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.”