Publications
2025
BACKGROUND: High and rising prescription drug costs for asthma and chronic obstructive pulmonary disease (COPD) contribute to medication nonadherence and poor clinical outcomes. The recently enacted Inflation Reduction Act includes provisions that will cap out-of-pocket prescription drug spending at $2,000 per year and expand low-income subsidies. However, little is known about how these provisions will impact out-of-pocket drug spending for Medicare beneficiaries with asthma and COPD.
OBJECTIVE: To estimate the impact of the Inflation Reduction Act's out-of-pocket spending cap and expansion of low-income subsidies on Medicare beneficiaries with obstructive lung disease.
DESIGN: We calculated the number of Medicare beneficiaries ≥ 65 years with asthma and/or COPD and out-of-pocket prescription drug spending > $2,000/year, and then estimated their median annual out-of-pocket savings under the Inflation Reduction Act's spending cap. We then estimated the number of beneficiaries with incomes > 135% and ≤ 150% of the federal poverty level who would become newly eligible for low-income subsidies under this policy.
PARTICIPANTS: Respondents to the 2016-2019 Medical Expenditure Panel Survey (MEPS).
MAIN MEASURES: Annual out-of-pocket prescription drug spending.
KEY RESULTS: An annual estimated 5.2 million Medicare beneficiaries had asthma and/or COPD. Among them, 360,160 (SE ± 38,021) experienced out-of-pocket drug spending > $2,000/year, with median out-of-pocket costs of $3,003/year (IQR $2,360-$3,941). Therefore, median savings under the Inflation Reduction Act's spending cap would be $1,003/year (IQR $360-$1,941), including $738/year and $1,137/year for beneficiaries with asthma and COPD, respectively. Total annual estimated savings would be $504 million (SE ± $42 M). In addition, 232,155 (SE ± 4,624) beneficiaries would newly qualify for low-income subsidies, which will further reduce prescription drug costs.
CONCLUSIONS: The Inflation Reduction Act will have major implications on out-of-pocket prescription drug spending for Medicare beneficiaries with obstructive lung disease resulting in half-a-billion dollars in total out-of-pocket savings per year, which could ultimately have implications on medication adherence and clinical outcomes.
BACKGROUND: Obesity is an established risk factor for venous thromboembolism (VTE). Observational data suggest that glucagon-like peptide 1 receptor agonists (GLP-1RAs) may reduce the risk of VTE. However, the effects of GLP-1RAs on VTE have not been tested in randomized controlled trials (RCTs).
OBJECTIVES: To investigate the impact of GLP-1RAs on VTE risk using data from RCTs.
METHODS: We conducted a systematic review and meta-analysis of placebo-controlled RCTs focusing on GLP-1RA use in patients with type 2 diabetes mellitus (T2DM) or obesity. Five databases were searched from inception to October 2024. The primary outcome was VTE, which was a composite of pulmonary embolism (PE), deep vein thrombosis (DVT), and VTE at other sites, and the secondary outcomes were the individual events.
RESULTS: Twenty-seven RCTs with 84,003 patients were analyzed. The median incidence of VTE was 1.1 and 2.5 per 1,000 patient-years in the GLP-1RA and placebo groups, respectively. There was no statistically significant difference in overall VTE risk between GLP-1RA and placebo groups (RR 0.70, 95% CI 0.46-1.07). However, GLP-1RAs were associated with a significantly lower risk of PE (RR 0.60, 95% CI 0.39-0.94). In contrast, there were no significant differences in the risk of DVT (RR 1.24, 95% CI 0.67-2.27) or VTE at other sites (RR 0.56, 95% CI 0.25-1.26).
CONCLUSIONS: In this meta-analysis of randomized trials, GLP-1RAs were not associated with a significant reduction in overall VTE risk but were associated with a lower risk of PE among patients with T2DM or obesity.
BACKGROUND: Although Medicare Advantage (MA) plans provide coverage to >50% of Medicare beneficiaries, it is unclear whether MA claims can be used similarly to Medicare Fee-For-Service (FFS) claims for clinical outcomes assessment. In this study, we evaluate the accuracy of claims algorithms previously validated in FFS to assess comorbidities and outcomes in MA patients after aortic valve replacement.
METHODS: We compared the concordance of 11 claims-based covariates (diabetes, hypertension, atrial flutter/fibrillation, myocardial infarction) and outcomes (stroke, disabling stroke, transient ischemic attack, major vascular complication, bleeding, permanent pacemaker implantation, death) among FFS and MA patients with the covariates and adjudicated outcomes in the multinational Evolut Low-Risk Trial (2016-2018). We used claims algorithms for 1-year outcomes and calculated sensitivity, specificity, positive predictive value, negative predictive value, and kappa, using adjudicated outcomes as the reference. We compared the kappa for MA versus FFS using the 2-sample z-test with a significance level of P<0.05.
RESULTS: Among 1139 US patients aged 65+ years old in the Evolut Low-Risk Trial, 782 patients (175 MA and 607 FFS) were linked to claims data and had complete comorbidity data. Among all covariates, claims algorithms for covariates had sensitivities ≥85% for identifying diabetes, atrial flutter/fibrillation, and hypertension in MA and FFS. For the outcomes, sensitivities were ≥85% for bleeding (comprehensive), permanent pacemaker implantation, and death. The kappa was higher in MA versus FFS for diabetes (P=0.03) and hypertension (P=0.025) but was lower in myocardial infarction (P<0.0001). There was no statistically significant difference in the kappa agreement between MA versus FFS for any of the selected outcomes.
CONCLUSIONS: Medicare claims have a similar level of kappa agreement in MA versus FFS for most covariates and outcomes. As patients shift to MA, ascertainment of outcomes using Medicare claims in postapproval studies remains valid for select outcomes.
IMPORTANCE: Although Medicare provides nearly universal health insurance coverage for individuals aged 65 years or older, clinicians and policymakers have expressed concern about access to and coverage of mental health services in the program. It is unclear how transitioning to Medicare affects adults with psychological distress, who may be particularly vulnerable to changes in mental health services.
OBJECTIVES: To examine the association of Medicare eligibility with use of mental health care, general health care, and acute care services among adults with psychological distress.
DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study using the 2009-2019 Medical Expenditure Panel Survey and a regression discontinuity design, health care use among adults aged 59 to 64 years and those aged 66 to 71 years with psychological distress, defined as those who scored 3 or higher on the 2-item Patient Health Questionnaire or 13 or higher on the 6-item Kessler Psychological Distress Scale, was evaluated. Data were analyzed from March 2023 to February 2025.
EXPOSURES: Medicare eligibility at age 65 years.
MAIN OUTCOMES: Mental health care use, including outpatient mental heath visits and psychotropic medication fills, general health care use, and acute care use.
RESULTS: The study population included 3970 adults with psychological distress (mean [SD] age, 64.0 [3.6] years; 59.7% [n = 2370] female). Medicare eligibility at age 65 years was associated with a decrease in outpatient mental health visits with any health care professional (adjusted change of -3.4 percentage points [95% CI, -5.4 to -1.4 percentage points]), no change in mental health visits with psychiatrists (-0.7 percentage points [95% CI, -4.1 to 2.6 percentage points]), and a decrease in psychotropic medication fills (-5.3 percentage points [95% CI, -10.3 to -0.3 percentage points]) among adults with psychological distress. There was no change in general health care use, including all outpatient visits (0.6 percentage points [95% CI, -5.4 to 6.5 percentage points]) and prescription drug use (0.1 percentage points [95% CI, -2.2 to 2.5 percentage points]). In contrast, Medicare eligibility was associated with increases in acute care use, such as inpatient admissions (5.5 percentage points [95% CI, 2.2-8.9 percentage points]) and emergency department visits (8.1 percentage points [95% CI, 3.3-13.0 percentage points]) among adults with psychological distress.
CONCLUSIONS AND RELEVANCE: These findings suggest that Medicare eligibility at age 65 years was associated with decreased use of mental health outpatient services and increased acute care use among adults with psychological distress. These findings highlight the need for policies that address gaps in mental health care in the Medicare program.
Although cardiovascular death rates vary markedly across US states, little is known about whether state-based inequities in the burden of cardiometabolic and lifestyle risk factors have changed over the past decade. We conducted a serial cross-sectional analysis of US adults using the Behavioral Risk Factor Surveillance System (BRFSS) survey, to evaluate changes in the age- and sex-adjusted prevalence of cardiometabolic risk factors (diabetes, hypertension, hyperlipidemia, and obesity) and lifestyle risk factors (binge alcohol drinking, physical inactivity, and cigarette smoking) across US states from 2011 to 2021. The study population included 945,160 adults in 2011 and 2021. The age- and sex-adjusted prevalence of diabetes (10.9% [95% CI, 10.7%, 11.0%] to 12.4% [12.2%, 12.6%]), hypertension (32.4% [32.1%, 32.7%] to 33.7% [33.4%, 34.0%]), and obesity (27.5% [27.2%, 27.7%] to 33.1% [32.8%, 33.5%]) increased from 2011 to 2021, while hyperlipidemia decreased (38.5% [38.2%, 38.8%] to 35.5% [35.2%, 35.9%]). State-based inequities in the prevalence of diabetes, hypertension, and obesity widened over this period. Across lifestyle factors, the prevalence of binge alcohol use (18.3% [18.0%, 18.5%] to 15.4% [15.2%, 15.7%]), physical inactivity (25.7% [25.4%, 27.4%] to 24.0% [23.6%, 23.7%]), and cigarette smoking (20.1% [19.8%, 20.3%] to 13.4% [13.2%, 13.7%]) decreased, while state-based inequities across these factors generally narrowed. In conclusion, the prevalence of hypertension, diabetes mellitus, and obesity increased among US adults from 2011 to 2021 while state-based inequities in the prevalence of these risk factors widened. In contrast, binge alcohol drinking, physical inactivity, and cigarette smoking all declined. Our findings suggest an urgent need for targeted strategies to address widening state-based inequities in cardiometabolic risk factors.
BACKGROUND: Microplastics are emerging as environmental pollutants with potential neurotoxic effects, yet their association with neurological disabilities remains largely unexplored.
METHODS: In this cross-sectional study comprising 218 coastal counties in the United States, we compared the self-reported prevalence of cognitive disability, mobility disability, self-care disability, and independent living disability in counties with very high and low marine microplastic levels (MMLs). Unadjusted and adjusted prevalence ratios (PRs) were computed using population-weighted quasi-Poisson regression across three different models to examine the relationship between disability prevalence and MMLs.
RESULTS: Counties exposed to very high marine microplastic levels had a higher mean prevalence of self-reported cognitive disability (15.2% vs. 13.9%), mobility disability (14.1% vs. 12.3%), self-care disability (4.2% vs. 3.6%), and independent living disability (8.5% vs. 7.7%) compared to those exposed to low levels (p < 0.001). Regression analyses revealed significantly elevated adjusted prevalence ratios (PRs) for cognitive (PR: 1.09 [95% CI: 1.06-1.12], p < 0.001), mobility (PR: 1.06 [1.03-1.10], p < 0.001), self-care (PR: 1.16 [1.11-1.20], p < 0.001), and independent living disability (PR: 1.08 [1.05-1.12], p < 0.001) in counties with very high microplastic exposure compared to those with low exposure.
CONCLUSIONS: This study highlights a significant association between marine microplastic pollution and the self-reported prevalence of cognitive, mobility, self-care, and independent living disabilities at the county level. While merely associative, these findings emphasize the urgent need for further investigation into the individual-level health impacts of microplastic exposure and underscore the importance of environmental interventions to mitigate potential risks.
IMPORTANCE: Improving cardiovascular health in rural areas is a national priority in the US. However, little is known about the current state of rural cardiovascular health and the underlying drivers of any rural-urban disparities.
OBJECTIVE: To compare rates of cardiometabolic risk factors and cardiovascular diseases between rural and urban US adults and to evaluate the extent to which health care access, lifestyle factors, and social risk factors contribute to any rural-urban differences.
DESIGN, SETTING, AND PARTICIPANTS: This nationally representative cross-sectional study analyzed data from US adults aged 20 years or older residing in rural vs urban areas using the 2022 National Health Interview Survey. Data were analyzed between August 2024 and February 2025.
EXPOSURE: County-level rurality.
MAIN OUTCOMES AND MEASURES: The primary outcomes were age-standardized rates of cardiometabolic risk factors (hypertension, hyperlipidemia, obesity, and diabetes) and cardiovascular diseases (coronary heart disease [CHD] and stroke).
RESULTS: The study population consisted of 27 172 adults, including 4256 adults (14.0%) residing in rural areas, 14 741 (54.8%) in small or medium metropolitan areas, and 8175 (31.2%) in urban areas. Mean (SD) participant age was 49.1 (17.8) years, and 4399 participants (50.8%) were female. Compared with their urban counterparts, rural adults were more likely to smoke, be insufficiently physically active, and have more social risk factors. Age-standardized rates of cardiometabolic risk factors were significantly higher in rural areas, including hypertension (37.1% vs 30.9%; rate ratio [RR], 1.20; 95% CI, 1.13-1.27), hyperlipidemia (29.3% vs 26.7%; RR, 1.10; 95% CI, 1.03-1.18), obesity (41.1% vs 30.0%; RR, 1.37; 95% CI, 1.27-1.47), and diabetes (11.2% vs 9.8%; RR, 1.15; 95% CI, 1.02-1.29). The same pattern was observed for CHD (6.7% vs 4.3%; RR, 1.58; 95% CI, 1.35-1.85), but no differences were observed for stroke. The magnitude of rural-urban disparities was largest among young adults (aged 20-39 years) for hypertension (RR, 1.44; 95% CI, 1.12-1.86), obesity (RR, 1.54; 95% CI, 1.34-1.77), and diabetes (RR, 2.59; 95% CI, 1.54-4.38). Rural-urban disparities in cardiovascular health were not meaningfully attenuated after adjustment for measures of health care access (insurance coverage, usual source of care, and recent health care utilization) and lifestyle factors (smoking and physical activity). However, accounting for social risk factors (poverty, education level, food insecurity, and home ownership) completely attenuated rural-urban disparities in hypertension (adjusted RR [aRR], 0.99; 95% CI, 0.93-1.06), diabetes (aRR, 1.02; 95% CI, 0.90-1.15), and CHD (aRR, 1.08; 95% CI, 0.91-1.29), but only partially attenuated disparities in obesity (aRR, 1.29; 95% CI, 1.20-1.39).
CONCLUSIONS AND RELEVANCE: This national cross-sectional study found substantial rural-urban disparities in cardiometabolic risk factors and cardiovascular diseases, which were largest among younger adults and almost entirely explained by social risk factors. These findings suggest that efforts to improve socioeconomic conditions in rural communities may be critical to address the rural-urban gap in cardiovascular health.