Inmaculada Hernandez

Background: Residents of western US states face elevated fine particulate matter (PM _2.5 ) exposure from increasingly frequent and intense wildfires, raising concerns about cardiovascular risk. Whether short‐term PM _2.5 exposure increases odds of hospitalization or emergency care in patients with established atrial fibrillation (AF) remains unclear. Methods: Using 2021 Medicare data, we identified patients with established AF residing in western US states. Zip code–level daily PM _2.5 was estimated using a 1 km ² geospatial model; high PM _2.5 was defined as ≥9.0 μg/m ³ . Odds ratios (ORs) for all‐cause and cardiovascular disease hospitalization and emergency department visits were estimated using conditional logistic regression at lag 0, 1, and 3 days, adjusting for extreme heat and public holidays. Results: The final cohort included 26 158 patients (mean age 79 ± 9.0 years) with established AF. Exposure to high levels of PM _2.5 was associated with 10% (95% CI, 1%–20%) increased odds of hospitalizations for cardiovascular disease. Specifically, high PM _2.5 was associated with 24% (95% CI, 3%–48%) increased odds of hospitalization and 34% (95% CI, 6%–70%) higher odds of emergency department visits for all AF‐related diagnoses. We did not observe significant interaction effects between PM _2.5 and extreme heat on the risk of hospitalization or emergency department visits for cardiovascular disease or AF. Conclusion: On days with elevated PM _2.5 levels, patients with AF were associated with higher odds of AF‐related or cardiovascular hospitalizations and emergency department visits, highlighting the need for targeted prevention strategies to protect vulnerable populations from the adverse effects of air pollution.

Background: Heart failure (HF) readmission rates vary across geographic regions in the United States, yet the impact of external exposome factors, such as contextual-level social determinants of health (SDoH), on adverse HF outcomes is not well understood. Objective: This study aims to examine the association between external exposome factors and the risk of HF readmission and all-cause mortality using a data-driven approach. Methods: We conducted a retrospective cohort study using electronic health record (EHR) data from the OneFlorida+ Network, including patients hospitalized for HF (HHF) from 2016 to 2022. A total of 1308 external exposome factors, covering a wide range of SDoH (eg, economic stability, education, health care access, natural and built environments, and social context), were linked to patients’ EHR data based on their county-level residential location. Patients were followed for 1 year after their first HHF to capture readmission and mortality events. We applied the least absolute shrinkage and selection operator regularization to preselect candidate variables, followed by a 2-phase external exposome-wide association study using mixed-effects logistic regression to identify key factors associated with the composite outcome of 1-year HF readmission and mortality. Results: Among 63,940 patients with HF (n=30,475, 48% women; mean age 65, SD 14 years), higher maximum temperature in May was significantly associated with increased risk of the composite outcome (adjusted odds ratio [aOR] 1.04, 95% CI 1.02-1.06; P<.001). Subgroup analyses showed consistent associations across age, sex, race, socioeconomic status, and rural or urban strata. Conclusions: Using a data-driven approach, we found that elevated maximum temperature in May (late spring) was significantly associated with HF readmission and mortality in Florida. Further investigations are warranted to uncover the intricate mechanisms through which extreme heat potentially influences HF outcomes.

This cross-sectional study evaluates whether certain pharmacy benefit manager practices result in increased out-of-pocket costs for Medicare Part D beneficiaries.

Aims To characterize trends in the initiation of newer anti-obesity medications (AOMs) and determine factors associated with their use among obese/overweight populations. Materials and methods This retrospective study utilized electronic health record data from OneFlorida+ (2015–2024). Adults eligible for AOMs were included, defined as having a BMI ≥30 kg/m² or a BMI of 27–29.9 kg/m² with at least one obesity-related comorbidity. The primary outcome was the initiation of newer AOMs, specifically glucagon-like peptide-1 receptor agonists (GLP-1 RAs) including liraglutide, semaglutide, and tirzepatide. Trends across years were examined, and a multivariable logistic regression identified sociodemographic, clinical, and healthcare utilization factors associated with AOM initiation. Results Of 319,949 adults, 1.8% initiated newer AOMs. Semaglutide accounted for 77.9% of initiations, tirzepatide 19.7%, and liraglutide 17.8%. Initiation trends showed liraglutide uptake peaked at 5% in 2018 but declined afterward, while semaglutide and tirzepatide uptake increased exponentially since 2022. Odds of initiation were lower for Black (aOR (95% CI): 0.87 [0.80– 0.94]) and Hispanic (0.84 [0.78–0.91]) groups vs. Whites, and for Medicaid (0.69 [0.63–0.76]) and uninsured (0.81 [0.74–0.87]) patients vs. privately insured. Higher odds were associated with being female, middle-aged, having more outpatient visits, and visiting endocrinologists. Conclusions The initiation of newer AOMs among overweight and obese populations remains low, but uptake has increased exponentially since 2022. Our findings reveal significant disparities in obesity care, highlighting the importance of addressing inequities in AOM access to improve obesity outcomes.

The Centers for Medicare and Medicaid Services (CMS) recently announced the Maximum Fair Price for the first 10 Medicare Part D drugs selected for price negotiation. By February 2025, CMS should announce the list of Part D drugs to be negotiated with implementation of the negotiated prices in 2027. To identify up to 15 Medicare Part D single-source drugs anticipated to be selected by CMS for price negotiation in 2025. We followed selection criteria identified in the Inflation Reduction Act and CMS guidance to identify drugs. We projected 2023 Part D gross spending using 2020-2022 data reported by CMS and linear prediction models. We ranked products according to the projected spending figure and identified those not eligible for selection because of (1) number of years since approval, (2) availability of a biosimilar or generic version, (3) approval for a single orphan indication, (4) whole human blood or plasma-derived, or (5) eligibility for the small biotech exception. We identified 13 products likely subject to Medicare drug price negotiation, including 4 anticancer therapies, 3 noninsulin antidiabetic products, 2 inhalers, 1 antifibrotic therapy, 1 gastrointestinal agent, 1 enzyme replacement therapy, and 1 product indicated for dyskinesia. These 13 products each had projected annual gross Part D spending more than $1 billion. We identified 7 additional products with uncertainty to complete the list of 15, including an insulin, an antiviral, an antibiotic, an immunologic agent, an antidiabetic, and 2 cancer drugs. These products had projected gross Part D spending between $877 million and $1.399 billion. Twenty-two products with comparable levels of spending were deemed ineligible for selection because of availability of a generic or biosimilar version (10 products), insufficient years since approval (8 products), eligibility for the small biotech exception (3 products), and expected market discontinuation (1 product). Our identification of products anticipated to be selected for negotiation in 2025 (with implementation of negotiated prices in 2027) will help inform manufacturers, payers, patients, and policymakers of the products that will likely see a decrease in Medicare drug prices as result of negotiation. We identified 22 products with levels of spending that are comparable with those anticipated to be selected for negotiation but are not eligible, primarily because of generic or biosimilar availability or insufficient time on market.

BACKGROUND: Antihypertensive medication use patterns have likely been influenced by changing costs and accessibility over the past 3 decades. This study examines the relationships between patent exclusivity loss, medication costs, and national health policies on antihypertensive medication use. METHODS: Using 1996 to 2021 Medical Expenditure Panel Survey data of US adults with hypertension taking at least 1 antihypertensive medication, we conducted a cross-sectional analysis. We explored the associations between patent exclusivity loss, per-pill costs, and Medicare Part D enactment on medication use over time, focusing on the most commonly used medications (lisinopril, amlodipine, losartan, hydrochlorothiazide, and metoprolol). RESULTS: The unweighted sample comprised 50 095 US adults (mean age, 62 years; 53% female). The survey-weighted number of adults taking antihypertensive medications increased from 22 million (95% CIs, 20–23 million) to 55 million (95% CI, 51–60 million) between 1996 and 2021. Loss of patent exclusivity led to increased medication fills, notably for lisinopril, amlodipine, and losartan, which all exhibited within-class dominance. However, per-pill cost decreases coinciding with Medicare Part D did not increase the number of individuals treated or the use of specific antihypertensive medications or classes. CONCLUSIONS: The increase in antihypertensive medication use over the past decades highlights the significant impact of loss of patent exclusivity on the uptake in the use of specific medications. These findings underscore the complexity of factors influencing medication use, beyond cost reductions alone, and suggest that policies need to consider multiple facets to effectively improve antihypertensive medication accessibility and utilization.

Background Coronavirus disease 2019 (COVID-19) has been associated with an increased risk of stroke. It remains unclear whether the risk of stroke associated with a diagnosis of COVID-19 differed with oral anticoagulation (OAC) use. The aim of this study was to evaluate the association between COVID-19 infection, OAC use, and stroke in patients with atrial fibrillation (AF). Methods A retrospective cohort study was conducted in individuals with established AF using data from Optum’s deidentified Clinformatics^® Data Mart Database. Cox proportional hazard models with time-dependent variables were employed to assess the association between possession of OAC, COVID-19 diagnosis in both inpatient and outpatient setting, and time to ischemic stroke. Results A total of 561,758 individuals aged 77 ± 10 were included in the study, with a mean follow up time of 1.3 years. OAC use was associated with a reduced stroke risk [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.82–0.88]. COVID-19 infection was associated with an increased risk of stroke (HR 2.11, 95% CI 1.87–2.38); this increased risk was particularly pronounced for patients diagnosed with an inpatient diagnosis of COVID-19 (HR 3.95, 95% CI 3.33–4.68). There was no significant interaction between OAC use and COVID-19 diagnosis (p value = 0.96). As a result, the relative increase in stroke risk associated with COVID-19 did not differ between patients on OAC (HR 2.12; 95% CI 1.71–2.62) and those not on OAC (HR 2.11; 95% CI 1.83–2.43). Conclusion In a nationwide sample of patients with established AF, we found the relative increase in stroke risk associated with COVID-19 was independent of OAC use.

The Centers for Medicare and Medicaid Services (CMS) are currently negotiating prices with pharmaceutical manufacturers for the first 10 Part D drugs selected for Medicare drug price negotiation. Non-publicly available data, including the net prices of selected drugs and their therapeutic alternatives, will play a central role in the determination of the maximum fair prices (MFPs). To estimate price benchmarks involved in the derivation of the starting point of the CMS initial price offer for the 10 drugs selected for Medicare price negotiation. For the 10 drugs selected for negotiation, we reported (1) the list price, (2) the net price after manufacturer discounts, (3) the maximum negotiated price based on the minimum statutory discount, and (4) the ceiling of the MFP, estimated as the lowest of the latter 2. We also estimated net prices for therapeutic alternatives to the selected drugs. Net prices were estimated using peer-reviewed methodology that isolates commercial discounts negotiated between payers and manufacturers from mandatory discounts under government programs. All price benchmarks were estimated at the product level, for 30-day equivalent dosing, using 2021 data. 6 products (apixaban, rivaroxaban, empagliflozin, sacubitril/valsartan, etanercept, and insulin aspart) had therapeutic alternatives with lower net prices, which will be integrated with clinical benefit data in the derivation of initial price offers. The other 4 products (ustekinumab, ibrutinib, sitagliptin, and dapagliflozin) had therapeutic alternatives with higher net prices than the drugs selected for negotiation. For ibrutinib and ustekinumab, prices based on the minimum discounts were considerably lower than the estimated net prices and will likely set the starting point of the initial price offer. For dapagliflozin and sitagliptin, the starting point of the initial price offer will likely resemble their existing net prices. Our analyses identify different negotiation scenarios for the first 10 drugs selected for Medicare price negotiation, based on key elements involved in the derivation of the initial price offer. Our analyses can help improve transparency in the negotiation process, because the CMS is not required to reveal the information used in the derivation of price offers.