Tuesday report

Obesity

Tuesday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • An OPM news release tells us,
    • U.S. Office of Personnel Management (OPM) Director Scott Kupor joined the Ruthless Podcast to discuss a number of wide-ranging topics including OPM’s ongoing efforts to bring top talent into the federal workforce and enhance operational efficiency across government.
    • WATCH HERE
  • The American Hospital Association News informs us,
    • “The House Appropriations Committee today released bill text for a continuing resolution to fund the government through Nov. 21. The bill also extends key health care programs set to expire Sept. 30 through the length of the CR. They include extending the Medicare-dependent Hospital and low-volume adjustment programs, telehealth and hospital at home flexibilities, delaying Medicaid Disproportionate Share Hospital cuts, and extending the Cybersecurity Information Sharing Act. The House is expected to vote on the measure this week. The Senate will follow in an attempt to avert a government shutdown by Sept. 30.”
  • Politico adds,
    • “A group of GOP senators are working on legislation to extend Affordable Care Act subsidies with policy changes designed to win over conservatives, according to four people granted anonymity to disclose private discussions.
    • “This group has gotten “technical assistance” from the Senate Finance Committee, which has jurisdiction over the subsidies, according to two of the sources. The Obamacare subsidies are set to expire at the end of this year.”
  • Per the AHA News,
    • “The House Ways and Means Oversight Subcommittee today hosted a hearing on tax-exempt hospitals. The AHA submitted a statement for the hearing, highlighting the amounts that tax-exempt hospitals spend annually on community benefits and where those funds are spent. The AHA also highlighted its analysis released Sept. 10 that found tax-exempt hospitals provided nearly $150 billion in total benefits to communities in 2022, marking a nearly 50% increase in community benefit spending from 2017. Additionally, the AHA explained why a flexible community benefit approach is best for communities as opposed to suggestions for a definition and evaluation from the Internal Revenue Service.” 
  • Per a Congressional news release,
    • Sens. Chuck Grassley (R-Iowa) and Ben Ray Luján (D-N.M.) reintroduced bipartisan legislation bolstering pharmacists’ ability to serve older Americans in communities that lack easy access to doctors or where pharmacists can provide certain basic medical services.
    • The Pharmacy and Medically Underserved Areas Enhancement Act encourages pharmacists to offer health care services (like health and wellness screenings), immunizations and diabetes management by authorizing Medicare payments for those services where pharmacists are already licensed under state law to provide them. Many states already allow pharmacists to provide these services. However, there is currently no way for pharmacists to receive Medicare reimbursement for providing them. * * *
    • “Grassley and Luján also requested feedback from stakeholders on pharmacists providing services for chronic care needs, given the unique pressing challenges of chronic care among seniors. Text of the request-for-information (RFI) can be found HERE.
    • “The full text of the legislation is available HERE.”
  • Healthcare Dive reports,
    • “Doctors — especially specialists — are pushing back against proposed changes to Medicare payment that would tamp down on reimbursement next year.
    • “Medicare’s proposed physician fee schedule for 2026 includes a base rate hike of 2.5%. But it also includes an efficiency adjustment that would reduce payment by 2.5% for thousands of procedures and changes to how regulators calculate practice expense that would lower reimbursement for services performed in facilities like hospitals.
    • “The reforms are meant to account for increased efficiency in procedures that doctors perform frequently, realign payment for primary and specialty care, and recognize larger indirect costs for doctors in office-based settings.
    • “Many physicians support those goals. But the policy changes themselves are a bad idea, doctors are warning the CMS.”
  • Fierce Healthcare points out,
    • “In its annual health plan ratings, the National Committee for Quality Assurance (NCQA) found that 11 out of 998 rated plans earning top marks, more than double last year’s total. 
    • “Of the 11 plans to achieve a 5-star rating, eight were commercial plans and three were Medicare plans. They included Blue Cross and Blue Shield of Massachusetts, UPMC Health Plan and several Kaiser Foundation Health Plans.  An additional 55 plans earned a 4.5-star rating. Most plans ranked between 3 and 4 stars, same as in 2024. The NCQA says its ratings help consumers and regulators assess the quality and effectiveness of health plans. 
    • “The report found year-over-year improvements in coordination and continuity of care in Medicare. The NCQA also identified progress across nearly all six diabetes-related measures. The Kidney Health Evaluation for Patients with Diabetes metric showed an average increase of over 5% across all product lines. 
    • “Additionally, the NCQA found improved adult and adolescent immunization rates. Though childhood immunization rates continued to decline, they did so at a slower pace than last year.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “A safety issue with certain Boston Scientific defibrillation leads has resulted in a series of new Class I recalls, according to the U.S. Food and Drug Administration (FDA). Unlike some recalls, these do not require a product to be immediately removed from the market. However, there are specific recommendations all clinicians should follow. 
    • “The FDA first shared details with the public about these concerns in early August, noting that some of Boston Scientific’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) were associated with a potential risk of rising low-voltage shock impedance (LVSI). If this occurs, it can make the leads less effective over time. 
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” the agency said at the time.”
  • The AHA News adds,
    • “The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.” 
    • “In addition, the FDA issued an early alert for certain Medline convenience kits containing Medtronic DLP Left Heart Vent Catheters due to issues found with certain lots of cannula products where the catheter may not retain its shape. Medline sent a notice to affected customers that recommended they destroy any affected product after completing the list of recall actions.” 

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy weight-loss drug helps patients stop thinking about food, according to a new study.
    • “According to results of the study, which were presented at a medical conference in Austria, patients taking Wegovy for weight-loss experienced a substantial drop in so-called “food noise”—unwanted and intrusive thoughts about food—alongside improvements in their mental well-being and lifestyle.
    • “Novo Nordisk said the number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy, while 64% of respondents reported improved mental health and 80% reported healthier habits while taking the drug.
    • “It is very encouraging to see these new data from people using Wegovy that, in addition to weight-loss, Wegovy may help quiet disruptive thoughts about food, support improved mental well-being and help enable people to live healthier lives,” said Filip Knop, incoming chief medical officer at Novo Nordisk.
    • “The U.S.-based Inform study released Tuesday surveyed 550 people taking Wegovy for weight-loss to assess the impact of the drug on mental well-being and eating habits relating to food noise.”
  • MedPage Today adds,
    • “A higher 7.2 mg dose of semaglutide led to significantly greater weight loss compared with placebo in adults with obesity, with or without type 2 diabetes.
    • “Participants across two randomized trials also had improvements in cardiovascular risk factors.
    • “Secondary and exploratory analyses suggested that the 7.2 mg dose led to a greater change in body weight versus the currently approved highest dose of 2.4 mg.”
  • Per a National Institutes of Health news release,
    • ‘The National Institutes of Health (NIH) has launched effort aimed at reducing the rate of preventable stillbirths in the United States. Investigators will develop tools, devices and other technologies that have the potential to affect diagnosis and prevention efforts relevant to stillbirth, which occurs in 1 in 160 deliveries in the U.S. About 23,600 stillbirths at 20 weeks or greater gestation are reported annually.
    • “More than 60% of stillbirth cases remain unexplained even after exclusion of common causes, such as congenital abnormalities, genetic factors, and obstetric complications. NIH will fund the Stillbirth Research Consortium for more than $37 million over five years, pending the availability of funds, with $750,000 in co-funding from the Department of Health and Human Services.
    • “This consortium will provide an integrated, collaborative program to support cutting edge research to identify the root causes of stillbirth and inform evidence-based strategies to address stillbirth risks,” said Alison Cernich, Ph.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. “Too many families needlessly face the grief of stillbirth.”
    • “People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. The rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. About 40% of stillbirths that occur during labor and birth are considered potentially preventable.” 
  • Genetic Engineering and Biotechnology News reports,
    • “A novel strategy developed by scientists at Rice University allows scientists to zoom in on tiny segments of proteins inside living cells, revealing localized environmental changes that could indicate the earliest stages of diseases such as Alzheimer’s, Parkinson’s, and cancer. The study results could offer promise for drug screening that targets protein aggregation diseases.
    • “The research team engineered a fluorescent probe known as AnapTh into precise subdomains of proteins, creating a tool that monitors microenvironmental shifts in real time. Unlike conventional techniques that provide only broad signals, this approach reveals how distinct regions of the same protein behave differently during the aggregation process. The work, led by Han Xiao, PhD, professor of chemistry and director of Rice’s SynthX Center, enhances the basic understanding of disease mechanisms and lays the groundwork for identifying drug targets and screening potential therapeutics at an earlier stage.
    • “We essentially built a molecular magnifying glass,” Xiao said. “This allows us to visualize subtle environmental changes that previously went unnoticed, and those early changes often hold the key to understanding protein-related diseases.” Xiao and colleagues reported on their findings in Nature Chemical Biology, in a paper titled, “Real-time imaging of protein microenvironment changes in cells with rotor-based fluorescent amino acids,” in which they concluded: “These results demonstrate that the technology reported in this paper provides a versatile tool for exploring microenvironment changes of protein substructures at high spatial resolution, enabling direct visualization of the local environment around specific amino acid residues.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY unveiled plans to build a $5 billion manufacturing facility in Virginia as part of the drugmaker’s pledge to bolster its domestic medicine production with four new pharmaceutical manufacturing sites.
    • “Eli Lilly said the new plant, located just west of Richmond in Goochland County, will be the first dedicated, fully integrated active pharmaceutical ingredient and drug product facility for its emerging bioconjugate platform and monoclonal antibody portfolio.
    • “The Indianapolis company said the site also will boost its domestic manufacturing of antibody-drug conjugates.
    • “Eli Lilly said the new plant will create more than 650 new company jobs, along with 1,800 construction jobs.
    • “Eli Lilly in February said it would invest $27 billion to build four new pharmaceutical manufacturing sites in the U.S., more than doubling its U.S. capital expansion commitments since 2020 to more than $50 billion.”
  • and
    • “So far this year, more than a dozen drugmakers [, including Lilly,] have pledged to spend more than $350 billion collectively by the end of this decade on manufacturing, research and development and other functions in the U.S., a Wall Street Journal tally of company announcements showed.
    • “The vast majority of our products going into the U.S. are manufactured in the U.S.,” GSK Chief Executive Emma Walmsley said in an interview Tuesday when the company announced its $30 billion U.S. investment in research and development and supply-chain infrastructure over the next five years. “This of course adds to it, and it’s about the new pipeline that’s going through.”
  • Modern Healthcare informs us,
    • “Health systems are revamping pediatric care to fight emergency department overcrowding before Medicaid funding cuts further endanger access. 
    • “Many emergency rooms are full, leading to care delays and provider burnout. Hospital operators have responded by tasking social workers with triage duties and setting up virtual consultations with specialists. They are also consolidating emergency services and asking data analytics companies to better track and predict capacity and utilization trends, health system executives said. 
    • “Health systems have crafted many of these strategies around pediatric patients, who may bear the brunt of the Medicaid cuts authorized by the “One Big Beautiful Bill,” among other federal policy changes, experts said.
    • “The population that will get hit the hardest in emergency medicine will be pediatrics,” said Dr. Ken Heinrich, chief medical officer of emergency medicine at staffing company SCP Health. 
    • “Providers are facing a surge in pediatric mental health issues, fueling care backlogs across hospital emergency departments. Providers have enlisted social workers and adjusted their emergency department layouts to meet that demand.”
  • and
    • “Labcorp has completed its acquisition of BioReference Health’s oncology diagnostic testing assets for up to $225 million. 
    • “The independent laboratory company paid $192.5 million at closing and and could pay up to $32.5 million more in an earn-out tied to the assets’ performance, according to a Monday news release.
    • “Labcorp previously acquired select clinical, reproductive and women’s health diagnostic assets from BioReference last September for more than $237 million.”
  • MedCity News notes,
    • “Berry Street, a nutrition therapy company, has launched its GLP-1 Nutrition Pathway Program, which is meant to provide nutrition support for those starting, taking and getting off of GLP-1s.
    • “The New York City-based company works with health plans and connects patients in need of nutrition support to a network of registered dietitians. It provides personalized treatment plans for patients struggling with weight management, diabetes, heart health, kidney disease and numerous other conditions.”
  • Per a UHC press release,
    • “Building on our March announcement committing to modernize pharmacy payment models, Optum Rx has increased reimbursement minimums for brand drugs for approximately 2,300 independent pharmacies – those not affiliated with a pharmacy services administrative organization (PSAO), chain or other entity – across the country. This move, which went into effect on September 1, 2025, will support the long-term sustainability of pharmacies, which play a critical role in patient care. 
    • “This is the latest announcement from Optum Rx, which continues to expand on initiatives to transform how pharmacies are reimbursed for drugs. Optum Rx first launched improved reimbursement earlier this year, with Epic Pharmacy Network, a PSAO representing more than 1,000 independent pharmacies, being the first PSAO to partner with us.”
  • BioPharma Dive lets us know,
    • “Novartis is broadening its bet on drugs that can destroy disease-causing proteins, agreeing Monday to a new deal with biotechnology company Monte Rosa Therapeutics.
    • “Through the collaboration, the companies will work to develop multiple novel protein “degrading” drugs for immune conditions. Monte Rosa will conduct discovery and early testing before Novartis takes over development for programs it chooses to license. The biotech will get $120 million in upfront cash per deal terms. It could also receive as much as $5.7 billion overall should various development and sales milestones be met, plus royalties on sales of any eventual products.”
    • Monte Rosa is among the many companies pursuing “molecular glue” drugs, which force together a target protein with an enzyme that flags it for destruction by the cell’s waste disposal system. The approach is seen as a way to access tough-to-reach drug targets, and is one of several strategies biotechs are using to degrade harmful proteins, rather than bind and block them as traditional drugs do.
  • Per Beckers Hospital Review,
    • “Amazon has added Fay, a dietitian platform, as the first nutrition care service available through its Health Benefits Connector.
    • “The collaboration allows eligible Amazon customers to discover and enroll in Fay’s insurance-covered nutrition services while browsing for wellness and health benefits, according to a Sept. 16 news release.
    • “Fay connects individuals with registered dietitians based on their goals, health history and insurance eligibility. Services include counseling, preventive care and coaching, which the company said are often available at no cost to patients.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Healthcare accreditation body URAC is rolling out the nation’s first accreditation program for users and developers of healthcare artificial intelligence. 
    • “The first-in-the-nation program will evaluate risk management, business management and performance monitoring with specific modules for users and developers. URAC accredits organizations ranging from small pharmacies to multistate payer organizations. 
    • The organization, which has been accrediting healthcare organizations for decades, hopes the URAC gold star will help promote trust in AI.
    • “We think that this is a great opportunity to give people that seal of approval, that gold star, that someone independent has gone in behind the scenes and audited to make sure that this is trustworthy,” Shawn Griffin, M.D., CEO and president of URAC, said in an interview.”
  • and
    • “Aegis Ventures’ digital consortium gained three new members as health systems look to collaborate to develop and scale artificial-intelligence-powered health tech solutions and tackle common pain points.
    • “Yale New Haven Health System, Keck Medicine of USC and Hartford HealthCare joined the collaborative, expanding its reach to 14 regional health systems. The consortium, which includes Northwell Health, UPMC, Stanford Health Care and Vanderbilt Health, will codevelop, invest in and deploy health tech solutions alongside Aegis Ventures. 
    • “The partnerships with the three new health systems will accelerate the consortium’s pipeline of companies with two startups set to launch this fall, according to John Beadle, co-founder and managing partner of Aegis Ventures.
    • “Next year, I think we could be more aggressive, just given that the model of the blueprint worked well. We have the right set of partners, the right team, the resources are in place to do it, but I think we’re most focused on seeing this year out really strong,” Beadle said.”
  • and
    • “Healthcare technology and AI company Innovaccer has acquired Story Health, a digital specialty care platform with health system inroads.
    • “Financial terms of the deal, announced Tuesday, were not disclosed. Innovaccer said the deal adds to its scalable Healthcare Intelligence Cloud offering, which in recent months was bolstered by the company’s other strategic acquisitions.
    • “Healthcare doesn’t change through dashboards alone,” Abhinav Shashank, co-founder and CEO of Innovaccer, said in the announcement. “It changes when data and AI power completely new clinical models. Story Health has proven that in specialty care; and we’re excited to bring this technology and clinical expertise to our health system customers nationwide.”
    • “Cupertino, California-based Story Health, a Fierce 15 2024 honoree, launched in late 2020 and has raised about $27 million in funding from backers such as Northpond Ventures, B Capital Group, LRVHealth, Define Ventures and General Catalyst. Its approach combines virtual coaching, biometric monitoring and care team alerts to support patients with chronic conditions between clinical visits.”

Monday report

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

From Washington, DC

  • Federal News Network tells us,
    • “Less than two months away from this fall’s Open Season, Democrats in Congress are raising concerns that the Office of Personnel Management may not be fully prepared to administer the major health insurance program for millions of Postal Service employees and annuitants.
    • “Top Democrats from several congressional committees sent a letter Friday to OPM Director Scott Kupor to push for answers about key issues recently identified in the new Postal Service Health Benefits program. The letter comes a few months after the agency’s inspector general office found “critical” staffing vacancies and funding issues in the PSHB’s central enrollment platform, which all program participants must use to enroll or make changes to their insurance options.
    • “Given the potential for severe consequences among PSHB enrollees, the Postal Service, and carriers, we urge that OPM immediately address the critical issues identified in OPM OIG’s flash report,” the lawmakers said in Friday’s letter, signed by the top Democrats on the Senate Homeland Security and Governmental Affairs Committee and the House Oversight and Government Reform Committee as well as both congressional appropriations committees.” ***
    • “The concerns in Congress come just ahead of OPM’s anticipated announcement of the 2026 premium rates for both the PSHB and FEHB programs by the end of September. It also comes a couple months ahead of this year’s Open Season, when millions of federal employees and annuitants will be able to update their health enrollment options ahead of plan year 2026. This year’s Open Season will run from Nov. 10 to Dec. 8 for the 2026 plan year.
    • “The lawmakers gave OPM until the end of the week to explain in more detail when it will staff up to the 11 employees it determined it needs to run the platform. They’re also pushing OPM for answers on its contingency plan if the data platform fails, and how it will ensure the PSHB is appropriately funded for the upcoming budget cycle.”
  • Healthcare Dive informs us that “a key CDC panel meets this week [September 18 and 19] to discuss vaccines. Here’s what to know. Advisers hand-picked by HHS Secretary Robert F. Kennedy Jr. are set to vote on guidelines for measles, hepatitis B and COVID vaccines.”
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of five new members to the CDC Advisory Committee on Immunization Practices (ACIP). [The appointees are named in the release.] These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to transparency, evidence-based science, and diverse expertise in guiding the nation’s immunization policies. In June, Secretary Kennedy reconstituted ACIP to restore public trust in vaccines.
  • and
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Sept. 15 announced that states can now apply for funding from the Rural Health Transformation Program created under the One Big Beautiful Bill Act. The program will fund $50 billion to rural providers from fiscal year 2026 to FY 2030. CMS said the funds would support goals of promoting preventative health and addressing root causes of diseases, improving efficiency and sustainability, strengthening workforce recruitment and retention, initiating innovative care models, and fostering the use of innovative technology for efficient care delivery, data security and access to digital health tools.  
    • “CMS said half of the funds would be distributed evenly to states with an approved application, while the other half would be awarded to states based on individual state metrics and applications that “reflect the greatest potential for and scale of impact” on rural communities. States have until Nov. 5 to apply, and CMS will announce the recipients by Dec. 31.”
  • Per MedPage Today,
    • Reaction is generally positive to a federal initiative aimed at increasing electronic health record (EHR) interoperability and giving patients and providers quicker access to information about visits.
    • The voluntary initiative, announced on July 30, would require all participating EHR companies to connect directly to national data-sharing networks approved by the Centers for Medicare & Medicaid Services (CMS), the American Medical Association (AMA) noted in a Sept. 5 statement. “These systems must now deliver real-time, full patient information, including clinical notes, images, and medication lists that physicians actually use in care, rather than the basic data fields that are now available.
    • “EHR companies that have agreed to participate in the initiative include Epic, Amazon, eClinicalWorks, Oracle Health, and TruBridge.”
  • Deloitte points out in a white paper,
    • “Strategic investments in disease prevention, early detection, and other proactive measures could save the US health care system up to $2.2 trillion a year by 2040—more than $7,000 per person—according to new research from Deloitte’s actuarial and health care teams. These investments could also help save Medicare more than $500 billion a year on medical and prescription drug claims, strengthen the program’s long-term financial outlook, and expand the number of years beneficiaries live in good health. Deloitte analysis suggests that lowering Medicare spending in this way could delay potential insolvency and ease the need for benefit reductions or tax increases to maintain the program as it currently exists.”
  • Per Fierce Pharma,
    • “Forty-two years after approving the potent diuretic Bumex (bumetanide) as both an oral and infused treatment for edema, the FDA has endorsed a new version of the drug to be delivered as a nasal spray.
    • “The U.S. regulator has signed off on Corstasis Therapeutics’ Enbumyst to relieve the edema associated with congestive heart failure (CHF), chronic kidney disease (CKD) and liver disease. Edema is the accumulation of fluid in the body’s tissues that causes swelling.
    • “It is the first FDA nod for Nevada-based Corstasis, which develops outpatient therapies for the treatment of fluid overload in patients with cardiorenal and hepatic diseases. Edema is the leading cause of hospitalization and readmission for patients with CHF, CKD and cirrhosis of the liver, accounting for more than 1 million visits annually, Corstasis explained.”

From the public health and medical/Rx research front,

  • The American Medical Association lets us know what doctors wish their patients knew about healthy aging.
  • Per Health Day,
    • “A new type of noninvasive brain stimulation may help people with moderate to severe depression feel better faster than standard treatments, researchers in a new report say.
    • “The method, called high-definition transcranial direct current stimulation (HD-tDCS), uses small electrodes on the scalp to deliver mild electrical currents to specific parts of the brain involved in mood regulation.
    • “In the trial conducted by UCLA researchers, 71 adults with major depression were randomly assigned to receive either active HD-tDCS or a sham treatment for 20 minutes a day over 12 working days. 
    • “The group receiving real treatment showed a greater drop in their depression scores than the control group, according to findings published Sept. 11 in JAMA Network Open.”
  • and
    • “Women who overcome cervical cancer might have another potentially life-threatening health crisis on their horizon, researchers say.
    • “Cervical cancer survivors have nearly double the risk of developing anal cancers compared to the general population, researchers reported Sept. 11 in JAMA Network Open.
    • “And their risk increases as they grow older, and as time passes since their cervical cancer treatment, results show.
    • “Both types of cancer are linked to infection with human papillomavirus (HPV), researchers noted. The virus is mainly spread during intimate contact.
    • “We’ve known for a long time that both cervical and anal cancers are caused by HPV, the human papillomavirus,” senior researcher Ashish Deshmukh said in a news release. He’s the co-director of the Cancer Prevention and Control Research Program at the Medical University of South Carolina Hollings Cancer Center in Charleston.
    • “But what hasn’t been well-understood is how that shared risk might connect the two diseases over a woman’s lifetime,” Deshmukh said.”
  • Per Healio,
    • “A telephone-based weight-loss intervention helped women with breast cancer and obesity lose almost 5% of their baseline body weight, according to results of a randomized phase 3 trial.
    • “Participants lost significant weight regardless of race, ethnicity, menopause status, income and more.
    • “The data are the first from the Breast Cancer Weight Loss (BWEL) trial, which is evaluating whether weight loss can reduce recurrence, development of new cancers and mortality.”
  • Beckers Hospital Review calls attention to “seven new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.”
  • Per BioPharma Dive,
    • “An experimental drug from biotechnology company aTyr Pharma missed its main goal in a Phase 3 trial, failing to help people with an inflammatory lung condition called pulmonary sarcoidosis significantly cut down on their use of steroids after nearly a year of treatment.
    • “The drug, called efzofitimod, is aTyr’s only clinical-stage prospect, and the company believed it might help reduce the inflammation and accompanying steroid use in people with pulmonary sarcoidosis. ATyr is also testing the drug in a Phase 2 trial in systemic sclerosis-related interstitial lung disease.” 

From the U.S. healthcare business front,

  • Willis Tower Watson explains how “alternative plan designs help employers offer affordable, high-value care; guiding members to better providers with transparent costs. Success depends on clear goals, smart design & strong analytics.”
  • The Employee Benefits Research Institute reports,
    • “The 2025 EBRI Employee Mental Health Survey, based on a survey of 3,103 employees in March and April 2025, explored workers’ experiences with both physical and mental health care to better understand their behaviors and attitudes toward health care generally and mental health care more specifically. The survey also explored access to care and patterns of health care use. For this report, all employees who reported that they or a covered family member used mental health care services are referred to as respondents reporting a mental health condition. Of note, a number of respondents who reported utilizing mental health services did not report a mental health condition. This is consistent with the well-documented underreporting of mental health conditions.”
  • Healthleaders Media considers why patients are filing more complaints against hospitals, thereby illustrating oversight gaps and trust issues that demand CEO attention.
  • MedCity News discusses what’s next for Walgreens following its private equity sale.
  • Per MedTech Dive,
    • “Intuitive Surgical unveiled new software capabilities for the da Vinci 5 robot that give surgeons more information, such as a replay of key moments in a procedure. Surgeons can review the video as the procedure is ongoing without removing their head from the console.
    • “Another new feature is a gauge displaying measurements of the force applied to the patient’s tissue by instruments. Intuitive’s force feedback technology already allows surgeons to sense the instrument pressure applied to tissue.
    • “The updates, which received 510(k) clearance from the Food and Drug Administration, are the first in a planned series of new system capabilities designed to improve patient outcomes and surgeon and hospital efficiency, the company said Friday.”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will develop a special report for the Centers for Medicare & Medicaid Services (CMS) for treating Crohn’s disease and ulcerative colitis. ICER will evaluate Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.). This report will be submitted to CMS as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2028.  
    • “While the final list of drugs subject to negotiation will not be released until February 2026, ICER is developing this report with the expectation that Entyvio® will be subject to negotiation next year.  
    • “Building on our two previous reports, ICER’s expertise in comparative clinical effectiveness and value will continue to help inform the important conversations around Medicare drug price negotiation,” said ICER’s President and CEO Sarah K. Emond, MPP. “While we know CMS may consider many different factors and inputs during negotiations, we believe ICER’s approach to applying the guidance in a consistent framework.”

Weekend update

David Ermer–Congress, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports that the Democrat “Party wants expanded Obamacare subsidies restored in any deal to keep government funded past Sept. 30.”
    • “Democrats are more confident in their negotiating stance compared with March, when a similar attempt to play hardball fizzled. While today’s talks pit them against Republican leaders who want a two-month spending deal with no big additions, they are finding support among rank-and-file GOP lawmakers fearing political backlash if their voters are hit by higher health-insurance bills next year.
    • “Republicans have to come to meet with us in a true bipartisan negotiation to satisfy the American people’s needs on healthcare, or they won’t get our votes, plain and simple,” Senate Minority Leader Chuck Schumer (D., N.Y.) said Thursday.
    • “Senate Majority Leader John Thune (R., S.D.) said he was open to discussions about extending the subsidies, but not as a condition of a short-term spending bill he has proposed to keep the government open into November. Such an extension would give Congress more time to iron out full-year spending deals.
    • “The fight centers on the extension of expiring Affordable Care Act tax credits. The subsidies, which expanded the payments offered under the existing ACA, or Obamacare, were first passed in 2021 by Democrats as a temporary measure tied to a Covid-19 aid law. Republicans didn’t renew them in their sprawling tax-and-spending legislation President Trump signed in July, meaning they will expire at the end of this year.”
  • According to the legislative calendars for the House of Representatives and the Senate, next week is scheduled for a District / State work break which means that we have seven legislative days before the end of federal government’s fiscal year. Fortunately, with respect to prospects for a government shutdown, there is no national election this year so Congress will be in session for the fourth quarter rather than on the campaign trail.
  • The New York Times reports,
    • “The Food and Drug Administration has warned Hims & Hers, a major telehealth purveyor of widely popular obesity drugs, to stop “false or misleading” marketing, according to a copy of a letter sent to the company and obtained by The New York Times.
    • “The F.D.A.’s letter was one of about 100 warning letters sent to drug advertisers this week. The agency commissioner, Dr. Marty Makary, said on Tuesday that the letters were being sent to traditional pharmaceutical companies as well as to online pharmacies.
    • “The letter, sent on Tuesday to Hims & Hers, warned the company to halt the use of marketing language that falsely implies that one of its products is approved by the F.D.A. The agency has not yet publicly released the letter.
    • “Hims & Hers has capitalized on a huge demand for weight-loss drugs like Novo Nordisk’s drug Wegovy, offering low-cost, copycat versions made through a process of mixing drug ingredients known as compounding. In the past few years, telemedicine companies like Hims & Hers have emerged as an aggressive new type of drug advertiser.”

From the judicial front,

  • Federal News Network reports,
    • “A federal judge in San Francisco found the Office of Personnel Management unlawfully directed agencies to fire probationary federal employees en masse.
    • “U.S District Court Judge William Alsup ruled late Friday that OPM “exceeded its own powers,” and “directed agencies to fire under false pretense,” telling probationary employees that they were being terminated for poor performance.
    • “The ruling doesn’t reinstate any of the 25,000 probationary federal employees fired around mid-February, but it does direct many agencies to update their personnel records to specify that these employees were not fired for poor performance or misconduct. Agencies must also send letters to impacted employees starting they were not fired for performance.
    • “The ruling, in a lawsuit led by federal employee unions, applies to the departments of Commerce, Defense, Health and Human Services, Labor, Treasury, Transportation and Agriculture. OPM, NASA, the State Department and the Office of Management and Budget are exempt from the ruling.”

From the public health and medical/Rx research front,

  • The Wall Street Journal explains how to start ditching ultraprocessed foods.
    • “When choosing ready-to-eat snacks and meals, check the label and aim for products that clock in at less than 1.5 calories per gram, says Kevin Hall, a former scientist at the National Institutes of Health who led the agency’s research on ultraprocessed foods before he left in the spring. Ultraprocessed foods are often energy-dense, containing more calories per gram than less-processed foods. 
    • “The particular combinations of fat, sugar, sodium and carbs that ultraprocessed foods often contain aren’t generally found in nature. Researchers call these combinations “hyperpalatable,” and they exert a strong effect on our brain’s reward system, which makes us crave them, says Tera Fazzino, associate director of the Cofrin Logan Center for Addiction Research and Treatment at the University of Kansas.”
  • Medscape considers whether oral GLP-1s can transform the obesity treatment landscape?
    • “Experts agreed that there’s room for a wide variety of obesity medications.
    • “Patients could also consider bariatric surgery, said Karan Chhabra, MD, assistant professor in the Department of Surgery and the Department of Population Health at the NYU Grossman School of Medicine in New York City. He is the coauthor of a study recently presented at the American Society for Metabolic and Bariatric Surgery’s 2025 Annual Scientific Meeting that showed that patients who underwent bariatric surgery experienced significantly more weight loss after 2 years than patients who received weekly injections of semaglutide or tirzepatide.
    • “Expanded access to GLP-1s for chronic weight management could help many people, but only time will tell what the specific impact of oral GLP-1 medications will be [e.g., will oral GLP-1 drugs carry a materially lower price?].”
  • The New York Times Well newsletter offers “five simple steps to calm yourself down. These techniques can help you handle the ups and downs of daily life.”
    • “There are lots of ways to deal with the ups and downs of daily life, Marc Brackett, the founding director of the Yale Center for Emotional Intelligence, told me. He’s developed a framework called RULER — recognize, understand, label, express and regulate — and it’s used in over 5,000 schools nationwide.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Imaging company Siemens Healthineers and minimally invasive medical device maker Cook Medical announced a partnership Saturday to offer one of the first turnkey interventional MRI suite solutions.
    • “The solution comprises Siemens Healthineers’ MRI technologies and services like its interventional planning software along with Cook Medical‘s medical devices designed for MRI, including catheters, guidewires and sheaths. Both companies will provide specialized training and ongoing clinical support.
    • “Currently, hospitals that seek to build an interventional MRI suite have to buy the equipment separately and create their own suite.
    • “Interventional MRI provides real-time imaging during minimally invasive procedures including those in oncology for soft tissue tumors, pediatric cases and structural heart conditions. Compared with interventional fluoroscopy and interventional CT, the technology offers superior image quality for soft tissues and eliminates radiation exposure.”
  • and
    • “B. Braun announced Friday it has acquired digital robotic-assisted 3D surgical microscopy company True Digital Surgery for an undisclosed amount.
    • “Previously, B. Braun, a Germany-based global medical device company, held a minority stake in the firm and partnered on developing the Aesculap Aeos robotic digital microscope. The acquisition will allow B. Braun to leverage the firm’s expertise to further advance the microscope’s development.
    • “B. Braun’s surgical division Aesculap launched the microscope in the U.S. in September 2020. It provides surgeons with 3D digital visualization while performing complex ophthalmology, neurosurgery, ENT and spinal surgeries.”
  • BioPharma Dive informs us,
    • “Takeda on Thursday said Rhonda Pacheco will become head of its U.S. business unit on Sept. 29. Pacheco has been at Eli Lilly for more than a decade and, since 2023, has been the group vice president of the pharmaceutical company’s cardiometabolic health unit, where she oversaw the lucrative launches of Lilly’s GLP-1 drugs. At Takeda, she’ll succeed Julie Kim, who was selected this year to take over for retiring CEO Christophe Weber in June 2026 and will serve as “interim” head of the company’s global portfolio ahead of the transition.”
  • Health Exec points out,
    • “Non-profit health system Mayo Clinic said on Monday that it’s planning to close six clinics in Minnesota, its home state, in an effort to remedy staffing shortages. 
    • “Specifically, the clinics in Belle Plaine, Caledonia, Montgomery, North Mankato, St. Peter and Wells will all be shutting their doors forever. In addition, its hospital in Albert Lea will end elective surgeries in some specialties, including gynecology and orthopedics. However, a spokesperson for Mayo Clinic told HealthExec future procedures will be moving to nearby patient care centers. The hospital is still operating as normal, and its emergency room remains open. 
    • ‘Mayo Clinic said the changes will go into effect Dec. 10. It’s launched a resource webpage to answer common questions patients may have, as it says it’s working to transition all of them to new locations. Patients will “receive a letter and portal message explaining the changes” and presenting them with options, the online FAQ confirms. In some cases, that means shifting in-person visits over to telehealth.” 
  • Per HR Dive,
    • “Pay raise budgets for next year are predicted to mirror 2025’s increases, according to a Sept. 3 report from The Conference Board. On average, companies said they plan to up their salary budgets by 3.4% in 2026.   
    • “Actual increases this year were on average 3.4%, lower than the 4% predicted in last year’s survey but still higher than the 3% average seen prior to 2020, The Conference Board said.
    • “Today’s labor market is one of recalibration, not retreat,” Mitchell Barnes, an economist at The Conference Board, said in a news release. “Companies are rebalancing their workforce and labor strategies,” slowing headcount growth and investing in training, Barnes noted.”

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.”

Monday report

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

From Washington, DC

  • Federal News Network discusses OPM recent hiring reforms, including last Friday’s Rule of Many.
  • Here’s a link to OPM’s fact sheet on the Rule of Many.
  • FedSmith recommends the FEHB and PSHB enrollees and covered family member “have your annual physical ahead of the Health Care Open Season” which starts in early November. Doing so allows the enrollee to “review health changes and update your FEHB coverage.” Intriguing idea.
  • Per a Congressional news release,
    • “Nearly five years after the No Surprises Act (NSA) was signed into law, delays and inconsistent rulemaking by Biden-era regulators have resulted in a patchwork system that fails to provide the transparency and protection for patients that Congress intended. In a letter to Secretaries of the Departments of Health and Human Services, Treasury, and Labor, Ways and Means Committee Republicans urged the Trump Administration to build on its previous work and the work of Congress and successfully implement the crucial patient protections provided under the No Surprises Act.
      • “The [Ways and Means] Committee is the first and only congressional committee to hold hearings examining challenges cited by patients and other stakeholders regarding the NSA’s implementation… Nearly five years after the NSA’s passage, and spanning multiple administrations, many of these identified challenges remain unresolved… We look to this Administration to continue building on the work done by the Committee to prioritize necessary regulatory and sub-regulatory improvements so patients can realize the full potential and benefits of the NSA,” wrote Committee members.”
  • In the FEHBlog’s view, patients are reaping the benefits of the NSA while health plans are getting the short end of the stick. The federal government should take steps to improve the arbitration process.
  • The American Hospital Association News tells us
    • “The Federal Trade Commission Sept. 5 voted 3-1 to vacate the noncompete final rule issued last year by the previous administration. The rule banned, as an unfair method of competition, contractual terms prohibiting workers from pursuing certain employment after their contract with an employer ends.” * * * 
    • “The FTC Sept. 4 issued a request for information on noncompete agreements, saying it seeks to “better understand the scope, prevalence, and effects of employer noncompete agreements, as well as to gather information to inform possible future enforcement actions.” 
  • and
    • “The White House Sept. 5 issued an executive order modifying the scope of reciprocal tariffs announced in April to establish a framework of trade deals with international partners on certain goods such as critical minerals and pharmaceutical products.   
    • “The order established a Potential Tariff Adjustments for Aligned Partners Annex, consisting of a list of products to which President Trump would be willing to apply the “most favored nation” tariff, pending any future reciprocal trade deal. Pharmaceuticals and their ingredients were one of four product categories listed.”

From the Food and Drug Administration front,

  • Reuters reports,
    • “The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, used for weight loss and diabetes, amid concerns that many of the items may be adulterated and pose a safety risk.
    • “The move comes as the FDA cracks down on unapproved compounded drugs, which had filled the gap during shortages of patented treatments. Soaring demand for Novo Nordisk (NOVOb.CO), opens new tab and Eli Lilly’s (LLY.N), opens new tab obesity drugs has fueled a booming global market for cheaper, and sometimes even counterfeit versions.”
  • STAT News informs us,
    • “On Monday, eGenesis, a Cambridge-based biotechnology company, announced that it had been cleared by the Food and Drug Administration to begin a trial of kidneys from donor pigs that have been CRISPR’d to make their organs more human-friendly. Now, Massachusetts researchers will be performing more surgeries like [Bill] Stewart’s to see whether these animal parts could serve as a lifeline for people with end-stage renal disease.
    • “It’s the latest advance in a scientific swine race some hope might solve America’s organ shortage.” * * *
    • “Meanwhile, Revivicor, a subsidiary of Maryland-based United Therapeutics, has been trying its own porcine organs — including the first pig-to-human heart and kidney transplants — from animals with fewer genetic modifications. In February, United Therapeutics got the okay from the FDA to begin a clinical trial of its so-called “UKidney.” A spokesperson told STAT the company is “at least a month away” from performing the first transplant of the trial.”

From the judicial front,

  • Bloomberg Law reports,
    • “Top pharmacy benefit managers UnitedHealth Group Inc., Express Scripts Inc., and CVS Caremark notched a win after a federal judge partially dismissed certain class action claims that they conspired in an unfair pricing scheme for insulin products.
    • “The claims by the plaintiffs, which included self-funded payors and state attorneys general, are barred by an indirect purchaser rule and certain state laws, Judge Brian Martinotti for the US District Court for the District of New Jersey said in an order filed Sept. 5.” * * *
    • “Because the claims are barred by the indirect purchaser rule, the court is compelled to dismiss the civil claims under the Racketeer Influenced and Corrupt Organizations Act, Martinotti said.” * * *
    • “The order, however, denied the PBMs’ motion to dismiss the plaintiff’s unjust enrichment claims under Illinois law. “Unjust enrichment under Illinois law is not prevented by the indirect purchaser rule, and therefore, SFP Plaintiffs’ unjust enrichment claims in Illinois are sustained,” Martinotti said.”
  • Healthcare Dive relates,
    • “A federal judge dismissed several claims in the high-profile antitrust lawsuit against electronic health record giant Epic on Friday, but allowed other allegations by startup Particle Health to continue.
    • “Last year, Particle sued the EHR vendor, arguing Epic had used its large market share to crush competition in tools for payers. Epic filed a motion to dismiss the suit in December. 
    • “The judge agreed with Epic on five of the nine claims, dismissing Particle’s assertions that the vendor had maintained a conspiracy to uphold its market dominance, as well as claims of defamation and trade libel. However, the court declined to throw out three federal antitrust claims and Particle’s allegation that Epic had interfered with a business contract.” 
  • Per Federal News Network,
    • “A federal appeals court is ordering the dismissal of a case led by a group of states challenging the Trump administration’s termination of probationary federal employees, striking a significant blow to one of the two major cases that had challenged this year’s efforts to downsize the workforce by firing probationary workers en masse.
    • “Nineteen states and the District of Columbia filed the lawsuit in March, arguing that widespread firings at many agencies led to a sharp increase in unemployment claims and other sudden pressure on state budgets.
    • “In some cases, states said they had to expend “substantial resources” —sometimes creating new websites or opening new phone lines — to handle the volume of unemployment claims coming from fired probationary employees.
    • “But the U.S. Court of Appeals for the Fourth Circuit ruled in a 2-1 opinion on Monday that the plaintiffs “failed to allege a cognizable and redressable injury” from the widespread terminations.”

From the public health and medical/Rx research front,

  • Genetic Engineering and Biotechnology News reports,
    • “The global pandemic may be over, but SARS-CoV-2 continues to infect people around the world. Indeed, the United States has recorded roughly 750 deaths from COVID-19 over the past month.
    • “Now, an siRNA screen performed by scientists at Scripps Research has pinpointed dozens of human proteins that SARS-CoV-2 uses to complete its replication cycle. These findings could open the door to new drugs that target host proteins rather than the virus. This strategy may lead to new treatments effective against SARS-CoV-2 and other coronaviruses, even as the pathogens continue to evolve.
    • “This work is published in PLOS Biology in the paper, “Global siRNA screen identifies human host factors critical for SARS-CoV-2 replication and late stages of infection.”
  • BioPharma Dive adds,
    • “Pfizer and partner BioNTech said Monday their updated COVID-19 booster spurred strong immune responses against currently circulating coronavirus strains in late-stage testing, adding a key piece of evidence in support of the recently approved shot.
    • “According to Pfizer and BioNTech, the booster led to at least a four-fold increase in levels of LP.8.1-neutralizing antibody titers in a study cohort of people either over 65 or who are between 18 and 64 and have an underlying health condition. No new safety concerns were identified.
    • “The two companies ran the study to provide to the Food and Drug Administration additional information about the vaccine’s immunological impact. The results have been submitted to the agency, they said.”
  • Medscape notes that long Covid has been hitting doctors and nurses hard.
  • Per a National Institute of Standard and Technology news release,
    • “A type of drug called monoclonal antibodies (mAbs) can halt the growth of breast tumors, block the effects of rheumatoid arthritis, and treat many other diseases, from leukemia and colon cancer to asthma and osteoporosis. To manufacture these drugs, pharmaceutical companies genetically engineer living cells, grow those cells in large bioreactors, and harvest the mAb proteins that the cells produce.
    • “To support the manufacturing of these drugs, researchers at the National Institute of Standards and Technology (NIST) have collaborated with biotech company MilliporeSigma and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to develop a “living” reference material: specially tailored living cells that make mAbs with well-known properties.”
  • The American Medical Association lets us know what doctors wish parents knew about when to obtain emergency care for their children.
  • Per Healio,
    • “Individuals younger than 50 years with COPD faced an elevated risk for premature death and incident hospitalization/death due to chronic lower respiratory disease or heart failure, according to results published in NEJM Evidence.
    • “Clinicians can take away from our article that COPD is not uncommon in younger adults and should be considered as a possible diagnosis in young adults with 10 pack-years of smoking or respiratory symptoms,” Elizabeth C. Oelsner, MD, DrPH, general internist, respiratory epidemiologist, and Herbert Irving Associate Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, told Healio.
  • Per BioPharma Dive,
    • “BioNTech’s experimental bispecific cancer drug pumitamig helped shrink tumors in three-quarters of people with small cell lung cancer who were enrolled in a Phase 2 trial, and stabilized disease in all of them, the company said Monday.
    • “Company executives said the study’s results at an interim data checkpoint confirmed the dose it has selected for an ongoing Phase 3 trial with chemotherapy in the “extensive stage” form of the disease that can’t be treated with surgery or radiation. That trial may not have data until 2028.
    • “Pumitamig, also known by the code-name BNT327, is a drug targeting the PD-1 immune pathway and the cancer growth driver VEGF, a hotly contested area of biotech development. Opdivo maker Bristol Myers Squibb signed a deal with Germany-based BioNTech to co-develop pumitamig for $1.5 billion upfront and $2 billion a year through 2028.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The U.S. labor market is slowing, and job gains are largely in health services, which include healthcare and social services.
    • “Health services have been a consistent source of job growth, but impending Medicaid cuts could hinder the sector’s growth.
    • “There are concerns that Labor Department data might be overstating strength in health services, which could be revised lower.”
  • Fierce Health points out,
    • “Despite the hype about weight loss drugs known as GLP-1s, serious questions have remained about their efficacy when patients wean off the drugs.
    • “To date, studies have cast doubt on whether patients who stop taking the drugs can keep off the weight long-term. Some data suggest that those who discontinue regain between 14%and two-thirds of what they lost.
    • “But Omada Health, a virtual chronic care provider, is challenging the notion of inevitable weight gain with new data.
    • “When coupled with wraparound lifestyle support, 63% of Omada members maintained or continued to lose weight 12 months after discontinuing GLP-1s. At one year post-discontinuation, members showed just 0.8% average weight change. The analysis was based on 816 patients.”
  • Beckers Hospital Review informs us,
    • “Cleveland Clinic is expanding its presence in Florida with plans to build a $500 million hospital in West Palm Beach. The project will mark the system’s 24th hospital and significantly increase its footprint in Palm Beach County
    • “The hospital will be built on newly acquired land and comprise about 150 inpatient beds, an emergency department, a medical office building and an ambulatory surgery center.
    • “Palm Beach County has long been an area where we have planned to grow to enhance care for the community,” Cleveland Clinic President and CEO Tom Mihaljevic, MD, said in a Dec. 19 news release. “Our expansion plan will transform care for the community with a new hospital and outpatient clinics that provide a broad range of specialties, greater access and innovative patient experience programs.” 
  • BioPharma Dive reports,
    • “Drug developers from around the world rang in a new era of sleep medicine Monday, as data from a series of clinical trials show narcolepsy can be effectively treated by amplifying a specific brain protein.
    • “That protein, called orexin-2, helps regulate important body functions like appetite, arousal and wakefulness, which has in turn made it a promising target for drug companies. Johnson & Johnson, for instance, hopes that by blocking orexin-2, its experimental medicine seltorexant can be used to combat insomnia in patients with major depression.”
    • “More commonly, though, developers are looking to boost this protein to keep people with narcolepsy awake longer. The furthest along in this pursuit is Takeda Pharmaceutical with its drug oveporexton, which recently met the main and secondary goals of two late-stage clinical trials that focused on the most common, “Type 1” form of narcolepsy.
    • “On Monday, at a medical conference focused on sleep therapies, Takeda presented more detailed results from these studies.”
  • and
    • “Rapport Therapeutics’ market value doubled on Monday after the neurology-focused drugmaker unveiled mid-stage study results for an experimental seizure medicine that widely beat analyst and investor expectations.
    • “Treatment with Rapport’s drug, called RAP-219, reduced the frequency of clinical seizures by 78% versus the study’s baseline, a result that was matched by a similar reduction in electrographic seizure signs measured by a brain implant.
    • “As a result, Rapport said it plans to advance RAP-219 into two Phase 3 trials in the third quarter of next year. Shares in the company climbed by as much as 194% Monday morning to swell its capitalization above $1 billion”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of brensocatib (Brinsupri™, Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “NCFB is an incredibly burdensome condition with impacts that go well beyond its respiratory effects and include social, emotional, and productivity challenges,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “ICER’s analyses found that brensocatib, the first medication to be specifically indicated for NCFB, reduces the rate of pulmonary exacerbations and may also somewhat slow the rate of deterioration in lung function. Despite these benefits, however, we found that brensocatib’s expected discounted price was far out of alignment with the modest clinical improvements demonstrated in clinical studies. Pricing policy that balances innovation signals while addressing affordability and value will be an important topic at the public meeting.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on September 25, 2025. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

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.”

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday update

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research,

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

From the U.S. healthcare business front,

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