Simplicity is a virtue.

From Washington, DC,

• The American Hospital Association News reports,
  • “The Department of Health and Human Services announced Sept. 8 through the Substance Abuse and Mental Health Services Administration that it will award $383.4 million in grants to support behavioral health treatment, prevention and crisis response efforts. HHS said $252 million will support the 988 Suicide and Crisis Lifeline, suicide prevention and mobile crisis services. Of the remaining grants, $81.4 million will be used toward substance use treatment and prevention initiatives, and $50 million will be used to support mental health services. The Sept. 8 announcement coincided with 988 Day, which raises awareness about the 988 lifeline and the importance of mental health and suicide prevention.” 

• Bloomber Law reports,
  • “The Trump administration is pursuing additional drug pricing deals with pharmaceutical companies, Centers for Medicare and Medicaid Services Administrator Mehmet Oz told Bloomberg Television.
  • “Officials have announced more than two dozen voluntary agreements with pharmaceutical companies so far, and Oz said “there are more deals in the works.” He spoke ahead of his scheduled keynote address at the Republican midterm convention in Dallas Wednesday night.
  • “Each of the agreements is bespoke, but companies generally have agreed to lower the prices they charge public programs for medicines and to launch new drugs at prices similar to those paid by other developed nations in exchange for relief from tariffs. Some companies also are offering the discounted prices directly to consumers on a Trump-branded website, though critics argue the savings are minimal for patients with insurance.”

• Axios adds,
  • “There are troubling new signs that the overhaul of Medicare drug coverage in the Inflation Reduction Act is dramatically driving up program spending. 
  • “Why it matters: The upward trajectory could threaten some seniors’ coverage for outpatient prescription drugs — and it could force painful tradeoffs over the next decade as Medicare consumes a growing share of the nation’s debt. 
  • “Follow the money: The IRA limited what seniors have to pay for outpatient drugs and shifted the remaining cost to taxpayers, insurers who provide stand-alone Medicare drug plans and drug manufacturers.
  • That was good news for enrollees who take expensive drugs for conditions like cancer, multiple sclerosis or rheumatoid arthritis and faced potentially crushing out-of-pocket costs.
  • But federal data shows demand for drugs is surging as they become more affordable, exceeding congressional scorekeepers’ spending estimates and setting off more alarms.
  • “Driving the news: Last week, congressional Medicare advisers reported that more than 1 in 5 enrollees hit Medicare Part D’s $2,000 patient cost cap in 2025 — shifting new costs to the government.”

• Beckers Behavioral Health breaks down the Labor Department’s September 8 enforcement guidance concerning the mental health parity act into seven things to know:
  • “Certain behavioral health treatment exclusions could draw scrutiny.
  • “Prior authorization and medical necessity processes are a key enforcement area.
  • “The agency is looking closely at behavioral health networks.
  • “Compliance depends on how policies operate in practice.
  • “Telehealth, cost-sharing and visit limits can also raise compliance concerns.
  • “Plans are expected to use monitoring mechanisms to identify disparities.
  • “Corrective actions can require changes to coverage and plan operations.”

• STAT News relates,
  • “ARPA-H, the government agency that funds cutting-edge health research, plans to commit $62.7 million to develop artificial intelligence bots that direct treatment of heart failure. Among the goals of the program, called ADVOCATE, is to produce partially autonomous AI devices authorized by the Food and Drug Administration to help treat patients, including assessing symptom severity, prescribing drugs, and ordering lab tests. 
  • “ARPA-H on Wednesday announced the first batch of awards to health tech companies Atman Health, UpDoc, Tempus AI, and teams from Stanford University, Duke University, and the Kaiser Permanente health system. ARPA-H may still fund additional teams. The amount committed for the first year is $33.7 million, and the remainder may be renegotiated up or down.” 

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

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

From the Food and Drug Administration front,

• Fierce Pharma reports,
  • “In an accelerated decision, the FDA expanded Bayer’s Hyrnuo indication, granting first-line approval for a rare tumor type in patients with non-small cell lung cancer. 
  • “Before the expansion, Hyrnuo was available only after other NSCLC treatments failed. But the FDA’s latest go-ahead makes the tyrosine kinase inhibitor (TKI) an initial therapy option for any patient with locally advanced or metastatic non-squamous NSCLC whose tumors test positive for HER2 tyrosine kinase domain activating mutations.   
  • “The expanded indication was won using data from Bayer’s ongoing phase 1/2 Soho-01 trial, in which Hyrnuo demonstrated a 75% objective response rate in previously untreated patients. Six percent of patients showed a complete response, and 70% showed a partial response to the twice-daily oral medication, Bayer said Wednesday. Responses lasted more than six months for 73% of patients.”
• and
  • “With a phase 3 win now fleshed out and an FDA filing recently submitted, BioMarin is advancing expansion plans for Voxzogo, looking to extend the dwarfism drug’s reach as it faces new pressure in its inaugural achondroplasia indication. 
  • “On Wednesday, BioMarin unveiled detailed results from the phase 3 CANOPY-HCH-3 trial assessing Voxzogo in children with hypochondroplasia (HCH), a milder form of achondroplasia, where the company announced a topline win back in May. 
  • “Aside from the average 2.33 cm/year improvement in annualized growth velocity (AGV) on Voxzogo that BioMarin reported out earlier this year, the company dug deeper into the magnitude of benefit its medicine could offer to children with HCH across measures like standing height and arm span after a year of treatment.
  • “BioMarin shared the data Wednesday at the European Society for Paediatric Endocrinology annual meeting and simultaneously published the results in the New England Journal of Medicine.” 

• Cardiovascular Business points out,
  • “Luma Vision, an Irish medtech company focused on electrophysiology and interventional cardiology technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its updated Verafeye imaging and visualization platform. The company previously received FDA clearance for the artificial intelligence-powered offering in 2025; this update covers the platform’s expanded capabilities ahead of a planned commercial launch in 2027.
  • “The Verafeye platform provides ultrasound imaging courtesy of a 360° catheter that creates real-time 2D and 3D maps of the patient’s heart. It also offers advanced visualization and navigation capabilities, helping users track imaging and ablation catheters during treatment. In addition, users are able mark locations as they go to confirm they achieve the necessary alignment.”

From the public health and medical / Rx research front,

• The Washington Post reports,
  • “First responders and other New Yorkers around the World Trade Center that day have reported conditions including respiratory issues, mental health impacts and dementia. Toxins were present in the air soon after the attacks even though people were assured it was safe, according to a trove of records released this week by New York City officials.
  • “Twenty-five years later, attention is increasingly falling on cancer. 
  • “The number of 9/11 survivors who are receiving aid for cancer has roughly tripled over the last five years, according to a Washington Post analysis of reports from the World Trade Center Health Program, which funds health care for first responders and 9/11 survivors in New York. In June 2021, 8,870 survivors received aid for cancer treatment, jumping to 27,300 survivors in 2026 — numbers that sharply outpaced cancer claims among first responders.
  • “Of the roughly 54,000 survivors enrolled in the health program as of June, about half are receiving aid for cancer. Five years ago, that share was 35 percent.” * * *
  • “A recent New York University study of a smaller cohort of 9/11 survivors receiving medical aid as of 2024 reported a similar increase in cancer cases; it found that cases had increased around 2.5-fold between 2019-2024.
  • “This is something that we are worried about,” said Alan Arslan, an associate professor of population health at NYU and one of the authors of the study. “We’re seeing more and more patients.”

• The Wall Street Journal relates,
  • “Dr. Henry Heimlich devised a new technique more than 50 years ago to stop people from choking. Simplicity, studies, shrewd promotion by its inventor—and a demonstration on The Tonight Show Starring Johnny Carson—made the Heimlich maneuver a go-to method.
  • “Now, it is fighting for the stage.
  • “Advocates, companies and some politicians argue that the Heimlich maneuver and back blows, another established method of rescuing people from choking, aren’t always enough. On social media and in state legislatures, they are plugging portable anti-choking devices, designed to suction stuck food or other objects from a person’s airway.
  • “Texas enacted a law last year requiring school districts to stock at least one such device on each campus with at least one employee trained to use it. New York City passed one, too. At least nine other states have weighed or are weighing bills to put devices into schools or other facilities.
  • “It’s a priority,” said New Jersey state Sen. Kristin Corrado, who co-sponsored one bill. “If we have the opportunity to save a life, we have to use all means available.” 
  • “The main U.S. maker—a company called LifeVac—has donated more than 10,000 devices to schools across the country.” * * *
  • “But medical guidelines and many researchers say there isn’t enough evidence to recommend anti-choking devices. State health departments, emergency responders and teachers unions have pushed back against proposals to require them in schools because medical guidelines haven’t endorsed them. New York City said it wouldn’t implement its law unless the devices are recommended in medical guidelines.”

• Beckers Behavioral Health tells us,
  • “The synthetic opioid cychlorphine has been linked to at least 55 deaths nationally from 2025 to 2026, with prevalence highest in Ohio, Tennessee and Texas, MedPage Today reported Sept. 8.
  • “The Office of National Drug Control Policy said in an April drug threat notice that cychlorphine may be “up to 10 times more potent than fentanyl” and an overdose may require multiple doses of naloxone.
  • “In Tennessee, the Knox County Regional Forensic Center reported 41 overdose deaths between July 2025 and February 2026. The center tracked as many as 63 cychlorphine-associated deaths through June 30, and cychlorphine was found to be the cause in 58 of those cases.
  • “Cychlorphine has been found mainly in powders and tablets as well as counterfeit pills. Shravani Durbhakula, MD, MPH, of Vanderbilt University School of Medicine in Nashville, Tennessee, said snorting and inhaling are common, though oral exposure and injection are also possible.”

• Cardiovascular Business informs us,
  • “A majority of transcatheter aortic valve replacement (TAVR) present with a history of heart failure (HF). According to new data published in the Journal of Cardiovascular Medicine, however, many of those patients are not being given the HF medications they need after undergoing TAVR.
  • “Cardiovascular morbidity and mortality remain high after TAVR,” wrote first author Elena Surkova, MD, MSc, PhD, a senior medical director at AstraZeneca and consultant cardiologist with Royal Brompton and Harefield Hospitals, and colleagues. “There is a lack of detailed data on the prevalence of HF in patients undergoing TAVR, medication prescription rates, including the main pillars of HF standard of care, and predictors of HF worsening following the procedure.”

• The American Medical Association lets us know what doctors want patients to know about West Nile virus
  • “Most West Nile virus infections cause no symptoms, but some can lead to severe illness. Mosquito-bite prevention remains the best defense.”

• MedPage Today adds,
  • “A gender gap historically seen in the suicide rates of 10- to 14-year-olds in the U.S. has tightened.
  • “In 2017, the suicide rate of boys was twice that of girls, but by 2024, it was only 4% higher.
  • “The author noted that the nearly equal suicide rates for 10- to 14-year-old boys and girls in the current study marked the “first time this has happened in the available records.”

• Health Day notes,
  • “Autism spectrum disorder (ASD) diagnoses increased disproportionately among females after 2020, across age groups, while remaining stable or declining among males, according to a study published online July 22 in JAMA Network Open.
  • “Erick Messias, M.D., Ph.D., from St. Louis University, and colleagues evaluated age- and sex-specific incidence trends of ASD from 2016 to 2024 to quantify the temporal patterns before and after the COVID-19 pandemic. The analysis included electronic health record data from 171,134 individuals who had at least one clinical encounter annually at a large health care system.”

• Per Genetic Engineering and Biotechnology News,
  • “The results of a preclinical study by researchers at the University of East Anglia suggest that an experimental anticancer drug could stop osteoporosis and help women prevent weight gain after the menopause. Their study in mice found that the small molecule drug CADD522 not only protected against osteoporosis but could also reduce body fat and reverse some of the metabolic changes linked to menopause. Currently in development for cancer therapy, CADD522 is a small molecule inhibitor of the transcription factor RUNX2, which is helps to drive the growth and spread of several cancers.
  • “Research lead Darrell Green, PhD, at UEA’s Norwich Medical School, said, “We have uncovered an entirely new way of tackling the disease. We found that a drug originally developed to stop cancer could help millions of women facing the twin challenge of fragile bones and midlife weight gain. We hope our work could lead to a new generation of osteoporosis treatments that tackle bone loss while also addressing some of the wider metabolic consequences of menopause.”
  • “Green is senior and co-corresponding author of the team’s report in npj Drug Discovery, titled “RUNX2 inhibitor CADD522 improves bone microarchitecture and lipid metabolism in post-menopausal bone loss.” In their paper the team concluded that their collective studies “… identify RUNX2 inhibition as a therapeutic strategy that simultaneously improves skeletal integrity and metabolic homeostasis, supporting further development of CADD522 for osteoporosis and other RUNX2-driven diseases.”

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

• The International Foundation of Employee Benefit Plans reports,
  • “Medical stop-loss premiums in 2026 show an increase from 13.6% on a $100,000 deductible to 15.9% on a $750,000 deductible, as reported by the 2026 Aegis Risk Medical Stop-Loss Premium Survey, cosponsored by the International Society of Certified Employee Benefit Specialists. Notably, this increase is approximately 5% to 5.5% higher than increases seen for the previous 2025 renewals. This impact was not surprising, as many underwriters reported increased severity and frequency in stop loss-claims in late 2024 and a resulting erosion in claims-to-premium loss ratios thereafter and throughout 2025. The survey captured necessary correction to 2026 premiums. The measured increases, rising alongside the size of deductible, reflect leveraged medical trend, as the underlying growth in expense of a catastrophic medical claimant is fully borne by an unchanged deductible.
  • “Survey response uniquely captures final, negotiated premium and reflects any pricing improvement from renewal marketings and concessions across all deductibles. In comparison, several large direct underwriters reported an average 2026 increase in the low 20% range on their own book-of-business. However, those are weighted by in-force policies unable to locate lower cost alternatives. The comparatively lower increases observed in this survey reflect the 2026 renewal rate opportunity found in the market. Looking ahead, an ongoing return to underwriter discipline and need to restore insurer loss ratios to a more profitable position does not indicate any easing on the 2027 renewal cycle.”
    
• Fierce Pharma relates,
  • “Shifts in drug pricing and market access policies around the world have caused an “earthquake” that will reverberate for years to come, a survey of industry leaders found.
  • “Healthcare consultancy Numerof & Associates generated the insights in a survey of 175 executives from 67 pharmaceutical companies. The qualitative survey revealed the belief that the current era of policy change is unlike anything that the industry has experienced before. After going through a period of fast change, the industry is braced for more upheaval in the coming years. 
  • “While there has always been change throughout the industry, the past 24 to 36 months have felt more exponentially transformative than anything I have seen over the last 30 years,” an executive said. “What we may experience over the next five years could exceed the cumulative level of change we saw over the previous several decades.”
  • “Another executive characterized the policy environment as an “earthquake” that is “not going to settle down soon,” while a third person predicted that the need for politicians to try to address the cost of healthcare will ensure ongoing change. 
  • “The executives were talking after a succession of policy changes in key markets. Medicare gained the authority to directly negotiate prices for some drugs, and the most-favored-nation (MFN) policy tied U.S. prices to overseas markets.” 

• Healthcare Dive tells us,
  • “UnitedHealthcare is still drilling down on actions it can take to make its Medicare Advantage plans more profitable next year, even as the insurer is expected to exit more underperforming geographies. But the company could be poised for growth in the markets where it remains, according to new comments from a top executive.
  • “We think we’re going to be very competitive in terms of our pricing next year,” CFO Wayne DeVeydt said during Wells Fargo’s annual healthcare conference Wednesday morning. “We think our benefits will be competitive … We still have a few markets where we’re right-sizing some of the products, but I think we’ll be well-positioned for 2027.”
  • “DeVeydt’s comments come as market watchers try to get a sense of how 2027 open enrollment will pan out, following an especially turbulent sign-up period for 2026 after insurers culled their plans in a bid to resuscitate flagging margins.”

• Modern Healthcare adds,
  • “UnitedHealth Group and CVS Health are looking into acquisitions, executives said at a Wells Fargo conference.
  • “UnitedHealth Group identified value-based care companies and companies that would fit into its Optum Insight division as targets.
  • “CVS Health will seek “bolt-on” acquisitions and resume share buybacks next year.”

• Beckers Payer Issues informs us,
  • “Anthem is now covering three surgical meshes for breast reconstruction, according to a clinical guideline published Aug. 27.
  • “DuraSorb Monofilament Mesh, GalaFLEX and TIGR Matrix Surgical Mesh “are considered medically necessary when used for breast reconstruction surgery,” the guidance said.
  • “We regularly review our medical coverage policies to ensure they’re aligned with credible medical evidence and the latest treatment standards and expert recommendations,” an Elevance Health spokesperson told Becker’s.” * * *
  • “ABC affiliate WFTS-TV in Tampa, Fla., has been reporting on breast cancer insurance denials, including for mesh, in recent years. It reported how Cigna updated its policy to cover mesh for breast reconstruction in 2025.
  • “Despite calls for insurer coverage, mesh for breast reconstruction has not secured FDA approval.”
• and
  • “UnitedHealth Group’s Optum has sold interest in some of Optum’s Florida WellMed clinics to private equity company TPG, Bloomberg originally reported Sept. 9. UnitedHealth Chief Financial Officer Wayne DeVeydt told Bloomberg that the healthcare company was looking for a partner “that could actually work with us locally,” and UnitedHealth “didn’t need the dollars.” 
  • “We entered a strategic partnership designed to strengthen operating performance through dedicated support for clinic operations, targeted investments in technology and tools, and enhanced operating capabilities,” an Optum spokesperson told Becker’s Sept. 9. “The transitioning clinics will remain part of Optum’s network and continue providing high-quality care to patients. We remain committed to serving Florida patients through our integrated, value-based care model.”

• Beckers Behavioral Health lets us know,
  • “Santa Fe, N.M.-based Quel Health launched a telehealth platform focused on using GLP-1 receptor agonists in addiction care. 
  • “The platform is available in 41 states and the District of Columbia, with national coverage planned by year-end, according to a Sept. 8 news release from the company. Quel also named Wernersville, Pa.-based Caron Treatment Centers a founding strategic partner.” * * *
  • “The approach follows work at Caron’s Pennsylvania and Florida campuses, where Steven Klein, MD, PhD, co-founder and chief medical officer of Quel Health, and his team evaluate GLP-1 receptor agonists in patients whose primary diagnosis was substance use disorder rather than obesity or diabetes.” 
     
• Per Fierce Healthcare,
  • “Employers Health and Judi Health are teaming up to launch StarkRx, a new cost-plus benefit offering designed to drive transparency for employers.
  • “The approach unites the expertise of Employers Health as a group purchasing organization for pharmacy benefits that’s backed by employers with the technology available through Judi. The goal, the partners said, is to ensure that self-funded employers have greater access to transparency data that they can use to identify and manage cost drivers.
  • “Employers are expected to see another year of significant healthcare cost increases in 2027, with pharmaceuticals serving as a major factor behind the trend. A recent analysis from Marsh (formerly Mercer) estimated that costs could increase by 8.2% next year.
  • “Advanced, high-cost therapies and GLP-1 medications were both cited as key cost drivers in that analysis.”
• and
  • “H1 has acquired Defacto Health, a healthcare data company focused on provider network intelligence, in a move to expand its offerings for health plans and strengthen its healthcare data assets.
  • “H1 is an AI-powered platform that brings healthcare data, domain expertise and an artificial intelligence platform to life science companies. The company built an AI-powered platform that helps identify and engage the right doctors for critical workflows across pharma, health plan, health system and technology companies. 
  • “Defacto Health is an AI-driven provider intelligence platform that aggregates and analyzes health insurance payer networks, provider directories and medical demographics data. The company maintains data on payer networks, healthcare providers and the insurance plans providers accept, helping health plans assess directory accuracy, isolate error clusters and benchmark their networks.”

• Beckers Hospital Review reports,
  • “The American Medical Association released its 2027 Current Procedural Terminology (CPT) code set Sept. 9, an update that adds 299 codes and continues to build out billing for clinical AI.
  • “The set takes effect Jan. 1 and carries 453 total editorial changes: 299 new codes, 74 revisions and 80 deletions, the AMA said.
  • “Ten of the new codes describe AI-related services, raising the total number of AI-related CPT codes to 43. The AMA also updated Appendix S, its taxonomy that sorts medical AI by how much of the work the machine does — assistive, augmentative or autonomous — and guides how new tools get coded.
  • “As new technologies and clinical approaches emerge, the nation’s health system needs a reliable way to describe the care physicians provide,” said AMA President Willie Underwood III, MD. Dr. Underwood said a physician-led coding system gives that work “unmatched scale, expertise and legitimacy.”
  • “The set’s key clinical change, released in August, is a maternity coding overhaul that retires the decades-old global maternity bundle in favor of separate reporting across antepartum, labor, delivery and postpartum care.”

• MedTech Dive offers “5 takeaways from Oura’s IPO filing.”
  • The wearables firm’s sales are growing, and it is adding more paid members, but questions loom about whether the company will need to approach future features as a medical device.
• and tells us,
  • “Labcorp said Tuesday it has acquired MLM Medical Labs to add global central laboratory and biomarker capabilities for clinical trials.
  • “MLM is a global central and specialty laboratory provider with operations in the U.S., Germany and South Africa. 
  • “The deal makes Labcorp the only central laboratory provider with a wholly owned lab network across four continents, the acquiring company said. Neither party disclosed the financial terms of the deal.”