Simplicity is a virtue.

From Washington, DC,

• Roll Call reports,
  • “House Republicans are scrapping the last two weeks the chamber was scheduled to be in session before the midterm elections.
  • “Under the revised schedule announced Thursday, the House will return for votes the evening of Monday, Sept. 14, a week after Labor Day, for what is now expected to be only a one-week session before members return to their home districts.
  • “President Donald Trump signed a stopgap spending bill on Wednesday that will keep the government open through Dec. 11, which some argue has essentially negated the need for an extended September session. 
  • “I don’t think there’s any probably compelling reason that we need to be here” late in the month, said Rep. Robert B. Aderholt, R-Ala., a House appropriator.
  • “I think everybody’s so focused on the election at this point that we’ll just have to wait till the election’s over,” he added, when asked about passing more of the House’s fiscal 2027 spending bills.”
• FEHBlog observation — September 14 also is the first day that the Senate returns from its State work break.

• Fierce Healthcare relates,
  • “A leading Democrat in the House is probing the behavior of No Surprises Act arbiters.
  • Energy and Commerce Committee Ranking Member Frank Pallone, D-New York, sent letters to six certified independent dispute resolution (IDR) entities, seeking details on how each of them is conducting arbitration and staying in compliance with the law as IDR payouts rise.
  • “Pallone’s office sent letters to C2C Innovative Solutions, Inc.; Commence; Dane Street, LLC; EdiPhy Advisors, LLC; National Medical Reviews, Inc.; and ProPeer Resources, LLC on Thursday, per an announcement.
  • “In the letters, he notes the rising number of surprise medical bills that are reaching IDR, rather than being resolved in negotiations, and escalating payments for services resolved through arbitration. A study released in August by researchers at the Georgetown University Center on Health Insurance Reforms estimated that costs related to IDR reached $22.4 billion at the end of 2025.”

• Per a Centers for Medicare and Medicaid Services news release,
  • “The Trump Administration announced today that a $120 million investment is being delivered to strengthen rural health and expand access to high-quality care for Hoosiers through the federal Rural Health Transformation Program (RHTP). These investments will support locally driven solutions across eight regions of the state including removing barriers to technology, transportation, and health education. They will provide nutritional support and counseling with community-specific pilot programs that will address the impact food and nutrition have on health and healthcare. This funding will also help address prevention and management of chronic conditions such as diabetes and obesity.
  • “This investment will strengthen maternal and infant health services, expand access to primary and behavioral health care, and provide critical mental health and crisis response resources. It will also help build the next generation of the rural health workforce through expanded recruitment, training and retention efforts, while creating a coordinated transportation network to help patients get to the care they need.” 

• Beckers ASC Review lets us know,
  • The Federal Trade Commission has widened its scrutiny of healthcare deal-making and dominant vendors over the past month, touching hospital M&A, ASC consolidation and the EHR  market in quick succession. 
  • [The article points out] three recent FTC moves to know.

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

• Tammy Flanagan, writing in Govexec, discusses reliable rules for your retirement recordkeeping.

• Ronald Sanders, a NAPA fellow, former OPM associate director and former agency CHCO, writing in Federal News Network, “explains why federal HR leaders should be treated like adults and held accountable.”

From the Food and Drug Administration front,

• Eating Well reports,
  • “The FDA recalled 75,250 packages of Hodo’s Chili Crisp Lightly Fried Tofu due to potential contamination.
  • “The 8-ounce packages contain UPC 850565007842 and contain use-by dates from May 15 through November 7, 2026.
  • “The recall affects 29 states; check your fridge and return or dispose of affected tofu for a refund.
  • “The tofu may contain ink; seek medical care if you are experiencing any health concerns.”

• Per FDA news releases,
  • “As part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation, the U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
  • “Botanical drug products are products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials and are intended to diagnose, cure, mitigate, treat or prevent disease. While there is broad interest in botanical products, their inherent complexity and variability can present unique challenges for research, product development and regulatory review.” * * *
  • “The public will have 60 days following publication in the Federal Register to submit comments to the docket. Stakeholders are encouraged to submit comments electronically at https://www.regulations.gov by searching for Docket No. FDA-2026-N-9550, entitled “Advancing Development of Botanical Drug Products; Request for Information.”  Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
  • “The comment period closes November 3, 2026.”
• and
  • “The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro is the first FDA-approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease.
  • “For patients with Alexander disease and their families, there have been no approved treatment options — only supportive care while the disease progresses,” said Emily Freilich, M.D., Director of the Division of Neurology I in the FDA’s Center for Drug Evaluation and Research. “Today’s approval is a landmark moment for this community, offering the first therapy that addresses the underlying cause of this rare and serious disease.”
  • “Alexander disease is a rare, progressive neurological disorder caused by mutations in the gene that produces glial fibrillary acidic protein (GFAP). When this protein is abnormal, it accumulates in the brain’s supportive cells, causing damage to the nervous system over time. The disease affects less than 1 in a million people and can cause a wide range of serious and potentially life-threatening problems, including seizures, loss of developmental milestones, difficulty walking, muscle weakness, and increased pressure in the brain.
  • “Zanvastro is an antisense oligonucleotide — a type of medicine that works by reducing the production of the abnormal GFAP protein before it can accumulate and cause further damage. It is administered as an injection into the spinal canal every three months by a trained healthcare professional.”

• Cardiovascular Business adds,
  • “Boston Scientific is warning clinicians about an ongoing safety concern with its LUX-Dx family of insertable cardiac monitors (ICMs). 
  • “The U.S. Food and Drug Administration (FDA) has classified the issue as a Class II recall. No patient injuries have been reported at this time. 
  • “According to Boston Scientific, no devices need to be returned or replaced. However, there are steps users can take to address the issue until it can be properly fixed.”
• and
  • “Heartvue.ai, a medtech company based in Tennessee, has secured U.S. Food and Drug Administration (FDA) clearance for its new artificial intelligence (AI)-enabled imaging software that views, processes and evaluates cardiac MRI scans. Innolitics, an Austin-based consulting firm, helped guide Heartvue.ai through the regulatory process.
  • “The newly cleared software, Heartvue.Proton, uses advanced AI algorithms to automate measurements of 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification. Automating these measurements saves time, though each result is still reviewed and confirmed by a trained clinician. The software was designed to integrate with a hospital’s PACS or EHR system and slide right into any existing cardiology or radiology workflow.
  • “This clearance also includes a Predetermined Change Control Plan (PCCP), which helps Heartvue.ai make specific updates to this software without submitting additional requests to the FDA.”

From the public health and medical / Rx research front,

• Per a CVS Health news release,
  • “CVS Health® (NYSE: CVS) today announced that updated 2026-2027 COVID-19 vaccines are now available at CVS Pharmacy® and MinuteClinic® locations for patients at no-cost with most insurance plans. Appointments are available at CVS.com, MinuteClinic.com and through the CVS Health® app, and walk-ins are accepted at CVS Pharmacy and MinuteClinic.
  • “We know patients value having convenient access to the vaccines and preventive care services they need,” said Amy Compton-Phillips, MD, Executive Vice President and Chief Medical Officer, CVS Health. “With updated COVID-19 vaccines available at CVS Pharmacy and MinuteClinic, we’re making it easier for people to get vaccinated close to home and on a schedule that works for them.”
  • “CVS Pharmacy offers COVID-19 vaccinations for eligible patients based on state regulations*, while MinuteClinic provides vaccinations for patients beginning at 18 months of age. Pharmacists and MinuteClinic providers are available to answer questions and help patients make informed decisions about vaccination based on their individual health needs.”

• Nature reports,
  • “Just one week after the landmark US approval of a game-changing drug for advanced pancreatic cancer, the same therapy is showing promise against the world’s biggest cancer killer: lung cancer.
  • “In a small clinical trial of the drug daraxonrasib (Rasonque), tumours shrank in more than 30% of participants with the most common form of lung cancer, non-small-cell lung cancer. Each participant had a tumour-promoting mutation in a member of the RAS family of proteins, and had previously tried other therapies.
  • “We consider the results incredibly promising,” says Kathryn Arbour, a thoracic oncologist at the Memorial Sloan Kettering Cancer Center in New York City, and an author of the study, which was published on 2 September in the New England Journal of Medicine¹. “These are exciting times.”
  • “A larger study in which participants with non-small-cell lung cancer are randomly assigned to receive either daraxonrasib or standard chemotherapy is under way. Regulators such as the US Food and Drug Administration (FDA) are likely to require results from that trial before approving the drug as a lung cancer treatment.”
    
• Beckers Hospital Review interviews five health system leaders about their “plans to fast-track breakthrough pancreatic cancer drug.”

• The New York Times relates,
  • “Can psilocybin, the hallucinogenic compound also known as magic mushrooms, inoculate cancer patients against the debilitating nerve damage caused by chemotherapy? At first blush, such an outcome might seem like wishful thinking.
  • “But a study published on Thursday in the journal Science makes a compelling case that administering psilocybin shortly before cancer treatments might prevent chemotherapy-induced peripheral neuropathy, a condition that affects about two-thirds of patients who receive chemo.
  • “The scientists studied mice, but the results are so promising that human trials are beginning this month. If successful, the treatment could revolutionize cancer therapy and improve the quality of life for millions.
  • “There are no effective treatments for neuropathy, which causes pain, tingling and numbness in the hands and feet, and can force patients to scale back or halt chemotherapy when the discomfort becomes too much to bear.” * * *
  • “Researchers said they did not yet know whether psilocybin could treat or reverse the symptoms of neuropathy in patients who already have it.
  • “If the results hold up in humans, the treatment could open a new chapter in the emerging field of psychedelic medicine, which until now has largely been focused on psychiatric conditions.”

• Beckers Hospital Review considers whether medication safety is improving.

• BioPharma Dive adds,
  • “A dual-acting cancer drug developed by China-based Akeso helped people with lung cancer live longer after treatment than did Merck & Co.’s blockbuster immunotherapy Keytruda, the company said Thursday, results that support an emerging body of evidence suggesting the medicine may become a future backbone of non-small cell lung cancer care.
  • “Akeso and its U.S.-based licensee Summit Therapeutics didn’t disclose full results, which came from a new data cut of the trial in Chinese enrollees with non-small cell lung cancer that first brought wide attention to “ivonescimab.” Full data is expected at a lung cancer conference later this month.
  • “The trial won’t be used as the main evidence to support U.S. approval, as the Food and Drug Administration will want to see outcomes from a global trial in this setting. Those are expected to come in 2028. It does, however, build confidence that a separate, all-important trial could show ivonescimab in combination with chemotherapy outperforms Keytruda and chemo.”

• MedTech Dive notes,
  • “Ablation with Abbott’s dual-energy catheter, the TactiFlex Duo, was safe and effective in treating atrial fibrillation patients after one year, study results showed.
  • “The device combines pulsed field ablation, or PFA, and radiofrequency energy in one catheter to give physicians more flexibility in complex cases of AFib, an irregular heart rhythm that can lead to stroke or heart failure.
  • “Data from the FlexPulse IDE study, presented at the European Society of Cardiology Congress last week and published in the journal EP Europace, is the basis for Abbott’s Food and Drug Administration submission to market TactiFlex Duo in the U.S. The catheter received Europe’s CE mark earlier this year.” 

• Cardivascular Business tells us,
  • “Xylitol, a sugar substitute often found in gum, baked goods and toothpaste, may significantly increase a person’s risk of dying or experiencing a heart attack or stroke, according to new data presented at the European Society of Cardiology (ESC) Congress 2026.
  • “The study’s authors noted that xylitol is a sugar alcohol that does occur naturally in the body in very low amounts. However, high levels of xylitol are also added to many sugar-free foods to help them taste sweeter, and the long-term cardiovascular implications of this trend have not been sufficiently explored. 
  • “The group reviewed data more than 17,000 participants in one of two datasets: the Canadian Longitudinal Study on Aging (CLSA) and the European Prospective Investigation into Cancer (EPIC)-Norfolk. According to CLSA data, the six-year risk of a major adverse cardiovascular event (MACE) was 57% higher among individuals who consumed the most xylitol than it was among those who consumed the least xylitol. According to EPIC-Norfolk data, the 30-year risk of a MACE was 18% higher among individuals who consumed the most xylitol than it was among those who consumed the least xylitol.” 
• and
  • “Stroke patients should begin their road to recovery as soon as they are medically stable, according to a new guideline from the American Stroke Association (ASA) and American Heart Association (AHA). In fact, starting within the first 48 hours is recommended to maximize the patient’s chance of a full recovery.
  • “The new document, published in full in Stroke, highlights the importance of giving each patient a rehabilitation plan personalized to meet their own needs.[1] It is also critical that delays are kept to a minimum, and that specialists should start addressing physical, cognitive, communication and emotional concerns as quickly as possible.
  • “Each person faces a different set of challenges,” Lorie Gage Richards, PhD, an associate professor at the University of Utah and chair of the volunteer writing group behind this new guideline, said in a statement. “Recovery doesn’t look the same for everyone, and care should be personalized to fit each person’s needs. The goal is to help individuals gain as much independence as possible to perform everyday activities while improving their overall quality of life.”
  • “Sara Kutzle, who survived a stroke in 2021 at the age of 39 years old, helped craft the new guideline. She shared her perspective with the writing group, noting that it took a lot of hard work to feel like herself again.”

• Health Day informs us,
  • “For community-dwelling older adults without clinical cardiovascular disease, atorvastatin is associated with a lower risk for major cardiovascular events, but does not improve disability-free survival, according to a study published online Aug. 28 in the New England Journal of Medicine to coincide with the annual meeting of the European Society of Cardiology, held from Aug. 28 to 31 in Munich.”
• and
  • “Heart disease often starts decades before symptoms appear, and a major new study shows just how early.
  • “Currently, a person’s risk of developing atherosclerotic cardiovascular disease is estimated according to their risk factors, such as age, sex, smoking status, blood pressure and cholesterol levels, and this determines whether primary prevention strategies are prescribed,” said co-lead author Dr. Henning Bundgaard of Rigshospitalet-Copenhagen University Hospital in Denmark. 
  • “This approach relies on an estimation — not on knowledge of the presence of the actual disease (i.e., atherosclerotic plaques),” he said. “And we may be missing important opportunities to prevent cardiovascular events in individuals in whom atherosclerosis has built up many years previously.”

• MedPage Today adds,
  • “Unruptured brain aneurysms were identified more frequently in recent years, a systematic review and meta-analysis showed.
  • “In studies of healthy people who had MR or CT angiography, the prevalence of an unruptured intracranial aneurysm rose from 2.9% to 6.6% over two decades, reported Nima Etminan, MD, of the University of Heidelberg in Mannheim, Germany, and co-authors.
  • “After adjusting for age and sex, the prevalence ratio was 1.8 (95% CI 1.1-2.8) for 2016-2022 compared with 2002-2015.
  • “The increase in unruptured aneurysms “is only in part explained by aging of the population and improvements in vascular imaging, which suggests that other, as yet unknown (e.g., environmental), risk factors play a role as well,” Etminan and colleagues wrote in Lancet Neurology.”

• Genetic Engineering and Biotechnology News points out,
  • “A study by researchers at Harvard Medical School has shown that loss of function in the aldehyde dehydrogenase family 3 member B2 (ALDH3B2) gene can convert human pancreatic duct cells into functional β-like cells that can secrete insulin in response to glucose, and which lowered blood glucose levels when transplanted into diabetic mice. The team, headed by Peng Yi, PhD, an investigator at Joslin Diabetes Center, and assistant professor of medicine at Harvard Medical School, suggests that their results point to ALDH3B2 as a gene that could potentially be targeted in human pancreatic duct cells to replenish β cell mass for diabetes therapy.
  • “Senior and co-corresponding author Yi, together with first and co-corresponding author, Jian Li, a postdoctoral research fellow in the Yi lab at Joslin Diabetes Center and Harvard Medical School, reported on their findings in Science Translational Medicine, in a paper titled “Loss of function of ALDH3B2 transdifferentiates human pancreatic duct cells into β-like cells.”

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

• Beckers Hospital Review reports,
  • “After a brief post-pandemic lull, hospital consolidation is accelerating again, with large health systems expanding across state lines, absorbing independent hospitals and reshaping regional care markets. 
  • “From portfolio resets and strategic exits to cross-market mergers and billion-dollar investments, these moves reflect how scale, capital access and geographic reach are becoming critical advantages in today’s healthcare landscape.
  • “[The article includes a non-exhaustive list of] 31 large health systems that have announced or plan to close strategic mergers, acquisitions or partnerships this year.”

• Beckers ASC Review relates,
  • “A Brookings Institution analysis published Sept. 3 maps how deeply the five largest U.S. health insurers — covering 126 million Americans — have expanded into owning the physician practices, ASCs, pharmacies and PBMs they also pay for care through. Researchers used 2025 SEC filings, IRS Form 990s and state insurance-subsidiary schedules to trace the money.”
    
• Fierce Healthcare tells us,
  • “West Virginia University Health System and Independence Health System’s have come to terms with Pennsylvania’s Attorney’s General Office on a planned acquisition that would bring the former organization to 30 hospitals.
  • “The settlement deal (PDF), filed in state court on Aug. 31 and shared Wednesday by the attorney general, includes terms requiring WVU Health System to keep the Independence hospitals and facilities open for at least five years, and to notify the office of any significant service changes. 
  • “WVU Health System also must install policies to block competitively sensitive information from flowing between its insurance and provider subsidiaries, maintain charity care and financial assistance policies and negotiate in good faith with payers, among other terms outlined in the agreement.”

• Per Beckers Hospital Review,
  • “Salem (Ore.) Health Hospitals & Clinics completed its affiliation Sept. 1 with Stayton, Ore.-based Santiam Hospital and Clinics.
  • “The affiliation received approval in August from the Oregon Health Authority and Oregon Department of Justice. Both parties initially submitted the transaction for review in April through Oregon’s Health Care Market Oversight program, but withdrew the filing July 3, which ended the agency’s comprehensive review, and submitted a request for an emergency exemption that same day. 
  • “Under the affiliation, Santiam employees will become Salem Health staff, with Salem Health investing millions into improvements on healthcare infrastructure at Santiam Health, according to a news release.”

• Modern Healthcare adds,
  • “Centene will exit California and Oregon commercial group markets next year.
  • “Nationwide, Centene serves nearly 500,000 enrollees through its commercial plans, representing less than 2% of its 25.9 million members.
  • “Centene has announced leadership changes, market exits in multiple states and voluntary employees buyouts as it navigates declining enrollment and federal funding cuts.”

• Beckers Payer Issues informs us,
  • “Pharmacy benefit managers LucyRx and Abarca Health completed their strategic combination, according to an Aug. 20 news release.
  • “Across commercial and government markets, the PBMs serve more than 9 million members total. The companies now operate as wholly owned subsidiaries of Healthcare Revolution Partners. They still maintain their independent brands, leadership and client relationships.
  • “The combination unifies LucyRx’s employer focus and clinical capabilities with Abarca’s integrated claims and benefits platform, Darwin, and its knowledge of the government, regulatory, compliance and health plan landscape.”

• Per Fierce Healthcare,
  • “Judi Health is expanding its list of clinical partners with the addition of Color Health, WellTheory and Cylinder.
  • “Each of these organizations targets a key area of focus for employers and plan sponsors and will be immediately available to Judi Health’s clients. Initially launching as pharmacy benefit manager Capital Rx about a decade ago, the company has invested in becoming an enterprise health solution that brings medical and pharmacy together.
  • “Other partners already in the Judi fold include Sword Health and Progyny, the company said in an announcement.
  • “Color Health operates the country’s first virtual cancer clinic with certification from the American Society of Clinical Oncology, and cancer care is the top condition driving healthcare costs for many employers. WellTheory, meanwhile, offers a solution for managing autoimmune and inflammatory conditions.”
• and
  • “Telehealth platform GoodRx announced Thursday the launch of a companion family plan as part of its subscription service that offers free and low-cost prescriptions and savings on common healthcare services.
  • “GoodRx Companion Family Plan covers a primary member and up to four members, with no age restrictions and the inclusion of pets. The plan costs $24.99 per month or $16.99 for members paying annually. 
  • “Families don’t experience healthcare costs one person at a time,” said Wendy Barnes, president and CEO of GoodRx. “They’re simultaneously managing prescriptions and care for kids, parents, partners, and even pets. Expanding Companion across the entire household allows us to support consumers in a way that reflects this reality.”
  • “Barnes added that the new plan also advances the platform’s strategy to be a “more central part of how consumers navigate and pay for healthcare.”