • “Ninety-three percent of respondents report that their organizations deploy third-party AI solutions, though only 44% have a dedicated data platform or environment for tool testing. But 92% of respondents report testing third-party tools prior to deployment.
    • “What’s emerging from this research is a clear recognition that implementation is only the first step,” said Rob Bart, M.D., UPMC chief medical officer, in a statement. “Health systems are now focused on building the governance structures, testing capabilities and organizational strategies necessary to ensure AI delivers meaningful and measurable value.”
    • “The “Validation and Trust: The Governance of AI Solutions at Health Systems” report drew insights from 27 healthcare leaders, including those from health systems and ambulatory care organizations.” 
  • Healio adds,
    • “Many patients report high comfort with health systems using AI-written portal messages, noting it gets them information quickly and reduces clinician workload.
    • “Their comfort comes with caveats, though. Patients want both clinician oversight and transparency that AI is being used.”

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.”

Tuesday report

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

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the public health and medical/Rx research front,

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

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

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

Monday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Friday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “The timeline is slipping for senators to strike a bipartisan deal on a short-term funding patch before their August recess as leadership struggles to work out the finer details.
    • “Senior appropriators had been hopeful of unveiling text before the weekend for a stopgap measure expected to keep the government funded into early December. But sources say leaders are now more likely to release text later this weekend or early next week amid snags over a federal grant rule and other add-ons.
    • “The Trump administration’s proposed rule would give senior political appointees greater influence over the grant approval process and has drawn pushback from appropriators on both sides of the aisle.
    • “Senate Appropriations Chair Susan Collins, R-Maine, noted Thursday that the rule has drawn considerable criticism from “a wide range of groups.”
    • “So, I hope we’ll take advantage of this opportunity to delay it,” she said. “But that’s up to the leadership. It’s obviously not a funding issue.”
    • “The grants dispute is among the last-minute hitches and “anomalies” that negotiators have said leadership is sorting through as senators aim for floor consideration next week.
    • “The Senate is currently scheduled to take a procedural vote Monday on the legislative vehicle for the continuing resolution that is needed to stave off a partial government shutdown on Oct. 1, when the new fiscal year begins.
    • “The House has already passed a Republican-crafted stopgap bill to extend current funding through Dec. 4. But senators say further “anomalies,” or deviations from current spending, are needed, noting the gap between add-ons requested by the White House and the House GOP’s bare-bones funding patch.”
  • Bloomberg Law relates,
    • “The Trump administration will increase Medicare payments for hospital services by 2.3%, or $2.1 billion in fiscal year 2027, according to a final rule released Friday.
    • “The final rule (RIN 0938-AV79) from the Centers for Medicare & Medicaid Services also includes a 2.2% reimbursement bump of $54 million for long-term care hospitals, along with several new hospital quality reporting measures.
    • “These include the adoption of quality measures for diabetes, deep vein thrombosis/pulmonary embolisms, quality care planning, and mortality rates. 
    • “The final rule also expands the agency’s Comprehensive Care for Joint Replacement (CJR) Model, which holds hospitals financially accountable for the quality and cost of hip, knee, and ankle replacements, through incentive payments
    • “The agency says the program has produced strong evidence of cost savings while maintaining quality of care. 
    • “The mandatory model will now be expanded nationwide beginning Jan. 1, 2028.”
  • Beckers Hospital Review points out nine things to know about today’s rule.
  • Here’s a link to CMS’s Fact Sheet on today’s rule.
  • The American Hospital Association News adds.
    • “The Centers for Medicare & Medicaid Services today finalized a 2.3% payment update for long-term care hospitals for fiscal year 2027 relative to FY 2026. This includes a 3.2% market basket update, reduced by a 0.9 percentage point productivity adjustment. In addition, CMS finalized its decision to freeze the outlier threshold at $78,936, the same level as FY 2026. For the LTCH Quality Reporting Program, CMS finalized the removal of two measures related to COVID-19 vaccination and a shortened data reporting timeline.
    • :In a statement shared with media today, Joanna Hiatt Kim, AHA’s vice president of payment policy, said, “[W]e remain concerned about continued inadequacies in the LTCH payment system that have contributed to declining patient volumes and the closure of facilities across the country, threatening access to care for medically complex patients. Although the AHA appreciates that CMS did not further raise the outlier threshold in this final rule, broader reforms are needed to support the LTCH field. We remain committed to working with the Administration and Congress to advance the AHA’s LTCH reform principles and promote a more sustainable payment framework that preserves patient access to LTCH services.”
  • The American Hospital Association News further informs us,
    • “The Department of Health and Human Services today issued a notice announcing a revised 340B Rebate Model Pilot Program, allowing qualifying drug manufacturers to use rebates rather than upfront discounts to effectuate the 340B ceiling price for certain drugs purchased by 340B covered entities. 
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “The AHA is deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients. The agency’s analysis dramatically understates the true costs of this program, ignoring the hundreds of millions of dollars in compliance expenses, cash-flow disruptions, and operational burdens that will inevitably divert scarce resources away from patient care. At a time when many hospitals are already under severe financial strain, this policy will force hospitals in rural and other underserved communities to spend more on bureaucracy and less on the services and care that patients depend on every day. As we continue to review today’s notice, the AHA is considering all available options to prevent this flawed program from going into effect.” 
    • “HHS’ Health Resources and Services Administration said the pilot is designed to test a rebate-based approach for a set of drugs while gathering information on program integrity, operational impacts and the interaction between the 340B program and Medicare’s Drug Price Negotiation Program. The pilot is limited to drugs included on the Centers for Medicare & Medicaid Services Medicare Drug Price Negotiation Selected Drug Lists for initial price applicability years 2026 and 2027. 
    • “Under the notice, manufacturers that wish to participate must submit plans to HRSA by Aug. 24. HRSA said it will make approval decisions by Sept. 24, and approved rebate models will take effect Jan. 1, 2027. Participating manufacturers must commit to the pilot for at least one year. “
  • Per an HHS news release,
    • ‘The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $73.2 million in grants to strengthen children’s mental health services, suicide prevention programs, and to expand assisted outpatient treatment (AOT) to those with serious mental illness.”
  • OPM posted in the Federal Register today direct final rules (previously known as interim final rules with opportunity for public comment)
    • FLSA Claims and Compliance
      • to update the provisions concerning Fair Labor Standards Act (FLSA) claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • and
    • Procedures for settling claims
      • to update the provisions concerning administrative claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued governmentwide guidance to departments and agencies on preparing Fiscal Year 2027 Annual Staffing Plans, advancing the Trump Administration’s efforts to modernize federal workforce planning, strengthen merit-based hiring, and ensure agencies are strategically positioned to deliver efficient, high-quality services to the American people.
    • “The guidance implements Executive Order 14356, Ensuring Continued Accountability in Federal Hiring, and provides agencies with a framework for conducting rigorous, bottom-up workforce planning that prioritizes mission-critical positions, modern technology talent, and early career hiring while improving governmentwide visibility into staffing needs.
    • “Annual Staffing Plans will require agencies to identify workforce needs based on mission requirements—not historical staffing levels—and reserve budget and positions for critical hiring priorities, including artificial intelligence, cybersecurity, software engineering, and other technology roles. The guidance also directs agencies to leverage governmentwide hiring initiatives such as US Tech Force and the Early Career Talent Network to improve hiring quality, reduce duplication, and accelerate recruitment across the federal government.”
  • Kevin Moss, writing in Federal News Network, explains “How a household with two federal employees can save on their FEHB premiums by enrolling self-only.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, a disease previously known as metastatic hormone-sensitive prostate cancer.
    • “The July 31 approval expands the use of Pluvicto to patients whose prostate cancer has spread but has not yet become resistant to hormone therapy. The treatment is intended for patients whose tumors express prostate-specific membrane antigen (PSMA), a protein found on many prostate cancer cells.”
  • MedTech Dive relates,
    • “Surgical robotics company MMI has received the Food and Drug Administration’s approval to expand an early feasibility study of microsurgery for Alzheimer’s disease.
    • “The REMIND study is evaluating the safety and feasibility of using MMI’s Symani robotic system in microsurgery procedures to re-establish drainage pathways in the deep cervical lymph nodes of patients with neurodegenerative disease. Patients in the trial also have confirmed lymphatic abnormalities.
    • “The FDA gave MMI the go-ahead to expand the number of people who can enroll in the study to 15, from up to five in the initial group, the company said Thursday.”
  • The American Journal of Managed Care lets us know,
    • “Late last week] six peptides received narrow advisory support for potential 503A Bulks List inclusion, an atypical outcome given FDA staff recommendations against all seven under review. 
    • “Legal compounding remains prohibited absent FDA acceptance and completion of proposed and final rulemaking; none of the substances is FDA-approved. 
    • “FDA reviewers cited short, underpowered studies insufficient for safety/efficacy across proposed indications, including limited BPC-157 trial data. 
    • “Committee reconstitution drew conflict-of-interest scrutiny, with increased representation from clinicians and businesses involved in prescribing, producing, or promoting peptides. 
    • “Payers should expect persistent cash-pay utilization and unregulated online procurement, necessitating rigorous medication reconciliation and adverse-event monitoring given sparse human safety data.”

From the judicial front,

  • Per a Justice Department news release,
    • “New York ophthalmology practices Mark D. Fromer, P.C. doing business as Fromer Eye Centers and Floral Park Ophthalmology P.C. have agreed to pay a total of $2.3 million to resolve alleged violations of the False Claims Act arising from their billing for trans-cranial doppler ultrasounds (TCDs) through a kickback arrangement with a third-party testing company. The Estate of Mark Fromer, the former owner of Fromer Eye Centers, also joined in the settlement with the practice. Both practices have agreed to cooperate with the Justice Department’s ongoing investigations of other participants in the alleged scheme.” * * *
    • “The claims resolved by the settlements are allegations only and there has been no determination of liability.“

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 31, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Considering multiple data sources, COVID-19 activity is low and stable nationally but is beginning to show early signs of an increase in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) confirmed 53 new US measles cases this week, bringing the total for the year to 2,371 cases.
    • “All but 16 of the cases were locally acquired in 45 US jurisdictions, with the rest tied to international travel, the CDC said in its weekly update. There have been 37 new measles outbreaks reported this year, with 94% of cases associated with outbreaks (defined as three or more cases).” * * *
    • “Among the current measles hotspots is Pennsylvania, which has reported 31 new cases over the past seven days and now has 167 cases for the year, according to the Pennsylvania Department of Health. Officials in neighboring Ohio yesterday confirmed four new cases in unvaccinated individuals in Ashtabula and Tuscarawas counties. It’s Ohio’s third measles outbreak this year.”
  • The American Journal of Managed Care gives us “FAQs: Cyclospora Recovery, Treatment, and Outbreak Prevention Strategies.”
    • “Epidemiologic and traceback evidence implicates shredded iceberg lettuce from Taylor Farms de Mexico as the exposure source, despite a disclosed false-positive border test not changing investigation conclusions. 
    • “Symptom onset typically occurs about one week post-exposure and includes profuse watery diarrhea, anorexia, nausea, bloating, weight loss, and fatigue, while some infections remain asymptomatic. 
    • “Higher-risk groups include immunocompromised patients, older adults, and those with limited care access, who may need longer antibiotic courses and closer monitoring for dehydration and prolonged illness. 
    • “TMP-SMX is the treatment of choice but requires individualized risk–benefit assessment given adverse reactions and a clinically meaningful, though comparatively lower, association with C difficile. 
    • “Public health control relies on clinician/lab case reporting, standardized exposure questionnaires, and FDA traceback; absent whole-genome sequencing for Cyclospora, marker-based genotyping supports source identification.”
  • The Wall Street Journal adds,
    • “In the verdant fields of California’s Salinas Valley, Larry Cox is watching his lettuce wilt.
    • “Cox and his two sons run Coastline Family Farms, which supplies leafy greens to some of the country’s biggest restaurant chains and grocery stores. But this week, in the region known as America’s Salad Bowl, around 300,000 pounds of his romaine hearts were chopped and plowed back into the soil.
    • “There is no evidence that his, or any of the nation’s homegrown lettuce, was infected with the parasite behind an illness outbreak that has sickened thousands of people so far. Even so, that hasn’t stopped Cox’s dependable restaurant and grocery customers from cutting back on orders.
    • “Many growers are destroying the crops they can’t find buyers for. Since lettuce has about a 30-day growing cycle, farmers that are plowing their crops back into the ground are weighing whether to replant or dial back. 
    • “It is incredibly demoralizing,” Cox said. “I would’ve been better off taking a vacation in the South of France than planting the crop.”
  • USA Today relates,
    • “As electric bikes and scooters become an increasingly common way for young people to get around, injuries tied to the devices are climbing at an alarming rate.
    • “New research from Truveta, a health data and analytics firm supported by a coalition of 30 U.S. health systems, analyzed over 12,000 emergency room visits nationwide. The findings revealed that injury rates associated with e-bikes and e-scooters among children and adolescents surged 7.5-fold between January 2023 and May 2026, an increase compared to the rates seen in adults.
    • “ER visits related to e-bikes and e-scooters have increased by 671% for children and adolescents, said Karen Gilbert Farrar, PhD, lead researcher at Truveta. “Just to put that in context, that’s if one patient is was being seen in 2023, that’s now nearly eight patients in 2026.”
    • “The findings also highlight the severity of many crashes: more than one-third of injured patients suffered head or neck injuries. And nearly 7% of child and adolescent visits that were related to e-bike and e-scooter use involved traumatic brain injury, Farrar said.”
  • Health Day lets us know,
    • “E-cigarettes could be reshaping the future of cancer in the United States, by offering people a less-toxic option than smoking, a new study argues.
    • :Smokers are increasingly switching to vaping and other forms of nicotine use, researchers reported July 27 in the journal JNCI Cancer Spectrum.
    • :They’re also sticking with their vapes, rather than swapping back and forth with tobacco cigarettes, researchers found.
    • “Our results show that exclusive cigarette use is being replaced by exclusive use of other combustible products, mainly e-cigarettes, especially among young adults,” said lead researcher Kenneth Michael Cummings, in a news release.”
  • and
    • “Work stress could be eating away at the sleep of most middle-aged working folks, undermining their health, a new study says.
    • “Nearly 70% of a small group of people ages 50 to 66 experienced persistent sleepproblems, even though they had no history of sleep disorders, researchers reported July 28 in the journal Scientific Reports.
    • “Even more concerning, more than 9 out of 10 (92%) of the participants met the clinical threshold for a sleep disorder at least once during the yearlong study, researchers said.
    • “I was genuinely surprised by the sheer scale of sleep problems we uncovered in this otherwise undiagnosed group,” lead researcher Athanasios Tsanas said in a news release. He is a professor of digital health and data science at the University of Edinburgh in the U.K.”
  • BioPharma Dive tells us,
    • “A Novo Nordisk heart drug missed the main goal of a Phase 3 trial, failing to show it prevented heart attacks, strokes or cardiovascular death in people with hardened arteries or chronic kidney disease, the company said Friday.
    • “Called ziltivekimab, the drug is part of a sprawling clinical program involving three late-stage trials that have collectively enrolled more than 20,000 people. Two others, in people with heart failure or who’ve had an acute heart attack, are ongoing. Results are expected next year. They all aim to show lowering levels of an inflammatory protein called IL-6 can can reduce the risk of heart-related complications and death.
    • “Novo gained control of ziltivekimab through a 2020 acquisition of Corvidia Therapeutics, for which it paid $725 million up front and promised up to $2.1 billion in total payouts. Novo said it will take a “non-cash impairment charge” in the third quarter but will not need to change its operating profit forecasts.” 

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

  • Fierce Healthcare reports,
    • “Cigna executives offered investors a look at the progress the company has made in the rollout of its new Signature pharmacy benefits model, which moves away from traditional drug rebates.
    • “CEO Brian Evanko said during the company’s earnings call that the team is “making strong progress in the build-out” of the model. It will roll out to Cigna Healthcare’s fully insured plans in 2027, before a wider launch in 2028.
    • ‘In particular, the model is designed around the affordability of brand-name drug products, and the company projects that it could save members 30% per month on branded medications. Through Signature, tech platforms will surface the lowest price to the member at the pharmacy counter, even if that’s a cash-pay option or provided by a manufacturer’s direct-to-consumer programs.
    • “We see significant early interest from health plans and employers as we prepare for our broader market launch in 2028,” Evanko said. “At the same time, we’re adding value and winning business today, with 2027 representing one of our strongest selling seasons in recent years.”
  • and
    • “Alignment Healthcare delivered a strong second quarter, in what CEO John Kao said was supported by the deployment of its new artificial intelligence-powered stratification model.
    • “This advancement improved our ability to predict which members are going to be hospitalized,” Kao said. “Our model now accurately and dynamically predicts the 10% of members who will account for nearly 70% of hospital admissions over the next 30 days.” 
    • “Kao said the on the company’s Thursday earnings call it plans to “reinvest a portion” of savings to areas that produce “tangible, measurable returns,” including market expansions, branding and “deepening AI capabilities.
    • “Beyond its potential to unlock efficiencies in our cost structure, AI represents a meaningful opportunity to further enhance our care model and support providers,” Kao said. “Most importantly, our approach to AI is grounded in decades of clinical expertise and reinforces our commitment to high-quality care. This is further supported by a governance framework to ensure responsible use, human accountability, and equitable treatment of our members.” 
  • Healthcare Dive relates,
    • “Siemens Healthineers has struck a 10-year deal to support diagnostic imaging, cardiology and radiation oncology at Cleveland Clinic, the company said Thursday.
    • “Building on its 35-year relationship with the academic medical center, Siemens Healthineers will provide diagnostic imaging and therapeutic technologies, including magnetic resonance imaging, computed tomography, radiation oncology, interventional radiology and X-ray.
    • “Siemens Healthineers is expanding an existing team dedicated to Cleveland Clinic, adding on-site technicians and training personnel to its current group of more than 30 people.”
  • Beckers Hospital Review points out,
    • “A total of 438 urban hospitals closed across the U.S. between 2000 and June 2026, according to data shared with Becker’s from New Haven, Conn.-based Yale University’s Health Care Affordability Lab.
    • “Between 2001 and 2023, the period for which both openings and closures are fully tracked, urban hospitals posted a net gain of 11 nationally, with 396 openings and 385 closures. However, there were significant losses in individual states. New York lost a net 33 urban hospitals over that period, California lost 29 and Pennsylvania lost 24.
    • “The data covers general, short-term acute-care hospitals and excludes specialty facilities such as psychiatric, rehabilitation, children’s and VA hospitals. Urban and rural classifications follow the census-tract-level definition from the Health Resources & Services Administration’s Federal Office of Rural Health Policy.
    • “The tables [found in the article] show urban hospital net change by state from 2001 to 2023 and total urban closures by state from 2000 through June 2026. States with no urban hospital activity in the Yale dataset are not listed.
  • Fierce Pharma informs us,
    • “The small inflection point we noticed two weeks ago regarding Eli Lilly’s Foundayo does not appear to be a flash in the pan. Weekly total prescriptions for the small molecule reached 29,388, a new high for the oral GLP-1 receptor agonist after three weeks of consecutive growth, according to IQVIA data cited by Citi. 
    • “As IQVIA may be missing some scripts from telehealth channels, we will get a clearer picture of Foundayo’s launch progress when Lilly reports its second-quarter earnings on Wednesday, Aug. 5. Analysts at Jefferies have been modeling $71 million in U.S. sales for the quarter based on IQVIA data.
    • “Meanwhile, Novo Nordisk’s Wegovy pill remains far ahead in the oral GLP-1 race with total scripts also hitting a new record of about 171,700, according to Citi. The number represents 1.1% growth from its previous best recorded during the prior week.
    • “Coincidentally, the entire GLP-1 class also saw its total scripts grow 1.1% sequentially across diabetes and obesity uses. Lilly’s Zepbound regained some lost ground with total scripts up 1.9% week over week. That’s compared to Wegovy, which now makes up 40.6% of the obesity market after a 0.2% sequential decline in total scripts.” 
  • Per Fierce Healthcare,
    • “WellSpan Health inked an expanded multi-year partnership with artificial intelligence company Hippocratic AI, which expands AI-powered capacity across the network.
    • “Through the update, Hippocratic AI’s generative AI agent—Ana—will expand from handling inbound calls and primary care appointment scheduling to post-discharge follow-up and chronic disease check-ins.
    • “Initial workflows will focus on closing care gaps through outreach to patients with missed imaging appointments, executives say. Every new use of the AI agent will follow governance, safety and implementation structures in coordination with WellSpan teams.
    • “WellSpan Health CEO Roxanna Gapstur, Ph.D, said in a statement the future of the industry will “be shaped by the organizations that build the culture, governance and clinical capabilities” to utilize AI responsibly at scale.
    • “At WellSpan, we’ve been intentional about creating this foundation, so innovation advances safely, strengthens clinical excellence and earns trust,” Gapstur said. “Our expanded partnership with Hippocratic AI is an investment in the future of care — one that expands access, supports our care teams and creates a more personalized experience for every patient we serve.”

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.”