Tuesday Report

Rx coverage

Tuesday Report

David Ermer–AHRQ, CDC, CMS, Electronic health records, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services today announced prescription drug reforms that will become effective Oct. 1 originating from the Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule. Health IT tools certified by the HHS Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology will allow drug prescribers to compare drug prices in real time and identify lower-cost alternatives available under a patient’s insurance coverage, particularly if they are covered under Medicare Part D. Providers will also be able to submit prior authorizations for medical services electronically to accelerate the process. The HTI-4 rule was released in July as part of the Centers for Medicare & Medicaid Services’ inpatient prospective payment system final rule for fiscal year 2026.”
  • Beckers Hospital Review informs us,
    • “HHS launched a [public] dashboard Aug. 27 to track organ transplants that skip patients next in line on transplant waiting lists. 
    • “The practice, called “allocation out of sequence,” is growing in frequency. In 2024, organ procurement organizations skipped waitlisted patients for 19% of transplants from deceased donors, six times more often than from a few years prior. The frequency increase is partly driven by clinicians prioritizing favoritism and ease over fairness, according to The New York Times. 
    • “The Organ Procurement and Transplantation Network’s policies and national law mandates organ allocation follow a “match run” to rank eligible recipients based on medical urgency, distance and other factors, according to HHS. 
  • Beckers Payer Issues points out,
    • “Medicare Shared Savings Program Accountable Care Organizations generated record savings and continued to improve quality performance in 2024, CMS said Aug. 28.
    • “In 2023, the program saw $2.1 billion in net savings.” * * *
    • “Nearly all ACOs met quality reporting requirements, with more shifting to digital measures that use electronic health information. ACOs also saw health outcomes improve around controlled blood pressure, poor A1c control and depression screenings.” 
  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM), in collaboration with the Assistant to the President for Domestic Policy, today sent a comprehensive Frequently Asked Questions (FAQ) document to agencies to help support the implementation of the Merit Hiring Plan, pursuant to President Trump’s Executive Order 14170. The FAQ provides detailed guidance to federal agencies on reforming the hiring process to prioritize merit and fairness.
    • A key highlight of the Merit Hiring Plan is the introduction of a two-page resume limit for federal job applications submitted through USAJOBS, taking effect September 27, 2025. This reform ensures hiring managers focus on the most relevant qualifications and experience, streamlining the review process. OPM is providing a transition period until the deadline, along with updated USAJOBS guidance and resume-building tools online to assist applicants in meeting the new standard.
  • The Government Accountability Office released a report titled “Illicit Fentanyl: DHS Has Various Efforts to Combat Trafficking but Could Better Assess Effectiveness.
    • “With about 48,000 deaths in 2024, fentanyl continues to be the primary cause of overdose deaths in the United States.
    • “The Department of Homeland Security has various efforts to combat the trafficking of illicit fentanyl. For example, it inspects incoming travelers and shipments and conducts patrols along the border.
    • “We reviewed these efforts and found issues with how DHS assesses their effectiveness. For example, DHS hasn’t set performance goals and measures—so it’s hard to know if DHS is making progress in its efforts to stop the flow of fentanyl.
    • ‘We recommended, among other things, that DHS set such performance goals and measures.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. Approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.
    • Nicotine pouches contain concentrated nicotine that can be harmful or potentially fatal to young children, even in small amounts. Toxic effects in young children have been reported with nicotine doses as low as 1 to 4 milligrams. Symptoms of nicotine poisoning may include confusion, vomiting, and loss of consciousness. 
    • “I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children. Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion.” 
    • “The FDA is also issuing information for consumers on how to properly store nicotine pouches and prevent accidental exposure to children.” * * *
    • To date, the FDA has authorized 20 nicotine pouch products, all of which make use of child-resistant packaging, which are listed at www.fda.gov/authorizednicotinepouches.  

From the public health and medical/Rx research front,

  • The AP reports,
    • “A New York City hospital and another city-run building were sources for a deadly outbreak of Legionnaires’ disease in Harlem that killed seven people and sickened dozens of others, health officials announced Friday. 
    • “The New York City Health Department said bacteria from cooling towers atop Harlem Hospital and a nearby construction site where the city’s public health lab is located matched samples from some of the ill patients.
    • “The agency said they consider the bacterial cluster officially over since the last day anyone reported symptoms of Legionnaires’ disease was three weeks ago on Aug. 9. Since the outbreak, seven people have died and 114 people have been diagnosed with Legionnaires’ disease, while six people are in the hospital.” * * *
    • “City health officials said all facilities in the affected area have cleaned and disinfected their cooling towers. 
    • “They also are considering a series of changes to try to prevent future outbreaks. Among them are requiring building owners to test for Legionella every 30 days instead of the current 90-days and increasing the fines for violations for failure to comply with local cooling tower regulations.”
  • Beckers Hospital Review points out,
    • “Following almost a decade of decline, prostate cancer incidence in the U.S. increased 3.0% per year between 2014 through 2021, according to a report published Sept. 2 in CA: A Cancer Journal for Clinicians. Incidence of advanced-stage prostate cancer at diagnosis had the highest rate of increase at about 4.7% per year.
    • “At the same time, prostate cancer mortality continued to decline, though at a slower rate than the previous two decades. Prostate cancer mortality declined by 0.06% over the past decade, compared to the 3% to 4% annual decline seen in the late 20th and into the early 21st centuries.
    • “For the report, researchers analyzed cancer incidence and mortality data collected by the CDC and the National Cancer Institute through 2021 and 2023, respectively.” * * *
    • “Read the full report here.” 
  • NPR Shots relates
    • “People who inherit two copies of a gene variant called APOE4 have a 60% chance of developing Alzheimer’s by age 85.
    • “Only about 2% to 3% of people in the U.S. have this genetic profile, and most of them don’t know it because they’ve never sought genetic testing.
    • “But three scientists are among those who did get tested and learned that they are in the high-risk group. Now, each is making an effort to protect not only their own brain, but the brains of others with the genotype known as APOE4-4.”
  • Check out their stories.
  • Per Health Day,
    • “Common over-the counter painkillers might be quietly fueling antibiotic resistance, a new study warns.
    • “Ibuprofen and acetaminophen appear to enhance mutations in E. coli, making the common bacteria more resistant to the broad-spectrum antibiotic ciprofloxacin, researchers reported in the journal npj Antimicrobials and Resistance.
    • “What’s more, the two drugs amplify this effect when used together, researchers found.
    • “Antibiotic resistance isn’t just about antibiotics anymore,” said lead researcher Rietie Venter, an associate professor with the University of South Australia.
    • “This study is a clear reminder that we need to carefully consider the risks of using multiple medications – particularly in aged care where residents are often prescribed a mix of long-term treatments,” she said in a news release.”
  • BioPharma Dive relates,
    • “Ionis on Tuesday said its new lipid-lowering drug Tryngolza met the main goals of two Phase 3 clinical trials that could expand its use. Results showed the drug significantly reduced triglyceride levels in people with severely elevated levels of the fat in their bloods and prevented accompanying pancreatitis episodes.
    • “The company will ask the Food and Drug Administration by the end of the year to add severe hypertriglyceridemia to Tryngolza’s label. The drug, Ionis’ first wholly owned product, gained approval in December for a rare inherited condition called familial chylomicronemia syndrome, for which it recorded $25.6 million in sales over the first six months of 2025.”
  • Per a corporate news release,
    • “United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its TETON-2 study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF) met its primary efficacy endpoint of demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo.
    • “Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann estimate, p <0.0001) from baseline to week 52 in patients with IPF. Benefits of Tyvaso were observed across all subgroups, such as use of background therapy (nintedanib, pirfenidone, or no background therapy), smoking status, and supplemental oxygen use.
    • “Statistically significant improvements relative to placebo were also observed in most secondary endpoints, including time to first clinical worsening event, as well as changes from baseline to week 52 in percent predicted FVC, King’s Brief Interstitial Lung Disease quality of life questionnaire (K-BILD), and diffusion capacity of lungs for carbon monoxide (DLCO). While not statistically significant, both time to first acute exacerbation of IPF and overall survival at week 52 trended in favor of Tyvaso. Treatment with Tyvaso was well-tolerated, and the safety profile was consistent with previous Tyvaso studies and known prostacyclin-related adverse events. No new safety signal was seen.
    • “It is a profound honor to witness the power of scientific innovation realized for patients in need,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “TETON-2’ssuccessful outcomeaffirms the anti-fibrotic power of Tyvaso. We have unlocked new hope for patients with IPF and their families.”
  • The American Medical Association lets us know what doctors wish their patients knew about rebound congestion.
  • Per MedPage Today,
    • “Patients with type 2 diabetes who were treated with GLP-1 receptor agonists were less likely to develop peptic ulcer disease (PUD), a nationwide study found.
    • “In an analysis of more than 65,000 patients, GLP-1 users had 44% lower odds of PUD compared with non-users (adjusted OR 0.56, 95% CI 0.45-0.71, P<0.001), reported Trisha Pasricha, MD, MPH, of Beth Israel Deaconess Medical Center in Boston, and colleagues.
    • “In a subgroup of patients with a history of metformin use, switching to a GLP-1 receptor agonist for second-line treatment was associated with a 56% lower hazard of PUD compared with switching to insulin (adjusted HR 0.44, 95% CI 0.30-0.63, P<0.001). By 2 years, the cumulative PUD risk was 1.8% in the GLP-1 group versus 4.5% in the insulin group, the authors reported in Clinical Gastroenterology and Hepatology.”
  • and
    • “A personalized message about advanced colorectal neoplasia risk to patients and providers had no effect on colorectal cancer screening uptake, a randomized trial showed.
    • “Among 1,084 average-risk patients, the predicted probability of completing colorectal cancer screening with a personalized decision aid was 36.8% versus 41% with a generic decision aid (P=0.18), reported Peter H. Schwartz, MD, PhD, of the Indiana University School of Medicine in Indianapolis, and colleagues.
    • “For the 214 providers who were sent personalized notifications about patients’ risk, the predicted probability of the patient completing screening was 41.5% versus 36.4% for those who received a generic notification (P=0.135), they noted in the Annals of Internal Medicine.
    • “The overall result was negative, although there were some really interesting results in subgroups,” Schwartz told MedPage Today.”
  • and
    • “Among older adults, the incidence of myocarditis or pericarditis was lower among those who received the high-dose inactivated flu vaccine versus the standard-dose vaccine.
    • “There were only two cases of myocarditis observed among over 300,000 study participants, both in the standard-dose group.
    • “These results may not be generalizable to younger people, who are at greater risk of inflammatory cardiac conditions.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna’s health services division Evernorth has invested $3.5 billion in Shields Health Solutions as the company continues to build out its lucrative specialty pharmacy business.
    • “Shields, which helps hospitals and other providers create and manage their own specialty pharmacies, is one of five standalone businesses created from pharmacy behemoth Walgreens, which was acquired and chopped up by private equity firm Sycamore Partners last week.
    • “Evernorth’s investment in the form of preferred stock does not give Evernorth a controlling stake in Shields and is not expected to materially impact Cigna’s earnings guidance for 2025. The deal does give the company the option to invest more in Shields in the future.”
  • Fierce Healthcare announced its “FIERCE 50 OF 2025, the people and organizations advancing what’s possible in health, science and patient care.”
  • Beckers Hospital Review tells us,
    • “The University of Texas at San Antonio merged with The University of Texas Health Science Center at San Antonio on Sept. 1 to become The University of Texas at San Antonio. 
    • “The University of Texas System shared plans to merge the two entities into a unified institution in late August 2024. 
    • “The institution, which is now Texas’ third-largest public research university, comprises 15 colleges and schools across six campuses, around 40,000 students, 17,000 employees, more than 320 undergraduate and graduate degrees, $486 million in annual research expenditures and a $1.3 billion endowment, according to a Sept. 1 news release.”
  • Hook’em. 
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative effectiveness of apitegromab (Scholar Rock Holdings), as well as the disease-modifying therapies nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA). Apitegromab is an investigational new drug seeking FDA approval for improving motor function in patients with SMA.” * * *
    • ICER has calculated a health benefit price benchmark (HBPB) to be between $4,600 and $30,200 per year.\
    • ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, carers and patient advocates, and representatives from US payers — convened to discuss the pricing implications and recommendations to ensure fair access. Key recommendations stemming from the roundtable discussion include: 
      • The manufacturer should set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments. Given the small average improvement in motor function for patients treated with apitegromab and the uncertainty about serious adverse events, manufacturer pricing should reflect ICER’s value-based price range in moderating launch pricing.
      • The use of SMN-directed therapy after gene therapy or in combination should only be done in the context of research studies.
      • A randomized trial should be performed of first-line therapy in asymptomatic patients identified through newborn screening to better understand the comparative advantages and disadvantages of each of the three SMN-directed therapies.
    • ICER’s detailed set of policy recommendations is available in the Final Evidence Report and in the standalone Policy Recommendations document. 
  • Per Healthcare Dive,
    • “Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. 
    • “The study, published on Aug. 22, looked at 950 AI medical devices authorized by the Food and Drug Administration through November 2024. Sixty of the devices were associated with 182 recall events. 
    • ‘The most common causes of recalls were diagnostic or measurement errors, followed by functionality delay or loss. About 43% of all recalls also took place within one year of FDA authorization. 
    • “Tinglong Dai, lead author of the study and a professor at the Johns Hopkins Carey Business School, said the “vast majority” of recalled devices had not undergone clinical trials. For the majority of AI-enabled devices, which went through the FDA’s 510(k) pathway, clinical studies are not required. 
    • “Unfortunately, it’s not required, and so people don’t do it,” Dai said in an interview. “So, that’s why we believe it is one of the most important drivers of the recalls.”
    • “By comparison, the study found that devices that had gone through retrospective or prospective validation were subject to fewer recalls.” 
  • Per BioPharma Dive,
    • “Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead Pharmaceuticals that could be worth billions of dollars.
    • “The deal, announced Monday, revolves around a preclinical drug that Arrowhead designed to silence the genetic instructions for “alpha-synuclein,” a protein tied to Parkinson’s disease and other brain-eroding illnesses. Novartis has now agreed to pay $200 million for an exclusive license to research, develop, manufacture and commercialize the drug.
    • “Arrowhead could receive an extra $2 billion or more by hitting certain development goals and collecting royalties on any resulting products. Per deal terms, Novartis will also be able to select additional disease targets outside of Arrowhead’s current pipeline to advance using the latter’s drug making technology, which centers on a technique called RNA interference.
    • “The companies plan to close their agreement sometime this year.”
  • and
    • “The biotechnology careers of John Maraganore and Clive Meanwell have brought them into collaboration time and time again.
    • “As the respective founders of Alnylam Pharmaceuticals and The Medicines Company, the two previously partnered on the drug that would ultimately become Leqvio, which was later bought in a $10 billion acquisition of Medicines Co. by Novartis. And before Alnylam, Maraganore had led development at Biogen of Angiomax, which was later licensed to Meanwell’s company.
    • “Now, the two have partnered to launch and run Corsera Health, which aims to make a preventive medicine for cardiovascular disease as well as an artificial intelligence tool to identify who could benefit from earlier heart intervention. 
    • “Corsera’s target are younger people who are not “willing to wait 40 years to see whether they have a heart attack,” Meanwell said. “They’re saying, ‘What can I find that will help me?’”
    • “Corsera’s lead drug, an RNA interference therapeutic now in preclinical testing, is designed to be a once-yearly injection that blocks two targets known to drive cardiovascular disease: PCSK9 and angiotensinogen. The company expects to begin clinical testing by the end of the year.”

Thursday report

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

From Washington, DC,

  • The Washington Post reports,
    • “The White House on Thursday selected a top deputy of Health and Human Services Secretary Robert F. Kennedy Jr. to serve as acting head of the Centers for Disease Control and Prevention after a clash over vaccine policy ended in the departure of several agency leaders, according to two people familiar with the decision.
    • “The selection of Jim O’Neill, currently the deputy secretary of HHS, as interim leader of the CDC, potentially clears a path for Kennedy to continue his efforts to overhaul federal vaccine policy after the agency’s previous leader, Susan Monarez, balked at his requests.” * * *
    • “Pressed by lawmakers in his confirmation hearings in May about his public health beliefs, O’Neill said that he was a staunch supporter of vaccines.
    • “I’m very strongly pro-vaccine, I’m an adviser to a vaccine company, I support the CDC vaccine schedule,” he told senators in one exchange. But he also said that the federal government had overreached during the coronavirus response, and he criticized the Biden administration’s efforts to mandate coronavirus vaccines for federal workers.”
  • BioPharma Dive informs us,
    • “A federal vaccine panel recently remade by Health and Human Services Secretary Robert F. Kennedy Jr. will meet in September to discuss and potentially vote on recommendations for vaccines against COVID-19, hepatitis B and measles. 
    • A”ccording to a federal notice posted Thursday, the Advisory Committee on Immunization Practices will meet Sept. 18 and 19. A detailed agenda is not yet available, but the notice mentions that vaccines for respiratory syncytial virus may also be discussed. 
    • “The anticipated meeting will be the second by the reconstituted ACIP since Kennedy fired all 17 of its prior members and replaced them with seven hand-picked advisers. In the first, the new panelists appeared skeptical of evidence supporting COVID shots’ safety and efficacy and debated a controversial preservative that’s long been a target of vaccine skeptics despite data showing it to be generally safe.” 
  • Per a Congressional news release,
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, called for the U.S. Department of Health and Human Services Advisory Committee on Immunization Practices (ACIP) to indefinitely postpone their September 18th meeting.
    • “Serious allegations have been made about the meeting agenda, membership, and lack of scientific process being followed for the now announced September ACIP meeting. These decisions directly impact children’s health, and the meeting should not occur until significant oversight has been conducted. If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership,” said Dr. Cassidy.”
  • Per another Congressional News release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will convene for a markup followed by a hearing on President Trump’s 2026 Health Care Agenda on Thursday, September 4. The markup will be held at 9:30 AM and will be immediately followed by the health care hearing at 10:00 AM.
    • “Secretary Kennedy has placed addressing the underlying causes of chronic diseases at the forefront of this Administration’s health care agenda,” said Crapo. “I look forward to learning more about the Department of Health and Human Services’ Make America Healthy Again actions to date and plans moving forward.”
  • The Congressional Research Service issued a report about “Expiring Health Provisions of the 119th Congress” while Healthcare Dive points out “top healthcare legislation to watch so far this year. Federal lawmakers have proposed dozens of bills targeting core healthcare issues, including 340B, Medicaid, AI and site-neutral payments.
  • The American Hospital Association News notes,
    • “The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology Aug. 26 released a notice seeking comments on a proposed survey of health technology companies to assess implementation and experiences with information blocking, the 21st Century Cures Act and health care application programming interfaces. Comments must be submitted by Sept. 25.”
  • and
    • “The AHA Aug. 26 responded to a request for information as part of the introduction of the Healthy Moms and Babies Act, bipartisan legislation that seeks to improve maternal and child health by increasing services and support and coordinating care. The AHA responded to a request to provide feedback on how to incorporate a low-volume payment adjustment for home health models for pregnant and postpartum women. In response to the RFI from the bill’s co-sponsors, Sens. Chuck Grassley, R-Iowa, and Maggie Hassan, D-N.H., the AHA highlighted the financial and staffing challenges that rural hospitals face, among other issues, which can lead to obstetric unit closures and other reductions in labor and delivery services.”
  • Per Beckers Hospital Review,
    • The American Hospital Association sharply criticized a 340B rebate model pilot program from the Health Resources and Services Administration, an agency of HSS, warning the model threatens to undermine three decades of success under the existing 340B drug pricing program. 
    • In an Aug. 27 letter addressed to Thomas Engels, administrator of the HRSA, the AHA outlined serious concerns about the agency’s decision to shift from upfront discounts to a rebate model for select Medicare Part D drugs. 
    • The association also urged the agency to abandon the pilot, calling the model a “solution in search of a problem” that could harm safety-net hospitals. “There is no sound reason for HRSA to make such a profound change,” the letter stated. “We are confident that what it calls a ‘test’ will ultimately fail.” 
  • Tammy Flanagan, writing in Govexec, discusses “Important dates for Social Security and Medicare; Key milestones and deadlines every beneficiary should know.” 

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA approved the first-ever generic form of a GLP-1 receptor agonist specifically indicated for weight loss, Teva Pharmaceuticals announced Thursday.
    • “The generic form of liraglutide (Saxenda) is indicated for adults with obesity or overweight with at least one weight-related comorbidity in combination with diet and exercise, as well as for adolescents ages 12 to 17 who are over 132.2 lb with obesity.
    • “Liraglutide was first approved in 2014 for chronic weight management in adults, and this indication was expanded in 2020 to include teens.” * * *
    • “This is the first GLP-1 generic for weight loss, but other generics have been previously approved for type 2 diabetes, including liraglutide (Victoza) and exenatide (Byetta).”

From the public health and medical research front,

  • JAMA informs us,
    • “Question  Does partial heart transplant provide a safe and effective valve replacement option that also has capacity for growth in patients with congenital heart disease?
    • “Findings  In this case series of 19 patients who underwent partial heart transplant, all valves demonstrated functional durability and growth over time with maintenance immunosuppression. No patient experienced valve-related reintervention, and leaflet measurements confirmed true tissue growth.
    • “Meaning  Partial heart transplant appears to be a safe and feasible procedure that enables valve growth, representing a promising solution to overcome the limitations of current nongrowing valve replacement options.”
  • The New York Times writes about youngsters who successfully have received partial health transplants.
  • Per MedPage Today,
    • “A study of over 112,000 U.S. adults found that 14% started a GLP-1 receptor agonist after bariatric surgery.
    • “Timing of GLP-1 agent initiation after bariatric surgery varied, and optimal timing needs to be investigated further.
    • “Sleeve gastrectomy patients and those who regained more weight after surgery were more likely to start a GLP-1 agent.”
  • and
    • “Estradiol hormone therapy was associated with higher memory scores in postmenopausal women.
    • “Transdermal estradiol was linked with better episodic memory, while oral estradiol was tied to prospective memory.
    • “Alzheimer’s risk is higher in women and may be related to menopausal loss of neuroprotective sex steroids.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Novo Nordisk has taken the next step in selling its drugs directly to patients by pointing them to telehealth providers that can write prescriptions for its popular obesity medication Wegovy. The company now links to select virtual providers on the NovoCare direct-to-patient pharmacy website it launched earlier this year, joining other pharma giants that have leaned into direct sales through their own online portals. 
    • “These new direct-to-consumer medication sites combine telehealth access points with pharmacy fulfillment, coupons, and patient information — sometimes with exclusive cash-pay pricing. Eli Lilly launched LillyDirect in January 2024 and was followed by Pfizer’s patient-facing site PfizerForAll later in the year. Partnering with telehealth companies is growing as a pharma marketing tactic even as the practice has come under scrutiny from lawmakers and health policy experts who raise concerns it may create improper relationships between drugmakers and health care providers.”
  • The American Medical Association offers details on GLP-1 spending in the U.S.
  • Healthcare Dive reports,
    • “Walgreens is officially a private company after the troubled retailer’s $10 billion sale to private equity firm Sycamore Partners closed Thursday.
    • “Moving forward, Walgreens’ healthcare subsidiaries Shields Health Solutions, CareCentrix and VillageMD will operate as separate businesses. The Boots Group, Walgreens’ international retail pharmacy chain, will also be spun out, creating five standalone companies.
    • “Sycamore appointed retail veteran Mike Motz as Walgreens CEO, replacing current chief executive Tim Wentworth. Motz has formerly served as CEO of Staples U.S. Retail, a Sycamore portfolio company, and as president of Canada-based pharmacy chain Shoppers Drug Mart.” 
  • Modern Healthcare relates,
    • “Lewis Drug locations are set to become part of Sanford Health this fall, following a decades long partnership between the two organizations. 
    • “Lewis Drug, a retail pharmacy company, will continue to operate under its own brand, according to a Thursday press release. Its existing staff will be employed by Sanford Health. 
    • “The two organizations have a joint venture, Lewis Family Drug, comprised of 44 locations offering retail items and pharmacy services. Sanford Health operates clinics at 11 Lewis Drug locations. While there are no immediate plans for additional clinics after the deal is expected to be finalized this fall, Sanford is open to that possibility in the future, Nick Olson, executive vice president and chief financial officer of Sanford Health, said Thursday.”
  • and
    • “U.S. Digestive Health, a large gastroenterology practice in Southeastern Pennsylvania, has been sold by private equity firm Amulet Capital Partners to SCA Health, a subsidiary of UnitedHealth Group under the Optum umbrella. 
    • “The deal, completed in January with little public notice, shifts a network of about 150 physicians and 24 ambulatory surgery centers across Pennsylvania and Delaware to the nation’s largest health insurer. Financial terms were not disclosed.
    • “Amulet, based in Greenwich, Connecticut, formed U.S. Digestive in 2019 by consolidating three regional practices.” 
  • Per Beckers Payer Issues,
    • “The California and Texas medical associations are urging Cigna to rescind a new policy they say will increase administrative burdens and create a barrier to appropriate reimbursement.  
    • “Beginning Oct. 1, Cigna’s new Evaluation and Management Coding Accuracy policy will review CPT evaluation and management codes 99204-99205, 99214-99215, and 99244-99245 for billing and coding accuracy. Some services may be adjusted by one level when guidelines are not met. 
    • “To better align with the American Medical Association’s Evaluation and Management services guidelines, Cigna Healthcare will implement a new reimbursement and coding accuracy policy for E/M codes that are being inappropriately billed as a higher level,” a Cigna spokesperson told Becker’s. “This review will only apply to approximately 3% of in-network physicians who have a consistent pattern of coding at a higher E/M level compared to their peers. Claims will be individually reviewed for coding accuracy and payment may be adjusted by one level to meet AMA guidelines. Physicians may request reconsideration or appeal our decision if they feel the higher payment is appropriate.”

Tuesday report

David Ermer–Congress, Medical / Rx research, No Surprises Act, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Government Accountability Office informs us
    • “Health care spending is higher in the U.S. than in any other high-income country. Yet, our health outcomes are worse. 
    • “It’s a tough issue to tackle. But when GAO faces tough policy challenges, the Comptroller General of the U.S. (and head of GAO) can convene a forum of experts to get their insights.  
    • Today’s WatchBlog post looks at our recent report about a forum on health care spending and quality of care.” * * *
    • During our forum on health care spending, experts from government, academia, and industry identified five key areas where—if action was taken—costs could be reduced and care improved. We provided approaches in these key areas to Congress in our report as potential options for addressing this issue.   
  • Politico reports,
    • President Donald Trump plans to appoint Dan Scavino, a longtime loyalist and White House deputy chief of staff, to run the Presidential Personnel Office, empowering him with the power to decide who can and cannot serve in the administration.
    • “Dan Scavino is one of President Trump’s most trusted and longest serving advisors,” said White House Press Secretary Karoline Leavitt. “There is nobody better to ensure the president’s administration is staffed with the most qualified, competent, and America First-driven workers. There is much still to be done and Dan’s leadership will ensure the highest quality, most dedicated workforce ever.”
  • Health Affairs Forefront offers a No Surprises Act litigation status check written by Professor Katie Keith.
    • “Nearly five years ago, President Trump signed the No Surprises Act into law, establishing new patient protections against surprise medical bills. Since the law took effect in 2022, millions of consumers have been protected from unexpected bills for out-of-network care—from emergency services to anesthesia to air ambulance rides. While the law has successfully protected consumers from the most common types of surprise out-of-network bills, its implementation has been hobbled by aggressive litigation.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY said a third late-stage study of its experimental anti-obesity pill hit its key goals, paving the way for the drugmaker to begin regulatory submissions.
    • “Eli Lilly on Tuesday said the Phase 3 study of orforglipron in adults with obesity or overweight and type 2 diabetes met the primary and all key secondary endpoints at all three doses, showing significant weight loss, meaningful A1C reductions and improvements in cardiometabolic risk factors at 72 weeks.
    • “The Indianapolis company said study participants lost an average of 22.9 pounds, or 10.5% of their body weight, on the highest dose, with A1C, a measure of blood-sugar levels, reduced by an average of 1.8%.
    • “Eli Lilly said orforglipron also showed a safety profile consistent with injectable GLP-1 medicines, such as its blockbuster Mounjaro and Zepbound drugs.
    • “Eli Lilly said it now has the full clinical data package it needs to initiate global regulatory submissions for orforglipron this year.”
  • BioPharma Dive adds,
    • “An RNA medicine developed by Regeneron Pharmaceuticals and Alnylam Pharmaceuticals helped control symptoms of the chronic autoimmune disease generalized myasthenia gravis in adults enrolled in a late-stage study, Regeneron said Tuesday.
    • “Regeneron also tested the RNA medicine, called cemdisiran, together with an antibody drug it developed and sells as Veopoz for another disease. However, study results suggested the combination was not as effective as cemdisiran alone.
    • “Regeneron, which licensed cemdisiran from Alnylam, plans to submit the drug for U.S. approval in myasthenia gravis sometime in the first quarter next year. It is also testing the drug in paroxysmal nocturnal hemoglobinuria and geographic atrophy that is tied to age-related macular degeneration.”
  • Genetic Engineering and Biotechnology News notes,
    • “Germ cells pass DNA to the next generation and undergo massive reorganization of their DNA packaging to generate totipotency, or the ability to differentiate into any cell type. Understanding the mechanism of germ cell nucleome formation can offer valuable applications for addressing infertility. 
    • “In a new study published in Nature Structural & Molecular Biology titled, “The mitotic STAG3-cohesin complex shapes male germline nucleome,” researchers from Kyoto University have discovered STAG3-cohesin, a new mitotic cohesin complex that helps establish the unique DNA architecture of spermatogonial stem cells, which give rise to sperm. This discovery offers new strategies for treating infertility and certain cancers.”
  • JAMA posted a research letter about “Trends in County-Level MMR [Measles, Mumps and Rubella] Vaccination Coverage in Children in the United States.”
    • “Although the national- and state-level declines in MMR coverage are well documented, MMR vaccination coverage can vary substantially within a state.6 We generated a standardized dataset with annual county-level vaccination rates for children from 2017 to 2024 for all states in the US where this information was available and evaluated spatiotemporal trends in vaccination coverage during this period. This open, high-resolution dataset serves as a resource to explore the US vaccination landscape and its implications for vaccine-preventable disease.”
  • Per MedPage Today,
    • “Moderate-to-severe traumatic brain injury (TBI) increased malignant brain tumor risk in a large retrospective study of civilians.
    • “This risk persisted when findings were meta-analyzed with data from two other cohorts.
    • “The results echoed outcomes that emerged in an earlier study of young U.S. war veterans with TBI.”
  • Consumer Reports, writing in the Washington Post, lets us know “what can make you dizzy? Could it be an inner-ear issue? Your medications? How to figure out the problem — and fix it.”

From the U.S. healthcare business front,

  • Bloomberg Law reports,
    • “Rising health-care costs are fueling the comeback of a strategy to limit hospital bills, but the evolving model requires employers to take on more work and risk in ditching the big insurance companies.
    • “Reference-based pricing” typically determines a provider’s payments from Medicare rates, plus a premium ranging from 25-50%. Those rates fluctuate depending on the market and provider type, but advocates say they usually shave around 30% off a plan’s annual costs.
    • “The strategy is part of employers’ ongoing search for alternatives to traditional health insurance as they confront an expected 9% spike in costs next year. But hospitals say RBP vendors are just middlemen looking to profit at patients’ expense.” * * *
    • “The whole thing is very ugly from a patient perspective in the sense of it’s often not very clear what the rules are,” said Molly Smith, American Hospital Association’s group vice president for policy. “They often don’t understand whether or not they have a network.”
    • “RBP companies blame the bad reputation on early iterations that sparked a series of lawsuits and left patients with steep bills. Many vendors today collaborate more with providers and protect patients, they said.
    • “The differences in the models is how you deal with access issues, how do you deal with balance bills,” said Scott Ray, founder of RBP vendor 6 Degrees Health.”
  • Modern Healthcare adds,
    • “Concierge and direct primary care practices are gaining traction among physicians, employers and patients increasingly frustrated with traditional care pathways.
    • “The growth of these practices, where patients pay membership fees in exchange for increased access to physicians, is a symptom of Medicare and Medicaid reimbursement that has not kept pace with inflation, advisers, doctors and policy experts said. Growing care backlogs, coding and documentation tasks that take doctors away from patients and seemingly ever-rising health insurance premiums are also contributing, they said.
    • “A year ago, I would’ve told you these care models were a slowly evolving, quiet phenomenon,” said Dr. Zirui Song, an associate professor of healthcare policy at Harvard Medical School and a primary care provider at Massachusetts General Hospital. “It is now evolving quite rapidly — it is not so quiet anymore.”
  • Beckers Hospital Review provides us with large for-profit healthcare system “payer mixes by patient service revenue, patient admissions or both in the first six months of 2025,” and tells us about three new drugs that OptumRx, a UnitedHealth subsidiary, is tracking this year. 
  • BioPharma Dive relates “Biopharmaceutical firms in the U.S. and Europe are increasingly turning to China’s biotech sector for new medicines. Follow this year’s dealmaking with this database.”
  • Per Fierce Healthcare,
    • “Health tech company Waltz Health will merge with Eversana with the goal of shaking up access to prescription drugs.
    • “The deal will bring together Waltz’s proprietary drug marketplaces and direct-to-payer model with Eversana’s global pharmaceutical commercialization platform. In tandem, the two platforms will be well positioned to tackle the misaligned incentives in the drug supply chain and close gaps for patients, the companies said.
    • “The combination will be especially critical in driving down the cost of pricey specialty pharmacy products, including GLP-1s, according to an announcement. Financial terms of the deal were not disclosed.”
  • Per Modern Healthcare,
    • “Independent laboratory company Quest Diagnostics and Corewell Health entered a definitive agreement to build a jointly owned lab in Michigan. 
    • “The Diagnostic Lab of Michigan would be based at the Corewell Health Southfield Center in Southfield, Michigan. It would focus on automated microbiology and high-throughput molecular testing.
    • “Quest would also manage Corewell Health’s 21 inpatient and outpatient hospital labs as part of the joint venture. Financial terms were not disclosed.” 

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.” 

Monday Report

David Ermer–Congress, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Huffington Post discusses OPM’s August 15, 2025, second addendum to its 2026 call letter for FEHB and PSHB benefit and rate proposals.
  • Bloomberg Law reports,
    • “Drugmakers are responding to President Donald Trump’s call to launch direct-to-consumer sales, sparking questions about how the strategy could upend the industry’s traditional players—or help preserve the status quo.
    • “Trump’s push for drugmakers to offer direct sales at the lowest price offered in other developed nations is stoking a burgeoning tactic by drugmakers aimed at ending rebates they pay to pharmacy benefit managers and health plans. But the strategy’s potential to lower patients’ costs is still unclear.
    • “Manufacturers are building a variety of direct-to-consumer pipelines that can either use patients’ insurance plans or bypass them in favor of cash payments. Industry observers say the range of options makes it hard to predict what the ultimate impact on insurers, pharmacy benefit managers, pharmacies, and wholesalers will be, and whether the new world benefits drugmakers more than consumers.
    • “It looks like they’re offering reduced prices, when, in fact, those prices are still unaffordable for people,” said Anna Kaltenboeck, president of Verdant Research and a former adviser to the Senate Finance Committee under ranking member Ron Wyden (D-Ore.).
    • “If drugmakers were serious about lowering costs for consumers, Kaltenboeck said, they could simply lower their prices across the board.
    • “This is yet another iteration of trying to avoid the conversation that we need to have about the way in which pharma companies set list prices in the United States,” she said.”
  • Reginfo.gov remains under maintenance at 6 pm ET today. P.S. At 8 am ET on Tuesday, reginfo.gov is back online but it’s displaying the Fall 2024 semi-annual regulatory agenda. So, there is more work to be done.
  • Per an HHS press release,
    • The U.S. Department of Health and Human Services (HHS) today launched MAHA in Action—a dynamic new platform showcasing the powerful federal initiatives and state-led reforms advancing President Donald J. Trump and Secretary Robert F. Kennedy, Jr.’s Make America Healthy Again (MAHA) agenda.
    • This interactive tool offers a clear, accessible window into the bold actions reshaping America’s food, health, and public safety systems. MAHA in Action is more than a tracker—it’s a public declaration of the profound changes already underway.
    • “Make America Healthy Again isn’t just a slogan—it’s a mission statement, and we’re delivering results, fast,” HHS Secretary Kennedy said. “The MAHA in Action tracker puts the wins on the map. It gives the public, the press, and policymakers real-time visibility into how we’re restoring health, integrity, and accountability to every corner of our public health agency.”
    • The MAHA in Action webpage features updates on federal reforms being implemented across HHS agencies, including removing petroleum-based dyes and harmful additives from the U.S. food supply, closing the GRAS loophole that allows chemicals into food often with unknown safety data, restoring public trust in vaccine safety and scientific transparency, and finding the root causes of the chronic disease epidemic including autism. * * *
    • “Explore the platform here and find out what changes are happening in your state.”
  • HCP Live tells us,
    • “On August 15, 2025, the US Food and Drug Administration (FDA) approved Tonix Pharmaceuticals’ TNX-102 SL, under the name Tonmya, for treating adults with fibromyalgia, the first new drug for the indication in more than 15 years.
    • “For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” Philip Mease, MD, director of Rheumatology Research at the Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, said in a statement.1 “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”
    • “TNX-102 SL is a sublingual formulation of cyclobenzaprine and is also the first member of a new class of non-opioid analgesic drugs for fibromyalgia. Tonix originally announced the FDA’s acceptance of its new drug application for the medication in December 2024.

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about sodium consumption.
  • McKinsey and Company delves into “Closing the Black maternal-health gap: Healthier lives, stronger economies.”
  • The American Hospital Association News informs us,
    • “The Texas Department of State Health Services Aug. 18 announced that the state’s measles outbreak is over. The department said it had been more than 42 days since a new case was reported, surpassing the threshold to declare an end to an outbreak. There have been 762 confirmed measles cases during the West Texas-centered outbreak since late January. Of those, 99 individuals were hospitalized, and two school-aged children had died.”
    • “Nationwide, there have been 1,356 confirmed measles cases in 40 states this year, according to the latest Centers for Disease Control and Prevention data from Aug. 13. The vaccination status of 92% of all cases is classified as “unvaccinated or unknown.” 
  • Per a Senate news release,
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a statement following the Texas Department of State Health Services formally declaring the end of the measles outbreak in West Texas. It has been more than 42 days since a new measles case was reported in any of the counties that previously had ongoing transmission.
    • “I commend the Texas Department of State Health Services and the Trump administration for their work to stop this measles outbreak, saving lives in Texas and beyond,” said Dr. Cassidy. “But this tragedy was entirely preventable, and work must continue to curb outbreaks in other states. Misinformation about the measles vaccine fueled the spread of this outbreak, killing three Americans and hospitalizing many more. No child in the United States should ever die of a vaccine-preventable disease.”
    • “The measles vaccine is effective, safe, and the best way to protect yourself and your family from contracting this deadly disease. I encourage every parent to vaccinate their child to prevent needless death in the future,” continued Dr. Cassidy.”
  • Amen to that statement.
  • The Wall Street Journal reports,
    • “Gwen Orilio didn’t know how long she had to live after her stage-four lung cancer diagnosis. The disease had already infiltrated her eye, so the 31-year-old didn’t bother opening a retirement account.
    • “Ten years later, Orilio is still alive. And she still has metastatic cancer. 
    • “Keeping her going is a string of new treatments that don’t cure the disease but can buy months—even years—of time, with the hope that once one drug stops working a new one will come along. Orilio started on chemotherapy, and then switched to a new treatment, and then another, and another, and another.
    • “What’s next? What do I have lined up for when this one stops working?” said Orilio, a high-school math teacher who lives in Garner, N.C. “My motto is that the science just needs to stay a step ahead of me, and so far it’s been working.” 
    • “This past winter, she started a retirement fund at age 41. 
    • “Orilio is part of a new era of cancer treatment challenging the idea of what it means to have and survive cancer. A small but growing population is living longer with incurable or advanced cancer, navigating the rest of their lives with a disease increasingly akin to a chronic illness. The trend, which started in breast cancer, has expanded to patients with melanoma, kidney cancer, lung cancer and others.”
  • NBC News relates,
    • “More children died from the flu this past season than any year outside of the swine flu pandemic in 2009. Most of them were unvaccinated. 
    • “That’s why some doctors are hoping that the first nasal flu vaccine available for use at home can improve vaccination rates among people, especially children, who are afraid of needles. 
    • “AstraZeneca’s FluMist Home, which was approved last fall, is now available with a prescription for children ages 2 and over, and adults up to age 49.” * * *
    • “FluMist Home is available only online. People ordering the nasal spray will need to complete a medical screening questionnaire at FluMist.com that is reviewed by a health care professional, according to the drugmaker. FluMist Home’s online pharmacy will then collect the insurance information and bill the health plan directly.”
  • BioPharma Dive points out,
    • “A small, New Jersey-based drug developer plans to push an experimental psychedelic compound into late-stage testing now that it’s scored positive results in a postpartum depression study.
    • “That study enrolled 84 women with moderate to severe postpartum depression, each of whom received a single injection of Reunion Neuroscience’s “RE104” and were then monitored for four weeks. Participants were split into two groups. One got the full, 30 mg dose of RE104, while the other got a far lower dose and served as an “active control” arm.
    • “According to Reunion, the trial achieved its main goal as the 30 mg group showed significantly greater reductions on a widely used depression scale where lower scores indicate less severe symptoms. Seven days after treatment, scores in the experimental arm had fallen by 23 points, versus 17.2 points in the active control arm.
    • “Reunion said researchers also saw “clinically meaningful” responses in the higher dose group that started the day they received their injections and lasted through the 28-day follow up. Just over 77% had scores that improved by 50% or more one week after treatment. In the control arm, 62% hit that milestone. Between the two groups, 71% of the former achieved “remission” of their depression symptoms at Day 7, compared to 41% in the latter.
    • “Reunion said its drug — which functions similar to psilocybin, a molecule found in some psychedelic mushroom species — was well tolerated by patients. There were no serious adverse events, nor was there any treatment-emergent treatment-emergent seizures or suicidal ideation or behavior.”

From the artificial intelligence front,

  • A journalist and mother writing in the N.Y. Times, calls attention to a material weakness in AI chatboxes.
    • “Most human therapists practice under a strict code of ethics that includes mandatory reporting rules as well as the idea that confidentiality has limits. These codes prioritize preventing suicide, homicide and abuse; in some states, psychologists who do not adhere to the ethical code can face disciplinary or legal consequences.
    • “In clinical settings, suicidal ideation like [the journalist’s late daughter Sophie expressed] typically interrupts a therapy session, triggering a checklist and a safety plan. Harry [the AI chatbox] suggested that Sophie have one. But could A.I. be programmed to force a user to complete a mandatory safety plan before proceeding with any further advice or “therapy”? Working with experts in suicidology, A.I. companies might find ways to better connect users to the right resources.
    • If Harry had been a flesh-and-blood therapist rather than a chatbot, he might have encouraged inpatient treatment or had Sophie involuntarily committed until she was in a safe place. We can’t know if that would have saved her. Perhaps fearing those possibilities, Sophie held her darkest thoughts back from her actual therapist. Talking to a robot — always available, never judgy — had fewer consequences.
    • “Harry didn’t kill Sophie, but A.I. catered to Sophie’s impulse to hide the worst, to pretend she was doing better than she was, to shield everyone from her full agony. (A spokeswoman for OpenAI, the company that built ChatGPT, said it was developing automated tools to more effectively detect and respond to a user experiencing mental or emotional distress. “We care deeply about the safety and well-being of people who use our technology,” she said.)”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Fierce Healthcare is honoring its 2025 Most Influential Minority Executives.
    • “This year, we’re recognizing 11 leaders who are leading the charge in pushing healthcare forward. They represent influence across sectors, from provider organizations to payers to digital health, and are critical voices both in the U.S. and globally.
  • Check it out.
  • MedCity Dive notes,
    • “GLP-1s have proven to be highly effective for obesity but are extremely expensive and often have serious side effects, such as nausea, vomiting, dizziness and fatigue.
    • “That’s why Noom, a digital weight loss company, has introduced microdosing for GLP-1s. The company’s program involves beginning with a very low dose and gradually increasing to no more than 25% of the standard maintenance dose, with the goal of finding the lowest effective amount that supports weight loss while minimizing side effects and reducing cost.” * * *
    • “Is this microdosing program safe and effective? Noom says that due to the smaller doses, patients reduce the risk and intensity of side effects. The company also provides clinical oversight to ensure safety.
    • “However, at least one obesity medicine specialist isn’t so convinced that Noom’s microdosing offering is safe. And the concern isn’t so much with the prescribing of smaller doses, but the use of compounded GLP-1s, as they are not FDA-approved.
    • “The microdosing itself is not necessarily an issue. … For example, for patients on Ozempic for diabetes, we would off-label do this once in a while, especially when patients had more gastrointestinal side effects or they were losing weight faster than they wanted. … What I sort of take issue with Noom is that, one, I don’t know what medication or even substance somebody’s pumping into their bodies. And then two, what are the actual doses? Or what are the actual equivalents [compared to branded GLP-1s]?” argued Dr. Disha Narang, an endocrinologist and director of obesity medicine at Endeavor Health.”
  • Fierce Healthcare lets us know,
    • “National pricing data show the cost of healthcare services varies greatly by payer, geography, setting and facility, presenting new fiduciary considerations for employers.
    • “Since 2022, health plans have been required to release machine-readable files disclosing negotiated rates of healthcare services with providers. Hospitals are also required to release the costs of shoppable services.
    • “Data analytics firm Trilliant Health ingested UnitedHealthcare and Aetna transparency files from February to April 2025 to create a new report. Now, those massive swaths of information are slowly becoming more actionable for employers, they will need to plan accordingly, said Chief Research Officer Allison Oakes in an interview with Fierce Healthcare.
    • “Because this pricing information wasn’t historically available, employers weren’t necessarily responsible for picking the highest value health plan for their employees,” she said. “This also shifts the onus and responsibility to employers to use the leverage they have in the market to start changing some of this pricing as well.”
  • CVS Health highlights its value-based program for behavioral health care through clinical collaboration.
    • “There is still a clear need for high-quality, evidence-based behavioral health care in the U.S.
    • “One way to get there is through innovative payment models, including value-based care (VBC) models.
    • “The value-based care arrangement between Aetna, a CVS Health company and health plan, and virtual eating disorder provider Equip is an example of success. Of the Aetna members treated by Equip since 2021, 86% have made progress in their eating disorder treatment and the average reduction in eating disorder symptoms is 70%, validated through the Eating Disorder Exam Questionnaire (EDE-Q).
  • Beckers Hospital Review identifies “seven new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • MedTech Dive tells us, “The Food and Drug Administration has authorized more medical devices that incorporate artificial intelligence. Keep track of the latest developments in this database” which MedTech Dive updated today.

Thursday report

David Ermer–CDC, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • MedPage Today tells us,
    • “HHS Secretary Robert F. Kennedy Jr. last month quietly endorsed recommendations from his handpicked vaccine advisors that everyone in the U.S. ages 6 months and older receive a flu shot for the upcoming season.” * * *
    • “ACIP reaffirms the recommendations for routine annual influenza vaccination of all persons aged ≥6 months who do not have contraindications for the 2025-2026 season,” the ACIP page states. “With no current CDC Director and pending confirmation of a new CDC Director, this recommendation was adopted by the HHS Secretary on July 22, 2025, and is now an official recommendation of the CDC.”
    • “A new CDC director, Susan Monarez, PhD, is now in place. * * *
    • “Another ACIP recommendation from the June meeting earned an endorsement Aug. 4 from Monarez. ACIP called for infants younger than 8 months who were born during or entering their first respiratory syncytial virus (RSV) season who are not protected by maternal vaccination to receive one dose of clesrovimab (Enflonsia)opens in a new tab or window. The monoclonal antibody joins a similar long-acting shot, nirsevimab (Beyfortus),opens in a new tab or window as an option for this population.”
  • Beckers Hospital Reviews lets us know six things about the tariffs that took effect today.
  • Federal News Network informs us,
    • “The Postal Service’s board of governors is urging its regulator not to put limits on its ability to set higher mail prices, after posting another multibillion-dollar quarterly net loss.
    • “USPS posted a $3.1 billion net loss for the third quarter of fiscal 2025 — a greater loss than the $2.5 billion net loss it saw for the same period last year.
    • “But Postmaster General David Steiner said USPS is “on the right path,” under a 10-year reform plan launched by his predecessor, former Postmaster General Louis DeJoy.
    • “The strategy is sound. Now we have to execute,” Steiner said during a public meeting of the USPS Board of Governors on Thursday. “But we can’t execute unless all of our team is working together. We all need to be rowing the oars in the same direction.”
  • Healthcare Dive relates,
    • “Amwell has extended a contract with the Defense Health Agency to support virtual care at the military health system, one of the company’s most significant growth initiatives, for another year, the telehealth vendor said Tuesday. 
    • “However, the deal cut out deployments for Amwell’s behavioral health and automated care programs “due to budget restrictions being broadly enforced by the Department of Defense,” CEO Ido Schoenberg said during a second quarter earnings call on Tuesday. 
    • “The contract change led the telehealth firm to revise its guidance for 2025. Amwell now expects revenue from $245 million to $250 million this year, down from its previous outlook of $250 million to $260 million.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of drug manufacturing facilities in the U.S. The program, called FDA PreCheck, was created in response to a May 5 executive order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs the FDA to streamline and accelerate the development of domestic pharmaceutical manufacturing by eliminating unnecessary or duplicative regulations and improving inspection processes. 
    • “The program consists of a two-phase approach to facilitate new manufacturing facilities. The first provides manufacturers with more frequent FDA communication during stages such as facility design, construction and pre-production. The second focuses on streamlining development of the chemistry, manufacturing and controls section of the drug application through pre-application meetings and early feedback.” 
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Thursday lifted its recommendation to pause use of Valenva’s chikungunya vaccine Ixchiq in older adults but added new warnings about the shot’s risks and limited who is eligible to receive it.
    • “The FDA’s action follows a similar move by the European Medicines Agency, which had paused use along similar lines as the FDA. However, the U.S. regulator’s changes to Ixchiq’s labeling appear likely to curtail how broadly its used in the future.
    • “Vaccination with Ixchiq is not advisable for most U.S. travelers. For most U.S. travelers, the risk of exposure to chikungunya is low,” the updated label says.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care flagged a problem with certain t:slim X2 insulin pumps where a wiring issue with certain devices’ speakers can cause them to malfunction and stop delivering insulin. 
    • “Tandem said it has received reports of 700 adverse events and 59 injuries. There have been no reports of death. The problem, if not addressed, presents the risk of hyperglycemia in people with diabetes. The company said in a Thursday announcement that it has also alerted the Food and Drug Administration and regulators outside of the U.S. 
    • “The company sent a letter to customers in July. The FDA has not yet posted the device correction in its recall database.”
  • Fierce Pharma adds,
    • “When Jazz Pharmaceuticals’ incoming CEO Renee Gala takes the reins at the drugmaker next week, she’ll have a brand-new launch to manage.
    • “Wednesday, the FDA approved Jazz’s Modeyso (dordaviprone) for patients ages 1 and older with H3 K27M-mutant diffuse midline glioma who have progressive disease following prior therapy. The drug, picked up in the company’s $935 million buyout of Chimerix earlier this year, is the first systemic therapy for those with the aggressive brain cancer.”

From the judicial front,

  • Healthcare Dive reports,
    • “UnitedHealth and Amedisys have agreed to a settlement with the Department of Justice, clearing the path for their $3.3 billion merger to go through.
    • “The settlement, filed with the Maryland district court on Thursday, requires UnitedHealth and Amedisys to divest certain businesses in order to placate the DOJ’s concerns that the merger is anticompetitive. Amedisys has also agreed to pay a $1.1 million civil penalty to the U.S. for not fully complying with regulators during the merger review process.
    • “Regulators’ tentative greenlight of the multibillion-dollar deal is a win for UnitedHealth, which originally proposed plans to acquire the home health and hospice provider in 2023. However, the merger has been tied up in litigation after the DOJ and four states sued to block it in November.”
  • Per Fierce Healthcare,
    • “The drug price negotiation program has withstood another procedural effort in striking down one of the Inflation Reduction Act’s most significant provisions.
    • “In the U.S. Court of Appeals for the 6th Circuit, a panel of judges upheld (PDF) a lower court’s decision to dismiss the lawsuit.
    • “A judge dismissed the lawsuit last year, saying most of the plaintiffs lacked standing to bring the case, but the U.S. Chamber of Commerce was able to file a new suit. The U.S. Chamber could now appeal to the Supreme Court, reported The Hill.”
  • The Hill adds,
    • “Federal judges in Texas and Connecticut on Thursday ruled against arguments challenging the constitutionality of the Medicare Drug Price Negotiation Program, delivering two more blows to the pharmaceutical industry this week after an appeals court upheld the dismissal of a similar case.
    • “In Connecticut, the U.S. 2nd Circuit Court of Appeals upheld (PDF) a decision granted by U.S. District Judge Michael P. Shea last year against pharmaceutical company Boehringer Ingelheim. The company’s diabetes medication Jardiance was among the first 10 drugs chosen for Medicare negotiations, and two more of its products were chosen for the following round of negotiations.”
    • “In Texas, U.S. District Judge David Alan Ezra dismissed the lawsuit brought forward by the trade group PhRMA with prejudice, closing the case.”

From the public health and medical research,

  • The Wall Street Journal reports,
    • “Ultraprocessed foods make up the majority of calories Americans are eating, according to a report released Thursday by the federal government. But there are signs this consumption might be declining.
    • “Sandwiches, baked goods, salty snacks and other ultraprocessed foods accounted for 55% of the calories Americans age 1 and older consumed from August 2021 to August 2023, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics study. 
    • “That proportion is getting smaller. For adults, the mean percentage of calories consumed from ultraprocessed foods fell 3 percentage points to 53% since 2018 and for children and teens, it fell nearly 4 percentage points to 61.9%, the report found.
    • “Statistically, the decline is significant,” said Anne Williams, a senior service fellow at the CDC and lead author of the report. For adults consuming around 2,000 calories a day, the drop between the 2017 to 2018 figures and the latest report translates to around 60 fewer calories a day coming from ultraprocessed foods on average, said Williams.
    • “Ultraprocessed foods have been linked to an array of health issues, including obesity, Type 2 diabetes, cancer, cardiovascular disease and depression. There isn’t a set definition for ultraprocessed foods but researchers consider them foods made with ingredients not normally found in a home kitchen, including high-fructose corn syrup and emulsifiers such as soy lecithin.”
  • MedPage Today adds,
    • “Eating French fries multiple times a week was associated with a higher risk of type 2 diabetes, though this wasn’t the case for baked, boiled, or mashed potatoes, researchers said.
    • “For every increment of three servings weekly of French fries, the rate of type 2 diabetes increased by 20% (95% CI 1.12-1.28), and for every increment of three servings weekly of total potato, the rate increased by 5% (95% CI 1.02-1.08), reported Walter Willett, MD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues.
    • “However, consumption of combined baked, boiled, or mashed potatoes was not significantly associated with risk of type 2 diabetes (pooled HR 1.01, 95% CI 0.98-1.05), they noted in The BMJ.
    • “Importantly, our substitution analysis showed that replacing all forms of potatoes — especially fries — with whole grains was linked to a lower risk of type 2 diabetes, whereas swapping them for white rice was associated with the opposite effect,” co-author Seyed Mohammad Mousavi, PhD, also of the Harvard T.H. Chan School of Public Health, told MedPage Today. “This reinforces that it’s not just about the potato itself, it’s about how it’s prepared and what foods it’s replacing in the diet.”
  • Genetic Engineering and BioTechnology News reports,
    • “Parkinson’s disease (PD) is the second-most common neurodegenerative disorder after Alzheimer’s and is caused by the degeneration of dopamine-producing neurons in the brain, leading to motor dysfunction, such as tremors and slowed movements.  
    • “Vamsi Mootha, MD, institute member at the Broad Institute, explains that a striking epidemiological association exists between heavy smoking and lowered PD risk. As smoking causes elevated carbon monoxide exposure which disrupts oxygen delivery by hemoglobin, he speculates that a low oxygen state in the brain may offer an unexpected protective mechanism against this incurable neurological disease that affects more than 10 million people worldwide. 
    • “In a new study published in Nature Neuroscience titled, “Hypoxia ameliorates neurodegeneration and movement disorder in a mouse model of Parkinson’s disease,” Mootha’s lab has now shown that low oxygen environments, similar to the thin air found at Mont Blanc, which reaches an elevation of approximately 16,000 feet, can successfully recover neuron function and alleviate motor symptoms in mice with Parkinson’s-like disease.:
    • * * * “The fact that we actually saw some reversal of neurological damage is really exciting,” said Mootha in a public release. “It tells us that there is a window during which some neurons are dysfunctional but not yet dead—and that we can restore their function if we intervene early enough.”
  • Health Day relates,
    • “Vaccination with the updated COVID-19 mRNA vaccine containing the severe acute respiratory syndrome coronavirus-2 Omicron JN.1 lineage [the fall 2024 vaccine] was not associated with an increased risk for 29 adverse events, according to a study published online July 28 in JAMA Network Open.
    • “Niklas Worm Andersson, M.D., Ph.D., from Statens Serum Institut in Copenhagen, Denmark, and colleagues examined the association between vaccination with JN.1-containing vaccines and the risk for 29 serious adverse events adapted from prioritized lists of adverse events of special interest to COVID-19 vaccines. Outcome rates during the first 28 days after JN.1-containing vaccine administration (i.e., the risk period) were compared to outcome rates during the remaining period.”
  • Per MedPage Today,
    • “Superagers — a group of adults over age 80 with the memory capacity of much younger people — maintained good brain morphology, tended to be gregarious, and appeared to be resistant to neurofibrillary degeneration and resilient to its consequences, more than two decades of research showed.
    • “In contrast to neurotypical peers who had age-related brain shrinkage, this group had a region in the cingulate gyrus that was thicker than younger adults, reported Sandra Weintraub, PhD, of Northwestern University Feinberg School of Medicine in Chicago, and colleagues.
    • “Superagers also had fewer Alzheimer’s-related brain changes, greater size of entorhinal neurons, fewer inflammatory microglia in white matter, better preserved cholinergic innervation, and a greater density of evolutionarily progressive von Economo neurons, Weintraub and colleagues wrote in a perspective piece in Alzheimer’s & Dementia.
    • “No particular lifestyle was conducive to superaging, the researchers said. Some superagers appeared to follow all conceivable recommendations for a healthy life. Others did not eat well, enjoyed smoking and drinking, shunned exercise, suffered stressful life situations, and did not sleep well.
    • “Superagers also did not seem to be medically healthier than their peers and took similar medications as they did. However, the superager group was notably sociable, relishing extracurricular activities. Compared with their cognitively average peers, they rated their relationships with others more positively. On a self-reported questionnaire of personality traits, they tended to endorse high levels of extraversion.
    • “It wasn’t the social and lifestyles aspects of superaging that surprised the researchers; it was “really what we’ve found in their brains that’s been so earth-shattering for us,” Weintraub said in a statement.”

From the healthcare artificial intelligence front,

  • Fierce Healthcare informs us,
    • “OpenAI released its most advanced reasoning model, GPT-5, which it touts as its most useful model for healthcare.
    • “The application of ChatGPT for healthcare played a leading role in the company’s Summer Update meeting on Thursday, during which it did live demos of the upgraded model. 
    • “Sam Altman, CEO of OpenAI, said health is one of the top reasons consumers use ChatGPT, saying it “empowers you to be more in control of your healthcare journey.” The company prioritized improving its healthcare features for this version of the product, Altman said. 
    • “GPT-5 will be available on the free version of the ChatGPT app, which means more consumers could start to rely on the product for assistance in making treatment decisions, understanding test results and determining what questions they should ask their doctors in the clinic.” 
  • Beckers Health IT points out,
    • “Oakland, Calif.-based Kaiser Permanente has been experimenting with AI in its patient portal, increasing patient engagement and experience in the process.
    • “The health system’s Southern California Permanente Medical Group, headquartered in Pasadena, launched the Kaiser Permanente Intelligent Navigator for its 4.9 million patients in October. The platform allows patients to chat with AI via a text box to book appointments and connect with the care they need.
    • “Care is local, but at the same time it’s virtual and it’s become a global commodity,” Khang Nguyen, MD, assistant executive medical director for care transformation at Southern California Permanente Medical Group and chief medical officer of care navigation for the Permanente Federation, told Becker’s. “So patients are really expecting artificial intelligence to support healthcare in a way that is supporting other industries, in the sense that people are able to describe what they want versus being given choices.” * * *
    • “In a study that evaluated nearly 3 million patient encounters using the AI between October and March, the tool detected urgent medical issues with 97.7% accuracy and recommended appropriate care paths with 88.9% accuracy. Patients successfully booked appointments more than half the time, compared to the industry average of 30%. The portal’s patient satisfaction scores went up by about 9%.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly shares plunged about 14% in midday trading Thursday after the company reported less-than-stellar results of a new study of an experimental anti-obesity pill that is expected to become a blockbuster.
    • “The pill helped people lose up to about 12% of their body weight after more than a year of treatment. The results could clear the way for the shot alternative to be on the market next year, but the magnitude of weight loss fell short of Wall Street expectations.
    • “The drugmaker also raised its earnings outlook for the year after revenue surged in its latest quarter on continued demand for its weight-loss and diabetes treatments.”
    • “The Lilly pill, orforglipron, is expected to become a big seller if regulators approve it for sale. Morgan Stanley analysts had said that under their bull-case scenario, the drug’s use for both obesity and diabetes could generate annual sales of up to $40 billion by 2033.
    • “Yet the latest clinical-trial results may dent some of that enthusiasm. The magnitude of weight loss fell short of what some analysts were predicting: 13% to 15% or more. 
    • “The Lilly pill is one of two that could hit the market within the next year or so, ushering in a new chapter of the weight-loss drug boom. Novo Nordisk has applied for regulatory approval of an anti-obesity pill version of its Ozempic and Wegovy, which could become available by the end of this year.”
  • Modern Healthcare relates,
    • “Aetna will end nearly 90 Medicare Advantage plans across 34 states in 2026, the company notified third-party sellers this week.
    • “The CVS Health subsidiary’s financial performance has represented a bright spot in the Medicare Advantage market compared with competitors such as UnitedHealth Group. This month, CVS Health raised its annual earnings guidance amid a $2 billion turnaround plan. The company cut the second-most plans in 2025, after Humana.
    • “The majority of the Medicare Advantage plans Aetna plans to eliminate next year are PPOs. Beginning in September, Aetna will stop paying commissions to brokers that enroll new members in these plans, according to a notice the company distributed to brokers on Monday.”
  • and
    • “UPMC and GoHealth Urgent Care have rebranded 81 urgent care centers as part of a joint venture between the two organizations. 
    • “The centers span Pennsylvania and West Virginia and offer care for non-life-threatening ailments, including flu, fever, earaches, insect bites, sprains, simple fractures and cuts requiring stitches. They will also offer virtual care options and are staffed with UPMC clinicians, according to a Thursday news release.
    • “The centers were previously owned by UPMC, including sites it acquired last month from MedExpress, another urgent care provider. Financial details of the joint venture were not disclosed.” 
  • Beckers Payer Issues adds,
    • “As major insurers pull back on their Medicare Advantage offerings, health system-owned plans told Becker’s they’re eyeing an opportunity to regain ground ahead of the annual enrollment season.” * * *
    • “I do think it’s an opportunity. Over time, the playing field is going to level somewhat, which is going to be a challenge for the nationals. For the community health plans, I think it’s going to be a benefit,” Rob Hitchcock, president and CEO of Intermountain’s Select Health, said.
    • “What you want is a healthy mix. You do want the national players to be strong, but you also want the community health plans to be strong,” he added.
  • NFP, an Aon company, discusses pharmacy deserts.
    • “A pharmacy desert is more than just a rural problem. It’s any area, urban, suburban or rural, where people lack reasonable access to a pharmacy. That usually means:
      • “More than one mile away in urban areas.
      • “Two miles in suburban areas.
      • “10 miles in rural regions.
    • “However, distance isn’t the only factor. Even if a pharmacy technically exists nearby, lack of public transportation, limited hours or closures of independent stores can make access nearly impossible, particularly for lower-income communities or those with mobility challenges.” * * *
    • “Pharmacy deserts are growing, and they have real consequences for employee health, equity and cost. While benefit consultants cannot control the closures, clients can guide their employees toward solutions that help their people stay healthy and protected, no matter where they live.”

Midweek report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
  • Fedsmith lets us know,
    • “The summer of 2025 experienced an unusually high surge in incoming retirement claims, starting in May and continuing into June. This surge can be largely attributed to the significant number of federal employees who have left federal service through various programs, including deferred resignation, Voluntary Early Retirement Authority (VERA), and others.
    • “According to OPM, approximately 154,000 federal employees have resigned under the deferred resignation program, and OPM Director Scott Kupor said recently that he anticipates the total federal workforce reduction to be at least double that number in the near future.”
  • Per an OPM press release,
    • The U.S. Office of Personnel Management (OPM) today announced that registration is now open for its innovative Executive Development Programs, designed specifically for Senior Executives Service (SES), GS-15, and GS-14 leaders.
    • These programs are closely aligned with President Trumpʼs new Executive Core Qualifications (ECQs) for senior executives, ensuring participants develop the critical competencies needed for todayʼs federal leadership roles.
    • By focusing on these updated standards, OPM is empowering leaders to deliver meaningful results and advance the mission of government agencies nationwide, drive President Trumpʼs ambitious agenda, and improve performance and accountability across the federal government. The program is highlighted by training videos from key Trump Administration leaders and distinguished career Senior Executives.
  • The American Hospital Association News tells us,
    • “A new analysis published Aug. 6 by the Peterson Center on Healthcare and KFF found that Health Insurance Marketplace insurers will propose a median premium increase of 18% for 2026. A previous analysis reported 15% based on preliminary findings. The new findings were examined from individual market filings, which provide additional details and are publicly available. The proposal more than doubles last year’s 7% median proposed increase.
    • “Insurers are citing the increase on higher prescription drug costs as well as labor costs, inflation, the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The report found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase costs of certain drugs, medical equipment and supplies. Final rates will be determined in late summer.”
  • Bricker Graydon informs us,
    • “As employers increasingly struggle with rising health plan costs, the IRS has provided some good news.  Recently, the IRS announced that the Affordable Care Act (ACA) affordability threshold will increase to 9.96% of household income for plan years starting in 2026.  This is an increase from the 9.02% that applied to 2025.  This significant increase means employers have more room to potentially increase the employee portion of premiums for 2026. 
    • “The ACA affordability percentage is used to determine if ACA employer penalties may apply to employer-provided coverage. An employer’s health coverage will be considered affordable as long as the employee’s required contribution for the lowest-cost, self-only coverage does not exceed 9.96% of their income (or an IRS-approved safe harbor equivalent, such as the W-2, rate-of-pay, or federal poverty line methods). For example, under the federal poverty line safe harbor, monthly employee contributions will need to remain below approximately $129.89 in 2026.”

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP points out,
    • “Clarametyx Biosciences said this week that its investigational antibody treatment for cystic fibrosis patients plagued by chronic bacterial lung infections will receive priority review and development incentives from the US Food and Drug Administration (FDA).
    • “The company said in a press release that the FDA had granted CMTX-101, a monoclonal antibody designed to rapidly collapse bacterial biofilms, Fast Track and Qualified Infectious Disease Product (QIDP) designations under the Gaining Antibiotic Incentives Now Act. The two designations mean Ohio-based Clarametyx will get more frequent interactions with the agency, an expedited review process and potentially accelerated approval, and an additional 5 years of market exclusivity if CMTX-101 is approved.”
  • Cardiovascular Business reports,
    • “Boston Scientific’s Watchman device is associated with a heightened risk of air embolism events if the implant procedure is performed without positive pressure-controlled ventilation, according to the U.S. Food and Drug Administration (FDA). Air embolism is a rare, but potentially fatal complication that occurs when air enters the bloodstream and creates a blockage in a patient’s blood vessel. 
    • “According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk of negative left atrium pressure and air ingress,” according to a new FDA advisory. “This risk is especially prevalent in patients with preexisting low left atrial pressure, hypovolemia and partial upper airway collapse.”
    • “The FDA emphasized that air embolism can lead to “severe outcomes, including life-threatening or fatal consequences.” 
    • “Because of this risk, which has been associated with 120 serious injuries and 17 deaths as of July 30, Boston Scientific is updating the assembly instructions of several access systems used to implant the Watchman device in patients with nonvalvular atrial fibrillation.”
  • and 
    • “The U.S. Food and Drug Administration (FDA) is sharing additional details about a safety issue with certain Boston Scientific defibrillation leads. 
    • “According to the agency, some of the company’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) have been associated with a potential risk of rising low-voltage shock impedance (LVSI). This issue, linked to calcification, may make the devices less effective as time goes on.
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” according a new FDA advisory. “As of July 24, Boston Scientific has reported 386 serious injuries and 16 patient deaths associated with this issue.”
    • “The FDA is still reviewing the situation. At this time, the agency has not determined if this is a Class I recall. The goal of this early alert is to provide details as quickly as possible.” 

From the judicial front,

  • MedTech Dive relates,
    • “The Federal Trade Commission has moved to block Edwards Lifesciences’ planned acquisition of JenaValve Technology, citing concerns that the deal threatens to reduce competition in the market for devices to treat aortic regurgitation.
    • “The agency alleged that over two days in July 2024, Edwards signed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring transcatheter aortic valve replacement devices to market to treat the potentially fatal heart condition. Edwards closed the acquisition of JC Medical in August 2024.
    • “The FTC said Edwards’ proposed $945 million acquisition of JenaValve would combine the only two companies conducting U.S. clinical trials for a TAVR aortic regurgitation, or TAVR-AR, device.
    • “The deal threatens to reduce competition in the TAVR-AR market, likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers,” the agency stated in a federal court complaint.
    • “The commission voted 3-0 to issue an administrative complaint and seek a temporary restraining order and a preliminary injunction to halt the transaction pending an administrative proceeding. The complaint and injunction request were filed in the U.S. District Court for the District of Columbia.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP relates,
    • “In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 23 more measles cases, bringing the national total for the year to 1,356 cases, the most since the United States achieved measles elimination in 2000.
    • “One more state reported cases, Wisconsin, lifting the number of affected states to 41. Three more outbreaks were reported, putting the nation’s total at 32 for the year. For comparison, the country had 16 outbreaks for all of 2024. 
    • “Of confirmed illnesses this year, 87% were part of outbreaks, compared with 69% for 2024. And of infected patients, 92% were unvaccinated or had unknown vaccination status. Though about 65% of cases occurred in children, 34% were recorded in adults ages 20 years and older.”
  • NBC News reports,
    • “A second person has now died and more than 50 people have fallen ill as part of a growing Legionnaires’ cluster in Harlem, city health officials reported Monday.
    • “The disease was initially detected on July 25; since then, two people have died and 58 people have been diagnosed, the New York City Health Department revealed in its latest update.
    • “Legionnaire’s, a type of pneumonia, is caused by the bacteria Legionella, which grows in warm water. The cases from the cluster have been found in five Harlem ZIP codes: 10027, 10030, 10035, 10037 and 10039, along with the bordering communities, according to health officials.
    • “If you’re in those ZIP codes that have demonstrated exposure, then we want you to monitor your symptoms and get to a healthcare provider as soon as you can so you can get access to antibiotics, because it is treatable,” said Dr. Tony Eyssallenne, the deputy chief medical officer for the city’s Health Department.”
  • STAT News notes,
    • “Hundreds of wildfires burning across the Canadian provinces of Manitoba and Saskatchewan are pushing smoke across Canada and the American northeast. Canadian towns close to the wildfires are experiencing the worst of the smoke pollution, but even here in Boston, there was a brief ground stop at the airport Monday due to smoke and haze. 
    • “It’s getting better, but here’s a reminder: 
      • “Wildfire smoke is particularly harmful to kids’ respiratory health. One study found that a 10-unit increase of fine particulate matter from wildfire smoke was associated with a 30% spike in pediatric admissions for respiratory problems. “It’s quite a big bit of a difference,” the lead author said.
      • “Researchers have found that people who live in areas with high levels of fine particulate matter could have a greater risk of developing dementia, with a particularly strong link seen between the condition and exposure to wildfire emissions. Still, there are a lot of questions remaining about other long-term effects.
      • “In California, between 2008 and 2010, somewhere between 52,480 and 55,710 people died prematurely due to chronic exposure to wildfire smoke. The economic impact of those deaths was at least $432 billion.”
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Aug. 5 announced a new campaign educating youth ages 12-17 on substance use, mental health and how they are connected. The campaign includes facts about drugs, including prescription medications, and how they can lead to addiction and other health problems. It also includes tips and resources to help improve mental health and recognize the link between mental health and substance use.”
  • The Washington Post reports,
    • “Seven years of investigation by scientists at Harvard Medical School has revealed that the loss of the metal lithium plays a powerful role in Alzheimer’s disease, a finding that could lead to earlier detection, new treatments and a broader understanding of how the brain ages.
    • “Researchers led by Bruce A. Yankner, a professor of genetics and neurology at Harvard Medical School, reported that they were able to reverse the disease in mice and restore brain function with small amounts of the compound lithium orotate, enough to mimic the metal’s natural level in the brain. Their study appeared Wednesday in the journal Nature.
    • “The obvious impact is that because lithium orotate is dirt cheap, hopefully we will get rigorous, randomized trials testing this very, very quickly,” said Matt Kaeberlein, former director of the Healthy Aging and Longevity Research Institute at the University of Washington, who did not participate in the study. “And I would say that it will be an embarrassment to the Alzheimer’s clinical community if that doesn’t happen right away.”
    • “Yankner, who is also the co-director of the Paul F. Glenn Center for Biology of Aging Research at Harvard, said: “I do not recommend that people take lithium at this point, because it has not been validated as a treatment in humans. We always have to be cautious because things can change as you go from mice to humans.” He added that the findings still need to be validated by other labs.”
  • Per MedPage Today,
    • “Most therapies for low back pain provide only short-term relief; it’s unclear, however, whether benefits from cognitive functional therapy (CFT) may last longer.
    • “Investigators in this study performed 3-year follow-up with participants in a 6-month trial of CFT versus usual care.
    • “Compared with usual care, patients receiving CFT either with or without biofeedback for 6 months continued to show more improvement after 3 years.”
  • Per Beckers Hospital Review,
    • “Healthcare experts are calling for the end of routine use of diphenhydramine, the active ingredient in a common allergy medication, sold as Benadryl, citing safety concerns that outweigh benefits, CNN reported Aug. 1. 
    • “It’s time to move on. For every single indication that people are using diphenhydramine, there are better drugs that are more effective at treating the symptoms people are trying to treat with fewer side effects,” said Anna Wolfsen, MD, an allergist at Massachusetts General Hospital in Boston. “I’ve had patients where I worried that diphenhydramine was impairing their ability to drive or fully participate in their daily lives.”
    • “The widely used, first-generation antihistamine is commonly used to treat allergies. However, other second-generation antihistamines, including brand names such as Claritin, Zyrtec and Allegra, offer the same or better relief with fewer side effects, experts told CNN.” 

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Hinge Health beat investor expectations on revenue in the digital musculoskeletal care company’s first public earnings results.
    • “Revenue increased 55% year over year to $139.1 million in the second quarter, the firm said in earnings released Tuesday. 
    • “The digital health company reported an operational loss of $580.7 million, compared with $17.6 million last year, driven by a stock-based compensation expense largely related to Hinge’s recent IPO, a spokesperson told Healthcare Dive.”
  • STAT News tells us,
    • “Exact Sciences announced on Wednesday that it acquired the rights to a blood-based colon cancer screening test from rival firm Freenome.
    • “Exact is paying Freenome $75 million for exclusive rights in the United States to current and future versions of the Bay Area company’s test, which is currently under review by the Food and Drug Administration. Freenome is eligible for up to $700 million in additional milestone payments.
    • “The deal ratchets up Exact’s intense competition with Guardant Health, which received FDA approval last year for its own blood-based colon cancer test.
    • “Exact had been developing its own blood-based colon cancer test. Last year, the company reported promising initial results from a study of more than 3,000 samples. But on Wednesday, the company disclosed that additional testing showed that the liquid biopsy test wasn’t quite accurate enough to win Medicare reimbursement. Instead, Exact will now look to market Freenome’s test to patients, pending approval.” 
  • Per Fierce Healthcare,
    • “Days after decreasing full-year guidance by about half a billion dollars, Oscar Health missed earnings projections for the second quarter.
    • “The insurer posted a higher-than-anticipated loss per share of 89 cents, according to estimates by FactSet, reported Sherwood News.
    • “Oscar also recorded a net loss of $228 million, one quarter after having a net profit of $275 million. The insurer saw quarterly revenues hit $2.86 billion and its medical loss ratio (MLR) climb to 91.1%.
    • “The stark jump from a MLR of 79% was due to an increase in market morbidity in the Affordable Care Act exchanges, leading to a net risk adjustment transfer accrual, CEO Mark Bertolini told investors.”
  • and
    • “Blue Shield of California is teaming up with Gemini Health to roll out a new member tool that offers greater transparency at the pharmacy counter.
    • “The tool, called Price Check My Rx, will be available in the insurer’s existing member app, allowing members to see in real time the out-of-pocket price for any new or refilled prescriptions submitted by their provider and covered under their pharmacy benefits.
    • “When the prescription is submitted electronically, the platform will send the member a push notification that prompts them to look at the pricing details and explore alternatives, including low-cost options, if they prefer. Jigar Shah, chief marketing and strategy officer for Blue Shield, told Fierce Healthcare that the tool fits within the payer’s broader goal of simplifying the patient experience.”
  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy sales jumped 67% in the second quarter, despite generic competition in the U.S. market.
    • “The company reduced its full-year guidance due to the impact of copycat versions of its diabetes and obesity drugs.
    • “Outgoing CEO Lars Fruergaard Jorgensen expressed confidence in future growth under incoming CEO Maziar Mike Doustdar.”
  • BioPharma Dive adds,
    • “Scientists at Nxera Pharma have worked for the past year to develop a pipeline of wholly owned obesity drug candidates that the Tokyo and Cambridge, U.K.-based pharmaceutical company unveiled Wednesday. Chief among the seven new programs is an oral GLP-1 agonist that Nxera says is based on “differentiated chemistry” and is distinct from a compound it discovered together with Pfizer under a research alliance. Coincidentally, Pfizer disclosed Tuesday it discontinued development of that compound, a decision Nxera said was made “due to a portfolio decision.” 
  • Per MedTech Dive,
    • “BD is investing more than $35 million to expand production of prefilled flush syringes at a facility in Columbus, Nebraska, the company said Monday.
    • “The investment will add around 50 jobs at the site and equip BD to make hundreds of millions of additional units a year to meet growing demand from U.S. hospitals and health systems.
    • “BD framed the spending as part of an ongoing commitment to its Posiflush line, which has seen it invest more than $80 million to expand production of the syringes over the past three years.”

Tuesday report

David Ermer–AHRQ, CMS, Generative AI, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SDOH, Telehealth, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Many seniors enjoy the perks that come with Medicare Advantage. But those extras—like dental coverage and free gym memberships—are being scaled back.
    • “Insurers are cutting benefits and exiting from unprofitable markets, and Wall Street is cheering them on. Once rewarded by investors for rapid expansion in the lucrative privatized Medicare program, companies are now being applauded for showing restraint amid rising medical costs and lower government payments.” * * *
    • “To be clear, major insurers aren’t exiting Medicare Advantage. Apart from Cigna, which sold its Medicare business last year, the big players are still betting on the program—some are likely to take advantage of the turmoil to increase their market share. And the market is arguably still well served and competitive, especially in densely populated areas. Even after some moderation last year, the average beneficiary this year had 42 plan options from which to choose, according to health-research nonprofit KFF. 
    • “As the industry pivots to leaner operations, Wall Street may regain confidence. But the era of red-hot Medicare Advantage growth is over, at least for now. While Democrats have led efforts to cut overpayments, Republicans also face mounting pressure to curb spending—especially after recent tax cuts, notes Deutsche’s [George] Hill. He warns that more regulatory shifts may be coming, including a potential overhaul of the star ratings system, which governs billions in bonus payments tied to plan quality and patient satisfaction.
    • “Until that picture clears, investors will continue to reward restraint and tightly managed risk. In today’s Medicare Advantage market, and across government insurance programs, growth is taking a back seat to profitability.
  • BiioPharma Dive tells us,
    • “The U.S. plans to put tariffs of up to 250% on pharmaceutical imports over the next year and a half, President Donald Trump said in a Tuesday interview with CNBC.
    • “Trump said he would put a “small tariff” on such imports initially but added that he would raise the duties to 150% and then 250% in “one and a half years maximum.” The president indicated that announcements of pharmaceutical tariffs, as well as duties on semiconductors, would be announced “within the next week or so.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the beginning of a coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA), including the cancellation and de-scoping of various contracts and solicitations. The decision follows a comprehensive review of mRNA-related investments initiated during the COVID-19 public health emergency.
    • “We reviewed the science, listened to the experts, and acted,” said HHS Secretary Robert F. Kennedy, Jr. “BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.” * * *
    • “While some final-stage contracts (e.g., Arcturus and Amplitude) will be allowed to run their course to preserve prior taxpayer investment, no new mRNA-based projects will be initiated. HHS has also instructed its partner, Global Health Investment Corporation (GHIC), which manages BARDA Ventures, to cease all mRNA-based equity investments. In total, this affects 22 projects worth nearly $500 million. Other uses of mRNA technology within the department are not impacted by this announcement.” * * *
    • “The move signals a broader shift in federal vaccine development priorities. Going forward, BARDA will focus on platforms with stronger safety records and transparent clinical and manufacturing data practices. Technologies that were funded during the emergency phase but failed to meet current scientific standards will be phased out in favor of evidence-based, ethically grounded solutions – like whole-virus vaccines and novel platforms.”
  • Roll Call lets us know,
    • “The Trump administration is escalating its push against what has become a key part of the way states, localities and communities respond to the overdose epidemic: harm reduction. 
    • “A public health approach aimed at mitigating the negative health effects associated with drug use, harm reduction aims to prevent overdoses and infectious disease transmission.
    • “Methods can involve the use of opioid overdose reversal medications such as naloxone, providing sterile needles to limit the transmission of infectious diseases, test strips that detect fentanyl in drugs, and “safe consumption sites,” where people can use drugs under supervision in case they need intervention.” * * *
    • “In a “Dear Colleague” letter sent to states last week, Art Kleinschmidt, principal deputy assistant secretary at SAMHSA, said he doesn’t consider naloxone a harm reduction method and as such it would continue to be funded by the government. Kleinschmidt said test kits and other services can also be funded through grants.
    • “But the letter stated that federal funding can’t be used to “purchase pipes or other supplies for safer smoking kits nor syringes or needles used to inject illicit drugs” or “any other supplies to promote or facilitate drug use.” 
    • “Moving forward, SAMHSA funds will no longer be used to support poorly defined so-called “harm reduction” activities; rather, SAMHSA is providing guidance to state agency leadership and to grantees through new award terms and conditions that provide clarity on what supplies and services previously defined under the umbrella of harm reduction can be supported with SAMHSA funding,” Kleinschmidt wrote.” 

From the public health and medical research front,

  • The American Hospital Association News informs us,
    • “Patients in the hospital for surgeries had better outcomes in 2024 than they did in 2019, according to a new report released today by the AHA and Vizient. 
    • “The significant improvement aligned not only with better performance on patient safety metrics — such as reductions in infections and falls — but also with marked declines in three major surgical patient safety indicators: severe bleeding, sepsis and respiratory failure. * * *
    • “The new findings build on a report AHA released in collaboration with Vizient last year showing that hospitals and health systems performed better on key patient safety and quality measures in the first quarter of 2024 than they did before the COVID-19 pandemic. In fact, hospitals’ efforts to improve safety led to 200,000 Americans hospitalized between April 2023 and March 2024 surviving episodes of care they wouldn’t have in 2019.” 
  • MedPage Today reports,
    • “Unhealthy alcohol use is a leading cause of death and serious illness among U.S. adults.
    • “In new draft guidance, the USPSTF reaffirmed that all adults should be screened for unhealthy alcohol use and [newly] recommended brief behavioral counseling interventions when appropriate.
    • “The task force found insufficient evidence to make the same recommendation in adolescents.”
    • The public comment period ends on September 2, 2025.
  • Healio adds,
    • “Testing for hepatitis C virus infection every 6 to 12 months — or even more frequently — among people who inject drugs could be a beneficial, cost-effective strategy, according to a study published in JAMA Health Forum.“
    • USPSTF recommends hepatitis c screening for adults aged 18 to 79 without known liver disease.
      • “Most adults need to be screened only once. Persons with continued risk for HCV infection (e.g., PWID) should be screened periodically. There is limited information about the specific screening interval that should occur in persons who continue to be at risk for new HCV infection or how pregnancy changes the need for additional screening.”
        • The JAMA Health Forum study fills in the screening interval information gap.
  • Per STAT News,
    • “Nathan Young, a community neurologist at the Mayo Clinic, recently saw a patient whose diagnosis he couldn’t quite nail down. Parkinson’s seemed a likely possibility, but Young was concerned she might instead have a rare neurological disorder called progressive supranuclear palsy, or PSP, which can progress much more rapidly. 
    • “I opened a can of worms,” said Young: He ordered a PET scan of the patient’s brain, but the radiology report only confused matters. Instead of ruling out PSP, it suggested yet a third diagnosis: Alzheimer’s. 
    • “Normally at this point, Young would call in other specialists as reinforcements, including Mayo’s renowned experts. But this time he had something different to help: a new AI tool called StateViewer.”
    • “Developed by Mayo’s Neurology AI program, StateViewer takes scans like the one Young ordered — they’re called FDG-PET scans, named for the radioactive tracer they use — and spits out a report of similar brains that have been scanned in Mayo’s clinical and research networks. The output: a differential diagnosis of nine potential types of dementia. In development over the last several years, StateViewer hit the rails at all three Mayo campuses four months ago, and it’s been run thousands of times on patients’ brain scans.”
  • and
    • “Vertex Pharmaceuticals said Monday afternoon that its next-generation non-opioid pain reliever failed to significantly outperform placebo in a Phase 2 trial.
    • “The experimental drug, codenamed VX-993, is similar to the company’s recently approved pill Journavx but could potentially be given at higher doses and formulated as an IV infusion. The hope is that it could thus provide superior relief or offer an alternative to IV opioids. But after Monday’s results, the company said it would discontinue efforts to develop the drug as a single-agent medicine for acute pain.”
    • “We do not plan to advance VX-993 as monotherapy in acute pain, because we do not expect that it will be superior to our [existing] NaV1.8 inhibitors,” said CEO Reshma Kewalramani during a Monday afternoon earnings call with investors, using a scientific shorthand for the class of drugs. She noted that the company will continue a trial testing the drug in patients with diabetes who have chronic nerve pain.”
  • Cardiovascular Business points out,
    • “A surgeon at Cleveland Clinic has performed the world’s first robotic-assisted heart surgery of its kind, using CardioPrecision’s CoreVista Robot Enabling Platform to implant Corcym’s Perceval Plus aortic heart valve through a small incision in the patient’s neck.
    • “The successful operation, known as AVATAR (Advanced Videoscopic Aortic valve surgery by Transcervical Approach using Robot assistance), was performed by Marijan Koprivanac, MD, a cardiovascular surgeon with Cleveland Clinic’s Heart, Vascular and Thoracic Institute. Other robotic techniques for aortic valve replacement have already been in use, including the robotic aortic valve replacement procedures developed at the WVU Heart and Vascular Institute, what sets this approach apart is the fact that everything is done through that small incision in the neck. 
    • “Combining the artificial heart valve with this new surgical technology means patients should experience less pain and time in the hospital following heart surgery,” Koprivanac said in a statement. “In fact, we believe that this may be one of the least invasive surgical heart valve replacement options now available.”
  • Per Genetic Engineering and Biotechnology News,
    • “Amyotrophic lateral sclerosis (ALS) is an incurable neurological disorder affecting motor neurons (MNs), which are nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing. Many ALS clinical trials, including those testing promising drugs, have fallen short of expectations, commonly because the extent of the disease can vary, and not all patients respond the same way to medications.
    • “Scientists at Case Western Reserve University now report new insights into one type of ALS, that may point towards a therapeutic approach for different types of the disorder. The team studied inducible pluripotent stem cell (iPSC)-motor neurons (MNs) carrying the P56S mutation in a protein called vesicle-associated membrane protein-associated protein-B (VAPB), which is responsible for a familial form of ALS. Their findings provided evidence that the mutation activates integrated stress response (ISR) via mitochondrial dysfunction in motor neurons and also indicated that pharmacological inhibition of ISR using ISRIB helped to rescue ALS-associated phenotypes in both VAPB P56S and patient-derived IPSC-MNs.
    • “Although the research centered on this rare form type of ALS, the investigators are optimistic the positive results could provide clues for potentially treating the devastating disorder more broadly. Study lead Helen Cristina Miranda, PhD, an associate professor of genetics and genome sciences at Case Western Reserve’s School of Medicine, suggested, “This work could help lay the foundation for genetically informed clinical trials.”
    • “Miranda and colleagues reported on their study in EMBO Molecular Medicine, in a paper titled “Convergent activation of the integrated stress response and ER–mitochondria uncoupling in VAPB-associated ALS,” concluding, “This is the first study to mechanistically connect a known ALS mutation with ISR activation, highlighting the potential for mutation-specific therapeutic targeting and patient stratification in ISR-modulating clinical trials.”
  • The National Institutes of Health announced a “new study to test if mothers’ diet prevents early sign of food allergy in babies. NIH trial to assess if eating peanuts, eggs during pregnancy, breastfeeding protects infants.”
    • “The study, called Expecting Mother’s Study of Consumption or Avoidance of Peanut and Egg (ESCAPE), will be led by Kirsi Järvinen-Seppo, M.D., Ph.D., chief of Pediatric Allergy and Immunology and Founders’ Distinguished Professor in Pediatric Allergy at University of Rochester Medicine. Results are expected in 2029. 
    • “More information about the trial, including contacts for people who are interested in participating, is available at ClinicalTrials.gov under study identifier NCT06260956.”
  • NIH Research Matters covers the following topics this week: “Treating CoQ10 deficiency | Specialized blood vessels in organoids | Fat-fueled neurons.”
  • Beckers Hospital Review identifies “seven new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • CIGNA, writing in LinkedIn, discusses the importance of access to mental health services.
    • “Virtual care appointments have emerged as a valuable tool in providing mental health services, particularly in remote or underserved areas. Connecting with mental health professionals via telephone, video calls, and even smart phone apps, make it easier to access care without the need for travel. Additionally, virtual care often reduces wait times, providing quicker access to necessary care.
    • “Community-based mental health programs are another effective approach. These programs use the strengths and resources of local communities to provide support and care. Community health workers, peer support groups, and local organizations can play a vital role in delivering mental health services and promoting mental well-being.
    • “Integrating mental health services into primary care is also promising. By training primary care providers to recognize and address mental health issues, individuals can receive holistic care that addresses both their physical and mental health needs. This integration can help improve overall health outcomes.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump’s demand that drugmakers make more of their medicines available direct to consumers in the U.S. at lower cost, Pfizer CEO Albert Bourla said Tuesday.
    • “We have serious discussions in the industry,” Bourla told investors on a conference call Pfizer held to discuss its earnings for the second quarter. “I’m connected very often individually with all the major companies, and they are all ready to roll up their sleeves and execute something like that.”
  • MedTech Dive relates,
    • “Alcon has agreed to buy implantable lens maker STAAR Surgical for about $1.5 billion in total equity value, the companies said Tuesday.
    • “Alcon, which will purchase all outstanding shares of STAAR for $28 per share in cash, expects STAAR’s refractive surgery offerings to complement Alcon’s laser vision correction business.
    • “BTIG analyst Ryan Zimmerman said Alcon is getting “a solid deal” given STAAR’s setbacks in the China market. The company is betting on a recovery in China and the longer-term health of lens-based refractive surgery, said the analyst.”
  • Per Fierce Healthcare,
    • “Shares of Hims & Hers tumbled 12% in after-hours trading Monday after the company’s second-quarter revenue missed Wall Street analysts’ expectations.
    • “The company faces headwinds in its compounded GLP-1 drug business after pharma giant Novo Nordisk pulled the plug on a monthlong collaboration to make its weight loss drug Wegovy available on the telehealth company’s platform. The company had to off-board GLP-1 subscribers from the branded version of the drug, executives said.
    • “Hims & Hers continues to sell compounded semaglutide, the active ingredient in Novo’s Wegovy and Ozempic drugs, and these generic versions are more affordable than the branded drugs.
    • “Analysts, however, seem pleased by what they see as strong results and the online health and wellness company’s growth plans, including international expansion, new hormone health offerings and building out standalone lab testing.”
  • and
    • “Online therapy provider Talkspace continues to make big investments in artificial intelligence, seeing opportunities to improve the experience for patients and cut down on paperwork for providers.
    • “Talkspace connects people via an app with therapists who provide counseling remotely, either over the phone, by video chat or by text.
    • “The company is building out foundational large language models specifically for behavioral health using its internal, de-identified clinical data sets, as it claims to have the “largest behavioral health datasets in the industry,” consisting of millions of therapeutic interactions on the Talkspace platform over the past 12 years.
    • “Unlike existing, horizontal, general-purpose LLMs, we are working closely with mental health clinicians experienced with evidence-based therapeutic frameworks,” CEO Jon Cohen, M.D., told investors during the company’s second-quarter earnings call Tuesday. “Talkspace behavioral health LLMs are being developed specifically to understand the language complexity and workflows of mental health delivery. Once up and running, these behavioral health LLMs will be an integral part of how we provide higher-quality care to our Talkspace members.”
  • Modern Healthcare reports,
    • “Virtual behavioral health provider Cerebral announced Tuesday it had acquired Resilience Lab, which offers therapy and medication management through its online platform. The deal, which closed last week, includes Resilience’s clinician development program aimed at training and supporting early-career therapists. 
    • “The combined organization will be led by Cerebral CEO Brian Reinken under the Cerebral brand, with Resilence Lab Co-founder Marc Goldberg holding the president role, according to a spokesperson. Dr. Carl Marci will join the company as chief medical officer, and Resilience Lab Co-founder Christine Carville will serve as chief clinical officer. Cerebral representatives declined to disclose financial details of the deal.”
  • and
    • “Quest Diagnostics has completed its acquisition of some clinical testing assets from Spectra Laboratories, a subsidiary of dialysis company Fresenius Medical Care.
    • “Under the agreement, Quest will provide dialysis-related clinical testing to independent clinics formerly served by Spectra Laboratories.
    • “As part of a separate deal with Fresenius, Quest said in a Tuesday news release it expects to complete the acquisition of select dialysis-related water testing assets by the end of the year. It also said it plans to start providing comprehensive dialysis-related laboratory services for centers operated by Fresenius in the U.S. The transition of services is slated to be completed by early next year.”

Thursday report

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Centers for Medicare and Medicaid Services finalized three payment rules on Thursday, all of which will take effect on October 1, 2025, according to the American Hospital Association News.
    • “The Centers for Medicare & Medicaid Services July 31 issued a final rule that would increase Medicare inpatient prospective payment system rates by a net 2.6% in fiscal year 2026, compared with FY 2025, for hospitals that are meaningful users of electronic health records and submit quality measure data.    
    • “This 2.6% payment update reflects a hospital market basket increase of 3.3% as well as a productivity cut of 0.7%. This update also reflects CMS’ proposal to rebase and revise the market basket to a 2023 base year. In addition, the rule includes a $2 billion increase in disproportionate share hospital payments and a $192 million increase in new medical technology payments. Overall, it would increase hospital payments by $5 billion in FY 2026 as compared to FY 2025. 
  • and
    • The Centers for Medicare & Medicaid Services today finalized a 3.0% payment update for long-term care hospitals for fiscal year 2026 relative to FY 2025. This includes a 3.4% market basket update, reduced by a 0.7 percentage point productivity adjustment. In addition, although CMS will increase the outlier threshold from $77,048 to $78,936, it says outlier payments will increase by 0.3%.  
  • and
    • “The Centers for Medicare & Medicaid Services today issued a final rule for the skilled nursing facility prospective payment system for fiscal year 2026. The rule will increase aggregate payments by 3.2%, which reflects a 3.3% market basket update, a 0.7 percentage point cut for productivity, and an increase of 0.6 percentage points for the market basket forecast error for FY 2024.”
  • STAT News reports,
    • “President Trump escalated his demands that pharma companies lower U.S. drug prices in line with what other countries pay, sending letters to 17 major drug companies Thursday that called on them to take actions by Sept. 29.
    • “He specifically asked the firms to: provide their full portfolio of drugs to Medicaid patients at prices in line with what other major wealthy countries pay; guarantee that new drugs will be offered to Medicare, Medicaid, and commercial payers at those lower prices; implement direct-to-consumer distribution models for “high-volume, high rebate” drugs; and repatriate increased revenues that they earn abroad back to the U.S. 
    • “The companies he sent letters to were: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, Gilead, EMD Serono, Pfizer, Novo Nordisk, AstraZeneca, Amgen, Genentech, Johnson & Johnson, GSK, Merck, Regeneron, Sanofi, and Eli Lilly.”
  • The AHA News tells us,
    • “The Department of Health and Human Services today issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. 
    • “The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. 
    • “HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date.” 
  • Per an HHS news release,
    • “Susan Monarez, Ph.D., was sworn in today as Director of the Centers for Disease Control and Prevention (CDC) by U.S. Health and Human Services Secretary Robert F. Kennedy, Jr.”
  • The Departments of Labor, HHS, and Treasury as well as OPM issued CAA 2021 and ACA FAQs (No. 71, government link) Thursday morning. The FAQs brings us up to date on the application of the Fifth Circuit’s Texas Medical Association case to QPA calculations and reiterates that “The maximum annual limitation on [in-network] cost sharing for the 2026 plan year will be $10,600 for self-only coverage, and $21,200 for other than self-only coverage.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long period.”
  • The New York Times reports,
    • “The Food and Drug Administration on Wednesday approved a medical device that offers new hope to patients incapacitated by rheumatoid arthritis, a chronic condition that afflicts 1.5 million Americans and is often resistant to treatment.
    • “The condition is usually managed with medications. The device represents a radical departure from standard care, tapping the power of the brain and nervous system to tamp down the uncontrolled inflammation that leads to the debilitating autoimmune disease.
    • “The SetPoint System is an inch-long device that is surgically implanted into the neck, where it sits in a pod wrapped around the vagus nerve, the longest nerve in the body. The device electrically stimulates the nerve for one minute each day.
    • ‘The stimulation can turn off crippling inflammation and “reset” the immune system, research has shown. Most drugs used to treat rheumatoid arthritis suppress the immune system, leaving patients vulnerable to serious infections.”

From the public health and medical research front,

  • STAT News reports,
    • “U.S. kindergarten vaccination rates inched down again last year and the share of children with exemptions rose to an all-time high, according to federal data posted Thursday.
    • “The fraction of kids exempted from vaccine requirements rose to 4.1%, up from 3.7% the year before. It’s the third record-breaking year in a row for the exemption rate, and the vast majority are parents withholding shots for non-medical reasons.
    • “Meanwhile, 92.5% of 2024-25 kindergartners got their required measles-mumps-rubella shots, down slightly from the previous year. Before the Covid-19 pandemic, the vaccination rate was 95% — the level that makes it unlikely that a single infection will spark a disease cluster or outbreak.” * * *
    • “In the last decade, the percentage of kindergartners with medical exemptions has held steady, at about 0.2%. But the percentage with nonmedical exemptions has risen.”
  • BioPharma Dive lets us know,
    • “Eli Lilly’s popular diabetes drug Mounjaro proved about as effective as its older medicine Trulicity in protecting heart health in the largest and longest clinical trial of the newer GLP-1 therapy to date.
    • “According to summary results released by Lilly Thursday, Mounjaro met the main goal of the head-to-head study, which enrolled more than 13,000 people with Type 2 diabetes and heart disease and ran for nearly five years.
    • “While Mounjaro’s benefit wasn’t great enough for researchers to declare it superior to Trulicity, the rate of all-cause mortality was 16% lower for the newer drug, which in addition to stimulating the GLP-1 hormone receptor like Trulicity, also activates another known as GIP.”
  • Per MedPage Today,
    • “The past two respiratory virus seasons tallied at least 41 pediatric cases of influenza-associated acute necrotizing encephalopathy (ANE), a rare but severe neurologic condition, a multicenter case series showed.
    • “And most of these (76%) occurred in previously healthy children with no significant medical history, Andrew Silverman, MD, MHS, of Weill Cornell Medicine in New York, and colleagues from the Influenza-Associated ANE Working Group reported in JAMA.
    • “There hasn’t been any formal national surveillance of ANE to know whether the case counts for these two seasons are higher than normal, but that certainly seemed to be the case, Silverman said.
    • “Anecdotally, there seems to be an uptick in cases in the U.S.,” Silverman told MedPage Today. “From informally surveying all of these senior pediatric neurologists who have seen zero to one case in their career, now it seems like all of a sudden we’re forced to know more about ANE and how to treat it.”
    • “Mortality was high, at 27%, with 11 deaths. Patients died a median of 3 days from symptom onset, primarily from cerebral herniation (91%).”
  • Per Health Day,
    • “Blood-based colon cancer tests have become more common in recent years, offering a non-invasive option for screening
    • “Follow-up colonoscopy is recommended when a test result is ‘abnormal,’ but new data shows less than half of people following guidelines
    • “More must be done to educate people on the potentially life-saving importance of proper follow-up during colon cancer screening.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health reported earnings that beat Wall Street’s expectations and upgraded its projection for 2025, as its health-insurance business showed signs of recovery.
    • “The healthcare giant’s results underscore a split among health insurers. On one side are companies struggling this year with a surprise financial squeeze from higher-than-expected medical costs, a list that includes Centene, Molina Healthcare and the industry bellwether, UnitedHealth Group. 
    • “On the other side, Humana and CVS, which both had major financial challenges last year, say that the higher medical costs are largely in line with what they had projected. Humana, like CVS, had second-quarter results that came in above analysts’ predictions, and raised its 2025 guidance.” * * *
    • “89.9%: The share of insurance premiums at Aetna spent on healthcare costs, known as the medical-loss ratio. It is a bit higher than last year’s 89.6%, but lower than the FactSet consensus of 90.5%.”
  • Beckers Payer Issues tells us,
    • “The Cigna Group reported a net income of $1.53 billion in the second quarter of 2025, compared to $1.55 billion during the same quarter last year, according to its July 31 financial report. 
    • “Total revenue was $67.2 billion for the three months ended June 30, up 11% year over year. Cigna said the increase was primarily driven by Evernorth Health Services and includes growth of existing client relationships and strong specialty pharmacy growth.” * * *  
    • “Cigna’s medical loss ratio was 83.2% in the second quarter, up from 82.3% during the same period last year. The company attributed the increase to expected higher stop-loss medical costs.” 
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • ICER announced today that it will assess the comparative clinical effectiveness and value of therapies targeting abnormal complexes of immunoglobulin for IgA nephropathy. These are expected to include sibeprenlimab (Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and budesonide (Tarpeyo®, Calliditas Therapeutics AB).  
    • The assessment will be publicly discussed during a meeting of the CTAF in February 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment

Tuesday report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Senate confirmed Susan Monarez to be Director of the Centers for Disease Control and Prevention today by a 51 to 47 vote. The AP adds,
    • “She holds a doctorate in microbiology and immunology from the University of Wisconsin and did postdoctoral research at Stanford University. Prior to the CDC, Monarez was largely known for her government roles in health technology and biosecurity.”
  • MedCity News tells us,
    • “On Thursday, a coalition of 28 healthcare organizations sent a letter to leaders in Congress calling on them to extend the Affordable Care Act enhanced premium tax credits, which are set to expire at the end of the year.
    • “The letter was addressed to John Thune, Senate majority leader; Chuck Schumer, Senate minority leader; Mike Johnson, speaker of the House; and Hakeem Jeffries, minority leader of the House. The letter was led by Keep Americans Covered and was signed by healthcare organizations including AHIP, Blue Cross Blue Shield Association, the American Medical Association, Kaiser Permanente, Families USA and more.” 
  • STAT News reports,
    • “Health secretary Robert F. Kennedy Jr. could “imminently” overhaul a key federal advisory panel that recommends which preventive services insurers must pay for, according to a person familiar with the plans. 
    • “The person said that federal health officials are actively vetting new members for the U.S. Preventive Services Task Force. David Mansdoerfer, an adviser to a Kennedy-aligned group of physicians, said he’s aware of people being considered for the panel, but declined to name them.” * * *
    • “Mansdoerfer added that the existing panel is “M.D. heavy” and a reconstituted panel is more likely to include “allied health professionals,” which are health care providers who aren’t nurses or physicians, like physical therapists and dietitians.” 
  • Following up on yesterday’s post about Medicare Part D, here is a link to the CMS guidance upon which the Wall Street Journal relied.
  • World at Work informs us,
    • “Health savings accounts (HSAs) have become a staple total rewards offering over the last decade, but a new study by the Employee Benefit Research Institute (EBRI) showed employees are still leaving the full value of these accounts on the table.
    • “The June 12 EBRI report pulled data from 14.5 million accountholders, containing more than $48 billion in total assets — roughly 40% of the entire HSA universe. The analysis revealed:
      • “Low balances. End-of-year balances increased in 2023 (the most recent analysis period) to $4,747 but are still modest compared with average out-of-pocket maximums for HSA-eligible health plans ($8,300 for individual coverage in 2025, $16,600 for family coverage)
      • “Low contributions. Relative to 2022, average HSA contributions increased in 2023. However, after adjusting for inflation, both employer and employee contributions were higher in the 2010s. Also, notably, the average combined HSA contribution was $760 less than the statutory maximum contribution for individuals and $4,660 less than the statutory maximum contribution for accountholders with family coverage.
      • “High withdrawals. More than half of accountholders withdrew funds, and the average distribution rose to $1,801.
      • “Low investment. Only 15% of accountholders invested in assets other than cash. 
    • EBRI found that, essentially, employees use HSAs as specialized checking accounts rather than investment accounts, and in doing so, miss out on the triple tax advantage available if they maximize contributions, minimize withdrawals and invest their balances.
    • “The good news is that, here we are 20-plus years after HSAs launched, and they’ve become pretty standard. They’re a typical plan offering from most employers of all sizes — not just large or small companies, or in certain industries,” said Alexander Domaszewicz, a principal and healthcare consultant at advisory firm Mercer. “If we live long enough, we’ll have healthcare expenses, and we want to be prepared for that. But while awareness and visibility of HSAs have grown, they’re still intimidating to folks.”
  • Beckers Payer Issues calls attention to recent No Surprises Act developments.
  • Federal News Network lets us know,
    • “The Trump administration is detailing how it expects agencies to recruit more political appointees through the new “Schedule G” hiring category, while also reminding agencies that all non-career hires must be approved by the White House.
    • “The Office of Personnel Management on Tuesday outlined how agencies should adopt the federal employment classification President Donald Trump created earlier this month. Generally, the new Schedule G broadens agencies’ options for hiring political appointees, beyond the avenues already available to presidential administrations for picking their own staff members.
    • “In its guidance on Trump’s new hiring authority, OPM said agencies will have to run any Schedule G hires they want make by the White House for review and approval.
    • “As a matter of practice,” OPM said, agencies will have to send all their political hires to their White House liaison — a position that coordinates with the White House on hiring and retention of political appointees — before agencies can advance any Schedule G appointments.”

From the Food and Drug Administration front,

  • Bloomberg Law informs us,
    • “Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his handling of Sarepta Therapeutics Inc.’s gene therapy. 
    • “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” Department of Health and Human Services spokesperson Andrew Nixon said in a written statement. 
    • “Prasad did not immediately respond to a request for comment about his departure.” 
  • The Washington Post reports,
    • “The Food and Drug Administration pushed Tuesday to restrict a synthetic opioid found in tablets, gummies and drinkable shots commonly sold in convenience stores.
    • “Health officials announced they will seek to add 7-OH — a potent substance synthesized from a compound in the kratom leaf — to the tier of controlled substances reserved for the most addictive drugs, such as heroin and LSD.
    • “The FDA, researchers and kratom companies have grown increasingly alarmed by the rise of 7-OH products they say are distinct from all-natural teas and powders derived from a leaf that grows on trees native to Southeast Asia.
    • “FDA Commissioner Marty Makary said at a news conference that the agency is not asking to restrict natural products made from kratom, which contains trace amount of the compound. In a report released Tuesday, the agency said it maintains concerns about kratom broadly but needed to act urgently on 7-OH because of its risk of sedation, nausea, breathing problems and addiction.”
  • From the judicial front,
    • Fierce Healthcare reports,
      • “A new law in Arkansas banning pharmacy benefit managers from owning pharmacies has been blocked by a federal judge, the latest development in one of the industry’s most-watched new pieces of legislation.
      • “Judge Brian Miller said the law may violate (PDF) the Commerce Clause in the constitution and is likely preempted by TRICARE, a health care program for military families. The state is barred from enforcing the law until final disposition, a ruling shows.
      • “Act 624 appears to overtly discriminate against plaintiffs as out of state companies and the state has failed to show that it has no other means to advance its interests,” said Miller, adding other enacted state laws already can properly restrict PBMs.
      • “Arkansas Attorney General Tim Griffin said he plans on appealing the decision, reported the Associated Press.
      • “We’re pleased with the Court’s decision to grant a preliminary injunction to stop the implementation of Act 624,” a CVS Health spokesperson said in a statement. “We continue to be focused on serving people in Arkansas and are actively looking to work together with the state to reduce drug prices and ensure access to pharmacies.”

From the public health and medical researach front,

  • KFF considers whether our country’s measles elimination status is at risk.
  • The Agency for Healthcare Research and Quality released a medical expenditures survey report titled “Healthcare Expenditures for Heart Disease among Adults Aged 18 and Older in the U.S. Civilian Noninstitutionalized Population, 2022.”
    • “In 2022, 7.8 percent of adults aged 18 and older were treated for heart disease, and men were more likely than women to have treated heart disease (8.4 % vs. 7.2%).
    • “Among age groups, the treated prevalence of heart disease was highest for those aged 65 and older (22.8%) compared to only 6.0 percent for adults aged 45-64, and 1.4 percent for adults ages 18-44.
    • “In 2022, healthcare expenditures to treat heart disease for adults in the US totaled $100.0 billion (with an average cost of $4,900 per adult with diagnosed and treated heart disease).
    • “The largest portion of heart disease expenditures were incurred through hospital inpatient stays (46.1%) and prescribed medications (20.5%).
    • “The majority of heart disease treatment costs were paid by Medicare (57.6%) and private insurance (24.2%).”
  • Per MedPage Today,
    • “The global incidence of liver cancer is projected to double by 2050.
    • “Sixty percent of liver cancers are preventable by controlling risk factors including hepatitis B and C, alcohol consumption, and MASLD.
    • “The Lancet Commission estimated that a 2-5% reduction in the age-standardized incidence rate of liver cancer could prevent up to 17.3 million new cases and save up to 15.1 million lives.”
  • Per Neurology Adviser,
    • “Urinary tract infections (UTIs) may be a trigger for myocardial infarction (MI) or stroke, with an increased risk for both within the first 7 days of infection, according to the findings of a study published in BMJ Open.”
    • “Growing evidence suggests that acute infection plays a role in the pathogenesis of cardiovascular disease.
    • “Researchers from Cardiff University in the United Kingdom conducted this self-controlled cases series using data from the Secure Anonymised Information Linkage (SAIL) Databank which houses nation-wide data from Wales. Patients (N=105,930) with MI (n=51,660) or stroke (n=58,150) between 2010 and 2020 were evaluated for general practitioner suspected or confirmed UTI before or after MI or stroke event. The peak risk period was defined as up to 90 days after UTI.
    • “The MI and stroke cohorts consisted of 63% and 49% men, with mean ages of 69 and 74 years for men and 77 and 79 years for women, respectively.”
  • STAT News reports,
    • “A major Alzheimer’s disease medical group is recommending that specialists may use certain blood tests to help diagnose patients with cognitive impairment in lieu of more complex and invasive tests, a move that could lead more people to get treated for the devastating disease.
    • “The Alzheimer’s Association, in its first clinical guidelines on blood biomarker testing, said Tuesday that tests that have over 90% sensitivity (ability to identify positive results) and 90% specificity (ability to identify negative results) can be used instead of current diagnostic methods like PET scans and cerebrospinal fluid tests.
    • “The group said that tests that have over 90% sensitivity and 75% specificity can be used to triage patients, meaning negative results rule can rule out Alzheimer’s with high probability but positive results should be confirmed with the standard diagnostic methods, given that these blood tests have a higher likelihood of false positives.
    • “The authors stressed that the guidelines should not be considered a substitute for a full clinical evaluation and that they apply only to people who are in the care of specialists and have already been confirmed to have cognitive impairment. The authors also noted that there’s wide variability in the blood tests on the market and that many do not meet the accuracy thresholds.”
  • Per Benefits Pro,
    • “Researchers at Cigna’s Evernorth Research Institute are seeing early signs that offering patients semaglutide and other GLP-1 agonists might cut the cost of managing mental health problems.
    • “Duy Do and two other Evernorth researchers found that using Ozempic or similar drugs to control blood sugar reduced use of office visits to treat depression by 13% and reduced use of office visits to treat anxiety by 15%.
    • “Use of GLP-1 agonists did not reduce use of emergency room visits or inpatient care for depression or anxiety, but the researchers say their work shows the need for understanding how GLP-1 agonist use affects people’s mental health and use of mental health services.
    • “Given the high economic burden of mental health disorders among patients with T2DM, further research is needed to confirm the clinical and cost-effectiveness of [GLP-1s] in reducing the overall health care burdens for this patient population,” Do and colleagues conclude.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “UnitedHealth Group anticipates its 2025 earnings to fall below expectations due to rising costs and operational issues.
    • “CEO Stephen Hemsley aims to restore UnitedHealth to high performance, projecting earnings growth for the coming year.
    • “UnitedHealth is facing industry upheaval with rising healthcare costs, government actions, and ongoing Justice Department probes.”
  • Modern Healthcare tells us,
    • “Humana is offering certain employees voluntary early retirement buyouts.
    • “Employees age 50 or older with at least three years of service are eligible for the program, although those working in certain business-critical areas will be ineligible, a company spokesperson said Tuesday. He said the window to apply for voluntary early retirement will be open for several weeks.
    • “The Louisville, Kentucky-based health insurer said the offers are part of ongoing evaluations Humana conducts to adjust staffing and drive organizational efficiency.”
  • Beckers Hospital Review lets us know,
    • “U.S. News & World Report released its 2025-2026 Best Hospitals rankings and ratings July 29, which included its list of 504 Best Regional Hospitals across 49 states and 95 metropolitan areas.
    • “The latest edition of Best Hospitals, now in its 36th year, evaluated more than 4,400 hospitals on measures such as risk-adjusted mortality rates, preventable complications and level of nursing care.” 
    • The article lists the no. 1 ranked hospitals in each eligible state.
  • Cardiovascular Business points out the best heart hospitals according to U.S. News and World Report.
  • Fierce Healthcare informs us,
    • “Earlier this year, CVS Health announced that it would invest $20 billion in improving the consumer experience and making the healthcare journey simpler.
    • “Now, its health benefits arm, Aetna, is unveiling its new Care Paths program, which connects members who have certain health needs—launching with diabetes, joint health and maternity care—to a more personalized view of their benefits and more directly with the care team supporting them. The platform is powered by artificial intelligence and offers users individualized recommendations for health and wellness programs related to their conditions as well as care kits when available.
    • “The goal, the insurer said, is to make members’ interactions with their health plans feel less transactional and instead more holistic. Aetna offered an exclusive look at the new offering to Fierce Healthcare.”
  • and
    • “Sword Health, a company that provides virtual physical therapy and mental health, is now offering an AI assistant for payers and providers to tackle operational and administrative tasks.
    • “The new AI division marks a notable expansion from the company’s core business of virtual care services like digital musculoskeletal care, pelvic health and movement health.
    • “The launch of the new division, called Sword Intelligence, marks a “pivotal evolution” in Sword Health’s strategy, according to the company.
    • “Sword Intelligence allows us to move beyond delivering care to our own members to enabling the entire healthcare industry to scale it efficiently and effectively,” Virgilio “V” Bento, founder and CEO of Sword Health, told Fierce Healthcare when reached via email.”
  • The Wall Street Journal further reports,
    • “Merck & Co. said it is embarking on a multi-year cost-savings plan, which includes cuts to its workforce and real-estate footprint, as it looks to redirect resources toward new product launches.
    • “The plan comes as the drug company on Tuesday logged lower revenue and sales in its latest quarter and narrowed its full-year guidance.
    • “The company said it expects the plan to result in $3 billion in annual cost savings by the end of 2027, which it plans to reinvest to support new products as well as its pipeline across multiple therapeutic areas.
    • “As part of the cost-savings plan, Merck expects to eliminate certain administrative, sales and research-and-development positions.
    • “The company didn’t disclose how many workers would be affected but said it would continue to hire employees in new roles across strategic growth areas of its business.
    • “Merck said it also would reduce its global real-estate footprint and continue to optimize its manufacturing network.
    • “The company expects the workforce cuts and real-estate reductions to result in annual cost savings of about $1.7 billion, which would be substantially realized by the end of 2027.”
  • and
    • “Novo Nordisk shares plunged after losing its lead in the weight-loss drug market to competitors like Eli Lilly.
    • “The company lowered its 2025 sales growth forecast due to copycat versions of Wegovy and slower Ozempic sales.
    • “Maziar Mike Doustdar was named chief executive, effective Aug. 7, succeeding Lars Fruergaard Jorgensen.”