Friday report

NCQA

Friday report

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, Telehealth, U.S. Healthcare–

From Washington, DC

  • Fierce Healthcare reports,
    • “The Trump administration has proposed flat rates in Medicare Advantage (MA) for 2027, and insurers argue in new commentary that those levels do not reflect the realities of the program.
    • “In late January, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed advance notice governing MA and Part D. 
    • “The proposal includes a net payment rate increase of 0.09% in MA, meaning levels will be essentially flat if the plan becomes final.
    • “The proposed rule drew immediate ire from the industry, which is already navigating significant financial challenges in this market. Multiple leading players have elected to exit certain MA markets. 
    • “In official comments (PDF) submitted Wednesday to the CMS, the AHIP said the proposed rule “risks undermining CMS’ goal of providing beneficiaries with stable, affordable choices during the annual enrollment period.”
    • “At a time of sharply rising medical costs and high utilization of medical services, the combined effect of the proposed policy changes and growth rates will not keep pace with the cost of caring for seniors in 2027,” the organization, which is the largest lobbying group representing insurers, said in its comment letter.”
  • MedPage Today relates,
    • A top health official at the Centers for Medicare & Medicaid Services (CMS) [Chris Klomp] hedged on payment reform, but committed to helping physicians address prior authorization challenges, during the American Medical Association’s (AMA) National Advocacy Conference.”
  • Per Beckers Health IT,
    • “CMS has rolled out an app directory for Medicare recipients as part of the agency’s push to digitize healthcare.
    • “The Medicare App Library seeks solutions that fall under one of three use cases: “kill the clipboard,” conversational AI assistants, or diabetes and obesity prevention and management.
    • “We are calling on health app developers, tech-enabled organizations, and innovators to voluntarily align around a shared framework for data and access that empowers people, improves care, and accelerates progress,” CMS stated Feb. 23. “This is a movement, not a mandate. It is a call to action, not a regulation. Let’s show what’s possible when we work together — and finally bring healthcare into the modern era.”
  • Federal News Network tells us
    • “Tens of thousands of federal employees at U.S. Customs and Border Protection are expected to continue receiving pay during the Department of Homeland Security’s current funding lapse, according to an email viewed by Federal News Network.
    • “CBP, a component of DHS, plans to use discretionary funding from the One Big Beautiful Bill Act to exempt and continue paying more than 57,600 agency employees who have been working throughout the partial shutdown this month. Details of the agency’s decision come from an email sent this week by the National Treasury Employees Union, obtained by Federal News Network.
    • “Under the current shutdown, CBP will “exempt” and provide pay to a large portion of its workforce, including law enforcement personnel and certain civilian agency employees. Some other CBP employees, however, are still considered “excepted” and will not receive pay until after the shutdown ends.”
  • MedTech Dive informs us,
    • “The Trump administration is imposing a six-month moratorium on Medicare enrollment for certain suppliers of durable medical equipment, prosthetics and orthotics, or DMEPOS, as part of a broader plan to combat fraud in healthcare.
    • “The administration said Wednesday that the nationwide halt on enrollment would give the government time to consider more actions “to further mitigate longstanding instances of fraud, waste, and abuse perpetrated by certain DMEPOS companies.”
    • “The temporary freeze applies to all applications for initial enrollment and changes in majority ownership for medical supply companies.
    • “Durable medical equipment includes items such as walkers, wheelchairs, oxygen equipment, hospital beds, continuous positive airway pressure machines and blood sugar monitors.”
  • NCQA, writing in LinkedIn, announced its “Advanced Primary Care Pilot Program” and invited readers to “Meet Our Primary Care Partners!”
  • The Labor Department’s Employee Benefits Security Administration let us know about extending the public comment period on its proposed Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure rule to April 15, 2026.

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “The Food and Drug Administration on Tuesday posted a warning letter sent to Beta Bionics in late January.
    • “The letter raised concerns with how the diabetes tech company handled complaints of severe low and high blood sugar associated with its automated insulin delivery system. The FDA also flagged problems with the company making modifications to its device without notifying regulators.
    • “In an annual report filed Tuesday, the company said it has already taken several corrective actions, including improvements to the processes identified in the warning letter. The company is also preparing a written response to the letter.”
  • Cadiovascular Business informs us,
    • “Cara Medical, a medtech company focused on advanced imaging technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its new platform that noninvasively visualizes a patient’s cardiac conduction system.
    • “The CARA System, which previously earned the FDA’s breakthrough device designation, was designed to help interventional cardiologists and electrophysiologists plan ahead before procedures and then guide them during treatment. It can be used for structural heart interventions such as transcatheter aortic valve replacement (TAVR) as well as pacing procedures.
    • “The newly cleared system includes two primary components. The CARA Metis Simulator is a preprocedural planning software that identifies the cardiac conduction axis on CT angiography results and generates a 3D map of the patient’s conduction system. The CARA Atlas Navigator, meanwhile, overlays that map onto live fluoroscopic images to assist with intraprocedural guidance. 
    • “Artificial intelligence (AI) algorithms play a role in both components, extracting metadata and detecting the user’s catheter for visualization, but all AI calculations can still be confirmed by a physician.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits and hospitalizations among infants and children 4 years and younger.
    • Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) has ended its investigation into the recent multistate infant botulism outbreak traced to ByHeart powdered formula and lowered the total case number by three. In a Public Health Alert issued earlier this week, California, CDC, and Food and Drug Administration scientists reported 51 infections, but yesterday the CDC said it has excluded three suspected cases, for a total of 48 (28 confirmed, 20 probable) in November and December 2025. While the outbreak is over, investigators continue to probe how Clostridium botulinum bacteria got into the formula, the CDC said.
    • “A report published yesterday in the CDC’s Morbidity and Mortality Weekly Report describes how officials used artificial intelligence (AI) to identify contaminated ice in a beer cooler as the source of a 2024 Salmonella enterica outbreak at a county fair. Ice is an uncommon vehicle for Salmonella spread at public events, noted author Katherine Houser, RN, of the Brown County Health Department in Mount Sterling, Illinois. The outbreak sickened 13 people (seven confirmed, six probable cases). AI tools helped synthesize background information to support and contextualize the environmental health team’s assessment, Houser said.”
  • The CDC also announced today,
    • “As of February 26, 2026, 1,136 confirmed* measles cases were reported in the United States in 2026. Among these, 1,130 measles cases were reported by 28 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New Mexico, New York City, New York State, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin. A total of 6 measles cases were reported among international visitors to the United States. 
    • “There have been 10 new outbreaks** reported in 2026, and 90% of confirmed cases (1,023 of 1,136) are outbreak-associated (152 from outbreaks starting in 2026 and 871 from outbreaks that started in 2025).”
  • MedPage Today informs us,
    • “Identical stool samples sent to seven direct-to-consumer microbiome testing companies produced substantially different bacterial profiles and health assessments.
    • “Across 18 commonly reported microbial genera, no company’s results matched the consensus; and only three genera of 1,208 identified taxa appeared in every report.
    • “Researchers attributed the discrepancies to differences in laboratory methods and analysis pipelines, and say the results underscore the need for standardized testing and quality controls.”
  • The Wall Street Journal considers
    • “Why All The Fuss About Bone Density?
    • “Like most of my peers, I’m being bombarded daily with hectoring advice about my bones. What’s a 40-something woman to do?” * * *
    • “For guidance, [the journalist] consult[s] with Dr. Karen Tang, the author of “It’s Not Hysteria: Everything You Need to Know About Your Reproductive Health (but Were Never Told),” who offers a more measured take.” 
  • Medscape adds,
    • “A low-dose, single pill that combines three antihypertensive treatments is as effective as standard-dose monotherapy — in some cases even better — for treating mild-to-moderate hypertension, according to the first phase 3 double-blind trials comparing the medications.
    • “Investigators for the HM-APOLLO-301 and HM-APOLLO-302 phase 3 clinical trials, which were published in the Journal of the American College of Cardiology, contend there is now concrete evidence to support the efficacy of the single-pill therapy.
    • “They argue that starting with the traditional single-agent therapy and then titrating up can delay blood pressure control, increase the possibility of adverse effects, and affect patient adherence.”
  • The University of Minnesota’s CIDRAP relates,
    • “The results of a randomized controlled trial (RCT) indicate that meningococcal B vaccine is not effective at preventing gonorrhea infection in high-risk groups.
    • “The results, presented this week at the Conference on Retroviruses and Infections by a team of Australian researchers, show that among gay and bisexual men with a history of gonorrhea infection who received either the 4CMenB vaccine or placebo, gonorrhea incidence was essentially the same—roughly 48% in both arms.
    • “The 4CMenB vaccine is designed to protect against four serogroups of Neisseria meningitidis, which can cause invasive meningococcal disease. But in recent years, observational studies have suggested 4CMenB might also provide moderate cross-protection against Neisseria gonorrhoeae, the bacterium that causes gonorrhea—one of the most common sexually transmitted infections (STIs) worldwide.” 
  • Genetic Engineering and Biotechnology News reports,
    • “CAR T cell therapy has revolutionized the treatment of many blood cancers, but has shown little success against solid tumors, which account for more than 85% of all cancers.
    • “Columbia University researchers have now developed a new form of highly sensitive CAR T cells, known as HIT T cells, that aims to overcome one of the biggest barriers in solid tumor immunotherapies, which is the way that solid tumors lack a single, widely shared surface target.
    • “Headed by Michel Sadelain, MD, PhD, director Columbia Initiative in Cell Engineering and Therapy (CICET), the researchers engineered an ultra-sensitive and highly selective chimeric antigen receptor called an HLA-independent T cell (HIT) receptor, which is capable of detecting even the smallest amounts of the protein CD70 on tumor cells.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance is consolidating control of its health insurance businesses under Felicia Norwood, its head of government benefits, as the company looks to improve coordination across its Medicaid, Medicare and commercial plans and — hopefully — bolster waning profits.
    • “Mark Kaye, Elevance’s CFO, will also take on leadership of health services division Carelon as current president Peter Haytaian leaves to spend more time with his family, according to a press release Thursday announcing the executive changes.
    • “Haytaian will leave the role effective May 4 and stay on as an advisor through the end of the year. The executive first joined Elevance in 2012 through its acquisition of Amerigroup before becoming president of Carelon in 2021.”
  • Beckers Payer Issues adds,
    • “Longtime UnitedHealth Group executive Heather Cianfrocco is leaving the company.
    • Ms. Cianfrocco has served as executive vice president of governance, compliance and information security at UnitedHealth since April 2025. She briefly served as CEO of Optum from 2024 to 2025 before being succeeded by Patrick Conway, MD, who previously led Optum Rx. 
    • “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she wrote on LinkedIn Feb. 27. “I am leaving with so much pride in what we have accomplished together. I’ve had the privilege of working alongside some of the most talented, mission-driven people who show up every day determined to make health care easier to navigate, more affordable and more human.”
  • Beckers Hospital Review notes,
    • “CVS Caremark is expanding its use of Surescripts’ Touchless Prior Authorization platform to accelerate approvals for select specialty medications.
    • “The prior authorization technology connects directly to patients’ EHRs to gather required clinical data and match it with prior authorization criteria, according to a Feb. 25 news release. When requirements are met, CVS Caremark can approve medications automatically in as little as 22 seconds.
    • “The platform is currently used for select specialty drugs, including Vivitrol and Epidiolex, which treat substance use disorder and epilepsy. These medications typically require complex approvals because of their high impact and specialized clinical use cases.”
  • Healthcare Dive tells us,
    • “Teladoc Health projects membership in its business-to-business integrated care unit will decline this year, in part due to the expiration of enhanced Affordable Care Act subsidies, management said during a fourth-quarter earnings call Wednesday.
    • “The company expects 97 million to 100 million members in U.S. integrated care in 2026, down from 101.8 million at the end of last year. 
    • ‘Teladoc expects the decline will be driven by enrollment reductions at some client health plans in government programs, which were impacted by the lapse of more generous financial assistance for ACA coverage, CEO Chuck Divita said on the call.”
  • Fierce Healthcare adds,
    • “Walgreens is wading into the self-pay GLP-1 space, going head-to-head with telehealth subscription offerings.
    • “The retail pharmacy giant launched a digital weight management service to offer access to personalized, clinician-guided support for weight loss. The service expands Walgreens’ virtual healthcare platform and provides patients with access to licensed doctors and nurse practitioners, FDA-approved medication options and ongoing virtual support, according to the company in a press release.
    • “Virtual visits through the weight management service cost $49 with no requirement for a monthly subscription. The program, currently available in 28 states, is intended for eligible overweight and obese adults ages 18-64 who plan to self-pay for their GLP-1 medication.”
  • Healthexec summarizes news from “the 2026 ViVE conference, part of HLTH, [which] just wrapped up in California. On the show floor, people from across the healthcare and health IT space gathered for four days of events, thought leader insights and product showcases on the floors of the Los Angeles Convention Center. 

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Govexec.com reports,
    • “While the Homeland Security Department is shut down, the vast majority of employees—about 92%—are still reporting to work. In some cases, however, workers are finding creative solutions to get out of their regular duties and save money while their paychecks hang in the balance. 
    • “My unit is rotating voluntary furlough days,” said one DHS staffer.  “Workers in that office are taking turns to take time off work, which, during a shutdown, entails being placed in an unpaid furlough status. 
    • “[We] conserve finances by not commuting, since we’re only allowed to telework in emergency situations,” the employee said, noting some employees in the unit commute 80 miles per day and are therefore seeing significant savings on gas when they do not go to work. The employees who accept the furloughs have used the time to schedule medical appointments, handle errands or tackle home projects.” * * *
    • “Most DHS employees will not miss a full paycheck until the beginning of March. Craig Carter, president of the Federal Managers Association, said the impacts are already being felt across the DHS workforce.” 
  • The OPM Office of Inspector General has posted its semi-annual report to Congress for the period ended September 30, 2025. Here is a link to the OPM management’s response to this report.
  • Legistorm tells us about GAO report number GAO-26-107169 which was issued yesterday.
    • “What GAO Found
      • “The No Surprises Act, among its provisions, generally prohibits providers from balance billing in certain circumstances—such as emergency services—for individuals with private health insurance. Balance billing is when insured patients receive a bill from an out-of-network health care provider for the amount above any applicable cost-sharing that exceeds the health plan or issuer’s payment. An unexpected balance bill is referred to as a surprise bill.
      • “GAO analyzed the percentage of claims that were in-network for selected specialties to examine potential changes in network participation after the act’s implementation. Increases in the percentage of in-network claims may indicate increases in provider participation, while decreases may indicate reduced participation.
      • “Among specialties likely to be affected by the No Suprises Act protections—emergency medicine, radiology, anesthesiology, and air ambulance—the percentage of in-network claims increased for three of the four specialties after the act took effect. For example, GAO found the percentage of in-network facility claims (typically submitted by hospitals) and professional claims (typically submitted by physicians) for emergency medicine declined before the No Surprises Act took effect, then increased afterward.
      • “Payment changes for the selected services largely reflected continuations of trends prior to the No Surprises Act taking effect. For example, the inflation-adjusted payment for in-network emergency medicine services billed by facilities increased in 2022 and 2023, continuing the trend since 2019. Meanwhile, the inflation-adjusted payment for in-network emergency services billed by physicians or their practices decreased in 2022 and 2023, continuing previous trends.”
    • FEHBlog note: This is encouraging news.
  • NCQA writes in LinkedIn
    • “NCQA has updated its State of Health Care Quality Report to include data for HEDIS® Measurement Year (MY) 2024. This free resource, available on the NCQA website, offers valuable insight into healthcare quality performance nationwide.
    • “You can use this report to:
      • “Learn more about each quality measure, how it is defined and why it matters.
      • “Access national averages and historical trends for over 90 measures of clinical quality and patient satisfaction.
      • “Compare performance across different products, like Commercial, Medicare and Medicaid.
      • “We will add data for MY 2025 in February 2027, or you can get it sooner through NCQA’s Quality Compass®.
    • “The report is available through this link. You can also find a link to the report on the HEDIS Measures and Technical Resources web page.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Tracy Beth Høeg, the top drug regulator at the Food and Drug Administration, indicated in her first address to staff that she’ll scrutinize antidepressants and the shots used to protect babies from RSV.
    • “Høeg told employees on Thursday that her top priorities include two issues she’s focused on in the recent past: evaluating the safety of antidepressants taken by pregnant women and of monoclonal antibodies that protect infants against RSV.
    • “I’ve been interested to learn we really haven’t been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job,” Høeg said. “I actually think that there’s agreement about that, and among the CDER staff that I’ve been working with on this issue, so I’m excited to see that.”
    • “Høeg also discussed her interest in vaccine policy, and mentioned she’d like to “bring that interest” into the drug center.”
  • Radiology Business relates,
    • “GE HealthCare has secured three notable new MRI clearances from the U.S. Food and Drug Administration. 
    • “On Thursday, the company announced the clearance of two MRI systems, Signa Sprint with Freelium and Signa Bolt, and one artificial intelligence-enabled workflow platform. Each of the three cleared produts were designed with the rising demand for MR imaging in mind, according to the company’s president and CEO of MR, Kelly Londy. 
    • “Achieving FDA clearance of our next-generation Signa MRI technology underscores our commitment to expanding access to high-quality imaging and elevating the standard of care for patients everywhere,” Londy said in an announcement. “As MRI demand continues to rise across clinical areas, providers need solutions that deliver greater efficiency without compromising diagnostic precision.”
  • BioPharma Dive informs us,
    • “Roche said Friday that the Food and Drug Administration will decide by Dec. 18 whether to approve its experimental drug giredestrant in breast cancer, setting the stage for a verdict that could intensify the competition surrounding a new class of oral, tumor-fighting medications.  
    • “Roche’s submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies at keeping people with a certain type of advanced breast cancer alive without their disease getting worse. The pill has also since proven helpful to people in the “adjuvant” setting after surgery. 
    • “If approved, giredestrant would become the third new oral “SERD” on the market, following clearances for Menarini Group’s Orserdu and Eli Lilly’s Inluriyo. Roche believes giredestrant has the potential to stand out from its competitors, but faces persistent doubts about the class’ commercial outlook.”

From the judicial front,

  • The American Hospital Association News reports,
    • The Supreme Court Feb. 20 ruled [in a 6-3 opinion written by the Chief Justice] that the International Emergency Economic Powers Act [of 1977] does not authorize the imposition of global tariffs. The court held that IEEPA does not provide the president with “the independent power to impose tariffs on imports from any country, of any product, at any rate, for any amount of time.” The court did not address whether the government will have to refund the tariff revenue or what other legal authorities the president may have to impose similar tariffs. [The Court remanded those decisions to the lower courts.]
  • Bloomberg Law reports,
    • “The FTC has asked a federal appeals court to revive requirements for companies to divulge more information to US antitrust regulators ahead of potential mergers.
    • “The Federal Trade Commission Wednesday appealed a Feb. 12 decision from a US district court judge in Texas blocking a 2024 Biden-era rule. The case is pending in the US Court of Appeals for the Fifth Circuit.
    • “The regulation updated a decades-old US pre-merger notification program to require companies share more about overlapping business lines and ownership structures, among other details. Companies seeking combinations valued at $133.9 million or more must undergo an initial 30-day review by the FTC and Justice Department under the notice system.”
  • and
    • “The [U.S. Court of Appeals for the] First Circuit rejected a lawsuit accusing Cigna Health & Life Insurance Co. of obesity discrimination, shutting down an attempt to broaden coverage of blockbuster GLP-1 weight-loss drugs.
    • “Pressure to cover the drugs is growing for insurers and employers as their uptake among the general public increases. One in five adults has taken a GLP-1 drug at some point, according to a November 2025 poll from health-care think tank KFF.
    • “The US District Court for the District of Maine previously dismissed Jamie Whittemore’s case, along with a similar case against Elevance Health Inc. The district judges determined that Whittemore didn’t prove that obesity qualified her as disabled.” * * *
    • “Here, even if Whittemore plausibly alleged that obesity is a physical impairment, she failed to allege sufficient facts to support an inference that her obesity substantially limits her major life activities,” Judges Lara E. Montecalvo, Sandra L. Lynch, and Ojetta Rogeriee Thompson wrote in their opinion Thursday.”
  • Per a Justice Department news release,
    • “The Justice Department’s Antitrust Division, together with the Attorney General of Ohio, filed a civil antitrust lawsuit today challenging OhioHealth Corporation’s (OhioHealth) anticompetitive contract restrictions that force Ohio patients to pay higher prices for healthcare.
    • “The complaint, filed in the U.S. District Court for the Southern District of Ohio, seeks to enjoin OhioHealth, the largest healthcare system in central Ohio, from enforcing its anticompetitive contractual terms and continuing to suppress healthcare competition.”
  • Per Beckers Payer Issues,
    • “An insurance brokerage president and the CEO of a marketing company were each sentenced to 20 years in prison for their roles in a scheme to fraudulently enroll individuals in subsidized ACA plans to obtain commission payments from insurers.”

From the public health, medical and Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits for RSV are highest among infants and children less than 4 years old. RSV hospitalizations are highest among infants and children less than 4 years old. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country; however, trends vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits among infants and children 4 years and younger. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Feb. 19 released a report on the low use of COVID-19 antiviral drugs among individuals age 65 and older, a population at high risk of severe illness from the disease. The report found that from June 2023 through September 2025, 16%-23% of COVID-19 patients older than 65 received an antiviral prescription during low occurrences of COVID-19, compared to 37%-38% during higher occurrences. Adults ages 75-84 and 85 and older were more likely to receive an antiviral prescription than those ages 65-74. “COVID-19 vaccination and treatment can prevent severe COVID-19 among older adults,” the CDC wrote. “Efforts to improve health care provider and patient knowledge regarding the benefits of COVID-19 vaccination and antivirals, especially for older adults, are needed to reduce the risk for severe illness and death.”
  • The University of Minnesota’s CIDRAP adds,
    • “Two studies examined the effects of COVID-19 vaccination in pregnancy, with one estimating that full vaccination and a booster dose reduce the risk of preeclampsia (PE) by 15% and 33%, respectively, and the other finding no elevated risk of miscarriage before 20 weeks’ gestation among pregnant or soon-to-be-pregnant recipients of the Pfizer/BioNTech or Moderna vaccines.”
  • The CDC also announced,
    • “As of February 19, 2026, 982 confirmed* measles cases were reported in the United States in 2026. Among these, 976 measles cases were reported by 26 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New York City, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin. A total of 6 measles cases were reported among international visitors to the United States. 
    • “There have been 7 new outbreaks** reported in 2026, and 89% of confirmed cases (870 of 982) are outbreak-associated (73 from outbreaks starting in 2026 and 797 from outbreaks that started in 2025).”
  • The University of Minnesota’s CIDRAP adds,
    • “Utah has confirmed 300 measles cases in an ongoing outbreak, with the virus now spreading in Salt Lake County and new exposures at high schools in that county, according to an update yesterday from the Salt Lake County Health Department (SLCoHD).
    • “The first measles symptoms are often cold- or flu-like, with cough, runny nose, red/watery eyes, and fever, so you may think you have a common respiratory illness and can continue engaging in normal activities,” said Dorothy Adams, executive director of SLCoHD. “But please stay home if you have any signs of illness, especially now that we know measles is actively circulating in our community.”
  • Per the AHA News,
    • “The ongoing measles outbreak in South Carolina has reached 973 cases, the state’s Department of Public Health reported Feb. 20. Of those, 906 cases are unvaccinated, 26 are fully vaccinated, 20 are partially vaccinated and the vaccination status of 21 cases is unknown. Nationally, 982 confirmed measles cases across 26 jurisdictions have been reported to the Centers for Disease Control and Prevention since Jan. 1. The CDC said there have been seven outbreaks reported in 2026 and that 89% of confirmed cases are outbreak-associated.” 
  • Cardiovascular Business informs us,
    • “The American College of Cardiology (ACC) and American Heart Association (AHA) have developed their first clinical practice guidelines focused on the treatment and management of acute pulmonary embolism (PE). The new document, published in full in JACC and Circulation, highlights the importance of diagnosing patients as quickly as possible and determining the best course of action.
    • “A PE is a potentially fatal blood clot that travels through the heart and then becomes lodged in an artery in the lungs. Treating PEs quickly—and effectively—can help minimize the patient’s risk of death and cardiac arrest. Anticoagulants are the most common PE treatment, but catheter-based interventions and surgery may be necessary for more severe cases.
    • “There have been significant advances in the understanding of PE and treatments to effectively manage this condition,” Mark A. Creager, MD, chair of the document’s writing committee and director emeritus of the Heart and Vascular Center at Dartmouth Health, said in a statement. “This guideline is a road map to help clinicians navigate these advances for the safest and most effective approaches to care for people with this condition.”
  • Per Radiology Business,
    • “New research highlights the potential for a PET- and MRI-based imaging approach for differentiating a new type of dementia from Alzheimer’s disease. 
    • “Limbic-predominant age-related TDP-43 encephalopathy, also known as LATE, was recently recognized as a type of dementia that occurs in older adults, typically presenting as memory-related cognitive decline. Due to its impact on memory, it is often mistaken for AD. 
    • “However, both LATE and Alzheimer’s present differently on imaging. While AD is identified due to the accumulation of amyloid and tau proteins on the brain, LATE involves clumps of the protein TDP-43 in the limbic system. It is important to differentiate between the two due to the differing treatment methods for each. 
    • ‘A new paper in the Journal of Nuclear Medicine describes how combining PET and MRI imaging data can help distinguish between the two in living patients. 
    • “The distinction in the causes of these types of dementia is critical, especially in the era of anti-amyloid therapies,” Satoshi Minoshima, MD, PhD, professor of radiology and imaging sciences at the University of Utah, Salt Lake City, said in a news release. “Because LATE has a different underlying pathology and a seemingly different prognosis, it cannot be diagnosed or treated in the same way as Alzheimer’s disease.” 
  • The University of Connecticut, the FEHBlog’s alma mater, writes in LinkedIn about research on Parkinson’s Disease treatments.
  • Per BioPharma Dive,
    • “Grail’s multi-cancer early detection test failed to meet its primary endpoint in a key study, sending the company’s shares tumbling about 50% in Friday trading.
    • “The NHS-Galleri trial evaluated annual screening with the Galleri MCED test in England’s National Health Service over three years in 142,000 asymptomatic participants aged 50 to 77.
    • “Grail said the study aimed to show testing could help reduce late-stage cancer diagnoses and increase detection rates to support national screening in England. A U.S. premarket approval application for Galleri, submitted earlier this month, includes data from the trial on test performance, clinical validation and benefit of detection at stages I through III, including reduction in stage IV cancer diagnoses, the company said.”
  • Per Health Day,
    • “An ancient Chinese mind-body practice can lower a person’s blood pressure as well as medication or a program of brisk walking, a new study says.
    • “Baduanjin is a widely practiced eight-movement sequence that combines slow, structured movement, deep breathing and meditation.
    • “The practice lowered people’s blood pressure by about 3 to 5 points, similar to benefits sustained by people asked to take up walking, according to clinical trial results published Feb. 18 in the Journal of the American College of Cardiology.”
  • Per Genetic Engineering and Biotechnology News,
    • “Stanford Medicine researchers and collaborators have developed a universal vaccine candidate that studies in mice suggest protects against a wide range of respiratory viruses, bacteria, and even allergens. Unlike any vaccine used today, the new vaccine, delivered intranasally, was found to provide broad protection in the lungs for several months. The novel vaccination strategy integrates the two branches of immunity—innate and adaptive—creating a feedback loop that sustains a broad immune response.
    • “The research team, headed by Bali Pulendran, PhD, the Violetta L. Horton Professor II, director of the Institute for Immunity, Transplantation and Infection, and a professor of pathology, microbiology and immunology at Stanford University, demonstrated that vaccinated mice were protected against SARS-CoV-2 and other coronaviruses,  Staphylococcus aureus and Acinetobacter baumannii (common hospital-acquired infections), and house dust mite allergen. Pulendran said the new vaccine has worked for a remarkably wide spectrum of respiratory threats that the researchers tested. Speaking to GEN, Pulendran emphasized that the reported work is preclinical, and the team’s goal is to translate their research carefully and responsibly. “If it ultimately proves safe and effective in humans, the potential impact could be transformative: simplifying seasonal vaccination and improving readiness for emerging respiratory threats,” Pulendran said.”

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

  • Beckers Payer Issues reports,
    • “Medicare Advantage now covers about 55% of eligible beneficiaries nationwide — more than 35 million people — but health systems are confronting a question that until recently felt almost taboo: What happens when participation in the country’s fastest-growing Medicare program no longer makes financial sense?
    • “Over the past three years, Becker’s has reported on roughly 90 hospitals and health systems that have terminated some or all of their commercial Medicare Advantage contracts. In 2026 alone, at least 15 systems have gone out of network with one or more Medicare Advantage plans, and the trend is showing no signs of slowing down. 
    • ‘This year, 1 in 10 Medicare Advantage enrollees — about 2.9 million people — will be forced to disenroll from their plan following a spike in plans exiting the market, according to a Feb. 18 study published in JAMA.
    • “Behind many of those decisions lies what Scripps Health CFO Brett Tande describes as a classic “sunk-cost” dilemma: after years of building infrastructure, staffing and strategy around Medicare Advantage, can systems realistically walk away — even when contracts are losing money?
    • “For a growing number of health systems, the answer is becoming clearer.
    • “Becker’s connected with executives from Providence, Scripps Health, Ascension, MemorialCare and Mayo Clinic to understand how they are reassessing their participation in Medicare Advantage and what that shift could mean for providers, payers and patients.”
  • Kaufmann Hall notes,
    • “Partnerships, like all relationships, are de facto collaborative. Certain success factors are well known, including the importance of cultural alignment, constant communication and effective post-closing integration. Based on our collective experience assisting health systems with the negotiation of strategic partnerships, we share other lessons learned that are important considerations. These are tangible steps that require intentional focus and may require hard choices during the partnership development process but are important for ensuring long-term success. We hope these “inside baseball” lessons and case studies are useful for organizations when negotiating their next strategic partnership.”
  • and
    • “Amazon last week announced it would expand its same-day pharmacy delivery service to 4,500 cities nationwide. The move expands Amazon’s market share against other drug delivery providers like Walmart and CVS Caremark. It adds same-day delivery services to 2,000 communities, including remote areas in Alaska, the Navajo Nation and islands only accessible by ferry and only navigable by horse-drawn carriage. The expansion demonstrates the retail giant’s ability to scale its logistics network in healthcare, offering faster access to medications compared with traditional mail-order pharmacies, which can take up to 10 days to deliver drugs.”
  • Behavioral Health Business relates,
    • “Madison Health Group (MHG) has announced its plans to purchase managed behavioral health provider Magellan Health.
    • “This comes roughly five years after payer giant Centene Corporation (NYSE: CNC) bought Magellan Health at a valuation of $2.2 billion.
    • ​”Magellan Health manages behavioral health services for health plans, employers and government agencies.
    • ​”Following the deal, Magellan will become an independent organization, with MHG’s backing to support innovation. Specifically, the new funds will be used to expand its clinical programs into new markets, leveraging “enhanced technology, AI, data and analytical solutions” for its clients, according to social media posts.”
  • Fierce Healthcare tells us,
    • “Carrot is expanding its parenting benefits with on-demand virtual pediatric care through Blueberry Pediatrics. 
    • “Carrot, a fertility and family-building benefits platform working with payers and employers, will offer Blueberry as an add-on. The new offering will be available to families with kids under 12. It is expected to roll out in the next few months. The offering will be covered by the plan sponsor, and members are not expected to incur out-of-pocket costs.
    • ‘Parents will have 24/7 access to on-demand virtual visits with board-certified pediatricians from Blueberry for common issues like ear infections, rashes, colds and the flu. Families can connect with pediatricians around the clock via secure messaging, video or audio. Members will also get a home medical kit with a wireless digital ear scope, pediatric pulse oximeter and thermometer. This will help Blueberry clinicians remotely assess children.”
  • Per Modern Healthcare,
    • “Early lessons are emerging as the digital health sector’s ambient AI focus shifts from clinical documentation to prior authorization.
    • “Companies such as Abridge, Suki and Cohere say their solutions can do for prior authorization what ambient AI has done for documentation and clinician burnout. The importance of partnerships become an integral part of their efforts in this area.
    • “In August, Abridge announced a partnership with Pittsburgh-based insurer Highmark Health and its integrated health system Alleghany Health Network to develop a tool that would approve prior authorization requests at the point of care. Prior authorization was the logical next step for Abridge after clinical documentation, said Clinical Strategy Principal Matt Troup.
    • “Six months in, the collaboration has shown the importance of building connections with providers and payers when developing ambient AI for prior authorization.
    • “[Our partnership] just gave us access to bring everyone to the table, to figure out, what we can possibly do in this space,” Troup said. “Is it actually possible to get these approvals in real-time, upstream in the conversation, if both the payer and provider are aligned on the impact that this can have in healthcare.” 

Tuesday report

David Ermer–Congress, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NCQA, Patient safety, SCOTUS, Uncategorized–

From Washington, DC,

  • Federal News Network reports,
    • “The House [of Representatives] passed a spending package to end a short-term partial government shutdown and fund most federal agencies through the end of the fiscal year.
    • “The spending deal, which includes a two-week continuing resolution for the Department of Homeland Security, was passed by the Senate last Friday.
    • “President Donald Trump signed the spending package into law on Tuesday afternoon.” * * *
    • “The spending package includes language guaranteeing back pay to federal employees who were briefly furloughed during the partial shutdown.” * * *
    • “After Trump signed the spending plan into law, OPM directed furloughed employees to return to work.”
  • The Wall Street Journal notes,
    • Twenty-one Republicans voted against the package [on the final vote [217-214] for passage], largely hard-liners who wanted to use the spending package as a vehicle to tighten election procedures. Twenty-one Democrats—mostly a collection of appropriations-committee members and centrists—voted for it.
  • Fierce Healthcare adds,
    • “The legislation finalizes several key healthcare extenders including provisions of the Medicare telehealth program and Acute Hospital Care at Home waiver as well as major supplementary funding programs for rural hospitals and those with high proportions of government-covered patients. The bill provides a five-year extension of the Acute Hospital Care at Home program and a two-year extension for Medicare telehealth flexibilities. The telehealth provisions in the bill include removing Medicare’s geographic requirements for telehealth and expanding the types of practitioners able to furnish telehealth services for the government health program.
    • “The bill also introduces reforms to pharmacy benefit manager (PBM) practices, including elements that would prevent PBMs from tying compensation in Part D to the list price of drugs, and boost price transparency for employers in their PBM contracts.
    • “Other provisions in the bill require that Medicare Advantage plans provide accurate provider lists, addressing so-called “ghost networks” that have come under fire in recent years. It would also require that health systems establish unique identification numbers for outpatient services, allowing the Centers for Medicare & Medicaid Services to track pricing in these facilities.”
  • Rep. Jodey Arrington (R TX), the chairman of the House Budget Committes, writing in Real Clear Health, shares his vision of a second reconciliation bill that would focus on healthcare.
  • The HHS Office of Inspector General posted “Medicare Advantage Industry Segment-Specific Compliance Program Guidance.”
  • Per an AHIP news release,
    • “Public and private payers are delivering greater value to Americans and the health care system by advancing value-based care (VBC). AHIP, in collaboration with the Centers for Medicare & Medicaid Services (CMS), today released the results of the 2025 Alternative Payment Model (APM) Adoption Survey. The findings reaffirm the commitment of the federal government and private health plans to advance VBC and APM models that shift away from fee-for-service (FFS) models toward payment arrangements that reward quality, efficiency and improved patient outcomes.
    • “This year’s survey highlights how health plans continue to work hand-in-hand with providers to advance value-based care and drive meaningful improvement for patients. These innovative payment models reward outcomes, resulting in patient-centered, high-quality, coordinated care that is more affordable for Americans,” said Danielle Lloyd, MPH, AHIP’s senior vice president of private market innovations and quality initiatives for Clinical Affairs.” * * *
    • To view the full 2025 survey findings, click here.
  • NCQA announced today,
    • “Every year, NCQA seeks public comment about proposed changes to HEDIS Volume 2.
    • “Public comment is your opportunity to weigh in on the relevance, scientific soundness and feasibility of new and revised measures for HEDIS. Your feedback helps us determine changes to our programs, procedures and processes.
    • “This year’s public comment is open February 13–March 13.
    • We’d like input on:
      • Seven new HEDIS measures.
      • Revising three HEDIS measures.
    • “This year’s public comment will go live Friday, February 13, at 9:00a.m. ET.
    • “We’ll post the link and more details here, so check back on February 13.”
  • The Washington Post relates,
    • “The American Society of Plastic Surgeons has issued a broad recommendation against gender transition surgeries for youths, becoming the first major medical association in the United States to narrow its guidance on pediatric gender care amid a crackdown by the Trump administration.
    • “A statement sent Tuesday to the group’s 11,000 members and obtained by The Washington Post recommends surgeons delay gender-related chest, genital and facial surgery until a patient is at least 19 years old. Fewer than 1,000 minors in the United States receive such surgeries every year, according to research published in JAMA, the American Medical Association’s journal, and the vast majority of the procedures are mastectomies, not genital surgeries.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products. The agency said Abiomed found its Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices could display inaccurate information due to a malfunction of the differential pressure sensors. The company reported 22 injuries associated with the issue since Jan. 15.” 
  • MedTech Dive relates,
    • “Abbott received a warning letter from the Food and Drug Administration related to its FreeStyle Libre continuous glucose monitors.
    • “The warning letter, dated Jan. 23 and posted to the FDA’s website on Tuesday, concerns performance specifications and testing for the glucose sensors’ accuracy. An Abbott spokesperson wrote in an email that the company is implementing corrective actions and providing ongoing updates to the FDA.
    • “The warning letter does not affect Abbott’s ability to manufacture, market or distribute Libre products, wrote Leerink Partners analyst Mike Kratky and J.P. Morgan analyst Robbie Marcus.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN said the U.S. Food and Drug Administration rejected an initial submission for its Saphnelo lupus drug in injection form, and vowed to work with the regulator to move forward with an updated application.
    • “The U.K. pharmaceutical company said Tuesday that the FDA issued a complete response letter, which indicates that a new drug application can’t be approved in its present form, regarding Saphnelo for subcutaneous administration. The company said it subsequently provided information requested in the letter and that it was committed to working with the FDA to progress the application as quickly as possible.
    • “A decision on the updated application is expected in the first half of 2026, AstraZeneca said.
    • “The drug, a treatment for the autoimmune disease systemic lupus erythematosus, is already approved as an intravenous infusion and that form of administration remains commercially available, AstraZeneca said.”
  • Fierce Biotech tells us,
    • “As the first CAR-T treatment for an autoimmune disease draws ever closer, officials at the FDA have signaled a willingness to support the development of these novel cell therapies with a flexible regulatory approach.
    • “While interested in CAR-T therapies’ potential to achieve durable, drug-free remission in serious autoimmune conditions, the FDA is equally wary of their “unpredictable long-term toxicity,” according to an article published Monday in the Annals of Internal Medicine.
    • “In the article, Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research, and two other regulators said that, recognizing the complexity of autoimmune conditions in terms of seriousness and type, the agency will work with CAR-T makers “on a case-by-case basis to encourage appropriate study populations in rheumatologic autoimmune disease.”
    • “Simultaneously, citing a need to monitor a drug’s effect on fertility, the FDA officials recommended that industry conduct long-term follow-up studies for CAR-T products in the autoimmune setting, “as is standard for genetic therapies and CAR T-cells for oncologic indications.”
    • “While the FDA “shares enthusiasm for this class of products,” it will “carefully shepherd” the advancement of clinical studies “focused on the development, durability, and long-term safety of CAR T-cell therapies,” the regulators wrote.”
  • STAT News lets us know, “AI could soon renew prescriptions without clinician help. Should the FDA make sure it’s safe? Doctronic claims its AI doctor doesn’t need FDA approval. Experts aren’t so sure.”

From the public health and medical / Rx research front,

  • Nature reports,
    • “Nearly 40% of new cancer cases worldwide are potentially preventable, according to one of the first investigations1 of its kind, which analysed dozens of cancer types in almost 200 countries.
    • “The study found that in 2022, roughly seven million cancer diagnoses were linked to modifiable risk factors — those that can be changed, controlled or managed to reduce the likelihood of developing the disease. Overall, tobacco smoking was the leading contributor to worldwide cancer cases, followed by infections and drinking alcohol. The findings suggest that avoiding such risk factors is “one of the most powerful ways that we can potentially reduce the future cancer burden”, says study co-author Hanna Fink, a cancer epidemiologist at the World Health Organization’s International Agency for Research on Cancer in Lyon, France.
    • “The study was published today in Nature Medicine.”
  • The American Journal of Managed Care relates,
    • “The majority (57.5%) of commercially insured patients had at least 1 chronic condition in 2024. The average allowed amount1 for a patient with no chronic conditions was $1590, whereas the average allowed amount for a patient with 1 chronic condition was nearly double ($3039). Of 44 common chronic conditions studied, hyperlipidemia, or high cholesterol, was the most common, with a crude prevalence2 of 21.2%. These and other findings are reported in a new FAIR Health white paper: Chronic Conditions in the United States: A Study of Commercial Claims.” * * *
    • “Many patients had more than 1 chronic condition. For example, 11.5% of patients had 2 conditions, and 9.1% had 3.
    • “Some chronic conditions frequently co-occur. In the commercially insured population, 33.4% of patients had hyperlipidemia, hypertension, obesity, or some combination of these, and 4.3% had all 3.3 Half the patients with any one of these conditions had more than 1.” * * *
    • “For the complete white paper, click here“
  • CNN tells us,
    • “Men develop a greater risk of cardiovascular disease years earlier than women — starting at around age 35, according to a new long-term study.
    • “The report, published Wednesday in the Journal of the American Heart Association, followed more than 5,000 adults from young adulthood and found that men reached clinically significant levels of cardiovascular disease about seven years earlier than women.
    • “Experts advise both men and women to monitor their heart health in early adulthood and to see their doctor regularly.
    • “Heart disease doesn’t happen overnight; it develops over years. One of the things I think oftentimes people aren’t aware of is that it can start really early in your 30s or 40s,” said study coauthor Dr. Sadiya Khan, professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine in Chicago.
    • “Even if you don’t have heart disease at that time, your risk can start at that time.”
  • MedPage Today adds,
    • “National data showed 79% of adults with hypertension didn’t have their blood pressure within the blood pressure goal recommended by guidelines.
    • “Most of those uncontrolled hypertension cases went untreated by blood pressure medication.
    • “These findings highlight a large gap in hypertension control that treating hypertension earlier and more intensively could address.”
  • The New York Times observes,
    • “For much of the 20th century and beyond, social scientists attributed a range of chronic mental health problems to dysfunction between infants and their mothers, who were categorized as overbearing, rejecting, domineering or ambivalent.
    • “But a team of researchers from Pennsylvania State University has found that at times the early parenting behavior of fathers may have a greater impact on children’s health.
    • “For a study published recently in the journal Health Psychology, the scientists observed three-way interactions between 10-month-old infants, their fathers and their mothers, and then checked in on the families when the children were 2 and 7.
    • “They found that fathers who were less attentive to their 10-month-olds were likely to have trouble co-parenting, instead withdrawing or competing with mothers for the children’s attention. And at age 7, the children of those fathers were more likely to have markers of poor heart or metabolic health, such as inflammation and high blood sugar.
    • “Mothers’ behavior did not have the same effect, said Alp Aytuglu, a postdoctoral scholar at Penn State’s College of Health and Human Development and an author of the paper.
    • “We of course expected that family dynamics, everybody in the family, fathers and mothers, would impact child development — but it was only fathers, in this case,” Dr. Aytuglu said.”
  • Per Health Day,
    • “More than one-quarter of young children experience persisting symptoms after concussion (PSaC), according to a study published online Jan. 26 in Pediatrics.
    • “Sean C. Rose, M.D., from The Ohio State University in Columbus, and colleagues assessed the frequency of PSaC after early childhood concussion and identified potential predictors of PSaC. The analysis included 235 young children (ages 6 months to <6 years) with concussion, 108 with orthopedic injury, and 75 community controls.
    • “The researchers found that at one month postinjury, PSaC were documented in 28 percent of children with concussion, higher than in the orthopedic injury group (10 percent) and the community control group (2 percent). PSaC were documented in just under one-quarter of children at three months postconcussion (24 percent) and 16 percent at 12 months. PSaC at one month postconcussion was predicted by total symptom burden in the emergency department (odds ratio, 1.108). There were no associations for age, loss of consciousness, receiving brain imaging in the emergency department, attending daycare or school, or parent education with PSaC.”
  • and
    • “The symptoms women experience on the verge of menopause could be vastly different from what they might expect, a new study says.
    • “Women in perimenopause – the time leading up to their final period, as well as the year after – expect to be plagued with hot flashes and night sweats.
    • “However, these women reported symptoms like exhaustion and fatigue far more frequently than those typically associated with menopause, researchers reported Jan. 28 in the journal Menopause.
    • “This study shines a light on how little we still understand about perimenopause and how much it affects people’s daily lives,” lead researcher Dr. Mary Hedges said in a news release. She’s a community internal medicine physician at the Mayo Clinic in Jacksonville, Florida.”
  • Per BioPharma Dive,
    • “An experimental obesity shot Pfizer got through a buyout of Metsera helped enrollees in a mid-stage trial lose significantly more weight than a placebo, spurring up to an 11% reduction over 28 weeks using a regimen that switched from a weekly to monthly dose after 12 weeks.
    • “When including only participants who completed the trial, the shot helped people lose up to 12 percentage points more of their body weight than those who received a placebo. Though cross-trial comparisons can be misleading, the results “look slightly inferior” to what was seen in testing of Eli Lilly’s blockbuster Zepbound at a similar timepoint, wrote Leerink Partners analyst David Risinger.
    • “Pfizer executives noted on a conference call that, going forward, they intend to test a far higher dose than they did in Phase 2 testing. Phase 3 trials starting later this year will involve a dose that’s double the highest one used in the Phase 2.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente and Renown Health have wrapped the paperwork on a deal forming an insurance and outpatient care joint venture in northern Nevada. 
    • “The arrangement announced last September (see below) represents an entry into the geographic market for Kaiser, the country’s largest nonprofit health system. It brings Hometown Health—an existing health plan run by Renown Health, a Reno-based, two-hospital nonprofit system—plus an existing primary care medical office under joint ownership. The partners have plans to open two more facilities in 2026, plus retail pharmacies in 2027. 
    • “This joint venture with Renown Health allows us to extend our value-based care model and nation-leading health outcomes to northern Nevada, in collaboration with Renown Health’s trusted local teams,” Greg Adams, chair and CEO of Kaiser, said in a Tuesday announcement. “Together, we will improve health outcomes; expand access to affordable, high-quality care; and serve the needs of this growing community.”
    • “Financial terms of the transaction were not disclosed.” 
  • and
    • “Primary care company Carbon Health filed for Chapter 11 bankruptcy relief in Texas. 
    • “The company, which offers both in-person care at nearly 100 clinics and virtual care services, said Monday it reached a restructuring agreement with its existing lenders that establishes a “clear path to recapitalization and new ownership.”
    • “Carbon Health intends to pursue a dual-track, court-supervised process that allows it to enter a Chapter 11 plan premised on a debt-for-equity exchange, and a post-petition marketing and sale process for all or a portion of its assets, the company said in a press release issued Monday.
    • “This structure is intended to maximize value while preserving flexibility as the process moves forward,” Carbon Health executives said.
    • “To implement the restructuring, Carbon Health and certain affiliates have filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas.”
  • Healthcare Dive relates,
    • “Humana is launching an artificial intelligence tool that aims to help its call center workers answer beneficiaries’ questions about their coverage, the insurer said Tuesday. 
    • “Agent Assist, developed in partnership with Google Cloud, can summarize conversations between workers and enrollees in real time while highlighting relevant information, like the member’s benefit and eligibility details and important context from the call, Chris Sakalosky, vice president of strategic industries at Google Cloud, said via email.
    • “The insurer began rolling out Agent Assist in October, and plans to implement the tool across Humana’s service centers this year.”
  • Per MedCity News,
    • “About 50 million people in the U.S. are affected by autoimmune disease, and about 80% of them are women. When women give birth, they often experience significant hormonal changes that can trigger new diagnoses or symptoms of autoimmune disease.
    • “That’s why WellTheory, a platform focused on autoimmune disease, launched a new program last week aimed at supporting women in the postpartum period.
    • ‘Atherton, California-based WellTheory treats autoimmune conditions such as Addison’s disease, celiac disease, multiple sclerosis and lupus. Using a collaborative care model, it partners with patients’ physicians to deliver personalized plans focused on nutrition, stress, sleep and movement. The company offers video sessions, unlimited expert messaging and diagnostics. It serves both employers and health plans.
    • “The new postpartum program includes personalized care plans and one-on-one support with autoimmune and hormonal health experts. WellTheory also provides advanced hormonal testing if appropriate, including assessment of sex hormones, cortisol levels and metabolites. This helps identify root causes of conditions like postpartum depression.”
  • Adam Fein writing in his Drug Channels blog lets us know,
    • “The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which track all U.S. spending on healthcare. (Links below.)
    • “We spent an astounding $5,278,588,000,000 on healthcare in 2024. Yes, that’s $5.3 trillion!
    • “Retail outpatient prescription drugs accounted for less than 9% of that total. More than half of net outpatient drug spending was paid by federal, state, and local government programs. Below, we delve into the spending trends, which reveal the impact of the Inflation Reduction Act (IRA) on Medicare spending, the boom in healthcare marketplaces, and the post-pandemic bust in Medicaid. 
    • “Contrary to what you might read, the government’s data show that drug spending growth was not driven by purportedly “skyrocketing” drug prices. In reality, nearly all of the increase in drug spending reflected higher utilization—more people treated, more prescriptions dispensed, and shifts among drugs dispensed—rather than higher net prices.”
  • Per Fierce Pharma,
    • “Armed with what CEO Robert Davis called the “broadest and widest pipeline we’ve had in years,” Merck is preparing for its post-Keytruda future with what it foresees as a host of major sales opportunities over the next decade.
    • “Thanks in part to its recent acquisitions of Verona Pharma and Cidara Therapeutics, the company sees new growth drivers delivering potential annual revenue of more than $70 billion by the “mid-2030s,” Merck said in its fourth-quarter and full-year earnings presentation (PDF).
    • “To put the $70 billion number into context, Davis pointed to the figure as being more than double the $35 billion Keytruda is expected to pick up during its peak sales year in 2028. The oncology superstar is slated for a loss of exclusivity (LOE) in 2028, and a growing pipeline of Keytruda biosimilars is already lining up to take a shot at the drug’s massive market.
    • “Our belief in our ability to have substantial growth once we get closer to the LOE is as high as it’s ever been,” Davis emphasized on a conference call. “And we’re not done.”
  • and
    • “During the first six months of Maziar Mike Doustdar’s tenure as Novo Nordisk’s CEO, the company enjoyed a run of positive momentum highlighted by the launch of its Wegovy pill and a recent stock-price runup. But investor optimism came to a sudden halt Tuesday as the company warned of significant sales and earnings declines in 2026.
    • “Tuesday, Novo put out word that it’s expecting sales and earnings to slide between 5% and 13% this year. In 2025, Novo generated sales growth of 10% and operating profit growth of 6%, the company said.
    • “A few factors are playing into the 2026 guidance. For one, the company said it’s expecting sales to decline in the U.S. amid “intensifying competition” and lower prices in some areas of its business. Novo is also warning of a sales hit from the recent “Most Favored Nation” pricing deal it struck with the Trump administration.
    • “The company is also forecasting a currency hit as the U.S. dollar has lost value against the Danish krone, Novo’s local currency.”
  • Per MedTech Dive,
    • “Medtronic plans to acquire CathWorks, which makes tools to help detect coronary artery disease, the companies announced on Tuesday. Medtronic will pay up to $585 million, with the potential for undisclosed earn-out payments after the acquisition closes.
    • “The companies have worked together since 2022, when Medtronic agreed to co-promote CathWorks’ FFRangio System in the U.S., Europe and Japan.
    • “The FFRangio System uses artificial intelligence and computational science to provide an assessment of the entire coronary tree using routine angiograms, a type of X-ray for imaging blood vessels. The system can provide fractional flow reserve, or FFR, values that help detect what lesions are causing a reduction in blood flow. The system can also help physicians measure the dimensions of a lesion during an operation.”
  • Per Radiology Business,
    • “RadNet Inc. is entering the Midwest by acquiring a 60-year-old private practice’s outpatient imaging assets. 
    • “The Los Angeles company has reached a deal to acquire six freestanding centers, all operated by Indianapolis-based Northwest Radiology, for an undisclosed sum. 
    • “Founded in 1967, NWR is one of Indiana’s largest independent imaging groups, employing 18 physicians. They will continue to provide contracted services across the practice’s former locations. 
    • “The centers are primarily located in Carmel, a growing northern suburb of Indianapolis recently recognized by Travel & Leisure magazine for its livability. RadNet—which, as a publicly traded company, will eventually disclose the purchase price in a future regulatory filing—expects to net $18 million in annual revenue from the sale. 
    • “Steve Forthuber, president and CEO of Eastern Operations for RadNet, said the practice has built “remarkable trust and confidence” among the local physician community. The company plans to work closely with NWR radiologists to further expand their “clinical reach and capabilities.” 

Friday report

David Ermer–CDC, Congress, FDA, Medical / Rx research, NCQA, Obesity, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Democrats again blocked Republicans’ seven-week stopgap spending bill, effectively guaranteeing that the government shutdown will stretch into next week, while the Trump administration froze funding for a Chicago transit project in its latest swipe at blue cities and states.
    • “The GOP measure failed with 54 in favor, and 44 opposed. Republicans control the chamber 53-47 but needed 60 votes to advance the measure under Senate rules.
    • “Earlier Friday, the Trump administration said it is freezing $2.1 billion in federal funds allocated for Chicago in its latest budgetary maneuver targeting Democratic priorities and projects during the shutdown.” 
  • Our OPM Director remains on the job. Today’s Secrets of OPM blog post from Director Scott Kupor discusses OPM’s efforts to handle the retirement surge stemming from the Fork in the Road program.
  • Tammy Flanagan, writing in Govexec, offers “Some good news for federal employees: TSP shows steady growth and healthy fund performance. The Thrift Savings Plan has surpassed $1 trillion in assets, providing steady returns in 2025.”
    • “There has been a lot to worry about for federal employees and their benefits in 2025, but one thing that has been doing very well is the Thrift Savings Plan! The TSP will continue its normal daily operations during the current lapse in appropriations. Visit tsp.gov/shutdown/  for additional information and updates.”  
  • NCQA, writing in LinkedIn, discusses what the organization has learned about defining best practices in wellness and patient engagement.

From the Food and Drug Administration front,

  • Per MedPage Today,
    • “The FDA approved lurbinectedin (Zepzelca) plus either atezolizumab (Tecentriq) or atezolizumab and hyaluronidase (Tecentriq Hybreza) as first-line maintenance therapy for extensive-stage small cell lung cancer, the agency announced on Thursday.
    • “As the first approved combination in this setting, lurbinectedin-atezolizumab is indicated for patients whose disease has not progressed after atezolizumab, carboplatin, and etoposide induction therapy.”
  • and

From the judicial front,

  • SCOTUSblog provides us with news from this week’s long conference.
    • “The Supreme Court on Friday morning agreed to hear oral arguments this winter in a challenge to a Hawaii law that makes it a crime for someone who has a concealed carry permit to carry a handgun on private property without the property owner’s affirmative permission. The announcement that the justices will take up Wolford v. Lopez came as part of a short list of cases from the court’s “long conference” on Monday, at which they considered all of the petitions that became ripe for review during the justices’ summer recess.
    • “In addition to the Hawaii case, the justices added four other new cases – on topics ranging from Cuba’s liability for its confiscation of property in that country in the 1960s to the Fifth Amendment’s takings clause – to the list of cases in which it will hear oral arguments during the 2025-26 term.”
  • Beckers Payer Issues points out,
    • “A federal judge in Massachusetts denied a bid by a coalition of 21 Democratic-led states to halt new ACA rules they argue will impose significant barriers to receiving health coverage.
    • “The lawsuit was filed in July challenging a final rule that CMS introduced earlier this year to amend ACA marketplace regulations, which the states argued will lead to millions of people losing access to health insurance, raise costs for states, and reduce the availability of essential health benefits.”
  • Modern Healthcare adds,
    • “The [District of Massachusetts] decision also sets the stage for a potential larger legal battle if various courts reach differing decisions on the rule’s implementation. The regulation was partially stayed across the country in August as part of a separate case out of the U.S. District Court for the District of Maryland, meaning several provisions in the rule aren’t in effect despite the latest ruling.” * * *
    • “Katie Keith, a director of the Center for Health Policy and the Law at the Georgetown University Law Center’s O’Neill Institute for National and Global Health Law, said the Maryland injunction keeps the same provisions being challenged in Massachusetts from kicking in. That includes a minimum $5 monthly premium for those automatically re-enrolled into fully subsidized health plans and new income verification requirements.
    • “It’s like the rule never went into effect,” Keith said.
    • “But if the attorneys general appeal, their case would head to the 1st U.S. Circuit Court of Appeals, Keith said. That could potentially set up differing rulings on the same regulation, known as a circuit split, since an appeal is pending at the 4th U.S. Circuit Court of Appeals in the Maryland case.”

From the public health and medical / Rx research front,

  • Health Day informs us,
    • “Cardiovascular diseases (CVDs) were the leading cause of disability-adjusted life-years (DALYs) and deaths in 2023, according to a study published online Sept. 24 in the Journal of the American College of Cardiology.
    • “Gregory A. Roth, M.D., M.PH., from the University of Washington in Seattle, and researchers from the Global Burden of Cardiovascular Diseases and Risks 2023 Collaborators described the global, regional, and national burden of CVDs and risk factors including 18 subdiseases and 12 associated modifiable risk factors in 1990 to 2023 in 204 countries and territories.” * * *
    • “Our analysis shows wide geographic differences in CVD burden that can’t be explained by income level alone,” Roth said in a statement. “Given this kind of variation, our findings offer the opportunity to tailor local health policies to target the most relevant risks for specific populations.”
  • The Wall Street Journal explains why it is so important for infants to receive the Hepatitis B vaccine at birth.
    • “It’s the first and only shot most U.S. babies receive: the hepatitis B vaccine—a constant for decades in U.S. newborn care that doctors say is responsible for virtually eliminating childhood cases of the disease.
    • “Now that routine protection could be at risk as the Trump administration considers delaying the shot, the latest in a string of moves that undercut longstanding vaccine recommendations. The president recently quipped that perhaps the vaccine could be delayed until as late as age 12.
    • “Say what? Doctors warn that even delaying the vaccine by a few months would lead to more childhood cases and, ultimately, deaths.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A new study in npj Dementia using data from the UK Biobank shows that COVID-19 survivors aged 50 and older had a higher likelihood of developing new-onset dementia (NOD) compared to uninfected controls. 
    • “A total of 54,757 participants met the inclusion criteria for the study, including 16,017 with COVID-19 and 38,740 non-COVID participants. The median observation period was 24.1 months.
    • “According to the authors, compared with matched non-COVID controls, prior COVID-19 infection was associated with a 41% increased risk of all-cause dementia (hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.13 to 1.75). Men, unvaccinated participants, those with high blood pressure, and those with frequent alcohol use had the highest association with NOD.”
  • Per MedPage Today,
    • “A decline in maternal smoking in the U.S. corresponded with a decline in infants born with gastroschisis, researchers found.
    • “In an examination of more than 25 million live births, maternal smoking fell from about 9.5% in 2017 to about 4% in 2023, and concurrently, the incidence of gastroschisis, a birth defect in which organs are outside the body, dropped from about 2.5 to about 1.5 per 10,000 births, reported Zane Hellmann, MD, MHS, of Yale University in New Haven, Connecticut.
    • “Mothers who had any history of smoking within 3 months of conception were significantly more likely to have a baby with gastroschisis, at a rate of 5.0 per 10,000 births — a nearly 3-fold increase compared to mothers without a history of smoking, at a rate of 1.75 per 10,000 births, Hellmann noted in a presentation during the American Academy of Pediatrics annual meeting.
    • “I think that this highlights the effects that national public health can have on the general population [and] on future generations,” Hellmann said.”
  • Per Medscape,
    • In adults with obesity who achieve ≥ 5% weight loss on a low-calorie diet, a 1-year exercise program produces a greater increase in late-phase postprandial GLP-1 response compared with usual activity, a change that may help curb appetite and prevent weight regain.
  • and
    • The benefits of omega-3 fatty acids (FAs) are well known to medical professionals, but your patients may not be as well versed on their benefits or where to find them or how to add them to their diets. [The article shares] some tips to help explain omega-3 FAs.

From the U.S. healthcare business front,

  • Kaufman Hall considers “Rethinking payer-provider relationships after the One Big Beautiful Bill: Where will the money come from?”
  • Per MedPage Today,
    • “With all the changes to the healthcare sector — from vaccine recommendations to efforts to crack down on pharmacy benefit managers — how are health insurers responding? 
    • ‘MedPage Today Washington Editor Joyce Frieden talked with Paul Markovich, CEO of Ascendiun, a healthcare company based in California, about how his company — which includes Blue Shield of California — is meeting the challenges.“
  • The University of Minnesota’s CIDRAP alerts us,
    • “Direct mailing human papillomavirus (HPV) self-testing kits to women’s homes was cost-effective for those who regularly undergo cervical cancer screening, those overdue for screening, and those with unknown screening histories who opted in, per a Kaiser Permanente–led study published today in JAMA Network Open.
    • “The cost-effectiveness and budget-impact analysis was based on the results of a randomized clinical trial conducted from November 2020 to July 2022. The test-delivery costs of Kaiser Permanente Washington and Medicare included wellness-based or screening-only visits. The 31,355 participants, aged 30 to 64 years, were identified through electronic medical records (EHRs).
    • “Regularly screened participants were randomly assigned to usual care (UC), education (UC and mailed educational materials), direct mail (UC, education, and mailed self-sampling kit), or opt-in (UC, education, and mailed invitation to request kit). 
    • “Participants overdue for screening were assigned to UC, education, or direct mail. Those with an unknown screening history were assigned to UC, education, or opt-in.
    • “Home-based testing addresses well-documented screening barriers and can mitigate the impact of appointment backlogs and scheduling constraints on patients and health care systems,” the study authors wrote. “However, cost-effectiveness has not been evaluated across other screening histories.” * * *
    • “In this economic analysis of a randomized clinical trial, directly mailing HPV kits to individuals who were screening adherent and overdue for screening was economically dominant over other strategies,” the researchers wrote. “Program costs declined rapidly over 4 years. Results support directly mailing HPV kits to eligible individuals as an effective, efficient, and affordable outreach strategy.”

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Democrats made their case to President Trump for restoring billions of dollars in healthcare spending as part of any deal to avoid a government shutdown, but they said there was no breakthrough in talks, further dimming hopes of a last-minute deal.
    • “It was a frank and direct discussion” with the president and Republican leaders, “but significant and meaningful differences remain,” said House Minority Leader Hakeem Jeffries (D., N.Y.) after leaving the meeting at the White House.” * * *
    • “The open question headed into Monday’s meeting was whether Trump the dealmaker would show up, or if he was content to let Democrats go home empty-handed. Trump believes he is in a strong position and that Democrats will be blamed for shutting down the government, according to allies. A Republican close to the talks said that while Trump likes to be a dealmaker, there may not be much of a deal to be made.
    • “[Senate Minority Leader Chuck] Schumer [D., N.Y.] and Senate Majority Leader John Thune (R., S.D.) have signaled any deal would likely focus on extending health-insurance subsidies. Those enhanced Affordable Care Act tax credits, first passed in 2021 by Democrats, are set to expire at year’s end. Democrats and some Republicans want an extension, but Republicans are seeking some new income limits on who receives subsidies. They also say discussions should only take place after Congress passes the stopgap bill keeping the government funded through late November.
    • The Senate was set to vote again before the Wednesday deadline on the same GOP bill that Democrats had previously rejected. Republicans have a 53-47 majority, but they need 60 votes to pass most legislation. With the House out this week, that is currently the only option available.
  • Modern Healthcare adds,
    • “The federal government is on track to shut down at midnight EST Wednesday, when fiscal 2026 begins. President Donald Trump and the Republican-led Congress have failed to enact annual appropriations bills to finance government operations. Negotiations with Senate Democrats continued Monday.
    • “Medicare, Medicaid, the Children’s Health Insurance Program and the federal health insurance exchanges would continue operating for the immediate future, HHS announced. The first three programs are mandatory and not subject to annual appropriations and CMS would cover exchange expenses with insurance company user fees.”
  • Federal News Network reminds us,
    • “Even if an agency doesn’t pay health premiums on time to OPM, federal employees and other enrollees in the Federal Employees Health Benefits (FEHB) program, as well as participants in the Postal Service Health Benefits (PSHB) program, maintain coverage throughout the duration of a shutdown, OPM has said in shutdown guidance.
    • “Those same rules apply to coverage through the Federal Employees Dental and Vision Insurance Program (FEDVIP), the Federal Employees’ Group Life Insurance (FEGLI) program and the Federal Long Term Care Insurance Program (FLTCIP).
    • “While all FEHB and PSHB participants maintain health coverage during a shutdown, those who are excepted or furloughed are not expected to pay health premiums while a shutdown is ongoing. Enrollees, however, will have to make any payments for premiums that accumulate during a shutdown, once the shutdown ends.”
  • Govexec offers part 2 of a series of commentaries about OPM in the second Trump Administration while FedSmith reminds folks about five mistakes to avoid during the upcoming FEHB / PSHB / FedFlex Open Season.
  • Avalere Health calls attention to key health policy actions to watch for during the rest of this year.
  • Mercer Consulting informs us,
    • “The 2026 changes to the Medicare Part D drug benefit passed under the Inflation Reduction Act are generally modest compared to the significant adjustments made in 2025. However, new instructions related to determining the creditable coverage status of prescription drug coverage allow plan sponsors to utilize a revised methodology for 2026. Plan sponsors should review the new methodology as they determine the most suitable one for their particular group health plan.
    • “Prior to Oct. 15 each year, plan sponsors providing prescription drug coverage must notify Part D-eligible individuals enrolled, or seeking to enroll, in their group health plan about whether the plan’s drug coverage is creditable — generally, whether it’s expected to pay, on average, at least as much as the Part D standard prescription drug coverage. Additionally, plan sponsors are required to report the creditable coverage status of their prescription drug plans to the Centers for Medicare and Medicaid Services each year, within 60 days of the plan year’s start.
    • “The IRA significantly enhanced Medicare Part D beginning in 2025, raising concerns among some plan sponsors about whether their drug coverage would remain creditable.  Instructions provided by CMS for 2026 take into account the IRA’s enhancements and increased flexibility in how plan sponsors may determine whether their drug coverage is creditable going forward, updating their Simplified Determination Methodology for 2026. And for the first time, some Health Savings Account-qualifying High-Deductible Health Plans may be able to use the SDM to determine creditable coverage status.”
  • The American Hospital Association News tells us,
    • “The Office of Science and Technology Policy issued a request for information Sept. 26 seeking feedback on federal regulations that hinder AI development, deployment or adoption. The OSTP is requesting comments on regulations across all sectors, including health care, where the underlying assumptions, technical requirements or compliance frameworks may create unnecessary barriers to beneficial AI applications. The agency is accepting comments through www.regulations.gov until Oct. 27.”
  • and
    • “The AHA Sept. 29 sent recommendations to the Department of Health and Human Services and the Centers for Medicare & Medicaid Services to help ensure insurance plans adhere to the agencies’ health insurer pledge to reform prior authorization processes. They include monitoring plans’ progress in fully implementing existing regulations, such as the interoperability and prior authorization final rule and reforms issued in the 2024 Medicare Advantage final rule. “As a result of the enormous detrimental impact that certain prior authorization practices routinely place on patients, physicians and hospitals, the AHA has been actively pushing for reforms in this area for a long time and working with health plans to collaboratively reduce the burdens associated with these programs,” the AHA wrote.”
  • and
    • “The AHA Sept. 29 asked the Trump administration to provide exemptions for health care personnel from the proclamation issued Sept. 19 announcing changes to the H-1B visa program. The proclamation increases the fee to $100,000 for new H-1B petitions filed by employers, as well as implements other restrictions on the entry of certain nonimmigrant workers. Of nearly 400,000 H-1B petitions approved in fiscal year 2024, 16,937 of those, or 4.2% of the total filed petitions, were for medicine and health occupations, and half of those approved petitions were for physicians and surgeons.” 
  • The Labor Department’s Bureau of Labor Statistics issued its annual report
    • “Seventy-two percent of private industry workers had access to medical care plans and 45 percent of workers participated. Dental care was available to 30 percent of private industry workers in establishments with less than 100 workers, 50 percent of private industry workers in establishments with 100-499 workers, and 70 percent of private industry workers in establishments with 500 workers or more. Vision care benefits were available for 21 percent of workers in establishments with less than 100 workers, 34 percent of private industry workers in establishments with 100-499 workers, and 44 percent of private industry workers in establishments with 500 workers or more. on employee benefits in the United States.
  • Per Beckers Payer Issues,
    • “The National Committee for Quality Assurance has named Vivek Garg, MD, as its next president and CEO, effective Jan. 5.
    • “Dr. Garg succeeds NCQA founder and current president Margaret O’Kane, who will retire at the end of this year. He currently serves as chief medical officer at Humana’s CenterWell Senior Primary Care.
    • “Dr. Garg previously held leadership positions at CareMore and Aspire Health, Oscar Health and One Medical Group.”

From the Food and Drug Administration front,

  • Fierce Pharma lets us know,
    • “Kedrion Biopharma has scored an FDA approval for Qivigy for adults with primary humoral immunodeficiency (PI), a group of disorders that prevent the immune system from operating effectively. 
    • “As an intravenous immunoglobulin (IVIG) therapy, Qivigy provides patients with antibodies that are intended to help them ward off infections.
    • “Along with the approval, the Italian plasma collection specialist was quick to point out in a release that it plans to increase its investments in the United States. To support the production of Qivigy, Kedrion announced plans to invest more than $260 million in expanding its U.S. network with over 40 new plasma collection centers. 
    • “The company also said it will invest more than $60 million to expand capacity at its manufacturing facility in Melville, New York.”
  • and
    • “Johnson & Johnson’s Tremfya continues to expand its reach as now the FDA has approved the IL-23 inhibitor as a treatment for two pediatric patient populations.
    • “The agency endorsed Tremfya as a treatment for children 6 years and older who weigh at least 40 kg (88 pounds) with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
    • “In addition, children 6 and older with active psoriatic arthritis are now eligible for the drug, provided they weigh at least 40 kg, J&J said in a Sept. 29 release.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “About 58 million pounds of corn dogs and other sausage-on-a-stick products were recalled across the U.S. because pieces of wood may be embedded in the batter. (AP)
    • Meanwhile, supermarket chain Albertsons recalled several of its store-made deli products because they may contain Listeria, shortly after federal health officials warned consumers not to eat certain pasta meals sold at Walmart and Trader Joe’s over Listeria concerns. (AP)
  • and
    • “Widespread HPV vaccination slashed infection risk and delivered protection for vaccinated and unvaccinated adolescent girls and young women alike, according to a cross-sectional analysis of six regional surveillance studies.
    • “Between 2006 and 2023, the adjusted proportion of vaccinated women in the six studies who were positive for the high-risk HPV-16 and HPV-18 types covered by the first FDA-approved 2-valent HPV vaccine (2vHPV) dropped 98.4%, said Jessica Kahn, MD, MPH, of Albert Einstein College of Medicine in New York City, and colleagues.
    • “In the 17-year period, the proportion of vaccinated women who tested positive for HPV types covered by the later 4-valent vaccine (4vHPV) dropped 94.2% and fell 75.7% for types covered by the current 9-valent vaccine (9vHPV).
    • “Those declines were paired with evidence of herd protection. The proportion of unvaccinated adolescent girls and young women who were positive for at least one HPV type covered by 2vHPV dropped 71.6%. The proportion positive for at least one HPV type covered by 4vHPV fell 75.8%, they noted in JAMA Pediatrics.”
  • and
    • “In the Southern Hemisphere, the adjusted flu vaccine effectiveness rates against outpatient visits and hospitalizations were 50.4% and 49.7%.
    • “Only 21.3% of flu outpatients and 15.9% of hospitalized flu patients were vaccinated.
    • “Health authorities in the Northern Hemisphere might expect similar levels of protection against influenza, experts said.”
  • STAT News notes,
    • “Heart attacks, heart failure, and strokes don’t come out of nowhere, a new study concludes. The first time they strike, patients, clinicians, and researchers might think there were no red flags.  
    • “But a prospective cohort study reports that more than 99% of people who experienced these illnesses had at least one of four risks for cardiovascular disease. They had “suboptimal” high blood pressure, cholesterol, or blood glucose, or they were current or former smokers. More than 93% of the more than 9.3 million people in two national cohorts followed for 20 years had more than one risk factor.
    • “Among women under 60, often considered to be at lowest risk, more than 95% had at least one nonoptimal risk factor before heart failure or stroke.
    • “This almost universal prevalence of warning signs is far higher than reported in other studies, the new paper asserted.
    • “Every practicing cardiologist has seen cases in which individuals without any known risk factors sustain an MI or develop significant coronary disease,” Neha Pagidipati of the Duke Clinical Research Institute wrote in a companion editorial, referring to myocardial infarction, or heart attack. “However, the prevalence of CVD without traditional risk factors may be significantly lower than previously described.”
  • MedPage Today adds,
    • “The increase in early-onset cancers is not necessarily due to a rise in clinically meaningful cancers, researchers argued, but may be due to increased diagnostic scrutiny and overdiagnosis.
    • “Of the eight fastest-rising cancers, only two — colorectal and endometrial cancer — have shown a slight increase in early-onset mortality.
    • “For the six other cancers, stable or declining mortality rates alongside rising diagnoses suggest that greater detection (rather than more disease) may account for the trend.”
  • Per Health Day,
    • “Acute cystitis may signal the presence of urogenital cancers in middle-aged adults, according to a study published online Sept. 16 in BMJ Public Health.
    • “Filip Jansåker, M.D., Ph.D., from Lund University in Sweden, and colleagues examined the subsequent risks for urogenital cancers in men and women aged 50 years and older diagnosed with acute cystitis. The analysis included roughly 1.67 million men and 1.89 million women, including 177,736 men and 427,821 women diagnosed with acute cystitis (first event) from 1997 to 2018.” * * *
    • “It is plausible that urogenital cancer, and perhaps even precancerous changes in the urogenital organ, might increase the risk of cystitis because of compromised urinary tract and host defense,” the authors write.”
  • Genetic Engineering and Biotechnology News relates
    • “Bispecific antibodies and chimeric antigen receptor (CAR) T cells demonstrate potent cancer immunotherapy in clinical use, yet most cancers remain poorly targetable. High-affinity antibodies needed to maximize cancer killing also detect low antigen expression in normal tissue, which causes toxicity in healthy tissue. Identifying cancer-restricted cell-surface protein antigens remains an ongoing challenge. 
    • “In a new study published in Cell titled, “Safe immunosuppression-resistant pan-cancer immunotherapeutics by velcro-like density-dependent targeting of tumor-associated carbohydrate antigens,” researchers from the University of California (UC), Irvine, have reported that targeting cancer-associated glycans with binding proteins can trigger tumor cell death without toxicity to surrounding tissue. The biologically engineered immunotherapies, known as glycan-dependent T cell recruiter (GlyTR) compounds, were shown to be safe and effective in models for a spectrum of cancers, including breast, colon, lung, ovaries, pancreas and prostate. 
    • “It’s the holy grail—one treatment to kill virtually all cancers,” said Michael Demetriou, MD, PhD, a professor of neurology, microbiology and molecular genetics at the UC Irvine School of Medicine and corresponding author of the study. “GlyTR’s velcro-like sugar-binding technology addresses the two major issues limiting current cancer immunotherapies: distinguishing cancer from normal tissue and cancer’s ability to suppress the immune system.”

From the healthcare business front,

  • STAT News reports,
    • “Perimenopause is the new buzzword in the business of women’s health.
    • “The menopause market has proved so successful that companies are increasingly pushing products aimed at younger women too.”
  • Beckers Hospital Review breaks down the massive 138-hosptial Common Spirit health system’s revenue by region for the fiscal year ending June 30 in 2025 and 2024.
  • MedPage Today points out,
    • “Among more than 3 million Medicare Advantage enrollees, value-based payment models outperformed fee-for-service models for all 15 clinical quality outcomes.
    • ‘The mean score differences for blood glucose control and blood pressure control indicated “markedly better performance” with value-based payment models.
    • “Clinical quality performance consistently improved as financial arrangements moved toward 2-sided risk sharing.”
  • The Brown & Brown consulting firm discusses “Practical Approaches for Employers to Manage High-Cost Claimants in Health Plans.”
    • “Managing high-cost claimants requires a delicate balance of cost control, care quality and employee experience. Employers who invest in data-driven decision making, proactive care management and thoughtful plan design are best positioned to reduce the financial impact of high-cost claimants without sacrificing the well-being of their workforce.
    • “By taking a strategic and holistic approach, employers can turn a major cost challenge into an opportunity to enhance healthcare delivery, improve outcomes and foster a healthier, more productive employee population.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • “today that it will assess the comparative clinical effectiveness and value of Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Novavax) for the prevention of COVID-19, including both the short- and long-term effects of the infection.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in June 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The Wall Street Journal reports,
    • “Novartis NOVN said it is launching a direct-to-patient platform in the U.S. to sell a discounted version of its Cosentyx drug, the latest big pharma company to move to cut prices ahead of the Trump administration’s deadline.
    • “The Swiss pharmaceutical company said Monday that it would offer select units of Cosentyx—a drug treating immune-mediated inflammatory conditions like psoriasis and psoriatic arthritis—at a 55% discount to cash-paying patients with a prescription. The platform will come into effect on Nov. 1.
    • “Novartis’s launch of a direct-to-patient platform and the discount comes after President Trump said in a letter to pharmaceutical companies in July setting a deadline of Sept. 29 to impose cuts on drug prices.”
  • Fierce Pharma adds,
    • “As pharma companies face an imminent deadline from President Donald Trump related to his “Most Favored Nation” (MFN) drug pricing demands, the industry’s top U.S. lobbying group is touting three “major actions” by its members and calling for some policy shifts of its own.
    • “The timing of the Sept. 29 press release by the Pharmaceutical Research and Manufacturers of America (PhRMA) coincides with the deadline set by the president when he laid out the steps pharma companies “must take” to align certain U.S. prices with lower prices overseas. 
    • “But rather than directly addressing the core component of Trump’s demand, the PhRMA communication centers on its members’ infrastructure spending, patient financial assistance programs and a new website designed to compile drugmakers’ direct sales offerings.
    • “PhRMA members are planning $500 billion in U.S. investments over the next 10 years, including $100 billion in projects that haven’t been announced yet, PhRMA CEO Steve Ubl wrote in an accompanying Washington Post op-ed piece Monday.
    • “Besides the capital projects, the industry trade group also plans to launch a website compiling its members’ direct sales offerings. Over the last several months, Big Pharma players have been rolling out new direct-to-patient sales platforms that offer cash-paying patients steep discounts to list prices for certain medicines. This is one component of the president’s push to rein in U.S. prices, and pharmaceutical companies are happy to stick it to middlemen in the U.S. whenever possible.”
  • Per BioPharma Dive,
    • “Antibody drug specialist Genmab on Monday agreed to acquire Dutch biotechnology company Merus in an $8 billion deal centered around a drug that’s shown potential treating head and neck cancer.
    • “Per deal terms, Genmab will pay $97 per share in cash to acquire Merus, representing a 41% premium to the biotech’s closing price on Friday of about $68.  
    • “The deal hands Genmab a drug called petosemtamab and that’s in late-stage testing for head and neck cancer. Phase 2 data presented at the American Society of Clinical Oncology meeting in May showed that the drug helped extend survival when used alongside Merck & Co.’s immunotherapy Keytruda, a result that boosted shares and suggested it could change care for those tumors.”
  • and
    • “Emma Walmsley, the first woman to lead a big pharma company as CEO, will step down from that post Dec. 31, handing the reins of one of Britain’s premier drugmakers to commercial chief Luke Miels.
    • “In a statement Monday, GSK said Walmsley, who has been running GSK since 2017, will depart as part of a succession plan. Miels’ selection was the outcome of a “rigorous process” conducted over the last few months and that included consideration of “internal and external candidates.” He’ll start serving as GSK’s full-time CEO on Jan. 1.
    • “The CEO change ends a nine-year run for Walmsley atop GSK. During that time, Walmsley steered the big drugmaker through a turbulent period, during which it spun out its consumer health business to focus on innovative drugs while facing persistent investor pressure to boost its productivity and growth prospects.
    • “GSK also deepened its investment in oncology, expanded its HIV drug portfolio and brought to market the first vaccine for respiratory syncytial virus.
    • “Yet GSK missed an opportunity during the COVID-19 pandemic, when it decided against developing its own vaccine and partnerships with Sanofi and CureVac hit setbacks and delays.” * * *
    • ‘Miels joined GSK in 2017 after stints at AstraZeneca, Roche and Sanofi, in positions in Europe, Asia and the U.S. He will be paid a base salary of nearly 1.4 million pounds and qualify for bonuses of up to 300%, in addition to other incentives and benefits, according to GSK’s statement.
    • “Walmsley, meanwhile, will also step down from GSK’s board effective Dec. 31, but will remain with the company through Sept. 30, 2026, to support Miels “given the potential impact to GSK’s operating environment arising from geopolitics and new technologies.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NCQA, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Govexec tells us,
    • “Federal employees have been asking a lot of questions since the White House put out guidance this week suggesting large swaths of them would face layoffs under a government shutdown if one occurs next week.
    • “So far the answer many of them are getting is: we are planning to send you home without pay, but only until the shutdown ends. That is to say, agency officials are telling employees they will face their normal shutdown furloughs, but not reduction-in-force notices. 
    • “We were told we won’t be RIF’d, regardless of whether we have to work,” said one General Services Administration employee, whose office is typically furloughed during a funding lapse. 
  • The Centers for Medicare and Medicaid Services announced,
    • [A]verage premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program are expected to remain stable in 2026. Average premiums are projected to decline in both the MA and Part D programs from 2025 to 2026.
    • CMS is committed to ensuring these programs work for Medicare beneficiaries while maintaining access to high-quality, affordable healthcare options, safeguarding taxpayer dollars, and making sure beneficiaries have the information they need to make informed choices about what is best for them. 
    • CMS releases this key information, including 2026 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2025, to December 7, 2025.
    • “Millions of Medicare beneficiaries will continue to have access to a broad range of affordable coverage options in 2026,” said CMS Administrator Dr. Mehmet Oz. “We want every beneficiary to take advantage of Open Enrollment—compare your options and choose the plan that gives you the right care at the best price.”
  • The American Hospital Association News informs us,
    • President Trump, late Sept. 25, announced that starting Oct. 1, the U.S. will impose a 100% tariff on any branded or patented pharmaceutical product, unless a company is building its pharmaceutical manufacturing plant in America. The president’s post on Truth Social said “is building” will be defined as “breaking ground” or “under construction” and that there would be no tariff on “these Pharmaceutical Products if construction has started.”   
    • As of 3 p.m. ET on Sept. 26, the administration has not released any official documents related to the tariff announcement.  
  • BioPharma Dive adds,
    • “The new pharmaceutical tariffs President Donald Trump announced on Thursday, which will go into effect on Oct. 1, could have a limited impact on the pharmaceutical industry due to multiple exemptions for generics, exports from Europe and companies already onshoring manufacturing.
    • “The tariffs, unveiled via a post on the social media platform Truth Social, haven’t been accompanied by legal documents, leaving key details unclear. However, the 100% levies, which are much smaller than the figure previously floated by the Trump administration, alleviate some uncertainty around U.S. drug pricing policy.
    • “The announcement comes days before the expected release of programs meant to align U.S. drug prices with what’s paid in Europe and elsewhere. Published reports have suggested those policies may be more modest than Trump originally proposed, however.”
  • FedWeek points out,
    • “A new bipartisan group of House members has been formed with a focus on the impact on jobs and delivery performance of the Delivering for America reorganization initiative.
    • “The Congressional Postal Service Caucus will focus on improving on-time delivery rates, protecting postal employees, and stopping harmful facility consolidations that reduce access in rural and underserved areas,” said a statement from the founding members. A caucus is a less formal organization than a congressional committee, typically focusing on issues—and trying to build consensus on them—that cross committee areas of jurisdiction.”
  • NCQA, writing in LinkedIn, lets us know about NCQA researchers sharing findings on emerging topics in health care.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza and RSV activity is low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. The percentage of emergency department visits for COVID-19 are highest in children 0-4 years old. Hospitalization numbers and the percentage of emergency department visits are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is low nationally.
  • The University of Minnesota CIDRAP adds,
    • “The current COVID wave began in June, marked by a slow rise that never approached levels seen last summer.
    • “Wastewater SARS-CoV-2 detections are now at the moderate level and are highest in Northeast, followed by the West and the South.”
  • Prevention notes,
    • “The Stratus COVID variant, a.k.a. XFG, is currently the dominant strain of the virus in the U.S., causing 78% of cases in the country, according to CDC data.
    • “It’s an Omicron variant, and it’s a hybrid of two strains—LF.7 and LP.8.1.2,” says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York.
    • Stratus has several mutations to the spike protein, which the virus uses to infect your cells and make you sick, per the World Health Organization (WHO). But the WHO also notes that the threat posed by Stratus is “low.”
  • The Wall Street Journal reports,
    • “President Trump’s return to office has supercharged the debate about childhood vaccinations. Trump himself recently stated that “children get these massive vaccines…like you give to a horse…they get like 80 vaccines,” while Health Secretary Robert F. Kennedy Jr. asserts that babies get up to 92 vaccine doses. In justifying Florida’s decision to end mandatory vaccine mandates for children, state surgeon general Joseph Lapado asked: “Who am I to tell you what your child should put in [their] body? I don’t have that right.”  
    • “These statements misstate the amount and number of vaccines administered to children. Over the course of 18 years, it’s typically 30 doses—in quantities about a tenth of a teaspoon—for about 16 different pathogens. But the critics raise important questions that parents have every right to ask. Why give vaccines so early in a baby’s life? And why shouldn’t parents just pick and choose what goes into their child?  
    • “The crucial context for this discussion is two facts. First, vaccines constitute only a minuscule fraction of the exposure to pathogens that children’s immune systems must contend with. Second, our bodies develop the most enduring antibodies in the early years of life.”
  • JAMA relates,
    • “For years, most observers attributed the higher number of Alzheimer disease cases among women to the simple fact that they live longer than men on average.
    • “Recently, though, scientists have come to recognize that the explanation for the sex gap in the prevalence of Alzheimer disease, the cause of most cases of dementia, is far more nuanced and complex, involving both biological and sociocultural factors.
    • “Research has focused on such potential contributors as women’s exposure to sex hormones, the genes in the X chromosome, the prevalence and effect of risk factors such as hearing loss, the apolipoprotein E ε4 (APOE4) variant, and diminished cognitive reserve related to lower education levels.
    • “Approximately 2 out of every 3 people living with Alzheimer disease in the US is a woman, Harvard neuropsychologist Rachel Buckley, PhD, noted. “Women actually tend to live with dementia for much longer than men.”
  • Per Health Day,
    • “An experimental pill can significantly reduce hot flashes and night sweats for women after menopause a new clinical trial has determined.
    • “Elinzanetant produced a nearly 74% reduction in the frequency and severity of these menopause symptoms within three months, researchers reported recently in JAMA Internal Medicine.
    • “Further, this relief lasted for a year, the trial found.
    • “This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” researcher Dr. JoAnn Pinkerton said in a news release. She’s director of midlife health at University of Virginia Health in Richmond.”
  • and
    • “Routine screening can help find kids who are suffering from undiagnosed asthma in communities with high levels of the breathing disorder, a new study says.
    • “Asthma screening during well-child visits found that more than two-thirds (35%) of children with no previous diagnosis of asthma had at least one risk factor for the disease, researchers will report Monday at an American Academy of Pediatrics’ meeting in Denver.
    • “Further, about 24% of kids with risk factors were subsequently diagnosed with asthma, researchers said.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Commercially insured patients pay substantially different rates for the same procedure, with negotiated costs for inpatient procedures varying by an average ratio of 9.1, according to an August report from market intelligence firm Trilliant Health.
    • “The report reviewed health plan transparency data from Aetna and UnitedHealthcare, focusing on 11 inpatient and outpatient procedures.
    • “A coronary bypass without cardiac catheterization, excluding major complications or comorbidities, had negotiated rates ranging from $27,683 to $247,902. Another finding: Outpatient procedures at ambulatory surgery centers would often cost less than those taking place in a hospital’s outpatient department. Colonoscopies, for example, would cost 67.5% less on average than the median hospital rate.
    • “By reviewing a sample of 10 hospitals featured on a collection of “best hospitals” rankings, the researchers also found no correlation between cost and quality.”
  • and
    • “Regional, nonprofit health plans are falling behind large national insurers, with 71% recording an operating loss in 2024 and more than half having two years or less before regulatory intervention is triggered, according to a Sept. 24 report from HealthScape Advisors.
    • “Executives and boards of directors now face the most important decision of their leadership tenures: How do we survive?” the report said.” 
  • Kauffman Hall explains,
    • “The rise of ambulatory surgery centers (ASCs) marks a shift in how surgical care is delivered across the U.S. Amid soaring healthcare costs, tighter reimbursement and advancing surgical technology, health systems are rethinking where and how procedures are done. Many are moving complex surgeries like total joint replacement and spine out of hospitals and into ambulatory settings. Once limited in scope, ASCs are becoming key players in strategically important service lines like orthopedics.” * * *
    • “ASCs are not a magic wand for health systems. While they offer savings to payers, the economics are fragile for providers. Healthy margins require lean operations, smart sourcing and trusted partnerships.
    • “There’s a growing demand for more complex procedures in outpatient settings, but ASCs need to strategically position themselves to meet this demand in an operationally and financially sustainable way.
    • “With advances in surgical technology and care coordination, ASCs are ready to deliver on the promise of value-based care. The challenge for health systems isn’t just to shift where care is delivered, but to rethink how surgical care is structured, managed and financed for long-term performance.”
  • Optum, writing in LinkedIn, discusses how “breakthrough cancer drugs offer better outcomes – but soaring costs pose challenges.”
  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it will offer its asthma and diabetes drugs at an up to 70% discount in the U.S. ahead of a Trump administration deadline for pharmaceutical companies to cut drug prices.
    • “The company said it would launch a direct-to-consumer platform on which eligible patients with prescriptions will be able to purchase its Airsupra and Farxiga drugs in cash at a discount. The platform will be available beginning Oct. 1.
    • “In July, President Trump sent pharmaceutical companies a letter setting a Sept. 29 deadline to propose cuts to their drug prices.
    • “In response, several drugmakers have rolled out direct-to-consumer platforms to offer discounted drugs. Earlier this week, Bristol Myers Squibb said it would offer its plaque psoriasis drug at an up to 80% discount, expanding on its discounted program for blood clot drug Eliquis, which it announced in July.”
  • Fierce Pharma adds,
    • “In an expansion of its previous moves to cut insulin prices, Sanofi will cap the price of each of its insulin products at $35 per month in the U.S. regardless of a patient’s insurance status.
    • “The move, which goes into effect at the start of next year, comes two years after the company slashed the price of its most popular insulin, Lantus, to $35 monthly for those with commercial insurance.
    • “Before that, in June of 2022, Sanofi reduced the price of an unbranded Lantus biologic from $99 per month to $35 for those in the U.S. without insurance.
    • “Sanofi’s cost-cutting efforts have mirrored those of the world’s other two primary sellers of insulin—Novo Nordisk and Eli Lilly—and come as advanced insulin products and insulin biosimilars are reaching the market.”


Friday report

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NCQA, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Democrats blocked Republicans’ stopgap measure that would keep the government funded until late November and insisted that major healthcare spending be added to the bill, raising the odds for a partial shutdown in less than two weeks.
    • “Friday’s vote in the Republican-controlled Senate was 44 in favor and 48 against, short of the 60 votes required. Sens. Rand Paul of Kentucky and Lisa Murkowski of Alaska were the only Republicans to vote against the measure, while Democratic Sen. John Fetterman voted in favor. Several Republicans were absent. 
    • “The GOP-led House narrowly passed the measure earlier in the day in a 217-212 vote largely along party lines.
    • “The failure of the bill in the Senate set the stage for a down-to-the-wire standoff, with both parties standing firm and saying the other one would take the blame for a fall shutdown. * * *
    • Democrats proposed an alternative that would fund the government through Oct. 31 and reverse hundreds of billions of dollars in cuts to Medicaid enacted under the Republican tax-and-spending legislation that Republicans have rebranded the “working families tax cut.” The Democratic alternative would permanently extend certain ACA subsidies that expire at the end of this year. * * *
    • Republicans rejected the Democratic proposal as unserious. It failed in its own vote with 47 in favor and 45 opposed, short of the 60-vote requirement. Republicans control the Senate 53-47.
    • “The Democrats want a ransom payment of more than $1 trillion to keep the government open for only four more weeks,” said Senate Majority Whip John Barrasso (R., Wyo.).
    • [Senator Lisa] Murkowski [(R. AK), who voted against both the Republican plan and the Democratic proposal, said she wants a continuing resolution that extends enhanced ACA subsidies for two years, in addition to addressing some fiscal year 2026 appropriations and funding for the public media.
    • “Both of these were messaging bills,” she said. “They both did what everybody predicted was going to happen, which was, they were going to go down.
  • STAT News reports good news from Atlanta,
    • “A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated.
    • “The decision, if signed off on by federal health leaders, would preserve insurance coverage for the shots, and is similar to the Food and Drug Administration’s approvals of the updated vaccines earlier this year. The Advisory Committee on Immunization Practices, convened by the Centers for Disease Control and Prevention, emphasized that for people under 65, the benefits of vaccination are most clear for people with risk factors for severe Covid-19.
    • “This vote provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal health insurance marketplace,” a Health and Human Services spokesperson said.”
  • and
    • “A key government advisory committee voted Friday to postpone a vote on whether to delay infants’ first hepatitis B vaccine — temporarily alleviating fears that a new recommendation on shot timing could reverse the significant progress made in controlling the disease’s spread in recent decades.
    • “The decision followed a lengthy deliberation on Thursday by the newly reconstituted Advisory Committee on Immunization Practice, which pressed scientists from the Centers for Disease Control and Prevention on the necessity of the birth dose, and brought into question the veracity of the data presented on the risks and benefits of the vaccine. But ultimately, members voted to push the vote.”
    • “I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature,” Robert Malone, a member of the committee, said on Friday. All of the members of the committee, except its chair, Martin Kulldorff, voted to table the vote.”
  • Per a Congressional news release.
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement on the Advisory Committee on Immunization Practices (ACIP) postponing a vote to change the recommendation for the hepatitis B vaccine for newborns. If a recommendation for a vaccine is altered without a scientific basis, insurance companies may decide to no longer cover it for patients free of charge. Additionally, doctors will lack the necessary information to counsel families, so they make the best health care decisions for their children.
    • “At Wednesday’s hearing, Cassidy underscored the importance of families having access to the hepatitis B vaccine at birth.”
  • Here is an informative Blue Cross link to an article about No Surprises Act abusive practices by providers particularly in the arbitration / IDR process.  In my opinion, which supplements the Blue Cross recommendations, the NSA arbitration process would be more equitable if the Tri-Agencies added more substance from the AAA baseball / final offer rules to its IDR procedures. 
  • Beckers Payer Issues informs us,
    • “CMS has finalized a rule requiring Medicare Advantage plans to submit provider directory data for inclusion in the Medicare Plan Finder. 
    • “The change, aimed at improving transparency and beneficiary decision-making, takes effect January 1, 2026.
    • “Under the rule, MA plans must make provider directory information available to CMS in a standardized format for online publication, update the data within 30 days of becoming aware of changes, and attest at least once a year to the accuracy of the information.
    • “CMS said the move is designed to allow beneficiaries to more easily compare provider networks across plans without having to navigate multiple websites. The agency expects to publish an operational guide in the coming months with technical specifications for plans to follow, along with a testing period before the data appears publicly online.”
  • The American Hospital Association News explains that this CMS rule was part of a larger rulemaking.
    • “The Centers for Medicare & Medicaid Services Sept. 18 released a final rule on policy and technical changes to Medicare Advantage, the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year 2026. Yesterday’s final rule follows one released in April on other changes for MA and prescription drug programs. In the latest final rule, CMS finalized a requirement aimed at increasing beneficiary access to provider directory data in the CMS Medicare Plan Finder platform.”
  • The Government Accountability Office released a report titled “Urban Hospitals: Factors Contributing to Selected Hospital Closures and Related Changes in Available Health Care Services.”
    • “About half of U.S. hospitals are in urban areas. More urban hospitals closed than opened from 2019 to 2023.
    • “All of the 5 hospitals in our review struggled financially before they closed, with inpatient volumes decreasing at 4 of them. The anticipated cost of upgrading or maintaining aging facilities also contributed to the closures of all 5 hospitals.
    • “After closure, 2 of the hospitals still provided outpatient services, while the other 3 stopped all services.
    • “Representatives from local hospitals, providers, and community organizations told us some community residents continued having trouble getting health care after all 5 hospitals closed.”
  • Last but not least, OPM Director Scott Kupor released his regular Friday blog post which concerns OPM’s mine in Boyers, PA, that holds paper personnel records.
    • “The Boyers mine is but one of many examples of opportunities for modernization across the federal government. None of these challenges are rocket science – maybe with the exception of our friends at NASA – but they have been plagued for too long by a system that doesn’t demand inventiveness and efficiency as first-class citizens in the government vernacular. OPM aims to create fluency in this new language – and we are starting with one retirement piece of paper at a time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales.
    • “To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday.
    • “The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.
    • “Keytruda is approved to treat 18 types of cancer, including of the skin, lung, breast and colon. It has been given to 2.9 million patients and helped former President Jimmy Carter extend his life by nearly a decade. Since arriving in 2014, Keytruda has generated $146 billion in sales for Merck. The drug accounts for nearly half of Merck’s revenue.”
  • Per MedPage Today,
    • “The FDA approved the Altaviva implantable nerve stimulator for urge urinary incontinence (UUI), a common symptom of overactive bladder (OAB), Medtronic announced.
    • “Inserted near the ankle in a minimally invasive procedure, the device generates low-level electronic impulses that stimulate the tibial nerve to restore bladder-brain communication. The device is the third tibial neuromodulator for UUI, joining the eCOIN device approved in 2022opens in a new tab or window and the Revi System approved in 2023.
    • “The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” Kevin Benson, MD, of Sanford Health in Sioux Falls, South Dakota, said in a statement. “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has published an early alert about risks posed by Abbott’s Tactiflex Ablation Catheter.
    • “Officials published the alert Thursday in response to Abbott writing to customers. The company updated its instructions after reviewing three reports of catheter tips detaching in patients. 
    • “Abbott had not received any reports of serious injuries or deaths as of Sept. 11. However, the potential for harm led the FDA to class the safety action as a potentially high-risk issue.”
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells).
    • “The FDA remains committed to facilitating the development of effective and safe therapies for rare diseases and will continue to work diligently to help ensure patients with rare diseases have access to innovative treatments,” said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research.
    • Barth syndrome primarily affects males, typically starts with severe heart failure in infancy, and causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina, and exercise intolerance. The quality of life and daily functioning of patients with Barth syndrome are significantly affected throughout their lives.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in adults 65 years and older. Hospitalization numbers are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is very low nationally.
  • The AHA News points out,
    • “The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a public awareness and education campaign; the launch of an online platform for physicians, researchers and health systems to share best practices and clinical insights; and an Agency for Healthcare Research and Quality report also released Sept. 18 that covers the sources of health coverage for adults with long COVID.” 
  • Fierce Pharma lets us know,
    • “The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn. 
    • “The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.
    • “Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.”
  • Per Health Day,
    • “Aspirin can cut by more than half the risk that colon cancer will come back following initial treatment, a new clinical trial has found.
    • “Daily aspirin reduced by 55% the risk of cancer recurrence in patients whose colorectal cancer is driven by a genetic mutation, researchers reported Sept. 17 in the New England Journal of Medicine.
    • “Aspirin is a drug that is readily available globally and extremely inexpensive compared to many modern cancer drugs, which is very positive,” lead researcher Anna Martling, a professor of molecular medicine and surgery at Karolinska Institute in Sweden, said in a news release.
    • “The study focused on people whose colon cancer was driven by a mutation of the PIK3 gene, which helps regulate cell growth and division in the human body.
    • “Every year, about 107,320 new cases of colon cancer and 46,950 cases of rectal cancer are diagnosed in the United States, according to the American Cancer Society.”
  • NBC News reports,
    • “Wildfire smoke is responsible for tens of thousands of deaths each year and will do more harm to U.S. residents by midcentury than any other threat driven by climate change, including extreme heat. 
    • “That’s the conclusion of a new research paper that provides some of the most extensive modeling of the growing health toll of wildfire smoke on public health in the U.S. 
    • “The study, which was published in the journal Nature on Thursday, found that each year, on average, wildfire smoke is causing more than 41,400 excess deaths, or more than would be normally expected without smoke given the demographics of the U.S. That figure is more than twice what was previously recognized in other studies. 
    • “By midcentury, the study’s authors expect that number to grow by an additional 26,500 to 30,000 deaths as human-caused climate change worsens and the risk of wildfires igniting increases. 
    • “Wildfire smoke is a much larger health risk than we might have understood previously,” said Marshall Burke, a professor of environmental social sciences at Stanford University and a study author.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are working directly with employers to improve cancer care and lower costs as demand — and employers’ healthcare expenses — surge.
    • “Providers are gearing up to treat more cancer patients, hoping to ease employers’ mounting frustration with steep premium increases, long appointment wait times and unnecessary treatment, health system and care navigation company executives said. Cutting out insurers through direct contracts could add transparency to employers’ healthcare costs and help standardize treatment strategies, they said.
    • “Employers and unions have no choice but to take a really hard look at solutions that are going to steer patients to high-quality and lower-cost care,” said Emily Kauff, executive director of Memorial Sloan Kettering Cancer Center’s MSK Direct. “Employers are in crisis — they need lower costs and better value in cancer care.”
  • Beckers Payer Issues adds,
    • “Patients who get primary care from older adult-focused, value-based care organizations are more likely to use these services regularly, according to a study published in NEJM Catalyst: Innovations in Care Delivery, a digital journal published by The New England Journal of Medicine. 
    • “The study, produced by Humana Healthcare Research and Suhas Gondi, MD, attending physician at Boston-based Massachusetts General Hospital, covered 3.2 million Medicare Advantage members and included six older adult-focused facilities, most full-risk practices, according to Humana Chief Medical Officer Kate Goodrich, MD. The team found value-based care — as opposed to physicians offering a greater volume of services — is linked to increased use of primary care services.
    • “The exciting thing about this paper is that it shows that in those higher or more mature types of practices that are focused on seniors, they’re getting more primary care, and they’re getting more consistent primary care,” Dr. Goodrich told Becker’s.
    • “This research builds from a 2024 study on how older adult-focused organizations can increase access to primary care, particularly among underserved populations.”
  • Per Modern Healthcare,
    • “UnitedHealth Group has named Sandeep Dadlani CEO of its Optum Insight technology arm, Dadlani announced in a social media post Thursday. 
    • “Dadlani previously served as UnitedHealth’s executive vice president and chief digital and technology officer. He succeeds Dhivya Suryadevara, who had served in that role and CEO of the Optum Financial healthcare banking division since May.
    • “In a LinkedIn post, Dadlani wrote that it was his first week as CEO of Optum Insight, which includes the Change Healthcare claims processing division.” 
  • and
    • “VillageMD is selling 32 Texas clinics to Harbor Health, an Austin-based primary and specialty clinic group that also offers health plans.
    • “The deal includes 10 clinics in Austin, 10 in San Antonio, six in El Paso and six in Dallas. More than 80 clinicians will join Harbor as part of the transaction, according to a Thursday news release. 
    • “Financial details were not disclosed.”
  • Beckers Payers Issues looks into why Blue Cross of Massachusetts consistently achieves a very high NCQA scorecard.

Thursday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, NCQA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “Top Senate Republicans and Democrats reached a deal Thursday night to tee up two votes on Friday on the two parties’ competing approaches to averting a partial government shutdown when current agency funding expires at the end of the month.
    • “Under the agreement announced by Senate Majority Leader John Thune, R-S.D., and Minority Leader Charles E. Schumer, D-N.Y., assuming the House passes the GOP-drafted, seven-week continuing resolution, then the Senate would take up Democrats’ alternative proposal first. That would be subject to a 60-vote threshold for passage.
    • “If Democrats can’t get 60 votes for their bill — which they aren’t expecting — then the chamber would proceed to a vote on the House-passed CR, also with a 60-vote threshold. That vote is also not expected to succeed.”
    • “However, the idea is for the two sides to head home for the weekend armed with proof that they have to start talking to each other about a compromise that can get 60 votes and get to President Donald Trump’s desk in time to prevent a shutdown.
    • “Schumer had proposed the arrangement earlier in the day, with an eye toward getting the initial votes over with in time for senators to attend conservative activist Charlie Kirk’s funeral in Arizona on Sunday.”
  • Roll Call adds,
    • “Democratic and Republican congressional leaders were engaging in a game of shutdown chicken Thursday, the day before the House’s expected vote on a seven-week stopgap bill due Sept. 30 to prevent a lapse in federal agency funding.
    • “House GOP leaders were feeling good about their odds of getting the bill through their chamber Friday morning, although they still had a little work to do on their side shoring up concerns about added member security funds in the continuing resolution being too skimpy, at $30 million. 
    • “Optimistic, but not certain,” House Appropriations Chairman Tom Cole, R-Okla., responded Thursday when asked for his outlook on passage.”
  • Per Congressional news releases
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, highlighted the importance of delivering President Trump and Secretary Kennedy’s mission to restore radical transparency at the U.S. Centers for Disease Control and Prevention (CDC) to protect children’s health.
    • “This comes after the HELP Committee held a hearing with former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. To deliver on the President’s mission of radical transparency, the Committee is inviting U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and HHS officials to respond by speaking with Committee members.”
  • and
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a statement following the U.S. Senate passage of the SUPPORT for Patients and Communities Reauthorization Act, which bolsters prevention, treatment, and recovery services for Americans with substance use disorders and mental illness. Earlier this year, the U.S. House of Representatives passed the bill with strong bipartisan support. The SUPPORT Reauthorization Act now heads to President Trump’s desk for signature.
    • “The opioid and mental health crisis is tearing apart families,” said Dr. Cassidy. “The SUPPORT Act equips communities with vital tools to combat this scourge and save lives. I’m grateful to my colleagues for their work to pass this bill and look forward to it being signed into law.”
  • MedTech Dive tells us,
    • “A House of Representatives committee has advanced a bill that would give eligible breakthrough devices four years of Medicare coverage.
    • “The House Ways and Means Committee debated the bill Wednesday, revealing concerns about the risk of fraud, the type of evidence required and the weakening of the Centers for Medicare and Medicaid Services’ authority.
    • “Despite the concerns, the bill received bipartisan support and was passed in a 38 to 3 vote. Two medtech trade groups welcomed progress on a topic that they have lobbied about for years.”
  • Beckers Payer Issues notes,
    • “Senate and House [Democrat] lawmakers have introduced a bill that would bar health insurers from buying independently owned clinics and require existing conglomerates to divert their provider businesses.  
    • “The Patients Over Profits Act would:
      • “Prohibit insurance companies or their subsidiaries from owning Medicare Parts B and C providers 
      • “Require insurers and their subsidiaries who also own Parts B or C providers to divest, and if they do not, a civil lawsuit can be brought by the Federal Trade Commission, state attorneys general, HHS inspector general or the Justice Department’s antitrust division. 
      • “Bars the HHS secretary from contracting with a Medicare Advantage organization that also owns a Part B or C provider.” 
  • and
    • “Three Medicare Advantage plans scored a full five stars in this year’s health plan rankings from the National Committee for Quality Assurance.
      • Kaiser Foundation Health Plan in Southern California – HMO
      • Kaiser Foundation Health Plan in Northern California – HMO
      • Network Health in Wisconsin – PPO
    • “An additional 17 plans, including six more Kaiser Foundation Health Plans from around the country, scored 4.5 stars in 2025.”
  • The Wall Street Journal reports,
    • Health secretary Robert F. Kennedy Jr.’s handpicked slate of vaccine advisers voted [8-3] to no longer recommend a combined shot for measles, mumps, rubella and varicella [chickenpox (MMRV)] for children under age 4. 
    • The move came as some states, insurers, public health leaders and a U.S. senator called into question whether Americans should rely on the committee’s decisions.
  • The FEHBlog listened to a good chunk of today’s meeting, and the ACIP decision was based on a concern about children under age 4 suffering febrile seizures as a result of the MMRV shot.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) today announced it is moving to decertify a major organ procurement organization (OPO) after an investigation uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. In one 2024 case, a mistake led a surgeon to decline a donated heart for a patient awaiting transplant surgery.
    • “CMS’s decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, is part of Secretary Robert F. Kennedy, Jr.’s reform initiative announced in July. At that time, an HHS investigation into another OPO found that at least 28 patients may not have been deceased at the time of organ preparation, 73 patients showed neurological signs incompatible with donation, and the Biden administration had closed its own investigation without action.”
  • OPM Director Scott Kupor added to his blog last Monday September 15 with a post titled “Sorry, Not Everyone Gets an A.” In a related news release, OPM explains Director Kupor’s latest blog post explains why an OPM final rule published September 15 “promotes excellence and accountability.”
  • Federal News Network informs us,
    • “The Office of Personnel Management is putting a pause on plans to relocate some of its employees, but said “new efforts” to do so are underway.
    • “In February, OPM gave remote employees more than 50 miles away from the office an ultimatum: Agree to a “management-directed reassignment” (MDR) and relocate to office space in another geographic region, or face termination.
    • “OPM said it would cover relocation expenses for employees who accept reassignment and gave employees until March 7 to make their decision.
    • “But in a new memo, obtained by Federal News Network, the agency states “relocation efforts for OPM employees are on pause.”
    • “The memo said all employees should continue to work at their current duty station, and that “there is no longer an expectation that the first cohort of employees will be relocated to their new duty station by December 2025.”
    • “The memo suggests OPM is taking a fresh look at relocation plans under OPM Director Scott Kupor, who took office in July.“
  • Tammy Flanagan writing in Govexec, follows up on her article from last week about picking the best date for federal retirement in 2026.

From the Food and Drug Administration front,

  • MedPage Today points out,
    • “The FDA gave premarket approval to the first medical device for the treatment of women with symptomatic moderate-to-severe intrauterine adhesions, known as Asherman syndrome, maker Womed announced on Tuesday.
    • “The resorbable adhesion barrier device (Womed Leaf) is intended for women undergoing hysteroscopic surgery for Asherman syndrome.
    • “Asherman syndrome is caused by scarring of the uterus after procedures such as dilation and curettage or fibroid removal and can occur in 20% to 45% of those procedures. The condition can cause female infertility, pelvic pain, and recurrent miscarriages. Current treatment options for intrauterine adhesions have high recurrence rates.” * * *
    • “Womed said the device will be available in the U.S. in early 2026.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31 federal district court decision that also vacated the FDA’s 2024 final rule. The AHA previously urged the FDA to not apply the 2024 final rule to hospital and health system LDTs when it was proposed. 
    • “The AHA appreciates that FDA and the federal district court have acknowledged the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care,” said Roslyne Schulman, AHA director of outpatient payment, emergency readiness and public health policy. “The return to enforcement discretion for LDTs rightly recognizes that applying the device regulations to these tests would likely prompt many hospital laboratories, particularly small ones, to stop offering safe and effective tests upon which patients and their communities rely. This action will help to assure patient access to innovative and targeted diagnostic tests while reducing regulatory burden and costs for both hospitals and the federal government.”
    • “Today’s final rule will become effective following official publication in the Federal Register Sept. 19.”

From the public health and medical/Rx research front,

  • The Wall Street Journal relates,
    • “Novo Nordisk’s daily Wegovy pill led to similar weight loss as the weekly injection in a late-stage trial.
    • “The Wegovy pill, already under review, could be the first GLP-1 pill approved for weight loss.
    • “Trial results showed improved cardiovascular risk factors and increased daily activity for patients.
    • “Currently, less than 2% of individuals with obesity in the U.S. receive obesity medication and Wegovy in a pill may also address patient preference for oral treatment,” Martin Holst Lange, chief scientific officer and head of research & development at Novo Nordisk, said.
    • “Pending FDA approval, ample supply will be available to meet the expected U.S. demand as we hope to set a new treatment benchmark for oral weight loss medications,” he added.”
  • and
    • “Lilly and Novo Nordisk haven’t disclosed specific pricing plans for their pills, but some analysts expect them to be priced at a discount to the injectables.
    • “The leading weekly injected medicines, Novo Nordisk’s Wegovy and Lilly’s Zepbound, have been highly effective at helping people lose significant weight. Zepbound’s highest dose has been shown to help people lose an average of more than 22% of their body weight after more than a year of treatment, while Wegovy can help people lose about 17%. 
    • “Yet their manufacturers have struggled to make enough to meet demand, partly because of limited manufacturing capacity for the complex task of making sterile injectable drugs packaged in an auto-injector device. Making pills is less complex, and there is more global capacity. And, pills don’t require cold-chain distribution and storage, while the injectables need to be kept refrigerated.” * * *
    • “Novo Nordisk may be constrained in how much of its new weight-loss pill it can manufacture because it must cram a lot of the main ingredient into each pill to ensure each person absorbs enough by ingestion, analysts have noted. That is because, like injected semaglutide, the pill is made up of peptides, which are larger than the small molecules that pills are traditionally made of.” * * *
    • Lilly took a different approach than Novo Nordisk. The main ingredient for its GLP-1 pill, orforglipron, is a small molecule, meaning the pills can be manufactured in a more traditional way.
  • Fierce Pharma adds,
    • “Over the last six years, three GLP-1 drugs have been approved for children aged 10 and older with type 2 diabetes. Now this rapidly growing patient population is a step closer to gaining access to Eli Lilly’s dual-action GLP-1/GIP treatment Mounjaro, as its effectiveness in controlling blood sugar has been demonstrated in a phase 3 trial of kids ages 10-17.
    • “The SURPASS-PEDS study—which enrolled 99 children with type 2 diabetes who do not get adequate blood sugar control with metformin, insulin or a combination of both—achieved its primary and secondary endpoints. After 30 weeks of treatment, Mounjaro provided improvements over placebo in the blood sugar measurement, A1C, and in patients’ body mass index (BMI).
    • “The study’s primary endpoint was accomplished, with Mounjaro-treated patients experiencing an average A1C reduction of 2.2% versus .05% for those on placebo from a mean baseline of 8.05%.
    • “Lilly said that it has submitted the results to regulators in a bid to gain an expanded indication for the juggernaut diabetes medication.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “Researchers led by a team at INSERM and King’s College London have shown how stretching the skin stimulates immune cells and increases the skin’s ability to absorb large molecules, including those present in vaccines.
    • “Using a device that applies suction pressure to stretch the skin, the researchers reported that skin stretching activated a local immune response and increased skin permeability without tissue damage via the opening of hair follicles. They also reported that applying vaccines topically while stretching the skin resulted in more effective immunization than subcutaneously injecting the vaccine in mice.”
    • “Just stretching the skin was more effective than delivering the same vaccine with a needle, which shows the practical relevance of this immune activation,” said Stuart Jones, PhD, at King’s College London. “This new pathway into the skin could be used in lots of different ways—we showed its potential for vaccine delivery, but we’re also starting to think about delivering cell therapies and whether it could be used for diagnostics.”
  • Per Healio,
    • “People with obesity and diabetes who undergo bariatric surgery face a significantly lower risk for several adverse health outcomes vs. those treated with GLP-1s, new data show.
    • “Surgery should not be reserved as a last resort; it should be part of early, shared decision-making for patients with type 2 diabetes and obesity,” Ali Aminian, MD, director of Cleveland Clinic’s Bariatric and Metabolic Institute, told Healio. “Evidence shows that surgery provides added, durable benefits beyond medications alone.”
  • Per MedPage Today,
    • “Oral bacteria and fungi may help reshape the pancreatic microbiome and promote carcinogenesis.
    • “Earlier research has connected periodontal disease and clinical candidiasis with greater pancreatic cancer risk.
    • “Altogether, the study identified a more than threefold increase in cancer risk for everyone standard deviation rise in a microbial risk score comprised of 27 bacteria and fungi.”
  • and
    • “One in 10 childhood blood cancers may result from medical imaging-associated radiation exposure.
    • “Cancer risk increased with cumulative radiation dose, ranging from 1.41 times higher to 3.59 times higher.
    • “Children exposed to at least 30 mGy had 25.6 excess blood cancers per 10,000 by age 21.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ascension wrapped its 2025 fiscal year with a $490.9 million operating loss (-1.9% operating income) but a $917.7 million net income, an improvement over the prior year it attributed to greater volumes, improved labor productivity and a tighter rein on non-labor spending.
    • “The major Catholic nonprofit is coming off of a $1.8 billion operating loss in fiscal 2024 and a $3 billion operating loss in fiscal 2023, though those dip to $1.4 billion and $1.5 billion, respectively, when removing impairment and nonrecurring losses. It’d also suffered a major cybersecurity incident at the end of fiscal 2024, the recovery from which leadership said spanned multiple quarters and included consistent volume recovery.
    • “We have been intentional in directing resources toward initiatives that generate measurable impact, from service line growth to process redesign, while also ensuring both stewardship and sustainability,” Saurabh Tripathi, executive vice president and chief financial officer, said in a statement. “This combination of operational discipline and strategic investment increases our flexibility to expand access, enhance services, and ensure the commitment to our mission.”
    • Ascension, which owns or has interests in about 120 hospitals and other healthcare facilities across 16 states, logged $25.3 billion of total operating revenue in fiscal 2025, a roughly $3.2 billion decline (-11.3%) largely reflecting the system’s recent divestments.”
  • The Wall Street Journal relates,
    • “Roche ROG Holding said it agreed to buy 89bio ETNB for up to $3.5 billion, seeking to bolster its drug pipeline by adding an experimental treatment for a liver disease linked to obesity.
    • “The Swiss drugmaker has been looking to enter the weight-loss drug field, a key target of its recent dealmaking activity. With Eli Lilly and Novo Nordisk ahead in the race due to approved drugs that are generating billions of dollars in sales, Roche is betting that a new generation of treatments and potential drug combinations for adjacent conditions can help it to carve out a future role in the market.
    • “The main asset in the pipeline of San Francisco-based 89bio is a drug candidate for a fatty liver disease known as MASH, or metabolic dysfunction-associated steatohepatitis, that is mostly due to obesity.
    • “We intend to be a leader in the cardiovascular space going forward, and being a player in the obesity space is important to make that happen,” Teresa Graham, chief executive of Roche Pharmaceuticals said in an interview.”
  • Per Modern Healthcare,
    • “Cigna aims to strengthen its grip on the specialty pharmacy market through a recent deal with Shields Health Solutions.
    • “The company’s Evernorth Health Services subsidiary, which includes the pharmacy benefit manager Express Scripts and the specialty pharmacy Accredo, announced a $3.5 billion investment into Shields Health Solutions on Sept. 2.
    • “The move shores up a slice of the specialty pharmacy market Cigna wanted to bolster, President and Chief Operating Officer Brian Evanko said during the Morgan Stanley Global Healthcare Conference Sept. 10.” * * *
    • “What caught a lot of people off guard by the [Cigna] transaction is it’s not intuitively the best fit with a retail-oriented PBM,” said Aryeh Sand, a partner at investment banking firm Solomon Partners. “Shields historically is more aligned with health systems.”
  • and
    • “Ten Wisconsin rural hospitals formed a clinically integrated network, following dozens of rural providers that have joined similar initiatives over the past two years. 
    • “The Wisconsin High Value Network looks to pool the expertise and scale of the independent rural hospitals, which have combined $880 million in net revenue, to improve care and lower costs. The Cibolo Health-backed network, announced Thursday, will give providers the data infrastructure and bargaining power to hone primary care services and expand alternative payment models, said David Hartberg, CEO of Vernon Health in Viroqua, Wisconsin, and board chair of the Wisconsin High Value Network.
    • “Cibolo, a rural hospital advisory firm, helped launch similar coalitions in North Dakota, Minnesota, Ohio, Montana and Nebraska. Cibolo will manage daily operations of the Wisconsin High Value Network.”
  • Per BioPharma Dive,
    • “Biogen is buying Alcyone Therapeutics after working with the company for more than two years on a better delivery system for neurological medicines built around antisense oligonucleotides.
    • “Under terms announced Thursday, Biogen will spend $85 million upfront to acquire the privately held company and promise additional payments to Alcyone investors if certain development and regulatory goals are reached. Biogen will gain all rights to ThecaFlex DRx, an implantable subcutaneous port and catheter device it’s been developing with Alcyone since 2023.
    • “The companies have two studies underway testing the system’s delivery of Biogen’s Spinraza drug for spinal muscular atrophy, Biogen said. Lowell, Massachusetts-based Alcyone has been developing ThecaFlex DRx since 2019 and manufactures the product locally.”
  • Per MedTech Dive,
    • “Siemens Healthineers and Stryker are partnering to develop a robotic system that can perform a range of elective and emergency neurovascular procedures, including treatment for strokes and aneurysms, the companies said Wednesday.
    • “The collaboration includes system design, access device and implant integration, imaging for robotic navigation and procedural workflow optimization. The project will combine Siemens Healthineers’ expertise in robotics and imaging with Stryker’s experience in neurovascular technologies.
    • “Carsten Bertram, head of advanced therapies at Siemens Healthineers, said the partnership will focus on creating an ecosystem of image guidance, robotics and devices to help physicians provide faster and more precise care to patients.”
  • Per Fierce Pharma,
    • “With both companies on an upward trajectory, argenx and its manufacturing partner Fujifilm Biotechnologies are taking a logical next step by expanding their collaboration.
    • “In addition to manufacturing drug substance for argenx’s autoimmune blockbuster Vyvgart at its facility in Hillerød, Denmark, Fujifilm will also make the product at its large-scale complex in Holly Springs, N.C. The CDMO will initiate production of Vyvgart at the plant in 2028.
    • “Fujifilm’s Holly Springs is slated to become operational this year and has already secured contracting work from several large drugmakers.” * * *
    • “Fujifilm began building the $2 billion Holly Springs campus in 2021, billing it then as the largest end-to-end biologics production plant in the world, with the expectation to employ roughly 725 at the facility.
    • “Then, in April of last year, Fujifilm upped its ante on the site, earmarking an additional $1.2 billion for its construction and increasing its expected headcount at the facility to 1,400 by 2031.” 

From the artificial intelligence front,

  • Beckers Payer Issues reports,
    • “Hawaii Medical Service Association and Blue Cross and Blue Shield of Kansas joined Blue Shield of California as co-founders of Stellarus, according to a Sept. 18 news release from the technology company. 
    • “Stellarus said it aims to help health plans of all sizes integrate AI and fresh technology to expedite prior authorization, reduce administrative costs and elevate member experience.
    • “Given Hawaii’s size and geographic position, we are better off if we enhance our ability to innovate and grow our technological capacities by investing in Stellarus with like-minded, mission-driven, not-for-profit health plans that are trying to accomplish the same things and solve the same problems,” said President and CEO of Hawaii Medical Service Association Mark Mugiishi, MD.” 
  • Beckers Hospital Review lets us know,
    • “Rochester, Minn.-based Mayo Clinic nurses and informatics teams have developed a [patent pending] in-house AI tool to help streamline clinical workflows.
    • “The tool, called the Nurse Virtual Assistant, integrates directly into Mayo’s EHR and provides a nurse-specific patient summary with links to resources including Lippincott guidelines, intravenous administration protocols and a clinical policy library, according to a Sept. 17 news release.
    • “Mayo Clinic said the tool is designed to reduce the time nurses spend navigating multiple systems, allowing them to focus more on patient care. It was tested and validated in a research study approved by Mayo’s institutional review board before being expanded to more than 9,600 nurses across inpatient and emergency department units.”
  • Per AHA News,
    • “The Joint Commission and the Coalition for Health AI released guidance Sept. 17 on the responsible use of artificial intelligence in health care, the first installment from their partnership that launched in June. The guidance includes recommendations on AI policies, local validation, monitoring and use for interpretation and integration into new or existing processes. CHAI and the Joint Commission plan to release further guidance and a playbook by year’s end.”

Midweek update

David Ermer–CDC, COVID-19 vaccine, FDA, HSA, Medical / Rx research, NCQA, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Roll Call lets us know,
    • “House Republican leaders overcame a key procedural hurdle Wednesday evening, paving the way for floor consideration of the short-term stopgap funding measure they will need to pass with GOP votes later this week due to near-uniform Democratic objections.
    • “The chamber adopted the rule for floor debate on the bill on a 216-210 party-line vote.” * * *
    • “If the GOP bill can get out of the House, [Senate Minority Leader Chuck] Schumer [(D NY)] did offer an exit strategy of sorts on Wednesday night, offering a chance to look at a future commitment to deal with the expiring exchange subsidies once the CR passes rather than insist on changes to the bill now before the Sept. 30 deadline.
    • “Well look, we have two weeks [until October 1, the beginning of the new federal fiscal year]. They should sit down and talk to us, and we maybe can get a good proposal,” Schumer said. “We’ll sit down and negotiate if they will sit down and negotiate. We don’t have a red line, but we know we have to help the American people.”
    • “Republican leaders argue the current income thresholds to qualify for the tax credits are too high, and GOP senators are discussing lowering those in any extension.”
  • The Wall Street Journal reports,
    • “The former director of the Centers for Disease Control and Prevention [Susan Monarez] said she was fired after refusing to compromise her scientific integrity, testifying that Robert F. Kennedy Jr. asked her to preapprove vaccine recommendations and remove career scientists.” * * *
    • “Republican senators largely defended Kennedy and sought to cast Monarez as either untrustworthy or disloyal. Some questioned her hiring of lawyers who have represented Hunter Biden and other officials targeted by Trump.” 
  • Here is a link to the Senate Health, Education, Labor and Pension Committee’s website on this hearing.
  • Roll Call tells us, “Senate Republicans took a final procedural step Wednesday to speed up consideration of President Donald Trump’s lower-level nominees, setting up the confirmation of dozens of appointees as early as this week.”
  • Modern Healthcare points out,
    • “The House passed the Lower Costs More Transparency Act of 2023 with a PBM provision in the last Congress. The Senate, however, only advanced PBM bills as far as committee consideration. At the end of 2024, a version of all those measures was added to a popular bipartisan package of healthcare legislation, in part because of the work of Rep. Buddy Carter (R-Ga.), a pharmacist who pushed the PBM provisions with House leaders. 
    • “The bill was on the verge of passing as part of the annual government funding bill when leaders pulled it from consideration because then-presidential adviser Elon Musk and President Donald Trump raised objections. PBM industry groups argued the provisions aimed at them were giveaways to drug companies, which they say are ultimately responsible for drug prices.
    • “In an interview [with Modern Healthcare], Carter said he expects PBM legislation to pass this year. 
  • The Plan Sponsor Council of America notes,
    • “The PSCA’s 2025 HSA Survey shows employees are increasing contributions to their health savings accounts, and more are investing those assets when given the opportunity, leading to an increase in average account balances for the third consecutive year.
    • “PSCA’s seventh annual HSA survey, sponsored by HSA Bank, was conducted in the summer of 2025 and reflects responses from nearly 600 employers with an HSA program. The survey tracks employee and employer HSA trends from 2024.
    • “The survey shows that 20 percent of participants now invest their HSA savings, up from 18 percent the prior year. Also, two-thirds of employers now offer investments, a 12 percent increase over a two-year period.”
  • Per MedTech Dive,
    • “The Food and Drug Administration posted two notices on Tuesday warning about unauthorized blood pressure and infant monitoring devices sold over the counter.
    • “Many devices for measuring blood pressure and monitoring infant vital signs are currently sold over the counter without FDA marketing authorization, the agency said. The FDA recommended looking for an authorized device.
    • “The regulator has sent warning letters in the past to companies for selling monitoring devices without authorization.” 
  • From Justice Department news releases,
    • “Today, the Antitrust Division of the Department of Justice announces its collaboration with the Federal Trade Commission (FTC) to identify over 125 anticompetitive regulations in response to the President’s Executive Order on Reducing Anti-Competitive Regulatory Barriers. Under the leadership of President Trump, the Antitrust Division, in close coordination with the FTC and federal agencies, conducted a comprehensive, government-wide effort to identify and reform anticompetitive regulations that distort markets and stifle competition.
    • “In America we believe in free markets, not central planning by government regulators or powerful monopolists,” said Assistant Attorney General Abigail Slater of the Justice Department’s Antitrust Division. “Lowering barriers to entry by removing anticompetitive regulations will free America’s innovators and entrepreneurs to do what they do best: drive America’s future success.”
  • and
    • “An indictment was unsealed Friday charging two Florida men for their roles in a scheme to submit approximately $34.8 million in false and fraudulent claims to Medicare for medically unnecessary products. As part of the scheme, the defendants and their co-conspirators targeted thousands of Medicare beneficiaries and, through deceptive telemarketing, persuaded them to accept medical equipment that they did not need, such as orthotic braces and continuous glucose monitors.” * * *
    • “According to court documents, Kenneth Charles Kessler III, 42, of Miami-Dade County, Florida, and Michael Andrew Gomez, 42, of Broward County, Florida, are charged in connection with their ownership and operation of seven durable medical equipment (DME) supply companies based in Florida. Kessler and Gomez are accused of paying illegal kickbacks and bribes to purported marketing companies that targeted thousands of Medicare beneficiaries with deceptive and aggressive telemarketing campaigns. The indictment alleges that these marketing companies obtained the beneficiaries’ personally identifiable information and arranged for purported telemedicine companies to generate doctors’ orders for unnecessary medical equipment. Kessler and Gomez allegedly used these doctors’ orders to submit false and fraudulent claims to Medicare through their network of DME companies.
    • “Kessler and Gomez are both charged with conspiracy to commit health care and wire fraud, two counts of health care fraud, conspiracy to defraud the United States and to offer and pay health care kickbacks, and two counts of offering and paying kickbacks in connection with a federal health care program. If convicted, Kessler and Gomez each face up to 65 years in prison. A federal judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.”

From the Covid vaccine front,

  • STAT News informs us,
    • “Amid growing concern about Americans’ access to vaccines, the country’s biggest health insurance association said its member plans will continue to cover all shots recommended by a federal advisory committee prior to any changes by its new slate of appointees.
    • “America’s Health Insurance Plans’ announcement comes just ahead of the first meeting of the Advisory Committee on Immunization Practices’ 12 members handpicked by Health and Human Services Secretary Robert F. Kennedy Jr. The selection of the five newest members was announced Monday, and their meeting is Thursday and Friday. Experts have speculated that, among other steps, the panel will drop the existing recommendation that newborns receive the hepatitis B vaccine, a move that could lead to a resurgence of the virus and, as a result, liver disease and cancer.” * * *
    • “AHIP said its plans will cover all vaccines recommended by ACIP as of Sept. 1, 2025, and that there would be no cost sharing for patients through the end of 2026. That includes updated Covid-19 and influenza vaccines. Health insurers are required to make vaccines free if they are recommended by ACIP and adopted by the Centers for Disease Control and Prevention, but AHIP’s pledge ensures coverage will continue even if the new members change the panel’s recommendations.” 
  • The Washington Post warns that ACIP could increase the age at which senior citizens can receive the Covid vaccine without cost sharing from 65 to 75.
    • “The people familiar with the deliberations cautioned that the situation is fluid and rapidly changing. The recommendations would also need to be approved by the acting director of the Centers for Disease Control and Prevention before taking effect, and it’s unclear how quickly that would happen.
    • “If a senior is concerned about losing access to a coronavirus vaccine, “they should absolutely try to get vaccinated as soon as possible,” said Caitlin Donovan, senior director at Patient Advocate Foundation. But even if more restrictive guidelines take effect, she noted most seniors have an underlying condition such as diabetes, heart issues or a history with smoking. * * *
    • “If you can’t find an appointment quickly, contact your primary care physician and discuss your options,” Donovan said. “They should be willing to write you a prescription after considering your risk levels.”
  • The New York Times adds,
    • “Four Democratic-controlled Western states on Wednesday issued their own recommendations on who should get three common seasonal vaccines, a sharp rejection of efforts by Health Secretary Robert F. Kennedy Jr. to upend vaccine policy at the federal level.
    • The so-called West Coast Health Alliance — which includes health officials in California, Oregon, Washington and Hawaii — recommended that every resident 6 months and older receive the flu vaccine this fall. They also recommended that broad swaths of the population receive a Covid-19 shot, including pregnant women and all children from 6 months to 2 years old, and that R.S.V. vaccines be given to infants under 8 months and adults over 75, as well as to others with certain risk factors.
    • “The detailed guidance generally mirrors clinical recommendations that have been made by the federal government and by national medical organizations such as the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.”

From the public health and medical/Rx research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Today in its weekly update, the Centers for Disease Control and Prevention (CDC) said there are 1,491 confirmed measles cases in the United States this year in 42 jurisdictions, an increase of 37 cases in the past week. 
    • “Eighty-six percent of cases have been linked to one of 38 reported outbreaks, and roughly 12% of all case-patients have required hospitalization. 
    • “Last year the country recorded only 285 measles cases, and 2025 has been the worst year for measles activity in the United States since the virus was officially declared to be eliminated in 2000.”
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) has launched an effort to advance research on whole-person health and create an integrated knowledge network of healthy physiological function. Whole person health involves looking at the whole person—not just separate organs or body systems—and considering multiple factors that promote health. For example, a multicomponent lifestyle intervention including healthy diet, physical activity and stress management may improve multiple and interconnected aspects of health including cardiovascular (e.g. blood pressure), metabolic (e.g. glucose metabolism) and musculoskeletal function (e.g. muscle strength).
    • “Biomedical research is largely organized around the study of specific organs and diseases. In contrast, we do much less research on health itself, which is an integrated process involving the whole person,” said Helene M. Langevin, M.D., director of NIH’s National Center for Complementary and Integrative Health, which leads the NIH-wide program.
    • “The five-year research initiative will proceed in several stages, drawing from existing scientific knowledge to develop a complete, working model of healthy human physiology. It will build on the NIH Human Reference Atlas and the Human BioMolecular Atlas Program (HuBMAP) to connect the complex anatomy and function of the body’s different organs and systems into a single “map.”
    • “Future stages of the project will link common clinical measures, such as blood pressure, blood glucose and cholesterol, to major physiological functions. This initiative will also populate the framework with existing human data and ultimately build and test an interactive model of whole-person health.
    • “By organizing healthy physiological function into a whole-body knowledge network, researchers will be able to explore scientific questions about health in a new way,” said Dr. Langevin. “With our ability to acquire new scientific data at an increasingly dizzying speed, the importance of integrating and connecting new data to what we already know is greater than ever. The Whole Person Reference Physiome will lay a foundation for understanding the factors that drive declines in health and mechanistic pathways to health restoration.”
  • and
    • “Research supported by the National Institutes of Health (NIH) shows that repeated head impacts from contact sports can cause early and lasting changes in the brains of young- to middle-aged athletes. The findings show that these changes may occur years before chronic traumatic encephalopathy (CTE) develops its hallmark disease features, which can now only be detected by examining brain tissue after death.
    • “This study underscores that many changes in the brain can occur after repetitive head impacts,” said Walter Koroshetz, M.D., director of NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “These early brain changes might help diagnose and treat CTE earlier than is currently possible now.”
    • “Scientists at the Boston University CTE Center, the U.S. Department of Veterans Affairs Boston Healthcare System and collaborating institutions analyzed postmortem brain tissue from athletes under age 51. Most of them had played American football. The team examined brain tissue from these athletes, using cutting-edge tools that track gene activity and images in individual cells. Many of these tools were pioneered by the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. The researchers identified many additional changes in brains beyond the usual molecular signature known to scientists: buildup of a protein called tau in nerve cells next to small blood vessels deep in the brain’s folds.
    • “For example, the researchers found a striking 56% loss of a specific type of neurons in that particular brain area, which takes hard hits during impacts and also where the tau protein accumulates. This loss was evident even in athletes who had no tau buildup. It also tracked with the number of years of exposure to repetitive head impacts. The findings thus suggest that neuronal damage can occur much earlier than is visible by the currently known CTE disease marker tau. The team also observed that the brain’s immune cells, called microglia, became increasingly activated in proportion to the number of years the athletes had played contact sports.”
  • The American Journal of Managed Care informs us,
    • “Early-onset T2D is rising in the US, especially among underserved populations, with a worse cardiometabolic profile than later-onset cases.
    • “Financial hardships are more significant for younger adults, women, and minority groups with T2D, necessitating policies addressing medical and financial well-being.
    • NHANES data from 1999 to 2020 shows increased prevalence of early-onset T2D, highlighting the need for improved screening and diagnosis in younger adults.
    • ‘Study limitations include cross-sectional data, potential recall bias, and exclusion of institutionalized populations, affecting generalizability and causal inferences.’
  • Per Healio,
    • “Walking quickly for 15 minutes per day was associated with a significant reduction in all-cause mortality and CVD mortality, according to a cohort study published in American Journal of Preventive Medicine.
    • “Many studies have explored the health benefits provided by regular walking, including recent findings on the ideal step count and how walking can improve life expectancy for middle-aged adults.”
  • The Wall Street Journal reports,
    • “Eli Lilly’s diabetes pill, orforglipron, showed better blood sugar control than Novo Nordisk’s oral semaglutide in a Phase 3 trial.
    • “Orforglipron met primary and secondary goals across doses, with some participants reaching near-normal blood sugar levels.
    • “Lilly said the results, combined with the pill’s scalability, show its potential as a key Type 2 diabetes treatment.”
  • Per BioPharma Dive,
    • “Roivant and subsidiary company Priovant said Wednesday their inflammatory disease pill succeeded in a Phase 3 trial in the rare condition dermatomyositis, significantly reducing signs and symptoms of the disorder by more than placebo when used for one year.”
    • “Company executives said they plan to ask the Food and Drug Administration to approve the pill, called brepocitinib, in early 2026, based on trial results they called “the first ever positive registrational trial for a targeted therapy” in dermatomyositis.
    • “Brepocitinib is being developed by Priovant Therapeutics, which is part owned by Pfizer. The big drugmaker licensed the pill to Roivant in 2022 as part of a pipeline cull.”
  • and
    • AstraZeneca reported divergent outcomes from two late-stage studies on Wednesday. In one Phase 3 trial, a subcutaneous form of its marketed medicine Sophnelo helped lower signs of disease activity in people with the most common form of lupus. In the other, its drug Fasenra, used to treat asthma and a few other conditions, failed meaningfully lower the rate of moderate or severe chronic obstructive pulmonary disease attacks. The under-the-skin injection of Sophnelo is being reviewed by regulators. AstraZeneca will analyze the Fasenra data to “further understand the results,” the company said.
  • Per Fierce Pharma,
    • “SK Biopharmaceutical’s Xcopri (cenobamate) met the bar in a phase 3 trial that could support the company’s ambitions of building a blockbuster with an expansion into another seizures subtype.
    • “The South Korean pharma won FDA approval for Xcopri in 2019 as a treatment for partial-onset seizures, also known as focal seizures, in adults. Since then, with rapid global growth, SK has outlined blockbuster ambitions for the drug by 2029. 
    • “Now, with a positive phase 3 trial, another indication for primary generalized tonic-clonic (PGTC) seizures could be on the table.”
  • Beckers Hospital Review identifies “four new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports
    • “Baltimore-based Johns Hopkins Medicine has ended contract negotiations with UnitedHealthcare without a new deal, The Baltimore Banner reported Sept. 15. 
    • “Johns Hopkins went out of network with UnitedHealthcare on Aug. 25 after eight months of negotiations and several extensions of their existing agreement. 
    • “Health system leaders did not rule out an agreement in the future, but a spokesperson told The Banner they decided to make patients “aware of this stalemate now, to provide our patients and their employers the time they need to explore alternative insurance options during the upcoming open enrollment season.” 
    • “Both parties have said the impasse was not about money but other provisions in the contract, according to the report. Johns Hopkins said UnitedHealthcare was demanding overly burdensome prior authorization requirements. The payer said the system wanted to be able to exclude certain employer-sponsored plans.
    • “UnitedHealthcare Mid-Atlantic CEO Joseph Ochipinti told the news outlet the payer remains at the negotiation table. He said they expect “network providers to honor their commitment to care for the individuals and families who rely on them as in-network providers.”
  • and
    • lists the top NCQA rated commercial health plans in each state.
  • Per a Healthcare Cost Institute news release,
    • “Primary care offers patients a critical connection point to the health care system. With contact, continuity, comprehensiveness, and coordination as its base1, primary care has been shown to improve health outcomes and population health, reduce health disparities, and save health care dollars. Despite the virtues and benefits of primary care, it seems to be getting harder to access. In 2025, there were 7,901 primary care health professional shortage areas. A recent report found that primary care physicians per capita declined between 2012 and 2021, and fewer trainees chose to pursue primary care than specialty care over the same period.
    • “In response, a number of states are innovating to increase investment in primary care. By one estimate, nearly 20 states have taken action to improve primary care with initiatives ranging from defining and measuring primary care to setting specific primary care spending targets.
    • “This analysis assesses what portion of total health care spending is dedicated to primary care, in alignment with many of the primary care spending targets that are expressed as a percentage of total health care spending. We defined the percentage of primary care as the portion of ambulatory spending rendered by primary care providers (PCPs) relative to total medical and prescription spending among people with Employer-Sponsored Insurance (ESI) and Medicare Fee-for-Service (FFS) between 2018 and 2022. 
    • “The results presented below are based on a narrow definition of primary care provider based on provider specialty. We conducted the same analysis using an expanded list of specialties, (e.g., obstetrics and registered nurses and other allied practitioners). As expected, the share of primary care spending was higher using the broader definition. Otherwise, the patterns observed with the narrow definition also applied to the broader definition. The results of the analysis using both definitions are available in the downloadable data.
    • “Approximately 4% of spending went to primary care in 2022.”
  • Beckers Health IT lets us know,
    • “Epic’s revenue rose to $5.7 billion in 2024, a company spokesperson told Becker’s, as the EHR vendor continues to add health system customers.
    • “That number is up from $4.9 billion in 2023 and $1.2 billion in 2012. Epic has continued to consolidate its U.S. market share lead over the past few years, from 31% of acute care hospitals in 2021 to 42.3% in 2024, per KLAS Research. Its nearest competitor, Oracle Health, clocked in at 22.9%. Epic is the market share leader for all U.S. acute care hospital types except standalone facilities with 200 beds or fewer.”

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical/Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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