Impact of Health Care Policy on Quality, Outcomes, and Equity in Cardiovascular Disease


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What is Health Policy?

Health policy is the collection of federal, state, and local statutes and regulations that determine the “rules of the game” in health care. Many of the major issues in health policy are driven by statute, also known as law. For example, in 1965, President Lyndon B. Johnson signed into law the Social Security Act Amendments, commonly referred to as the Medicare bill. This law established both Medicare, a health insurance program for older Americans, and Medicaid, a health insurance program for Americans living in poverty. More recently, U.S. health policy has been shaped by a number of provisions in the Affordable Care Act (ACA), signed into law by President Barack Obama in 2010.

While these laws, often hundreds or even thousands of pages in length, set specific provisions in place, they leave a great deal of detail to regulation. Regulation, in contrast to law, is not passed by Congress, but rather developed and implemented by government agencies. For example, while the ACA established a number of value-based payment (VBP) programs that will be explored in detail later in this chapter, regulatory guidance from the Centers for Medicare and Medicaid Services, commonly known as CMS, determines the annual collection of metrics, scoring systems, and payment modifications that puts them into practice.

The United States has much higher health care costs, but worse health outcomes, including cardiovascular outcomes, than other economically comparable countries. In 2018, the United States accounted for over $3.6 trillion in health care spending. Of this total, 34% was funded by private insurance, 21% by Medicare, 16% by Medicaid, 3% by public health agencies and departments, 10% by individuals in the form of “out-of-pocket” spending, and the remaining 15% by other public sources including the Veterans Health Administration, Indian Health Service, and Department of Defense ( Fig. 6.1 ). In total, this spending comprised 17.7% of the U.S. gross domestic product (GDP) in 2018, or over $11,000 per capita. Despite this spending, the United States has higher age-adjusted per-capita cardiovascular mortality and has seen fewer gains in these metrics over the past few decades than many other countries worldwide. Just as importantly, what successes the United States has had in reducing cardiovascular disease (CVD) incidence and prevalence over time have been uneven—major differences in CVD outcomes exist by race, ethnicity, income, and geography.

FIGURE 6.1, National health care expenditures. Pie chart of United States’ national health care expenditures in 2018 broken down by payer type. Private insurance spending accounted for the largest proportion of expenditures.

U.S. health policy fundamentally shapes how medicine is practiced, how care is delivered, and to some degree, the health outcomes that are achieved. A basic understanding of health policy is crucial for the practicing cardiologist as he or she works to deliver high-quality, cost-efficient care and achieve excellent outcomes for patients. Much of health policy falls into two major “buckets”: coverage and access policy, and payment and delivery system policy, which will be explored in turn in this chapter. This chapter will focus primarily on public insurance (Medicaid and Medicare), because the federal and state governments largely set the norms in health policy, with private insurers often following their lead. The chapter will end with a section on health equity, since health policy also plays a major role, along with other social policies, in large and persistent cardiovascular and overall health disparities across the United States.

Insurance Coverage and Access Policy

The primary goal of health insurance is to offer financial protection against unexpected illness or injury. Prior studies suggest that CVD is commonly associated with financial hardship. For example, almost half of patients admitted for acute myocardial infarction (AMI) report some level of financial stress. Similarly, about 45% of patients with atherosclerotic CVD report financial hardship due to their medical bills, particularly among those who lack insurance or have low income. Insurance coverage is therefore a key policy area in cardiovascular medicine.

However, in the United States, insurance is variable and complex. In 2018, 55% of the population had private health insurance obtained through an employer, known as employer-sponsored insurance. An additional 11% of the population purchased private insurance on the individual market, meaning directly from an insurance company. Eighteen percent of the U.S. population was covered by Medicaid, a state-administered public program for people living in poverty; 18% by Medicare, a federally administered public program for people over the age of 65, with disabilities, or with end-stage renal disease or other special qualifying conditions; and 1% by other public sources. Approximately 9% of the population was uninsured. Note that since people can have more than one source of insurance coverage, these numbers add up to greater than 100%.

The ACA had profound implications for coverage and access policy. Health insurers were prevented from denying coverage based on preexisting conditions and from dropping people’s coverage when they got sick. Annual and lifetime coverage caps were prohibited. Preventative care, vaccinations, and routine medical screening were required to be exempted from co-payments or deductibles. Children were allowed to stay on their parents’ insurance plans until age 26. The profit insurance companies could earn on health insurance premiums was also capped, with insurers being required to spend 80% to 85% of premiums on direct health care costs. The ACA expanded access to health insurance in two ways. First, it created insurance exchanges, which are online marketplaces that individuals and small businesses can use to compare and purchase insurance plans. States had the option to create their own state-based marketplace, but the majority rely on the federally facilitated marketplace on the healthcare.gov website. Individuals making between 100% and 400% of the federal poverty level (the FPL was $12,760 for an individual and $21,720 for a family of three in 2020) and who purchase insurance through these exchanges are eligible for subsidies to lower the cost of their premiums.

The second major way that the ACA expanded coverage was via Medicaid expansion. Medicaid is a state-administered health insurance program focused on providing coverage for individuals living in poverty, and covers 76 million beneficiaries, more than half of all births, and 60% of nursing home care nationwide. Prior to the ACA, all states covered pregnant women and children in households with incomes up to 200% to 300% of FPL, but coverage for other groups varied broadly. In many states, childless adults living in poverty were not eligible for Medicaid coverage at all. The ACA provided funding for states to extend Medicaid coverage to a broader group of eligible individuals, including for parents and childless adults with incomes at or below 138% of the FPL. However, the Supreme Court’s ruling in National Federation of Independent Business v. Sebelius (2012) effectively made Medicaid expansion voluntary, and as of 2020, 12 states have declined to expand ( Fig. 6.2 ).

FIGURE 6.2, Map of states that have and have not expanded Medicaid. A majority of states have implemented Medicaid expansion, with only 12 states declining to expand as of 2020.

States that have elected to expand Medicaid have seen a significant decrease in uninsurance rates, particularly among low-income populations, and a reduction in disparities in insurance coverage across major racial/ethnic categories. From 2012 to 2016, the proportion of AMI admissions that were for individuals lacking insurance decreased from 18% to 8% in Medicaid expansion states, whereas it only decreased from 26% to 21% in nonexpansion states.

A growing body of evidence demonstrates that health insurance coverage, and Medicaid expansion in particular, has positive effects that extend beyond financial security to improve health and well-being. Medicaid expansion has led to greater access to primary, preventative, and specialist care for low-income individuals. , Expansion states saw improvements in the identification and treatment of cardiovascular risk factors, such as diabetes, hypertension, and dyslipidemia. Additionally, use and adherence of prescription cardiovascular medications have increased. , Medicaid expansion is also associated with better access to behavioral health services, a reduction in cigarette purchases, and an increase in smoking cessation attempts.

The increase in detection and treatment of chronic disease, behavioral health conditions, and addiction associated with Medicaid expansion has had an impact on health outcomes. , , Expansion is associated with fewer preventable hospitalizations, although evidence on its effects on emergency department use has been mixed. One study showed that even accounting for demographic, clinical, and economic differences, counties in expansion states had 4.3 fewer deaths from cardiovascular causes per 100,000 residents per year after Medicaid expansion than if they had followed the same trends as counties in nonexpansion states (roughly a 2.5% difference). Studies of early Medicaid expansions suggest that gains have particularly benefited racial and ethnic minorities, with all-cause mortality reductions greatest for nonwhites (41.0% relative reduction) and residents in poorer counties (22.2% relative reduction).

Payment and Delivery System Policy to Improve Quality and Reduce Costs

Another key area of health policy refers to the group of policies that together dictate how care is reimbursed, as well as the quality metrics on which it will be measured and rewarded. Until the early 2000s, the vast majority of cardiovascular care was covered under “fee-for-service” arrangements. For the most part, such arrangements did not include any payment adjustments for quality or outcomes. A fixed payment was simply rendered for services provided, irrespective of the quality of care that was delivered.

However, consensus grew that cardiovascular care delivery was suboptimal. While clinical trials had made it clear which medications and procedures should be used in which situations, and guidelines began to codify those findings into statements aimed at facilitating optimal care delivery, the reality of clinical practice did not always match the guidelines. The Institute of Medicine, now known as the National Academy of Medicine, released Crossing the Quality Chasm in 2001, calling attention to the wide gap between scientific knowledge and the implementation of high-quality care. A subsequent study published in 2004 demonstrated that appropriate quality of care was only being delivered 54.9% of the time, including in the acute, chronic, and preventive care domains. Performance varied across cardiovascular conditions, from 68.0% guideline-concordant care for coronary artery disease, to 64.7% for hypertension, 63.9% for congestive heart failure (HF), 59.1% for cerebrovascular disease, 48.6% for hyperlipidemia, 45.4% for diabetes, and 24.7% for atrial fibrillation. A number of follow-up studies across care settings (e.g., inpatient, outpatient) and specialties (e.g., cardiovascular specialists, primary care clinicians) broadly documented suboptimal adherence to quality indicators.

As a result, several different types of health policy reform initiatives were introduced to address quality issues in cardiovascular care, many in the ACA. The majority of the changes to Medicare under the ACA were focused on moving the program away from simply paying for the volume of services rendered, and toward paying more explicitly for the quality and costs, collectively the “value,” of care delivered. The sections below will outline some of these key changes and review the strength of evidence for their efficacy. Additionally, just like any evaluation of a new drug or treatment strategy in cardiovascular medicine, these policies needed to be evaluated not only in terms of their efficacy, but also in terms of their impact on patient safety. For policies, adverse “safety” events typically take the form of unintended adverse consequences, like reducing access to care, unduly penalizing clinicians for serving high-risk patients, or worsening clinical outcomes.

Public Reporting

The earliest move toward value was public reporting. In 2004, a consortium of payers and quality organizations, led by Medicare, created Hospital Compare as the first national public reporting program ( Table 6.1 ). While participation was voluntary, hospitals that did not participate experienced a payment reduction, so nearly all hospitals joined the program within a few months of its inception. Program developers hoped that publicly posting hospitals’ performance online would encourage health systems and clinicians to improve their performance through peer pressure, and allow patients the opportunity to select where to receive care based on performance. Initially, Hospital Compare only included processes of care, such as giving aspirin to patients with AMI. It later expanded to include clinical outcomes such as mortality and readmission rates for AMI and HF, added in 2008 and 2011, respectively.

TABLE 6.1
Payment and Delivery System Policy Overview for Cardiovascular Conditions
Policy Year Implemented Overview
Public Reporting
Hospital Compare 2004 Public reporting of clinical outcomes and processes
Value-Based Purchasing Programs
Hospital Readmissions Reduction Program 2012 Hospitals are penalized up to 3% of their Medicare reimbursements for HF, AMI, pneumonia, COPD, joint replacement, and CABG
Hospital Value-Based Purchasing 2012 Hospitals receive bonuses or penalties based on their performance on a set of quality metrics in four core domains: safety, clinical care, efficiency and cost reduction, and patient/caregiver-centered experience
Physician Quality Reporting System 2006, 2011 Initially a public reporting program, but it transitioned into a penalty program in 2011, where physicians and group practices faced negative payment adjustments for failing to report performance data
Physician Value-Based Modifier 2015 Physicians are assigned bonuses and penalties based on performance on quality, outcome, and cost measures
Quality Payment Program 2015 Physicians must choose one of two tracks:
Merit-Based Incentive Program, which consists of four domains: clinical quality measures, measures of electronic medical record use, measures of costs of care, and measures of practice improvement activities
Alternative payment models, including accountable care organizations and bundled payment models
Alternative Payment Models
Medicare Shared Savings Program 2012 Participants are paid on a fee-for-service basis, but are held accountable for their beneficiaries’ quality and costs each year.
Bundled Payments for Care Improvement (and BPCI-Advanced) 2011, 2018 Quality and costs are evaluated over the course of an “episode,” triggered by a hospitalization and typically 30, 60, or 90 days in length. If Medicare payments for an episode of care are less than the target, then the participant is eligible to keep a portion of the savings; however, if payments exceed the target, the participant must reimburse Medicare some of the difference.
AMI , Acute myocardial infarction; COPD , chronic obstructive pulmonary disease; CABG , coronary artery bypass grafting; HF , heart failure.

Beyond these national efforts, some states implemented their own public reporting, typically focused more narrowly on mortality following cardiac procedures. In the 1990s, New York State began publicly reporting hospitals’ outcomes for coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), as well as for individual surgeons and interventional cardiologists. Other states including Massachusetts, Pennsylvania, New Jersey, California, and Washington subsequently implemented public reporting programs as well, though some only temporarily.

Evaluations of the efficacy of public reporting programs have been underwhelming. Patients have been unlikely to utilize publicly reported information, with many preferring to rely on advice from friends or family. Public reporting on Hospital Compare—either of processes or of outcomes—was not associated with improvements in mortality rates above and beyond secular trends. Public reporting for PCI has similarly failed to show a consistent association with improvements in clinical outcomes. While studies have demonstrated lower mortality among patients undergoing PCI in reporting versus nonreporting states, overall outcomes for AMI have been, if anything, worse in reporting states, suggesting that selection bias has driven the apparent improvements in procedural mortality.

Public reporting for hospital processes and outcomes has not been associated with unintended consequences, but public reporting for PCI has been associated with a negative safety signal. Use of coronary angiograms and PCI for AMI are lower in reporting states compared to nonreporting states, and these differences are highest among critically ill patients, such as those in cardiogenic shock, who may benefit most from the procedure. This is likely due to risk aversion; the majority of surveyed interventional cardiologists admit to avoiding high risk but indicated PCIs due to concern that a bad outcome might negatively impact their publicly reported performance outcomes. Data for CABG have been more mixed but have raised concerns about reductions in access to care for racial and ethnic minorities and clinically high-risk individuals.

Concern that public reporting may lead to risk-aversive behavior and impede access to care, particularly for critically ill patients with cardiogenic shock, has prompted some states (New York, Massachusetts) to begin excluding these patients from their public reports. These policy changes have been associated with a substantial increase in the use of PCI for patients with cardiogenic shock and a reduction in associated in-hospital mortality, although PCI rates in this population still remain lower in reporting states compared with nonreporting states.

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