Author + information
- Received November 7, 2018
- Revision received November 27, 2018
- Accepted December 2, 2018
- Published online February 11, 2019.
- Javier Valero-Elizondo, MD, MPHa@jvaleromd,
- Rohan Khera, MDb@rohan_khera,
- Anshul Saxena, PhDc@anshulsaxena,
- Gowtham R. Grandhi, MD, MPHa@gowthyharsha,
- Salim S. Virani, MD, PhDd,e@virani_md,
- Javed Butler, MD, MPH, MBAf@JavedButler1,
- Zainab Samad, MD, MHSg@ZainabASamad,
- Nihar R. Desai, MD, MPHa,h@nihardesai927,
- Harlan M. Krumholz, MD, SMa,h,i@hmkyale and
- Khurram Nasir, MD, MPH, MSca,h,i,∗ (, )@khurramn1
- aCenter for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut
- bDivision of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas
- cCenter for Healthcare Advancement and Outcomes, Baptist Health South Florida, Miami, Florida
- dMichael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
- eBaylor College of Medicine, Houston, Texas
- fDepartment of Medicine, University of Mississippi, Jackson, Mississippi
- gDivision of Cardiology, Department of Medicine, Duke University, Durham, North Carolina
- hSection of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut
- iDepartment of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut
- ↵∗Address for correspondence:
Dr. Khurram Nasir, Section of Cardiovascular Medicine, Yale School of Medicine & Center for Outcomes Research and Evaluation, Yale New Haven Health System, 1 Church Street, Suite 200, New Haven, Connecticut 06510.
According to the American Heart Association, atherosclerotic cardiovascular disease (ASCVD) is not only the leading cause of mortality and morbidity in the United States, but it is also responsible for the highest health care costs for a single class of disease (1). The medical care that accompanies ASCVD often carries large per-capita medical expenditures (1), with an average annual out-of-pocket (OOP) spending of over $2,000, with almost one-half of direct expenditures being related to medication expenses (2). Even among those with health insurance, many people with ASCVD are inadequately protected from financial hardship due to the high costs of insurance, including deductible, copays, and coinsurances.
Despite widespread public concern, we lack national estimates on the burden of financial hardship from medical bills, as well as economic and insurance factors disparities, among patients with ASCVD. Furthermore, an appraisal of tradeoffs that people face as a result of financial hardship from medical bills, such as foregoing essential needs (e.g., food security), and certain critical aspects of medical care (e.g., cost-related medication nonadherence), may inform policy efforts to mitigate these risks.
To address this knowledge gap, we assessed the national burden of financial hardship from medical bills among individuals with ASCVD, as well as its relationship with potential consequences, including financial distress, food insecurity, and cost-related medication nonadherence, in a representative sample of nonelderly U.S. adults with ASCVD.
We used 5 years of data (2013 through 2017) from the National Health Interview Survey (NHIS). The NHIS, compiled by the National Center for Health Statistics/Center for Disease Control & Prevention, is constructed from annual, cross-sectional national surveys that incorporate complex, multistage sampling to provide estimates on the noninstitutionalized, U.S. population (3). Because NHIS data are publicly available as deidentified data, this study was exempt from the purview of the institutional review board committee.
We used a self-reported diagnosis of coronary or cerebrovascular disease to identify those with ASCVD. Specifically, individuals were included if they responded positively to ever having been told by a doctor that they had any of the following: coronary heart disease, angina, a heart attack (myocardial infarction), and/or stroke. We limited our study to focus on nonelderly (18 to 64 years of age) adults with ASCVD to capture the population without universal financial protections from public insurance.
Financial hardship from medical bills
Individuals were defined as having any financial hardship from medical bills (yes/no) if they (or anyone in their family) reported having problems paying medical bills in the past 12 months and/or currently having medical bills being paid off over time. Those reporting problems paying medical bills were additionally asked if they currently had any medical bills they were unable to pay at all.
To further study the graded responses from financial hardship from medical bills, we divided our study population into 3 mutually exclusive categories: no financial hardship from medical bills, financial hardship from medical bills but able to pay, and unable to pay bills at all.
High financial distress, food insecurity, and cost-related medication nonadherence
Financial distress was derived from 6 questions regarding the level of worry concerning several financial matters, including: having enough for retirement, ability to pay medical costs of serious illness or accident, maintaining standard of living, ability to pay costs of usual health care, inability to pay normal monthly bills, and inability to pay rent/mortgage/housing costs. All questions were answered on a 4-point scale, ranging from “not worried at all” to “very worried.” An aggregate score was created, with a higher score associated with greater stress. Participants within the highest quartile (i.e., those with the highest scores) were considered as having high financial distress.
Food security in the last 30 days was created based on the 10-item questionnaire as recommended by the U.S. Department of Agriculture Economic Research Service. A raw score ranging from 0 to 10 was calculated, with the following categories: food secure (score 0 to 2), low food security (score 3 to 5), and very low food security (score 6 to 10). For this study’s purposes, food insecurity included those who had either low or very low food security.
Cost-related medication nonadherence was found in individuals who reported any of the following behaviors in order to save money in the last 12 months: skipping medication doses, taking less medicine, or delaying filling a prescription.
Other covariates included in this study included sex, race/ethnicity, family income (based on family income as a percentage of the federal poverty limit from the Census Bureau: high-income [≥400%], middle-income [200% to 400%], low-income [<200%]), education, insurance status, and geographical region. Cardiovascular risk factor (CRF) profile was calculated based on the presence of individual, self-reported CRFs. Individuals were categorized as poor (≥4 CRFs), average (2 to 3 CRFs), and optimal (0 to 1 CRF). Self-reported chronic comorbidities were aggregated, and categorized as having 0, 1, or ≥2 comorbidities.
The survey-specific Rao-Scott chi-square test was used to assess differences in categorical variables, with survey-weighted proportions used to study prevalence in our study population. Unadjusted and adjusted survey-specific logistic regression models were used as measures of association between measures of financial hardship from medical bills and explanatory variables, such as family income or type of insurance. Additionally, we assessed the association between measures of financial hardship from medical bills and their potential consequences: financial distress, food insecurity, and cost-related medication nonadherence. Variance estimation for the entire pooled cohort was obtained from the Integrated Public Use Microdata Series. For all statistical analyses, p < 0.05 was considered statistically significant. All analyses were carried out using Stata, version 15.1 (StataCorp, College Station, Texas), and took into account the complex survey design of the NHIS to achieve nationally representative results.
From 2013 to 2017, the NHIS total sample was 164,696 surveyed individuals, of which 123,706 were 18 to 64 years of age, and 6,160 reported having ASCVD. Overall, 2,741 (representing 3.9 million) nonelderly adults with ASCVD (45.1%; 95% confidence interval [CI]: 43.4% to 47.7%) were part of families that reported having any financial hardship from medical bills. Moreover, 1,229 (representing 1.64 million) nonelderly adults with ASCVD (18.9%; 95% CI: 17.6% to 20.2%) reported being unable to pay medical bills at all (Table 1). In stratified analysis, the highest burden of any financial hardship from medical bills and an inability to pay bills was reported among uninsured and low-income individuals. In multivariate analysis, low-income individuals with ASCVD, compared with higher-income individuals, had 1.34 (95% CI: 1.12 to 1.59) and 2.24 (95% CI: 1.79 to 2.80) higher odds of being in families facing any financial hardship from medical bills and an inability to pay medical bills, respectively. Similarly, uninsured individuals with ASCVD, compared with those who were insured, had 1.86 (95% CI: 1.46 to 2.36) and 3.27 (95% CI: 2.49 to 4.30) higher odds of being in families facing any financial hardship from medical bills and with an inability to pay medical bills at all, respectively.
Among individuals with ASCVD, a graded increase in prevalence of high financial distress, food insecurity, and cost-related medication nonadherence was reported across financial hardship categories (Central Illustration panel A). After adjusting for established confounders, including family income and insurance, individuals with ASCVD who reported an inability to pay medical bills had higher odds of high financial distress (odds ratio [OR]: 3.60; 95% CI: 2.68 to 4.82), food insecurity (OR: 2.89; 95% CI: 2.14 to 3.90), and cost-related medication nonadherence (OR: 3.39; 95% CI: 2.44 to 4.71) when compared with those without financial hardship from medical bills. As shown in Central Illustration panel B, the prevalence of the combination of all 3 consequences was significantly higher among those with an inability to pay bills at all when compared with those without any financial hardship from medical bills (19% vs. 2%; p < 0.0001).
The costs of managing ASCVD are substantial (1) and constitute a major source of concern at a personal level, especially for low-income families and uninsured, who generally may not have enough financial reserves with which to offset the burden of unexpected health care expenditures (4). Our study highlights that a substantial proportion of nonelderly ASCVD patients and their families in the United States struggle with medical bills. In NHIS, a contemporary, nationally representative dataset, we found that 45% of patients with ASCVD who are younger than 65 years of age, or an estimated 3.9 million individuals nationally, reported financial hardship from medical bills, including problems affording medical care expenses within the past year, or being burdened by medical debt. Notably, 1 in 5 patients with ASCVD, or 1.9 million nationally, are in families reporting receiving medical bills they cannot afford to pay. Moreover, at least one-third of patients with ASCVD in families constrained by financial hardship from medical bills are at significant risk for consequences that can prevent them to receive adequate medical care, such as self-perceived financial distress, food insecurity, and cost-related medication nonadherence.
Our study underscores the fact that although insurance coverage is critical to protect against risk of financial burden from unexpected medical bills, current insurance structure falls short in protecting from financial hardship. The vast majority of individuals with ASVCD reporting problems paying bills and paying them over time are insured. In our national sample of nonelderly adults with ASCVD, 1 in 5 (19%), most of them insured, reported inability to pay medical bills, suggesting inadequate protection (underinsurance) against substantial financial impact of OOP health expenses. With many families in the United States reporting limited savings/assets to cover these unexpected expenses, the current trends toward diversion of a greater proportion of cost sharing by payers will likely further exacerbate risk of financial hardships induced by medical care, especially among low-income ASCVD patients and their families.
Our study also adds to the existing published reports by highlighting potential tradeoffs associated with financial hardship from medical bills. Nearly 1 in 3 ASCVD patients with financial hardship from medical bills reported either significant financial distress, cutting back on basic amenities such as food, and avoiding much needed medications. In fact, 1 in 5 of those unable to pay medical bills at all reported all 3 consequences. Of particular concern is the association of financial hardship from medical bills with medication nonadherence (dose delays, cessation, and/or modifications) as a maladaptive coping strategy (5). Although this phenomenon has previously been reported among low-income families (6) and older minorities (7), our study suggests that the presence of financial hardship from medical bills irrespective of income and insurance status is a key determinant of cost-related medication nonadherence among patients with ASCVD. Future interventions aimed at improving medication adherence may look to focus on cost-related barriers and limiting financial toxicity from regular medical care.
The findings of our study should be interpreted in light of several limitations and considerations. First, the construct used to define financial hardship from medical bills in this study is based upon available data in the survey; other items or ways to frame questions could have further strengthen reliability. However, the items used to create these domains have been widely used in prior studies and shown to correlate well with objective measures of financial burden from OOP costs for medical expenditures (8). Second, the question used in NHIS assessed not only about an individual but whether anyone in the household had financial hardship from medical bills and precludes direct assessment of the proportion of medical bills related to ASCVD. However, Khera et al. (2) in a recent study detailed that health care spending on family members with ASCVD represented a mean of 70% of the overall family-level OOP health spending, with the respective proportion being slightly higher for low-income families. Third, we were unable to ascertain the proportion of financial burden from a catastrophic event or long-term bills due to routine management. A recent survey suggested that nearly two-thirds of individuals with financial burden from medical bills reported it due to one-time or short-term medical expenses (9). Finally, the cross-sectional nature of data in our study prevents us from establishing causality; for example, food insecurity may contribute to problems paying off medical bills; however, prior studies have suggested that food security is unlikely to have an impact on a higher overall or OOP medical expenditures (10).
The current health care system fails to protect a significant proportion of nonelderly ASCVD patients from financial hardship and its dire consequences.
The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Dr. Krumholz has received research agreements from Medtronic and Johnson & Johnson (Janssen), through Yale, to develop methods of clinical trial data sharing; a grant from Medtronic and the Food and Drug Administration, through Yale, to develop methods for postmarket surveillance of medical devices; and work under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures that are publicly reported; chairs a cardiac scientific advisory board for United Health; is a participant/participant representative of the IBM Watson Health Life Sciences Board; is a member of the advisory board for Element Science; is on the physician advisory board for Aetna; and is the founder of Hugo, a personal health information platform. Dr. Desai is supported by grant K12 HS023000-01 from the Agency for Healthcare Research and Quality; has received research funding from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and support from Johnson & Johnson and Medtronic, through Yale University, to develop methods of clinical trial data sharing. Dr. Butler has received research support from the National Institutes of Health, Patient Centered Outcomes Research Institute, and the European Union; and has served as a consultant for Adrenomed, Amgen, Array, AstraZeneca, Bayer, Berlin Cures, Boehringer Ingelheim, Bristol-Myers Squibb, CVRx, G3 Pharmaceutical, Innolife, Janssen, Lantheus, Luitpold, Medtronic, Merck, Novartis, Relypsa, Roche, Sanofi, StealthPeptide, SC Pharma, Vifor, and ZS Pharma. Dr. Khera is supported by the National Heart, Lung, and Blood Institute (grant 5T32HL125247-02) and the National Center for Advancing Translational Sciences (grant UL1TR001105) of the National Institutes of Health. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- atherosclerotic cardiovascular disease
- body mass index
- cardiovascular risk factor
- National Health Interview Survey
- Received November 7, 2018.
- Revision received November 27, 2018.
- Accepted December 2, 2018.
- 2019 American College of Cardiology Foundation
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