Introduction
In March 2023, the United States District Court in the Northern District of Texas determined that much of preventive care coverage required under the Affordable Care Act (ACA) was unconstitutional. The ruling means that the preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) since 2010 are no longer required to be covered by insurance without a cost to patients.Footnote 1 Under the ACA, preventive services with strong evidence ratings that are recommended by the USPSTF are required to be fully covered by private insurance plans and state Medicaid expansion programs.Footnote 2 The implications of the case are profound when it comes to the nation’s leading causes of mortality and the significant inequities that continue to shape health outcomes.
In 2021, about one in four deaths in the United States involved cardiovascular disease (CVD) as an underlying cause.Footnote 3 That year, CVD caused 931,578 deaths in the United States.Footnote 4 Specifically, heart disease has been the leading cause of death for about 100 years.Footnote 5 This disease is estimated to touch nearly half of all adults in the country,Footnote 6 and its burden falls unequally across a range of demographic groups.Footnote 7 Among these disparities is a growing gap based on education.Footnote 8
In 2016, the USPSTF issued a recommendation that doctors prescribe statin therapy for all adults between forty to seventy-five years old with at least one risk factor for CVD and a greater than ten percent risk of experiencing a cardiovascular event, such as a heart attack or stroke.Footnote 9 Pursuant to the preventive care provisions of the ACA, this recommendation meant that eligible patients could not be charged for the cost of statins.Footnote 10 Instead, an insurance provider would typically absorb the cost of these medications.Footnote 11
The preventive services provisions of the ACA expanded patient access to important interventions to enable earlier diagnosis and treatment for the leading causes of death in the United States. The district court’s decision in Braidwood Management, Inc. v Becerra alters this basic formulation and, if upheld, would likely trigger significant out-of-pocket costs for access to statins.
I. Cardiovascular Risk and Prevention
Although CVD remains the leading cause of death in the United States, progress against cardiovascular mortality reflects the significant impact of prevention tools in recent decades.Footnote 12 The initial USPSTF recommendation in 2016, and the updated version in 2022, are both grounded in a comprehensive analysis of the impact of statins on mortality and morbidity.Footnote 13 The USPSTF based its statins recommendation on the role of these drugs in reducing cholesterol levels that heighten the risk of cardiovascular events.Footnote 14 Although other interventions, including diet modification and exercise, can also contribute to lowering cholesterol levels for many adults, statins are the leading medical tool for doing so and are the most widely prescribed drug in the United States.Footnote 15
The primary prevention trials for statins, which focused on those who had not experienced a cardiovascular event, demonstrated significant reductions in cholesterol levels and overall cardiovascular risk.Footnote 16 The USPSTF’s review found that for “adults at increased CVD risk but without prior CVD events, statin therapy for primary prevention of CVD was associated with reduced risk of all-cause mortality, and CVD events. Benefits of statin therapy appear to be present across diverse demographic and clinical populations …”Footnote 17 Meta-analysis of existing studies suggests that statins can reduce mortality by nearly thirty percent.Footnote 18
The number of people in the United States taking statins increased from 31 million shortly before the passage of the ACA to 92 million shortly after publication of the USPSTF’s recommendation that led to statins coverage without cost to patients.Footnote 19 There remain significant disparities in the use of statins across demographic groupsFootnote 20 and there are similar disparities in the lifetime cardiovascular risk experienced by adults.Footnote 21
Many factors contribute to these health disparities, including varying insurance coverage and health care access,Footnote 22 physician prescribing practices,Footnote 23 and other social determinants of health. One factor that is especially relevant to Braidwood is the ultimate cost to patients of using statins and the impact of these costs on health outcomes. Most research on the topic finds that introducing patient cost-sharing in the form of copayments (“copays”) generally reduces the utilization of statins.Footnote 24 Requiring copayments for statins presents a significant barrier to medication adherence, even among patients previously hospitalized for coronary heart disease, a form of CVD.Footnote 25 Lower statin adherence is also associated with elevated mortality for patients with CVD.Footnote 26 However, much of the impact of increased copayments on reducing medication adherence and increasing mortality is mitigated by higher levels of education.Footnote 27
The significant impact of introducing copayments for statins was demonstrated in British Columbia, where statin coverage shifted from a zero-copay approach to patient cost-sharing under a major insurance plan.Footnote 28 The introduction of required copayments for statins “significantly reduced” statin adherence.Footnote 29 In fact, the shift in cost to patients “almost doubled the risk of stopping statins.”Footnote 30 Relatedly, a randomized trial in the United States found that eliminating out-of-pocket costs for statins dramatically increased patient adherence in terms of taking the medication regularly and also reduced disparities between different populations.Footnote 31 These findings are consistent with experiments reducing cost-sharing and copayments for other health services, which suggest that the impact is greatest on vulnerable patients and lowering these costs can reduce health disparities.Footnote 32
II. Disparities in Cardiovascular Outcomes
Just as there are wide disparities in the use of statins, so too are there significant differences in the health outcomes for those living with CVD. Heart disease risk is linked to education, income, and race, among other demographic factors. While research has revealed the critical impact of each of these dimensions on health in general, recent studies have highlighted the growing significance of education in shaping mortality.Footnote 33 The mortality divide based on education in the United States has grown dramatically in recent decades, especially with respect to CVD mortality. In 1992, the cardiovascular mortality rate for those without a college degree was twenty-six percent greater than for those with a college degree.Footnote 34 By 2019, this disparity grew nearly four times larger:Footnote 35 those without a college degree experienced almost double the risk of dying from CVD.Footnote 36
Falling mortality from CVD has been one of the key drivers of overall gains in life expectancy in the United States and elsewhere.Footnote 37 In the decade before 2014, CVD deaths in the United States fell by more than twenty-five percent.Footnote 38 The gains against cardiovascular mortality were experienced across all levels of education in the period before 2010.Footnote 39 However, after 2010, significant progress only continued for those with a college degree.Footnote 40
Lower levels of education are associated with a higher lifetime risk of cardiovascular events across adulthood. As compared with those who completed college, the risk of a cardiovascular event was thirty percent greater for individuals with no college degree and fifty-eight percent greater for those who did not complete high school.Footnote 41 Lower educational attainment is linked to a higher risk of coronary artery disease independent of an individual’s level of income.Footnote 42 The heart risk for those without a college education is comparable to those with a prior heart attack and higher levels of education:
Patients without college education and prior history of MI [myocardial infarction] had the highest risk for all-cause mortality during follow-up. Notably, all-cause mortality incidence was similar in patients who were college educated and had a prior MI as those who were not college educated but had no history of MI.Footnote 43
Looking across U.S. states with different levels of compulsory education provides a window into the different levels of cardiovascular risk based on education. Greater education is associated with improvements in major risk factors for CVD.Footnote 44 Higher levels of education in two different national health surveys were associated with lower levels of cardiovascular risk factors, including smoking and improved HDL cholesterol.Footnote 45 The relationship between education and cumulative cardiovascular risk is consistent across years of schooling and demonstrates an “inverse dose-response relationship.”Footnote 46
Lower levels of education are also associated with relatively worse outcomes after a cardiovascular event. Studies have found that this result holds both for short-term outcomes over thirty days and long-term outcomes spanning more than one year for patients that experienced a heart attack.Footnote 47 Although patients with less education have more underlying health challenges on average, they generally receive less medical intervention and are less likely to be referred for higher levels of cardiac care.Footnote 48 While studies suggest that approximately half of the elevated cardiovascular risk experienced by those with less education can be explained by traditional risk factors, these cannot account for the rest of the disparity.Footnote 49
Slowing progress against CVD was a central explanation for the reversals in overall life expectancy in the United States before the COVID-19 pandemic.Footnote 50 The growing gap in cardiovascular mortality between those with college degrees and those with lower levels of educational attainment is one of the most important factors in understanding disparities in overall life expectancy in the United States.Footnote 51
Conclusion
Cardiovascular mortality is higher in the United States than in comparable high-income countries,Footnote 52 and the United States is unique among its peers with respect to the growing divergence in health outcomes between college graduates and those who have not completed college.Footnote 53 A decade ago, scholars recognized that life expectancy gains in the United States were not keeping pace with those of other industrialized nations.Footnote 54 In response, some highlighted the potential for a focus on educational attainment to enhance health outcomes and significantly reduce health disparities.Footnote 55 For those in the United States with a college degree, life expectancy rose until the beginning of the COVID-19 pandemic. The magnitude of life expectancy gains for U.S. college graduates between 1992 and 2019 were second only to the overall gains in the best performing high-income country: Japan.Footnote 56 By contrast, the United States ranked last among twenty-two high-income countries in terms of overall life expectancy for those nearly twenty years before the pandemic.Footnote 57
One key to explaining this growing divergence is that the life expectancy for those in the United States without a college degree peaked in 2010.Footnote 58 Since then, overall life expectancy in the United States remained essentially flat before the pandemic while other high-income nations continued to register significant gains.Footnote 59 In many ways, the recent crisis of life expectancy in the United States is a product of the experience of the two-thirds of Americans without a college degree.
The district court holding in Braidwood, if upheld by reviewing courts, will likely worsen existing disparities in life expectancy in the United States. The preventive coverage at risk involves the diseases that cause the greatest mortality. Heart disease remains the leading killer in the United States — and yet the ruling would impose new cost barriers on the most widely prescribed treatment for preventing cardiovascular mortality. The existing data on the impact of copays on preventive service uptake and mortality rates strongly suggest that such a change would have a disproportionate impact on those with less education.
Effectively reversing these growing mortality disparities in the United States requires a broader range of strategies at the individual and community levels. Recent work found that including such socioeconomic risk factors in clinical decision-making reduced socioeconomic disparities.Footnote 60 Incorporating socioeconomic factors like educational attainment into clinical decision-making might better address the cardiovascular treatment gap, even though it could raise other challenges.Footnote 61
A broader research agenda is needed to better understand and address the causes of growing disparities in heart health and life expectancy in the United States. More insight into the underlying mechanisms that contribute to the growing education gap is crucial to more effectively responding to this challenge. However, existing research already makes clear that reducing access to the current tools against leading causes of mortality — like preventive services at risk in the Braidwood litigation — will only increase the life expectancy gap in the United States.