Friday report

Mental health care

Friday report

David Ermer–CDC, CMS, FDA, Government Contracting, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Avalere Health offers insights concerning HHS Secretary’s decision to fill out the membership of the U.S. Preventive Services Task Force announced yesterday.
    • “For life sciences companies and health plans, the USPSTF’s ability to resume its work—and potential new approaches to evidence review with its new members—will be consequential. The Task Force’s recommendations influence preventive care practice, clinical quality strategies, and, most notably, health plan preventive service coverage requirements.” * * *
    • “Health plans should prepare for the potential release of delayed recommendations and for a more active USPSTF agenda. This includes maintaining processes to assess coverage requirements, benefit configuration, coding, provider-network capacity, member communications, and implementation timelines once final A or B recommendations are issued. USPSTF last shared a recommendation update in August 2025, with four topics pending final recommendation statements.
    • “As the Task Force resumes activity under new leadership and a substantially different membership profile, transparency, methodological consistency, and implementation relevance will be central to maintaining trust in its recommendations.”
  • Per a Centers for Medicare and Medicaid Services (CMS) news release.
    • “The Centers for Medicare & Medicaid Services (CMS) is working to end skyrocketing drug costs as the agency announces today that all 50 states, plus the District of Columbia and Puerto Rico, have applied to participate in an initiative which provides most-favored-nation pricing for certain prescription drugs to people with Medicaid. Forty states and Puerto Rico have already signed agreements to participate in this historic program that will lower Medicaid drug costs to what other countries pay, saving an estimated $64.3 billion in taxpayer dollars over the next ten years, while preserving or enhancing beneficiaries’ quality of care.” * * *
    • “The GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model is a landmark CMS Innovation Center initiative designed to not only lower drug spending in Medicaid but also improve quality of care and health outcomes by increasing access to critical medications and strengthening the Medicaid program overall. Under the GENEROUS Model: 
      • “Participating manufacturers will make covered outpatient drugs available at most-favored nation pricing to participating state Medicaid programs.
      • “Under agreements with states, participating manufacturers will be invoiced by states for supplemental rebates to effectuate international prices. CMS will monitor pricing accuracy. CMS will share in rebates with states via a reduction in the federal share of Medicaid payments.” * * *
    • “Remaining states have until Sept. 30, 2026, to sign agreements with CMS to participate in the model. The GENEROUS Model launched in January 2026 and runs for five years.
    • “For information on states participating the GENEROUS Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/generous.” 
  • In today’s Federal Register, the Federal Acquisition Council promulgated proposed rules implementing the Revolutionary FAR Overhaul’s (RFO) FAR provision deviations.
  • The FAR Council explains on the acquisition,gov website,
    • “The RFO Phase 2 rule-making process has been organized in 12 FAR Cases, as outlined in the chart. The FAR Council has published Proposed Rules (PR) for the first 4 of 12 RFO-related FAR cases.
    • “With this publication, it’s the perfect time to show how public feedback informed key changes from the model deviations to the proposed rules. Your voice made a difference. The FAR Council received almost 1,600 valuable comments, primarily from industry (80%), but also from industry associations (7%) and federal government employees (13%). The public feedback received informed the FAR Council’s work in preparing the proposed rules. 
    • ‘While all public comments received may not be reflected, the tables below highlight examples of key policy updates that resulted from some of the public feedback submitted via acquisition.gov. The tables are organized by the RFO-related FAR rules, and will be continuously updated as the remaining RFO-related rules are published over the coming months.” 
  • Per Department of Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Financial Resources (ASFR), today announced a new Department-wide policy establishing the HHS Personal Protective Equipment (PPE) Forecast. This is the first official, recurring process to identify, consolidate, and publish anticipated HHS purchases of personal protective equipment covered by the Make PPE in America Act.
    • “The new forecast will give U.S. PPE manufacturers a clearer and more predictable signal of future HHS demand. By turning the Department’s acquisition plans into actionable market visibility, the initiative will help domestic companies make better-informed decisions about hiring, production, capital investment, and manufacturing capacity while strengthening the supply chains HHS relies on during routine operations and public health emergencies.” * * *
    • American manufacturers and small businesses can review HHS procurement forecast opportunities through the HHS Small Business Customer Experience platform.
  • and

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

  • OPM Director Scott Kupor resorted to his Secrets of OPM blog [found on Substack) to ably debunk recent challenges to the cost savings created by last year’s massive reduction in federal employment.
    • “GAO estimates that agencies spent about $9.5 billion on all paid administrative leave in 2025 and attributes about $6.7 billion of that to the Deferred Resignation Program. For the sake of argument, let’s charge the entire $9.5 billion to DRP anyway. It was a one-time expense.
    • “What did the taxpayer get for it? Using rough averages, the fully loaded cost of a federal employee is about $150,000 per year. For 270,000 employees, that is more than $40 billion in annual costs. These are not one-time costs, but costs incurred every year in perpetuity.
    • “So, for a one-time expense of at most $9.5 billion, taxpayers save more than $40 billion each year. That’s a 400+% annual return, and the outlay paid for itself in under six months.”
  • Here is a link to Senator Adam Schiff’s (D CA) news release about the letter that he and fifteen other Democrat Senators sent to OPM on October 16 questioning the OPM’s use of FEHB and PSHB protected health information to help OPM’s effort to combat fraud, waste, and abuse in hose programs.
    • “We support responsible efforts to protect the integrity of federal health-benefit programs. However, OPM’s proposals create an unnecessarily broad, decades-long, re-identifiable medical history of millions of workers, retirees, spouses, children, and other family members. We strongly urge OPM to suspend further implementation while these concerns are addressed and to work with Congress, federal employees and retirees, health plans, privacy and civil-rights experts, reproductive-health advocates, and other affected stakeholders to establish safeguards commensurate with the sensitivity of the information at issue. 
    • “We request a written response and briefing by OPM on the office’s efforts related to the above requested actions no later than September 25, 2026.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy.
    • “The approval, announced Sept. 18, 2026, applies to patients whose ESR1 mutation is identified using an FDA-authorized test. The FDA also approved the Guardant360 CDx assay as a companion diagnostic to identify patients with ESR1-mutated breast cancer who may be eligible for the treatment combination.
    • “Inluriyo and Verzenio are both manufactured by Eli Lilly and Company.”
  • MedTech Dive relates,
    • “Cognita Imaging recently received a $1.29 million research contract from the Food and Drug Administration to test a new method of evaluating artificial intelligence-generated radiology reports. The goal is to assess whether a “jury” of large language models can evaluate another AI model’s report, and which cases need radiologist oversight.
    • “The contract, which started on June 22 and will run for 18 months, is intended to address a core problem with generative AI. Currently, most tools are evaluated against a panel of radiologist experts, but for models that can evaluate a wide variety of cases and generate different outputs, this becomes more challenging and time-consuming.”
  • STAT News tells us,
    • “In January, a paper published in Science analyzed government mortality figures, data on drugs seized by the DEA, and Reddit posts to determine that decreasing fentanyl potency due to Chinese government crackdowns could explain the recent decline in U.S. opioid overdose deaths. But when another research team tried to replicate that study, they didn’t come to the same conclusion.
    • “A simplistic supply shock is not supported by the evidence,” the authors wrote yesterday in Science Advances.
    • “The researchers noted that as fentanyl purity increased across the country, there was no associated national drop in overdose rates. While there did seem to be a broad association between declining purity and overdoses, it was shared with other, unrelated trends. And importantly, the DEA acknowledged at the time that increasing purity in its drug seizures was likely due to a change in its sampling plan.
    • “It’s also critical not to overlook geographic variability in the drug supply, the replication study authors wrote. As one of them told Lev Facher when the first study was published, many regions had declining overdose rates before potency apparently began to drop. — Theresa Gaffney

From the public health and medical /Rx research front,

  • The Centers for Disease Control and Prevention announced today
    • “As of September 18, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low overall.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 177 new cases added today, the US measles count has climbed to 3,471. * * *
    • “Today’s increase marks the sixth straight week of triple-digit increases in cases.
    • “The CDC today noted 39 outbreaks, one more than last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level in July. 
    • “The 2026 total is already 52% higher than the 2025 total, with more than three months left in the year.
    • “All but 17 of this year’s cases have been locally acquired, with the rest tied to international travel. Cases have been confirmed in 45 states plus New York City and Washington, DC.
  • The Washington Post tells us,
    • “Paul Nestadt is about as steeped in suicide prevention as a person can be.” * * *
    • “Nestadt has sought to intervene in ways that don’t require pinpointing people at risk.
    • “Chief among them: making it harder for people to carry out the act of killing themselves.
    • “Instead of asking every doctor to figure out which patient will die by suicide and locking that patient up, it might be that we need to make sure there aren’t loaded guns available,” Nestadt said.
    • “Although medication and therapy are lifesaving measures, many clinicians, researchers and people who have lost loved ones to suicide agree that more is needed. When it comes to firearms, however, broad policy approaches face major constitutional and political challenges.
    • “Research shows that limiting access to lethal means is one of the most promising approaches to save lives. It can involve erecting barriers on buildings and bridges to prevent people from jumping, as well as decreasing the number of pills someone can buy or be prescribed at once.
    • “And reducing access to guns, which are the most common and lethal method used for suicide in the United States.”
  • Beckers Behavioral Health shares summaries of “34 new behavioral health study findings to know.”
  • MedPage Today lets us know,
    • “A quarter of patients with cirrhosis caused by metabolic dysfunction-associated steatotic liver disease (MASLD) presented before the age of 50 with distinct risk profiles, data from a prospective study showed.
    • “In models adjusting for demographic and metabolic factors, a high genetic risk score and type 2 diabetes were independently associated with early-onset MASLD cirrhosis.
    • “Reliance on age-dependent first-line liver fibrosis tools can miss cases, the researchers suggested.”
  • Per Health Day,
    • “Wearable sensors might be the key to better tracking and treating a person’s knee arthritis, a new study says.
    • “Strapped to the foot, these sensors work as well as motion capture cameras in tracking a person’s natural stride, researchers reported recently in the journal JMIR Formative Research.
    • “This stride data could be used to track how a person with knee arthritis walks, allowing doctors to track arthritis progression and potentially offer individualized therapy, researchers said.”
  • and
    • “More people are seeking emergency help for gambling problems in the face of expanded online betting markets, a new study says.
    • “ER visits for gambling disorders nearly doubled following the legalization of single-event sports betting and expansion of online gambling markets in Ontario, researchers reported Sept. 15 in the American Journal of Preventive Medicine.
    • “Most people experiencing gambling problems will never seek care, so the concern is that the increases in ED visits for gambling disorders we observed may be revealing much larger increases in gambling-related harm,” senior researcher Dr. Daniel Myran said in a news release. He’s research chair at North York General Hospital in Toronto.”
  • Per Genetic Engineering and Biotechnology News,
    • “Diabetic kidney disease is one of the most common and serious complications of diabetes, yet the chain of events linking high blood sugar to kidney damage remains incompletely understood. Now, a stem cell-based model suggests that glucose itself may help trigger an inflammatory response inside kidney tissue—one that can damage key epithelial cells.
    • “Researchers led by Benjamin S. Freedman, PhD, at the University of Washington and University of Miami, report that human kidney organoids exposed to elevated glucose developed tissue-intrinsic inflammation and epithelial cell detachment, including detachment of podocytes, specialized cells essential for the kidney’s filtration barrier. The study, “Elevated glucose in kidney organoids induces tissue-intrinsic inflammation driving epithelial detachment,” was published recently in Stem Cell Reports.
    • “High sugar causes inflammation in these organoids even though they lack an immune system,” Freedman said. “This was unexpected and gives us a new way to think about how diabetes can affect kidneys and other organs.”
  • Per Beckers Hospital Review,
    • “An investigational immunotherapy was found to almost double median overall survival in patients with previously treated squamous non-small cell lung cancer, according to new trial data.
    • “Gotistobart, developed by BioNTech and OncoC4, showed a median overall survival of 18.5 months, nearly double the 10-month median among patients who received standard of care chemotherapy, according to a Sept. 14 news release from the companies.
    • “The trial results were presented Sept. 14 at the International Association for the Study of Lung Cancer’s World Conference on Lung Cancer in Seoul.”

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

  • Modern Healthcare reports.
    • “Molina Healthcare is pulling its all of its Medicare plans from three states for the 2027 plan year, the company notified third-party marketers Friday.
    • “The health insurer announced in February that it would completely exit the national market for individual Medicare Advantage plans to focus on Dual Eligible Special Needs Plans, or D-SNPs, for people who qualify for both Medicare and Medicaid. The company tried to sell the individual Medicare Advantage business but failed to find a buyer.
    • “In Connecticut, Mississippi and Nevada, Molina Healthcare is going a step further by ending individual, D-SNP and other Medicare plan sales, according to the notice.”
  • Beckers Clinical Leadership relates,
    • “Two UC Health emergency departments avoided more than 3,500 unnecessary head and cervical spine CT scans over 23 months with no missed injuries identified, according to a study published in the Western Journal of Emergency Medicine.
    • “The quality improvement campaign ran at University of Cincinnati Medical Center and West Chester Hospital in West Chester Township, Ohio. The campaign paired continuing education on clinical decision rules for head and cervical spine imaging with decision-support software embedded in the EHR, plus quarterly feedback showing physicians how their own ordering compared with peers’. Teams also created patient handouts to reassure those who expected a scan they did not need.
    • “Physician-researchers estimated the effort eliminated 3,542 scans in low-risk trauma patients, avoiding $6.2 million in patient charges at roughly $1,750 per scan and saving 14,168 hours of patient waiting time. The campaign also avoided 6,021.4 millisieverts of radiation exposure — the equivalent of roughly 2,000 years of background radiation for one person.
    • “A safety review identified no patient harm and no missed injuries.” * * *
    • “View the full study here.”
  • Beckers Hospital Review tells us,
    • “Paul Krakovitz, MD, became CEO of Greensboro, N.C.-based Cone Health on March 16, roughly 15 months after the five-hospital system joined Risant Health, the nonprofit created by Oakland, Calif.-based Kaiser Permanente. Dr. Krakovitz previously held leadership roles at Cressey & Company, Intermountain Health and Cleveland Clinic.
    • “Now, Risant is involved in Cone Health’s value-based care work, bringing tools developed through Kaiser Permanente’s experience with the model to the community health system. Risant is also helping fund Cone Health’s $40 million effort to rebuild its Epic platform after years of technical debt limited the system’s ability to adopt newer capabilities.
    • “Dr. Krakovitz discussed with Becker’s the system’s work with Risant, its Epic investment and Cone Health’s efforts to move away from volume and toward more proactive care.
    • “He said Risant has brought additional resources and focus to Cone Health’s value-based care strategy while the health system remains focused on its local community.
    • “The value-based care tools that Risant brings from a national scale is just something that is incredibly unusual to be able to deploy in a community health system, and it’s a huge benefit, both for our clinicians and for our community,” Dr. Krakovitz said.”
  • Beckers Health IT adds,
    • “Techstars and the Mid-Atlantic Permanente Medical Group selected nine startups for a healthcare accelerator focused on emerging technologies and care delivery.
    • “More than 1,200 startups applied for the 2026 Techstars Healthcare Accelerator powered by Permanente Medicine Mid-Atlantic States, according to a Sept. 18 news release.
    • “The three-month program began Sept. 14 and will connect participating companies with Techstars investors and mentors as well as physicians and healthcare leaders from the Mid-Atlantic Permanente Medical Group.”
  • Beckers Hospital Review points out,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • “Here [in the article] are 60 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1, 2026.
  • Fierce Healthcare informs us,
    • “Angle Health raised $600 million in equity financing, reaching a total valuation of $2.7 billion, to continue expanding its artificial intelligence-native healthcare benefits platform for small businesses.
    • “According to the company, the financing includes a $200 million series C funding round and a $400 million tender offer. The startup’s valuation has more than doubled since its December series B round when it raised $134 million, the Wall Street Journal reported. The company raised a $58 million series A round in January 2023.
    • “Vitruvian Partners led the round, with participation from new investor Town Hall Ventures and existing investors Blumberg Capital, Portage Ventures, PruVen Capital and Y Combinator. They expect to close the round later in September.”
  • and
    • “Oura and Counsel Health are teaming up to participate in CMS’ 10-year chronic condition management program, betting that continuous health data from Oura’s smart ring paired with medical AI can help move the needle on conditions like hypertension.
    • “Counsel Health, an AI-native primary care company, plans to participate in CMS’ Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model under the early cardio-kidney-metabolic (eCKM) track, with smart ring maker Oura serving as the preferred wearable partner.
    • “It is an early example of how the CMS chronic care initiative could become a proving ground for AI-powered, wearable-enabled care delivery.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.
    • “The research was published in the Expert Review of Pharmacoeconomics & Outcomes Research.”
  • Fierce Pharma notes,
    • “As expected, the past U.S. Labor Day holiday took a toll on obesity drugs’ prescription numbers. According to IQVIA data cited by Citi, weekly scripts for Novo’s Wegovy pill dropped roughly 12% sequentially to about 161K for the last week. The decline for Foundayo was modest, at just 1%, as the Lilly drug still managed to rake in more than 47K scripts. 
    • “Lilly this week said Foundayo captured more than 30% of new patients in the U.S. market for oral obesity ​treatments, Reuters reported. 
    • “Citing Bloomberg Symphony data, Jefferies analysts suggested in a Friday note that Foundayo’s recent acceleration “has been driven primarily by retail/commercial channels.”
    • “Elsewhere, Lilly’s total Zepbound scripts were down 8.5% week over week, but the GIP/GLP-1 drug expanded its market share by 0.4% versus Novo’s Wegovy franchise, whose scripts decreased 10% during the period.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Happy Constitution Day!

From Washington, D.C.,

  • The American Hospital Association News reports,
    • “A Capitol Hill briefing Sept. 17 in Washington, D.C., hosted by 11 national healthcare organizations, including the AHA, highlighted the growing epidemic of workplace violence and its effects on staff well-being and patient safety. At the briefing, titled Protecting Those Who Care: Addressing Violence Against Healthcare Workers, Hill staff heard panelists’ personal experiences with physical and verbal attacks on the job and how hospitals are working to reduce the incidence of violence. The panelists were: Elizabeth Wells, M.D., executive vice president, chief clinical officer, and physician-in-chief, Children’s National Hospital; Jonathan Ripp, M.D., chief wellness officer and dean for well-being, Icahn School of Medicine at Mount Sinai; Tiffany Covarrubias-Lyttle, RN, associate professor of nursing, University of Lynchburg; and, Sheila Roth, Ph.D., professor emeritus, Carlow University. Reps. John Joyce, R-Pa., and Joe Courtney, D-Conn., also made brief remarks during the event.
    • “In a joint statement, the AHA and other participating organizations said, “Workplace violence, including physical assaults, threats, intimidation, and harassment, erodes the safety and dignity of healthcare workers, directly contributes to staff burnout and turnover, and staffing shortages, and compromises the quality of care and patient safety. This violence undermines providers’ ability to ensure safe, healing environments for all.”
    • “The AHA’s Hospitals Against Violence initiative includes resources and best practices for hospitals to use and share to address workplace and community violence.” 
  • Beckers Clinical Leadership relates,
    • “HHS Secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, bringing the influential preventive care panel to 16 members.
    • “Mr. Kennedy made the appointments Sept. 17 through the Agency for Healthcare Research and Quality. The eight join eight members currently serving on the volunteer panel of prevention and evidence-based medicine experts.
    • “The task force carries outsized weight for health system and payer leaders: preventive services that the panel grades “A” or “B” must be covered by most private insurers without cost-sharing under the ACA. Its composition effectively shapes which screenings and preventive services patients can get at no cost.” * * *
    • “Seth Corey, MD, a pediatric hematologist-oncologist at Cleveland Clinic, will chair the task force. The other seven appointees are:
      • “Patrick Hunter, MD, a pediatrician at Pensacola (Fla.) Pediatrics and member of the Florida State Board of Medicine
      • “Ronald Karlsberg, MD, a clinical professor of medicine at Los Angeles-based Cedars-Sinai Medical Center’s Smidt Heart Institute
      • “Venkatesh Murthy, MD, PhD, professor of preventive cardiology at the University of Michigan in Ann Arbor
      • “Stephen Parente, PhD, a health finance professor at the University of Minnesota’s Carlson School of Management in Minneapolis
      • “Goldie Stands-Over-Bull, MD, lead family medicine physician at Texas Native Health in Dallas
      • “Louis Wilson, MD, a gastroenterologist and managing partner at Wichita Falls (Texas) Gastroenterology Associates
      • “Dennis Wulfeck, MD, a diagnostic radiologist and president of the practice board at Radiology Partners’ MBB Radiology in Jacksonville, Fla.” 
  • U.S. News and World Report tells us,
    • “The U.S. Senate ⁠health ⁠committee will hold a confirmation ⁠hearing next week for Dr. Heidi Overton, President Donald Trump’s pick to ​lead the embattled Food and Drug Administration, the panel said on Thursday.
    • “The hearing will take place ‌on September 24, the Senate Health, ‌Education, Labor, and Pensions Committee said in a statement. Trump nominated Overton, a White ⁠House policy aide, ⁠in August, turning to an “America First” ally to steady an agency ​shaken by staff losses, low morale and fights over vaccines, the abortion pill and drug approvals.
  • Per Department of Health and Human Services news releases,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today launched the new Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a major research effort to transform how autism is understood, diagnosed, and supported across the lifespan. SPECTRA will bring together biological, clinical, behavioral, and real-world data with advanced computational tools to enable earlier and more accurate diagnosis, identify factors that shape individual health and developmental trajectories, and develop more precise approaches to care tailored to each person’s needs.
    • “Autism is not one-size-fits-all, and our science and care cannot be either,” said HHS Secretary Robert F. Kennedy, Jr. “Millions of American families are impacted by autism, and they need better answers about why it presents so differently from one person to another and which approaches can best meet each person’s needs. SPECTRA will harness the best of American science and innovation to deliver those answers — and turn them into better outcomes for people with autism and their families.” * * *
    • “Learn more about SPECTRA on its program page, including information about the solicitation.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today issued a Request for Information (RFI) calling on Americans, scientists, physicians, industry, and public health experts to submit evidence and information on the potential health effects of electromagnetic fields (EMFs), radiofrequency (RF) radiation, and wireless radiation exposure.
    • “The RFI will help HHS evaluate the state of the science, compare U.S. and international safety standards and regulatory approaches, identify critical research gaps, and develop practical, evidence-based recommendations for policymakers, families, schools, communities, and public health professionals.
    • “Wireless technologies are part of daily life, and our science must keep pace,” said HHS Secretary Robert F. Kennedy, Jr. “The MAHA Strategy directed HHS to examine electromagnetic radiation and health research, and we are acting on that directive. I encourage scientists, physicians, industry, public health experts, workers, parents, and citizens to bring us the best available evidence so we can identify the gaps and focus federal research where it is needed most.” * * *
    • “More information about the RFI can be found at the Federal Register [PDF].”
  • The International Foundation of Employee Benefit Plans helpfully shares information about “Red Flags for Mental Health Parity Compliance Problems.”

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

  • FedSmith reports,
    • “Federal retirees and Social Security recipients are only one inflation report away from knowing their 2027 cost-of-living adjustment (COLA). The Bureau of Labor Statistics (BLS) will release the September inflation report on October 14. That report will provide all three CPI-W figures needed to calculate the 2027 COLA.”
    • “The latest estimate from The Senior Citizens League (TSCL) puts the 2027 Social Security COLA at 3.5%. The organization lowered its estimate from 3.6% after the latest inflation report.
    • “Because Social Security and Civil Service Retirement System (CSRS) benefits use the same underlying inflation measure, that estimate also indicates the COLA CSRS retirees may receive. For most Federal Employees Retirement System (FERS) retirees eligible for a COLA, however, a 3.5% increase in the CPI-W would result in a 2.5% FERS COLA because FERS uses a different formula.”
  • Serving those We Serve tells us what federal and Postal employees should know about the redesigned Social Security Statement.
  • Tammy Flanagan, writing in Govexec, lets us know how to navigate the Pay.gov maxe for federal retirement deposits.
    • “Don’t let missing service credits or opaque OPM billing notices shrink your monthly annuity. Here is what you need to know before clicking submit.”
  • MeritTalk informs us,
    • “The Office of Personnel Management (OPM) used governmentwide OneGov deals to give every employee access to six artificial intelligence (AI) platforms, and more than 70% of its workforce actively uses at least one, according to OPM CIO Adam Starr.
    • “Speaking Tuesday at the GovExec Government & AI Summit in Washington, D.C., Starr said OPM has leaned heavily on the General Services Administration’s (GSA) OneGov agreements to rapidly expand employee access to AI.
    • “The OneGov deals were key to our ability to innovate at OPM with AI,” Starr said. “We basically bought all of the AI offerings at $1, and so we gave every employee six AI tools, and we encourage them to use it.”
    • “Those tools include Google’s Gemini, Microsoft Copilot, xAI’s Grok, OpenAI’s ChatGPT, Anthropic’s Claude, and Perplexity AI, Starr said.
    • “The strategy is intentionally multi-model. Starr said he wants employees to have access to several platforms because AI models are evolving quickly and vendors are regularly “leapfrogging each other.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A., MPS IIIA is a rare inherited disease that progressively damages the brain and nervous system, causing children to lose cognitive, language and other developmental abilities over time. Until today, treatment was limited to managing symptoms; there was no FDA-approved therapy designed to change the underlying course of the disease.
    • “The Trump Administration is committed to bringing safe and effective treatments to patients with the most urgent and unmet needs. The approval of Fayuvi marks a historic moment for children and families living with MPS IIIA, which is a disease that has, until now, offered no approved treatment to alter its devastating course,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Gene therapy holds tremendous promise for rare diseases like Sanfilippo syndrome type A, and this milestone reflects the FDA’s commitment to action.”  
    • “Fayuvi is a one-time, intravenous (given directly into a vein) gene therapy that uses a modified, non-infectious virus called an adeno-associated virus serotype 9 (AAV9) to deliver a working copy of the SGSH gene into the patient’s cells. This enables the body’s cells to produce sulfamidase — the enzyme that is missing or deficient in MPS IIIA — allowing heparan sulfate to be properly broken down in lysosomes and reducing its harmful buildup throughout the body and brain.”
  • Targeted Oncology reports,
    • “FDA 510(k) clearance covers robotic colonoscopy for screening, surveillance, diagnostic evaluation, and advanced therapy including EMR and ESD across the full colon. 
    • “Triton 1 targets limitations of manual scope manipulation by adding robotic control intended to enhance stability, maneuverability, and procedural efficiency during flexible endoscopy. 
    • “CARE I (NCT06935734) reported 100% cecal intubation and no adverse events, meeting primary safety/efficacy end points in a first-in-human cohort. 
    • “Detection performance in CARE I included ADR 54.2% and polyp detection rate 67.5%, exceeding a cited 35% ADR industry threshold. 
    • “Endoscopist ergonomics improved, with a 67% lower perceived procedural workload versus manual colonoscopy on NASA-TLX, suggesting reduced physical and cognitive operator burden.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for a vessel-sealing technology used with its Hugo soft tissue robotic surgery system.
    • “The clearance, which Medtronic disclosed Wednesday, brings LigaSure technology, used in more than 45 million procedures worldwide, to the company’s robotic-assisted surgery platform.
    • “Targeting markets dominated by Intuitive, Medtronic has identified an opportunity to win share by pairing its platform with energy instruments that physicians use in non-robotic surgeries.”
  • MedPage Today informs us,
    • “Unapproved use of deoxycholic acid injection (Kybella) outside of the submental fat region may carry a risk of neuromuscular and other potentially serious adverse events, according to an FDA labeling update.
    • “A review of the FDA Adverse Event Reporting System (FAERS) revealed 129 cases of adverse events associated with use of deoxycholic acid in unapproved areas since the product was approved in 2015, the agency stated in a safety communication. The reports included some serious adverse events, such as blurred or reduced vision with periorbital use of deoxycholic acid injection and muscle or nerve injury, including facial paresis and paresthesia.
    • In announcing deoxycholic acid injection’s approval, the FDA emphasized, “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”

From the judicial front,

  • Bloomberg Law reports,
    • “An out-of-network healthcare provider can’t sue Cigna Health and Life Insurance Co. to recover more than $3 million it won against the plan through the No Surprises Act’s independent dispute resolution process, a federal appeals court said Thursday.
    • “The text and structure of the federal law, which created a process for resolving disputes between health plans and out-of-network providers, make clear that it doesn’t provide a private right of action to enforce arbitration awards obtained through that process, Judge Michael H. Park said. The US Court of Appeals for the Second Circuit thus affirmed the dismissal of East Coast Advanced Plastic Surgery LLC’s suit against Cigna.
    • “Although the NSA gives providers a right to payment from health plans for certain services, it delegates enforcement authority to multiple federal agencies and to states,” Park said for the unanimous panel. “This statutory scheme reflects Congress’s intent that the NSA, including payment of IDR awards, be enforced through administrative action rather than private litigation.”
  • Beckers ASC Review relates,
    • “San Tan Valley, Ariz.-based Rita Ntusa Anagho has been sentenced to 14 years in federal prison for orchestrating a $69 million Medicaid fraud scheme through her addiction treatment clinic, according to a Sept. 17 news release from the Department of Justice.
    • “Ms. Anagho, 54, a licensed nurse practitioner, owned and operated Tusa Integrated Clinic, which fraudulently billed Arizona’s Medicaid agency more than $69 million between about May 2022 and March 2023; the agency paid roughly $54.9 million on the false claims, according to court documents. 
    • “Ms. Anagho and her co-conspirators allegedly targeted patients covered under Arizona Medicaid’s American Indian Health Care Program, which reimburses at higher rates than other Medicaid plans, paid illegal kickbacks to sober home owners for patient referrals, and falsified treatment records to conceal the scheme.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “The U.S. cancer death rate declined 35% between 2015 and 2024, averting more than 4.8 million deaths, according to the American Association for Cancer Research’s 16th annual Cancer Progress Report, published Sept. 16.
    • Here are [three] things [the article has eight] healthcare leaders need to know from the report:
    • Death rates fell an average of 4.2% per year for lung cancer, 1.3% for colorectal cancer and 1.2% for female breast cancer between 2015 and 2024.
    • An estimated 2.1 million new cancer cases will be diagnosed in 2026.
    • By 2050, the number of annual cancer diagnoses is projected to rise to 2.5 million.
    • More than 18.6 million people with a history of cancer were living in the U.S. as of Jan. 1, 2025.
    • AACR researchers expect 22 million people to be living with cancer or a history of cancer by 2035.
    • “Read the full report here.”
  • Healio points out,
    • “Around 2.71 billion people worldwide were exposed to secondhand smoke in 2023.
    • “An expert encouraged clinicians to screen women, children and patients with cardiac issues for exposure.” * * *
    • “Despite the findings, Flor and colleagues highlighted progress from tobacco-reducing policies in the Americas, as “of the 79 countries attaining the highest level of achievement in smoke-free protections globally, 24 are in the Americas, approximately 70% of the countries in that region.”
  • STAT News adds,
    • “For years, researchers have known that, among people diagnosed with lung cancer, the prevalence of nonsmokers has been increasing. But they have been trying to determine what factors — whether genetic, environmental, or something else — might put these “never-smokers” at heightened risk. 
    • “Now, researchers have identified a very rare genetic variant that is associated with 25-fold higher odds of lung cancer, they reported in the journal Science on Thursday. In the U.S., the variant is far more common among people in Southern Appalachia than in other regions. 
    • Experts said that the variant likely only plays a role in a small portion of never-smoker lung cancer cases. But the research provides further evidence that these types of tumors can be tied to distinct risk factors, which may in turn require thinking differently about screening programs and treatment strategies. More broadly, the new study highlights the types of narrow but crucial discoveries that can be made by turning to large datasets replete with health information from millions of people. In this case, the investigators relied on genetic data from 23andMe.” * * *
    • “The variant in question — known as T790M — is a version of a gene called EGFR, which typically helps regulate how cells grow and divide. Select EGFR mutations can crop up over a person’s life and are among the most important drivers of lung cancer, and in turn are targeted by some cancer drugs.”
  • The Washington Post calls attention to “5 movements physical therapists say every adult over 50 should do daily.”
    • These simple moves can help you maintain mobility and independence as you age.”
  • Beckers Behavioral Health informs us,
    • “A 13-item Mental Wellness Tool detected common or severe mental disorders, substance use disorders and suicide risk among patients receiving psychiatric emergency department care at a New York City hospital, according to a Sept. 17 Medscape report.
    • “Existing mental health screening tools typically assess for one disorder, and screening for a range of psychiatric conditions can take well over 45 minutes and require several assessment tools. The mwTool-13 is designed to screen for multiple conditions in a single assessment.
    • “The mwTool-13 can be administered in 2 to 10 minutes, according to a Sept. 3 study published in Psychiatric Services.”
  • The Wall Street Journal shares readers views on patient portals.
  • Health Day tells us,
    • “Nearly two-thirds of suspected poisonings in young children probably do not need the emergency department and can be handled by a call to the local poison control center, according to a study published in the August issue of Clinical Toxicology.
    • “Liam P. McLoughlin, M.D., from Rutgers New Jersey Medical School in Newark, and colleagues investigated the medical necessity of pediatric emergency department presentations for poison cases where a poison control center was not contacted prior to presenting at the emergency department. The analysis included toxicologist reviews of summaries from 348 poison control center cases, originating from a health care facility, involving patients aged younger than 6 years.” * * *
    • “A big takeaway from the paper is that more needs to be done to make sure parents, schools, and communities know the poison center is a resource they can turn to when a poisoning is suspected,” McLoughlin said in a statement. “The poison center is available 24/7, 365, and is staffed by amazing people who can provide life-saving information by phone at no cost.”
  • and
    • “Exercise is already recommended to help people with cancer manage fatigue and improve quality of life. Now, there is evidence the benefits may go further.
    • “A new study finds structured exercise may help people with cancer live longer and have more time free of disease.
    • “Chih-Chen Tzang of the National Taiwan University and colleagues analyzed 21 clinical trials involving more than 8,400 cancer patients.
    • “Some followed supervised exercise programs that included aerobic exercise, strength training or both. Others did not.
    • “Over an average follow-up of about five years, those who exercised were 23% less likely to die and 17% less likely to have their cancer return before death.
    • “The benefits were strongest among people with early-stage cancer, those who did aerobic exercise — alone or with strength training — and those who completed at least 70% of their exercise program.”
  • Per Genetic Engineering and Biotechnology News,
    • “The genome editing toolbox provides unprecedented opportunities to engineer the human genome. However, genome editing for therapeutic benefit continues to have its limitations. Most current methods rely on untargeted gene delivery or short DNA edits that need to be individualized to each patient.
    • “Now, a new paper describes a novel genome engineering method, prime assembly, that allows long DNA fragments to be integrated into precise and programmable target positions within living cells. This approach, which leverages CRISPR-targeted dual flap synthesis, may allow for the development of universal gene therapies.
    • “This work is published in Nature in the paper, “Targeted genomic integration and rearrangement using prime assembly.”
  • Per Fierce Pharma,
    • “Roche’s T-cell engager portfolio has notched another milestone, as a phase 3 trial of the company’s Lunsumio met its primary endpoint in earlier-line follicular lymphoma.
    • “Without sharing any specific data, Roche and its subsidiary Genentech said Lunsumio’s combination with lenalidomide (Revlimid) demonstrated a statistically and clinically meaningful improvement in progression-free survival against rituximab (Rituxan) plus lenalidomide, known as R2, in the phase 3 Celestimo study. 
    • “The trial enrolled follicular lymphoma (FL) patients who have received at least one prior line of treatment, and it serves as the confirmatory study required to convert Lunsumio’s existing accelerated approval as a monotherapy in third-line FL into a full approval, while also potentially moving the drug earlier into the second-line setting.”

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

  • Beckers Payer Issues reports,
    • “The National Committee for Quality Assurance has named the highest quality and most effective health plans of 2026 based on clinical quality, patient experience and health plan accreditation status.
    • “The ratings were released Sept. 16 and are based on 2025 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover approximately 236 million people. Some MA plan data is from 2024 because of reporting schedules, and NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 956 plans received a rating.
    • “Commercial plans that received a five-star rating:
      • BCBS Massachusetts
      • Capital District Physicians’ Health Plan (New York)
      • Capital District Physicians’ Healthcare Network (New York)
      • Harvard Pilgrim Health Care (Massachusetts, Maine)
      • Independent Health (New York)
      • Kaiser Mid-Atlantic (Washington, D.C.; Maryland; Virginia)
      • Kaiser Northern California
      • UPMC Benefit Management Services
      • UPMC Health Plan
  • and
    • “When Providence announced it was shutting down its health plan earlier this year after a $102 million loss in 2025, it joined a growing list of health systems stepping back from the insurance business. Carle Health’s Health Alliance, Michigan Medicine’s U-M Health Plan and others have wound down or are exiting, citing volatility in Medicare Advantage and government payer markets that have made provider-sponsored plans increasingly difficult to sustain.
    • “Terry Gilliland, MD, president and CEO of Danville, Pa.-based Geisinger, is watching the same environment unfold and coming to the opposite conclusion.
    • “Rather than say, this is hard and dump the plan, we’ve made the necessary changes including leadership top to bottom to grow profitably,” Dr. Gilliland said.”
  • and
    • “CVS Health’s Aetna is expanding prior authorization bundles for cancer, available to some Medicaid members as of Sept. 1.
    • “The update impacts Medicaid members with providers in Oklahoma, Illinois, Maryland, New Jersey, Virginia, Florida, Kentucky and West Virginia who use the Eviti portal for prior authorizations. Aetna anticipates broadening eligibility to Medicare and commercial members in the first half of 2027.
    • “According to a Sept. 17 news release, Aetna observed providers submitting four different prior authorizations, on average, for its members needing cancer treatments. These bundles allow a single prior authorization request that could encapsulate medical oncology and radiation oncology services with high-tech imaging needs. The expansion builds upon an early rollout of the bundles. 
    • “By approving a broader set of treatments and related services upfront, we’re removing barriers that can delay care,” Aetna COO and Medicaid President Katerina Guerraz said.”
  • Beckers Hospital Review relates,
    • “St. Louis-based Ascension has reached an agreement to transfer full ownership of its co-owned Arizona managed care health plan, Mercy Care, to CVS Health subsidiary Aetna, a spokesperson for Ascension confirmed with Becker’s. 
    • “Ascension co-owns the plan with San Francisco-based CommonSpirit’s Dignity Health, the spokesperson confirmed. The agreement is subject to regulatory reviews and approvals.
    • “Mercy Care has long served vulnerable populations, families and individuals across Arizona through Arizona Health Care Cost Containment System Medicaid programs and Medicare Duals Special Needs Plans,” the spokesperson said. “Aetna has successfully managed Mercy Care’s day-to-day operations and administrative services for over 20 years.”
  • and
    • “HCA Healthcare CFO Mike Marks said payers have outpaced hospitals on AI-driven claims processing, adding another layer to the friction hospitals face on denials, underpayments and prior authorization.
    • “I know there’s a lot of talk about AI in the hospital revenue cycle, we’re behind the payers, in my view,” Mr. Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference in Nashville, Tenn., where the 190-hospital system is also headquartered.
    • “Payers, he said, have real incentives driving their AI investments, including medical loss ratios and patient populations to manage.
    • “They’ve been working really hard on their version of AI in their claims shop,” he said.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare is seeing softer elective surgery volumes as patients lose coverage through the health insurance exchanges, with broader affordability pressures potentially contributing to the slowdown, CFO Mike Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference.
    • “The 189-hospital, for-profit system continues to see strong overall demand for healthcare services, but the movement of patients from exchange coverage to uninsured status is weighing on elective procedures.
    • “On the inpatient side of elective, and frankly, on the outpatient surgery side as well, the biggest issue is HICS,” Mr. Marks said, referring to health insurance exchange coverage. “This movement out of HICS to uninsured — as people in our communities have lost coverage on the exchange [and] become uninsured — they generally lose access to elective care. That is the primary driver of the slowdown in our elective surgery volumes is exchanges.”
  • Beckers ASC Review tells us,
    • “Brentwood, Tenn.-based Surgery Partners has completed the sale of its ownership interests in its Idaho Falls, Idaho, facilities to Intermountain Health for $797 million in gross proceeds, according to a Sept. 17 news release.
    • “The deal includes Mountain View Hospital and Idaho Falls Community Hospital, values the combined facilities at about $1.15 billion, and delivered Surgery Partners $587 million in net cash proceeds at closing, subject to customary post-closing adjustments. Physician ownership of Mountain View Hospital will remain unchanged under Intermountain’s leadership, and the proceeds will primarily go toward paying down debt, which is expected to improve the company’s balance sheet leverage by about 30 basis points from 4.4x at the end of the second quarter.
    • “Excluding the Idaho Falls facilities, Surgery Partners expects a 50% reduction in its Medicaid payor mix, to under 2% of revenue, along with the elimination of its neonatology, obstetrics, inpatient pediatrics and retail and compounding pharmacy service lines.”
  • Fierce Healthcare informs us,
    • “Big box retailer Walmart is launching a six-month pilot program that places pharmacists in a new “Health Ambassador” role at five rural stores to help customers navigate health and wellness resources.
    • “Walmart’s Health Ambassador Associate will be able to aid patients in understanding their health goals and help connect them to relevant services and resources.
    • “The Health Ambassador role will be piloted at locations serving rural and underserved communities across the U.S., including in Lexington, Tenn.; Caro, Mich.; Franklin, Va.; Fort Scott, Kan.; and Searcy, Ark.
    • “The pilot will initially focus on three healthcare areas: diabetes, weight management and maternal health. Health Ambassadors can also aid customers in nutrition, movement, sleep and stress management through the program’s in-person conversations and tailored coaching.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.”
  • and
    • “Blue Shield of California announced Thursday that it plans to expand its Virtual Blue program, doubling program enrollment for members.
    • “Beginning in January 2027, the benefit will be included in fully insured preferred provider organization (PPO) plans for employers with 101 to 3,000 employees, as well as for certain individual and family plans, the insurer said.
    • “The expansion will allow an additional 200,000 mid-size employer PPO members and 60,000 individual and family plan members to utilize the program, increasing its total enrollment to more than 410,000 participants, executives say.
    • The virtual-first program, first launched in 2023 in collaboration with Accolade and TeleMed2U, has more than 150,000 members as of April. The program gives members access to a range of virtual health services at no additional cost, along with care from providers in Blue Shield’s PPO network.
  • Per BioPharma Dive,
    • “Novo is investing in oral biologics, signing a deal with fellow Danish company Orbis Medicines to discover multiple “macrocycles” that have the “potential to replace injectable medicines,” Orbis said Thursday.
    • “Orbis could receive as much as $1.4 billion in up front and downstream payouts, as well as sales royalties, in the deal. The companies didn’t specify the number of drugs on which they would collaborate, nor specific diseases, only mentioning that they’ll pursue unnamed cardiometabolic targets.
    • “The use of macrocycles is one way Novo could overcome some of the limitations of standard oral peptide medicines, such as poor digestive absorption. The highest dose of Novo’s Wegovy pill contains 20 times the highest injectable dose because most of the drug’s active ingredient is chewed up before reaching the bloodstream.”
  • and
    • “North Immunology, in the early stages of developing a potential competitor for the widely popular inflammatory disease drug Dupixent, plans to go public next year via a reverse merger with Aethlon Medical.
    • “After the merger, the companies expect North Immunology investors to own 95.25% of the new entity, with the rest going to Aethlon shareholders. Those who own Aethlon stock immediately prior to the merger will also get a contingent value right entitling them to potential proceeds from Aethlon’s legacy Hemopurifier business. 
    • “The new company will operate as North Immunology and trade on the Nasdaq under the ticker symbol “NRTX,” Aethlon said Thursday. North Immunology’s executives will lead the combined entity, and its directors will populate the board, along with some new independent directors. The companies expect the transaction to close in the first quarter of 2027.”
  • Healthcare Dive points out,
    • “Healthcare organizations are rapidly adopting agentic artificial intelligence, but governance frameworks for managing the technology are not evolving at the same pace, according to a new survey from digital identity security firm Imprivata.
    • “More than 85% of leaders responsible for AI strategy at healthcare organizations say they’re confident they have visibility into AI agent activity and are able to fully control and govern an autonomous agent’s actions.
    • “However, 72% of respondents admit AI tools are deployed without IT approval at least occasionally within their organizations, highlighting a disconnect between confidence and reality.”

Midweek report

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

Simplicity is a virtue.

From Washington, D.C.,

  • STAT News reports,
    • “Normally, discussions about how congressional advisers study Medicare spending are quite dry. Not so at the House Ways and Means Committee on Wednesday.
    • “In a party line vote, committee Republicans pushed forward a bill that seeks to change how the Medicare Payment Advisory Commission studies Medicare Advantage spending. In particular, this bill would direct the nonpartisan agency to study the topic of overpayments to Medicare Advantage plans in a manner that’s more favorable to insurers.” * * *
    • “It’s a bit of a change in tune for some Republicans, especially those who are doctors, who had become frustrated with Medicare Advantage insurers that deny care to patients. 
    • “However, Rep. Greg Murphy (R-N.C.), who is among those doctors who have criticized certain industry practices, said he had no problem supporting the bill. 
    • “Asking for more information so that we can make real choices and reform the Medicare Advantage system, I am absolutely for,” he said.”
  • and
    • “Democrats are vowing to aggressively pursue oversight if they win control of either the House or Senate in November’s midterm elections. Health care issues, including President Trump’s drug pricing deals, are potential targets. 
    • “It’s common for parties to turn to oversight when they take control of a congressional chamber. Lawmakers can use oversight to tell a story about the other side. It also avoids intraparty divisions by focusing attention on what the other party has done. And if Democrats want to keep the focus on Trump, even though he can’t run again, oversight is a good way to do that.”
  • MedPage Today adds,
    • “Nicole Saphier, MD, President Donald Trump’s third surgeon general nominee, was grilled at her confirmation hearing Wednesday about her stance on childhood vaccines, voicing support for immunization as she seeks to serve in an administration that has moved to make sweeping changes to vaccine guidance.
    • Saphier, a radiologist and former Fox News Channel contributor, faced tough questioning about her views on the safety of childhood vaccines by Sen. Bill Cassidy, MD (R-La.), who pressed her to declare whether she believed there was a link between vaccines and autism — which widespread scientific consensus has concluded doesn’t exist, yet which the Trump administration has repeatedly pushed to revisit.
    • “I do not believe childhood vaccines cause autism,” Saphier said. She also said “the MMR [measles, mumps, and rubella] vaccine is our greatest tool for combating measles,” in response to a question by Cassidy over whether parents should give children that shot, and which the president recently ordered be spaced out.
  • Healthcare Dive relates,
    • “Health plans are generally performing better on quality and performance ratings, though nonprofit insurers continue to surge past their for-profit peers.
    • “The National Committee for Quality Assurance released its 2026 ratings on Tuesday, which score commercial, Medicare and Medicaid plans across a range of measures of clinical quality, patient experience and health outcomes. Eighteen plans nabbed the standards organization’s highest 5-star rating, up from 11 last year. All of them are nonprofits.
    • “Of the major publicly traded carriers, CVS had the highest scores, averaging at about 4 stars, according to a Healthcare Dive analysis of the data. Meanwhile, plans’ average rating ticked up slightly, from 3.483 last year to 3.493 in 2026 thanks to improvements in commercial and Medicaid plans, though Medicare insurers’ average rating slipped.”
  • Healthcare Finance News tells us
    • “The American Hospital Association and American Medical Association are urging the Centers for Medicare & Medicaid Services to reconsider proposed reductions to Medicare physician payments for 2027, warning that the cuts could threaten patient access and the financial stability of physician practices.
    • “Comments on the proposed rule, which was released in July, were due Monday.
    • “The AMA voiced its concerns earlier this month about a CMS plan to cut physician pay when doctors provide a separately identifiable office or outpatient evaluation and management (E/M) visit on the same day as most procedures are performed. 
    • “The agency scrapped this same plan eight years ago, the AMA said, after physicians and other stakeholders raised serious concerns. 
    • “But CMS is pitching a similar idea in its 2027 Medicare physician payment schedule proposed rule,” the AMA said. “If finalized, most changes, including this one, would be scheduled to take effect Jan. 1.”
    • “The AMA called for annual physician payment updates tied to medical inflation, arguing that the lack of consistent inflationary adjustments has contributed to the erosion of physician practice sustainability.”
  • The American Hospital Association News tells us,
    • “The Workgroup for Electronic Data Interchange has launched its fall 2026 survey to assess industry readiness for the Centers for Medicare & Medicaid Services’ interoperability and prior authorization final rule. Survey responses are anonymous, and all results are aggregated. The survey will close on Oct. 9. WEDI plans to use the results to make recommendations to CMS, inform stakeholders and assist WEDI in its development of industry guidance and education.” 

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

  • Govexec reports,
    • “Senate Democrats again urged the Trump administration Wednesday to abandon its plans to collect detailed health information from federal workers, retirees and their families, saying recent tweaks to “de-identify” records are insufficient to protect employees’ privacy.
    • “Last December, the Office of Personnel Management published an information collection request in the Federal Register that would require insurers who participate in the Federal Employees Health Benefits and Postal Service Health Benefits programs to provide monthly reports with identifiable health data on their enrollees.
    • “Following pushback from federal employee groups and medical ethicists, OPM in June revised its proposal, purporting to take steps to mask employees and retirees’ identities in the data collection. But organizations that represent federal workers and retirees warned that the agency still hadn’t done enough to protect patients’ privacy.
    • “In a letter to OPM Director Scott Kupor, a group of six Senate Democrats, led by Sens. Adam Schiff, D-Calif., and Mark Warner, D-Va., who previously requested the proposal’s withdrawal, wrote that the proposed pseudonymization of records does not their “fundamental” concerns with the plan, particularly the agency’s insistence that it may re-identify insurance claimants in the future.”
  • FedWeek relates,
    • “OPM has provided some additional information on agency responsibilities to conduct the annual survey of federal employees—which it plans to shift to them from itself under a pending rules proposal—although still not setting a schedule for conducting this year’s version.
    • “A September 17 Federal Register notice states that the survey traditionally called the Federal Employee Viewpoint Survey will be renamed as the Annual Employee Survey, and reaffirms the intention in the earlier rules proposal to reduce the number of core questions from 16 to 10.
    • “That is to include dropping longstanding questions asking employees about their overall level of satisfaction with their job; with the recognition they receive for doing good work; with their organization overall; with the information they receive about what is going on in it; with their level of involvement with decisions that affect their work; and whether they would recommend their organization as a good place to work.
    • “OPM traditionally used those satisfaction-related questions in creating an index that was widely—although not officially—seen as a proxy for morale.”

From the U.S. Food and Drug Administration front,

  • Good Housekeeping reports,
    • “FDA issued a Class II recall on September 11 for six hand soap products from Intercon Chemical Co. distributed across 15 states. The original recall happened on June 29 due to potential bacterial contamination.
    • “Two soap variants contained harmful bacteria including Pseudomonas aeruginosa and Serratia marcescens, which can cause serious infections like pneumonia, UTIs, and blood infections, especially in immunocompromised individuals.
    • “Consumers should identify recalled products by UPC codes and lot numbers listed for Intercon, Clearly Better, Summit, Vestis, and Laura Lynn brands, then stop use immediately and seek medical attention if symptoms develop.”
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new generic radiopharmaceutical alternative from drugmaker Curium, aimed at competing with another treatment on the market. 
    • “Bexlutry (lutetium Lu 177 dotatate) is a radioligand therapy designed to deliver targeted radiation for treating a group of rare cancers originating in the digestive track and pancreas. Boston-based Curium scored the approval through the FDA’s 505(b)(2) pathway, supported by published evidence and targeted bridging data. 
    • “This demonstrated that Bexlutry achieved a similar biological and chemical profile to the previously approved Lutathera, manufactured by rival firm Novartis. 
    • “Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer,” Mike Patterson, Curium’s CEO of North America, said in a statement Sept. 14. “Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy.”

No Surprises Act News

  • Politico reports,
    • “A Senate committee held stakeholder roundtables on Tuesday to discuss reforms to the 2020 No Surprises Act, which set up how doctors and insurers are paid for unexpected medical bills, Simon reports.
    • “The act, originally co-sponsored by Health, Education, Labor and Pensions Chair Bill Cassidy, shielded patients from unexpected out-of-network emergency care bills. But it has come under fire for creating a case backlog in a system that critics argue can pay disproportionately in favor of doctors.
    • “Employers, physicians, insurers and unions — groups typically at odds — held a cordial, constructive talk about possible solutions, according to four people familiar with the meetings who were granted anonymity to speak candidly. Committee staff also met separately with the arbitrators responsible for overseeing and resolving payment disputes.
    • “Over three hours, the stakeholder group didn’t settle on any policy changes, but they agreed on the need to eliminate the dispute backlog by filtering out ineligible claims and encouraging faster payouts. The group emphasized the importance of benchmark rates for medical services, known as qualified payment amounts, when determining payouts and that only emergency care bills should be eligible for arbitration.
    • “It is early, and the devil will be in the details, so to speak, as conversations continue, but overall a positive vibe,” said one of the four people familiar with the discussion. Another of the four, who was a provider attendee, said, “It was pointed but respectful.” * * *
    • “What’s next: The Senate HELP Committee will hold a roundtable with members next week to talk through legislative solutions.”

From the judicial front,

  • Healthcare Dive reports,
    • “A group of independent pharmacies in Arkansas are suing Express Scripts, one of the largest pharmaceutical middlemen in the U.S., for allegedly underpaying for tens of thousands of prescriptions.
    • “The lawsuit filed Tuesday, which seeks hundreds of millions of dollars in damages, is the first filed under a state law passed last year giving Arkansas pharmacies the ability to go after PBMs for reimbursing them below the acquisition cost of drugs, according to lawyers for the plaintiffs.
    • “We’re committed to reimbursing pharmacies at competitive rates and will defend ourselves against these allegations,” an Express Scripts spokesperson said.

From the public health and medical / Rx research front,

  • The New York Times offers advice on whether you are eating enough fiber in your diet.
    • “With so much attention on protein lately, you’d be forgiven for forgetting about fiber.
    • “But if you’re like most adults in the United States, you’re probably falling short of the recommended minimum of 21 to 38 grams per day, depending on your age and sex. The average U.S. woman consumes about 15 grams of fiber daily, and men consume about 18 grams per day.
    • “Closing that gap may be one of the best strategies for improving your health. Fiber nourishes gut microbes, lowers blood pressure and cholesterol, improves digestion and reduces the risks of heart disease, Type 2 diabetes and certain cancers.
    • “It can seem like a big challenge to eat enough fiber, but nutrition experts say it doesn’t have to be. You just have to know where to look.”
  • Cardiovascular Business adds,
    • “Eating four to six servings of whole-grain foods per day is associated with multiple cardiovascular benefits, according to a new meta-analysis published in European Heart Journal. 
    • “The authors focused on data from more than 6,500 adults from the United States, Europe, Asia, Canada, Australia or Brazil who participated in one of 87 different clinical trials. Overall, eating 48 grams of whole-grain food—oats, brown rice or quinoa, for example—each day was associated with improvements in body weight, waist circumference, total cholesterol, blood pressure, LDL cholesterol, glucose and interleukin-6 levels. These are all known risk factors of cardiovascular disease.
    • “This is the largest and most comprehensive meta-analysis of randomized controlled trials on whole grain intake and cardiovascular risk factors,” senior author Helda Tutunchi, PhD, a nutrition specialist with Tabriz University of Medical Sciences in Iran, explained in a statement. “Unlike previous reviews, we looked specifically at how much whole grain people need to eat to get the greatest benefits. We also evaluated the certainty of the evidence and found high-certainty evidence for improvements in several outcomes, including body weight, waist circumference and total cholesterol.”
    • “Tutunchi added the impact of eating more whole-grain foods appears to be through “several modest improvements acting together” as opposed to “one large effect on a single risk factor.”
  • Health Day relates,
    • “Women’s risk of having a harmless tumor caught and treated as a result of breast cancer screening is much lower than once thought, a new evidence review has concluded.
    • “Overdiagnosis — the detection of breast cancers that never would have harmed a woman’s health during her life — occurs in fewer than 5% of cancer screenings, researchers reported Sept. 14 in the Journal of the National Cancer Institute.
    • “That’s far lower than previous estimates, which held that as many as 30% to 50% of breast cancer detected through screening might represent overdiagnosis, researchers said.
    • “These earlier studies were inaccurate because they tracked breast cancer screenings for a limited period of time, the research team argued.”
  • and
    • “ADHD is linked to a nearly 50% increase in GI problems, a new evidence review says.
    • The association was even stronger for specific GI problems, including an almost doubled risk of constipation, a 58% increase in irritable bowel syndrome and more than four times higher odds of losing bowel control, researchers reported Sept. 10 in the Journal of Attention Disorders.
    • “Almost every gut symptom we looked at: constipation, IBS, even indigestion, appeared to be associated with ADHD,” said lead researcher Sarah Blake, a medical student at the University of Warwick Medical School in the U.K.
    • “These symptoms can have a real impact on daily life, but they could easily be overlooked if the focus is on ADHD itself,” she added in a news release.
    • “There are several potential explanations for these links, including ADHD-related eating patterns, side effects from medication and even ties between ADHD and gut bacteria, researchers said.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Scientists studying Alzheimer’s disease have long focused on genes, proteins, and cells, but one class of molecules has remained largely outside the playbook: microproteins. These small proteins, produced from small open reading frames (ORFs) and typically measuring 150 amino acids or fewer, have been difficult to detect and study. Yet growing evidence suggests they may have important roles in health and disease.
    • “Now, researchers at the Salk Institute have created what they describe as the first microprotein atlas of the human frontal cortex with and without Alzheimer’s disease. The study, “A microprotein atlas of the human frontal cortex in Alzheimer’s disease,” was published in Nature Aging. The resource integrates transcriptomics, mass spectrometry, and deep-learning-predicted spectra across postmortem brain samples to identify microproteins that have been overlooked in standard protein catalogs.
    • “We still do not fully understand the molecular mechanisms of healthy aging, and that is especially true for microproteins, which have been inadvertently overlooked for decades,” said senior and co-corresponding author Alan Saghatelian, PhD, professor and the Dr. Frederik Paulsen Chair at Salk, in a press release. “Our atlas allows scientists to systemically investigate microproteins in aging and neurodegeneration, which should bring us closer to understanding and tackling diseases like Alzheimer’s or Parkinson’s.”
  • Per an Institute for Clinical and Economic Review (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 tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “Downloads: Evidence Report | Voting Questions | Public Comments | Response to Public Comments
    • “Parkinson’s disease is a chronic and progressive neurological condition largely characterized by the loss of motor skills and physical function,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “There are currently no disease-modifying treatments, so symptom management is paramount. While tavapadon provides some relief from key symptoms, benefits were similar to those of older, generic drugs, and discontinuation from tavapadon due to adverse events was relatively high. The combination of modest benefit and uncertainties around discontinuation raise important questions about tavapadon’s long-term value.”
    • Register here to watch the live webcast of the October 1st ICER public meeting.

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

  • Beckers Hospital Review reports,
    • St. Louis-based Ascension narrowed its operating loss by $371 million in fiscal 2026, as stronger revenue, higher patient volumes and operational improvements moved the health system closer to breakeven, according to financial documents published Sept. 16.
  • and
    • “Fitch revised Chicago-based CommonSpirit Health’s rating outlook to negative from stable on Sept. 16, while affirming the health system’s “A-” rating. 
    • “The revision follows CommonSpirit’s financial results through the quarter ended March 31, which fell short of management’s internal margin targets, Fitch said in a Sept. 16 report. Fitch pointed to an uneven path to sustained profitability as the system executes several overlapping initiatives at once, including an Epic EHR rollout, insourcing revenue cycle operations and its multiphase Project Impact plan, which targets an 8% EBITDA margin by fiscal 2029.” 
  • Beckers Behavioral Health relates,
    • “U.S. News & World Report named 50 hospitals to its 2026-2027 Best Children’s Hospitals Pediatric & Adolescent Behavioral Health list.
    • “U.S. News evaluated 91 hospitals for their care of children and teens with mental and behavioral health conditions, including autism, anxiety, depression, eating disorders, ADHD, bipolar disorder, schizophrenia, language and learning disorders, and substance abuse and addiction.
    • “Programs and care in areas such as medication screening and safety, speed and efficiency of the emergency department, and management of side effects were among the factors used to rank hospitals.”
  • Beckers Payer Issues tells us,
    • “SCAN Health Plan has emerged as a major Medicare Advantage partner for retailers, with Walmart now partaking in a co-branded plan.
    • “The health insurer and retailer are launching the plan in two states, according to a Sept. 16 SCAN news release. More than 2 million enrollees are expected to have access.
    • “The MA offering could tie in pharmacy and vision services, food, and over-the-counter benefits, pending regulatory approval. The news release also said Walmart will leverage Everyday Health Signals, its AI-driven platform for tailored nutrition and wellness, in the collaboration.
    • “What makes this collaboration unique is Walmart’s role in customers’ everyday lives. Because customers regularly turn to Walmart for groceries and other everyday essentials, we have an opportunity for those who choose to participate, to use insights from their shopping experiences to make nutrition guidance more relevant and actionable,” said Pravene Nath, MD, group director for consumer health and data solutions at Walmart U.S.” * * *
    • “In August, SCAN announced plans to roll out insurance products with Costco, as well.” 
  • Beckers Physician Leadership shares the new math of physician independence.
    • “Independent physicians have spent more than a decade watching the share of their peers who own their own practices shrink. 
    • “New data exists that tells the story of what it now costs to stay independent, how much deal-making and closure activity is still working against that choice, and where regulators and a new wave of physician-owned infrastructure are starting to push back.
    • “Taken together, the figures describe less a single trend than a recalculated equation — one where the cost of going it alone, the cost of selling and a growing set of options in between are all moving at once.”
  • MedCity News informs us,
    • “Thatch, a health benefits platform, announced on Tuesday that it raised $108 million in funding, reaching a $1 billion valuation.
    • “Thatch helps employers offer Individual Coverage Health Reimbursement Arrangements (ICHRAs) — which recently rebranded as CHOICE Arrangements — in which employers can provide their employees tax-free money so they can purchase their own individual health insurance plans. Employees can also use the funds for certain healthcare expenses, including GLP-1s and therapy. More than 5,000 employers use the company, including Jersey Mike’s and Smoothie King. 
    • “The Series C funding round was from The General Partnership, Index Ventures, General Catalyst and Andreessen Horowitz. ADP Ventures, Paychex, Eli Lilly and Company, Scale Venture Partners, QuantumLight, SemperVirens, Quiet Capital and Avid Ventures also participated. In total, Thatch has raised $192.5 million in equity funding.”
  • Fierce Healthcare adds,
    • “Ayble Health secured a $16 million oversubscribed series A funding round to accelerate its expansion into artificial intelligence-driven precision digestive and autoimmune healthcare.
    • “Neon led the funding round, with participation from Unum Ventures, Upfront Ventures, M13, Cleveland Clinic Ventures, DigiTx, Accomplice and several individual investors. 
    • “I’ve been tracking the GI space closely for years, and what Ayble has built is different,” said Kimmy Scotti, Neon founding and managing partner, in a statement. “Having invested early in top digital health companies, I’ve seen what it takes to build a category-defining company in healthcare. Ayble has spent years building the clinical evidence before they scaled the business. That earns trust from the full ecosystem: health systems, payers, and most importantly, patients, and it’s what makes a durable market leader.”
  • BioPharma Dive points out,
    • “Novartis will pay $125 million up front for rights to a delivery platform designed to get drugs into the brain.
    • “Sironax, a Boston-area biotechnology company, said Tuesday that Novartis has exercised an option to acquire full ownership of that startup’s brain delivery platform. Sironax’s technology is meant to overcome a major challenge in neurological drug development: delivering therapeutics across the “blood-brain barrier.”
    • “Sironax will receive the nine-figure payout following the close of the transaction and will continue to retain rights to develop, manufacture, and commercialize certain assets with the platform. The company currently has three programs in early-stage trials that it plans to move forward using the purchase proceeds.”
  • Cardiovascular Business notes,
    • “Jaguar LAA, a new California-based medtech startup, has purchased key assets related to performing left atrial appendage (LAA) closure procedures from Johnson & Johnson. 
    • “Johnson & Johnson has owned these assets since it acquired the medtech company Laminar for $400 million back in 2023. Now, some original Laminar employees have partnered with investment firm Santé Ventures to buy back the assets and push forward as Jaguar LAA, a brand new company.
    • “The financial terms of this acquisition have not yet been made public.” 
  • The Wall Street Journal lets us know,
    • “Novo Nordisk NOVO.B, the Danish drugmaker behind blockbuster diabetes and weight-loss drugs Ozempic and Wegovy, is partnering with Anthropic to use artificial intelligence for drug research.
    • “Novo said Wednesday it would use Anthropic’s science-specific platform, known as Claude Science, to help speed up the discovery and development of new medicines and strengthen the pharmaceutical company’s software development.
    • “The partnership is the latest by a slate of major drugmakers, including Eli Lilly, Merck and Roche, that are placing big bets that AI can help them discover and produce medicines more quickly. 
    • “AI can help us increase productivity in R&D and compress the path from research to marketed product. But beyond this, AI tools can also offer completely new scientific opportunities and aid reasoning and understanding of human biology and drug mechanics,” Novo Chief Executive Mike Doustdar said.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Energy and Commerce Subcommittee on Health held a hearing Sept. 15 to discuss more than a dozen legislative proposals regarding Medicare provider payment and healthcare cybersecurity. The AHA provided comments to the subcommittee on bills designed to improve long-term physician payments, including proposals to increase the budget neutrality threshold in the Medicare physician fee schedule and a bill to replace the Merit-based Incentive Payment System with the Data-driven Performance Payment System. The AHA also commented on bills to provide grants for the adoption of cybersecurity best practices, direct the Department of Health and Human Services to create a strategy for rural hospital cybersecurity staff training, and improve obstetric emergency preparedness in rural healthcare settings.” 
       
  • MedPage Today relates,
    • “Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearing Tuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • “Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearingopens in a new tab or windowTuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • “Committee chairman Sen. Mike Crapo (R-Idaho) took the opposite view. “You have met all of the requirements and standards of this committee in vetting a nominee, and you are completely and well qualified to be deputy secretary at the Department of Health and Human Services,” he told Klomp.” 
  • The Wall Street Journal adds,
    • “Pennsylvania health officials announced Tuesday a fourth measles-associated death, the latest fatality in the commonwealth where recently reported deaths from the vaccine-preventable disease have inflamed politics at the local and national level.
    • “The death follows those of two infants in the state’s Lancaster County in mid-August amid a growing measles outbreak. The state health department’s classification of those deaths spurred a highly politicized debate over vaccinations and sparring between the state’s Democratic governor and the nation’s health secretary.
    • “Over the weekend, a coroner in Pennsylvania’s Jefferson County said a 40-year-old woman there died from complications from measles. The Mifflin County Coroner’s Office on Tuesday said an 18-year-old resident died due to a rare neurological complication from measles. The state health department said it worked with local coroners’ offices to determine both individuals tested positive for measles and the deaths didn’t result from an unrelated cause.
    • “That’s four total measles-associated deaths in our Commonwealth and the first Pennsylvania has seen in 35 years,” Pennsylvania Gov. Josh Shapirosaid in a post on social media Tuesday. “These are tragedies, and four families are grieving.”
  • Per a U.S. Census Bureau news release,
    • “The U.S. Census Bureau today announced that real median household income was $87,460 in 2025, the highest on record dating back to 1967.
    • “The official poverty rate fell 0.5 percentage points to 10.2% in 2025. The following 2025 findings were not statistically different from 2024: the Supplemental Poverty Measure (SPM) rate in 2025 was 13.1% and in 2025, 26.7 million people (7.9%) were uninsured for the entire year, according to the 2026 Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • ‘These findings come from three Census Bureau reports, “Income in the United States: 2025,” “Poverty in the United States: 2025” and “Health Insurance Coverage in the United States: 2025.”
  • Beckers Hospital Review tells us,
    • CMS will add four condition tracks to its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model starting in spring 2027, the agency said in a Sept. 15 news release.  
    • Four things to know: 
      • “The expansion adds heart failure, chronic obstructive pulmonary disease, substance use disorders and tobacco cessation to the model. CMS will also expand support for chronic musculoskeletal pain, extending coverage for certain conditions beyond the model’s initial 12-month care period.
      • “The model already covers hypertension, diabetes, chronic musculoskeletal pain and depression. CMS says 3 out of 4 Medicare beneficiaries qualify for at least one track.
      • “The ACCESS model ties Medicare payments to measurable improvements in patient health rather than paying solely for individual services. Participating organizations can offer virtual care, health coaching, remote monitoring, and connected devices and wearables between regular doctor visits.
      • “There are currently 160 organizations participating in the ACCESS model, and CMS said Medicare will continue to add to the list throughout the model’s 10-year run. The model supports those with traditional Medicare. Medicare Advantage enrollees are not eligible, but CMS said MA plans may offer similar programs.”

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

  • OPM included the following additions in today’s Federal Register.
    • Rules
      • Reduction in Force; Correction
      • Shared Certificates and Pooled Hiring Actions
    • Proposed Rules
      • Promoting Employee Accountability
  • Federal News Network reports,
    • “The fewest number of federal employees submitted their retirement papers in August as compared to the rest of 2026. The Office of Personnel Managements says it received only 7,618 retirement claims last month. This is down from more than 10,000 claims OPM received in July. Additionally, OPM’s backlog of retirement claims is at the lowest of the year at just over 15,400. The average number of days to process a claim for August also dropped considerably: to 70 days for a digital claim, down from 98 days the month before, and to 79 days for all claims, down from 109 days in July. (Federal retirement claims down, as the backlog hit lows for 2026 – OPM)”
  • Kevin Moss, writing in Federal News Network, discusses
    • “Healthcare affordability series part 8: Enrollment flexibility for two-person families can lead to premium savings.”
      • “Most of the time, self-plus-one is cheaper, but there are plans where you’ll save more enrolling as self & family.”
  • Govexec relates,
    • “More ‘Big Balls’-type young feds are what the OPM chief wants 
      • “In an interview on Monday, Scott Kupor also discussed implementing skills-based hiring, which had been a priority of the Biden administration as well.”

From the U.S. Food and Drug Administration front,

  • STAT News relates,
    • “The Food and Drug Administration is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday. 
    • “The pilot was first announced in June as part of Operation TrialBlazer, the Department of Health and Human Services initiative that pledged to shorten the FDA’s drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia.
    • “Too often, the U.S. pathway can be measured in years, while other countries’ pathways are measured in months,” the department wrote in the TrialBlazer roadmap.”
  • and
    • “Vera Therapeutics said Tuesday that its recently approved drug Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease, according to final, two-year results from a Phase 3 clinical trial. 
    • “In July, the Food and Drug Administration granted accelerated approval to Trutakna for the treatment of IgA nephropathy, or IgAN, a disease caused by the buildup of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.
    • “With the final data from the study in hand, Vera said it will seek full approval of the drug from the FDA during the fourth quarter.”
  • Cardiovascular Business tells us,
    • “XCath Robotics has received the FDA’s breakthrough device designation for its Iris surgical robotic system that performs remote robotic-assisted mechanical thrombectomy in acute ischemic stroke patients.
    • “This represents a significant step forward for the Houston-based medtech company. The FDA’s breakthrough devices drogram helps support the development of medical devices that have the potential to provide more effective treatment for patients with life-threatening or irreversibly debilitating conditions. This provides XCath Robotics with more opportunities to interact with FDA experts and receive support as the company works toward U.S. regulatory approval for the Iris system.
    • “Back in March, the Iris system was used to complete the world’s first telerobotic stroke thrombectomy. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the system to perform the historic procedure in Santiago, Panama, while the patient was 120 miles away in Panama City.”

No Surprises Act News

  • The FEHBlog did receive his CMS invitation to join its Independent Dispute Resolution Gateway this morning, and the FEHBlog promptly took CMS up on its offer. The process went smoothly.
  • The Paragon Institute September 15, 2026, Newletter’s kicks off with an article about “Fixing the No Surprises Act’s Broken Arbitration System.”
    • “Congress already required much of this transparency through the NSA’s Advanced Explanation of Benefits provisions, but those requirements have yet to be fully implemented. The administration should finish that work. Once patients have meaningful advance information about networks and prices, there is no justification for a federal arbitration system setting payments for elective care.
    • “For emergency services, a different approach is needed, and Congress has two reasonable options. It could eliminate federal IDR entirely while maintaining the prohibition on balance billing, leaving insurers and providers to settle payment disputes through private arbitration, litigation, or state law.
    • “Alternatively, Congress could retain IDR solely for emergency services but impose meaningful guardrails. Awards should have a reasonable upper limit so arbitration does not continue producing payments wildly disconnected from market prices. Congress should also reform how arbitrators are paid, and if an upper limit is implemented, insurers should face penalties when they fail to pay awards on time.
    • “The administration can make additional improvements now: require arbitrators to explain their decisions, audit firms with unusually high provider win rates or awards, strengthen eligibility reviews, improve arbitrator training, prohibit conflicts of interest and forum shopping, and restore a meaningful filing fee.
    • “The No Surprises Act solved a real problem by protecting patients from bills they could neither anticipate nor avoid. Those protections should remain. But protecting patients from surprise bills does not require a federal arbitration system that rewards providers for staying out of network and raises health care costs for everyone.”

From the fraud, waste, and abuse front,

  • Healthcare Dive reports,
    • “The federal government is once again targeting fraud in durable medical equipment suppliers, publishing a report Monday through the HHS’ Office of the Inspector General that urges regulators to crack down on suspect billing in Medicare Advantage.
    • “The OIG found that, in addition to other issues, MA organizations don’t screen for fraudulent medical equipment suppliers as often when they’re out of network, compared to in-network suppliers.
    • “MA organizations should tighten the screening process for suppliers and the CMS should use its fraud prevention tool more regularly, the OIG said.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “In recognition of Suicide Prevention Month, Susan Szulewski, M.D., president and chief operating officer, McLean Hospital and vice president, Mass General Brigham Behavioral and Mental Health, wrote on the importance of healthcare organizations working to reduce the stigma surrounding suicide and create a supportive environment with timely access to care and a clear path forward. READ MORE“
  • Per a CDC news release,
    • “Today, the Centers for Disease Control and Prevention and the Ad Council are launching a new round of public service announcements (PSAs) encouraging people to understand their risk of prediabetes and take action to prevent or delay type 2 diabetes.
    • “Now in its 10th year, the national “Do I Have Prediabetes?” campaign encourages viewers to take a 1-minute prediabetes risk test on DoIHavePrediabetes.org. This year’s “Undo It” PSAs spotlight that while there are many scenarios in life we can’t undo, prediabetes is something that can be reversed. 
    • “Prediabetes is a serious health condition that increases the risk of type 2 diabetes, heart attack and stroke. Because prediabetes often has no symptoms, many people do not know they have it. Research shows that early diagnosis can inspire individuals to adopt healthier habits, including eating better, being active and managing weight, that can reverse prediabetes and delay or prevent type 2 diabetes.
    • ‘If someone receives a high score on the risk test, that person is encouraged to speak to a doctor to confirm a diagnosis of prediabetes with a blood test, then enroll in the National Diabetes Prevention Program.” 
  • Healio tells us,
    • “Development of alcohol use disorder, depression or stress after a traumatic event was a strong predictor of major adverse cardiac and cerebrovascular events for both men and women, researchers reported.
    • “Evaluation of psychiatric predictors of major adverse events may be an important step in the prediction of CV risk after a traumatic event, according to data published in the Journal of the American Heart Association.
    • “Experiencing traumatic events can have long-lasting consequences for mental health that can take many forms, but research to date had yet to comprehensively consider these. Indeed, nearly all work on trauma and CVD had focused on PTSD and other stress-related disorders — the quintessential trauma-related mental health disorders — but depression, anxiety and substance use disorders are also common following trauma and are relevant to cardiovascular disease risk,” Jennifer A. Sumner, PhD, associate professor of psychology at the University of California, Los Angeles, told Healio. “We wanted to comprehensively investigate different posttraumatic mental health conditions as possible predictors of CVD onset. Also, given sex differences in both posttraumatic psychopathology and CVD, we examined whether links between various psychiatric disorders following trauma and CVD might differ for men vs. women.”
  • Health Day informs us
    • “New research suggests that the blood pressure and heart rate guidelines doctors use to guide emergency treatment in children are misleading in cases of traumatic injury. 
    • “These thresholds for “hemodynamic instability” — the inability of the circulatory system to get blood to organs — may be different for children with traumatic injuries versus healthy children, researchers wrote Sept. 9 in the Journal of the American College of Surgeons.
    • “Recognizing hemodynamic instability is fundamental in trauma care because these vital signs tell us when a child may be at increased risk of death or complications and when we may need to intervene,” explained study senior author Dr. Zain Hashmi. He’s an assistant professor of trauma and acute care surgery at the University of Alabama at Birmingham.
    • “Blood pressure and heart rate guidelines are often used by doctors to decide when to start resuscitation treatments, including blood transfusions, Hashmi said in a news release. However, the values used in children were not developed specifically for trauma patients and may not accurately reflect when the risk of death begins to rise in injured children, he added.” 
  • Medscape points out,
    • “A new international consensus statement providing evidence-based guidance on smoking cessation for people with type 2 diabetes (T2D) has been issued by a multidisciplinary international panel called the DiaSmokeFree Working Group. 
    • “The central message “is that smoking cessation needs to be treated as an integral part of diabetes management rather than as generic lifestyle advice,” statement co-author Riccardo Polosa, MD, PhD, professor of internal medicine at the University of Catania in Catania, Italy, told Medscape Medical News.
    • “There is evidence that this is under-prioritized in diabetes care,” he added. “Clinicians understandably focus on glucose, blood pressure, lipids, and medications, while smoking may receive only brief and mostly ineffective advice.”
  • Today’s issue of NIH’s Research Matters covers the following topics:
    • “Depression may stall development of new neurons 
      • “Researchers found that a part of the brain important for memory struggles to make new neurons in people with depression.
      • “The study sheds light on how the brain is altered in depression and suggests new treatment targets.”
    • GLP-1 drug slows aging in mice 
      • A GLP-1 drug extended lifespan and prevented age-related decline in older female mice.
      • Understanding how calorie restriction and GLP-1 drugs slow aging could lead to new ways to treat age-related diseases.
    • Antibodies may prevent tick-related syndrome 
      • “Researchers identified rare antibodies that may help combat alpha-gal syndrome, a condition that causes allergic reactions to red meat and dairy products.
      • “With further development, the finding could lead to treatments for this tick-related allergic condition.”

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

  • Beckers Payer Issues reports,
    • “Aetna’s two-year financial turnaround has taken hold following a leadership overhaul, thousands of ongoing cost management initiatives and a margin recovery plan expected to complete by 2027.
    • “Once you get the fundamentals in place, you start getting credibility, not only with investors, but internally with our employees, and then, in particular, with our members,” Aetna President Steve Nelson said Sept. 9 at the Wells Fargo Healthcare Conference. “We can be a little more disruptive and innovative. Aetna has a legacy of being innovative in terms of product and clinical programs, and we are getting back to that.”
    • “The insurer has spent the past two years in recovery mode after a period of financial turmoil driven by Medicare Advantage cost pressures, previously unfavorable star ratings and major losses in the ACA business, which it exited for 2026. Mr. Nelson, who also serves as executive vice president at CVS Health, was tapped to lead the insurer in late 2024.”
  • and 
    • “Health Care Service Corp. has completed the rebranding of its Medicare supplement and supplemental health and life products under the HealthSpring name.
    • “The move finishes a transition that began last year, when HCSC shifted the Medicare Advantage and Part D business it acquired from Cigna for $3.3 billion to the HealthSpring brand. 
    • “HealthSpring has more than 3 million members. HCSC said it is the second-largest Medicare supplement carrier by policyholders, with plans available in 48 states and Washington, D.C. Its supplemental health and life products, which include hospital indemnity and dental, vision and hearing benefits, are offered in 49 markets and D.C.”
  • and
    • “The Blue Cross Blue Shield Association has tapped Daniel Serrano to serve as CFO.
    • “The president and CEO of the BCBS Association, Kim Keck, announced the update Sept. 14 on LinkedIn. 
    • “With critical capabilities for this moment, including a practitioner’s orientation to data-driven financial management and a strong track record of aligning financial performance with operational outcomes, Dan is a great fit for our organization,” she said.”
  • Fierce Healthcare adds,
    • “Member trust in insurers is on the decline among Gen Z and Millennials, down 10.5% between 2023 and 2026, new research from Accenture found.
    • “This trust gap, according to analysts, could cost $3 billion in future member lifetime value for the largest commercial payers over the next decade. 
    • “When members don’t trust their health plan, they don’t just disengage; they route around it,” said Bracken Flynn, Accenture’s Health industry principal director, in a statement. “Our data shows that younger consumers aren’t asking for less from their insurer. They want more. They’re looking for a partner that helps them navigate care, understand costs, and make confident decisions. The insurers that earn that trust now will define what health coverage means for the next generation.”
    • “During a Sept. 14 AHIP webinar, Flynn said the report—which polled 1,200 consumers—found members trust insurers when they believe the health plan will help them make good healthcare decisions and navigate them to the best care.
    • “That’s across clinical and administrative touchpoints,” Flynn said. “And so it’s a partnership. In practice, it’s a partnership.”
    • “The lack of trust in insurers is causing younger members to turn to artificial intelligence tools, with 62% of respondents saying they have used AI to help choose a health plan.”
  • The American Hospital Association News relates,
    • “A new report from Kaufman Hall prepared for the AHA highlights new insights and data on hospital mergers and acquisitions. An AHA blog accompanying the report is also available.
    • “The report discusses how hospital merger reviews should look beyond the potential impact on commercial insurance prices and consider what proposed transactions mean for all patients, particularly the nearly 60% of hospital patient days attributable to Medicare, Medicaid and Medicare Advantage beneficiaries whose payment rates are largely set by government programs. Drawing on analyses of challenged and canceled transactions, the report also finds that hospitals seeking partners often serve more vulnerable communities and face greater financial pressures, and that when proposed deals do not move forward, struggling hospitals can experience significant financial deterioration that threatens services, workforce stability and access to care.
    • “These findings suggest that a more comprehensive analysis of hospital M&A transactions, one that considers impacts on all patients served, broadens the focus to impacts beyond pricing, and considers the consequences if an M&A transaction is not permitted to proceed, would ensure not only competitive but also healthy hospital markets that can continue to provide the fullest possible range of services,” the report says.”
  • AHIP relates,
    • “New data highlighted by Washington Post Intelligence show hospital system consolidation continues to accelerate, with 40 new mergers and acquisitions announced already in the first half of 2026 — nearly as many as throughout all of 2025. 
    • “Clear evidence demonstrates that anticompetitive hospital consolidation leads to higher healthcare costs for patients, families and employers. Hospital spending already makes up the largest share (40%) of insurance premiums, accounting for over $1.6 trillion in spending nationwide.”
  • Beckers Hospital Review adds,
    • “Salt Lake City-based Intermountain Health has acquired the nine-story, 235,000 square-foot Fairbourne Building in West Valley City, Utah, and plans to convert it into a medical campus.”
  • and
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said.”
  • Cardiovascular Business points out,
    • “U.S. News & Report has published its annual ranking of the top children’s hospitals in the United States, once again producing a separate list for the best hospitals for cardiology and heart surgery. This represents the 20th year that U.S. News.& World Report has compiled these rankings.
    • “For two decades, U.S. News has helped guide families to top-tier pediatric care,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement. “Finding the right medical team for a rare diagnosis or complex surgery can be overwhelming, and U.S. News’ annual evaluation of the Best Children’s Hospitals provides a clear starting point for parents and referring pediatricians alike.”
    • “Nearly 200 U.S. facilities were eligible for these rankings. Each one is either a freestanding children’s hospital or a large multidisciplinary pediatric department working within a major medical center.
    • “This latest ranking of the Best Children’s Hospitals for Cardiology and Heart Surgery includes some familiar names at the top. For instance, Texas Children’s Hospital in Houston is No. 1, just like it was in 2019, 2020, 2021, 2022, 2023, 2024 and 2025. 
    • “Meanwhile, Children’s Hospital Colorado and Duke Children’s Hospital and Health Center are No. 2 and No. 3, respectively. That is where each one landed in the previous year’s ranking as well. 
    • “Going a bit deeper, Children’s Hospital of Philadelphia came in at No. 4, and Children’s Health Dallas came in at No. 5.” 
  • MedCity News lets us know,
    • “Virtual solutions for chronic kidney disease (CKD) management don’t slow disease progression, nor do they reduce total healthcare spending, according to a new analysis by the Peterson Health Technology Institute (PHTI).
    • “PHTI is an independent evaluator of digital health solutions. For the analysis, PHTI reviewed more than 5,400 articles and other evidence. The solutions evaluated in the report include DaVita IKC, Evergreen Nephrology, Healthmap Solutions, Interwell Health, Kidneylink, Monogram Health, Somatus and Strive Health. These companies take on financial responsibility for the total cost of care for patients with stage 3–5 CKD, and typically work with Medicare Advantage plans and Medicare’s Kidney Care Choices model.
    • “The assessment focuses on managing chronic kidney disease before patients progress to end-stage kidney disease, including the need for dialysis or a kidney transplant.”
  • Managed Healthcare Executive tells us,
    • “GLP-1s now dominate market momentum, with obesity products surging from near-zero in 2022 to $55B annually and diabetes GLP-1s sustaining double-digit year-over-year growth. 
    • “Independent pharmacies are reassessing dispensing economics, with refusal rates declining to 35% for weight-loss GLP-1s and 8% for diabetes GLP-1s. 
    • “Distribution remains retail-heavy (~80%), but mail fulfillment is increasing, reaching 12.9% of GLP-1 prescriptions as direct-to-consumer channels expand. 
    • “Diabetes category mix is shifting away from insulin, whose sales share has dropped to 9.8% and prescription share to 16%, reflecting GLP-1 substitution dynamics. 
    • “Medicare Part D Bridge uptake appears immediate, with 9,000 paid claims in three days, alongside a large pipeline exploring neuropsychiatric, SUD, cancer-risk, women’s health, and systemic inflammation indications.”
  • The Wall Street Journal informs us,
    • “Legend Names Novartis Executive as CEO
      • “Ingrid Zhang takes the helm of the cancer therapy company, filling a post vacant since its previous CEO abruptly resigned in July.”
  • Per Beckers Health IT,
    • “Oracle has expanded its fiscal 2026 restructuring plan by approximately $700 million, bringing expected costs to roughly $2.8 billion as the company pursues strategic initiatives and operational efficiencies that include adopting and integrating AI across certain functions.
    • “The Sept. 11 Securities and Exchange Commission filing does not specify what actions the additional $700 million will cover or how many employees could be affected. Oracle said restructuring expenses under the broader plan include employee severance, contract termination and other exit costs.
    • “As of Aug. 31, prior to the additional $700 million, Oracle estimated total restructuring costs of up to $2.1 billion.
    • ‘The disclosure comes as Oracle employees across social media reported a recent round of layoffs, including at Oracle Health. Business Insider first reported the layoffs Sept. 14, citing three people affected and an email notification.”
  • and
    • “Mayo Clinic and Thermo Fisher Scientific have launched Precure, a joint venture designed to detect biological signs of disease before patients develop symptoms, according to a news release shared with Becker’s.
    • “Rochester, Minn.-based Mayo Clinic, will serve as majority owner of the entity and Thermo Fisher joins as a minority partner. Precure will build one of the world’s largest human multi-omics datasets — integrating proteomic and genomic data with longitudinal clinical information drawn from 1 million biospecimens collected over several years, according to the release.
    • “At Mayo Clinic, we are committed to transforming patient care through innovation,” said Gianrico Farrugia, MD, president and CEO of Mayo Clinic. “By harnessing the full potential of multi-omics data, Precure, LLC aims to help us better understand disease before symptoms appear.”
    • “Thermo Fisher will contribute its Olink Explore HT proteomics platform and Orbitrap mass spectrometry technology to the effort. Marc Casper, Thermo Fisher Scientific’s chairman and CEO, said the venture has “the potential to create a step change in how we generate and apply multi-omics data to improve human health.”
    • “Target disease areas include cancer, cardiometabolic conditions, neurological disorders and immune-mediated disease — conditions where biological changes often precede clinical diagnosis by years. Advanced AI and large-scale data analytics will be used to identify patterns across the datasets and translate them into actionable insights.”
  • Per Beckers Clinical Leadership,
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said. 
    • “These efforts aim to create a public, multimodal dataset to “help reach a future where cancer patients can get rapid personalized cancer vaccines when they are diagnosed,” the OpenAI Foundation said in a Sept. 15 news release. 
    • “UNC Lineberger’s $40 million grant is part of a $125 million funding program, called Public Data for Health, established by the foundation.”
  • and
    • “Ambient artificial intelligence handed many physicians their evenings back. For nurses, the same promise is proving harder to keep, and the reason is buried in the flow sheet.
    • “Physician ambient scribes listen to a visit and draft a narrative note when it ends. Nursing documentation does not work like that. It lives in structured flow sheets, entered field by field across a shift, every time a nurse assesses, medicates or turns a patient.
    • “Nursing documentation occurs throughout the entire shift. It’s every time we interact with a patient,” said Stephanie Clements, BSN, RN, senior vice president and chief nurse executive at Chesterfield, Mo.-based Mercy. “It’s very different than summarizing care at the end of a period.” 
    • “That difference is why early attempts to copy the physician model — record the encounter, generate the note — have not mapped cleanly onto the bedside, and why some nurses have found the tools slower, not faster, at first.
    • “Yet the systems furthest along say the payoff is real when the technology is built for nurses from the get-go.” 

Notable Deaths

  • The New York Times reports
    • “Harold P. Freeman, an influential oncology surgeon whose knowledge of the devastating effects of breast cancer on poor Black women inspired him to create a landmark program at Harlem Hospital Center, helping patients navigate the health care bureaucracy, died on Aug. 11 in Atlanta. He was 93.
    • “His death, at a hospital, was confirmed by his son Neale.
    • “Dr. Freeman’s patient navigation program became a model for hospitals around the world, helping to eliminate barriers to early cancer detection. The program’s success influenced the passage of the federal Patient Navigator Outreach and Chronic Disease Prevention Act of 2005, which provided $25 million for similar programs across the United States. In 2024, Medicare began providing providers with reimbursement for some navigation services for cancer, heart failure, H.I.V./AIDS and other high-risk conditions.
    • “There are no navigation events or meetings that don’t acknowledge Dr. Freeman’s role in patient navigation,” Dr. Shanthi Sivendran, the interim chief patient officer of the American Cancer Society, said in an interview. “There wasn’t a patient navigation concept before him.”
  • and
    • “The milk truck would pull up to the house, and out would come the groceries — not just milk, but also eggs, cheese, juice, cereal and baby formula. It might have stopped at a rich family’s house, or a poor one. No one could tell the difference, which was precisely the point.
    • “Vermont’s supplemental food program for low-income women, infants and children, the first in the nation to be implemented statewide, began in 1974. It was the brainchild in part of Dr. Anthony Robbins, then one of the country’s youngest state health commissioners, at 33; he had secured a federal grant to made the program possible.
    • “Not only did the program provide much-needed supplies, but it also shielded families from the stigma of receiving public assistance.
    • “The milk truck was stopping at practically every house — high income, low income, whatever,” Donna Bister, a former director of the program, known widely as WIC, said in an interview. The program is now available in all 50 states.” * * *
    • “Dr. Robbins died on July 5 at his home in Rockport, Mass. He was 85. His death, which was not widely reported at the time, was caused by complications of long Covid, heart disease and Parkinson’s disease, his wife, Phyllis Freeman, said.
    • “He was considered to be on the cutting edge of health care,” Madeleine Kunin, a former governor of Vermont, said in an interview. “He was a bright light.”
  • RIP Doctors.

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Department of Health and Human Services announced Sept. 8 through the Substance Abuse and Mental Health Services Administration that it will award $383.4 million in grants to support behavioral health treatment, prevention and crisis response efforts. HHS said $252 million will support the 988 Suicide and Crisis Lifeline, suicide prevention and mobile crisis services. Of the remaining grants, $81.4 million will be used toward substance use treatment and prevention initiatives, and $50 million will be used to support mental health services. The Sept. 8 announcement coincided with 988 Day, which raises awareness about the 988 lifeline and the importance of mental health and suicide prevention.” 
  • Bloomber Law reports,
    • “The Trump administration is pursuing additional drug pricing deals with pharmaceutical companies, Centers for Medicare and Medicaid Services Administrator Mehmet Oz told Bloomberg Television.
    • “Officials have announced more than two dozen voluntary agreements with pharmaceutical companies so far, and Oz said “there are more deals in the works.” He spoke ahead of his scheduled keynote address at the Republican midterm convention in Dallas Wednesday night.
    • “Each of the agreements is bespoke, but companies generally have agreed to lower the prices they charge public programs for medicines and to launch new drugs at prices similar to those paid by other developed nations in exchange for relief from tariffs. Some companies also are offering the discounted prices directly to consumers on a Trump-branded website, though critics argue the savings are minimal for patients with insurance.”
  • Axios adds,
    • “There are troubling new signs that the overhaul of Medicare drug coverage in the Inflation Reduction Act is dramatically driving up program spending. 
    • “Why it matters: The upward trajectory could threaten some seniors’ coverage for outpatient prescription drugs — and it could force painful tradeoffs over the next decade as Medicare consumes a growing share of the nation’s debt. 
    • “Follow the money: The IRA limited what seniors have to pay for outpatient drugs and shifted the remaining cost to taxpayers, insurers who provide stand-alone Medicare drug plans and drug manufacturers.
    • That was good news for enrollees who take expensive drugs for conditions like cancer, multiple sclerosis or rheumatoid arthritis and faced potentially crushing out-of-pocket costs.
    • But federal data shows demand for drugs is surging as they become more affordable, exceeding congressional scorekeepers’ spending estimates and setting off more alarms.
    • “Driving the news: Last week, congressional Medicare advisers reported that more than 1 in 5 enrollees hit Medicare Part D’s $2,000 patient cost cap in 2025 — shifting new costs to the government.”
  • Beckers Behavioral Health breaks down the Labor Department’s September 8 enforcement guidance concerning the mental health parity act into seven things to know:
    • “Certain behavioral health treatment exclusions could draw scrutiny.
    • “Prior authorization and medical necessity processes are a key enforcement area.
    • “The agency is looking closely at behavioral health networks.
    • “Compliance depends on how policies operate in practice.
    • “Telehealth, cost-sharing and visit limits can also raise compliance concerns.
    • “Plans are expected to use monitoring mechanisms to identify disparities.
    • “Corrective actions can require changes to coverage and plan operations.”
  • STAT News relates,
    • “ARPA-H, the government agency that funds cutting-edge health research, plans to commit $62.7 million to develop artificial intelligence bots that direct treatment of heart failure. Among the goals of the program, called ADVOCATE, is to produce partially autonomous AI devices authorized by the Food and Drug Administration to help treat patients, including assessing symptom severity, prescribing drugs, and ordering lab tests. 
    • “ARPA-H on Wednesday announced the first batch of awards to health tech companies Atman Health, UpDoc, Tempus AI, and teams from Stanford University, Duke University, and the Kaiser Permanente health system. ARPA-H may still fund additional teams. The amount committed for the first year is $33.7 million, and the remainder may be renegotiated up or down.” 

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

  • My Federal Retirement tells us about “What FEHB Enrollees Should Know if They Get a Letter from Medicare This Month.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “In an accelerated decision, the FDA expanded Bayer’s Hyrnuo indication, granting first-line approval for a rare tumor type in patients with non-small cell lung cancer. 
    • “Before the expansion, Hyrnuo was available only after other NSCLC treatments failed. But the FDA’s latest go-ahead makes the tyrosine kinase inhibitor (TKI) an initial therapy option for any patient with locally advanced or metastatic non-squamous NSCLC whose tumors test positive for HER2 tyrosine kinase domain activating mutations.   
    • “The expanded indication was won using data from Bayer’s ongoing phase 1/2 Soho-01 trial, in which Hyrnuo demonstrated a 75% objective response rate in previously untreated patients. Six percent of patients showed a complete response, and 70% showed a partial response to the twice-daily oral medication, Bayer said Wednesday. Responses lasted more than six months for 73% of patients.”
  • and
    • “With a phase 3 win now fleshed out and an FDA filing recently submitted, BioMarin is advancing expansion plans for Voxzogo, looking to extend the dwarfism drug’s reach as it faces new pressure in its inaugural achondroplasia indication. 
    • “On Wednesday, BioMarin unveiled detailed results from the phase 3 CANOPY-HCH-3 trial assessing Voxzogo in children with hypochondroplasia (HCH), a milder form of achondroplasia, where the company announced a topline win back in May. 
    • “Aside from the average 2.33 cm/year improvement in annualized growth velocity (AGV) on Voxzogo that BioMarin reported out earlier this year, the company dug deeper into the magnitude of benefit its medicine could offer to children with HCH across measures like standing height and arm span after a year of treatment.
    • “BioMarin shared the data Wednesday at the European Society for Paediatric Endocrinology annual meeting and simultaneously published the results in the New England Journal of Medicine.” 
  • Cardiovascular Business points out,
    • “Luma Vision, an Irish medtech company focused on electrophysiology and interventional cardiology technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its updated Verafeye imaging and visualization platform. The company previously received FDA clearance for the artificial intelligence-powered offering in 2025; this update covers the platform’s expanded capabilities ahead of a planned commercial launch in 2027.
    • “The Verafeye platform provides ultrasound imaging courtesy of a 360° catheter that creates real-time 2D and 3D maps of the patient’s heart. It also offers advanced visualization and navigation capabilities, helping users track imaging and ablation catheters during treatment. In addition, users are able mark locations as they go to confirm they achieve the necessary alignment.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “First responders and other New Yorkers around the World Trade Center that day have reported conditions including respiratory issues, mental health impacts and dementia. Toxins were present in the air soon after the attacks even though people were assured it was safe, according to a trove of records released this week by New York City officials.
    • “Twenty-five years later, attention is increasingly falling on cancer. 
    • “The number of 9/11 survivors who are receiving aid for cancer has roughly tripled over the last five years, according to a Washington Post analysis of reports from the World Trade Center Health Program, which funds health care for first responders and 9/11 survivors in New York. In June 2021, 8,870 survivors received aid for cancer treatment, jumping to 27,300 survivors in 2026 — numbers that sharply outpaced cancer claims among first responders.
    • “Of the roughly 54,000 survivors enrolled in the health program as of June, about half are receiving aid for cancer. Five years ago, that share was 35 percent.” * * *
    • “A recent New York University study of a smaller cohort of 9/11 survivors receiving medical aid as of 2024 reported a similar increase in cancer cases; it found that cases had increased around 2.5-fold between 2019-2024.
    • “This is something that we are worried about,” said Alan Arslan, an associate professor of population health at NYU and one of the authors of the study. “We’re seeing more and more patients.”
  • The Wall Street Journal relates,
    • “Dr. Henry Heimlich devised a new technique more than 50 years ago to stop people from choking. Simplicity, studies, shrewd promotion by its inventor—and a demonstration on The Tonight Show Starring Johnny Carson—made the Heimlich maneuver a go-to method.
    • “Now, it is fighting for the stage.
    • “Advocates, companies and some politicians argue that the Heimlich maneuver and back blows, another established method of rescuing people from choking, aren’t always enough. On social media and in state legislatures, they are plugging portable anti-choking devices, designed to suction stuck food or other objects from a person’s airway.
    • “Texas enacted a law last year requiring school districts to stock at least one such device on each campus with at least one employee trained to use it. New York City passed one, too. At least nine other states have weighed or are weighing bills to put devices into schools or other facilities.
    • “It’s a priority,” said New Jersey state Sen. Kristin Corrado, who co-sponsored one bill. “If we have the opportunity to save a life, we have to use all means available.” 
    • “The main U.S. maker—a company called LifeVac—has donated more than 10,000 devices to schools across the country.” * * *
    • “But medical guidelines and many researchers say there isn’t enough evidence to recommend anti-choking devices. State health departments, emergency responders and teachers unions have pushed back against proposals to require them in schools because medical guidelines haven’t endorsed them. New York City said it wouldn’t implement its law unless the devices are recommended in medical guidelines.”
  • Beckers Behavioral Health tells us,
    • “The synthetic opioid cychlorphine has been linked to at least 55 deaths nationally from 2025 to 2026, with prevalence highest in Ohio, Tennessee and Texas, MedPage Today reported Sept. 8.
    • “The Office of National Drug Control Policy said in an April drug threat notice that cychlorphine may be “up to 10 times more potent than fentanyl” and an overdose may require multiple doses of naloxone.
    • “In Tennessee, the Knox County Regional Forensic Center reported 41 overdose deaths between July 2025 and February 2026. The center tracked as many as 63 cychlorphine-associated deaths through June 30, and cychlorphine was found to be the cause in 58 of those cases.
    • “Cychlorphine has been found mainly in powders and tablets as well as counterfeit pills. Shravani Durbhakula, MD, MPH, of Vanderbilt University School of Medicine in Nashville, Tennessee, said snorting and inhaling are common, though oral exposure and injection are also possible.”
  • Cardiovascular Business informs us,
    • “A majority of transcatheter aortic valve replacement (TAVR) present with a history of heart failure (HF). According to new data published in the Journal of Cardiovascular Medicine, however, many of those patients are not being given the HF medications they need after undergoing TAVR.
    • “Cardiovascular morbidity and mortality remain high after TAVR,” wrote first author Elena Surkova, MD, MSc, PhD, a senior medical director at AstraZeneca and consultant cardiologist with Royal Brompton and Harefield Hospitals, and colleagues. “There is a lack of detailed data on the prevalence of HF in patients undergoing TAVR, medication prescription rates, including the main pillars of HF standard of care, and predictors of HF worsening following the procedure.”
  • The American Medical Association lets us know what doctors want patients to know about West Nile virus
    • “Most West Nile virus infections cause no symptoms, but some can lead to severe illness. Mosquito-bite prevention remains the best defense.”
  • MedPage Today adds,
    • “A gender gap historically seen in the suicide rates of 10- to 14-year-olds in the U.S. has tightened.
    • “In 2017, the suicide rate of boys was twice that of girls, but by 2024, it was only 4% higher.
    • “The author noted that the nearly equal suicide rates for 10- to 14-year-old boys and girls in the current study marked the “first time this has happened in the available records.”
  • Health Day notes,
    • “Autism spectrum disorder (ASD) diagnoses increased disproportionately among females after 2020, across age groups, while remaining stable or declining among males, according to a study published online July 22 in JAMA Network Open.
    • “Erick Messias, M.D., Ph.D., from St. Louis University, and colleagues evaluated age- and sex-specific incidence trends of ASD from 2016 to 2024 to quantify the temporal patterns before and after the COVID-19 pandemic. The analysis included electronic health record data from 171,134 individuals who had at least one clinical encounter annually at a large health care system.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of a preclinical study by researchers at the University of East Anglia suggest that an experimental anticancer drug could stop osteoporosis and help women prevent weight gain after the menopause. Their study in mice found that the small molecule drug CADD522 not only protected against osteoporosis but could also reduce body fat and reverse some of the metabolic changes linked to menopause. Currently in development for cancer therapy, CADD522 is a small molecule inhibitor of the transcription factor RUNX2, which is helps to drive the growth and spread of several cancers.
    • “Research lead Darrell Green, PhD, at UEA’s Norwich Medical School, said, “We have uncovered an entirely new way of tackling the disease. We found that a drug originally developed to stop cancer could help millions of women facing the twin challenge of fragile bones and midlife weight gain. We hope our work could lead to a new generation of osteoporosis treatments that tackle bone loss while also addressing some of the wider metabolic consequences of menopause.”
    • “Green is senior and co-corresponding author of the team’s report in npj Drug Discovery, titled “RUNX2 inhibitor CADD522 improves bone microarchitecture and lipid metabolism in post-menopausal bone loss.” In their paper the team concluded that their collective studies “… identify RUNX2 inhibition as a therapeutic strategy that simultaneously improves skeletal integrity and metabolic homeostasis, supporting further development of CADD522 for osteoporosis and other RUNX2-driven diseases.”

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

  • The International Foundation of Employee Benefit Plans reports,
    • “Medical stop-loss premiums in 2026 show an increase from 13.6% on a $100,000 deductible to 15.9% on a $750,000 deductible, as reported by the 2026 Aegis Risk Medical Stop-Loss Premium Survey, cosponsored by the International Society of Certified Employee Benefit Specialists. Notably, this increase is approximately 5% to 5.5% higher than increases seen for the previous 2025 renewals. This impact was not surprising, as many underwriters reported increased severity and frequency in stop loss-claims in late 2024 and a resulting erosion in claims-to-premium loss ratios thereafter and throughout 2025. The survey captured necessary correction to 2026 premiums. The measured increases, rising alongside the size of deductible, reflect leveraged medical trend, as the underlying growth in expense of a catastrophic medical claimant is fully borne by an unchanged deductible.
    • “Survey response uniquely captures final, negotiated premium and reflects any pricing improvement from renewal marketings and concessions across all deductibles. In comparison, several large direct underwriters reported an average 2026 increase in the low 20% range on their own book-of-business. However, those are weighted by in-force policies unable to locate lower cost alternatives. The comparatively lower increases observed in this survey reflect the 2026 renewal rate opportunity found in the market. Looking ahead, an ongoing return to underwriter discipline and need to restore insurer loss ratios to a more profitable position does not indicate any easing on the 2027 renewal cycle.”
  • Fierce Pharma relates,
    • “Shifts in drug pricing and market access policies around the world have caused an “earthquake” that will reverberate for years to come, a survey of industry leaders found.
    • “Healthcare consultancy Numerof & Associates generated the insights in a survey of 175 executives from 67 pharmaceutical companies. The qualitative survey revealed the belief that the current era of policy change is unlike anything that the industry has experienced before. After going through a period of fast change, the industry is braced for more upheaval in the coming years. 
    • “While there has always been change throughout the industry, the past 24 to 36 months have felt more exponentially transformative than anything I have seen over the last 30 years,” an executive said. “What we may experience over the next five years could exceed the cumulative level of change we saw over the previous several decades.”
    • “Another executive characterized the policy environment as an “earthquake” that is “not going to settle down soon,” while a third person predicted that the need for politicians to try to address the cost of healthcare will ensure ongoing change. 
    • “The executives were talking after a succession of policy changes in key markets. Medicare gained the authority to directly negotiate prices for some drugs, and the most-favored-nation (MFN) policy tied U.S. prices to overseas markets.” 
  • Healthcare Dive tells us,
    • “UnitedHealthcare is still drilling down on actions it can take to make its Medicare Advantage plans more profitable next year, even as the insurer is expected to exit more underperforming geographies. But the company could be poised for growth in the markets where it remains, according to new comments from a top executive.
    • “We think we’re going to be very competitive in terms of our pricing next year,” CFO Wayne DeVeydt said during Wells Fargo’s annual healthcare conference Wednesday morning. “We think our benefits will be competitive … We still have a few markets where we’re right-sizing some of the products, but I think we’ll be well-positioned for 2027.”
    • “DeVeydt’s comments come as market watchers try to get a sense of how 2027 open enrollment will pan out, following an especially turbulent sign-up period for 2026 after insurers culled their plans in a bid to resuscitate flagging margins.”
  • Modern Healthcare adds,
    • “UnitedHealth Group and CVS Health are looking into acquisitions, executives said at a Wells Fargo conference.
    • “UnitedHealth Group identified value-based care companies and companies that would fit into its Optum Insight division as targets.
    • “CVS Health will seek “bolt-on” acquisitions and resume share buybacks next year.”
  • Beckers Payer Issues informs us,
    • “Anthem is now covering three surgical meshes for breast reconstruction, according to a clinical guideline published Aug. 27.
    • “DuraSorb Monofilament Mesh, GalaFLEX and TIGR Matrix Surgical Mesh “are considered medically necessary when used for breast reconstruction surgery,” the guidance said.
    • “We regularly review our medical coverage policies to ensure they’re aligned with credible medical evidence and the latest treatment standards and expert recommendations,” an Elevance Health spokesperson told Becker’s.” * * *
    • “ABC affiliate WFTS-TV in Tampa, Fla., has been reporting on breast cancer insurance denials, including for mesh, in recent years. It reported how Cigna updated its policy to cover mesh for breast reconstruction in 2025.
    • “Despite calls for insurer coverage, mesh for breast reconstruction has not secured FDA approval.”
  • and
    • “UnitedHealth Group’s Optum has sold interest in some of Optum’s Florida WellMed clinics to private equity company TPG, Bloomberg originally reported Sept. 9. UnitedHealth Chief Financial Officer Wayne DeVeydt told Bloomberg that the healthcare company was looking for a partner “that could actually work with us locally,” and UnitedHealth “didn’t need the dollars.” 
    • “We entered a strategic partnership designed to strengthen operating performance through dedicated support for clinic operations, targeted investments in technology and tools, and enhanced operating capabilities,” an Optum spokesperson told Becker’s Sept. 9. “The transitioning clinics will remain part of Optum’s network and continue providing high-quality care to patients. We remain committed to serving Florida patients through our integrated, value-based care model.”
  • Beckers Behavioral Health lets us know,
    • “Santa Fe, N.M.-based Quel Health launched a telehealth platform focused on using GLP-1 receptor agonists in addiction care. 
    • “The platform is available in 41 states and the District of Columbia, with national coverage planned by year-end, according to a Sept. 8 news release from the company. Quel also named Wernersville, Pa.-based Caron Treatment Centers a founding strategic partner.” * * *
    • “The approach follows work at Caron’s Pennsylvania and Florida campuses, where Steven Klein, MD, PhD, co-founder and chief medical officer of Quel Health, and his team evaluate GLP-1 receptor agonists in patients whose primary diagnosis was substance use disorder rather than obesity or diabetes.” 
       
  • Per Fierce Healthcare,
    • “Employers Health and Judi Health are teaming up to launch StarkRx, a new cost-plus benefit offering designed to drive transparency for employers.
    • “The approach unites the expertise of Employers Health as a group purchasing organization for pharmacy benefits that’s backed by employers with the technology available through Judi. The goal, the partners said, is to ensure that self-funded employers have greater access to transparency data that they can use to identify and manage cost drivers.
    • “Employers are expected to see another year of significant healthcare cost increases in 2027, with pharmaceuticals serving as a major factor behind the trend. A recent analysis from Marsh (formerly Mercer) estimated that costs could increase by 8.2% next year.
    • “Advanced, high-cost therapies and GLP-1 medications were both cited as key cost drivers in that analysis.”
  • and
    • “H1 has acquired Defacto Health, a healthcare data company focused on provider network intelligence, in a move to expand its offerings for health plans and strengthen its healthcare data assets.
    • “H1 is an AI-powered platform that brings healthcare data, domain expertise and an artificial intelligence platform to life science companies. The company built an AI-powered platform that helps identify and engage the right doctors for critical workflows across pharma, health plan, health system and technology companies. 
    • “Defacto Health is an AI-driven provider intelligence platform that aggregates and analyzes health insurance payer networks, provider directories and medical demographics data. The company maintains data on payer networks, healthcare providers and the insurance plans providers accept, helping health plans assess directory accuracy, isolate error clusters and benchmark their networks.”
  • Beckers Hospital Review reports,
    • “The American Medical Association released its 2027 Current Procedural Terminology (CPT) code set Sept. 9, an update that adds 299 codes and continues to build out billing for clinical AI.
    • “The set takes effect Jan. 1 and carries 453 total editorial changes: 299 new codes, 74 revisions and 80 deletions, the AMA said.
    • “Ten of the new codes describe AI-related services, raising the total number of AI-related CPT codes to 43. The AMA also updated Appendix S, its taxonomy that sorts medical AI by how much of the work the machine does — assistive, augmentative or autonomous — and guides how new tools get coded.
    • “As new technologies and clinical approaches emerge, the nation’s health system needs a reliable way to describe the care physicians provide,” said AMA President Willie Underwood III, MD. Dr. Underwood said a physician-led coding system gives that work “unmatched scale, expertise and legitimacy.”
    • “The set’s key clinical change, released in August, is a maternity coding overhaul that retires the decades-old global maternity bundle in favor of separate reporting across antepartum, labor, delivery and postpartum care.”
  • MedTech Dive offers “5 takeaways from Oura’s IPO filing.”
    • The wearables firm’s sales are growing, and it is adding more paid members, but questions loom about whether the company will need to approach future features as a medical device.
  • and tells us,
    • “Labcorp said Tuesday it has acquired MLM Medical Labs to add global central laboratory and biomarker capabilities for clinical trials.
    • “MLM is a global central and specialty laboratory provider with operations in the U.S., Germany and South Africa. 
    • “The deal makes Labcorp the only central laboratory provider with a wholly owned lab network across four continents, the acquiring company said. Neither party disclosed the financial terms of the deal.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC

  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, September 15, 2026, at 10:00 AM ET to consider Gerard Klomp to be Deputy Secretary of Health and Human Services (HHS); James Gadwood to be Chief Counsel for the Internal Revenue Service (IRS) and an Assistant General Counsel in the Department of the Treasury; Ge Bai to be an Assistant Secretary of HHS; and Andrew A. De Mello to be a Judge of the United States Tax Court.” * * *
    • “Opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • Beckers Hospital Review reports,
    • “HHS has selected four senior leaders for the FDA, including directors for the agency’s drug, biologics and tobacco centers and its first deputy commissioner focused on technology and artificial intelligence.
    • “Jared Seehafer was selected as the FDA’s first deputy commissioner for technology and artificial intelligence, according to a Sept. 8 HHS news release. He will serve as the agency’s senior leader for technology, software and AI and lead FDA-wide strategy and priorities in those areas.
    • “Michael Davis, MD, PhD, was selected as director of the Center for Drug Evaluation and Research after serving as acting director since May, when his predecessor was fired days after the agency’s commissioner stepped down. He will lead the center responsible for helping ensure safe, effective and high-quality drugs are available to the public.
    • “Karim Mikhail was selected as director of the Center for Biologics Evaluation and Research after serving as acting director, a post that has seen frequent turnover over the past year and a half. The center regulates biological products, including vaccines, blood and blood products and cellular and gene therapies.
    • “Bret Koplow, PhD, was selected as director of the Center for Tobacco Products after serving as acting director. He has served at the FDA since 2011.”
  • Behavioral Health Business informs us,
    • “The Trump administration today released guidelines on renewed enforcement efforts under the Mental Health Parity and Addiction Equity Act (MHPAEA), after halting enforcement of the law in 2025.  
    • “The latest guidelines are not the administration’s revised parity law, but rather a framework for enforcement action and identifying red flags during the interim. 
    • “A Sept. 8 bulletin from the Assistant Secretary for the Department of Labor’s Employee Benefits Security Administration (EBSA), Daniel Aronowitz, describes the agency’s intent to more substantially enforce the parity law’s nonquantitative treatment limitation (NQTL) requirements, which resulted from collective industry feedback.” * * *
    • “The renewed enforcement focus will fall into three buckets, identified as areas of enforcement need in a 2025 report from the agency to Congress: treatment limitations and exclusions; standards for medical necessity and review and standards for determining network adequacy, admissions and provider reimbursement methodologies.” 
  • Beckers Hospital Review tells us,
    • “ACA insurers requested a median rate increase of 15% for 2027, according to a Peterson-KFF Health System Tracker analysis. However, [as explained in the article,] some states are pushing back — while others are abiding by those requests — as they finalize increases.”

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

  • FedScoop reports,
    • “The Office of Personnel Management is looking to prevent data on the federal government’s public job board, USAJobs, from making its way onto misleading websites. 
    • “Last week, OPM updated terms of service for users of its USAJobs application programming interface (API) to include prohibitions on several actions related to the sale or redistribution of data from the website “to third parties as a standalone product or feed.” 
    • “Data provided to you through the API is for the explicit use of the requesting company or individual identified on the USAJOBS Program Office API Registration Form. No other use of the data provided is permitted without prior approval, in writing, from OPM USAJOBS,” said an emailed notice sent to API users, including FedScoop. 
    • ‘While the reason for that change wasn’t initially clear, an OPM spokesperson told FedScoop via email Friday that the policy change is aimed at preventing “unauthorized services that appear to be USAJOBS or allow users to apply for federal jobs outside USAJOBS.” 
  • Federal News Network interviews Tammy Flanagan about questions that federal and postal employees may have about their FEHB and PSHB coverage as they turn 65 years old.

From the judicial front,

  • Beckers Payer Issues reports,
    • “Humana lodged a federal complaint Sept. 3 against Bayer AG and its acquired company, Monsanto, the business behind the weedkiller Roundup, seeking recoveries to address payments for Medicare Advantage members’ non-Hodgkin lymphoma-related care.
    • “Roundup’s active ingredient, glyphosate, has previously been linked to cancer risks. The lawsuit, filed in the U.S. District Court for the District of New Jersey, follows Monsanto’s proposed $7.25 billion settlement in February to resolve Roundup claims alleging non-Hodgkin lymphoma injuries. The settlement would act as a long-term compensation program, addressing current and future claims. Monsanto announced other settlement agreements in 2020, as well.
    • “However, Humana argues the February proposal does not confirm reimbursement for Medicare Advantage organizations that have already paid for relevant care. While the settlement acknowledges government payers, it establishes an “other insurers” category, including contracted payers. The complaint said this settlement lacks a “functional” lien-resolution program.”

From the fraud, waste, and abuse front,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “As part of the White House Anti-Fraud Task Force’s ongoing efforts to crush fraud in the healthcare system and protect taxpayer dollars, the Centers for Medicare & Medicaid Services (CMS) has identified and is barring 11 medical supply companies with more than $3.4 billion in suspected fraudulent billing practices in 2025 and 2026 from receiving future Medicare Advantage (MA) Part C and Part D payments. These 11 durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers, (1) had submitted no claims prior to 2025; (2) used improper billing practices for their claims; (3) had billed for medical equipment to beneficiaries already deceased; and (4) supplied equipment to beneficiaries who never requested or received it. Four of the suppliers had already been revoked from Original Medicare and began billing Medicare Advantage plans instead.” 

From the public health and medical / Rx research front,

  • Beckers Hospital Review reports,
    • “Albuquerque, N.M.-based Presbyterian Hospital said it found Legionella pneumophila in limited areas of the water system, including two rooms, Fox affiliate KRQE reported Sept. 7.
    • “The hospital implemented testing for the bacteria after a patient who recently received care at the hospital tested positive for Legionnaires’ disease. However, officials with the New Mexico Department of Health told CBS affiliate KOAT there is no definitive evidence showing the patient contracted the bacteria from Presbyterian. No additional cases have been identified and there is no known exposure to other patients or staff.
    • “The hospital received the environmental testing results Sept. 3 and immediately implemented safety precautions in affected areas.”
  • MedPage Today relates,
    • “Nicotine was long thought to fuel the inverse relationship between smoking and Parkinson’s disease.
    • “In this study, nonsmokers with high carbon monoxide (CO) levels had less Parkinson’s risk, suggesting CO may underlie smoking’s neuroprotective effects.
    • “The study followed more than 500,000 people for 12 years, measuring exhaled CO at baseline.”
  • and
    • “In a study of perimenopausal and recently postmenopausal women with vasomotor symptoms, initiation of menopausal hormone therapy (MHT) was associated with a 22% reduction in cardiovascular events.
    • “Notably, benefits were observed in those who initiated hormone therapy within 10 years of menopause onset and in Black women.
    • “The authors cautioned that given the lack of consistent cardiovascular benefit and the overall risk-benefit balance, the findings shouldn’t be used to support the use of MHT for cardiovascular prevention.”
  • Healio adds,
    • “Menopause remains inconsistently documented in electronic health records, according to a new systematic review published in Menopause.
    • “We expected to find some variation in how menopause was documented, but the extent of the inconsistency was striking,” Robin R. Austin, PhD, DNP, DC, MSN, RN, NI-BC, FAMIA, FAAN, an associate professor at the University of Minnesota School of Nursing, told Healio. “Menopause status and symptoms were often identified indirectly or incompletely, making it difficult to understand where a woman is in the menopause transition.”
  • Reuters tells us,
    • “Prescriptions for GLP-1 weight-loss drugs among children under 12 in the U.S. have risen more than 300-fold since 2019 as doctors seek new, effective ​treatments for younger patients with obesity, according to a study published on ‌Friday.
    • “The study, which included more than 3.5 million children aged between eight and 11 years with obesity but not diabetes, found that prescriptions for GLP-1 weight-loss drugs rose from 0.03% in ​2019 to 9.3% as of June.” * * *
    • “Although the drugs are not approved ​for use in children under 12 years, clinical guidelines allow the ⁠medications to be used for obesity in children as young as eight years ​old in certain cases.
    • “94% of the children prescribed GLP-1s had severe obesity, and ​about 65% had at least one related condition, such as high cholesterol, high blood pressure, and sleep apnea.” * * *
    • “While the absolute numbers of ​children under 12 receiving GLP-1 treatment is still low, the study shows that GLP-1 use ‌is ⁠accelerating rapidly, said lead investigator and obesity medicine specialist Dr. Babak Orandi of NYU Langone Health.”
  • Fierce Pharma adds,
    • Novo Nordisk has reported a phase 3 weight-management win for Wegovy in children, with two out of five kids no longer classified as having obesity after receiving the GLP-1 drug for 68 weeks.
    • Wegovy, the brand name for semaglutide in indications including obesity, is FDA approved for reducing body weight in people aged 12 years and older. Yet Wegovy and other GLP-1 drugs are increasingly used off-label in younger children, with a recent study finding that prescriptions in kids aged 8 to 11 jumped from 0.03% in 2019 to 9.3% in 2026.
    • Novo’s Step Young phase 3 trial suggests the younger children may benefit from Wegovy. Participants received weekly Wegovy injections of either 1.7 mg or 2.4 mg, based on their weight at the start of the trial, or placebo. All participants were assigned a reduced-calorie diet and increased physical activity.
  • STAT News informs us,
    • “In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday. 
    • “Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma.” 
  • BioPharma Dive adds,
    • “Roivant said Tuesday a would-be treatment for a particular kind of high blood pressure associated with lung inflammation met all of its main and secondary objectives in a Phase 2 trial. Roivant’s medication, “mosliciguat,” reduced by 56% a measure of how difficult it is for blood to flow through the lungs of people with pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Roivant claimed that result was the “highest ever reported” in a randomized pulmonary hypertension trial and has already begun a Phase 3 study. The “exceptional” results, along with plans to develop mosliciguat in other conditions, could yield a drug with more than $10 billion in yearly sales, wrote Leerink Partners analyst David Risinger. Roivant shares surged 20%.”
  • and
    • “A new kind of cancer cell therapy from Bristol Myers Squibb has come through in a mid-stage trial, the company announced Tuesday. Dubbed arlocabtagene autoleucel or arlo-cel, the therapy is a CAR-T treatment directed at GPRC5D, a cell surface protein that’s overexpressed on diseased cells in multiple myeloma. Bristol Myers didn’t provide specific details. But it said arlo-cel demonstrated a “statistically significant and clinically meaningful” response rate in people whose multiple myeloma had progressed following at least four treatment lines — among them drugs aimed at BCMA, a more established multiple myeloma target.”
  • Fierce Pharma notes,
    • “In further validation of the DLL3 target pioneered by Amgen’s Imdelltra, the T-cell engager has delivered an overall survival win in first-line small cell lung cancer (SCLC).
    • “Imdelltra, used together with AstraZeneca’s Imfinzi, led to a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared with Imfinzi alone as a first-line maintenance treatment for extensive stage SCLC, Amgen announced Tuesday.
    • “The Imdelltra regimen also showed superior progression-free survival and objective response rate, with safety consistent with the drugs’ known profiles, the company added.”
  • Genetic Engineering and BioTechnology News lets us know,
    • “Although the highly contagious bacterium Clostridioides difficile (C. diff) causes severe disease in adults, it has been reported to not cause symptoms in infants. Based on that, the assumption has been that infant colonization was not a serious health issue. That said, the consequences of early-life colonization on host development remain unknown. Now, in a new study, researchers at Children’s Hospital of Philadelphia (CHOP) are challenging that long-held assumption, with new findings suggesting that the bacterium can reshape the developing infant gut and may have long-term consequences.
    • “This work was published in Science in the paper, “Early-life colonization with Clostridioides difficile remodels the developing gut.”
  • The New York Times points out,
    • “Last year, a clinical trial conducted by Insilico Medicine, a company that aims to accelerate drug discovery using artificial intelligence, indicated that one of its drug candidates could help treat patients suffering from a chronic lung disease.
    • “Now, the company says that data from the same clinical trial shows a more intriguing possibility: that the drug could also slow the aging process.
    • “The molecular structure of the drug, called rentosertib, was generated with the assistance of A.I. Results of the new study, published Monday in the journal Nature Biotechnology, show that the drug reduced the biological markers of age as measured by six “aging clocks,” a different kind of A.I. technology designed to predict a person’s morbidity and mortality.
    • ‘This elaborate clinical trial is a milestone in the widespread effort to improve health care using the same A.I. techniques that underpin popular chatbots like ChatGPT and image generators like Midjourney. Insilico is just one of many start-ups, tech giants and academic labs working to accelerate drug discovery and honeother medical tasks with help from these methods.”
  • and
    • “It is one of biology’s most ingenious rhythms: Every baby is born young. No matter how much wear and tear their parents’ DNA accumulated over their lifetimes, reproduction erases the molecular scars, handing a clean slate to the next generation.
    • “Now, a new frontier in biotechnology aims to harness this natural mechanism to do something once thought impossible: scrub away the biological detritus of our own past. By mimicking Mother Nature’s magic eraser, geneticists are working to open a new avenue for treating or preventing disease later in life — not by editing genes themselves, but by altering when, where and how genes are expressed.
    • “All of this is possible thanks to the epigenome, a network of chemical tags throughout the body that latch on to DNA and tell each cell type how to behave. If a person’s DNA is a string of notes in a musical score, the epigenome is the collection of the conductor’s pencil markings left on the page — accumulated through experience over time, indicating which notes to play louder or softer or to skip entirely.”

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

  • Beckers Payer Issues reports,
    • “Growth in healthcare spending, not insurer profit margins, drove the vast majority of commercial premium increases over more than a decade, according to a study published Sept. 4 in JAMA Health Forum.
    • “Researchers at Yale University and the University of Wisconsin-Madison analyzed CMS data from 2011 to 2024 covering the large group, small group and individual markets, which included information on premiums, health spending and insurer markups for each state and year. The data did not include self-insured employers, which cover roughly half the U.S. population.”
  • Fierce Healthcare relates,
    • “After a failed round of in vitro fertilization this year, Anne Hug’s fertility doctor said she had a single polyp in her uterus that should be removed to improve the chance of pregnancy. Hug, a professor of radiology, learned that the American College of Obstetricians and Gynecologists says the procedure can be done in a doctor’s office with local numbing.
    • “Her doctor referred her to a physician at the same hospital, which is part of a large Ohio health system. That doctor’s plan was to do the procedure in a hospital operating room, with anesthesia administered by an anesthesiologist.
    • “Hug balked at the $18,000 estimate.
    • “The estimate for the in-office procedure was around $3,000. The bill when she was forced at the last minute to switch to the surgery center was around $6,000. She now wonders, “How is it legal for these hospitals to force patients to have procedures done in a hospital when professional organizations recommend differently?”
    • “Hug’s experience is a classic example of the predicted outcome of “vertical integration” in the healthcare system, when one company owns or controls multiple parts of a supply chain and can therefore direct patients to more expensive treatment options.”
  • Beckers ASC Review tells us,
    • “Twenty-seven states [listed in the article] have opted out of the federal requirement that a physician supervise CRNAs administering anesthesia, according to the American Association of Nurse Anesthesiology’s most recent fact sheet, updated in July 2026.
    • “Vermont and Ohio became the 26th and 27th states to opt out, making the move in July 2026. The full list stretches back more than two decades, and for ASC leaders dealing with anesthesia staffing costs, where a state falls on that list is directly relevant to how much flexibility they have to restructure anesthesia coverage.” * * *
    • “In opt-out states — provided state law and facility policy also allow it — ASCs have more room to build CRNA-based staffing model models. Seattle-based Proliance Surgeons moved to a CRNA-only staffing model in 2025 after the anesthesiology group it was partnered with decided not to renew its contract. After switching the new model, the organization reported no patient care delays and no cases redirected to hospitals over provider-availability concerns.
    • ‘That’s just one case study, but as more states move away from the federal supervision requirement, the staffing-model conversation for ASCs is likely to keep shifting from “how much do we pay for anesthesiologist coverage” to “do we need anesthesiologist coverage for this case mix at all.”
  • The American Hospital Association News notes,
    • “A report on obstetric services in hospitals by the University of Minnesota Rural Health Research Center found that between 2010 and 2024, 718 hospitals nationwide lost obstetric services due to obstetric unit or hospital closure. The report found that 9% of those losses happened from 2023-2024. Between 2010-2024, 14% of hospitals (16% of rural hospitals, 13% of urban hospitals) lost obstetric services, while 35% (42% rural, 30% urban) never had obstetric services during that period. By 2024, 57.5% of rural hospitals and 43.6% of urban hospitals across the U.S. were without obstetric services.” 
  • Healthcare IT News explains how “telemedicine becomes more deeply embedded into hospital workflows.”
    • “Health systems are using virtual nursing, tele-ICU, remote specialty care and EHR-integrated teams to extend scarce expertise, support bedside clinicians and redesign care delivery.”
  • Beckers Physician Leadership discusses the “uneven collapse of private medical practice.”
    • “While the decline of independent practice has persisted as a general trend across medicine, the consolidation of physician practices has played out differently across specialties. 
    • “A 2025 specialty-level breakdown of independent practice published by the American Medical Association found private-practice rates ranging from 70.4% in ophthalmology down to 30.7% in gastroenterology, a nearly 40-percentage-point gap between the most and least independent of the five specialties driving the bulk of physician practice mergers and acquisitions activity.”
  • Fierce Healthcare informs us,
    • “Oura, the smart ring maker and health tracking company, filed to go public on Thursday [September 10] to fuel its next phase of growth as it aims to build an artificial intelligence-powered health platform.
    • “The company has not specified the number of shares to be offered or the price range for the proposed offering. Oura intends to list on the Nasdaq under the ticker symbol “OURA.”
    • “Founded in Finland in 2013, Oura’s smart rings continuously track more than 50 health metrics, including heart rate, sleep, daily movement and activity, stress, fertility windows and metabolic health.”
  • and
    • “Five Kansas health systems have launched a regional collaboration, called Astra Health, to pool resources and coordinate services while retaining their independence. 
    • “The new shared services organization was announced Tuesday and will include LMH Health, The University of Kansas Health System, Amberwell Health, Newman Regional Health and Salina Regional Health Center. Together, the organizations see more than half a million patients annually and extend into every county in the state. 
    • “The partnership will help participating hospitals improve quality, share best practices, enhance performance measurement, and strengthen care delivery in the communities they serve,” Shelly Kortkamp, M.D., president and CEO of LMH Health, said in an announcement.”
  • and
    • “Health tech startup Forus banked $150 million in series C funding as it aims to expand its artificial intelligence-powered network to more medical specialties and care settings.
    • “The fresh funding comes just four months after the company announced it raised $160 million in a series B round. The latest funding round boosts Forus’ valuation to $3 billion, tripling from its series B round in May, according to the company. Forus has raised more than $300 million to date.
    • “Bain Capital Ventures, an investor in Forus since its seed round, led the latest round, with every existing institutional investor reinvesting, including Thrive Capital, General Catalyst, Accel, Redpoint, BoxGroup, Pear VC, Vast Ventures and SV Angel.”
  • Per BioPharma Dive,
    • “BrainChild Bio, a cell therapy developer making CAR-T treatments for children with rare brain cancers, has banked $116 million in a round of venture financing, the company announced Tuesday.
    • “CAR-T therapies are powerful treatments engineered from immune cells. A handful have been approved to treat certain blood cancers, and many companies are studying their potential on other tumors and even autoimmune diseases.
    • “But according to BrainChild founder and Chief Scientific Officer Michael Jensen, few companies have tried to test CAR-T treatments against brain cancer. “The prejudice is that the brain would be intolerant to having cells directly administered,” he said. 
    • “BrainChild is different. Spun out of research at Seattle Children’s Hospital three years ago, the company is working on a pair of brain cancer cell therapies designed specifically for children.”
  • Per Fierce Pharma,
    • “Spying a “golden decade” beyond the branded drug industry’s looming patent cliff, Sandoz is making big bets on its biosimilar capabilities in the coming years. 
    • “Under the company’s so-called Bio100 plan, Sandoz is setting the ambitious goal to establish a portfolio of more than 100 biosimilars by 2040, up substantially from the 13 it currently markets. Meanwhile, the company also aims to expand the overall biosimilar loss of exclusivity (LOE)-value it holds from some 50% today to around 80% from 2035 onwards.
    • “Part and parcel to that, Sandoz hopes to double its net sales from 2025 through the middle of the next decade, according to a Sept. 8 release outlining the strategy. For all of last year, the Swiss drugmaker reported 5% net sales growth at constant currencies to $11.1 billion.” 
  • Tech Target offers “6 use cases for improving employee retention using predictive analytics.”
    • Predictive analytics can identify employees who are good candidates for promotion. Learn other use cases for improving employee retention using predictive analytics.

Happy Labor Day

David Ermer–Congress, Mental health care, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The House of Representatives and the Senate will be on District/State work breaks this week following Labor Day.

From the public health and medical / Rx research front

  • The New York Times reports,
    • “Medications are like barnacles,” said Dr. Michael Steinman, a geriatrician at the University of California, San Francisco, and co-director of the U.S. Deprescribing Research Network. “They’re easy to start, but they can be hard to stop.” * * *
    • “Recent studies of three medications or classes of drugs widely used among older Americans illustrate the problem.
      • The Drawbacks of Benzodiazepines
      • Overprescribing Antibiotics
      • When Aspirin isn’t the Answer.
  • Health Day relates,
    • “Heart-pumping aerobic exercise can boost key thinking skills among women after menopause, a new study says.
    • “Postmenopausal women who practiced aerobic exercise four days a week for half a year performed better on cognitive tests than those who focused on stretching and toning, researchers reported recently in the Journal of Alzheimer’s Disease.
    • “Women who did aerobics specifically improved in their executive function — the brain skills that help people plan, juggle tasks, stay focused and maintain independence, results showed.”
  • Beckers Behavioral Health tells us,
    • “Suicide-related emergency department visits among children increased 74% from 2016 to 2022, according to a study published Sept. 3 in Annals of Emergency Medicine. The study represented more than 5 million pediatric mental health ED visits in the U.S.”

From the U.S. healthcare business front,

  • Avalere Health points out,
    • “Publicly traded health plans recently reported their second quarter financial performance. To assess reported trends, Avalere Health analyzed 10Q forms and filings and earnings call transcripts from six publicly traded health plans: Centene, Cigna, CVS Health, Elevance Health, Humana, and UnitedHealth. Overall, we found that while margins have increased year-over-year, elevated medical costs continue to pressure plans, forcing plans to reexamine membership profitability and reevaluate growth strategies.”
  • The Wall Street Journal reports,
    • “About 92% of U.S. health providers now encourage or require prepayment or collect a payment method on file during the medical estimate process.
    • “The trend is driven by insurers shifting more costs to patients, leaving hospitals struggling to collect unpaid bills after procedures.
    • “While federal law doesn’t bar prepayment requests for nonemergency services, some states are enacting laws to address aspects of the trend.”
  • and
    • “China is emerging as a favored destination for overseas cancer patients seeking CAR-T therapy due to lower costs and biotech innovation.
    • “CAR-T therapy in China can range from $150,000 to $230,000, compared with $550,000 to $850,000 in the U.S.
    • “Chinese regulators have approved nine CAR-T products, the most in the world, including the first approved CAR-T therapy for solid tumors.”
  • Beckers Hospital Review offers “A tale of 2 retailers: What drives success for co-branded Medicare Advantage plans.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NCQA, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House voted Sept. 1 on a continuing resolution (H.R. 6500) to fund the federal government through Dec. 11. The measure passed on a 370-48 bipartisan vote; the Senate passed its version by a vote of 90-6 on Aug. 8. The CR delays the Office of Management and Budget from finalizing its federal financial assistance proposed rule and prohibits any similar measure from being issued or finalized prior to Dec. 11. The AHA July 13 commented with concerns about the proposed rule, which would revise the Uniform Grants Regulation governing federal financial assistance.”
  • and
    • “The AHA Aug. 31 submitted comments urging the National Association of Insurance Commissioners Health Care Affordability and Mitigation Working Group to take a more comprehensive approach to evaluating healthcare affordability policies in a series of issue briefs being developed as a resource for state regulators and policymakers. The AHA called on the working group to assess consumers’ total financial burden, including premiums, deductibles, cost sharing and access to care, rather than focusing solely on any one measure, such as premium reductions or payer savings. The AHA also encouraged the working group to provide balanced analyses of policy options, including potential tradeoffs and unintended consequences, and to consider how health plan practices, such as prior authorization requirements, claims denials and network design, affect both affordability and patient access to care.”
  • Beckers Hospital Review adds,
    • “Mark Cuban argues the fundamental problem in U.S. healthcare is not whether the system is run by the public sector or the private sector. It is that hospitals do not know what their own services cost.
    • “During an Aug. 18 episode of KFF Health News’ “What the Health?” podcast, the entrepreneur and co-founder of Cost Plus Drug Co. said the lack of granular cost information undermines hospital pricing, reimbursement negotiations and broader debates over healthcare reform.
    • “The fundamental issue is transparency and trust … [and] there are a lot of hospitals that don’t know their costs,” he said. “They just know their cash balance.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today hosted the Live Real Life Symposium at the Hubert H. Humphrey Building in Washington, D.C., bringing together leaders from technology, medicine, research, education, government, and advocacy groups to examine the harms of screen use in children and discuss actionable approaches to supporting healthier childhood development.
    • “Our children get one childhood, and we cannot allow screens to replace the real-world experiences they need to grow and thrive,” said HHS Secretary Robert F. Kennedy, Jr. “Through the Office of the Surgeon General’s Live Real Life initiative, we are giving families practical tools to put technology in its proper place and get children back to playing, exploring, connecting, and experiencing the world around them.”
    • “The symposium is part of the HHS Live Real Life campaign, a national effort to help families, schools, and communities reduce harmful screen use and create more opportunities for children to engage in the experiences essential to healthy development.
    • “The event builds on the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents issued earlier this year, which outlines how factors such as age, content, design, purpose, and duration influence when screen engagement may be beneficial and when it becomes harmful.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $58 million investment is being delivered to improve health outcomes for Hawaiians through the federal Rural Health Transformation Program (RHTP). This investment will strengthen Hawaii’s healthcare workforce, improve infrastructure, advance technology, and support innovative approaches tailored to the unique healthcare needs across the state. 
    • “President Trump understands that every American deserves high-quality healthcare, no matter where they live,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are putting resources directly into rural communities to strengthen the health workforce, modernize infrastructure, expand access, and bring care closer to home. We are giving states the flexibility to build solutions around the people they serve, while demanding accountability for results. That is how we strengthen rural health, improve the lives of patients and families, and Make America Healthy Again.”
    • “President Trump made a historic commitment to rural America, and these investments are turning that commitment into better care for patients in communities across Hawaii,” said Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz. “This is what rural health transformation should look like: federal investment that is putting patients first, driving lasting improvements and expanding healthcare for the hardworking Americans who call these communities home.”
  • Reuters relates,
    • “U.S. Centers for Medicare and ​Medicaid Services Administrator ‌Dr. Mehmet Oz said on ​Monday [August 31] that 600,000 ​seniors have signed ⁠up to receive ​GLP-1 weight loss ​medications in the first two months of ​a new ​federal program created to expand ‌access ⁠to the highly sought-after treatments.
    • “Under the so-called Medicare ​Bridge ​program, ⁠which launched in July, ​millions of ​older ⁠Americans qualify for obesity medications at ⁠just $50 ​a ​month.”
  • GAO’s WatchBlog suggests “Nine Ways Congress Can Combat Fraud in the Federal Government,”
  • Fierce Healthcare tells us,
    • “Komodo Health, an AI-powered healthcare intelligence company, is teaming up with the National Committee for Quality Assurance (NCQA) to modernize how healthcare quality measures are developed.
    • “The multi-year strategic partnership will allow NCQA researchers to tap into Komodo’s Healthcare Map, made up of over 330 million de-identified patient journeys, to analyze care across insurance types, care settings and patient populations from a single longitudinal data source. 
    • “They will have access to Komodo’s Marmot, an AI-powered healthcare intelligence platform, to explore complex questions with transparent, reproducible outputs. NCQA is solely responsible for developing HEDIS measures.” * * *
    • “The goal is to allow NCQA to evaluate new measures more quickly and efficiently and to ensure HEDIS reflects real-world evidence. Developing new quality measures has historically required pulling from disparate datasets, including field testing with individual payers and other partners. This could take two to three months, and often had to be done separately for each population studied.
    • “Using Komodo’s Healthcare Map has greatly streamlined that process,” Tricia Elliott, VP of quality implementation at NCQA, told Fierce Healthcare in emailed comments. “Because the Healthcare Map includes insights from Medicare, Medicaid and commercial populations, our researchers can evaluate measures across multiple insurance types using a single, consistent data source rather than running separate analyses.”

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

  • Govexec reports,
    • “Each portfolio within the federal government’s 401(k)-style retirement savings program gained value last month, snapping a two-month streak of lackluster market performance.
    • “The international stocks of the Thrift Savings Plan’s I Fund sported the best performance, gaining 3.32% last month. So far this year, the I Fund has grown 19.18%.
    • “The C Fund, which is made up of large- and mid-size businesses, increased 2.72% in August, good for 13.12% growth since the start of 2026. And the small- and mid-size companies in the S Fund finished August 2.27% in the black, bringing its 2026 gains to 16.10%.”
  • OPM’s Director Scott Kupor added a new post to this Secrets of OPM blog today.
    • “Last week we at OPM recognized excellence among our team members through the Director’s Awards Ceremony.
    • “It not only gave me a chance to put my tuxedo to good use (which I almost never have a chance to do) and to tell the one joke I could remember that’s appropriate for a work setting, but – all kidding aside – it gave us an opportunity to recognize those who have gone above and beyond in service of the American people. And in doing so gave us the opportunity to walk the walk about what a high-performance culture means – one in which we are not afraid to call out individuals and teams that truly exceed expectations and in which we disproportionately reward excellence.
    • “I’ve written about this before (link to WAPO editorial), but the federal government has under-served its employees by trapping them in a system that treats accountability too lightly and fails to reward its top performers. We see this in the historical annual employee ratings systems – where less than 0.5% of a 2 million strong employee base rates below expectations and where nearly every SES (our most senior executives) is rated above expectations. And, as a result, we see this in the annual bonus system which provides little differentiation between satisfactory performance and those who consistently knock the cover off the ball.
    • “We’ve been working to change this culture into one that holds low performers accountable and forces managers to distinguish among their employees based on actual performance – both in ratings and in rewards (link to performance blog). While the Director’s Awards are not a substitute for the traditional end-of-year evaluation cycle, it is a great venue for us to practice what we preach.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Baxter International has recalled one lot each of 70% Dextrose Injection and Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter.
    • “The 70% Dextrose Injection may contain stainless steel particles, according to an Aug. 25 FDA alert. The affected product is lot Y495066, which expires July 31, 2027. It was distributed July 25-28, 2026, to healthcare providers and distributors in select states, including Alabama, Georgia and Tennessee.
    • “Baxter also recalled lot Y493475 of Anticoagulant Sodium Citrate Solution due to the potential presence of fiberglass. The product, which expires Dec. 31, 2027, was distributed July 2-11, 2026, to one customer in the U.S.” * * *
    • “As of Aug. 25, Baxter had not received any reports of adverse events related to either issue. Customers were instructed to immediately discontinue use of affected units and return them.”
  • Oncology News Central relates,
    • “On Aug. 31, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft (Besremi) for adults with essential thrombocythemia (ET), marking the first approval for the rare blood cancer in nearly three decades.
    • “Regulators based their decision on results from the open-label, multicenter, randomized SURPASS ET clinical trial. The phase 3 study enrolled 174 adults with ET who had an inadequate response to hydroxyurea. 
    • “Today’s FDA approval of [ropeginterferon alfa-2b] for ET is a significant advancement for patients and reflects PharmaEssentia’s longstanding commitment to advancing innovative therapies for people living with myeloproliferative neoplasms,” PharmaEssentia CEO Ko-Chung Lin, PhD, said in a statement. “We have been working closely with the FDA, healthcare providers, advocacy organizations, and payers to bring this important treatment option to the ET community.”
  • STAT News lets us know,
    • “Medical device giant Stryker earlier this summer received Food and Drug Administration authorization for a surgical display system using Apple’s Vision Pro headset. Specifically indicated for imaging during minimally invasive surgery for hip impingement and labral repair, SportSuite Vision allows a surgeon to place multiple displays that are usually scattered around an operating room in their preferred configuration in the Vision Pro’s display. During a procedure, surgeons usually need to swivel their heads and bodies to refer to CT imaging, arthroscopic video, and Stryker software.
    • “The De Novo authorization was based on hundreds of hours of lab testing, including work on cadavers and testing interactions with other staff, but the company is announcing today that a surgeon at Duke Health completed a real procedure using the technology.
    • “Matt Moreau, VP and general manager of sports medicine at Stryker, told me the company has long wanted to create such a “surgical cockpit,” but Vision Pro is the first to deliver on the technical capabilities necessary, including  high-quality passthrough video that allows a surgeon to see the operating room and staff around them.”

From the judicial front,

  • “A panel of three Republican judges (two Trump first term appointees and one George H.W. Bush) from the U.S. Court of Appeals for the 11th Circuit unanimously overruled a district court decision holding the False Claims Act’s qui tam provision unconstitutional.  Here is an 11th Circuit link to the opinion.”
  • In short this is the Court’s holding:
    • “Here, a relator brought an FCA suit against defendants that she alleged committed Medicare fraud, and the defendants moved for judgment on the pleadings or dismissal on the grounds that the qui tam provisions violated the Constitution’s Appointments Clause, Take Care Clause, and Vesting Clause. The district court granted the defendants’ motion and held that the qui tam provisions violate Article II’s Appointments Clause because relators qualify as officers of the United States and, as such, must be (but are not) presidentially appointed.
    • “We disagree and hold that relators are not officers of the United States because they do not occupy a continuing position established by law. Accordingly, we join our sister circuits that have addressed this issue and hold that the qui tam provisions of the FCA do not violate the Appointments Clause. Therefore, we vacate the district court’s order dismissing this case and remand for the district court to evaluate the defendants’ remaining constitutional arguments.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “COVID-19 cases are ticking up in almost every U.S. state as summer draws to a close, according to the latest data from the Centers for Disease Control and Prevention.
    • “COVID-19 activity was still categorized overall as “very low” nationwide by the agency as of Aug. 28, though cases are consistently increasing. This is likely the result of what has come to be known as the “summer surge,” a pattern that doctors have observed each year since around 2022. Unlike other respiratory illnesses such as the flu, COVID-19 tends to flare not only during the typical winter cold and flu season, but also toward the end of summer.
    • “Experts previously told USA TODAY that this is likely caused by multiple factors, including behavioral and environmental changes (the amount of time spent cooped up in AC, going back to school, etc.), as well as the virus’s life cycle and how our immunity to it waxes and wanes.
    • “COVID-19 is rising nationally but from a low baseline,” Dr. Syra Madad, infectious disease epidemiologist at Harvard’s Belfer Center and chief biopreparedness officer for New York City’s public hospitals, previously told USA TODAY. “The increase became apparent in parts of the South and West during July and more clearly nationwide by late July and early August.”
  • Beckers Behavioral Health relates,
    • “The CDC predicts 67,798 drug overdose deaths in the U.S. during the 12 months ending in March 2026, a 12.3% decrease compared to the same time period in the previous year, according to an Aug. 31 news release from the agency.”
  • NPR tells us,
    • “Maria Uloko sees the same scenario in her urology practice in Los Angeles every day: A woman has been diagnosed with recurrent urinary tract infections (which means she’s had at least two in six months or three in a year), taken repeated rounds of antibiotics, and feels confused as to why the infections keep coming back.
    • “Then, Uloko tells these patients something that often feels both revelatory and frustrating. “Most of them don’t actually have UTIs, even though that’s been their diagnosis time and time again,” she says. “In fact, millions of women are being treated for UTIs they may not actually have.”
    • “Uloko is the co-author of a recent study published in The Journal of Sexual Medicine that backs this up. She and her fellow researchers reviewed the medical records of 253 women with recurrent UTIs and found that just 15% showed evidence of problems that were limited to the bladder or urinary tract. The remaining 85% had signs of hormonally driven inflammation of the vulvar region and 75% had pelvic floor dysfunction.
    • “These conditions produce identical symptoms as UTIs — burning with urination, urgency, frequency, and/or lower abdominal pain — but require different treatment.
    • “What we found is that in women with recurrent UTIs, the majority didn’t have a bladder problem at all; they had a vulvar problem,” says Uloko.”
  • STAT News informs us,
    • “New guidelines released Monday highlight the many new treatments that have hit the market in recent years for the prevention of migraine. 
    • “The guidance for health care providers comes from the American Headache Society and the American Academy of Neurology, which last updated their recommendations in 2012. 
    • “There has been a wealth of new treatment available,” said Rebecca Burch, guideline co-author and neurologist at the University of Vermont Medical Center. Burch also co-authored the previous guidance. 
    • “Among the key updates are at least a half dozen medications that were approved for migraine prevention by the Food and Drug Administration since 2012. Many of those focus on blocking the calcitonin gene-related peptide, or CGRP, pathway, which is implicated in migraine. 
    • “The new guidelines advise doctors to offer preventive treatment to people who have at least four migraine or severe headache days per month, or whose migraines interfere with their ability to work or complete daily tasks. An estimated 15% of Americans experience migraines, with women disproportionately affected. Many try to manage their pain with over-the-counter options once an attack has begun.” 
  • Health Day points out,
    • “Adults who spend hours scrolling social media every day are more likely to develop depression, a new study says.
    • “Around 2.5 hours or more of scrolling per day is linked to self-reported depression, researchers recently reported in the journal npj Mental Health Research.
    • “The study found that social media is more closely linked to depression than other factors like your job, your educational background, or your time spent playing video games, surfing the web or watching TV, researchers said.
    • “It’s a damning picture. Social media is harmful for individuals across the lifespan,” senior researcher Hans Breiter, a professor at the University of Cincinnati, said in a news release.
    • “We should not subject ourselves to a product using addiction science to optimize our viewing time,” Breiter said.”
  • Per Reuters,
    • “People taking popular GLP-1 obesity drugs who remain on low starter doses will ​lose some weight but may still experience side effects, although significantly less nausea than those who graduate ‌to higher manufacturer-recommended doses, a new study suggests.
    • “And they are unlikely to experience the double-digit weight-loss percentages seen with the higher doses, the study found.
    • “The GLP-1 drugs semaglutide, sold as Ozempic and Wegovy by Novo Nordisk (NOVOb.CO), and Eli Lilly’s (LLY.N) tirzepatide, sold under the brand names Mounjaro and Zepbound, are prescribed ​initially at a low dose followed by gradual titration to higher doses, to help the body adjust and minimize side ​effects.”
  • Cardiovascular Business notes,
    • “Catheter ablation does not significantly improve the quality of life of patients with symptomatic atrial fibrillation (AFib) more than a sham procedure involving sedation, venous access and electrical cardioversion, according to new late-breaking data presented at ESC Congress 2026. The findings were simultaneously published in The Lancet.[1]
    • “PVI-SHAM-AF was a randomized, double-blind, sham-controlled trial included more than 250 patients with symptomatic paroxysmal or persistent AFib. Patients were randomized to undergo either catheter ablation or a sham procedure. The sham procedure was rather complex, involving sedation, venous access, time in the electrophysiology lab and even cardioversion. Each participant completed an AF Effect on the Quality of Life Questionnaire (AFEQT) at baseline and again after six months. 
    • “Overall, 173 patients were treated with catheter-based pulmonary vein isolation (PVI) ablation and another 89 patients were treated with the sham procedure. After six months, AFEQT scores improved from 61.3 to 81.1 in the catheter ablation group and from 59.2 to 74.9 in the sham procedure group. This was not viewed as a significant difference. 
    • “On the other hand, the authors noted that catheter ablation was still proven to be effective in reducing the risk of recurring episodes of AFib. Freedom from AFib after six months occurred in 73% of catheter ablation patients and 52% of sham procedure patients.”
  • and 
    • “Metformin, a popular type 2 diabetes medication used to reduce blood glucose levels, does not appear to make a significant impact on outcomes for patients with heart failure with reduced ejection fraction (HFrEF). That is according to two separate studies presented at European Society of Cardiology (ESC) Congress 2026.
    • “The first of the two studies, Met-HeFT, included 940 heart failure patients in Denmark who either presented with type 2 diabetes or face an increased risk of developing type 2 diabetes. The mean age was 70 years old, and 84% of patients were men. Study participants were randomized to either undergo treatment with metformin or a placebo.
    • “Overall, after a mean follow-up period of 3.7 years, there was no significant difference in the study’s primary endpoint—a composite of mortality, worsening heart failure symptoms, acute myocardial infarction or stroke—between the two groups. That outcome occurred in 25.1% of metformin patients and 23.4% of placebo patients. Secondary endpoints, including new-onset diabetes and unplanned heart failure rates, were also not significant different between the two treatment options.
    • “It is worth noting, however, that just approximately one in 10 patients presented with type 2 diabetes. The remaining patients were all determined to face a heightened risk of developing type 2 diabetes.”
  • BioPharma Dive adds,
    • “A pill developed by Novartis succeeded in a pair of Phase 3 trials in people with a common form of multiple sclerosis, bolstering confidence in the drug’s prospects and sending company shares up by over 4% on Tuesday.
    • “The Swiss pharmaceutical giant didn’t provide detailed study results. Still, Novartis revealed the therapy, remibrutinib, demonstrated “superiority” over the drug Aubagio in reducing yearly relapse rates and inflammatory brain lesions in study participants. Treatment was associated with “clinically meaningful” effects on disability progress and, notably, didn’t impact liver safety — an issue for multiple drugs in remibrutinib’s class. 
    • “The findings could position remibrutinib, which is already approved as Rhapsido for chronic skin hives, to become a bigger sales contributor in the future. Novartis is looking to remibrutinib and other late-stage prospects to offset revenue losses from multiple patent expirations. It intends to share the MS study results with health regulators.” 
  • and
    • “An experimental drug Alumis has been testing in a form of lupus failed a mid-stage study, but the company will press forward after observing positive signs in a subgroup of trial participants.
    • “According to Alumis, the drug, envudeucitinib, missed all of its main and secondary objectives in systemic lupus erythematosus. Still, “robust” responses were seen in trial volunteers with “high interferon gene signature,” meaning certain genes controlled by interferons are overexpressed. A majority of people with moderate-to-severe SLE fit this description, Alumis said.
    • “Alumis will meet with regulators to discuss a path toward a Phase 3 trial. Company shares plummeted by nearly 55% on the results, though, nearly erasing all of Alumis’ stock gains this year. The company’s market value had soared following positive results in psoriasis in January.” 

From the U.S. healthcare business front,

  • Beckers Payers Issues calls attention to the following:
    • “Several of the nation’s largest health insurers rolled out reimbursement policy changes Sept. 1, ranging from new lab testing coverage limits at UnitedHealthcare to a billing overhaul at Blue Cross Blue Shield of Michigan that has drawn pushback from providers.”
  • and 
    • “UnitedHealthcare has released the specific procedure codes it will exempt from prior authorization as part of the insurer’s previous pledge to reduce requirements by 30% before the end of 2026.
    • “The code lists cover 1,700 procedure codes for a range of services across commercial, Medicare Advantage, individual exchange, and Medicaid plans. Effective Oct. 1, providers will no longer need to seek the insurer’s approval for many outpatient procedures, including lesion excisions, fracture treatments, joint injections, arthroscopies, colonoscopies, endoscopies, biopsies, hernia repairs and soft tissue tumor removals. Genetic and molecular testing codes also make up a large  portion of the lists.
    • “UnitedHealthcare CEO Tim Noel said in May that prior authorization “should only be used when it truly protects patients and improves care.” At the time, the insurer said it requires prior approval for just 2% of its medical services, with roughly 92% of submitted requests approved in less than 24 hours on average. The 30% reduction builds on an earlier 20% cut to commercial prior authorization requirements in 2023.”
  • HR Dive reports,
    • “Despite the current economic turbulence, most employees in a majority of companies will be getting a base salary increase for 2027, according to a large survey by Korn Ferry.
    • “Almost half (47%) of the 5,512 participating employers said they expect to provide salary hikes to at least 95% of their employees, while 79% expect to do so for at least 80% of employees. Only 2% said they are planning no increases for anyone.
    • “U.S. organizations expect to boost overall base-salary budgets next year by an average of 3.3% and a median of 3%. The median increase for U.S. executive and senior management is also anticipated to come in at 3.0%. 
    • “The survey was conducted in June of this year.”
  • Fierce Pharma unveiled its Fierce 50 awardees of 2026.
  • Beckers Hospital Review tells us,
    • “Philadelphia-based University of Pennsylvania Health System recorded operating income of $336.9 million (2.5% operating margin) for fiscal year 2026, up from operating income of $246.7 million (2.1% margin) during the same period last year, according to its Aug. 28 financial report.”
  • and
    • “Boston-based Dana-Farber Cancer Institute posted an operating loss of $9.1 million (-0.9% margin) in the third quarter of fiscal 2026, compared with an operating loss of $2.6 million (-0.3% margin) in the same quarter last year, according to its Sept. 1 financial report.”
  • and
    • “From R1 RCM striking an agreement to acquire an AI-powered touchless prior authorization company to IKS Health acquiring TruBridge, [the article identifies] 12 revenue cycle company mergers and acquisitions that have been announced or completed since March 17.”
  • Beckers Clinical Leadership informs us,
    • “Single specialty and multi-specialty groups were the top two highest-paying settings for physicians, followed by hospitals, Doximity found. 
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of nearly  23,000 responses collected in 2025, according to a company news release.  
    • “Among settings, solo practice had the largest drop in compensation year-over-year at -3.8%, while urgent care centers had the highest growth for the second year in a row, the report said.” 
  • and
    • “Most physicians say they’d still choose medicine if they had it to do over again, but nearly half say they’re likely to leave clinical practice within the next two years, according to Doximity’s 2026 Physician Compensation Report.
    • “Doximity, a digital platform for U.S. medical professionals, released the report Aug. 25. The findings are based on a survey of physicians conducted in June on how AI is changing physician careers and pay, along with salary data from more than 23,000 physicians collected in 2025, according to a company news release.”
  • MedTech Dive notes,
    • “Medtronic kicked off its fiscal year with double-digit revenue growth, building on momentum the company posted coming out of its previous year.
    • “Medtronic grew revenue by 13.7% to $9.8 billion in its fiscal first quarter, fueled by double-digit growth in its cardiovascular and medical surgical businesses. The strong quarter prompted the company to increase its organic revenue growth forecast for the full fiscal year.
    • “Importantly, these results reinforce our confidence and the durability of our business,” CEO Geoff Martha told investors on a Tuesday earnings call.
    • J.P. Morgan analyst Robbie Marcus wrote in a note to investors that Medtronic beat Wall Street’s consensus expectations in sales by about $220 million in the quarter.
    • “Much like in the fourth quarter, Medtronic’s cardiovascular unit was a bright spot for the company. The business brought in $3.93 billion in revenue, representing nearly 20% growth year over year.”

Thursday report

David Ermer–CDC, CMS, FDA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

  • Fierce Pharma points out,
    • “The Trump administration looks set to unveil a new slate of most-favored-nation (MFN) drug pricing deals with several mid-sized biopharma companies, according to Bloomberg.
    • “The announcement is expected on Monday [August 31, 2026], the news service reported this week, citing sources familiar with the plan. Drugmakers that have agreed to the voluntary deals are expected to provide their products to state Medicaid programs at prices aligned with those they charge in foreign countries.  
    • “In exchange, the companies could secure tariff relief and may win exemption from Medicare pilot discount programs that are in the works, Bloomberg wrote.” 
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $93.3 million investment is being delivered to help rural hospitals advance new state-of-the-art models of care and improve health outcomes for Georgians through the federal Rural Health Transformation Program (RHTP). 
    • “This investment will help 87 rural hospitals prepare for value-based care, expand training and recruitment for nurses, EMTs and paramedics, and improve access to maternal and behavioral health services, newborn screening, and other critical health services through telehealth, transportation and expanded care networks. It will also bring next-generation technology to rural communities—including surgical robotics, dementia care capacity, and telehealth infrastructure—to modernize care. By strengthening and expanding rural care, this funding will also help retain health care professionals in rural Georgia. This investment will strengthen rural hospitals, expand telehealth and healthcare access, build dementia care capacity, and grow the rural healthcare workforce through technology-enabled care initiatives across the state. With these investments, Georgia has now committed the full $218 million awarded to the state for its first year of funding through the RHTP.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services has released a fact sheet and FAQs on the 340B Part D claims data repository that will go live Oct. 1. Data submissions would currently be voluntary for 340B hospitals. However, the agency recently proposed to make data submissions mandatory starting in 2027. The fact sheet and FAQ provide an overview of the repository along with other key details.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced [in the news release] the nine winners of the 2026 KidneyX EMPOWER: Living Link Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them. The challenge was run through the Kidney Innovation Accelerator (KidneyX), a public-private partnership between HHS and the American Society of Nephrology (ASN).
    • “Every American waiting for a kidney deserves the best chance at a longer, healthier life,” said HHS Secretary Robert F. Kennedy, Jr. “Living kidney donation saves lives, yet too many willing donors face barriers that should not exist. We are removing those barriers and backing innovators with practical solutions that support donors, strengthen transplant care, and give more Americans a chance to live.”
  • The International Foundation of Employee Benefit Plans reports,
    • “The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments) released Affordable Care Act (ACA) and Health Insurance Portability and Accountability Act (HIPAA) Implementation Frequently Asked Questions (FAQs) Part 74 addressing health-contingent wellness programs, including tobacco-related wellness programs. The FAQs cover completion of reasonable alternative standard and disclosure requirements. 
    • “The new guidance comes after tobacco-related wellness programs have been the subject of recent class-action lawsuits challenging the tobacco surcharges some employers add to premiums for their group health plans through workplace wellness programs. The FAQs released today announce the Departments’ approach to enforcement for health-contingent wellness programs that reward an employee if they satisfy a standard related to a health factor.
    • “Until further guidance or regulations are issued, the departments will not take enforcement action against plans or issuers that do not give employees the wellness program reward retroactively to the beginning of the plan year after the employee completes a reasonable alternative standard. Under the terms of the enforcement relief in these FAQs, plans and issuers only need to provide the reward prospectively, from the point where the employee completes the alternative standard, if retroactive rewards are not otherwise provided.”
  • Beckers Hospital Review tells us,
    • “Medicare’s GLP-1 Bridge program is seeing early uptake at major retail pharmacies, with CVS and Walgreens each filling about 100,000 prescriptions less than two months after the program launched in July, according to an Aug. 26 NPR report.
    • “We expected there would be uptake,” Walgreens’ chief pharmacy officer Rick Gates told NPR. “I think there’s been a little bit more uptake than we even expected.”
    • “Walgreens stocked additional Wegovy, Zepbound and Foundayo ahead of the launch but has not experienced supply issues. Walmart said Bridge prescriptions have also increased week over week and have been filled at more than 5,000 Walmart and Sam’s Club pharmacies nationwide.
  • The No Suprises Act’s (“NSA”) regulating agencies, which includes OPM, corrected errors found in the final Independent Dispute Resolution rule published in the Federal Register on June 5, 2026.

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

  • Federal News Network reports,
    • “Artificial intelligence may become a more prominent part of the federal hiring process, following new guidance from the Office of Personnel Management.
    • “In a memo Thursday, OPM encouraged agencies to more widely adopt AI tools in their recruitment efforts. Without increasing AI use, agencies may be compromising the effectiveness and efficiency of the federal hiring process, OPM said.
    • “Despite 2025 guidance from the Office of Management and Budget defining “high-impact” standards for AI usage, agencies have been “overly cautious” about using the technology in hiring, said Adam Starr, OPM’s CIO and a senior advisor.
    • “Too often, agencies were defaulting to the view that any use of AI in hiring was subject to the high-impact standard. In reality, that is not the case,” Starr said Thursday in a blog post. “Instead, the inclusion of AI as a complement to human judgment is not only acceptable but leads to better outcomes.”
  • Tammy Flanagan, writing in Govexec, advises “Want to retire at the end of 2026? Start planning now.”
    • OPM is still working through a sizable retirement backlog, and year-end retirees have plenty to sort out before they leave federal service.

From the Food and Drug Administration front,

  • The American Hospital Association reports,
    • “The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and 37 serious injuries as of Aug. 17. The alert was issued due to the products experiencing purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly. Abiomed sent a letter to all affected customers recommending the devices be removed from where they are used or sold.” 
  • The Washington Post relates,
    • “The Food and Drug Administration on Thursday green-lit updated coronavirus vaccines for higher-risk Americans, such as older adults and people with at least one underlying health condition, vaccine manufacturers announced.
    • “The approved shots from vaccine manufacturers Pfizer-BioNTech and Moderna, which make mRNA-based vaccines, have an updated formulation aimed at better targeting the coronavirus variants circulating around the country. The FDA also cleared an updated vaccine from Sanofi, which doesn’t use mRNA-based technology and was originally licensed by Novavax, a Sanofi spokesperson confirmed. The companies said the vaccines are expected to be available in the coming days.”
    • “Most Americans typically get vaccinated against the coronavirus at retail pharmacies.
    • “Pharmacies are actively preparing to receive the updated shots, so they can begin vaccinations as soon as they receive shipments and all state requirements are met, according to Brigid Groves, a vice president at the American Pharmacists Association.”
  • Reuters tells us,
    • “The U.S. Food and Drug Administration said on Thursday it approved a ​treatment from Roivant (ROIV.O) and partner Priovant Therapeutics for a rare disease, ‌making it the first oral drug for the condition affecting skin and muscles.” * * *
    • “Branded as Lisraya, the drug was approved for ​dermatomyositis, a condition that causes painful skin rashes and progressive muscle weakness ​and, if untreated, can severely reduce quality of life.”
  • CNBC informs us,
    • “The Food and Drug Administration approved a once-daily HIV pill from Gilead that could help simplify care for some patients whose virus is already under control but who remain on complicated treatment regimens. 
    • “The tablet combines bictegravir, the backbone of Gilead’s blockbuster HIV pill Biktarvy, with lenacapavir, a centerpiece of the company’s long-term strategy for HIV treatment and prevention. 
    • “The new pill is also aimed at people who are doing well on a single-tablet regimen, including Biktarvy, and want to switch to a new treatment.”

From the judicial front,

  • Michelle Roberts, an attorney, lets us know,
    • In Central States v. McClain [decided August 26, 2026, a panel of the U.S. Court of Appeals for the] Seventh Circuit held that ERISA does not preempt Arkansas Insurance Department Rule 128. Applying Rutledge, the court treated the Rule’s dispensing fee requirement as a permissible cost regulation rather than a mandate dictating plan choices, and under Gobeille, it held that the Rule’s reporting requirement fell within the exception for reporting incidental to an unpreempted state law. The panel affirmed dismissal at the pleading stage while expressly reserving whether Congress’s new pharmacy-compensation reporting provision under 29 U.S.C. § 1185o will change the analysis once it takes effect.
  • In National Infusion Centers v. Kennedy, also decided August 26, 2026, held
    • “The Plaintiffs challenge the constitutionality of the Drug Pricing Program created by the Inflation Reduction Act of 2022. They claim violations of the nondelegation doctrine, the Eighth Amendment’s Excessive Fines Clause, and the Fifth Amendment’s Due Process Clause. The district court granted the Government’s motion for summary judgment. We AFFIRM.”
  • Govexec reports,
    • “The Equal Employment Opportunity Commission voted 2-1 Wednesday to propose new regulations that would overhaul how federal workers may pursue workplace discrimination claims, removing employees’ right to request a hearing before an administrative judge and outright banning class action cases outside of federal court.
    • “Currently, federal workers alleging discrimination at their employing agency must undergo up to 90 days of pre-complaint counseling, which includes informing employees about the EEO process and sometimes mediation, after which their agency will conduct an internal investigation. Once that is complete—or after 180 days—the employee may request a hearing before an EEOC administrative judge.
    • “But under a new proposed rule, set for publication Friday in the Federal Register, complainants would no longer go through pre-complaint counseling, instead directly filing their complaints to EEOC within 60 days of the alleged discriminatory incident. And they would no longer be guaranteed a hearing; that decision would instead be made by officials within the EEOC’s Office of the Federal Sector.
    • “Under the plan, complainants would have to affirmatively request a hearing when they appeal a final agency decision, and in some cases submit an explanation justifying its need. Those who do receive a hearing under the new process would no longer have the benefit of discovery, a practice by which parties can request and receive documentation related to the case.
    • “Additionally, while employees with similar allegations of discrimination may elect to have their individual complaints processed “jointly,” EEOC would cease consideration of class action cases. If employees wish to proceed as a class, they would each have to exhaust their individual cases before the agency and then file a class action lawsuit in federal court.”

From the public health and medical / Rx research front

  • The Wall Street Journal reports.
    • “[H]ow much water do we really need to drink a day? The question feels more pressing than ever given rising temperatures, heat waves and the fact that chugging water is almost a competitive sport these days. The answer may be less than you think and varies based on your size, health, activity level and where you live.” * * *
    • “The most cited recommendations for water come from the National Academy of Medicine, which calls for a total daily fluid intake of 3.7 liters for men and 2.7 liters for women. 
    • “But here’s the thing: That is total fluid intake, not water specifically. And here’s the other thing: Roughly 20% of our fluids come directly from food, studies have found.
    • “That leaves roughly two liters of fluids daily for women and three for men, says Kavouras. That translates to about 68 ounces and 101 ounces from beverages. 
    • “Stavros Kavouras, founding director of Arizona State University’s Hydration Science Lab in Phoenix and DrHydration on social media. estimates the average pour of water in the U.S. is 12 to 16 ounces. So that works out to about four to six glasses of fluids daily for women and six to eight for men.”
  • The New York Times relates,
    • “Scientists have uncovered a wealth of clues about how genetic mutations lead to severe forms of autism, offering opportunities for testing drugs that could treat the condition, according to a study published Thursday.
    • “The researchers charted how mutations change the way proteins work together in cells, altering the development of the brain.
    • “This is making maps of unknown territories that’s really necessary to move the biology forward,” said Dan Geschwind, a neurogeneticist at the University of California, Los Angeles, who was not involved in the study.
    • “Researchers have been studying autism for over 80 years, but it has only been in recent years that they have been able to explore its molecular biology. One reason that progress has been so slow is that autism is not just one condition, but a broad constellation of them.”
  • Radiology Business adds,
    • “A new analysis details the prevalence of amyloid-related imaging abnormalities (ARIA) on MRI in individuals who are being treated with new Alzheimer’s disease therapies. 
    • “Kisunla (donanemab) is an FDA-approved intravenous monoclonal antibody infusion for early symptomatic Alzheimer’s disease; it works by essentially scrubbing amyloid deposits from the brain, which in turn helps reduce cognitive symptoms associated with the neurodegenerative disease. While effective, a known side effect of the treatment is that is causes ARIA. 
    • “Symptoms of ARIA include headache, confusion, dizziness, vision changes and nausea, but if left unchecked, the symptoms can become severe. This is why experts (and the FDA) recommend scheduled MRI brain scans on individuals being treated with modern monoclonal antibody infusion treatments. 
    • “Now, a new study is offering detailed insight into how common ARIA is in individuals being treated with donanemab. Published in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitorin, the analysis suggests that up to 20% of patients may exhibit signs of ARIA on imaging.” 
  • MedPage Today tells us,
    • “Despite recommendations by the U.S. Preventive Services Task Force and the American Cancer Society, cervical cancer screening rates are declining.
    • “From 2005 to 2023, the proportion of women ages 21 to 29 never screened for cervical cancer increased from 12.5% to 31.9% (average annual percentage change [AAPC] 5.2%), with a notable increase from 2010 to 2023 (AAPC 7.9%).
    • “Regional-stage and distant-stage cervical cancer incidence has increased by 2.3% and 2.6%, respectively, per year among women ages 30 to 64 since 2017.”
  • and
    • “Almost 80% of patients with early-stage rectal cancer avoided surgery for a year or longer when treated with chemoradiation in a randomized trial.
    • “The organ-preservation strategies of chemoradiation and radiotherapy were both associated with few adverse events without sacrificing oncologic control.
    • “Longer follow-up is needed to determine long-term disease control and safety.”
  • and
    • “People who experience an opioid overdose are at greater risk of death, but data on which opioid agonist treatments are most effective in supporting this high-risk population are limited.
    • “In a retrospective cohort study of opioid overdose survivors, starting methadone was associated with a reduced risk of death during the subsequent year compared with starting buprenorphine-naloxone.
    • “In an accompanying commentary, experts questioned whether methadone is truly “intrinsically superior” to buprenorphine-naloxone.”

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

  • Beckers Payer Issues reports,
    • “Mona Chitre, PharmD, will serve as the market president for the newly created employer and government markets segment under Optum Rx, UnitedHealth Group’s pharmacy benefit manager.
    • “Dr. Chitre will begin her role Aug. 31, according to an Aug. 26 LinkedIn post. She said the role unifies the commercial, health system, coalition, labor and trust, and public sector businesses.
    • “Dr. Chitre most recently founded and was the president of Candesa Pharmacy Solutions, under The Lifetime Healthcare Companies. Under the same parent, she previously was Excellus BlueCross BlueShield’s chief pharmacy officer, according to her LinkedIn profile. She brings 26 years of experience across healthcare and pharmacy, she said.”
  • Fierce Healthcare relates,
    • “Cigna is looking to better link medical and supplemental benefits for its members, and has unveiled a new employer benefit that aims to further that goal.
    • “The insurer’s new Medical with Smart Coverage plans will be available as an option for employers with 500 to 2,999 employees that currently offer a high-deductible health plan. Cigna intends to expand access further in 2028, according to an announcement.
    • “The plan is designed to offer members support in managing unexpectedly high costs should they occur. Enrollees can access up to $7,000 in supplemental cash benefits that they can use during these health events to cover key needs such as transportation, child care or hotel stays.”
  • Beckers Hospital Review non-exhaustively lists “68 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • and tells us
    • New Haven, Conn.-based Yale New Haven Health System reported operating income of $33 million (0.5% operating margin) through the third quarter of 2026, up from an operating loss of $40.2 million (-0.7% margin) during the same period last year, according to its Aug. 25 financial report. 
  • and
    • “Pittsburgh-based UPMC recorded an operating loss of $18.3 million (-0.2% operating margin) for the second quarter of 2026, down from operating income of $111.2 million (1.3% margin) during the same period last year, according to its Aug. 27 financial report.”
  • Fierce Healthcare adds,
    • “Corewell Health showed its plans for two major hospital campus expansions that will run the Michigan nonprofit system $1.7 billion.
    •  “As our communities grow and patient needs become more complex, we are building the capacity, technology and care environments needed today for our patients and team members for many years to come,” President and CEO Tina Freese Decker said in the organization’s Thursday announcement. 
    • “The larger of the two projects is coming to Corewell Health Butterworth Hospital in Grand Rapids. The 780,000-square-foot, 11-story tower will include a new ED, 180 private patient rooms, 17 operating rooms and a hyperbaric chamber, Corewell said.” * * *
    • “The other new tower comes with a $440 price tag for the organization and will be built at Corewell Health Beaumont Troy Hospital, which serves a “rapidly growing” community and is also “consistently” above 90% capacity.”
  • and 
    • “Healthcare navigation platform Transcarent launched on Tuesday a bundled payment model for cancer therapies.
    • “The payment model, which the company touts as a first-of-its-kind, supports bispecific T-cell engager (BiTE) and CAR T therapies. Transcarent connects its members to leading oncology providers across various settings, including academic medical centers and high-quality community-based cancer care sites.
    • “Advanced cancer therapies are changing what’s possible for patients, but they’re also creating new challenges for employers trying to manage costs and access,” said Snezana Mahon, Transcarent’s president, in a statement. “This model gives employers more predictable costs while helping Members receive expert care closer to home without sacrificing quality.”
    • “The model enhances Transcarent’s Centers of Excellence (COE) program through easier access and navigation of more affordable care—offering potential savings of up to $150,000, executives say.
    • “Moreover, members undergoing treatment through the COE network are supported throughout their journey by certified oncology nurse navigators (ONNs).” 
  • Beckers Physician Leadership informs us,
    • “More than half of U.S. physicians, 59.4%, are now employed by a hospital or health system, according to a new analysis from Trilliant Health that assessed 700,000 physicians across the country.
    • “Here are four more things to know
      • “1. The hospital-employment rate is highest in the Midwest at 67.2% and lowest in the South at 52.4%, with the Northeast at 62.9% and the West at 60%. Multiple factors are driving the trend, with declining Medicare reimbursement chief among them. 
      • “2. The AMA estimates Medicare physician pay has declined 33% in real terms between 2001 and 2025 while practice costs rose 59% over the same period. 
      • “3. Among physicians who sold their practices to a hospital or health system, 79.5% cited the ability to negotiate higher payment rates as an important or very important reason for doing so. 
      • “4. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, with an additional 4,200 absorbed by insurers, private equity firms and pharmacy chains between 2024 and 2025.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Hill reports,
    • “Lawmakers are sounding the alarm over the nation’s $40 trillion debt, lamenting Congress’s inability to meaningfully confront a problem that has grown increasingly difficult to ignore.
    • “Both parties have spent years trying to tackle the rising debt. Republicans have frequently pointed to federal spending and entitlement programs as the main drivers, while Democrats have emphasized the need for higher taxes on wealthy Americans and corporations alongside spending reforms.
    • “But efforts to reach a broader deal have repeatedly stalled as both parties have balked at the politically painful trade-offs needed to put the nation on a more sustainable fiscal path.” 
  • Modern Healthcare relates,
    • “A Senate bill [S. 3097 – Health Information Privacy Reform Act] would create medical privacy protections for consumer health products such as wearables and wellness apps.
    • “The legislation unanimously passed the Senate health committee last month and a similar bill is pending in the House.
    • “Stronger privacy rules could hamper some tech companies while benefiting others as well as providers eager to tap into new technology.”
  • Per a CMS news release,
    • “The Trump Administration announced an additional $4.2 million, made possible through the federal Rural Health Transformation Program (RHTP), is being put to work in West Virginia to expand patients’ transportation options and remove service barriers.
    • “By injecting millions into the Rural Health Link initiative, the Administration is upending the status quo that has limited transportation options for residents in need of critical healthcare services and delivering on its commitment to West Virginians who deserve the best access to care no matter their zip code. These funds will help increase medical transportation capacity, service availability, and improve geographic coverage for patients across the Mountain State.” 

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

  • Today’s Washington Post included an oped written by OPM Director Scott Kupor about his agency’s efforts to improve the merit system.
    • “At the Office of Personnel Management — Washington’s chief HR agency — my team has spent the past 20 months reforming this system. Our goal is simple and uncontroversial: Merit matters, not how long employees have been in a role or what college degree they earned, both in hiring and in day-to-day performance. That means accountability for employees who can’t deliver and distinction for those who knock the cover off the ball.”
  • Govexec adds,
    • “An agency spokeswoman said that a four-person communications team — all under the age of 30 — is spearheading the effort to make OPM’s social media more appealing to younger potential hires.”
  • Tammy Flanagan writing in Govexec, lets us know,
    • “Retiring from federal service is a major milestone, of course, but it does not end the need to understand how federal benefits work. In the years after retirement, life events and new opportunities can raise important questions about insurance, survivor benefits, beneficiary designations and the effect of returning to government employment.
    • “Today I will highlight several post-retirement issues that federal employees may want to plan for in advance. This is not an all-inclusive list, but it’s a list that will hopefully remind you that it is important to review your benefits and be sure to understand how they can change as life goes on.” * * *
    • “Health benefits can also change after retirement, not only the premiums and the benefits, but your needs may change over time. Outside of open season, FEHB changes generally must be tied to a Qualifying Life Event (QLE), such as marriage, divorce, death of a family member, or a move out of a plan’s service area, and many changes must be requested within 60 days of the event.
    • “Annuitants should confirm the effective date with OPM because the timing can depend on the type of change. For example, some enrollment decreases may be made at any time and are commonly effective at the beginning of the month after OPM receives the election, while other changes follow the qualifying life event rules.
    • “There is a little-known option to change insurance just because you have reached age 65, it is QLE 2L. This is your “ace in the hole” that you can only use once in your lifetime to change plans outside of open season.
    • “This is generally used to change plans when enrolling in Medicare after retirement, but if not used at age 65, it can be used later – but only once!”

From the Food and Drug Administration front,

  • CBS News reports,
    • “A New York-based consumer healthcare company is recalling nearly 40,000 bottles of eye drops over concerns about the product’s sterility. 
    • “Prestige Consumer Healthcare initiated the recall on July 29 due to “lack of assurance of sterility,” according to a U.S. Food and Drug Administration notice.
    • “The recall is due to potential contamination,” the notice says.
    • “The recall affects 15mL bottles of Clear Eyes’ Maximum Itchy Eye Relief, which mitigates itchiness, redness and other eye irritations, according to the product description. The eye drops were distributed nationwide.”
  • Fierce Pharma relates,
    • “If at first you don’t succeed in gene therapy, then try, try again. That’s the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. 
    • “Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos. 
    • “The accelerated approval specifically covers the gene therapy—previously coded as DTX401—in adults and kids over the age of 8 years with GSDIa, an ultrarare genetic disorder driven by a deficiency of the enzyme G6PC, which is needed to release glucose from the liver into the bloodstream. The liver is less capable of controlling glucose levels in these patients, leading to potentially life-threatening hypoglycemia episodes and other complications. 
    • “By Ultragenyx’s reckoning, there are between 1,500 and 2,500 people living with GSDIa in the U.S. out of an estimated global patient population of 6,000 to 8,000 “within commercially accessible geographies,” the company said in an Aug. 19 release.” 
  • HCPLive tells us,
    • “The U.S. Food and Drug Administration (FDA) has approved Glenmark Pharmaceuticals’ fluticasone propionate nasal spray, USP, 0.05 mg (50 mcg)/spray, a generic version of Haleon’s Flonase Nasal Spray indicated for nasal symptoms of allergic rhinitis, the company announced on August 20, 2026.¹
    • “The approval of fluticasone propionate nasal spray, USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area,” said Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals. “We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.” * * *
    • “FDA approval was secured through the bioequivalence pathway, so no independent clinical efficacy or safety program accompanied authorization beyond equivalence to the reference product.” * * *
    • “Distribution will be handled by Glenmark Pharmaceuticals Inc., USA, while pricing and launch timing were not disclosed.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A growing number of Americans say their cannabis use is problematic, according to a large new study released Wednesday.
    • “The study, based on nationally representative data of U.S. adults, found that more than 9 percent of the men — or almost 1 in 10 — reported symptoms of cannabis use disorder in 2024, up from about 7 percent in 2021. The prevalence of cannabis use disorder also rose among women, increasing to nearly 6 percent in 2024, up from about 5 percent in 2021. Symptoms of the disorder include not being able to cut back or quit, or continuing to use the drug despite it leading to interpersonal problems.
    • “The notion that cannabis is not addictive may basically be incorrect,” said Dr. Nora D. Volkow, the director of the National Institute on Drug Abuse and the paper’s senior author.”
  • and
    • “There is no one-size-fits-all approach to managing treatment-resistant depression.
    • “At the UC Davis clinic, if patients don’t improve after trying two antidepressants in succession and undergoing psychotherapy, they may be prescribed a low dose of an additional drug such as an atypical antipsychotic or lithium, Dr. Debra Kahn, director of the Advanced Psychiatric Therapeutics Clinic at UC Davis Health said. Clinicians will ensure that medical problems that could be contributing to symptoms are addressed, too.
    • “One additional therapy that has been shown to help people with treatment-resistant depression is transcranial magnetic stimulation, or T.M.S., which was cleared by the U.S. Food and Drug Administration to treat depression in 2008, Dr. Kahn said. It uses magnetic pulses to stimulate parts of the brain to release mood-boosting chemicals including norepinephrine, dopamine and serotonin, she said.
    • “T.M.S. is tolerated well and has no long-term serious side effects, Dr. Kahn said. * * *
    • “Ketamine, an anesthetic commonly used in surgery, is increasingly used to address treatment-resistant depression. In 2019, the FDA approved Spravato, an intranasal spray containing esketamine. In a 2019 trial, 52.5 percent of patients with treatment-resistant depression who took esketamine with an antidepressant for 28 days experienced a significant resolution of their symptoms compared with about 31 percent of people who took an antidepressant with a placebo.” * * *
    • [T]here is unlikely to be one “magic pill” that cures treatment-resistant depression, Dr. Kahn said. People may benefit from a combination of approaches, and they may also need to combine treatments with lifestyle changes.”
  • MedPage Today tells us,
    • “The relationship between physical activity and dementia risk may depend on whether the activity is recreational exercise or job-related labor, a study of more than 4.2 million people suggested.
    • “High physical activity levels were linked to a 20% lower risk of all-cause dementia (relative risk [RR] 0.80, 95% CI 0.75-0.86) over 10 years compared with the lowest level of physical activity, reported Natan Feter, PhD, of the University of Southern California in Los Angeles, and colleagues in a systematic review and meta-analysis.
    • “Leisure-time activities like walking, running, swimming, cycling, or playing sports followed a similar pattern and were tied to lower dementia risk (RR 0.76, 95% CI 0.65-0.88), the researchers wrote in Lancet Public Healthopens in a new tab or window. Household physical activity also appeared beneficial, but evidence was from a single study.”
  • and
    • “A recent report advocated against using BMI as a standalone tool in measuring health risk.
    • “Longitudinal data suggested that high waist circumference was associated with elevated mortality risks, while high BMI was tied to lower mortality risks, among older adults.
    • “Underweight status was associated with a higher mortality risk compared with normal weight in both men and women, regardless of waist circumference.”
  • The American Medical Association lets us know “what doctors want patients to know about mosquito bites.
    • “Mosquito bites spark immune reactions from itchy bumps to Skeeter syndrome and severe illnesses, but prevention and knowing warning signs can reduce risks.”
  • Cardiovascular Business informs us
    • “Transcatheter aortic valve replacement (TAVR) continues to gain momentum as a go-to treatment option for severe, symptomatic aortic stenosis. However, surgical aortic valve replacement (SAVR) remains a significantly safer option for patients 60 years old and younger, researchers confirmed in a new study published in JTCVS Open.[1]
    • “Current guidelines recommend SAVR for patients younger than 65 years, yet an increasing number of younger patients are undergoing TAVR with uncertain long-term results,” wrote first author Jessan A. Jishu, MD, with the Tulane University School of Medicine, and colleagues. “Given this lack of clarity and growing real-world adoption of TAVR among younger individuals, this study uses a large-scale database representative of practices in the United States to confirm the findings from these previous studies by assessing short- and long-term outcomes of SAVR versus TAVR in patients younger than 60 years, a population in whom long-term durability and reintervention risk are of particular concern.”
    • “Jishu et al. explored the TriNetX database, exploring real-world data from nearly 10,000 patients who underwent TAVR or SAVR from 2006 to 2025. Approximately 80% of patients were treated with SAVR, but TAVR grew more common from 2020 to the end of the study.”
  • and
    • “A Cedars-Sinai Health Sciences University-led study has identified molecular changes that appear to trigger atherosclerosis years before inflammation, sharing their findings in European Heart Journal.
    • “The group believes this could a key discovery in the development of next-generation early prevention therapies. 
    • “The study’s authors found previously unrecognized molecular pathways and a possible master regulator protein called MLXIPL that could become future targets for clinicians working to stop plaque from ever developing.
    • “We analyzed proteins and gene activity in coronary artery tissue from young adults who died of trauma and had no known coronary artery disease, and we found that more than half already had preclinical atherosclerosis,” first author Sarah Parker, PhD, an associate professor of cardiology and biomedical sciences and co-director of the proteomics and metabolomics core at Cedars-Sinai Health Sciences University, said in a statement. “This suggests that changes in cellular metabolism and communication begin before the inflammation long considered a hallmark of the disease.”
    • “Parker said this research provides a direct picture of what is happening inside the artery wall and may explain why some people are more vulnerable to heart disease than others.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of ifezuntrigene inilparvovec (uniQure N.V.) for Huntington’s disease. This therapy is also known as AMT-130.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in March 2027, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.”  

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

  • The Wall Street Journal reports,
    • “Surging healthcare costs are walloping U.S. workers, and they will only worsen next year. For 2027, employers may be facing the biggest health-insurance increase in at least two decades.
    • “Americans with workplace coverage are expected to spend an average $5,297 this year on healthcare, $388 more than 2025, according to a new estimate from benefits-consulting firm Aon. The spending represents a combination of payroll deductions for premiums and out-of-pocket charges like deductibles and copays.
    • “The burden is likely to grow significantly next year, when U.S. employers expect their healthcare costs to go up by 11.1%, according to a new survey from WTW, another big benefits consultant—the steepest rise in more than 20 years.
    • “That would represent the fifth year of escalating increases, according to WTW. “Employers are telling us that this is utterly unsustainable,” said Jeff Levin-Scherz, population-health leader at WTW. Expensive cancer treatments and wide adoption of weight-loss drugs are among the factors pushing up spending.”
  • and
    • “Costco sells its dedicated members everything from travel packages to gasoline. Now the retail giant is gearing up to enter a huge new market: Medicare. 
    • “The warehouse chain plans a limited rollout of Costco-branded Medicare plans, working with SCAN Group, a nonprofit insurer. Nationally, Medicare is a more than $600 billion business for insurers, but the two companies said they would start by selling their jointly named Medicare Advantage products in two states, and a Medicare supplement in a third. 
    • “SCAN and Costco executives said the three target markets include around five million Medicare enrollees but declined to disclose exact locations or timing, citing regulatory limits on disclosure pending approval by the Medicare agency.
    • “SCAN is based in Long Beach, Calif., and Southern California is a core market for the nonprofit, which focuses on Medicare and has about 460,000 members. SCAN also offers Medicare Advantage plans in Arizona, Nevada, New Mexico, Texas and Washington state.”
  • Modern Healthcare adds,
    • “Centene is scaling back its Medicare Advantage presence next year as the health insurance company looks to cut costs. 
    • “The insurer plans to completely withdraw from Oklahoma, Tennessee and Hawaii, according to a notice the company distributed to third-party marketing organizations last week.
    • “Centene is also preparing to exit at least 158 counties and cancel 133 Medicare Advantage plans, according to a Modern Healthcare analysis. Modern Healthcare compared the company’s list of available policies for 2027 to the Centers for Medicare and Medicaid Services enrollment file for this month.
    • “The cancellations would drive about a third of Centene’s Medicare Advantage membership, or more than 340,300 enrollees, to shop for new coverage, according to the Modern Healthcare analysis. Members may have alternative Centene plans from which to choose.” 
       
  • The Health Care Cost Institute released a report about the “Effects of vertical integration on providers’ billing and practice patterns in Medicare (2018-2022)”
  • Fierce Healthcare notes,
    • “The blockbuster success of GLP-1 weight loss drugs has caused major ripple effects across healthcare and pharma, representing a significant growth engine for drugmakers but a cost challenge for payers.
    • “GLP-1s are also potentially disrupting a healthcare system built around treating obesity-related complications, forcing providers, insurers and investors to rethink where future revenue and growth will come from, according to a new report from Wells Fargo.
    • “For decades, the healthcare industry has built service lines, reimbursement models and care pathways around the downstream consequences of obesity. Diabetes clinics, cardiology service lines, sleep medicine, orthopedics, bariatric surgery, pharmacy and chronic disease management have all grown inside a system where obesity was widespread, persistent and often untreated.
    • “GLP-1s may be starting to upend that model as the growing use of obesity drugs begins to influence utilization patterns, hospital economics, pharmaceutical R&D and long-term healthcare spending, wrote Robin Wenzel, head of Wells Fargo Industry Insights and John Teasley, market executive, Wells Fargo Healthcare Banking, in the report.
    • “The latest data from the Centers for Disease Control and Prevention and the National Center for Health Statistics indicates that 40.3% of U.S. adults have obesity, and 9.4%, roughly one in ten, have severe obesity. That makes obesity not an outlier, but a baseline condition around which much of U.S. healthcare now operates, the report authors assert.
    • “GLP-1 drugs for weight management move the management of obesity upstream, to prevention in the context of a system designed around late-stage disease. That puts traditional obesity-related service lines, and healthcare’s obesity revenue engine, under pressure, according to the report.”
  • Beckers Hospital Review points out how 14 large health systems performed financially during the three months ended June 30, and tells us,
    • “New CMS data shows emergency department visit times climbed in the vast majority of states compared with the same period last year, though wide variation persists across the country.
    • “The agency’s “Timely and Effective Care” dataset covers children and adults treated at hospitals paid under the Inpatient Prospective Payment System or Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures. Data was collected in the 12-month period ending Sept. 30, 2025. Learn more about the methodology here.
    • :Nationwide, the median time patients spent in the ED was 162 minutes for the 12-month period ending September 2025, stable from the same period a year prior, according to CMS data.:
  • Healthcare Dive notes,
    • “Name: Dr. Shantanu Nundy
    • “Previous title: Executive vice president of care delivery and chief health officer, Accolade
    • “New title: Chief medical officer, Humana
    • “Nundy will become Humana’s new CMO effective Aug. 31, the Kentucky-based insurer announced Thursday.
    • “He’s replacing Kate Goodrich, who served as CMO from 2022 to October 2025, when she left for a role in the health services division of Humana’s rival insurer UnitedHealth. The CMO post has sat empty since.
    • “As CMO, Nundy will help design Humana’s products, platforms and use of artificial intelligence with a clinical eye, according to the release.”
  • and
    • “Name: Arun Kumar Bhaskara-Baba
    • “Previous title: Chief information officer, Honeywell Aerospace and Defense
    • “New title: Chief information officer, Mayo Clinic
    • “Bhaskara-Baba joined Mayo Clinic as CIO in May, the Minnesota-based health system confirmed in a statement. He’s at the helm of Mayo’s information technology systems across its network of 16 hospitals and 45 multispecialty clinics.
    • “Bhaskara-Baba is succeeding Cris Ross, who retired in 2024 after 12 years in the role.
    • “Bhaskara-Baba brings more than 25 years of tech experience to the role. He joins Mayo from Honeywell Aerospace and Defense, where he directed digital strategy and scaled the company’s artificial intelligence capabilities as CIO.”
  • Fierce Healthcare informs us,
    • “Cityblock Health, a company primarily focused on providing care for urban Medicaid and dual-eligible members, plans to acquire Homeward Health to expand deep into rural markets, the company announced Thursday.
    • “Combined, the two companies will serve nearly 250,000 people and are positioned to reach the 120 million people receiving government-funded healthcare in the U.S., Toyin Ajayi, Cityblock Health CEO and co-founder, wrote in a blog post.
    • “Cityblock said it signed a definitive agreement to acquire Homeward in an all-stock transaction. Financial details of the deal were not disclosed.”
  • and
    • “Carrum Health, a company with value-based Centers of Excellence for employers, is teaming up with Included Health, a virtual care and health navigation company working with employers and plans.
    • “Carrum’s Centers of Excellence network for specialty care will be embedded directly into Included Health’s Alternative Health Plan to help connect members to high-quality specialty care with more predictable costs. The partners will connect plan design, navigation and value-based care into one coordinated experience. 
    • “As employers face steep healthcare cost increases, specialty care often drives a lot of healthcare spending. From 2023 to 2025, the U.S. saw the highest three-year stretch of healthcare cost growth in over a decade, according to the Business Group on Health. The Carrum integration will deliver greater cost predictability with bundled rates, outcomes accountability and streamlined contracting.”
  • Healthcare Dive adds,
    • “Healthcare revenue cycle management company R1 has agreed to acquire Humata Health, a company specializing in artificial intelligence-powered prior authorizations.
    • “R1 is banking that Humata’s AI expertise will help it streamline the preapproval process required by insurers for certain medical treatments, and further its goal of automating how healthcare providers get paid for their services.
    • “The acquisition is expected to close in the third quarter this year, after which Humata’s team will start integrating its technology into R1’s revenue cycle platform. An R1 spokesperson declined to share the financial terms of the deal.”