STAT+: CMS signals intent to revamp how it pays for clinical software and AI

For years, Medicare has been wrestling with how to pay for artificial intelligence and other software-based clinical tools. The Centers for Medicare and Medicaid Services is good at calculating the costs of physical items, from a cotton swab to the wear and tear on a CT scanner. But an algorithm to predict cardiac risk from a CT scan, or an AI-based map to visualize prostate cancer’s spread? Less so.

This month, in its proposed rules for hospital outpatient payments and physician fees for 2027, CMS has signaled that it’s ready to build a more consistent payment structure for clinical software and AI that factors in their impact on patient outcomes. It’s starting — as an interim step, just for 2027 — by proposing a practical change to the way it labels and pays for several clinical software and AI services. 

After requesting feedback several times on AI and software payment structures, “it’s really the first time that we’ve heard the agency say that they are planning a different policy moving forward,” said Cybil Roehrenbeck, executive director of industry group the AI Healthcare Coalition. Medicare payment — and its influence on private insurers’ coverage of emerging technologies — has a significant impact on what clinical software and AI gets commercialized and reaches patients.

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Increased Levels of Micro- and Nanoplastics Found in the Blood of Heart Attack Patients

The results of a newly reported study have shown that people who suffered a serious heart attack had higher levels of micro- and nanoplastics (MNPs) in their blood, compared with MNP levels in patients diagnosed with chronic ischemic heart disease and those who have normal blood vessels supplying the heart. The study findings also revealed that people who smoke and people exposed to higher levels of air pollution had higher levels of micro- and nanoplastics in their blood.

Headed by teams at Sapienza University of Rome, at the University of Verona, and at the Research Centre on Environmental Pollution and Cardiovascular Diseases at the University of Campania “Luigi Vanvitelli,” the study included 61 patients at Sant’Andrea University Hospital or Azienda Ospedaliera Universitaria Integrata of Verona, diagnosed with either a heart attack, chronic ischemic heart disease, or normal coronary arteries.

The researchers say their study adds to growing evidence that environmental pollution may affect cardiovascular health. Research lead Emanuele Barbato, MD, PhD, at Sapienza University of Rome, said, “These findings do not prove that microplastics cause heart attacks, but they reveal a strong association between environmental exposures, microplastics in the blood and cardiovascular disease. In our study, smoking history was strongly linked to microplastics in the blood. Our findings suggest that smoking might make it easier for micro and nanoplastics to enter the blood stream via the lungs. Air pollution may act in a similar way.”

Barbato is director of the Cardiology Unit of Sant’Andrea University Hospital, Rome, Italy, and senior author of the team’s published paper in European Heart Journal, titled “Micro- and nano-plastics in the coronary circulation and air pollution exposure in ischemic heart disease presentation.”

Cardiovascular diseases are increasingly related to lifelong environmental exposures, the authors noted. Among such exposures, MNPs are ubiquitous environmental pollutants, and evidence is increasing that they accumulate in human tissues following exposure and are emerging as a risk factor for health. Pasquale Paolisso, MD, PhD, at Sant’Andrea Hospital Sapienza University of Rome, said, “Micro and nanoplastics are tiny plastic particles that are found virtually everywhere in the environment, including the air we breathe, the water we drink, and many foods we consume. In recent years, scientists have begun to detect these particles in human tissues and organs, raising concerns about their potential health effects.”

Research findings have raised concerns about the potential role that MNPs may play in cardiovascular diseases. “Emerging evidence indicates that MNPs, once considered inert contaminants, are biologically active pollutants contributing to the pathophysiology of cardiovascular diseases, particularly by promoting the development and progression of atherosclerotic plaques and potentially triggering adverse cardiovascular events,” the team stated.

However, as Paolisso further noted, “… very little was known about whether these particles are present in the coronary circulation—the blood flowing through the arteries that supply the heart—or whether environmental exposures such as smoking and air pollution might influence their presence.” As the authors explained, “… current knowledge is predominantly based on in vitro experiments and preliminary ex vivo findings, highlighting the need for in vivo and clinical investigations.”

For their newly reported study the team measured MNPs in coronary and peripheral blood, in 61 patients at Sant’Andrea University Hospital or Azienda Ospedaliera Universitaria Integrata of Verona, who were undergoing coronary angiography for suspected coronary artery disease (CAD). Patients were stratified as those with ST-segment elevation myocardial infarction (STEMI), chronic coronary syndromes (CCS) and controls with normal coronary arteries.

As well as taking blood samples from the vessels supplying the heart and from elsewhere in the body, the team collected data on whether the patients were smokers and their exposure to pollution, both on the day of testing and over the preceding two years. Coronary micro and nanoplastics were analyzed at the Research Centre for Environmental Pollution and Cardiovascular Diseases, University of Campania ‘Luigi Vanvitelli,’ a center dedicated to understanding how environmental pollutants influence cardiovascular health.

The results showed that micro and nanoplastics were detected in 84% of patients diagnosed with heart attack, compared with 40% of patients with chronic ischemic heart disease and 32% of patients with normal coronary arteries. “The observation that IL-6 and TNF-α concentrations were highest in STEMI patients, particularly within the coronary circulation, and were more elevated in the presence of detectable MNPs supports an exploratory association between MNP burden and a localized pro-inflammatory milieu in patients with obstructive CAD,” the investigators suggested.

Heart attack patients also had a greater variety of plastic types in their blood. The most common type of plastic was polyethylene (PE), which is commonly used in packaging and consumer products. “Across all study cohorts, PE was the most frequently identified polymer, being present in 97% of the patients with detectable MNPs,” the investigators added.

Patients exposed to higher long-term levels of air pollution (PM2.5; particles measuring 2.5 μm or less in diameter) were more likely to have microplastics in their blood, and smokers were six times more likely to have microplastics in their blood. All patients who were smokers and were exposed to higher air pollution levels had plastics in their blood, compared with only 12.5% of patients who did not smoke and were not exposed to higher levels of air pollution. “MNPs, PM2.5, and smoking constitute potentially modifiable environmental risk factors for cardiovascular diseases, with significant implications for public health and cardiovascular disease prevention,” the scientists stated. “Future research should aim to quantify individual MNP exposure, assess combined pollutant burden, and validate interventions that target this expanded network of environmental cardiovascular hazards.”

Barbato added, “The results highlight the need to consider microplastic pollution as part of the broader environmental determinants of health. Policies that reduce air pollution, tobacco exposure, and environmental plastic contamination could have benefits that extend beyond environmental protection and potentially improve cardiovascular health.”

In an accompanying editorial Andreas Daiber, PhD, at University Medical Centre of the Johannes Gutenberg University, Mainz, and colleagues pointed to the observation by Paolisso et al. of an association between NMP levels and exposure to air pollution and tobacco smoking. “While the underlying mechanisms remain unclear, this finding underscores a key principle: environmental exposures rarely occur in isolation,” Daiber and colleagues stated. “Individuals are exposed to multiple environmental stressors simultaneously, including air pollution, noise, chemical contaminants, plastics, and climate-related stressors, especially in the urban setting. These exposures may interact through shared biological pathways, leading to additive or synergistic effects on cardiovascular risk.”

And while substantial uncertainties remain, “the convergence of epidemiological, clinical, and mechanistic evidence suggests that plastic pollution may represent a previously underestimated cardiovascular risk factor,” Daiber et al. continued. “Addressing this challenge will require coordinated efforts across disciplines and policy domains. In the era of the Anthropocene, protecting cardiovascular health will increasingly depend on reducing not only traditional risk factors but also the growing burden of environmental pollutants (the detrimental part of the exposome), among which plastics may soon play a central role.”

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Real-Time, Objective Assessment of Facial Paralysis Using a Mobile Tool (FaceADE): Feasibility Case-Control Study

<strong>Background:</strong> Patients with facial paralysis require detailed clinical assessment and long-term follow-up to monitor facial function. The current standard of care for evaluating facial symmetry and movement uses validated clinician scoring tools such as the House-Brackmann facial paralysis score or the Electronic Clinician-Graded Facial Function Scale (eFACE). Existing tools are difficult to use in normal clinic workflows and do not provide real-time facial movement tracking, representing an unmet need. Therefore, we developed FaceADE, a novel iOS app leveraging native 3D image acquisition capabilities on the iPhone to rapidly quantify facial movement in patients with facial paralysis. <strong>Objective:</strong> This study aimed to benchmark FaceADE against 2D image analysis and establish the feasibility of measuring oral commissure movement in patients with facial paralysis and healthy controls. <strong>Methods:</strong> Patients were enrolled in a tertiary care clinic focused on facial paralysis treatment. Patients underwent image capture using the FaceADE app assisted by study team personnel. Measurements of lip commissure position and movement were obtained from 20 patients with facial paralysis and 10 healthy volunteers without facial paralysis. Measurements of lip movement and symmetry gathered from FaceADE were benchmarked against 2D measurements using open-source image analysis software (ImageJ). <strong>Results:</strong> FaceADE measurements of lip commissure position and movement showed strong agreement with 2D measurements in both healthy volunteer and facial paralysis cohorts. The intraclass correlation coefficient was 0.96 (95% CI 0.90-0.98; <i>P</i>&lt;.001) in the healthy volunteer cohort and 0.82 (95% CI 0.72-0.88; <i>P</i>&lt;.001) in the facial paralysis cohort. Bland-Altman analysis found strong agreement between the 2 methods for these measurements. The 95% CI contained 97.5% (39/40) of data points in the healthy cohort and 91.2% (73/80) of data points in the facial paralysis cohort. <strong>Conclusions:</strong> Our proposed mobile method of measuring clinically important lip commissure position and movement is feasible for use at the time of care delivery. In the future, this technology may be useful for a quantitative assessment of facial paralysis severity.

STAT+: Hospital chain HCA warns of lower profits as more patients go uninsured

The country’s biggest hospital chain lowered its 2026 profit outlook on Tuesday after treating more uninsured patients than expected in the second quarter. 

Many of those uninsured patients had dropped their Affordable Care Act plans after losing enhanced subsidies, HCA Healthcare said, an early indicator of the fallout from the expiration of ACA enhanced premium tax credits in January. 

All in, HCA now expects the increase in uninsured patients stemming from the end of those subsidies to lower its income by between $1 billion and $1.2 billion this year, up from an earlier projection of a $600 million to $900 million hit. 

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Perception and willingness toward second-generation long-acting antipsychotics among patients with schizophrenia: a cross-sectional survey in Fujian, China

ObjectiveTo assess perceptions and willingness toward second-generation antipsychotic long-acting injectables (SGA-LAIs) among patients with schizophrenia, to identify the influencing factors, and to provide evidence for optimizing clinical implementation strategies.MethodsA cross-sectional survey was conducted in which patients with schizophrenia who attended outpatient follow-up visits at a tertiary psychiatric hospital were recruited via convenience sampling. A validated, expert-reviewed questionnaire was administered. Data were analyzed using descriptive statistics and chi-square tests, with binary logistic regression models employed to explore the determinants of patients’ willingness to accept SGA-LAIs.ResultsThe sample characteristics included 126 males (55.5%), 114 patients (50.2%) aged 31–50 years, 140 patients (61.7%) with an illness course exceeding 5 years, and 126 patients (55.5%) with experience with SGA-LAIs. Overall, 155 participants (68.3%) expressed positive willingness to use SGA-LAIs, whereas 72 participants (31.7%) expressed negative willingness. Univariate analysis revealed significant differences between the willingness-positive and willingness-negative groups in terms of disease course (χ² = 12.314, P = 0.006) and prior SGA-LAI experience (χ² = 55.525, P < 0.001). Binary logistic regression analysis revealed that patients with prior SGA-LAI experience (OR = 11.11, 95% CI: 5.41~23.26, P < 0.001), a disease course of 5–10 years (OR = 2.898, 95% CI: 1.134-7.407, P = 0.026), and a disease course of > 10 years (OR = 3.282, 95% CI: 1.300-8.288, P = 0.012) demonstrated significantly greater willingness to accept SGA-LAIs. Among the willingness-positive group, the most endorsed advantages of SGA-LAIs were “avoiding daily medication” (80.7%) and “increased effectiveness” (68.4%), and the primary concern was “injection pain” (56.8%). In the willingness-negative group, the predominant reasons for refusal were “rejection of needles” (93.1%) and “rejection of changing therapeutic regimens” (79.2%).ConclusionThe overall acceptance of and willingness to use SGA-LAIs among patients with schizophrenia followed up in psychiatric hospitals are high. Experience with SGA-LAIs and disease course were identified as independent factors influencing patients’ willingness to use SGA-LAIs. In clinical practice, patient acceptance can be enhanced by strengthening doctor-patient communication, prioritizing medication education for patients with a long disease course, and improving patients’ initial experience with SGA-LAIs, thereby supporting broader clinical adoption of SGA-LAIs.

Cellares and Sonoma Biotherapeutics Agree to Automate Engineered Treg Cell Therapy Manufacturing

Officials at Cellares and Sonoma Biotherapeutics say their companies will automate the manufacturing of SBT-77-7101, an engineered regulatory T cell (Treg) therapy for autoimmune and inflammatory diseases. The product is in Phase I clinical development for poly-refractory rheumatoid arthritis (RA) in patients who have exhausted all available treatment options.

Cellares plans to translate SonomaBio’s SBT-77-7101 manufacturing process onto its Cell Shuttle and automate in-process and release testing through the Cell Q™ quality control system. The company operates its first commercial-scale Smart Factory in Bridgewater, NJ, with additional facilities under construction in Europe and Japan.

“Tregs are uniquely sensitive to the manufacturing process. Cellares brings the Cell Shuttle platform, and global infrastructure to help us deliver on our clinical ambitions at scale for the hardest-to-treat RA patients.” said Stephen Dilly, PhD, president, CEO, and board chair of Sonoma Biotherapeutics.

“Every new cell therapy modality we bring to the Cell Shuttle and Cell Q expands what is possible for the field and for patients in need,” added Fabian Gerlinghaus, co-founder and CEO of Cellares. “Tregs are among the most technically demanding cell types to manufacture reliably. We are honored to partner with SonomaBio and demonstrate that our platform can directly translate to Tregs.

“SonomaBio has developed one of the most advanced Treg programs in the clinic, and we look forward to contributing to their clinical success as they bring this groundbreaking therapy to patients.”

 

 

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