Tuesday report

COVID-19

Tuesday report

David Ermer–CMS, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “The Trump administration released its ‘Make America Healthy Again’ strategy to improve children’s health.
    • “The strategy includes a vaccine framework, lenient approach to pesticides, and focus on processed foods and dyes.
    • “The FDA will modernize infant-formula nutrient requirements and increase testing for heavy metals and other contaminants.”
  • and
    • “President Trump signed an executive order to increase federal enforcement of pharmaceutical advertisements.
    • “The FDA is sending thousands of enforcement letters to drugmakers regarding misleading advertisements on multiple platforms.
    • “HHS wants to amend FDA guidance, closing a loophole allowing abbreviated descriptions of drug side effects in TV ads.”
  • Per a Congressional news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced that the HELP Committee will hold a hearing next week on delivering President Trump’s mission to restore radical transparency at the Centers for Disease Control and Prevention (CDC). This is crucial to protecting the health of American children.
    • “At the hearing, the HELP Committee will hear from former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. The Committee is also planning to invite current officials at the Department of Health and Human Services to respond by speaking with Committee members at a future hearing.”
  • STAT News tells us,
    • “More than 160 U.S. lawmakers have urged the Trump administration to abandon a newly announced pilot program that would allow pharmaceutical companies to offer rebates for a small number of therapies to hospitals that participate in a federal drug discount program.
    • “At issue is the 340B discount program, which was created to help hospitals and clinics care for low-income and rural patients. Drug companies that want to take part in Medicare or Medicaid must offer their medicines at a discount — typically, 25% to 50%, but sometimes higher — to participating hospitals and clinics. Right now, drug companies generally provide the discounts at the time of purchase.” * * *
    • “The latest controversy has been over double discounts, an issue that can be traced, in part, to the Inflation Reduction Act, which allows Medicare to negotiate the prices of some drugs. The concern is a significant issue for drugmakers, since certain medicines, including big-selling heart and cancer treatments, have been selected by Medicare for price negotiations.
    • “The Inflation Reduction Act imposes a maximum fair price on drugs paid for by Medicare and obligates the companies to pay added inflation rebates in Medicare. But the requirement overlaps with 340B, because drugmakers must offer hospitals the lower of the maximum fair price or 340B price, and pay inflation rebates only on drugs not sold at the 340B price.”
  • The American Hospital Association is opposed to the rebate pilot.
    • “The AHA Sept. 8 urged the Federal Trade Commission and Antitrust Division of the Department of Justice to investigate several drug companies’ concerted efforts to impose rebate models within the 340B Drug Pricing Program, saying the actions may violate antitrust laws. 
    • “These drug companies sought to switch from providing ‘upfront discounts’ on 340B drugs to a model in which 340B hospitals must purchase even the costliest drugs at full price and then submit for a rebate,” AHA wrote. “If successful, this concerted effort would essentially obligate America’s safety-net hospitals to advance interest-free loans to the world’s largest and most profitable drug companies. This new ‘rebate model’ would inflict untold harm on hospitals, patients and communities. And for your purposes, the publicly available information suggests potential anticompetitive activity.”  
    • “The AHA letter details a timeline of many actions taken by several drug companies over a six-month period highlighting a potential antitrust conspiracy to limit 340B discounts.”
  • STAT News also informs us,
    • “Medicare is delaying implementation of a Biden-era rule that would have made Medicare Advantage plans notify members about their unused supplemental benefits — services such as vision and dental. 
    • “Medicare didn’t say how long it’s delaying implementation but disclosed in a notice late Monday that insurers had asked questions and sought technical guidance on the rule. The agency said it’s delaying implementation “for contract year 2026 and beyond” because of “logistical concerns.” 
  • Per a Government Accountability Office news release,
    • “When Medicare beneficiaries need medical devices or health care services, they can choose from among the items and services that Medicare has decided to cover. 
    • “Medicare sets time frames for determining coverage and meets its goals more than 80% of the time. However, the agency doesn’t systematically identify the reasons why some decisions are delayed, which may make it harder to improve timeliness.
    • ‘There are also concerns that Medicare isn’t transparent about how it prioritizes reviews of new coverage requests. Making this information available could improve the quality of requests.
    • “Our recommendations address these issues.”
    • Here is a link to the full report.
  • Federal News Network points out,
    • “Federal employees, on average, are waiting longer to see their retirement applications processed. New data from the Office of Personnel Management for August shows it takes an average of 70 days to process a claim from a retiring fed. But if retirement claims are coming to OPM in less than 60 days, those cases take on average 45 days to complete. At the same time, OPM received more than 9,400 retirement claims last month. OPM’s backlog of retirement claims dropped by 2,000 to 24,300.” 
  • Per MedTech Dive,
    • “Microbot Medical has received 510(k) clearance for its Liberty Endovascular Robotic System, the company said Monday.
    • “The Food and Drug Administration clearance positions Microbot to start marketing the single use, remotely operated robotic system for peripheral endovascular procedures.
    • “Siemens Healthineers launched a robotic system for peripheral vascular interventions in 2021 but withdrew from the market to focus on neurovascular procedures two years later.”

From the public health and medical/Rx research front,

  • The Washington Post reports,
    • “‘Kissing bug’ disease is now endemic in the [southern] U.S., CDC says. What is it?
    • “The U.S. is seeing a rise in Chagas disease, which is a life-threatening illness transmitted through “kissing bugs” known to bite human faces. Pets can be carriers.”
  • MedPage Today tells us,
    • “The monoclonal antibody romosozumab (Evenity) increased bone mineral density (BMD) in premenopausal women with idiopathic osteoporosis, according to a small, phase II open-label study.
    • “Among the 29 women enrolled, treatment with romosozumab was associated with a 15% gain in BMD in the lumbar spine, a 5.3% increase at the total hip, and a 5.4% increase at the femoral neck as measured by dual-energy x-ray absorptiometry at 1 year (all P<0.001), reported Lauren Lynch, MD, PhD, of Columbia University Irving Medical Center in New York City.”
    • “Increases in BMD at all three spots were significant by month 6 of treatment, she said at the American Society for Bone and Mineral Researchopens in a new tab or window annual meeting.
    • “Treatment with romosozumab was also tied to a 3.4% gain in trabecular bone score at 1 year (P<0.001).
    • “These promising data provide support for future randomized controlled trials that test romosozumab as a therapeutic option for premenopausal idiopathic osteoporosis,” said Lynch.”
  • Per Healio,
    • “Body composition measurements may be better predictors of colorectal cancer incidence than BMI.
    • “An evaluation of more than 9,000 postmenopausal women who had dual-energy X-ray absorptiometry-determined adiposity found those with higher visceral adipose tissue and android fat had greater risk for developing the malignancy. Those with increased subcutaneous adipose tissue, more closely related to BMI, did not.”
  • and
    • “The prevalence of mild, moderate and severe obstructive sleep apnea in U.S. adults are each expected to rise by 2050, according to results published in The Lancet Respiratory Medicine.
    • “By projecting a rise in OSA prevalence, the research helps fill a critical gap in public health planning and ensures that health systems, payers and policymakers can prepare for rising demand,” Carlos M. Nunez, MD, chief medical officer at Resmed, told Healio.”
  • The International Foundation of Employee Benefit Plans lets us know,
    • “Many people could benefit from a nudge to help them exercise more, improve their finances or get a recommended health screening.
    • “A recent report from the International Foundation of Employee Benefit Plans suggests that organizations that provide motivation in the form of incentives tend to have better participation in their wellness programs, likely leading to improvement in several workforce measures.
    • “Workplace Wellness and Financial Education: 2025 Survey Report uncovers insights into the types of wellness incentives organizations offer and their impact on program participation as well as overall worker wellness and organizational goals.
    • “More than four in ten (44%) survey respondents said they offer an incentive for at least one of their wellness initiatives. In addition, 19% said incentives are offered through a vendor or health care provider. Thirty-eight percent said they do not offer incentives.” 
  • Beckers Hospital Review identifies the states that vaccinate their populations the most and those that vaccinate their populations the least based on a Wallet Hub report published Sept. 9.

From the U.S. healthcare business front,

  • The American Hospital Association reports
    • A JAMA internal medicine study published Sept. 8 found that since the COVID-19 pandemic, Medicare Advantage beneficiaries have been experiencing longer hospital stays than those under Traditional Medicare. The study examined more than 89 million hospitalizations from 2017 to 2023 and found the average length of stay for MA admissions during that period increased from 6 to 7.1 days, while Traditional Medicare admissions grew from 5.8 to 6.3 days. The researchers noted that these trends “may reflect insurance-related discharge barriers” and that the results “are consistent with hospital industry reports.” They point to prior authorization or limited post-acute care networks as possible causes. 
  • The Wall Street Journal informs us,
    • Novartis agreed to buy Tourmaline Bio in a roughly $1.4 billion-dollar deal that boosts its cardiovascular drug pipeline with access to the targeted therapy drug pacibekitug.
    • The Swiss pharmaceutical company said Tuesday that it would offer Tourmaline Bio shareholders $48 a share, valuing the company at approximately $1.4 billion on a fully diluted basis. Tourmaline’s board has approved the deal.
    • Tourmaline Bio [which is based in Massachusetts] is a clinical-stage biopharmaceutical company developing pacibekitug which is a treatment option for atherosclerotic cardiovascular disease.
  • Per STAT News,
    • “Eli Lilly has developed artificial intelligence models that can help predict the behavior of potential drug candidates, based on the data the drugmaker has collected over the last two decades and at the cost of more than a billion dollars. Now, it’s opening up some of those models to biotech companies that want to use them to jumpstart their science.
    • “The only catch? Lilly wants to use data from those other companies to improve its models.”
  • Modern Healthcare tells us,
    • “The vast majority of UnitedHealthcare Medicare Advantage members will be enrolled in policies with high quality scores next year, parent company UnitedHealth Group announced Tuesday.
    • “UnitedHealthcare anticipates that 78% of its Medicare Advantage enrollees in 2026 will have plans in contracts that earned at least four out of five stars under the Star Ratings quality measurement program. That compares with 71% this year.
    • “The performance is consistent with expectations. UnitedHealth Group wrote in a filing to the Securities and Exchange Commission. The company also reaffirmed its full-year adjusted earnings outlook of at least $16 per share on revenues of $445.5 billion-$448 billion.”
  • Per Healthcare Dive,
    • “Mayo Clinic plans to close six of its clinics in Minnesota by Dec. 10 and reduce services at its Albert Lea hospital, the nonprofit provider said Monday.
    • “The health system will shutter clinics in Belle Plaine, Caledonia, Montgomery, North Mankato, St. Peter, and Wells and stop offering elective surgeries and procedures in ophthalmology, gynecology, endoscopy, orthopedics and podiatry at the hospital and clinic in Albert Lea.
    • “Mayo said it is consolidating services in part to address lower patient volumes and staffing shortages. Consolidating services will help the system “strengthen rural health care delivery and ensure safe, high-quality and sustainable care for generations to come,” Mayo said.”
  • Fierce Pharma reports,
    • “Amid a yearslong wave of enthusiasm and uptake for Eli Lilly and Novo Nordisk’s blockbuster obesity medicines, the drugs have scored a strong endorsement from an independent U.S. cost watchdog.
    • “In a draft report (PDF), the Institute for Clinical and Economic Review (ICER) determined the drugs are “highly cost-effective” because of their ability to help patients lose weight, reduce metabolic risk factors and address obesity-related health complications. The group specifically looked at Novo’s injectable semaglutide at the 2.4-mg dose, Novo’s investigational oral semaglutide 25-mg dose and Lilly’s injectable 15-mg dose of tirzepatide.
    • “After reviewing the health benefits of the medicines, the cost watchdog said the drugs met the mark on “commonly used cost-effectiveness thresholds.”
    • “Because treatment with all three drugs results in substantial weight loss and improvement in metabolic risk factors, we have high certainty that all three drugs have substantial net health benefit over lifestyle modifications alone,” ICER reviewers said in the report.”
  • Per Fierce Healthcare,
    • “Hospitals’ operating margins continued to soften through July as volumes remained strong, but spending on supplies and drugs inched upward, according to Kaufman Hall’s latest monthly performance report.
    • “The firm’s operating margin index of nationwide hospitals was a median 1.7% across seven months when including health system allocations for the cost of shared services and 5.3% when excluding those. That’s a low point for 2025 but still above hospitals’ performance during the same period in 2024.
    • “Looking at July alone, the index showed a 2.6% median operating margin with health system allocations and 6.2% without. In June, those were 3.4% and 7%, respectively.
    • “While performance has generally been strong this year, profitability has decreased slightly over the past few months,” Erik Swanson, managing director and data and analytics group leader with Kaufman Hall, said in a release.”
  • and
    • “Telehealth GLP-1 company Remedy Meds, founded in 2024, announced its intent to acquire health tech unicorn Thirty Madison for $500 million in an all-stock deal. 
    • “The deal will create a larger, multibrand platform across women’s, men’s and metabolic health, executives said. The deal also positions Remedy Meds as a more competitive player in the direct-to-consumer health space, up against Hims & Hers and Ro. 
    • “Thirty Madison was valued at $1 billion in June 2021, launching it to unicorn status. In the years since, the company has completed several mergers and acquisitions, including with women’s-health-focused company Nurx. 
    • “Remedy Meds is a relative newcomer compared with the company it plans to buy, having only been founded in January 2024. Its founder Haris Memon founded and sold a home goods company called Miracle Brands in July 2023 before entering the healthcare market.”
  • Per MedTech Dive,
    • “Senseonics has struck a deal to retake control of the commercialization and distribution of its implantable continuous glucose monitors, the company said Wednesday.
    • “Ascensia Diabetes Care is currently the exclusive worldwide distributor of the Eversense devices. That will change at the start of 2026, when Senseonics will resume responsibility.
    • “BTIG analysts said in a note to investors that the move shows “Senseonics is doubling down on its view that the one-year sensor will finally enable an inflection in patient demand for the implantable glucose monitor.”

Friday report

David Ermer–ACA, CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • This week’s blog post from OPM Director Scott Kupor concerns the value of incentives.
    • “Charlie Munger wasn’t talking about the federal General Schedule (GS) pay scale when he addressed a 1995 Harvard crowd on the critical role that incentives play in driving employee behavior, but he may as well have been. Because, unfortunately, 30 years later, his premonition remains true: how we pay federal employees remains one of the most critical – and backward – drivers of employee behavior.”
  • Bloomberg Law tells us,
    • “The Trump administration is rewriting the playbook for government hiring, allowing managers to select from a broader list of qualified candidates instead of having to choose from the top three scorers on a competitive exam.
    • “The new rule replaces the “rule of three,” under which civil service examiners narrow down a list of qualified applicants for a position while still giving the president and other senior officials the final say.
    • “The change will give hiring managers more latitude on which job candidates they exclude, allowing them to eliminate applicants if they’re passed over more than three times for the same position.’
  • Federal News Network informs us,
    • “Just three federal agencies, when combined, make up more than half of the total federal workforce reductions that have occurred so far under the Trump administration.
    • “The departments of Defense, Treasury and Agriculture have cut their staffing levels this year by a cumulative total of about 106,000 employees, according to data compiled by the non-profit Partnership for Public Service. That’s out of an estimated 199,000 federal employees governmentwide who have left their jobs since January, either voluntarily or by force.
    • “In terms of scale, the Defense Department has lost the most at 55,000 employees. The Treasury Department follows just after DoD with a loss of 30,000 employees — mostly from the IRS. And the Agriculture Department has 21,000 fewer employees, the Partnership found in its data report, which compiles findings from agency documents and media reports.”
  • Govexec considers how yesterday’s semi-annual regulatory agenda could impact federal employees.
  • STAT News reports,
    • “The Food and Drug Administration is now publishing complete response letters to drugmakers shortly after they are issued, marking a major shift in transparency into regulation by the agency. Yesterday, the FDA disclosed 89 previously unreleased CRLs from 2024 and 2025, including rejections for Replimune, Capricor Therapeutics, and Ultragenyx.
    • “Traditionally, it’s been up to companies to disclose the reasons for an FDA rejection, a process that critics contend can lead drugmakers to misrepresent what the agency said. In July, the agency announced its intention to release letters in “real time,” and published a batch of letters for drugs that had eventually won approval. Yesterday’s release went beyond that.”
  • The FDA adds, “Decision letters are accessible to the public as a centralized dataset at openFDA.”

From the public health and medical/Rx research front,

  • The Centers for Disease and Prevention announced today,
    • “COVID-19 activity is peaking in many areas of the country with elevated emergency department visits and hospitalizations nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is peaking nationally. Emergency department visits for COVID-19 are elevated in children 0-4 and 5-17 years old. Hospitalizations are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • ‘RSV activity is very low.
    • “Vaccination
      • “RSV immunization products will be available beginning in September across most of the continental United States. To protect against RSV-associated lower respiratory tract infections, all infants should receive either maternal RSV vaccination during pregnancy or a long-acting RSV monoclonal antibody, nirsevimab or clesrovimab.
      • “A CDC MMWR report published on August 28, 2025, outlines recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of clesrovimab for preventing severe RSV-related illness in infants. Clesrovimab could further increase access to and protection for infants in the 2025–26 respiratory virus season.”
  • Beckers Hospital Review points out steps that states are taking to override the FDA’s limited Covid vaccination recommendation which the CDC’s Advisory Committee on Immunization Practices (ACIP) will take up at a September 18-19 meeting.
  • Beckers Payer Issues adds that the “Massachusetts’ Division of Insurance and Department of Public Health has issued a bulletin Sept. 3 requiring insurance carriers to cover vaccines as outlined by the state, not just the CDC.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “In a weekly update, the US Centers for Disease Control and Prevention (CDC) today [September 3] reported 23 more measles cases, lifting the country’s total to 1,431, the most since the country reached elimination status in 2000.
    • “For the first time, health officials divided out the cases confirmed in international visitors, which account for 18 of the national cases.
    • “The number of outbreaks remained the same, at 35, double the number for 2024. So far, 86% of cases are linked to outbreaks, compared to 69% last year. To date, 92% of patients were unvaccinated or have an unknown vaccination status. School-age kids are the most affected group, followed closely by adults ages 20 years and older.”
  • The New York Times identifies “6 More Things E.R. Doctors Wish You’d Avoid. Stay out of the emergency room with these tips.
    • “Last winter, I wrote about things emergency room doctors wish you’d avoid, and many more E.R. doctors wrote in to tell me what I had missed.”
      • “Never put your feet on the dashboard.
      • “Don’t forget your eyes when doing yardwork.
      • “And never mow the lawn in open-toed shoes.
      • “Watch out for the front burner.
      • “If you’re choking, forget about privacy.
      • “Don’t take another person’s prescription medication.”
  • The American Hospital Association News notes,
    • “A Health Affairs study published Sept. 2 found that less than 40% of Medicare beneficiaries with opioid use disorder received standard care in alignment with quality measures. Researchers analyzed Medicare enrollment, claims and encounter data to assess the extent to which beneficiaries with OUD received treatment in alignment with eight nationally recognized quality measures in 2020. The study found that Medicare Advantage performed worse than fee-for-service Medicare on six of eight measures, and that Medicare performed worse than Medicaid on all three comparable OUD quality measures available.
    • “The authors said a variety of initiatives could be used to improve OUD treatment for Medicare beneficiaries, including enhanced Medicare coverage, policies enabling more providers to treat beneficiaries with OUD, policies and programs to facilitate care connections following hospitalization or an emergency department visit, and initiatives encouraging beneficiaries to seek treatment.”
  • Medscape explains “Everything Patients Need to Know About Aging on GLP-1s.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CVS Health is tapping into health system partnerships as it rapidly expands primary care offerings.
    • “CVS has added primary care services at more than 400 MinuteClinic sites across 12 states and Washington, D.C., in the last year or so, said Dr. Creagh Milford, interim president of retail health at CVS Health and president at CVS-owned Oak Street Health. The goal is to offer primary care at all MinuteClinic sites and build a payer-agnostic network to serve patients, he said.
    • “However, the strategy requires buy-in from residents, which isn’t a guarantee in all communities.
    • “The healthcare conglomerate has formed primary care clinical affiliations with three health systems to help with the primary care shift and is looking for more partners. Milford said several dozen conversations are underway about similar agreements. 
    • “We’re seeing a lot of traction,” Milford said. “One of the things that had been a challenge between MinuteClinic and our health system partners is, how do we better coordinate care?” 
    • “The clinical affiliations are another way for health systems to respond to physician shortages and expand access to care.
    • “CVS’ first primary care-driven affiliation was with Atlanta-based Emory Healthcare Network, which was announced in February. As part of the agreement, MinuteClinic offers in-network adult primary care at all 35 clinics in Georgia to most payers through Emory’s integrated network.” 
  • Per Cardiovascular Business,
    • “Congenital heart disease surgical procedures are relying more on 3D echocardiography as it is rapidly transforming the way congenital heart procedures are planned, guided and help manage patients afterwards. The technology is offering cardiac surgeons and interventional cardiologists clearer images, better communication, and safer procedures for even the smallest patients.
    • “3D echo captures the heart in real time and with the full structure of the heart. You can cut through with. So pre-surgical planning and it is now moving into the operating room. Because of the release of the pediatric 3D transesophageal echo (TEE) probes, we can characterize the valve tissues that the surgeons are repairing quite nicely,” explained Pei-Ni Jone, MD, FASE, director of the echocardiography laboratory at Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee.
    • “She said 3D echo offers a surgical view of the valve non-invasively and it can visualize valve failures that happen in the operating room or help determine if a surgeon needs to go back on bypass to repair something.”
  • Per MedTech Dive,
    • “A clinical trial of Medtronic’s Hugo robot has met its primary effectiveness and safety endpoints, the company said Thursday.
    • “Physicians used the robotic-assisted surgery system to treat 193 patients. All of the surgeries were successfully completed. Two people had surgical safety events in the 30 days after treatment that were resolved without complication. 
    • ‘Medtronic has filed for authorization of the system in a urology indication and plans to expand into hernia repair later. The company will compete with Intuitive Surgical for the hernia market.”
  • The American Journal of Managed Care notes,
    • “Rideshare transportation for abnormal [fecal immunochemical test] FIT results can double colonoscopy completion rates, reducing [colorectal cancer] CRC cases and deaths significantly.
    • “The intervention is cost-saving, generating more than $330,000 savings per 1000 people screened due to earlier cancer detection.
    • “Early FIT screening, starting between ages 40 and 49 years, is crucial as CRC rates rise among younger populations.
    • “The study’s microsimulation model projects long-term CRC outcomes, supporting further trials to validate rideshare intervention effectiveness.”

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Beckers Health IT informs us,
    • “Federal lawmakers have introduced a bill to extend Medicare telehealth flexibilities and CMS’ hospital-at-home waiver.
    • “The Telehealth Modernization Act of 2025 would prolong the telehealth program through Sept. 30, 2027, and CMS’ reimbursement of acute hospital care at home through 2030. The measures otherwise expire Sept. 30.
    • “Telehealth is a vital part of our healthcare system, and we must ensure that it is available to patients who need it,” said U.S. Rep. Earl “Buddy” Carter, R-Ga., in a Sept. 2 news release. “By extending telehealth flexibilities for patients, we are making healthcare more accessible, regardless of their physical location.”
    • “Mr. Carter introduced the House bill with Rep. Debbie Dingell, D-Mich., while a companion Senate bill is being led by Sens. Tim Scott, R-S.C., and Brian Schatz, D-Hawaii. Nearly 50 health systems have called for the telehealth extension.”
  • Federal News Network reports,
    • “The Office of Personnel Management is taking a closer look at the details for implementing President Donald Trump’s proposal for a larger pay raise for federal law enforcement personnel next year.
    • “The announcement from OPM comes a couple days after Trump called for a 3.8% pay raise in 2026 for federal employees working in law enforcement jobs.
    • “Certain frontline law enforcement personnel are critical to implementing the President’s strategy to secure the border, protect our country and keep American citizens safe,” OPM said this week in new guidance. “Without special salary rates, the government may find it difficult to recruit and/or retain the number of these personnel needed to properly enforce our borders, uphold our immigration laws and protect law-abiding citizens.”
    • “It’s not yet clear which specific positions or how many law enforcement officials will be included in the new special salary rate. OPM said it plans to consult with the departments of Homeland Security, Justice and Interior to define which jobs will be eligible for the larger law enforcement pay raise next year.
    • “Generally, though, OPM said the upcoming special salary rate will cover agents in the Border Patrol and the Drug Enforcement Administration, criminal investigators at Immigration and Customs Enforcement (ICE), Secret Service personnel, officers at the Federal Protective Service and the FBI, and correctional officers at the Federal Bureau of Prisons — among several other groups.”
  • and
    • “After unveiling a series of immediate acquisition changes over the summer, the Trump administration is on track to debut a formal rulemaking to overhaul and streamline the Federal Acquisition Regulation, or the FAR, this fall.
    • “Larry Allen, the associate administrator for General Services Administration’s Office of Government-wide Policy, discussed the ongoing FAR revisions and the forthcoming rulemaking during AFCEA Bethesda’s “Health IT” conference in Washington on Wednesday.
    • “Under an April executive order, the White House Office of Federal Procurement Policy and the FAR Council are leading an effort to “return the FAR to its statutory roots, rewritten in plain language, and remove most non-statutory rules.”
    • “In recent months, the FAR Council has issued a series of “class deviations” for multiple parts of the FAR. Recent deviations have focused on prioritizing the use of governmentwide contracts and simplifying commercial acquisition.” * * *
    • “In follow-up guidance to the executive order, the Office of Management and Budget said the FAR Council will turn to formal rulemaking after it has posted model deviations for all FAR parts.”
  • It’s worth adding that reginfo.gov no longer carries an “under repair” warning and while the regulatory review pages are up to date, the regulatory agenda page still features the Fall 2024 edition.
  • Govexec considers whether FEGLI Option B is really the best life insurance choice? FEGLI plans remain a solid life insurance option for federal employees, but, depending on the coverage, it may also be wise to look to the private market.
  • Following up on yesterday’s FEHBlog, Beckers Hospital Review notes,
    • “A federal rule enabling real-time access to prescription drug pricing, coverage details and prior authorization requirements is set to take effect Oct. 1. 
    • “The regulation, finalized in July as part of the CMS Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System final rule, will require healthcare providers to use certified health IT systems to electronically submit prior authorization requests, check real-time prescription drug pricing during patient encounters and share electronic prescription data with pharmacies and insurers.”
  • Fierce Healthcare adds,
    • “The Department of Health and Human Services’ investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday. 
    • “The news comes as Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability. 
    • “A press release by HHS says Health Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
    • “The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to HHS’ Office of the Inspector General to assist their investigations, Assistant Secretary Thomas Keane said in a statement.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Through the RDEP process, sponsors will receive clearer guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness.
    • “Drug developers – and the patients they hope to treat – deserve clear, consistent information from the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “These principles ensure that FDA and sponsors are aligned on a flexible, common-sense approach within our existing authorities, and that we incorporate confirmatory evidence to give sponsors a clear, rigorous path to bring safe and effective treatments to those who need them most.”    
  • BioPharma Dive reports,
    • “Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its main revenue driver a few years ago.
    • “After some delays, the Food and Drug Administration is set to issue an approval verdict on this medicine sometime between October and the end of December. If cleared for market, the oral drug would be sold as Vyglxia and used to treat patients with spinocerebellar ataxia, a type of genetic disorder where the progressive erosion of nerve cells causes problems with movement, coordination and brain function.”
  • Per MedTech Dive,
    • “Medtronic has received an expanded label from the Food and Drug Administration to pair its MiniMed 780G insulin pump with a glucose sensor being developed by Abbott for Medtronic.
    • “Medtronic and Abbott will submit required compliance documentation for sensor integration and marketing in the coming weeks, finishing the regulatory process, the companies announced Tuesday.
    • “The FDA decision also expands the insulin pump to adults with Type 2 diabetes.”

From the public health and medical/Rx research front,

  • The American Hospital News tells us,
    • “The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory syncytial virus this upcoming respiratory virus season compared to last year’s, according to its 2025-26 outlook released Aug. 25. The agency is predicting higher peak weekly COVID-19 hospitalization rates this season, particularly if a variant with moderate immune-escape properties emerges.”
  • and
    • “The AHA Sept. 3 released a study conducted by KNG Health Consulting that found Medicare patients who receive care in a hospital outpatient department are more likely to come from geographically isolated and medically underserved communities and be sicker and more complex to treat than Medicare patients treated in independent physician offices. Specifically, the study found that Medicare patients who are seen in HOPDs — including those with cancer — are more likely to be from rural and lower-income areas, living with more severe chronic conditions, dually-eligible for both Medicare and Medicaid, previously hospitalized or cared for in a hospital emergency department, and under 65 and eligible for Medicare based on disability.”
  • The Wall Street Journal discusses how to get the new Covid vaccine.
  • NBC News adds,
    • “An over-the-counter nasal spray which has been used for years as a safe and effective treatment for seasonal allergies could potentially prevent Covid infections, according to clinical trial results released Tuesday.
    • “The antihistamine azelastine works as an antiviral against a range of respiratory infections, including influenza, RSV and the virus that causes Covid, a growing number of studies have shown.” * * *
    • “Our findings suggest azelastine could serve as a scalable, over-the-counter prophylactic against Covid, especially when community transmission is elevated or in high-risk settings such as crowded indoor events or travelling,” said Dr. Robert Bals, professor of internal medicine and pneumology at Saarland University and the study’s senior author.
    • “The trial had limitations, namely that the participants were all young and relatively healthy, he said. 
    • “Bals said that azelastine should not be seen as a replacement for vaccinations, and larger studies were needed before recommending it as a routine preventative measure for the general public, and especially vulnerable groups.”
  • Per a National Institutes of Health news release,
    • “Researchers funded by the National Institutes of Health (NIH) have found that a single injection of the antibiotic benzathine penicillin G (BPG) successfully treated early syphilis just as well as the three-injection regimen used by many clinicians in the United States and elsewhere. These findings from a late-stage clinical trial suggest the second and third doses of conventional BPG therapy do not provide a health benefit. The results were published today in The New England Journal of Medicine.
    • “Benzathine penicillin G is highly effective against syphilis, but the three-dose regimen can be burdensome and deter people from attending follow-up visits with their healthcare providers,” said Carolyn Deal, Ph.D., chief of the enteric and sexually transmitted infections branch of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “The new findings offer welcome evidence for potentially simplifying treatment with an equally effective one-dose regimen, particularly while syphilis rates remain alarmingly high.”
    • “Syphilis is a common sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. The United States reported 209,253 total syphilis cases and 3,882 congenital syphilis cases in 2023, representing 61% and 108% increases over 2019 numbers, respectively. Without treatment, syphilis can result in neurological and organ damage as well as severe pregnancy complications and congenital abnormalities. Syphilis can also increase a person’s likelihood of acquiring or transmitting HIV.
    • “BPG is one of the few antibiotics known to effectively treat syphilis, and stockouts are common worldwide. The antibiotic is currently being imported to the United States to resolve a nationwide shortage.”
  • Per Beckers Hospital Review,
    • “Researchers have successfully used repurposed cancer drugs to target dormant breast cancer cells, aiding in the delay or prevention of recurrence, according to a study published Sept. 2 in Nature Medicine. 
    • “Researchers from Philadelphia-based University of Pennsylvania’s Abramson Cancer Center and Perelman School of Medicine enrolled 51 breast cancer survivors to identify and target the cells with existing cancer drugs.” * * *
    • “Read the full study here.” 
  • Per Healio,
    • “Nonsurgical treatments may offer long-term reductions in pain and disability for patients with chronic low back pain.
    • “Treatment options included cognitive behavioral therapy, mindfulness and exercise.”
  • Per Health Day,
    • “Guidelines recommend that preschoolers diagnosed with ADHD first get six months of behavioral therapy before drug therapy is initiated
    • “New research shows this rule is followed by U.S. doctors only about 14% of the time, and that could mean poorer outcomes for kids
    • “A lack of access to therapists is often cited as a reason for starting meds soon, but experts say there are ways around that.”

From the U.S. healthcare business front,

  • Fierce Pharma points out,
    • “After joining multiple other drugmakers on the U.S. investment bandwagon earlier this year, Gilead Sciences is providing further details on where it plans to channel its $32 billion pledge.
    • “Gilead has broken ground on a new pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, the company said Tuesday.
    • “The new facility, which will reach five stories and cover 180,000 square feet, will serve the company’s technical development and manufacturing teams, leveraging a mix of digitalization, autonomous robotics and real-time digital monitoring. Additionally, the project is expected to boost Gilead’s capabilities and capacity around biologics, which the company described as a “central pillar” of its broader growth strategy.”
  • Beckers Hospital Review lets us know,
    • “Cincinnati-based TriHealth has completed the acquisition of Clinton Memorial Hospital, a 140-bed facility in Wilmington, Ohio, marking its sixth acute care hospital.
    • “The facility will be renamed TriHealth Clinton Regional Hospital and serve as a hub for the system’s specialized services, including women’s health, cancer, heart and vascular, neurosciences and stroke care.
    • “This new name will extend TriHealth’s brand promise to ‘see, to hear and to heal … delivering surprisingly human care’ to the residents of Clinton County,” TriHealth President and CEO Mark Clement said in a Sept. 2 news release. “And it will also affirm TriHealth’s commitment to invest in the hospital and expand services locally, establishing it as a regional hub for TriHealth’s exceptional, nationally recognized care.”
  • Fierce Healthcare reports,
    • “HonorHealth, an Arizona-based health system, is acquiring a number of Evernorth Care Group locations across Phoenix.
    • “Evernorth Care Group lists 18 centers offering integrated primary care services to nearly 80,000 patients throughout the metropolitan area. The clinics will become part of HonorHealth at the close of the deal, slated for January 2026, pending regulatory approvals.
    • “This acquisition enhances the services we offer and expands Valley residents’ access to care,” HonorHealth CEO Todd LaPorte said in the announcement. The financial terms were not disclosed.” 
  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s prior authorization gold card program has seen a more than 40% increase in the number of qualifying provider groups in 2025, the company shared with Becker’s.
    • “Launched in October 2024, the program reduces prior authorization requirements in favor of advance notification for provider groups that consistently adhere to evidence-based care guidelines.
    • “Providers can lose gold-card status because of patient safety issues, failure to cooperate with quality and patient safety activities, failure to make timely responses to requests for information, or because they no longer meet program requirements. UnitedHealthcare conducts annual evaluations for gold card qualification, with determinations effective on Oct. 1 every year. 
    • “On Sept. 1, provider groups could begin viewing their program status in the UnitedHealthcare Provider Portal. Starting Oct. 1, additional groups will be eligible.”
  • and
    • “Economic uncertainty and policy changes from the current administration have changed the way health plans operate over the past year. Many have found workarounds to continue efficiency and growth.
    • “Becker’s connected with five leaders to learn their biggest accomplishments so far in 2025.”
    • Check it out.
  • Milliman has posted its “2025 Milliman Retiree Health Cost Index.”
  • McKinsey & Co. discusses “the quantum revolution in pharma: Faster, smarter, and more precise.”
    • “Quantum computing presents a multibillion-dollar opportunity to revolutionize drug discovery, development, and delivery by enabling accurate molecular simulations and optimizing complex processes.”
  • Radiology Business notes,
    • “Hospital- and private equity-affiliated radiology practices command significantly higher prices than their independent practice counterparts, according to new research published Tuesday. 
    • “Consolidation of imaging groups has accelerated in recent years, with limited evidence on how this change impacts economics within the specialty. Researchers with Brown University recently set out to understand how such M&A activity has changed prices for radiology services, sharing their findings in the Journal of the American College of Radiology (JACR). 
    • “They found a noteworthy gap, with negotiated professional prices for hospital-based radiology services about 43% higher than independents. That’s compared to about 16% higher for investor-backed radiologists versus others in private practice. 
    • “Our findings demonstrate significant differences in negotiated radiologic service prices by practice ownership, with hospital and PE-affiliated practices able to negotiate higher professional fees than independent practices,” corresponding author Yashaswini Singh, PhD, MPA, a healthcare economist and professor with the Providence, Rhode Island, institution, and colleagues concluded. “These results highlight the financial implications of ongoing consolidation in radiology and underscore the need for continued research into how these trends affect radiologists, insurers and patients.”

Friday report

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

From Washington, DC,

  • Here’s a link to this week’s blog post from the OPM Director Scott Kupor. The week’s post concerns the federal government’s budget.
  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today announced that its guidance memorandums to federal agencies will now be housed directly on OPM.gov to make them easier to find and more accessible. The former page will be transitioned to a new page on OPM’s website and will also be available here.
  • The New York Times reports,
    • “CVS and Walgreens, the country’s two largest pharmacy chains, are for now clamping down on offering Covid vaccines in more than a dozen states, even to people who meet newly restricted criteria from the Food and Drug Administration.
    • “On Thursday, Amy Thibault, a spokeswoman for CVS, said the vaccine was not available at pharmacies in 16 states, citing “the current regulatory environment” and emphasizing that the list could change.
    • “On Friday, CVS issued an update: It could administer vaccines in 13 of the 16 states, and in the District of Columbia, to people who had obtained a prescription from a doctor or other medical provider. (As of Friday morning, its online scheduling tool still did not allow anybody to book an appointment in those places; Ms. Thibault said an update was in progress.) In Massachusetts, Nevada and New Mexico, CVS still cannot offer the shots at all, Ms. Thibault said.
    • “She did not provide an explanation for the change.
    • “Walgreens said in a statement that it was “prepared to offer the vaccine in states where we are able to do so” to people who met the F.D.A. criteria. When a New York Times reporter tried to schedule vaccine appointments in all 50 states, the Walgreens website said patients would need a prescription in 16 of them. Though there is some overlap, it’s not the same set of 16 as CVS, underscoring the level of confusion.” * * *
    • “CVS will make the vaccines readily available nationwide if the advisory panel recommends them, Ms. Thibault said. (In the 34 states where the company hasn’t set limits, people can simply check a box when they make an appointment online to attest that they meet the F.D.A. criteria, without a prescription or other documentation.) But since the panel hasn’t yet made a decision, the company is holding back in states where it believes its pharmacists need a C.D.C. endorsement.”
  • Fierce Healthcare informs us,
    • “While data released earlier this week raised questions about the administrative costs associated with No Surprises Act (NSA) arbitrations, a second study suggests the legislation is working to reduce out-of-pocket costs for members.
    • “Researchers at Harvard University and Mass General Brigham examined a sample of 17,351 privately insured adults, 8,204 of which lived in states that gained protections against surprise billing thanks to the legislation. The remaining 9,147 lived in states where some kind of program was already in place to protect consumers against these costs.
    • “The study found a significant decrease in out-of-pocket spending for people living in the new intervention states. The study attributes savings of $567 in yearly out-of-pocket costs to the protections.
    • “In fact, the study suggests that these protections are leading to greater savings for consumers than other policy changes such as Medicaid expansion and the drug pricing policies under the Inflation Reduction Act (IRA). Expanded Medicaid was tied to a $152 decrease in annual out-of-pocket spending, while the IRA is estimated to drive $400 in savings each year for people with Medicare Part D coverage.”
    • “Our study findings support anecdotal reports that the NSA has successfully shielded patients from surprise billing,” the researchers wrote.
  • FEHBlog note — The two studies do not contradict each other.
  • The American Academy of Actuaries released a report on Medicare’s financial condition.
    • “Consistent with prior trustees’ reports, the 2025 Medicare Trustees Report stresses the serious financial challenges facing the Medicare program. It remains critical to address the HI [Medicare Part A trust fund] shortfall sooner rather than later. In addition, Medicare spending will continue to grow faster than the economy, increasing the pressure on beneficiary household budgets as well as the federal budget, threatening the program’s sustainability.
    • Medicare’s financial challenges could be more severe than projected, which leaves policymakers with the challenge to address the short- and longer-term challenges of program solvency while understanding the potential implications on beneficiary’s ability to afford and receive appropriate health care. Understanding the implicit and explicit consequences of any potential change or lack thereof requires continued collaboration between actuaries, program and agency staff, consumer advocates, and Congress.

From the Food and Drug Administration (FDA) front,

  • Fierce Pharma reports,
    • “While Sanofi originally had its eye on tolebrutinib when it purchased its partner Principia Biopharma for $3.7 billion five years ago, another one of the BTK inhibitors inherited from the biotech has made it across the FDA finish line first.
    • “The drug rilzabrutinib, which is now approved as Wayrilz in immune thrombocytopenia (ITP), has been hailed (PDF) by Sanofi as a potential “multi-indication blockbuster” that could deliver 2 billion to 5 billion euros at its sales peak. 
    • “The FDA’s approval on Fridayspecifically clears Wayrilz for use in adults with persistent or chronic ITP who haven’t responded to prior therapy. 
    • “The regulatory endorsement marks the first approval for a Bruton tyrosine kinase (BTK) inhibitor to treat ITP in the U.S., where the condition is estimated to affect around 100,000 people, Mike Quigley, Ph.D., Sanofi’s CSO and global head of research, said in an interview with Fierce.”
  • and
    • “Aiming to deliver blockbuster sales of its Alzheimer’s disease-fighting antibody Leqembi in its 2027 fiscal year, Eisai has cleared a key regulatory hurdle in its quest to grow the medicine’s reach.
    • “The FDA has approved a once-weekly subcutaneous maintenance dose of the drug in an autoinjector, dubbed Leqembi IQLIK, according to a joint press release from the Japanese pharma and its commercialization partner Biogen.
    • “In line with the label of the drug’s intravenously infused formulation, Leqembi IQLIK is cleared for use in Alzheimer’s patients with mild cognitive impairment or mild dementia. Patients may switch to the new subcutaneous maintenance dose after 18 months of intravenous (IV) initiation treatment every two weeks, or they can opt to stick with infusions every four weeks for maintenance therapy, Eisai said in its release.
    • “IQLIK’s approval could be a “gamer changer” in Alzheimer’s treatment, Katsuya Haruna, senior group officer and EVP of US business operations at Eisai, said in an interview with Fierce Pharma, noting that the 15-second injection is now the first and only amyloid therapy that can be administered at home.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP adds,
    • “SARS-CoV-2 detections in wastewater are “very high” in Alabama, Hawaii, Louisiana, Nebraska, Nevada, South Carolina, Texas, Utah, and Washington, DC. They are high in 11 states. “Nationally, the wastewater viral activity level for COVID-19 is currently moderate,” the CDC said.
    • “In comparison, flu and respiratory syncytial virus (RSV) wastewater levels are listed as very low nationwide. ED visits for those two diseases are also listed as very low, but they are increasing for flu.”
  • Per Medscape,
    • “For older adults, the vaccine against respiratory syncytial virus (RSV) appears to be most effective in the first year after administration, according to new researchthat shows the benefits of the immunization fall roughly 60% within about 1.5 years.
    • “The database analysis showed that among adults aged 60 years or older, the effectiveness of the RSV vaccine at preventing infections fell from 71% at the 4-month mark to 40% 19 months after receipt.
    • “For clinicians, “the big takeaway is that the RSV vaccine works well, especially in the first year, and remains worth recommending to older patients, especially those at higher risk,” said Kersten Bartelt, RN, a research clinician at Epic Research, an arm of the records company, who helped conduct the analysis.”
  • The New York Times reports,
    • “A salmonella outbreak linked to eggs has sickened 95 people across 14 states, federal health officials said on Thursday. Eighteen people have been hospitalized.
    • “The company Country Eggs, of Lucerne Valley, Calif., has issued a recall of its large brown cage free “sunshine yolks” and “omega-3 golden yolks” eggs, according to the Food and Drug Administration.
    • “The recalled eggs were sold in grocery stores and delivered to food service distributors in California and Nevada between June 16 and July 9 and have sell-by dates between July 1 and Sept. 18. The recalled cartons were also sold under the brand names Nagatoshi Produce, Misuho and Nijiya Markets.
    • “Most of the people who have become ill so far — 73 of the 95 — are from California, according to the Centers for Disease Control and Prevention. But infections have been reported in 13 other states across the country, including in Washington State, Minnesota, New York and Pennsylvania. No one has died.”
  • Kaufmann Hall lets us know,
    • “A new report shows that the difference between expected and observed mortality rates for hospitalized surgical patients continues to improve. Hospitals have achieved nearly a 20% increase in survival rates for these patients compared with expected, reflecting advances in evidence-based care and safety practices. However, the analysis, from Vizient and the American Hospital Association, also finds that the average length of stay has risen by almost a full day over the past five years, due to increasing patient acuity and insurer-related delays in post-acute care placement, particularly in Medicare Advantage plans. This trend suggests ongoing challenges in balancing improved patient outcomes with efficient hospital throughput.”
  • Per Fierce Pharma,
    • “Flying high after an FDA approval four months ago to treat generalized myasthenia gravis (gMG), Johnson & Johnson’s much-touted Imaavy (nipocalimab) has taken a hit, coming up short as part of a combination therapy in a rheumatoid arthritis (RA) trial.
    • “Without revealing data from the phase 2a Daisy proof-of-concept study, J&J said that after 12 weeks, Imaavy provided no added benefit when added to an anti-TNFα therapy in patients with refractory RA.
    • “Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of nipocalimab in combination with an anti-TNFα therapy for RA,” the company said in its release.
    • “Despite the setback, J&J added that it is still “confident” that Imaavy can live up to the $5 billion-plus peak sales potential the company has pegged for the FcRn-blocking monoclonal antibody.”
  • Per Fierce Biotech,
    • “Zydus Therapeutics has racked up a phase 2b/3 win in primary biliary cholangitis (PBC), clearing the path to a filing to establish the company as a challenger to Gilead Sciences, Intercept Pharmaceuticals and Ipsen.
    • “The phase 3 part of the trial randomized 149 people to receive the PPAR agonist saroglitazar or placebo. After 52 weeks of daily oral dosing, 48.5% of patients on the Zydus drug met the biochemical response, achieving the primary endpoint of the trial. Zydus plans to discuss the data with the FDA with hopes of filing for approval in the first quarter of 2026.
    • “If approved, saroglitazar will enter a market served by other drugs, including rival PPAR agonists. The FDA approved two PPAR agonists in PBC last year, clearing Gilead’s Livdelzi and Ipsen’s Iqirvo to compete for the market with Intercept’s FXR agonist Ocaliva.
    • “Gilead reported (PDF) a 62% biochemical response rate in the study that supported approval of Livdelzi. Ipsen’s Iqirvo achieved (PDF) a 51% biochemical response rate in its pivotal trial.
    • “Unlike the PPAR agonists, Intercept’s Ocaliva carries a boxed warning. The FDA rejected a filing for full approval of the product in November—while leaving the accelerated nod in place—and flagged liver injury reports in December.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “The University of Pennsylvania Medical Center (UPMC) continues to flip last year’s losses, reporting this week a $348.6 million operating income (2.1% operating margin) for the six months ended June 30 thanks to increased volumes and a tighter underwriting margin.
    • “The integrated nonprofit had posted a $313.3 million operating loss (-2.2%) during the same period a year prior. Both half-year periods included tens of millions in restructuring costs—$30 million in 2025 and $87.8 million in 2024—under an effort the system had launched last year.
    • “For its second quarter alone, UPMC notched a $111.2 million operating gain compared to the prior year’s $210.3 million operating loss, both inclusive of restructuring costs. Total operating revenue during the first half of 2025 came to $16.5 billion.”
  • Beckers Payer Issues points out “Californians enrolled in Medicare Advantage are facing slower growth in healthcare costs compared to those in traditional Medicare, according to new research from the UCLA Center for Health Policy Research.”
  • Genetic Engineering and BioTechnology News offers its “updated A-List of the top 10 best-selling prescription drugs based on 2024 sales. Top-selling drugs are ranked based on sales or revenue reported for 2024 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, sponsor(s), 2024 sales, 2023 sales, and the percentage change between those years.”
  • BioPharma Dive tells us,
    • “Novo Nordisk is again looking for help outside its own laboratories as it works to build on the success of Ozempic and its sister medicine Wegovy.
    • “In the latest deal, Novo will provide research funding for Replicate Bioscience as well as up to $550 million in payments to work on new treatments for obesity, Type 2 diabetes and other cardiometabolic disorders.
    • “The agreement includes an unspecified amount of cash upfront as well as money tied to certain milestones, Replicate said Thursday.”
  • Per Fierce Pharma,
    • “Pfizer is taking a curtain call for Vyndaqel, the low-dose version of its blockbuster tafamidis franchise for the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM).
    • “Pfizer will discontinue Vyndaqel in the U.S. by the end of 2025, multiple amyloidosis patient groups alerted their members on social media earlier this month.
    • “The move will leave the high-dose Vyndamax as the only tafamidis brand on the market.
    • “This decision was made to enhance patient-centered care and convenience as Vyndamax offers the same active ingredient and clinical benefits as Vyndaqel, but in a single capsule taken once daily, making it easier for patients to take their prescription,” according to the posts, which appear to be relaying a message from Pfizer.”

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.”

Midweek Update

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

From Washington, DC,

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

From the Food and Drug Administration (FDA) front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday report

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Here is a link to OPM Director Scott Kupor’s latest blog post which is titled “Supporting Agencies through Change.” Thanks, Director Kupor for keeping us abreast of your activities.
  • The Wall Street Journal reports,
    • “President Trump removed former congressman Billy Long as the commissioner of the Internal Revenue Service after less than two months in the job.
    • “Long is being replaced on an interim basis by Treasury Secretary Scott Bessent, a senior White House official said. Bessent is the latest leader of a federal bureau that has gone through a series of commissioners since the start of Trump’s second term. Long was sworn in as the commissioner in June. 
    • “Long said Trump is appointing him as ambassador to Iceland.” 
  • The American Hospital Association News tells us,
    • “President Trump Aug. 7 issued an executive order, “Improving Oversight of Federal Grantmaking,” requiring government agencies to review new and discretionary grants to ensure grant funding advances the administration’s policy priorities. Among other provisions, the order restricts agencies from funding programs that “fund, promote, encourage, or facilitate: (A) racial preferences or other forms of racial discrimination … (B) denial by the grant recipient of the sex binary in humans … (C) illegal immigration; or (D) any other initiatives that compromise public safety or promote anti-American values.” The executive order also encourages agencies to award grants to institutions with lower indirect cost rates, to a broad range of recipients rather than repeat players, and to include clear benchmarks for measuring progress and success, as well as a commitment to Gold Standard Science. Within 30 days, agencies will update the terms and conditions for new and existing discretionary grants, which may permit immediate termination of existing grants.”
  • and
    • “The U.S. Departments of Labor, Health and Human Services, and the Treasury announced Aug. 7 that they are reconsidering the definition of short-term, limited-duration insurance through a formal rulemaking process. Until new rules are finalized, the departments will not prioritize enforcement actions against insurers that do not fully comply with the 2024 definition, including related notice requirements.
    • “HHS encourages states to adopt a similar enforcement approach and will not penalize states that either follow this federal approach or apply their definitions of STLDI under state law.”
  • STAT News informs us,
    • “Federal health officials are citing an extensive list of studies purported to document harms caused by messenger RNA vaccines as scientific justification for canceling hundreds of millions of dollars in investment in the technology. 
    • “Health secretary Robert F. Kennedy Jr. provided only a brief explanation for the decision earlier this week, arguing the mRNA vaccines are not effective and not as safe as alternatives, and referencing a review of scientific research on mRNA by “experts,” without identifying them. On Friday, when asked if the Department of Health and Human Services had a scientific justification, a spokesperson provided a link to a 181-page list of studies compiled by a number of people, including a current Trump administration adviser who served in the president’s first administration and was the subject of controversy for pushing unproven Covid-19 treatments. 
    • “The other contributors are people who have all previously criticized Covid-19 public health interventions, such as lockdowns and mRNA vaccines. 
    • “Taken together, the studies cited generally appear to advance research that has been disputed by other scientists, who argue that mRNA vaccines are overwhelmingly safe.”

From the Food and Drug Administration front,

  • MedPage Today relates,
    • “The FDA on Friday granted accelerated approval to zongertinib (Hernexeos) for non-squamous non-small cell lung cancer (NSCLC) patients harboring HER2 tyrosine kinase domain (TKD) activating mutations.
    • “Approval of the tyrosine kinase inhibitor stipulates use in adults with unresectable or metastatic disease who have received prior systemic therapy and was based on results from the open-label, phase Ia/Ib Beamion LUNG-1 study.”
  • Fierce Pharma adds,
    • “After telegraphing an investigation in November, the FDA has moved to restrict the use of bluebird bio’s gene therapy Skysona in certain patients.
    • “The FDA has updated Skysona’s indication, allowing it to be used only in patients who do not have an available human leukocyte antigen (HLA)-matched donor for stem cell transplant. The one-time therapy is approved to treat cerebral adrenoleukodystrophy (CALD), a rare inherited neurological disorder in which the accumulation of harmful fatty acids in the bloodstream damages the protective myelin sheath around nerve fibers.
    • “The FDA decided that Skysona should not be used in patients with alternative treatment options due to concerns of an increased risk of blood cancer.” * * *
    • “Skysona, with a list price of $3 million per treatment, recorded no sales in the first three months of 2025. Beta-thalassemia therapy Zynteglo saw its sales rise to $26.3 million during the first quarter, compared with $18.6 million a year ago. The sickle cell disease gene therapy Lyfgenia brought in $12.4 million in sales during the period, while Vertex’s rival CRISPR-based treatment Casgevy pulled in $14.2 million.” * * *
    • “As commercial progress of the three gene therapies fails to impress and a debt payment nears its due date, bluebird bio recently sold itself to Carlyle and SK Capital Partners for $49 million, or $5 per share, following some investor resistance to a previous lower offer price.”
  • Per an FDA news release,
    • “I [FDA Commissioner Marty Makary] am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline, has officially ended. This marks a significant milestone for public health and reinforces the FDA’s commitment to ensuring Americans have consistent access to life-saving medical products.” * * *
    • “For other IV fluids still in shortage, the FDA is working closely with manufacturers and will continue to monitor the supply to help ensure patients have access to the medicines they need. The availability of reliable medical products is essential to patient care and the overall resilience of our healthcare system. Addressing this shortage has been a top priority for the FDA and aligns with the Trump Administration’s broader commitment to strengthening the U.S. drug and medical supply chain.”
  • MedTech Dive lets us know,
    • “Boston Scientific has updated the instructions for use for products deployed in the implantation of its Watchman heart device to reduce a risk associated with 120 serious injuries and 17 deaths.
    • “The Food and Drug Administration released an early alert about the update Wednesday. Sharing information from Boston Scientific, the FDA said implanting the heart device without controlling the patient’s breathing increases the risk of an air bubble getting into the vascular system.
    • “Patients are only at risk during the implant procedure. People who have a previously implanted Watchman device do not need additional management.”

From the judicial front,

  • The Wall Street Journal reports,
    • “[The prescription drug manufacturer] GSK will receive $370 million from a U.S. patent settlement between CureVac and BioNTech regarding mRNA-based Covid-19 vaccines.
    • “GSK will get an upfront cash payment of $320 million and a 1% royalty on future U.S. sales of related mRNA vaccine products.
    • “The settlement does not affect GSK’s ongoing patent litigation against Pfizer and BioNTech in the U.S. or Europe.”
  • Healthcare Dive reports,
    • “Healthcare bankruptcies dropped to a three-year low during the second quarter of 2025, according to a new report from Gibbins Advisors. Just seven companies with at least $10 million in liabilities filed for Chapter 11 protections, compared with 14 in the same period last year.
    • “The restructuring advisory firm predicts there will be 16% fewer filings this year compared to 2024, as less large healthcare companies and providers declare bankruptcy.
    • “However, the dip may be short lived. Challenging market conditions, including impacts from cuts to Medicaid, could hit providers’ bottom lines as early as 2026, potentially spurring a new wave of bankruptcies, according to Gibbins.”

From the public health and medical research front,

  • The JAMA Network reports,
    • “Although the average life expectancy in the US remains lower than before the COVID-19 pandemic, 2023 marked the second consecutive year of improvement, according to a new report from the US Centers for Disease Control and Prevention (CDC). The authors attributed increases in life expectancy across all groups to decreased mortality from COVID-19, heart disease, unintentional injury, cancer, and diabetes.
    • “The overall average life expectancy rose by almost a year between 2022 and 2023, from 77.5 years to 78.4 years. During this period, male life expectancy increased from 74.8 to 75.8, whereas female life expectancy increased from 80.2 to 81.1. The average female life expectancy has exceeded that of males for decades, but the size of this gap continues to fluctuate.
    • “When analyzed by race and ethnicity, life expectancy increased for all populations in 2023. The American Indian and Alaska Native population experienced the greatest jump in mean life expectancy, a 2.3-year rise from 67.8 to 70.1.”
  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota CIDRAP adds,
    • “Amid a slow but steady rise in COVID activity, SARS-CoV-2 wastewater detections last week rose from the low to the moderate level, with the highest levels in the West, followed by the South, where detections in Louisiana are at the very high level, the US Centers for Disease Control and Prevention (CDC) said today in its latest weekly data updates. 
  • and
    • “Today in JAMA Network Open, University of Michigan-led research suggests that the US 2023-24 mRNA COVID-19 vaccines were cost-effective for people older than 65 years and in certain situations for younger adults.” * * *
  • and
    • “A survey conducted in emergency departments (EDs) in eight US cities found that 86% of adult respondents were not up to date with recommended vaccines, and half had not even heard of one or more of these vaccines.
    • “But the results of the survey, conducted by a team of US researchers and published yesterday in Morbidity and Mortality Weekly Report, also found that nearly half of the respondents said they would be willing to get a missing shot if they were offered one during their ED visit, and most of those participants said they’d be willing to get all of their missing vaccines.
    • “The authors of the study say the findings indicate that screening for vaccine coverage in EDs, which millions of Americans rely on as their only source of healthcare, could help boost recommended vaccine uptake in populations that have no primary care provider, such as immigrants, the uninsured, and homeless people.”
  • Per JAMA Network,
    • “The tau protein is known to be ubiquitous in neurons. Its naturally unfolded and highly flexible character allows it to interact with many components in neurons, especially microtubules in axons, helping to give these elements structure and promote growth. But when tau undergoes certain abnormal biochemical modifications such as phosphorylation, the pliable protein can lose function and can misfold and aggregate, leading to the development of neurofibrillary tangles and contributing to neurodegeneration. That’s why high levels of phosphorylated tau (p-tau) serve as one of the two main fluid biomarkers for Alzheimer disease (AD)—and why it surprised researchers when they recently discovered that infants have levels of p-tau far higher than people with AD.
    • “I was used to just hearing ‘p-tau is Alzheimer disease,’” said Fernando Gonzalez-Ortiz, MD, PhD, of the University of Gothenburg in Sweden who published the recent findings with a team of international collaborators. “In the Alzheimer disease field, we are sometimes very focused on thinking that p-tau is one of the bad guys, like tau phosphorylation is a completely pathological process, but that is not the case.”
    • “Using blood samples from umbilical cords and data from the Norwegian Dementia Disease Initiation cohort, Gonzalez-Ortiz and his colleagues found that healthy newborns had serum concentrations of p-tau217, an AD biomarker, around 10 pg/mL, nearly 3 times higher than those measured in patients with AD.
    • “The observation, which appeared this June in Brain Communications, led Gonzalez-Ortiz to a question: “What does it mean that the baby can handle these high concentrations of p-tau, but the adult brain can’t?” * * *
    • “Maybe in the future, therapies that target the clearance mechanisms and then enhance clearance, in combination with antiamyloid therapies, might lead to not only getting rid of amyloid, but also to preventing aggregation of tau,” Gonzalez-Ortiz said.
    • “His team’s next step is to differentiate the forms of p-tau present in the infant samples. Villain noted that it could also be useful to test the ratio between p-tau and total tau in the specimens to understand whether infants simply have more tau in their bloodstream.”
  • The University of Minnesota CIDRAP relates,
    • “A study of adults hospitalized with community-acquired pneumonia (CAP) in Georgia and Tennessee shows that a sizable fraction of infections was caused by Streptococcus pneumoniae, including serotypes covered by recently approved vaccines, researchers reported yesterday in JAMA Network Open.
    • “The prospective active-surveillance study, led by researchers at Vanderbilt University Medical Center, analyzed data on patients with clinical and radiologic evidence of CAP at three hospitals in Georgia and Tennessee from 2018 through 2022.” * * *
    • “The authors note that the annual incidence of 43 hospitalizations per 100,000 adults extrapolates to 114,800 US hospitalizations for pneumococcal CAP each year, based on current population estimates.
    • “Results of this study demonstrate that pneumococcal CAP remains an important cause of hospitalizations in the US,” they wrote. “With vaccination as the primary preventive measure for pneumococcal pneumonia, improved pneumococcal vaccines with appropriate vaccination coverage could lessen the burden of severe pneumonia on the US population, especially among older adults.” 
  • The Wall Street Journal reports,
    • “With a 33-year high in U.S. measles cases, researchers are reviving the search for treatments because of falling vaccination rates.
    • “Biotechs and universities are developing drugs for vulnerable, unvaccinated people.
    • “Monoclonal antibodies could offer immediate immunity, benefiting newborns, the immunocompromised and vaccine skeptics, scientists say.”
  • Per Health Day,
    • “Automatically mailing a stool test kit to people’s homes might be the best way to boost colon cancer screening among younger adults, a new study says.
    • “More 45- to 49-year-olds went ahead with cancer screening when they received an unsolicited stool test kit in the mail, rather than having to actively opt into screening or choose a test, researchers reported Aug. 4 in the Journal of the American Medical Association.
    • “Removing the need for patients to actively opt into screening can lead to better outcomes, particularly when trying to engage younger, generally healthy adults who may not yet perceive themselves at risk for cancer,” senior researcher Dr. Folasade May said in a news release. She’s a gastroenterologist and cancer prevention researcher at the UCLA Health Jonsson Comprehensive Cancer Center.”

From the U.S. healthcare business front,

  • Modern Healthcare interviews Debra Sukin, president and CEO of Texas Children’s, about the impressive financial turnaround at Texas Children’s, the largest pediatric hospital system in the U.S.
    • “How did you make a turnaround happen?
      • “We set out to best address the redesign of our organizational structure and realign the leadership team. We began to chart a course, entity by entity, department by department, in terms of how we were going to achieve our strategic goals.
      • “I’m a very data-driven leader. Organizing the way that we look at data, share data and use data to make decisions became absolutely paramount. We could easily see all our respective entities and where there were opportunities for improvements, and most importantly, identify how we were going to look beyond just expense management. 
      • “It was also about growth. It was about homing in on those opportunities and treating additional patients who needed our care.” 
  • Fierce Healthcare adds,
    • “Ascension [Healthcare, another large health system,] is taking a more intentional approach to innovations with a new unit dedicated to exploring, vetting and deploying tech tools across the major nonprofit health system.
    • “The organization announced this week the launch of its Clinical Innovation Institute (CII), which Ascension Chief Clinical Officer Thomas Aloia, M.D., describes as an “umbrella” aggregating and presiding over other innovation and tech programs that were already active within Ascension.
    • “We are absolutely not starting from scratch,” he said. “I would say we’re driving at about 60 miles per hour, and this organizational backing and support is going to take us to drive even faster.”
  • Healthcare Dive lets us know,
    • “Community Health Systems has found a new buyer for its three-hospital portfolio in Pennsylvania, approximately nine months after a proposed sale of the same facilities to WoodBridge Healthcare collapsed.
    • “Hospital turnaround firm Tenor Health Foundation signed a letter of intent to acquire Regional Hospital of Scranton, Moses Taylor Hospital and Wilkes-Barre General Hospital, collectively Commonwealth Health System, last week, a CHS spokesperson told Healthcare Dive. 
    • “The hospitals have been hemorrhaging money in recent fiscal years, according to reports filed to the Pennsylvania Health Care Cost Containment Council. Lawmakers have previously expressed worry that CHS could close the facilities if they could not find a buyer, reducing patients’ access to care.” 
  • Per Fierce Healthcare,
    • “In its first public earnings call after its initial public offering in June, virtual chronic disease provider Omada Health reported $61 million in revenue, up 49% year over year. The company has added 52% more members since Q2 2024 for a total of 752,000 members.
    • “Omada went public in early June, at a valuation of $1.1 billion, during what has turned out to be a worse-than-expected year for digital health exits due to economic uncertainty and tariffs. Hinge Health, a virtual MSK solution, also went public in May and reported its Q2 earnings on Wednesday.
    • “Omada ties remote monitoring devices with coaching and AI to help consumers control their chronic diseases. The company treats diabetes, hypertension, obesity and musculoskeletal conditions and leans on its multi-condition approach to differentiate itself from competitors.”