Publications

BACKGROUND: High out-of-pocket costs can impede access to guideline-directed cardiovascular drugs. The 2022 Inflation Reduction Act (IRA) will eliminate catastrophic coinsurance and cap annual out-of-pocket costs for Medicare Part D patients by 2025.

OBJECTIVES: This study sought to estimate the IRA's impact on out-of-pocket costs for Part D beneficiaries with cardiovascular disease.

METHODS: The investigators chose 4 cardiovascular conditions that frequently require high-cost guideline-recommended drugs: severe hypercholesterolemia; heart failure with reduced ejection fraction (HFrEF); HFrEF with atrial fibrillation (AF); and cardiac transthyretin amyloidosis. This study included 4,137 Part D plans nationwide and compared projected annual out-of-pocket drug costs for each condition in 2022 (baseline), 2023 (rollout), 2024 (5% catastrophic coinsurance eliminated), and 2025 ($2,000 cap on out-of-pocket costs).

RESULTS: In 2022, mean projected annual out-of-pocket costs were $1,629 for severe hypercholesterolemia, $2,758 for HFrEF, $3,259 for HFrEF with AF, and $14,978 for amyloidosis. In 2023, the initial IRA rollout will not significantly change out-of-pocket costs for the 4 conditions. In 2024, elimination of 5% catastrophic coinsurance will lower out-of-pocket costs for the 2 costliest conditions: HFrEF with AF ($2,855, 12% reduction) and amyloidosis ($3,468, 77% reduction). By 2025, the $2,000 cap will lower out-of-pocket costs for all 4 conditions to $1,491 for hypercholesterolemia (8% reduction), $1,954 for HFrEF (29% reduction), $2,000 for HFrEF with AF (39% reduction), and $2,000 for cardiac transthyretin amyloidosis (87% reduction).

CONCLUSIONS: The IRA will reduce Medicare beneficiaries' out-of-pocket drug costs for the selected cardiovascular conditions by 8% to 87%. Future studies should assess the IRA's impact on adherence to guideline-directed cardiovascular therapies and health outcomes.

IMPORTANCE: Black adults with heart failure (HF) disproportionately experience higher population-level mortality than White adults with HF. Whether quality of care for HF differs at hospitals with high proportions of Black patients compared with other hospitals is unknown.

OBJECTIVE: To compare quality and outcomes for patients with HF at hospitals with high proportions of Black patients vs other hospitals.

DESIGN, SETTING, AND PARTICIPANTS: Patients hospitalized for HF at Get With The Guidelines (GWTG) HF sites from January 1, 2016, through December 1, 2019. These data were analyzed from May 2022 through November 2022.

EXPOSURES: Hospitals caring for high proportions of Black patients.

MAIN OUTCOMES AND MEASURES: Quality of HF care based on 14 evidence-based measures, overall defect-free HF care, and 30-day readmissions and mortality in Medicare patients.

RESULTS: This study included 422 483 patients (224 270 male [53.1%] and 284 618 White [67.4%]) with a mean age of 73.0 years. Among 480 hospitals participating in GWTG-HF, 96 were classified as hospitals with high proportions of Black patients. Quality of care was similar between hospitals with high proportions of Black patients compared with other hospitals for 11 of 14 GWTG-HF measures, including use of angiotensin-converting enzyme inhibitors/angiotensin receptor blocker/angiotensin receptor neprilysin inhibitors for left ventricle systolic dysfunction (high-proportion Black hospitals: 92.7% vs other hospitals: 92.4%; adjusted odds ratio [OR], 0.91; 95% CI, 0.65-1.27), evidence-based β-blockers (94.7% vs 93.7%; OR, 1.02; 95% CI, 0.82-1.28), angiotensin receptor neprilysin inhibitors at discharge (14.3% vs 16.8%; OR, 0.74; 95% CI, 0.54-1.02), anticoagulation for atrial fibrillation/flutter (88.8% vs 87.5%; OR, 1.05; 95% CI, 0.76-1.45), and implantable cardioverter-defibrillator counseling/placement/prescription at discharge (70.9% vs 71.0%; OR, 0.75; 95% CI, 0.50-1.13). Patients at high-proportion Black hospitals were less likely to be discharged with a follow-up visit made within 7 days or less (70.4% vs 80.1%; OR, 0.68; 95% CI, 0.53-0.86), receive cardiac resynchronization device placement/prescription (50.6% vs 53.8%; OR, 0.63; 95% CI, 0.42-0.95), or an aldosterone antagonist (50.4% vs 53.5%; OR, 0.69; 95% CI, 0.50-0.97). Overall defect-free HF care was similar between both groups of hospitals (82.6% vs 83.4%; OR, 0.89; 95% CI, 0.67-1.19) and there were no significant within-hospital differences in quality for Black patients vs White patients. Among Medicare beneficiaries, the risk-adjusted hazard ratio (HR) for 30-day readmissions was higher at high-proportion Black vs other hospitals (HR, 1.14; 95% CI, 1.02-1.26), but similar for 30-day mortality (HR 0.92; 95% CI,0.84-1.02).

CONCLUSIONS AND RELEVANCE: Quality of care for HF was similar across 11 of 14 measures at hospitals caring for high proportions of Black patients compared with other hospitals, as was overall defect-free HF care. There were no significant within-hospital differences in quality for Black patients vs White patients.

BACKGROUND: High out-of-pocket prescription drug costs contribute to financial toxicity, medication nonadherence, and adverse cardiovascular (CV) outcomes. Policymakers recently passed the Inflation Reduction Act, which will cap Medicare out-of-pocket drug costs at $2,000/year and expand full low-income subsidies (LIS). It is unclear how these provisions will affect Medicare beneficiaries with CV risk factors and/or conditions.

OBJECTIVES: The authors sought to characterize the population of Medicare beneficiaries with CV risk factors/conditions experiencing out-of-pocket prescription drug costs >$2,000/year and estimate their potential savings under the Inflation Reduction Act's spending cap; identify sociodemographic characteristics associated with out-of-pocket costs >$2,000/year; and characterize beneficiaries newly eligible for LIS under the Inflation Reduction Act.

METHODS: This was a cross-sectional study of Medicare beneficiaries aged ≥65 years with ≥1 CV risk factor/condition from 2016 to 2019.

RESULTS: An annual estimated 34,056,335 ± 855,653 Medicare beneficiaries (mean ± SE) had ≥1 CV risk factor/condition, of whom 1,020,484 ± 77,055 experienced out-of-pocket drug costs >$2,000/year. The likelihood of experiencing out-of-pocket drug costs >$2,000/year was lower among adults ≥75 years vs 65 to 74 years (adjusted OR: 0.67; 95% CI: 0.49-0.93) and for low-income vs higher-income adults. Among beneficiaries currently spending >$2,000/year, estimated median out-of-pocket drug savings would be $855/year and total annual savings $1,723,031,307 ± $91,150,609 under the Inflation Reduction Act. An estimated 1,289,861 beneficiaries would also become newly eligible for LIS.

CONCLUSIONS: More than 1 million older adults with CV risk factors and/or conditions spend >$2,000/year out-of-pocket on prescription drugs and will likely benefit from the Inflation Reduction Act's cap, with estimated total out-of-pocket savings of $1.7 billion/year, while another 1.3 million will also become newly eligible for LIS.

BACKGROUND: Medicare links hospital performance on readmissions and mortality to payment solely on the basis of outcomes among fee-for-service (FFS) beneficiaries. Whether including Medicare Advantage (MA) beneficiaries, who account for nearly half of all Medicare beneficiaries, in the evaluation of hospital performance affects rankings is unknown.

OBJECTIVE: To determine if the inclusion of MA beneficiaries in readmission and mortality measures reclassifies hospital performance rankings compared with current measures.

DESIGN: Cross-sectional.

SETTING: Population-based.

PARTICIPANTS: Hospitals participating in the Hospital Readmissions Reduction Program or Hospital Value-Based Purchasing Program.

MEASUREMENTS: Using the 100% Medicare files for FFS and MA claims, the authors calculated 30-day risk-adjusted readmissions and mortality for acute myocardial infarction, heart failure, chronic obstructive pulmonary disease, and pneumonia on the basis of only FFS beneficiaries and then both FFS and MA beneficiaries. Hospitals were divided into quintiles of performance based on FFS beneficiaries only, and the proportion of hospitals that were reclassified to a different performance group with the inclusion of MA beneficiaries was calculated.

RESULTS: Of the hospitals in the top-performing quintile for readmissions and mortality based on FFS beneficiaries, between 21.6% and 30.2% were reclassified to a lower-performing quintile with the inclusion of MA beneficiaries. Similar proportions of hospitals were reclassified from the bottom performance quintile to a higher one across all measures and conditions. Hospitals with a higher proportion of MA beneficiaries were more likely to improve in performance rankings.

LIMITATION: Hospital performance measurement and risk adjustment differed slightly from those used by Medicare.

CONCLUSION: Approximately 1 in 4 top-performing hospitals is reclassified to a lower performance group when MA beneficiaries are included in the evaluation of hospital readmissions and mortality. These findings suggest that Medicare's current value-based programs provide an incomplete picture of hospital performance.

PRIMARY FUNDING SOURCE: Laura and John Arnold Foundation.

IMPORTANCE: Declines in cardiovascular mortality have stagnated in the US over the past decade, in part related to worsening risk factor control in older adults. Little is known about how the prevalence, treatment, and control of cardiovascular risk factors have changed among young adults aged 20 to 44 years.

OBJECTIVE: To determine if the prevalence of cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, obesity, and tobacco use), treatment rates, and control changed among adults aged 20 to 44 years from 2009 through March 2020, overall and by sex and race and ethnicity.

DESIGN, SETTING, AND PARTICIPANTS: Serial cross-sectional analysis of adults aged 20 to 44 years in the US participating in the National Health and Nutrition Examination Survey (2009-2010 to 2017-March 2020).

MAIN OUTCOMES AND MEASURES: National trends in the prevalence of hypertension, diabetes, hyperlipidemia, obesity, and smoking history; treatment rates for hypertension and diabetes; and blood pressure and glycemic control in those receiving treatment.

RESULTS: Among 12 924 US adults aged 20 to 44 years (mean age, 31.8 years; 50.6% women), the prevalence of hypertension was 9.3% (95% CI, 8.1%-10.5%) in 2009-2010 and 11.5% (95% CI, 9.6%-13.4%) in 2017-2020. The prevalence of diabetes (from 3.0% [95% CI, 2.2%-3.7%] to 4.1% [95% CI, 3.5%-4.7%]) and obesity (from 32.7% [95% CI, 30.1%-35.3%] to 40.9% [95% CI, 37.5%-44.3%]) increased from 2009-2010 to 2017-2020, while the prevalence of hyperlipidemia decreased (from 40.5% [95% CI, 38.6%-42.3%] to 36.1% [95% CI, 33.5%-38.7%]). Black adults had high rates of hypertension across the study period (2009-2010: 16.2% [95% CI, 14.0%-18.4%]; 2017-2020: 20.1% [95% CI, 16.8%-23.3%]), and significant increases in hypertension were observed among Mexican American adults (from 6.5% [95% CI, 5.0%-8.0%] to 9.5% [95% CI, 7.3%-11.7%]) and other Hispanic adults (from 4.4% [95% CI, 2.1%-6.8%] to 10.5% [95% CI, 6.8%-14.3%]), while Mexican American adults had a significant rise in diabetes (from 4.3% [95% CI, 2.3%-6.2%] to 7.5% [95% CI, 5.4%-9.6%]). The percentage of young adults treated for hypertension who achieved blood pressure control did not significantly change (from 65.0% [95% CI, 55.8%-74.2%] in 2009-2010 to 74.8% [95% CI, 67.5%-82.1%] in 2017-2020], while glycemic control among young adults receiving treatment for diabetes remained suboptimal throughout the study period (2009-2010: 45.5% [95% CI, 27.7%-63.3%]) to 2017-2020: 56.6% [95% CI, 39.2%-73.9%]).

CONCLUSIONS AND RELEVANCE: In the US, diabetes and obesity increased among young adults from 2009 to March 2020, while hypertension did not change and hyperlipidemia declined. There was variation in trends by race and ethnicity.

BACKGROUND: After the Centers for Medicare and Medicaid Services modified reimbursement rates for outpatient peripheral vascular intervention in 2008 with the intent of improving access to care, providers began to increasingly perform peripheral vascular interventions in privately owned office-based clinics. Little is known about the characteristics of patients treated in this setting and their long-term outcomes as compared with those treated in hospital-based centers.

METHODS: In this retrospective cohort study, Medicare beneficiaries ≥66 years undergoing outpatient femoropopliteal peripheral vascular interventions in office-based clinics and hospital-based centers from 2015 to 2017 were identified. Sociodemographics, comorbidities, and institutional characteristics were compared across sites. Multivariable Cox proportional hazards models were used to estimate the adjusted associations between practice site location and outcomes. The primary outcome was the composite of major amputation or death analyzed through the end of follow-up.

RESULTS: Among 134 869 patients, 29.9% were treated in office-based clinics and 70.1% in hospital-based centers. Patients treated in office-based clinics were more often Black (16.9% versus 11.9%), dually enrolled in Medicaid (26.3% versus 19.6%), and residents of lower-resourced regions (32.6% versus 25.6%). Over a median follow-up time of 800 days (interquartile range, 531-1119 days), patients treated in office-based clinics had reduced risks of major amputation or death compared with outpatients treated in hospital-based centers (hazard ratio, 0.92 [95% CI, 0.89-0.95]). They also had lower adjusted all-cause mortality (hazard ratio, 0.93 [95% CI, 0.90-0.96]), major lower extremity amputation (hazard ratio, 0.84 [95% CI, 0.79-0.89]), and all-cause hospitalization (hazard ratio, 0.86 [95% CI, 0.84-0.88]). These findings persisted after stratification by critical limb ischemia, race, dual enrollment, and regional socioeconomic status, as well as among operators treating patients in both clinical settings.

CONCLUSIONS: In this large nationwide analysis of Medicare beneficiaries, office-based clinics treated a more socioeconomically disadvantaged population compared with hospital-based centers. Long-term outcomes were comparable between locations. As such, these clinics appear to be selecting lower-risk patients for outpatient peripheral vascular interventions, although there remains the possibility of unmeasured confounding.

AIMS: Although cardiovascular (CV) mortality increased during the COVID-19 pandemic, little is known about how these patterns varied across key subgroups, including age, sex, and race and ethnicity, as well as by specific cause of CV death.

METHODS AND RESULTS: The Centers for Disease Control WONDER database was used to evaluate trends in age-adjusted CV mortality between 1999 and 2020 among US adults aged 18 and older. Overall, there was a 4.6% excess CV mortality in 2020 compared to 2019, which represents an absolute excess of 62 802 deaths. The relative CV mortality increase between 2019 and 2020 was higher for adults under 55 years of age (11.9% relative increase), vs. adults aged 55-74 (7.9% increase), and adults 75 and older (2.2% increase). Hispanic adults experienced a 9.4% increase in CV mortality (7400 excess deaths) vs. 4.3% for non-Hispanic adults (56 760 excess deaths). Black adults experienced the largest % increase in CV mortality at 10.6% (15 477 excess deaths) vs. 3.5% increase (42 907 excess deaths) for White adults. Among individual causes of CV mortality, there was an increase between 2019 and 2020 of 4.3% for ischaemic heart disease (32 293 excess deaths), 15.9% for hypertensive disease (13 800 excess deaths), 4.9% for cerebrovascular disease (11 218 excess deaths), but a decline of 1.4% for heart failure mortality.

CONCLUSION: The first year of the COVID pandemic in the United States was associated with a reversal in prior trends of improved CV mortality. Increases in CV mortality were most pronounced among Black and Hispanic adults.

OBJECTIVE: To examine the effects of Medicare eligibility and enrollment on the use of high-value and low-value care services.

DATA SOURCES/STUDY SETTING: The 2002-2019 Medical Expenditure Panel Survey.

STUDY DESIGN: We employed a regression discontinuity design, which exploits the discontinuity in eligibility for Medicare at age 65 and compares individuals just before and after age 65. Our primary outcomes included the use of high-value care services (eight services) and low-value care services (seven services). To examine the effects of Medicare eligibility, we conducted a regression discontinuity analysis. To examine the effects of Medicare enrollment, we used the discontinuity in the probability of having Medicare coverage around the age eligibility cutoff and conducted an instrumental variable analysis.

DATA COLLECTION/EXTRACTION METHODS: N/A.

PRINCIPAL FINDINGS: Medicare eligibility and enrollment led to statistically significant increases in the use of only two high-value services: cholesterol measurement [2.1 percentage points (95%: 0.4-3.7) (2.2% relative change) and 2.4 percentage points (95%: 0.4-4.4)] and receipt of the influenza vaccine [3.0 percentage points (95%: 0.3-5.6) (6.0% relative change) and 3.6 percentage points (95%: 0.4-6.8)]. Medicare eligibility and enrollment led to statistically significant increases in the use of two low-value services: antibiotics for acute upper respiratory infections [6.9 percentage points (95% CI: 0.8-13.0) (24.0% relative change) and 8.2 percentage points (95% CI: 0.8-15.5)] and radiographs for back pain [4.6 percentage points (95% CI: 0.1-9.2) (36.8% relative change) and 6.2 percentage points (95% CI: 0.1-12.3)]. However, there was no significant change in the use of other high-value and low-value care services.

CONCLUSION: Medicare eligibility and enrollment at age 65 years led to increases in the use of some high-value and low-value care services, but there were no changes in the use of the majority of other services. Policymakers should consider refining the Medicare program to enhance the value of care delivered.