Midweek Update

CDC

Midweek Update

David Ermer–CDC, CMS, COVID-19 vaccine, Generative AI, Government Contracting, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Meritalk reports,
    • “With the Office of Personnel Management (OPM) on track to lose one-third of its workforce by the end of the year, OPM Director Scott Kupor said on Tuesday that he’s looking to technology to help steady the agency during its ongoing restructuring.
    • “Kupor, who the Senate confirmed as OPM director last month, said that his team is currently conducting a “reprioritization” effort to determine the top critical areas for the agency to focus on – and whether or not they need more headcount to get the job done.
    • “There may be cases where maybe we actually are short people,” Kupor said during an Aug. 26 event hosted by Federal News Network.
    • “We’re not perfect, and I fully acknowledge that there just may be areas where we need to revisit. So, there will be, I’m sure, some places where we have cut deeper than was appropriate, and we’ll have to make some changes,” he said.
    • “Some of those hiring efforts could target fresh talent, but Kupor said the agency may also look to rehire some employees who chose to participate in the deferred resignation program.”
  • The Wall Street Journal reports at 8:35 pm ET Wednesday,
    • “Susan Monarez, the director of the Centers for Disease Control and Prevention, has been pushed out of the job, a senior Trump administration official said Wednesday.
    • “Monarez, who led the agency for less than a month, clashed with Health and Human Services Secretary Robert F. Kennedy Jr. and members of his staff, the official said. President Trump had nominated her to lead the CDC in March after dropping his first pick. Previously the agency’s acting director, Monarez was the first CDC head without a medical degree in more than 70 years.
    • “Lawyers for Monarez said in a statement that she has neither resigned nor received notification from the White House that she has been fired. They also said she will not resign. “When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda,” they said. “For that, she has been targeted.”
    • “Three senior CDC leaders, including Dr. Debra Houry, the agency’s chief medical officer, submitted their resignations Wednesday, according to emails viewed by The Wall Street Journal.”
  • Healthcare Dive tells us,
    • “The process set up by the No Surprises Act to settle disputes between providers and insurers about out-of-network claims is generating billions of dollars in extra costs for the healthcare system — costs that could trickle down in the form of higher consumer premiums, according to a new analysis.
    • “Independent dispute resolution, or IDR, has created an estimated $5 billion in total costs between its inception in 2022 and the end of last year, according to the report published in Health Affairs on Monday. The high amount of claims, significant provider participation and lofty offer amounts are driving the spending, researchers found.
    • “The analysis raises questions for policymakers concerned about curbing healthcare costs. In particular, Washington should consider tackling the high volume of ineligible disputes clogging up the process — and scrutinize the role of private equity, given providers backed by the firms are responsible for an outsized portion of disputes, researchers said.”
  • FEHBlog note — The No Surprises Act arbitration which is supposed to resemble baseball arbitration fails to include the safeguards found in actual baseball arbitration like a hearing at which the parties have access to both offers and can debate them before the decisionmakers.
  • Fierce Healthcare informs us,
    • “The National Committee on Quality Assurance (NCQA) has launched an artificial intelligence working group to determine how to best measure performance of high-risk AI once it has been deployed by health plans and providers. 
    • “The 35-year-old organization runs a spate of quality measurement and reporting programs, like health plan accreditation and the Healthcare Effectiveness Data and Information Set (HEDIS) measures used by 90% of health plans, according to the Office of the Assistant Secretary for Planning and Evaluation. 
    • “The NCQA has convened more than 30 organizations to share their experiences using AI and help create standards for the technology. Some members of its AI working group are the American Academy of Family Physicians, America’s Health Insurance Plans, Blue Cross Blue Shield of Tennessee, the Community Care Plan, Covered California, the Kaiser Foundation Health Plan and United HealthCare.
    • “As the modality of care, as the channels of healthcare delivery continue to evolve, and as we continue to see a very evolving healthcare delivery landscape, we do want to take a very hard look at what additional things we can do to continue putting that lens on quality and putting quality front and center,” Vik Wadhwani, chief transformation officer at NCQA, said in an interview.”
  • Kushner & Co. reminds us that the time for circulating Medicare prescription drug creditable coverage notices is approaching. The deadline is October 15, 2025.
    • For 2025, with the Inflation Reduction Act lowering the out-of-pocket maximum to $2,000 (from $8,000 in 2024), many employer prescription drug plans—and especially those with High-Deductible Health Plans—may find that their plans are no longer creditable. Further, new changes for 2026 may also impact these notices. Be sure to check with your group medical plan insurance carrier or TPA [or PBM] to ensure you’re in compliance in determining whether your prescription drug plan is creditable or noncreditable.
  • The FAR Council today finalized the inflation adjustments to FAR thresholds which take effect on October 1, 2025. The key change for FEHB carriers is the following:
    • “The cost or pricing data threshold at FAR 15.403–4, for contracts awarded before July 1, 2018, increases from $750,000 to $950,000. For contracts issued on or after July 1, 2018, the threshold increases from $2 million to $2.5 million.”
    • 90 Fed. Reg. 41873 (August 27, 2025)
    • OPM’s FEHBAR treats this threshold as the subcontract preapproval threshold for experience rated carriers and the flow down trigger for the significant events clause. 48 C.F.R. Secs. 1652.222-70, 1652.244-70.

From the Food and Drug Administration (FDA) front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration authorized three new Covid-19 vaccines—from Pfizer and its partner BioNTech, and Moderna and Novavax—that target a variant of the coronavirus known as LP.8.1. This was the dominant circulating strain when FDA advisers picked a target in May. 
    • “The companies are expected to begin shipping doses to pharmacies and other vaccination sites within days. This is the fourth-year companies have updated Covid shots to target the primary variant that is circulating, in hopes the shots will better protect people from severe illness through the fall and winter months.
    • “In a change this year, the FDA cleared use of the updated vaccines in a smaller population. The three vaccines are cleared for everyone 65 and older, and for people in younger populations who have underlying conditions that put them at higher risk of severe Covid-19. 
    • “Pfizer’s vaccine was cleared for at-risk people ages 5 through 64, Moderna’s in at-risk people six months and older, and Novavax for at-risk people 12 and older.
    • “In previous years, U.S. health officials recommended the booster shots in most people six months and older, even if they didn’t have at-risk conditions.” * * *
    • “In deciding on vaccine coverage, health insurers typically follow recommendations by the Advisory Committee on Immunization Practices, or ACIP, which advises the CDC. They may also consider clinical recommendations from medical societies. 
    • “No meeting has been scheduled for ACIP to consider the new updated boosters. Kennedy fired all members of the ACIP in June and replaced them with people including some vaccine skeptics.
    • “A trade group for health-insurance companies, America’s Health Insurance Plans, said health plans will continue to follow requirements for ACIP-recommended vaccines.”
  • FEHBlog note — Indeed, the Affordable Care Act requires that health plans waive cost sharing for in-network administration of vaccines recommended by ACIP and confirmed by the CDC (or the HHS Secretary in the event of a vacancy in the CDC directorship.).
  • Cardiovascular Business adds,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about a new safety issue associated with Johnson & Johnson MedTech’s Automated Impella Controller (AIC). 
    • “This latest alert was put in place after Johnson & Johnson MedTech received reports that some of the Pump Driver Circuit Assemblies of its AICs contain 25V-rated tantalum capacitors instead of the expected 35V-related tantalum capacitors. This can cause the pump’s performance to suffer, and there a risk of the pump stopping altogether and triggering an “Impella Failure” or “Impella Stopped. Controller Failure” alarm. 
    • “One patient death has been linked to this issue. 
    • “This alert covers a total of 69 AICs. Full lists of the affected product codes and serial numbers are available as part of the FDA’s advisory. Anyone with one of the affected devices is urged not to use it any longer. Instead, the device should be quarantined until additional information is made available.
    • “The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” according to the advisory.”

From the judicial front,

  • Bloomberg Law reports,
    • “Cigna Health & Life Insurance Co. reached a class-wide settlement in a family’s lawsuit saying the insurer breached its fiduciary duties by failing to maintain an up-to-date list of in-network medical providers.
    • “The parties reached a preliminary agreement after a mediation session with a retired judge and plan to file details of the deal for court approval by Sept. 19, they said in a status report docketed Monday in the US District Court for the Northern District of Illinois. The filing didn’t include details about the terms of the settlement.” * * *
    • “Judge Manish S. Shah allowed portions of the case to advance in February, saying the family has a viable fiduciary breach claim based on Cigna’s failure to properly resolve the matter in a way that didn’t force them to foot the bill. But Shah dismissed the family’s claim for wrongfully denied benefits under the Employee Retirement Income Security Act because Cigna correctly paid their benefits according to the terms of their health plan.”

From the public health and medical research front,

  • Fierce Healthcare lets us know,
    • “Advancements in technology, testing and imaging have transformed cancer detection and risk assessment, enabling them to be faster and more precise.
    • “But providing patients with a cancer risk score or identifying those at high risk is only one step in cancer prevention. Getting patients to act on their cancer risk and get supplemental screening is the next big leap, and CancerIQ is focused on closing this gap.
    • “The company, which offers healthcare providers a cancer-focused precision health platform, developed new capabilities to provide patients at elevated risk for cancer with “hyper-personalized” patient education, engagement and navigation support. The new features were built on insights from thousands of high-risk patient journeys and backed by behavioral science with the aim to drive sustained follow-through on supplemental screenings that detect cancer earlier, according to executives.
    • “The first release focuses on screening breast MRI, with plans to support additional patient populations, including those eligible for low-dose lung CT.”
  • BioPharma Dive reports,
    • “People with early breast cancer who were treated in a late-stage study with Eli Lilly’s drug Verzenio and standard hormone therapy lived longer than those given hormone therapy alone, the company reported Wednesday.
    • “The summary results come from Lilly’s monarchE study, which began in 2017 and enrolled more than 5,600 adults with high-risk breast cancer that tested positive for hormone receptors but negative for a protein called HER2. Lilly said the improvement in survival was “statistically significant and clinically meaningful.”
    • “The study previously met its main goal, showing the addition of Verzenio improved invasive disease-free survival — data that supported a 2021 approval in this treatment setting. The overall survival findings, which were a secondary endpoint, will be presented at an upcoming medical meeting, Lilly said.”
  • STAT News relates,
    • “Akeso, a Chinese biotech with a drug positioned to rival Merck’s megablockbuster Keytruda, has reported for the first time that the therapy can improve patient survival.
    • “The therapy, ivonescimab, showed a statistically significant survival benefit as a second-line treatment when combined with chemotherapy to treat non-small cell lung cancers. The patients’ cancers had progressed after getting therapies targeting EGFR, a protein that can drive tumor growth. 
    • “The company described the results of the Chinese trial as clinically meaningful in a report for the first half of the year released on Tuesday. But it didn’t delve into details, which Akeso plans to share at an upcoming medical conference.”
  • Per Fierce BioTech,
    • “Amylyx’s withdrawn-from-market Relyvrio has failed to make an impact on primary or secondary endpoints in a rare neurodegenerative disease, prompting the company to discontinue the program.
    • “Oral therapy Relyvrio, which Amylyx is again referring to as AMX0035, was tested in progressive supranuclear palsy (PSP), a fatal and rapidly progressing condition that impacts mobility, eye movements, swallowing and speech. Currently, there aren’t any approved treatments for the disease.”
    • “Amylyx’s phase 2/3b study was measuring AMX0035’s impact on disease progression and severity using a 28-item, condition-specific scale. The phase 2 portion of the trial found no difference in patients receiving AMX0035 compared to placebo at 24 weeks, according to an Aug. 27 company release.
    • “Given the results, the company has discontinued the phase 2b trial, plus a related open-label extension study. Amylyx has also terminated plans for the phase 3 portion of the study.”
  • Per Health Day,
    • ‘Few teens with depression receive treatment, with disparities seen based on residence, gender, and race, according to a study published online Aug. 20 in PLOS Mental Health.
    • “Su Chen Tan, from the University of Tennessee in Knoxville, and colleagues used data from adolescents (aged 12 to 17 years) with major depressive episodes (MDE) participating in the 2022 U.S. National Survey on Drug Use and Health to assess mental health service utilization by rurality, race/ethnicity, gender, age, health insurance coverage, and poverty level.
    • “The researchers found that 19.2 percent of adolescents experienced MDE, but only 47.5 percent received treatment within the past year. There were significantly lower odds of receiving specialist treatment for adolescents in rural areas versus their urban counterparts (adjusted odds ratio [aOR], 0.64). Further, odds of receiving telehealth services were significantly lower for rural adolescents (aOR, 0.64) but were significantly higher for adolescents with insurance (public insurance: aOR, 2.99; private insurance: aOR, 3.82). Compared with younger adolescents, older adolescents had lower odds of utilizing school-based services (aOR, 0.52). Female adolescents had greater odds of utilizing any mental health treatment than male adolescents (aOR, 1.59), while Black adolescents had significantly lower odds of utilizing any mental health treatment versus non-Hispanic White adolescents (aOR, 0.36).”
  • and
    • “Two-thirds of women in their child-bearing years have an increased risk for birth defects due to a lifestyle factor they can change, a new study says.
    • “These risk factors — low levels of vitamin B9 (folate), unmanaged diabetes or exposure to tobacco smoke — increase the odds of a serious birth defect in any child they might have, researchers said.
    • “Heart defects, cleft palates and defects of the brain and spinal cord are among the problems that could be headed off if women took steps to improve their health prior to pregnancy, researchers reported today in the American Journal of Preventive Medicine.”

From the U.S. healthcare business front,

  • Healthcare Dive points out Blue Shield of California names interim CEO Mike Stuart to permanent chief executive.
  • Beckers Payer Issues notes,
    • “AM Best has downgraded its outlook for the health insurance sector from stable to negative, citing escalating medical costs and increased utilization across government, commercial and ACA plans.
    • “The credit rating agency noted higher utilization of specialty drugs, increased physician visits, more inpatient admissions and a surge in behavioral health claims. The coding intensity of medical services has also increased, according to an Aug. 25 news release.”
  • STAT News reports,
    • “Dressed in red and black jackets reminiscent of Star Trek uniforms, the heads of Epic’s data and AI divisions, Phil Lindemann and Seth Hain, described an aspirational vision for artificial intelligence at the end of last week’s Epic UGM keynote. Using the data stored in Cosmos — Epic’s de-identified patient record research database — the company trained an AI model that can generate many possible future timelines for a patient, then tell the doctor which outcomes are most likely, like what might happen during a hospital stay, or if the patient might end up in the emergency department in the next year. 
    • “Just as a large language model can be trained once and then used to generate different kinds of text, like an email or a poem, without being specifically trained on how to write either emails or poems, Epic’s “large medical model,” trained on all sorts of medical events and outcomes, could replace individual predictive medical algorithms. If the model, which Epic calls CoMET — the Cosmos Medical Event Transformer — can achieve performance similar to machine learning algorithms specifically trained to predict readmissions or asthma attacks, “that’s a breakthrough in how we can get risk prediction embedded into clinical care,” said Lindemann.
    • “This idea isn’t entirely new. Researchers like Arkadiusz Sitek at Massachusetts General Hospital have built models that predict future patient medical events before. But, Sitek told STAT, the scale of CoMET is impressive and suggests this approach will work in a large population. Epic trained and evaluated its model on 115 billion medical events from 118 million unique patient records collected from January 2012 to April 2025. The work was detailed in a preprint posted last week with Microsoft and Yale researchers.”
  • FIerce Healthcare informs us,
    • “Four hospitals are sending heart failure patients home with a virtual care support team under a newly unveiled collaboration between the American Heart Association (AHA) and remote chronic disease monitoring platform Cadence.
    • “The American Heart Association Connected Care pilot program aims to reduce 30-day readmissions by addressing “critical gaps in heart failure care” that occur after heart failure patients leave the hospital.
    • “It will see the participating hospitals integrate program referrals into their discharge workflows. Enrolled patients are given and taught to use connected vital sign monitors, which a Cadence virtual care team uses to provide ongoing clinical support, adjust treatments or direct the patient to an in-person provider if necessary.
    • “Almost one in four heart failure patients are readmitted to the hospital within 30 days of discharge, and fewer than a fifth receive post-discharge medical therapies in line with clinical guidelines, according to study data cited in the announcement.”
  • Beckers Hospital Review identifies “five new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

Monday report

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

From Washington, DC,

  • Fierce Healthcare tells us,
    • “Medicare patients have increasingly checked themselves out of the hospital against the advice of medical staff since 2006, with a temporary spike in self-discharges coinciding with the COVID-19 public health emergency, according to a new claims review conducted by the Department of Health and Human Services Office of Inspector General (HHS OIG).
    • “The increasing rate of acute care hospital discharges against medical advice (AMA) was prevalent across most demographics including enrollee type, hospital size, population density and medical condition, the office wrote in its review published Thursday.
    • “That said, discharges AMA increases were higher among hospitals with lower quality-of-care ratings (as measured by overall hospital quality star ratings) and among dually enrolled patients and those with mental health diagnoses.
    • “The HHS OIG said the rate increases are noteworthy, as Medicare patients who left AMA were more than twice as likely to be readmitted to the hospital or die within 30 days of discharge compared to those discharged to their homes.”
  • Beckers Clinical Leadership informs us,
    • The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics are diverging from the CDC’s vaccine recommendations, which no longer advise routine COVID-19 shots for healthy children and pregnant women.
    • On Aug. 22, ACOG published clinical guidance regarding vaccination during pregnancy. The OB-GYN group reaffirmed support for COVID-19 inoculation during pregnancy, adding that data show COVID-19 vaccines protect pregnant patients and infants from COVID-19 complications. 
    • “Three days before, the pediatrics organization released its annual vaccine recommendations. The AAP’s 2025-26 virus season guidance says children between 6 months and 2 years old should receive a COVID-19 vaccine; the CDC advises “shared clinical decision-making” between the clinician and parent or patient.” 
  • The Groom Law Group opines,
    • “On January 17, 2025, the ERISA Industry Committee (“ERIC”) filed suit against the Departments alleging that the 2024 {Mental Health Parity] Final Rule exceeded the Departments’ statutory authority, violates the Due Process Clause of the Fifth Amendment, is arbitrary and capricious, and otherwise violates the Administrative Procedure Act.
    • “In light of the litigation challenging the 2024 Final Rule, the Departments announced a non-enforcement policy of the Final Rule while they reconsider the 2024 Final Rule, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation. The Departments’ announcement noted that MHPAEA’s statutory obligations, including the requirements related to [Non-Quantitative Treatment Limitations] NQTL comparative analyses, as amended by the CAA, 2021, continue to have effect.  The Departments also stated that they will “undertake a broader reexamination of each department’s respective enforcement approach under MHPAEA, including those provisions amended by the CAA, 2021.”
    • “Importantly, plans and issuers are still required to develop and maintain MHPAEA NQTL comparative analyses and provide them to regulators upon request.  In addition, plans must also make NQTL comparative analyses available upon request to:
      • “Applicable state authorities.
      • “A participant or beneficiary (including a provider or other person acting as a participant’s or beneficiary’s authorized representative) who has received an adverse benefit determination related to MH/SUD benefits; and
      • “Participants and beneficiaries who request the comparative analyses at any time under ERISA section 104.”
  • Beckers Hospital Review helpfully explains the 340B drug program.
    • “More than three decades ago, Congress created the 340B program to help safety-net hospitals and clinics​​ expand resources and care for underserved communities. 
    • “By requiring pharmaceutical companies to offer deep discounts on outpatient drugs, the program has become a hallmark resource to help health systems support vulnerable patients. In recent years, however, the program has drawn scrutiny from federal lawmakers as several drugmakers have introduced alternative rebate and drug pricing models, raising questions about the direction of the program. 
    • “Hospitals have also faced increased scrutiny in recent years over how they are utilizing 340B savings. This intensified after a Senate report published in April found some of the largest health systems were exploiting the system. According to the report, Cincinnati-based Bon Secours Mercy Health and Cleveland Clinic generated hundreds of millions of dollars by acquiring discounted 340B drugs and then charged patients significantly higher prices. Both health systems defended their participation in the 340B program, telling Becker’s they operated the program in compliance with federal rules.”
  • Check it out.  

From the Food and Drug Administration (FDA) front,

  • MedPage Today reports,
    • “The PCSK9 inhibitor evolocumab (Repatha) got the FDA’s blessing for cardiovascular protection, with or without a history of cardiovascular disease (CVD).
    • “Evolocumab is now indicated for the wider pool of adults at increased risk for major adverse cardiovascular events (MACE) — namely cardiovascular death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization — 10 years after it first hit the market.
    • “The drug keeps its older LDL cholesterol-lowering indication in adults with hypercholesterolemia, adults and children with heterozygous familial hypercholesterolemia, and individuals with homozygous familial hypercholesterolemia.”
  • Per Fierce Pharma,
    • “Less than three weeks after lifting a pause on the use of Valneva’s chikungunya vaccine Ixchiq, the FDA has done an about-face, banning the use of the shot in the United States.
    • “On Friday [August 22], the agency suspended Valneva’s license “based on serious safety concerns,” citing 21 hospitalizations and three deaths, including one from encephalitis directly attributed to the live-attenuated vaccine. With the decision, the price of the French company’s shares has plummeted by 22%.
    • “In a release, Valneva called (PDF) the FDA’s decision “sudden,” after the regulator had lifted a previous halt on the use of the vaccine in older adults on August 6. The company added that the agency’s move came after it received four reports of side effects from its Vaccine Adverse Event Reporting System (VAERS), each happening outside of the U.S. The reports included one user who was hospitalized for two days.
    • “Valneva believes all cases describe symptoms consistent with those previously reported during clinical trials and post-marketing experience, particularly among the elderly individuals for whom the vaccine’s prescribing information includes warnings and precautions,” the company said in its statement.”
  • MedTech Dive relates,
    • “Boston Scientific has recalled carotid artery stents because of a manufacturing defect that has led to additional interventions to recover the devices.
    • “The Food and Drug Administration, which shared information about the recall Friday [August 22], said the company reported six cases that required additional intervention as of July 29.
    • “Boston Scientific told customers not to use affected Carotid Wallstent Monorail Endoprosthesis devices last month. The recall affected 26,570 devices, 1,333 of which are in the U.S.”

From the public health and medical research front,

  • The Washington Post reports,
    • “A rare human case of a flesh-eating parasite known as New World screwworm has been confirmed in a Maryland resident as the Trump administration is trying to prevent the resurgence of an insect largely eradicated from livestock decades ago.
    • “The case was confirmed Aug. 4 in a person who had traveled to the United States from El Salvador, said Andrew Nixon, a spokesman for the Department of Health and Human Services.
    • “The resident has recovered without evidence of infecting other humans or animals, state health officials said in a statement Monday.
    • “A recent New World screwworm outbreak in Central America has raised concerns that it could spread to the United States and devastate the cattle industry. But state and federal health officials said the Maryland case is not cause for alarm, and plans for a new sterile fly production facility in South Texas aim to tamp down global threats from the pest.
    • “The risk to public health in the United States from this introduction is very low,” Nixon said.
    • Livestock are not at particular risk due to the Maryland case, the National Cattlemen’s Beef Association said.”
  • STAT News points out,
    • “In a milestone for the newly resurgent field of xenotransplantation, a 39-year-old brain-dead person in China has become the first human to receive a lung from a pig. With consent from the person’s family, researchers took the organ from a CRISPR’d pig, trimmed it, and stitched it into their chest, where it remained for nine days.
    • “The procedure was intended to test whether pigs that have been gene-edited to make their organs less recognizable to the human immune system — and thus less prone to rejection — could one day be used to supply hospitals for transplants. In the past few years, surgeons in the U.S. have transplanted pig hearts and kidneys into both living patients and people who had been declared clinically dead because they lacked brain function. Last year, doctors in China became the first to attempt a similar procedure with a liver from a pig. This is the first time anyone has tried it with a lung. 
    • “The clinical need for donor lungs is enormous. According to the Global Observatory on Donation and Transplantation, 8,236 lung transplants were performed worldwide in 2024, an increase of 6% over the previous year, but tens of thousands more patients remain on waitlists. The results of the experiment, which were published Monday in Nature Medicine, are exciting, experts told STAT, because they suggest that lung xenotransplantation could, one day in the future, become an option for patients. But they also point to how much more work has to be done before that day can arrive.” 
  • Per MedPage Today,
    • “People who carried the Alzheimer’s disease APOE4 risk gene had a lower risk of developing dementia if they followed a Mediterranean diet, an observational study of healthcare professionals suggested.
    • “Adherence to the Mediterranean diet more effectively modulated dementia-related metabolites in APOE4 homozygotes than in people with lower genetic risk, wrote Dong Wang, MD, ScD, of Mass General Brigham in Boston, and colleagues in Nature Medicine.
    • “We found that greater adherence to the Mediterranean diet was associated with a lower risk of dementia and slower cognitive decline in the overall study population,” said co-author Yuxi Liu, PhD, also of Mass General Brigham. 
    • “The protective association was most pronounced among individuals carrying two copies of the APOE4allele, where each one-unit increase in the Mediterranean diet score was associated with approximately a 35% lower risk of dementia,” Liu told MedPage Today. “These findings suggest that adherence to the Mediterranean diet may mitigate the elevated genetic risk conferred by APOE4.”
  • Health Day notes,
    • “Pediatricians should screen children annually for mental or developmental issues, the American Academy of Pediatrics (AAP) recommends in a new clinical report.
    • “The recommendation comes in response to a mental, emotional and behavioral health crisis that’s been brewing among America’s youth, the AAP says.
    • “Up to 1 in 5 children in the U.S., including kids as young as 2, are living with a mental or behavioral health problem like depression, anxiety, ADHD or suicidal thoughts and feelings, according to the report published online today in the journal Pediatrics.
    • “And in 2020, suicide became the second-leading cause of death among kids aged 10 to 14 and the third-leading among 15- to 24-year-olds. AAP said the rate increased 41% between 2000 and 2017.
    • “The AAP argues that pediatricians are in the best position to spot early concerns and get children the help they need.”
  • The American Medical Association lets us know what doctors wish their patients knew about taking naps.

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Philadelphia-based Thomas Jefferson University, owner of Jefferson Health, recorded an operating loss of $196 million (-1.2% operating margin) in fiscal 2025, down from an operating income of $1.3 million (0% margin) in 2024, according to its Aug. 22 financial report. 
    • “The results for the year ended June 30 include 11 months of Lehigh Valley Health Network activity, according to the report. Jefferson merged with the Allentown, Pa.-based health system on Aug. 1, 2024. On a 12-month pro forma basis, Jefferson’s operating loss was $197 million.
    • “Due to the Lehigh Valley Health Network acquisition, Jefferson saw significant increases to its operating revenue and operating expenses in 2025. Revenue rose 57.6% year over year to $15.8 billion. Operating expenses rose 59.5% year over year to $16 billion. 
    • “Jefferson attributed the unfavorable financial results in 2025 primarily to the Jefferson Health Plan, pharmacy trend and organizational inflationary pressures.”
  • Health Leaders Media tells us,
    • “Rural health systems and hospitals are struggling to stay open and don’t have the resources on hand to treat more of their patients.
    • “Telemedicine platforms can enable small providers to connect with specialists at larger organizations, giving them the opportunity to treat more patients rather than transferring or referring them elsewhere.
    • “Larger health systems can also use the technology to create a hub-and-spoke platform that allow them to market their specialists and services to other hospitals.”
  • Per BioPharma Dive,
    • “AbbVie has bought a psychedelic compound from a little-known drug company, in a deal that could be worth north of $1 billion.
    • “The acquisition, announced Monday, makes AbbVie one of the few large pharmaceutical firms to significantly invest in an area of drug development that many on Wall Street expect to become quite lucrative. Analysts at RBC Capital Markets recently wrote the psychedelic space is “approaching a tipping point” as larger studies near completion. Just last week, the small biotechnology company Reunion Neuroscience announced plans to push its main drug, which boosts certain brain proteins that interact with psychedelics like LSD and psilocybin, into late-stage testing.
    • “That news came less than two months after U.K.-based Compass Pathways disclosed data from a relatively large study wherein patients with hard-to-treat depression were given a version of a psychedelic compound found in many mushroom species. Gilgamesh Pharmaceuticals also unveiled positive results this year, from a mid-stage clinical trial focused on a drug that works similarly to Reunion’s.”
  • Fierce Healthcare adds,
    • “BeOne Medicines is monetizing its stake in Amgen’s first-in-class lung cancer drug Imdelltra for up to $950 million.
    • “Royalty Pharma will pay BeOne $885 million upfront for certain royalty payments from Amgen tied to ex-China sales of its DLL3 T-cell engager Imdelltra.
    • “Within the next 12 months, BeOne has an option to sell additional royalty rights to Royalty for up to $65 million.
    • “The royalties represent “a significant portion” of “tiered mid-single digit” payments based on Imdelltra’s annual sales above $1.5 billion, BeOne said in an Aug. 25 securities filing. Royalty, in a separate release, said the royalty level is about 7%.”
  • and
    • “With a buyout of scPharmaceuticals worth up to $360 million, MannKind is looking to dive into the large and growing field of cardiometabolic treatments.
    • “Endocrine and orphan lung disease-focused MannKind will shell out $5.35 per share—plus a contingent value right (CVR) of $1.00 per share—to buy scPharmaceuticals and Furoscix, the latter company’s on-body infuser that delivers furosemide.
    • “The total deal value of $360 million represents a 31% premium to scPharmaceuticals’ Aug. 22 closing price, according to a Monday press release.
    • “With the deal, MannKind will add scPharmaceuticals’ Furoscix to its lineup of marketed products. The 2022-approved drug is an on-body infuser that delivers generic furosemide as a self-administered, subcutaneous loop diuretic to help relieve the fluid retention and swelling that accompany heart failure and other conditions.”
  • Per MedTech Dive,
    • “Terumo plans to acquire OrganOx, a maker of organ preservation devices, in a roughly $1.5 billion deal that will allow the Tokyo-based medical device maker to enter the transplantation sector.
    • “OrganOx’s liver perfusion system supplies oxygenated blood, medications and nutrients to the donor organ near body temperature. The device allows functional assessment of the organ to support the decision on whether to transplant.
    • “U.K.-based OrganOx launched the system in 2022 in the U.S., where it competes with an organ preservation device from TransMedics Group. Called Metra, OrganOx’s system is also approved in the U.K., European Union, Australia and Canada.”
  • and covers the key medtech issues to watch in the final months of the year.
  • Fierce Healthcare adds,
    • “As fitness trackers get artificial intelligence updates, Google developed an AI-powered personal health coach for the Fitbit app. Built with Gemini, the AI-based health coach combines a fitness trainer, a sleep coach and a health and wellness advisor.
    • “We set out to build a new kind of coach: world-class expertise that’s always available whenever you need it. It constantly adapts based on your personal health and wellness metrics and is uniquely tailored to your goals and real-life circumstances,” said Andy Abramson, head of product at Fitbit.
    • “Fitbit will roll out a preview of the personal health coach as part of Fitbit Premium in the redesigned app available with the latest Fitbit trackers, Fitbit smartwatches and Pixel Watches.
    • “The health coach can build personalized fitness plans, with detailed workout suggestions and metric targets that focus on weekly progression. The coach can adjust workout plans based on real-time data and daily insights.”

Friday report

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • Here is a link to the OPM Director’s weekly blog post.
    • “Of course, government doesn’t – and shouldn’t – function like private entrepreneurship. We can’t shoot for the moon and embrace unbridled risk as do venture-backed startups. But government can embrace a growth mindset – not leaving good enough alone, but instead always thinking about ways in which we can improve operational efficiency, try new things, and embrace change.”
  • Govexec reports,
    • “President Trump has just nine days to issue his likely plan to freeze federal employees’ salaries in 2026, before sizeable automatic and across-the-board increases take hold.
    • “Each August, the president must issue an alternative pay plan, declaring an economic emergency to avert the automatic implementation of sizeable increases to locality pay due to the 1990 Federal Employees Pay Comparability Act. Administrations of both parties have bemoaned the way that the law calculates those automatic adjustments, hence the annual sidestep of that provision.”
  • and
    • “The Internal Revenue Service is no longer planning to pursue layoffs as it seeks to rebuild parts of its workforce. The tax agency is now working to plug staffing holes with hiring, reassignments and rescinding the administration’s deferred resignation offer for some employees upon finding mission-critical staffing gaps. 
    • “The decision to forgo layoffs, confirmed by two sources briefed on the matter, marks a significant reversal for an agency that has shed about a quarter of its staff and had earlier this year planned to issue widespread reductions in force.”
  • Per a National Institutes of Health news release,
    • “I [NIH Director Jay Bhattacharya, MD] am pleased to announce the release of NIH’s new plan to promote gold standard science across all agency activities. Building on NIH’s longstanding commitment to scientific integrity, this forward-looking plan incorporates the nine, interlocking tenets of gold standard science adopted by the U.S. Government and aligns with the Department of Health and Human Services’ framework for achieving these principles.”
  • STAT News lets us know,
    • “The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting System, was updated quarterly. 
    • “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public,” FDA Commissioner Marty Makary said in a statement. “We’re closing that waiting period and will continue to streamline the process from start to finish.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal court in Maryland has blocked [Dropbox link to opinion] several parts of a health insurance exchange enrollment and eligibility rule days before they were set to take effect.
    • “The U.S. District Court for the District of Maryland temporarily stayed seven provisions from a Centers for Medicare and Medicaid Services rule issued June 20 and set to go live Monday.
    • “Judge Brendan Herson’s Friday ruling temporarily blocks a $5 premium penalty on auto-reenrollments, along with a policy disqualifying people for advance payment of subsidies if they didn’t file income taxes and failed to reconcile their tax credits in a previous year. 
    • “It also stops regulators from eliminating guaranteed insurance coverage for individuals with past-due premiums and pauses a requirement that exchanges verify certain household income data.
    • “Also on pause are policies to require pre-enrollment eligibility checks ahead of a special enrollment period and a change to the formula used to calculate plan tiers. 
    • “The ruling allows CMS’ methodology for calculating premium adjustments, along with its elimination of a 60-day window for enrollees to resolve household income data, to go forward. 
    • “The court did not weigh in on other provisions in the regulation, such as the shorter open enrollment period. Plaintiffs are not contesting the changes to the low-income enrollee signup period.”

From the public health and medical research front,

  • The Centers for Disease Prevention and Prevention announced today.
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. Emergency department visits for COVID-19 are increasing among all ages and highest in young children. COVID-19 model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
    • “Vaccination
      • “Research finding: An MMWR report released August 21, 2025, found that in the first RSV season (2023–24) where RSV prevention products were available, 29% of infants born during October 2023–March 2024 were immunized against RSV through receipt of nirsevimab (a monoclonal antibody) or maternal RSV vaccination during pregnancy. The report used data from immunization information systems representing 33 states and the District of Columbia. State-specific immunization coverage ranged from 11% to 53%. Preliminary data from the 2024–25 season suggested that RSV immunization coverage increased nationally.
      • “The recent FDA approval and CDC recommendation for an additional monoclonal antibody, clesrovimab, could further increase access and immunization coverage for infants in the 2025–26 respiratory virus season. RSV immunization products will be available beginning in September for most of the continental United States.”
  • The University of Minnesota’s CIDRAP adds,
    • “Emergency department (ED) visits for COVID, still at low levels, also rose, up 15.2% compared to the previous week. Levels are higher in the South, Southeast, and West compared with other parts of the country. The CDC said ED visits are rising for all age groups and are highest in young children.
    • “Hospitalization rates have shown a slight upward trend since July, and the rate of deaths from COVID remains low with no change reported compared with the previous week. 
    • “Due to technical issues, the CDC did not report wastewater data for COVID, influenza A, or respiratory syncytial virus (RSV) today and said it would resume updates as soon as possible. Last week, it said the overall detection level was low and highest in the West.”
  • and
    • “The Kansas Department of Health and Environment (KDHE) yesterday announced the end of a large measles outbreak in the southwestern part of the state, after two incubation periods passed with no new cases.” * * *
    • “Elsewhere, the Wisconsin Department of Health Services and Oconto County Public Health have identified five more measles infections linked to nine earlier cases reported from Oconto County in early August, bringing the total to 14. 
    • “Officials said the ongoing investigation indicates that measles is spreading locally. Oconto County is located in northeastern Wisconsin and is part of the Green Bay area.
    • “In other measles developments, the Pennsylvania Department of Health yesterday issued an alert about potential measles exposures in four counties after an out-of-state traveler visited the state while contagious. The exposures occurred in Adams, Clearfield, Lancaster, and York counties. Locations included two Mennonite facilities, along with a travel center, a restaurant, and an entertainment venue.”
  • Genetic Engineering and Biotechnology tells us,
    • In neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Parkinson’s, and Alzheimer’s, healthy brain cells are damaged by aberrant reactive oxygen species (ROS). A potential treatment involves neutralizing ROS using antioxidant drugs. But these approaches failed to penetrate the brain effectively or proved unstable or indiscriminately damaged healthy cells. 
    • Now, a new study led by scientists at the Institute for Basic Science (IBS) in Daejeon, South Korea explores how the brain defends itself against hydrogen peroxide, a particularly harmful ROS. Using advanced imaging and molecular analysis, they discovered that hemoglobin exists in the nucleolus of astrocytes, where it acts as a “pseudoperoxidase” that breaks down H₂O₂ into harmless water. Full details are published in a new Signal Transduction and Targeted Therapy paper titled “Hemoglobin as a pseudoperoxidase and drug target for oxidative stress-related diseases.”
    • “The key was to uncover hemoglobin’s antioxidant potential in the brain and design a ‘first-in-class’ compound that could selectively enhance it,” said Won Woojin, PhD, first author on the study. “By boosting a natural defense mechanism rather than introducing an external antioxidant, we achieved strong and lasting protection across multiple disease models associated with oxidative stress.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Pittsburgh-based insurer Highmark brought in $16.5 billion in revenue for the first half of 2025, leaning on its health system and other diversified businesses as headwinds batter its payer unit.
    • “That includes $121 million in operating income and $329 million in net income for the first six months of the year. As of June 30, the company had $10.3 billion in net assets.
    • “The midyear financial results reflect an ongoing rebound at Allegheny Health Network, Highmark’s health system. The AHN posted $2.8 billion in revenue and $72 million in operating income for the first half of the year, bolstered by significant improvements to volumes across multiple categories.
    • “In the first half of the year, inpatient discharges and observations were up by 4% and outpatient registrations were up by 5% compared to the first six months of 2024. The AHN also saw a 7% increase in physician visits and a 4% increase in emergency room visits year over year.”
  • Beckers Hospital Review points out,
    • “Boston-based New England Baptist Hospital has the lowest hospital wide readmission rate, while Oroville (Calif.) Hospital has the highest, according to CMS’ Unplanned Hospital Visits database.
    • “The data, released Aug. 6, is based on provider data for hospital return days, including unplanned readmission measures and measures of unplanned hospital visits after outpatient procedures. The data was collected between July 1, 2023, and June 30, 2024.
    • “The article identifies] the 10 hospitals with the highest and lowest hospital wide readmission rates, along with their respective scores.
  • Medical Economics relates,
    • “For decades, referrals and word-of-mouth were the main routes to finding a new physician. Now, according to rater8’s 2025 report, “The Next Evolution of Patient Choice: The Rise of AI in Healthcare Search,” patients are increasingly relying on artificial intelligence (AI), online reviews and social media when deciding where they should seek care.
    • “The survey of more than 1,000 U.S. adults found that 70% are open to — or are already using — AI tools to research physicians. Among patients, 26% said AI recommendations directly influenced their decision — nearly equal to primary care referrals (28%) and health care review sites (29%).”
  • MedTech Dive calls attention to the fact that the “robotic surgery market battle is heating up. After a busy summer of surgical robotics news, check out MedTech Dive’s roundup of coverage in the space.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NCQA, NIH, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The OPM Inspector General recently issued a data brief titled Evaluation of FEHBP Medical Conditions by Premium Expenditure during Contract Years 2019 through 2021. The most expense conditions, representing 10% of spending, was cancer.
  • STAT News reports,
    • “The Centers for Disease Control and Prevention is increasing security after the shooting at its Atlanta headquarters earlier this month, leaders told employees in an email reviewed by STAT.
    • “Additional guards have been added to nearly all campuses, according to the email. CDC is in talks with the Federal Protective Services to increase security at two the campuses where it provides security as well, per the email.”
  • and
    • “Sens. Roger Marshall (R-Kansas) and John Hickenlooper (D-Colo.) are leading a new push to strengthen requirements on price transparency in hospitals, Marshall writes in a new STAT First Opinion article.
    • “The two senators introduced a new bill, the Patients Deserve Price Tags Act, which would require machine-readable files for all negotiated and cash prices, require hospitals to post prices for services, and require patients to receive an explanation of benefits as well as an itemized bill.
    • “It’s part of a years-long movement to crack down on billing practices among providers — one the White House joined in earlier this year via executive order.
    • “But the bipartisan push is far from a guarantee of changes in the current law. Even some widely backed health proposals in Congress have been left behind in must-pass packages. Read Marshall’s piece.”
  • Per a CMS news release,
    • “The U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) are establishing the Healthcare Advisory Committee—a group of experts charged with delivering strategic recommendations directly to HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz to improve how care is financed and delivered across Medicare, Medicaid and the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.
    • “Every American high-quality, affordable care – without red tape, corporate greed, or excessive costs,” said HHS Secretary Robert F. Kennedy Jr. “This new advisory committee will unite the best minds in healthcare to help us deliver real results, hold the system accountable, and drive forward our mission to Make America Healthy Again.” * * *
    • “For more information or to submit nominations, visit the Federal Register Notice at: https://www.federalregister.gov/d/2025-16136.” 
  • Healthcare Dive observes,
    • “White House data sharing plan boasts big ambitions, but has scant details.
    • “Improving health data exchange is a worthy goal, but the initiative has to overcome challenges like data security, under-resourced providers and slow technology uptake, experts say.”
  • Per BioPharma Dive,
    • “The United States and the European Union formalized the terms of the framework trade agreement the two trading partners announced at the end of July, per a joint statement published by the White House Thursday.
    • “The statement provides additional clarity and detail surrounding the terms U.S. President Donald Trump and European Commission President Ursula von der Leyen shared following negotiations in Scotland on July 27, including a 15% tariff on EU imports by the U.S. The two trading partners will “promptly document” the agreement, per the statement.
    • “Under the agreement, the U.S. committed to apply either a tariff of 15% or a “most-favored nation” duty rate on EU imports, with the higher of the two to be enforced. The U.S. will set a cap of 15% on tariffs for imports of pharmaceuticals, semiconductors and lumber, per the statement. Those sectors are currently under Section 232 investigation. Similar probes have led to sector-specific tariffs of up to 50%.
    • “The U.S. also plans to apply only the most-favored nation rate set by the World Trade Organization to aircraft and aircraft parts, generic pharmaceuticals, chemical precursors and “unavailable natural resources,” effective Sept. 1. The two trading partners will “consider other sectors” to add to that group.”
  • The Government Accountability Office tells us,
    • “Over the last decade, federal revenues from tobacco excise taxes have dropped by more than 30%—from about $14 billion to $9 billion from fiscal years 2014 to 2024.   
    • “This loss in revenues is the result of 1) declines in sales for smoking products and 2) differing tax rates for these products. It also coincides with the emergence of new products that aren’t taxed at all.” * * *
    • “If similar tobacco products were taxed the same rate (keeping in mind that some aren’t taxed at all), federal revenues would increase. We estimated that if the tax rate for pipe tobacco were increased to the same rate as roll-your-own tobacco, the federal government could collect at least $1.5 billion dollars in additional revenue for both products from fiscal years 2025-2029.  
    • “Federal revenue would also likely increase if the minimum tax rate for large cigars was the same as that for small cigars. However, it’s a bit trickier to determine a precise estimate because of limited information about the retail prices of large cigars and how consumers might respond to increased taxes.  
    • “We previously recommended that Congress consider leveling (or equalizing) the tax rate on similar tobacco products.  For a more in-depth look at tobacco taxes, check out our new report.” 
  • Tammy Flanagan, writing in Govexec, points out that “Federal employees older than 70 may be leaving thousands on the table. Find out if you or your spouse is missing Social Security benefits.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds.
    • “Plant, once owned by Catalent and now owned by Novo Nordisk, is widely used by pharma industry.
  • and
    • “The Food and Drug Administration has agreed to decide by late next month whether to approve an ultra-rare disease drug developed by Stealth BioTherapeutics, a significant step after the company claimed it may have to close its doors if an agency endorsement is not made in coming weeks.
    • “The move comes after protracted uncertainty surrounding the fate of the medication, which was developed to treat Barth syndrome, a rare illness that afflicts about 150 people in the U.S. The company and the FDA have struggled to agree on ways to generate enough of the right kind of study data to make the drug available to this tiny population of patients.”
  • PharmaPhorum lets us know,
    • “Iterum Therapeutics has become the first drugmaker to bring an oral antibiotic in the penem class to market in the US, launching Orlynvah as a treatment for uncomplicated urinary tract infections (uUTIs).
    • The launch of the product – which comes a few months after Orlynvah (sulopenem etzadroxil and probenecid) was approved by the FDA – keeps the Dublin, Ireland-headquartered biotech ahead of rival companies bidding to bring new therapies for uUTIs to the US market.
    • That includes GSK with Blujepa (gepotidacin) – which was approved in March by the FDA as the first drug with a new mechanism of action for uUTIs in nearly three decades – as well as Alembic Pharma with Pivya (pivmecillinam), cleared for uUTIs in 2024 and acquired when Alembic bought Utility Therapeutics last month. Both Blujepa and Pivya are due to be launched in the US before the end of the year.
    • Specifically, Orlynvah was given a green light by the FDA for adult women with uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis with limited or no alternative oral antibacterial options. It was initially turned down by the agency, which issued a complete response letter (CRL) to Iterum in 2021 with a request for more data.
  • Per MedTech Dive,
    • “NeuroOne Medical Technologies received Food and Drug Administration clearance for a minimally invasive nerve ablation system to treat trigeminal neuralgia, a condition that causes severe, chronic facial pain.
    • “Trigeminal neuralgia is typically treated with medication or invasive procedures. NeuroOne’s OneRF ablation system uses radiofrequency energy to create lesions to interrupt pain signals.
    • “NeuroOne filed its FDA submission in April, earlier than previously anticipated. The Eden Prairie, Minnesota-based company said Monday it now expects to launch the device on a limited basis in the fourth quarter of this year.”
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for the rare genetic disease hereditary angioedema, making the therapy, known as donidalorsen, the third new medicine to reach market this year for the rare genetic condition.
    • “Donidalorsen, which Ionis will sell under the brand name Dawnzera, is approved to prevent the swelling attacks associated with hereditary angioedema in adults and children at least 12 years of age. Dawnzera has a list price of $57,642 per dose, company executives said in a conference call.
    • “The price is “based on the efficacy, the data and the supporting evidence,” Chief Global Product Strategy Officer Kyle Jenne told analysts on the call. “The payers, we believe, will be very accepting of the price, since it’s in line with the other products that are in the HAE space today.”
  • and
    • “A total of 1,176 products have received the Food and Drug Administration’s breakthrough device designation since 2015, according to the agency’s latest update on Wednesday.
    • “The FDA gives the designation to devices that may provide more effective treatment or diagnosis of life-threatening or debilitating conditions. In its 2025 fiscal year, which began in October, the agency had granted 136 breakthrough designations as of June 30.
    • “The FDA shared the update as medical device companies lobby for faster Medicare coverage of breakthrough devices.”

From the judicial front,

  • Bloomberg Law reports,
    • “A divided US Supreme Court let the Trump administration cut off potentially hundreds of millions of dollars in medical research grants that government officials say don’t align with the president’s policies.
    • “The justices largely put on hold a federal trial judge’s decision that the National Institutes of Health acted in an “arbitrary and capricious” manner when it terminated thousands of grants as part of President Donald Trump’s crackdown on diversity, equity and inclusion.”

From the public health and medical research front,

  • Per an FDA news release,
    • “FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Frozen, Raw, Half-shell Oysters from Republic of Korea Potentially Contaminated with Norovirus.”
  • Health Day informs us,
    • “Seniors with known heart-related problems aren’t doing a very good job taking steps to protect their health, a new study says.
    • “Older folks with high blood pressure, stroke survivors and heart failure patients in the United States all have been neglecting Life’s Essential 8 — a checklist of lifestyle factors that can protect heart health, researchers found.
    • “On average, participants with one cardiovascular disease had a Life’s Essential 8 score 9 points lower than those without cardiovascular disease,” lead researcher James Walker, a medical student at Northwestern University in Chicago, said in a news release.
    • “Life’s Essential 8 recommends that people eat healthy, exercise, avoid smoking, sleep better, lose excess weight, and manage their cholesterol, blood sugar and blood pressure levels, according to the American Heart Association.”
  • MedPage Today lets us know,
    • “Patients taking GLP-1 agonists for weight loss had a small but significantly lower risk of developing cancer, a large retrospective cohort study showed.
    • “With follow-up ranging from 1 to 11 years, use of GLP-1 agonists, such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), was associated with a 17% lower cancer risk as compared with non-users. Cancer incidence was lower for 12 of 13 recognized obesity-related cancers, plus lung cancer. The difference between users and non-users reached statistical significance for endometrial and ovarian cancers and meningioma.
    • “The only outlier was kidney cancer, which occurred more often among users of GLP-1 agonists and was associated with a non-significant 38% increased risk, reported Jiang Bian, PhD, of the Regenstrief Institute in Indianapolis, and co-authors in JAMA Oncology.
    • “Given that more than 137 million individuals in the U.S. are currently eligible for GLP-1RA [receptor agonist] therapies, even modest changes in cancer risk could have substantial public health implications,” the authors stated in their discussion. “This study is one of the first to assess the association between GLP-1RA use and cancer risk in the broad, real-world population with obesity or overweight who are eligible for AOMs [anti-obesity medications].”
  • Per a National Institute of Standards and Technology news release,
    • “Scientists at the National Institute of Standards and Technology (NIST) have developed a new technology for measuring how radiation damages DNA molecules. This novel technique, which passes DNA through tiny openings called nanopores, detects radiation damage much faster and more accurately than existing methods. It could lead to improved radiation therapy for cancer and more personalized care for individuals during radiological emergencies.
    • “With nanopore sensing, we’re not just measuring radiation damage; we’re rewriting the rules on how quickly and effectively we can respond to both cancer care and emergencies,” said NIST physical scientist Joseph Robertson.”
  • Per a National Institutes of Health news release,
    • “In a first-of-its-kind study, researchers found that the brain’s control center for a lost appendage can persist long after surgical amputation, which stands in stark contrast to longstanding theories about the brain’s ability to reorganize itself, also known as plasticity. Scientists from the National Institutes of Health (NIH) and their colleagues examined human brain activity before and after arm amputation and found that the loss of a limb does not prompt a large-scale cerebral overhaul. Published in the journal Nature Neuroscience, this study offers new insight into the mysterious phantom limb syndrome and could help guide the development of neuroprosthetics and pain treatments for people with limb loss.
    • “A team of scientists from NIH and University College London acted on a unique window of opportunity, running MRI scans on three participants in the months prior to a planned amputation (performed for separate medical purposes) and then up to five years after.
    • “It’s not often you get the chance to conduct a study like this one, so we wanted to be exceedingly thorough,” said co-author Chris Baker, Ph.D., of NIH’s National Institute of Mental Health (NIMH). “We approached our data from a variety of angles and all of our results tell a consistent story.”
  • Per NCQA.
    • ‘Chronic kidney disease (CKD) affects nearly 36 million adults in the U.S., yet it remains underdiagnosed and undertreated. NCQA convened an expert panel of clinicians and patient advocates to discuss current challenges and future opportunities associated with the assessment, diagnosis and management of CKD.’
    • This NCQA article discusses this convention.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth is forming a new board committee to “monitor and oversee financial, regulatory and reputational risks” as the healthcare juggernaut tries to improve its standing with lawmakers, regulators, investors and the U.S. public.
    • “The “public responsibility committee” will “provide an additional layer of governance,” UnitedHealth said in a securities filing on Wednesday. The committee’s key responsibilities include underwriting and forecasting, regulatory relationships, reputational matters and mergers and acquisitions — all areas for which UnitedHealth has been in the public eye.
    • “Michele Hooper, who’s served on UnitedHealth’s board since 2007, will step down as lead independent director to chair the committee. Hooper, who will remain a director, will be replaced as lead independent director by F. William McNabb, the former CEO of investing firm the Vanguard Group who has served on UnitedHealth’s board since 2018.”
  • The International Foundation of Employee Benefit Plans discusses various GLP-1 coverage strategies.
  • Per Beckers Hospital Review,
    • “Philadelphia-based Temple Health has acquired Redeemer Health’s 20% stake in Chestnut Hill Hospital, giving the academic system an 80% ownership interest in the hospital.
    • “This was a planned transaction that comes approximately two and a half years after Chestnut Hill Hospital was acquired by an alliance consisting of Temple Health, [Meadowbrook, Pa.-based] Redeemer and the Philadelphia College of Osteopathic Medicine,” a spokesperson for the health system told Becker’s. “Temple Health manages Chestnut Hill Hospital and now has an 80% ownership stake in the hospital.”
    • “With the transaction, Redeemer has exited the alliance, while the Philadelphia College of Osteopathic Medicine retains a 20% ownership stake in the148-bed hospital.”
  • and
    • “Sacramento-based Sutter Health plans to close its Jackson, Calif.-based Sutter Amador Surgery Center on Oct. 3.
    • “In an open letter to the community, obtained by Becker’s, Sutter Amador Hospital CEO Michael Cureton, Sutter Amador Surgery Center’s ambulatory services administrator, Branden Nelson, and the surgery center’s executive of operations, Johnny Russell, said the outpatient surgery center closure will help “align resources with areas of growing need” in the community it serves.”
  • Radiology Business relates,
    • “A “hybrid” artificial intelligence strategy—using a combination of radiologist readers and standalone AI interpretation of cases—can cut rads’ workloads by nearly 40%, according to new research. 
    • “Such technology has shown great promise in boosting physician performance, including helping to triage scans requiring added attention. However, AI implementation in breast cancer screening remains limited for various reasons, amid concerns it may miss some relevant cases, experts wrote Tuesday in RSNA’s Radiology.” 
  • BioPharma Dive reports,
    • Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday a deal to pay $350 million to buy privately held Interius BioTherapeutics for a technology designed to reprogram immune cells in patients’ bodies.
    • If successful, Interius’ “in vivo” approach could yield a simpler alternative to the CAR-T therapies Gilead’s Kite Pharma division have brought to market, each of which includes extravagant production processes that involve manipulating cells in a lab. 
    • Gilead spent $12 billion to buy Kite nearly a decade ago and, since then, has become a leader in CAR-T therapies. That business has sputtered recently amid declining demand and competition from other developers. But Gilead is still investing through acquisitions and partnerships, such as a collaboration with Arcellx in multiple myeloma.
  • and
    • “Sarepta on Thursday said it’s reached agreements that remove about $700 million from a pile of debt due in 2027.
    • “The private agreements with debt holders will allow Sarepta to exchange the 1.25% convertible senior notes due in 2027 for $602 million worth of 4.875% convertible senior notes due in 2030, up to 6.7 million shares of Sarepta stock and about $123 million in cash. Separately, the company entered into a private placement of about 1.4 million shares.
    • “The transaction “significantly enhances our balance sheet flexibility and strengthens our financial position,” Sarepta CEO Doug Ingram said in a statement. Sarepta will still have $450 million in existing convertible notes due in 2027.”
  • and
    • “Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest among certain firms in buying floundering drugmakers and shutting them down.
    • “Xoma on Wednesday agreed to buy Mural Oncology, a cancer biotech once spun out of Alkermes. Per deal terms, a Xoma subsidiary will acquire Mural for $2.035 per share. Mural stockholders could get up to another $0.205 per share if the company’s net cash holdings at the deal’s closing exceeds $36.2 million.
    • “The deal values Mural at the level of its cash reserves and represents a roughly 13% premium to the company’s closing share price of $1.80 on Tuesday. Xoma will wind down Mural’s business afterwards, according to the announcement.
    • “In acquiring and liquidating Mural, Xoma is extending a pattern among certain firms and investors to shut down drug companies whose depressed share prices leave them worth less than their cash holdings. Historically, these biotech “zombies” would pivot to new projects or merge with another drug company. Of late, however, investors are heightening pressure on company boards to return cash to shareholders instead.”

Midweek report

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

From Washington, DC

  • Bloomberg Law notes,
    • Gender-affirming care will no longer be covered for federal workers in 2026, according to a letter the Trump administration sent to insurance carriers. * * *
    • The announcement, dated Aug. 15, cements the administration’s expected move to halt gender-affirming care following President Donald Trump’s January executive order to enforce laws based on a person’s biological sex. The exclusion likely tees up legal challenges under Title VII of the 1964 Civil Rights Act and Section 1557 of the Affordable Care Act, both of which contain anti-discrimination protections.
    • “This discriminatory policy denying medical care to government employees and their dependents is not only cruel—it is illegal,” Omar Gonzalez-Pagan, Lambda Legal counsel and health-care strategist, said in a statement. “The federal government cannot simply strip away essential healthcare coverage from transgender employees while providing comprehensive medical care to all other federal workers.”
  • The American Hospital Association News points out,
    • “A JAMA study published Aug. 18 found that plan design changes by Medicare Part D insurers, particularly for Medicare Advantage plans, following passage of the Inflation Reduction Act of 2022 could lead to higher cost sharing for some beneficiaries who do not reach the $2,000 out-of-pocket maximum for prescription drug coverage in 2025. Researchers said policies prevented premium increases in 2025, but Part D plans may have responded by increasing deductibles or medication cost sharing. The study found mean deductibles for MA plans decreased from $153 in 2019 to $66 in 2024, before sharply increasing to $228 for 2025. Additionally, the proportion of MA beneficiaries with coinsurance for preferred brand-name drugs ranged from 0.8% to 2.5% from 2019 to 2024, before increasing to 27.7% in 2025.”
  • BioPharma Dive tells us,
    • “A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices.
    • “DTC advertising has long been a target of Health and Human Services Secretary and MAHA leader Robert F. Kennedy Jr. While Congress has taken some interest in passing a ban on those ads, real reform hasn’t gained momentum.” * * *
    • “Listed under “policy reforms” within the draft, the focus on DTC advertising states that the FDA, HHS, the Federal Trade Commission and Department of Justice would “increase oversight and enforcement” under current laws for DTC prescription drug advertising violations. Instead of focusing on all media platforms, the agencies will “prioritize the most egregious violations,” such as those by social media influencers and telehealth companies.”
  • AP reports,
    • “When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert advisers who are carefully vetted for their independence, credentials and judgment.
    • “But increasingly, the agency isn’t calling them.
    • “Instead, FDA Commissioner Marty Makary has launched a series of ad hoc “expert panels” to discuss antidepressants, menopause drugs and other topics with physicians and researchers who often have contrarian views and financial interests in the subjects.”

From the judicial front,

  • Beckers Payer Issues informs us,
    • “A federal judge has approved a $2.8 billion settlement resolving antitrust claims brought by healthcare providers against the Blue Cross Blue Shield Association and its independent entities, ending more than a decade of litigation.
    • “The settlement was approved Aug. 19 and covers a class of millions of hospitals, physician practices, and other providers nationwide who accused the Blues of conspiring to divide up markets to avoid competing with one another, which allegedly drove up costs and reduced reimbursements.
    • “Under the agreement, about $1.78 billion will be distributed to healthcare facilities, while $152 million is earmarked for medical professionals. The settlement also implements structural reforms valued at more than $17 billion, including how BCBS plans process claims, and how they communicate, contract with, and make payments to providers. The settlement applies to providers who treated BCBS members between July 2008 and October 2024.”
  • Per Healthcare Dive,
    • “A federal judge has vacated a Biden-era rule that would have curbed Medicare Advantage plans’ payouts to agents and brokers.
    • “On Monday, Judge Reed O’Connor of the Texas Northern District Court ruled that the CMS overstepped its authority in trying to cap payments to MA sales organizations beyond direct compensation, and in prohibiting contracts that incentivize brokers to steer seniors to specific plans.
    • “CMS may only regulate how compensation is used, not engage in ratemaking,” O’Connor wrote in his decision. It’s a loss for smaller plans, which argue that the status quo benefits larger and wealthier insurers, and a setback for efforts to curb predatory marketing in the privatized Medicare program.”
  • and
    • “Elevance has lost a legal bid to improve its Medicare Advantage quality ratings for 2025.
    • “On Monday, a Texas federal judge threw out the insurer’s suit and offered a biting indictment of Elevance’s legal argument, saying it relied on distorted math.
    • “The lower star ratings will cost Elevance at least $375 million in bonus payments and rebates.”
  • Per a U.S. Justice Department news release,
    • “Troy Health, Inc. (Troy), a North Carolina-based provider of Medicare Advantage, Medicare Part D, and Dual Eligible Special Needs Plans, has entered into a non-prosecution agreement with the Department of Justice to resolve a criminal investigation into a health care fraud and identity theft scheme involving the use of artificial intelligence and automation software to illegally obtain Medicare beneficiary information and fraudulently enroll beneficiaries into its Medicare Advantage plans.
    • “Troy told low-income Medicare beneficiaries that it would use new technologies, including its proprietary artificial intelligence platform, to improve patient health outcomes,” said Acting Assistant Attorney General Matthew Galeotti of the Justice Department’s Criminal Division. “Instead, the company misused patient data to enroll beneficiaries in its Medicare Advantage plan without their consent. Today’s resolution reflects the Criminal Division’s emerging focus on corporate enforcement in the health care space and holding both individuals and companies accountable when they defraud our medical system to enrich themselves at the expense of the American taxpayer.”
  • Per a news release from the U.S. Attorney for the Northern District of California,
    • “American Psychiatric Centers, Inc., doing business under the name Comprehensive Psychiatric Services (CPS), has agreed to pay $2.75 million to resolve allegations that CPS violated the False Claims Act by submitting false claims to government healthcare payors for certain psychotherapy services.
    • “CPS, which is headquartered in Walnut Creek, Calif., provides behavioral medicine services for individuals and families in the State of California.  Since at least 2015, CPS and its healthcare providers have submitted claims to government payors using Current Procedural Terminology codes 90833 and 90836, which are “add-on” codes to be used when psychotherapy services are performed in conjunction with an evaluation and management visit, and which require specific documentation.
    • “The settlement announced today resolves the government’s allegations that, from Jan. 1, 2015, through Dec. 31, 2022, CPS submitted fraudulent claims using these add-on codes in instances where its healthcare providers either had not provided the services described by those codes or had failed to sufficiently document that such services had been provided.  CPS will pay $2,615,569.32 to the United States and $134,430.68 to the State of California. * * *
    • “False claims increase costs and undermine the integrity of our federal health care programs, including the Federal Employees Health Benefits Program,” said Derek M. Holt, Special Agent in Charge, the U.S. Office of Personnel Management Office of the Inspector General (OPM OIG). “We support the work of our law enforcement partners and colleagues to investigate fraudulent medical billing that wastes taxpayer dollars.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 19, 2025, a total of 1,375 confirmed measles cases were reported by 42 jurisdictions: Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York City, New York State, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.
    • “There have been 35 outbreaks reported in 2025, and 87% of confirmed cases (1,190 of 1,375) are outbreak-associated. For comparison, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.”
  • Per Medscape,
    • “The experimental drug obicetrapib, a potent oral cholesteryl ester transfer protein (CETP) inhibitor, significantly slowed Alzheimer’s disease (AD) biomarker progression over 12 months in patients with cardiovascular disease, new research showed.
    • “Results revealed the drug led to a 20% improvement in levels of phosphorylated tau 217 (p-tau217) — an important indicator of AD pathology — in patients carrying the apolipoprotein E (APOE4) allele. About 65% of people with AD are APOE4 carriers.
    • “The treatment was already shown to reduce LDL cholesterol and increase HDL cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
    • “It’s encouraging to have a drug that treats cardiovascular disease and treats or prevents AD, study investigator Philip Scheltens, MD, PhD, professor of neurology and founder of the Alzheimer’s Center, Amsterdam University Medical Center, Amsterdam, the Netherlands, told Medscape Medical News.“
  • Per the University of Minnesota’s CIDRAP,
    • “Non-White US Lyme disease patients with Medicaid or Medicare coverage were more likely than their White peers to be female, hospitalized at diagnosis, diagnosed outside of primary care and the summer months, and to have disseminated disease (more widespread in the body), per a new study by Pfizer scientists co-developing a vaccine against the tick-borne infection with Valneva.
    • “From 2016 to 2021, the researchers analyzed claims-based data from 15 Lyme-prevalent states and Washington, DC, on Medicaid beneficiaries 18 years and younger and 19 and older and Medicare fee-for-service beneficiaries younger than 65 and 65 and older. 
    • “The findings were published Monday in Emerging Infectious Diseases.”
  • Medscape also calls attention to five things to know about cervical cancer.
  • Per the AHA News,
    • “B. Braun Medical has voluntarily recalled two lots of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL IV fluids due to particles inside the container, according to the Food and Drug Administration. The company said there have been no reports of serious injury, death or other adverse events associated with the issue. B. Braun said affected products should be returned to the company and not be destroyed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies are looking to cut costs by ranking providers like they tier pharmaceuticals.
    • “Last week, HealthPartners announced plans to offer large employers its Simplica NextGen Copay, a plan that sets fixed copays by provider and eliminates coinsurance and deductibles. CVS Health subsidiary Aetna is rolling out Aetna Informed Choice, a new plan for employers based on its variable copay plan, a spokesperson said in an email. In February, Blue Cross and Blue Shield of Minnesota launched a new investment arm focused on developing tools for its variable copay plan, Coupe Health.
    • “There’s been a resurgence in them,” said Katherine Hempstead, senior policy officer at the Robert Wood Johnson Foundation, a healthcare research philanthropy. 
    • “Variable copay plans are part of the tide of alternative health plans that have emerged in recent years, promising to help employers save costs without shifting more of the expenses to employees by raising deductibles. Like high-deductible plans, variable copay plans operate on the assumption that giving consumers “skin in the game” will drive them to select the most cost-effective service. High-deductible plans often raise costs for patients and insurers because high upfront costs drive patients to forego preventive care or drugs needed to manage their condition, worsening their health, according to a 2018 study by the University of Southern California Leonard D. Schaeffer Center Institute for Public Policy and Government Service. 
    • “The variable copay plans are constructed similarly to a tiered provider network, a long-standing health insurance benefits design that gives members the option of seeing the full array of providers but lowers cost-sharing if enrollees choose the preferred clinicians. 
    • “These are not new and not shiny,” said Sabrina Corlette, co-director of the Georgetown University Center on Health Insurance Reforms.”
  • Per Beckers Hospital Review,
    • Rochester, Minn.-based Mayo Clinic recorded an income from current activities of $380 million (7.1% margin) in the second quarter of 2025 quarter, down from $449 million (8.9% margin) during the same period last year, according to its Aug. 18 financial report. 
    • Total operating revenue was $5.3 billion for the three months ended June 30, up from $5 billion during the same period last year. Mayo’s net patient service revenue was $4.5 billion, an 8.6% increase year over year. The system attributed the growth to strong outpatient, surgical and hospital volumes, as well as increased service demand. 
  • and
    • “Somerville, Mass.-based Mass General Brigham recorded an operating income of $74.4 million (1.3% operating margin) in the third quarter of 2025, up from $47.2 million (0.9% margin) during the same period last year, according to its Aug. 15 financial report. 
    • “The system reported total operating revenue of $5.8 billion for the three months ended June 30, a 12% increase year over year. Patient care revenue totaled $3.7 billion, an 8% increase year over year. The system said this reflected a 3% increase in acute care discharges. Premium revenue increased 19% year over year to $671 million.”
  • Modern Healthcare adds,
    • Hospital costs are growing as an increasing number of sicker patients visit the emergency department, according to a new report.
    • “The average cost of an inpatient stay rose 4.8% from mid-2023 to early 2025, according to the latest national data from Sg2, a data analytics company owned by group purchasing organization Vizient. At academic medical centers, per-case cost growth nearly doubled the rate of expense inflation at community hospitals between the first quarters of 2022 and 2025.
    • “Most people arriving at emergency departments require immediate attention, which may help explain why treatment costs are increasing. Hospitals are having a tough time keeping up with demand for care as the population ages, leading to overcrowded ERs and full inpatient units. 
    • “Providers are expected to get even busier over the next 10 years, potentially creating more care backlogs, according to the report.” 
  • Beckers Hospital Review also shares RN median hourly rates by state.
    • “Median hourly base pay for registered nurses varies across states, with RNs in California earning the most, according to SullivanCotter’s “2025 Health Care Staff Compensation Survey Report.”
    • “The survey, released in July, covers nearly 2.5 million healthcare employees across over 2,660 participating organizations, including more than 800,000 individual RNs, licensed practical nurses and nursing managers.”
  • MedTech Dive offers an interview with Josep Solà, the CEO of Aktiia, whose company received In July, FDA authoriz[ation for] the first over-the-counter cuffless blood pressure monitor.
  • and tells us
    • “Venture capital investment in medtech surged at the start of 2025, prompting PitchBook to forecast a strong year ahead for funding in the sector after several sluggish years.
    • “The market data research firm counted 11 rounds worth at least $100 million each, and $4.1 billion in total venture capital funding in the first quarter alone. Brain implant startup Neuralink’s $650 million Series E financing, announced in June, was a standout as momentum continued in the second quarter.
    • “In a steady stream of private financings this summer, heart devices have been a focus. In July, Kardium announced it raised $250 million as it prepares to launch its pulsed field ablation system for atrial fibrillation, and Field Medical brought in another $35 million to study PFA in ventricular tachycardia.”
  • Beckers Hospital Review relates,
    • “Walgreens Specialty Pharmacy, which earned $25.9 billion last year from U.S. prescription revenue, has expanded its limited distribution drug portfolio to 265 medications, the company said Aug. 19. 
    • “Limited distribution drugs are specialty medications that have complex regimens, high costs and/or special handling requirements. Therapies for chronic diseases and cancers are typically administered at specialty pharmacies. These medications account for about 75% of drugs in development, according to Walgreens. 
    • “The company’s specialty pharmacy added leukemia drug Imkeldi (imatinib), HIV preventive Yeztugo (lenacapavir) and chronic skin condition treatment Imkeldi (imatinib) to its network.” 

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, NIH, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor, who is a lawyer, posted his latest blog entry today. The post is titled “Building Momentum Through Legal Wins.”
  • STAT News reports,
    • “US Health Secretary Robert F. Kennedy Jr.’s regulatory roadmap shows the Trump administration plans to continue efforts scaling back on gender-affirming care, advancing its Make America Healthy Again agenda, and restructuring how it grapples with Covid-19 vaccines.
    • “The US government on Friday posted the semi-annual regulatory agenda that details planned rulemaking for the Department of Health and Human Services, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and other federal health agencies.
    • “The agenda was originally posted online Friday morning but later was removed and replaced with an “under maintenance” message. The Office of Management and Budget’s press office did not immediately respond to an email seeking comment.”
  • The reginfo.gov website on which the semi-annual regulatory agenda is posted still says “The system is under maintenance. It will be back shortly” at 6 pm ET.
  • OPM circulated a last minute 2026 benefit change via this carrier letter (Dropbox link).
    • “For Plan Year 2026, chemical and surgical modification of an individual’s sex traits through medical interventions (to include “gender transition” services) will no longer be covered under the FEHB or PSHB Programs. This exclusion expands upon Carrier Letter 2025-01a and applies regardless of age.”
    • The letter also describes exceptions to this rule.
  • The Hill informs us,
    • “By the end of 2025, the Trump administration likely will have shed around 300,000 workers, Office of Personnel Management Director Scott Kupor told Reuters on Thursday.
    • “The mass departures, which Kupor claimed were largely accounted for by voluntary buyouts rather than firings, would constitute a 12.5 percent reduction of the federal workforce from when President Trump was inaugurated in January.”
  • Federal News Network reports,
    • “The Office of Personnel Management has officially canceled this year’s version of the signature survey that assesses governmentwide satisfaction and engagement levels of federal employees.
    • “In a memo distributed to agency chief human capital officers on Friday afternoon, obtained by Federal News Network, OPM said after initially only delaying the survey, it has now fully scrapped plans to conduct the 2025 Federal Employee Viewpoint Survey.”
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Innovation Center Aug. 12 released an FAQ on the Wasteful and Inappropriate Service Reduction Model, a six-year technology-enabled prior authorization program pilot. CMS will partner with third-party entities to implement the program for a specified list of services delivered to patients with Original Medicare. The FAQs address patient rights, the coverage review process for beneficiaries and providers, safeguarding against inappropriate denials, protecting patient data and more. The model begins Jan. 1.”
  • and
    • “The Health Resources and Services Administration has awarded more than $15 million in grants to 58 rural health organizations for four-year projects as part of the Federal Office of Rural Health Policy’s Rural Health Care Services Outreach program. The awardees must use innovative, evidence-informed models to address health care needs unique to their communities that are designed to expand access to care and improve health outcomes. The projects will be conducted by a local network of partnering organizations that may include rural hospitals, community-based organizations, health departments, schools, health centers, rural health clinics, academic institutions and other local and state entities.  
  • NCQA, writing in LinkedIn, informs us,
    • “NCQA and The Praxis Project are collaborating on a perinatal measure development project to create, validate and implement an actionable set of measures that align health plans toward improving perinatal health. The project team is developing up to eight new measures for potential inclusion in HEDIS® (Healthcare Effectiveness Data and Information Set) and in other national accountability programs.
    • “Currently, the teams are seeking testing partners—health plans, health systems, state agencies, community-based organizations, Federally Qualified Health Centers, birth centers—to help evaluate the feasibility, validity, reliability and usability of the new measures through a learning network, beginning this fall.”

From the Food and Drug Administration front,

  • BioPharma Dive lets us know,
    • “The Food and Drug Administration granted full approval to a first-of-its-kind treatment for recurrent respiratory papillomatosis, a rare and potentially life-threatening condition caused by persistent HPV infections. Thursday’s clearance of Precigen’s Papzimeos, an immunotherapy that helps clear HPV-infected cells, was based on study results showing a little more than half of drug recipients didn’t need surgery within a year of therapy. Center for Biologics Evaluation and Research director Vinay Prasad, who rejoined the FDA this week, described the approval as proof “randomized trials are not always needed to approve medical products.”
  • Cardiology Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about ongoing safety issues with a series of cannulae used to vent the left side of the heat during cardiopulmonary bypass surgery procedures. The agency’s alert includes dozens of lots of Medtronic’s DLP Left Heart Vent Catheters with malleable bodies and vented connectors. 
    • “The FDA put this early alert in place after receiving multiple reports of the catheters “resisting shape retention when being bent.” The devices were specifically designed to be easy to bend, holding their shape in a way that helps clinicians work in safe, efficient manner. When the devices fail to retain their shape, however, it can cause delays in care while a replacement catheter is located. 
    • “If the issue is not identified prior to use and the clinician uses the cannula, it may lead to abrasion and perforation (cuts),” according to the FDA’s advisory. “Perforation of critical heart tissue may potentially lead to death if it is complicated, unnoticed or untreated.”
    • “This issue has been linked to three serious injuries as of July 28. No patient deaths have been reported.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota’s CIDRAP lets us know,
    • New survey data from the Centers for Disease Control and Prevention (CDC) shows that uptake of two vaccines routinely recommended for teens increased last year, while coverage with another recommended shot remained flat.
    • The data from the 2024 National Immunization Survey-Teen, published yesterday in Morbidity and Mortality Weekly Report, show that, among 16,325 US adolescents aged 13 to 17 years, coverage with more than one dose of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine increased from 89.0% in 2023 to 91.3% in 2024. Coverage with one or more dose of the quadrivalent (four-strain) meningococcal conjugate vaccine (MenACWY) rose from 88.4% to 90.1%.
    • Coverage with one or more Tdap dose was 90% or higher in 39 states, while coverage with one or more MenACWY dose was 90% or higher in 30 states. The survey also found that coverage with other recommended and catch-up vaccines increased in 2024, including the meningococcal group B vaccine (up 4.5 percentage point among 17-year-olds); the measles, mumps, and rubella vaccine (a 1.3-percentage-point increase in 13- to 17-year-olds with 2 or more doses); and the hepatitis B vaccine (a 1.3-percentage-point increase in teens with 3 or more doses).
    • “These findings highlight progress in public health activities to improve vaccination coverage,” CDC researchers wrote.
    • “Human papillomavirus (HPV) vaccine coverage among teens remained unchanged for the third straight year, however, with 78.2% having received one or more doses and 62.9% reporting they were up to date with the HPV vaccine. Coverage with one or more HPV vaccine doses was 80% or higher in 26 states and the District of Columbia.”
  • MedPage Today relates,
    • “Genetic susceptibility accounts for 20% of ovarian cancer risk, and risk-reducing bilateral salpingectomy remains the gold standard for prevention.
    • “In this study, about 24% of patients with high-grade serous ovarian cancer had missed opportunities for risk-reducing surgery before cancer diagnosis.
    • “Among the women with a first-degree family history of ovarian cancer, 43.2% had mutations that increased susceptibility to ovarian cancer.”
  • and
    • “A BMJ guideline put patient risk into the equation for assessing the suitability of SGLT-2 inhibitors and GLP-1 receptor agonist drugs for type 2 diabetes.
    • “Their use in type 2 diabetes was only strongly recommended for people at higher risk of cardiovascular and kidney complications.
    • “Meanwhile, these costly medications continue to be used more and more in the U.S. for a variety of indications.”
  • The AHA News points out,
    • “The American Heart Association and American College of Cardiology Aug. 14 released new guidelines on high blood pressure prevention, suggesting earlier treatment can reduce the risk of cognitive decline and dementia, as well as cardiovascular disease, stroke and kidney disease. The new guidelines replace those issued in 2017 and include new or updated recommendations for medication options and managing high blood pressure before, during and after pregnancy. The guidelines also reinforce the importance of healthy lifestyle behaviors such as eating a nutritious diet, being physically active, and maintaining or achieving a healthy weight.”
  • Per an NIH news release,
    • “Scientists at the National Institutes of Health (NIH) successfully reduced the severity of late-onset Tay-Sachs (LOTS) disease in human cell cultures and a mouse model by using a novel gene-editing treatment. LOTS is a rare form of Tay-Sachs disease, with signs and symptoms such as muscle weakness, loss of coordination, muscle spasms, and sometimes loss of mental function beginning in late childhood to adulthood. Similar disorders for which this breakthrough has implications include GM1 gangliosidosis, Sandhoff disease, Niemann-Pick disease, Krabbe disease and Gaucher disease.
    • “LOTS is a genetic disorder caused by a mutation in the HEXA gene that causes a deficiency of an enzyme that is critical to breaking down a fatty substance in the brain, known as GM2 ganglioside. The buildup of this fatty substance damages nerve cells in the brain and spinal cord. The amount of enzyme still being produced by the body affects the severity of the disease and the age of onset. By deploying the correction to the HEXA gene, scientists were able to increase the activity of the enzyme, known as beta-hexosaminidase A, delay symptom onset and significantly extend lifespan in the mouse model.
    • “With LOTS, a slight correction will go a long way. This editing may only need to increase enzyme activity by about 10% to keep symptoms from getting worse, and improve their quality of life,” said paper author Dr. Richard Proia of NIH’s National Institute of Diabetes and Digestive and Kidney Diseases. “We’ve figured out that opening the door to increased enzyme activity is possible, now we have to figure out how to do it in a person.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Shares of UnitedHealth Group (UNH.N), opens new tab surged nearly 14% on Friday after billionaire Warren Buffett’s Berkshire Hathaway (BRKa.N), opens new tab bought 5 million shares of the company, providing a shot in the arm for investors who think the health conglomerate will turn around under its new CEO.
    • “The shares have lost nearly half their value in the last year as the company struggled to adapt to rising healthcare costs and changes to government reimbursement plans that affected its health insurance and Optum patient care businesses.”
  • The Wall Street Journal relates,
    • “Nike co-founder Phil Knight and his wife, Penny Knight, are donating $2 billion to Oregon Health & Science University’s Knight Cancer Institute—the largest known single gift to a U.S. university, coming at a time when colleges’ public funding is under siege.
    • “The gift will roughly double the size of the cancer center, expanding its capacity to treat patients and conduct research. 
    • “The effort will be led by Dr. Brian Druker, a cancer-research pioneer known for developing Gleevec, a drug that transformed the survival of patients with chronic myeloid leukemia, a cancer of the blood and bone marrow. Druker, an OHSU professor who led the Knight Cancer Institute as chief executive officer until December, will return as the organization’s president. 
    • “We couldn’t be more excited about the transformational potential of this work for humanity,” the Knights said in a news release Thursday.”
  • Per Beckers Hospital Review,
    • “Hospitals and health systems are preparing for a rise in high-risk pregnancies, even as many labor and delivery units shut down. 
    • “Vizient company Sg2 projected that the proportion of high-risk pregnancies will accelerate alongside a rise in obesity-related comorbidities, including high blood pressure and diabetes. 
    • “Baptist Medical Center Jacksonville, part of Jacksonville, Fla.-based Baptist Health, is expanding its labor and delivery services in preparation for a 14.5% increase in high-risk pregnancies over the next decade, NPR affiliate WUSF reported Aug. 14. 
    • “The conundrum is this: Multiple health systems and hospitals are ending labor and delivery services, citing a decrease in birth rates, financial challenges and a workforce shortage. And although the national birth rate is declining, neonatal ICU admissions are increasing.
    • “There are a few factors contributing to the trend, including better survival rates of premature infants, an advancing maternal age and a rise in chronic maternal conditions. 
    • “In response to this trend, a different system of the same name, Little Rock, Ark.-based Baptist Health, announced in June an effort to improve maternal and children health outcomes for high-risk pregnancies. The initiative is Nashville, Tenn.-based Vanderbilt University’s Maternal Infant Health Outreach Worker Program, which targets economically disadvantaged and geographically isolated communities.” 
  • Per MedTech Dive,
    • “Oracle Health is releasing a new artificial intelligence-backed electronic health record, months after the technology giant first teased the “next generation” system.
    • “The EHR allows clinicians to use voice commands to access information, like a patient’s latest lab results or a list of current medications, cutting down the amount of time providers spend navigating through health records, the technology giant said in a press release Wednesday. 
    • “The AI-backed product is now available for ambulatory providers in the U.S., pending certification by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT, Bharat Sutariya, SVP and chief health officer at Oracle Health, told Healthcare Dive. Oracle plans to launch functionality for the acute care market in 2026.” 

Thursday report

David Ermer–CDC, CMS, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • The OPM Director Scott Kupor announced an Award for Savings program which is open to OPM employees.
    • “For all savings identified between now and October 31, we will share 5% of the annual savings with whomever discovers it, up to $10,000 per award. To qualify, savings must be new actions not already identified, and we must be able to implement them.” 
  • Federal News Network reports,
    • “The Office of Personnel Management says new questions for federal job candidates, asking how they will advance the Trump administration’s policies, will appear on nearly all job applications, but candidates can still choose not to answer them without being penalized.
    • “OPM is telling agencies it is “mandatory” to include the Trump administration’s four new essay questions on nearly all applications on USAJobs, as part of the federal hiring process.” * * *
    • “In follow-up guidance, however, OPM downplayed the importance of the essays as just one piece of a candidate’s overall application. The HR agency said it’s optional for job candidates to answer the essays, and that candidates won’t be disqualified from consideration if they skip them.”
  • Federal News Network interviews Tammy Flanagan about smart tips to use when filling out the online federal retirement application.
  • NextGov/FCW tells us,
    • “The Trump administration is pushing forward in its deregulatory effort to overhaul the primary rules for how the government purchases goods and services, known as the Federal Acquisition Regulation.
    • “The FAR Council released new text for six parts of the FAR on Thursday — parts 4, 8, 12, 38, 40 and 51 — including the section dealing with commercial acquisition. 
    • “We’re removing hundreds of unnecessary requirements,” a senior administration official told Nextgov/FCW about the changes, offering the removal of requirements for commercial contractors to report the names and compensation of the five most highly paid executives as an example. 
    • “The goal is to reduce costs and time to deliver and increase competition, they said.”
  • The Wiley law firm has been doing a good job staying abreast of the FAR changes on its Decoding the FAR Overhaul website.
  • The American Hospital Association News points out,
    • “The White House Aug. 13 released an executive order directing the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response to develop a list of 26 drugs considered critical for national health and security. The order calls for the ASPR to gather a six-month supply of drug ingredients and place them in the Strategic Active Pharmaceutical Ingredients Reserve with a preference for domestic sourcing and manufacturing. The ASPR is also instructed to update a 2022 list of 86 essential medicines and propose a plan to obtain and store a six-month supply of drug ingredients for those remedies.”
  • and
    • “The Trump administration Aug. 13 issued an executive order revoking a 2021 order by the previous administration that established a “whole-of-government” effort to promote competition in the U.S. economy. The 2021 order encompassed 72 initiatives by more than a dozen federal agencies to address competition issues across the economy, including in health care, financial services, technology and agriculture. It also established a White House Competition Council tasked with coordinating, promoting and advancing federal efforts to improve competition in the U.S. economy.”
  • and
    • “The Department of Health and Human Services Aug. 14 announced it will reinstate the Task Force on Safer Childhood Vaccines, a federal panel to provide oversight on vaccines for U.S. children. The original task force was disbanded in 1998. HHS said the new group will work with the Advisory Commission on Childhood Vaccines to provide recommendations on developing, promoting and refining childhood vaccines that result in fewer and less serious adverse reactions than vaccines currently available, as well as improvements in vaccine development, production, distribution and adverse reaction reporting. 
    • “The new group will be led by senior leadership from the National Institutes of Health, the Food and Drug Administration and the Centers for Disease Control and Prevention. NIH Director Jay Bhattacharya will serve as chairman.” 
  • AHIP notes,
    • “A new peer-reviewed study published by The American Journal of Managed Care (AJMC) found that Medicare Advantage (MA) plans consistently delivered higher quality care than fee-for-service (FFS) Medicare before and during the COVID-19 pandemic.” * * *
    • “Nearly 35 million seniors and individuals with disabilities nationwide choose MA for their health coverage because it provides them with better care at lower costs than FFS. The new study’s findings add to a growing body of evidence that MA’s coordinated, value-based approach delivers superior quality and better health outcomes—while saving beneficiaries an average of more than $3,400 per year versus FFS.”
    • “Read the full study at AJMC, and learn more about the superior value of MA.”
  • Per Modern Healthcare,
    • “Penn Medicine and Saint Francis Health System recently received federal go-ahead to launch hospital-at-home programs, despite the program’s uncertain future.
    • “The Centers for Medicare and Medicaid Services’ Acute Hospital Care at Home waiver is set expire at the end of next month. Congress still must decide if it will extend or end the program, which provides Medicare reimbursement at the same rate for in-home care as in-facility care.
    • “Still, CMS approved waivers about two weeks ago for Tulsa, Oklahoma-based Saint Francis Health System’s program at two facilities.” 
  • and
    • “With just four months to go until a new, mandatory Medicare payment model commences, the hospital sector may be behind schedule.
    • “Health systems must ready themselves for the Transforming Episode Accountability Model, a five-year bundled payment demonstration known as TEAM, which sets episode-based fee-for-service Medicare reimbursements for five common procedures at nearly 750 hospitals.
    • “With just four months to go until a new, mandatory Medicare payment model commences, the hospital sector may be behind schedule.
    • “Health systems must ready themselves for the Transforming Episode Accountability Model, a five-year bundled payment demonstration known as TEAM, which sets episode-based fee-for-service Medicare reimbursements for five common procedures at nearly 750 hospitals.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “The Centers for Disease Control and Prevention (CDC) has not updated national measles statistics since August 6.  A notice on the CDC website that appeared after last week’s shooting said, “The data on this page will not be updated on Wednesday, August 13, 2025. CDC will resume updates as soon as possible.” * * *
    • “Colorado has reported a measles case in an unvaccinated child from Adams County who had recently traveled to Chihuahua state, which is Mexico’s measles hot spot. The child is under 5 years old and is hospitalized. * * *
    • “Idaho has confirmed its first measles case since 2023, in an unvaccinated child from Kootenai County. This county includes Coeur d’Alene, where measles was recently detected in wastewater. This marks the first confirmed case of measles in the Idaho panhandle since 1991.”
  • MedPage Today lets us know,
    • “In a nationally representative survey, 34% of U.S. adults were unaware of HPV and 38% were not aware of the HPV vaccine.
    • “Even individuals who were aware of HPV often didn’t know about its links to cervical and oral cancers.
    • “Public awareness of HPV and the HPV vaccine was lowest in Midwestern and Southern states.” * * *
    • “Given that the HPV vaccine has been approved in the U.S. for nearly two decades, “it was indeed surprising that a third of U.S. adults have not heard of HPV or the HPV vaccine,” Sonawane told MedPage Today. “Our hypothesis was in the range of 10% to 15%.”
  • Per the American Journal of Managed Care,
    • “Coinfection of HIV and HCV [Hepatitis C] leads to worse outcomes, necessitating effective HCV treatment in this population.
    • “Direct-acting antivirals show over 95% efficacy, yet HCV clearance rates in coinfected individuals remain below national targets.
    • “Study across seven U.S. jurisdictions showed modest increases in HCV clearance and testing rates among coinfected patients.
    • “Undetectable HIV viral loads and certain demographics, such as men who have sex with men, were linked to higher HCV clearance rates.
    • “Study limitations included incomplete data and potential COVID-19 pandemic impacts on results.”
  • Per Medscape,
    • “Hearing aid use was linked to fewer neuropsychiatric symptoms (NPS) in patients with dementia, such as apathy and irritability, than nonuse, new research showed.
    • “In a cross-sectional cohort study of more than 10,000 participants, hearing loss was not associated with a significantly greater number of symptoms than no hearing loss. However, the use of hearing aids in individuals with both dementia and hearing loss was linked to significantly fewer and less severe NPS than nonuse.
    • “Hearing aid use may represent an underutilized, nonpharmacological intervention to address NPS,” lead study author Ahjeetha Shankar, Johns Hopkins University School of Medicine, Baltimore, and colleagues wrote.”
  • Per Cardiovascular Business,
    • “Palliative care should play a significant role in the day-to-day management of heart failure (HF) patients, according to new recommendations from the Heart Failure Society of America (HFSA).
    • “HF patients are associated with high mortality and a considerably worse quality of life, the group wrote. Care teams should be doing everything in their power to help patients control their symptoms and live the best lives possible. 
    • “The HFSA guidance is available in full in the Journal of Cardiac Failure. * * *
    • “Click here to review the full consensus statement.”
  • STAT News reports,
    • “A study in rural China demonstrating the power of intensive blood pressure control clinched the deal. The large, cluster-randomized controlled trial convincingly demonstrated that well-controlled blood pressure — below 130/80 mm Hg — lowered the risk of dementia by 15% and cognitive impairment by 16%. 
    • “That was the solid evidence reviewers needed to form the foundation for a new guideline from leading medical groups on how to treat high blood pressure, Dan Jones, chair of the guideline writing committee and a past president of the American Heart Association, told STAT. He called the study from China the first one to definitively show that rigorous lowering of blood pressure with a goal of below 120 systolic does decrease the risk of dementia.”
    • “We don’t have recommended changes related to dementia but we are able to say with certainty that lowering blood pressure reduces the risk of dementia and that’s such good news for people around the world and for Americans,” said Jones, a former dean of the University of Mississippi School of Medicine.”
  • and
    • “In a small study, an engineered antibody showed “amazing” promise in countering metastatic cancer.
    • “That is, according to a Phase 1 clinical trial published Thursday in Cancer Cell. Researchers directly injected the drug, which stimulates the immune system to attack cancer cells, into 12 patients’ tumors. Six of the patients had significant tumor reduction even in non-injected sites, with two experiencing complete remission. The research could lay the groundwork for new treatments for the most advanced cancer patients.
    • “Seeing this in humans is really great news,” said Katelyn Byrne, a cancer biologist at Oregon Health and State University who was not involved in the study. “Especially for patients where we don’t have any options on the table, to be able to put this on the table now — it’s amazing.” 
  • The New York Times adds,
    • “Treating chronic pain is hard. An experimental approach shows promise.
    • “A guitarist in a death metal band was one of several people who found that personalized deep brain stimulation eased their pain and helped them reduce pain medication.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans tells us,
    • “U.S. employers project a median health care cost increase of 10% for 2026, according to new survey results from the International Foundation of Employee Benefit Plans. A similar Foundation survey conducted in 2024 projected a median cost increase of 8% for 2025.” * * *\
    • “When I spoke to Julie Stich, CEBS, Vice President of Content at the International Foundation, she shared that the 10% projected increase is attributed to a variety of factors impacting organizations’ medical plan costs, with catastrophic claims and specialty/costly prescription drugs topping the list. Employers have indicated that cost-sharing, plan design and purchasing/provider initiatives will be the most impactful techniques to manage costs.”
  • The Wall Street Journal reports,
    • “Pharma giant Eli Lilly said it is negotiating to raise drug prices in Europe, starting in the U.K. with the weight-loss drug Mounjaro, so that it can comply with the Trump administration’s goal of bringing down prices in the U.S.
    • “Lilly said Thursday that it has an agreement with the U.K. government to raise the list price of Mounjaro for patients who pay for it out-of-pocket. Lilly will more than double the list price of Mounjaro’s highest dose from about $165 to about $446. The new price is in line with the prices paid in the rest of Europe and other developed countries, Lilly said. 
    • “Mounjaro is the only Lilly medicine with a significantly lower list price in the U.K. than average prices in Europe and other developed countries, so we are adjusting the list price to bring it into line with these countries,” a Lilly spokesman said. 
    • “The higher price, however, won’t apply to those who get it prescribed through the U.K.’s National Health Service, the spokesman said.
    • “The move is part of the pharmaceutical company’s talks with foreign governments to raise prices in developed nations, the company said. It plans to implement any price adjustments by Sept. 1.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group and Amedisys have officially closed their $3.3 billion merger deal just one week after securing a key settlement agreement with the feds that allowed proceedings to advance.
    • “In a filing with the Securities and Exchange Commission, Amedisys said that the deal had officially closed Thursday, just over two years from when it was announced in late June 2023.
    • “That makes the home health company now a wholly-owned subsidiary of UnitedHealth, where it will join the company’s Optum unit. Amedisys was originally set to be acquired by Option Care Heath, but the organization was outbid by UnitedHealth.
    • “To make sure the merger was consummated, the two parties agreed last week to divest 164 home health and hospice facilities across 19 states, securing approval from the Department of Justice to move forward.”
  • and
    • “Humana and health tech company DrFirst are joining forces in a bid to close gaps in care for people with chronic health needs.
    • “The program’s initial launch focuses on boosting the use of statins among eligible members, which can improve care for people with cardiovascular conditions or diabetes while also meeting a key Medicare metric set by the Centers for Medicare & Medicaid Services.
    • “DrFirst’s prescription orchestration platform is embedded in the provider’s workflow, and through it, Humana can send the clinical team prescription recommendations for high-risk patients. Should they agree with the suggestion, the provider can then with one click submit a script and document why the care was necessary.
    • “I think it’s a very simple and very elegant way of helping the insurer and the provider get on the same page without requiring external workflows, external portals, external faxes,” Colin Banas, M.D., chief medical officer for DrFirst, said in an interview with Fierce Healthcare.
  • Per MedTech Dive,
    • “Apple said Thursday that it is updating its watches with a redesigned blood oxygen feature after a recent U.S. customs ruling. The software update will go out to the Apple Watch Series 9, Series 10 and Ultra 2 devices on Thursday.” * * *
    • “With the update, sensor data from Apple’s blood oxygen app will be measured, calculated and displayed in the paired iPhone app. Previously, the readings were displayed on the user’s watch. Apple said that there will be no change to previously purchased Apple Watches that have the original blood oxygen feature or devices sold outside of the U.S.”

Midweek Update

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Today, the Government Accountability Office released a report on priority open recommendations made to the U.S. Office of Personnel Management.
    • “In May 2024, GAO identified 16 priority recommendations for the Office of Personnel Management (OPM). Since then, OPM has implemented three of those recommendations.
      • Specifically, OPM took actions to better mitigate cybersecurity risks, improve its payroll database, and strengthen privacy protections for personally identifiable information on its IT systems.
    • In August 2025, GAO identified one additional priority recommendation for OPM, bringing the total number to 14. These recommendations involve the following areas:
      • preventing improper payments,
      • strengthening IT security and management,
      • addressing mission critical skills gaps,
      • improving the federal classification system,
      • making hiring authorities more effective,
      • improving payroll data, and
      • addressing employee misconduct and improving performance management.
    • OPM’s continued attention to these issues could lead to significant improvements in government operations.
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) this week released new data fueling a narrative of rampant broker fraud on the Affordable Care Act (ACA) exchanges.
    • “Plans received data finding 23% of enrollees did not have a claim in 2019. That number jumped sharply to 35% last year.
    • “Before the pandemic, the data were largely consistent across three categories: members on state-based exchanges, members on the federal exchange in Medicaid expansion states and on the federal exchange in non-expansion states. No matter the group, about 22% to 24% of enrollees did not have a claim.
    • “But, by 2024, expansion states on the federal exchange saw an increase from 22% to 32%, and the non-expansion population jumped from 24% to 41% without a claim, according to the agency’s data. Meanwhile, enrollees on state-based exchanges without claims climbed modestly from 22% to 24%.”
  • The suspicion is that brokers have been adding phantom enrollees to highly federal government subsidized silver and bronze plans.
    • The Paragon Health Institute adds,
      • “As Paragon discussed in our The Great Obamacare Enrollment Fraud series, large-scale fraud schemes have led to people enrolling in exchange plans without their knowledge, and others being misled by false offers of cash or gift cards to apply for insurance. A few months ago, a Bloomberg exposé revealed fraud rings in Florida, including brokers earning thousands daily by enrolling people who often had no idea.”
  • An HHS news release features a trip that HHS Secretary Robert F. Kennedy took to Alaska last week to highlight rural and tribal health priorities.
  • Beckers Health IT considers whether the Trump administration can achieve its goal of doing away with clipboards in healthcare. It’s worth pointing out
    • “Curtis Cole, MD, vice president and chief global information officer of Ithaca, N.Y.-based Cornell University, said he’s “hopeful that something positive” will come from the plan, but he’s not “particularly sanguine.”
    • “A lot of it looks like the all-too-frequent use of computers to make bad processes work faster, rather than fixing the fundamental problem,” he said.
    • “He pointed to the lack of a national patient identifier, which other developed nations have. The Trump administration is advocating for digital identity verification to link patients to their records, but Dr. Cole says those systems often have incorrect or incomplete information.”
  • HIPAA, a 1996 federal law, calls for HHS to create a national patient identifier but Congress has blocked funding for that initiative. 
  • STAT News reports,
    • “A handful of drug companies have formed a group to present lawmakers with research on what the industry sees as the negative impacts of Medicare drug price negotiations, according to lobbying records.
    • “The group is called the IRA Watchdog after the Inflation Reduction Act, which directed Medicare to negotiate the prices for some drugs. Its members are Merck, AstraZeneca, Bristol Myers Squibb Company, and Eli Lilly, according to lobbying disclosure records. The group describes itself as a “coalition analyzing the impact of Medicare Drug Price Negotiation on patients.” * * *
    • “The IRA Watchdog is not a stand-alone lobbying organization. It’s housed in the firm DLA Piper, and its two lobbyists were staffers for former Sen. Richard Burr (R-N.C.), who while in Congress championed the biotech sector, a key driver of the economy in his home state. Burr is a senior policy adviser at DLA Piper and the chair of its health policy strategic consulting practice.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of Brinsupri to treat a chronic condition that results in dilated airways in the lungs, chronic cough and frequent respiratory infections.
    • “Brinsupri is the first drug to treat bronchiectasis not caused by cystic fibrosis and the first in a new class of drugs called DPP-1 inhibitors that could treat multiple inflammatory conditions. Startup Expedition Therapeutics just signed a deal with Fosun Pharma for most rights to a DPP-1 inhibitor, while Boehringer Ingelheim and Haisco Pharmaceutical Group have drugs in development.
    • “Wall Street analysts forecast as much as $6 billion in annual sales for Brinsupri. Insmed’s market valuation has swelled to more than $25 billion in anticipation of coming sales from Brinsupri, its other approved drug Arikayce and pipeline candidates in lung disease and Duchenne muscular dystrophy.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “Fewer Americans are reporting that they drink alcohol amid a growing belief that even moderate alcohol consumption is a health risk, according to a Gallup pollopens in a new tab or window released Wednesday.
    • “A record high percentage of U.S. adults, 53%, now say moderate drinking is bad for their health, up from 28% in 2015. The uptick in doubt about alcohol’s benefits is largely driven by young adults — the age group most likely to believe drinking “one or two drinks a day” can cause health hazards — but older adults are also now increasingly likely to think moderate drinking carries risks.
    • “As concerns about health impacts rise, fewer Americans are reporting that they drink. The survey found that 54% of U.S. adults said they drink alcoholic beverages such as liquor, wine, or beer. That’s lower than at any other point in the past three decades.
    • “The findings of the poll, which was conducted in July, indicate that after years of many believing that moderate drinking was harmless — or even beneficial — worries about alcohol consumption are taking hold. According to Gallup’s data, even those who consume alcohol are drinking less.”
  • Health Day informs us,
    • “Nearly 70 percent of U.S. children in car crashes with a fatality are not using proper child passenger restraints, according to a study published online July 31 in Traffic Injury Prevention.
    • “Arthi S. Kozhumam, from the Northwestern University Feinberg School of Medicine in Chicago, and colleagues identified child, driver, vehicle, neighborhood, and policy-level factors associated with suboptimal child passenger safety practices in motor vehicle collisions (MVCs) with a fatality. The analysis included data from child passengers (younger than 13 years old) in cars and light trucks with known restraint status and seating location identified from the Fatality Analysis Reporting System database (2011 to 2021).”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-supported clinical trial has found that the outcome of treating complicated Staphylococcus aureus bloodstream infections with two intravenous (IV) doses of the antibiotic dalbavancin seven days apart is just as good as daily IV doses of conventional antibiotics over four to six weeks. Nearly 120,000 S. aureus bloodstream infections and 20,000 associated deaths occurred in the United States in 2017. The study results provide the clearest evidence to date for the safety and effectiveness of dalbavancin therapy for complicated S. aureus bloodstream infections, expanding the number of antimicrobial treatment options for clinicians and patients. The findings were published today in the Journal of the American Medical Association.
    • “Given the small number of antimicrobial drugs available to treat Staphylococcus aureus bloodstream infections and the bacteria’s growing drug resistance, establishing dalbavancin as a beneficial therapy for these severe infections gives us a vital new alternative to treat them,” said John Beigel, M.D., the acting director of the Division of Microbiology and Infectious Diseases at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which sponsored and funded the trial.”
  • Medscape offers “Perspectives on Managing Antibiotic Resistance.”
  • Per MedPage Today,
    • “Men had higher mortality and hospitalization rates than women after a dementia diagnosis.
    • “These relationships held even after controlling for age and comorbidity burden.
    • “The study was based on over 5.7 million Medicare patients with up to 8 years of follow-up.”
  • and
    • “Applying five published definitions for long COVID yielded a prevalence that ranged from 30.84% to 42.01% at 3 months and 14.23% to 21.94% at 6 months.
    • “Up to a third of the variation in prevalence rates could be attributed to the differences in long COVID definitions.
    • “While ideal, there may never be a single, standardized long COVID definition, given the divergent needs of researchers and clinicians.”
  • and
    • “Clear” e-cigarettes had disproportionately greater cardiovascular effects than other types of vapes when smoking conditions were controlled.
    • “Clear” e-cigarettes contained synthetic coolants, menthol, and other flavorings despite their marketing.
    • “Acute increases in blood pressure may be related to the synthetic coolants reducing tobacco or nicotine harshness and facilitating deeper inhalation.”
  • The National Institute of Standards and Technology explains why “Wearable, Implantable and Ingestible Medical Devices Could Revolutionize Your Health Care.”
  • Genetic Engineering and Biotechnology reports,
    • “Targeted DNA editing by CRISPR technology has great potential for applications in biotechnology and gene therapy. However, precise gene editing remains a challenge largely due to insufficient control of the DNA repair process. While mechanisms exist to accurately repair double-stranded breaks, DNA end joining repair can occasionally lead to genetic errors.  
    • “In a new study published in Nature Biotechnology titled, “Precise, predictable genome integrations by deep learning–assisted design of microhomology-based templates,” researchers at the University of Zurich (UZH) have found that repair at the genome-cargo interface is predictable by artificial intelligence (AI) models and adheres to sequence-context-specific rules. The AI tool, named “Pythia,” predicts how cells repair their DNA after it is cut by CRISPR/Cas9 and opens the door to more accurate modeling of human diseases and next-generation gene therapies. 
    • “Just as meteorologists use AI to predict the weather, we are using it to forecast how cells will respond to genetic interventions. That kind of predictive power is essential if we want gene editing to be safe, reliable, and clinically useful,” said Soeren Lienkamp, PhD, professor at the Institute of Anatomy of UZH and co-corresponding author of the study.” 

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “Providence posted a $21 million operating loss (-0.3% operating margin) for the second quarter of the year as elevated volumes and revenues outpaced year-over-year expense increases.
    • “The operating performance is an improvement over the prior year’s $123 million operating loss (-1.6% operating margin), for which the 51-hospital nonprofit credited its “continued focus on staffing and reductions from expense management initiatives.” The system is sitting at a $265 million operating loss (-1.7% operating margin) across six months.
    • “Providence executives cheered the system’s steady march toward breakeven after several consecutive years of losses.
    • “Still, the organization stressed a slew of economic headwinds it refers to as a “polycrisis” affecting nonprofit health systems like Providence as cause for continued expense reduction. Among these are inflation, tariffs, new state regulations around staffing and charity care, payment delays from commercial payers and the impending federal funding cuts of the “one big, beautiful bill.” 
  • and
    • “Health tech and artificial intelligence companies see ripe opportunities to offer solutions that help patients access and share their medical data with digital health apps. And it comes at a time when the federal government is pushing for consumer-directed data exchange.
    • “HealthEx, a company that built data rights management solutions, launched a platform to provide real-time patient access to complete health records. The company worked with a team of industry partners to develop a process that verifies patient identity, captures consent and retrieves clinical records, enabling the data to flow without the patient doing multiple patient portal logins.
    • “The company aims to create an “Apple Wallet” for health records, executives said.
    • “CLEAR, an identity verification tech company often found at airports, worked with HealthEx on the initiative, along with national electronic health record company athenahealth, healthcare interoperability company MedAllies and the CommonWell Health Alliance.”
  • Beckers Hospital Review points out,
    • “Three-quarters of the hospitals on U.S. News & World Report’s 2025-26 Honor Roll list also earned top marks in CMS’ latest Overall Hospital Quality Star Ratings, underscoring a notable overlap in national measures of hospital excellence. 
    • “CMS released its 2025 star ratings Aug. 6, evaluating more than 4,600 hospitals nationwide on 46 quality measures spanning mortality, safety, patient experience, readmissions, and timely and effective care. This year, 290 hospitals earned a five-star rating. U.S. News published its 2025-26 Honor Roll on July 29, recognizing 20 hospitals for top performance across 15 specialties and 22 procedures and conditions.
    • “While the two lists use different methodologies and scoring systems, their alignment highlights organizations that excel across quality- and reputation-based benchmarks.”
  • Beckers Payer Issues notes,
    • “Optum has acquired Kingsport, Tenn.-based Holston Medical Group, WJHL reported Aug. 11. 
    • “The 200-provider medical group has more than 70 locations in Northeast Tennessee and Southwest Virginia, according to the report. 
    • “Holston Medical Group is pleased to join Optum to support our efforts to continue to provide exceptional health care services to patients in the communities we serve,” an Optum spokesperson said in a statement shared with the news outlet. “Holston Medical Group and Optum share common goals around providing patients with high-quality, local care with a focus on value and innovation. We look forward to the breadth of clinical expertise and capabilities that we will gain as part of Optum.”
  • Per BioPharma Dive,
    • “PureTech Health, a biotechnology firm with a web of startup subsidiaries, announced Tuesday the launch of a new company that will develop a respiratory disease treatment it’s been advancing through clinical testing.
    • “Called Celea Therapeutics, the company debuts with a drug candidate nearing late-stage trials that the company believes could treat multiple inflammatory lung diseases. Known as deupirfenidone or LYT-100, the drug is initially being evaluated against idiopathic pulmonary fibrosis, a rare and chronic condition. 
    • “Sven Dethlefs, who has spearheaded the deupirfenidone program under PureTech over the last year, will lead Celea. Prior to joining PureTech, Dethlefs was the CEO of Teva North America, where he oversaw the company’s specialty and generic businesses in the U.S. and Canada.”
  • Per MedTech Dive,
    • “Heartflow’s initial public offering grossed $364.2 million after the volume and price of the shares sold exceeded the original expectations.
    • “The company listed last week and completed the sale of the overallotment on Monday, adding almost $50 million through the sale of additional shares.
    • “Heartflow’s stock rose in its first two days on public markets, closing at almost $30 on Monday. The company priced its IPO at $19 a share.
    • “Heartflow has developed software for making 3D heart models from coronary computed tomography angiography scans. In a clinical trial, the company linked its lead product, Heartflow FFRCT Analysis, to a 78% improvement in identifying patients in need of revascularization.”

Tuesday report

David Ermer–CDC, FDA, Medical / Rx research, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Bloomberg informs us,
    • “Scott Kupor, the new director of the US government’s human resources agency [OPM], wants to make it easier to fire federal workers and drop college degree requirements for certain jobs.
    • “Kupor is exploring ideas to lure young talent from Silicon Valley and other industries, including relieving student debt and creating “information exchanges” between the private and public sectors.
    • “Kupor also suggests potentially investing pension money in a sovereign wealth fund, saying “every other major country has a sovereign wealth fund where they have professional money managers who actually manage their retirement assets on behalf of the population.” * * *
    • “[Kupor] acknowledged that he can’t move on many of these ideas without the support of the White House, Congress or other agencies, like the Treasury Department. Kupor hasn’t raised many of these proposals with the White House yet, but said his team is engaged with the executive branch on a daily basis.”
  • MedTech Dive tells us,
    • “The U.S. is extending its pause on additional retaliatory tariffs for imports from China until Nov. 10, according to an executive order signed by President Donald Trump on Monday.
    • The order said the extension is appropriate following “significant steps” from China on addressing U.S. trade concerns in ongoing discussions between the two countries.
    • Since May 14, the U.S. has been charging many imports from China an extra 30% duty. That rate — a combination of 20% tariffs tied to fentanyl trafficking and a 10% baseline reciprocal tariff — came as the two countries agreed to pause duties imposed as part of a tit-for-tat tariff escalation for 90 days. The pause was originally set to expire Aug. 12.

From the Food and Drug Administration front,

  • Per HCPLive,
    • “FDA approval of PharmaTher’s ketamine for surgical pain management follows minor application deficiencies, without requiring new trials.
    • “Ketamine’s inclusion on the WHO’s Essential Medicines list and its shortage since 2018 have led to the use of compounded products with potential risks.
    • “The ketamine market is expected to grow from $750 million to $3.42 billion by 2035, with a 16.4% compound annual growth rate.
    • “This approval supports further ketamine development for psychiatric, neurological, and chronic pain disorders, aligning with PharmaTher’s strategic goals.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has identified a Class I recall of Draeger SafeStar and TwinStar Filters due to a risk of misleading carbon dioxide readings. The readings could result in health care providers administering unnecessary or harmful treatments based on incorrect waveform interpretations. Using the affected filters could result in serious injury or death.
    • “In addition, the FDA Aug. 9 released a notice on a voluntary DermaRite recall of its DermaKleen, Dermasarra, Kleenfoam and Perigiene products due to a microbial contamination that can result in serious and life-threatening infections.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Bayer BAYN said it would commercialize and complete research into a new potential cancer drug developed by U.S. biotech company Kumquat Biosciences.
    • “Under the global exclusive license deal, announced by both companies on Tuesday, Kumquat will be responsible for the Phase 1a study of its KRAS G12D inhibitor, while Bayer will work on taking the drug to market.
    • “The inhibitor targets a type of change in the DNA of genes that drives the growth of tumors, and is most frequently linked to pancreatic, colorectal and nonsmall cell lung cancers.
    • “As part of the agreement, Kumquat will receive up to $1.3 billion, and additional tiered royalties on net sales, they said.”
  • BioPharma Dive lets us know,
    • “Padcev, an antibody-drug conjugate Pfizer acquired in its $43 billion buyout of Seagen, met the primary goal of a bladder cancer trial, helping people ineligible for chemotherapy when used in combination with Merck & Co.’s Keytruda before and after surgery, the companies said Tuesday.
    • “The drugmaker said it will discuss approval applications with health regulators, which could expand Padcev’s use in bladder cancer into the so-called neo-adjuvant and adjuvant settings. Padcev is currently used with Keytruda in locally advanced and metastatic disease that can’t be operated on, and alone in people whose disease has progressed after treatment.
    • “Padcev, which is co-promoted with Astellas in the U.S., is a fast-growing drug in Pfizer’s oncology business — on track to record around $2 billion in sales in 2025. Pfizer has been under pressure because of declining revenue from its COVID-19 vaccine and drug, and is looking to new products to lift sales.”
  • Medscape discusses the repurposing cancer drugs to treat Alzheimer’s Disease.
  • Per MedPage Today,
    • “The risk of new-onset diabetic retinopathy (DR) increased slightly, but significantly, in patients taking GLP-1 receptor agonists for diabetes, despite a lower risk of vision-threatening complications, a large retrospective study suggested.
    • “A propensity-matched comparison showed a 7% higher incidence of new DR among users of GLP-1 agonists. The risk of ischemic optic neuropathy did not differ significantly between users and non-users. Moreover, in a subgroup of patients with existing DR, use of the drugs was not associated with an increased risk of progression to proliferative retinopathy or diabetic macular edema (DME).
    • “The findings suggest that patients with type 2 diabetes treated with GLP-1 agonists require regular screening and monitoring for ophthalmic complications, regardless of baseline DR status, reported Sarju Ganatra, MD, of Beth Israel Lahey Health in Burlington, Massachusetts, and co-authors in JAMA Network Open.”

From the U.S. healthcare business front,

  • Beckers Hospital Reviews tells us,
    • “Physicians and advanced practice providers are logging more work than ever, but rising productivity isn’t translating into higher reimbursement, according to Kaufman Hall’s “Physician Flash Report,” published Aug. 11. 
    • “Productivity levels, measured in work relative value units per full-time employee, reached 6,449 for physicians and 5,030 for advanced practice providers in the second quarter of 2025. That marks a 12% increase for physicians and an 11% increase for APPs year over year.
    • “Increases in productivity metrics, coupled with higher compensation and expenses, reflect a reality that physicians and advanced practice providers are working more than ever before,” Matthew Bates, managing director and physician enterprise service line leader at Kaufman Hall, said in a news release. “Revenue has increased because physicians and providers are working more, but the data also show that reimbursement is not keeping pace. In the coming months if more patients lose insurance coverage, this trend will likely get worse.”
    • “Kaufman Hall analysts said changes to the Medicare physician fee schedule that took effect in 2021 — which initially increased wRVU totals for evaluation and management services — no longer account for the recent growth in productivity. The increases now reflect rising workloads rather than changes in how work is measured.
    • “The report also highlighted a troubling staffing trend.  Medical support staff levels continue to fall relative to wRVU generation, a pattern Kaufman Hall has tracked since 2023. The firm cautioned that ongoing workforce challenges could become a barrier to future growth if left unaddressed.
    • “Meanwhile, hospital financial performance improved in June, according to Kaufman Hall’s latest “National Hospital Flash Report.” Outpatient revenue and operating room minutes increased, contributing to stronger performance compared to the previous month.
    • “Higher performing hospitals are nimbler on both the revenue and expense sides,” said Erik Swanson, managing director and data and analytics group leader at Kaufman Hall. “They may be expanding their outpatient footprint, diversifying services, or managing expenses like purchased services by centralizing some functions. They are also more likely to have value-based care or bundled care arrangements in place.”
  • Modern Healthcare reports,
    • “Healthcare systems are reassessing their urgent care strategies as patient demand shifts and tried-and-true business models no longer bring the same returns. 
    • “Many systems are looking to facility acquisitions and joint ventures to access new patients through the lower-cost settings, rather than just provide a one-off visit. However, the booming urgent care business has turned into oversaturation in some areas, leaving systems to decide whether their resources would be better used elsewhere.”
    • Provider groups of all sizes have tapped into the urgent care model, but recent growth is driven by larger institutions, such as private equity-backed platforms and health systems, Urgent Care Consultants President Alan Ayers said. More than 430 urgent care centers opened in new locations in the first half of 2025. Nearly 40% of those centers are affiliated with hospitals, according to data from Urgent Care Consultants. 
    • Systems are increasingly viewing urgent care centers as an entry point into the larger organization that can beef up patient volumes. Health systems have to reevaluate where they stand amid retail clinics, telehealth services and other competitors. Transactional patient interactions at many urgent care centers are not sustainable, system executives said.”
  • and
    • “Cardinal Health announced an agreement to purchase Solaris Health in a $1.9 billion deal, the company’s latest acquisition in the urology category and an expansion of its multispecialty strategy.
    • “Urology is an attractive specialty for us,” said Jason Hollar, chief executive officer of Cardinal Health, in a statement. Among other recent urology acquisitions, Cardinal Health recently completed the purchase of Academic Urology & Urogynecology.
    • “Solaris Health has more than 750 providers in 14 states.”
  • and
    • “Highmark Health and clinical documentation vendor Abridge are developing a tool that uses generative artificial intelligence to approve prior authorization requests at the point of care, the companies announced Tuesday.
    • “The Pittsburgh-based health system and Blue Cross Blue Shield insurer will incorporate the software into its operations, and Highmark Health and Abridge have bigger plans.
    • “The companies intend to eventually market the utility to other health insurance companies, said Highmark Health Chief Analytics Officer Richard Clarke.” 
  • Beckers Hospital Review points out,
    • “Oak Park, Ill.-based West Suburban Medical Center is facing an uncertain future after its sister hospital, Weiss Memorial Hospital in Chicago, closed Aug. 8 prior to CMS’ termination of its Medicare program Aug. 9, NBC 5 Chicago reported.
    • “El Segundo, Calif.-based Pipeline Health System sold West Suburban and Weiss Memorial to Princeton, N.J.-based Resilience Healthcare in late 2022.”
  • Per Fierce Healthcare,
    • “Maven Clinic, a global virtual clinic for women’s and family health, is launching new features to support women and men trying to conceive.
    • “Understanding the menstrual cycle is key to increasing chances of conceiving naturally. Yet Maven providers say that new members in its Trying to Conceive track—intended to support natural conception—often do not understand their ovulation. Even though nearly 75% of members report tracking their cycles in apps, many still struggle to interpret the data. 
    • “Nobody uses a physical calendar anymore. Everyone tracks their fertility on a device or an app,” Neel Shah, M.D., Maven’s chief medical officer, explained. But simply tracking dates may not be enough. “Getting pregnant is about attempts. People might think they’re trying within their fertile window, but they’re not ovulating, and so it’s not going to work.” 
    • “Maven’s new cycle tracker, available to Fertility & Family Building members starting this fall, learns each member’s unique cycle and offers personalized predictions. It can flag possible irregularities and recommend appointments with a Maven specialist to determine potential underlying diagnoses. Finding these out early could save couples money and stress, Shah said. For example, an irregular period might be caused by a thyroid condition that could be addressed with a $5 medication.
    • “The tracker is integrated with the Apple Watch and will soon also be integrated with the Oura Ring. Wearables can offer important insights relevant to a woman’s cycle, such as body temperature, heart rate or and sleep data, according to Shah.
    • “Complementary to the offering are at-home semen test kits for men.” 

Monday update

David Ermer–CDC, CMS, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today issued new government-wide guidance to ensure that performance awards are meaningfully targeted to the highest-performing federal employees. The updated policy directs agencies to strengthen performance management practices, normalize ratings, and reserve the largest awards and bonuses for employees who have demonstrated exceptional contributions to their agencyʼs mission. The guidance also encourages agencies to expand use of non-cash awards, such as time-off and quality step increases, and to recognize real-time accomplishments throughout the year
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. visited the CDC headquarters in Atlanta today in response to Friday’s tragic gunfire attack that claimed the life of DeKalb County Police Officer David Rose. 
    • “CDC security led Secretary Kennedy on a tour of the Roybal Campus, pointing out shattered windows across multiple buildings, including the main guard booth. Health and Human Services Deputy Secretary Jim O’Neill and CDC Director Susan Monarez accompanied him on the tour. 
    • “Secretary Kennedy visited the DeKalb County Police Department, where he met with Police Chief Greg Padrick. Later, he met privately with the widow of Officer David Rose, who courageously gave his life in the line of duty. He offered his deepest condolences and reaffirmed the agency’s commitment to honoring Officer Rose’s bravery, sacrifice, and service to the nation.” 

From the judicial front,

  • It occurred to the FEHBlog this afternoon that we recently passed the August 7 deadline for the parties to submit a joint status report to the federal court considering a challenge to the Biden Administration’s 2024 mental health parity rule amendments.  
    • It turns out that the status report (Dropbox link) was timely submitted on August 7.
    • The parties reported,
      • “The Departments continue to consider whether to issue a notice of proposed rulemaking to revise or rescind the 2024 Rule and to determine when it would be appropriate to add a MHPAEA regulatory action to the agencies’ Semiannual Regulatory Agenda.
      • “Pursuant to the Court’s May 12, 2025, Minute Order, the parties will file another joint status report on or before November 5, 2025, to report on Defendants’ progress.” 
    • The most recent semi-annual regulatory report appearing on reginfo.gov is Fall 2024 dated 12/13/2024.
  • Fierce Healthcare reports,
    • “Hospital and health system groups are skeptical the Trump administration will have enough time to weigh and incorporate providers’ concerns before opening its 340B rebate pilot program up to drugmaker applicants. 
    • “In a letter sent to the Health Resources and Services Administration (HRSA), which oversees the controversial subsidy program, seven provider associations requested HRSA extend the timeline for stakeholder comments and give itself a broader window to consider public comments. 
    • “Specifically, the current timeline outlined by HRSA in late July requires comments on the program to be submitted by Sept. 8, and for drugmakers to submit their applications and rebate plans by Sept. 15. Approvals would be made by Oct. 15, and the pilot is slated to begin at the top of the year 
    • “Instead, the associations have floated a Sept. 15 comment period, an Oct. 20 manufacturer application deadline and a Nov. 3 approval date.
    • “With the fundamental changes a rebate model will impose on all 340B stakeholders, it is impossible for the agency to meaningfully consider, in just seven days, all the feedback it will surely receive,” the associations wrote in their letter (PDF). “Moreover, drug companies have spent years developing and preparing for a rebate model, but the agency’s current timeline would give 340B hospitals far less time to prepare.”

From the public health and medical research,

  • The American Medical Association lets us know what doctors wish their patients knew about joint injuries and treatment.
  • Consumer Reports, writing in the Washington Post, discusses “how to get more out of physical therapy. It can reduce pain, boost strength, get you as healthy as possible for surgery and more.”
  • Medscape lets us know what doctors wish their patients knew about “How High-Fiber Diets and Supplements Can Improve Health for Patients With Obesity.”
  • Per MedPage Today,
    • “Previous research on associations between prediabetes and mortality has produced conflicting results.
    • “This study found that prediabetes was statistically significantly associated with mortality only among adults ages 20 to 54 years.
    • “Mortality risk in younger adults could be due to metabolic or behavioral risk factors.” * * *
    • “Elizabeth Selvin, PhD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, who was not involved in the study, told MedPage Today that the findings were “very consistent with [the 2019 study] demonstrating that prediabetes in older adults is not strongly associated with mortality.”
    • “Current definitions of prediabetes are very broad and they capture a lot of people who are not at high risk for poor outcomes, especially in old age,” she said. “In older ages, mild elevations in glucose are extraordinarily common and seem to reflect mild metabolic dysfunction corresponding with aging rather than severe hyperglycemia that leads to diabetes.”
  • BioPharma Dive reports,
    • “An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday. 
    • “IO Biotech, however, still believes the vaccine performed well enough to warrant a potential approval consideration from U.S. regulators. The company noted how the study, which compared a regimen of its shot and Merck & Co.’s immunotherapy Keytruda to Keytruda alone, failed by the slimmest of margins. Executives also pointed to other analyses showing potentially stronger benefits among those who hadn’t previously received drugs like Keytruda or aren’t likely to respond to them. 
    • “It was a very narrow miss, just by a hair,” said Mai-Britt Zocca, IO’s CEO, on a Monday conference call with Wall Street analysts.
    • “Called Cylembio, IO’s cancer vaccine consists of engineered peptides that are supposed to provoke an immune response to certain proteins expressed on tumor cells. Those proteins are two of the immune “checkpoints,” PD-L1 and IDO1, long studied by drugmakers.”
  • and
    • “An experimental Novartis drug has succeeded against a tough-to-treat autoimmune condition, boosting the outlook for a multibillion-dollar acquisition the Swiss pharmaceutical company made last year. 
    • “According to Novartis, the drug, called ianalumab, met its main goal in two Phase 3 studies in Sjögren’s syndrome, a chronic and progressive immune disease. Novartis didn’t provide specifics, but said Monday that treatment with ianalumab led to statistically significant improvements in disease activity compared to a placebo in each trial, as measured by a widely used index evaluating symptoms. The drug was also “well tolerated” and demonstrated “a favorable safety profile,” the company said in a statement. 
    • “Novartis will share the findings at an upcoming medical meeting and submit them to global health regulators.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente closed its second quarter of the year with a billion dollars of operating income and a $3.3 billion bottom line—but operating headwinds on the horizon have leadership taking a hard look at the health system’s cost structure and potential efficiencies.
    • “The quarter’s performance is a step ahead of last year, when the integrated nonprofit reported $908 million of operating income and $2.1 billion in net income.
    • “It’s also a fair jump in the scale of Kaiser’s operations. Consolidated operating revenues and expenses during the most recent quarter were $32.1 billion and $31.1 billion, respectively, up from $29.1 billion and $28.2 billion in the second quarter of 2024. These reflect a 3.2% operating margin in the second quarter of 2025 and a 3.1% operating margin in the second quarter of 2024.
    • “Together with the year’s opening quarter, Kaiser now sits at about $63.9 billion of operating revenue and nearly $2 billion of operating income for the first half of the year. Kaiser said its operating income runs highest during the beginning of the year due to the timing of its health plan’s open enrollment”
  • Healthcare Dive tells us,
    • “Major for-profit hospital chains reported lower-than-expected volumes in second quarter earnings results, causing some to cut back on volume and earnings expectations for the year.
    • “Executives at the for-profit hospital chains — HCA Healthcare, Tenet Healthcare, Community Health Systems and Universal Health Services — attributed the volumes to different factors, from lower Medicaid admissions to a decline in consumer confidence, which impacted spending on healthcare services. 
    • “Softer volumes caused HCA, Tenet and CHS to lower their full-year outlooks for admissions. UHS did not report expectations for volume growth.”
  • Here are links to Kaufmann Hall’s June 2025 flash reports on hospitals and physicians, both of which were released today.
  • Beckers Hospital Review points out CMS’s 290 five star and 229 one star hospitals.
    • “Every year, CMS assigns star ratings to U.S. hospitals based on 46 hospital quality measures, which are divided into five categories: mortality, safety, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2020 to December 2024, depending on the measure. The ratings were updated in July and released Aug. 6.” “
  • The American Journal of Managed Care informs us,
    • “Prescribing semaglutide in routine clinical practice was associated with meaningful—but smaller than seen in clinical trials—improvements in cardiovascular risk factors, along with an unexpected rise in non-drug health care spending, according to a new study published in JAMA Network Open.1
    • “Analyzing data from more than 23,500 adult patients across Yale New Haven Health System and Sentara Healthcare, researchers found that patients experienced an average 3.8% reduction in body weight and significant reductions in blood pressure (–1.5 mm Hg for diastolic; –1.1 for systolic), total cholesterol (–12.8 mg/dL), and hemoglobin A1c (HbA1C) at 13 to 24 months following their first semaglutide prescription. However, during the same time period, monthly health care expenditures rose by $80 per patient, not including the cost of semaglutide itself.
    • “These findings highlight a disconnect between clinical benefits and short-term cost savings, warranting caution when extrapolating trial-based projections to clinical settings,” the researchers said.”